F. HOFFMANN-LA ROCHE LTD, SWITZERLAND AND ANOTHER vs. CIPLA LTD., MUMBAI CENTRAL, MUMBAI

* HIGH COURT OF DELHI: NEW DELHI

% Judgment reserved on: 01.06.2012
Judgment pronounced on: 07.09.2012

+ CS (OS) No.89/2008 and C.C. 52/2008

1. F. Hoffmann-La Roche Ltd,
Switzerland.
2. OSI Pharmaceuticals, Inc.,
New York. ..... Plaintiffs
Through Dr.C.S.Vaidyanathan, Sr.Advocate with
Mr.Pravin Anand, Ms.Archana Shanker,
Mr.Shrawan Chopra, Mr.Mahabir N.,
Ms.Lakshmi Kruttika Vijay, Ms.Prachi
Agarwal, Advocates

versus

Cipla Ltd., Mumbai Central, Mumbai ..... Defendant
Through Mr.Harish Salve, Sr.Advocate with
Ms.Pratibha M.Singh, Ms.Bitika Sharma,
Ms.Ujjwala Jeremiah and
Ms.Anusuya Mehrotra, Advocates

CORAM:
HON'BLE MR. JUSTICE MANMOHAN SINGH

MANMOHAN SINGH, J.
1. Two plaintiffs, namely, F. Hoffmann-La Roche Ltd. and OSI
Pharmaceuticals Inc., have filed the suit for permanent injunction restraining
infringement of patent, rendition of accounts, damages and delivery up
through their duly constituted attorney, namely, Mr.Shivprasad Laud,
against Cipla Ltd. Mumbai, having its office also at Delhi.
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2. The plaintiff No.1 Company claims that it is one of the world‘s
leading research-focused healthcare groups in the fields of pharmaceuticals
and diagnostics. It is stated in the plaint that for the purpose of research and
development, the said plaintiff engages inter alia into collaborative
agreements and alliances with numerous partners and invests approximately
7 billion Swiss Francs in such activities.
3. It is averred in the plaint that the plaintiff No.2 jointly owns a patent
with Pfizer Products Inc. in respect of a small drug molecule medically
termed as a ―Human Epidermal Growth Factor Type-I/Epidermal Growth
Factor Receptor‖ (HER/EGFR) inhibitor which is popularly known as
‗Erlotinib‘ (pronounced as err-lot-i-nib). This drug marked a major
breakthrough and innovation in the treatment of cancer and is used to
destroy some types of cancer cells while causing little harm to the normal
human cells. Various tests conducted on this drug have shown a marked
increased in the survival benefit in the patients suffering from advanced or
metastatic non small cell lung cancer, the metastatic NSLC is most prevalent
form of NSLC being the most prevalent form of this cancer.
4. This drug is administered in the form of a tablet. The tablet
formulation of Erlotinib is sold by the plaintiffs under the trademark and
name of ―Tarceva‖, which is registered in the name of plaintiff No.1. The
drug Erlotinib and its formulation ―Tarceva‖ has been approved by the U.S.
Food & Drug Administration in the year 2004 and thereafter by the
European Union in the year 2005.
5. A specific statement has been made in para-7 of the plaint that
plaintiff No.2 along with M/s Pfizer Products Inc. had applied for grant of
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patent in respect of drug Erlotinib and its process vide application
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No.537/DEL/1996 on 13 March, 1996. The Controller General of Patents,
Trademarks and Designs, New Delhi, granted a certificate bearing Patent
rd
No.196774 (hereinafter referred as IN‘774 or suit patent) dated 23
th
February, 2007 which has been recorded in the Register of Patents on 6
July, 2007. The molecular name of patent is ‗A NOVEL [6, 7-BIS(2-
METHOXYETHOXY) QUINAZOLIN-4-YL]- (3-ETHYNYLPHENYL)
AMINE HYDROCHLORIDE‘. It is averred that the drug as well as the
process of its manufacture is patented as per the provisions of the Patent Act,
1970 and entitled to their protection as such. The plaintiffs‘ product
Erlotinib Hydrochloride Tablets (Tarceva), which was registered by the
Central Drug Standard Control Organization, Directorate General of Health
rd
Services, Government of India vide Registration Certificate dated 23
December, 2005 is issued in the name of plaintiff No.1. It is also stated in
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the said paragraph that on 8 January, 2001, the plaintiff No.2 and the
plaintiff No.1 had entered into a Development Collaboration and Licensing
Agreement (the Licence Agreement) wherein the plaintiff No.1 has a licence
to use, sell and offer for sale the licensed products including the drug
Erlotinib, which is the subject matter of the present suit. The plaintiff No.1
is further licensed and authorized to cause enforcement of any intellectual
property rights for any of their products.
6. Under these circumstances, it is averred by the plaintiffs that the
plaintiff No.1 is actively engaged in manufacture, marketing and sale of the
innovative drug Tarceva (Erlotinib) in various countries including India.
The plaintiff No.1 introduced Tarceva in India sometime in April 2006. The
announcement regarding the launch of Tarceva by Roche Scientific
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Company (India) Pvt. Ltd., a wholly owned subsidiary of the Roche Group
in India, was given wide publicity by the media inter alia in view of its
importance in the cancer treatment.
7. The case of the plaintiffs against the defendant is that the defendant is
also engaged in manufacture and marketing of pharmaceutical and health
care products in India and the plaintiffs had learnt that the defendant is
involved in several actions for violation of intellectual property rights
including patent rights as the plaintiffs noticed from various news reports
appearing in the print as well as electronic media about the plans of the
defendant to launch a generic version of the drug Tarceva (Erlotinib) in
India and also for exporting the same to various countries. One of such
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reports appeared on 11 January, 2008 in an English daily ―Mint‖ published
by the Hindustan Times Group and from the aforesaid report, for the first
time the plaintiffs came to know about the plans of defendant to infringe and
violate legal rights of the plaintiffs with regard to patent.
8. The claim of the plaintiffs is that provision of Section 48 of the Patent
Act, 1970 provides for exclusive right of the patentee of a product or a
process to prevent any third parties from non-consensual usage of the
product or the process. Section 68 provides that an assignment inter alia by
way of a licence of a patent has to be compulsorily by way of an instrument
in writing embodying all the terms and conditions governing their rights and
obligations. In the present case, it is stated that the licence agreement which
is executed between the plaintiff No.1 and plaintiff No.2 contains all the
terms and conditions for grant of licence to the plaintiff No.1 by plaintiff
No.2.
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9. It is submitted that as the plaintiff No.2 and Pfizer Products Inc. are
the registered owner of the patent in question and the drug Tarceva
(Erlotinib) has been developed after a long and substantial research. The
said invention is liable to be protected and no person other than the
authorized person can be allowed to copy the same. The defendant in the
present case with the unlawful manner is infringing the legal rights of the
plaintiffs. Therefore, the plaintiffs had no other option but to initiate the
appropriate remedy against the defendant for permanent restraining from
manufacturing, selling, offering for sale, marketing, distributing in any
manner the drug Tarceva (Erlotinib) or any other generic version of the said
drug. The prayer is also sought by the plaintiffs to direct the defendant to
render all accounts in relation to such infringing activities as well as to give
damages to the plaintiffs from the defendant inter alia for violation of their
legal rights.
th
10. The suit was filed by the plaintiffs on 15 January, 2008. Along with
the suit the plaintiffs also filed an application under Order XXXIX, Rule 1 &
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2 CPC. First time when the matter was listed on 16 January, 2008 notice
was issued in the interim application. The statement was made by the
defendant in Court that the defendant has been marketing the disputed drug
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for the past three weeks. The matter was adjourned to 18 January, 2008.
The arguments in the interim application were heard for some time and the
nd
same was adjourned to 22 January, 2008. The defendant filed its written
st
statement as well as counter claim and documents on 21 January, 2008.
Further arguments were addressed in the interim application i.e. I.A.
No.642/2008. During the course of the hearing of the arguments, the
defendant filed an application, being I.A. No.1272/2008 seeking to bring on
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record facts about US application US6900221 of Polymorph B. It is stated
in the application that the applicant/ defendant had recently discovered that
the suit patent is a mixture of Polymorph A and B and Tarceva is Polymorph
B version of the compound namely Erlotinib Hydrochloride. Time was
sought by the plaintiffs to file the reply.
11. In the written statement, the following defences are raised by the
defendant:
a) The plaintiffs have not filed the copy of the specification.

b) The patent of the plaintiffs has been granted under suspicious
circumstances,
c) No documents which vest any right in plaintiff No.1 of ownership or
right to sue have been placed on record,
d) The patent in question is liable to be revoked, It only sought to
improve from the existing prior art as Quinazoline compounds are
known to inhibit growth have been used as anti cancer treatment and
are available in the market for treatment of various cancers, Thus, it
is a derivative of a known compound and hence not patentable under
Section 3(d) of the Indian Patent Act.
e) The plaintiffs in a subsequent patent filed in the United States Patent
Office have admitted the short comings in the patent in issue. The
details of the same are mentioned in the counter claim filed by the
defendant.
f) The plaintiff has engaged in Bio-isosterism process which makes the
said patent obvious. One of the well-known text books in an article
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entitled ―Isosterism and Molecular Modification‖ in Drug Design by
C W Thornber, published in 1979 discusses about the isosterism.
g) There is no inventive step in the patent.
h) The alleged patented product is nothing but a derivative from Gefitnib
of AstraZeneca for which a patent was refused in India on the ground
that the said product was already in prior use and was in the public
domain. Under such circumstances, the patent office ought not to
have granted a patent for the product Erlotinib.

i) The manner in which the plaintiff is seeking to protect Erlotinib which
is nothing but a derivative of Gefitinib establishes that the plaintiff is
indulging in ever-greening.
j) In the area of life-saving drugs, it is thus in the public interest of the
general public and patients suffering from diseases like cancer, no
injunction can be granted.
k) The plaintiffs‘ capsule costs ` 4,800/- per tablet and equivalent tablet
of defendant costs 1,600/-.
`
l) No documents have been placed on record to establish the plaintiff
No.1‘s right to sue. The alleged patent was in the name of Pfizer Inc.
No documents to support as to the manner in which the rights were
transferred have been placed on record.
m) No statistical comparisons have been produced.
n) The plaintiffs have failed to place on record the collaboration or
licencing agreement. In order to file a suit for infringement, the title
of the plaint has to be clearly established which the plaintiff No.1 has
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failed to do so. As far as the plaintiff No.2 is concerned, no documents
have been placed on record to show as to how the original patent
which has been filed in the name of Pfizer Inc. only and is now
claiming to be jointly owned by plaintiff No.2.
o) The defendant has been granted approval from the Government of
Goa from manufacturing the said tablet in various pack seizes of 30,
60, 100, 500, 1000 tablets. The defendant has made sale of the
produce since December, 2007. In the written statement the defendant
also denied all the averments made in the plaint.
12. The defendant has also filed the counter claim, being C.C.
No.52/2008, on various grounds under Section 64 of the Patent Act.
th
13. The written statement to the counter claim was filed on 18 August,
th
2008 and on 27 September, 2008 replication to the written statement of the
defendant was filed by the plaintiff.
14. The order was reserved in I.A. No.642/2008 under Order XXXIX,
Rule 1 & 2 CPC. The injunction application of the plaintiffs was dismissed
th
vide order dated 19 March, 2008. The operative para-87 of the order reads
as under:
―87. The result of the above discussion is that the plaintiff
is not entitled to claim an ad-interim injunction, in the terms
sought. However, this Court is not unmindful of the fact
that if no equitable balancing order protecting its interest is
made at this stage, there is a likelihood of the plaintiff being
prejudiced at the final stage. Therefore, the defendant is
hereby directed to:
i) Furnish an undertaking to this Court, within two weeks,
to pay damages in the event of the suit being decreed. A
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director or other person, on behalf of the Defendant duly
authorized by a specific resolution of its Board of Directors,
shall execute the undertaking. The undertaking shall also
include a stipulation that it would continue to bind the
Defendant, regardless of its change in composition.
ii) Towards effectuating direction (i) above, maintain
faithful accounts of its sale of the product Erlocip and file
quarterly accounts in. This Court, supported by the affidavit
of one of its Directors, affirming about the veracity of the
same;
iii) File an annual statement of the sales figures, of Erlocip,
duly authenticated by its chartered accountants, on the basis
of its records, including the Sales tax and Excise returns.‖

15. The plaintiffs filed an appeal before the Division Bench against the
dismissal of their interim application, being FAO (OS) No.188/2008. By an
th
order dated 24 April 2009, the said appeal was also dismissed.
16. The plaintiffs also challenged the said order of the Division Bench
before the Supreme Court in Special Leave to Appeal (Civil)
No.20111/2009. The said Special Leave Petition was dismissed by order
th
dated 28 September, 2009 with the following direction:
―Heard learned counsel for the parties.
This Special Leave Petition is directed against the interim
order. The Civil Suit is pending before the original side of
the Delhi High Court, therefore, we are not inclined to
interfere with the impugned judgment. The Special Leave
Petition is accordingly, dismissed.
However, in the facts and circumstances of the case, we
request the learned Single Judge dealing with the Civil Suit
to conclude the trial as expeditiously as possible without
being influenced by any observation made by the Division
Bench in the judgment.‖
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th
17. When the matter was listed before this Court on 18 September, 2008,
the following issues were framed in respect of the suit and the counter claim:
―1. Whether the manufacture, marketing and sale of
ERLOCIP by defendant is infringing the plaintiffs‘ Indian
Patent 196774? OPP
2. Whether the Indian Patent 196774 is liable to be revoked
on the grounds raised in written statement and counter-
claim of the defendant? OPD
3. Whether the plaintiffs are entitled to permanent
injunction as prayed for? OPP
4. Whether defendant/counter-claimant proves that the
plaintiff‘s subsequent US Patent 6900221, is to the effect
that the compound of claim No.1 of the suit patent is a
mixture of two Polymorph A and B Compound and need to
be separated to perform and get the claimed compound for
acceptable efficacy; and its effect on the plaintiff‘s patent?
OPD/CC.
5. Relief.‖
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18. In the order dated 19 March, 2008, it was directed by the Court that
the parties shall complete their pleadings. The plaintiffs were given four
weeks time to file the replication to the written statement in the suit and
written statement to the counter claim. The defendant was given two weeks
time thereafter to complete its pleadings.
19. In the plaintiffs‘ application, being I.A. No.12872/2008, the Court
also extended the time to file the documents within eight weeks on behalf of
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both the parties. The matter was listed before the Joint Registrar on 13
January, 2009 for admission/denial of the documents and before Court on
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24 February, 2009. On 13 January, 2009, two documents were admitted
by the defendant, being Ex.P-1 and Ex.P-2. The documents of the defendant
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were admitted by the plaintiffs which were exhibited as Ex.D-1 to Ex.D-14
at the time of admission/denial of the documents.
th
20. When the matter was listed before this Court on 24 February, 2009,
the order was passed in I.A. No.12762/2008 with the consent of the parties
that the evidence be got recorded by a retired Additional District Judge
Sh.S.N.Chopra as a Commissioner and the matter was sent to him on
st
1 April, 2009 for fixing dates for cross-examination of witnesses. Parties
were also granted time to file their affidavits by way of evidence.

21. The plaintiffs filed three affidavits, namely, Mr. Shivprasad Laud as
PW-1, Prof. Mr. Roger Griffin PW-2 and Prof. Mr. Nick Thatcher as PW-3.
st
The said evidence was filed on 31 March, 2009 vide entry No.57771.
22. It appears from the record that the defendant also filed the replication
to the written statement filed by the plaintiffs to the counter claim filed on
behalf of the defendant along with copies of few patents i.e. by way of
st
documents on the same date, i.e. 31 March, 2009 vide filing No.58515.
23. The defendant produced its evidence by way of three affidavits,
namely, Sh. R. Gopalakrishnan, DW-1, Sh. Shashirekha Kanathala, DW-2,
Dr. Ashwini Nangia DW-3 and DW-4 Dr. Rajender Kumar Lohiya,
Examiner, Patent Office, New Delhi.
24. Both the parties have exhibited the documents in a following manner:

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25. The following are marked documents:

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26. During the trial, objection has been raised on behalf of the learned
counsel for the defendant to Mark PX 5, Mark PX 7, Mark PX 8, Mark PX 9
to PX 14, Mark PX 16, Mark PX 27, Mark PX 32.
27. The cross-examination of the witnesses was commenced in April,
2009 and concluded in November, 2010. Final arguments in the present suit
effectively commenced in November, 2011. Both parties have also filed
written submissions. The arguments on behalf of the defendant were
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concluded on last working day before summer vacation i.e. 1 June, 2012.
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28. I shall first be taking up issue no. 2 relating to challenge set up by the
Defendant praying for revocation of the patent as this is the issue which may
go into the root of the matter and the decision in the same may have bearing
on the other issues, I propose to decide the same first. The said issue reads as
under:
“Whether the Indian Patent 196774 is liable to be revoked
on the ground raised in written statement and counter-
claim of the Defendant? OPD”

29. The onus to prove the present issue is on defendant. The defendant
has prayed for revocation of the suit patent by way of counter claim raising
mainly the following grounds:
a) That the invention, so far as claimed in any claim of the complete
specification, was claimed in a valid claim of earlier priority date
contained in the complete specification of another patent granted in
India.
b) That the subject of any claim of the complete specification is not
an invention within the meaning of this Act.
c) That the invention so far as claimed in any claim of the complete
specification is not new, having regard to what was publicly
known or publicly used in India before the priority date of the
claim or to what was published in India or elsewhere in any of the
documents referred to in Section 64 of the Patents Act.
d) That the invention so far as claimed in any claim of the compete
specification is obvious or does not involve any inventive step,
having regard to what was publicly known or publicly used in
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India or what was published in India or elsewhere before the
priority date of the claim.
e) That the complete specification does not sufficiently and fairly
describe the invention and the method by which it is to be
performed, that is to say, that the description of the method or the
instructions for the working of the invention as contained in the
complete specification are not by themselves sufficient to enable a
person in India possessing average skill in, and average knowledge
of, the art to which the invention relates, to work the invention, or
that it does not disclose the best method of performing it which
was known to the patentee for the patent and for which he was
entitled to claim protection.
f) That the scope of any claim of the complete specification is not
sufficiently and clearly defined or that any claim of the complete
specification is not fairly based on the matter disclosed in the
specification.
g) That the patent was obtained on false suggestion or representation.
h) That the subject of any claim of the complete specification is not
patentable under this Act.
i) That the patentee for the patent has failed to disclose to the
Controller the information required by Section 8 or has furnished
information which in any material particular was false to his
knowledge.
Re: Obviousness or lack of inventive step
30. The defendant has explained the concept of lack of inventive step in
detail by contending that the patent IN‘196774 (Ex.PW1/5) (hereinafter
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referred to as the ‗Suit Patent) lacks inventive step in as much as arriving at
the said patent is obvious to the person skilled in the art. The said concept of
obviousness has been explained by the defendant by contending in the
counter claim that:
1) That the suit patent no. IN‘774 is Erlotinib Hydrocholride
structurally looks as follows:

The said structure of the patent is based on the teachings of
European Patent 566226 (hereinafter referred as EP‘226) where
under there are number of structures are mentioned as examples
and one of the structures depicted therein teaches any person
skilled in the art to arrive at the Indian Patent.
2) It is contended in the counter claim that EP’0566226 (Ex.D3) is
a patent filed by Zeneca Ltd. on 15.01.1993 in respect of
Quinazoline derivatives. It is stated that this patent concerns a
Markush formula of a Quinazoline derivative, the
pharmaceutically acceptable salts thereof. This patent was
published on 08.11.1995. This patent discloses a molecular
structure in a quinazoline derivative in which methyl is at third
position. This molecular structure (Example 51) is the closest
prior art to the suit patent.
3) The defendant has contended that not merely the said EP‘226
patent is prior art but there are structural similarities between
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the suit patent compound and the one depicted therein. A
comparison of the closest prior art (example 51 of EP‘226) and
the granted claim of suit patent (example 20 of suit patent)
reveal that they are depicted in the same manner. This also
shows that the patentee was aware the existing state of art. It is
contended that Structural similarities by itself may be sufficient
to lead an inference of obviousness.
4) It is contended in the counter claim that after knowing the
nature of art, the plaintiffs have just replaced the component of
alkyl group and by treating the same arrived at the desired
result. It is stated that the mere the substitution of Methyl with
Ethynyl which are members of same alkyl group can be done
by any reasonable person skilled in the art . It is also contended
that the said substitution is a mere workshop result. Had it not
been so, the plaintiffs would have explained the positive steps
towards according the treatment with Ethynyl and difficulties
faced by them during experimentation. The complete
specification is absolutely silent on the ways of arriving at such
substitution. In these circumstances, as per the defendant, it
would be safe to infer that the suit patent was obvious to the
person skilled in the art.
5) It is contended that Example 51 of the EP’226 is the closest
prior art : - From the analysis of the specification it is clear that
IN‘774 is a patent which relates Quinazoline derivative. It is
established in the art and known art that Quinazoline derivative
has anti cancer properties. From the perusal of all the relevant
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patents EP‘534, EP‘507, US‘498, EP‖226 it is clear that they all
belong to a family of patents which are related to similar
compound having identical/similar characteristics and similar
effect. Any person who is working on Quinazoline derivative
would obviously look at these patents. The compounds
disclosed in EP‘226 (patent which is an admitted prior art in the
complete specification of suit patent) are compounds which are
obvious to try permutations and combinations on. There is
sufficient motivation to do further developments in the
preferred compound which are disclosed in EP‘226. EP‘226
explains and shortlists preferred compounds and thereafter
specific preferred compounds. EP‘226 itself discloses 3
preferred compounds amongst which one is example 51 which
is the closest prior art.
6) It is also stated by placing reliance on the documents that the
aspect of substitution of methyl component with that of ethynyl
one which are part of the same alkyl group is not uncommon in
the field of experimentation though it may not relate to the
same drug. This has been explained by the defendant by way of
evidence that the substitution of Methyl with Ethynyl in the
light of the five patents which act as a sample (being
EP0477700, US4138590, US5427766, US5736534 and
WO93/04047 Exhibited by DW3 as Exhibit DW3/2 to Exhibit
DW3/6 respectively) is common. The five said patents are
sufficient in themselves to establish a motivation.
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7) The defendant has filed the evidence by way of Affidavit of
Prof Nangia DW 3 in support of its averments and grounds
raised in the counter claim. The said deponent deposes that as
to how EP‘226 would act as prior art to the suit patent IN‘774.
He also deposes as to how the suit patent would have been
arrived at by the inventor by starting from EP‘226. The EP‘226
is taken as a starting point on the basis of limited disclosure
made in complete specification of the suit patent. In the suit
patent there are five European patent publications including
EP‘226 which have been disclosed. It is EP‘226 which
discloses that Quinazoline derivative has anti cancer properties.
Prof. Nangia DW 3 picked up EP‘226 and on the basis of his
knowledge and have tried to explain that how the substitution
can be made at the third meta position of example 51 of
EP‘226. Such substitution can be tried and made following the
concept of Bio-isosterism. On the basis of the same one of the
possible substituent is Ethynyl.
8) The said affidavit of DW 3 deposes after citing the structures of
example 51 from EP‘226 and alongside the structure of the suit
compound that two structures are identical in nature barring the
rd
substituents in as much as –ch3 (methyl) in 3 Position in EP‘
226 is replaced with –C=C (ethynyl) in IN‘ 774. It is deposed in
the affidavit of DW 3 that after going through EP 0477700
(Ex.DW3/2), US 4138590 (Ex.DW3/3), US 5427766
(Ex.DW3/4), US 5736534 (Ex.DW3/5), WO 193004047
(Ex.DW3/6), it is evident that there is a clear teaching that
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methyl and ethynyl may be used interchangeably. It is deposed
that there is no fixed pattern can be laid down as to the
superiority of one over the other as a matter of rule. In some
cases methyl is found to be superior to ethynyl and in some
cases vice versa.
9) It is deposed in the said affidavit of DW 3 that that when the
said EP‘ 700 is referred, there are three tables namely Table -1
2 and 3. It is stated in the affidavit that in table 2, the properties
of compounds having methyl and ethynyl substituents are
shown to have identical MIC value, but Table 3 shows that
methyl and ethynyl substitutents have substantially similar
properties with ethynyl showing showing marginal higher
value. It is therefore stated in the affidavit that the said patent
teaches as how the methyl and ethynyl can be used
interchangeably as antiviral agents.
10) Likewise, it is stated in the affidavit that US 4138590
(Ex.DW3/3) in column 10 provides that the comparative data in
the table indicating that methyl substitution gives a better blood
platlet aggregate than the compound having ethynyl
substitutent. Thus, the US‘ 590 goes on to teach that one may
use methyl, ethynyl or phenyl interchangeably. Similarly, US
766 (Exht.DW3/4), column 3 – H methyl, ethynyl or vinyl are
used interchangeably.
11) Thereafter DW3 deposes that US 534 Exht.DW3/5 which is
owned by Lee. D Arnold, who is incidentally one of the two
inventors of IN‘ 774. It is stated that US‘ 534 is a continuation
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in part (CIP) application of application 200259 dated February
23, 1994 while IN‘774 finds basis in a CIP of application no.
PCT/IB95/00436 dated June 6, 1995. It is stated that before the
priority date of IN‘774, Mr. Arnold had himself studied methyl,
ethyl, ethynyl, and ethynyl derivatives of 4-Heterocycle
substitution quinazolines which are very close analogues of the
claimed compound in IN‘774. It is deposed that Mr. Arnold
was wholly aware of the interchangeability of the methyl and
ethynyl heterocycle position of quinazoline and on the basis of
such knowledge it would have been obvious for him to try a
similar interchangeability approach in N-pheny l quinazolines.
If Mr. Arnold in IN‘774 patent had included both methyl and
rd
ethynyl in the 3 position, the compound having methyl would
have been identical to the aforesaid compound of EP‘226. It is
deposed that the witness would presume that for such reason
reference to methyl as a interchangeably usable substituent in
the place of ethynyl was omitted. It is stated that while the
patent holder acknowledges the other documents as prior art.
However, the patent holder did not mention US 534 which was
prior in time containing a vital information as to the
interchangeability of methyl with ethynyl. It is deposed that it
rd
could be possible that the ethynyl substitution in 3 position in
IN‘774 would not have worked but still it was always a
reasonable approach on the part of the research scientist to try
such alternative which in other applications have proved
successful.
CS(OS) No. 89/2008 Page No.30 of 275


12) It is deposed that there could not have been a guarantee to the
inventor that the ethynyl substitution would work but due to the
successful use of both methyl and ethynyl in an interchangeable
manner in several chemical compounds, it was not at all
surprising to substitute methyl with ethynyl.
31. By raising the aforementioned grounds supported by the evidence of
DW-3 and the contentions afore-recorded, the defendant prays that the suit
patent is liable to be revoked on the ground of the lack of inventive step.
(There are other affidavits filed of DW-1 and DW-2 which are mainly not
relating to aspect of revocation and are discussed later on in another head.
32. Per contra, the plaintiffs have filed the written statement to the counter
claim, adduced the evidence of PW-3 and PW-2, Mr. Nick Thatcher and Mr.
Robert Griffin, in support of the same thereof and proceeds to answer the
grounds of the counter claim by contending the following:
a) It is contended by the plaintiffs that the defendant has not discharged
the onus casted on the same by not explaining as to how the said
EP‘226 will act as a motivation towards arriving at the suit patent
invention. The same has been explained by the plaintiffs in the
following manner:
(1) It is submitted The Defendant merely relies upon the prior arts
stated by the Plaintiffs in their own patent specification of the suit
patent, IN‘774, namely, EP0520722A1 (EP‘722), EP0566226A1
(EP‘226), EP0602851A1 (EP‘851), EP0635498A1 (EP‘498) and
EP0635507A1 (EP‘507) – all of which disclose ‗4-
anilinoquinazoline‘ derivative compounds possessing anti-cancer
CS(OS) No. 89/2008 Page No.31 of 275


properties. Each of these prior arts, EP‘722, EP‘226, EP‘851,
EP‘507, and EP‘498 have same core structure i.e. ―4-
anilinoquinazoline‖ core structure
and are
represented by ‗Markush Structure‘ thus encompassing millions of
compounds. It is stated that a Markush structure means a General
formulae or description to represent various substitutions on core
structure used in patent application. ( Q. 112, PW2 ,)
(2) Each of these prior arts discloses specific compounds for which
biological activity has been tested (by in vitro and/or in vivo tests)
and specific values are provided. It is stated that in vitro testing
means testing a pharmaceutical compound outside the cell. For
example, in a test tube. In vivo testing means testing a
pharmaceutical compound inside a living cell. For example, inside
an animal .
(3) It is stated by the plaintiffs that the compounds tested in prior arts
EP‘722, EP‘851, EP‘507, and EP‘498 were found to have better or
similar IC50 values as compared to compounds in EP‘226. In all,
there are seventeen specific compounds for which biological
activities are reported. {In IC , IC stands for "inhibitory
50
concentration" i.e. the amount of drug required to give 50%
inhibition of a given biological activity. It is a measure of
effectiveness of the drug. Lower the IC 50 value, more potent is the
CS(OS) No. 89/2008 Page No.32 of 275


drug. Daiichi Sankyo v. Matrix Laboratories & Ors., 2009-1511
(Fed. Cir. 2010) at p. 4 [reported as 670 F . Supp.2d 359]}
Thereafter a chart is depicted below showing such IC values of
the compounds:


(4) It is submitted that a person skilled in the art will, at the first stage
of research, look at these seventeen compounds because of the
―well-defined IC ‖ value. As evident from the above chart, a
50
CS(OS) No. 89/2008 Page No.33 of 275


person skilled in the art will in particular look at Example 2(5) i.e.
6,7-dimethoxy-4-(5-indolylamino)-quinazoline (structure provided
below), disclosed in the EP‘851 which has the IC 50 value of 1nm.

(5) Therefore, amongst all tested compounds in prior art, the
compound [6,7-dimethoxy-4-(5-indolylamino)quinazoline] as
disclosed in EP‘851 has the least IC 50 value, therefore representing
the most potent compound having anti cancer properties.

6,7-dimethoxy-4-(5-indolylamino)quinazoline
(6) Therefore it is submitted that the defendant has provided
absolutely no evidence to show why EP‗226 is the starting prior art
as opposed to EP ‗851. This has been shown by the plaintiffs to
contend that when it comes to possibilities, then any one
compound can be out of many can be a starting point for further
development.
(7) In fact, this is conclusively established by DW3, the defendant‘s
own witness who states in paragraph 4(a) of his Evidence Affidavit
that was directed to the specific prior art document, EP‘226.

b) It has been orally argued and countered by the plaintiffs that there is
no formal proof on record to show as to how the plaintiffs had taken
CS(OS) No. 89/2008 Page No.34 of 275


Example 51 of EP‘226 patent as a lead compound and treated the
same as base to arrive at the suit patent. It has been stated that EP‘ 226
patent discloses numerous formulae and several structures of the
quinazolines derivatives, it cannot assumed by the Court at the behest
of the defendant‘s saying that the same would act as prior art solely by
looking at one of the several depictions cited in the EP‘226.
c) The plaintiffs have countered depositions made in the affidavit of
Mr. Nangia where under he has deposed about the process of arriving
at the suit patent by treating EP‘226 as a base is obvious to the person
skilled in art. The plaintiffs criticized the said depositions and process
explained thereunder by calling the same as ―hindsight‖ as the
defendant today is aware of the patent of the plaintiffs and also of that
of the EP‘226 and thus, it is very easy to state that EP‘226 would have
taught the suit patent. This has been explained by the plaintiffs in the
following manner:
 The defendant has selected Example 51 with full knowledge of
the structure of Erlotinib Hydrochloride, i.e. the defendant has
selected Example 51 as the lead compound purely on the basis
of hindsight. The defendant has stated that the difference
between Example 51 and Erlotinib Hydrochloride is that the
Example 51 has a 3‘-methyl group, whereas Erlotinib
Hydrochloride contains 3‘-Ethynyl group in the phenyl ring of
the ‗4-Anilinoquinazoline‘ core structure. The defendant argues
that this makes the structure of Erlotinib Hydrochloride obvious
to a person skilled in the art.
CS(OS) No. 89/2008 Page No.35 of 275



Example 51 of EP’226
 It is submitted that the above submission is incorrect
and erroneous, and that the defendant has failed to provide
any motivation for a person skilled in the art to replace the
methyl group [-CH 3 ] of the Example 51 with ethynyl group
[-C≡CH] .
 EP‘226 discloses ―4-anilinoquinazoline core compounds‖ by
way of a Markush structure representing millions of
compounds. Further, EP‘226 discloses 80 examples providing
102 specific exemplified compounds, 32 specifically preferred
compounds, 18 claimed compounds and five prominent
compounds for which specific IC50 values are given.
 Example 51 is part of the 102 exemplified compounds, 32
specific preferred compounds and of 18 claimed compounds
(claim 7, claim 9 and claim 11) of EP‘226, however, Example
51 does not feature amongst the five prominent compounds
mentioned in EP‘226 for which IC50 value have been provided.
Therefore, there is no teaching, suggestion or motivation in
EP‘226, regarding any ―useful properties‖ or ―potent and
promising activity‖ to select Example 51 as the lead compound.
CS(OS) No. 89/2008 Page No.36 of 275


d) The plaintiffs have further endeavoured to put shadow on the affidavit
of Prof Nangia by contending that no motivation or reason exists to
select Example 51 of EP‘226 is bolstered by the ―expert‖ witness of
the Defendant. DW3, Dr. Nangia, has straight-away arrived at
Example 51 of EP‘226 as the lead compound on instructions of his
lawyer, Mr. S. Majumdar. (Para 4 and 6, Evidence Affidavit of DW3;
Question nos. 5, 7, 8, 14, 52, 60, 83, 84, PW2,). He has neither
provided any reason for selecting Example 51 as the starting point nor
has he independently evaluated whether Example 51 was the best
starting point as compared to other compounds of EP‘226.
Thus, the Defendant has completely failed to provide any reason/
motivation for a person skilled in the art to select Example 51 of
EP‘226 as the lead compound over the 5 prominent compounds for
which defined biological data (IC 50 values) is provided in EP‗226.
e) It is further argued orally as well as contended in writing that even if it
is admitted for the sake of argument that Example 51 is the correct
lead compound for the obviousness enquiry, it is submitted that the
Defendant has failed to prove that there was any motivation for a
person skilled in the art to modify the 3’-prime position in Example
51 of EP’226. This has been explained by the plaintiffs in the
following manner:
 It is submitted that there are ten positions available in the 4-
anilinoquinazoline core structure where substitutions can be done i.e.
five positions in the phenyl ring and five positions in the quinazoline
core.
CS(OS) No. 89/2008 Page No.37 of 275






 In EP‘226, Methyl is kept constant in 3 ‘-position:
a. In 73 (72%) out of 102 exemplified compounds,
b. In 25 (78%) out of 32 specific preferred compounds,
c. In 9 (50%) out of 18 claim compounds, and,
d. In 4 (80%) out of the 5 prominent compounds for which specific
IC50 values are given.


 Therefore, EP‘226 clearly teaches a person skilled in the art to make
substitutions at the 6, 7 position on the quinazoline ring while keeping
3‘-Methyl on phenyl ring constant or undisturbed. Thus, it is
submitted that the Defendant has failed to provide any
teaching/suggestion/motivation for a person skilled in the art to make
a substitution at the 3‘-prime position of the phenyl ring of
‗4-anilinoquinazoline‘ core structure and not on any other positions.

f) The plaintiffs have further replied the counter claim and the ground of
obviousness by arguing orally as well as in writing that the defendant
has not explained the motivation which may come to the person
CS(OS) No. 89/2008 Page No.38 of 275


skilled in art to substitute the ethyl with that of methyl component.
This has been articulated by the plaintiffs by explaining in the
following terms:
 The defendant has failed to prove that there was any motivation
to substitute Methyl with Ethynyl. It is submitted that even
though Example 51 and Erlotinib Hydrochloride may look
similar when represented in two-dimensional format, however,
in actual practice, the Example 51 and Erlotinib Hydrochloride
are structurally and functionally different due to presence of the
different functional group, methyl group [-CH ] in Example 51
3
with ethynyl group [-C≡CH] in Erlotinib Hydrochloride.
 It is pertinent to note that in chemistry, any change may have
dramatic and unpredictable effect on the activity of the
molecule. This has been conclusively stated by the Plaintiffs‘
witness, PW2, in his affidavit and cross examination
( paragraphs 21 and 26.10, Evidence Affidavit of PW2,; Q, 52,
59, 60, 88, 94, 119, 139-149, PW2, )
 More specifically, in the field of pharmaceutical sciences, any
change in the structure of a compound can alter its activity and
affects the manner in which the compound interacts with the
target site, such as EGFR kinase, and thus affecting its
biological activity.

 Further, the activity of a compound cannot be predicted in
advance without performing empirical studies. As an
CS(OS) No. 89/2008 Page No.39 of 275


illustration, the core of the enzyme, here being EGFR kinase, is
considered a lock and the claimed compound, here being
Erlotinib Hydrochloride, which acts on the enzyme, is
considered as the key . In pharmaceutical sciences, the
researcher in order to make a key for the lock has to perform
empirical studies to arrive at a particular conclusion. The
researcher cannot make arbitrary choices and do further
development without any reasons to do so. One has to apply the
reasoned approach for further development of compounds since
a small change anywhere in the molecule may alter activity of
the compound for a particular target, such as EGFR kinase, and
therefore it is not possible to predict activity of the compound
in advance without performing the empirical studies.
 In the case of the methyl and ethynyl group, the difference in
the physical properties such as bond angle, bond length and
bond strength of the methyl group [-CH 3 ] and ethynyl group [-
C≡CH] , affect the manner in which Example 51 and Erlotinib
Hydrochloride interact with the target protein, EGFR kinase,
and the differences in the chemical properties of the methyl
group [-CH 3 ] and ethynyl group [-C≡CH] may affect the
reactivity of the Example 51 and Erlotinib Hydrochloride with
respect to the EGFR kinase.
CS(OS) No. 89/2008 Page No.40 of 275

The methyl group [-CH ] has a tetrahedral structure. In contrast, the
3
ethynyl group [-C≡CH] , has linear structure. Due to this difference in the
shape, the methyl group [-CH ] and the ethynyl group [-C≡CH] interact
3
very differently with the EGFR kinase. The methyl group [-CH ] being a
3
tetrahedral structure does not fit well within the core of the EGFR kinase,
however, the ethynyl group [-C≡CH] being linear in shape fit perfectly
within the core of the EGFR kinase and thus possesses better activity.


Importantly, this has not been disproved by the Defendant in any
manner. In fact, the Defendant has presumed that any change will result in
CS(OS) No. 89/2008 Page No.41 of 275


the same or similar activity and has explained obviousness in its Counter
Claim and Replication to the Counter Claim on this presumption.
g) The plaintiffs have simultaneously countered the basis of obviousness
which has been laid down by the defendant in relation to substitution
of ethyl in lieu of methyl component. This has been also elaborately
explained by the plaintiffs and argued too during the time of oral
arguments, the same can be explained as under:
 It is submitted that the both the road-maps suggested by the
Defendant for the substitution of Methyl with Ethynyl at the 3‘
position are misleading and misconceived:
I. The bio-isosterism route in Counter-Claim, and,
II. The direct interchangeability route in Replication to Counter-
Claim.
I. Counter-Claim – Bioisosterism Route:
 The Plaintiffs submit that there is no reason/motivation to modify
3‘-position to Ethynyl since as shown hereinabove, the teachings
of EP‘226 direct a person skilled in the art that 3‘-Methyl should
be left undisturbed for good biological activity.
 The Plaintiffs submit that there is no reason/motivation to modify
3‘-position to Ethynyl since as shown hereinabove, the teachings
of EP‘226 direct a person skilled in the art that 3‘-Methyl should
be left undisturbed for good biological activity.
 Nonetheless, the Defendant, without showing any motivation, has
arbitrarily selected Example 51 having 3‘-Methyl as the lead
CS(OS) No. 89/2008 Page No.42 of 275


compound and applied bio-isosterism principle to arrive at the
claimed compound having 3‘-Ethynyl group.
 The Defendant proceeds to arbitrarily replaces Methyl group at 3‘-
position with Cyano group. The Defendant has provided absolutely
no teaching/suggestion/motivation for a person skilled in the art to
change Methyl to Cyano. EP‘226 describes that ‗R2‘ i.e. 3‘-
position in Markush structure stands for 45 different substituents.
Therefore, EP‘226 provides for 43 substituents other than Methyl
or Cyano for 3‘ position. The Defendant has not provided a n y
teaching/suggestion/ motivation that a person skilled in the art will
substitute Methyl with only Cyano group and not the other 43
functional groups disclosed for R2 position.
 It is submitted that none of the 32 specific preferred compounds or
the 18 claimed compounds or the 5 prominent compounds in
EP‘226 include the Cyano substitution at the 3‘ position. Instead
this position is largely dominated by Methyl as stated above. Thus,
the Defendant has failed to provide any reason as to why a person
skilled in the art would substitute the ―Methyl‖ group with
―Cyano‖ group. The Plaintiffs submit that the same is done only on
the basis of ‗Hindsight‘ after knowing the structure of Erlotinib
Hydrochloride‖
II ― Methyl to Ethynyl Direct Interchangeability :
 It is submitted, that the Defendant filed their replication to counter-
claim after the Plaintiffs filed the Evidence Affidavits of their
witnesses. It is submitted that once the Plaintiffs pointed out the
CS(OS) No. 89/2008 Page No.43 of 275


fallacy of the Defendant‘s argument on obviousness in its written
statement to the counter claim the Defendant dropped the bio-
isosterism route, and adopted a completely new route i.e. direct
inter-changeability of Methyl to Ethynyl. This new route taken by
the Defendant to explain a claim of obviousness is based on 5
completely new patent documents which were not mentioned or
disclosed prior to the filing of the Replication to the Counter
Claim. The Plaintiffs had no opportunity to provide evidence on
the new route taken by the Defendant. Therefore, the Plaintiffs
submit that the 5 documents filed with the Replication to the
Counter Claim cannot be taken on record. Each document is a
material fact by itself. Defendant‘s act has surprised the plaintiffs
and will cause prejudice, if it is read in evidence.
 It is further submitted that replication to counter-claim is not part
of the pleadings. Even if the replication is considered to be a part
of the pleadings, then the grounds taken cannot be different from
what has already been stated in the Counter Claim.
 It was submitted by the plaintiffs that assuming that the 5 prior arts
are read in evidence, it is submitted that the Defendant has still
failed to explain why a person skilled in the art would have been
motivated to replace the Methyl group with the Ethynyl group.
 The defendant‘s arguments in the Replication to the Counter Claim
are totally artificial and can only be the result of hindsight bias. In
other words, the defendant starts the discussion by presuming that
the structure of claimed compound, Erlotinib Hydrochloride is
CS(OS) No. 89/2008 Page No.44 of 275


known and only then proceeds to discuss the prior art. ( Paragraph
8 of the Evidence Affidavit of DW3 )
 This approach is completely erroneous, since the inventive step
must be examined on the priority date of the suit patent i.e. on
30.3.1995. The Plaintiffs submit that on the priority date of the suit
patent and without having the knowledge of claimed compound,
Erlotinib Hydrochloride, there was no motivation to replace the
Methyl group with Ethynyl group.
 It is submitted that 5 patent documents (US4138,590;
EP0477700A1; WO1993/04047; US5,427,766; US5,736,534) are
cited by the Defendant in the Replication.
 Of these five patent documents, two patent documents
US5,427,766 and US5,736,534 are not valid prior arts under
Section 64(1)(f) because they were published subsequent to the
priority date of the Suit Patent.
 The Plaintiffs submit that out of the 2 cited patent documents,
which are not valid prior arts, one document US‘534 belongs to the
same inventor as the suit patent.
 US‘534 was filed prior to the suit patent but was published almost
3 years after the priority date of suit patent.
 Additionally, US‘534 does not even disclose ―4- anilino
quinazoline‖ compounds. Instead US‘534 discloses ―4-
heterocyclic substituted quinazoline‖ compounds. Therefore, no
structural similarity exists between the compounds of the US‘534
and the suit patent.
CS(OS) No. 89/2008 Page No.45 of 275


 The Defendant has erroneously contended that since the inventor
was common and he already had knowledge of including Ethynyl
in 3‘-position, the claimed compound of suit patent becomes
obvious.‖
h) It has been contended orally as well as in writing that the inference of
non obviousness can be drawn by the Court on the basis of the
commercial success of the product which is a subject matter of the
patent, the same may become weighty consideration for assuming that
the invention in question qualifies the tests of obviousness. In this
respect, the plaintiffs have mainly relied upon the evidence by way of
affidavit of Mr. Thatcher which has been articulated by the plaintiffs
and their counsel in the following manner:
 ―Evidence with respect to this consideration can include assertions
based on cogent evidence that the claimed invention yields
unexpectedly improved properties or properties not present in the
prior art or even that the claimed invention was copied by others.
In the present case, such evidence has been provided extensively
by the Plaintiffs‘ witnesses.
 Specifically, the Plaintiffs‘ witness, PW-3 Dr. Nick Thatcher in his
capacity as an experienced oncology clinician, has stated that the
patented compound Erlotinib Hydrochloride was efficacious in the
treatment of non-small cell lung cancer conferring consistent
survival benefits across multiple patient sub-groups including
smokers ( Paragraphs 25-27, 32 of the Evidence Affidavit of PW3 ).
 In his opinion, the results shown by the patented compound
Erlotinib Hydrochloride were even more surprising and
CS(OS) No. 89/2008 Page No.46 of 275


unexpected since they were far superior than the results of the
Phase III trial of the compound Gefitinib which was targeted
towards the same treatment. ( Paragraphs 29-33 of the Evidence
Affidavit of PW3 ). This has also been reiterated by the second
expert witness produced by the Plaintiffs, Prof. Roger Griffin in
response to a question posed to him during cross examination ( Q.
152 and 154 )
 Dr. Thatcher has further stated that Erlotinib Hydrochloride is the
only Quinazoline derivative approved for the treatment of patients
who have incurable advanced or metastatic pancreatic cancer.
( Paragraphs 34-37 of the Evidence Affidavit of PW3 ).
33. In placing this evidence on the Court‘s record, Dr. Thatcher has relied
on several articles including:
i. Ex. PW1/X6: "Erlotinib in Previously Treated Non-Small Cell Lung
Cancer"
ii. Ex. PW1/X7: "Symptom Improvement in Lung Cancer Patients
Treated with Erlotinib: Quality of Life Analysis of the National
Cancer Institute of Canada Clinical Trials Group Study BR.21"
iii. Ex. PW1/X8: "Erlotinib plus gemcitabine compared with gemcitabine
alone in patients with advanced pancreatic cancer: a phase III trial of
the National Cancer Institute of Canada Clinical Trials Group."
iv. Ex. PW2/D2: "Gefitinib plus best supportive care in previously
treated patients with refractory advanced non-small-cell lung cancer:
results from a randomised, placebo-controlled, multicentre study
(Iressa® Survival Evaluation in Lung Cancer)"
CS(OS) No. 89/2008 Page No.47 of 275


v. Ex. PW3/1: "Does potency predict clinical efficacy? Illustration
through an antihistamine model"
vi. Ex. PW3/2: "Salvage Therapy for advance Non-Small Cell Lung
Cancer: Factors Influencing Treatment Selection"
vii. Ex. PW3/3: "Smoking History and Epidermal Growth Factor Receptor
Expression as Predictors of Survival Benefit from Erlotinib for
Patents with Non-Small Cell Lung Cancer in the National Cancer
Institute of Canada Trials Group Study BR.21"
viii. Ex. PW3/5: ―US FDA Public Health Advisory: New Labelling and
Distribution Program for Gefitinib‖
34. By placing reliance on the aforementioned reply, submissions,
evidence, anomalies in relation to the case of the counter claimant, it has
been argued by the learned senior counsel for the plaintiffs that there is no
case made out for obviousness for so many reasons stated, explained and
articulated above. The defendant has therefore failed to discharge burden of
obviousness.
35. Likewise, the plaintiffs have responded to the other grounds of the
counter claim and have also discussed the law subject wise.
36. I have gone through the records of the proceedings including plaint,
counterclaim, written statement, replication and evidence adduced by the
parties and also given the careful consideration to submissions advanced at
the bar noted above in detail. Let me now deal with the various aspects
involved in the revocation of patent one by one.


CS(OS) No. 89/2008 Page No.48 of 275


Re: Lack of Inventive step in the Suit Patent
37. Firstly, I think it is for me to discuss the challenge which has been laid
by the defendant to the plaintiff‘s suit patent in relation to lack of inventive
step. As it is seen above, the ground of lack of inventive step in the
plaintiff‘s Ex PW1/5 IN‘774 patent has been set up by urging several points
which as per the defendant would demonstrate that the plaintiff‘s patent was
anticipated. Likewise, the plaintiffs have equally taken pains to find out
number of anomalies in the grounds raised by the defendant by responding
on each and every point seeking to justify as to why the plaintiffs reply
should be accepted and not the defendant‘s ground. I think much labour and
exercise has been done by finding out defects on either side‘s stand which
has resulted into several sub categorizations of the competing stands of the
parties rather than putting the positive case on either side. This I have
noticed at the outset as the same will also come in to aid while weighing the
evidence of the competing parties.
38. As there are number of arguments and grounds raised by the parties in
relation to the concept of lack of inventive step, persons skilled in the art and
thereafter while making the submissions, the terminologies are transposed
with the ones laid down in US judgments and English judgments suitably as
per the convenience of the parties by contending that the said person is one
who is an ―unimaginary person‖ or for that matter what ―motivated‖ the
inventor to choose any structure as lead compound and various other facets
which are laid down as tests in such judgments are being imported in order
to satisfy this Court, I think it is necessary to discuss the patent law as
governing in India in form of Patents Act 1970 in order to find out the true
CS(OS) No. 89/2008 Page No.49 of 275


test on basis of which the obviousness or inventive step in the patent is
required to be tested.
39. Indian Patents Act 1970 has been amended in the year 2005 where
under the concept of the product patent in relation to pharmaceuticals has
been introduced. The definition of inventive step is the defined under
Section 2 (1) (ja) of the patents Act. The definition of ―inventive step‖ in
The Patents (Amendment) Act which is inserted by way of amendment of
2005 u/s 2(ja) reads as under:-
2(1) (ja) "inventive step" means a feature of an invention
that involves technical advance as compared to the existing
knowledge or having economic significance or both and
that makes the invention not obvious to a person skilled in
the art;‖
40. The provisions relating to revocation of Patents which are statutorily
engrafted u/s 64(1) (f) provides specifically a ground of lack of inventive
step for the purposes of revocation. The said provision reads as under:-
64. Revocation of patents
1) Subject to the provisions contained in this Act, a patent,
whether granted before or after the commencement of this
Act, may, [be revoked on a petition of any person interested
or of the Central Government by the Appellate Board
or on a counterclaim in a suit for infringement of the
patent by the High Court] on any of the following grounds,
that is to say—
(a) that the invention, so far as claimed in any claim of
the complete specification, was claimed in a valid claim of
earlier priority date contained in the complete specification
of another patent granted in India;
CS(OS) No. 89/2008 Page No.50 of 275


(b) that the patent was granted on the application of a
person not entitled under the provisions of this Act to apply
therefor:
(c) that the patent was obtained wrongfully in
contravention of the rights of the petitioner or any person
under or through whom he claims;
(d) that the subject of any claim of the complete
specification is not an invention within the meaning of this
Act;
(e) that the invention so far as claimed in any claim of the
complete specification is not new, having regard to what
was publicly known or publicly used in India before the
priority date of the claim or to what was published in India
or elsewhere in any of the documents referred to in Section
13 : 2
(f) that the invention so far as claimed in any claim of the
complete specification is obvious or does not involve any
inventive step, having regard to what was publicly known
or publicly used in India or what was published in India or
elsewhere before the priority date of the claim;
(g) that the invention, so far as claimed in any claim of
the complete specification, is not useful;
(h) that the complete specification does not sufficiently
and fairly describe the invention and the method by which
it is to be performed, that is to say, that the description of
the method or the instructions for the working of the
invention, as contained in the complete specification are not
by themselves sufficient to enable a person in India
possessing average skill in, and average knowledge of, the
art to which the invention relates, to work the invention,
or that it does not disclose the best method of
performing it which was known to the applicant for the
patent and for which he was entitled to claim protection;
CS(OS) No. 89/2008 Page No.51 of 275


(i) that the scope of any claim of the complete
specification is not sufficiently and clearly defined or that
any claim of the complete specification is not fairly, based
and clearly defined or that any claim of the complete
specification is not fairly, based on the matter disclosed in
the specification;
(j) that the patent was obtained on a false suggestion or
representation;
(k) that the subject of any claim of the complete
specification is not patentable under this Act;
(l) that the invention so far as claimed in any claim of the
complete specification was secretly used in India, otherwise
than as mentioned in sub-Section (3), before the priority
date of the claim;
(m) that the applicant for the patent has failed to disclose
to the Controller the information required by Section 8 or
has furnished information which in any material particular
was false to his knowledge;
(n) that the applicant contravened any direction for secrecy
passed under Section 35 or made or caused to be made an
application for the grant of a patent outside India in
contravention of Section 39;]
(o) that leave to amend the complete specification under
Section 57 or Section 58 was obtained by fraud.
[(p) that the complete specification does not disclose or
wrongly mentions the source or geographical origin of
biological material used for the invention;
(q) that the invention so far as claimed in any claim of the
complete specification was anticipated having regard to the
knowledge, oral or otherwise, available within any local or
indigenous community in India or elsewhere.]'
(2) For the purposes of clauses (e) and (f) of sub-Section
(1),—
CS(OS) No. 89/2008 Page No.52 of 275


(a) no account shall be taken of [personal document or
secret trial or secret use]; and
(b) where the patent is for a process or for a product as
made by a process described or claimed, the importation
into India of the product made abroad by that process shall
constitute knowledge or use in India of the invention on the
date of the importation, except where such importation
has been for the purpose of reasonable trial or
experiment only.
(3) For the purpose of clause (1) of sub-Section (1), no
account shall be taken of any use of the invention—
(a) for the purpose of reasonable trial or experiment
only; or
(b) by the government or by any person authorized by
the government or by a government undertaking, in
consequence of the applicant for the patent or any person
from whom he derives title having communicated or
disclosed the invention directly or indirectly to the
government or person authorized as aforesaid or to the
government undertakings; or
(c) by any other person, in consequence of the applicant
for the patent or any person from whom he derives title
having communicated or disclosed the , invention, and
without the consent or acquiescence of the applicant or of
any person from whom he derives title.
(4) Without prejudice to the provisions contained in sub-
Section (1), a patent may be revoked by the High Court
on the petition of the Central Government, if the High
Court is satisfied that the patentee has without reasonable
cause failed to comply with the request of the Central
Government to make, use or exercise the patented invention
for the purposes of government within the meaning of
Section 99 upon reasonable terms.
CS(OS) No. 89/2008 Page No.53 of 275


(5) A notice of any petition for revocation of a patent under
this Section shall be served on all persons appearing from
the register to be proprietors of that patent or to have shares
or interest therein and it shall not be necessary to serve a
notice on any other person.‖
41. On the bare reading of the aforementioned Sections, it is clear that the
definition of ―inventive step‖ nowhere accords any differential treatment to
any particular type of invention. Rather, it lays down the general test which
is indicative towards technological advancement and the non obviousness of
an invention to a person skilled in art. Besides the same, the said definition
of inventive step u/s 2(ja) which has been newly inserted in the Patents Act
(Amendment) 2005 once read with grounds of revocation u/s 64 nowhere
indicate any special treatment or different tests to be applied for any
particular type of invention more specifically medicinal, chemical,
industrial, etc.
42. On conjoint reading of the Section 64 read with Section 2(ja), it is
clearly discernible that there are certain essential ingredients of Section 2(ja)
in order to call any invention to qualify the threshold of inventive step. The
said ingredients are:-
a) That the said invention involves a technical advancement as compared
to existing knowledge or economic significance or both; and
b) That makes the invention non obvious to the persons skilled in art.
43. These are conjunctive requirements u/s 2(ja) which means that not
merely there should be a technical advancement in the invention but at the
same time, it should not be obvious to the person skilled in art. Therefore,
both the requirements are to be satisfied conjunctively. It is noteworthy here
again that beyond the said two ingredients, there is no further ingredient
CS(OS) No. 89/2008 Page No.54 of 275


which should be read into in order to enlarge or limit the scope of the
Section.
44. Consequently, what follows from the above discussion is that as per
the provision of Patents Act there is nothing which is indicative of the fact
that any stricter approach is to be followed while testing the patents relating
to chemical compounds due to any reason whatsoever including that the
patent relates to chemical compounds which are preexisting in the field and
therefore some departed approach unlike other kinds of patents may be
followed in order to adjudicate upon the obviousness relating to chemical
compounds or medicinal patent be it product or process.
45. One has to travel not very far in order to understand the test relating to
obviousness which has been minutely discussed by the Supreme Court of
India in the case of Biswanath Prasad Radhey Shyam vs Hindustan Metal
Industries cited as AIR 1982 SC 1444 , which is a Three Judges Bench
decision. In the said judgment, tests of patentability are discussed in extenso
and the expressions used under the Patents Act which has been defined and
discussed thoroughly including the expression ―inventive step‖. The said
judgment is a landmark judgment followed by the Courts across the country
and is still holding the field till date and all the matters relating to Patent
infringement are decided on the basis of the tests carved out in said case of
Biswanath Prasad(supra) till date without any departure.
46. It is further noteworthy that in the said case too, a decision was
rendered after trial culminating into the final adjudication. The said case and
the observations made therein by Hon‘ble Supreme Court of India gains
more importance due the said reason also as I am proposing to decide this
CS(OS) No. 89/2008 Page No.55 of 275


case finally. In the said case of Biswanath Prasad (supra) , Hon‘ble
Supreme Court has laid down the test as to what constitutes inventive step.
In the words of Hon‘ble Supreme Court of India it was observed thus:-
―24. Whether an alleged invention involves novelty and
an 'inventive step', is a mixed question of law and fact,
depending largely on the circumstances of the case.
Although no absolute test uniformly applicable in all
circumstances can be devised, certain broad criteria can
be indicated. Whether the "manner of manufacture"
patented, was publicly known, used and practised in the
country before or at the date of the patent ? If the
answer to this questseion is 'yes', it will negative novelty
or 'subject matter' . Prior public knowledge of the alleged
invention which would disqualify the grant of a patent can
be by word of mouth or by publication through books or
other media. "If the public once becomes possessed of an
invention", says Hindmarch on Patents (quoted with
approval by Fry L. J. in Humpherson v. Syer, "by any
means whatsoever, no subsequent patent for it can be
granted either to the true or first inventor himself or any
other person; for the public cannot be deprived of the right
to use the invention........ the public already possessing
everything that he could give."
25. The expression "does not involve any inventive step"
used in Section 26(1) (a) of the Act and its equivalent
word "obvious", have acquired special significance in
the terminology of Patent Law. The 'obviousness' has to
be strictly and objectively judged. For this
determination several forms of the question have been
suggested. The one suggested by Salmond L. J. in Rado
v. John Tye & Son Ltd. is apposite. It is: "Whether the
alleged discovery lies so much out of the Track of what
was known before as not naturally to suggest itself to a
person thinking on the subject, it must not be the
obvious or natural suggestion of what was previously
known." (Emphasis Supplied)
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26. Another test of whether a document is a publication
which would negative existence of novelty or an "inventive
step" is suggested, as under:
" Had the document been placed in the hands of a
competent craftsman (or engineer as distinguished from
a mere artisan), endowed with the common general
knowledge at the 'priority date', who was faced with the
problem solved by the patentee but without knowledge
of the patented invention, would he have said, "this
gives me what I want?" (Encyclopaedia Britannica;
ibid). To put it in another form: "Was it for practical
purposes obvious to a skilled worker, in the field
concerned, in the state of knowledge existing at the date
of the patent to be found in the literature then available
to him, that he would or should make the invention the
subject of the claim concerned ?" Halsbury, 3rd Edn, Vol.
29, p. 42 referred to by Vimadalal J. of Bombay High Court
in Farbwrke Hoechst & B. Corporation v. Unichem
Laboratories.‖ (Emphasis Supplied)
47. From the bare reading of the afore quoted observations of Supreme
Court, it is manifest that the Hon‘ble Supreme Court has laid down the test
for the purposes of ascertaining as to what constitutes an inventive step
which to be seen from the standpoint of technological advancement as well
as obviousness to a person who is skilled in the art. It is to be emphasized
that what is required to be seen is that the invention should not be obvious to
the person skilled in art. These are exactly the wordings of New Patents
Act, 2005 u/s Section 2(ja) as seen above. Therefore, the same cannot be
read to mean that there has to exist other qualities in the said person like
unimaginary nature of the person or any other kind of person having distinct
qualities.
CS(OS) No. 89/2008 Page No.57 of 275


48. Such observations made in the foreign judgments are not the guiding
factor in the true sense of term as to what qualities that person skilled in art
should possess. The reading of the said qualities would mean qualifying the
said statement and the test laid down by the Supreme Court.
49. The said observations relied upon by the parties are judicially created
tests depending upon the nature of the case and the subjective satisfaction of
the Judge in the given case. As there is no such requirement which exists at
least in Indian Patent Act defining the further qualities of a person skilled in
art, therefore, one has to leave the said point there and then which is that
what is required to be seen is the obviousness from the standpoint of a
person who is skilled in art.
50. Normal and grammatical meaning of the said person who is skilled in
art would presuppose that the said person would have the knowledge and the
skill in the said field of art and will not be unknown to a particular field of
art and it is from that angle one has to see that if the said document which is
prior patent if placed in the hands of the said person skilled in art whether he
will be able to work upon the same in the workshop and achieve the desired
result leading to patent which is under challenge. If the answer comes in
affirmative, then certainly the said invention under challenge is anticipated
by the prior art or in other words, obvious to the person skilled in art as a
mere workshop result and otherwise it is not. The said view propounded by
Hon‘ble Supreme Court in Biswanath Prasad (supra ) holds the field till date
and has been followed from time to time by this Court till recently without
any variance.
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51. Therefore, it is proper and legally warranted to apply the same very
test for testing the patent; be it any kind of patent. It would be improper to
import any further doctrinal approach by making the test modified or
qualified what has been laid down by the Hon‘ble Supreme Court in of
Biswanath Prasad (supra ).
52. It is also not disputed that the Courts internationally have laid down
certain other criterion while dealing with the patents relating to chemical
compounds and the tests are somewhere seem to be different from what has
been governing the field in Indian context as per the Indian Patents Act,
1970 as amended in 2005. However, the said test laid down by the Courts
either in Europe or in US cannot be as a matter of natural consequence
applied in the Indian context on the mere insistence of the parties. This is
more so when the observations of Hon‘ble Supreme Court earmarking
―inventive step‖ and defining the scope and ambit of the same are governing
the field with no caveat or exception to any particular kind of patents.
53. This is also emerging from amendments made in the year 2005 which
speaks in the same voice with that of the view of Supreme Court while
introducing the product and process patents for medicines. All this is
indicative of the legislative intent that the legislature was conscious while
providing the definition of inventive step that it is according patent
protection to medicines, still no such other treatment either in the form of
explanation or proviso to the definition of inventive step or anywhere has
been provided.
54. On the other hand, wherever it was necessary, such explanations in
the form clarifications relating to medicinal patents are provided like
CS(OS) No. 89/2008 Page No.59 of 275


explanation appended to Section 3(d) which provides that the Polymorphic
version of the drug shall deemed to the same substance unless backed by the
efficacy. In absence of any such intent to provide such different tests of
obviousness in pharmaceutical patents, it would be legally impermissible to
import any such new tests which may somehow seem or appear to be facets
of the tests of obviousness as Indian Act nowhere provides such
requirement.
55. Therefore, it would be wise to say that there exists a jurisprudential
difference between the countries like India where the patent law is still at the
nascent stage vis-à-vis the European countries where the law has developed
uptil one level and far away in US where the patent law is operating at the
advanced stage. The tests shall accordingly vary as per the prevalent
conditions of the respective countries.
56. In the country like India where we have followed the Product Patent
Regime relating to medicines and pharmaceuticals reluctantly after 10 years
since 1995 as phase by phase basis as against the US where the said regime
is preexisting for a healthy passage of time, it is but natural that the tendency
of the Courts in such countries to protect the patents and to lay down the
tests for measuring the obviousness, novelty shall vary and will certainly be
at the advanced stage than that of what has been existing in India.
57. One must also not forget that the tests are carved out by also
considering the language of the Statute, coupled with other factors including
avowed object of the Act and constitutional goals to be achieved and not in
abstract. Accordingly, the test of obviousness as discussed above in the
Indian context holds good so far as Indian Statute is concerned and may
CS(OS) No. 89/2008 Page No.60 of 275


change in the future depending upon the change of definition of ―inventive
step‖ in case the legislature deems fit to amend the definition of inventive
step or in the alternative provide some safeguards to medicinal patents so as
to deal with them differently. Till the time it is not done so, it cannot be said
that the test of American Courts and European Courts may be applied when
it comes to adjudicate the obviousness of Indian Patents.
58. This clarification became necessary as lots of decisions are cited at the
bar where American Courts have first laid down some tests and thereafter
year after year changed the approach which goes either in favour of the
plaintiffs in one case and in favour of defendant in another. I think it is not
prudent to just follow such decisions in favour of either side and would be
correct approach to consider only those decisions which go in consonance
with our Indian patent law regime and judgments passed by the Supreme
Court of India. It does not mean that the English and American decisions are
not helpful. The aid is being taken from such decisions where it is necessary,
which goes consistent with Indian law.
59. The discussion done above is also evident from the conflicting
opinions existing in the English Courts in UK where the similar debate is
prevalent too, the reference is invited to the decision of the Court of appeal
in the case of Dr. Reddy’s Laboratories (UK) Ltd. vs. Eli Lilly and Co. Ltd..
reported as 2010 RPC Page No.9 where the Court of appeal has observed
that the ordinary approach relating to obviousness should be followed even
in cases relating to patents involving chemical compounds rather than what
has been followed by other European Courts, patent offices and no special
approach is warranted in the law. It is however different matter that in the
CS(OS) No. 89/2008 Page No.61 of 275


result, the Court of appeal decided in favour of the patentee but what is
important is the observations relating to the tests of obviousness which as
per the Court are the same as ordinary approach of obviousness. In the
words of Court of Appeal, it was observed thus :-

60. It has also been recognized by the author in the Book titled ―Modern
Law of Patents‖ where this decision of Dr. Reddy‘s (supra) has been quoted
to suggest that the ordinary approach of obviousness should be applied in
adjudging the patentability of inventions involving chemical compounds
relating to selection inventions. Learned Author observed thus:-
CS(OS) No. 89/2008 Page No.62 of 275

61. From the abovementioned view taken by the Court of Appeal as well
as by the learned author, it is clear that even the European Courts are still
thinking as to whether any such departure or special treatment should be
given to medicinal patents or not when it comes to deciding the obviousness
and in the said case Dr. Reddy‘s (supra) it was laid down that the ordinary
approach of obviousness would suffice.
62. There is no reason why in the present case, the same observation
should not be applied and more so when Hon‘ble Supreme Court of India
lays down the tests of inventive step in the case of Bishwanath Prasad
(Supra) which is in consonance with the observations of Court of appeal that
the obviousness has to be tested on the basis of technological advancement
and what has been known to the person skilled in art and nothing beyond the
same. Therefore, the tests which are further modified and are doctrinal in
nature are not relevant for the purposes of seeing the obviousness of a patent
or for that matter any other patent.
63. Now, the related question arises as to what can be said to be obvious
to the persons skilled in art and how to determine the same. It is seen above
that the Supreme Court in Bishwanath Prasad observed that the question of
obvious to the person skilled in art is a mixed question of fact and law.
Therefore, a person setting up a challenge to the patent must aver so and
CS(OS) No. 89/2008 Page No.63 of 275


establish the facts material to establish obviousness. The said material facts
are bundle of facts which can be said to be chain of events making the
invention obvious to the person skilled in the art. The said chain of events in
the case of Bishwanath Prasad which were established on record in that case
are the 6 points mentioned in the judgments which are established on the
record in that case.
64. Therefore, one has to immediately advert to the question as to what
chain of events is necessary in order to establish obviousness to the person
skilled in art in relation to chemical compounds. Is it only the establishment
of the fact that there is depiction of the similar looking compound in the
examples in the cited prior art and coupled with the further experimentation
which may find somehow common place after the priority date of the patent
or something more. I think for the same, some guidance from English
authorities or the books can be taken only to the limited extent of finding out
as to what are the essential facts or material facts necessary to establish the
obviousness should be proved by the applicant for revocation.
65. The chain of events which are necessary for the purposes of finding
obviousness in relation to selection of chemical compounds from the larger
formula or molecule are discussed in the book titled as "The Modern Law of
Patents" by Roughton, Johnson, Cook & Fysh, 2011 Edition, (Lexis Nexis),
wherein the learned author quotes an authority from European Patent office.
The learned author observed thus:
―2.125 In T279/89 Moulded polyurethane elastomers/ Texaco, the Board of
Appeal gave some practical requirements which must be satisfied for a
selection invention to be novel, in particular:
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(a) The selection invention or range should be narrow.
(b) The selection invention or range should be sufficiently far removed
from the known range illustrated by means of the examples.
(c) The selected area should not provide an arbitrary specimen from the
prior art, is not mere embodiment of the prior description but another
invention (purposive selection) (In T279/89 Moulded polyurethane
th
elastomers/ Texaco (unpublished*) 9 July 1991 at (r 4.1); this test
was based on the earlier decision T198/84 Thiochloroformiates/
Hoechst, (1985) OJ EPO 209)‖
―2.126 the meaning of ―narrow‖ and ―sufficiently far removed‖ in
criterion (a) and (b) is decided on case by case basis. Furthermore, in
relation to criterion (c), a technical effect which only occurs in the
individual selection (or in a range) within a larger range is indicative
of this criterion has been satisfied. It is not enough, however to
discover that a subrange within a range demonstrates a new
characteristic, rather the range itself had to be new.‖ (Emphasis
Supplied)
66. From the reading of the aforementioned observations of the learned
author, it is clear that the afore noted chain of events or material facts are to
be satisfied at least for the purposes of calling the invention new and non
obvious, for the purposes of challenge which has been set up against the
patentee, these very chain of events are to be established by the
counterclaimant conversely as the onus is upon the defendant to show that
the patent is obvious in the revocation proceedings. Therefore, after
analyzing the aforenoted events, the following material facts are essentially
required to be established by the counterclaimant:
CS(OS) No. 89/2008 Page No.65 of 275


a. The selection of the impugned invention is taken from the
examples of the known prior art.
b. That the selected invention is not far removed from the known
range illustrated in the example. Rather, the same is closer to
the known range.
c. That the selection area is not on the basis of any purpose of the
inventor and is merely an arbitrary picking up the compound.
The above noted tests are some broad criterion on the basis of which,
it can be tested that the whether the onus of the counterclaimant is
discharged so far as it relates to revocation of the patent by establishing the
material facts necessary for the same. The existence of the said events is
essentially a question of the fact and shall vary from case to case basis as
noted by Modern Law of Patents (supra). These factors are also inclusive
and not exhaustive as there may exists some more chain of events which
may prove helpful in arriving at the finding of obviousness to the person
skilled in art as attending circumstances peculiar to the said case.
67. It is also necessary to examine the legal aspect of onus of proof
involved in the revocation proceedings. It is well settled principle of law
that the onus of proof in the revocation proceedings is akin to the principle
of onus of proof involved in the civil cases which is on balance of
probabilities.
68. Sh. P. Narayanan in his book titled ―Patent Law‖ Fourth Edition,
published by Eastern Law House, has observed in relation to standard of
proof required in the revocation proceedings by citing English authorities
that the said standard of proof is based upon balance of probabilities and is
CS(OS) No. 89/2008 Page No.66 of 275


not beyond the reasonable doubt which is required in criminal cases. The
learned author observes in the following words:-
“15-16 Standard of proof required. The court will not
allow grants, which have on the evidence been proved to
be invalid to remain on the register. The court is not
concerned with proof beyond reasonable doubt which is
required in criminal cases, but with the normal
standard required in civil cases, namely proof based on
the balance of probabilities.” (Emphasis Supplied)
[Languerre‘s patent [1970] RPC 587 at 595 (a case of
revocation under s. 33 of the U.K. Act of 1949), decision
affirmed by CA [1071] RPC 384. See also Bonninton
Castings Ltd v Wardlaw (1965) ac 613 AND Halsbury‘s
rd
Laws of England, 3 Ed. Vol 15, p. 272‖]
69. On the reading of the aforementioned excerpts from the book of
learned author, it is amply clear that the onus of the proof which is required
to be discharged in the cases of the revocation and infringement proceedings
are based on the balance of the probabilities. The said onus of the proof
cannot be equated with the Burden of the Proof of criminal cases which is
that one has to prove the case beyond reasonable doubt.
70. This discussion on onus of proof in revocation proceedings became
necessary in order to delimit the scope of the enquiry as to weighting of the
evidence. This is due to the reason that the parties in instant case continue to
insist on the anomalies done by each other and also stating the lack of
evidence on either side one way or the other. Therefore, it has become
necessary to point out that the evidence of the parties are to be tested on the
balance of the probabilities. Though, the defendant had raised almost all
the grounds available in Section 64 of the Act. However, this Court inclines
CS(OS) No. 89/2008 Page No.67 of 275


to discuss only those grounds on which specific pleadings and evidence
adduced by the counter claimant.
71. Let me apply the principle of laws enunciated above relating to
obviousness and test the present case on the basis of balance of the
probabilities in order to see whether the defendant has discharged the burden
as to show the obviousness or lack of inventive step in the suit patent. I
propose to discuss the same by enumerating the following pointers:
1. The defendant has filed counter claim alleging the ground as to
obviousness or lack of inventive step of the suit patent IN‘774.
In order to support the ground, it is stated and documents to the
effect have been filed that the suit patent is anticipated by
EP‘226. The said document depicts the structure of the
compound as example 51 which seems to be similar in structure
and look with that suit patent but the same does not coincide
with the suit patent as it contains certain further treatments by
way of substitution of ethynyl at the third position with that of
methyl.
2. The defendant has also filed documents containing the
specifications of EP 477700, US 4138590, US 5427766, US
5736534, WO 193004047though objected to that they are after
replication, which showed that in the field of derivative
compounds, it is not uncommon or unusual to substitute the
treatment of ethyl or ethynyl with that of methyl components.
The said documents are filed and marked as Exhibit DW 3/ 2 to
3/6 respectively. I think the said documents have been filed by
CS(OS) No. 89/2008 Page No.68 of 275


the defendant after the replication to the counterclaim has been
filed after framing of issues. The admissibility of the said
documents have been questioned by the learned counsel for the
plaintiffs that they are not to be admitted in evidence as no
permission was sought in this respect from the Court and the
plaintiffs are taken by surprise. I have answered this in detail in
the later part of the discussion.
3. The defendant has filed an affidavit of Mr. Nangia (DW-3) as
expert who has explained in his words as to how the suit patent
is anticipated by EP‘ 226. It has been explained in the said
affidavit in detail as to the aspect of arriving of the said subject
invention on the basis of the teachings of the Zeneca patent
which is EP‘ 226.
4. The learned counsel for the plaintiffs has cross examined Mr.
Nangia DW-3 where under DW gave some answers to the
question which may mean that the witness has analyzed the said
patents on the basis of instructions of Solicitors and has less
knowledge of the Patent law, DW also has been cross examined
on the aspect of hindsight and the fact that there are number of
the compounds revealed by the plaintiffs suit patent IN774.
5. On reading the depositions of Mr. Nangia, the following
position emerges:
 That DW3 has deposed positively that the chemical
structure of EP‘226 which looks someway similar in the
structure to the chemical structure of the suit patent with
the reaction of methyl component at the third position
CS(OS) No. 89/2008 Page No.69 of 275


finds mention in the one of the example 51 of the
EP‘226.
 That DW has deposed that US 534 and other patents
cited in the documents someway indicate the use of
methyl and ethyl component.
 On the basis of the aforementioned two facts, the
conclusion was deduced by DW 3 that due to the reason
that the inventor Mr. Arnold was common in US 734 and
US‘ 498 which corresponds to IN‘774, therefore the said
Indian patent was obvious to the person skilled in art.
Likewise, Mr. Nick Thatcher PW3 and Mr. Robert Griffin PW2
have filed the affidavits.
6. The defendant has cross examined the plaintiff‘s witnesses
PW3 and PW2 who state that they are the experts. However, the
careful reading of the depositions made in the affidavits would
reveal that the said experts nowhere inform in the express terms
as what was the lead compound for the purposes of arriving at
the invention, what steps were taken from to time in order to
work upon the said compound from time to time and thereafter
as to when eventually the said compound was arrived at. The
expert evidence as well as the evidence by way of affidavit is
completely silent about the same.
7. The defendant has been able to cross-examine the plaintiffs‘
witnesses which reveal that the plaintiffs‘ witnesses inform that
they were not involved in the research of quinazoline
derivatives with the owners namely OSI which is answer to
CS(OS) No. 89/2008 Page No.70 of 275


question Nos.15 and 16, the said witness PW2 Roger Griffin
informs that he is not into the field of quinazoline derivatives
but into quinazolinone. Though he denies the suggestion that he
does not have the knowledge about the same. The said witness
further states on being asked that the he is not aware the name
of the scientists who have invented the suit patent. Accordingly
if the said expert witness does not properly know about the
derivatives in question, nor himself worked upon the invention,
not is even aware of the said scientists who are involved in the
invention, not even consulted with the plaintiffs at the relevant
time of 1995 when the invention was made and the said witness
deposes in the affidavit everything relating to experimentation
and working on of the invention on the ―might have been‖ basis
or ―would have been‖ basis, it can be safely said that the said
witness is not aware of the state of affairs through which the
said invention has passed through including the number of
experiments, work upon done on the said invention in order to
arrive at the desired result.
It can also be concluded in view of statements contained in the
affidavit of Roger Griffin that the said deposition on what ―might
have‖ happened or ―would have‖ done basis are all speculative in
nature. The witness is not aware personally as to whether the said
happenings and steps of experimentation narrated in the affidavit have
in fact actually taken place. Under these circumstances, it is one of the
probabilities which may have happened as per the witness who is
CS(OS) No. 89/2008 Page No.71 of 275


himself not aware of the state of affairs through which the invention
passed through.
72. Mr. Thatcher (PW3) has been cross examined at great length by the
defendant where also similar answers are coming forth. Mr. Thatcher in his
affidavit indeed deposes about some kind of efficacy which may be shown
in clinical trial but the same is again not clarifying the aforestated questions,
which goes into the root of the matter. The said affidavit again informs about
clinical trial about efficacy tests but does not inform and deposes as to what
were the steps defining the work upon done on the said patent invention
from time to time and how many trials were made in order to arrive at
Ernotilib Hydrochloride. Such depositions if could have been filed and made
in the affidavit by the scientist or research and department official of the
plaintiff company involved in invention could have brought forward the
positive case of the plaintiffs in relation to innovativeness and inventive step
which is missing in the present case.
73. Mr. Salve, learned senior counsel and Ms. Pratibha Singh both have
submitted that the impugned patent is obvious and is based on EP‘226 by
making comparison of specification of EP‘226 vis-à-vis that of IN‘774 and
its connected US Patent in the following manner:
 It is submitted that the Patent specification (Exhibit PW1/5) consists
of the following Sections;
1. Background of the Invention.
2. Summary of Invention.
3. Detailed description of the Invention.
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4. Examples
5. Claims
The specification was originally titled as “Quinazoline Derivatives”
OR “Quinazoline Derivatives Compound and Composition” . Thereafter,
finally, the title was changed to the present title which is “A novel [6,7-
bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine
hydrochloride and a process for preparing the same”.
74. It is submitted that it is important to note the fact that this change took
th
place in February, 2007 i.e. 14 February, 2007 when the original 27 claims
were replaced with 2 claims i.e. One Product Claim and One Process Claim.
The reading of the specification does not disclose any connection
whatsoever with the Claims as granted except for one Example i.e.
Example 20.
75. Counsel for defendant also submits that after analysis of the
specification reveals that this is nothing but cut and paste job done by
alleged inventor. He relied upon the following:-
A. Background of Invention: The entire Background of the
Invention has been copied word to word from EP566226
(Exhibit D-6) and WO 1995023141 (Exhibit No.PW2/D1 and
Exhibit P2/DA).
B. Summary of Invention: Coming to the Summary of the
Invention, it deals with the Markush Formula consisting of
several compounds and the possible substitution thereof. The
purpose of the Invention merely mentions the various
substitution and does not give any reason whatsoever as to why
CS(OS) No. 89/2008 Page No.73 of 275


the said substitutions have been made. Out of 100 compounds
mentioned in the Summary, only one line at Page-6 line 22
mention the claim compound. None of the remaining
compounds contained in that summary has any connection with
the Claimed compound. The statement at Page-10 with relation
to hyperproliferative disease in mammals is extremely general
in nature.
C. Detailed description of the Invention: In the detailed
description of the invention, the first line mentions that the
compound in Formula 1 and the pharmaceutically acceptable
salts may be prepared by any process known to be applicable to
the preparation of chemically-related compound. After saying
so, different processes are discussed. The entire detailed
description relates to processes and has no mention of NSCLC.
In fact in the detailed description at several places as per the
language of the specification recognizes that these are known
procedures. For instance:- Page-14 line 30, Page-15 line 15,
Page-15 line 26, Page-16 line 1, Page-18 line 14, Page-18 line
33, Page-19 line 3 to 4, Page-19 line 8 to10, Page-22 line 26,
Page-27 line3. Even the detailed description is not sure of the
kinds of effect that the compound may have. This is clear from
Page-20 line 31, Page-21 line 2, and Page-27 line 7.
He also relied upon various compounds disclosed in EP‘226
which have been picked up and the Methyl with Ethynyl
substitution has been made. Methyl and Cyno are shown as
substituent in EP‘226. By applying the well known principle of
CS(OS) No. 89/2008 Page No.74 of 275


Bioisosterism, Methyl and Ethynyl substitution is known in the
art.

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76. It is also argued by the defendant‘s counsel that the said substitution is
in several of the compounds disclosed in EP‘226. The examples disclosed in
the suit patent are a mere variation of Methyl and Ethynyl compared to
EP‘226. From this it is clear that when the patent was filed, it contained no
inventive step whatsoever and it was merely a trial and error long sought
which was being tried by the Applicants. The fact that more than one
example is a copy of compound specifically disclosed in EP‘226 further
establishes that this is nothing but a combination method without any
CS(OS) No. 89/2008 Page No.80 of 275


inventive step. What appears to have happened in the present case is in the
compound disclosed in EP‘226 or other similar Claim of Quinazoline
Derivatives have been altered by substituting Methyl/ Flouro with Ethynyl in
order to arrive at the IN‘774. If not for this explanation, there could be no
other explanation whatsoever as to how the same very substitution using
Ethynyl has been made in so many compounds. There is also no discussion
whatsoever in the entire specification as to what are the effects of such
substitution & the efficiency of each of the compounds disclosed. There is
also no comparative data or any data relating to studies.
77. The closest prior art for this case in comparison with the Claim 1 is
Example 51 of EP‘226. The said example 51 is one of the preferred
compounds in EP‘226 and even by applying the test of obviousness the
compound preferred in EP‘226 is a good starting point. There is no
disclosure in the specification as to how claimed compound in Claim 1 is a
technical advancement of example 51 of EP‘226.
78. EP‘226 patent related to ―quinazoline derivatives, or pharmaceutically
acceptable salts thereof, which possess anti-cancer activity,‖ as well as their
methods of manufacture, pharmaceutical compositions containing them, and
the compounds‘ use in mammals.
The following disclosure was provided for example 51 of Zeneca‘s
European patent application No.0566226:
―Example 51
2–Bromoethyl methyl ether (D.834 g) was added to a
stirred mixture of 6,7–dihydroxy–4–(3'–
methylanilino)quinazoline (0.534 g), potassium carbonate
(0.828g) and DMA (10 ml). The mixture was stirred at
CS(OS) No. 89/2008 Page No.81 of 275


ambient temperature for 16 hours. The mixture was
evaporated and the residue was partitioned between ethyl
acetate and water. The organic layer was dried (MgSO4)
and evaporated. The residue was purified by column
chromatography using increasingly polarmixtures of
methylene chloride and methanol as eluent. The gum so
obtained was dissolved in ethyl acetate (4 ml) and acidified
by the addition of a saturated solution of hydrogen chloride
in diethyl ether. The precipitate was isolated. There was
thus obtained 6,7–di–(2–methoxyethoxy)–4–(3'–
methylanilino)quinazoline hydrochloride (0.292 g). m.p.
218–220°C.‖

79. In view of the aforementioned discernible facts and evidences
emanating from the records of the present case, I find that the defendant has
been able to establish the following:
 That there is an indication of some structurally similar compound
present in the form of example 51 of EP‘226. (except the position of
methyl which in the suit patent has been replaced with ethynyl at the
particular position)
 That there is some kind of similarity in the abstracts of specification
EP‘226 vis-à-vis with that EP566226 (Exhibit D-6) and WO
1995023141 (Exhibit No.PW2/D1 and Exhibit P2/DA and PW 1/5
which has resulted into IN‘774.
 That there can be a possibility of treatment of ethynyl instead of
methyl as they are related to the same kind of group of alkyl which is
done in the other patents relied upon by DW3.

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80. If one sees the afore-noted three facts emerging from the evidence of
the defendants, it is clear that the defendant has been able to show some
selection of the compound or range of compounds from the known range as
shown and depicted in EP‘226, but still it is not shown on record by positive
evidence as to how the said selected range is not far removed from the
known range and how the selection was arbitrary in nature. The answers to
the said two crucial material facts are essential in order to say that the
defendant has been able to successful discharge and displace the onus of the
proof lying upon him. This could have been done by the defendant by
showing clinically that the substitution of the compound containing ethynyl
component are not far removed from that of the methyl component. There
should have been depositions to this effect which are not there in the
affidavit of PW3. The said finding of far removed of the range cannot be
simply arrived at by mere look of the structure and assuming the state of the
affairs that it is so simple to the substitute the ethynyl with the methyl at the
particular position. Therefore, the defendant has not able to demonstrate as
to how the said suit patent compound or range is not far removed from the
one depicted in EP‘226.
81. As recorded above in the defendant‘s submissions, where in
comparison is done by defendant relating to compounds of EP‘226 with that
of the suit patent compound, it is clear that some range of compounds is
selected from the earlier range already contained in EP‘226 wherein ethynyl
position has been replaced at third position with that of the methyl or cyno
and others. The said argument has been considered but cannot be said to be
solely aiding the defendant towards the discharging the onus of the proof
casted upon it towards proving the reason behind of selection of the range
CS(OS) No. 89/2008 Page No.83 of 275


(whether arbitrary or purposeful). There should have been depositions in the
affidavit to the effect that the how the selection of such a range was arbitrary
and nor purposeful. I find the affidavit of Mr. Nangia DW3 is equally
speculative as he deposes that the substitution of the ethynyl and methyl can
lead to efficacy by vice versa basis. He deposes that there is no guarantee of
the desired result but the possibility. I think the said deposition does not
satisfy the criteria as to how the said selection of range was not purposeful
but arbitrary in nature. This should have been explained by the defendant
only once the defendant witness is so sure about the obviousness and further
deposing positively about the arbitrariness in the selection, which in fact has
not been done so in the present case. All this is seen above discussion that
there are same material facts which are required to be proved on which the
law is applied in order to arrive at the finding of obviousness. The said
submissions done orally by comparing the compounds and advanced at the
final arguments stage cannot take the form of depositions when none are
present in the form of depositions in the affidavits DW 1, 2 and 3 or in the
pleadings and therefore the third material fact relating to reason behind the
selection is not established.
82. Even if the case of the defendant as per the later submissions made
during final arguments is seen to be established, still, the material facts
relating to second and third requirements as noticed above still remain to be
established are as how the said selected range is not far removed from the
earlier range and how the said selection is an arbitrary selection of the
compound and why not purposive selection of the same. A submission is
canvassed at the bar that there are some similarities in the compounds cited
as examples in EP‘226 vis-à-vis IN‘774. The said example coupled with
CS(OS) No. 89/2008 Page No.84 of 275


later denotes the substitution of ehynyl with that of methyl a third position
and that is the reason why the said method is arbitrary and based on trial and
error. It is also stated that there are similarities in the abstract of the EP‘226
with that of IN‘774 with the specification initially filed as marked as Ex D6
which reveal that there is cut and copy job done by the inventor.
83. The said submissions are neither present in the written-statement nor
in the counter claim nor same are deposed in the affidavit of DW1, 2 and 3
towards establishment of the fact that the said working on the compounds is
arbitrary and based on trial and error. I find that the said submissions cannot
be believed in the abstract in the absence of the any positive evidence
coming from the defendant‘s end showing some tenability of the same
clinically as to how the said invention could be arrived at on trial and error
method or selection is arbitrary. This could have been done by the defendant
by going step by step. Firstly to show the example from the known
compound, which the defendant has done, secondly to show as to how the
said selection is not far removed not merely by relying upon the structural
similarity or generally saying that the ethynyl or methyl could reap the
similar results but by clinically showing what is the effect of the said
working of ethynyl at the several positions and how it is not far removed
from EP‘226 and lastly by showing that the entire selection is arbitrary. All
this could have been done by the defendant in the affidavit by showing
positive evidence. Failure on the part of the defendant to establish the bare
minimum material facts would thus lead to inference as to non obviousness.
84. In the absence of the positive evidence from defendant to the effect
that the selection of the range is arbitrary by non application of mind which
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is crucial factor in discerning whether the said impugned patent is obvious or
not, It cannot be assumed on a priori basis that the mere fact that there exist
some similarities in the structure of ranges, the replacement of the third
position with ethynyl may follow and thus the said patent is obvious based
on trial and error method.
85. The defendant counsel has argued at length and it has also been
deposed that US‘ 534 along with the other specifications establish the
substitution of ethynyl and methyl components are usual.
I find that if the evidence to show the selection is arbitrary is not
present on record and even it is established on the record that there is a sort
of inspiration taken from EP‘226, the existence of the said fact, by itself
does not denote obviousness. This is due to the reason that it is seen in the
deposition of the PW-3 Nick Thatcher and in the other pleadings also stating
that there were certain defects in the medicine GEFTINIB and for the said
reason the said medicine was not able to cure the patients properly and
consequently was not recommended. Therefore, even if it is shown that the
starting point of the invention is EP‘226 and there are changes made in the
chemical structures cited as example compounds in the said patent by
reacting the same with ethynyl later on in relation to selected range, I do not
find that such selection can be arbitrary, rather it can be inferred that there
may be some further experimentations done in future on the Geftinib
compounds which eventually narrowed down the examples cited by the
defendant in its submissions, ultimately resulted into the claim No.1 of the
patent. All this rather indicates towards purposeful selection rather than
arbitrary one.
CS(OS) No. 89/2008 Page No.86 of 275


86. I am inferring this in view of totality of the circumstances, the
plaintiffs are engaging into manufacturing of the drugs, their inventors
surely are the persons skilled in the field and are aware of quinazoline
derivatives and the compounds therein. Of-course, the inventors cannot
change the main compound as the said characteristic of curing the cancer
emerges from the said very compound which is a quinazoline derivatives.
The plaintiff‘s inventor being a conscious person is equally aware of
the defects in the pre-existing medicine or compound and its inability to cure
the disease properly and therefore would select the range from the point
from where the last research ended. Therefore, there is no harm so far as
taking the compounds from the previous state of the art is concerned unless
it is further backed by the evidence that the said selection and the working
thereupon is not far removed from the known range, further that the said
selection and the working is arbitrary in nature. On the other hand, it
indicates that inventor was conscious about the existing state of art.
Accordingly, even if the range from EP‘226 is selected by the plaintiffs to
conduct the further workings upon the same, unless shown contrary, it
cannot be said that the said selection to be an arbitrary one.
87. Another reason which persuades me to infer to the contrary in the
absence of the evidence is that there is a commercial success of the medicine
worldwide which has been widely recognized and the same is proven to be
successful medicine. This is clear from the depositions of PW 3 Nick
Thatcher. It is true that the said commercial success per se is not
determinative of the fact that there is a non obviousness, but it at least
somehow acts as an attending circumstance to show that there could have
CS(OS) No. 89/2008 Page No.87 of 275


existed the purposeful research on the existing state of the art by the person
who is skilled in the art, who has made certain experiments and by
narrowing down the compounds resulting in a single compound which has
been widely successful and efficacious.
88. Such inference of non establishment of the arbitrary selection is due to
the reason that lack of the evidence in the form depositions of defendant‘s
witnesses showing the existence of the said material fact which is that the
said selection of the range is arbitrary. The only thing which is deposed by
Mr. Nangia (DW-3) that the inventor Mr. Arnold was common in US‘ 534
and US 498 and therefore, he was fully aware of the substitution of
capability of methyl with that of the ethynyl component. I find that by itself
does not explain as to how the said selection of the range from EP‘226 is
arbitrary. If the inventor is common to US 534 and US 498, that event itself
show that the inventor is skilled in the art and is continuously working
towards the making of anti cancer drugs, but the same nowhere indicates
that his selection may be random or arbitrary.
89. The defendant has not been able to fully discharge the onus of proof
of establishing the obviousness due to non establishment of three material
facts. After appreciation of the evidence of the competing parties, I find that
the defendant has not been able to show as how the selection of the range of
the compound was arbitrary as merely contending vociferously without any
deposition will not suffice. On the other hand, plaintiffs though have
responded to the defendant‘s case by pointing out number of mistakes on the
part of the defendant. The defendant has not pointed out whether the lead
compound was example 51 of EP‘226 or not.
CS(OS) No. 89/2008 Page No.88 of 275


90. On balance of probabilities, it can be said that the defendant is not
able to discharge the onus lied upon him, though the defendant was able to
show that there is a selection of range from the compound which is not far
removed at least structurally but has failed to established that the role of the
said change in the reaction is bare minimal or the said reactants are known to
the person skilled in the art. It is also not established on record clinically to
show as to how the suit patent compound is not far removed from the
selection or example 51 of EP‘226 by positive evidence in the form of
depositions and I find the structural similarity on the look and perusal is not
the decisive of this establishment of the far removed material fact.
91. The said material fact goes into the root of the matter and affects the
case of the defendant, consequently must be given the treatment prescribed
in the law as per the stages of the suit. To sum up, the bundle of facts or
chain of events leading towards inference as to the obviousness of the patent
are not clearly established on record as per the evidence of the defendant.
The similar is the case with the plaintiffs but the same remains
inconsequential as the initial onus by satisfying the three requirements was
on the defendant which the defendant failed.
92. Again, it is reiterated that what has been stated in Biswanath Prasad
(supra) that the inventive step is a mixed question of fact and law and not a
pure question of law which means that both the parties should discharge the
onus on facts as well as in law, as to how the innovativeness cannot be
ascribed to particular invention and corresponding response to dislodge the
case.
CS(OS) No. 89/2008 Page No.89 of 275


93. Even if one sees in law whether this kind of inference was correct
then it is again worthy to go back to the Biswanath Prasad (supra) where the
Hon‘ble Supreme Court had drawn the inference as to non obviousness on
the basis establishment of six discerning facts which are as under :-
“The learned trial Judge, after a careful appraisal of the
evidence produced by the parties, found that the following
facts have been established:
"(i) The manufacture of utensils is an old industry at
Mirzapur and at other places in U.P. and in other parts of
India;
(ii) lathe is a well-known mechanism used for spinning
and a number of other processes; (iii)adapters were in use
for holding turnably, articles (7) of suitable sizes, for
holding plates and dishes, also, were in use before 1951;
(iv) the tailstock was probably used in this industry before
1951;
(v) no bracket or angle, as used in the defendant's
machine (Ex. CC) appears to have been used in this
industry before 1951;
(vi) work on plates and dishes was suspended at Mirzapur
for a few years before 1951."
94. The learned trial judge in the said case of Biswanath (supra) exactly
criticized the evidence of inventor by saying that they have not shown as to
what was going through the mind of inventor at the time of working upon
the invention and also how many experiments were carried out. Para 48 of
the said judgment of Hon‘ble Supreme Court recording the trial Court
findings is reproduced below:-
“48. The learned trial Judge then noted that Purshottam,
who was stated to be the inventor, and, as such, was the
CS(OS) No. 89/2008 Page No.90 of 275

95. Thereafter, the Hon‘ble Supreme Court affirmed the finding of the
learned trial judge by observing that they do not find any piece of evidence
as misread and overlooked or omitted from the consideration and view
expressed by the trial judge as reasonable and entitled to be given due
weight and proceeded to set aside the order of Division Bench which
interfered at that time the order of trial judge.
CS(OS) No. 89/2008 Page No.91 of 275


96. A careful analysis of Biswanath (supra) would reveal that in similar
circumstances also the evidence of patentee was criticized as to the reason
that no positive evidence was given to dislodge the claim of lack of novelty,
inventive step and obviousness. The same has attained judicial stamping of
Hon‘ble Supreme Court by observing it as weighty and reasonable approach.
Applying the same to the instant case which is based on the same facts, it is
equally reasonable in law to draw such inference as to the non obviousness
when the defendant has not been able to discharge the onus by showing the
material facts leading to inference of obviousness.
97. The only difference in the present case with that of Bishwanath Prasad
case (supra) is that on facts in Bishwanath (supra), the defendant therein was
able to discharge the onus by proving the material facts leading towards
obviousness which has been seen above in six points noted above in the
judgment of Supreme Court, and the patentee was not able to dislodge the
same. On the contrary, in the present case, the defendant has attempted to
move forward towards the direction of proving the said facts, however, not
able to establish on record as to how the said substitution of ethynyl with the
methyl was obvious on the date of priority of the US‘ 498 which 30.3.1995,
how the selected range is not far removed from the known compound, also
that how the said selection of compound range is not purposeful and merely
arbitrary. The plaintiffs evidence in response is equally weak and therefore,
the same can be criticized on the same count by not establishing the material
facts as to how the substitution of ethynyl with methyl is innovative and
steps towards the arriving of the invention by providing who conducted such
experiment, and how many and during what period.
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98. Accordingly, I reject all the submissions of the defendant on this issue
including the argument that the defendant has not shown what motivated the
plaintiffs to take example 51 as prior art, all other motivation submissions
without prejudice ones, the submission relating to replacement of ethyl from
methyl component, secondary consideration as to assuming obviousness.
99. I do not agree with submissions of the defendant that the mere fact
that there were commonality in the wordings of the specification of EP‘226
with that of US 498, there can be any inference which can be drawn as to
non obviousness as that the specification is copied from EP‘226. It needs to
be emphasized that the chemical research requires lots of experimentation on
the existing compounds. Therefore, the background of the inventions arising
out of the same molecule or compound may be same, may have similar
properties which may be expressed in the limited ways, therefore the reading
of the same may look similar in grammatically. But that does not testify the
fact that chemical compounds are the same nor the structural similarities are
decisive factor. The structural similarities may be one of the indicators that
the said invention or compound is derived from particular compound or set
of the compounds, but may not be sole criteria as per settled law. Unless the
other factors like selection of range, arbitrary nature of selection, are
established.
100. The defendant has sought to rely upon 5 patent documents namely EP
477700, US 4138590, US 4138590, US 5427766, US 5736734, WO
193004047 (DW 3/2 to 3/6) which are the documents filed along with the
st
replication on 31 March 2009 to show that the use of the ethynyl, methyl or
phenyl is as product substituent is not alien to chemical science and
CS(OS) No. 89/2008 Page No.93 of 275


therefore, the said change if any done by the plaintiffs in EP‘ 226 would
make the invention as workshop result. I do not find agreement with the
submission of the learned counsel for the defendant and also the depositions
made by DW 3 in this respect. My reason of rejecting such submissions can
be enumerated as under:
 Firstly the said documents are filed with this Court after framing of
th
issues which were framed on 18 September, 2008. In fact,
replication along with documents DW-3/2 to DW3/6 was filed after
producing the complete evidence of the plaintiffs. No leave of the
Court is sought to bring these documents on record. Order 8 rule 1 A
of the code of civil procedure provides as amended in the year 2002
mandates that the documents are to be filed along with the written
statement. There is another provision under the code which is order
13 rule 1 which also provides for the production of the original
documents. The said provisions read as under:
―Order VIII
[1A. Duty of defendant to produce documents upon which
relief is claimed or relied upon by him
(1) Where the defendant bases his defence upon a document
or relies upon any document in his possession or power, in
support of his defence or claim for set off or counter claim,
he shall enter such document in a list, and shall produce it
in Court when the written statement is presented by him
and shall, at the same time, deliver the document and a
copy thereof, to be filed with the written statement.
(2) Where any such document is not in possession or power
of the defendant, he shall, wherever possible, state in whose
possession or power it is.
(3) A document which ought to be produced in Court by the
defendant under this rule, but, is not so produced shall not,
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without the leave of the Court, be received in evidence on
his behalf at the hearing of the suit.].
(4) Nothing in this rule shall apply to documents—
(a) produced for the cross-examination of the plaintiff's
witnesses, or
(b) handed over to a witness merely to refresh his memory.]
Order XIII
[1. Original documents to be produced at or before the
settlement of issues
(1) The parties or their pleader shall produce, on or before
the settlement of issues, all the documentary evidence of in
original where the copies thereof have been filed along with
plaint or written statement.
(2) The Court shall receive the documents so produced
Provided that they are accompanied by an accurate list
thereof prepared in such form as the High Court directs.

(3) Nothing in sub-rule (1) shall apply to documents,-
(a) produced for the cross-examination of the witnesses of
the other party, or
(b) handed over to a witness merely to refresh his memory.]

101. On the plain reading of order 8 rule 1 A (3), it is manifest that there is
legislative command engrafted in the said provision which is not to receive
the documents in evidence which ought to have been filed and produced by
the defendant under this but has not been produced. The Court‘s discretion
to receive such document is conditional of the fact of defendant seeking to
leave from the Court to produce the said document on the record. The said
leave is thus a jurisdictional fact which enables the Court to exercise such
discretion as to the reception of the document in evidence which has not
been produced in the manner prescribed under Order 8 Rule 1A. The said
CS(OS) No. 89/2008 Page No.95 of 275


provision has been added after amendment which unequivocally speaks of
the said legislative mandate emerging therefrom.
102. The said provision of sub rule added in order 8 rule 1A is in pari
materia with the similar amendment effected in the order 7 rule 14 wherein
the similar sub rule 3 has been added by way of amendment and therefore
can be given the same interpretation as give to the corresponding sub rule 3
of order 7 rule 14. The said provision has come up for interpretation before
Courts from time to time. Recently, learned single judge of this Court
(Hon‘ble Badar Durrez Ahmed, J.) in the case of Gold Rock World Trade
Ltd. vs. Veejay Lakshmi Engineering Works , (2008) 149 PLR 40, has
interpreted the sub-rule 3 of Order 7 Rule 14 and arrived at the same
conclusion by observing the following:
―Plain reading of Order 7 Rule 14 (3) makes it clear that a
document which ought to be produced in Court by the
plaintiff when the plaint is presented, or to be entered in the
list to be added or annexed to the plaint but is not produced
or entered accordingly, shall not, without the leave of the
Court, be received in evidence on his behalf at the hearing
of the suit. The learned Counsel for the plaintiff submits
that leave of the Court ought to be granted to the plaintiff
for producing the additional documents referred to in the
application under Order 7 Rule 14 and as also for calling
the witness for producing the documents mentioned in the
other application. The learned Counsel for the plaintiff
referred to the decision of the Supreme Court in the case of
Salem Advocate Bar Association, Tamil Nadu v. Union of
India . With reference to paragraph 13 thereof, the learned
Counsel submitted that the Court may permit leading of
such evidence even at a later stage subject to any terms that
may be imposed upon by the Court which may be just and
proper.
CS(OS) No. 89/2008 Page No.96 of 275


4. I have heard counsel for the parties. The Supreme
Court decision in Salem Advocate Bar Association (supra)
was in the context of additional evidence. By virtue of the
1976 amendment, Rule 17-A had been introduced in Order
18. The said Rule 17-A granted discretion to the Court to
permit production of evidence not previously known or
which could not be produced despite due diligence. Rule
17-A of Order 18 was deleted by the Code of Civil
Procedure (Amendment) Act, 1999 which took effect on
1.7.2002. While considering the effect of this deletion the
Supreme Court observed:
13. In Salem Advocate Bar Assn. v. Union of India , it
has been clarified that on deletion of Order 18 Rule 17-A
which provided for leading of additional evidence, the law
existing before the introduction of the amendment i.e. 1-7-
2002, would stand restored. The Rule was deleted by
Amendment Act of 2002. Even before insertion of Order 18
Rule 17-A, the court had inbuilt power to permit parties to
produce evidence not known to them earlier or which could
not be produced in spite of due diligence. Order 18 Rule
17-A did not create any new right but only clarified the
position. Therefore, deletion of Order 18 Rule 17-A does
not disentitle production of evidence at a later stage. On a
party satisfying the court that after exercise of due diligence
that evidence was not within his knowledge or could not be
produced at the time the party was leading evidence, the
court may permit leading of such evidence at a later stage
on such terms as may appear to be just.
Thus, the Supreme Court held that the insertion of
Rule 17-A was only clarificatory of the in-built power of
the Court to permit parties to produce evidence not known
to them earlier or which could not be produced in spite of
due diligence. The learned Counsel for the plaintiff sought
to invoke this in- built power of the court even in respect of
Order 7 Rule 14(3) which relates to production of
documents at a belated stage. There would be no difficulty
in holding that the in-built power referred to in the said
CS(OS) No. 89/2008 Page No.97 of 275


Supreme Court decision could also be invoked when the
question of granting leave arises in the context of Rule
14(3) of Order 7. Consequently, before leave of the Court
can be granted for receiving documents in evidence at a
belated stage, the party seeking to produce the
documents must satisfy the Court that the said
documents were earlier not within the party's
knowledge or could not be produced at the appropriate
time in spite of due diligence . It has been submitted by the
learned Counsel for the defendant that the documents
pertain to a settlement between the plaintiff and a foreign
party (COGETEX). The settlement was arrived at, as per
the statement recorded in the cross-examination of PW1, on
7.10.1996. However, there is not a whisper of this statement
even in the replication which was filed on 11.9.1997. In
fact, the affidavit by way of evidence was filed by the
plaintiff in the year 2003 and even in that affidavit, there is
no reference to the documents which are now sought to be
introduced . In my view, these circumstances clearly show
that the conditions necessary before leave of the Court
can be granted have not been satisfied. It cannot be said
that the plaintiff was not aware of the documents
earlier, or that the same could not be produced in spite
of due diligence on the part of the plaintiff. All the
material now sought to be introduced, was well within
the knowledge of the plaintiff at least in the year 2003.
As the plaintiff was not diligent enough at that point of
time, this Court is left with no alternative but to reject
its request.”(Emphasis Supplied)

103. I find that the similar situation has arisen in the present case. Till the
final arguments were addressed in this matter, the defendant had never made
this attempt to bring the said documents on record. No application for
seeking a permission of this Court has been preferred which enables the
Court to exercise such discretion vested in the Court. The plaintiffs have
strongly objected to taking these documents on record and its admissibility
CS(OS) No. 89/2008 Page No.98 of 275


at the time of recording of the evidence of DW3 Mr. Nangia and the said
objection has been categorically recorded by the learned LC Mr. S.M.
Chopra leaving it to this Court to decide. In the absence of any leave sought
from the Court which leaves no room for the Court to exercise any such
discretion, I upheld the objection raised by the learned counsel for the
plaintiffs as no steps have been taken by the defendant to cure such
objection till date by seeking a permission of this Court. Therefore, the
question of taking the documents on record at such belated stage after the
commencement of trial does not arise unless the leave of the Court is sought
in the prescribed manner providing the sufficient reasons for non-filing at
the earlier stage. In fact these documents were filed along with replication
in counter-claim filed by the defendant and after production of evidence of
plaintiffs. In case, these documents are taken on record, I am of the
considered view that a great injustice would be done to the plaintiffs as no
chance of rebuttal at present would be available.
104. Even if the said documents in the form of 5 patents are looked into for
my satisfaction and conscious, it is seen that EP 700 relates to antiviral
agents where there has been use of methyl and ethynyl in relation to
reactions. I think the said argument is misconceived and based on lack of
understanding in chemistry. Everybody knows this fact that methyl, ethynyl
and phenyl also belongs to alkyl group and no one can deny this fact and the
same can be reacted interchangeably. The defendant is showing 5 patents to
show the same, I would say there may exist numerous of them where there
experimentations are done on the basis of the methyl, phenyl, ethynyl from
time to time to see the efficacy in relation to different fields of chemical
compounds and process. But that by itself does not really answer the
CS(OS) No. 89/2008 Page No.99 of 275


question, the question is that why there would be an arbitrary adoption of
example 51 and why the said plaintiff would apply and react the ethynyl
only by replacing the methyl at the third position, when the as per the
plaintiffs version which is not disputed by the defendant EP‘226 teaches to
keep the methyl component stable and not variable. The said patents cited
relating to different fields of derivative compounds containing reaction with
ethynyl or methyl are thus irrelevant for the purposes of adjudging the
obviousness of the present suit compound which quinazoline derivative.
 The only patent out of 5 ones is US 534 which relates to Quinazoline
derivatives invented by Mr. Arnold who is common inventor of the
present patent and the said application was filed as PCT application
on January 27, 1995 and thereafter the patent which the defendant is
relying upon was filed in US in the year 1996. To this, the response
of the plaintiffs is that the said application as PCT was published on
August 31, 1995 and prior to the same, the same cannot be treated as
prior art to the plaintiffs patent US 498, the priority date of which is
March 30, 1995, I agree with the submission of the plaintiffs. The
prior art in the form of prior patent can be said to be pre published
document only when the said patent gets published prior to the
priority date of the application filed before the patent office.
Therefore, till the time, the PCT version of US 534 was not published
on August 31, 1995, the US 498 filed on March 30, 1995 as a priority
date cannot be anticipated by way of the said PCT application.
 Further, the said invention provides again some references to methyl,
ethynyl at 6 and 7 position and the said compound was structure wise
CS(OS) No. 89/2008 Page No.100 of 275


is totally different though it has common quinazole core.
Accordingly, the mere presence of methyl and ethynyl reactions at
the different place would not make the patent obvious. If the
defendant is argument is to be believed that the methyl and ethynyl
reactions are so common and was present in EP 534, then it is
noteworthy to mention that EP‘226 is mentioned as prior art even in
US 534, If it was so obvious to the person skilled in the art, then why
the inventor who is Mr. Arnold and the owner of US 534 which is
Pfizer, who was also the stakeholder in US 498 and IN‘774 in the
instant case earlier with the plaintiff No. 2 herein had to wait to apply
for US 498 for months together, then the same very patentee as the
defendant states that he was aware of methyl and Ethynyl substitution
could have easily arrived this successful compound even prior to
arriving at US 534 but in fact it is not so in the instant case. What
follows from the same is that it is not so easy to assume that the mere
fact that there is ethynyl or methyl reactions are known and therefore
the result is the suit patent compound unless it is backed by positive
evidence which is missing in the instant case.
 Mr. Nangia DW 3 deposes that US 534 provides a vital information as
to substitution capacity of ethynyl and methyl component, I think the
same again is not positive evidence to show as to how US 534
teaches where to apply to ethyl and methyl component in to which of
structures or range of compounds and at which position, the
deposition is therefore as good as saying that the mere fact ethynyl
and methyl components are used, the reasonable person skilled in art
would arrive at the suit compound, I have already answered above
CS(OS) No. 89/2008 Page No.101 of 275


about the mere existence of ethynyl and methyl as reactant unless
their role as reactants are defined is inconsequential to infer
obviousness.
 Mr. Nangia (DW3) also deposes that Mr. Arnold as a common
inventor was fully aware of the interchangeability of methyl and
ethynyl amongst other at the c phenyl ring appended to the 4-
hetrocycle position of quinazoline and on the basis of such
knowledge, it would have been obvious for him to try a similar
interchangeability in N- phenyl quinazolines, I again find that the
said deposition is based on speculation and not on cogent medical
reasoning, as the US 534 nowhere teaches as to which of the
compound of quinazoline derivatives like example 51 in EP‘226, the
said interchangeability is to be effected nor does the said patent talks
about phenyl quinazolines which is relating to the suit patent, further
the position or the place of the reaction is also not made obvious.
Therefore, the said depositions made are again based on one premise
which is that the reactant methyl and ethylyne interchangeability
which per se is inconsequential.
 The order of controller of the patents dated 27.6.2007 in respect to
pre-grant opposition to IN 77 wherein the said opposition was filed
by Natco Pharmaceuticals also analyses on similar count the prior
arts containing some relevance pertaining the substitution of methyl
with that of ethynyl component. Similar are the prior art documents
DW 3/2 to 3/6 relied by the defendant now in order to enable this
Court to infer such obviousness. I reject the same in view of finding
the concurrence with the findings of the Controller that the said
CS(OS) No. 89/2008 Page No.102 of 275


document does not reveal as to how the applicant for the patent learnt
about the said reactions, where to react, why not to react with phenyl
and at what position. Therefore, the similar prior arts are rejected. So
far as the emphasized prior art US 534 is concerned, my answers in
specific are recorded above.
In view of the same, I find that the documents which are marked as
DW 3/2 to 3/6 are not relevant for the purposes of showing the obviousness
of the suit patent compound on the basis of EP‘226. And these cannot be
considered otherwise an opportunity has to be given to the plaintiffs to rebut
the same in evidence and a great injustice and prejudice would be caused if
the same are taken on record.
105. There is a related argument raised relating to technique of Bioisosteres
which as per the defendant is groups or substituents having similar chemical
or physical properties that impart similar biological properties to a chemical
compound. As per the defendant, the suit patent could have been arrived at
by using the said technique and therefore the suit patient is obvious. The said
argument in other words means the substitution of ethynyl with that of
methyl being a component of the same group which can make the suit patent
obvious by knowing about the said concept. My answers to this would be the
same as recorded in preceding paragraphs relating to the prior arts
containing some hint towards the substitution of ethynyl with that of methyl
or vice versa. The question is not merely substitution which may be one step
towards obviousness but there should something more to indicate as to how
the skilled person in the art would be persuaded to apply the said component
with the compound and what position. The evidence relating to the same is
CS(OS) No. 89/2008 Page No.103 of 275


still missing from the defendant‘s end which does not indicate that it is
merely an arbitrary selection and not purposefully.
106. So far the decision of District Court of Delaware in the case of OSI
Pharmaceuticals LLC & Ors. v. Mylan Pharmaceuticals is concerned where
there is some finding that the US equivalent of the suit patent is not obvious,
I find the same is not relevant as after the due consideration of the entire
evidence lead by the parties on record in the present case, the inference as to
lack of inventive step has been drawn due to the plaintiffs have not been able
to set up a positive case so as to ascribe inventive step to the suit patent. In
view of the same, even if the said judgment is considered which is of
District Court of foreign jurisdiction having merely persuasive value may
not be able to influence the final conclusion reached by this Court on
weighting the evidence of parties in the present case, thus the same is not
applicable to the present case.
107. Various English decisions were referred to by both parties as
discussed earlier in detail the jurisprudential difference existing in the tests
adopted by the Courts in India with that of Courts in US. Thus, due to
operation of the said doctrinal tests like motivation, suggestion and teaching
and others existing in US which gives a kind of presumption of validity to
the patent but similar position does not happen to the Indian jurisdiction
where the patent is always vulnerable to challenge unless displaced by
positive evidence. The details of several decisions referred by the plaintiffs
in support of the arguments of motivation, suggestion and teaching tests are
given as under:
a. Technograph v. Mills & Rockley , 1972 RPC 346 at Pg. 355 (35)
CS(OS) No. 89/2008 Page No.104 of 275


b. Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007) at pages
10, 11, 17-18, 21 [reported as 492 F.3d 1350]
c. Daiichi v. Mylan, 670 F . Supp.2d 359 at pages 14-15
d. Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., Nos. 2005-1396, -
1429, -1430 (Fed. Cir. 2006) , at pages 9 [reported as 471 F.3d
1369]
e. Star Scientific v. RJ Reynolds, No. 2010-1183 (Fed. Cir. 2011) at
Pg 17, 19-20 [reported as 537 F.3d 1357]
f. Apotex v. Sanofi , 2008 SCC 61 at paras 79, 87, 90 and 92. Eisai Co.
v. Dr. Reddy’s Laboratories, 2007-1397, -1398 (Fed. Cir. 2008) at
pages 8, 9 [reported as 533 F.3d 1353].
g. Genetics Institute v. Novartis Vaccines and Diagnostics, 2010-
1264 (Fed. Cir. 2011) at pages 22-23, 25-26, 28- 29, 34-35
[reported as 655 F3d 1291 ]
h. Sabaf v. Meneghetti , 2003 RPC 14 para 43

i. Generics UK v. Daiichi , 2009 RPC 23 at para 22, 23 – Will not
pursue every avenue relentlessly if there is only the mildest motive
for doing so; must be obvious to try.

108. I may however notice that the said test of motivation, suggestion and
teaching seems to be one of the facets of the theory of the person skilled in
the art. However, its application of the same by the US Courts and
sometimes in EU in the distinct circumstances is such cases somehow leads
to the conclusion that challenge to the patents in the pharmaceuticals are
tested on the stricter tests and dismissed unless the said tests are qualified by
the person setting up challenge. Rather, I am of the view that the tests laid
down Supreme Court in Bishwanath Prasad (supra) relating ordinary
obviousness relating to Patents which have also been applied by the Courts
in England in the case of Court of Appeal in Dr. Reddy (supra). Therefore,
CS(OS) No. 89/2008 Page No.105 of 275


the decisions referred to by both sides delivered by District Court
whatsoever value they hold do not persuade me to change my decision.
109. The defendant has cited several decisions in order to support the
arguments of test for obviousness and structural similarities:
Test for Obviousness:
 KSR International Co. v Teleflex Inc., 550 U.S. 398 (2007)
 Altana Pharma AG v Teva Pharmaceuticals USA Ltd., 566 F.3d
999 (2009)
 Application of Gerald McLaughlin, 443 F.2d 1392 (1982)
 Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd.
[1985] R.P.C 59
 Actavis v Novartis [2010] FSR 18
 Glaverbel SA vs. Dave Rose & Ors MIPR 2010 (2) 0046

Structural Similarities:
 In re Petering and Fall; 133 USPQ 276
 In re Dilon; 16 USPQ 2d 1897
 In re Merck; 800 F. 2d 1091
 Richard Ruiz v A. B. Chance Co., 69 USPQ.2d 1686
Likewise, the plaintiffs have also relied upon the following decisions
relating to success rate or efficacy may be considered to be secondary
consideration to the obviousness and other legal aspects:
Case laws on secondary considerations:
i. Technograph v. Mills & Rockley , 1972 RPC 346 at Pg 360 (line 30)
ii. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p.
506 (line 26-27).
iii. Star Scientific v. RJ Reynolds, 537 F.3d 1357 at p. 18, 20
iv. Eli Lilly v. Zenith, 471 F.3d 1369 at pages 14-15
v. Genetics Instt v. Novartis , 655 F3d 1291 at p. 30
CS(OS) No. 89/2008 Page No.106 of 275


vi. Eisai v. Dr. Reddy’s, 533 F.3d 1353 at p. 2
vii. Apotex v. Sanofi ,

Inventive Step and Obviousness
i. FH&B v. Unichem , AIR 1969 Bom 255 at para 13
ii. Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007) at p. 6
[reported as 492 F.3d 1350]
Because a patent is presumed to be valid, 35 U.S.C. § 282, the
evidentiary burden to show facts supporting a conclusion of invalidity,
which rests on the accused infringer, is one of clear and convincing
evidence.

iii. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p.
480 (line 15).
Line 15: ―It was common ground that when the validity of a patent is
attacked under the relevant provisions of Section 32(1) of the 1949
Act, the onus of proof lies, as regards each allegation, on the party
launching attack.
Who is a Person skilled in the Art?
i. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p.
498 (lines 15-27) – Obviousness adjudged by the person of ordinary
skills in the art and not the inventor (or his rival).

Hindsight is impermissible in an obviousness enquiry.
i. FH&B v. Unichem , AIR 1969 Bom 255 at Para 16
ii. Technograph v. Mills & Rockley , 1972 RPC 346 at pages 353 (line
40), 362 (line 35).
iii. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p.
505 (line 35).
CS(OS) No. 89/2008 Page No.107 of 275


iv. Sabaf v. Menenghetti , 2003 RPC 14 at p. 279-280 (Para 43,44) –
Dangers of hindsight are notorious;
v. Daiichi Sankyo v. Matrix Laboratories & Ors., 2009-1511 (Fed.
Cir. 2010 ) at pages 14, 15, 18 [reported as 670 F . Supp.2d 359]
Structural Similarity :
a. Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007) at p. 9, 19
[reported as 492 F.3d 1350]– Generalization should be avoided
insofar as specific chemical structures are alleged to be prima facie
obvious one from the other
b. Eisai Co. v. Dr. Reddy’s Laboratories, 2007-1397, -1398 (Fed.
Cir. 2008) at p. 4 [reported as 533 F.3d 1353].
c. Daiichi Sankyo v. Matrix Laboratories & Ors., 2009-1511 (Fed.
Cir. 2010 ) a at p. 11 [reported as 670 F . Supp.2d 359]

d. Genetics Institute v. Novartis Vaccines and Diagnostics, 2010-
1264 (Fed. Cir. 2011) at p. 22 [reported as 655 F3d 1291 ]
Mosaicing -
a. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p.
505 (line 35) – When assessing whether a person of ordinary skills
in the art would look at unrelated pieces of prior art to arrive at the
patented solution, ―(I)t is very dangerous and in law not
permissible to assess obviousness in the light of carefully selected
pieces of prior knowledge only.‖
b. Technograph v. Mills & Rockley , 1972 RPC 346 at Pg 355 (line 5),
356 (line 5)
c. Sabaf v. Menenghetti , 2003 RPC 14 at Pg 279 (43).

110. I may notice lastly that the finding arrived at as to non-establishment
of obviousness is due to the lack of evidence and deposition in the present
case wherein the defendant is not able to show by way of positive evidence
three requirements as to material facts leading up to obviousness in the
chemical compounds. If the chemical compounds are held to be obvious on
the basis of mere perusal and appearance of the structures and assuming that
CS(OS) No. 89/2008 Page No.108 of 275


the slight change here and there is inconsequential without a positive
evidence medically and clinically as to how the said reaction is immaterial,
then several novel compounds can be declared obvious by such exercise and
the same shall affect the research process adversely. The innovation or
invention in the sense of chemical compound is not merely to innovate a
new set of the compound per se but also making improvements in the
existing state of the art by taking the aid of the already existing compound
and working upon the same by way of experimentation by way of the
reactants. This is the reason why, the Court cannot simply be satisfied by
mere reliance of similar structure in the previous art and thereafter assuming
that slight substitutions are inconsequential. Therefore, the establishment of
the material facts is essential, which is missing in the present case.
Resultantly, no ground of obviousness or lack of inventive step under
Section 64 (1) (f) of the Patents Act is made out due to the inability of the
defendant to discharge the onus casted upon it.
Re: Patent violating Section 3(d) of Patents Act 1970 (as amended in
2005)
111. Now, I shall be proceeding to discuss the challenge which has been
set up the defendant in relation to Section 3(d) of Patents Act.
112. The defendant has raised in the counter claim a ground that the suit
patent violates Section 3(d) of the Patents Act by urging that the patent
applied by the plaintiffs is another form of the EP‘ 226 and therefore is an
attempt by the inventors like the plaintiffs to renew the patent of the
invention which has already pre existing in the art. Learned counsel for the
defendant in order to set up the said challenge has explained the concept of
CS(OS) No. 89/2008 Page No.109 of 275


the evergreening as well as the provisions of Section 3(d) by making the
submissions in the following manner:
113. It is submitted that prior to the introduction of Product Patents in
India, the country could derive and consider the vast experiences of global
markets where Product Patents have been granted with respect to
medicines/drugs. The experience of other countries revealed that there was a
practice in the pharmaceutical industry to increase the term of patents for
medicines and pharmaceutical substances by claiming different forms of the
same substance as being patentable inventions. This can be illustrated with
the following examples:-
 It is submitted that the term of a patent is 20 years. Unlike in other
countries, India does not have patent term of extension. [In USA,
patent term extensions can be granted under some circumstances].
 In India if a new drug is invented in the year 2000 and applied for a
patent, the term of the patent irrespective of whenever it is granted
comes to an end in 2020. However, this term of 20 years is sought to
be extended by pharmaceutical companies by applying for different
―forms‖ of the same molecule.
 This concept of increasing the term of the patent by claiming different
form of known substance as inventions is known as Evergreening.
 For e.g.: EP‘226 which was applied for by Astrazeneca UK Limited
was the main patent with respect to Quinazoline derivatives. This
patent disclosed a large number of molecules encompassed in a
Markush formula which could be effective in treating different forms
CS(OS) No. 89/2008 Page No.110 of 275


of cancer. One patent which was filed, originating from EP‘226 was
for the drug GEFITINIB. When GEFITINIB was applied for in India,
the same was rejected by the Patent office with the following
observations.
th
 The EP‘226 was published on 20 October, 1993. The Gefitinib
th
patent which is a selection patent from EP‘226 had a priority date 27
rd
April, 1995, it was filed in India on 23 April, 1996. The Defendant
has referred to EP226 as GEFITINIB patent only for the purpose of
convenience of arguments in pleadings.

 Pre-grant opposition was filed by NATCO and G.M. Pharma Ltd. and
the ground of anticipation and obviousness were raised. i.e. Exhibit
DW1/7 (NATCO order) is recorded as below;
―Opponent further argued that the applicant is merely
attempting to claim prior art in the quise of selection patent
and referred to a cited decision T-0124/87 of European
technical board of appeal.‖
In the Gefinitib patent the invention was claimed in the 7
metha positions in the Quinazoline molecule and R2 was
shown as 3‘ 4 diholo substituents. The applicant had also
provided reference to various foreign patents granted for
the Gefinitib for the specific molecule claimed in this patent
and even the comparative test data was provided.
The Controller held as follows:
―On the basis of the arguments and evidence given by both
parties I am of the opinion that the basic skeleton of the
prior art compound and the present invention are same.
The prior art also teaches chloro fluoro substituent in the
th
aniline attached to the 4 position of the quinozoline
CS(OS) No. 89/2008 Page No.111 of 275


th
molecule and a methoxy group at the 7 position of the
quinozoline. But I find that none of the compound
disclosed in the prior art is identical to the compound
disclosed or claimed in the proposed claim-1 in the present
th
application with respect to the 3, 4 and 7 position of the
quinozoline molecule. The prior art does not teach
exclusively the claimed compound. Therefore the said
selected compound of the present invention is novel over
the prior art.‖
―Regarding closest prior art issue I find that in the present
application following substitution has been claimed.
(a) 3‘ & 4‘ position; could be chloro or fluoro
th

(b) 7 position of quinozoline ring; Methoxy and
(c) ―….position of the quinozoline ring; a basic group.‖

―Following the above basis, I find that the compound of
Table 3 within example 34 comes structurally closure to the
claimed compounds than any of the compounds of example
26, 41 and 64 of the prior art in disclosing the same 3‘ 4‘
substituent and 7 – methoxy substituent. Therefore
compound 5 within example 34 is the closest prior art
compound, which would require minimum structural
modification in order to reach the compound claimed in the
present invention.
The requirement for a comparison with the closest prior art
is based on the principle of the structural dependence of the
properties of the substance i.e. on the fact that these
properties reflect the structure of the substances.
Therefore it is very difficult to accept the applicant‘s claim
of 16 fold potency of the compound of the present
invention against the compound disclosed in the prior art
because the comparison provided is not against the closest
prior art.‖
―I do not agree with the contention of the applicant that ―the
compound 5 of the example 34 of the prior art EP/0566226
CS(OS) No. 89/2008 Page No.112 of 275


was not considered for comparative test data as the same
compound did not contain a basic group‖. The technical
advancement could only be demonstrated by looking
forward from the prior art to the claimed invention and not
the other way around. The proper approach to demonstrate
the inventive step is to move forward from the prior art i.e.
the comparative test data should have been provided vis-à-
vis the structurally closest compound of the prior art which
in my opinion is the compound 5 of example 34 of
EP/0566226, because this compound of the prior art differ
from the claimed compound only in the presence of the
basic group, which the applicant admitted, play an
important role in the activity of the claimed compound.‖
―I agree with the opponent‘s contention that for the
demonstration of ‗technical advancement‘ must be shown
to have been achieved by a claimed invention vis-à-vis the
prior art by way of demonstrating the presence of an
unexpected effect over the closest prior art. Any
comparative test data provided against said compound 5 of
example 34 could have highlighted the criticality of the
‗basic group‘ in achieving an enhanced activity, which
could have formed the basis for the invention. Therefore, I
have no doubt that the applicant has failed to provide
comparative test data vis-à-vis the structurally closed
compound of the prior art.‖
The Controller of Patents thereafter further, holds as follows:
―Regarding patent ability under Section 3(d), I find that the
test data provided by the applicant does not substantiate the
applicant‘s claim or significant enhanced potency residing
in the selection of a basic group at 6-position of the
quinazoline ring. The applicant has attempted to claim
enhanced efficacy by demonstrating that the compounds of
the claimed invention possess 4 to 16 fold potency
compared to the compounds of the prior art. Based on my
findings under the ground of obviousness and lack of
inventive step wherein I concluded that the claim of the
CS(OS) No. 89/2008 Page No.113 of 275


applicant that the compounds of the present invention are 4
to 16 times more potent than the prior art compounds, are
not persuasive, I conclude that all the compounds claimed
in the present invention do not significantly differ in
efficacy compared to the prior art which is the explicit
requirement under Section 3(d) and therefore is not
patentable under Section 3(d) of the Patent Act.‖
For conclusion the Controller holds as follows:
―In view of my findings in the preceding paragraphs, I
conclude that the present invention as claimed in revised
claim 1 to 12 of the application number 841/DEL/1996 is;
(a) Novel over the prior art disclosure of EP 0566226
(b) Obvious and does not involve an inventive step over
the prior art EP 0566226;

(c) Not an invention within the meaning of Section
2(1)(j) of the Patent Act 1970;

(d) Is not patentable invention within the meaning of
Section 3(d) of the Patents (Amendment) Act.‖

The said order was not challenged by the Natco/opponent and
ultimately suit patent was granted to the plaintiffs.
114. The defendant, by placing reliance of the decision in the opposition
proceedings relating to the IN‘507 (which is a fresh application made by the
plaintiffs for registration of patent of Polymorph-B version and the same
was rejected by the controller of patent) which is an order of controller dated
15.12.2008 where there is a finding as to evergreening or violation of
Section 3(d) of the Patents Act; and the structural similarities existing
between the plaintiffs suit Patent IN‘774 as well as the EP‘226 more so
when both are derivatives of Quinazoline and all other contentions recorded
above, has urged this Court should consider the challenge and proceed to
CS(OS) No. 89/2008 Page No.114 of 275


hold that the suit patent violates the provisions of Section 3(d) of the Patents
Act.
115. Per contra, the plaintiffs while defending the counter claim for
revocation have given several reasons as to why this Court should not infer
any such violation of Section 3(d) by contending the following:
a) ―The defendant has alleged that the Erlotinib compound that has been
patented by the Plaintiffs is allegedly a ‗derivative‘ of ―Quinazoline‖
which is ―known‖ for its anti-cancer activity and hence, since no new
property or enhanced efficacy has been shown by the suit patent over
the known substance, the same is not patentable under Section 3(d) of
the Indian Patent Act. ( paragraphs 16-18 of the Written Statement;
paragraph 3.5-3.10 of the Counter Claim) .
b) In this regard, it is pertinent to note that the Defendant has not led
any evidence to prove this averment. However, in any event, the
averment of the Defendant is completely fallacious and does not merit
any consideration in light of the following:
i. It is submitted that "Quinazoline Derivatives" refer to a very wide
range/class/family of compounds having a common Quinazoline
ring, and the patented Erlotinib compound is just one specific
compound of this family. It has further been admitted by the
Defendant‘s expert witness that the Erlotinib compound was not
known as a drug or a compound in the year 1995 from which is the
date that the patent claims priority.
ii. Furthermore, it is pertinent to note that Quinazoline Derivatives
have diverse uses that are not targeted to anti-cancer activity or
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even limited to pharmaceutical uses. Quinazoline Derivatives are
also used as dyes, etc. Therefore, merely to infer from the term
'Quinazoline Derivatives' that a newly invented compound is a
'derivative' and hence have similar activity, obvious/non-
inventive/non-novel, would be illogical.
iii. Lastly, it is submitted that the Defendant‘s averment that no
efficacy data has been provided is completely erroneous. It is
submitted that the suit patent has specifically mentioned IC
50
values for the patented compounds.‖
116. The plaintiffs have also filed the evidence by way of affidavit of
Mr. Thatcher PW3 in order to substantiate that there exist some kind of
efficacy which has been deposed by the witness in his affidavit in the form
of reference to the clinical trial and other aspects of efficacy. The said
efficacy is deposed in the form of clinical trials conducted by the plaintiffs.
This aspect of efficacy involved in the suit patent is deposed in the affidavit
in order to show that even if the said derivative Ertolinib is found to be one
of the forms of the EP‘226 patent, still the same being an efficacious cannot
be presumed to be same substance by virtue of explanation appended to
Section 3(d).
117. I have considered the records of the proceedings in the present case in
relation to the challenge under Section 3(d) of the Patents Act. The onus was
again on the defendant at the first place to show as to how the plaintiff‘s
compound of Ertonolib Hydrochloride is a new form of known substance.
The defendant has set up a challenge on the ground of violation of
Section 3(d) in paragraph 3.5 and the said challenge runs uptil 3.10 of the
counter claim. Likewise in paragraph 17 to 19 of the written statement, there
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is a reference of Section 3(d) as ground of invalidity of the patent. The said
ground is taken by contending the following in particular:
1. The alleged patent for Erlotib is liable to revoked as being a
Quinazoline Derivative. The said derivative of the known compound
is thus not patentable. There are at least three patents which date back
since 1993 which disclose Quinazoline Derivative.
2. The defendant again provided similar averment in the counter
claim that the suit patent is derivatives of the prior arts compounds.
3. There is an aspect of lack of efficacy which is also mentioned
in the paragraph 3.5 to 3.7 of the counter claim in order to contend
that provisions of Section 3(d) are attracted.
118. In order to discharge the said onus, the defendant has relied upon the
documents showing the compounds in EP‘226 patent and also read the
observations of the Controller of Patents in this respect while finding that
IN‘507 is hit by Section 3(d). The DWs.1, 2 & 3, Mr. Gopalakrishnan,
Ms. Shashirekha and Mr. Ashwin Nangia do not depose anything specific in
their affidavits about the challenge as to Section 3(d) and rather the
depositions of Mr. Nangia attempted to show that the plaintiffs‘ product is
Polymorphic B version of the compound which is the subject matter of the
suit patent and the same is free from the combination of Polymorph A and B
of the suit patent. The said affidavit of Mr. Nangia though deposes as to how
the IN‘774 would be obvious to the person skilled in the art but does not
deposes as to how the IN‘774 is the new form of same substance based on
EP‘226.
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119. The defendant, however, has set up the challenge as to the clinical
trials relating to efficacy as relied by the PW3 Nick Thatcher. Learned
counsel for the Defendant did cross examination of Mr. Thatcher where
under, there were questions asked as to on whether the clinical trials relied
upon by the defendant are conducted on Tarceva or the suit patent, the
witness answered that the trials are conducted on both. No clear picture has
emerged so as to say with certainty from the cross examination as the said
clinical trials are either bad or were never conducted. It is correct that the
PW3 states that clinical trials were conducted in the years 2004 and 2005,
but that by itself is not conclusive of the fact that the clinical trials were not
related to the IN‘774 except to presume that by that time Polymorph B
version was in existence and therefore the said trials may or may not relate
to the suit patent compound. Besides this I find number of questions on
Polymorphism but no specific question or suggestion relating to the
Section 3(d) or evergreening is put to the plaintiffs‘ witness PW3 and PW2.
120. I have gone through the said averments in the counter claim, written
statement and depositions made in the affidavit and also the submissions of
the learned counsel for the defendant in this respect. I have already observed
that the depositions made by the Defendant‘s witnesses do not contain any
specific mention as to how the said patent of the plaintiffs in relation
Erlotinib Hydrochloride is the new form of what has been mentioned in the
EP‘226. The affidavit does depose that EP‘226 is a closest art. The said
affidavit of DW does not indicate except deposing that the same is falling
with in quinazoline derivative as to how EP‘226 and the suit patent are
derivative of each other. There should be some positive deposition towards
the same. The deposition of DWs do not contain the comparison as to what
CS(OS) No. 89/2008 Page No.118 of 275


was claimed in EP‘226 and what was granted in EP‘226, though it does
contain a mention that the example 51 of EP‘226 corresponds with the
structure of suit patent. It is also conceded position that the EP‘226 was
based on the treatment of Methyl component whereas the plaintiff‘s patent is
based on the treatment of the said compound with Ethynyl component. All
these are attending circumstances which would reveal that the defendant is
not able discharge the onus on the defendant to show that the suit patent
IN‘774 is new form of old substance which is EP‘226. However, it is not in
dispute that EP‘226 relates to quinazoline derivatives also contain some
compounds, which are structure wise akin to the suit compound excepting
the reaction of ethynyl at the third position, would do not axiomatically
permit this Court to believe that the suit patent IN‘774 is a new form of
EP‘226 unless shown clinically with some evidence.
121. It is one thing to say that the Patent lacks the inventive step in as
much as the same is obvious to the person skilled in art as the same may
amount to workshop result which is per se not patentable. However, it is
another thing to say the patent is a new form of the old substance which is
pre-existing. The line may be blurred between the two but there lies a subtle
difference. This is the reason why even the legislature thought it appropriate
to insert and define both the concepts separately under Section 2 (j) (a) and
Section 3(d).
122. There are some more facts which may be required to be proved which
include the complete analysis as to what was actually the old substance, how
it can be said to be same as that of the subject invention or new use of the
same substance. In the present case, though the defendant has stated in the
CS(OS) No. 89/2008 Page No.119 of 275


affidavit that there was a preexisting patent of EP‘226, but the defendant at
the same time could not provide any positive evidence as to whether the suit
patent coincides with the said compound which was the subject matter of
EP‘226 or new form of what is contained in EP‘226. There is an attending
circumstance which is that the suit patent specification corresponded with
EP‘226 which somehow seems to provide a hint that the plaintiffs had
worked on the EP‘226, but the presence of the same by itself nowhere
establish that the said compound is the new form of the same compound as
stated in EP‘226. I have already noticed and observed that there may be a
cases in chemical substances where the research is common and the same is
represented in a very limited manner, accordingly it is not safe to assume
that mere fact that there is grammatical similarity in the description of the
invention in abstract or in the middle may lead to the inference as to the
same substance or new form of the old substance. Yet another crucial aspect
is that there is no deposition in defendant‘s affidavit as to how EP‘226 and
the IN‘774 are the same or same substance. EP‘226 contains several
depictions of compound and out of which one of the example 51 form
alleged to be worked upon by the plaintiffs by further reactants in order to
arrive at the suit patent, the existence of the said fact itself cannot establish
that the suit compound is new form of the old compound, unless proven to
be contrary. Rather, the reaction with the new reactant may give birth to new
compound or new of the form of the old compound which the defendant is
supposed to establish and clarify but the defendant is unable to do in the
instant case.
123. Consequently, I find that so far as the challenge as to violation of
Section 3(d) is concerned, the defendant has not been able to discharge its
CS(OS) No. 89/2008 Page No.120 of 275


onus of proof. It is noteworthy the plaintiffs on the other hand has been able
to provide the evidence of the efficacy in the evidence of PW3 Mr. Thatcher.
The PW3 has also suitably deposed in the affidavit as to how the plaintiffs
patent Erlotinib is not the same as that of EP‘226 namely Gefitinib. The
cross examination of the PW3 deals with aspect of the clinical trials and
challenge to the same vis-à-vis EP‘226 but nothing can be inferred to the
contrary while going such cross examination. Accordingly, the plaintiffs
have been able to at least justify that the said product Erlotinib is not the
same as that of GEFTINIB. This has been done by the plaintiffs by
comparing the efficacy. The plaintiffs have not led any positive evidence in
the form of deposition before the Court (except comparing the structure as to
how they are structurally different), as to how the same shall not be called as
new form of the same substance either. However, considering the evidence
as to efficacy differences, it can still be inferred that the plaintiffs‘ patent is
not hit by Section 3(d).
124. So far the finding of controller in the opposition proceedings relation
IN 507 by way of order dated 15.12.2008 (Ex.DW1/12 ) is concerned which
is on Section 3(d) is concerned, the conclusions deduced by the controller
nowhere finds that the said IN‘507 is a new form of EP‘226 and rather the
said order finds that the said IN‘507 is Polymorphic form of Erlotinib
Hydrochloride which is IN‘774 compound. Therefore, the said finding of the
controller will not enable this Court to infer that the suit patent is hit by
Section 3(d) of the Act. The said order was passed in the application filed
by the plaintiffs for registration of Polymorph-B. The defendant‘s stands in
the said opposition and in the counter-claim filed in the present suit are
different. In case, the defendant‘s admissions made in the opposition to
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IN‘507 are applied here, the prayer made in the counter-claim is liable to be
rejected.
125. Accordingly in relation to aspect of Section 3(d), I find that the
defendant has not able to discharge the onus casted upon it. Thus, the
impugned patent is not hit by Section 3(d) of the Patents Act.
126. I therefore reject the submissions of the learned counsel for the
defendant on the count of Section 3(d). I think there is no reason to further
advert to case laws and legislative intendment relating to Section 3(d) when
I find that the defendant has not discharged the onus of proof on balance of
the probabilities on the count of the violation of Section 3(d) of the Act.
Re: Violation of Section 8 of Patents Act.
127. There is a ground which is raised in the counter claim set up by the
defendant that the impugned patent IN‘774 has been registered in violation
of the information which is required to be given to the patent office and the
patentee who is the plaintiff is guilty of not disclosing the material facts
before the patent office and also before this Court.
128. Before examining the ground of violation of Section 8 of the Patent
Act 1970 in the revocation proceedings, it would be wise to consider as to
what are the requirements of Section 8 of the Act and what kind of
disclosure is required to be given under Section 8 of the Act.
129. Section 8 of the Indian Patents Act, 1970 as amended in 2005 reads as
under:-
―8. Information and undertaking regarding foreign applications
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(1) Where an applicant for a patent under this Act is
prosecuting either alone or jointly with any other person an
application for a patent in any country outside India in
respect of the same or substantially the same invention, or
where to his knowledge such an application is being
prosecuted by some person through whom he claims or by
some person deriving title from him, he shall file along with
his application-
(a) a statement setting out the name of the country where
the application is being prosecuted, the serial number and
date of filing of the application and such other particulars as
may be prescribed; and
(b) an undertaking that, up to the date of the acceptance of
his complete specification filed in India, he would keep the
Controller informed in writing, from time to time, of details
of the nature referred to in clause (a) in respect of every
other application relating to the same or substantially the
same invention, if any, filed in any country outside India
subsequently to the filing of the statement referred to in the
aforesaid clause within the prescribed time.
(2) The Controller may also require the applicant to furnish,
as far as may be available to the applicant, details relating
to the objections, if any, taken to any such application as is
referred to in sub- Section (1) on the ground that the
invention is lacking in novelty or patentability, the
amendments effected in the specifications, the claims
allowed in respect thereof and such other particulars as he
may require.‖

130. As the said Section 8 has been raised as a ground of challenge in the
revocation, it would be necessary to also reproduce Section 64 relating to
revocation where clause sub clause (m) reads as under:-
―64(1) (m) that the applicant for the patent has failed to
disclose to the Controller the information required by
CS(OS) No. 89/2008 Page No.123 of 275

131. On the conjoint reading of both the above Sections, it is clear that
there is a mandatory provision provided u/s 8 where under the applicant for
patent is under obligation to disclose the information to the Controller of
Patents regarding any patent application which is pending in the country
outside India in respect of the same or substantially the same invention or
where to his knowledge such application is being prosecuted by some person
through whom he claims title, he shall file along with the same or
subsequently a statement setting out the detailed particulars of such
application and also give an undertaking to that effect.
132. It is also manifest from the collective reading of Section 64(m) with
that of Section 8 that the consequences of not disclosing the information as
per Section 8 would lead to the revocation of patent as the violation of
Section 8 can be raised as a ground for revocation of patent and the same is
permissible by way of Section 64(1) (m).
133. The question then arises for consideration is as to what extent the
disclosure is required to be made by an applicant for patent in the Patent
Office and how the Court has to deal with the same when the violation of the
said provision is pressed into service by calling upon the Court to examine
as a ground of rectification or revocation proceedings.
134. For doing the same, one has to understand the scope and ambit of
Section 8 as to what can be subsumed within purview of Section 8 which
may attract Section 64 and as a matter of consequence may lead to
revocation of patent.
CS(OS) No. 89/2008 Page No.124 of 275


135. From the closer and minute reading of Section 8, it may be seen that
Section 8(1) has the following ingredients:-
a) That where application for patent either along or jointly is
prosecuting the application for patent outside India;
b) In respect of the same or substantial invention;
c) Where to his knowledge such application is being prosecuted by
some person through whom he claims or by some person deriving
the title from him, he shall file along with his application; and/or

d) Subsequently a statement setting out a detailed particular of such
application; and
e) Undertaking that upto the grant, he shall keep the Controller
informed in writing from time to time of the detailed particular as
required under clause (a) in respect of every other application
relating to the same invention if any filed in any country outside
India subsequently to the filing of statement within the prescribed
time.
136. If the ingredients of Section 8 are examined closely, it can be
discerned that the obligation which is casted upon the applicant for patent
relates to any application which he is prosecuting either along or jointly on
the date of patent or where the application which is being prosecuted by
some person through whom he claims title on the date of application. This
is evident from the wordings “ …is prosecuting either along or jointly ” used
in the said Section or “ is being prosecuted by someone through whom he
claims… ” which means that the said Section talks about the applications
which are being prosecuted or is prosecuted by the applicant or his
CS(OS) No. 89/2008 Page No.125 of 275


predecessors in the foreign countries at the time of preferring the patent
applications in India.
137. It is also seen from the reading of said Section that Section 8(1)
covers within its sweep not merely the applications which are being
prosecuted at the time of filing of patent, but also the other applications
which are filed subsequently during the time when the prosecution before
the Indian Patents Office is underway. This is clear from the undertaking
which the applicant for patent has to give under clause 8 (b) relating to the
applications preferred in countries outside India subsequently to the filing of
statement referred to in clause (a).
138. Careful examination of entire scheme of Section 8(1) of the Act
would reveal that the Section-8 is aimed at to provide the Controller true and
faithful disclosure of all the information relating to the applications for
patents which are same or substantially the same invention and also to
provide the information to the Controller in relation to the title of the said
Patent owned by the applicant and the other persons in the foreign countries.
139. Thus, the twin requirements of ascertainment of the foreign
applications relating to the same or similar patent, the title and details
contained in those applications have to be furnished and complied with
mandatorily in order to apprise the Controller about the current
developments in relation to the inventions in foreign countries which are
same or substantially the same. This is due to the reason that when the
Controller is abreast with the updated information provided to him as to the
development and the prosecution trend going in foreign country, then the
same may affect his decision making in adjudging the substantial issues
CS(OS) No. 89/2008 Page No.126 of 275


arising in the patent including the aspect of prior art, title, obviousness or
other related issue depending upon the views which the other foreign offices
take in relation to the same or substantially the same invention and that is
why, it is the bounden duty of the applicant for patent to keep the Controller
informed from time to time in relation to prosecution progress and also
coupled with the title aspect in relation to patents to the Controller and any
violation of the same may attract Section 64(1)(m) of the Patents Act upon
the insistence of the adversary party.

140. This is the only way Section 8 and Section 64(1)(m) can be reconciled
and interpreted. Otherwise, curtailing the sweep and ambit of Section 8
would mean that it will become highly difficult to examine as to what sort of
information was mandatorily required and what was not required.
141. It is, however, to be noted that the necessary ingredients noted above
must be satisfied in order to attract Section 8 which include foreign
application or the application outside India and not the Indian application.
Therefore, the expression “any other application” should also be read in the
context with the accompanying words which are “relating to the same or
substantially the same invention if any filed in country outside India” o nly
in relation to foreign applications which is also clear from the head note as
well as from the ingredients of Section, the said provision will attract in
relation to Indian application. Therefore, the Court seized of with the
revocation u/s 64(1)(m) will examine the question of disclosure or non
disclosure as envisaged u/s 8 must confine itself to the enquiry which is
permissible u/s 8 and not beyond the same which is relating to information
CS(OS) No. 89/2008 Page No.127 of 275


and undertaking regarding foreign application and the aspects relating to the
same.
142. Let us see whether in the instant case provisions of Section 8 gets
attracted. It has been said by the defendant that the plaintiffs as Patentee has
not disclosed before the Indian Patent Office while prosecuting IN‘774
about the patent namely US‘221 which was filed subsequently in 2000 in US
which relates to the same or substantially the same invention. This ground is
raised in the instant case as it is the case of the plaintiffs that the compound
which is involved in the suit patent IN‘774 and the compound which was
filed subsequently in India in the form of IN‘507 as well as in US‘221 are
one and the same and the subsequent ones being the derivative of previous
one would not have any impact on the enforceability of the previous one in
the instant suit. This has also assailed by the Defendant by stating what has
been in actual use in the market is the Polymorphic version B which was
filed subsequently and not the one claimed in IN‘774 which is the suit
patent.
143. Essentially, the challenge of the defendant is that had the full and
faithful disclosure relating to the filing of the substantially same patent been
made before the learned Controller in relation to applications preferred
before foreign country like in the case of US‘221, the same would have
impacted upon the patentability of the IN‘774 which is the suit patent and
also influenced the decision making of the Controller in grant or non grant
of the patent. It is also the case set up by the defendant that there are
agreements which are related documents where under the patent title has
been flown in favour of the current patentee has not been properly informed
CS(OS) No. 89/2008 Page No.128 of 275


and filed before the Patent Office in order to apprise the Patent Office about
the developments in relation to ownership of the patent and neither any
chance has been given to the Defendant or any other opponent to set up a
challenge. (The title aspect has been dealt with by me under the head of
concealments and false representation).
144. To this challenge, response of the plaintiffs is that there are
disclosures made before the Patent Office in the form of filing Form 3 along
with Patent application on 13.3.1996 when the statutorily prescribed form
was filed making the disclosure as of that date. Thereafter, the disclosure
was made on 1.6.2006 when second Form-3 was preferred and also later
during the pendency of the opposition proceedings which is stated to be
along with the reply statement with the pre grant opposition and the said
form filed in 2006 was also re-filed in the opposition proceedings pending
between the patentee and the third party. Therefore, the plaintiffs are of the
firm belief that the true disclosure has been made. Secondly, it is also stated
that Polymorphic version B of the said compound would not come within
the meaning of same or substantially the same invention used u/s 8. Thirdly,
it is stated that the said Polymorphic version B compound was filed four
years after the suit patent IN‘774 in the year 1996 in India and the same is
different from the suit patent and therefore the same ought not to have been
disclosed to the Patent Office on the count of being different in nature.
145. It is also stated that independent of all this, when the derivative
compound in Polymorph form B was filed before the Controller of Patents
subsequently in India by way of IN‘507, There is a complete adjudication
done by the Controller in an opposition proceedings on all the aspects
CS(OS) No. 89/2008 Page No.129 of 275


including the kind of similarity between the said compound and it is
Polymorph form considering the impact of US‘221. Therefore, there is no
need for this Court to go into the question now as to whether such disclosure
is warranted or not. It is urged that the said decision of the Controller
otherwise came on 15.12.2008. However, IN‘774 was granted in February
2007. Consequently, the plaintiffs who were always under the belief prior to
the said order of the controller that the suit patent IN‘774 and US‘221 are
different could not have filed the said description of US‘221 prior to the
order dated 15.12.2008. The alleged similarity or substantial similarity has
been held by the Controller in the opposition proceedings later in point of
time and till that time the plaintiffs were under the belief that both the
compounds are distinct and therefore the disclosure was not warranted.
146. By submitting all of the aforenoted in response, it has been said that
no disclosure was required to be made when it comes to US‘221
subsequently relating to Polymorphic version B of the compound. Even
otherwise Natco in its pre-grant opposition lost the objection of Section 8.
The opposition of Natco was filed by the same patent agent to the suit
patent. The said order passed by the controller was never challenged by the
Natco. It is also a matter of record. The defendant did not file either
pre-grant or post-grant opposition to the suit patent.
147. There are few facts which are discernible in the instant case which are
worth noting for the purposes of analyzing the present aspect as to whether
the disclosure or non disclosure was warranted:-
a) That the suit patent contains the compound which comprises of
combination Polymorphs A & B;
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b) That it has been brought to the notice of the Court that there is
another compound Polymorph B which is at the instance of the
defendant that in the patent filed by the plaintiffs in US‘221 there are
categorical statements made in the specifications exhibited as DW1/9
that earlier patent comprising the combination of Polymorph A & B
was unstable.
c) It is also the admitted position that medicine which is sold in the
market relates to the tablet version and it is categorical stand of the
Defendant that what has been sold in the market is in consonance
with subsequent patent which is US‘221 which relates to Polymorph
B version and the same is rejected in India as IN‘507 to which the
plaintiffs have not been able to give any answer except by urging
time and again that it is immaterial that there is an existence and
filing of Polymorph B vis-à-vis the compound containing the
combination thereof A & B as both are same in their properties and
efficacies.

148. Considering this backdrop, one has to analyze whether such disclosure
was warranted. In the light of afore noted discernible facts, it is seen the
application which was filed in US‘221 was in the year 2000 and the patent
was filed in 1996 and patent was granted in the year 2007. The language of
Section 8 is very clear where under it is stated that there is a continuous duty
of the inventor or the applicant for patent to inform from time to time the
Controller about the developments in the patent including filing of
subsequent applications in foreign countries relating to same or substantially
the same invention.
CS(OS) No. 89/2008 Page No.131 of 275


149. If in the light of the day, which is today when the plaintiffs once faced
with the challenge from the defendant as to validity of the suit patent and as
to the fact that drug sold in the market corresponds to the suit patent IN‘774,
is urging that the existence of Polymorph version B and the usage of the
same in the market of the said version is immaterial as suit patent IN‘774
and its subsequent Polymorphic versions are the same, then it does not lie in
the mouth of same very plaintiffs to urge to the contrary while filing two
applications for patents in India as IN‘774 and In 507 to contend that they
are distinct from each other. If the said patent was relating to the same field
which is of the same compound or derivative of the same compound, the
same could have been disclosed to the Patent Office that the Polymorph
version of the same has been filed in 2000 in US patent office. This is more
so, when the specification of subsequently filed patent as US‘221 exhibited
as DW 1/9 contained the same information relating to efficacy and the
stability of the earlier patent whatever inference the Patent Controller could
have drawn either in favor of the patentee or against him, that by itself does
not absolve the responsibility of the plaintiffs as applicant for patent to
disclose such information before the Controller.
150. It is legally untenable to say that the plaintiffs were under the belief
that US‘221 was a different invention at that point of time and it is only
when the Patent Office declared in December 2008 as a deeming fiction that
they are substantially the same, this has been learnt by the plaintiffs and by
the time IN‘774 was granted. The plaintiffs who claim to be one of the
leading companies in medicinal research and masters in chemical science
cannot be oblivious to the fact that conversion of one compound into another
Polymorph version may be either same or similar to the earlier version of the
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compound. It is not reasonable to presume that upon the decision of the
Controller in the year 2008 only, the said researchers remained in the
company of plaintiffs were enlightened of the fact that both the patents are
actually the same or substantially the same inventions. Therefore, it cannot
be said that it is only later on the patentee was able to understand the
similarity between the two inventions.
151. It is also pertinent to mention that what is the requirement of law u/s 8
is the disclosure in respect of same or substantially the same invention which
may subsume within its ambit the inventions which are substantially the
same but may have slight difference here and there and that is the reason the
legislature has used two expressions ―same or substantially the same‖. The
plaintiffs cannot deny the nexus between the previous invention which is
IN‘774 and the one which is Polymorphic B version of the said compound
as it is evident from the specification as Ex.DW1/9 itself. Therefore, the
same ought to have been disclosed before the Patent Office in order to
comply with the provisions envisaged u/s 8.
152. There are no depositions which are made by the defendants witness
DWs.1, 2 and 3 in their affidavit. Likewise, the plaintiffs‘ witnesses also did
not depose the about the justification as to non disclosure. Therefore, the
challenge is restricted to what has been stated in the counter claim and the
written statement and thereafter the submissions advanced by the parties at
the bar.
153. When the defendant has raised this challenge in the counter claim and
also filed the documents to that effect that there is an application which was
made in US in 2000 as US‘221 containing a nexus between the previous
compound and the Polymorphic B version of the same and also has read in
CS(OS) No. 89/2008 Page No.133 of 275


consonance with the stand which is preferred by the plaintiffs now that both
the versions are of the same nature and non grant of one in India is
inconsequential, The defendant is able to discharge the onus which lied on
him to show that there was an obligation to disclose. Thereafter, it was upon
the plaintiff to displace the onus and justify as to how the said disclosure
was not required or the said disclosure was actually made. The responses
which are coming forth from the plaintiffs for filing of Form-3 twice in 1996
and 2006 nowhere relates to foreign application and does not satisfy as to
how the disclosure was properly made of the developments which happened
in the year 2000. The fact that the Controller incidentally dealt with such
application filed in US‘221 while testing the opposition with the third party
does not absolve the responsibility of the plaintiffs as applicant for patent to
disclose the said information before the Controller which could have
impacted the decision making of the Controller.
154. Likewise, the stand of the plaintiffs that both the inventions are
different also seems unjustifiable in the light of their present stand before
this Court and no other response has been made except what has been
discussed above in detail by the plaintiffs. In view of the same and also the
requirements of Section 8 discussed above, it cannot be said that the
plaintiffs have been able to displace the said onus casted upon them as to
why the disclosure was not made as per the requirement of Section 8 of the
Act. It appears at this stage from the attending circumstances that the
disclosure was not made and the said Section was in fact violated by
the patentee and therefore the ground contained in Section 64(1)(m) is made
out.
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155. The submission canvassed by Dr. Vaidyanathan on instructions that
the defendant has given up the objection under Section 64(1)(m) by putting
some reliance on the pleadings of reply to C.M.No.219 preferred in
continuation of the opposition order passed by the controller is rejected. I do
not find that there can be estoppel against the statutorily prescribed ground
of revocation especially when the said ground has been categorically urged
in the counter claim in paragraph-4 and paragraph-21(i) of the written
statement.

156. Consequently, the ground of violation of Section 8 read with Section
64(1)(m) is made out. However, still there lies a discretion to revoke or not
to revoke which I have discussed later under the head of relief. Under these
circumstances, even in case, the said compliance of Section 64(1)(m) of the
Act has not been made by the plaintiffs, still there lies a discretion in the
Court not to revoke the patent on the peculiar facts and circumstances of the
present case. The said discretion exists by use of the word ―may‖ under
Section 64 of the Act. Thus, solely on one ground of non-compliance of
Section 8 of the Act by the plaintiffs, the suit patent cannot be revoked.
Re: Ground of concealments and false representation under Section 64
(1)(j)

157. The defendant has further raised the ground of concealments by
elaborating that the suit patent has been obtained on the basis of the false
statements and misrepresentation and therefore the IN‘774 is liable to be
revoked under Section 64(1) (j) of the Patents Act 1970. Learned counsel
for the defendant has pointed out series of the concealments besides
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Section 8 requirements, the same can be enumerated in the following
manner:
 Concealment of all agreements and status of title of plaintiffs;
 Concealments of patents filed with respect to Erlotinib Hydrochloride
abroad and in India;
 No witness was produced who had knowledge of the patent filings in
India or abroad;
 Concealment about the true form of TARCEVA;
 TARCEVA was launched after the Polymorph B patent was filed;
 No product was ever launched by the Plaintiffs which was a
combination of Polymorph A+B;
 Contradictory stands as to the second patent being an independent or a
selection patent before the patent office;
 Creation of backdated agreements and over-reaching this Court
without disclosing later agreements and getting recordals done behind
the back of the Court;
 No clinical trials record has been filed or produced or pleaded;
 Witnesses were specifically briefed not to answer questions on
Polymorphism.
158. By placing reliance upon the aforementioned concealments, learned
counsel for the defendant urged that the plaintiffs are guilty of non
disclosure of material facts which may have bearing upon the decision of the
present case as stated above. It is also argued that the plaintiffs have
deliberately withheld the documents of this Court which are title documents
and also from the patent office, therefore, the adverse inference may be
CS(OS) No. 89/2008 Page No.136 of 275


drawn against the plaintiffs and on that count too the patent is liable to
revoked being based on the false suggestions and non disclosure.
159. On the bare reading of the said ground under Section 64(1)(j), it is
amply clear that the said ground does not raise any qualification as to what
aspects can be said to be false representation or for that matter false
suggestion.
160. Although there is no doubt that the said ground is speaking for itself
as to what it covers within its ambit but for the sake of clarity
th
Sh.P.Narayanan in his book titled as Patent Law, 4 Edition, Eastern Law
House, discusses the said ground by noting the ambit and sweep of the said
provision by observing that the said ground may include any aspect relating
to patent application. Therefore, the said ground as it is worded in the
Statute Book has to be read in the widest term and should not be necessarily
curtailed. While discussing the said ground u/s 64(1)(j) the learned author
has observed thus :-
“16-10 Section 64(1)(j) –“ The patent was obtained on a
false suggestion or representation”
There is no similar ground under s. 25 for opposing the
grant.
A patent may be revoked on the ground that it was
obtained on a false suggestion or representation. There
is no limitation as to the nature of the false suggestion or
representation. It may thus relate to the specification or
relate to any fact or statement required to be made in
connection with the application for a patent.
Ordinarily, however, false suggestion or representation
is alleged in respect of something contained in the
specification.
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If false suggestion is alleged, it must be established on
the basis of the documents in which the alleged false
suggestion was made, the onus being of course on the
objector. (Emphasis Supplied)
161. From the bare reading of the said observations coupled with the
wordings of Section 64(1)(j), it can be said that any other kind of
concealment which affect the prosecution of the patent before the office of
Controller can certainly be urged as the ground for challenging the patent u/s
64 (1)(j). Therefore, the Court can look into any such concealment if any
made before the Controller of Patents affecting materially the prosecution of
the patent. Therefore, once the Defendant criticizes the grant of patent on
the ground of misrepresentation, then the Court after looking into the facts
which are material or non material can draw an inference by analyzing as to
which of the concealments would have material bearing while securing the
patent.
162. So far as concealments relating to title are concerned, it has been
stated that there are deficiencies in the documents relating to title. Number
of inconsistencies has been pointed out in order to state that the title of the
patent is defeated and does not inure in favor of the plaintiffs. It is stated
that the agreements are created as an afterthought and have been recorded
later on in the back of the party in order to deprive them the chance of
disputing the said documents.
163. The response given by the plaintiffs in this respect is that the plaintiffs
are the true owner of the patent in question and even if there are certain
documents which have been executed by them subsequently, the same do
not affect the passing of the title as the same may amount to feeding the
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grant of estoppel. The said principle enunciates that even a person at the
time of effecting the grant did not have the title but subsequently attains the
title or his title subsequently becomes perfect, then the said perfection of
title shall inure in favor of the purchaser who has purchased the said
property and therefore the title is fed by the principle of estoppel existing in
common law.
164. This has been explained by the plaintiffs by placing the reliance on the
judgment passed by Hon‘ble Supreme Court in the case of Renu Devi vs.
Mahendra Singh & Ors . , AIR 2003 SC 1608 at para 12–15, that this
feeding the grant by estoppels is a principle of equity is part of the common
law and fully applies in India. Section 43 of the Transfer of Property Act is
just one facet of the application of this principle but this principle being of
common law is not limited to Section 43 alone. This is a principle of equity
that if a person who has no title whatever to property grants it by a
conveyance which in from would carry the legal estate, and he subsequently
acquires an interest sufficient to satisfy the grant, the estate, instantly passed.
It is thus argued by the plaintiffs that the subsequent attainment of title does
not affect the status of the plaintiffs as a patentee.
165. It is also stated by the plaintiffs that no one besides the plaintiffs has
come to dispute the said title and the challenge which is set up by the
defendant is also based on some bald allegations and therefore the same
should not be seriously considered as affecting the title of the patentee. To
this, the defendant responds that the said principle of feeding the grant by
estoppel is applicable to immovable properties and not to moveable
properties.

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Lack of Title/Ownership in respect of plaintiffs
166. During the course of the arguments the learned counsel for the
defendant has challenged the ownership of the suit patent as well as title
documents. It was argued by the defendant that the entire patent office
record shows that there are many discrepancies in order to claim the
ownership of the patent in question which also lacks valid title in order to
maintain the suit for patent. No doubt, certain averments have also been
made in the written statement questioning the rights of the plaintiffs to sue
for infringement of patent against the defendant. The defendant has also
sought to allege that the plaintiffs have fraudulently obtained the patent
which is contrary to Section 64(1)(j). It is a matter of fact that the patent
was issued in the names of the plaintiffs. No issue in this regard was
framed by the Court. The objection about the title and ownership was not
proved by the defendant in its evidence. Since the patent has been granted
in favour of the plaintiffs and no issue has been framed by the Court, this
Court is not inclined to go into the objection raised by the defendant with
regard to the lack of title/ownership. In case any discrepancy with regard to
chain of documents/deeds as well as on stamp duty or other objection raised
by the defendant is there, I am of the view that the defendant would have
pressed for framing of issue in this regard at the appropriate time and ought
to have proved the same before Court. The said discrepancies whatsoever
are otherwise too trivial and do not material affect the case as to title unless
shown otherwise.
167. Therefore, it cannot be said that the titles of patent is defective solely
by pointing out certain defects which are intermittent in the chain of title
relating to patent. Therefore, the said concealments will not strictly fall
CS(OS) No. 89/2008 Page No.140 of 275


within the purview of Section 64(1) (j) and may not be relevant for the
purposes of discussion chapter of revocation.
168. There is another aspect which has been raised by the Defendant that
the grant of patent is bad on account of improper examination of the patent
by the Controller.
169. This aspect has been explained by the defendant by placing the
reliance on all these events between the relevant dates which is 22.2.2006 till
9.2.2007, it is stated that no proper examination was conducted by the Patent
Office and there are procedural irregularities committed by the Patent Office
while granting the said Patent and therefore the said patent is granted under
suspicious circumstances where the practice and procedure have been
overlooked considerably.
170. The defendant has cited several documents containing the prosecution
history in order to support this challenge that there was a case of improper
examination. It is further contended that as per Section 13(3) of the Patent
Act whenever the claims are amended in the patent specification then the
patent has to be re-examined and advertised again, and the process of
registrability falls from there and then. It cannot be the case that after the
amendments the patent is not examined and investigated upon by the
Controller by overlooking the provisions of Section 13(3). It is therefore
argued that there is serious challenge which exists is that the claims were
amended on the very last day and taken on record without any examination
which is complete irregularity apparent on the face of record.
171. The plaintiffs responded the same by stating:
 That the Defendant has not discharged the burden which is cast upon
him to show that the patent was examined improperly.
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 That it is not the ground for revocation as envisaged in Section 64 to
examine as to whether any improper examination has happened
during the time when the patent was examined.
 That the counter claimant has not taken any such ground u/s 64 to
urge such improper examination.
 That there are no pleadings to the effect of improper examination and
no allegation of improper examination has been pleaded anywhere
and patentee has been taken to surprise.
 That the obligations in the examination report have been made by the
patentee and the Patent Office has examined the application thrice by
two different examiners.
 That the amendments to the claims prior to the grant of patent need
not be advertised.
 That that rule 81(2), Section 57(3) and 57 (6) collectively would
reveal the said position. It is also stated that the amendments which
were made were already falling within the scope of the patent
specification which was originally filed and the said amendment was
permissible and therefore no useful purpose would have been served
by re advertising the said amendments in the patent.
172. So far as the improper examination of the patent as a ground is
concerned, there is no need for any specific mention of the said expression is
covered in the grounds of revocation when there is a ground of revocation in
para-4 which provides that the patent is obtained on false suggestion and
representation which can include any aspect relating to prosecution of the
patent application which can materially affect the decision making or the
grant of the patent.
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173. The said improper examination may arise either on the default of the
controller or examiner by overreaching the process of the law and not
following the provisions of the Act or on the basis of misrepresentation of
the applicant for the patent. The complaint of the defendant when it criticizes
the examination process is based on two fold grounds which include both the
defaults at the controller‘s end and consequent contravention of the
provisions of the Act as well as the misrepresentations made by the
plaintiffs. It may also be possible that the misrepresentations made by the
plaintiffs might have persuaded the controller to proceed in the manner
which has lead to contravention of the provisions of the Act. Therefore, it
cannot be said that no such ground is available for revocation under the
Patents Act.
174. The Court can surely look into the deeper aspects of the patent
including its prosecution history which may reveal that the patent ought not
to have been granted due to the representations of the plaintiffs before the
patent office by drawing an inference from the plaintiffs conduct if not
ascribing any malice to the patent controller. Therefore, the plaintiff‘s
objection that no such ground exists is therefore rejected. It is also clarified
that the defendant has raised such ground in the counter claim relating to
false suggestions and misrepresentations.
175. The next question which arises for consideration is whether the
amendments which are made prior to the grant can be allowed to remain
unpublished under the Patents Act and the same can proceed to grant of
patent without publication of the said modification / amendment. This is due
to the reason that the defendant has raised the said objection as to non
CS(OS) No. 89/2008 Page No.143 of 275


publication of the amended specification. For the purposes of said
discussion, following provisions are relevant:-
“13. Search for anticipation by previous publication and by
prior claim

(1) The examiner to whom an application for a patent is
referred under Section 12 shall make investigation for the
purpose of ascertaining whether the invention so far as
claimed in any claim of the complete specification—

(a) has been anticipated by publication before the date of
filing of the applicant's complete specification in any
specification filed in pursuance of an application for a
patent made in India and dated on or after the 1st day of
January, 1912;
(b) is claimed in any claim of any other complete
specification published on or after the date of filing of the
applicant's complete specification, being a specification
filed in pursuance of an application for a patent made in
India and dated before or claiming the priority date earlier
than that date.

(2) The examiner shall, in addition, make an investigation
[x x x] for the purpose of ascertaining, whether the
invention, so far as claimed in any claim of the complete
specification, has been anticipated by publication in India
or elsewhere in any document other than those mentioned
in sub-Section (1) before the date of filing of the applicant's
complete specification.

( 3) Where a complete specification is amended under
the provisions of this Act before [the grant of a patent],
the amended specification shall be examined and
investigated in like manner as the original specification.
(Emphasis Supplied)

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57. Amendment of application and specification before
Controller
(1) Subject to the provisions of Section 59, the Controller
may, upon application made under this Section in the
prescribed manner by an applicant for a patent or by a
patentee, allow the application for the patent or the
complete specification l[or any document relating thereto]
to be amended subject to such conditions, if any, as the
Controller thinks fit:

PROVIDED that the Controller shall not pass any order
allowing or refusing an application to amend an application
for a patent or a specification l[or any document relating
thereto] under this Section while any suit before a court for
the infringement of the patent or any proceeding before the
High Court for the revocation of the patent is pending,
whether the suit or proceeding commenced before or after
the filing of the application to amend.

(2) Every application for leave to amend an application for
a patent 2[or a complete specification or any document
relating thereto] under this Section shall state the nature of
the proposed amendment, and shall give full particulars of
the reasons for which the application is made.

3[(3) Any application for leave to amend an application for
a patent or a complete specification or a document related
thereto under this Section made after the grant of patent and
the nature of the proposed amendment may be published.]

(4) Where an application is 4[published] under sub-Section
(3), any person interested may, within the prescribed period
after the 5[publication] thereof, give notice to the Controller
of opposition thereto; and where such a notice is given
within the period aforesaid, the Controller shall notify the
person by whom the application under this Section is made
and shall give to the person and to the opponent an
opportunity to be heard before he decides the case.
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(5) An amendment under this Section of a complete
specification may be, or include, an amendment of the
priority date of a claim.

3[(6) The provisions of this Section shall be without
prejudice to the right of an applicant for a patent to amend
his specification or any other document related thereto to
comply with the directions of the Controller issued before
the grant of a patent.]

59. Supplementary provisions as to amendment of
application or specification

1[(l) No amendment of an application for a patent or a
complete specification or any document relating thereto
shall be made except by way of disclaimer, correction or
explanation, and no amendment thereof shall be allowed,
except for the purpose of incorporation of actual fact, and
no amendment of a complete specification shall be allowed,
the effect of which would be that the specification as
amended would claim or describe matter not in substance
disclosed or shown in the specification before the
amendment, or that any claim of the specification as
amended would not fall wholly within the scope of a claim
of the specification before the amendment.]

2[(2) Where after the date of grant of patent any
amendment of the specification or any other documents
related thereto is allowed by the Controller or by the
Appellate Board or the High Court, as the case may be,—

(a) the amendment shall for all purposes be deemed to form
part of the specification along with other documents related
thereto;

(b) the fact that the specification or any other documents
related thereto has been amended shall be published as
expeditiously as possible; and
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(c) the right of the applicant or patentee to make
amendment shall not be called in question except on the
ground of fraud.]

(3) In construing the specification as amended, reference
may be made to the specification as originally accepted.

176. There are Patent rules 2003 (as amended in the year 2006) wherein
there is a procedure prescribed for amendment or to carry out the
amendment in the specification which reads as under:-
―81. Amendment of application, specification or any
document relating thereto – (1) An application under
Section 57 for the amendment of an application for a patent
or a complete specification or any document related thereto
shall be made in the Form 13.
(2) If the application for amendment under sub-rule (1)
relates to an application for a patent which has not been
[granted] the Controller shall determine whether and
subject to what conditions, if any, the amendment shall be
allowed.
[3(A) If the application for amendment under sub-rule (1) is
made after grant of patent and the nature of the proposed
amendment is substantive, the application shall be
published.
(b) Any person interested in opposing the application for
amendment shall give a notice of opposition in Form 14
within three months from the date of publication of the
application.
(c ) The procedure specified in rules 57 to 63 relating to the
filing of written statement, reply statement, leaving
evidence, hearing and costs shall, so far as may be, apply to
the hearing of the opposition under Section 57 as they apply
to the hearing of an opposition proceedings.]
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177. On the conjoint reading of the aforementioned provisions, following
position emerges:-
a) Where the complete specification is amended before the grant of
patent, the amended specification shall be examined and
investigated in the like manner as the original specification which
is clear from Section 13(3) of the Patents Act.
b) Section 57 provides for the amendment of application and
specification or document before the controller and the said
provision is subject to Section 59.
c) The reading of head note of Section 57 and the wordings of the
said Section would indicate that the said Section provides for the
process of amendments carried either prior to the grant of patent
and/ or after the grant of patent.
d) A reading of Section 57(3) would reveal that any application for
leave to amend the complete specification made after the grant of
the patent and the nature of proposed amendment may be
published.
e) The said Section 57 though seemingly provides for the process of
amendment for both pre grant and post grant proceedings. But, so
far as publication is concerned, sub Section 3 only expressly
provides for publication in the case where amendments are
proposed after the grant which would invite construction of the
said provision.
f) Section 57(6) provides that the provision of this Section shall be
without prejudice to the right of applicant for patent to amend his
CS(OS) No. 89/2008 Page No.148 of 275


specification or any document related thereto to comply with the
directions issued before the grant of patent.
g) The conjoint effect of Section 57(6) and Section 57(3) indicates
that the amendments which are filed under Section 57 relates to
voluntary amendments and not the amendments which are
consequent upon the directions of the Controller as the same
remains unaffected as per sub Section 6 of Section 57 of the Act.
178. Uptil this stage, there is no confusion. However, the debate begins
when one sees Rule 81(3) (a) read with Section 57 (3) which provides that
the application for amendment made after the grant shall be published and
reads it with Section 13(3) alongside which says that when the complete
specification is amended before the grant of patent, the amended application
shall be examined and investigated in the like manner.
179. Now the question arises as to whether the expression ―examined and
investigated‖ as original specification would include the stage of publication
or not in order to come to the finding as to whether publication of the
amendment is possible pre grant in the absence of express provision
regarding such publication of amendment.
180. For the purposes of the same, one has to consider Section 57(3) and
rule 81(3) deeply as both the provisions are inserted by virtue of
amendments made and carried out in the year 2005 which came to into effect
on 1.1.2005. Section 57(3) as it was prior to the amendment reads as under:-
“57(3) – Any application for leave to amend an
application for a patent or a complete specification or a
document related thereto under this Section made after
the acceptance of the complete specification and the
nature of the proposed amendment may be advertised in
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the Official Gazette if the amendment, in the opinion of
the Controller, is substantive.”
181. Likewise, Rule 81 (3) was also substituted with the corresponding
amendment of 2005 and the said Rule as it stood prior to the date of
amendment reads as under:-
“81(3)(a) – If the application for amendment under sub-
rule (10 is made after the acceptance of the complete
specification and the nature of the proposed amendment
is substantive, the application shall be advertised in the
Official Gazette.
(b) Any person interested in opposing the application for
amendment shall give a notice of opposition in Form 14
within three months from the date of advertisement of the
application in the Official Gazette.
(c ) the procedure specified in rules 57 to 63 relating to
the filing of written statement, reply statement, leaving
evidence, hearing and costs shall, so far as may be, apply
to the hearing of opposition under Section 57 as they
apply to the hearing of the opposition to the grant of
patents”
182. From the bare reading of the provisions existing prior to the
amendment vis-à-vis newly inserted provisions after the amendment of
2005, it is amply clear that the amendments are indicative of the legislative
intent which is manifest on the face of it. The said legislative intent
emerging from the reading of the provisions can be enumerated as under:
a) That prior to the amendment of 2005, the said Section 57(3) as
well as rule 81(3) provided that any application for amendment of
specification after the acceptance shall be advertised and the same
holds good both under the Section as well as for rule as they stood
prior to the amendment.
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b) After the amendment, the said aspect of publication has been
qualified by addition of words ―made after grant‖ in order to
provide the aspect of publication only when the amendments are
proposed after grant.
c) This is also clear when the said amendment has been carried out
restricting the duty to publish with the corresponding discretion
which is conferred upon the controller to issue further directions
which will remain unaffected. This has been done by insertion of
Section 57(6) wherein the controller in any case may give such
directions in spite of what has been contained in Section 57.
d) The legislative intent of this nature is self-evident from the fact
that the amendment of 2005 conferred the right of post grant
opposition to the third party in addition to pre grant opposition and
thereafter the patent is also vulnerable to challenge in civil court or
in IPAB in the form of revocation proceedings and therefore there
are ample opportunities conferred upon the third party opponent
with the additional right to object post grant which was earlier
absent prior to the amendment.
e) Therefore, the legislative intent which is emerging from the
collective reading of the Sections as seen above is that the process
for grant of patent has been simplified with less obstructions and
opposition right has been classified into two parts so that there
should be less obstruction or hurdles at the pre grant stage and the
patent should proceed smoothly towards the grant and in the event
amendments are carried out after acceptance but prior to grant, the
same can be taken care of at the post grant stage where the third
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party has got the right to challenge the said patent post grant.
Accordingly, consciously the said Section 57(3) and also rule
81(3) have been amended whereas the earlier provisions were
giving wider right of opposition to the third party upon publication
of each and every amendment with the corresponding duty to the
controller to advertise every amendment on the other hand, the
newly enacted provisions wherein both rights and duties are
curtailed in the pre-grant stage by not insisting the publication
prior to the grant but after acceptance and the same are shifted to
the post grant stage in order to align the scheme of the Act.
183. This can be the only recapitulation and interpretation which can be
done in the light of what existed prior to amendment and what has been
conferred after the amendment. It is thus seen that the legislature has
consciously amended the said provision and the amendments done cannot be
rendered otiose by conferring any additional duty upon the Controller to
advertise which was his duty prior to the amendment of the Act and this
would be doing injustice to the express words of the Statute and the mandate
and command emerging therefrom in the form of amended provisions which
will tantamount to reducing the words of the Statute into dead letters.
Therefore there exists no such duty on the controller to publish each and
every amended if the complete specification is amended after acceptance but
before the grant.
184. Now, still, the question remains what is the import of the words
―examined and investigated‖ as stated under Section 13(3). This is important
for discussion as the defendant is also setting up a challenge to the effect that
the patent application has not been examined properly within the meaning of
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Section 13(3). The said words ―examined and investigated‖ have the same
meaning what has been stated in the preceding and subsequent Sections
relating to the examination process and investigations carried out during
such examination and nothing beyond the same. This can be seen by having
closer look at the examination process under the Patents Act. For the
purposes of the same Section 12, 13 and 14 are reproduced hereinafter:
“12. Examination of application

(1) When a request for examination has been made in
respect of an application for a patent in the prescribed
manner. [under sub-Section (1) or sub-Section (3) of
Section 11B, the application and specification and other
documents related thereto shall be referred at the earliest by
the Controller] to an examiner for making a report to him in
respect of the following matters, namely,—

(a) whether the application and the specification and other
documents relating thereto are in accordance with the
requirements of this Act and of any rules made thereunder;

(b) whether there is any lawful ground of objection to the
grant of the patent under this Act in pursuance of the
application;

(c) the result of investigations made under Section 13; and

(d) any other matter which may be prescribed.

(2) The examiner to whom the application and the
specification and other documents relating thereto] are
referred under sub-Section (1) shall ordinarily make the
report to the Controller within [such period as may be
prescribed].

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13. Search for anticipation by previous publication
and by prior claim

(1) The examiner to whom an application for a patent is
referred under Section 12 shall make investigation for the
purpose of ascertaining whether the invention so far as
claimed in any claim of the complete specification—

(a) has been anticipated by publication before the date of
filing of the applicant's complete specification in any
specification filed in pursuance of an application for a
patent made in India and dated on or after the 1st day of
January, 1912;

(b) is claimed in any claim of any other complete
specification published on or after the date of filing of the
applicant's complete specification, being a specification
filed in pursuance of an application for a patent made in
India and dated before or claiming the priority date earlier
than that date.

(2) The examiner shall, in addition, make an investigation
[x x x] for the purpose of ascertaining, whether the
invention, so far as claimed in any claim of the complete
specification, has been anticipated by publication in India
or elsewhere in any document other than those mentioned
in sub-Section (1) before the date of filing of the applicant's
complete specification.

(3) Where a complete specification is amended under the
provisions of this Act before [the grant of a patent], the
amended specification shall be examined and investigated
in like manner as the original specification.

(4) The examination and investigations required under
Section 12 and this Section shall not be deemed in any way
to warrant the validity of any patent, and no liability shall
be incurred by the Central Government or any officer
thereof by reason of, or in connection with, any such
CS(OS) No. 89/2008 Page No.154 of 275


examination or investigation or any report or other
proceedings consequent thereon.

1[14. Consideration of the report of examiner by
Controller

Where, in respect of an application for a patent, the report
of the examiner received by the Controller is adverse to the
applicant or requires any amendment of the application, the
specification or other documents to ensure compliance with
the provisions of this Act or of the rules made thereunder,
the Controller, before proceeding to dispose of the
application in accordance with the provisions hereinafter
appearing, shall communicate as expeditiously as possible
the gist of the objections to the applicant and shall, if so
required by the applicant within the prescribed period, give
him an opportunity of being heard.‖

185. Upon the conjoint reading of the aforementioned provisions, the
following aspects relating to scheme of the examination and investigation of
the patent applications can be discerned:
1. Section 12 provides that upon receipt of the request for
examination, the controller shall forward the said request for the
purposes of examination to the examiner, who shall in turn send
his report to the controller within the prescribed time. The said
report shall contain the matters provided under Section 12 (1) (a)
to (d). This is clear from reading of Section 12 (1) and Section 12
(2).
2. The said examiner so appointed under Section 12 shall thereafter
proceed to make the examination and investigation as per the
Section 13 and make the investigations in relations to the matters
of anticipation and prior claim as contained in the Section 13. This
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is clear from the collective reading of Section 12 and 13 (1) and
(2).
3. The patent application and the specification so amended shall be
examined and investigated in the like manner as that of the original
specification. The said Section 11 (3) provides that the criterion for
the evaluating the amended specification for the purposes of
examination and investigation under Section 12 and 13 would be
in the like manner. The said wordings ―examined and investigated
in like manner‖ by itself do not indicate either that the clock will
set back for the purposes of the procedure or process of registration
of the patent but the said provision only provides that the threshold
for the enquiry as to the amended specification shall be same or at
par with that of the original specification.
4. The said Section 13(3) and the entire process of examination and
investigation as per Section 12 and 13 does not talk about any
issuance of the examiner report at each successive stages of the
examination by the examiner or by the controller. The only place
where the examination report is referred and provided under the
Patent Rules under the chapter of the examination and investigated
is under rule 24B (3) which reads as under:
“24. Publication of application

The period for which an application for patent shall
not ordinarily be open to public under sub-Section
(1) of Section 11A shall be eighteen months from the
date of filing of application or the date of priority of
the application, whichever is earlier:

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2[PROVIDED that the period within which the
Controller shall publish the application in the Journal
shall ordinarily be one month from the date of expiry
of said period, or one month from the date of request
for publication under rule 24A.]

24A. Request for publication

A request for publication under sub-Section (2) of
Section 11A shall be made in Form 9.
24B. Examination of application

(l)(i) A request for examination under Section 11B
shall be made in Form 18 3[within forty-eight
months] from the date of priority of the application or
from the date of filing of the application, whichever
is earlier;

4[(ii) The period within which the request for
examination under sub-sec. (3) of sec.11B to be
made shall be forty-eight months from the date of
priority, if applicable, or forty-eight months from the
date of filing of the application;

(iii) The request for examination under sub-Section
(4) of Section 11B shall be made within forty-eight
months from the date of priority or from the date of
filing of the application, or within six months from
the date of revocation of the secrecy direction,
whichever is later;

(iv) The request for examination of application as
filed according to the 'Explanation' under sub-Section
(3) of Section 16 shall be made within forty-eight
months from the date of filing of the application or
from the date of priority of the first mentioned
application or within six months from the date of
filing of the further application, whichever is later;]

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(v) The period for making request for examination
under Section 11B, of the applications filed before
the 1st day of January, 2005 shall be 1[the period
specified under Section 11B before the
commencement of the Patents (Amdt.) Act, 2005 or]
the period specified under these rules, whichever
expires later.

(2)2[(i) The period within which the Controller shall
refer the application and specification and other
documents to the examiner in respect of the
applications where the request for examination has
been received shall ordinarily be one month from the
date of its publication or one month from the date of
the request for examination whichever is later:

PROVIDED that such reference shall be made in
order in which the request is filed under sub-rule (1).]

(ii) The period within which the examiner shall make
the report under sub-sec. (2) of sec. 12, shall
ordinarily be one month but not exceeding three
months from the date of reference of the application
to him by the Controller.

3[(iii) The period within which the Controller shall
dispose off the report of the examiner shall ordinarily
be one month from the date of the receipt of the such
report by the Controller.]

(3) A first examination report along with the
application and specification shall be sent to the
applicant or 4[his authorised agent ordinarily within
six months from the date of the request for
examination or six months from the date of
publication, whichever is later]. In case other
interested person files the request for examination, an
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intimation of such examination may be sent to such
interested person.

2[(4) The time for putting an application in order for
grant under Section 21 shall be twelve months from
the date on which the first statement of objection is
issued to the applicant to comply with the
requirements.]‖

From the reading of the aforementioned Rule 24B, it is clear that the
said rule provides for the process of examination of the patents. The said
Rule also provides for the matters like under Section 11B, explanation
appended to Section 16 under Rule 24B as purposes for which the request
for examination is necessary and the consequent to which the examination
report shall be issued. The said Rule 24B nowhere lays down for the
purposes of Section 13(3) a similar procedure for filing the request for
examination report as done for the other purposes which is again indicative
of the view that Section 13(3) only provides a guideline as to the likeness in
the manner of examination as a process but does not indicate that the clock
relating to prosecution shall be set back and the re-examination in the form
examination report can be insisted upon. It is thus still within the discretion
of the controller whether to examine and investigate the said patent in the
like manner as that of the original specification without issuing a formal
examination report or he may proceed to issue the report as per he deems fit.
But the same cannot be insisted upon by the third party on the premises that
the said examination process should actually result in the examination report
when the Rule 24B does not provides for the said purpose a similar
examination procedure, though controller may adopt the same approach of
examination.
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Besides, the said reference of the word ―first examination report‖,
there is no mandate either under the Act or under the rules to issue the
examination report at every stage of the objections. However, it is altogether
different matter, that the patent office as a matter of the practice issues the
examination reports at the subsequent stages also. This is necessary to
indicate as to how far under the law and rules framed thereunder, it can be
insisted that the authority has to perform the act in a particular manner when
no such reference exists either in law and rules made thereunder and even no
consequences are prescribed for.
5. There is reference to the words ―first examination report‖ when it
comes to the examination of the application, however the
legislature as well as the framers of the rules use separate words
called ―gist of objections‖ when it comes to the process of
investigation under Section 13. This is equally essential to indicate
the separate requirements prescribed under the law. This can also
mean in practice, which I think is logical that if the examination
report has been issued and replied by the applicant, the gist of
objections which are residual may follow for further investigation.
The same can be cured either by reply or by personal hearing or by
both depending upon the satisfaction of the examiner as well as the
requirement of the rule if any.

Thus, what follows from the above is that every gist of objections
cannot be equated with an examination report and it cannot be said
that in the event, the reply of the applicant falls short of the reply
to the examination report which might have been a detailed one to
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say that the said reply to the gist of the objection should also be in
the same manner as that of the reply to the examination report.
This is due to the reason that there may be some objections which
may require less of an enquiry and investigation.

Thus, there is no set pattern either prescribed under the Act or the
rules so far it relates to dealing with the kind of the objections
which remain pending satisfaction of the examiner and thus in
those circumstances the applicant cannot be accused of not filing a
satisfactory response which the third party expects the applicant to
respond and even if the said objection is eventually cured during
the time of hearing with the examiner. In those circumstances, it
can also not to be said equally that there is no such examination
and investigation conducted.

6. It is also noteworthy to mention that the cases where the wordings
used are ―gist of the objections‖ either under the Act in the form of
Section 13, 14, 15 or in the rules (rule 28 and 29) for the purposes
of the investigation under Section 13 of the Act, the right to
hearing is also given to that of the applicant. It does not provide
the mode as to whether the applicant has to file the response to the
said gist necessarily or can simply make a request for hearing or
proceed to attend the hearing. The said aspect again indicates that
the satisfaction and curing of the objections enlisted in the gist of
the objections can be taken care of even in the mode of personal
hearing with the examiner. This seems logical in practice even due
CS(OS) No. 89/2008 Page No.161 of 275


to the reason that when number of times, there are conversations
exchanged between the authorities and the applicant, still there is a
room of dissatisfaction or ambiguity in the mind of the examiner,
the examiner can inform the gist of the objections and call for
hearing and clarify his doubts. There is no irregularity in such
cases if the applicant request for hearing to make his submissions
rather than to provide a detailed response.

7. The examination and investigation is the matter which is for the
satisfaction of the examiner so as to the report to the controller as
to whether the said invention submitted in the application satisfies
the matters mentioned under Section 12. The same is clear from
the Section 13 (4) which expressly provide that the matters of the
examination and investigation do not in any way warrant the
validity of the patent and no liability can be ascribed to the central
government or the officers in relation to the examination or
investigation or proceeding thereof. In other words, the said
Section is itself making it clear that the said examination and
investigation is a matter of the satisfaction of the examiner and
does not guarantee the validity of the patent.

8. The said satisfaction is that of the examiner and therefore it is with
in the power of the examiner to choose the manner in which he
feels fit to get himself completely satisfied that the application is in
order for grant. Of course, the said satisfaction cannot be purely
subjective and arbitrary but has to be based on reasonable and
CS(OS) No. 89/2008 Page No.162 of 275


justifiable grounds. However, in order to aid the functioning of the
authority seized of the complex issues like patent, each and every
step taken by the said authority towards the grant of the patent can
also not be called into question by calling it irregular without any
positive evidence as to what has persuaded the person leveling any
such allegation to make the same by urging some factual or legal
malice involved in the same. In the absence of the same, no a priori
assumption can be drawn of irregularities unless the said manner is
prescribed by the Act and the rules and violated by the authority on
the face of it.

9. There is a difference between the amendments which are required
by the examiner or the controller during the course of the
examination and investigation process calling upon the applicant to
amend the specification in order to make the application in order as
against the amendments which are made voluntarily by the
applicant for the patent. This is clear from the collective reading of
the Section 13(3), Section 14 and Section 15, rule 28, 29, 30 read
with Section 57.

This difference is essential for understanding as to which of the
amendments which may be made by the applicant by itself may
require further examination and investigation for the purposes of
the satisfaction of the examiner and controller as against the
amendments which are made during the course of the examination
and investigation which are made in order to further the
CS(OS) No. 89/2008 Page No.163 of 275


satisfaction of the controller or examiner who is seized of the
application of the applicant. In the later kind of cases, the
examination and investigation are being done by the examiner side
by side by calling upon the applicant to make appropriate changes
in the application and specification so as to make his application in
order for grant. This is seen from Section 14 and 15 read with rules
28, 29, 30 which talks about the procedure as to anticipation and
amendments which the controller may ask in order to remove the
objection as to anticipation.

In those cases, the amendment is consequential to the examination and
investigation, the same cannot be said to be re-examined by invoking
Section 13(3).
186. The aforementioned discussion relating to process of examination and
investigation will enable this Court to consider the challenge as to the
improper examination laid by the defendant. Let me now deal with the said
objections raised by the defendant.
187. The defendant has raised the challenge relating to examination
process by contending the following:
A perusal of the entire Patent office record prior to the grant reveals as
follows:
 The Patent had a total of 27 claims – Not clear whether they were
24 claims first and then 3 claims were added;

 It was these 27 claims that were examined by the Patent office;
[FER 22.2.06]
 Response dated 2.6.06 – dealt with only these 27 claims. Only
claims 19 to 23 were deleted– Response mentions that
CS(OS) No. 89/2008 Page No.164 of 275


corresponding US‘498 has been granted. By this time even US‘221
and US‘613 are granted but this is not mentioned;
 FER dated 12.7.06 – specific objection raised that Claims 1 to 12
and 20 are not allowable under 3(d) and 2(1)(j) as the efficacy over
the known compounds not established. Thus the patent office was
conscious that efficacy over compounds of EP‘226 have to be
established. The Patent office refers to EP‘226 as the known parent
compound.
 Response dated 27.10.2006 – Claims are NOT narrowed down as
argued by the Applicant. The claims on file are in fact
REPLACED with two new claims. Even page 53 which is page
on which Claims are typed was replaced . The Applicant
understood which is the known parent compound and referred to
Gefitinib which was derived from EP‘226 in its response and tried
to show efficacy. The Defendant‘s submission is that there was no
efficacy established qua the compound claimed in suit patent
because BR 21 trials were carried out on the Polymorph B form.
These trials were already part of the second application IN/507. So
the articles relating to Polymorph B could not have been cited
when there was a separate patent application for IN/507. The two
new publications filed before the Patent office are of the yea rs
2005 and 2006 and they relate to the Polymorph B form.
 FER dated 9.1.2007 –Patent office raises a very serious objection
that Erlotinib Hydrochloride is a well known Polymorph. Thus
claim 1 is not allowable.
 No response is sent. A personal discussion is held. This is admitted
in the Plaintiffs‘ chart also. All the important objections are given a
go-by. Nothing new is said in the Response dated 9.2.2007. Same
documents already filed are referred to. Fresh Form 1, Form 2
and Fresh page 53 [i.e. Claims] are filed. The objection as to
Polymorph is not even dealt with or mentioned.
 The fresh claims have not been examined and investigated as per
the statutory mandate.

CS(OS) No. 89/2008 Page No.165 of 275


188. Now let me deal with the said objections one by one and test the same
on the principles culled out above in relation to examination and
investigation:
 On the unclarity of the claims whether they are 24 or 27. I have
gone through the complete specification which is Exhibit PW1/5
as well as the one which has been relied by the defendant as
Exhibit DW 1/6 to say that there is unclarity with the said claims.
The said specifications under the head of claims runs from 1 to 27.
The same holds also good for the initial version of the complete
specification relied by the defendant to set up such challenge. If the
defendant is unclear about the said claims, this Court is equally
unclear unless there is a positive evidence to the said effect that
how such allegation can be said to be substantiated. I think at the
first place, there does not seem to be any infirmities in the claim
and secondly, the defendant has not been able to establish as to
how the defendant can state that initially there were 24 claims and
3 claims were added later on where there is no document on record
to show the same.
 The examination report dated 22.2.2006 was issued and replied on
2.6.2006. I think firstly, it is essential in order to adjudge the
scope of examination and investigation as to what were the
objections raised by the examiner, the same objections are
reproduced hereinafter:

1) Subject matter of claims does not constitute an invention
under Section 2 (1) (j) as it lacks novelty and inventive
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step in view of citation nos. JP 7138238, JP 6073023 and
JP 6336481
2) Claims 19 to 24 falls within the scope of sub clause of
Section 3 (i)
3) Claims 1 to 27 are not clear in respect of the expressions
as indicated therein.
4) Claims 1 to 27 are not clearly worded.
5) Title is inconsistent with description and claims

6) Power of attorney should be filed
7) Pages of the specification should be renumbered
8) Extraneous matter of the specification should be deleted.
9) Abstract should be filed with a title and concise summary
of the invention within 150 words in accordance with
rule 13 (7)(a) of the Patent Rules 2003.
10) Details regarding applications for patents which may be
outside India from time to time for the same or
substantially the same invention should be furnished
within three months from the dates of the filing of the
said applications under clause (b) of sub Section (1) of
Section 8 and rule 12 (1) of Indian Patent Act.
11) Details regarding the search and/ or examination report
including claims of the applications allowed, as referred
to in rule 12 (3) of the Patent Rules 2003 in respect of the
same or substantially the same inventions filed in all
major Patent offices such as USPTO, EPO and JPO etc,
along with the appropriate translation where applicable
CS(OS) No. 89/2008 Page No.167 of 275


should be submitted within a period of 3 months from the
date of the receipt of this communication as provided
under Section 8 (2) of the Act.

The said objections were responded by the applicant by way of
response dated 2.6.2006. The said response includes the response to
paragraph 2 which calls upon the applicant to state that claim 19 to 24 are
bad due to operation of Section 3 (i) of the Act, the applicant in response
deleted claims 19 to 23 and amended claim 24 in order to propose to cure
such objection.
 The defendant challenge in this respect is that the plaintiffs at some
places state that claim 9 to 23 were amended and in fact 19 to 23
were amended and thus examination is bad. I do not think that the
plaintiffs‘ version in these proceedings or anywhere else except
before the patent office is material for the purposes of the
examination and investigation. There was an objection relating to
claim 19 to 24, which was proposed to be cured by the applicant
for the patent by omitting certain claims and suitably proposing to
amend certain which is permissible. Thus, no infirmity on this
count is found in the said examination process.

 The connected challenge of the defendant is that the information
under Section 8 was called upon by the examiner, which was not
fully supplied as the applicant talked only about US‘ 498 but does
not inform about US‘221 and US 613. I agree with the defendant
and has already arrived at the finding that the applicant has not
CS(OS) No. 89/2008 Page No.168 of 275


supplied the complete information relating to foreign application
under Section 8 and the same has been dealt with under the
separate head of this judgment in detail.

 The defendant has stated that the examination report dated
12.7.2006 refers to the specific objection relating to claim 1 to 12
and 20 are not allowable as the efficacy over the known compound
is not established. EP‘226 has to be cited as known compound. The
response to the same dated 27.10.2006 merely replaced 2 new
claims and no where satisfied the objection. It is also stated that the
applicant could not have relied upon the clinical trials which were
carried out on Polymorph B form. The two new publications filed
before the patent office related to the new compound.

 I have gone through the record of the examination reports of the
22.2.2006, response thereto on 1.06.2006, thereafter the objections
th th
raised on 12 July 2006 and response thereto on 27 October
2006. I think the applicant has attempted to answer the aspect of
efficacy by annexing the two publications relating to clinical trials
in their response on 27.10.2006. it is equally seen that the applicant
has responded to the objection of Section 3(d) and 2 (1) (j) of the
Act by dedicating the paragraph relating to the same. Thereafter,
the applicant demanded a hearing in the matter. I find the said
response whatsoever credibility it holds is sufficient for the
purposes of satisfaction of the examiner till the time the examiner
himself does not raise the objection to the same.
CS(OS) No. 89/2008 Page No.169 of 275



 I think defendant is missing the point which is that this Court has
to test the examination and investigation process and not the fact
that the examiner was at fault of being satisfied with the said
response. For the same, there are other grounds of lack of novelty
and inventive step, which can be independently satisfied by the
defendant to challenge the patent. So far as the examination
process goes on this count and the response thereto this Court finds
the same in the order. The said response dated 27.10.2006
addresses the reply to all the objections however so brief or
elaborate it may be. It is a matter of satisfaction of examiner and
the applicant and cannot be called into question when there is no
apparent illegality on the record in relation to the violation of the
rules in the process of the examination and investigation.

 I also do not agree with the defendant that the applicant could not
propose to amend the claims or replace the same. If the examiner is
reluctant to allow the said claim on the basis of the prior art by way
of prior publication or prior claim, it is well within right to of the
applicant to propose amended claims or replace the claims. The
controller or the examiner is equally within its duty to consider
those amendments as per the mandate laid down under Section 13,
14, 15 of the Patents Act. Therefore, even if 2 claims were
replaced or proposed to be amended, I do not find any such malice
or irregularity in such exercise done either by the applicant or for
that matter patent office.
CS(OS) No. 89/2008 Page No.170 of 275


 So far as the aspect of clinical trials is concerned, this Court in any
case is testing the said trials and its credibility in this suit. The
examination process cannot be said to be bad on this count either
till the time the process done is fair and reasonable.

 The defendant further stated that examination report dated
9.1.2007 raised some objection that the erlotinib Hydrochloride is
a well known Polymorph and the said claim 1 is not allowable. The
defendant states that no response thereto is sent and straightaway
the personal discussion is held and thus the said examination
process is bad. To this my response would me on the basis of the
elaborate discussion relating to examination and investigation
process done above wherein I have stated that the gist of the
objections can be either suitably replied or can be cured on the
basis of the personal hearing which sounds reasonable in the
practice in the absence of any legislative measure or rules
containing set pattern. The said practice cannot be said to be
unusual or abnormal to ascribe any malice or arbitrary behavior.

 The defendant is further raising this challenge by asserting that the
claims were amended during the last few days between October
2007 to January 2007, the examiner got satisfied within that time
and the objections which were serious enough which went un
replied still got cured by the examiner and in turn the said case
became the perfect case for grant of the patent and therefore there
is an infirmity. I think one has to pause here for a moment and then
CS(OS) No. 89/2008 Page No.171 of 275


has to see process of examination and investigation step by step
rather than to come immediately to anxious conclusion that the
said examination is bad. No doubt that there was a gist of
objections raised by the examiner of the patent dated 9.1.2007. But
it would be factually wrong to state that no steps were taken in
furtherance to the said letter. The noting mad of the examiner
contained in the order sheets where under there is an order dated
22.2.2007 clearly records that the agents have re-filed the
documents on 14.2.2007 in response to the letter dated 9.1.07. The
said document is placed on record. Therefore, it would be factually
incorrect to say that no response was ever filed to such gist of
objections raised on 9.1.2007.
Thereafter, a personal hearing has been held on 22.2.2007, in which
the said examiner records that the case has been discussed and the formal
objections have been met with. It is also stated that the submissions have
been made by the applicant attorney to meet with the technical objections
which have been considered and the necessary amendments have been
carried out to meet the objections. It is here noteworthy mention that the
amendments which the examiner is mentioning are the ones which were
proposed in response to the earlier gist of the objections where under the
cover of the letter dated 27.10.2006, 2 claims were replaced and the claim of
erlotinib hydrochloride was introduced and the said response also submitted
that the said compound is not anticipated by any of the prior art and
therefore not hit by Section 3(d) and 2 (1) (j) of the Act. The said response
if read with the personal hearing done on 22.2.2007, it is clear that no such
amendments were also allowed on the very last day as contended by the
CS(OS) No. 89/2008 Page No.172 of 275


defendant. Rather, the said amendments were carried out as a process of the
examination and investigation.
 Now, I again recall my discussion above that the amendments
which are consequential to the process of the examination and
investigation cannot be equated with the ones which are voluntary
ones. The amendments which are forming the part of the process of
the examination are examined simultaneously as done in the
present case. Thus, once the letter dated 27.10.2006 proposes 2
new claims, thereafter the letter containing the gist of objections is
received on 9.1.2007 containing the objections relating to the
erlotinib hydrochloride which is a part of the new claim 1, the said
examination done by the examiner is as per Section 13(3) of the
Act and is in consonance with the provisions of the Act.
Thereafter, during the investigations, the personal hearing is
carried out when all such amendments were again considered, it
cannot be stated that the patent office was at default in not
examining and investigating the new claims. Rather, the
examination and investigation of the said claims started right from
th
the 9 January 2007 when the gist of objections relating to the
same were handed over to the applicant and thereafter the attempt
to satisfy the same by the applicant. Consequently, no infirmity
can be found on the said count either.

 So far as the republication of the amended claims are concerned, I
have already discussed the same that the republication of the
amendments during the pre grant stage is not the legislative intent
as the patent act has been amended considerably in this respect,
CS(OS) No. 89/2008 Page No.173 of 275


thus, no republication is warranted. Even no issue was framed and
no evidence was led by the defendant.
189. Here, I think, at this stage, it is time to examine the submission made
by the defendant that the examiner of the patent ought to have passed a
speaking order as to how the objections stood removed when there were
objections prior to the personal hearing. I find that the said submission
though seems to be attractive but the same cannot be acceded to. This is due
to the reason that the said order of personal hearing has to be read in the
context along side with the previous process of examination and
investigation carried out by the patent office and responses thereto given by
the applicant herein. The overall collective reading of the same would be
determinative of the fact that whether there existed sufficient grounds for the
examiner to satisfy himself or herself while arriving at the positive finding
that the patent in question is fit for grant or not. I find there is a substantial
compliance of the provisions in relation to the same if one reads the entire
record of examination process holistically rather than in isolation. No doubt,
there was an objection in relation to ertolinib Hydrochloride being a known
Polymorph in the letter dated 9.1.2007. However, there is a response on
record of 14.2.2007 wherein the applicant has explained as to how Erlotinib
Hydrocholride is efficacious than Geftinib and thus does not attract
Section 3(d). Pursuant to the same, if there is a personal hearing held that
the examiner records its satisfaction both on technical objections as well as
on other objections after considering the records of the patent office, I do not
think that the said satisfaction of the examiner is vitiated by the speaking
order. Rather, I think that the said satisfaction is based on what has been
placed on record and the order is not non speaking, the finding as to the
CS(OS) No. 89/2008 Page No.174 of 275


application is in order for the grant is arrived after meeting all the objections,
thus no infirmity can be found on the said examination and investigation
process.
190. I wish to again reiterate that the process of examination and
investigation is a matter between the examiner and the applicant till the time
there is third party opposition is received, therefore, the same has to be
adjudged from the same standpoint by ascertaining as to what was passing
through the examiner‘s mind when he or she proceeded to remove the said
objections and what was the material placed before him or her. It would be
unjust to examine the said examination process from the perspective of third
party as the third party would come into the picture at the later stage during
pre-grant opposition and no right of the third party would be deprived till the
time of conclusion of examination and investigation as per the new scheme
of the Act. If the examination and investigation is vitiated by way of
contravention of the provisions of the Act and Rules, then certainly
illegalities can be ascribed to the said process but if not, then it cannot be
said that the examination process is bad on the mere complaint of the third
party when the things which went on before the patent office seems to be
sequential, just and reasonable.
191. I also do not agree with the defendant‘s submission that the patent
specification does not explain the working of the invention in respect of
formulation, dosages etc or the same does not compare with the prior art. All
this would cover under the separate ground for revocation of the patent
which is misdescription, but the same cannot be used to say that the
examination and investigation is bad in process.
CS(OS) No. 89/2008 Page No.175 of 275


192. I find the submission of the defendant meritless that there is no
correlation between the originally granted claims with that of the final ones.
It is seen that the answer to the same clearly finds mention that in the order
of the patent controller dated 4.7.2007 while disposing of the opposition
preferred by Natco Pharmaceuticals where under the Controller observed
that the claims as finally granted were covered by the scope of Claims 1, 10
and 19 as originally filed. I think that on this basis again, the examination
and investigation process cannot be said to be bad as the patent office
including the controller was well aware of the fact as to what it was
proceeding to do at that time by granting the patent.
193. I have already discussed in detail to what extent the examination and
investigation process is to be looked into by this Court and have interpreted
the Sections and rules in great detail in order to find out as to how one has to
test the said process in the revocation proceedings. In the light of the same, I
do not find any aid from the judgment of IPAB in the cases of Novo Nordisk
Healthcare AG vs. Asst Controller of Patents & Designs , [2009] 41 PTC
577 (IPAB) and Hindustan Unilever Vs Controller of Patents and Designs
and Ors , 2008 (38)PTC 379 (IPAB) as relied upon by the defendant. I think
the plain reading of Sections, rules and analysis done above sufficiently
explains as to how to evaluate the examination and investigation process in
relation to the patent application by the civil Court seized of the revocation
proceedings in the light of the scheme of the act.
194. I wish to further clarify that it may be the case that the patent may
attract the objections as to novelty and inventive step and other tests of
patentability but the examination as a process cannot be said to be bad on the
same count. The said grounds are to be urged in the revocation independent
CS(OS) No. 89/2008 Page No.176 of 275


of the ground false representation. Therefore, I do not find that the plaintiffs
have made any such false suggestion or representation before the controller
so far as it relates to improper examination.
195. There is no evidence lead on the aspect of the misrepresentation and
concealments either by the counter claimant or by the plaintiff. The said
aspect of improper examination has been raised in the counterclaim and
argued purely on the factual aspects without leading any evidence in relation
to the same. This is another reason which persuades this Court to observe
that the defendant has not discharged its onus of the proof in relation to the
aspect of concealments and misrepresentation.
196. To sum up the findings on the concealments and misrepresentation on
facts of the present case, it can be observed as under:
1. The defendant has established that the plaintiffs as patentee has
not disclosed the information as required by the controller as
per Section 8 of the Act which is evident upon from the
examination report dated 22.8.2006 and the responses thereto
which do not record the subsequent patent in US‘221 which
ought to have been disclosed. Thus the ground of revocation
under Section 64 (1) (m) is made out.

2. The defendant has failed to discharge the onus of the proof on
facts that there were concealments made in relation to the
prosecution besides the above before the patent office or there
is an improper examination done by the patent office.
Therefore, the examination and investigation process cannot be
called into question by the defendant in view of the discussion
done above.

3. The amended claims stands examined as the same were
consequential to the process of the examination and
investigation and thereafter the gist of the objections was issued
on 9.1.2007 and replied on 14.2.2007 coupled with the personal
CS(OS) No. 89/2008 Page No.177 of 275


hearing on the same, therefore the examination and
investigation process cannot be said to be bad in so far as it
relates to amended claims. Likewise, the said amendments were
not in law entitled to be published in view of the avowed
legislative intent emerging from the amendments carried out in
the year 2005.

4. The challenge on the ground of ownership title and other
concealments have not been established by the defendant by not
discharging the onus casted upon it. No issue was framed. No
evidence was led by the defendant.

In view of the afore noted conclusions deduced, it can concluded that so far
as the grounds of revocation are concerned, the defendant is able to
discharge the onus of proof only in relation to ground as per Section 64 (1)
(m), and for all other grounds, the defendant has failed to discharge its onus
of proof as casted upon the defendant under the law.
It is seen that though the ground under Section 64(1) (m) of the Act
has been met, still there lies a discretion in the Court to proceed to revoke or
not to revoke the Patent. The said discretion exists by usage of the word
―may‖ under Section 64 of the Act. It is a settled principle of the law that
the word ―may‖ shall ordinary be read as in its grammatical meaning and not
as shall unless the context otherwise provides so. Applying the said principle
of law, it is clear the usage of the word ―may‖ under Section 64 confers a
discretion of widest amplitude upon rectification Court which is evident
from the language of the Section. The authorities on the subject also
indicates towards existence such discretion, Sh. P Narayanan in his renown
book titled as Patent law observes on the discretion vested with the
revocation Court in the following words:
CS(OS) No. 89/2008 Page No.178 of 275


―15-15 Discretion of the Court- The Court has a discretion
to revoke or not to revoke a patent under Section 64(1).
This appears to follow from the use of the words ―a patent
may be revoked‖…… ―(Emphasis Supplied)
Therefore, I exercise the discretion in this matter by not to revoke the patent.
The reasoning for the same shall follow in answer to the issue no. 5 which is
a relief in to revocation.

Re: Relief of revocation
197. I have observed in above discussion that the defendant has only made
out one ground under Section 64 (1) (m) relating to non disclosure of foreign
applications before the controller and the rest of the grounds after evaluation
of the evidence and submissions are rejected by me.
198. In the said ground, the objection of the defendant is that the disclosure
of US‘221 Ex.DW1/8 could have impacted the grant of IN‘774 as the said
patent relates to substantially the same or the same invention. However, the
said position taken by the defendant has to seen by this Court in the light of
the stand of the defendant which exists today before this Court. In this Court
while resisting the infringement claim, the defendant argued that as the
plaintiffs state that both the compounds are different in their Polymorphic
forms, therefore the defendant is stating so. In effect, the defendant supports
the said position that the combination of Polymorphs A and B as contained
in IN‘774 is distinct from Polymorphic version B which is contained in
US‘221.
199. In the light of the said stand taken by the defendant, I find that the
discretion tilts in favour of the plaintiffs and against the defendant as no
CS(OS) No. 89/2008 Page No.179 of 275


useful purpose will be served by revocation of the mark on the sole ground
of revocation when the defendant is stating otherwise before this Court.
200. It is equally well-settled that the party cannot be allowed to approbate
or reprobate at the same time so as to take one position, when the matter is
going to his advantage and another when it is operating to his detriment and
more so, when there is a same matter either at the same level or the appellate
stage.
201. In the case of Kok Hoong vs. Leong Cheong Kweng Mines Ltd. ,
reported in 1964 Appeal Cases 993, the Privy Council held that "a litigant
may be shown to have acted positively in the face of the Court, making an
election and procuring from it an order affecting others apart from himself,
in such circumstances the Court has no option but to hold him to his conduct
and refuse to start again on the basis that he has abandoned." (Emphasis
Supplied)
202. In the case of Dwijendra Narain Roy vs. Joges Chandra De , reported
in AIR 1924 Cal 600, the Division Bench of the Calcutta High Court has
succinctly held :
"It is an elementary rule that a party litigant cannot be
permitted to assume inconsistent positions in Court, to play
fast and loose, to blow hot and cold, to approbate and
reprobate to the detriment of his opponent. This wholesome
doctrine, the learned Judge held, applies not only to
successive stages of the same suit, but also to another suit
than the one in which the position was taken up, provided
the second suit grows out of the judgment in the first."
(Emphasis Supplied)

CS(OS) No. 89/2008 Page No.180 of 275


203. Applying the said principle of the law to the present case, I do not find
that the discretion to revoke the patent should be exercised when such stand
of the defendant is inconsistent and more so when no other ground relating
to the revocation of the patent is satisfied under Section 64. Therefore, the
defendant is not entitled to relief of cancellation or revocation of the Patent
No.196744.
Re: Infringement of Patent
204. Now I shall proceed to discuss the issue no. 1 relating to infringement
of the patent. The issue as framed by this Court reads as under:
―Whether the manufacture, marketing and sale of
ERLOCIP by Defendant is infringing the Plaintiffs‘ Indian
Patent 196774?‖
205. The onus to prove the said issue lies upon the plaintiffs. The plaintiffs
claim to be the owner of the IN‘ 774 titled as Erlotinib Hydrochloride
comprising the two claims, however the one relevant to the proceedings is
reproduced hereunder:
―Claim 1 of the suit patent reads as follows:
1. A novel [6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-
ethynylphenyl) amine hydrochloride compound of the formula A
A ‖
206. The case of the plaintiffs is that the defendant has infringed the suit
patent wherein the rights are granted in claim No.1.
CS(OS) No. 89/2008 Page No.181 of 275


The said suit patent has the same invention and corresponds with US
patent No.5747498 (for short, it would be referred to as US‘ 498) date of
th
application of the suit patent with priority of 30 March, 1995. The date of
th th
US‘498 is 28 May, 1996, it was granted on 5 May, 1998.
207. The plaintiffs in the paragraph 11 of the plaint have stated that the
defendant had been proposing to launch the generic version of the drug
namely Tarceva (Erlotinib) which they had learnt from the Newspaper
articles published on 11.1.2008 in the English Daily titled as Mint and this
led the plaintiffs to file the present suit on the basis of IN‘774. In the plaint,
the plaintiffs contends that they own a patent no. 196774 dated 23.2.2007 in
respect of a compound namely [6,7-bis (2-methoxyethoxy) quinazolin-4-
y1]-(3-ethynylphenyl) amine hydrochloride. It is contended that the
plaintiff‘s drug is administered in the form of tablet. The tablet formulation
of Erlotinib is sold by the plaintiffs under the trade mark and the name
TARCEVA. It is also stated in the plaint that the drug as well as the process
of its manufacture is patented under the provisions of the Patents Act, 1970
and this entitled to the protection.
208. The plaintiffs have claimed the following relief on the said basis in the
prayer clause:
―a) Pass a decree of permanent injunction restraining the
defendant, its directors, officers, servants, agents, and all
others acting for and on its behalf from manufacturing,
using, selling, offering for sale, distributing, exporting or in
any manner infringing the legal rights of the plaintiffs in the
drug Tarceva (Erlotinib) and from manufacturing, selling
offering for sale, distributing or exporting in any manner
any generic version of the drug Tarceva..……‖

CS(OS) No. 89/2008 Page No.182 of 275


209. The aforementioned relief is claimed for the purposes of permanent
injunction and other reliefs are sought in the prayer clause. As noticed upon
careful reading of the prayer clause, what has been prayed in the suit seeking
permanent injunction of the infringement of the legal rights in the drug
Tarceva (Erlotinib) and also from manufacturing, marketing the generic
version of the drug Tarceva. This is necessary to highlight at the threshold
as at the time of institution of the suit, it was the understanding of the
plaintiffs that the drug Tarceva corresponds with that of the patent and
therefore the infringement was sought of the legal rights of the Tarceva
(Erlotinib) medicine or drug.
210. The defendant had been served and filed written statement raising
several defenses and challenges to the suit patent which has been discussed
already and will be discussed under this head so far they relate to resisting
the claim of the infringement.
211. An important development took place when the defendant raised a
challenge to the plaintiffs‘ IN‘774 by way of the counter claim. In the
counter claim in paragraph 3.8 to 4.3, the defendant explained that the
impugned patent is an admixture of the Polymorph A and B and the drug
Tarceva which has been manufactured in the market is based on the stable
version of derived from Indian Patent which has been a subject matter of
Patent in US‘221 and in India the same patent application bearing No.IN-
507/DEL has been refused.
212. To this, the plaintiffs herein in response in the written statement to the
counter claim in paragraph 2 did not deny the factum of rejection of
plaintiffs‘ application of Polymorph B version of the compound but has
pointed out certain admission which as per the plaintiffs would proceed to
CS(OS) No. 89/2008 Page No.183 of 275


show that the defendant had admitted the aspect of the infringement of the
plaintiff‘s patent. This became relevant as a matter of backdrop of issue
relating to infringement so that at the later stage, the arguments and
submissions made later on may be evaluated on the pleaded facts of the
parties.
213. The plaintiffs have thereafter filed the evidence by way of affidavit of
Mr. Shiv Prasad Laud (PW1) who is a constituted attorney of the plaintiffs.
He has deposed about the aspect of the infringement on the basis what has
been stated in the packaging of the defendant namely Erlotinib
Hydrochloride and also some declaration made before the authorities as to
what had been contained in the medicine is ERLOTINIB
HYDROCHLORIDE. It is noteworthy to mention that no clinical tests have
been placed on record either by attorney of the plaintiffs or by the expert of
the plaintiffs which would show and analyzes as to what are the exact
constituents of the plaintiffs drug Tarceva and the defendant‘s drug
ERLOCIP more specifically the question whether the same corresponds with
the Indian Patent in the entirety or whether the same are the Polymorphic
version B of the suit patent compound. Rather, the plaintiffs attorney has
deposed everything on the basis of what has been shown in the physical
form of literature of the drug of the defendant which only demonstrates that
it contains Erlotinib Hydrochloride. There are other evidence of Mr.
Thatcher PW 3 and Mr. Roger Griffin PW 2 who are experts, they have
deposed mostly on the other aspects of efficacy and how the suit patent is
not anticipated and not on the question of the exact constituents of the drug
TARCEVA and that of the Defendant.
CS(OS) No. 89/2008 Page No.184 of 275


214. The defendant on the other hand has filed the evidence Ms. Shashikala
(DW2) who claimed to be an expert and a person competent to make X ray
diffraction in order to analyze the compound contained in the plaintiff‘s drug
Tarceva. It is specifically deposed in the affidavit of Ms. Shashikala that she
has analyzed the xray diffraction of the said product of the plaintiffs
TARCEVA and came to the conclusion that the said drug is based on the
Polymorphic version B of the compound namely N- (3-ethynylphenyl)-6-7-
bis (2-methoxyethxy)-4-Quinazolinamine. It is also deposed that the said
features of Polymorph B contained in Tarceva corresponds with the US
patent 221. (the corresponding Indian patene IN‘507 of which has been
refused by Indian Patent office). The tests had been conducted in the lab of
the Cipla as well as the Independent laboratories namely IIT, Mumbai. The
results of the said x ray defraction arising out the tests from Cipla and from
IIT have been compared by Ms. Shashikala in her affidavit and thereafter
she has come to the conclusion that the plaintiff‘s drug is Polymorphic B
version of the said compound.
215. Learned counsel for the plaintiffs has cross examined DW2
Ms. Shashikala at great length. The cross examination of Ms. Shashikala
reveals that though in her affidavit she claimed to be inventor of some
patented inventions but once she was confronted with the documents relating
to structure of the patents she has not been able to make out as to what are
the structures of the compounds at several places like Exhibit PX 25 and PX
26 as cited by the learned counsel for the plaintiff. It has also come out well
that Ms. Shashikala may know little about the chemical structure and may
not be knowing the subject invention well even as it is apparent from her
answers which were mainly that she either does not know or does not recall.
CS(OS) No. 89/2008 Page No.185 of 275


She however maintained all through her cross examination that her role was
confined to analyze the x-ray diffraction and compare it with the trends of
what has been appended as Figure 3 in the US ‗221 patent. No questions
were asked by the learned counsel for the plaintiffs on the aspect as to when
such x-ray reports were taken, where are the originals of the said x-ray
diffractions, about the correctness of the trends and no suggestions were put
to Ms. Shashikala that the reports submitted by her are not correct or false. It
is also not put to her that the reports are false as the plaintiffs are
manufacturing the medicine or drug which actually corresponds to suit
patent IN‘774. Further, it is also not suggested to her that the reports are
prepared only as a replica to trends contained in US patent 221 by looking at
the diffractions stated therein and actually no such trends ever emerged. The
only thing which was put to her was that Indian Patent ‗774 is broad enough
to cover any Polymorphic form prepared by anybody. Besides the same,
nothing was to put to her to bring out a positive case that the plaintiff‘s
patent corresponds to the drug manufactured by them in the market.
216. In the absence of the said suggestions, it can be said that the defendant
has at least shown on record that the plaintiffs‘ product which is being
manufactured and sold as Tarceva is Polymorphic B version of the
compound. It is also clear from the plaintiffs maintaining before the DW2
and asking her that IN‘774 compound would cover Polymorphic versions
made by anybody and all other questions like diamond and graphite are
Polymorphic versions of carbon etc. The plaintiff has thereafter not led any
further evidence to dispel such the fact establishment that the plaintiffs‘
product is actually a Polymorphic B version of the plaintiffs compound. At
this stage, it is suffice to observe about the establishment of this fact. It is
CS(OS) No. 89/2008 Page No.186 of 275


altogether different matter as to what bearing this fact will have at the
plaintiffs‘ case of infringement of patent, which shall be seen later.
217. Thereafter, The defendant has also lead the evidence of professor
Nangia (DW3) who in paragraph 35, 36 and 37 of his affidavit specifically
deposes that the tablet of form of Erlotinib Hydrochloride cannot be made
by way of simply following the suit patent No.774. It was deposed that the
example 4 and 5 in US‘221 patent are relevant for the same purpose and the
same shows that the there is further process of reaction of the said
compound with that of other constituents like ethanol and water in order to
arrive at Polymorphic version. Therefore, it is stated that the suit patent
compound may not automatically lead to Polymorphic version.
218. Mr. Nangia was again cross examined where under no questions were
put as to factual incorrectness of plaintiffs product being Polymorphic
version B of the compound. The questions were asked as to existence of
Polymorphs of the compounds in general and that Erlotinib Hydrochloride
from Erlotinib base and similarity of the properties, structural formula of the
compound with that of the Polymorph. All this indicates that the plaintiffs
maintained the position all the time that the said Polymorphic version B may
be covered within the suit patent. This at least establishes that the plaintiffs
do not seriously dispute that the plaintiffs‘ drug available in the market is a
Polymorph B of the compound which is subject matter of the patent.
219. The plaintiffs have not led any positive evidence to the effect to
establish on record that the Polymorphic versions are always the same as
that of the underlying compound. It is also not established on record by way
of depositions of the plaintiffs that how many Polymorphic versions are
available of the suit compound. If there are, then whether all are the same in
CS(OS) No. 89/2008 Page No.187 of 275


the nature, characteristics, properties in all respects with the parent
compound. It is also not established by the plaintiffs‘ deposition that the
chemical structure of the plaintiff‘s compound may not change when the
same is converted into from admixture of Polymorph A & B to Polymorph
B. I think all these questions if at all answered in the form of the evidence
would have simplified the plaintiff‘s case so as to establish that the direct
case of infringement rather than to say simply that if at all Polymorph B
exists in Defendant‘s tablet, the same is an infringement of the Plaintiffs
Indian Patent‘774 as it is covered within its ambit.
220. Nevertheless, let me now consider and evaluate what the parties have
to say about the case of infringement of the patent at this juncture.
 The plaintiffs contend that the claim defines the scope of the
invention and therefore the court while determining the
infringement of the patent has to compare what has been contained
in the claim of the invention vis-à-vis the constituents of the
product of the defendant. The plaintiffs state that in the instant case
IN 196774 (IN‘774 or the ‗suit patent‘) patent is targeted towards
invention of novel ―4-anilino quinazoline‖ compounds having anti-
cancer activity. The invented compounds are inhibitors of
Epidermal Growth Factor Receptor (EGFR) tyrosine kinase and
are used for treating cancer by virtue of their property that destroy
some types of cancer cells while causing little harm to the normal
human cells ( PW2, para 15 of affidavit; PW3, para 13 of
affidavit ). The specification of the suit patent details 105
compound examples, but has restricted the scope of patent
protection to only one compound Erlotinib Hydrochloride which is
disclosed in example 20 and Claim 1 .

 The claims of suit patent are restricted to only 2 claims. Claim 1 of
IN‘774 is a claim for the compound Erlotinib Hydrochloride per se
(DW 3, Q. 22) and Claim 2 is a process claim for the manufacture
of Erlotinib Hydrochloride. In the present case, the Plaintiffs have
only asserted infringement of Claim 1 of the suit patent –
CS(OS) No. 89/2008 Page No.188 of 275


“A novel [6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-
ethynylphenyl) amine hydrochloride compound of the formula A
A ‖
 It is submitted that the compound claimed in claim 1 of the suit
patent is the Active Pharmaceutical Ingredient (API) of the
Plaintiff‘s drug, TARCEVA®. It is pertinent to note that
TARCEVA® has been approved by the DCGI for the treatment of
Non-Small Cell Lung Cancer (NSCLC) in the year 2005 and
pancreatic cancer in the year 2006.

 It is submitted that Section 48 (a) of the Patents Act, 1970 provides
that the patentee can prevent third parties, who do not have his
consent, from making, using, offering for sale, selling or importing
the said product in India. Therefore, in the present case, the
Plaintiffs seek to restrain the Defendant from making, using,
offering for sale, selling or importing the claimed compound
Erlotinib Hydrochloride.

 The plaintiffs have argued that for the purposes of the infringement
of patent, the court has to read the claim and then compare it with
the product of the defendant. It is argued by stating that the
infringement of a patent constitutes the unauthorized act of making
or using or offering for sale, selling or importing the claimed
invention. Section 48 provides that infringement analysis has to be
assessed upon comparison of the Claims of the suit patent with the
accused product or process. Therefore, the test to determine
infringement is a 2 step process:

i. First, the claim needs to be interpreted;
ii. Second, the impugned product has to be compared with the
claim.
CS(OS) No. 89/2008 Page No.189 of 275


 As per Section 48, it is erroneous to compare the impugned product of
the Defendant with the Plaintiff‘s product. Therefore in the present
suit, the infringement should be judged as whether the Defendant‘s
product, i.e., ERLOCIP, falls under the scope of the Claim 1 of
IN‘774.

 The plaintiffs have cited several authorities wherein the rules of
interpretation of the claims in patent are laid down by the courts from
time to time. The said authorities relating to several propositions can
be discussed in the following manner:

i. Interpretation of a patent is a question of law and not fact.
( Markman v. Westview , 517 US 370 at p. 384).
ii. Claims have to be interpreted as on the date of priority of the
patent application. ( Philips v. AWH , 415 F. 3d 1303 at p. 1313)
iii. If the words in the claims are clear and unambiguous then no aid of
any other document to interpret is admissible. ( Philips v. AWH ,
415 F. 3d 1303 at p. 1314; F.H.&B. Corporation v. Unichem , AIR
1969 Bom 255 at para 8)
iv. If the words in the Claims are ambiguous, then the case of Philips
v. AWH (415 F. 3d 1303 at p. 1314-1318) states that the following
documents, in this hierarchy, can be looked into to give meaning:

a) Patent Specification of the same patent;
b) Prosecution History of the same patent;
Dictionary and other external sources as on the
c)
priority date.

221. It is stated that the Claim 1 of suit patent is for the novel compound
[6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-ethynylphenyl) amine
hydrochloride; which is represented by the below formula:

CS(OS) No. 89/2008 Page No.190 of 275


The scope of a patent for a new compound covers the compound and
for whatever purpose it is used.

 The claimed compound {[6,7-bis (2-methoxyethoxy) quinazolin-4-
y1]-(3-ethynylphenyl) amine hydrochloride i.e. Erlotinib
Hydrochloride} of the suit patent is disclosed as Example 20 in the
patent specification. Further, Example 20 has characterized the
physical state of the claimed compound as solid and is identified as
a solid by its melting point.
 Claim 1 of the suit patent is for the Erlotinib Hydrochloride
compound per se, and not restricted to any particular Polymorphic
form or mixture of any forms, nor claims any particular
Polymorphic form. Therefore there is no requirement to provide X-
ray diffraction data in the patent specification. It is submitted that
X-ray diffraction data is used to characterize and identify the
Polymorphic form of a compound since an X-ray diffraction graph
is unique for a particular Polymorphic form of a compound.

222. The plaintiffs have submitted that they have discharge the onus of
proof upon them to show that the defendant product is infringing the patent
of the plaintiffs in the compound which is the subject matter of IN‘774. As
per plaintiffs, the following narration will indicate the discharge of the onus
of the proof:
a. That the plaintiffs have mentioned in the plaint that the cause of
action first arose in January 2008, where, by way of several
reports in the media, the Plaintiffs were made aware of the
potential infringement of the suit patent by the Defendant. One
such report appearing in ‗The Mint‘ stated that the Defendant
CS(OS) No. 89/2008 Page No.191 of 275


was ―to sell copycat version of the Roche drug‖. This report has
not been denied at any point by the Defendant or its
representatives. ( Q. 121 read with Q. 205 , DW1)

b. The packaging of the Defendant‘s product ERLOCIP ( Ex. P1 ,)
clearly shows that the Defendant manufactures, offers for sale,
and sells Erlotinib Hydrochloride tablets.



c. Further, the package insert of the Defendant‘s product
ERLOCIP ( Ex. P2 ) clearly shows the composition of the tablets
manufactured by the Defendant have the Active Pharmaceutical
Ingredient (API), Erlotinib Hydrochloride.


d. The license received by the Defendant from the Central Drug
Standard Control Organisation on October 19, 2007 ( Ex.
PW1/D2, ) was for manufacture of Erlotinib Hydrochloride
(DW 1, Q 220,).

e. The approval received by the Defendant from the Department
of Food and Drug Administration, Government of Goa in
December, 2007 was for manufacture of Erlotinib
Hydrochloride tablets.

CS(OS) No. 89/2008 Page No.192 of 275


f. It is further submitted that the Written Statement in the present
suit contains an express admission by the Defendant that it
manufactures and markets a generic version of Erlotinib
Hydrochloride. Importantly, the Written Statement does not
have any denial of infringement of Claim 1 of the suit patent. It
is therefore humbly submitted that the Plaintiffs in the present
case have discharged the onus of proving infringement of Claim
1 in view of the various admissions made by the Defendant
with respect to their product ERLOCIP.

g. During the course of the trial in the present suit, the
Defendant‘s witnesses have also made specific admissions as to
infringement of the Erlotinib Hydrochloride compound claimed
in Claim 1 of the suit patent which are stated below.

 Erlotinib Hydrochloride produced anywhere in the world
will always have the IUPAC name and chemical formula
“[6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-
Ethynylphenyl) amine hydrochloride compound” and the
chemical structure

(Q . 24 and Q. 35, DW2,; Q. 49, DW3, ). This is exactly what
has been claimed in Claim 1 of the suit patent IN‘774.
 The Active Pharmaceutical Ingredient, i.e. the component of
the drug that actually acts on the target, in the Defendant‘s
product ERLOCIP is Erlotinib Hydrochloride (Q. 34,
DW2, ).
 The International Non-Proprietary Name of their Product is
Erlotinib Hydrochloride ( Q. 190, DW1 ,).
CS(OS) No. 89/2008 Page No.193 of 275


By highlighting the aforementioned statements from the cross examination,
it is submitted by the plaintiffs that they have discharged the onus of the
proof upon them to establish the infringement of the IN‘ 774.
h. Besides, the above stated statements, it is submitted that the
defendant has always understood the Erlotinib Hydrochloride as
a compound and not in Polymorphic form in any manner.
i. It is therefore submitted that even prior to January 2008, when
the Defendant was ―unaware‖ of the existence of Erlotinib
Hydrochloride in Polymorph B form, it had made patent
applications, received Government approvals and manufactured
Erlotinib Hydrochloride tablets under the trademark ERLOCIP.
It is therefore reiterated that the defence taken by the Defendant
that it manufactures Erlotinib Hydrochloride in Polymorph B
form is an afterthought and a last ditch effort by the Defendant
to mislead this Court and deny the claim of infringement by the
Plaintiffs.

j. It is submitted that there is not even a whisper of this defence
either in the pleadings or in Defendant‘s interim application
I.A. No. 1272 of 2008 before this Court. In fact it is submitted
that in the Replication to the Counter Claim, the Defendant in
fact specifically denies that it is manufacturing Erlotinib
Hydrochloride in Polymorph B form. ( Paragraphs 3.8, 4-4.5 of
the Reply on merits, Replication to the Counter Claim , Part I(B)
of the Court Record).

CS(OS) No. 89/2008 Page No.194 of 275


k. It is further submitted the Defendant has not placed on record
any X Ray Diffraction data to show that it is manufacturing
Erlotinib Hydrochloride in Polymorph B form or that the same
differs from Erlotinib Hydrochloride as claimed in Claim 1 of
the suit patent IN‘774.

l. Therefore the Defendant‘s averments in oral arguments that the
product manufactured by them is the Erlotinib Hydrochloride in
Polymorph B form and therefore, the product does not infringe
claimed compound Erlotinib Hydrochloride of suit patent
IN‘774 is false and contrary to their own admissions.

m. In the absence of any such pleading or evidence, it is submitted
that the Defendant has not rebutted or explained away its
admissions that it has the license and governmental approvals to
manufacture ‗Erlotinib Hydrochloride‘ and not any
Polymorphic form, and that it does so under the brand
ERLOCIP.

The plaintiffs submitted that without prejudice whatever alleged
difference exists between the combination of Polymorph A and
B and Polymorph B, the defendant could not have arrived at
Polymorph B form of the molecule which is stated by the
defendant without crossing the stage of preparation of
combination Polymorph A and B. therefore, the defendant
product even if the same is a Polymorphic B version of the
molecule would still infringe, the plaintiff‘s IN‘ 774. This has
been explained by the plaintiffs in the narration below:
CS(OS) No. 89/2008 Page No.195 of 275


n. Assuming for the sake of arguments that the statement of the
Defendant is correct, it is submitted once the tablet is
consumed, in the body the physical ‗form‘ of Erlotinib
Hydrochloride is irrelevant . This has been admitted by
Defendant’s own Polymorph expert witness, DW2 in Q.27.


o. Further, assuming for the sake of arguments that only Erlotinib
Hydrochloride in Polymorph B form can be made in tablet
form, it is submitted that defendant cannot arrive at Erlotinib
Hydrochloride in Polymorph B form without using the claimed
compound ‗Erlotinib Hydrochloride' itself. It is important to
note that the Defendant alleges to use the Polymorphic form of
the claimed compound and not any other compound or any
other salt of the main compound.
p. It is submitted that it is Defendant‘s own argument that one
person‘s finished product can be another‘s raw material. More
specifically, this implies that Erlotinib Hydrochloride tablets
CS(OS) No. 89/2008 Page No.196 of 275


(the finished product allegedly being Erlotinib Hydrochloride in
Polymorph B form) has to be made from Erlotinib
Hydrochloride bulk (i.e. the Active Pharmaceutical Ingredient
which is undisputedly the same Erlotinib Hydrochloride as
claimed in Claim 1 of the suit patent IN‘774).
q. Importantly, even the application for the Erlotinib
Hydrochloride in Polymorph B form in the US, US 6900221
(US‘221) states that Erlotinib Hydrochloride in Polymorph B
form results from re-crystallization of Erlotinib Hydrochloride
using different solvents and temperature condition. This has
been admitted by DW3 in ( Q.82 , DW3;), during the course of
cross examination.
r. Simply explained, different Polymorphic forms of a compound
are prepared in pharmaceutical sciences by re-crystallisation of
the main compound using different solvents under different
temperature regimes ( Q.22 & Q.24 , DW2 ,). Further, during
preparation of Polymorph of a compound there is no chemical
changes taking place on the molecule itself, however, during re-
crystallization the molecules are re-arranged/re-oriented in a
particular manner and it is this arrangement of molecules which
is designated as a particular Polymorphic form of a compound.
s. Importantly, there has been no evidence or process stated by
Defendant to show that Erlotinib Hydrochloride in Polymorph
B form can be made without using claimed Erlotinib
Hydrochloride. ( paragraph 35 of the Evidence Affidavit of
DW3)
CS(OS) No. 89/2008 Page No.197 of 275


t. It is submitted that it is Defendant‘s own argument that one
person‘s finished product can be another‘s raw material. More
specifically, this implies that Erlotinib Hydrochloride tablets
(the finished product allegedly being Erlotinib Hydrochloride in
Polymorph B form) has to be made from Erlotinib
Hydrochloride bulk (i.e. the Active Pharmaceutical Ingredient
which is undisputedly the same Erlotinib Hydrochloride as
claimed in Claim 1 of the suit patent IN‘774).
u. Importantly, even the application for the Erlotinib
Hydrochloride in Polymorph B form in the US, US 6900221
(US‘221) states that Erlotinib Hydrochloride in Polymorph B
form results from re-crystallization of Erlotinib Hydrochloride
using different solvents and temperature condition. This has
been admitted by DW3 in ( Q.82 , DW3), during the course of
cross examination.
v. Simply explained, different Polymorphic forms of a compound
are prepared in pharmaceutical sciences by re-crystallisation of
the main compound using different solvents under different
temperature regimes ( Q.22 & Q.24 , DW2 ). Further, during
preparation of Polymorph of a compound there is no chemical
changes taking place on the molecule itself, however, during re-
crystallization the molecules are re-arranged/re-oriented in a
particular manner and it is this arrangement of molecules which
is designated as a particular Polymorphic form of a compound.
w. Importantly, there has been no evidence or process stated by
Defendant to show that Erlotinib Hydrochloride in Polymorph
CS(OS) No. 89/2008 Page No.198 of 275


B form can be made without using claimed Erlotinib
Hydrochloride. ( paragraph 35 of the Evidence Affidavit of
DW3 )
x. It is a well settled principle that a Polymorphic form of a
compound will infringe the ‗basic compound patent‘ which in
this case is the suit patent. It is also a well settled principle that
the aforesaid holds true irrespective of the fact that the
‗Polymorphic form‘ in question is covered by a separate
‗Polymorph‘ patent.

y. In the present suit, since the claims relating to Polymorph form
per se were not allowed, the defendant is infringing the basic
compound patent i.e. the suit patent IN‘774. If claims related to
Polymorph form per se would have been granted, the defendant
would have infringed two patents, i.e. the suit patent as well as
the Polymorph patent.
z. In such an event, it is submitted that the manufacture of the
admittedly separate and distinct invention for Erlotinib
Hydrochloride in Polymorph B form will still infringe Claim 1
of IN‘774.
i. This concept has been statutorily recognized under
Sections 19 and 91 of the Patents Act, 1970.
ii. Section 19 states that where an application for a patent
cannot be performed without substantial risk of
infringement of any other patent, the Controller may
direct that a reference to such other patent be inserted in
CS(OS) No. 89/2008 Page No.199 of 275


the applicant‘s complete specification by way of notice to
the public.
iii. Following this, if the patent application is granted by the
Controller, then the patentees can under Section 91
license each other‘s related applications so as to enable
they can work the invention efficiently or to the best
advantage possible.
iv. This concept of cross-licensing has been expounded in
several leading commentaries including Philip W.
ATENTS FOR HEMICALS HARMACEUTICALS
Grubb‘s, P C , P
AND IOTECHNOLOGY
B (at p.4, 1999 edition) stating that,
― Exclusionary Right .... In a very common
situation where A has a patent for the basic
invention and B later obtains a patent for an
improvement to this invention, then B is not
free to use his invention without the permission
of A, and A cannot use the improved version
without coming to terms with B.”

v. This passage has been cited with approval in the case of
Hindustan Unilever Limited v. Lalit Wadhwa, 2007 (35)
PTC 377 at paragraphs 14 and 16.
a. Therefore, it is well-known as well as statutorily
recognized that more than one patent can cover a
single product.
vi. Thus, assuming that Erlotinib Hydrochloride in
Polymorph B form or any other Polymorphic form had
been granted a separate patent, then such patent could not
CS(OS) No. 89/2008 Page No.200 of 275


be worked without the approval and/or license of the
patentees to the suit patent IN‘774.
vii. This situation is also evident upon a reading of the US
Judgment, OSI Pharmaceuticals LLC & Ors. v. Mylan
Pharmaceuticals from the District Court of Delaware in
favour of Plaintiff No. 2 since the US Food and Drug
Administration's ("FDA's") publication titled "Approved
Drug Products with Therapeutic Equivalence
Evaluations" (known as the "Orange Book") lists Nos.
5,747,498 (corresponding to the suit patent), US
6,900,221 (corresponding to the patent for Erlotinib
Hydrochloride in Polymorph B form and related methods
of treatment) and US 7,087,613 (corresponding to the
®
methods of treatment) for the product Tarceva .
a. Thus, even if CIPLA re-crystallized Erlotinib
Hydrochloride compound to arrive at Erlotinib
Hydrochloride in Polymorph B form and sold it
under the brand name ERLOCIP, this would
amount to use of the compound claimed in Claim 1
of the suit patent IN‘774 and therefore is
infringement within the meaning of Section 48(a)
of the Patents Act.
viii. The plaintiffs also submitted that in any case while
deciding the opposition proceedings relating to
subsequent IN‘774 which comprised of Polymorph B, the
controller had found that the said Polymorph shall be
CS(OS) No. 89/2008 Page No.201 of 275


deemed to be same substance as per Section 3(d) of the
Act. Therefore, this Court should also treat the said
Polymorph B version to be the same as that of the IN‘997
and should proceed to hold the infringement of the patent
done by the defendant by giving effect to such fiction
provided under the law. This has been narrated by the
plaintiffs by contending the following:
a. In the pre-grant opposition order dated 15.12.2008 ( Annexure to
DW1/12 ), the Controller accepted the Defendant‘s contention that
Polymorph B was non-patentable subject matter under Section 3(d)
and rejected the application for Erlotinib Hydrochloride in Polymorph
B holding that:
i. The mere discovery of Erlotinib Hydrochloride in Polymorph B
form was not patentable;
ii. The thermodynamic stability of the Polymorph B form did not
meet the requirement of ―enhanced efficacy‖ within the meaning
of Section 3(d). Controller of Patents in a well reasoned pre-grant
opposition order of IN‘507 held that Erlotinib Hydrochloride in
Polymorph B is the ‗same pure substance‘ as suit compound
Erlotinib Hydrochloride.
iii. The above order has attained finality and the plaintiffs have not
appealed the same.
b. A rejection under Section 3(d) of the Patents Act deems
Erlotinib Hydrochloride in Polymorph B form to be the same as the
known substance i.e. the Erlotinib Hydrochloride compound as
claimed in Claim 1 of the suit patent, IN‗774. Therefore, once
CS(OS) No. 89/2008 Page No.202 of 275


Erlotinib Hydrochloride in Polymorph B form is deemed to be the
same pure substance as Erlotinib Hydrochloride under Section 3(d), it
is not permissible to treat Erlotinib Hydrochloride in Polymorph B
form as a different substance for the purpose of Section 48 or any
other provisions of the Act. The Supreme Court in various cases while
applying the principle of ‗deeming fiction‘ has held that if the statute
requires a person to treat an imaginary state of affairs as real, then one
must, unless prohibited from doing so, also imagine as real the
consequences and incidents which, if the putative state of the affairs
had in fact, existed must have inevitably flowed from. After one
imagines this specified state of the affairs, then one cannot cause or
permit one‘s imagination to boggle when it comes to the inevitable
corollaries of that state of affairs.
c. Therefore after the rejection of the application for Erlotinib
Hydrochloride in Polymorph B form, the separate invention of
Erlotinib Hydrochloride in Polymorph B form has been deemed by
legal fiction to be a part of the known substance i.e. Claim 1 for the
Erlotinib Hydrochloride compound under Section 3(d) of the Patents
Act.
d. The plaintiffs have also provided an instant where the US
District Court of Delaware in the case against some third party finds
on the admission of the defendant therein that the defendant in that
case infringed the US equivalent of the IN‘774. This has been
explained by the plaintiffs as under:
In the proceedings before the United States District Court
of Delaware between Plaintiff No. 2 (amongst others)
CS(OS) No. 89/2008 Page No.203 of 275


against Mylan Pharmaceuticals, Mylan admitted that a
generic version of Erlotinib Hydrochloride would
infringe Claim 35 of US Reissue Patent 41065E (US
RE‘065). Claim 35 in US RE‖065 corresponds to
Claim 1 of IN‘774 which is for the Erlotinib
Hydrochloride compound per se.
223. The plaintiffs contend that in view of the said position, this Court
should consider arriving at the conclusion that the plaintiffs have discharged
their onus of proof to show that the defendant‘s product is an infringement
of the plaintiff‘s patent containing a compound Erlotinib Hydrochloride.
224. Per contra, the defendant through its counsels has argued on the same
lines as recorded above prior to the plaintiffs submissions which can be
summarized in the following effect:
 That the plaintiffs have not lead any evidence to show that what
exactly Tarceva contains whether a Polymorphic version B or
combination of A and B.
 The plaintiffs have not asked any questions to the defendant‘s
witness to disprove the fact that the Tarceva actually contained
the suit compound.
 In view of the above and absence of the evidence by the
plaintiffs, it is established that Tarceva contained Polymorphic
version B of the compound.
 If that is so, then the plaintiffs are estopped by their express
admissions and conduct from contending to the contrary today
that the plaintiffs‘ drug Tarceva is covered with in the suit
CS(OS) No. 89/2008 Page No.204 of 275


patent compound. As per the defendant, the plaintiffs have
made the following admissions:

It is the admitted position on record that a separate patent application was
filed in USA for Polymorph B i.e. US‘221 and other countries. Separate
application for product and process being application no.s IN/507/DEL
and IN497/DEL were also filed in India for Polymorph B form of
Erlotinib Hydrochloride. In the said subsequent patent in USA and patent
applications in India clear admissions have been made that the suit patent
is related to Polymorph A+B but the second patent US‘221 and
corresponding applications in India relates to Polymorph B form of
Erlotinib Hydrochloride. The date of application of Polymorph B in
th st
USA under US‘221 was 9 November, 2000 which was granted on 31
may, 2005 and in India the plaintiffs‘ application for Polymorph B was
th
IN-507/DEL filed on 14 May, 2002.
 The defendant argued that the Plaintiffs had to explain these
admissions which have not been done throughout arguments till
conclusion of their arguments. No evidence was led nor was an
attempt was made to argue why these admissions cannot be
relied upon. The only argument of the Plaintiffs is that the
inventors are different of the suit patent and Polymorph B
patent or that the subsequent patent cannot be looked into. It is
absurd to argue and is not based on any legal proposition that
that in a counterclaim, admissions of the plaintiffs cannot be
looked into. All these patents being US‘221, US‘613 and
applications IN/497/DEL, IN/507/DEL belong to the same
CS(OS) No. 89/2008 Page No.205 of 275


family. For the Plaintiffs to ask the Court not to look at the
subsequent patents for the same product is a dishonest
argument. The Court has to see all the arguments,
circumstances and then decide.
 It is submitted by the defendant that IN‘774 suit patent derives
priority from US‘498. One patent derives priority from another
only if it relates to the ―same invention‖. Thus all statements
made qua US‘498 automatically apply to IN‘774. Hence the
same are binding on the Plaintiffs.
 No witness was produced to explain away the admissions by
the Plaintiffs. Not a single expert witness appeared from Roche
or OSI to explain the various patents on Erlotinib. Third parties
cannot explain. Mr.Laud PW1 was not a technical witness, so
he had no knowledge on Polymorphism.
 As per the Supreme Court judgment Bishwanath Prasad vs.
Hindustan Metal [1979] 2 SCC 511 paras 21, 36, 43 to 50 , the
inventor would have been the best witness. Apart from the
witness not being brought, the plaintiffs did not produce any
witness from Roche or OSI or Pfizer to establish their case.
 It is argued by the defendant that the plaintiffs have been
vehemently trying to define Polymorphism and at the same time
attempting to substantiate that the Polymorph B is subsumed in
the suit patent. The latter is completely false and factually
incorrect. Plaintiffs argue that the product is the same but it is
only the packing of the crystals which is different. E.g., of
Diamond and Graphite. However, Plaintiffs forget to consider
CS(OS) No. 89/2008 Page No.206 of 275


or point out that Diamond and Graphite have completely
different properties. One is soft and one is the hardest
substance. Their physical properties are miles apart.
 It is submitted that The Polymorph B patent application IN‘507
of Plaintiffs has been rejected in India. The Plaintiffs cannot be
better off after Polymorph B patent is rejected. Firstly Plaintiffs
consider Polymorph B as a new invention and a new product
and thus file an application for getting a patent. Thereafter,
when the said application is rejected by the Controller, the
Plaintiffs took a complete somersault and are arguing that the
second product is covered by the first patent. If that was the
case, why was the application made for the second product at
first place? The Plaintiffs cannot have it both ways.
 The defendant argued that Section 48 uses the words ―that
product‖. The product has to be identified. A product is a
commercially saleable product. This is clear from the following
decisions:
i. Delhi Cloth and General Mills Co Ltd vs. RR Gupta,
Commercial Tax Offcier, Jaipur (1976) 3 SCC 443
ii. UOI & Ors vs. Tata Iron and Steel Co( 1975) 1 SCC 78
iii. South Bihar Sugar Mills Ltd vs. UOI & Anr (1968) 3 SCR 21
iv. Bhor Industries Ltd Bombay vs. Collector of Central Excise
Bombay (1989) 1 SCC 602

Therefore, there is a fallacy in the argument of the plaintiffs that the
product in question is irrelevant. If the composition of the said product does
CS(OS) No. 89/2008 Page No.207 of 275


not match with the claims, then the same cannot be covered within the ambit
of the patent.
 The defendant argued that by relying on the IN‘774 after the rejection
of IN 507 relating to Polymorph B, the plaintiffs are indulging into the
act of double patenting which is impermissible. It has been argued that
the concept of umbrella patent is alien to patent law. It is clear that
double patenting is not permissible. The plaintiffs have not chosen to
respond to this. It is obvious that there cannot be two patents for the
same product. If Polymorph B is an independent invention, it cannot
be covered under the suit patent.

 The defendant contended that the plaintiffs have deliberately chosen
not to seek the patent of addition as per Section 55 if there was an
improvement of the same article. The plaintiffs have rather gone for
the fresh patent which means that they themself believed that the
Polymorphic version is distinct from that of the main compound. It is
stated that the plaintiffs cannot now therefore state that the working of
one patent is dependent upon on the other.
 It is stated that the clinical trials relied upon by the plaintiffs to
suggest some efficacy in the compound which find mention in the
affidavit of Mr. Nick Thatcher PW 3 are all relating to the
Polymorphic version B of the compound in question. The same are all
post 2000 documents in the form of articles which was the time when
the Polymorphic version was already in the field. The defendant has
enlisted such documents as under:
 ONCOLOGIST Dated 05.02.07
CS(OS) No. 89/2008 Page No.208 of 275


 THE NEW ENGLAND JOURNAL OF MEDICINE dated
14.07.05
 JOURNAL OF CLINICAL ONCOLOGY dated 10.08.05
 JOURNAL OF CLINICAL ONCOLOGY dated 20.05.07

Thus, it is stated that the said efficacy has not been shown by the use
of the suit patent but by the use of the Polymorphic version of the compound
which was the subject matter of IN 507.
225. By making the aforementioned submissions, learned senior counsel
for the defendant has stated that the defendant has been successfully
discharge the onus of proof of non infringement of the patent in the present
case.
226. I shall now proceed to evaluate the submissions advanced by the
parties alongside the discussion of the pleadings and evidence lead by the
parties to the same effect in order to determine the question of infringement
of patent. In order to facilitate the evaluation of the case of the either side, it
is felt expedient to first consider some legal aspects on the basis of which the
infringement of patent is determined.
227. It is also argued by the learned counsel for the defendant that the
Clinical Efficacy Studies as mentioned in the literature of the products of the
plaintiffs are pertaining to the product of Polymorph B and not pertaining to
suit patent.
Rule of Construction of Suit Patent Claim
228. The first question for the purposes of the discussion on the aspect of
the infringement of patent which arises for the consideration is that how the
CS(OS) No. 89/2008 Page No.209 of 275


Court has to test as to whether the impugned product is infringing the
patented subject matter especially when there is a patent claim on the subject
and there is a product which may not strictly covered within the patent claim
but contains something else as well in form of variant or reactants.
229. As per the plaintiffs, the test is that the Court has to see what has been
claimed in the patented invention and the product in question and if the
product which is claimed is subsumed within the product which is stated to
be infringing, the infringement is established. As per the plaintiffs, the Court
has to look only claims and product and if there is exists ambiguity, then the
resort must be taken to the specification and nothing else.
230. In effect, the plaintiffs state that the Court has to interpret the claim or
specification strictly and compare it with the product which is impugned in
order to find out infringement. I find the said tests appears to be correct so
far as it relates to simplicitor infringement cases where the impugned
product is straightaway subsumed in the claimed portion of the invention
without anything else in the said product. However, the question remains
whether the said test is determinative one even in cases where there exists a
patented claim for a product and another product which may substantially
contain the patented product but also contain some other variants or some
other parts in addition to the patented article or product. I think this requires
some discussion as the answer to this question will enable this Court to
determine in the infringement in instant case as well. The enquiry as to
answer to this question gains importance in view of the finding arrived by
me above that it has been established on record that the plaintiff‘s product is
a Polymorph B version of the compound due to manifold reasons explained
above. Therefore, the answer to this question will aid the decision of the
CS(OS) No. 89/2008 Page No.210 of 275


infringement in the instant case too.
231. True, it is that the Court has to strictly follow what is claimed in the
invention and compare it with the product which is alleged to the infringing
the patent. But the said rule of construction is not without an exception.
There may arise certain cases where the product which is alleged to be
infringing does not completely corresponds to what has been claimed in the
patented invention of the product. The product may be seemed to be
substantially containing the patented product but also contain some parts or
variants other than the same also. The Courts have in those cases developed
a different rule of construction of the patent claim and specification which is
a slight departure from what has been stated by the plaintiffs in the present
case.
232. The Courts in such cases have evolved the rule of the purposive
construction of the patent claim so that in the cases wherever the need be,
the claim in the invention is not construed too narrowly which was never the
intention of the inventor and not the purpose of the said invention so that the
maximum benefit should be given to the inventor by not interpreting the
patent claim in a pedantic manner and giving the same an effect which was
the real purpose for which the product was invented in furtherance of the
practical approach.
233. The said rule of purposive construction was used for a long period of
time in the Court of appeal in England and time and again the same was
approved to accord the benefit wherever possible to the inventor of the
patent. However, the Courts have from time to time thereafter also faced a
situation where the resort was taken to such construction of the patent claim
in order to enlarge the scope of the patent, which was never the intent or the
CS(OS) No. 89/2008 Page No.211 of 275


purpose of the said invention, the Courts also came across the cases where
the properties and characteristics of the product significantly varied from
what has been claimed in the patented invention. Those were the cases
where the alleged infringing product contained some additional variant or
the part in addition to the product or process under patent, the Courts in such
a case answered the said question by laying down that much shall dependent
upon the role of the said variant in the said product. The cases in which the
role of the said variant is inconsequential in nature and does not change the
nature and characteristics of the article, then in those cases, the product in
question is an infringement of the patent, in all other cases, where there is a
role of such variant which may alter the characteristics and quality of the
said product or process, there is no infringement of the patent. However,
what is a role of such variant in each case is essentially a question of the fact
and same shall depend upon case to case basis.
234. This rule of purposive construction aimed at following the practical
approach by finding out the purpose behind the invention was laid down by
Lord Diplock sitting in House of Lords in the famous case of Catnic
Components Ltd & Anr v. Hill & Smith Ltd , (1982) RPC 183. In the
famous speech of Hon‘ble Lord Diplock, it was observed thus:

―My Lords, in their closely reasoned written cases in the
House and in the oral argument, both parties to this appeal
have tended to treat ―textual infringement‖ and
infringement of the ―pith and marrow‖ of the invention as if
they were separate causes of action, the existence of the
former to be determined as a matter of the construction only
and of the latter upon some broad principle of the
colourable evasion. There is, in my view no such
dichotomy, there is but a single cause of action and to treat
CS(OS) No. 89/2008 Page No.212 of 275


it otherwise, particularly in cases like that which is the
subject of the instant appeal is liable to lead to confusion‖

He then further explained the applicability of the purposive construction in
interpreting the patent specification and the claim in the following words:
―My lords, a patent specification is a unilateral statement by
the patentee, in words of his own choosing, addressed to
those likely to have a practical interest in the subject matter
of his invention (i.e. skilled in the art), by which he informs
them what he claims to be the essential features of the new
product or process for which the letters patent grant him
monopoly. It is those novel features only that he claims to
be essential that constitute the so called ―a pith and
marrow‖ of the claim . A patent specification should be
given a purposive construction rather than a purely
literal one derived from applying to it the kind of
meticulous verbal analysis in which lawyers are too
often tempted by their training to indulge. The question
in each case is whether persons with the practical
knowledge and experienced of the kind of the work in
which the invention was intended to be used, would
understand that strict compliance with the particular
descriptive word or phrase appearing in a claim is
intended by the patentee to be essential requirement of
the invention so that any variant would fall outside the
monopoly claimed, even though it could have no
material effect upon the way the invention worked.”
(Emphasis Supplied).

The true question to be asked is thus in summary, whether
the strict compliance with the particular piece of the claim
language would be understood to be an essential
requirement of this invention. The necessary understanding
is that of those skilled in the art (though ultimately, as
explained below, the final determination of the true
construction is a matter for the Court, once properly
instructed, and not witnesses.‖
CS(OS) No. 89/2008 Page No.213 of 275


Lord Diplock then proceeded to lay down the exception to the said
principle or true question by discussing as to in which cases the said
question framed above will not arise. As per him, the said question of strict
construction of the claim and generally understanding of the persons skilled
in the art would not arise in cases where the variant which is included in the
invention would have material impact or effect on the working of the
invention. This is in a way exception to the rule of construction laid down by
Lord Diplock which is in applicable where there exists a role of the variant
which may have effect on the working of the invention. Lord Diplock
propounded this approach by observing in the following manner:

― The question, of course does not arise where the
variant would in fact have a material effect upon the
way the invention worked. Nor does it arise unless at the
date of the publication of the specification, it would be
obvious to the informed reader that this was so. Where
it is not obvious, in the light of then- existing knowledge,
the reader is entitled to assume that the patentee thought at
the time of the specification that he had good reason for
limiting his monopoly so strictly and had intended to do so,
even though subsequent work by him or others in the field
of the invention might show the limitation to have been
unnecessary. It is to be answered in negative only when it
would apparent to any reader skilled In the art that a
particular descriptive word or phrase used in a claim
cannot have been intended by a patentee, who was also
skilled in the art, to exclude minor variants which, to
the knowledge of both him and the readers to whom the
patent was addressed could have no material effect
upon the way in which the invention worked.”
(Emphasis Supplied).

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235. From the reading of the aforementioned quoted illuminating
observations of Lord Diplock in Catnic (supra), the following propositions
can be deduced:-
a) That there are exceptions to the rule of purposive construction of
patent claim which was aimed at giving the benefit to the inventor
even in cases where the product impugned does not strictly fall within
the ambit of the patent claim.
b) That much shall be dependent upon the role of variant attached with
the invention which is claimed in the patent in order to arrive at the
impugned product.
c) There is a compartmentalization of variants, viz major variants and
minor variants has been done by Lord Diplock in order to define as to
the permissible extent of applicability of rule of purposive
construction of the patent claim.
d) In cases where the variant attached to the invented work which is in
the form of product or process under challenge would have material
bearing upon the working of the invention. In such cases, the rule of
purposive construction is not applicable as in those cases the variant
attached its role thereof would exclude the product in question from
the ambit of the patented claim and thereby there will be no
infringement of patent.
e) The said rule of purposive construction is also not applicable where
the invention itself is obvious to the person skilled in art.
f) There is thereafter an exception to exception which is laid down by
Lord Diplock so as to determine in which cases where variant is
present, the said rule of purposive construction can still be applicable.
CS(OS) No. 89/2008 Page No.215 of 275


Those are the cases where it is proved on record that from the reading
of the patented claim the patentee could not have intended to exclude
the minor variants which to the knowledge of him as well as readers
of the patent could have no material effect in the way in which the
invention worked. The said exception can be sub-categorized into the
following fact finding enquiry:-
i) That one has to show by an evidence as to what is missing in
the patented claim and the product in question is a minor
variant;

ii) That there could not have been intention of the patentee to
exclude such minor variant from the ambit of invention;
iii) That the said minor variant could have no material effect on the
way in which the invention worked.
236. The presence of these facts collectively on record coupled with the
positive evidence to the said effect would be determinative of the fact that
the invention and the patented claim would subsume even the product which
contains some minor variant and thereby it an infringement. This approach
is popularly and widely known as Catnic approach as laid down by Lord
Diplock as it was decided in the case of Catnic Vs Hillsmith (supra) and the
later part of the tests relating to variants is known in UK as improver
questions as the same was decided in the leading case of Improver
Corporation and Ors. v. Remington Consumer Products Ltd. and Ors. ,
1990 FSR 181.

237. There was lot of debate thereafter post Catnic decision as to whether
the Catnic test and the rule of construction laid down in Catnic is the good
CS(OS) No. 89/2008 Page No.216 of 275


law or not in the House of Lords as well as in the Court of Appeal.
However, the recent line of authority emerging from the UK has approved
the Catnic approach and recently even the House of Lords again has put its
judicial stamping on the test laid down by the Lord Diplock.
a) Assidoman Multipack v Mead [1995] RPC 321 AT 328-337
b) Beloit Techologies Inc v Valmet Paper Machinery Inc (No.) 2, [1995]
RPC 705.

c) The Court of Appeal also approved the same in the case of Kastner v
Rizla [1995]RPC 585.

238. Thereafter, the House of Lords has more recently authoritatively
confirmed in the case of Kirin-Amgen vs. Hoechst Marion Roussel , [2005]
RPC 9 that Catnic approach is a good law by observing the following:-
“ The Catnic principle of construction is therefore in my
opinion precisely in accordance with the Protocol. It is
intended to give the patentee the full extent, but not
more than the full extent, of the monopoly which a
reasonable person skilled in the art, reading the claims
in context, would think he was intending to claim ”
(Emphasis Supplied)
239. In view of the above observations and the line of authorities emerging
from UK, it is clear that the test laid down by Lord Diplock in Catnic (supra)
holds the field and is a good law. The said case of Catnic has been followed
by the Indian Courts time and again while evaluating the patents in India so
far as it relates to obviousness and infringement claims and therefore the
approach laid down in Catnic is not alien to the Indian context and
consequently can be conveniently relied upon by the courts in India. (See
case Bajaj Auto Ltd., State Of vs Tvs Motor Company Ltd, MIPR 2008
CS(OS) No. 89/2008 Page No.217 of 275


(1) 217 where Catnic case has been relied upon by the Madras High Court
and same has been confirmed by the Division Bench while deciding the
appeal on 18.5.2009, although it is another matter in that the case how the
said approach was used depends upon the facts of that case)
240. To take the discussion further, the rule of purposive construction laid
down by Lord Diplock does not rest here and the Courts have taken this test
further in order to analyze the infringement claims in the future patent
claims by applying conveniently either the rule or the exception or the
exception to exception depending upon the facts and circumstances of the
case as to in which case there are major variants added in the product or
claim and in which case there are minor variants added to the patented
claim.
241. Justice Laddie of Patent Court in UK applied the Catnic approach in
the cases relating to chemical compounds in the case of Merck and Co. Inc.
Vs Generic UK Limited, reported as 2004 RPC page 31. The said case
gains its relevance as Justice Laddie laid down further test as to what the
patented claim should contain in order to arrive at the finding as to whether
the role of variants is sufficiently explained or not and further whether only
the patented claim or specification is relevant for the purposes of
construction or whether the attending circumstances can also be seen in the
light of absence of role of variant which is improperly explained in the
patented claim. The Judge answers the question by observing that the Court
is not precluded from drawing an inference from the facts which co relate
the patented claim with that of role of variants present in the impugned
product and in those cases it cannot be said that merely one has to read the
CS(OS) No. 89/2008 Page No.218 of 275


specification and claim and compare it with the product in order to arrive at
the infringement as by doing this the court would not be following the
Catnic approach by not examining the role of existing variants in the product
and its corresponding inclusion of the same in the patented claim depending
upon whether it is a major variant or minor variant.
242. This discussion has been done by Justice Laddie in the following
words:-
―38. The purpose of a patent is to convey to the public
what the patentee considers to his invention and what
monopoly he has chosen to obtain. These are not
necessarily the same. The former is primarily to be found
in the specification and the latter is primarily to be found in
the claims. Although he is not deemed to be a patent
lawyer, the Patentee should be taken to be aware of the
primary and rather different purposes of the specification
and the claims when drafting his patent. So the patentee
must be taken to know the framework of form and purpose
when he drafts his patent. It is his duty to communicate his
invention and his assertion of monopoly to the public in
language it will understand. He is warned by the Protocol
that his exclusive rights will not necessarily extend to
everything which from a reading of the specification it can
be seen that he contemplated. Furthermore, the drafting of
the specification ad claims has to be considered against the
background that no one is forced to apply for a patent or to
seek as wide protection as possible. The patentee can be
taken to be aware of the fact that there is always a balance
to be achieved between width of protection and validity. It
is up to the patentee to choose the level of risk he wishes to
run.
42. Notwithstanding the adaptability of scientific language,
the patentee is not expected to be omniscient or to exhibit
superhuman thoroughness in drafting. He may not be able
to foresee future developments which will be useable with
CS(OS) No. 89/2008 Page No.219 of 275


his invention but which make no material difference to the
way it works. For example, the invention may relate to a
mechanical device in which two parts are connected
together. A new method of connection might not be
covered by the exact words of the claim, but the notional
reader would be reasonably confident that the patentee may
choose a form of language which emphasizes which
features of an invention are important and which are not.
For example it is common to find claims which start with
general description followed by ―characterized in‖ followed
by a list of features. The addressee would appreciate that
the latter features are particularly important but the features
before the words ―characterized in‖ are less so. If there is
a variant to the latter which obviously does not affect
the way in which the invention works, the notional
reader may be reasonable confident that the inventor
wanted to cover this variant as well. In these types of
cases, the monopoly is likely to extend to the new
variant. (Emphasis Supplied)
43. In my judgment, the same principles underpin the
Protocol. The aim is always to determine objectively from
the words used particularly, but not necessarily exclusively,
in the claim to what the patentee wanted to claim exclusive
rights. The Protocol is directed at allowing protection for
the discernible intention of the patentee, to be derived from
the words used to express that intention.
45.The second sentence in the Protocol emphasizes the
primary of the claim. The notional addressee is not
expected to find the patentee‘s presumed intention from the
specification. In particular, as noted already, this sentence
makes clear that just because a reading of the specification
suggests that the patentee ―contemplated‖ a wider
protection than that set out in ‗the claims does not mean
that he obains that wider protection. The patentee is taken
to know the rules. If he wants a monopoly which covers all
embodiments which he contemplates may make use of his
technical contribution to the art, he should use language
CS(OS) No. 89/2008 Page No.220 of 275


which conveys that intention to the notional reader and that
language should primarily be found in the claims. It seems
to me that this part of the Protocol conveys the same
message as is to be found in the speed of Lord Cairns in
Dudeon v Thomson (87) 3 App Cas. 34 when he said that
there is no such thing as infringing the equity of a patent‖
49.Determining whether a skilled reader would
conclude with reasonable confidence that a particular
embodiment was one the patentee wanted to cover
involves assessing all the facts of the case. The wording
of the claims is the most important one, but is not
necessarily determinative. Matters such as the way the
inventor describes his inventive contribution and his
explanation, if any, of how the invention achieves its
claimed results are matters to be taken into account.
The factors, and how they interrelate to each other, will
vary from case to case.” (Emphasis Supplied)
243. From the above observations of Justice Laddie, it is clear that the
wordings of the claims and specifications are important but are not
necessarily determinative one and if the court has to conduct an enquiry in
view of Catnic approach as to whether the benefit which was aimed by Lord
Diplock by propounding the rule of purposive is to be given, all the
attending facts and circumstances are to be given due respect besides the
strict reading of the claims in order to objectively arrive at the conclusion as
to what actually the patentee intended to include within the ambit of his
patented claim. Justice Laddie thereafter compared /tested the said chemical
compound on the basis of improver questions which are exception to the rule
laid down in Catnic in the following words:-
“55. The first Improver question does not create a
factual dispute which needs to be resolved in order to
determine whether an embodiment outside the
CS(OS) No. 89/2008 Page No.221 of 275


contextual scope of the claim is within the monopoly
created by the patent. It is only question (3) which
determines construction. In most cases the answer to
the first question will not be in dispute. If the variant
does not work in the same way as the invention it cannot
be within the scope of the patent. The patentee could
not have intended otherwise. Thus a negative answer to
this question will inevitably lead to the third and crucial
question being answered in a way which excludes the
variant from protection. But what if it is unclear to
those skilled in the art whether the warrant works in the
same way as the invention, either because the way the
invention works is not clear or the way the variant
works is not clear, or both? In such a case it is
impossible for it to be apparent to the reader that the
limitations in the claim were not intended by the
patentee. In other words, adopting the purposive
construction set out in Catnic, the issue of construction
must be answered so as to exclude the variant from
protection. Much the same analysis applies to the
second Improver question. Where it is not obvious that
the variant works in the same way :
“….. the reader is entitled to assume that the patentee
thought at the time of the specification that he had good
reason for limiting his monopoly so strictly and
intended to do so…” (per Lord Diplock in Catnic p.243)
56. Neither of these questions justifies the carrying out
of experiments. At the most the answer to these
questions provide shortcuts to the only important
question namely question (3).
57. For the above reasons, if one is adopting the
structured approach, it is only Improver question (3)
which needs to be answered. However, it appears to me
that there is one respect in which that question needs to
be approached with caution. In formulating the
questions, Hffmann J. said he was applying the
guidance in Catnic. There is no doubt that the binding
CS(OS) No. 89/2008 Page No.222 of 275


authority on construction in this jurisdiction is the latter
case. That was confirmed by the Court of Appeal I
Kastner v Rizla Ltd [1995] RPC 585. Yet there appears
to be a potential difference between the way the issue of
construction was put in Catnic to the way it is explained
in Improver. Imagine the case where the notional
skilled reader does not understand why the patentee put
a limitation in the claim. According to Catnic, in such a
case the limitation is effective because it is not
“apparent” that the limitations “cannot have been
intended by the patentee”. The variants will be
excluded from the monopoly. By contrast the same
facts would be answered differently if Improver
question (3) is applied rigidly. Where the reason for
introducing the limitation is unclear, the skilled reader
could not say that he understood “that the patentee
intended to confine his claim”. Thus improver question
(3) would be answered in the negative and the claim will
be construed to include the variants. I think that this
difference is more imagined than real. At p.197 of
Improver it appears to have been accepted that if the
notional skilled addressee would speculate that the
patentee had good reason for including the limitation in
the claims, the limitation is effective. In other words the
Catnic approach was adopted. (Emphasis Supplied)”
244. In view of the above stated observations of Court in Merck (supra) it
is clear that the said Catnic approach is good law and can also be applied to
the cases relating to chemical compounds. Even in the case of Merck &
Co.(supra) Justice Laddie proceeded to apply the said test and came to the
conclusion that there was no infringement in the said case as the role of
variants outweighed the patented claim. This has been observed by learned
Justice Laddie in the following words in para 67 by applying the Catnic
approach and coming to the conclusion that further experimentation with the
CS(OS) No. 89/2008 Page No.223 of 275


reactants was never contemplated within the ambit of patented claim. In the
words of Justice Laddie:-
“67. As Hoffmann J. said in relation to Improver
question (1) whether use of a product or process outside
the acontextual scope of a claim has a material effect on
the way the invention works depends on the level of
generality at which one describes the way the invention
works. If in this case, the inventions consists simply of
running a process for making alendronate in which the
reaction is maintained in a fluid and homogeneous state,
it is not disputed that using other sulphoic acids (as long
as, when mixed with the other reagents, they are molten
at the reaction temperature) will work the same way.
Furthermore, it is also accepted that the processing and
crystallization features of claim 1 can b modified within
fairly wide limits without preventing the production of
alendronate, at least in moderate quality and at
moderate yield. However, if the invention consists of
running a process for making alendronate in which the
reaction is maintained in a fluid and homogeneous state
so as to secure high purity and a yield of at least 85-90
per cent, it is by no means clear that making the
alterations advocated by Mr Kitchin will result in a
process which works the same way.”
245. Justice Laddie also came to the conclusion that in the said case of
Merck (supra) it was not shown by evidence by the patentee about the role
of variants existing in the alleged infringing products. This has been
observed the learned Judge in the following words:-
“78. I was unconvinced by this cross-examination.
Furthermore, I think it is important to appreciate that
the test of obviousness in Improver question (2) cannot
be the same test as used to invalidate a patent over
published prior art. In the latter case it is enough to
demonstrate that the reader of the prior art found the
CS(OS) No. 89/2008 Page No.224 of 275


prospects of achieving the desired result sufficiently
encouraging to warrant trying it out, even if there are
commercial reasons why going down that route is
unattractive (see Brugger v Medic-Aid[1996] RPC 635,
661). Where however one is attempting to broaden the
patent monopoly to cover variants which are not within
the a contextual meaning of the claims, a higher degree
of confidence of success must be involved. The reader
must have little or no doubt that the variant will, not
may, work in the same way to produce the same results.
In my view, the distinction between the obviousness test
for invalidity and the obviousness required for
Improver question (2) is apparent from American Home
Products paras [28] and [29]. The claimant gets
nowhere near demonstrating the relevant level of
confidence in this case. For example, for Professor Scott
to say that he would be disappointed if he could not
improve the yield and purity were another sulphonic
acid to be used instead of MSA does not mean that it is
obvious that such improvement would be achieved.”
“79. In my view it is not proved that the notional skilled
reader would have even thought of substituting another
sulphonic acid for MSA. The hesitation of Dr.
Cunningham represented more closely the approach of
such a reader. Furthermore, it is not proved that any
skilled worker would have considered it obvious that
replacement of MSA by another sulphonic acid would
be so effective that it would achieve the same, or
substantially the same, level of purity and yield
promised by the patent. He would not have been
confident that such substitution would produce such a
yield and purity that the production of alendronate
could be achieved in a one-pot process as promised by
the patentee, rather than with a separate extraction and
purification step (as in the CIPLA process) Improver
question 2 is answered in the negative.”
246. The afore quoted observations of Justice Laddie make it apparent that
CS(OS) No. 89/2008 Page No.225 of 275


the test of obviousness to revoke a patent is distinct from the test of
obviousness to a person to whom the specification is made available to
arrive at the product containing variant is concerned. Both do not coincide
and if the Court believes that they coincide then the Court will be giving
much broader interpretation to claims on the basis of the teachings of the
patent. This is due to the reason what can be obvious to a person to further
work upon the invention may revoke the future patent but it cannot be said
afortiori follow that due to the reason that it is obvious for such person, the
said workings or variation done is subsumed within the patent claim itself.
That is why, one finds the respectful agreement with the proposition laid
down by Justice Laddie which is that obviousness as to revocation or for
testing patentablity does not coincide with the obviousness which may be
required to a person to make a product containing variant after studying the
patent.
247. To sum up this discussion on Catnic (supra) and Merck (supra), at this
stage, it is relevant to note the aforementioned observations of the Courts
and also the test which is that in the cases where the product contains further
variants or reacted versions of the compounds claimed in the patent, not
merely the claim in the specification is relevant but also all the facts
correlating the said invention with that of the role of such variant or reactant
are also important and necessarily to be looked into by the Court seized of
such kind of patent infringement suit while construing the patent
specification vis a vis the product or process in question.
248. This persuades me to reject the first submission of learned senior
counsel for the plaintiffs that the test is that the Court has to look into the
claim and the product and nothing else and no further document can be
CS(OS) No. 89/2008 Page No.226 of 275


imported to draw such inference. As I have found during the course of my
discussion above as held in the Merck(supra) that the claims are not always
decisive, the factors which correlate the role of the variant and reactant with
that of the patented claim are also relevant, therefore the Court can see all
such documents and draw inference according after analyzing everything.
249. Let me now apply the tests laid down in Catnic (supra) and Merck
(supra) to the facts and circumstances of the present case. As seen above, it
is already established fact on the evidence that the plaintiffs are making a
product which is a Polymorphic version B of the compound Erlotinib
Hydrochloride in view of the plaintiffs inability to provide any positive
evidence to dislodge the claim of the defendant that the plaintiffs are doing
so and time and again maintaining that the Polymorphic version is subsumed
in the underlying patent which is IN‘774 and all other reasons discussed
above. The stand what the defendant is taking is that the defendant is making
what the plaintiffs are making which is the Polymorphic B version of the
compound which was never intended to be included in the patent and does
not even corresponds with the patent claim. To which, the plaintiffs‘
response is two-fold, first is that the defendant is making Erlotinib
Hydrochloride which is under suit patent and the said position is thus
disputed, second is that in any case whatsoever is the case, due to manifold
reasons and admissions discussed and enumerated above, the defendant‘s
Polymorphic version B if any shall still fall within the ambit of the suit
patent. I shall now discuss both the said positions of the plaintiffs after
applying the test of comparison in the present case.
It is the case of the plaintiffs that the plaintiffs are concerned with the
claim 1 of the Compound namely Erlotinib Hydrochloride. It is seen that the
CS(OS) No. 89/2008 Page No.227 of 275


onus is on the plaintiffs to show that the said product of the defendant
corresponds with the patent claim which is subject matter of IN‘774. The
said onus is an independent to that of what position defendant‘s take in the
proceedings. As seen above during the discussion of Catnic principle which
is that whether the patent claim subsumes the product or the process
impugned is a matter to be examined from the standpoint as to whether the
patentee could have reasonably included the said product or process in
question which is he is impugning on the fair reading of the invention. the
said onus is thus operating independent and dehors to the position which the
defendant takes in the infringement action. This is due to the reason that it is
the plaintiffs who are alleging that there is an infringement of the patent
claim and not the defendant.
250. The plaintiffs in the instant case could have discharged the onus by
way of establishment of the following facts which are germane to the present
controversy:
1. By showing through the positive evidence which include the medical
and clinical evaluation of the product of the defendant and all other
facts incidental thereto to establish that the position which the
defendant is taking that the defendant‘s product is a Polymorphic
version B of the suit patent compound is incorrect and actually the
said version is the same which corresponds with that of the plaintiffs
patent. The plaintiffs do take the said position but not by way of
showing the evidence of the nature stated in this point but rather
taking another route of admissions, the impact of which shall be
discussed later in this head.

CS(OS) No. 89/2008 Page No.228 of 275


2. If the plaintiffs were unsuccessful in doing above in the instant case,
the plaintiffs could have then proceeded to approach the present
proposition by establishing that the fact through giving some positive
evidence in the form of depositions that how the role of the reactants
with which the patented invention is reacted pursuant to the arriving
at the product or process in question is bare minimal and the same is
sufficiently covered within the ambit of the patented claim. As seen
above in the case of Merck (supra) and Catnic (supra), this is
essentially a question of fact. The said fact finding is impossible
without the aid and assistance of the plaintiffs by showing the
positive evidence towards the establishment of such fact. The
positive evidence towards establishing the said facts could have been
done by deposing on the following facts:
 The fact as to what is exactly claimed in the patent claim as a
compound.
 The fact as to what is the actually the Polymorphic version B of
the said compound Erlotinib Hydrochloride
 The fact as to how many reactants or variants with which the
Erlotinib Hydrochloride as a compound is reacted with in order
to arrive at the Polymorphic version B of the same.
 The fact whether the properties and the characteristics of the
said compound changes or varies after the said variants or
reactants are reacted with or not. The plaintiffs in order to show
that there is an infringement should have deposed to the effect
that the said properties and characteristics are not changed
pursuant to the reaction.
CS(OS) No. 89/2008 Page No.229 of 275


 The fact that whether the change if any to the property or
characteristic is based on the role of the reactant in the said
process of crystallization or otherwise due to the presence of
the main compound itself.
 The fact that the conversion of the Polymorphic version B from
the main compound which is combination A and B is not based
on the major reactants and the result of minor reactants or
variants, the role of which is inconsequential to the products
and thus the same is impliedly covered or purposefully covered
within the purview of the claim contained in the specification.
 The fact that the defendant is making the Polymorphic version
B and consequently on the basis of what has been deposed
above is an infringement of the patent.

251. These are some of the facts which should have been deposed by the
plaintiffs in order to discharge the onus of proof to show that there is an
infringement done by the defendant by manufacturing the Polymorphic
version B which is sufficiently covered in the main compound due to the
aforesaid reason. The above stated list is not exhaustive but is inclusive in as
much as the plaintiffs could have shown some other facts connected to the
aforementioned fact finding enquiry.
252. Curiously, the plaintiffs do not adopt either of the route towards
establishment of the facts in order to arrive at the infringement. I think there
are certain reasons behind it which according to me are relevant for the
consideration:
CS(OS) No. 89/2008 Page No.230 of 275


 If the plaintiffs could have followed point 1 approach, then by the
establishment of the fact that what is contained in the product of the
defendant is sufficiently covered in the suit patent by clinical
examination of the product of the defendant, the infringement could
have been proved on balance of probabilities. The only basis which is
emerging for not following the said approach is due to the reason that
the plaintiffs are themselves aware that the tablet version of the
compound Erlotinib Hydrochloride cannot exist in the form as
contained in the claim of the suit patent. This has been clear if one
reads the US‘221 wherein it is stated that after much reactions are
done with several elements at the relevant temperature, the crystalized
version and pure form of the Erlotinib Hydrochloride is arrived at
which is sold in tablet form. As the plaintiffs were aware that the
tablet form could not have contained the exact version of the claimed
compound as they have themselves made the tablet in a stable form
after obtaining a subsequent patent in US‘221, corresponding to
IN‘507 which has been refused in India on the ground of Section 3(d)
of the Patents Act 1970. Having known all this, the plaintiffs have
consciously not followed the said approach 1 as enlisted above and
rather followed a middle path on the basis of some existing facts by
picking and choosing the versions of the parties from here and there in
the collateral litigations. I think the same by itself is not sufficient
discharge of the onus which is independently casted upon the
plaintiffs to show that the invention of the plaintiffs under IN‘774
subsumes the product in question of the defendant. Therefore, the
plaintiffs have followed this indirect route by relying on some stands
CS(OS) No. 89/2008 Page No.231 of 275


taken in the case of the defendant from time to time and not by
directly adducing any positive evidence to dislodge the defendant
position that the drug in question is made on the basis of Polymorphic
version B of the compound. The other reasons stated below would
further unveil as what compelled the plaintiffs by taking such stand
and not adducing the direct positive evidence towards the
establishment of the facts essential and material to determine the
infringement.
 The plaintiffs have not followed the approach 2 as the plaintiffs do not
want to adduce an evidence to the effect that the role of the reactants
or the variants attached to the said compound is minimal which
though may somewhere include their Polymorphic version B in the
suit patent compound but will directly affect their declaration made
before the US patent office in US‘221, as the same will undermine the
novelty, inventive step of the said invention claimed therein. The fact
of the claiming patentability in such Polymorphic version B itself is
indicative towards drawing an inference to the effect that the role of
the reactants or the variants and the experimentation thereof is not
minimal to subsume the said version within the claim of Indian Patent.
The said reactants and variants have major role as propounded by
Lord Diplock as well as Laddie J in Catnic (supra) and Merck (supra)
which will materially affect the working of the product as evident
from the US‘221 specification which reads that the said Polymorphic
version B is more stable and consists of several steps of chlorination
and then further reactions described in DW1/9, for which reason the
said invention as the plaintiffs is new and persuaded them to file a
CS(OS) No. 89/2008 Page No.232 of 275


new patent in US in the year 2002 as well as in India. The question
which can be then to be asked is if the role of the reactants was so
minimal so as to subsume in the main compound, then how can the
same very role of reactants to the compound can persuade the
plaintiffs to secure the patent in US. What follows from the same is
that the plaintiffs by securing the patent successfully in US, are not in
the position to contend before this Court that the said role of reactants
is minimal. That is the major reason why, the plaintiffs have not also
not followed the approach 2 by way establishment of the fact finding
as noticed above.
253. What is left by not following the above stated approaches is the case
of the plaintiffs before this Court which is that the plaintiffs attempt to
discharge this kind of independent onus by pinpointing the facts from here
and there from the stands taken by the parties during the progression of the
proceedings and calling upon this Court to draw an inferences as to the
establishment of the infringement therefrom.
254. The plaintiffs have filed the affidavit of PW3 namely Mr. Nick
Thatcher who stated to be a person who has qualified PHD on tumor
immunology. The said PW3 states to be familiar with the Erlotinib and other
quinazoline compounds in the treatment of the lung cancer. The said PW
discusses what contains in the IN‘774 by describing a formulation of the
said compound. PW3 discusses about the role of the said compound in
preventing human cancer. The said witness deposes that the Erlotinib is sold
in tablet form. It is stated that European Medicines Agency and other
references no references to the Polymorphic forms. The said witness
however does not depose positively as to what is clinically and medically
CS(OS) No. 89/2008 Page No.233 of 275


correct position as to whether the drug Tarceva is a Polymorphic version B
of the compound in the suit patent or not. The said PW3 nowhere relies upon
any x-ray diffraction reports relating to the said deposition which could have
clarified this aspect. Thereafter PW3 immediately proceeds to discuss
clinical trials, the success of the medicine by deposing that Erlotinib is the
only compound recommended for treatment of the cancer and that Erlotinib
and Astrazeneca‘s Gefitinib are different. There is no whisper in the entire
evidence relating to what exactly is the plaintiff‘s product and the defendant
products and the approaches discussed above are completely missing. The
said PW3 was cross examined in great detail where in some questions were
asked relating to US‘221 and about the existence of unstable version
Erlotinib Hydrochloride in other form, the answers to which were avoided
by stating I do not know, though in one answer the witness states that
clinically the stability of the compound is not important factor, but it is
unclear as for what purpose it is not important factor, in any case as the said
portion also does not find any mention in deposition and thus the role of the
said efficacy as stated in US‘221 has not been defined by the witness either
in evidence or cross examination. This strengthens the conclusion derived
above that the plaintiff‘s inability to follow any of the approaches
highlighted above leads to not discharging the onus of the proof.
255. Likewise is the evidence of Mr. Roger Griffin (PW2) who again
discusses the summary of IN‘774 by describing the chemical formulation as
well as the structural depiction of the compound. The in between contents of
the affidavit of Mr. Griffin are repetitive with that of Mr. Thatcher‘s
affidavit. Thereafter, PW discussed about the obviousness aspect, prior art
test, comparison with the other prior arts and thereafter discusses the
CS(OS) No. 89/2008 Page No.234 of 275


difference in the Erlotinib and Geftinib. The said affidavit of PW also does
not follow any of the approaches.
256. Lastly, PW1 Mr. Laud‘s affidavit as discussed above only deposes in
relation to infringement of patent on the basis of what is depicted on the
drug insert of the defendant‘s drug and what has been applied before the
drug controller. The said affidavit nowhere provides any hint towards what
exactly is the plaintiffs product or for that matter defendant so far as it
relates to the question of Polymorphic version or otherwise. The said
affidavit also does not address the role of the reactants in arriving at the
Polymorphic version. The witness was cross examined by the learned
counsel for the defendant where Mr. Laud says that he is not technical
person etc.
The sum total of all this discussion would be that the plaintiffs have
not been able to show by way of positive evidence as to what is the exact
nature of the plaintiffs and defendant products which are being sold in the
market, further, whether the said products corresponds exactly with the
claim of the suit patent is also not established. The plaintiffs have not been
able to provide any evidence as to whether the Polymorphic version if at all
is included with in the same patent claim (except by making legal arguments
and arguments on some alleged admission), if so, then what is the role of the
reactants with which the claimed compound is reacted in order to arrive at
the Polymorphic version and whether the properties and characteristic of the
Polymorphic version corresponds with that of the suit patent. Consequently,
the plaintiffs have not been able to discharge such onus of proof upon the
plaintiffs in relation to establishment of such facts which would aid towards
establishment of the infringement of the patent.
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257. The answer to all these questions can be found if one reads the
document DW1/6 which is the US221, placed on record by the defendant.
The said patent was applied in the year 2002 which provides that the US 498
which corresponds with IN‘774 relates Erlotinib Hydrochloride in the form
of combination of Polymorphs A and B. However, it has been seen that by
adopting the steps of chlorination, further steps stated in the said patent in
requisite temperature, the Polymorphic version B of the said compound can
be arrived at. Some of the excerpts from the said specification documents are
worth noting and the same reads as under:
―The present invention relates to Polymorphs and methods
for selective production of Polymorph of N- (3-
ethynylphenyl)-6,7-bis(2-methoxythoxy)-4-
quinazolinamine hydrochloride particularly in stable
Polymorph form.

The present invention also relates to novel uses of N- (3-
ethynylphenyl)-6,7-bis(2-methoxythoxy)-4-
quinazolinamine in either its hydrochloride or mesylate
forms, in an anhydrous or hydrous form as well as its
various Polymorph forms in the treatment of
hyperproliferative disorders, such as cancers in the
mammals.

―It is accordingly an object of the present invention to
provide a method for the production of Hydrochloride salt
of N-(3-ethynylphenyl)-6,7-bis(2-methoxythoxy)-4-
quinazolinamine in HCL form (formula 2) making it more
stable for tablet and oral administration and consisting
essentially of the stable Polymorphic form (Polymorph
form B) as well as the compound in such Polymorphic form
B and the intermediate Polymorph A in essentially pure
form.‖

―Stability of the hydrochloride compound is of concern for
CS(OS) No. 89/2008 Page No.236 of 275


its use in the treatment of the patients since variations will
affect effective dosage level and administration. It has been
discovered that the Hydrochloride of N- (3-ethynylphenyl)-
6,7-bis(2-methoxythoxy)-4-quinazolinamine exists in two
Polymorph form A and B. this contrasts with the mesylate
compounds which exist in three Polymorph states (mesylate
Polymorph A B and C). Polymorph B of the hydrochloride
was found to be thermodynamically more stable and
desirable form and the present invention comprises the
Polymorph B compound in the substantially pure
Polymorphic B form and pharmaceutical compositions of
the substantially pure form of the Polymorph B, particularly
in tablet form and a method of selective production of the
compound‖

―The Hydrochloride compound disclosed in the US Patent
no. 5747498 actually comprised a mixture of the
Polymorphs A and B, which because of its partially reduced
stability (i.e. from the Polymorph A component) was not
more preferred for tablet form than the mesylate salt
forms.‖
―Specifically, the present invention relates to methods
of produced the hydrochloride compounds forms of
N-(3-ethynylphenyl)-6-7-bis (2-methoxyethxy)-4-
Quinazolinamine and for producing the stable form B in
high yield. The mesylate salt of N- (3-ethynylphenyl)-6-7-
bis (2-methoxyethxy)-4-Quinazolinamine has been
discovered to exist in at least three Polymorphic forms
which have been designated A, B and C of increasing
stability with different x-ray powder patterns…….‖ (note
there are other paragraphs which compare such x-ray
diffractions which are not reproduced for the sake of
brevity.)‖

258. From the reading of the afore noted paragraphs of the specification of
US‘221, the following facts can be deduced:

 The said compound namely N-(3-ethynylphenyl)-6-7-bis (2-
CS(OS) No. 89/2008 Page No.237 of 275


methoxyethxy)-4-Quinazolinamine exists in different Polymorphic
versions and what contained in US‘498 which corresponds to IN‘774
is a combination of the Polymorphic A and B version of the said
compound.
 The stability of the compound varies with the existence in the
different Polymorphic forms and the most stable is the one in form B
which forms subject matter of US‘221 and the same is rejected in
India in the form of IN‘507.
 The Polymorphic B version is preferred in tablet form over the
combination form due to its reduced stability.
 Stability has been a matter of concerns for the patients.
 There are several steps involved in reactions of the said compound in
order to arrive at the pure Polymorphic form B
 Not merely the form changes and the characteristic changes, but the
working of the invention also changes as the dosage also gets affected
by the change in the Polymorphic form B as stated above.
259. The above facts noted in the specification of US‘221 are no where
clarified by the plaintiffs as incorrect which are relevant to qualify the tests
of the construction of their claim in the present suit patent. Upon the entire
reading of the said specification of US‘221 and the facts contained therein
which are facts correlating the product in question with that claim of the suit
patent, upon evaluating the current stand of the plaintiffs that IN‘774
sufficiently includes Polymorphic version in oral arguments, it is difficult to
reconcile as to how both the stands can co-exist and also the case of the
plaintiff is believable.
CS(OS) No. 89/2008 Page No.238 of 275


260. Applying the Catnic approach, it is beyond the cavil of any doubt that
either the said process of arriving at Polymorphic version B is stated to be
innovative enough by the plaintiffs themselves to sustain a new patent or to
be called as patent in itself or else the said role of the reactant could have
been bare minimum in the said Polymorphic version B which means that the
same can be covered in the suit patent. In absence of the explanation of the
said role either as a major or minor reactants coupled with the fact that both
in India as well as in US, the plaintiffs have applied for the patent for the
said process and product separately than the underlying compound, the
purposive construction of the claim and the specification of IN‘774 clearly
indicates that the said plaintiffs did not intend to include the Polymorphic
version B in the suit patent IN‘774. It can also be said that this will fall in an
exception to the rule of applicability of the purposive construction as no
benefit can be given to the plaintiff under the existing patent claim. This
inference can be easily drawn in the absence of any positive evidence
towards disproving the said fact by indicating that the role of the reactants
was minimal and rather inconsequential. Resultantly, the plaintiff has not
been able to discharge his burden towards proving an infringement of
IN‘774 committed by the defendant.
261. The plaintiffs can argue that the IN‘507 which corresponds with
US‘221 which has been relied upon by this Court to infer the role of
reactants have been rejected in India on the ground of Section 3(d) and
obviousness and thus there was in fact no role of the reactants in the
Polymorphic version and the said inference is incorrect. I think there is
inherent defect in such an argument due to the reason that the mere rejection
of the Indian Patent on the ground of new form of the old compound does
CS(OS) No. 89/2008 Page No.239 of 275


not automatically minimize the role of the reactant as inconsequential on
basis of which the compound was worked upon. There may arise a case
where the reactant role is still substantial in nature but they are mere
workshop results and not innovative one which may exclude Polymorph
from the suit patent and at the same time leads to rejection of new patent on
the ground of being obviousness or lack of novelty.
262. In this context, I find my respectful agreement with to the test laid
down by Justice Laddie (supra) in Merck which is that the obviousness in
the context of the patentability cannot be equated with the obviousness in
relation to person who is given a specification to arrive at the product
containing variant is concerned. If in the later case, the said person has to do
the further experimentation, then the same would fall outside the scope of
the claim in the original patent. I therefore think the rejection of IN 507 does
not affect the role of reactants which has been remained unexplained
throughout the present proceedings.
263. Now I shall deal with the plaintiffs‘ attempt to show infringement and
how the same does not discharge the onus of proof one by one. The
plaintiffs have attempted to establish infringement on the basis of what has
been written by the defendant on its packaging of the drug which is Erlotinib
Hydrochloride and what has been declared by the defendant before the
authority. It has been contended that the defendant has not made any
reference any Polymorphic version of the compound anywhere on the
product and therefore this Court should find that the onus as to establishment
of the infringement to be proved. I think the existence of the said fact by
itself does not establish infringement. It must be remembered that the
CS(OS) No. 89/2008 Page No.240 of 275


present claim of the plaintiffs is premised on the right of the plaintiffs in the
patent of a chemical compound, therefore the infringement of the same has
to be established by corresponding chemical analysis of the defendant‘s
product and not by mere comparison of the labels, strips or what is written
thereon to show that there is an infringement. The said description of the
defendant‘s product nowhere indicates as to which form of the compound,
the defendant is making. The defendant has categorically stated, it making
Polymorph B version which corresponds to the Tarceva product, to which
the plaintiff has not lead any direct evidence, therefore the mere comparison
of trade description, label, drug approvals are insufficient to arrive at the
conclusion as to infringement of what is claimed in the suit patent.
264. If at all there is a material on record which suggests that the
defendant is making generic version of Tarceva product, even then the same
by itself nowhere establishes infringement. This is due to the reason that the
defendant has been able to show by x-ray diffraction as to what contained in
Tarceva is the Polymorphic version B of the compound. Thus, again the
plaintiffs‘ argument on this count fails and cannot enable this Court to
assume infringement in the manner stated by the plaintiffs due to the reason
that in the prayer, the plaintiffs sought injunction against the defendant in
any manner infringing the legal rights in the drug Tarceva. In para-11 of the
plaint, it is specifically stated that the plaintiffs are manufacturing the drug
under the process of patented product. The said statement apparently untrue
as it is evident as per material available on record that they are marketing the
product under new version of Polymorph B for which the plaintiffs have
registration in India.
CS(OS) No. 89/2008 Page No.241 of 275


265. The plaintiffs‘ argument that the defendant‘s witness is able to
identify the formula of the erlotinib hydrochloride and thus the infringement
should be inferred on the basis of admission is equally incorrect because the
plaintiffs have knowingly sought to restrain the defendant from infringing
the legal rights in the product Tarceva. The prayer as to infringement of
Patent IN‘774 is not mentioned in the prayer clause. After the discussion
done under this head, it has been found that no such legal rights subsist in
the product Tarceva which is a Polymorphic version B which was never
intended to be included in the claim of the suit patent on the purposive
construction of the claim. These attending circumstances clearly establish
that on the date of filing the suit, the plaintiffs were aware that they are
manufacturing and marketing the product under new/latest version of
Polymorph B.
266. The plaintiffs‘ contention that the defendant‘s witness is able to admit
that the active ingredient in the drug is Erlotinib Hydrochloride and thus the
same is admission of the infringement. The said admission in my view is
ambiguous and not clear and unequivocal as the admission of active
ingredient in the product does not mean ruling out the role of the reactant or
variant. On the contrary, there are specific depositions of Mr. Nangia to
suggest that the change in characteristic of the product upon change from the
one form of the suit compound to another in form of Polymorph B version.
There are depositions of Mr. Nangia to the effect that there is no material on
record to show that the compound get automatically converted into
Polymorphic B version. In these circumstances, the mere admission of active
ingredient will not lead to any inference as to infringement by the defendant.
CS(OS) No. 89/2008 Page No.242 of 275


267. The plaintiffs‘ contention that the defendant has not mentioned about
the Polymorphic B version of the compound at anytime earlier by placing
reliance upon drug approvals, patent applications and all other places in
tabular form to show the alleged admissions. The answer of mine to this
contention would be again that the plaintiffs have to first establish
infringement on the basis of what is contained in the defendant‘s product
and not what the defendant claims to be doing. The defendant might have
been inspired by ongoing drug of the plaintiffs in the market which in fact
the defendant is doing as the defendant stand before press and media is clear
that the defendant is intending to launch the generic version of Tarceva
Drug. In case, the plaintiffs were able to prove before Court that the
defendant‘s products are not Polymorph B version but under the patented
product of suit patent, the position would have been different. . However,
until the plaintiff explains who is a patentee and is under duty to explain
what exactly is contained in the drug and how the patent is being infringed
in the said product by taking from what is contained in the drug, the
defendant cannot be imposed the responsibility of remaining in non- denial
mode. The question of admission and non denial would come when the
plaintiffs explain everything as to constituents of the plaintiffs‘ drug and
whether the same corresponds with the suit patent which is clearly missing
in the instant case. Therefore, the said alleged admissions are
inconsequential for the purposes of discharge of the plaintiffs‘ onus of the
proof.
268. Further, the admissions which the plaintiffs are setting up are not the
ones which are clear and unambiguous. There are chains of the facts which
are to be established in order to show an infringement. Mere identification of
CS(OS) No. 89/2008 Page No.243 of 275


the chemical structure of the compound by the witness and reading along
side with the fact that earlier in the written statement there was no reference
of Polymorphic B version made by the defendant and to say that would lead
to clear admission on the part of the defendant that what the defendant is
actually making is the drug under the suit patent will not actually establish
infringement. This more so, when the defendant is disputing such position
till date in the arguments as well as there is a reference of the Polymorphic
versions in the counter claim. In these circumstances, the admissions which
the plaintiffs are setting up are not clear and unambiguous to draw such
inference. This reasoning is in addition to the finding above which is more
crucial that the plaintiffs being a patentee have to inform fully as to what
contained in the drug and whether the same corresponds with the suit patent.
269. The argument of the plaintiffs that one compound has the ability to
remain in two or more Polymorphic forms by stating that the compound will
remain the same and its form shall change, the said argument again does not
explains as what was the role of the reactants while arriving at the
Polymorphic version B and how the said properties of the products under
both the Polymorph are same. The positive evidence should come from the
plaintiffs that the role of such reactants is inconsequential. But that is not so
done in the present case, thus, the mere explanation that the compound will
remain the same and only the alignment will change by citing the example
of the apple is inconvincible in absence of the deposition specific to the
instant case. I think chemical science is not so easy to propound a theory like
this which is that the substance shall remain a substance but only alignment
changes rather the change in alignment of the chemicals make lot of
difference in the products, their forms, characteristics. Learned counsel for
CS(OS) No. 89/2008 Page No.244 of 275


the plaintiffs himself asked that the question in cross-examination from
defendant‘s witness that diamond and graphite are two Polymorphic
versions of the carbon in the cross examination. If the answer is in
affirmative, then even if the plaintiffs have obtained the patent of the carbon
and thereafter attempted to obtain the patent diamond separately by showing
the working upon the carbon, the infringement has to be measured from by
comparing the rights under the diamond patent vis-à-vis the product of the
defendant and not by simply placing relying on the fact that the plaintiffs
have obtained carbon patent and as the diamond contains carbon, therefore it
will infringe carbon patent. This is due to the reason that the diamond is
different in form, composition and its features than the mere carbon.
Therefore, unless the plaintiffs explain from the purposive construction of
the claim that the inventor intended at the time of framing of the patent to
include such substance be it diamond in an example or Polymorphic B form
of the suit patent in the suit patent, the said onus of the plaintiffs is not
discharged. In the present case, the plaintiffs have not adduced any positive
evidence to show the role of the major or minor reactant. On the contrary,
the US‘221 patent specification reveals that there are number of the steps
involved in arriving at the Polymorphic version B. therefore, the argument
of the plaintiffs that the compound patent will take care of the Polymorphic
version in absence of the positive evidence is rejected.
270. The contention of the learned Senior counsel appearing on behalf of
the plaintiffs that the Polymorphic form loses its significance when the said
medicine is consumed and therefore what is left over is the suit compound,
therefore the Court should infer the infringement. Again, the said submission
does not addresses the key questions which are that why there is no positive
CS(OS) No. 89/2008 Page No.245 of 275


evidence defining clearly that the role of the reactants stated in US‘221 is
inconsequential in nature, the question that the tablet containing the
Polymorphic version of the compounds contains reactants?, if so what is the
role of the said reactants?, Whether the role of the reactants also leads to
change in the working of the invention? The said answers are not coming
forward rather it is evident for the reason given above that as regards the
plaintiffs Polymorphic version B, positive results of invention came after
filing of the said application for registration for Polymorph B.

271. Learned counsel for the plaintiffs has placed some reliance on the
answers given by DW1 and 3 that the Erlotinib Hydrochloride is an active
ingredient in the medicine of the defendant and the product in question
arrives different Polymorphic forms of a compound are prepared in
pharmaceutical sciences by re-crystallization of the main compound using
different solvents under different temperature regimes. During preparation of
Polymorph of a compound there is no chemical changes taking place on the
molecule itself, however, during re-crystallization the molecules are re-
arranged/re-oriented in a particular manner and it is this arrangement of
molecules which is designated as a particular Polymorphic form of a
compound. I think the same does not also rescue the case of the plaintiffs
and that is what exactly, I have arrived at after discussing Catnic approach.
The same has not been explained by the plaintiffs by defining the role of the
reactants, rather there is contra evidence which shows such steps are
material so such an extent which persuaded the plaintiffs to approach the
patent office again to secure the patent from US and also an attempt of
similar kind was made in India. Further, the said role of reactants stated in
the specification would show that the reactants and steps mentioned in
CS(OS) No. 89/2008 Page No.246 of 275


US‘221 leads to more stability and change in dosage etc which means that
the said role affects the working of the invention. In such a case, the
plaintiffs‘ argument cannot be acceded to.
272. The argument of dependency of working of one invention over the
other has been raised by the plaintiffs by contending the defendant is surely
infringing the suit patent as the Polymorphic version is a working upon the
suit patent. I think the said argument would have been believed only when
the plaintiffs would have shown that the role of such solvents and
temperature conditions are inconsequential. But, the US‘221 suggest that not
merely the said solvents and steps mentioned therein are material but also
affects the working, characteristics of the invention which takes it to another
level. Then in such a case, the Polymorphic version B of the compound falls
outside the scope of the patented compound as it was never intended by the
plaintiffs to be included at the first place. Therefore, the said principle
propounded by the plaintiffs does not aid the case of the plaintiffs for the
purposes of discharging the onus of the proof as to infringement.
273. The reliance on the judgment of the US District Court in the case of,
OSI Pharmaceuticals LLC & Ors. v. Mylan Pharmaceuticals will also not
assist the case of the plaintiffs. This is due to the reason that in the present
case after examining material evidence on record, I have found that the
plaintiffs have not been able to discharge the onus as to establishing the
infringement. The said judgment was rendered where the defendant admitted
the aspect of infringement of the patent and also in the context of the law
where both the patents US 498 and US‘221 are valid and here in India the
facts and circumstances are different. Moreover, the suit was also filed on
CS(OS) No. 89/2008 Page No.247 of 275


the basis of two registered Patent Nos.US-221 and US-613 of Poly-B. The
defendant challenged only validity. In India, admittedly the plaintiffs‘
application for Poly-B has been rejected. Thus, the said judgment is clearly
distinguishable in these circumstances.
274. Learned senior counsel for the plaintiffs has placed much reliance
upon the order of the controller of the patent dated 15.12.2008 in pre-grant
opposition wherein it was held that the Polymorphic version B is a new form
of old substance and therefore, the same Polymorphic version has to be
considered as the same substance which is subject matter of the suit patent,
there is a deeming fiction in law to treat the suit patent compound and
Polymorphic version B as a same substance and accordingly this Court
should treat the putative state of affairs as the ones which have been
conferred by the law to have been existing. I think there is no doubt that the
Court has to treat the affairs as those treated by the law with no further
enquiry so far as the fiction of the law is concerned. But let me see whether
Section 3(d) talks about any such deeming fiction. For the discussion
purposes, Section 3(d) is reproduced hereinafter:
―3. What are not inventions
The following are not inventions within the meaning of this
Act,—

(a) an invention which is frivolous or which claims
anything obviously contrary to well established natural
laws;

[(b) an invention the primary or intended use or commercial
exploitation of which could be contrary to public order or
morality or which causes serious prejudice to human,
animal or plant life or health or to the environment;]

CS(OS) No. 89/2008 Page No.248 of 275


(c) the mere discovery of a scientific principle or the
formulation of an abstract theory 2[or discovery of any
living thing or non-living substance occurring in nature;]

3[(d) the mere discovery of a new form of a known
substance which does not result in the enhancement of the
known efficacy of that substance or the mere discovery of
any new property or new use for a known substance or of
the mere use of a known process, machine or apparatus
unless such known process results in a new product or
employs at least one new reactant.

Explanation : For the purposes of this clause, salts, esters,
ethers, Polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and
other derivatives of known substance shall be considered to
be the same substance, unless they differ significantly in
properties with regard to efficacy;]‖

Upon the mere reading of the provision Section 3(d) of the Act as well
as the explanation appended thereto, it cannot be said that the provisions use
the words ―deeming‖ or ―deemed to be‖, rather the provisions states that the
Polymorphic versions shall be considered to be same substance unless they
differ significantly in properties with regard to efficacy. The said wordings
used are ―considered‖ and not ―deemed to be considered‖.
It is well settled principle of law that the Courts cannot under the
premise of interpretation can read into the words in the provisions of the
statute when they are not specifically legislated. The Court also cannot
enlarge or limit the scope of the provisions by reading into something which
is not present in the wordings of the Section.

CS(OS) No. 89/2008 Page No.249 of 275


Applying the same principle of law to the present case, when the
legislature used the word considered unless the Polymorphic version differs
in the efficacy, then the same shall be only considered unless the contrary is
proved. But that does not mean that it shall be deemed to be for all practical
purposes the same product or substance. Therefore, there is only a limited
scope of consideration which is enacted in the form of explanation till the
time the efficacy differences are shown and not the blanket fiction of law
which has been enacted.
It is equally well-settled principle of interpretation that the fictions
engrafted under the statute are to be given effect to by the Courts but by
confining the scope, ambit and purposes for which the said fictions are
enacted in the statute and not beyond the same. It is impermissible to extend
the scope of the fiction beyond the purpose for which the said fiction has
been enacted.
Applying the said principle of law to the present case, even if the
fiction is engrafted under Section 3(d) to treat the Polymorphic version as a
same substance, the said treatment has been accorded by the law only for the
purposes of applicability of Section 3(d). The said limited fiction nowhere
states and construed to mean that for all other reasons too including for the
purposes of measuring the infringement of the patent, the said Polymorphic
version B shall be deemed to the same substance.
Accordingly, I think reading the said explanation in the manner in
which the plaintiffs are reading would amount to extending the scope of the
fiction beyond the purpose which is impermissible in law. Therefore, this
CS(OS) No. 89/2008 Page No.250 of 275


fiction argument also does not aid the case of the plaintiffs in order to
discharge the onus of the proof upon the plaintiffs.

I think the controller of patent had arrived at the finding in the
pre-grant opposition order as he was not convinced with the evidence on
record as available with him as to how the Polymorphic version B
significantly differs from the efficacy and proceed to treat the same as same
substance by not treating the plaintiff‘s case within the later part of the
explanation which is an exception to the rule. At that point of time, the onus
was on the plaintiffs herein and the applicant therein to discharge the said
onus to the satisfaction of the controller to treat the case of the plaintiffs as
the one which may fall in the later part of the provision. The plaintiffs were
unsuccessful in discharging the said onus and consequently the finding of
Section 3(d) was arrived at by the controller.
Turning back to the present case, here the onus of the plaintiffs is
completely reversed, which is to establish the role of reactants are
inconsequential which means that in the present case, the plaintiffs have to
establish that the role of the reactants are such which is so immaterial or
minor so as to show that the product in question is subsumed within the
claims of the patent. The said onus has to be discharged by the plaintiffs
independently by showing the positive evidence.
There is no merit in the submission of the plaintiffs that the plaintiffs
failure to discharge onus to the contrary to show efficacy and ultimately a
different substance before the controller may lead to automatically the
discharge of onus to prove that the Polymorphic version B is the same
substance as that of the claimed in the patent. I think both the onus is
CS(OS) No. 89/2008 Page No.251 of 275


different and distinct lied upon on the plaintiffs at different occasions. The
failure to discharge the one cannot be equated to successful discharge of
other when both are inconsistent to each other.
There may arise a circumstance that the product in question may not
be so novel or obvious to the person or may not have industrial use or may
be based on same substance (but not identical) and hence not separately
patentable being not novel and at the same time, the said product also does
not fall within the ambit of the previous patent too. Thus, in order to
dislodge the said circumstance or eventuality, the plaintiffs have to establish
independently that the product in question and the suit patent is the same by
showing the role of the reactants. Therefore, there is no fiction argument
which will work here to discharge the said onus.
275. There is an argument raised that the US‘221 teaches a conversion
from one form to another Polymorphic form B and does not inform about
the separation. It has been argued that the defendant witness also admits so
in its affidavit by using the term ―transform‖ etc. I think this aspect is also
based on some kind of admission. The reasoning of mine is the same as
discussed above relating to other admission and the same also does not
answer the key questions which should have been addressed by the plaintiffs
themselves.
276. It is further submitted by the plaintiffs that the expert witness of the
Plaintiffs, Dr. Nick Thatcher (PW3), who has himself administered
TARCEVA® to patients and participated in clinical trials, has stated at
several places in response to questions posed to him that the Polymorphic
form of a compound has absolutely no relevance whatsoever to the
CS(OS) No. 89/2008 Page No.252 of 275


therapeutic efficacy of a product. ( Q. 26, Q. 73, Q. 91-96, Q. 112, Q. 115, Q.
154-157, Q. 168-169, PW3, ). It is also stated that there is an evidence to
show that the Polymorphic version B has no relevance to the efficacy of the
product. It is also stated as under:The conclusions from the questions posed
to PW-3 on this issue have been summarized for the convenience of this
Court below:
a. Polymorphism has never been raised as an issue in terms of
patient benefits. ( Q.115, PW3,)

b. Polymorphism has never been raised as a problem in terms of
the clinical benefits of Erlotinib Hydrochloride. Therefore, from
the patient activity point of view, the issue of the stability of the
compound in the suit patent (invented in 1995) in the tablet
form is irrelevant. ( Q. 168, PW3 )
c. If there was a clinical patient benefit difference based on
Polymorphism of the Erlotinib Hydrochloride, it would have
been known prior to commercial availability of the drug to
expert and experienced clinicians such as PW3. ( Q. 169, PW3 )
d. Even assuming, the compound was less stable than Polymorph
B, if there was a reasonable expectation of anti-tumor activity
the differences in stability may not be a big issue during clinical
trials. In fact, there are some anti-cancer drugs, which on
account of being unstable have to be protected from light
during patient administration. ( Q. 155-156, PW3 )
e. Further as borne out from the Investigators Brochure ( PW1/X2 ),
Erlotinib Hydrochloride was successfully administered in the
CS(OS) No. 89/2008 Page No.253 of 275


tablet form in trials conducted in 1997 i.e. two years prior to the
invention of Polymorph B form of Erlotinib.
277. I think the reliance of the plaintiffs on the defendant‘s cross
examination to this effect is a step towards the correct approach. But, it
should have first come from the plaintiffs end as to for what role then the
reactants played in order to arrive at the Polymorphic version B. How the
same can be termed as inconsequential when the same affects the change in
the property or form of the compound by making it solid, re-crystallized and
pure, how the said reactants do not affect the working of the product
materially when as per the plaintiffs own declaration before US patent office
in US‘221, the said reactions as steps make the compound the stable in form.
If the answers of these questions would have been emanated from the
plaintiffs in the form of depositions so as to establish that the Polymorphic
version was intended by the inventor to be included in suit patent itself, the
said onus could have been properly discharged. The said cross examination
done of Mr. Thatcher does not aid the case of the plaintiffs towards
establishment of all these material facts which the plaintiffs should have
informed the Court in the detail in the evidence.
It is also submitted by the plaintiffs that the defendant‘s contention
that the tablet form could not manufactured without the aid of the
Polymorphic B version is factually incorrect due to the following reasons:

i. Various modes of administration of the compound are mentioned
including in tablets in the specification of suit patent of 1995
( PW1/5 ).
CS(OS) No. 89/2008 Page No.254 of 275


ii. Example 20 of Suit Patent clearly demonstrates that Erlotinib
Hydrochloride was in solid form.
iii. PW2 had repeatedly reiterated that the specification is clear that
Erlotinib Hydrochloride was in solid form ( Q. 73-74, PW2 ).
iv. DW 3 has reiterated that IN‘774 results in solid form.
v. Trials conducted on Erlotinib Hydrochloride in 1997, shows that
Erlotinib hydrochloride were administered in tablet forms much
before Erlotinib Hydrochloride in Polymorph B form was known
( PW1/X2 ).
I think the aforenoted evidence is also one of the steps towards
discharge of the onus lied on the plaintiffs. It may be the case that the suit
patent may mention as example the mode of the administration in solid
form, but that by itself may not establish that what contained in the
plaintiffs‘ product is the same compound as claimed in the suit patent and
not the Polymorphic version B. The establishment of the fact tablet was
known in the year 1997 again nowhere indicates what is the current position
in the market. I think that may be indicative of the only fact which is that
somewhere down the line, the plaintiffs‘ suit patent contemplated an
administering of the compound in solid form or tablet form, but thereafter
this discussion ought to have been furthered by the plaintiffs by showing
positive evidence as to what happens till date is the Polymorphic version B,
the role of the steps mentioned in US‘221 is inconsequential and no where
affects the working of the invention, by not doing so, the onus of the
plaintiffs even by placing reliance on the aforementioned facts still remains
un-discharged.
CS(OS) No. 89/2008 Page No.255 of 275


278. In US‘221 specification it is clearly revealed that the said patent
IN‘774 corresponding to US Patent No.US‘498 is a mixture of Polymorph
A&B. Therefore, the plaintiffs had knowledge that the hydrochloride
compound in the suit patent was in the form of mixture of Polymorph A&B
way-back in the year 2000 when the said application US‘221 was made for
registration. However, the said fact was not revealed by the plaintiffs either
in the suit proceedings or in the pending application in the suit patent till the
date of grant of suit patent i.e. July, 2007. It is not denied by the plaintiffs
that the compound under the suit patent is not preferred form for making
tablets. The B-Polymorph form as admitted in US‘221 is more stable and
also suitable for making tablets. Significantly, in plaint the plaintiffs chose
not to provide the XRD graphs and data of the product ―Tarceva‖ although
in the said US Patent No.6900221 the plaintiffs have provided XRD data of
both A&B Polymorph forms and which were readily available to them at the
time of the filing of the suit.
The defendant in its evidence has been able to prove that Tarceva
tablets which are sold in India are wholly B Polymorph of the hydrochloride
salt of N-(3-ethynylphenyl)-6, 7-bis (2-methoxyethoxy)-4-quinazolinamine.
Under these circumstances, it is clear that the plaintiffs are not
manufacturing the drug wholly B Polymorph which was invented by the
plaintiffs after filing the applications for registration in US‘498 in the year
1995 and in India in the year 1996 and they are using the latest version of B
Polymorph. In normal case, this Court would have agreed with the
argument of the plaintiffs that at the time of deciding the issue of
infringement, the claims are to be interpreted with the product of the
defendant. However, in the present case, due to peculiar facts and
CS(OS) No. 89/2008 Page No.256 of 275


circumstances of the case, it became necessary to find out as to whether the
plaintiffs were marketing the drug covered under the suit patent strictly or
Polymorph B version as in the plaint, there was totally non-disclosure of the
US Patent 221 as well as pending application No.IN/PCT/2002/00507 for
Polymorph B. The plaintiffs were totally silent on these aspects from the day
the matter was filed in March, 2008.
279. As seen above, the plaintiffs have taken an indirect route of showing
admissions, attempting to establish infringement by the look and the feel of
the product as well as calling upon this Court to assume infringement on the
basis of the fiction of law, I think the said indirect route does not discharge
the burden of the plaintiffs which is independent and upon the plaintiffs. The
admissions which the plaintiffs are again and again emphasizing are all
ambiguous and disputed by the defendant here and there, the fiction
argument I have already dealt with, the claim interpretation also does not
reveal that the product in question falls within the ambit of the patent as the
rules are different when the product contains certain variants which is
apparent from the discussion done above. The sum and the substance of the
entire discussion is that the plaintiffs have not indulged into the clinically
examining the defendant product by pointing out as to what exactly the
defendant is manufacturing a Polymorphic version B or the combination of
A and B, on the other hand, the defendant has been able to provide the x-ray
diffraction by the evidence of DW1 Ms.Shashikala which gives a hint
towards the fact that the trends taken in x-ray are the same which are
mentioned in US‘221 which is relating to Polymorphic version B and there
is no cross examination on this aspect by the plaintiffs‘ counsel and no
attempt has also been made to dislodge the same.
CS(OS) No. 89/2008 Page No.257 of 275


280. The plaintiffs have admittedly no registration of Polymorph B version.
In fact, the plaintiffs filed the application for registration of the same under
No.IN‘507/DEL. The same was opposed by the defendant. The said
application was rejected on the ground that it does not qualify the
requirement of Section 3(d) of the Patents Act, 1970. In India, Section 3(d)
of the Act does not qualify variant of a basic drug Molecule unless such
version shows an enhanced therapeutic efficacy. Though the said
application was corresponded with the US‘226 application patent of which
was granted by US Patents Office who has accepted the claim of the
plaintiffs for the same enhanced therapeutic efficacy, the detail of which is
already referred in paras-257 & 258 of my order.
After rejection of the said application by the Controller of Patents in
India, his order was not challenged by the plaintiffs in higher Court. It is
pertinent to mention here that the condition similar to Section 3(d) in Indian
Patents Act is not the law in US. No suit for infringement of patent is
maintainable unless the patent is registered.
281. The contention of the learned counsel for the plaintiffs is that prior to
January, 2008, the defendant was unaware of the existence of Erlotinib
Hydrochloride in Polymorph B version, nor the defendant has taken the plea
of marketing its product in the written statement under the said form.
However, the said plea was taken later on. The entire story with regard to
the marketing of Polymorph B form is cooked up by the defendant at the
later stage. The said defence was taken by the defendant after having come
to know about the registered patent of the plaintiffs US‘221 and the pending
application of the plaintiff in India bearing No.IN‘507/DEL. The said plea
CS(OS) No. 89/2008 Page No.258 of 275


raised by the defendant is totally an after-thought. It is further urged by the
plaintiff that even otherwise the defendant could not have arrived at
Polymorph B form of the Molecule without crossing the stage of preparation
of combination of Polymorph A & B. Therefore, Polymorph B version
would still be infringement of the suit patent which was not restricted to any
particular polymorphic form.
282. As example 20 of the suit patent disclosed and characterized the
physical state of the claimed compound as solid by its melting point. From
the testimony of the witnesses of the plaintiffs, it is evident that the plaintiffs
have not proved in evidence that they are marketing their product Tarceva
other than Polymorph B version. Similarly, no evidence has been adduced
by the plaintiffs in order to prove that the defendant‘s product namely
ERLOCIP is other than Polymorph B version. The only explanation given
by the plaintiffs at the time of arguments in this regard is that the suit patent
was not restricted to any particular polymorphic form and the defendant
could not have arrived at Polymorph B of Molecule without crossing the
stage of preparation of combination of Polymorph A & B.
283. The defendant many times at the time of arguments has not denied the
fact that the defendant is marketing its products under Polymorph B version
which is similar to US‘221. The justification given by the defendant is that
since the patent application of the plaintiffs bearing No.IN‘507/DEL which
corresponds to 221 has been rejected by the Controller of Patents in India,
the defendant is entitled to manufacture and market its product under
Polymorph B version. Not only that the statement was also made by the
learned counsel for the defendant that any injunction passed on such patent
CS(OS) No. 89/2008 Page No.259 of 275


will not effect the business of the defendant, as it is marketing its products in
Polymorph B version. According to the defendant, the plaintiffs have
intentionally made the prayer in the plaint to restrain the defendant from
infringing the Tarceva product of the plaintiff as on the date of filing of the
suit the plaintiffs was aware that the Tarceva is marketed under
Polymorph B version.
284. This Court is conscious about the fact that a monopoly of the patent is
a reward of the inventor and there must be presumption of validity of the
patent but at the same time, law mandates that the Court must look at the
whole case, the strength of the case of the patentee and the strength of the
defence raised in the matter.
285. In these circumstances, in the absence of the discharge of onus of
proof by the plaintiffs which was independently lied upon them, the
plaintiffs have not been able to establish the infringement of the IN‘774 on
balance of the probabilities. Therefore, the said issue is answered against the
plaintiffs and in favour of defendant.
286. To sum up the findings arrived under this head relating non
establishment of the infringement of suit patent IN‘774 is based on the
following attending circumstances:
 The establishment of the fact on record that the plaintiffs‘ product
Tarceva does not corresponds exactly with the suit patent IN‘774
but is a Polymorphic version B of the suit compound.

 On the purposive construction of the claim of the suit patent
IN‘774 as per Catnic approach, it has been found that the plaintiffs
CS(OS) No. 89/2008 Page No.260 of 275


never intended to cover the Polymorphic version B of the said
compound under IN‘774 as it is apparent from the facts correlating
the product with that of the claim in the suit patent which are that
the plaintiffs have separately filed patent for Polymorph B in US
and India separately.
 The plaintiffs‘ inability to show the role of the reactants or variants
as major or minor at the time of establishing infringement which
could have enabled this Court to persuade that the said
Polymorphic version B was intended to covered within the ambit
of the suit patent IN‘774.
 The plaintiffs‘ failure to examine the product of the defendant‘s
clinically, file depositions thereto by establishing that the product
of the defendant is actually covered within the suit patent IN‘774.
 The plaintiffs‘ non-denial of the fact that the Tarceva is based on
the Polymorphic B version and non traversal to the defendant‘s
position that the defendant product is not actually Polymorphic B
version but is the one corresponding the suit patent.
 The plaintiffs maintaining the position that the Polymorphic
version B was intended to be covered within the purview of the
claim of the suit patent without establishing and defining the role
of the reactants as major and minor.
 The plaintiffs‘ inability to justify as to whether the Polymorphic
version of the said compound affects the working of the invention
materially or not.
CS(OS) No. 89/2008 Page No.261 of 275


 The existence of the attending circumstances like specification of
US‘221 which clearly provides that there are reactions done to the
suit patent compound subsequently which makes the product under
the Polymorphic version B more stable which lead to the
conclusion that not merely the role of such reactants are major but
innovative enough to call it as a patent in itself. The said US‘221
also reveals that the working of the product like dosages and form
like tablet one also changes than the earlier one.
 The factum of the rejection of the separate patent IN‘507 filed in
India which was the attempt of the plaintiff‘s to seek the separate
protection to the Polymorphic version B. this is again indicative of
the fact that the plaintiffs as a patentee never intended to include
the said Polymorphic version B in the suit patent but always
intended to treat the same as a separate invention. The plaintiffs‘
rejection of the patent in IN‘507 is due to the reason of failure of
the plaintiffs to satisfy the controller as to efficacy part under the
explanation appended to Section 3(d) and the said order has
attained finality.
 The plaintiffs‘ inability to show the positive evidence to establish
as to how the statements made in US‘221 are not relevant
especially when the role of the reactants and workings are clearly
defined therein. The plaintiffs could have done so by their own
defining the role of the reactants and their effect on the working by
leading contrary evidence.
CS(OS) No. 89/2008 Page No.262 of 275


 The plaintiffs not following the direct approach of establishing the
infringement by clinically examining the product and taking the
indirect route of showing the admissions and orders, product
packaging in order to call upon this Court to infer such an
infringement.
 The plaintiffs‘ inability to discharge its onus which is independent
to that of the stand of the defendants on their own by establishing
the infringement.
 The plaintiffs being themselves being aware of the fact that the suit
patent does not corresponds with the Tarceva drug and thereby
seeking the prayers in the suit relating to legal rights of Tarceva
drug and not seeking the prayers as to infringement of the Patent.
All the afore mentioned attending circumstances, coupled with the other
reasoning discussed above and the lack of evidence clearly enables this
Court to arrive at the finding that the plaintiffs have failed to discharge the
onus of the proof as to establishing the infringement of the suit patent
IN‘774 in the present case. The present issue No. 1 is answered accordingly.
Issue No.3

287. In view of my findings arrived at on issue No.1, the plaintiffs are not
entitled for permanent injunction as prayed as in the present case. As
discussed earlier that in the plaint reads that the permanent injunction is
sought against the defendant calling upon the Court to restrain the defendant
from manufacturing the generic version of drug Tarceva and violating the
legal rights in the drug Tarceva. It has been established on record on balance
CS(OS) No. 89/2008 Page No.263 of 275


of the probabilities in view of the answer of issue No. 1 which is in negative
that the defendant is not infringing the IN‘774 as the tablet Tarceva consists
of Polymorphic B version of the compound namely N-(3-ethynylphenyl)-6-
7-bis (2-methoxyethxy)-4-Quinazolinamine. Accordingly, no protection in
the form of permanent injunction can be granted.
Issue No.5
288. The issue No.5 relates to relief which may include damages or
rendition of the accounts. The plaintiffs have sought the exemplary damages
on the basis of the violation of its Patent rights in IN‘774. I have already
come to the finding that the plaintiffs have failed to discharge the onus of the
proof as to show the infringement of the IN‘774. Accordingly, the
discussion as to the aspect of calculation of damages and prayer for damages
is not warranted. The prayer of damages to the plaintiffs is accordingly
rejected.
Issue No.4
289. Now I shall proceed to answer issue no. 4. The said issue no. 4 reads
as under :
“Whether defendant/counter-claimant proves that the
plaintiffs’ subsequent US Patent 6900221, is to the effect
that the compound of claim No. 1 of the suit patent is a
mixture of two Polymorph A and B Compound and need to
be separated to perform and get the claimed compound for
acceptable efficacy; and its effect on the plaintiffs’
patent? OPD”

290. The afore noted issue can be classified into two parts:
CS(OS) No. 89/2008 Page No.264 of 275


 Whether the defendant has proved that the plaintiffs‘ subsequent US
patent 6900221 is to the effect that the compound of claim no. 1 of the
suit patent is a mixture of the two Polymorph A and B Compound
 Whether the defendant has proved that there is need of separation to
perform and the get the compound of acceptable efficacy and its effect
on the plaintiffs‘ patent.
291. I will now answer the said issue collectively as both are interlinked to
each other and classified only for the purposes of understanding.

292. The onus to prove this issued was on the defendant.
293. Once I have held that the plaintiffs themselves are not able to explain
the role of the existing two patents in US‘498 and US‘221 and in India in
IN‘774 and IN‘507 and also not able to reconcile as to for what purpose the
two patents were applied for. The plaintiffs should have shown by way of
the positive evidence, what was the role of the reactant as contained in
US‘221 in arriving at the Polymorphic tablet version of Tarceva drug and
how the said version is covered in the suit patent. In the absence of such
exercise done by the plaintiffs. I find that there is no need for the defendant
to further establish to the contrary by showing the same.
294. I find to limited extent the defendant has been able to discharge the
onus by relying the specification of US‘221 and comparing it with the
plaintiffs product Tarceva in the evidence of Ms. Shashikala PW2 and
proved that the plaintiffs product as sold in the market is Polymorphic
version B and trends in the x-ray defraction corresponds with what has been
contained in US‘221.
CS(OS) No. 89/2008 Page No.265 of 275


295. Therefore, it is clear that the defendant has been able to discharge the
onus to show that the plaintiffs‘ suit compound is a combination of A and B
and the compound need to be converted or separated in order to arrive at the
Polymorphic version B. I find that though there is no need for the defendant
to show by way of positive evidence that clinically the said Polymorphic
version needs to be separated or converted in strict sense of term in the
present case, unless the plaintiffs could have shown at the first place that the
said Polymorphic version B is covered within the suit patent, which the
plaintiffs are incapable in the instant case. Hence, I find that the existing
depositions and the statements made by the plaintiffs in US‘221 are
sufficient evidence in this case at least to displace such onus especially in
the light of the negative answer coming in relation to issue no. 3 relating to
infringement.
296. Now I shall deal with the submission of the learned counsel for the
plaintiffs in relation to the present issue which are as under:
 Firstly, the learned counsel for the plaintiffs relied upon the rules
of construction of the specification as done above for infringement
to urge that the Court has to the see the specification and not to
rely on other documents to draw the inference. I have already
answered the said submission under the head of the infringement
that the tests vary from case to case basis and where there is a
product containing variants, the tests laid down in Catnic (supra)
are applicable.
 Secondly, learned counsel stated that the evidence of the defendant
is inaccurate and improper to establish the present issue. I tend to
CS(OS) No. 89/2008 Page No.266 of 275


somehow agree with the learned counsel for the plaintiffs that the
evidence is not too strong to establish to the certainty about the
same but it‘s not too weak either especially in the light of the facts
of the present case. I find that the case in hand is peculiar to its
own facts wherein the plaintiffs are not able to explain and show
that the suit patent includes the Polymorphic version B of the
compound. Once, the plaintiffs themselves are not able to show the
same, I think the evidence of this kind may work towards the
discharge of the onus of the proof lied on the defendant.
 Learned counsel for the plaintiffs argued that no external aid of
construction can be used to draw an inference against the plaintiff.
I have already answered this submission under the infringement
head wherein I have stated that overall facts and the facts
correlating the invention with that of the product containing
variants are relevant and material facts and can be looked into by
the Courts. Thus, no such impediment exists in law to preclude this
Court from looking US‘221 while construing IN‘774 and claims
mentioned therein.
 The judgments relied upon by the plaintiffs like Glaverbel v.
British Coal Corporation, 1995 RPC 255 at pp. 268-270; Pfizer
Inc. v. Ranbaxy, 457 F.3d 1284 at p. 1290; Abbott v. Dey, 01-1374
at pp. 11-13. [reported as 287 F. 3d 1097 are all distinguishable on
facts as in one set of the facts, there may be need to accord literal
interpretation and in another Catnic approach is required to be
looked into and considered. Both are followed by the Courts in UK
CS(OS) No. 89/2008 Page No.267 of 275


including House of Lords. Thus, I do not find that the said
judgments are not laying correct law but the same are clearly
distinguishable in the present facts in view of Catnic approach
(supra) which has been followed consistently and even in relation
to chemical compounds in Merck (supra) following catnic in the
cases relating to chemical compounds.
 Learned counsel for the plaintiffs argued that the inventors of
US'221 believed that Erlotinib Hydrochloride would exist in many
other Polymorphic forms, it has been categorically stated in
US‘221 that the compound of claim 1 of US'498 was found to
‗ comprise of‘ Polymorphs A and B which can be distinguished
from ‗ consists of‘. I think one cannot read the words used in the
specification like that of the statute. The argument that comprise
may be construed to mean that the said patent may contain other
forms other than combination of A and B is untenable. If that is so,
then the next question arises that where was the occasion for the
defendant to take a separate patent US‘221 calling the process and
product arrived at consequent upon reactions as Polymorphic
version B as novel compound. Therefore, this kind of
interpretation cannot aid the case of the plaintiffs.
 Learned counsel pointed out weaknesses in the defendant‘s
evidence by arguing that the defendant has not carried out any
independent study, the defendant witnesses stated that they are not
conversant with the patent law, the conduct of the defendant is bad
etc. I have already addressed on the weakness of evidence by
CS(OS) No. 89/2008 Page No.268 of 275


observing that the in the light of the emerging position in the
present case, the said evidence though weak is sufficient to
discharge the onus.
 Learned counsel for the plaintiffs argued that the subsequent
statements made by the plaintiffs cannot be construed as
admissions to limit the claim of the suit patent. I have already
answered this submission that all the attending facts are relevant to
draw an inference. This Court is not coming to finding on the basis
of the admission but drawing an inference after evaluating the
evidence of the parties and looking into the facts preceding and
posterior to the filing of the patents in India and US as to what can
be the possible interpretation of the suit patent as contained in
claim 1.
 Learned counsel for the plaintiffs argued that there are admissions
made by the defendant in the opposition proceedings by reading
the pleadings of the plaintiffs in opposition proceedings. I would
say that the same are not admissions as the defendant while
contesting the opposition has merely stated that the IN 507 may
not be allowed as the same lacks efficacy and in a way same
substance to that of the Erlotinib Hydrochloride. However, that by
itself does not mean that the defendant could not show before this
Court that the US‘221 relates to Polymorphic version B and
IN‘774 relates only the main compound and both though relates to
same compound but there is a need of conversion or separation. I
think the argument of admission is totally misconceived as the
CS(OS) No. 89/2008 Page No.269 of 275


same relates to opposition proceedings containing separate onuses
vis-à-vis these proceedings.
 Learned counsel for the plaintiffs argued that the interpretation
given by the defendant to US‘221 is erroneous and the defendant
has failed to prove this issue in as much as US‘221 teaches that by
a process of re-crystallization, Erlotinib Hydrochloride in
Polymorph A and B form, is converted to Erlotinib Hydrochloride
in pure Polymorph B form ( DW1/9) . It is pertinent to note that
US‘221 teaches conversion and not separation. I think the
plaintiffs are going into the issue of use of the wordings in the
issue framed and in the specification. Whether the said compound
is covered or separated, the moot question is that there is
something which is done besides the compound as contained in the
suit patent in order to arrive at Polymorphic B. if the answer is in
affirmative, I think, the onus is discharged. I therefore find no
force in the present argument as the defendant has to prove the
case on balance of probabilities and not beyond reasonable doubt
especially when the plaintiffs have failed to discharge any such
onus as to show the infringement.
 It is also stated that the defendant ought to have conducted the
surveys to show that the efficacy wise, the suit patent and its
Polymorphic version are different rather than merely relying upon
specification. I think this could have been valid criticism from the
plaintiffs‘ side when the plaintiffs themselves could have been
discharge the onus that both the Polymorphic version and the
CS(OS) No. 89/2008 Page No.270 of 275


patented compound are same. As the plaintiffs have not done so at
the first place by clinically and medically examining the product, I
think it does not lie in the mouth of the plaintiffs to criticize the
defendant‘s evidence on this count.
 It is argued by the learned counsel for the plaintiffs that the
stability which has been mentioned in US‘221 relates to the
stability in storage. It has been canvassed that the statements
contain the specification of US‘221 are misread and
misinterpreted. The plaintiffs have sought to give their own
interpretation to the specification during the argument. I still find
that the overall reading of the specification of US‘221 indeed
shows that there are certain steps which are to be taken in the form
of further reactions to the compound claimed in suit patent in order
to arrive at the Polymorphic version. The factual dispute, which the
plaintiffs are canvassing now either should have been shown by
adducing an evidence, which is relevant here as well as in the
infringement action as what role these reactions, steps played in
the working of the invention. The reactions or variants are shown
in the specification playing a significant role which changes the
form of the compound from one to another as well as also changes
the advantages by making it more stable as stated therein.
Therefore, these trivial aspects may not lead to any change in the
case and the same are irrelevant.
 Learned counsel for the plaintiffs has placed reliance of the order
of the Controller in the opposition to IN‘507 as well as some
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statement made by the defendant where it is contended that there is
no thereaupatic efficacy increase between the suit compound and
the Polymorphic version B. It is correct that there are inconsistent
stands are taken by the defendant but the same are to be evaluated
in the light of the overall facts and circumstances. The stand taken
by the defendant itself does not lead to an inference when there is a
material on the record suggesting contrary. The specification to
US‘221 and thereafter the affidavit of Mr. Nangia and
Ms. Shashikala DW3 and DW2 clearly proves otherwise. In these
circumstances, drawing an aid from opposition proceedings and
treating it as admission by ignoring the evidence of the present
proceedings shall be a far-fetched argument.
297. So far the order of the controller of patents holding that the
Polymorphic version is violative of Section 3(d) of the Act, I have already
observed that the finding is arrived by the controller after being dissatisfied
that the plaintiffs case falls within the later part of the explanation appended
to Section 3(d). The plaintiffs if were dissatisfied with the findings should
have challenged the same before High Court which the plaintiffs have not
done so. Under these circumstances, the plaintiffs‘ inability and suffering an
adverse finding upon not satisfaction of the controller cannot lead to straight
conclusion that the Polymorph version B and suit patent coincide or they are
the same substance. The same has to be proved by the plaintiffs in
accordance with law and that is the reason why the plaintiffs are not able to
make out a case for infringement of patent. Thus, the said order also does
not rescue the plaintiffs automatically to dislodge the evidence lead by the
defendant.
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298. I have addressed almost all the submissions advanced by the learned
counsel for the plaintiffs. I think there are some submissions which are quite
repetitive and are common to this issue as well as the infringement issue.
Therefore, the cross-reference can also be made between the two issues in
order to find out the answers of the same as the necessity of deciding this
issue rests on the strength of the evidence which the plaintiffs have lead in
order to establish the infringement of the patent.
299. In view of the abovementioned discussion, I hold that the defendant
has proved that the plaintiffs‘ subsequent US‘221 patent contains the
admission on the part of the plaintiffs that claim No.1 of the suit patent is a
mixture of two Polymorph A&B and US‘229 patent has an effect on the suit
patent of the plaintiffs. The issue is accordingly decided in favour of the
defendant and against the plaintiffs.
Re: Objections relating to marking of documents
300. Both the parties have raised certain objection with regard to marking
of documents. There are certain documents which are not referred in the
pleadings and the same are marked in the affidavits of the witnesses. I have
seen the documents during the course of the proceedings which are mainly
patent specifications, orders of the controller and the documents filed with
the list of the documents filed by the parties. The said documents are, more
or less, of the public documents in nature which are relating to litigation,
which has happened between the parties and relied upon by the Controllers
and Patent offices as well. Therefore, in case, there are pleadings pertaining
to the contents of the documents, I am inclined to deal with the said
documents which are in the nature of public/Government documents
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considering the exposition of the law that the objections as to exhibit
numbers does not necessarily mean that the Court will not apply its judicial
mind which document to be looked into and which not. (See the judgment
passed in the case of Sudhir Engineering Company vs. Nitco Roadways
Ltd , 1995 (34) DRJ 86).
Public Interest and other submissions
301. There are other submissions advanced by the parties relating to the
impact of the public interest on the grant and non grant of the relief of
permanent injunction. Likewise, the plaintiffs have advanced the
submissions as to the grant of the damages and costs. I find that the said
submissions do not warrant discussion in view of the finding arrived by me
in relation to issue no. 1 wherein there is no case made out for infringement,
therefore, the question of grant of permanent injunction, damages or costs
does not arise.
Conclusion :
302. In view of the discussions done above relating to the several issues,
the following conclusions can be drawn which are enumerated issue wise:
1. Whether the manufacture, marketing and sale of ERLOCIP by
defendant is infringing the plaintiffs‘ Indian Patent 196774? OPP
Issue No.1 is decided in favour of the defendant and
against the plaintiffs.
2. Whether the Indian Patent 196774 is liable to be revoked on the
grounds raised in written statement and counter-claim of the
defendant? OPD
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Issue No.2 is decided in favour of the plaintiffs and
against the defendant.
3. Whether the plaintiffs are entitled to permanent injunction as
prayed for? OPP
AND
5. Relief.
In view of the findings arrived at on issue No.1, issue
Nos.3 and 5 are decided against the plaintiffs.
4. Whether defendant/counter-claimant proves that the plaintiff‘s
subsequent US Patent 6900221, is to the effect that the compound
of claim No.1 of the suit patent is a mixture of the two,
Polymorph A and B Compound and need to be separated to
perform and get the claimed compound for acceptable efficacy;
and its effect on the plaintiff‘s patent? OPD/CC.
Issue No.4 is decided in favour of the defendant and
against the plaintiffs.
303. In the result, both, the suit being CS(OS) No.89/2008 and the counter
claim being C.C. No.52/2008 are dismissed. No order as to costs.

MANMOHAN SINGH, J.
SEPTEMBER 07, 2012
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