Boehringer Ingelheim Pharma Gmbh & Co. Kg, vs. Vee Excel Drugs And Pharmaceuticals Private Ltd. & Ors.

2023:DHC:2249

* IN THE HIGH COURT OF DELHI AT NEW DELHI

th
% Judgment Reserved on : 27 January, 2023
th
Judgment Delivered on : 29 March, 2023

+ CS(COMM) 239/2019 & CCP(O) 82/2019, I.A. 6797/2019
(O-XXXIX R-1 & 2 of CPC), I.A. 9272/2019 (O-VII R-11 of CPC),
I.A. 2042/2020 (u/S 151 CPC), I.A. 2044/2020 (u/s 151 CPC)

BOEHRINGER INGELHEIM PHARMA GMBH
& CO. KG ..... Plaintiff
Through: Dr. Sanjay Kumar, Ms. Arpita
Sawhney, Mr. Arun Kumar Jana,
Ms. Meenal Khurana, Mr. Harshit
Dixit and Mr. Priyansh Sharma,
Advocates.
versus

VEE EXCEL DRUGS AND PHARMACEUTICALS PRIVATE
LTD. & ORS. ..... Defendants
Through: Mr. Mukesh Rana and Ms. Mamta,
Advocates for defendants No.1 and 2


+ CS(COMM) 240/2019 & CCP(O) 81/2019, I.A. 6802/2019 (O-
XXXIX R-1 & 2 of CPC), I.A. 9277/2019 (O-VII R-11 of CPC),
I.A. 2036/2020 (u/S 151 CPC), I.A.2038/2020 (u/S 151 CPC)

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG &
ANR. ..... Plaintiffs
Through: Dr. Sanjay Kumar, Ms. Arpita
Sawhney, Mr. Arun Kumar Jana,
Ms. Meenal Khurana, Mr. Harshit
Dixit and Mr. Priyansh Sharma,
Advocates.
versus

VEE EXCEL DRUGS AND PHARMACEUTICALS PRIVATE
LTD. & ORS. ..... Defendants
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 1 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Through: Mr. Mukesh Rana and Ms. Mamta,
Advocates for defendant No. 1

+ CS(COMM) 236/2022, & I.A. 5801/2022 (O-XXXIX R-1 & 2 of
CPC), I.A. 5802/2022(O-XXVI R-9 of CPC), I.A. 5803/2022(O-XI
R-1 (6) as amended by the Commercial Court Act), I.A. 5804/2022
(for directions), I.A.22459/2022 (for condonation of delay of 88
days in WS to the CC)

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG &
ANR. ..... Plaintiffs
Through: Dr. Sanjay Kumar, Ms. Arpita
Sawhney, Mr. Arun Kumar Jana,
Ms. Meenal Khurana, Mr. Harshit
Dixit and Mr. Priyansh Sharma,
Advocates.
versus

ALKEM LABORATORIES LTD & ANR. ..... Defendants
Through: Mr. Adarsh Ramanujan, Ms. Bitika
Sharma, Ms. Nitya Sharma,
Ms. Vrinda Pathak, Mr. George
Vithayathil and Mr. Skanda Shekhar,
Advocates.

+ CS(COMM) 237/2022 & I.A. 5806/2022 (O-XXXIX R-1 & 2 of
CPC), I.A. 5807/2022 (O-XXVI R-9 of CPC), I.A. 5808/2022 (O-
XI R-1 (6) as amended by the Commercial Court Act), I.A.
5809/2022 (for directions)

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG &
ANR. ..... Plaintiffs
Through: Mr. Ashok Aggarwal, Sr. Advocate
with Dr. Sanjay Kumar, Ms. Arpita
Sawhney, Mr. Arun Kumar Jana,
Ms. Meenal Khurana, Mr. Harshit
Dixit and Mr. Priyansh Sharma,
Advocates.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 2 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

versus

MICRO LABS LIMITED ..... Defendant
Through: Mr. G. Nataraj, Mr. Ankur Vyas,
Mr. Shashi Kant Yadav, Ms. Garima
Joshi, Ms. Harshita Agarwal,
Mr.Avinash K.Sharma,
Mr.R.Abhishek and Mr. Rahul
Bhujbal, Advocates.

+ CS(COMM) 238/2022 & I.A. 5811/2022 (O-XXXIX R-1 & 2 of
CPC), I.A. 5812/2022 (O-XXVI R-9 of CPC), I.A. 5813/2022 (O-
XI R-1 (6) as amended by the Commercial Court Act), I.A.
5814/2022 (for directions)

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG &
ANR. ..... Plaintiffs
Through: Mr. Ashok Aggarwal, Sr. Advocate
with Dr. Sanjay Kumar, Ms. Arpita
Sawhney, Mr. Arun Kumar Jana,
Ms. Meenal Khurana, Mr. Harshit
Dixit and Mr. Priyansh Sharma,
Advocates.
versus

NATCO PHARMA LIMITED & ANR. ..... Defendants
Through: Mr. J. Sai Deepak, Mr. G. Nataraj,
Mr. Ankur Vyas, Mr. Shashi Kant
Yadav, Ms. Garima Joshi,
Ms. Harshita Agarwal, Mr.Avinash
K.Sharma, Mr.R.Abhishek and Mr.
Rahul Bhujbal, Advocates.

+ CS(COMM) 296/2022 & I.A. 7109/2022 (O-XXXIX R-1 & 2 of
CPC), I.A. 7110/2022 (O-XXVI R-9 of CPC), I.A. 7111/2022 (O-
XI R-1 (6) as amended by the Commercial Court Act), 7112/2022
(for directions), I.A. 11729/2022 (u/S 151 CPC)

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 3 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

BOEHRINGER INGELHEIM PHARMA GMBH AND CO. KG &
ANR. ..... Plaintiffs
Through: Dr. Sanjay Kumar, Ms. Arpita
Sawhney, Mr. Arun Kumar Jana,
Ms. Meenal Khurana, Mr. Harshit
Dixit and Mr. Priyansh Sharma,
Advocates.

versus

MANKIND PHARMA LIMITED ..... Defendant
Through: Ms. Bitika Sharma, Ms. Nitya
Sharma, Ms. Vrinda Pathak and
Mr. George Vithayathil, Advocates.
CORAM:
HON'BLE MR. JUSTICE AMIT BANSAL

JUDGMENT

AMIT BANSAL, J.

I.A. 6797/2019 (O-XXXIX R-1 & 2 of CPC) in CS(COMM)239/2019
I.A. 6802/2019 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 240/2019
I.A. 5801/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 236/2022
I.A. 5806/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 237/2022
I.A. 5811/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 238/2022
I.A. 7109/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 296/2022

1. The present six suits have been filed on behalf of the plaintiff no.1,
Boehringer Ingelheim Pharma Gmbh And Co. Kg and its group company,
plaintiff no.2, Boehringer Ingelheim (India) Pvt. Ltd, against various
defendants, who are Indian Pharmaceutical Companies, seeking permanent
injunction restraining the defendants from infringing Indian Patent No. IN
243301 titled ―8 - (3 AMINOPIPERIDIN–1–YL)-XANTHINE
COMPOUNDS‖. All the aforesaid six suits were accompanied by
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 4 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

applications for grant of interim injunction under Order XXXIX Rules 1 and
2 of Code of Civil Procedure, 1908 (CPC).
Proceedings in the suits
2. Summons in CS(COMM) 239/2019 and CS(COMM) 240/2019 were
th
issued on 10 May, 2019 and an ad interim injunction was granted in favour
of the plaintiffs restraining the defendants from manufacturing
LINAGLIPTIN tablets and the said interim order has continued till date.
3. Summons in CS(COMM) 236/2022, CS(COMM)237/2022 and
th
CS(COMM) 238/2022 were issued on 19 April, 2022 and the following
interim/ pro tem arrangement was arrived at between the parties and the said
arrangement has continued till date:
“15. After some hearing, learned Senior Counsel
appearing on behalf of the Plaintiffs and learned
counsels appearing on behalf of the Defendants, on
instructions, agree that, as a pro-tem arrangement
between the parties, Defendants shall not
manufacture, sell, offer for sale and/or use
LINAGLIPTIN or LINAGLIPTIN tablets, or any
other pharmaceutical preparations or formulations
containing LINAGLIPTIN as the active
pharmaceutical ingredient, till the next date of
hearing.

16. It is further agreed that Defendants shall be at
liberty to sell the existing stock, already manufactured
and the Defendants shall disclose the existing stocks
and packaging, which they have already manufactured
along with details of batch numbers, dates of
manufacturing as well as the value of the stock, within
a period of one week from today, on an affidavit.
17. It is made clear that this is purely a pro-tem
arrangement between the parties for expeditious
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 5 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

disposal of the applications and will not be treated as a
precedent in any other case.”
4. Similar interim/ pro tem arrangement was arrived at between the
parties in CS(COMM) 296/2022.
5. Since the issues involved in all the aforesaid suits and applications for
grant of interim injunction are broadly similar, they are being decided by
th
way of this common judgment. As noted in the order dated 4 January,
2023, it was agreed between the parties that CS COMM (236/2022) shall be
taken as the lead matter. Accordingly, for the sake of convenience, detailed
facts of CS(COMM) 236/2022 have been recorded in the judgment.
However, submissions on behalf of the counsels in all the aforesaid suits
have been noted.
th
6. Submissions were heard on behalf of the counsels on 4 January,
th th th th
2023, 5 January, 2023, 9 January, 2023, 11 January, 2023, 18 January,
th th
2023 and 27 January, 2023 and the judgment was reserved on 27 January,
2023. Counsels for the parties have also placed on record various written
submissions along with judgments relied by them.
Factual Background
7. Case set up by the plaintiffs in CS(COMM)236/2022 has been
summarised below.
7.1 The plaintiff no.1 is engaged in the business of developing,
manufacturing and marketing pharmaceuticals in India through the plaintiff
no.2.
7.2 The plaintiff no. 1 was granted Patent IN 243301 (hereinafter also
th
referred to as ―suit patent‖ or ―IN‘301‖) on 5 October, 2010 under Section
43 of the Patents Act, 1970 (hereinafter ―Patents Act‖) for the invention
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 6 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

titled ―8- (3 AMINOPIPERIDIN–1–YL)-XANTHINE COMPOUNDS‖ for
th
a term of 20 years with effect from 18 August, 2003. The bibliographic
details of the suit patent are set out hereunder:

7.3 The medicinal products, ―Linagliptin Tablets‖ and ―Linagliptin +
Metformin Hydrochloride Tablets‖, covered by the suit patent were
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 7 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

launched in the Indian market under the brand name ―Trajenta/ Trajenta
Duo‖ in the years 2012 and 2014 respectively.
7.4 The plaintiff no. 2 obtained the requisite permission of the Drugs
Controller General of India (hereinafter referred to as ―DCGI‖) to import
and market ―Linagliptin Tablets‖ and ―FDC of Linagliptin + Metformin
Hydrochloride Tablets".
7.5 Linagliptin is an International Non-Proprietary Name (INN) of the
product covered by the suit patent. WHO document ―Recommended INN:
List 61‖, WHO Drug Information, Vol. 23 No. 1 (2009), 49-83 indicates the
name Linagliptin, along with its chemical structure and chemical name,
which is reproduced below:

7.6 No third party filed any pre-grant or post-grant opposition against the
suit patent.
7.7 Earlier, an Indian Patent No. 227719 (hereinafter referred to as IN
‗719) titled ―XANTHINE COMPOUNDS‖ was granted to the plaintiff no. 1
for the Markush formula being the ―genus‖ patent and its term expired on
st
21 February, 2022. The bibliographic details of the genus patent are set out
hereunder:

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 8 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

7.8 The suit patent is the ―species/selection patent‖ covering the specific
commercial embodiments being marketed by the plaintiff no. 2 in India. The
compound, Linagliptin, covered and claimed by the suit patent was invented
upon further research, which was carried out subsequent to the filing date of
IN ‗719 and before the earliest priority date of the suit patent.
7.9 The defendants are engaged in manufacturing and selling the product,
Linagliptin 5mg tablets (hereinafter ‗infringing product‘), covered by the
suit patent. Therefore, the infringing product contains ―Linagliptin‖ and
infringes the suit patent.
7.10 Accordingly, the present suit has been filed on behalf of the plaintiffs
seeking relief of permanent injunction along with other ancillary reliefs.
Case set up in the written statement
8. The case set up by the defendants in their written statement filed in
CS(COMM)236/2022 is summarised below.
8.1 The compound Linagliptin and its formulations were claimed in IN
st
‗719, the genus patent. The prior patent IN ‗719 expired on 21 February,
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 9 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

2022 and thus, the compound Linagliptin has fallen into public domain
nd
w.e.f. 22 February, 2022.
8.2 Under the Patents Act, there can only be one patent for one invention.
Therefore, the plaintiffs cannot have two patents for the same invention.
8.3 The plaintiffs are attempting to extend their monopoly over Linagliptin
beyond original 20-years term, by a further period of 1.5 years
(approximately) through a second subsequent patent, i.e., the suit
patent/species patent, which is legally untenable and impermissible under
Section 53(4) and Section 46(2) of the Patents Act, and amounts to double
patenting and evergreening.
8.3 It has been admitted on behalf of the plaintiffs in various proceedings
before Courts in India and abroad that the compound Linagliptin is protected
and covered by IN ‗719. The plaintiffs now cannot reprobate on the said
admission and assert that Linagliptin is 'specifically claimed‘ only in the suit
patent.
8.5 The plaintiffs have falsely pleaded that Linagliptin was never claimed
in IN '719 in paragraph 15 of the plaint in CS(COMM) 236/2022. The
plaintiffs have admitted before the Indian Patent Office that Linagliptin is a
part of the inventive step of earlier IN '719 patent and for the grant of the
said patent, also included Linagliptin in the list of 371 examples filed as a
part of the reply to the FER to show alleged enhancement in efficacy.
8.6 The plaintiffs have suppressed documents that are material to the

present dispute, including complete specification along with claims granted
in respect of earlier IN '719 patent; FER issued by the Indian Patent Office
qua IN '719 patent; and reply to the said FER filed by the plaintiffs.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 10 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

8.7 Linagliptin is the only commercial product for both IN' 719 patent and
the subsequent IN '301 patent, which is evident from the identical Form 27s
filed by the plaintiffs for both IN '719 patent and IN ‗301.
8.8 The suit patent, i.e., IN ‗301 is invalid and liable to be revoked under
various provisions of Section 64 the Patents Act. The defendants have also
filed a counter claim seeking revocation of the suit patent.
8.9 In terms of Section 13 (4) of the Patents Act, the grant of the subject
patent by the Indian Patent Office does not warrant its validity or render
presumption of validity of the same. Thus, the validity of the subject patent
can be challenged at any stage including by way of counter claim in the
instant infringement action.
8.10 The factum of plaintiffs instituting legal proceedings against various
third parties, prior to the expiry of the genus patent IN '719 with respect to
Linagliptin and asserting infringement of the genus patent IN '719 qua
Linagliptin and its formulations, in itself amounts to an admission on part of
the plaintiffs that the compound/ molecule Linagliptin and its formulations
were ―protected‖ by and ―claimed‖ in IN '719.
8.11 The plaintiff no.1 filed a patent infringement complaint before the
Canadian Federal Court asserting both the Canadian patents bearing no. CA
2435730 (equivalent to IN '719) and CA 2496249 (equivalent to IN '301),
seeking to restrain a third party, Sandoz, from dealing directly or indirectly
with Linagliptin.
nd
8.12 The defendants have started commercializing Linagliptin from 22
February, 2022, when the same has fallen into public domain. Thus, the
defendants have not indulged in any infringing activity and have not violated
rights of the plaintiffs envisaged under Section 48 of the Patents Act.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 11 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Submissions on behalf of the plaintiffs
9. Counsels appearing for the plaintiffs have made the following
submissions:
I. The suit patent has been successfully enforced by the plaintiffs against
various generic entities across the country. Reliance in this regard is
nd
placed on the judgment dated 2 June, 2022 passed by the Himachal
Pradesh High Court in OMP No. 85/2022 titled Boehringer Ingelheim
Pharma GMBH & CO. v. MSN Laboratories Private Limited .
II. The suit patent is an old patent, which is in its final year and has
worked since 2012, without any successful challenge worldwide,
including India. In fact, proceedings challenging the validity of the
suit patent were instituted in China, which were dismissed and the suit
patent was upheld. Reliance is placed on the judgment of this Court in
National Research Development Corp of India v. Delhi Cloth &
General Mills, (1979 SCC OnLine Del 206) to contend that if the
patent is sufficiently old and has been worked, a mere challenge is not
sufficient. The Court in such cases for the purpose of temporary
injunction ought to presume the patent to be valid.
III. None of the defendants have either filed a pre-grant or a post-grant
opposition in respect of the suit patent. Further, the revocation
petitions have been filed by some of the defendants only at a belated
stage.
IV. The defendants have admitted that they are manufacturing and selling
the product, Linagliptin, and other formulations of the same.
Admittedly, the defendants have not applied for a voluntary or a
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 12 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

compulsory licence from the plaintiffs. The aforesaid act of the
defendants amounts to violation of the rights of the plaintiffs under
Section 48 of the Act.
V. Once a patent is granted, the onus to make out a credible challenge to
its validity would rest squarely on the party challenging it by placing
on record cogent material. Reliance in this regard is placed on the
judgment of this Court in FMC Corporation & Anr. v. Best Crop
Science LLP & Anr. / NATCO Pharma Limited , (2021) 87 PTC 217 .
VI. The defendants have failed to raise a credible challenge to the suit
patent. Only bald allegations have been made in the pleadings with
regard to the validity of the suit patent.
VII. The defendants have relied upon various statements made by the
st
plaintiffs that are subsequent to the priority date of suit patent, i.e, 21
August 2002. No reliance can be placed on the same as they fall into
the category of hindsight analysis and ex-post facto cherry picking.

VIII. The genus patent IN ‗719 is not a prior art as the same was published
th
on 6 September 2002 after the priority date of suit patent IN ‗301,
st
i.e., 21 August 2002. Therefore, a person skilled in the art would not
have access to IN ‗719 as on the priority date of IN ‗301.
IX. For the purpose of determining anticipation by prior claiming, the
granted claims of the two patents have to be compared and not the
descriptions of the inventions disclosed in the two patents. Only when
the claim granted in the second patent is identical to the claim granted
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 13 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

in the first patent, the doctrine of prior claiming in terms of Section
13(1)(b) of the Act shall apply.
X. A comparison of claim 1 in IN ‗719 and claim 1 in IN ‗301 would
show that Linagliptin per se is neither disclosed, nor claimed in the
genus patent, IN ‗719. Therefore, no reliance can be placed on the
Form 27s filed on behalf of the plaintiffs.
XI. The judgment in AstraZeneca AB & Anr. v. Intas Pharmaceuticals
Ltd. , MANU/DE/1939/2020 , is not applicable to the facts of the
present case as unlike the said case, in the present case, there are two
independent inventions claimed under the two patents, IN ‗719 and IN
‗301.
XII. The Coordinate Bench of this Court in Novartis AG & Anr. v . Natco
Pharma Limited , 2021 SCC Online Del 5340 , has observed that the
judgment of the Supreme Court in Novartis v . Union of India , (2013)
6 SCC 1 , was purely based on the facts of that particular case. The
AstraZeneca (supra) has also been distinguished by the judgment of
the Himachal Pradesh High Court in MSN Laboratories (supra).
XIII. Reliance placed by the defendants on the judgment of the Supreme
Court in Novartis (supra) is misplaced as the said judgment deals with
the issue of patentability of the invention claimed by Novartis in terms
of Section 3(d) of the Act. Therefore, the scope of the proceedings
before the Supreme Court was entirely different as compared to the
present suit. The judgment in Novartis (supra) did not hold that there
was no distinction between the ―coverage‖ and ―disclosure‖. It held
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 14 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

that a ‗a wide gap‘ should not exist between the ―coverage‖ and
―disclosure‖ under the Indian Patent law.
XIV. Merely because one product encompasses working of both species
and genus patent does not ipso facto disclose that the species patent is
covered by the genus patent or that it is previously claimed in the
genus patent. There is no legal basis for the defendants‘ submission
that Form 27 disclosures are any admission of invalidity of species
patent. Reliance in this regard is placed on the judgment of this Court
in Novartis v . Natco (supra).
XV. The fact that 371 compounds were submitted by the plaintiffs before
the Patent Office, does not advance the case of the defendants as the
filing date of IN ‗301 was before the filing date of the said
submission.
XVI. In the written statement filed on behalf of the defendants in
CS(COMM) 239/2019 and CS(COMM) 240/2019, the defendants
therein have specifically pleaded that Linagliptin is not covered by the
genus patent, IN ‗719.
Submissions on behalf of the defendants
A. Submissions on behalf of defendants in CS(COMM) 236/2022
I. Merely because the suit patent, IN ‗301 is an old patent does not mean
that there cannot be any challenge to its validity. Section 13(4) of the
Act does not make any such distinction between old or a new patent.
The Patents Act, unlike the Trademark Act, 1999, does not have a
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 15 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

provision similar to Section 31 of the Trademarks Act, 1999, where
registration is prima facie evidence of validity of a trademark.
II. Linagliptin is the only commercial product for both IN ‗719 and IN
‗301 patents as evidenced from the working statements under Form
27s filed on behalf of the plaintiffs.
III. The plaintiffs have taken benefits based on the assertions that
Linagliptin is claimed and covered in IN ‗719 and therefore, now the
plaintiffs cannot assert to the contrary that Linagliptin was not
specifically claimed in IN ‗719. The plaintiffs cannot be permitted to
approbate or reprobate at the same time.
IV. Annexure B to the affidavit filed on behalf of the co-inventor is dated
st st
21 December, 2021, which is much after the priority date, 21
August, 2002, of the suit patent, IN ‗301. Therefore, no reliance can
be placed on the said affidavit.
V. The defendants have also filed an affidavit of an expert in support of
their submission that Linagliptin was covered and claimed in IN ‗719.
VI. Both IN ‗719 patent and IN ‗301 patent contain genus/Markush
claims. Claim 1 of IN ‗301 is itself a genus of compounds covering 22
alternatives.
VII. All the members of a Markush patents are entitled to protection once
the patent is granted. Therefore, the molecule Linagliptin was claimed
and protected under IN ‗719 and which is sought to be claimed and
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 16 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

protected in IN ‗301, which amounts to re-monopolisation and is not
permissible under the Patents Act.
VIII. Linagliptin is one of the 22 alternatives in claim 1 of IN ‗301 as also
one of the 7 compounds listed in claims 5, 6 and 7 of IN ‗301.
Linagliptin is also one of the alternatives in claim 1 as well as claim 3
of the earlier IN ‗719 patent.
IX. Reference to ‗claims‘ in Section 64(1)(a) of the Patents Act has to be
read with Section 10(4)(c) of the Patents Act, which refers to ‗claims‘
as ‗defining the scope of the invention for which the protection is
claimed‘. Therefore, what has to be examined is whether the later
patent, IN ‗301, protects what is already protected in the earlier patent,
IN ‗719.
X. The plaintiffs have already enjoyed a twenty-year monopoly on
Linagliptin under IN ‗719 patent and the defendants have waited for
the expiry of the aforesaid twenty-year monopoly before launching
their product in the market.
XI. The plaintiffs can be compensated by way of monetary damages that
are quantifiable in nature. In the present case, the plaintiffs have
licensed the suit patent and therefore, monetary damages can be
calculated in respect of the same.
XII. The plaintiffs import their products in India, while the defendants
manufacture their products in India.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 17 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

XIII. The product is a daily-use drug and there is a huge differential in the
price of the drug of the plaintiffs and the one manufactured by the
defendants. Therefore, public interest would be in favour of increased
access to the more affordable version of Linagliptin, which is
marketed by the defendants.
XIV. Reliance is placed on the Judgment passed by Rajiv Shakdher, J. in
AstraZeneca (supra) and the judgment passed by the Division Bench
of this Court in AstraZeneca AB & Anr. v. Intas Pharmaceuticals
Ltd. , (2021) 87 PTC 374 (DB) , upholding the aforesaid judgment.
The dispute in the present suits is fully covered by the aforesaid
judgments.
XV. The judgment in FMC (supra) was prior to the judgment of the
Division Bench in AstraZeneca (supra) and was specifically cited
before the Division Bench. Further, the judgment in FMC (supra) did
not refer to the earlier judgment of Rajiv Shakdher, J. in AstraZeneca
(supra)
XVI. Barring the judgment passed by the Himachal Pradesh High Court in
MSN Laboratories (supra), all other orders concerning the suit patent
do not address the issue of vulnerability of the suit patent. The
Himachal Pradesh High Court in MSN Laboratories (supra) cites the
judgment passed by the Division Bench in AstraZeneca (supra), but
does not examine or apply the same to the facts of the said case.
B. Submissions on behalf of the defendants in CS(COMM) 237/2022
and CS(COMM) 238/2022
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 18 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

I. Provisions of Section 64(1)(a) and Section 3(d) of the Patents Act are
unique to the patent law in India. In fact, similar provisions existed in
the UK Patent Act till 1977, when the UK Act was amended and the
aforesaid provision was deleted. Therefore, even if patents are granted in
favour of the plaintiffs worldwide, it would not alter the position in
India.
II. Section 53(4) of the Patents Act only uses the word ―covered‖.
Therefore, the only determination that is required to be made is whether
Linagliptin has been ―covered‖ under the earlier patent. All other
references in the Patents Act, i.e., Section 52(1) and Section 100(4) also
use the term ―covered‖. Therefore, even if the plaintiffs claim that
Linagliptin has not been disclosed in the genus patent, the position
would not change so long as it has been covered and claimed.
III. There is no merit in the submission of the plaintiffs that the defendants
have filed revocation petition belatedly. A person would file revocation
petition only when there are commercial reasons to do so and in the
present case, the defendants launched their product only in February,
2022. Immediately after receiving the cease and desist notice from the
plaintiffs in December, 2021, the defendants filed the revocation
petition.
IV. The judgment of Himachal Pradesh High Court in MSN Laboratories
(supra) is erroneous both in facts and in law. The aforesaid judgment has
placed reliance on the terms ―covered‖ and ―encompassed‖, when in fact
the word used in Section 10(4) of the Patents Act is ―claimed‖. In
paragraph 28 of the said judgment, the finding is on the wrong facts as
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 19 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

the patent application referred therein refers to IN ‗719 and not the suit
patent.
V. In terms of Section 64(1)(a) of the Patents Act, the only requirement that
has to be seen is whether the suit patent has been claimed in the earlier
patent. Admittedly, Linagliptin has been claimed in IN ‗719 as is evident
from the admission made by the plaintiffs in various litigations in India
and abroad and in terms of the regulatory filings made by the plaintiffs
in India.

VI. The suit patent is liable to be revoked under Section 64(1)(f) of the
Patents Act, as the invention under the suit patent is obvious and lacks
inventive step in view of the genus patent, IN ‗719 having an earlier
priority date.
VII. The suit patent is also liable to be revoked under Section 64(1)(m) of the
Patents Act as the plaintiffs have failed to disclose to the Patent Office
information required under Section 8 of the Patents Act.
VIII. The suit patent is not patentable in terms of Section 64(1)(d) and Section
64(1)(k) of the Patents Act. The absence of disclosure or any assertion in
IN ‗301 that the compounds of claim 1 have any significant
enhancement of therapeutic efficacy over IN ‗719 shows its invalidity
due to Section 3(d) of the Patents Act.

C. Submissions on behalf of the defendants in CS(COMM) 239/2019 and
CS(COMM) 240/2019
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 20 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

th
I. The ad interim order dated 10 May, 2019 passed in the aforesaid suits
was based on the submission of the plaintiffs that Linagliptin in all forms
and combinations is ―covered‖ by the two patents, IN ‗719 and IN ‗301.
II. The claims in IN ‗719 and IN ‗301 are identical claims and no claim for
Linagliptin 5mg as a product was made in any of the claims under both
the suit patents. What is claimed in the invention is not present in the
final product, i.e., Linagliptin 5mg. The invention has not been properly
described in either of the two suit patents and no skilled person can
decipher the invention from the claims. Therefore, the suit patents have
failed the test of patentability in terms of Section 2(1)(j), 2(1)(ja), Section
2(1)(ac) and Section 3(d) of the Patents Act.
III. The plaintiffs have failed to show the increase in potency, efficiency and
viability in respect of the Claims in the suit patent, IN ‗301 in
comparison to the Claims in genus patent, IN ‗719.
10. Counsel for the defendants in CS(COMM) 296/2022 adopts the
submissions made on behalf of the defendants in the aforementioned suits and

the same are not repeated for the sake of brevity.
Findings and Analysis
11. I have heard the counsels for the parties and perused the record of the
suits.
12. Based on the submissions of the counsels, for the sake of clarity and
ease of reading, I have formulated the following issues which require
determination for the purposes of grant of interim injunction in favour of the
plaintiffs:
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 21 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

I. Whether in cases of old patents, the validity of the same has to be
presumed by the Court?
II. Whether the validity of the suit patent has to be presumed on
account of defendants not having filed pre-grant or post-grant
opposition to the suit patent or having filed revocation petition
belatedly?
III. Whether the defendants have laid a credible challenge to the suit
patent?
IV. Whether balance of convenience is in favour of the plaintiffs and
against the defendants for the grant of interim injunction?
13. To begin with, I would address the first two issues formulated above.
I. Whether in cases of old patents, the validity of the same has to be
presumed by the Court?
II. Whether the validity of the suit patent has to be presumed on
account of defendants not having filed pre-grant or post-grant opposition
to the suit patent or having filed revocation petition belatedly?
14. To decide these issues, a reference may be made to Section 13(4) of
the Patents Act:
“ 13. Search for anticipation by previous publication
and by prior claim.—

(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 examination or investigation
or any report or other proceedings consequent thereon.
xxx xxx xxx
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 22 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249


15. Section 13(4) of the Patents Act makes it abundantly clear that no
distinction has been made between the old and the new patents. It
specifically states that grant of patent would not, in any manner, warrant its
validity. The Patents Act does not have any provision similar to Section
1
31(1) of the Trademarks Act, 1999, wherein it is provided that the
registration of a trademark would be a prima facie evidence of its validity.
Therefore, under the scheme of the Patents Act, the grant of patent is not a
prima facie evidence of its validity.
16. In Bishwanath Prasad Radhey Shyam v. Hindustan Metal
Industries , AIR 1982 SC 1444 ¸ the Supreme Court has observed that
Section 13(4) of the Patents Act makes it clear that examination and
investigations required under Section 12 and Section 13 of the Patents Act
shall not be deemed to warrant the validity of the patent. Therefore, even
when the patent crosses the threshold of examination by the patent office,
the challenger can put the patent in jeopardy. The relevant portion of the
judgment is set out below:
― 32. It is noteworthy that the grant and sealing of the
patent, or the decision rendered by the Controller in
the case of opposition, does not guarantee the validity
of the patent, which can be challenged before the
High Court on various grounds in revocation or
infringement proceedings. It is pertinent to note that
this position viz. the validity of a patent is not
guaranteed by the grant, is now expressly provided in
Section 13(4) of the Patents Act. 1970. In the light of

1
31. Registration to be prima facie evidence of validity . — ( 1 ) In all legal proceedings relating
to a trade mark registered under this Act (including applications under section 57), the original
registration of the trade mark and of all subsequent assignments and transmissions of the trade
mark shall be prima facie evidence of the validity thereof.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 23 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

this principle, Mr Mehta's argument that there is a
presumption in favour of the validity of the patent,
cannot be accepted . ‖
17. The aforesaid aspect was dealt with in the judgment of Rajiv
Shakdher, J. in AstraZeneca (supra). In the said case also, an argument was
raised on behalf of the plaintiffs therein that since the suit patents are old,
their validity has to be presumed. Relying upon the judgment in Bishwanath
Prasad (supra), Rajiv Shakdher, J. in AstraZeneca (supra) came to the
conclusion that the challenge to the validity of the patent can be made at any
stage and what is relevant is not the stage when the challenge is made, but
the credibility of the challenge. Accordingly, the submission of the plaintiffs
therein that older the patent, stronger the firewall was rejected by Rajiv
Shakdher, J. by observing as under:
“18.3 Furthermore, the argument advanced on
behalf of the plaintiffs that since the suit patents are
old and thus, should be presumed to be valid cannot be
accepted for two reasons.

i. First , there is a period of overlap between the
genus patent i.e. IN 147 and the species patent i.e. IN
625. The defendants, in this case, chose to wait [in
line with arguments advanced in their defence of the
suit actions] till such time the validity period of the
genus patent i.e. IN 147 expired.


ii. Second, as indicated above, the scheme of the Act
does not foreclose the right of the defendants in
defence to an infringement action to question the
validity of the patent. Section 107 of the Act, expressly
confers a right on the defendants to raise, in defence,
in an infringement suit, all those grounds on which
the patent can be revoked under Section 64 of the
very same Act. Therefore, the judgement in Bristol-
Myers Squibb Company and Ors vs. J.D. Joshi and
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 24 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Ors., MANU/DE/1889/2015, if read in context, would
demonstrate that it has not emasculated the right of the
defendant, as conferred under the Act, to challenge the
validity of the patent. The presumption of validity
exists only till such time the patent is challenged - a
challenge which is credible and no further. In my
opinion, if the plaintiffs‘ argument was to be
accepted, then, it would have to be held that the older
the patent, the stronger the firewall. Such an
interpretation, in my view, would be contrary to the
plain words of the Statute .”
18. The aforesaid judgement of Rajiv Shakdher, J. was upheld by the
Division Bench of this Court in the judgment in AstraZeneca (supra).
19. The plaintiffs have relied on the judgment of National Research
(supra) to contend that for the purpose of deciding an application for
temporary injunction, the patent ought to be presumed to be valid. The
relevant extract of the said judgment is set out as under:
7. For the grant of temporary injunction, principles
applicable to the infringement of Patent actions are
that there is a prima facie case, that the patent is valid
and infringed, that the balance of convenience is in
favour of the injunction being granted and that the
plaintiff will suffer an irreparable loss. It is also a rule
of practice that if a patent is a new one, a mere
challenge at the Bar would be quite sufficient for a
refusal of a temporary injunction, but if the patent is
sufficiently old and has been worked, the court would,
for the purpose of temporary injunction, presume the
patent to be valid one. If the patent is more than six
years old and there has been actual user it would be
safe for the court to proceed upon this presumption.
Terrell on the Law of Patents Twelfth Edition in para
830 has observed as follows :
“Prima facie evidence of validity :
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 25 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

The plaintiff must first establish such facts as
will satisfy the court that there are strong
prima facie reasons for acting on the
supposition that the patent is valid. The most
cogent evidence for this purpose is either that
there has been a previous trial in which the
patent has been held to be valid, or that the
patentee has worked and enjoyed the patent
for many years without dispute, or it may be
that as between the parties the plaintiff is
relieved from the onus of establishing validity,
as where the defendant has admitted it or is so
placed in his relationship to the plaintiff as to
be estopped from denying it”.

20. The aforesaid judgment attempted to borrow a rule of practice
stemming from the English decision in Smith v. Grigg Ld., (1924) 41 RPC
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 26 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

149 , which is commonly referred to as the six-year rule. However, the
application of this rule in the context of Indian Patent Law has been doubted
in various decisions of this Court. In F. Hoffmann La Roch & Anr. v. Cipla
Limited ¸ 2008 SCC OnLine Del 382 , while commenting on the aforesaid
six-year rule, a Single Judge of this Court specifically held that the same has
to be a rule of caution and not a rule of practice.
21. In my considered view, the said six-year rule cannot be relied upon to
presume the validity of a patent granted in India. The said rule can be
explained as one cautioning the Courts that patent infringement actions
stand on a slightly different footing from other cases, where the Courts
should not automatically grant injunction on a prima facie satisfaction of
infringement, since patents can be challenged even in defence.
22. The Division Bench of this Court in F. Hoffmann- LA Roche
Limited v. Cipla Limited, ILR(2009)Supp.(2)Delhi 551, has considered this
the specific submission that a plaintiff is entitled to the grant of an
injunction, since the patent is granted after examination at several levels.
Negating this submission, it was held that even if a patent survives the pre-
grant and post-grant challenges, it can still be made vulnerable to revocation
on grounds different from the ones raised at those stages.
23. This view is also fortified by Section 113 of the Patents Act, which is
set out below:
“ 113. Certificate of validity of specification and costs
of subsequent suits for infringement thereof. —(1) If
in any proceedings before the Appellate Board or a
High Court for the revocation of a patent under section
64 and section 104, as the case may be, the validity of
any claim of a specification is contested and that claim
is found by the Appellate Board or the High Court to
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 27 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

be valid, the Appellate Board or the High Court may
certify that the validity of that claim was contested in
those proceedings and was upheld.

(2) Where any such certificate has been granted, then,
if in any subsequent suit before a court for
infringement of that claim of the patent or in any
subsequent proceeding for revocation of the patent in
so far as it relates to that claim, the patentee or other
person relying on the validity of the claim obtains a
final order or judgment in his favour, he shall be
entitled to an order for the payment of his full costs,
charges and expenses of and incidental to any such suit
or proceeding properly incurred so far as they concern
the claim in respect of which the certificate was
granted, unless the court trying the suit or proceeding
otherwise directs: Provided that the costs as specific in
this sub-section shall not be ordered when the party
disputing the validity of the claim satisfies the court
that he was not aware of the grant of the certificate
when he raised the dispute and withdrew forthwith
such defence when he became aware of such a
certificate .‖

24. A reading of Section 113 of the Patents Act demonstrates the intent of
the legislature that it is only when the validity of the claim is upheld by the
High Court in a revocation petition under Section 64 of the Patents Act, the
High Court would issue a certificate to the said effect. Based on the
aforesaid certificate, the patentee, in any subsequent suit for infringement
shall be entitled to an order for payment of full costs, charges and other
expenses. Therefore, under the scheme of the Act, no inference of validity
arises at the stage of grant of patent.
25. Axiomatically, it would not matter if the defendants had filed a pre-
grant or a post-grant opposition to the suit patent. A challenge can be laid
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 28 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

either at the stage when an application is moved for grant of a patent, after
its publication or after its grant, or even by seeking revocation or by way of
a counterclaim in an infringement suit. It cannot be gainsaid that a person is
expected to raise a challenge to the validity of the patent only when the need
arises for the same. In case of commercial entities such as the defendant
companies, the need to raise challenge would arise only on account of
commercial realities and necessities.
26. Most of the defendant companies in the present suits did not launch
their products till the expiry of the genus patent, IN ‗719, which expired on
st
21 February, 2022. When the defendants launched their products, the
plaintiffs asserted their rights over the suit patent and claimed that the
products of the defendants are covered by the suit patent. It was only at that
stage that the cause of action arose in favour of the defendants to challenge
the suit patent and soon thereafter, the revocation petitions have been filed
on behalf of various defendants. Therefore, I do not find any merit in the
submission of the plaintiffs that merely because the suit patents were old
patents and no challenge was raised to their validity, the same have to be
presumed as valid.
27. Now, I proceed to address the third issue flagged above.
III . Whether the defendants have laid a credible challenge to the suit
patent?

28. In F. Hoffmann (supra), the Division Bench of this Court laid down
the judicial standard, which ought to operate at the stage of granting interim
injunction and observed that, at the preliminary injunction stage, the
defendant is required to show that the patent is vulnerable and that the
challenge to the validity of the patent raises a serious substantial question
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 29 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

and a triable issue. The relevant observations of the Court are set out as
under:
53. The plea of the plaintiff that since there is a multi-
“
layered, multi-level examination of the opposition to
the grant of patent it should accorded the highest
weightage, is not entirely correct. The contention that
there is a heavy burden on the defendant to discharge
since it has to establish that it has a stronger prima
facie case of the plaintiff is contra indicated of the
decisions in the context of Section 13(4). Reference
may be made to the decisions in Biswanath Prasad
Radhey Shyam v. Hindustan Metal Industries
[1979]2SCR757; Standipack Pvt. Ltd. v. Oswal
Trading Co. Ltd. AIR2000Delhi23 ; Bilcare Ltd. v.
Amartara Pvt. Ltd. 2007 (34) PTC 419(Del); Surendra
Lal Mahendra v. Jain Glazers (1979) 11 SCC 511. In
Beecham Group Ltd. v. Bristol Laboratories Pty Ltd.
(1967) 118 CLR 618 and Australian Broadcasting
Corporation v. O'Neill (2006) 229 ALR 457 it was held
that the defendant alleging invalidity bears the onus of
establishing that there is "a serious question" to be
tried on that issue. In Hexal Australai Pty Ltd. v. Roche
Therapeutics Inc. 66 IPR 325 it was held that where
the validity of a patent is raised in interlocutory
proceedings, "the onus lies on the party asserting
invalidity to show that want of validity is a triable
question." In Abbot Laboratories v. Andrx
Pharmaceuticals Inc. decision dated 22nd June 2006 of
the U.S.Court of Appeals for the Federal Circuit 05-
1433 the Court of Appeals followed its earlier ruling in
Helifix Ltd. v. Blok-Lok Ltd. 208 F.3d 1339 where it
was held (at 1359):

In resisting a preliminary injunction,
however, one need not make out a case of
actual invalidity. Vulnerability is the issue at
the preliminary injunction stage, while
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 30 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

validity is the issue at trial. The showing of a
substantial question as to invalidity thus
requires less proof than the clear and
convincing showing necessary to establish
invalidity itself.
In Erico Int'll Corprn v. Vutec Corprn U.S.Court of
Appeals for the Federal Circuit 2007-1168 it was held
that the "defendant must put forth a substantial
question of invalidity to show that the claims at issue
are vulnerable.

54. In the present case, the grant of a patent to the
plaintiffs for Erlotinib Hydrochloride as a mixture of
Polymorphs A and B will not ipso facto entitle them to
an interim injunction if the defendant is able to satisfy
the court that there is a serious question to be tried as
to the validity of the patent. The use by the learned
Single Judge of the expressions ―strong credible
challenge‖, ―arguable case‖ or that the defendants
claim being not unfounded, cannot be termed as
vague and inconsistent since they convey the same
meaning in the context of the strength of the
defendant's challenge.

55. The question before this Court is when can it be
said that the defendant has raised a credible challenge
to the validity of a patent held by the plaintiff in an
infringement action? During the course of the
argument it was suggested by counsel that the
challenge had to be both strong and credible. Also, the
defendant resisting the grant of injunction by
challenging the validity of the patent is at this stage
required to show that the patent is ―vulnerable‖ and
that the challenge raises a ―serious substantial
question‖ and a triable issue. Without indulging in an
exercise in semantics, the Court when faced with a
prayer for grant of injunction and a corresponding
plea of the defendant challenging the validity of the
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 31 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

patent itself, must enquire whether the defendant has
raised a credible challenge. In other words, that would
in the context of pharmaceutical products, invite
scrutiny of the order granting patent in the light of
Section 3(d) and the grounds set out in Section 64 of
the Patents Act 1970. At this stage of course the Court
is not expected to examine the challenge in any great
detail and arrive at a definite finding on the question
of validity. That will have to await the trial. At the
present stage of considering the grant of an interim
injunction, the defendant has to show that the patent
that has been granted is vulnerable to challenge.
Consequently, this Court rejects the contentions of
the plaintiffs on this issue and affirms the impugned
judgment of the learned Single Judge .”

29. In light of the dicta of the aforesaid judgment, it has to be examined
by the Court at the preliminary injunction stage, whether the defendants
have raised a credible challenge to the validity of the suit patent. The
challenger is required to establish that the patent is prima facie vulnerable to
revocation. In the present batch of cases, the challenge to the validity of the
suit patent is primarily based on the following grounds:
i. The suit patent has been prior claimed by the plaintiffs in the genus patent
(IN ‗719)
ii. The plaintiffs are guilty of evergreening of the suit patent (IN ‗301).
30. At this stage, a reference may be made to the statutory provisions of
the Patents Act relating to the above, which are set out below.
―3. What are not inventions. —The following are not
inventions within the meaning of this Act —

(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
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 32 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

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;

xxx xxx xxx

7. Form of application .—(1) Every application for a
patent shall be for one invention only and shall be
made in the prescribed form and filed in the patent
office.

xxx xxx xxx

10. Contents of specifications.—

(1)..
(2)..
(3)..
(4) Every complete specification shall—

(a) fully and particularly describe the invention and its
operation or use and the method by which it is to be
performed;

(b) disclose the best method of performing the
invention which is known to the applicant and for
which he is entitled to claim protection; and

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 33 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

(c) end with a claim or claims defining the scope of
the invention for which protection is claimed ;

(d) be accompanied by an abstract to provide technical
information on the invention:

(5) The claim or claims of a complete specification
shall relate to a single invention, or to a group of
inventions linked so as to form a single inventive
concept , shall be clear and succinct and shall be fairly
based on the matter disclosed in the specification.

xxx xxx xxx

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.

xxx xxx xxx

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 34 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

48. Rights of patentees. —

Subject to the other provisions contained in this Act
and the conditions specified in section 47, a patent
granted under this Act shall confer upon the patentee—

(a) where the subject matter of the patent is a product,
the exclusive right to prevent third parties, who do not
have his consent, from the act of making, using,
offering for sale, selling or importing for those
purposes that product in India;

xxx xxx xxx

53. Term of patent.—

(1) Subject to the provisions of this Act, the term of
every patent granted, after the commencement of the
Patents (Amendment) Act, 2002, and the term of every
patent which has not expired and has not ceased to
have effect, on the date of such commencement, under
this Act, shall be twenty years from the date of filing
of the application for the patent .
(2)...
(3) [Omitted by the Patents (Amendment) Act, 2005]
4) Notwithstanding anything contained in any other
law for the time being in force, on cessation of the
patent right due to non-payment of renewal fee or on
expiry of the term of patent, the subject matter
covered by the said patent shall not be entitled to any
protection.

xxx xxx xxx

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
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 35 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

petition of any person interested or of the Central
Government by the Appellate Board or on a counter-
claim 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 ;
(b) ..

(c) ..
(d) that the subject of any claim of the complete
specification is not an invention within the meaning of
this Act;
(e)..
(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:
(k) that the subject of any claim of the complete
specification is not patentable under this Act;
(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;

31. Section 7(1) of the Patents Act makes it abundantly clear that a patent
application can be filed only in respect of one invention. This position is
fortified by Section 10(5) of the Patents Act, which states that all the claims
of a complete specification shall relate to one single invention or a group of
inventions that are linked in a manner to form a single inventive concept.
Sub-section (4) of Section 10 provides the ingredients of a complete
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 36 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

specification, which include complete description of the invention and the
disclosure about the best method of performing the said invention, of which
the claimant seeks protection, followed by the claims for which the
protection is claimed, so that the protection is granted in terms of Section 48
of the Patents Act only in respect of what is sought for in the claims.
2
32. In order for a patent to be revoked under Section 64(1)(a) of the
Patents Act, the following factors have to be established:
i. The prior patent has to be the one granted in India.

ii. The said prior patent has to have an earlier priority date than the latter
patent application.
iii. The invention claimed in the latter patent was also claimed in the
earlier patent application.
iv. The date of publication of prior patent is irrelevant.
33. In the present case, it is undisputed that the genus patent, IN ‗719, is
an Indian patent having an earlier priority date than the species patent, IN
‗301. Therefore, what has to be examined is whether what has been claimed
in the species patent, has been claimed in the genus patent. The fact that in
the present case, the publication date of the genus patent was after the
priority date of the species patent, would not be relevant.
Comparison of suit patent and genus patent
34. A comparison of the similarities in Claims of both the genus patent as
well as the suit patent is set out below:

2
Section 64(1)(a) of the Patents Act was taken from a similar provision that existed in the UK Patents Act,

1949. However, the said provision was repealed from the aforesaid U.K. Act in 1977. Section 64(1)(a)
relating to prior claiming continues to exist in the Indian Patents Act. Therefore, as on date, Section
64(1)(a) is unique to the patent law in India.

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 37 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

35. The comparison above would show that substantial part of the
chemical structure in the Claim 1 of the suit patent and the genus patent are
structurally similar. Considering that the plaintiffs have themselves in the
proceedings before the Controller admitted that Linagliptin is one of the
possible substitutions of IN ‗719, it would leave no matter of doubt that both
the patents are attempting to cover the same subject matter as well. Clearly,
this would not be permissible under the Patents Act.
36. In addition to the proceedings before the Controller for the grant of
patent in India, the International Search Report (ISR) issued with respect to
the PCT publication of the suit patent by the International Search Authority,
the European Patent Office in this case, is of significant relevance (Page 618
of the documents filed on behalf of the plaintiffs along with their written
statement to the counter claim filed on behalf of the defendants in
CS(COMM) 236/2022) . The relevant snippets from the aforesaid ISR are
extracted as under:
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 38 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249



37. In the said ISR, the Examiner has highlighted the corresponding PCT
publication of the genus patent IN‘719, i.e., WO 02/068420 as a ‗P, X‘
reference. ‗P‘ references are not considered during the international phase.
However, they can be used for determination of novelty and inventive step
in regional/national procedures. Further, an ‗X‘ reference indicates that the
document is of particular relevance and the claimed invention cannot be
considered to be novel or involve an inventive step when the document is
taken alone.
38. In India, considering that prior claiming is a ground for revocation
under Section 64(1)(a) of the Patents Act, 1970, the ‗P, X‘ reference
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 39 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

document highlighted by the ISA is striking at the novelty and inventive step
of the suit patent. Therefore, there are indications of prior claiming not just
in the suit patent, but there were such indications even during the
International Phase of the prosecution of the suit patent.
39. In AstraZeneca (supra), the plaintiff, AstraZeneca, had a genus patent
th
(IN ‗147) in its favour, which had priority dates of 12 October, 1999 and
th
5 April, 2000. Subsequently, AstraZeneca also filed a species patent (IN
th
‗625) bearing 20 May, 2002 as its priority date. AstraZeneca asserted
infringement of their genus and species patents in various law suits in India
as well as abroad in respect of the compound, DAPA GLIFLOZIN
(hereinafter ‗DAPA‘). The Court was seized of the issue whether the DAPA
was covered and disclosed in both the aforesaid patents.
40. Two Coordinate Benches of this Court, Rajiv Shakdher, J. and Mukta
Gupta, J., delivered separate judgments refusing grant of interim injunction,
though on separate grounds. Relying upon the aforesaid provisions of the
Patents Act and the pleadings filed by AstraZeneca in the suits before this
Court and before the US District Court, Rajiv Shakdher, J., in his judgment,
observed that there was a definitive assertion that DAPA was covered in
both the genus and the species patents. Further, the fact that the plaintiffs
have filed an infringement suit for both the genus patent as well as the
species patent, leads to a prima facie view that DAPA has been claimed in
both the aforesaid patents. The relevant findings of Rajiv Shakdher, J are set
out below:
“22. In my view, the fact that the plaintiffs have
taken out an infringement action both for IN 147 and
IN 625 is a sufficient clue, at least at this juncture,
that DAPA is claimed in both suit patents. It seems
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 40 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

incongruous to me that a patent holder can take out
an infringement action for a patent and yet aver it is
not disclosed.

22.1 This is especially so as under our Act the
“complete specification” provision encapsulated in
various subclauses of subsection (4) of Section 10
require setting out by an applicant who seeks grant of
patent to fully and particularly describe the invention
and its operation or use and the method by which it is
performed, disclose the method of performing the
invention which is known to her/him and for which
she/he is entitled to claim protection and end with a
claim or claims defining the scope of the invention.
[See: Section 10(4)(a) to (c)] The applicant is also
required to provide an abstract of technical
information qua the subject invention. The claim or
claims forming part of complete specification inter
alia are required to be ―fairly based on the matter
disclosed in the specification ” [See: Section 10(5) of
the Act].

22.2 Therefore, in my view, the defendants‘
submission that IN 625 should be revoked on account
of prior claiming under the provisions of Section
64(1)(a) of the Act has substance, at least at this
stage .


22.3 What lends credence to this plea are the
provisions of Section 13 (1) (b) of the Act which
require the examiner to ascertain as to whether the
application referred to him for investigation under
Section 12 adverts to an invention which is anticipated
by a prior claim. Section 13 (1) (b), simply put, allows
an examiner to make use of an Indian patent
application or an Indian patent which, though
published, after the impugned patent bears a priority
date which is earlier than the impugned patent. The
fact that the said patent was published after the
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 41 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

impugned patent does not come in the way of the
investigation carried out by the examiner.

22.4 In the present case, the Indian genus patent
i.e. IN 147 bears the priority dates 12.10.1999 and
05.04.2000 whereas the Indian species patent i.e. IN
625 bears 20.05.2002 as its priority date. For the
purposes of Section 64(1)(a) this ingredient is
sufficient. Therefore, as long as the defendant can
establish that the inventions so far claimed in any
claim of the complete specification [in this case IN
625] was claimed in a valid claim of an earlier
priority date contained in the complete specification
of another patent [i.e. IN 147] – a ground for
revocation is made out. ”

41. Mukta Gupta, J., in her judgment in AstraZeneca AB v. Emcure
Pharmaceuticals Ltd. , 2020 SCC Online Del 101 , also did not grant interim
injunction in favour of AstraZeneca, though the grounds for not granting
injunction differed with the grounds taken by Rajiv Shakdher, J. Mukta
Gupta, J. in the aforesaid judgment observed that the defendants have laid a
credible challenge to the validity of the suit patent on the ground of
obviousness under Section 64(1)(f) of the Patents Act and on account of
non-compliance of Section 8(2) of the Patents Act.
42. Both the judgments of Rajiv Shakdher, J. as well as Mukta Gupta, J.
were taken in appeal by AstraZeneca. The Division Bench, of which I was a
part, dismissed the said appeals with costs of Rs. 5,00,000/- in favour of
each of the defendants. The Division Bench held that infringement of genus
patent, as claimed in the plaint, could arise only if DAPA was disclosed in
the genus patent. The relevant observations of the Division Bench are set out
below:
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 42 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

“18. Our doubts stemmed from, the
appellants/plaintiffs averring and pleading
manufacture and sale by the
respondent(s)/defendant(s) of DAPA to be in
infringement of two patents i.e. IN 147 and IN 625. It
was felt, that if DAPA was not disclosed and/or
known at the time of seeking patent IN 147 or US
equivalent thereof and was invented only
subsequently and patent thereof obtained in IN 625
or US equivalent thereof, there could be no
infringement by respondent(s)/defendant(s) of IN 147
by manufacturing and/or selling DAPA. Conversely,
once the appellants / plaintiffs claimed infringement
of IN 147 also, it necessarily followed that DAPA was
subject matter thereof and once it was the subject
matter thereof, how it could be the subject matter of
subsequent patent IN 625.



19. It was thus enquired from the counsel for the
appellants/plaintiffs, that if the patent IN 147 was/is
not of DAPA, how could the appellants/plaintiffs in the
suits from which these appeals arise, claim
infringement by the respondent(s)/defendant(s) of IN
147 also, by manufacturing DAPA. It was further
enquired, whether not from the factum of the
appellants/plaintiffs, in the suits from which these
appeals arise, having claimed infringement by the
respondent(s)/defendant(s) of both, IN 147 as well as
IN 625, the appellants/plaintiffs are deemed to have
admitted DAPA as the subject matter of both, IN 147
and IN 625.



20. We, at this stage, spell out the thought process
behind the aforesaid query.


21. In our opinion, with respect to one invention,
there can be only one patent. The appellants/plaintiffs
herein however, while claiming one invention only
i.e. DAPA, are claiming two patents with respect
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 43 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

thereto, with infringement of both, by the
respondent(s)/defendant(s). The same alone, in our
view, strikes at the very root of the claim of the
appellants/plaintiffs and disentitles the
appellants/plaintiffs from any interim relief. ”

43. With regard to the submission made on behalf of AstraZeneca that
DAPA is only covered and not disclosed in the genus patent and being
disclosed for the first time in the species patent, the Division Bench rejected
the aforesaid submission by observing as under:
“32. As far as the arguments of the counsel for the
appellants/plaintiffs, of DAPA being only covered and
not disclosed in IN 147 and being disclosed for the first
time in IN 625, and of DAPA being not obvious from
and capable of being anticipated from IN 147 are
concerned, we are also of the opinion that once the
appellants/plaintiffs, in the plaints in their suits
claimed the action of the respondent(s)/defendant(s)
of manufacturing medicines having DAPA as their
ingredient to be an infringement of both IN 147 and
IN 625, the appellants/plaintiffs are deemed to have
admitted DAPA to be the invention subject matter of
both, IN 147 and IN 625. Without DAPA being
disclosed in IN 147, there could be no patent with
respect to DAPA in IN 147 and which was being
infringed by the respondent(s)/defendant(s) by
manufacturing drugs/medicines with DAPA as
ingredient .

36. From the aforesaid provisions it follows, that from
IN 147 and/or US equivalent thereof, the invention as
described therein could be worked by anyone, save for
the exclusivity for the term thereof in favour of the
appellants/plaintiffs. However the claim of the
appellants/plaintiffs is, that DAPA was not disclosed
in the specifications of IN 147 but 80 other
compounds were disclosed. However if that were to be
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 44 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

the case, it being not the case of the
appellants/plaintiffs that the respondent(s)/
defendant(s) were manufacturing any of the said 80
compounds, the appellants/plaintiffs, for
manufacture by respondent(s)/defendant(s) of DAPA,
cannot claim infringement of IN 147 and could have
claimed infringement only of IN 625 in which DAPA
was disclosed .

37. The appellants/plaintiffs have also not
pleaded industrial application or sale of any product
subject matter of IN 147, other than DAPA… .”


44. The principles of law that emerge from the judgment of the Division
Bench are as follows:
i. Once a patentee claims infringement of an earlier genus patent in
respect of a product, it necessarily follows that the said product was
the subject matter of the earlier genus patent.
ii. Only one patent can be granted in respect of one inventive concept.
Therefore, a patentee cannot claim infringement of the two patents in
respect of the same inventive concept.
iii. The term of a patent is twenty years in terms of the Patents Act and it
cannot be granted successive protection by means of separate patents.
iv. The Indian law permits grant of a Markush patent. However, if one of
the combinations in the Markush patent includes the product in
question, it would form part of the inventive concept of the earlier
patent and cannot again be claimed as an inventive concept of a
subsequent patent.
v. The pleadings made on behalf of the plaintiff in the suit can be
considered by the Court to determine the stand of the plaintiff vis-à-
vis the genus patent and the species patent.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 45 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

45. The special leave petition filed by AstraZeneca against the aforesaid
th
judgment of the Division Bench, was dismissed vide order dated 19 July,
2022.
46. Now, I proceed to examine the facts in the present batch of cases in
light of legal principles laid down in the aforesaid judgments to see if a
credible challenge has been laid by the defendants to the suit patent.
47. At first, it may be relevant to refer to the pleadings of the plaintiffs in
CS(COMM) 239/2019 and CS(COMM) 240/2019. In both the aforesaid
suits, which were filed before the expiry of the genus patent, the plaintiffs
claimed infringement of both the genus (IN ‗719) and species patents (IN
‗301), by the defendants seeking to sell Linagliptin tablets or generic version
thereof. The relevant pleadings in the plaints filed on behalf of plaintiffs in
CS(COMM) 239/2019 and CS(COMM) 240/2019, which are identical, are
set out below:
“7. It is submitted that Plaintiff No. 1 was granted
subject patents on January 19, 2009 and October 5,
2010 under Section 43 of the Patents Act, 1970
(hereinafter referred to as ―the Patents Act‖) under
IN '719 and IN '301 for pharmaceutical products
entitled ―XANTHINE COMPOUNDS‖ and
―8-(3-AMINOPIPERIDIN-1-YL) - XANTHINE
COMPOUNDS‖ respectively as disclosed in its
applications for a term of 20 years. Copy of the Letters
Patents Documents (patent certificates) has been filed
as documents along with the patent specifications of
the subject patents as granted by the Patent Office-
which also has been filed as documents.

xxx xxx xxx

9. It is submitted that the medicinal product
" Linagliptin Tablet" and "Linagliptin + Metformin
Hydrochloride Tablets " covered by the subject patents
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 46 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

was introduced and launched in the Indian market
under the brand name "Trajenta/ Trajenta Duo" in
the year May 27, 2012 and January 21, 2014
respectively . The Plaintiffs have an active presence in
India since then.


10. Through the accompanying suit, the Plaintiffs
seek to enforce its subject patents and restrain the
Defendants from making, using, offering for sale,
selling, importing and/ or exporting the medicinal
product " Linagliptin Tablet" and/ or "Linagliptin +
Metformin Hydrochloride Tablets" covered by the
subject patents.


xxx xxx xxx

19. It is submitted that the aforesaid acts of the
Defendants, being inter alia, making, using, offering
for sale and selling, the product, including
Linagliptin/ Linagliptin Tablets covered by the
subject patents and manufacturing the said product,
are acts of infringement of Plaintiff No. l's exclusive
rights in the subject patents.

xxx xxx xxx

INFRINGEMENT ANALYSIS OF CLAIMS OF THE
PATENT IN IN „301
Therefore, Linagliptin as mentioned in the carton
of the infringing product is a compound claimed and
covered in Claim 1 of IN' 301.

The Tablets as mentioned therein contain "Linagliptin".

Therefore, Defendants' product, generic version of
Linagliptin Tablets, being manufactured by Defendant
No. 1, marketed by Defendant No. 2 and sold by
Defendant No. 3 fall Within the scope of Claim 1 of IN'
301 and accordingly, infringes it.

INFRINGEMENT ANALYSIS OF CLAIMS OF THE
PATENT IN IN „719
….. Therefore, Linagliptin as mentioned in the said
letter of the Office of the Joint Commissioner (Drugs),
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 47 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

carton of the infringing product is a compound claimed
and encompassed in Claim 1 of IN '719.

The Tablets as mentioned therein contain
"Linagliptin".

Therefore, Defendants' product, generic version of
Linagliptin Tablets, being manufactured by Defendant
No. 1, marketed by Defendant No. 2 and sold by
defendant No. 3 fall within the scope of Claim 1 of IN
'719 and accordingly, infringes it.”

48. Similar assertions as set out above in respect of Claim 1, have been
made with regard to Linagliptin falling within the scope of Claims 2, 3, 5, 6
and 7 of the genus patent. The same are not reproduced for the sake of
brevity.
49. Similar pleadings were also made by the plaintiffs in the suit filed
before Commercial Court, Ahmedabad, against Cadila Healthcare Limited,
and the same are not reproduced for the sake of brevity.
50. A perusal of the aforesaid extracts from the plaints would show that
repeated assertions have been made on behalf of the plaintiffs that
Linagliptin was ― covered ‖ by the subject patents. Admittedly, the subject
patents of CS(COMM)239/2019 and CS(COMM)240/2019 were both genus
and species patents. In fact, in paragraph 7 extracted above, it has been
averred that pharmaceutical products titled ‘XANTHINE COMPOUNDS‗
and ‖8-(3-AMINOPIPERIDIN-1-YL)-XANTHINE COMPOUNDS‖ have
been ― disclosed ‖ in the patent applications in respect of both the suit
patents. Further, it has been specifically averred in the aforesaid suits that
Linagliptin is a compound ―claimed‖ and ―encompassed‖ in the genus
patent, IN ‗719 and therefore, the plaintiffs claim infringement of both genus
and species patents. Hence, the submission made on behalf of the plaintiffs
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 48 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

that Linagliptin is not ―covered‖ or ―disclosed‖ in the genus patent is
erroneous on the face of it.
51. Based on the aforesaid averments in the plaints and the submission of
the plaintiffs that Linagliptin is ― covered ‖ both in genus and the species
th
patents, this Court passed an ad interim order dated 10 May, 2019 in
CS(COMM) 239/2019 and CS(COMM)240/2019. The relevant extracts of
the said order are set out below:
“11. The case of the Plaintiffs is that the Plaintiff No. 1
is the owner of the two granted patents. The first patent
IN 227719 is in respect of a large class of XANTHINE
COMPOUNDS. The said patent dates back to July,
2003. The second patent being IN 243301 dated
February 2005, is in respect of specific compounds.
The case of the Plaintiffs is that one of the compounds
which is covered by the said two patents is l-[(4-
methylquinazolin-2-yl]-3-methyl-7-(2-butyn-J-yl)-8-(3-
(S)-amino-piperidin-l-yl)-xanthine' as well as all its
derivatives including enantiomers, isomers and
pharmaceutically acceptable salts thereof The said
chemical compound was allotted the International
Non-proprietary Name (INN) - 'LINAGLIPTIN' by the
WHO. The Plaintiffs, thus, submit that the said two
granted patents cover LINAGLIPTIN in all forms,
including combinations thereof.


12. The Plaintiffs submit that recently they came
across the Defendants manufacturing
LINAGLIPTIN 5 mg tablets under the names
'UNIGLIP' and LINAMOND. These two products
are, in fact, completely covered by the patents which
are granted in favour of the Plaintiff and accordingly,
the Plaintiffs seek an injunction against manufacture
and sale of these products.

xxx xxx xxx
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 49 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249


19. LINAGLIPTIN, has the chemical formula l-[(4-methyl-
quinazolin-2-yl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(S)-amino-
piperidin-1 -yl)-xanthine. The INN name of this chemical
compound is LINAGLIPTIN. The said compound is
clearly covered by patent nos. IN 243301. IN 227719
relates to a Markush formula. While this court refrains
from giving any opinion as to the validity of either of the
Patents, the fact that they are old patents and there has
been no challenge to the same since 2003 and 2005,
does tilt the balance in favour of the Plaintiff…

21. Under these circumstances, the Defendants are
restrained from manufacturing LINAGLIPTIN or
LINAGLIPTIN tablets, or any other pharmaceutical
preparations or formulations containing
LINAGLIPTIN as the active pharmaceutical
ingredient till the next date. The Defendants shall,
however, disclose the existing stocks and packaging
which it had already manufactured. There shall,
however, be no restraint against the already
manufactured stock provided an affidavit is filed
disclosing the stock and value thereof to the Court
within a period of one week.”
52. A perusal of the aforesaid order shows that the same was passed on
the basis of the submissions of the plaintiffs that Linagliptin is ― covered ‖
under both the patents.
53. Now, a reference may be made to the statement of claims filed by the
plaintiffs in the Federal Court in Canada in the proceedings against another
drug manufacturing company, Sandoz.
“ A declaration pursuant to a 6(1) of the Parented
Medicines (Notice of Compliance) Regulations,
SOR/93-133 as amended ("NOC Regulations") that
the making, constructing, using and/or selling of
linagliptin tablets at a strength of 5 mg for oral
administration (the ―Sandoz Product) in accordance
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 50 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

with abbreviated new drug submission no 241601
(“ANDS”) filed with the Minister of Health by Sandoz
Canada Inc. Sandoz) for a Notice of Compliance
(“NOC”) for this drug, as referenced in Sandoz‟s letter
dated November 23, 2020, would infringe or induce
infringement of Canadian Patent Nos. 2,435,730
(―730 patent‖) , 2,496,249 (―249 patent),…, more
particularly:
 Claims 1-14, 16, 17, 19, 20, 22-26 of the 730 patent
(―730 Asserted Claims‖);
 Claims 1-17, 19-24, 26-29, 31-42 of the 249 patent
(―249 Asserted Claims‖);‖

54. Once again, a clear assertion has been made on behalf of the plaintiffs
that the selling of Linagliptin tablets by Sandoz would amount to
infringement of Canadian patent no. 730, which is equivalent to IN ‗719 and
the Canadian patent no. 249, which is equivalent to IN ‗301.
55. At this stage, a reference may be made to the Examination Report of
the Patent Office in respect of the genus patent application and the reply to
th
the said report. In the Examination Report of the Patent Office dated 6
September, 2007 in respect of IN ‗719, an objection was raised on behalf of
the Patent Office under Section 3(d) of the Act. In order to overcome the
th
aforesaid objection, a reply was filed on behalf of the plaintiffs on 6
September, 2008, wherein, to substantiate that the claimed compounds were
novel, the plaintiffs submitted a list of 371 compounds, one of which was
Linagliptin. Therefore, Linagliptin was specifically claimed by the plaintiffs
to obtain the grant of the genus patent. However, in the rejoinder filed on
behalf of the plaintiffs to I.A. 5806/2022, the plaintiffs make a complete U-
turn and state that Linagliptin has not been claimed in IN ‗719.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 51 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

56. Now, a reference may also be made to the Form 27s filed by the
plaintiffs before the Indian Patent Office. Form 27 is a statutory form
3
required to be filed by a patentee in terms of Section 146 of the Patents Act
4
read with Rule 131 of the Patent Rules, 2003. By way of the aforesaid
Form, a patentee has to provide periodical statements demonstrating that the
patented invention has commercially worked in India.
57. To illustrate, Form 27s filed in respect of the suit patent and the genus
patent for the year 2019 are set out below:
“ In the matter of Patent No. 243301 of 2003
The patentee(s) under Patent No. 243301 hereby furnish the
following statement regarding the working of the patented
invention referred to above on a commercial scale in India for the
year 2019:
(i)The patented invention:
( ✔ ) Worked ( ) Not worked [Tick ( ✔ ) mark the relevant box]
a) If not worked: reasons for not working and steps being
taken for working of the invention: NOT APPLICABLE

3
146. Power of Controller to call for information from patentees. —(1) The Controller may, at
any time during the continuance of the patent, by notice in writing, require a patentee or a licensee,
exclusive or otherwise, to furnish to him within two months from the date of such notice or within
such further time as the Controller may allow, such information or such periodical statements as to
the extent to which the patented invention has been commercially worked in India as may be
specified in the notice.

(2) Without prejudice to the provisions of sub-section (1), every patentee and every licensee (whether
exclusive or otherwise) shall furnish in such manner and form and at such intervals (not being less
than six months) as may be prescribed statements as to the extent to which the patented invention
has been worked on a commercial scale in India.

4
131. Form and manner in which statements required under section 146(2) to be furnished.—
Form and manner in which statements required under section 146(2) to be furnished
(1) The statements shall be furnished by every patentee and every licensee under subsection (2) of
section 146 in Form 27 which shall be duly verified by the patentee or the licensee or his authorised agent.
(2) The statements referred to in sub-rule (1) shall be furnished once in respect of every financial year,
starting from the financial year commencing immediately after the financial year in which the patent was
granted, and shall be furnished within six months from the expiry of each such financial year.
(3) The Controller may publish the information received by him under subsection (1) or subsection (2) of
section 146.

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 52 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249


b) If worked: quantum and value (in Rupees), of the patented
drug
(i) manufactured in India: NIL
(ii) imported from other countries. (give country wise
details): Details given as under:

Details given as under:
 Trajenta and Ondero - Imported from USA
 Trajenta Duo, Ondero Met, Glyxambi. Ajaduo - Imported from
Germany
 Trajenta Duo, Ondero Met - Imported from Greece

Volume is given in terms of strip of 10 tablets
xxx xxx xxx
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 53 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249


In the matter of Patent No. 227719 of 2002
The patentee(s) under Patent No. 227719 hereby furnish the following
statement regarding the working of the patented invention referred to
above on a commercial scale in India for the year 2019:

(i) The patented invention:
✔ ✔
( ) Worked ( ) Not worked [Tick ( ) mark the relevant box]
c) If not worked: reasons for not working and steps being
taken for working of the invention: NOT APPLICABLE


d) If worked: quantum and value (in Rupees), of the patented
drug
(iii) manufactured in India: NIL
(iv) imported from other countries. (give country wise
details): Details given as under:
 Trajenta and Ondero - Imported from USA
 Trajenta Duo, Ondero Met, Glyxambi. Ajaduo - Imported from
Germany
 Trajenta Duo, Ondero Met - Imported from Greece

Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 54 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Volume is given in terms of strip of 10 tablets.
(ii) the licences and sub-licences granted during the year:
Trajenta, Trajenta Duo and Glyxambi are marketed by Boehringer
Ingelheim India Private Limited and Ondero, Ondero Met and Ajaduo
are marketed by Lupin Limited.

(iii) state whether public requirement has been met
partly/adequately/to the fullest extent at reasonable price: YES, public
requirement has been met adequately at reasonable price.”

58. A perusal of the two Form 27s of the same period as extracted above,
would show that all the pharmaceutical products which the two patents
claim to be working in India, are exactly the same. In addition, the quantum
and value of import and sales of the said is also the same. Therefore, it is
evident that both IN ‗301 and IN ‗719 are directed towards the same
invention, which is not permissible as per Section 10 of the Act.
59. Senior counsel appearing on behalf of the plaintiffs submits that even
if there are ―mistakes‖ in the Form 27s filed on behalf of the plaintiffs, the
same cannot be a relevant factor for deciding the grant of interim injunction.
60. Frankly, I was quite amazed to note the aforesaid submission and I am
not sure if the aforesaid submission was made on instructions from the
plaintiffs. Such a statement, on the face of it, would amount to making a
submission that incorrect details have been provided by the plaintiffs in their
5
Form 27. Section 122 of the Patents Act provides for stiff consequences

5
122. Refusal or failure to supply information. —( 1) If any person refuses or fails to furnish— (a) to the
Central Government any information which he is required to furnish under sub-section (5) of section 100;
(b) to the Controller any information or statement which he is required to furnish by or under section 146,
he shall be punishable with fine which may extend to ten lakh rupees.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 55 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

including fine and/or imprisonment for providing false information in Form

27 under Section 146 of the Patents Act. Therefore, the aforesaid submission

is noted only to be rejected at the very outset.
61. In my considered view, the present batch of cases are squarely
covered by the judgment of Rajiv Shakdher, J. in AstraZeneca (supra) and
the judgment of the Division Bench in AstraZeneca (supra). The facts in the
present batch of cases are very similar to the facts in AstraZeneca (supra)
and the similarities can be summarized below:

i. Like in the case of AstraZeneca (supra), in the present matters also,
there is a batch of 9 suits. In some of the suits, genus and species patents
were asserted, while in the other suits only the species patent was
asserted as the genus patent had expired.
ii. Like in the case of AstraZeneca (supra), in the present case also, the
plaintiffs have asserted that Linagliptin was ‗claimed' in genus patent in
the infringement suits filed in India as well as abroad.
iii. In AstraZeneca (supra), an argument was taken that genus patent
covered DAPA but does not disclose the same. The same argument was
also taken in the present matters that the genus patent covers Linagliptin,
but does not disclose the same.
iv. Like in the case of AstraZeneca (supra), the genus patent in the present
matters also have Markush claims.

(2) If any person, being required to furnish any such information as is referred to in subsection (1),
furnishes information or statement which is false, and which he either knows or has reason to believe to be
false or does not believe to be true, he shall be punishable with imprisonment which may extend to six
months, or with fine, or with both .


Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 56 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

v. Like in the case of AstraZeneca (supra), the action for infringement of
the genus patent, has also been made in the foreign jurisdictions.
vi. Like in the case of AstraZeneca (supra), in the present matters also, the
drug in question are daily-use drugs used for treatment of Diabetes.
62. The plaintiffs have placed strong reliance on the judgement of C. Hari
Shankar, J. in Novartis v. Natco (supra). C. Hari Shankar, J. had
distinguished the judgment of the Division Bench in AstraZeneca (supra) on
the ground that the Division Bench judgment was confined to the facts of
that particular case. In view of the discussion above, I have come to the
conclusion that the facts of the present case are very similar to the facts in
AstraZeneca (supra). Therefore, the present batch of cases are squarely
covered by the judgment of the Division Bench in AstraZeneca (supra),
which is binding on me. Hence, the need is not felt to delve into the
judgment in Novartis v. Natco (supra). The judgment in Novartis AG v.
Natco Pharma Limited ¸ 2023 SCC Online Del 106, does not make any
reference to the judgment of the Division Bench in Astrazeneca (supra) and
the judgment in FMC (supra) was delivered prior to the judgment of the
Division Bench in AstraZeneca (supra).
Judgement of the Supreme Court in Novartis
63. In Novartis (supra), the Supreme Court was dealing with the issue
whether the therapeutic drug, beta crystalline form of Imatinib Mesylate,
qualifies as an invention under Section 2(1)(j) and Section 2(1)(ja) of the
Patents Act and whether the patent can be refused under Section 3(d) of the
Patents Act. Rejecting the submission of Novartis seeking to make a
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 57 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

distinction between coverage or claim in a patent and disclosure made
thereunder, the Supreme Court held as under:
“118. The submissions of Mr. Andhyarujina and Mr.
Subramanium are based on making a distinction
between the coverage or claim in a patent and the
disclosure made therein. The submissions on behalf of
the Appellant can be summed up by saying that the
boundary laid out by the claim for coverage is
permissible to be much wider than the
disclosure/enablement/teaching in a patent.

119. The dichotomy that is sought to be drawn
between coverage or claim on the one hand and
disclosure or enablement or teaching in a patent on the
other hand, seems to strike at the very root of the
rationale of the law of patent. Under the scheme of
patent, a monopoly is granted to a private individual in
exchange of the invention being made public so that, at
the end of the patent term, the invention may belong to
the people at large who may be benefited by it. To say
that the coverage in a patent might go much beyond
the disclosure thus seem to negate the fundamental
rule underlying the grant of patents.

xxx xxx xxx
156. However, before leaving Hogan and proceeding
further, we would like to say that in this country the
law of patent, after the introduction of product patent
for all kinds of substances in the patent regime, is in its
infancy. We certainly do not wish the law of patent in
this country to develop on lines where there may be a
vast gap between the coverage and the disclosure
under the patent; where the scope of the patent is
determined not on the intrinsic worth of the invention
but by the artful drafting of its claims by skillful
lawyers, and where patents are traded as a commodity
not for production and marketing of the patented
products but to search for someone who may be sued
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 58 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

for infringement of the patent. ”

Judgment of Himachal Pradesh High Court dated … in Boehringer v.
MSN Laboratories in OMP No. 85/2022

64. The plaintiffs have placed strong reliance on the abovementioned
judgement of a Single Judge of the Himachal Pradesh High Court, filed by
the plaintiffs against other defendants raising identical grounds as raised in
the present batch of cases. The principles laid down in the aforesaid
judgment with regard to the grant of injunction in a patent case as mentioned
in paragraph 23 of the said judgment are set out below:
“23. The principles which could be culled out on
the basis of various pronouncements which have been
made by the Courts while dealing with applications
filed under Order 39, Rules 1 and 2 of the Civil
Procedure Code in patents cases are as under-

“(i) The registration of a patent per se does not
entitle the plaintiffs to an injunction. The
certificate does not establish a conclusive right.


(ii) There is no presumption of validity of a
patent, which is evident from the reading of
Section 13(4) as well as Sections 64 and 107 of
the Patents Act.

(iii) The claimed invention has to be tested and
tried in the laboratory of Courts.

(iv) The Courts lean against monopolies. The
purpose of the legal regime in the area is to
ensure that the inventions should benefit the
public at large.

(v) The plaintiff is not entitled to an injunction
if the defendant raises a credible challenge to
the patent. Credible challenge means a serious
question to be tried. The defendant need not
make out a case of actual invalidity.
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 59 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Vulnerability is the issue at the preliminary
injunction stage whereas the validity is the issue
at trial. The showing of a substantial question as
to invalidity thus requires less proof than the
clear and convincing showing necessary to
establish invalidity itself.

(vi) At this stage, the Court is not expected to
examine the challenge in detail and arrive at a
definite finding on the question of validity of the
patent. That will have to await at the time of
trial. However, the Court has to be satisfied that
a substantial, tenable and credible challenge has
been made.

(vii) The plaintiff is not entitled to an injunction,
if the patent is recent, its validity has not been
established and there is a serious controversy
about the validity of the patent.”

65. Applying the aforesaid principles, the Single Judge of the Himachal
Pradesh High Court accepted the submission of the plaintiffs that Linagliptin
was ― claimed and covered ‖ only in IN ‗301, but was not ― claimed to be
covered ‖ in patent IN ‗719. Linagliptin was only ― claimed and
encompassed ‖ in IN ‗719.
66. Relying on the aforesaid observations, the plaintiffs submit that what
has been asserted in the pleadings is that Linagliptin was ―claimed‖ and
―encompassed‖ in the genus patent, IN ‗719. However, it has not been
averred that Linagliptin is ―covered‖ or ―disclosed‖ in the genus patent.
There is a difference between the word ―covered‖ and ―encompassed‖. The
word ―encompassed‖ cannot be taken to be equivalent of ―covered‖.
67. I do not find any merit in the aforesaid submission. As can be seen
from the paragraphs extracted from the plaints in CS(COMM)239/2019 and
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 60 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

CS(COMM)240/2019, repeated assertions have been made on behalf of the
plaintiffs that Linagliptin is ―covered‖ by both genus and species patent and
is also disclosed in both. In any case, the aforesaid submission is in the teeth
of the judgment of the Supreme Court in Novartis (supra), more particularly,
the paragraphs extracted above.
68. In the present case also, the plaintiffs are trying to make a distinction
between the words, ―claimed‖, ―covered‖, ―encompassed‖ and ―disclosed‖.
The words, ―covered‖ and ―encompassed‖ essentially mean the same thing
and the plaintiffs are only relying on semantics to make an artificial
distinction, which does not exist. When the product is specifically ―covered‖
in the claims of a patent, whether specific disclosure with regard to the same
has been made or not is immaterial. In fact, if the submissions of the
plaintiffs that Linagliptin has not been disclosed in the suit patent is to be
accepted, it would result in violation of the requirement of Section 10(4) of
the Patents Act that every complete specification of a patent must satisfy.
69. With the greatest respect, the aforesaid observations of Himachal
Pradesh High Court are at variance with the findings of the Supreme Court
in Novartis (supra) and the judgment of the Division Bench in AstraZeneca
(supra) . With due respect, I am not in agreement with the aforesaid view
taken by the Himachal Pradesh High Court.
70. The Himachal Pradesh High Court judgment extracts the Examination
th
Report dated 6 September, 2007 issued by the Patent Office to the
plaintiffs. Though, the judgement notes that the said Examination Report
pertains to IN ‗301, the counsels for both the sides are in agreement that the
Examination Report reproduced in the judgment pertains to IN ‗719.
th
Similarly, the judgment also reproduces the reply of the plaintiffs dated 13
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 61 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

June, 2008 to the aforesaid Examination Report. Once again, the counsels
for both sides agree that the response set out is also in relation to IN ‗719
and not IN ‗301.
71. Senior counsel appearing on behalf of the plaintiffs submits that this
is only a typographical error in the judgment and hence, the same may be
disregarded by this Court. On the other hand, the counsels for the defendants
submit that this is not a typographical error and had an important bearing on
the final outcome of the judgment.

72. The aforesaid Examination Report and the response by the plaintiffs
to the said Examination Report were relied by the Court to come to the
following conclusion:
“28. The fact that subsequently subject patent was
granted to the plaintiffs demonstrates that the Patents
Office was satisfied with the response so submitted to
its queries by the plaintiffs. That being the case, it
cannot be said that by highlighting these very facts or
the pleadings of plaint filed before the Delhi High
Court, the defendants could be said to have had laid
credible challenge to the subject patent so as to make it
vulnerable to deny interim relief to the plaintiffs at this
stage.”
73. The Single Judge has relied on the aforesaid Examination Report and
the response thereto by the plaintiffs to come to the conclusion that the
Patent Office was satisfied with the response, so as to grant the suit patent in
favour of the plaintiffs and also concluded that it cannot be said that the
defendants have laid a credible challenge to the subject patent.
74. With due respect, this was not a typographical error but a factual
error, leading to a definite conclusion with regard to the validity of the suit
patent. If it was only a typographical error, the plaintiffs would have filed an
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 62 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

appropriate application for rectification of the said error. No such
submission has been made on behalf of the plaintiffs of having filed such an
application.
Approbate and Reprobate
75. In Novartis (supra), Novartis had made admissions that its drug was a
part of a Zimmerman patent (genus patent) and had obtained drug approvals
on the basis of the aforesaid patent. Novartis also successfully stopped
Natco from marketing its drug in UK on the basis of the said Zimmerman
patent. Taking note of the aforesaid, the Supreme Court held that Novartis
cannot take a contrary plea later to the effect that its drug was covered in the
said patent, but not disclosed therein. The relevant observations of the
Supreme Court are set out below:
“126. From the above discussion it would be clear
that the drug Gleevec directly emanates from the
Zimmermann Patent and comes to the market for
commercial sale. Since the grant of the Zimmermann
Patent, the appellant has maintained that Gleevec (that
is, Imatinib Mesylate) is part of the Zimmermann
Patent. It obtained drug approval for Gleevec on that
basis. It claimed extension of the term of the
Zimmermann Patent for the period of regulatory
review for Gleevec, and it successfully
ATCO
stopped N Pharma Ltd. from marketing its drug in
UK on the basis of the Zimmermann Patent. Not only
the appellant but the US Board of Patent Appeals, in
its judgment granting patent for beta crystalline form
of Imatinib Mesylate, proceeded on the basis that
though the beta crystalline form might not have been
covered by the Zimmermann Patent, the Zimmermann
Patent had the teaching for the making of Imatinib
Mesylate from Imatinib, and for its use in a
pharmacological compositions for treating tumours or
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 63 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

in a method of treating warm-blooded animals
suffering from a tumoral disease. This finding was
recorded by the US Board of Patent Appeals, in the
case of the appellant itself, on the very same issue that
is now under consideration. The appellant is, therefore,
fully bound by the finding and cannot be heard to take
any contrary plea.”
76. The aforesaid findings in Novartis (supra) are squarely applicable in
the present case. In the present case also, the plaintiffs obtained interim
orders against the defendants in CS(COMM)239/2019 and
CS(COMM)240/2019 on the specific assertion that Linagliptin is ―covered‖
under IN ‗719 and therefore, infringed both genus and species patents. Till
the time the genus patent expired, the plaintiffs sought injunctive reliefs
claiming that Linagliptin is covered in both in IN ‘ 719 and IN ‗301 . It is only
after the expiry of the term of IN ‗719, the plaintiffs made the assertion in
the subsequent suits that Linagliptin is covered only in IN ‗301.
77. Further, to meet the objection raised in the examination report under
Section 3(d) of the Patents Act, the plaintiffs relied upon Linagliptin as one
of the products to show enhancement in efficacy. Not only that, in order to
show the working of IN ‗719, the plaintiffs relied upon the manufacture and
sale of Linagliptin as is evidenced in Form 27 filed on behalf of the
plaintiffs. Having obtained all these benefits based on the assertion that
Linagliptin is claimed and covered in genus patent, now it does not lie in the
mouth of the plaintiffs to take a stand to the contrary. The plaintiffs cannot
be allowed to approbate and reprobate.
78. It has been vehemently contended on behalf of the plaintiffs that no
reliance can be placed on any post grant admissions made by the plaintiffs
after the priority date of the suit patent. However, in the judgments of the
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 64 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Supreme Court in Novartis (supra) as well as the judgment of the Division
Bench in AstraZeneca (supra), the Court has placed reliance on admissions
made by the plaintiffs in the pleadings that were filed much after the grant of
the suit patent. Therefore, there is no merit in the submission of the plaintiffs
that reliance cannot be placed on any admissions made by the plaintiffs after
the priority date or after the grant of the suit patent.
79. As regards the reliance placed on behalf of the plaintiffs on the
affidavit of the expert, in my considered view, the effect of the same can be
considered at the stage of trial and not at this interlocutory stage, when the
Court is only taking the prima facie view with regard to the credibility of the
challenge raised by the defendants on the validity of the suit patent. The
defendants have also filed affidavit of the experts in support of their
contention that Linagliptin is covered under the genus patent and these
aspects can only be considered at the stage of trial.
80. The pleadings/admissions made by the plaintiffs in the present case,
when examined in light of the scheme of the Patents Act and the principles
of law laid down by the judgments above, leads me to a prima facie view
that Linagliptin was ―disclosed‖, ―claimed‖ and ―covered‖ under the genus
patent, IN ‗719 as well as the suit patent, IN ‗301. Had Linagliptin not been
disclosed or claimed in the genus patent, the plaintiffs could not have made
a claim for infringement of the genus patent in CS(COMM) 239/2019 and
CS(COMM) 240/2019. Therefore, at an interlocutory stage at least, the
requirements with regard to prior claiming under Section 64(1)(a) of the
Patents Act are satisfied in the present case.


Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 65 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

Evergreening
81. Mr. Sandeep Sethi, senior counsel appearing for the plaintiffs, had
used the analogy of patenting parts of a forest with the approach of patenting
adopted by the plaintiffs. He submitted that a patentee first files patents for
the tree and subsequently for specific leaf of that tree. This strategy where
the patentee first patents a large set of alternatives for the solution of a
particular problem and thereafter, a specific or more specific sets of
solutions of a problem is referred to as Selection Patents.

82. In the context of Indian Patent Law, the selection of optional
substitutions or selection of specific substances or compounds after coverage
in a prior patent is prohibited in terms of the decision of the Supreme Court
in Novartis (supra). Further, as per Section 10(4)(b) of the Patents Act, a
patentee has to disclose the best method of performing the invention, which
is known to the applicant. In the present case, if Linagliptin, which appears
to be the best method of performance of the genus patent was not disclosed,
then even the genus patent did not satisfy all the requirements that a
complete specification of a patent document needs to satisfy.
83. If the submission of the plaintiffs that Linagliptin was the product of
further research and development after filing of the genus patent is
considered, the species patent can at best be a patent of addition under
Section 54 of the Patents Act. The term of the patent of addition is also only
limited to the term of the original patent, which would be the genus patent in
this case.
84. On the issue of evergreening of the patent, the Division Bench in
AstraZeneca (supra) held that if the patent with respect to the same
invention is granted more than once, then it will be against the legislative
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 66 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

intent of limiting the life of the patent. Therefore, a patentee cannot restrain
a third party from dealing with the new product invented by the patentee
pursuant to further research, after the expiry of 20 years-term of the patent.
The observations made by the Division Bench in this regard are set out as
under:
“31. The Patents Act, though protects the rights
and interests of inventors, but for a limited period,
whereafter the monopoly of the patentee ceases and
comes to an end and the invention with respect to
which patent was granted, falls in public domain i.e.
open for all to practice and reap benefit of. A patent,
vide Section 48 of the Act, confers a right on the
patentee of a product patent, as DAPA is, to, during
the life of the patent, prevent others from making,
using, offering for sale, selling or importing, the new
product with respect whereto patent is granted. The
life of a patent is limited, whereafter, notwithstanding
the new product having been invented by the
patentee, patentee no longer has exclusive right to
make, use or offer for sale the same and anyone else
interested can also make, use or offer for sale the said
new product invented by the patentee, without any
interference from the patentee. If patents with respect
to the same invention can be granted more than once,
successively in time, the same will negate the
legislative intent of limiting the life of the patent and
enable the patentee to prevent others from making,
using or offering for sale, the new product invented
by the patentee, till the time patentee successively
keeps on obtaining patent therefor .”

85. A Coordinate Bench of this Court in FMC Corporation And Ors v.
GSP Crop Science Private Limited , 2022 SCC OnLine Del 3784 , held that
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 67 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

filing of multiple patents for different aspects of the same product with an
intention to extend the initial monopoly is not permissible under the Patents
Act. The relevant observations of the Court in GSP Crop Science (supra) are
set out below:
“31. Admittedly, the Markush patent and both the
product and process patents relating to CTPR have
expired in August 2022 and there can be no exclusivity
in the same. However, if one goes by the list of granted
and pending patents applications, the various
components, intermediates and manufacturing
processes of CTPR, if granted/validated, would result
in the Plaintiffs monopoly and exclusive rights till 2041
i.e., a further period of 19 years.
32. Thus, in the opinion of this Court, filing of such
multiple patents for different aspects of the same
product with an intention to extend the initial
monopoly in some form or the other, would not be
permissible. It is this very abuse that Section 3(d),
mandatorily required disclosures under S.10 and
other provisions of the Act, intend to curb.
33. Undoubtedly, multiple patents can be filed for
different aspects of a particular product, if the tests
for novelty, inventive steps and industrial applicability
are satisfied and the inventions are patentable.
However, serial patenting in order to ‗Evergreen‘ a
particular monopoly, is not permissible. ”
86. The aforesaid observations are also applicable in the present case. In
the present case also, the plaintiffs by filing multiple patents for different
aspects of the same product are seeking to extend the term of the patent
beyond twenty years, granted in respect of the genus patent, which expired
st
on 21 February 2022. In my considered view, the action of attempting to
patent both the genus and species patent would amount to evergreening or
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 68 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

layering of patent protection, which is impermissible under the Indian Patent
Law. Section 3(d) of the Patents Act has been incorporated in the statute to
ensure that such action of evergreening and layering is prevented.
87. In view of my findings above, it would not be necessary to consider
other grounds of revocation raised in the suits, which shall be considered at
the stage of the trial.
Balance of convenience
88. Finally, I would address the issue with regard to balance of
convenience and irreparable injury, the fundamental principles which govern
the grant of interim injunction.
i. Whether balance of convenience is in favour of the plaintiffs and
against the defendants for the grant of interim injunction?
ii. Whether the plaintiffs would suffer irreparable injury on account of
non-grant of interim injunction?
89. Rajiv Shakdher, J. in AstraZeneca (supra) also deliberated on the
issue of balance of convenience and irreparable harm while considering
grant of interim injunction. The relevant observations in this regard are set
out below:
“35.4 This is acutely true when seen in the context
of enforcement of patents concerning drugs. The Court
has to be vigilant towards attempts of the patentee
that aims at evergreening an invention which does
not inter alia involve an inventive step i.e. technical
advance or economic significance. Therefore,
depriving the defendants, at this stage, from
manufacturing and selling their drugs, when, during
the validity period of the genus patent i.e. IN 147 they
largely held themselves in check would, in my
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 69 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

opinion, not be appropriate, especially, when they
have set up a credible challenge to the suit patents.

35.5 What persuades me to decline injunction, in
addition to what I have stated above, is also the fact
that in this case damages if proved at trial, appear to
be compensable. The defendants have averred that
the plaintiffs have, possibly, licensed their rights
under the suit patents to two entities i.e. Sun and
Abbott . The packaging of the products of the drug sold
through these entities is indicative of this aspect. The
plaintiffs, however, for reasons best known to them
have not placed on record the agreements arrived at
with these entities in support of their plea. Therefore, it
has to be inferred that the said entities are licensees.

35.6 Besides this, the plaintiffs also aver that they
are importing their drug into the country. Therefore,
the plaintiffs seek to monetize their invention. Thus,
at the end of the trial, if they were to succeed, they
could be granted damages, if proved, under the law.
Thus, as long as a mechanism can be put in place for
securing the recovery of damages by the plaintiffs, it
would, at this stage, balance the interest of the parties.
[See: Dynamic Manufacturing, Inc. vs. David A. Craze,
and Miller Industries, Inc., 1998 WL 241201]”



90. The aforesaid findings in respect of balance of convenience are also
squarely applicable in the facts and circumstances of the present case. In the
present case, the plaintiffs have enjoyed a twenty-year monopoly of
Linagliptin under the genus patent. Except the defendants in CS (COMM)
239/2019 and CS(COMM)240/2019, the defendants waited for the twenty-
st
years term of the genus patent to expire on 21 February, 2022, before
launching their drugs in the market.
91. In the present batch of cases also, the plaintiffs do not manufacture
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 70 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

their drugs in India, but import their drugs into India. The plaintiffs have
licensed the suit patent to Lupin and Eli Lily , for which royalties are payable
by the said entities to the plaintiffs. Clearly, the intention of the plaintiffs is
to monetise the said invention. Therefore, the present case is one where
monetary damages can be calculated and awarded to the plaintiffs, in the
event, the plaintiffs succeed in the present suits. It is a settled position of law
that where monetary damages are the adequate compensation for the
plaintiffs, an interim injunction should not be granted.

92. Rajiv Shakdher, J in his judgment in AstraZeneca (supra), also delved
into the aspect of public interest and noted that a big gap existed between the
price of the drug offered by the plaintiffs, as against the price of the
defendants‘ drugs. Taking note of the fact that the drug is used in the
treatment of diabetes, which has wide prevalence in India, it was held that
balance of convenience would be in favour of the defendants.
93. Considering the elements of public interest, in the present case also,
the drug Linagliptin is used for treatment of diabetes, which is a widely
prevalent disease in India. In fact, diabetes is also considered as a co-
morbidity factor in the cases of Corona Virus infection, which resulted in a
global pandemic and large number of fatalities in India. Therefore, the
public interest also demands that large segments of population should have
easy and affordable access to an anti-diabetes drug. Undeniably, the
products of the defendants are significantly cheaper than that of the plaintiffs
and taking into account that Linagliptin is a daily-use drug, affordability
plays a major role in its access to wide sections of the public.
94. Therefore, in my considered view, balance of convenience would tilt
in favour of the defendants and against the plaintiffs. Irreparable injury
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 71 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

would be caused not only to the defendants but also to the public, if the
interim injunction is granted in favour of the plaintiffs.
Conclusion
95. Based on the discussion above, I am of the prima facie view that the
suit patent of the plaintiffs, i.e., IN‘301 is vulnerable to revocation on the
ground of prior claiming in terms of Section 64(1)(a) of the Patents Act. I
am also of the prima facie view that by filing multiple patent claims in
respect of the same invention, the plaintiffs have made an attempt towards
evergreening the invention and re-monopolizing the same. These attempts
on behalf of the patentees strike at the root of patent law in India. The
aforesaid conduct of the plaintiffs defeats the rights of the manufacturers of
generic drugs such as the defendant companies and is also detrimental
towards the public interest.
96. In view of the discussion above, the plaintiffs have failed to make out
a prima facie case for grant of interim injunction. Balance of convenience is
in favour of the defendants and against the plaintiffs. Irreparable injury
would be caused not only to the defendants but also to the public, if the
interim injunction is granted in favour of the plaintiffs.
97. Accordingly, all the applications in the aforesaid suits for grant of
interim injunction are dismissed with costs of Rs 2,00,000/- to each of the
defendants. In addition, costs of Rs. 2,00,000/- are also awarded in favour
of Delhi High Court Legal Services Committee on account of detriment
caused to the public interest.
98. The costs shall be paid to the defendants and Delhi High Court Legal
Services Committee within four weeks of the passing of this order.
99. The defendants shall maintain complete accounts of manufacture and
Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 72 of 73

Signing Date:29.03.2023 16:16:40

2023:DHC:2249

sale of the impugned products and file statement of accounts on half yearly
basis.
th
100. In view of the above, the interim order dated 10 May, 2019 passed in
CS(COMM) 239/2019 and CS(COMM) 240/2019 stands vacated. The pro-
tem arrangements arrived at between the parties in CS(COMM) 236/2022,
th
CS(COMM) 237/2022 and CS(COMM) 238/2022 vide order dated 19
th
April, 2022 and in CS(COMM) 296/2022 vide order dated 9 May, 2022,
also stand vacated.

101. There shall be no impediment on the manufacture and sale of products
with Linagliptin as the API on account of the suit patent i.e., IN‘301. The
defendants are permitted to manufacture and sell the aforesaid products, if
so advised, subject to necessary approvals.
102. Needless to state that the observations made herein are only for the
purpose of deciding the present applications and shall have no bearing on
the final outcome of the suits and the counter claim.

CS(COMM) 239/2019, CS(COMM) 240/2019, CS(COMM) 236/2022,
CS(COMM) 237/2022, CS(COMM) 238/2022 & CS(COMM) 296/2022

rd
103. List before Joint Registrar on 23 May, 2023 for further proceedings.


AMIT BANSAL, J.
MARCH 29, 2023
sr


Signature Not Verified
Digitally Signed By:AMIT
BANSAL
CS(COMM) 239/2019 and connected matters Page 73 of 73

Signing Date:29.03.2023 16:16:40