Shaafi Naturcure Llp vs Assistant Controller Of Patents And Designs
- Court
- Delhi High Court
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment reserved on: 15.05.2026
Judgment delivered on: 22.06.2026
+ C.A.(COMM.IPD-PAT) 109/2022
SHAAFI NATURCURE LLP .....Appellant
versus
ASSISTANT CONTROLLER OF PATENTS AND DESIGNS
.....Respondent
Advocates who appeared in this case:
For the Appellant : Mr. Kapil Kumar and Mr. Abhishek Jain,
Advocates.
For the Respondent : Mr. Sumit Nagpal, SPC with Mr. Tanmay Saini
and Mr. Kunal Khurana, Advocates.
CORAM:
HON’BLE MR. JUSTICE TUSHAR RAO GEDELA
J U D G M E N T
TUSHAR RAO GEDELA, J.
1. The present appeal has been filed under Section 117A of the Patents
Act, 1970 (hereinafter referred to as “ the Act ”) assailing the order dated
16.09.2020 (hereinafter referred to as “ impugned order ”) passed by the
Assistant Controller of Patents and Designs (hereinafter referred to as
“ learned Controller ”) whereby the respondent refused the Indian Patent
Application bearing no. 201911048481 (hereinafter referred to as “ subject
application ”) on the grounds that the invention does not meet the
requirements of Section 2(1)(j), Section 3(p) and Section 10(4)(a) and
10(4)(b) of the Act.
2. Briefly, the facts as stated in the appeal are as under:-
2.1 The appellant filed the present application titled “ A HERBAL
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POWDER COMPOSITION FOR THE TREATMENT OF ASTHMA ”
seeking grant of patent on 27.11.2019. It was numbered as Indian Patent
Application no.201911048481. Thereafter, the First Examination Report
(hereinafter referred to as “ FER ”) was issued on 01.01.2020. The appellant
claims to have filed a detailed response to the said FER on 20.06.2020
alongwith amended claims.
2.2 The respondent issued a notice of hearing on 29.06.2020 scheduling
the oral hearing on 29.07.2020. The appellant through its agent sought and
was granted an adjournment, scheduling the hearing to 28.08.2020.
2.3 The agent of the appellant addressed arguments on 28.08.2020 and
pursuant thereto, the appellant filed detailed written submissions on
11.09.2020. Consequent thereto, vide the impugned order dated
16.09.2020, the subject application was rejected.
2.4 Impugning the order dated 16.09.2020, the present appeal has been
preferred.
:-
CONTENTIONS OF THE APPELLANT
3. Appearing on behalf of the appellant, Mr. Kapil Kumar, learned
counsel, at the outset assailed the impugned order on the ground that the
five steps process directed to be followed by this Court in Hoffmann La
Roche Ltd. vs. Cipla Ltd.: 2015 SCC OnLine Del 13619 was not followed
and as such, the impugned order needs to be set aside and the patent
application be remanded back for reconsideration.
4. Learned counsel would contend that the refusal is erroneously
premised on the ground that the composition of the present invention is
obvious in view of the teachings contained in prior arts D1 to D10. He
would contend that apart from the six ingredients which have been claimed
in the present invention, there are several herbs which are also useful in the
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treatment of asthma, for example Adhatoda Vasica, Achyranthes Aspera,
Zingiber Officinane, Curcuma Longa and Calotropis Procera .
5. Learned counsel urged that the invention pertains to selection of
herbs out of a pool of several available herbs which are traditionally known
for treatment of asthma and thus, cannot be treated as a routine
experimentation. According to learned counsel, the inventive step lies in
the herbal composition in powdered form comprising six herbs for the
treatment of all five types of asthma. It is claimed that the inventor has
worked out and optimised the ratios of each of the ingredients which can be
useful for treatment of asthma. Notwithstanding the aforesaid submission,
learned counsel would contend that even if it is assumed, though without
admitting, that the present invention is a routine experiment, there is no
document much less any prior art document which discloses the
combination of six herbs as contained in the present invention in specific
ratios for the treatment of asthma.
6. Learned counsel emphasised that the subject matter of the prior art
documents D1 to D10, whether read alone or in combination, do not teach a
person skilled in the art to reach the present invention. He would contend
that the prior documents D1, D3, D6 and D7 are citations from Traditional
Knowledge Digital Library (hereinafter referred to as “ TKDL ”) and the
information provided therein being too skeletal, cannot be considered as an
enabling disclosure and thus, the same are not relevant prior art documents
to determine inventive step.
7. Dilating further on the aforesaid prior art documents D1 to D10,
learned counsel relied upon the detailed comparison of prior art documents
vis-a-vis the present invention in support of his contentions. The
submissions of the learned counsel regarding the prior art D1 to D10 are as
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follows:-
“D1, D3, D6 and D7 are citations from TKDL and the information
provided being too skeletal, that the same cannot be considered as an
enabling disclosure and is much beyond the workshop experiments to
arrive at the present composition and therefore, are not relevant prior art
documents for the purposes of judging inventive step.
D1 relates to aqueous formulation of Tephrosia purpurea leaves having
diuretic property and prepared as decoction for treating asthma. As well
established, diuretic property can only reduce water retention in the body
and will have limited ability when used as single compound formulation,
for treating Asthma.
D2 is directed to "Evaluation of antihistamic activity of herbal drug
isolated from Cuscuta reflexa Roxb.” wherein the extract used was
prepared in ethanol employing Soxhlet extractor. It only confirms mast
cell stabilizing activity through pre-clinical trials and emphasizes further
studies to understand its mechanism. Further, it makes a passing
reference for the traditional use of ethanolic extract of whole plant of
Cuscuta reflexa Roxb without any corroborations confirming safe use.
D3 relates to a composition comprising Cuscuta (aqueous extract of
seeds), sweet fennel (aqueous extract of fruit) and sugar based semisolid
preparation containing rose petals. The components of the said
composition are totally different from the claimed composition comprising
of specific parts of six herbs in specific proportion. It nowhere mentions,
let alone teaches the use of stems of Cuscuta in the treatment of asthma.
D4 provides passing reference to use of single component of fruit and
leaves of Morinda citrifolia for treating allergies, such as bronchitis,
asthma and pruritus. Further, it also shows the effect of noni as potential
anti-hypertensive, hypoglycemic and anti-dementia agent. Moreover, D4
also shows better effects of leaves of noni as compared to its fruits which
it itself is a negative teaching. The conclusion of the article arrived at
clearly indicates that further studies for detailed chemical analysis clinical
trials and the ailments/conditions are necessary.
D5 is a review article on single component Terminalia arjuna and use of
its fruit, leaves, seed and bark for various diseases including astringent,
cooling, aphrodisiac, cardiotonic, tonic in fractures, ulcers, diabetes,
cough, tumors, inflammation, skin disorders asthma, etc. Further, the
article mainly focuses on the use of T. arjuna in cardiac disorders.
Further, the study mentioned in respect of anti-inflammatory activity
focusses on a formulation of five medicinal plants (Commiphora mukul,
Terminalia arjuna, Boswellia serrata, Semecarpus anacardium and
Strychnos nux vomica) and makes passing reference in respect of use of T.
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arjuna as antiinflammatory agent.
D6 relates to a single compound formulation of Piper longum for various
ailments like Cough with expectoration, cough / bronchitis, Bronchial
asthma, Gastric tympanitis. Even the dose of Piper longum is not
mentioned, let alone the particular composition of the present invention or
any other component.
D7 relates to a single compound formulation of fruit of Piper nigrum for
cough, bronchitis or pain of chest in form of syrup but which asthma is not
specified.
D8 just mentions use of Leaf decoction, root powder of Tephrosia
purpurea for asthma, but the disclosure is not an enabling one. Further,
the mechanism of action as disclosed in D8 indicates use of Tephrosia
purpurea primarily as blood purifier.
D9. relates to alcoholic extract of Terminalia arjuna for asthma, but the
dose, asthma type is not disclosed, neither is there an indication to cure
all types of asthma. Further, the said prior art is not an enabling one.
D10 relates to a patent application with multi-components, two of which
are Piper nigrum and Piper longum. Further, the said application
discloses the synergistic polyherbal composition and therefore, does not
indicate standalone use of Piper nigrum and Piper longum in the
treatment of asthma. Even otherwise, the said prior art has been
mentioned in the complete specification.”
8. Learned counsel emphatically argued that the respondent has not
correctly considered or appreciated the affidavit filed by the inventor to
clarify the objections contained in the hearing notice as well as in the FER.
He would contend that if any evidence is developed after the patent grant,
the same is not excluded from consideration for understanding the full
range of an invention which may not have been achieved at the time of
filing the patent application. He also would contend that there is no
requirement that the properties and advantages of an invention were fully
known before the patent application was filed in order for that work to be
introduced into evidence. He argued that the annexures submitted
alongwith the affidavit of the inventor clearly demonstrated that the present
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invention involved technical ingenuity. According to him, Annexure A
which was filed alongwith the affidavit clearly showed the components,
their ratio/ranges, particular plant used, the form in which it is to be
provided/used, the types of asthma cured, clearly indicating that the
claimed composition per se is not obvious in view of the prior art
documents D1 to D10. Similarly, according to him, Annexure B appended
to the affidavit of the inventor related to information of individual
components, their efficacy and other aspects such as side effects etc., or the
types of asthma these compositions could cure individually which
demonstrated that individual herbs are not as effective as the specific
composition which at times could even result in side effects if taken
disproportionately.
9. Learned counsel also argued that the Guidelines For Processing of
Patent Applications Relating To Traditional Knowledge and Biological
Material, 2012 (hereinafter referred to as the “TK Guidelines” ) have not
been considered in its entirety and only certain portions have merely been
cherry picked, for example guiding principles nos.2 and 4, which has
caused prejudice to the appellant. Alternatively, learned counsel contended
that the TK Guidelines are mere guidelines and not binding in nature. He
would contend that the inventive step of an invention ought to be
acknowledged if the surprising effect of the claimed composition vis-a-vis
the already known prior art composition as provided in the form of an
illustration in the TK Guidelines. According to the learned counsel, in the
present case, the surprising effect has been demonstrated and proved which
has been ignored and overlooked by the respondent.
10. So far as the objection under Section 3(p) of the Act is concerned,
learned counsel would submit that none of the prior art teaching in D1 to
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D10 provide conclusive evidence that the components of the present
composition are useful for treatment of asthma only. In other words, he
would contend that the documents D1 to D10 showed that other parts of the
components of the present invention were traditionally used to treat various
other ailments and treatment of asthma was only by way of a passing
reference.
11. It was contended that the respondent failed to appreciate that the
submitted affidavit of the inventor shows the negative effects of altering the
ratio/ranges of the components. Based on this, the appellant submitted that
the knowledge that components of the present invention are conclusively
used for asthma is not motivating the inventors to refer to the cited prior art
documents.
12. In continuation of the aforesaid submission, learned counsel would
also submit that the efficacy of different permutations and combinations of
these herbal components may result in altogether a different activity or side
effects or may not be able to treat all five kinds of asthma. He would
contend that there is an unpredictability of activity with respect to these
herbal components as each of them have diverse 5-10 activities and thus,
the present invention involves greater human ingenuity and efforts and
therefore, cannot be simply construed or brushed aside as traditional
knowledge.
13. Learned counsel for the appellant also placed great reliance on the
agreement entered into between the appellant and the National Biodiversity
Authority (hereinafter referred to as “ NBA ”) to submit that once such
agreement has been entered into and executed with the authority, the
objection under Section 3(p) of the Act must either be construed to have
been met with or such objection is deemed to be unsustainable. According
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to the learned counsel, Section 3(p) of the Act must be read harmoniously
with the Biological Diversity Act, 2002 (hereinafter referred to as “ BDA ”).
He disputed the contention of the respondent that the agreement executed
between the appellant and NBA under Section 6 of the BDA is a mere
regulatory clearance for access to biological resources and has no nexus
with the patentability criteria under the Act. Thus, learned counsel would
contend that once such agreement has been executed and entered into with
the NBA, the objection under Section 3(p) of the Act would be rendered
otiose.
14. On the objections raised in terms of Section 10(4)(a) and (b) of the
Act, learned counsel would submit that the Complete Specifications
(hereinafter referred to as “ CS ”) clearly discloses the exemplary herbal
compositions and the method of preparing the same and thus, the basic
requirements of the aforesaid provisions have been clearly met. That apart,
he would contend that the affidavit of the inventor clearly demonstrated the
working examples falling within the ranges as claimed in the present
invention. In fact, the affidavit also discloses various compositions falling
outside the scope of the claims of the present application thereby
demonstrating negative effects of such compositions. Thus, according to
the learned counsel, the CS read with the contents of the affidavit provide
complete disclosure as required.
15. Additionally, learned counsel would emphasize that the affidavit of
the inventor also demonstrated the verifiable data of the composition which
was tried and tested on 300 individuals including children, women and men
to represent all age groups and genders. He would submit that the said
affidavit provides details of exceptional results captured on administration
of the composition of the present invention upon the 300 individuals which
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clearly demonstrated that the said composition showed enhanced efficacy
over a broad spectrum group without apparent side effects. Thus, according
to learned counsel, the objections raised under Section 10(4)(a) and
10(4)(b) of the Act have been fully met by the appellant.
CONTENTIONS OF THE RESPONDENT:-
16. Appearing for the respondent, Mr. Nagpal, learned CGSC strongly
refuted the contentions raised on behalf of the appellant.
17. At the outset, Mr. Nagpal broadly touched upon the various relevant
provisions of the Act, and the BDA, particularly Section 6. He would
contend that the permission sought by an entity or an individual under the
BDA is for the purpose of facilitating the entity or the individual to extract
natural resources and sets out the regime for conservation of biological
diversity, sustainable use of its components and fair and equitable sharing
of the benefits arising out of utilization of genetic resources. He also
emphasized that the Act is a regulatory mechanism to ensure that no person
shall undertake biodiversity related activities without approval of the NBA.
18. Learned CGSC would contend that Section 19 of the BDA provides
the manner in which a person who intends to obtain any biological resource
occurring in India is to apply to the NBA. He also stated that the provisions
of Section 19 also stipulated that in case any person intends to apply for a
patent or any other form of intellectual property rights, such person may
also file an application to the NBA. According to him, provisions of
Section 19 also provide that the NBA may make enquiries after consulting
the Expert Committee and grant approval to the applicant which may
include imposition of charges etc. However, he would forcefully contend
that there is no provision in the entire BDA which would consider an
application filed by an intended patentee as to the patentability of the
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subject invention of the intended patentee. He would submit that the same
is clear also from a bare perusal of the agreement dated 19.01.2021 placed
on record by the appellant. Thus, in sum and substance, learned counsel
would contend that other than providing a regulatory mechanism and
revenue sharing, the BDA does not contemplate conducting enquiries in
respect of patentability of a claimed invention.
19. From the aforesaid submission, learned CGSC would contend that
patentability of a claimed invention has to be considered purely under the
provisions of the Patent Act, 1970 and not the BDA. He further contends
that in the present appeal, the appellant has failed to overcome the
objections under Section 3(p) of the Act and has relied substantially on the
agreement dated 19.01.2021 and the affidavit along with the annexures
filed by the inventor, which is unsustainable in facts and law.
20. Having stated as above, learned CGSC referred to the additional
written submissions dated 02.05.2026 filed on behalf of the respondent and
read through the same. On merits, Mr. Nagpal would contend the claimed
composition comprises six herbal ingredients each of which is
independently known in the traditional systems of medicines for the
treatment of asthma, Bronchitis and related respiratory ailments. This is
clear from the teachings in the cited prior arts documents. Thus, according
to learned CGSC, the claimed invention is nothing but an aggregation of
properties of traditionally known components without any demonstrable
technical advancement or unexpected effect.
21. Referring to Annexure B to the Biodiversity Agreement dated
19.01.2021, learned counsel would submit that the invention for which
approval was granted describes the subject matter merely as “A HERBAL
POWDER COMPOSITION FOR THE TREATMENT OF ASTHAMA”.
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Other than that, the said Annexure makes no reference to classification of
asthma into five distinct categories or that the claimed composition was
capable of curing all such types of asthma. He emphasized that similarly,
even the CS did not refer to any such sub-classification. He would contend
that the differentiation into five types of asthma and the assertions made in
Column 6 of the Chart at page 141 of the paper book and the
accompanying affidavit are new technical features introduced for the first
time at the hearing stage and cannot be considered. Therefore, he
contended that the said chart constituting post-filing material does not form
part of the original disclosure in the CS, thus attracting objection under
Section 10(4)(a) and (b) of the Act.
22. Contrary to the contention of the appellant that the affidavit of the
inventor was not considered by the respondent, learned CGSC argued in
detail and referred to various paragraphs of the impugned order to contend
that not only was the subject patent application considered in totality but
the affidavit along with its annexures submitted by the inventor too was
considered in great detail. To demonstrate and make good the above
submission, learned CGSC invited attention to the following paragraphs of
the impugned order:-
“With respect to effect of the composition of the present application in
curing different types of asthma as mentioned in the hearing submission
by the applicant's agent and also in the Annexure A of the affidavit by the
inventor, it is pertinent to note that the complete specification as
originally filed is silent regarding the different types of asthma. The
specification, the claims of the instant application as well as the prior art
documents disclose the use of herbs in the treatment of asthma. There is
no basis for the statement that the asthma cured by the composition of the
instant application is different from the one disclosed in the teachings of
the prior art.
. .
An affidavit is submitted by the inventor providing data showing the
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negative effects of altering the ratio/ranges of the components. With
regard to the additional data, I would like to mention that the addition of
any descriptive material has to be at least implicitly disclosed in the
specification to be allowable.
. .
Without prejudice to the matter discussed in the above paragraph, the
data in the affidavit (see paragraph 8) lists various formulations
consisting of a combination of specific ranges of each of the 6 herbs of the
instant application and the side effects due to changes in the ratio of
ingredients and also a preliminary survey on 300 patients showing the
efficacy of the claimed formulation (see paragraph 15). Upon careful
consideration, it is observed that the data provided in the affidavit is
inconsistent with experimental data provided in the complete specification
as originally filed.
a. As per the specification, composition with only 4 herbs is equally
efficient in treating asthma in the same duration as composition
with all 6 herbs. This is not the case of the formulations listed in
the affidavit by the inventor.
b. Moreover, the specification discloses treating asthma with the
composition of the invention in a minimum duration of 3 months
(Example 1). However, as per the data in the affidavit, the
minimum duration for curing asthma is 4-5 months.
c. Importantly, the formulation number IV listed in paragraph 8 of
the affidavit consists of all the six herbs of the present application
in the preferred ranges as claimed in claim I. Thus, as per the data
provided in the affidavit, the composition as claimed in claim 1 is
considered to cause side effects such as increase kaphaa and also
tridosh.
Hence, the data provided in the affidavit by the inventor is not reliable
and failed to show any unexpected effect of the claimed composition.
Therefore, in view of the above, the applicant’s argument that the specific
composition with specific ratio/ ranges of components is required for the
enhanced efficacy is found not persuasive.”
23. Learned CGSC also contended that Column 6 of the Chart at page
141 of the paper book makes a blanket assertion that the claimed
composition is capable of curing all five types of asthma without any
supporting experimental data or technical evidence. He contended that the
Chart also did not disclose any specific formulation within the claimed
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ranges nor does it provide any details regarding experimental methodology,
comparative analysis or clinical validation. Thus, according to him, in the
absence of such foundational data, the statements in Column 6 lack
scientific substantiation.
24. Another relevant concern raised by the respondent is in respect of the
contents of the affidavits of the inventor, particularly paragraph 8, wherein
it was deposed that upon altering the ratios of the composition, the result
was either less effective or exhibited serious side effects. According to Mr.
Nagpal, learned CGSC, this clearly demonstrates that even the
compositions which are covered within the claimed ranges may not be
consistently effective and in fact, may produce undesirable effects. Thus, in
that view too, learned counsel would contend that the blanket assertion
made in Column 6 of curing five types of asthma with the given
compositions is unreliable and lacks evidentiary value. In fact, as an
example, the impugned order considered the Formulation IV which falls
within the claimed ranges and itself leads to adverse effects, such as
increase in kapha and tridosha thereby undermining the claim of technical
advancement. On the basis of such observations, learned counsel contended
that the conclusion reached by the respondent that the affidavit is not
reliable, ought not to be disturbed.
25. So far as the contention of the appellant in respect of prior art
documents D1 to D10 is concerned, learned CGSC submitted that contrary
to the submission of the appellant that the said prior art documents attribute
limited efficacy in relation to the specific types of asthma, however, none
of the cited prior art documents disclose any such limitations and uniformly
refer to treatment of asthma in general. Learned counsel would contend that
in support of the aforesaid contention, the appellant had relied upon
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Annexure A to the affidavit of the inventor, however, the same is based on
an unfounded and unsupported classification of asthma into different types
and thus, the contentions raised by the appellant qua the prior art
documents is unfounded. He would also contend that the contentions of the
appellant seem to be based on unilateral interpretation of the inventor
without submitting supporting disclosure or evidence and as such, cannot
be relied upon to establish inventive step.
ANALYSIS AND CONCLUSIONS:-
26. Heard learned counsel for the parties and perused the records of the
case.
27. At the outset, it may be relevant to consider the argument of learned
counsel for the appellant predicated on the provisions of the BDA. Learned
counsel had relied upon the provisions of the BDA to primarily submit that
once the NBA under the provisions of Section 19 grants approval to the
application filed by any person in terms of Section 3 of the BDA for the
purpose of obtaining any biological resource occurring in India, coupled
with the agreement being executed between the person and the NBA, the
objection under Section 3(p) of the Patents Act cannot be cited as an
objection by the respondent while considering the patentability of the
patent application of the appellant. Learned counsel had also contended that
the BDA being an expression of the policy decision of the Government, has
to be given primacy over the objections contained in Section 3 of the Act
and once the NBA grants approval and executes an agreement as stipulated
in the BDA, the objections under Section 3(p) of the Act would be rendered
otiose.
28. In the opinion of this Court, the aforesaid arguments are fallacious
and without any foundation. If one were to consider the Preamble of the
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BDA, it is clear that the said Act has been promulgated for the purposes of
(i) conservation of biological diversity, (ii) sustainable use of its
components, (iii) fair and equitable sharing of the benefits arising out of the
use of biological resources and knowledge, and (iv) for matters connected
therewith. On the plain reading of the Preamble and the objects of the
BDA, the main objective appears to be conservation of the biological
diversity so as to ensure that the biological resources and the associated
traditional knowledge is controlled under a regime and neither misused nor
abused by entities. Upon a cursory consideration of various sections
including Sections 3, 6, 7, 8, 18 and 19 of the BDA as also Rule 16 of the
Biological Diversity Rules, 2024, (hereinafter referred to as “ the Rules ”), it
is clear that the intention of the legislature was not only to protect and
regulate the utilisation of biological resources or the knowledge associated
thereto but also to ensure that the Government is able to gain financial
benefit from the revenue sharing borne out of the commercial utilisation of
such biological resources.
29. Sub-section 3 of Section 19 of BDA concerns itself with conducting
an inquiry by the NBA after consulting an expert committee for the
purposes of granting or refusing approval to an application filed by any
person subject to regulations being made in that regard and further subject
to terms and conditions as it may deem fit. A cumulative reading of
Sections 6, 7, and 19 of BDA also makes it clear that the right to file an
application for intellectual property rights to the appropriate authority is
subject to mandatory registration with the NBA before grant of such
intellectual property rights. The manner, mode and procedure for
registration and obtaining prior approval from the NBA before seeking
grant of intellectual property rights is prescribed in Rule 16 of the Rules.
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Nowhere does the Act or the Rules provide ascertainment of patentability
of the subject invention of a patent application. The approval that is granted
by the NBA is statutorily reduced into writing in the form of an agreement
on mutually agreed terms.
30. It appears to this Court that the basic framework of the regime
contemplated under the BDA is only for the purposes of ensuring that no
person or entity is able to utilise or extract biological resources without
obtaining registration and approval from the NBA. It is also manifest from
the provisions of the Act and the Rules framed thereunder that it is
mandatory to obtain necessary approval from the NBA by an entity or an
individual which is desirous of seeking a grant of intellectual property
rights in a composition or invention which would involve extraction and
utilisation of the biological resources for its invention etc. There is no
provision in either the BDA or the Rules which confer any power or
authority or even jurisdiction to the NBA to venture into or conduct any
inquiry in any manner whatsoever with respect to the patentability or
otherwise of any claimed invention. Thus, the mere grant of approval by
the NBA has no rationale or remote nexus with the patentability of a
claimed invention, which is the exclusive mandate of the Patents Act, 1970.
31. A fortiori, the aspect of patentability of a claimed invention being
met with, once NBA grants approval under the provisions of BDA, is
legally unfounded and is unsustainable. Ergo , the argument of the learned
counsel for the appellant in this context is unmerited.
32. Resultantly, the objection under Section 3(p) of the Act has to be
necessarily and satisfactorily overcome by the appellant. In view of the
above, this Court now proceeds to examine the appeal on merits.
33. The claimed invention is titled as “A HERBAL POWDER
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COMPOSITION FOR THE TREATMENT OF ASTHMA” and relates to a
herbal powder composition for the treatment of asthma. The said invention
is directed to a novel herbal powder composition which comprises a
mixture of six native Indian herbs useful for treating asthma. The field of
invention of the present invention is as follows:-
“FIELD OF THE INVENTION: The present invention
represents to a herbal powder composition for the treatment of
asthma. More precisely, the invention is directed to a novel
herbal powder composition comprising of a mixture of six
native Indian herbs useful for treating asthma or similar
airways conditions.”
34. The claimed herbal powder composition invention comprises of (a)
Tephrosia Purpura (Sarphooka), (b) Cuscuta Reflexa (Aftimoon Kasoos),
(c) Morinda Citrifolia (Noni), (d) Terminalia arjuna (Arjun Bark), (e) Piper
Longum (Pipal Bari), and (f) Piper Nigrum (Kali Mirchi).
35. As per the CS of the subject application, drying is normally carried
out in shade to prevent degeneration of the active ingredients due to UV
light. Using a mechanised crusher is contemplated to make sure that no
excessive heat is produced, as excessive heat could affect the properties of
the raw materials.
36. To prepare the powders of the composition, Tephrosia Purpura
(Sarphooka) is taken in an amount in the range of 25 to 60% by wt.,
(preferably 35 to 55% by wt., more preferably 40 to 50% by wt.), Cuscuta
Reflexa is taken in the range of I to 30% by wt., (preferably 5 to 25% by
wt., more preferably 8 to 20% by wt)., Morinda Citrifolia is taken in the
range of I to 30% by wt.,( preferably 5 to 25% by wt., more preferably 8 to
20% by wt.,) Terminnalia Arjuna is taken in the range of I to 30% by wt.,
(preferably 5 to 25% by wt., more preferably 8 to 20% by wt.); Piper
Longum is taken in the range of I to 30% by wt., (preferably 3 to 25% by
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wt., more preferably 5 to 20% by wt.) and Piper Nigrum is taken in the
range of I to 30% by wt., (preferably 5 to 25% by wt., more preferably 8 to
20% by wt).
37. The claims submitted along with the reply to FER are as follows:-
“We Claim:
1. A herbal powder composition for the treatment of asthma
comprising:
(a) Tephrosia purpura (Sarphooka), whole plant, 25 to 60% by wt;
(b) Cuscuta reflexa (Aftimoon Kasoos), stem and seeds, 1 to 30% by
wt;
(c) Morindacitrifolia (Noni), fruits, 1 to 30% by wt;
(d) Terminnalia arjuna (Arjun Bark), 1 to 30% by wt.;
(e) Piper longum (Pipal Bari) fruit, 1 to 30% by wt.; and
(f) Piper nigrum (Kali Mirch) fruit, I to 30% by wt.
2. The composition as claimed in claim 1 wherein Tephrosia purpura
is in the range of 35 to 55% by wt.
3. The composition as claimed in claim 1 wherein Tephrosia purpura
is in the range of 40 to 50% by wt.
4. The composition as claimed in claim 1 wherein Cuscuta reflexa is
in the range of 5 to 25% by wt.
5. The composition as claimed in claim 1 wherein Cuscuta reflexa is
in the range of 8 to 20% by wt.
6. The composition as claimed in claim 1 wherein Morindacitrifolia is
in the range of 5 to 25% by wt.
7. The composition as claimed in claim 1 wherein Morindacitrifolia is
in the range of 8 to 20% by wt.
8. The composition as claimed in claim 1 wherein Terminnalia arjuna
is in the range of 5 to 25% by wt.
9. The composition as claimed in claim 1 wherein Terminnalia arjuna
is in the range of 8 to 20% by wt.
10. The composition as claimed in claim 1 wherein Piper longum is in
the range of 3 to 25% by wt.
11. The composition as claimed in claim 1 wherein Piper longum is in
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the range of 5 to 20% by wt.
12. The composition as claimed in claim 1 wherein Piper nigrum is in
the range of 5 to 25% by wt.
13. The composition as claimed in claim 1 wherein Piper nigrum is in
the range of 8 to 20% by wt.
14. The composition as claimed in claim 1 wherein honey, warm
water or water at room temperature is applied as a carrier while
administering to the subject in need.
15. A process for the preparation of the composition as claimed in
claim 1 comprising the following steps:
(a) shade drying of Tephrosia purpura, Cuscuta rejlexa,
Morindacitrifolia. Terminnalia arjuna. Piper longum and Piper
nigrum separately;
(b) crushing/grinding the dried parts of Tephrosia purpura, Cuscuta
rejlexa, Morindacitrifolia, Terminnalia arjuna. Piper longum and
Piper nigrum, separately, maintaining the temperature in ambient
conditions to a fine powder; and
(c) mixing the powders so obtained in step (b) of Tephrosia purpura,
Cuscuta reflexa, Morindacitrifolia, Terminnalia arjuna. Piper longum
and Piper nigrum in the ratio as recited in claims 1 to 13.”
38. As per the impugned order, the cited prior arts disclose the
following:-
•
Dl discloses a single ingredient composition comprising Tephrosia
purpurea, useful in the treatment of asthma.
•
D2 discloses that Cuscuta reflexa is traditionally used for cough,
cold and asthma by the tribal Gujjar and Bakerwals of the Baramulla
district of Kashmir valley. D2 teaches the anti histaminic activities of
the ethanolic extract of Cuscuta reflexa.
•
D3 discloses a composition comprising Cuscuta reflexa along with
another herb, useful in the treatment of asthma.
•
D4 discloses that Morinda citrifolia (noni) was traditionally used to
relieve allergic symptoms such as bronchitis, asthma and pruritus.
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•
D5 discloses that the bark of Terminalia arjuna is used in Indian
Indigenous System of Medicine for the treatment of asthma,
bronchitis and cough.
• discloses a single ingredient composition comprising Piper
D6
longum, useful in the treatment of asthma.
•
D7 discloses a single ingredient composition comprising Piper
nigrum, useful in the treatment of bronchitis.
•
D8 teaches that roots, leaves, seeds and stem bark of Tephrosia
purpurea are traditionally used as folk medicine.
•
D9 discloses the anti-asthmatic activity of the alcoholic extract of T.
arjuna bark. The study suggests that the antiasthmatic activity of the
bark may be due to the mast cell stabilising effect.
39. Learned counsel for the respondent, during the arguments, had
submitted that there is a distinction in the description of “Asthma” in the
affidavit of the inventor which is conspicuous by its absence in the CS. The
learned counsel argued that as per the affidavit, the invention claimed
under the subject application treats five different types of asthma, and such
disclosure is not available in the CS. He had further contended that
wherefrom the 5 types of asthma have been classified, has neither been
evidenced nor documented by the inventor in the CS. In order to appreciate
the said contention, it is appropriate to reproduce the relevant para of the
affidavit. The same reads thus:-
“6. That asthma is of five types i.e. 1. Maha shwas 2. Urdhva shwas 3.
China shwas 4. Tamak shwas and 5. Kshudra shwas.
i. Symptoms of Maha shwas include continuous breathing, blurred
vision, facial swelling, constipation, difficulty in urination,
stuttering, wheezing sound of breathing.
ii. Symptoms of Urdhva shwas include difficulty in taking deep
breaths because of covering of channels of face and entire body by
Kaphaa causes acute pain in entire body. Pupils tend to fixate
upward, gazing around with wide open eyes, fainting, suffering
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with pain, dry mouth, irritability, excessive inhaling than exhaling
causing breathlessness.
iii. Symptoms of China shwas include excessive effort required in
exhaling breath, entire body aches, difficulty in breathing,
flatulence, excessive sweating, fainting, burning sensation around
ureter, watery eyes, weakness, panting, redness in one eye,
restlessness, dry mouth, change in skin color, mumbling.
iv. Symptoms of Tamak shwas include stiffness in head, by
increasing more kaphaa it r causes influenza, abnormal noise in
throat, heart pain, patient feels darkness all around and faints,
fainting after continuous coughing, pain while discharging
phlegm, feels temporary after expelling phlegm, throat pain,
discomfort in speaking, reduced sleep, chest pain when lying
down, sitting is more comfortable than lying down, sweating on
face, frequent dry mouth.
v. Symptoms of Kshudra Shwas include reverse airflow towards
upper respiratory tract, this type of asthma is not so painful, does
not inflict much pain to the body, and doesn't cause digestive
problems.
7. That the present composition, with specific ingredients in specific
proportions is effective on all types of aforementioned Asthma. However,
if the individual components are chosen or various combinations chosen
from these components itself to make various compositions, they are not
as effective as the composition being claimed in the present invention. To
show that the present composition is more effective and synergistic
(resulting in unexpected properties) as compared to any other
combination or individual plants, some experiments were conducted and I
found out some extraordinary results as elucidated in Annexure A and as
below:
• Some less effective compositions found are mentioned as below;
a) Only beneficial for stomach, not breathing Sarphooka +
Noni + Kali Mirch + Pipal Badi
b) Only beneficial for fever Aftimoon + Aijuna + Kali
mirch
c) Only beneficial for gastric ulcer ' Sarphooka + Kali
mirch + Noni
d) Only beneficial for Inflammation Saiphooka + Arjuna +
Pipal badi
Apart from above compositions, some other compositions were also tested
and it was found that such compositions were less effective on various
patients as compared the compositions of tire present invention
comprising all six components i.e. Sarphooka + Aftimoon + Noni +
Arjuna + Kali Mirch + Pipal Badi, which gave best results.”
40. To the said extent, the respondent appears to be correct. Indeed the
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appellant in its CS had not disclosed any information regarding 5 different
variants of asthma. Besides, even in the affidavit of the inventor, no
evidence or documentary proof of such different variants of asthma were
submitted. Thus, there being no tangible material or evidence of existence
of different types of asthma, the claim now brought forth in the affidavit
rightly could not be considered by the learned Controller.
41. Further, the learned counsel for the respondent submitted that the
applicant’s agent mentioned in their submission that “ the components if
used individually or in some other compositions or other forms could result
in negative side effects.” However, such information is not disclosed under
the CS of the subject application. This aspect was placed before the
respondent for the first time by the appellant by way of the affidavit and
annexures appended thereto. In this context, it is significant to note that the
learned Controller had taken into consideration Formulation IV whereby
the appellant disclosed that the said composition may result in adverse
effects like enhanced kapha and tridosha. In such circumstances, it was not
erroneous on the part of the learned Controller to have concluded that the
claimed invention or the composition containing 6 herbs appear to be
contrary to public health.
42. The data submitted through the affidavit, under paragraph 8,
provides various formulations which consist of combinations of specific
ranges of each of the 6 herbs of the subject application alongwith the side
effects, if the ratio of ingredients is changed.
43. Paragraphs 8 and 15 of the said affidavit is reproduced as follows:-
“8. That when I tried to alter the ratio/ranges of the components, the
compositions were either less effective or had serious side -effects as
mentioned below:
“I. Cold:
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1. Sarphooka - 70%
2. Noni - 5%
3. Kali mirch-5%
4. Arjuna - 5%
5. Pipal badi - 5%
6. Aftimoon-10%
II. Diarrhea:
1. Aftimoon - 40%
2. Arjuna-15%
3. Kali mirch - 10%
4. Noni-5%
5. Pipal badi - 10%
6. Sarphooka - 20%
III. Itching:
1. Kali mirch - 40%
2. Sarphooka - 25%
3. Aftimoon -10%
4. Aijuna-10%
5. Pipal badi-10%
6. Noni-5%
IV. Increase Kaphaa, increase tridosh
1. Sarphooka - 30%
2. Aftimoon-10%
3. Pipal badi - 30%
4. Kali mirch-10%
5. Noni-10%
6. Aijuna-10%
V. Hypoglycemic effects:
1. Sarphooka - 30%
2. Aftimoon - 5%
3. Pipal badi-10%
4. Kali mirch- 5%
5. Nom-10%
6. Arjuna-40%
VI. Damage of liver and kidney:
1. Sarphooka - 20%
2. Aftimoon-10%
3. Fipal badi - 15%
4. Kali mirch - 10%
5. Noni- 40%
6. Aijima-5%
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Thus, it is clear that the compositions with specific ratio/ranges will be
effective and if these are altered, there will be side effects and the
purpose will be defeated.
15. That I say that the composition was (tied on around-300 individuals,
which included children, women and men to represent all age groups and
genders and exceptional results were found with the composition of the
present invention in that the present composition could show enhanced
efficacy over a broad spectrum of group and most importantly without any
apparent side effects. In other words, a preliminary survey on 300 patients
confirmed safety and efficacy of the claimed formulation.
I. Data of children - Total 37 patients
15 Children symptoms: light fever, dry cough, suffocation, imitation,
shortness of breath, loss of appetite, weakness & headache.
Given treatment and cured in 4-5 months
22 Children symptoms: excessive thirst, indigestion, excessive cough,
cold, some had constipation, some had diarrhea, difficulty breathing
Given treatment and cured in 5-6 months
II. Data of female - Total 115 patients "
40 patients - Hoarsness in voice, constipation, suffocation, shortness of
breath in walking and climbing on stairs, High BP, sleeplessness, anger,
excess fat, dry cough, lack of saliva, excess thirst, oedema, inflammation
of any part of body, disorder of urination, frequent urination, urinary
disorders.
Given treatment and cured in 6 months
75 patients — stress, palpitation when walking & during activity, gastric
problem every time, diabetes, BP, cough, cold, congestion in throat,
vertigo, discomfort in breathing, nausea, heat in the body not fever, pain
in forehead, irritation in head, difficulty in exhale the cough.
Given treatment and cured in 5-6 months
III. Data of male - Total 147 patients
67 patients -symptoms: indigestion, common cold, diabetes, feeling fever
all the time, headache and breathlessness, gastric problem, lack of sleep,
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tightness in chest and throat, constipation, painful urination, oedema,
fatty liver, distention in stomach after food, itching in body.
Given treatment and cured in 6 months
53 patients - symptoms: acidity, nausea, nervousness, liver dysfunction,
swelling in feet, hoarseness, difficulty in breathing, shortness of breath
after activity, lack of appetite, palpitation any time, frequent urination,
excess thirst, sometimes diarrhea and constipation, high BP, pain in body,
taking inhaler.
Given treatment and cured in 5-6 months
27 patients - symptoms: fatty liver, shortness of breath, cough, phlegm,
headache while wheezing, constipation, excessive thirst, difficulty
walking, irritation
Given treatment and cured within 5 months.”
44. This Court notes that the only statement in the CS in this regard is in
the background of the specifications, which is reproduced as follows:-
“Although a role of herbal treatment of asthma is uncertain because of
lack of well controlled scientific studies, the use of traditional or herbal
medicines in the whole world has grown substantially over the last few
decades. Indian herbs and treatments mentioned in ancient Ayurveda, is
one of the oldest medical practices in the world and have benefited
patients for thousands of years. The combination of herbs is believed to
produce synergistic effects and reduce possible side effects.”
45. Moreover, while the affidavit discloses all the above information,
peculiarly, the CS of the present application is silent regarding the side
effects/any negative effects of the various combinations of the herbs in the
composition. From the above reproduced para, the submission of the
respondent that is “in some other compositions or other forms” cannot be
determined from the above disclosure from the CS. The formulation IV as
reproduced above from the said affidavit have possible side effects as per
the given information while falling within the claimed ranges under claim 1
of the subject application.
46. It is important to note that apart from the above reproduced para of
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CS of the present application, no other disclosure is mentioned in the
description regarding the side effects of changing the proportion or
changing the various combinations of herbs. The data filed under affidavit
submitted by the appellant clearly shows the negative effects of altering the
ratio/ranges of the components.
47. It is important to note that if an applicant files additional data before
the Patent Office, the addition of any descriptive material has to be at least
implicitly disclosed in the specification.
48. In AstraZeneca AB & Anr. vs Alkem Laboratories Limited , CS
(COMM) No.410/2020, decided on 02.11.2020, this Court emphasised that
the evidence filed after priority date to show technical advance can only be
taken into account to confirm the existence of technical effect which is
found embedded in the specification in question and which is capable of
being understood by a skilled person having common general knowledge
and not to consider the same evidence to establish its effect for the first
time. There relevant paras are reproduced hereunder:-
“103. The plaintiffs’ argument that post filing data relating to the
invention is admissible is based on two grounds.
i. First and foremost, the applicant may not be fully aware of the
advances and properties of the subject invention, in this case, the
compound DAPA, on the priority date. In this behalf, it is stated that
DAPA's properties for treatment of heart failure came to be known
only subsequently.
ii. Second, there is no requirement in law that all properties,
advantages, and characteristics should be stated on the filing date of
the patent application. In support of their plea, the plaintiffs relied
upon Genetics institute, LLC, vs. Novartis vaccines, 655 F.3d 1291
(2011); and Knoll Pharm. Co. vs. Teva Pharms. USA, Inc., 367 F.3d
1381, 1385. It was argued that the plaintiffs had complied with the
best code rule as engrafted in Section 10(4) of the Act which is
qualified by the expression "known to the applicant". It was also
contended that they had satisfied the examiner on the aspect of
inventive step and factually the examiner had raised no such
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objection in his examination report of October 2007. The plaintiffs
also sought to contend that they met the plausible unknown technical
effect test as formulated in Generics (UK) Limited vs. Yeda
Research and Development Company Limited, (2017) EWHC 2629
(Pat).
104. In this context, I may refer to the judgement in Generics (UK)
Limited vs. Yeda Research and Development Company Limited, (2017)
EWHC 2629 (Pat) cited on behalf of the defendants. In this case,
Generics, which was the claimant, sought revocation of a European
patent [entitled low-frequency glatiramer acetate therapy] of which the
defendant i.e. Yeda was the registered proprietor and a third party [i.e.
Teva] was the exclusive licensee. One of the issues which arose for
consideration before the Court concerned the lack of inventive step for
want of technical contribution and insufficiency.
105. On behalf of Generics, it was contended that the claimed inventions
made no technical contribution to the art and, therefore, did not involve
inventive steps as summarized in another judgement i.e. Generics (UK)
Ltd vs Yeda Research and Development Co Ltd, [2013] EWCA Civ 925
Alternatively, it was argued that the technical contribution was
insufficient as per principles summarised by Kitchin LJ in Idenix
Pharmaceuticals Inc vs. Gilead Sciences Inc, [2016] EWCA Civ 1089.
The Court after discussing the issue made the following crucial
observations.
“ 197. In case this case goes further, I must briefly address the
Defendants' reliance upon evidence which post-dates the priority
date of the Patent. It is Signature Not I.A.Verified No. 8826/2020
in CS (COMM) No. 410/2020 & I.A. No. 8859/2020 in CS
(COMM) No. Digitally Signed By:VIPIN KUMAR RAI Signing
Date:02.11.2020 15:05:16 common ground that such evidence
can only be relied upon to confirm the existence of a technical
effect which is plausible in the light of the specification and the
skilled person's common general knowledge, and not to establish
the existence of a technical effect for the first time. ”
[Emphasis is mine]
106. Therefore, what emerges is this: that post priority date evidence
which has been furnished in Dr. Washburn's affidavit to show technical
advance can only be taken into account to confirm the existence of
technical effect which is found embedded in the specification of IN 625
and is capable of being understood by a skilled person having common
general knowledge and not to rely upon the same to establish its effect
for the first time.
107. The plaintiffs have not been able to demonstrate, at least at this
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stage, the existence of such technical effect in the specifications. The
plaintiffs' argument that the examiner should have been conscious of the
inventive step objection or that evidence of technical advance could be
placed before the Court even at this juncture fails to take into account the
plain language of Section 64(1)(f) read with Section 2 (1)(ja) of the Act.
The defendants are entitled, as noted above, to submit, in support of their
challenge, that there is no demonstrable technical advance as on the date
of priority of IN 625
.”
(Emphasis supplied)
49. Since the examples contained in the CS have various issues,
considering the data/information submitted by way of the affidavit and
annexures appended thereto would amount to establishment of the effect
for the first time as the information disclosed in the affidavit has no
reference at all in the CS.
50. In view of the above ratio and having regard to the fact that the CS is
silent regarding the negative effects of the composition in case the ratio of
ingredients in the composition is changed, the data provided under
paragraph 8 of Annexure 1 of the affidavit submitted by the appellant
cannot be permitted to be taken into consideration and has rightly been
rejected by the respondent.
51. On the other hand, the appellant relied on Bayer Pharm
Aktiengesellschaft vs. The Controller General of Patents and Designs,
C.A.(COMM.IPD-PAT) 255/2022, decided on 13.03.2024 by this Court to
submit that working examples are required to demonstrate the feasibility
and workability of an invention and they do not define the patent’s scope.
52. However, it is important to note that the example provided by the
appellant shows that the examples do not support the claimed invention, as
the claims contain 6 ingredients to produce the synergistic effect, while the
data contains examples of 4 ingredients and shows synergy. In effect, it
would mean that the claimed invention, as claimed under claim 1
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comprising 6 ingredients claimed to be therapeutic, is in conflict with the
CS. The Examples 4, 5 and 6 are reproduced as follows:-
“Example 4
A person was administered 1 g of the composition (any of composition a.,
b. c. d. or e.) along with warm water, twice a day for a period of six
months. The morning dose was administered half an hour before breakfast
and the evening dose an hour after dinner. The person was found to get
significant relief from asthma.
Example 5
A person was administered 1 g of the composition (composition e.) along
with warm water, twice a day for a period of seven months. The morning
dose was administered half an hour after breakfast and the evening dose
an hour after dinner. The person was found to get significant relief from
asthma.
Example 6
A person was administered 1 g of the composition (composition f.) along
with warm water, twice a day for a period of seven months. The morning
dose was administered half an hour after breakfast and the evening dose
an hour after dinner. The person was found to get significant relief from
asthma.”
53. The composition (f.) under Example 6, has 4 ingredients only and it
still results in significant relief from asthma. In view of the above discussed
reasoning of non-acceptance of data provided under the affidavit and issues
discussed regarding the examples of the CS, we hold that the present
invention lacks the inventive step under Section 2(1)(ja) of the Act. In the
absence of synergy and motivation from the cited prior arts, specifically
D6, D7 and D10, to add/combine 2 or more ingredients, the inventive step
is not established. The subject application is also not an invention under
Section 2(1)(j) of the Act as the invention is disclosed under the cited prior
arts D1 to D10 and other combinations of 4-5 compounds also show the
synergy like the claimed composition of 6 compounds.
54. Further, the examples under the CS do not support the claim of the
present invention in terms of the duration of treatment. The CS of the
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subject invention discloses 5 compositions consisting of all 6 herbs. The
concentration of each herb in each composition is different. As per the
clinical study data, the duration of treatment is in the range of 3 months to
8 months, irrespective of the type of composition. For instance, under
Example 1, it is administered twice a day for a period of three months,
where the morning dose is administered half an hour before breakfast and
the evening dose an hour after dinner.
55. Therefore, from the said data in the CS of the subject application, it
can be stated that different proportions of the herbs show the same
efficiency within the same duration of treatment.
56. In the absence of the synergy of the compound under the claimed
composition, the present invention lacks an inventive step as per the
definition of Section 2(1)(ja) of the Act.
57. Therefore, the invention claimed under the subject application does
not constitute an invention under Section 2(1)(j) of the Act.
OBJECTION ON THE GROUND OF SECTION 3(p) OF THE ACT:
58. As per the impugned order, the subject application is not allowed
under Section 3(p) of the Act as well.
59. Section 3(p) of the Act is reproduced as follows:-
“(p) an invention which in effect, is traditional knowledge or which is an
aggregation or duplication of known properties of traditionally known
component or components.”
60. The TK guidelines under principle 2 state that the combination of
plants with already known therapeutic effects with further plants with the
same known therapeutic agents is considered to be an obvious combination
if all plants are previously known for treating the same disease. Similarly,
the guiding principle 4 states that discovering the optimum/workable
ranges of traditionally known ingredients by routine experimentation is not
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inventive. The principles 2 and 4 of the TK Guidelines are reproduced as
follows:-
“Guiding Principle 2: Combination of plants with known-therapeutic
effect with further plants with the same known-therapeutic agents wherein
all plants are previously known for treating the same disease is
considered to be an obvious combination.
Guiding Principle 4: Discovering the Optimum or Workable Ranges of
Traditionally known ingredients by Routine experimentation is not
inventive.”
61. Since all 6 ingredients are previously known for treating the same
disease, the present invention is an obvious combination as per the Guiding
Principle 2. Additionally, as per guiding principle 4, discovering the
optimum/workable ranges of traditionally known ingredients through
Routine experimentation is also not inventive.
62. Thus, applying the scheme provided in the aforesaid Guiding
Principle no.2 and 4 to the facts of the claimed invention and considering
the absence of synergy as discussed earlier, it appears that the combination
of the ingredients present therein are already known for their treatment of
asthma and adding further ingredients with same known effects would fall
foul of Section 3(p) of the Act. Therefore, the subject application is not
patentable under Section 3(p) of the Act.
OBJECTION UNDER SECTION 10(4)(a) and (b) OF THE ACT:
63. To address the objection under Section 10(4)(a) and (b) of the Act,
the appellant has relied on the data submitted by way of the affidavit. As
discussed above, the data submitted by way of affidavit has been held to be
unacceptable above and therefore, additional information/data provided by
the appellant cannot be considered to overcome the objection under
Section10(4)(a) and (b) of the Act.
Signature Not Verified
Digitally Signed
By:YASHRAJ
Signing Date:22.06.2026
17:20:40
C.A.(COMM.IPD-PAT) 109/2022 Page 31 of 32
64. In view of the issues regarding the CS discussed above, the rejection
of the data submitted through the affidavit and considering the
abovementioned judgement in AstraZeneca AB (supra), the CS is not fully
and particularly disclosing the claimed invention as required under
Section10(4)(a) of the Act. Additionally, the present invention also fails to
disclose the best method of performing the invention as required under
Section 10(4)(b) of the Act.
65. Accordingly, as a result of the above analysis, the appeal fails and is
dismissed alongwith pending applications, if any. No costs.
TUSHAR RAO GEDELA
(JUDGE)
Sumit/rl
JUNE 22, 2026/
Signature Not Verified
Digitally Signed
By:YASHRAJ
Signing Date:22.06.2026
17:20:40
C.A.(COMM.IPD-PAT) 109/2022 Page 32 of 32