Array Biopharma Inc vs Deputy Controller Of Patents And … on 23 July, 2026

July 28, 2026

Delhi High Court

Array Biopharma Inc vs Deputy Controller Of Patents And … on 23 July, 2026

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
30.06.2023 (hereinafter referred to as ‘impugned order’) under Section 15
of the Act refusing the Patent Application No. 450/DELNP/2015 titled
“PHARMACEUTICAL COMBINATION COMPRISING A B RAF
INHIBITOR AN EGFR INHIBITOR AND OPTIONALLY A PI3K ALPHA
INHIBITOR” (hereinafter referred to as “subject application”) on the
ground of lack of inventive step under Section 2 (1) (ja) of the Act and non
patentability under Sections 3(d) and 3(i) of the Act.

SPONSORED

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2. The facts as culled out from the appeal and germane, are as under:-

2.1. It is the case of the appellant that the subject patent traces its
origin to a priority application filed on 07.08.2012 (US 61/680,473),
followed by an international PCT application (PCT/US2013/053619)
on 05.08.2013, which was published as WO2014/025688 on
13.02.2014. The corresponding Indian patent application was filed
on 19.01.2015 and was published under Section 11A of the Act on
26.06.2015. A request for examination was subsequently filed on
01.08.2016.

2.2. The appellant submits that the Indian Patent Office issued the
First Examination Report (hereinafter referred to as “FER”) on
24.08.2018, to which a response was duly filed on 06.02.2019.

Thereafter, a hearing notice dated 25.09.2020 fixed the matter for
hearing on 19.10.2020. The appellant sought an adjournment on
14.10.2020, following which the hearing was rescheduled to
19.11.2020. A second adjournment request was filed on 12.11.2020,
resulting in the hearing being further rescheduled to 21.12.2020, and
subsequently by the Controller to 05.01.2021.

2.3. The appellant submits that the hearing under Section 15 of the
Act was conducted on 05.01.2021, after which written submissions
were filed on 20.01.2021. Following a considerable lapse of time,
another hearing notice dated 10.03.2023 fixed the matter for
17.03.2023. The appellant sought an adjournment on 14.03.2023,
and the respondent thereafter rescheduled the hearing to 21.03.2023,
citing an incorrect prior art citation.

2.4. The appellant submits that, after the rescheduled hearing, a
petition under Rule 138 was filed on 30.03.2023 seeking a one-

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month extension of time to file hearing submissions. The hearing
submissions were thereafter filed on 01.05.2023, thereby placing the
appellant’s substantive response and supporting material on record
for consideration by the Patent Office.

2.5. It is the case of the appellant that, notwithstanding the
prosecution history and the submissions made, the Controller passed
the impugned order on 30.06.2023 under Section 15 of the Patents
Act refusing the grant of the patent. Subsequently, on 18.08.2023,
Form-6 was filed to record Array BioPharma Inc. as the applicant on
record.

2.6. Hence the present appeal.

CONTENTIONS OF APPELLANT

3. Ms. Archana Shankar, learned counsel appeared for the appellant and
submits as under:

3.1. At the outset, learned counsel submits that the Claim 1 of the
subject application is in relation to a pharmaceutical combination. It
is stated that the claims of the subject application are directed to a
combination of 2/3 specific drugs having a specific structure and
formula with different mechanism of action. It is stated that the dual
combination comprises (a) compound A (encorafenib) which is a B-

Raf Inhibitor and (b) Cetuximab/Erlotinib (EGFR Inhibitor), while
the triple combination comprises (a) compound A (encorafenib)
which is a B-Raf Inhibitor and (b) Cetuximab/Erlotinib (EGFR
Inhibitor) and (c) compound B (PI3K-α Inhibitor). A table
demonstrating how the specific compound i.e. compound A (B-Raf
Inhibitor), compound B (PI3K – Inhibitor) and Erlotinib/Cetuximab
(EGFR Inhibitor) are used in the said combination and relied upon
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by the appellant is given below:

3.2. Predicated upon the aforesaid combination of specific
compounds, the learned counsel would assert that the data which has
been collated from the tests conducted in respect of each of such
combinations has revealed and demonstrated technical
advancement/synergistic effect. In order to further clarify, learned
counsel would submit that the data in the Complete Specifications
(hereinafter referred to as ‘CS’), also provides that the said
dual/triple combination of the specific drugs having three different
mechanism of actions as per the claimed invention is the synergistic
combination that improves the therapeutically relevant selectivity. It
is contended that the data clearly demonstrates surprising and
unexpected therapeutic benefits. In that, not only does the
combination demonstrate a synergistic therapeutic effect with regard
to alleviating, delaying progression of or inhibiting the symptoms but
also in fewer side effects, more durable response, an improved
quality of life or a decreased morbidity, in comparison to the
monotherapy applying one of the pharmaceutically therapeutic

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agents.

3.3. Dilating further on the aforesaid, learned counsel referred to
the clinical studies contained in the CS which have been verified as
two Phase Ib and Phase II clinical trial studies. She would submit
that Examples 2 & 3 in the CS provide the data from the clinical
studies. Learned counsel relied upon the following table to
substantiate her arguments:-

3.4. Pointing out to Group 6 in the aforesaid table, she would
contend that Compound A in dual combination with Cetuximab
slowed down the tumor progression to 12% and indicated significant
inhibition. It was stated that the said combination showed significant
improvement upon Compound A monotherapy in Group 2 (95%)
and Cetuximab monotherapy in Group 4 (88%). Referring to Group
8 of the aforesaid table, it is contended that Compound A,
Compound B and Cetuximab in triple combination resulted in tumor
progression as well as tumor regression by (-)2%. According to her,
this treatment immensely improved the treatment over and above
Compound A monotherapy in Group 2 (95%), Compound B
monotherapy in Group 3 (57%) and Cetuximab monotherapy in
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Group 4 (88%). For clarification, learned counsel would submit that
the lesser percentage is indicative of significant slowing down of
progression of the tumor. In other words, appellant asserts that the
data is clear indicator of surprising and unexpected properties of the
claimed invention using 2 or 3 specific drugs in comparison to the
Compound A alone being administered, or Compound B alone or
EFGR alone as also Compound A+B or Compound B+Cetuximab.
3.5. It is thus contended that the respondent neither appreciated nor
considered the aforesaid data nor analysed its synergistic surprising
effects.

3.6. It was next contended that the claim is a combination product
and not a method of treatment to fall under the exception stipulated
under Section 3(i) of the Act and the claimed invention has to be
assessed as a whole. Learned counsel would contend that in order to
appreciate the claimed invention the nature and scope of the same
must be determined by reading the claims, the complete
specifications and all the disclosures as a unified whole. It is stoutly
contended that the present claims are product claims directed to a
“pharmaceutical combinations” and not to a method of treatment of
human beings as has been incorrectly assessed by the respondent. It
is submitted that the erroneous conclusion is based on incorrect
characterisation of the invention by fragmenting the claim language
and reading individual portions of the specifications in isolation. In
other words, the subject matter which is excluded by Section 3(i) of
the Act is the process and not a product or a combination or even a
pharmaceutical entity.

3.7. It is emphasized that Claim 1 of the subject application
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provides for a functional descriptor of the claimed pharmaceutical
combination as a product and not as a method step. It only describes
a range of ways in which the constituent actives may be administered
without transforming the product into a method. The appellant relied
on the judgment in the case of Nestle SA vs. Controller of Patents &
Designs [CA (COMM).IPD-PAT) 22/2022] particularly upon para
14 & 15 to submit that the mere use of the expression “treatment” in
a claim need not necessarily render it as a method of treatment
proscribed under Section 3(i) of the Act. It was further stated that the
expression “composition for the treatment”, was held to be used for
defining the combination and not for claiming a method of treatment.

For similar reasons, the appellant also relied upon the judgment in
Medilabo RFP Ink Inc. vs. Controller of Patents, (CA
(COMM).IPD-PAT) 16/2024 of this Court.

3.8. It was emphasized that the clinical trial data and dosing
schedules in the CS demonstrates the clinical efficacy of the
combination, the synergistic interaction of the specific compounds as
a defined combination product. These are evidence of the
combination utility under Section 2(1)(ac) and not a definition of the
claimed invention. Learned counsel would submit that the use of the
terms “treatment” or “administration” in the claim would neither
alter nor display the inventive concept since the inventive concept
resides in the combination itself.

3.9. Learned counsel heavily relied upon the counterpart EP patent
number 2882440 where similar combination products were not
considered as methods for treatment. In order to substantiate the
similarity of objections in the European Patent Convention and the
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proscription in Section 3(i) of the Act, learned counsel referred to
Article 53(c) of the EP Convention wherein methods for treatment of
the human etc., are non patentable, yet, the European Counterpart of
the claimed invention was granted patent. Learned counsel has relied
upon the following table in order to substantiate the aforesaid
contentions:

3.10. To lend credence to the aforesaid submissions, learned counsel
relied upon the decision of the Intellectual Property Appellate Board
(IPAB) in the case of Ranbaxy Laboratories Ltd. vs. The Controller
of Patents & Designs (OA)/15/2011/PT/MUM) particularly para 3 to
submit that the combination of 2 or more actives are permitted and
the inventive concept/unexpected technical advantages is based on
the final outcome and effect of the said combination. Thus,
according to the learned counsel, the finding of the respondent that
the claimed invention is a method of treatment of human beings and
non patentable under Section 3(i) of the Act is not only erroneous but

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also unfounded.

3.11. The learned counsel next contended that the conclusion of the
respondent of the claimed invention being non patentable under
Section 3(d) of the Act also is erroneous and contrary to the facts on
record. It was contended that the provisions of Section 3(d) of the
Act are not attracted to a combination of independent Active
Pharmaceuticals Agents (APA).

3.12. Ms. Shankar stoutly contended that the claimed combination
of 2 or 3 pharmacologically active specific agents i.e. a B-Raf
Inhibitor, an EFGR Inhibitor and an optional PI3K-α is not a new
form, salt, ester, ether, polymorph, metabolite, isomer, or derivative
of any known substance referred to in the prior art. In fact, according
to the appellant the claimed invention is a combination of distinct
and independent APA. She relied upon the judgment of IPAB in
Ajantha Pharma Ltd. vs. Allergan Inc. & Ors. (Order No.173/2013)
where, it is stated that, the Board held that a combination of two
active drugs cannot be considered derivatives of each other and that
the “combination” referred to in the Explanation to Section 3(d) can
only mean a combination of two or more derivatives enumerated in
the Explanation or a combination of one or more such derivatives
with the known substance itself and not a combination of two
independent active substances. Based on such analysis, the objection
under Section 3(d) was rejected by the IPAB.

3.13. Thus, according to the learned counsel, it would follow from
the aforesaid decision of the IPAB that a combination of two or more
independent APA, each with its own distinct chemical identity,
mechanism of action and therapeutic profile, would clearly fall
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outside this Court and ambit of Section 3(d) of the Act. To the same
effect, reliance was placed on the judgment of the Calcutta High
Court in Topotarget UK Ltd. vs. Controller General of Patents &
Designs, Mumbai & Ors., (IPDPTA/50/2023).

3.14. In the alternative, learned counsel would contend that without
prejudice even assuming that Section 3(d) is applicable, the threshold
of enhanced therapeutic efficacy in any case is satisfied having
regard to the data placed on record by the appellant. Learned counsel
places reliance on the table referred to in para 3.3 above.
3.15. So far as the objections under Section 10 (4) of the Act are
concerned, learned counsel would submit that the appellant has
discharged its disclosure obligations fully and completely. It is
asserted that the CS not only discloses the invention, its operation
but also the best method known to the appellant for performing it.
The clinical trial data contained in the CS clearly demonstrates the
technical advancement achieved in the combinations disclosed. As
such, the disclosure, according to the appellant, is not merely
perfunctory or inadequate but exemplary.

3.16. Relying upon Topotarget (supra), learned counsel would
contend that the Court has clarified the scope of the requirement of
the disclosure as contemplated in Section 10(4) of the Act in the
context of pharmaceutical combination patents. It was stated that in
para 15, it was held that while Section 10(4) requires full and
particular description of the invention and its best method of
performance, the said requirement does not necessitate that the CS
should contain illustrative examples for every conceivable
embodiment or specific combinations falling within the scope of the
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claims. It was further held that the findings of insufficiency of
disclosure and lack of inventive steps in the same order are not only
contradictory but also irreconcilable.

3.17. Learned counsel next referred to the objections sustained by
the respondent in respect of Section 2(1)(ja) of the Act. At the outset,
learned counsel vehemently submitted that the impugned order does
not contain any analysis on the question of inventive steps. Equally,
it neither identifies the closest prior art document nor articulates the
technical problem that the claimed invention solves over the closest
prior art. According to her, the inventive step of the present
combination is clearly demonstrable and discernible from the
unexpected technical advantage brought out in the clinical trial data
set out in the CS. In reiteration of the earlier submissions, learned
counsel would submit that the inventive step is established by the
fact that the dual combination demonstrates a 12% reduction in the
tumor progression and the triple combination has achieved tumor
regression of (-)2%. It is stated that this unexpected result, which
was unforeseeable from the prior art, itself is a conclusive evidence
of inventive step under Section 2(1)(ja) of the Act and constitutes
technical advancement.

3.18. Distinguishing the 4 prior arts i.e. D1 to D4, learned counsel
would submit as under:

● Cited Document D1 is directed to a new chemical entity in the
B-Raf inhibitor class. The only combination disclosed in document
D1 is at paragraph 43 and Figure 1 which is a combination of a
specific Compound 9 (B-Raf inhibitor- Methyl N-[(2S)-1-({4-[3-(5-
chloro-2-fluoro-3-methanesulfonamidophenyl)-1-(propan-2-yl)-1H-

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pyrazol-4-yl]pyrimidin-2-yl}amino)propan-2-yl]carbamate) with
Compound A3 (a MEK inhibitor). Document D1 contains no
disclosure of, and provides no teaching towards, any combination
involving an EGFR inhibitor or a PI3K-α inhibitor.

● A Person Skilled in the Art from D1 would not be motivated
to replace the Braf inhibitor of D1 with B- Raf inhibitor Compound
A (INN Encorafenib) as claimed in the present invention and also
replace the MEK inhibitor of D1 with 2 other specific actives ( PI3K
and EGFR) of the present invention because none of the other cited
prior arts teach the said specific actives with 2 different mechanism
of action Erlotinib/Cetuximab and PI3K-α inhibitor (INN alpelisib).
● It is submitted that the Document D2/IPD2 must be read and
understood as a whole and it is not a combination patent. This prior
art is directed to prognostic methods for identifying tumours which
are not susceptible to B-Raf inhibitor treatment by detecting
mutations in a K-ras gene or protein.

● Figures 34A and 34B of D2, which the Controller relied upon,
relate to a specific B-Raf inhibitor in the context of this prognostic
teaching and the document do not disclose/suggest/teach any
combination of a B-Raf inhibitor with an EGFR inhibitor or a PI3K-
α inhibitor as claimed in the present application.

● Document D3 discloses two specific compounds none of
which is the specific actives with 3 mechanism of actions as recited
in claim 1 of the present application. D3 does not disclose:

“• The B-Raf inhibitor in D3 (Compound A of D3) is not
Encorafenib : the specific B-Raf inhibitor of the present invention.
• The PI3K inhibitor in D3 (Compound B of D3) is not Alpelisib —
the specific PI3K-α inhibitor of the present invention.

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• D3 contains no disclosure whatsoever of an EGFR inhibitor;
neither Erlotinib nor Cetuximab nor any other EGFR inhibitor appears
anywhere in D3.

• D3 accordingly contains no disclosure of the dual combination (B-
Raf + EGFR) or the triple combination (B-Raf + EGFR + PI3K-α) that
forms the subject matter of the present invention.”

● Cited document D4 is directed solely to a novel PI3K inhibitor
as a chemical entity. D4 addresses a different technical problem i.e.
the identification and characterisation of PI3K inhibitors and
compared to the present invention it is a non-analogous prior art.
3.19. Predicated upon the aforesaid distinction drawn, learned
counsel would forcefully contend that none of the aforesaid
documents whether considered independently or a combination
disclose or suggest, (a) the specific B-Raf Inhibitor Encorafenib
(Compound A of the present invention); (b) the specific EGFR
Inhibitors Erlotinib or Cetuximab (Compound 2 of the present
invention); (c) the specific PI3K-(put alfa mark) Inhibitor Alpelisib
(Compound 3 of the present invention) or (d) the dual combination of
Encorafenib with Erlotonib/Cetuximab, or the triple combination of
all three agents together.

3.20. Ms. Shankar would submit that by reading D1, D2, D3 and D4
as of the priority date, a person skilled in the art would have no
motivation let alone a reasonable expectation of success to select these
specific agents from the vast landscape of B-Raf Inhibitors, EGFR
Inhibitors and PI3K Inhibitors available and combine them in a
precise manner as put forth in the claimed invention. It was asserted
that no document in the prior art discloses the specific agents as
claimed. The learned counsel referred to and relied upon the
Guidelines for Examination of Patent Applications in the Field of
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Pharmaceuticals, October, 2014 (Clauses 7.2 and 7.6) as well as
MANUAL OF PATENT OFFICE PRACTICE AND PROCEDURE
Version 3.0 dated 26th November, 2019. Clauses 7.2 of the
Guidelines is reproduced as follows:

“Guidelines for Examination of Patent Applications in the Field of
Pharmaceuticals:

7.2 …..A generic disclosure in the prior art may not necessarily take away
the novelty of a specific disclosure. A specific disclosure in the prior art
takes away the novelty of a generic disclosure.”

3.21. Learned counsel also relied upon the judgments in Biomoneta
Research Pvt. Ltd. Controller General of Patents & Designs and
Anr., (2023/DHC/001816) particularly para 64, Groz-Beckert KG vs.
Union of India and Others (2023 SCC OnLine Cal 111) particularly
para 7, Guangdong Oppo Mobile Telecommunications Corp. Ltd. vs.
The Controller of Patents and Designs (AID No.20 of 2022)
particularly para 12 & 13, Titan Umreifungstechnik Gmbh and Co.
KG vs. Assistant Controller of Patents and Designs and Anr.
(2023:DHC:3832).

3.22. As a concluding argument, Ms. Shankar, learned counsel
submitted that each of the prior art documents D-1 to D-4 were cited
in the counterpart patent granted in Australia, Canada, EP and USA.
She would submit that though the said grant of patent may not be
binding upon the Indian Patent Office on the ground of territoriality,
however, such grant would surely have a persuasive value. She would
emphasize that in each of the said jurisdictions and for the same
combination product, the very same prior arts having been cited,
tested and distinguished granting patent which is the subject matter of
the subject application needs to be appreciated and rightly considered
by this Court. Additionally, she relies on the judgement of this Court
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in Biomoneta Research (supra) and Nestle SA (supra) and the
judgment of the Madras High Court in Shaperon Inc. v. Assistant
Controller of Patents and Designs [(T) CMA(PT) No.46/2023].
3.23. On the basis of the aforesaid arguments, she prays that the
impugned order may be set aside and the subject patent application be
allowed and patent be granted.

CONTENTIONS OF THE RESPONDENT.

4. Mr. Rohan Jaitley, learned CGSC, appearing for the respondent,
refutes the submissions made on behalf of the appellant and supports the
analysis and findings recorded in the impugned order. He submits as under:

4.1. At the outset, Mr. Jaitley, learned CGSC would contend that
the claimed invention is a method of treatment contrary to the
submissions made by the appellant, and thus, barred under the
provisions of Section 3(i) of the Act. He draws attention of the
phrase “for simultaneous, separate or sequential administration” is
not a statement as to what is a pharmaceutical product, but a
description of therapeutic protocol and is a treatment schedule which
is non-patentable. He would urge that the title of the application
itself would suggest that it is directed at the therapeutic use
combination rather than any fixed formulation. He would also
contend that the CS itself demonstrates that the inventive
contribution is the therapy by itself and not any physical product. He
would invite attention to the elaborate Phase Ib and Phase II clinical
trial protocol defining the patient population selection criteria, dose
escalation schedules, and treatment duration clearly depicts a
treatment methodology and definitely not a pharmaceutical product.

Further, according to him, the details such as “Compound A: Capsule
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for oral use as assigned once or twice daily; Compound B: Tablet
for oral use once or twice use daily; Cetuximab: Intravenous
Infusion 400mg/m2/250mg/m2 subsequent” is a clear and undoubted
pointer that this is a clinical treatment protocol and not a product
specification.

4.2. He would also contend that even otherwise there is nothing
novel about any physical product in the present subject patent
application. He would assert that Compound A is a known
compound; Cetuximab is a known drug; Erlotinib is a known drug,
Compound B is a known compound and all are available in a
pharmacy which can be obtained by any person separately.
Moreover, according to him, the appellant has not claimed any new
physical product rather, what is claimed is the idea of giving these
three known compounds/drugs to the same patient in sequence or
simultaneously. Consequently, it is apparent that this is a treatment
process and a therapy which is why the objections under Section 3(i)
have not been met with by the appellant either before the respondent
or even before this Court.

4.3. Learned CGSC would next contend that the claimed invention
does not involve any inventive step as envisaged under Section
2(1)(ja) of the Act. He would emphasize that what the appellant has
actually done is mosaicing and combining the teachings from the
multiple prior art documents D-1 to D-4 and presented the same as
the new invention which in view of the teachings in the prior arts
document render the claim obvious. According to him, there is a
clear motivation to combine them and a reasonable expectation of
success. In order to justify the aforesaid submission, the learned
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CGSC relied on the following table:

4.4. On the basis of the aforesaid tables, learned CGSC would
submit as under:

4.4.1. Prior arts D-1 and D-2 specifically disclose the specific B-Raf
inhibitor of the claimed invention and generally disclose the
combination with growth fact inhibitors and PI3K inhibitor.
4.4.2. Para 53-55 of the document at pg.308-310 of the appeal
paperbook discloses the compounds that can be used in
combination with one or more therapeutics such as growth
factor inhibitors and PI3K inhibitors. The present subject
application is covered by the prior art document D-2. In that,
para 71 of the said document discloses of inhibitors of EGFR
signalling like Erlotinib (TARCEVA), Gefitinib (IRESSA),
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Lapatinib, Pelitinib, Cetuximab, Panitumumab, Zalutumumab,
Nimotuzumab and Matuzumab.

4.4.3. If D-1, IPD-2 and D-4 are read together, person skilled in the
art (PSITA) working on the B-Raf mutant colorectal cancer,
would have been motivated to use the triple combination of
compound A (encorafenib), EGFR inhibitor
(Erlotinib/Cetuximab) and Compound B as the teaching is
specifically taught and supported by experimental synergy data.

This combined teaching has not been refuted by the appellant.
All individual elements are known, combination thereof is
specifically taught and the synergy is already demonstrated in
the prior art for the same cancer in the same models.
4.5. In addition to the aforesaid argument, learned CGSC
vehemently contended that the subject patent application is in the
nature of ever greening of the compounds and the patents. He would
contend that no monopoly should be granted for the reason that the
invention is not a pharmaceutical product rather is a therapeutic
regimen combining three separately available drugs and hence, non-
patentable under Section 3(i) of the Act unlike the product saving
carved out in European Patent Convention Article 53(c). He would
contend that such an exception was not carved out deliberately by the
legislature which was confirmed by the Supreme Court in Novartis
AG v. Union of India: (2013) 6 SCC 1.

4.6. Even on the merits of the inventive step, learned counsel
would contend that the claimed combination is obvious over the
prior art. In that, D-1 discloses compound A, specifically for B-Raf
V600E Colorectal Cancer; IPDII discloses combining B-Raf
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inhibitors with Cetuximab and Erlotinib for the same cancer with in
vivo data from the same animal model. The Correct D-4 discloses the
triple combination of Compound A, Compound B and EGFR
inhibitors including Erlotinib and Ceturimab by name with synergic
data. According to learned counsel, a person skilled in the art reading
these documents would have every reason and expectation to
combine these 3 known drugs for B-Raf mutant Colorectal Cancer.
Predicated on the aforesaid, learned CGSC would emphatically
submit that the results placed on record by the appellant are neither
surprising nor unexpected. The prior arts already disclose synergy
for this combination.

4.7. Learned CGSC next forcefully contended that even otherwise
“public interest” constitutes an independent and compelling reason
warranting refusal to grant patent. He relies upon the judgment of
this Court in Zydus Lifesciences Ltd. v. ER Squibb & Sons LLC,
Neutral Citation: 2026:DHC:178-DB, which according to him
recognized that public interest in access to life saving medicines and
health of the community is a paramount consideration that the Courts
and the Controller must weigh while adjudicating pharmaceutical
patent claims and that a grant of monopoly over a cancer treatment
combination available to the patients would be contrary to such
public interest. In other words, he would submit that a combination
of three drugs already independently available for the treatment of
Colorectal Cancer would directly impair patient access and the
contrary to public interest. In that view of the matter, learned counsel
would pray that the appeal be dismissed.

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ANALYSIS AND CONCLUSION

5. This Court has heard the arguments of Ms. Shankar learned counsel
for the appellant and Mr. Rohan Jaitley, learned CGSC for the respondent
and examined the record.

6. Before adverting to the merits of the appeal, it would be apposite to
understand the nature of the claimed invention. The CS of the subject
application, claims that the present invention pertains to a combination of a
B-Raf kinase inhibitor and an Epidermal Growth Factor Receptor (EGFR),
which is also known as ErbB-1 or HER-1 inhibitor and, optionally a third
inhibitor, a phosphatidylinositol 3-kinase (PI3-kinases or PI3K), and is
used for the treatment of proliferative diseases. The field of invention of the
subject application is reproduced as follows:

“FIELD OF THE INVENTION
A combination of a B-Raf kinase inhibitor and an epidermal growth factor
receptor (EGFR also known as ErbB-1 or HER-1) inhibitor and, optionally,
a phosphatidylinositol 3-kinase (PI 3-kinases or PI3K) inhibitor which is
used for the treatment of proliferative diseases. This invention also relates
to the uses of such a combination in the treatment of proliferative diseases;
to pharmaceutical compositions of the combination of agents and methods
of treating a subject suffering from a proliferative disease comprising
administering a therapeutically effective amount of such a combination to
the subject.”

7. The present invention under the subject application is useful for
separate as well as simultaneous/ sequential administration to a subject who
requires it for the treatment or prevention of a proliferative disease. For
better understanding, the summary of the invention is reproduced as
follows:

“SUMMARY OF THE INVENTION
The present invention relates to a therapeutic combination comprising: (a)
a B-Raf inhibitor, (b) an EGFR inhibitor and, optionally, (c) a PBK
inhibitor, useful for separate, simultaneous or sequential administration to a
subject in need thereof for treating or preventing a proliferative disease.
The present invention especially relates to a therapeutic combination
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comprising: (a) a B-Raf inhibitor of the formula”

or a pharmaceutically acceptable salt thereof (hereinafter referred
to as Compound A), (b) an EGFR inhibitor, and, optionally,

8. The dual combination claimed under claim 1 of the subject
application comprises B-Raf inhibitor Compound A (Encorafenib) which is
a B-Raf Inhibitor and Cetuximab/Erlotinib (EGFR inhibitor). Further,
optionally, claim 1 also claims a triple recombination of the compounds.
The triple recombination comprises of Compound A (Encorafenib) which
is a B-Raf inhibitor, Cetuximab/Erlotinib (EGFR inhibitor), and the third
compound which is Compound B (PI3K-α inhibitor). Claim 1 of the
present invention is as follows:

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9. Having noted the invention claimed, it may be necessary for this
Court to now examine the prior arts which were relied upon by the
respondent in the impugned order to refuse grant of patent.
PRIOR ART D1

10. The claimed invention under the Prior art D1 (W02011025927)
provides a novel class of compounds of formula I and pharmaceutical
compositions comprising such compounds and methods of using these
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compounds to treat/ prevent diseases associated with abnormal/deregulated
kinase activity, specifically diseases/disorders that involve abnormal
activation of B-Raf.

11. D1 discloses compounds of Formula I. The specific compounds 9, 20
disclosed in Table 1 of D1 which are reproduced as follows:

12. D1 under Para [0027] and [0047] discloses B-raf kinases which can
be used to treat kinase-related diseases. D1 under para [0047] also
discloses that the development of a kinase inhibitor for B-Raf leads to a
new therapeutic opportunity for treatment of several types of human
cancers such as metastatic melanomas, solid tumours, brain tumours such
as Glioblastoma multiforme (GBM), etc. The relevant paras are reproduced
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as follows:

“[0027] The present invention provides compounds, compositions and
methods for the treatment of kinase related disease, particularly B-Raf kinase
related diseases; for example, metastatic melanomas, solid tumors, brain
tumors such as Glioblastoma multiform (GBM), acute myelogenous leukemia
(AML), prostate cancer, gastric cancer, papillary thyroid carcinoma, ovarian
low-grade carcinoma, and colorectal cancer.

[0047] Therefore, development of a kinase inhibitor for B-Raf provides a
new therapeutic opportunity for treatment of many types of human cancers,
especially for metastatic melanomas, solid tumors, brain tumors such as
Glioblastoma multiform (GBM), acute myelogenous leukemia (AML), lung
cancer; papillary thyroid carcinoma, ovarian lowgrade carcinoma, and
colorectal cancer. Several Raf kinase inhibitors have been described as
exhibiting efficacy in inhibiting tumor cell proliferation in vitro and/or in vivo
assays (see, for example, U.S. Pat. Nos. 6,391,636, 6,358,932, 6,037,136,
5,717,100, 6,458,813, 6,204,467, and 6,268,391). Other patents and patent
applications suggest the use of Raf kinase inhibitors for treating leukemia
(see, for example, U.S. Patent Nos. 6,268,391, 6,204,467, 6,756,410, and
6,281,193; and abandoned U.S. Patent Application Nos. 20020137774 and
20010006975), or for treating breast cancer (see, for example, U.S. Patent
Nos. 6,358,932, 5,717,100, 6,458,813, 6,268,391, 6,204,467 and 6,911,446).
Data demonstrates that Raf kinase inhibitors can significantly inhibit
signaling through the MAPK pathway, leading to dramatic shrinkage in B-
Raf (V600E) tumors.”

[emphasis suppled]

13. Para 50 of D1 discloses that compounds of the invention need to be
administered in therapeutically effective amounts, via any of the usual and
acceptable modes known in the art, either singly or in combination with
one or more therapeutic agents. Para 53 to 55 of D1 also discloses the same
issue. Para 61 notes that such administration provides therapeutically
effective levels of the 2 compounds in the body of the patient. For the
purpose of convenience, the contents of para [0050] and para [0053] to
[0055] and [0061] are reproduced as follows:

“[0050] In general, compounds of the invention will be administered in
therapeutically effective amounts via any of the usual and acceptable
modes known in the art, either singly or in combination with one or more
therapeutic agents. A therapeutically effective amount may vary widely
depending on the severity of the disease, the age and relative health of the
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subject, the potency of the compound used and other factors. In general,
satisfactory results are indicated to be obtained systemically at daily
dosages of from about 0.03 to 30mg/kg per body weight. An indicated
daily dosage in the larger mammal, e.g. humans, is in the range from
about 0.5mg to about 2000mg, conveniently administered, e.g. in divided
doses up to four times a day or in retard form. Suitable unit dosage forms
for oral administration comprise from ca. 1 to 500mg active ingredient.

**** **** ****
[0053] Compounds of the invention can be administered in therapeutically
effective amounts in combination with one or more therapeutic agents
(pharmaceutical combinations). For example, synergistic effects can occur
with other anti-tumor or antiproliferative agents, for example, mitotic
inhibitors, alkylating agents, anti-metabolites, intercalating antibiotics,
growth factor inhibitors, cell cycle inhibitors, enzymes, topoisomerase
inhibitors, biological response modifiers, antibodies, cytotoxics,
antihormones, anti-androgens, an anti- angiogenesis agent, kinase
inhibitor, pan kinase inhibitor or growth factor inhibitor.
[0054] Compounds of the invention can be administered in therapeutically
effective amounts in combination with one or more suitable excipients
selected from com starch, potato starch, tapioca starch, starch paste, pre-
gelatinized starch, sugars, gelatin, natural gums, synthetic gums, sodium
alginate, alginic acid, tragacanth, guar gum, cellulose, ethyl cellulose,
cellulose acetate, carboxymethyl cellulose calcium, sodium
carboxymethylcellulose, methyl cellulose, hydroxypropyl methylcellulose,
microcrystalline cellulose, magnesium aluminum silicate, polyvinyl
pyrrolidone, talc, calcium carbonate, powdered cellulose, dextrates,
kaolin, mannitol, silicic acid, sorbitol, agar-agar, sodium carbonate,
croscarmellose sodium, crospovidone, polacrilin potassium, sodium starch
glycolate, clays, sodium stearate, calcium stearate, magnesium stearate,
stearic acid, mineral oil, light mineral oil, glycerin, sorbitol, mannitol,
polyethylene glycol, other glycols, sodium lauryl sulfate, hydrogenated
vegetable oil, peanut oil, cottonseed oil, sunflower oil, sesame oil, olive
oil, com oil, soybean oil, zinc stearate, sodium oleate, ethyl oleate, ethyl
laureate, silica, and combinations thereof.

[0055] An embodiment of the invention is a method of claim 12 or 13,
further comprising administering to the subject an additional therapeutic
agent. The additional therapeutic agent comprises an anticancer drug, a
pain medication, an antiemetic, an antidepressant or an anti-inflammatory
agent. Further, the additional therapeutic agent is a different Raf kinase
inhibitor or an inhibitor of MEK, mTOR, HSP90, AKT, PI3K, CDK9,
PAK, Protein Kinase C, a MAP kinase, a MAPK Kinase, or ERK and is
administered to the subject concurrently with a compound of the invention.

**** **** ****
[0061] The term “pharmaceutical combination” as used herein means a
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product that results from the mixing or combining of more than one active
ingredient and includes both fixed and non-fixed combinations of the
active ingredients. The term “fixed combination” means that the active
ingredients, e.g. a compound of Formula I and a coagent, are both
administered to a patient simultaneously in the form of a single entity or
dosage. The term “non-fixed combination” means that the active
ingredients, e.g. a compound of Formula I and a co-agent, are both
administered to a patient as separate entities either simultaneously,
concurrently or sequentially with no specific time limits, wherein such
administration provides therapeutically effective levels of the 2 compounds
in the body of the patient. The latter also applies to cocktail therapy, e.g.
the administration of 3 or more active ingredients.”

14. It is to be noted that compound A of claimed invention is disclosed
in para 43 of D1 as compound 9, namely, ((S)-methyl 1-(4-(3-(5-chloro-2-
fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl -lH-pyrazol-4-
yl)pyrimidin-2-ylamino )propan-2- ylcarbamate).

15. Additionally, it would be significant to note that para 55 of D1
specifies the additional inhibitor as an inhibitor of MEK, mTOR, HSP90,
AKT, CDK9, PAK, Protein Kinase C, a MAP kinase, a MAPK Kinase, or
ERK, including the PI3K inhibitor, however does not at all disclose PI3k-α
inhibitor which is specified in Claim 1 of the claimed invention.
PRIOR ART D2

16. Prior art D2 or IPD2 (1403/DELNP/2012) is titled as
“DETERMINING SENSITIVITY OF CELLS TO B-RAF INHIBITOR
TREATMENT BY DETECTING KRAS MUTATION AND RTK
EXPRESSION LEVELS” and pertains to cancer diagnostics and therapies
and specifically to the detection of mutations or RTK overexpression that
are diagnostic and/or prognostic and correlating the detection with
treatment of cancer.

17. Under para 56, D2 discloses administering an effective amount of an
inhibitor of EGFR signaling in combination with a B-Raf inhibitor. For the
purpose of clarity, para 56 is reproduced as follows:

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“[0056] In one embodiment, the subject matter disclosed herein relates to a
method of identifying a patient nonresponsive to treatment with a B-Raf
inhibitor, comprising determining the presence or absence of a K-ras mutation,
whereby the presence of a K-ras mutation indicates a patient will not respond to
said B-Raf inhibitor treatment. In one example, the method further comprises
administering an effective amount of a MEK or ERK inhibitor to said
nonresponsive patient. In another example, the method further comprises
administering an effective amount of an inhibitor of EGFR signalling. In
another example, the method further comprises administering an effective
amount of an inhibitor of EGFR signaling in combination with a B-Raf
inhibitor.”

18. Further, under para 71 and 72, D2 notes that EGFR signalling is
known in the art and includes erlotinib (TARCEVA®), gefitinib
(IRESSA®), Cetuximab etc., among others. Para 71 of D2 also discloses
erlotinib/ Cetuximab. Further, para 72 discloses some B-Raf inhibitors, but
the inhibitor Encorafenib is not disclosed in D2. The paragraphs 71 and 72
and other relevant para 69 and 70 are reproduced as follows:

“[0069] In certain embodiments, for those samples, tumors, cancers, subjects or
patients determined to be unresponsive to a B-Raf inhibitor, the methods further
comprise administering an effective amount of a ERK inhibitor to said
unresponsive samples, tumors, cancers, subjects or patients. In another
example, the method further comprise_s administering an effective amount of an
inhibitor of EGFR signaling. In another example, the method further comprises
administering an effective amount of an inhibitor of EGFR signaling in
combination with a B-Raf inhibitor.

[0070) EGFR signaling can be inhibited by a variety of methods, including
inhibiting EGFR kinase activity, binding to the extracellular domain of EGFR to
inhibit activation or by inhibiting the activity and signaling of EGF ligand.
[0071) Inhibitors of EGFR signaling are known in the art and include, for
example, erlotinib (TARCEVA®), gefitinib (IRESSA®), lapatinib, pelitinib,
Cetuximab, panitumumab, zalutumumab, nimotuzumab and matuzumab, and
those described in U.S. Pat. No. 5,747,498.

[0072] B-Raf inhibitors are known in the art and include, for example,
sorafenib, PLX4720, :PLX-3603, GSK2II8436, GDC-0879, N-(3-(5-( 4-
chlorophenyl)-I H-pyrrolo[2,3-b]pyridine-3-carbonyl)-2,4-
difluorophenyl)propane-l-sulfonamide, and those described in WO2007/002325,
WO2007/002433, WO2009111278, WO2009111279, WO20091l1277, WO20091
l 1280 and U.S. Pat. No. 7,491,829.

19. Additionally, para [0019] of the D2 specifies that the invention
therein, relates to methods of treating a tumour which is non-responsive to
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B-Raf inhibitor treatment. The said para further specifies that the methods
include administering a B-Raf inhibitor in combination with an EGFR
inhibitor. Further, it is important to note that although para 71 of D2
specifies the inhibitor erlotinib/ Cetuximab individually, however, not the
combination thereof. It is observed in paragraph 19 of D2 that EGFR
inhibitors are mentioned in combination with B-raf inhibitor, but it is only
EGFR inhibitors in general and not erlotinib/ Cetuximab specifically.
Further, the para [0019] only notes the B-raf inhibitor, and does not specify
the B-raf inhibitor, which is claimed in the present invention. Further, the
para [0072], while disclosing the various types of B-Raf inhibitors, also
does not specify Encorafenib/Compound A of the present invention.

20. D2 under para 51, specifies the combination of the RAF inh a and
Erlotinib (Tarceva) administered to Mice and notes the increased efficacy.
As given under para [0041] of D2, the RAF inhibitor used in para 51 is
RAF inh a which is 2,6-difluoro-N-(3-methoxy-IH-pyrazolo[3,4-b
]pyridin-5-yl)-3- (propylsulfonamido)benzamide). The said RAF inh a is
different from the Encorafenib as claimed under claim 1 of the claimed
invention of the subject application.

PRIOR ART D3

21. The invention under prior art D3 (WO 2011/046894 Al) relates to
a method of treating cancer in a mammal and to combinations
useful in such treatment. In particular, the method relates to a novel
combination comprising the B-Raf inhibitor: N-{3-[5-(2-amino-4-
pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol -4-yl]-2-fluorophenyl}-2,6-
difluorobenzenesulfonamide, (or it’s pharmaceutically acceptable salt or
solvate thereof), and the PI3K inhibitor:2,4-difluoro-N{2-(methyloxy)-5-
[4-(4-pyridazinyl)-6 -quinolinyl]-3-pyridinyl}benzenesulfonamide, (or it’s
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pharmaceutically acceptable salt thereof), or pharmaceutical compositions
comprising the same, as well as methods of using such combinations in the
treatment of cancer. Under Table 1, the D3 discusses the following:

22. Page 4 of the D3 specifies that Inhibitor PI3K isoforms, particularly
PI3K-α, are known to be useful in the treatment of cancer. It is important to
note that the invention under D3, is a combination of B-Raf inhibitor
dabrafenib not encorafenib on one hand, and PI3K inhibitor not PI3K-α
inhibitor namely, alpelisib, on the other.

PRIOR ART D4

23. Prior art D4 ( WO 2011/029082) relates to the following compound
of formula (I), which includes some provided substituents, to compositions
and use of the compounds in the treatment of diseases ameliorated by
inhibition of phosphatidylinositol 3-kinase.

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24. Document D4 discloses (page10) PI3K-α inhibitors of the invention
for treating proliferative diseases, including color. Page 30 of D4, discloses
the combination of EGFR and PI3K/Akt in the following language:

“….Furthermore, in an in vitro model of breast cancer with a cell line that
harbors a PTEN mutation and over-expresses EGFR inhibition of both the
PI3K/Akt pathway and EGFR produced a synergistic effect (She et al.，Cancer
Cell 8:287-297(2005)). These results indicate that the combination of gefitinib
and PI3K/Akt pathway inhibitors would be an attractive therapeutic strategy in
cancer.”

It is significant to note that, the above mentioned para of D4 does not
specify the EGFR inhibitor as claimed in the subject application. Further,
this combination also fails to specify the PI3K-α inhibitor as claimed in
Claim 1 of the claimed invention.

25. Predicated on the aforesaid observations in prior arts D1 to D4, in
conclusion it can be inferred that the combination of two compounds, that
is Compound A and Compound B, as specified in Claim 1 of subject
application is not disclosed in any of the prior arts D1 to D4. Though, D1
discloses B Raf inhibitor of formula 1 as claimed in the present invention
apart from also disclosing the combination of B Raf and PI3K inhibitor,
yet, this combination under D1, does not specify the PI3K-α inhibitor as
claimed in the present invention.

26. As observed and noted above, though, the prior art D2, under para 71
discloses Erlotinib/Cetuximab and B-Raf inhibitors, however, the inhibitor
Encorafenib is not disclosed. It is relevant to note that the invention
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claimed under D3 is a combination of B-Raf inhibitor – dabrafenib and not
Encorafenib on one hand and inhibitor PI3K and not PI3K-α, on the other.
However, it must be accepted that page 4 of prior art D3 discloses the
inhibitor PI3K-α and its use for the treatment of cancer. At page 30, the D4,
discloses the combination of EGFR and PI3K/Akt, however, does not
specify either the EGFR inhibitor or PI3Kα inhibitor as claimed in the
subject application.

27. As cited earlier, para 69 of D2 discusses the method for
subjects/patients unresponsive to B-raf inhibitors. The para further
discloses 3 other methods which are (i) administering an effective amount
of an ERK inhibitor, (ii) administering an effective amount of an inhibitor
of EGFR signaling, and (iii) administering an effective amount of an
inhibitor of EGFR signaling in combination with a B-Raf inhibitor.
Thereafter, para 70 of D2 discusses the methods for inhibiting EGFR
signalling. The methods under this para are inhibiting EGFR kinase
activity, binding to the extracellular domain of EGFR to inhibit activation
or by inhibiting the activity and signaling of EGF ligand. Under para 71,
D2 discloses the Inhibitors of EGFR signaling including Erlotinib and
Cetuximab. Reading para 70 and 71 together, it is clear that Erlotinib and
Cetuximab are mentioned in terms of the methods for inhibiting EGFR
signalling.

28. As discussed in earlier, the title and field of the invention of D2
states that the said invention particularly relates to the detection of
mutations or RTK overexpression that are diagnostic and/or prognostic and
correlating the detection with cancer treatment. In such a case, it becomes
crucial to discuss such motivation/teaching to choose the specific
compounds of the combination claimed under claim 1 of the present
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invention. The impugned order completely failed to discuss that how the
Person Skilled in the Art would be motivated to choose the claimed
compounds, i.e., Compound-A (Encorafenib) and Erlotinib / Cetuximab
(from D2 or any other cited prior arts) to apply it to the combination
mentioned under para 19 of D2.

29. Similarly, D4 at page 30 para 14 discusses the synergy between
EGFR and PI3K/Atk pathway, without specifying the claimed compounds
of present invention. Therefore, the submission of the respondent as
mentioned under para 4.4.3 above that D4 discloses all the 3 compounds as
claimed in claim 1 of the present invention, cannot be accepted. Thus it
can be safely inferred that none of the cited prior art D1 to D4 specify the
combination of compound A (B-Raf Inhibitor), Encorafenib, and
Erlotinib/Cetuximab (EGFR inhibitor). Further, the prior arts D1 to D4 also
fail to disclose the combination of compound A (B-Raf Inhibitor),
Encorafenib, and EGFR inhibitors Erlotinib or Cetuximab and optionally,
Compound B, i.e. PI3K-α inhibitor (alpelisib).

30. Having reached the aforesaid conclusion in respect of the prior arts
D1 to D4, this Court would now examine the other limb of the impugned
order in respect of technical advancement. While discussing the technical
advancement of the subject application, the impugned order notes the
following Table cited by the appellant in the CS of the present invention:

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31. Examples 2 and 3 of the claimed invention provide the data from the
clinical studies which, according to the appellant, indicate that the tumor
growth from day 1 to day 29 was reduced in group 6 and there was
regression in group 8. The dual combination of Compound A with
Cetuximab when administered on Group 6, slowed down the tumour
progression to 12% and significant inhibition. The table shows the
improvement in combination upon Compound A monotherapy in Group 2 (
95%) and Cetuximab monotherapy in Group 4 (88%). Similarly, the triple
combination of Compound A, Compound B, and Cetuximab when
administered on Group 8, resulted in tumor regression by -2%. This
treatment shows improvement upon Compound A monotherapy in Group 2
(95%), Compound B monotherapy in Group 3 (57%), and Cetuximab
monotherapy in Group 4 (88%).

32. Based on the above-mentioned data, the impugned order notes that
the cited prior arts also disclose similar combinations relying upon the data
cited in the documents D2 and D3. The impugned order also relied on the
data contained in Tables 2, 3 and 4 from D3.

33. It may be relevant at this stage to also examine Table 2 of D3 which
discloses the synergy and cytotoxicity data of the combined dosing of
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Compounds A & B for colon cancer cell lines. Table 2 contains the
combination of the PI3K inhibitor (Compound B) and the BRAF inhibitor
(Compound A). As per the page 21 of D3, Compound A is “N-{3-[5-(2-
amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol -4-yl]-2-
fluorophenyl}-2,6-difluorobenzenesulfon amide”, which is not
Encorafenib, the inhibitor as claimed under claim 1 of the subject invention
of the subject application. Similarly, Compound B used under Table 2 of
D3 is “2,4-difluoro-N- {2-(methyloxy) -5-[4- (4-pyridazinyl)-6-quinolinyl]-
3-pyridinyl}benzenesulfonamide”, which is Omipalisib and not
Cetuximab/Erlotinib, the EGFR as claimed in claim 1 of the subject
invention. Similarly, the combination in the prior art is the same as noted
above and the results under Table 3 and 4 on pages 30 and 34 respectively
of D3, are also the same.

34. In order to analyse and conclude that the claimed invention has not
been able to demonstrate enhanced efficacy in comparison to the prior arts,
the respondent also relied upon Figure 34B of D2, noting thereby that an
increased efficacy was observed when both compounds were administered
in combination. However, as discussed above, under prior art D2, as per
para [0041], the RAF inhibitor used in para 51 is “RAF inh a” {2,6-
difluoro-N-(3-methoxy-IH-pyrazolo[3,4-b]pyridin-5-yl)-3-(propylsulf-
onamido)benzamide)} which is different from Encorafenib as claimed
under claim 1 of the present invention of the subject application. The data
shown in Figures 34A and 34B is based on the result of the same
experiment.

35. The impugned order, based on the abovementioned data from D2
and D3, rejects the enhanced efficacy provided under examples 2 and 3 of
the CS of subject application however, fatally, does not discuss that the
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compounds used are BRAF and PI3K-α inhibitors which are not the same
as disclosed in prior arts D1 to D4. Similarly, the submission of the
respondent that D1, D2/IPD2 and D4 read together would teach PSITA to
come to the claimed triple combination, is without any explanation as to
what para/part of D1, D2 and D4 teaches to combine the 3 claimed
compounds.

36. Therefore, based on the above discussion, this Court is not satisfied
with the reasoning given under the objection of lack of inventive step in the
impugned order.

Objection under Section 3 (d) of the Act:

37. As noted above, Claim 1 of the present invention claims a
pharmaceutical combination which comprises a B-Raf inhibitor of
Compound A (or a pharmaceutically acceptable salt) and an EGFR
inhibitor (Cetuximab or Erlotinib) and optionally a PI3K-α inhibitor
(Compound B).

38. The impugned order states that the claimed compound is derivative
of the known compounds and therefore not allowable under Section 3(d) of
the Act. For clarity, Section 3 (d) of the Act is reproduced hereunder:

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

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

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39. In regard to the above, it would be apposite to consider the following
reasoning provided in the impugned order on non-patentability under
Section 3 (d) of the Act:

“5.3. Section 3(d) of Patents Act, 1970:

Claims 1-4 refer to a pharmaceutical combination comprising (a) a 8-Raf
inhibitor of the formula or a pharmaceutically acceptable salt thereof, (b) an
EGFR inhibitor, wherein me EGFR inhibitor is cetuximab or erlotinib, and,
optionally (c) a PI3K-a inhibitor, wherein the PI3K-a inhibitor is a compound of
Formula (1).

It is observed that the submission of the agents for the applicants have focused
on the efficacy of the combination as per table 1 at page 32 of the specification.
However, it has been shown in the subsequent sections, (especially lack of
inventive step) that such combinations are known from the prior art arts. In view
of the same, the claims of the invention fall u/s 3(d) of Patents Act, 1970.

A5.8. Non- patentability u/s 3(d) of Patents Act, 1970: The claimed invention
refers to a pharmaceutical combination comprising (a) a B – Raf inhibitor of the
formula or a pharmaceutically acceptable salt thereof, (b) an EGFR inhibitor,
wherein the EGFR inhibitor is cetuximab or erlotinib, and, optionally (c) a
PI3K-a inhibitor, wherein the PI3K-a inhibitor is a compound of Formula (I).
The agents for the applicant has shown table 1 at page 32 of the specification to
show efficacy of the claimed combination, however, such combinations and the
results are known from the prior art (see para on lack of inventive step u/ s
2(1)(ja) of Patents Act, 1970. Hence, the pharmaceutical combination of the
present application falls u/ s 3(d) of the Patents Act, 1970.”

40. Contrary to the reasoning of the learned Controller, the appellant
submitted that the present invention does not fall under Section 3(d) of the
Act as it is a claimed combination of two or three pharmacologically active
specific agents, that is, a B-Raf inhibitor, an EGFR inhibitor, and an
optional PI3K-α inhibitor and that none which is a new form, salt, ester,
ether, polymorph, metabolite, isomer, or derivative of any known substance
referred to in the prior art. As per the appellant, the present invention is a
combination of distinct, independent active pharmaceutical agents. The
impugned order states that such combinations are disclosed under the cited
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prior art, without specifying the known compounds.

41. Further, assuming that the learned Controller is considering the
individual compound of the combination as a known derivative, such
consideration has been rejected by the Calcutta High Court in Topotarget
UK Limited v. Controller General of Patents and Designs, Mumbai &
Ors. (IPDPTA/50/2023). The Calcutta High Court emphasised that under
Section 3(d) of the Act, a combination of two separate active drugs cannot
be treated as derivatives of each other and therefore fall outside the scope
of Section 3(d) entirely. The relevant para is reproduced as follows:

“Para 13: Section 3(d) is only applicable when the invention is a new form of a
single known substance and is put to the test of “therapeutic efficacy”. Section
3(d) is also applicable to combinations involving derivatives of a known
substance whether alone or with the known substance itself. A combination of
two separate active drugs cannot be treated as derivatives of each other and
therefore do not fall within the scope of section 3(d) of the Act. In the present
case, the appellant had claimed that the invention is directed towards a
composition and not a salt of PXD-101. Arginine and meglumine are inactive
ingredients and not derivatives of PXD-101. In such circumstances, the
invention was claimed to be a multi-component composition and fell outside
the scope and ambit of section 3(d) of the Act. This aspect of the matter has not
even been dealt with in the impugned order and vitiates the finding under
section 3(d) of the Act.”

42. Applying the aforesaid proposition it is clear that the learned
Controller has erroneously presumed the known compound from the
compounds disclosed under the cited prior art, which was neither specified
nor identified in the impugned order.

43. Learned controller, so far as efficacy and combinations are
concerned, has relied on the reasoning given under the objection of lack of
inventive step. However, it is significant to note that even the reasons
furnished for sustaining objections under section 2 (1) (ja) of the Act, also
do not identify the known compound. Additionally, this Court has already
rejected the objections raised under section 2(1)(ja) of the Act in the

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preceding paragraphs. Therefore, it can be inferred that the “known
compound” in the cited prior art is not identified by the learned Controller.

44. Thus, this Court is unable to agree with the reasoning provided by
the learned Controller under the objection of non-patentability under
Section 3(d) of the Act.

Objection under Section 3 (i) of the Act:

45. The reasoning provided under the objection of non-patentability
under Section 3 (i) of the Act in the impugned order is as follows:

“Section 3(i) of Patents Act, 1970: I •
Since no amendment to the claims have been carried-out, I refer to the
objection raised in the hearing letter and reiterate the same:

The amended claims relate to therapy and method of treatment and falls
u/ s 3(i) of Patents Act, 1970. The amended claims filed in response to the
submission by the agents for the applicant reads as follows :
“A pharmaceutical combination comprising: (a) a B-Raf inhibitor of the
formula· (Compound A) or a pharmaceutically acceptable salt thereof, (b)
an EGFR inhibitor, wherein the EGFR inhibitor is cetuximab or erlotinib
and, optionally, (c) a PI3K-a inhibitor, wherein the PI3K-a inhibitor is a
compound B of Formula (Compound B) or a pharmaceutically acceptable
salt thereof for simultaneous , separate or sequential administration.
Claims fall u/ s 3(i) of the Patents Act, 1970 since the invention relates to
a- ,”combination therapy” . The specification also clearly mentions on
page 22; the dose and treatment schedule which clearly shows that the
triple combination is a method of treatment and falls within the ambit of
combinational therapy. The contents on this page is provided for ready
reference:

“Compound A Capsule for oral use as assigned once or twice daily
Compound B Tablet for oral use as assigned once or twice daily
Cetuximab Intravenous infusion 400 mg/m2 initial infusion/ 250 mg/m2
subsequent infusions”. The inventive aspect lies in the · therapy and
treatment and thus falls u/ s 3(i) of Patents Act, 1970.
• It is noted that the agents for the applicants have provided the following
in the response regarding this objection: “Section 3(i) is not applicable to
the present application as claims of the present application are directed to
pharmaceutical combination. The ultimate use in treatment of cancer is
only its industrial application and therefore Section 3(i) by no stretch of
imagination is attracted”.

• The response provided by the agents for the applicant is not sufficient to
overcome this objection since the submission does not provide any
evidence which proves contrary to the objection raised in the hearing
letter.

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It maybe noted that since this objection is still not met and is maintained,
the application can be refused solely on this basis.
Notwithstanding the above, I provide my analysis and interpretation on
the other objections raised in the hearing letter.”

46. Contrary to the reasoning of the learned Controller, the appellant
submits that the claims of the subject application are product claims
directed to a “pharmaceutical combination” and not to a method of
treatment of human beings. Learned counsel for the appellant would submit
that the independent claim 1 is for a pharmaceutical combination and
unambiguously is a product claim.

47. For clarity, Section 3 (i) of the Act is reproduced as follows:

(i) any process for the medicinal, surgical, curative, prophylactic diagnostic,
therapeutic or other treatment of human beings or any process for a similar
treatment of animals to render them free of disease or to increase their
economic value or that of their products.”

48. While reading the expression “for simultaneous, separate or
sequential administration” under Claim 1 of the subject application in the
light of its CS, it is clear that same is a functional descriptor of the claimed
pharmaceutical combination and not a method step. It describes the range
of ways in which the constituent actives, as a defined combination, may be
administered without transforming the product into a method. This phrase
does not impose or claim any particular therapeutic protocol, physician
intervention, or sequential step.

49. The learned controller relied on the paragraph taken from example 1
of CS of the subject application, which describes the treatment schedule of
the study as under:

“Compound A Capsule for oral use as assigned once or twice daily Compound
B Tablet for oral use as assigned once or twice daily Cetuximab Intravenous
infusion 400 mg/m2 initial infusion/ 250 mg/m2 subsequent infusions”. The
inventive aspect lies in the · therapy and treatment and thus falls u/ s 3(i) of
Patents Act, 1970.”

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50. It is trite that working examples are provided by the patentee to
demonstrate the workability and practical implementation of the claimed
invention. For any invention to be patented, it is imperative for such
invention to be demonstrated to be not only theoretical but also practical.
Thus the mere providing of examples does not describe the scope of the
patent. The aforesaid view is fortified by the judgement of this Court in
Bayer Pharma Aktiengesellschaft vs. The Controller of Patents and
Design, Neutral Citation: 2024:DHC:2395, wherein, it was emphasised
that the working examples are essential for demonstrating the feasibility
and workability of an invention, and do not define the patent’s scope. The
relevant para is reproduced as follows:

“8. Regarding the objection under Section 3(i) of the Act, the Court
observes that the impugned order lacks a substantive basis for dismissing
the subject application on this specific ground. Moreover, under Section
10(4)(c) of the Act, to consider the invention as articulated by the Applicant,
it is imperative to interpret the scope of the claims. Claim 1, as delineated,
clearly indicates to the Court that it pertains exclusively to a product rather
than a process. Consequently, based on the claim’s composition and its
representation within the application, the Court determines that Section 3(i)
of the Act, which pertains to methods of treatment, does not apply to the
case at hand.

9. Therefore, the Court finds merit in the contention of Mr. Banerjee that
mere recitations of the unit numbers of the components in claim 1 cannot
render it ineligible for patent protection under Section 3(i) of the Act.
Notably, in the said claim, as defined, there is neither any reference to a
particular disease/ treatment, nor any reference regarding the modes/
manner of administration of the composition. In patent law, the claims of a
patent define the boundaries of the patent protection. That is, they set out
the legal limits of what the patent covers. The claims must be clear, specific,
and supported by the description within the patent application. They are the
most critical part of a patent application because they determine the extent
of protection granted by the patent. Working examples, on the other hand,
are provided in the subject application to demonstrate the practical
implementation of the invention. These examples are intended to show
that the invention is feasible and workable and how it can be carried out
in practice. They provide support and understanding for the claimed
invention, showing that it is not just a theoretical concept, but has
practical applicability. Thus, while working examples are essential for
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demonstrating the feasibility and workability of an invention, they do not
define the patent’s scope. The scope is determined by the claims, which
must be interpreted in light of the description and any examples provided.
The reasoning for applying Section 3(i) of the Act to the subject application
is therefore, misplaced. Mr Banerjee also relies on the decision of this
Court in Societe Des Produits Nestle SA v. The Controller of Patents and
Design and Anr.,2 where, in a similar situation, the Court referenced the
Manual of Patent Office, Practice and Procedure, which gives the guidance
for examination with respect to exclusion of medical, surgical, curative,
prophylactic, diagnostic, therapeutic or other treatment, and held that the
claims in respect of the composition are patentable, and not hit by Section
3(i) of the Act. In the present case as well, the claim 1, as defined, in the
opinion of the Court, does not render the application to be non- patentable.”

51. It is clear that claim 1 of the subject application is not framed as a
process/ a protocol/ a dosing schedule, or a treatment regimen. Therefore,
the subject matter of the present invention is excluded by Section 3(i) of the
Act as the said provision bars a process, not a product and a combination.
Objections under Section 10(5) & 10(4) (c) of The Act:

52. The impugned order notes that this objection is not met since the
claims are not clear and sufficiently definitive to the scope of the invention
in the absence of mention of any significant technological contribution over
the prior art cited documents. It may be apposite to reproduce the relevant
paragraph from the impugned order, which reads thus:

“5.4. Claims [u/ s 10(5) & 10(4) (c)]:

This objection is not met since the claims are not clear and sufficiently
definitive to the scope of the invention in the absence of mention of any
significant technological contribution over the prior art cited documents.
Thus, these claims are not allowable u/s 10(5).”

53. The paragraph extracted hereinabove sadly lacks in providing any
reason whatsoever. In view of the rejection by this Court of the reasons
furnished by the learned Controller on the objections in respect of technical
advancement as analysed in the preceding paragraphs, this Court is of the
considered opinion that this objection too, needs reconsideration.

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Signing Date:25.07.2026
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CONCLUSIONS:-

54. In view of the aforesaid analysis, the subject matter patent
application is remanded back to the learned Controller for denovo
reconsideration of the objections raised. The learned Controller is directed
to dispose of the subject patent application within a period of six months
from date of receipt of this Order.

55. Needless to state that the respondent shall grant an opportunity of
hearing to the appellant before deciding the matter.

56. It is made clear that the learned Controller shall decide the subject
patent application on its own merits without being influenced by the
observations made above.

57. The appeal is disposed of in the aforesaid terms.

TUSHAR RAO GEDELA
(JUDGE)

JULY 23, 2026
rl/sumit/kct

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Signing Date:25.07.2026
13:46:06

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