Delhi High Court
Novo Nordisk A/S vs Dr Reddys Laboratories Limited & Anr on 9 March, 2026
Author: C. Hari Shankar
Bench: C. Hari Shankar
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* IN THE HIGH COURT OF DELHI AT NEW DELHI
Reserved on: 19 January 2026
Pronounced on: 9 March 2026
+ FAO(OS) (COMM) 204/2025 & CM APPL. 78607/2025
NOVO NORDISK A/S .....Appellant
Through: Mr. Hemant Singh, Ms. Mamta
Jha, Mr. Rishabh Paliwal, Mr. Shreyansh
Gupta, Mr. Sanchit Sharma, Advs.
versus
DR REDDYS LABORATORIES LIMITED & ANR.
.....Respondents
Through: Mr. Gopal Subramanium, and
Mr. J. Sai Deepak, Sr. Advs. with Mr. Mohit
Goel, Mr. Sidhant Goel, Mr. Aditya Goel,
Mr. Deepankar Mishra, Mr. Kartikeya
Tandon, Mr. Pavan Bhushan, Mr. Avinash
Sharma, Mr. Raghav Kohli, Mr. Adnan
Yousuf and Mr. Ankit Malhotra, Advs.
CORAM:
HON'BLE MR. JUSTICE C. HARI SHANKAR
HON'BLE MR. JUSTICE OM PRAKASH SHUKLA
JUDGMENT
% 09.03.2026
C. HARI SHANKAR, J.
A. Some prefatory thoughts
1. This case makes us ponder, and we have said so in open Court.
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2. The dispute relates to a patent held by the appellant for
Semaglutide, which is an anti-diabetic. The appellant claims that, in
December 2024, it came to learn that the respondents were importing
Semaglutide. On the ground that said import infringed the appellant’s
patent, the suit, from which this appeal emanates, came to be instituted
only in 2025. The suit was accompanied, as such suits always are,
with an application seeking an interlocutory injunction restraining the
respondents from manufacturing or selling Semaglutide in the Indian
market. That application was rejected by the learned Single Judge on
2 December 2025, by a detailed and well-reasoned judgment. The
appellant is in appeal.
3. Thus far, we have no issue. What perturbs us is the fact that this
appeal has been preferred when the suit patent itself is to expire on 20
March 2026. On the date when this appeal was argued before us, and
judgment was reserved, a little over two months remained, for the suit
patent to expire. It is not the appellant’s case that the respondent is
manufacturing sub-standard drugs. In any event, after 20 March 2026,
the appellant would no longer be able to enforce the suit patent, and it
would be open to exploitation by the world at large.
4. What irreparable loss, we ask ourselves, is the appellant
suffering, as a result of the impugned judgment? Why, for that matter,
should we even spend valuable time of the Court when a mere two
months were left for the suit patent to expire? When Courts are
inundated with cases, of far greater urgency, which it has no time to
decide, should we at all entertain such an appeal? Is the appeal not
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liable to be dismissed even on the principles of balance of
convenience and irreparable loss, de hors the merits of the case?
5. At the highest, even if the appellant were to succeed, it would
have, to its credit, only a prima facie view in its favour. The opinions
we express would have no impact on the adjudication of the lis in the
suit. Why, then, should we express them at all?
6. This case, at least, relates to drugs. We have, before us, appeals
involving patent claims relating to far more pedestrian products, in
which interlocutory orders, under Order XXXIX of the CPC1, are
challenged. It is clear, to us, that the case does not involve any issue
of urgency, much less pressing urgency. And yet, such appeals are
argued for hours at a stretch, holding up, in the process, matters,
perhaps relating to the poor and needy, who may be waiting for years
without a job or means to fend for themselves and their families,
waiting for justice.
7. We wonder – if such persons could access the Court proceedings
– as, now, everyone can – and were to notice how Courts hear matters,
which are of no serious moment to either party or to the public at
large, for hours at a stretch, while they keep waiting, what would they
think? We can claim to be abiding by our oath of office only when we
can ensure that justice percolates down to the little man and his small
family, huddled beneath a torn blanket under the ramshackle railway
bridge, in the chilly winter night.
1 Code of Civil Procedure, 1908
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8. We are not, by these observations, seeking to run down
commercial or, for that matter, intellectual property litigation. We
agree that there may be cases which are of considerable moment.
Infringement of a patent relating, for example, of a part which has to
go into an aircraft, may be an extremely serious matter, as a duplicate
part could endanger the lives of thousands. Equally, for example, trade
mark infringement cases involving persons who sell duplicate drugs,
imitating the registered trade marks of others, may require expeditious
adjudication. For that matter, every person is entitled, in law, to assert
his intellectual property rights. Even so, at some stage, however,
sifting of the matters is, to our mind, essential.
9. We also understand the importance of ensuring the protection of
patent rights, especially in the case of pharmaceutical preparations,
and the disincentivisation to invent which may result, if such rights are
not safeguarded. A pre-eminent element of public interest also exists
in ensuring that scientists must be encouraged to invent.
10. We reiterate that our concern is only with a case such as this, in
which only two months were left for the suit patent to expire even
when we reserved judgment. No one, therefore, would stand to
benefit, even if we were to injunct the respondents for two months.
Would the interests of justice, in such a case, be not sufficiently
safeguarded by directing the respondents to maintain accounts of the
returns from sale of the allegedly infringing drug, for these two
months?
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11. We sincerely feel that, in such cases, the Court must, apart from
addressing itself to the merits of the matter, also consider whether,
applying the principles of balance of convenience and irreparable loss,
it should interfere. This is especially so as, in Wander Ltd v. Antox
(India) Pvt Ltd2 and Pernod Ricard v. Karanveer Singh Chhabra3,
the Supreme Court has clearly held that such appeals are merely
appeals on principle, and that the appellate Court should not disturb
the findings of the Commercial Court, unless they err on principle.
12. Nonetheless, we heard these matters, and reserved judgment
and are, therefore, duty bound to render judgment as well. We,
therefore, proceed to do so. However, we do not intend, in the
circumstances, this to be a de novo examination of the merits of the
appellant’s claim for injunction. We will remain strictly within the
Wander confines.
B. The Statute
13. Though the Patents Act, 19704 does not define “infringement”,
it does refer to it, and it is accepted, in law, that the proscriptions to
which Section 485 of the Act refers are the acts which, if committed,
would amount to infringement.
2 1990 Supp SCC 727
3 2025 SCC OnLine SC 1701
4 “the Act” hereinafter
5 48. Rights of patentees.–
Subject to the other provisions contained in this Act and the conditions specified in Section 47, a
patent granted under this Act shall confer upon the patentee–
(a) where the subject-matter of the patent is a product, the exclusive right to prevent third
parties, who do not have his consent, from the act of making, using, offering for sale, selling or
importing for those purposes that product in India;
(b) where the subject-matter of the patent is a process, the exclusive right to prevent third
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14. Section 64 enlists the circumstances in which a granted patent
can be revoked. The opening words of Section 64 make it clear that a
patent may be revoked on any of the grounds enlisted in the clauses
which follow, which indicates that each ground, independently,
constitutes a ground for revocation. Section 107(1)6 provides that
every ground on which a patent may be revoked under Section 64
shall be available as a ground of defence in any infringement suit. It is
also settled that, at the Order XXXIX stage, the defendant is only
required to set up a credible challenge to the validity of the suit patent,
on any one or more of the grounds contained in Section 64, to escape
an injunction. The Court is not required to delve deep into the merits
of the challenge at that stage, and has only to satisfy itself that the
defendant has made out a case of vulnerability of the suit patent to
revocation under Section 64. This position is classically captured in
the following passage from the judgment of the Division Bench of this
Court in F. Hoffmann-La Roche Ltd v. Cipla Ltd7:
“55. The question before this Court is when can it be said that
the defendant has raised a credible challenge to the validity of a
patent held by the plaintiff in an infringement action? During the
course of the argument it was suggested by counsel that the
challenge had to be both strong and credible. Also, the defendant
resisting the grant of injunction by challenging the validity of the
patent is at this stage required to show that the patent is
“vulnerable” and that the challenge raises a “serious substantial
question” and a triable issue. Without indulging in an exercise in
semantics, the Court when faced with a prayer for grant of
injunction and a corresponding plea of the defendant challenging
the validity of the patent itself, must enquire whether the defendant
has raised a credible challenge. In other words, that would in theoffering for sale, selling or importing for those purposes the product obtained directly by that
process in India:
6 107. Defences, etc. in suits for infringement.–
(1) In any suit for infringement of a patent, every ground on which it may be revoked under
Section 64 shall be available as a ground for defence.
7 159 (2009) DLT 243 (DB), referred to, hereinafter, as Roche-I
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context of pharmaceutical products, invite scrutiny of the order
granting patent in the light of Section 3(d) and the grounds set out
in Section 64 of the Patents Act 1970. At this stage of course the
Court is not expected to examine the challenge in any great detail
and arrive at a definite finding on the question of validity. That will
have to await the trial. At the present stage of considering the grant
of an interim injunction, the defendant has to show that the patent
that has been granted is vulnerable to challenge.”
The standard of responsibility of the defendant who raises a Section
107 defence, and the scope of examination of the merits of the
challenge at the Order XXXIX stage, as set out in the above passage
from Roche-I may be said, by now, to have become legally fossilized.
15. We now examine the scope of Sections 64(1)(a), (e) and (f)8 of
the Act, as they alone would be relevant for the conclusion at which
we propose to arrive.
16. Section 64(1)(a) is clear in its terms. It applies only where the
invention forming subject matter of the suit patent, “so far as claimed
in any claim” of the complete specification of the suit patent, has been
“claimed in a valid claim” of earlier priority date contained in the
complete specification of another patent granted in India. There is no
8 64. Revocation of patents.–
(1) Subject to the provisions contained in this Act, a patent, whether granted before or after
the commencement of this Act, may, [be revoked on a petition of any person interested or of the
Central Government or on a counter-claim in a suit for infringement of the patent by the High
Court] on any of the following grounds, that is to say,–
(a) that the invention, so far as claimed in any claim of the complete specification,
was claimed in a valid claim of earlier priority date contained in the complete
specification of another patent granted in India;
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(e) that the invention so far as claimed in any claim of the complete specification is
not new, having regard to what was publicly known or publicly used in India before the
priority date of the claim or to what was published in India or elsewhere in any of the
documents referred to in Section 13;
(f) that the invention so far as claimed in any claim of the complete specification is
obvious or does not involve any inventive step, having regard to what was publicly
known or publicly used in India or what was published in India or elsewhere before the
priority date of the claim;
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reference to disclosure, or coverage, or obviousness, or “newness” or
novelty. The clause uses only the expression “claim” and “claimed”.
The use is obviously deliberate, and the intention of the legislature in
employing the said expression has to be respected. The clause further
specifically employs the expression “the invention, so far as claimed
in any claim”. What matters, therefore, is not the invention per se, but
the extent to which the invention is claimed in the claim of the suit
patent. It is only, therefore, where the claim in the suit patent is
claimed in an earlier granted patent that Section 64(1)(a) would apply.
Identity of claims in the suit patent and the prior art is, therefore, the
sine qua non for Section 64(1)(a) to apply.
17. This interpretation is fortified by Section 13(1)(b)9 of the Act.
Section 13 sets out the responsibility of the Examiner in the Patent
Office, while scrutinising an application for grant of patent, and
examining whether it cannot be granted on account of “anticipation by
previous publication” or “anticipation by prior claim”. Insofar as
anticipation by prior claim is concerned, under Section 13(1)(b), the
Examiner is required to examine whether the invention, so far as
claimed in any claim of the complete specification of the applicant’s
patent application, is claimed in any claim of earlier priority date.
What is, therefore, required is a claim-to-claim comparison.
9 13. Search for anticipation by previous publication and by prior claim.–
(1) The examiner to whom an application for a patent is referred under Section 12 shall make
investigation for the purpose of ascertaining whether the invention so far as claimed in any claim of
the complete specification–
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(b) is claimed in any claim of any other complete specification published on or
after the date of filing of the applicant’s complete specification, being a specification filed
in pursuance of an application for a patent made in India and dated before or claiming the
priority date earlier than that date.
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18. The “person skilled in the art” has no role to play, while
applying Section 64(1)(a).
19. The distinction between clauses (e) and (f) of Section 64(1) is,
however, not so clear. Section 64(1)(e) applies where the invention, so
far as claimed in the suit patent is not “new”, having regard to prior
public knowledge or public usage in India. The scope and ambit of the
expression “new” is not disclosed in the Act. The clause, however,
covers “anticipation by prior publication”, in any document referred to
in Section 13. The relevant clauses of Section 13, for the purposes of
Section 64(1)(e), would be Section 13(1)(a) and 13(2)10, which
introduce the concept of “anticipation by publication”.
20. The Act does not define “anticipation”. It is generally accepted,
however, that “anticipation” dovetails into the concept of “novelty”,
and this interpretation also appears to be in sync with the provisions of
the Act, as Section 64(1)(e), which uses the expression “new” but does
not use the expression “anticipated”, requires reference to the
documents to which Section 13(1) refers, and Section 13(1), per
contra, uses the expression “anticipated by publication” but does not
use the expression “new”. One may, therefore, reasonably understand
10 13. Search for anticipation by previous publication and by prior claim.–
(1) The examiner to whom an application for a patent is referred under Section 12 shall make
investigation for the purpose of ascertaining whether the invention so far as claimed in any claim of
the complete specification–
(a) has been anticipated by publication before the date of filing of the applicant’s
complete specification in any specification filed in pursuance of an application for a
patent made in India and dated on or after the 1st day of January, 1912;
*****
(2) The examiner shall, in addition, make such investigation for the purpose of ascertaining
whether the invention, so far as claimed in any claim of the complete specification, has been
anticipated by publication in India or elsewhere in any document other than those mentioned in sub-
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the statutory provisions as envisaging an invention, or a claim, which
is “anticipated by publication” not to be “new”.
21. The jury is still out, however, on how exactly to determine
whether a claim, in a later patent application, is “anticipated by prior
publication”. Though Courts, in India, have, in several decisions,
sought to explain the expression, there is still lack of uniformity
among the decisions.
22. It is truly ironical that, while devoting an entire chapter11 to
“anticipation”, with the individual Sections titled “Anticipation by
previous publication”, Anticipation by previous communication to
Government”, Anticipation by public display, etc”, Anticipation by
public working” and “Anticipation by use and publication after
provisional specification”, not one of these provisions actually
explains what anticipation, in any of these contexts, means. The
provisions only set out circumstances which would not amount to
anticipation, without explaining the circumstances which would.
23. Perhaps, we would have to await an authoritative Apical
exposition on this issue.
24. We do not, however, propose to devote more time on Section
64(1)(e), as the findings of the learned Single Judge, with which we
agree, make out a clear prima facie case of vulnerability of the suit
patent to invalidity in terms of Section 64(1)(f).
11 Chapter VI
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25. Section 64(1)(f) invalidates the invention, so far as it is claimed
in any claim of the complete specification in the suit patent, which “is
obvious or does not involve any inventive step”, having regard to prior
public knowledge.
26. Unlike “anticipation” or “anticipation by prior publication”, the
Act does not even purport to define “obviousness”. The jury, however,
is not out on this one, and the legal position, in this regard, is
somewhat settled. “Obviousness” is to be decided by examining
whether a “person skilled in the art” would, from the teachings in prior
art, in conjunction with his existing prior knowledge, be able to arrive
at the invention claimed in the later patent. If he can, the claim in the
later patent is “obvious” from prior art, and would, therefore, not be
patentable. The presumption of obviousness can be dispelled by
establishing that, in transitioning from the teachings in prior art to the
claim in the later patent, an inventive step is involved. “Inventive
step” is defined, in Section 2(ja), as meaning “a feature of an
invention that involves technical advance as compared to the existing
knowledge or having economic significance or both and that makes
the invention not obvious to a person skilled in the art”.
27. F. Hoffmann-La Roche Ltd. v. Cipla Ltd.12, postulates the
following five inquisitorial steps which a Court must follow to decide
whether a later patent is “obvious” from prior art:
“120. From the decisions noted above to determine
obviousness/lack of inventive steps the following inquires are
required to be conducted:
12
(2016) 65 PTC 1 (DB), referred to, hereinafter, as Roche-II
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Step No. 1 To identify an ordinary person skilled in the art,Step No. 2 To identify the inventive concept embodied in
the patent,Step No. 3 To impute to a normal skilled but unimaginative
ordinary person skilled in the art what was common general
knowledge in the art at the priority date.
Step No. 4 To identify the differences, if any, between the
matter cited and the alleged invention and ascertain
whether the differences are ordinary application of law or
involve various different steps requiring multiple,
theoretical and practical applications,
Step No. 5 To decide whether those differences, viewed in
the knowledge of alleged invention, constituted steps which
would have been obvious to the ordinary person skilled in
the art and rule out a hideside approach.”
The Division Bench in Roche-II identified these five steps after a
careful study of authoritative prior pronouncements, largely from
judicial authorities overseas, on the issue. We have no doubt that the
aforesaid five steps could constitute a litmus test to arrive at a final
conclusion on obviousness of a later patent vis-à-vis prior art.
28. We, however, have our doubts as to the employability of these
steps by a Court which is examining an application for interlocutory
injunction under Order XXXIX of the CPC. The Supreme Court has,
inter alia in its decision in Brihan Karan Sugar Syndicate (P) Ltd. v.
Yashwantrao Mohite Krushna Sahakari Sakhar Karkhana13,
cautioned against Courts building deep into complicated factual and
legal issues while adjudicating on interlocutory applications. A prima
facie view is all that is justified at that stage. In arriving at such a
13
(2024) 2 SCC 577
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prima facie view, it is our respectful opinion that strict adherence to
the aforesaid five steps, postulated by the Division Bench in Roche-II,
would be both impractical and unnecessary.
29. This is apparent when one refers to the precedents to which
Roche-II adverted, and which have guided the Court to formulate the
above five steps. The first step, as per Roche-II, is identification of
the “person skilled in the art”. In this regard, the Division Bench takes
a leaf from the following exposition, in the judgment of the United
States Supreme Court in William T. Graham et al v. John Deere
Company of Kansas City et al14:
“In determining the level of ordinary skill in the art, you should
first determine whether there was a number of people who
regularly worked to solve the type of problem that the invention
solved, and, if so, determine the level of ordinary skill of such
people at the time the invention was made. You must consider the
level of skill as to the time the invention was made. Among the
factors that may be considered in your determination are:
(1) The various ways that others sought to solve the
problems existing;
(2) The types of problems encountered;
(3) The rapidity with which new inventions are made in
this art;
(4) The sophistication of the technology involved; and
(5) The educational background of those actively
working in the field.”
These tests, though undoubtedly of great pith and moment in a final
ascertainment of obviousness, if employed by the Court at the Order
XXXIX stage, would unquestionably result in the Court embarking on
a mini trial, which is what the judgment of the Supreme Court in
Brihan Karan Sugar Syndicate specifically proscribes.
14 383 US 1 (1966)
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30. With greatest respect to the eminent authors of the Roche-II
judgment, we are of the opinion that the detailed examination which
that decision advocates undertaking, in order to arrive at a conclusion
on the aspect of obviousness of the claims in a suit patent vis-à-vis
prior art would be more relevant at the stage of final adjudication of
the suit, after evidence is led, and the necessary material, on the basis
of which the five steps postulated in the decision may be meaningfully
applied, is available. At the Order XXXIX stage, the Court is only
required to satisfy itself, prima facie, that a credible challenge to the
validity of the claims in the suit patent, as obvious from the
disclosures contained in prior art, is made out. For this, the judge may
permissibly himself don the mantle of the “person skilled in the art”,
and examine the issue from such a perspective. For that matter, even if
the judge were, by an intricate exercise, able to fashion a “person
skilled in the art” for the purposes of the controversy before him, the
aspect of obviousness would, in the ultimate eventuate, be invariably
decided by the judge himself.
31. Though the learned Single Judge has, in the impugned
judgment, faithfully followed the five steps envisioned in Roche-II,
she has independently found Semaglutide to be obvious, to a person
skilled in the art, from the teachings in prior art, particularly IN
27596415. We are in entire agreement with her findings in that regard,
and find no scope for interference therewith, within the limited
peripheries of appellate jurisdiction being presently exercised by us.
15 “IN’964”, hereinafter
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32. We, therefore, would be limiting the present judgment to this
aspect of the matter as, even on this single score, the impugned
judgment deserves to be upheld.
C. Scope of interference in appeal – the Wander standard
33. Before proceeding to deal with the reasoning of the learned
Single Judge, and the relevant statutory provisions, we may reproduce
the following note of caution, entered by the Supreme Court in its
judgment in Wander, with respect to the nature of the jurisdiction that
an appellate Court exercises while dealing with appeals against
interlocutory orders passed in intellectual property matters:
“14. The appeals before the Division Bench were against the
exercise of discretion by the Single Judge. In such appeals, the
appellate court will not interfere with the exercise of discretion of
the court of first instance and substitute its own discretion except
where the discretion has been shown to have been exercised
arbitrarily, or capriciously or perversely or where the court had
ignored the settled principles of law regulating grant or refusal of
interlocutory injunctions. An appeal against exercise of discretion
is said to be an appeal on principle. Appellate court will not
reassess the material and seek to reach a conclusion different from
the one reached by the court below if the one reached by that court
was reasonably possible on the material. The appellate court
would normally not be justified in interfering with the exercise of
discretion under appeal solely on the ground that if it had
considered the matter at the trial stage it would have come to a
contrary conclusion. If the discretion has been exercised by the
trial court reasonably and in a judicial manner the fact that the
appellate court would have taken a different view may not justify
interference with the trial court’s exercise of discretion. After
referring to these principles Gajendragadkar, J. in Printers
(Mysore) Private Ltd. v. Pothan Joseph16:
“… These principles are well established, but as has been
observed by Viscount Simon in Charles Osenton &16 AIR 1960 SC 1156
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Co. v. Jhanaton17 ‘…the law as to the reversal by a court of
appeal of an order made by a judge below in the exercise of
his discretion is well established, and any difficulty that
arises is due only to the application of well settled
principles in an individual case’.”
34. The Supreme Court has, in Pernod Ricard, reiterated the
aforesaid principle in the following words:
19.8. In Wander Ltd., this Court elaborated the principles
governing the grant or refusal of interim injunctions in trademark
infringement and passing off actions. It was underscored that
appellate courts ought to be circumspect in interfering with the
discretionary orders of lower courts in such matters. Interference is
warranted only where the discretion has been exercised arbitrarily,
capriciously, perversely, or in disregard of settled legal principles.”
D. Facts
35. The appellant, as the plaintiff before the learned Single Judge,
asserted Indian Patent 26269718 for an invention titled “ACYLATED
GLP-1 ANALOGS COMPRISING NON-PROTEOGENIC AMINO
ACID RESIDUE”. The priority date of the suit patent is 18 March
2005. The suit specifically relates to Semaglutide, which is
specifically claimed as Claim 23 in the suit patent, which is an anti-
diabetic drug, and is sold by the appellant in India under the brand
names Wegovy and Rybelsus.
36. The appellant alleged that it had come to learn, in December
2024, that the respondents were importing and exporting Semaglutide,
which resulted in infringement of the suit patent. The appellant,
17 1942 AC 130
18 “IN’697”, hereinafter referred to as the suit patent
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therefore, addressed a notice to the respondents on 5 May 2025,
calling on the respondents to cease and desist from any further dealing
in Semaglutide. No response having been received from the
respondents. As the respondents did not oblige, the appellant
proceeded to institute CS (Comm) 565/2025, from which the present
appeal emanates, before the Intellectual Property Division of this
Court on 26 May 2025.
37. By order dated 29 May 2025, a learned Single Judge of this
Court bound the respondents to their statement that they would not
sell Semaglutide in India. That undertaking remains in effect till date.
38. The respondents did not dispute the fact that they were in fact
importing and exporting Semaglutide and that, therefore, stricto sensu,
they were infringing the suit patent. They, however, invoked Section
107(1) of the Patents Act, 197019, by contesting the validity of the suit
patent. Their defence was that the suit patent was vulnerable to
invalidity in terms of clauses (a), (e), (f) and (k) of Section 64(1) of
the Act.
39. The learned Single Judge has considered, seriatim, the plea of
prima facie invalidity of the suit patent under Section 64(1)(a), (e) and
(f) and found that the respondents have setup a credible challenge to
its validity.
19 “the Act”, hereinafter
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40. Thus, we are examining this appeal solely with a view to
ascertaining whether the learned Single Judge has so erred in principle
as to justify interference by us in appeal.
E. Our view, disclosed
41. We are not in agreement with the learned Single Judge that a
credible challenge to the validity of the suit patent had been set up by
the respondents under Section 64(1)(a), but we do agree that a credible
challenge under Section 64(1)(e) and (f), particularly under Section
64(1)(f) was clearly made out.
42. To our mind, Semaglutide is obvious to a person skilled in the
art from the complete specifications, and the teachings contained
therein, in IN 27596420. The learned Single Judge has also held so,
and we agree with her findings. The only point on which we differ
with the learned Single Judge is in her finding that these facts would
make out a credible challenge, under Section 64(1)(a), to the validity
of the suit patent. It appears, to us, that though a credible challenge to
the validity of the suit patent is thereby made out, the challenge would
be relatable, not to Section 64(1)(a), but to Section 64(1)(e) and (f).
43. As a credible challenge under any of the clauses of Section
64(1) would suffice to set up a successful defence, under Section
107(1), to an infringement action, we concur in the final decision of
the learned Single Judge that the respondents have been able to make
20 “IN’964”, hereinafter
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out a credible challenge to the validity of the suit patent. Ergo our
observation that no case for interference is made out.
F. The impugned judgment
44. We now proceed to set out the reasoning of the learned Single
Judge, to the extent it is necessary for our findings in the matter.
I. Re. Section 64(1)(a) – Anticipation by prior claiming
45. The respondents contended, before the learned Single Judge,
that Semaglutide stood claimed in IN’964, which was a granted patent
of earlier priority date, and was, therefore, vulnerable to invalidity on
the ground of anticipation by prior claiming. The learned Single Judge
has, in this context, recorded the stand of the respondents thus, in para
28 of the impugned judgment:
“28. The Defendants have contended that the Semaglutide
compound falling under the Suit Patent/IN’697 is not novel since
the same compound is claimed/disclosed under the Genus
Patent/IN’964, and therefore, applying the principle of Novartis
AG v. Union of India21, the Plaintiff is barred from appropriating
the same subject matter claimed in the Genus Patent/IN’964 again
in the subsequent Suit Patent/IN’697. Therefore, the Suit
Patent/IN’697 is vulnerable to invalidity under Section 64(1)(a) of
the Patents Act. It is contended that claims in the Suit
Patent/IN’697 are not novel as they are anticipated by the claims of
the Genus Patent/IN’964 and therefore, liable for revocation. It is
further contended that the teaching in the Genus Patent/IN’964
sufficiently enables the Semaglutide compound. The Defendants
also rely upon the admissions made by the Plaintiff on the scope of
the claims in Genus Patent/IN’964 in corresponding patent across
various foreign jurisdictions, as well as in Plaintiff’s filings before21
(2013) 6 SCC 1
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the Indian Patent Office, wherein the Plaintiff has claimed that the
Semaglutide compound is the only commercial product that has
resulted from both the Genus Patent/IN’964 and the Suit
Patent/IN’697.”
46. In response, the appellant contended, before the learned Single
Judge, that there was neither any valid claim, nor any enabling
disclosure in respect of Semaglutide in IN’964. It was contended by
the appellant that there were only two compounds specifically claimed
in IN’964 which were in Claims 18 and 21 thereof, and neither of
them was Semaglutide. As such, the appellant asserted that
Semaglutide could not be treated as invalid on the ground of
anticipation by prior claiming.
47. Having recorded these rival submissions, the learned Single
Judge has thus identified the issue arising before her for consideration:
“34. This aforesaid judgment lays down the legal proposition
that after the publication of a species patent, the defendant who
challenges the validity of the species patent on the ground of
anticipation by prior claiming in the genus patent has to establish
that the derivation of the claim in the species patent, from the claim
in the genus patent, is actually guided by the teachings in the genus
patent itself. It further holds that where a genus patent is a Markush
structure, the existence of enabling disclosure in the genus patent
attains significance.”
48. Proceeding thereafter to examine the merits of the respondents’
challenge, the learned Single Judge initially refers to a research article,
‘Discovery of the Once-Weekly Glucagon-Like Peptide-I (GLP-1)
Semaglutide, Journal of Medicinal Chemistry’, by Lau, J et al. This
research article, she notes, refers to the compound at Serial No.61 of
the Genus Patent /IN’964 as the ‘Alanine’ version of the semaglutide
or alternatively as ‘Ala Semaglutide’. The appellant also admitted that
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the only difference between the compound exemplified at Example 61
in Claim 21 of the Genus Patent/IN’964, and Semaglutide, was the
presence of the α-aminoisobutyric acid (Aib) amino acid in place of
Alanine (Ala) at the 8th position.
49. The learned Single Judge thereafter proceeds to observe as
under, in para 38 of the impugned judgment:
“Thus, to assess whether the Suit Patent/lN’697, i.e.. Semaglutide
compound, is claimed in the Genus Patent/lN ‘964, this Court will
examine whether there is a disclosure of each feature or sufficient
teachings in the claims of the Genus Patent/IN ‘964 enabling a
‘person skilled in the art regarding the features of the Suit
Patent/IN’ 697, i.e., the Semaglutide compound.”
The learned Single Judge thereafter proceeds to undertake a claim-to-
claim comparison between the claims in the Genus Patent/IN’964 and
the claims in the Suit Patent.
50. Following this, the learned Single Judge has extracted para 10
of the rejoinder filed by the appellant before her, which read as under :
“10. The first of the compounds in claim 23 of IN 697 is the
compound now known as Semaglutide. The novel and inventive
compound Semaglutide, comprises the native GLP-1(7-37)
peptide sequence with the following modifications:
10.1 substitution of the amino acid alanine (Ala) at position 8
with a-aminoisobutyric acid (Aib), a nonproteogenic amino
acid;
10.2 substitution of the amino acid lysine (Lvs) with arginine
(Arg) at position 34; and10.3 Lvs at position 26 acvlated on its side chain with a
moiety that comprises two “OEG” groups, a y-Glu group, and
a C18 fatty diacid, The specific OEG groups are “AEEA”
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groups – AEEA is short for 2-(2-(2-Aminoethoxy)ethoxy)acetic
acid. (Said moiety comprises at least two acidic groups,
wherein one acidic group is attached terminally).”
(Emphasis contained in the original)
51. The learned Single Judge thereafter proceeds, on the plea of
anticipation by prior claiming, to hold as under:
“40. The Defendants have contended that these features enlisted
by the Plaintiff are already exemplified in the Ala Semaglutide
compound/Example 61. The Plaintiff has also compared the
structure of the Semaglutide compound, as claimed in Claim 23 of
the Suit Patent/IN’697, with the Ala Semaglutide
compound/Example 61 of the Genus Patent/IN’964. The
comparison is set out below:
Name of Structural Similarities Difference
Compound between the
Semaglutide
compound
and the Ala
Semaglutide
compoundAla – Aib at the
Semaglutide 8th position
compound instead of
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Semaglutide
compoundFurther, Plaintiff has also made a comparison of Ala Semaglutide
compound/Example 61 of Genus Patent/IN’964 with Semaglutide
compound of the Suit Patent/IN’697 in the expert affidavit of
Gregory L Challis dated 11th July 2025. The extract of the
comparison is set out below:
Difference
Example 61 of IN'964 between
Example 61 of
IN '964 and
Example 4 of
IN '697
(Semaglutide):
Semaglutide
contains Aib
(which is a non-
proteogenic
amino acid) at
Example 4 of IN'697 (Semaglutide)
position 8.
Example 61
contains Ala at
position 8
which is a
proteogenic
amino acid.
Апy change in
peptide
sequence can
alter the
physical,
chemical and
pharmacologica
l properties of
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the resulting
compound.
Any such
change can also
raise the risk
immunogenicity
. In some
settings there
were fears that
non-proteogenic
amino acids
could
exacerbate this
risk (non-
proteogenic
amino acids are
amino acids
which do not
occur in nature
in proteins).
This risk could
be particularly
pronounced for
medicines taken
chronically
(such as
treatments for
type 2 diabetes)
as this provides
a long time for
immunogenicity
to develop.
41. The aforesaid comparisons filed by the Plaintiff
acknowledges that the sole/only difference in the Semaglutide
compound claimed in Claim 23 as exemplified in Example 4 of the
Suit Patent/IN’697 from the Ala Semaglutide compound/Example
61 of the Genus Patent/IN’964, is in the insertion of ‘Aib’, i.e., a
non-proteogenic amino acid, at the 8th position.
42. The tables above show that there is no dispute as to the
effect that the Plaintiff had already claimed a compound22 in Claim
21 of the Genus Patent/IN’964, which has the GLP-1 (7-37)
sequence with modification of Arg at the 34th position and Lys at
the 26th position with at least two [2] acidic groups, wherein one22
Example 61
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[1] acidic group is attached terminally. Thus, the differences set out
by the Plaintiff at paragraphs ’10’, ‘10.2’ and ‘10.3’ of its rejoinder
[as noted above] have already been claimed in the identical
positions of the Ala Semaglutide compound/Example 61.
It would also be relevant to note that substitution of the
amino acid Lys with Arg at position 34 has been specifically
claimed at Claim 18 of the GLP-1 (7-37) analogue. So also, the
preference for GLP-1 (7-37) analogue is also apparent in the
dependent claims of the GLP-1 (7-37) analogue.
43. In the aforenoted admissions of the Plaintiff, the issue that
arises for consideration is whether a ‘person skilled in the art’ will
be enabled by following the specific instructions of the claims of
the Genus Patent/IN’964 to substitute ‘Ala’ with ‘Aib’ residue at
the 8th position of the Ala Semaglutide compound/Example 61.
44. Upon perusal of the claims of the Genus Patent/IN’964, it is
apparent that the independent Claim 1 of the Genus Patent/IN’964
claims a GLP-1 analogue that comprises an amino acid sequence,
i.e., formula [V], where an unspecified amino acid at the 8th
position [Xaa8] could be selected from a broader group containing
‘Ala’, Gly, Val, Leu, lle, Lys, ‘Aib’, etc.
Later, in the dependent Claim 16 of the Genus
Patent/IN’964, the patentee has specifically claimed that the amino
acid at the 8th position of GLP-1 analogue claimed in Claim 1 of
the Genus Patent/IN’964 is ‘Aib’, thereby asserting that ‘Aib’ is
the preferred amino acid for the substitution at the 8th position.
Therefore, for a ‘person skilled in the art’, upon perusal of
the Ala Semaglutide compound/Example 61 or any compounds
claimed in Claim 21 of the Genus Patent/IN’964, he/she will be
enabled to make a substitution at the 8th position with ‘Aib’, in
light of specific Claim 16 of the Genus Patent/IN’964.
With Claim 16 of the Genus Patent/IN’964, it is evident
that the sole novel feature of the Suit Patent, i.e., ‘Aib’ at the 8th
position, was already claimed in the Genus Patent/IN’964.
45. Now, upon considering the independent Claim 1 of the Suit
Patent/IN’697, the Plaintiff/Patentee has claimed that the GLP-1
analogue has at least one [1] non-proteogenic amino acid residue at
position seven [7] and/or eight [8]. Thereafter, in the dependent
Claim 16 of the Suit Patent/IN’697, the patentee has specified that
at the 8th position of the GLP-1 analogue, it is nothing but ‘Aib’;
however, GLP-1 (7-37) analogue with ‘Aib’ at the 8th position was
already claimed in Claims 1, 11 and 16 of the Genus
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Patent/IN’964.
46. Therefore, from the Claims 1 and 21 [Example 61
compound therein], read with explicit disclosure of non-
proteogenic amino acid, i.e., ‘Aib’ at the 8th position in Claim 16 of
the Genus Patent/IN’964 as the most preferred non-proteogenic
amino acid of the inventor, a ‘person skilled in the art’ will be
enabled to make the substitution at the 8th position of the Ala
Semaglutide compound/Example 61. With this substitution, the
‘person skilled in the art’ will undoubtedly reach the Semaglutide
compound as claimed in Claim 23 [Example 4] of the Suit
Patent/IN’697. In view of Claim 21 [Ala Semaglutide
compound/Example 61] and Claim 16 of the Genus Patent/IN’964,
it is evident that all the features of the Semaglutide compound
enlisted by the Plaintiff in its rejoinder at paragraphs ’10’, ‘10.1’,
‘10.2’ and ‘10.3’ already stand claimed in the Genus
Patent/IN’964, with an explicit instruction to combine these
features. Thus, based on the analysis above, it could be concluded
that the Semaglutide compound, as claimed in the Suit
Patent/IN’697, was prior claimed in the Genus Patent/IN’964.”
52. Thus, in the afore-extracted paragraphs 40 to 46 of the
impugned judgment, the learned Single Judge essentially holds thus:
(i) The novel features of Semaglutide over prior art, as
identified by the appellant itself, in para 10 of the rejoinder filed
before the learned Single Judge were
(a) substitution of the amino acid alanine (Ala) with α-
aminoisobutyric acid (Aib) at position 8,
(b) substitution of the amino acid lysine (Lys) with
arginine (Arg) at position 34 and
(c) activation of lysine at position 26 on its side chain
with a moiety comprising at least two acidic groups in
which one acidic group is attached terminally.
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(ii) The defendants’ contention, per contra, was that these
features already stood disclosed in the exemplified Compound
61 in Claim 21 in the Genus Patent IN’964.
(iii) The appellant had itself undertaken a comparison of
Semaglutide, as Claim 23 in the Suit Patent, with Compound 61
in Claim 21 in the Genus Patent IN’964 and had also filed an
affidavit of an expert in that regard. The appellant clearly
admitted, at both points, that the only difference between the
exemplified Compound 61 in Claim 21 of the Genus Patent
IN’964 and Semaglutide as Claim 23 of the Suit Patent was the
replacement of ‘Ala’ at the 8th position, in the Genus Patent with
‘Aib’ in Semaglutide.
(iv) Claim 21 in IN’964 already claimed a GLP-1 sequence
which was modified with arginine at the 34 th position and lysine
at the 26th position with two acidic groups, one of which was
attached terminally. In other words, the purportedly novel
features of semaglutide, as contained in paras 10.2 and 10.3 of
the rejoinder filed by the appellant, before the learned Single
Judge, already stood claimed in Claim 21 of IN’964.
(v) The only issue to be considered, therefore, was whether a
person skilled in the art would be enabled, by the teachings in
the claims of IN’964, to substitute ‘Ala’ with ‘Aib’ at the 8 th
position in Compound 61 in Claim 21 of IN’964.
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(vi) Claim 1 of the genus patent IN’964 claimed a GLP-1
analogue with an amino acid sequence in which the amino acid
at position 8 could be selected from a group which included
‘Ala’ and ‘Aib’.
(vii) Dependant Claim 16 below Claim 1 in IN’964
specifically claimed an amino acid formed by substituting Aib
at position 8 of Claim 1. Thus, it was disclosed, in the genus
patent IN’964 that Aib was the preferred amino acid for
substitution at position 8 in claim 1 of IN’964.
(viii) A person skilled in the art would, therefore, be guided by
the teachings in the Genus Patent IN’964 to substitute Aib at
position 8 in claim 1 in the said Genus patent instead of Ala.
(ix) Thus, claim 1 and Example 61 in claim 21 of IN’964,
read with the disclosure of Aib at position 8 in claim 16 of
IN’964, was sufficient to enable a person skilled in the art to
substitute Aib at position 8 in the exemplified compound 61 in
Claim 21 of the Genus Patent IN’964. This substitution would
result in Semaglutide.
(x) As all other features of Semaglutide were already
claimed in IN’964, with the explicit instruction to combine
them, the learned Single Judge holds that semaglutide was
anticipated by prior claiming in the Genus Patent/ IN’964.
II. Section 64(1)(e) – Anticipation by prior publication
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53. To support their challenge to the validity of the suit patent under
Section 64(1)(e), the respondents again relied on IN’964 as the
applicable prior art. The learned Single Judge disposes of this
challenge by holding, in paras 83 and 84 of the impugned judgment,
that the findings returned in respect of the challenge under Section
64(1)(a) would apply mutatis mutandis to the challenge under Section
64(1)(e):
“83. In the present case, Defendants have identified Genus
Patent/IN’964, as the relevant prior art for challenging the validity
of the Suit Patent/IN’697 under Section 64(1)(e) of the Patents Act.
The priority date of the Suit Patent/IN’697 has already been
decided in the previous section as after the publication of the
Genus Patent/IN’964.
84. The analysis under Section 64(1)(a) of the Patents Act is
relevant in the fact of this case under Section 64(1)(e) of the
Patents Act and applies mutatis mutandis since the prior patent
referred to in the deliberations under Section 64(1)(a) and the prior
art referred to under Section 64(1)(e) in the facts of this case is the
same document i.e., Genus Patent/IN’964. In the considered view
of this Court, when Example 61 compound of Genus Patent/IN’964
is read in conjunction with the specific Claim 16 therein, the Genus
Patent/IN’964 specifically discloses the Suit Patent/IN’697, i.e.,
Semaglutide compound for a ‘person skilled in the art’ to
reproduce it without undue experimentation. Therefore, the Suit
Patent/IN’697 is anticipated by the Genus Patent/IN’964, which
was published before the priority date of the Suit Patent/IN’697.
III. Section 64(1)(f) – Obviousness
54. With respect to the challenge under Section 64(1)(f), the
respondents relied on three prior arts i.e. Genus Patent / IN’964 and
the teachings of Deacon et al [1998] and Knudsen et al [2004]. The
learned Single Judge, thereafter, proceeds on an intricate analysis of
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the facts before her, in compliance with the “5-step test” postulated by
the Division Bench in Roche-II.
G. Analysis
55. The exercise, as undertaken, is detailed and thorough, and
deserves commendation. However, we do not deem it necessary to
examine the findings of the learned Single Judge with respect to
Section 64(1)(f), as we are of the view that her findings, with respect
to Section 64(1)(a), as noted supra, make out a clear case of
obviousness of Semaglutide, as claimed in the suit patent, vis-à-vis the
claims and complete specification in prior art in the form of IN’964.
56. We feel, in fact, here, that the learned Single Judge has erred,
albeit to a slight degree, in conflating the concept of obviousness,
which is relevant for Section 64(1)(f), and anticipation by prior
claiming, which pertains to Section 64(1)(a). The findings returned by
the learned Single Judge, for holding a prima facie case to have been
made out under Section 64(1)(a), in fact make out a prima facie
credible challenge to the validity of the suit patent under Section
64(1)(f).
57. The following paragraphs from the impugned judgment would
make this apparent:
“28. The Defendants have contended that the Semaglutide
compound falling under the Suit Patent/IN’697 is not novel since
the same compound is claimed/disclosed under the Genus
Patent/IN’964, and therefore, applying the principle of Novartis
AG v. Union of India, the Plaintiff is barred from appropriating the
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the subsequent Suit Patent/IN’697. Therefore, the Suit
Patent/IN’697 is vulnerable to invalidity under Section 64(1)(a) of
the Patents Act. It is contended that claims in the Suit
Patent/IN’697 are not novel as they are anticipated by the claims of
the Genus Patent/IN’964 and therefore, liable for revocation. It is
further contended that the teaching in the Genus Patent/IN’964
sufficiently enables the Semaglutide compound. The Defendants
also rely upon the admissions made by the Plaintiff on the scope of
the claims in Genus Patent/IN’964 in corresponding patent across
various foreign jurisdictions, as well as in Plaintiff’s filings before
the Indian Patent Office, wherein the Plaintiff has claimed that the
Semaglutide compound is the only commercial product that has
resulted from both the Genus Patent/IN’964 and the Suit
Patent/IN’697.
*****
34. This aforesaid judgment23 lays down the legal proposition
that after the publication of a species patent, the defendant who
challenges the validity of the species patent on the ground of
anticipation by prior claiming in the genus patent has to establish
that the derivation of the claim in the species patent, from the
claim in the genus patent, is actually guided by the teachings in the
genus patent itself. It further holds that where a genus patent is a
Markush structure, the existence of enabling disclosure in the
genus patent attains significance.
*****
38. Thus, to assess whether the Suit Patent IN’697, i.e.,
Semaglutide compound, is claimed in the Genus Patent/IN’964,
this Court will examine whether there is a disclosure of each
feature or sufficient teachings in the claims of the Genus
Patent/IN’964 enabling a ‘person skilled in the art’ regarding the
features of the Suit Patent/IN’697, i.e., the Semaglutide
compound.”
(Emphasis supplied)
The italicized parts of the above paragraphs from the impugned
judgment pertain, not to the realm of anticipation by prior claiming
under Section 64(1)(a), but obviousness to a person skilled in the art,
under Section 64(1)(f). To this limited extent, we are unable to agree
23 Novartis AG v. Natco Pharma Ltd, 2023 SCC OnLine Del 106, authored by the author of this judgment,
sitting singly
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with the learned Single Judge that a prima facie credible challenge to
the validity of the suit patent had been laid by the respondents, under
Section 64(1)(a), which requires congruence of claims, and nothing
less.
58. The person skilled in the art, in fact, has no real part to pay in
Section 64(1)(a). His perspective is relevant to Section 64(1)(f) and,
to a lesser degree, to Section 64(1)(e).
59. However, the exercise undertaken by the learned Single Judge,
following these findings, though undertaken in the context of Section
64(1)(a), make out a clear case under Section 64(1)(f).
60. We have already extracted, earlier, the findings of the learned
Single Judge in that regard, and also paraphrased them in our own
words, and do not deem it necessary to reiterate them. Suffice it to
state that the learned Single Judge has held, in essence, that
(i) of the novel and inventive features of Semaglutide, as
identified by the appellant itself in para 10 of the rejoinder
filed before the learned Single Judge, the features in paras 10.2
and 10.3 were already claimed in Claim 21 of IN’964,
(ii) the appellant had itself acknowledged that the only
distinguishing feature between Compound 61 in Claim 21 of
the Genus Patent IN’964 and Semaglutide was the amino acid
‘Aib’ at the 8th position in place of ‘Ala’,
(iii) Claim 1 read with dependent Claim 16 in the Genus
Patent IN’964 teach that ‘Aib’ was a preferred amino acid for
substitution at position 8,
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(iv) the combined effect of these teachings would lead a
person skilled in the art to substitute, in Example 61 in Claim
21 of the Genus Patent IN’964, the ‘Aib’ amino acid in place
of ‘Ala’, which would result in Semaglutide.
61. Five of the inventors were common to the Genus Patent
IN’964 and the suit patent. Where the inventors are common, the
Division Bench of this Court has, in AstraZeneca AB v. Intas
Pharmaceuticals Ltd.24, held that the aspect of obviousness would
have to be viewed from the perspective of a “person in the know”,
rather than a “person skilled in the art”. This Bench has, in F
Hoffmann-La Roche AG v. Natco Pharma Limited25, approved and
followed the said test. Special Leave Petitions, preferred against both
these decisions, stand dismissed by the Supreme Court. The “person
in the know” test may, therefore, be regarded as having been
accorded Apical affirmation.
62. Viewed from the perspective of a person in the know, it is
prima facie clear that Semaglutide would be obvious from the
teachings contained in the Genius Patent IN’964 and that, therefore, a
credible challenge to the validity of the suit patent, under Section
64(1)(f), is made out.
63. Even on this sole ground, as the impugned judgment is liable
to be affirmed, we do not deem it necessary to enter into any other
aspect of the matter.
24 2021 SCC OnLine Del 3746
25 2025 SCC OnLine Del 6390
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64. We also do not deem it necessary to reproduce the submissions
of learned Counsel for the appellant in this regard, as, on the aspect
of obviousness of Semaglutide from the teachings contained in the
Genus Patent IN’964, there is no substantial traversal.
Conclusion
65. We, therefore, see no reason to disturb the impugned judgment
of the learned Single Judge.
66. The appeal is dismissed.
67. Observations contained in this judgment, needless to say, are
only prima facie, and would not influence the learned Single Judge
while adjudicating the suit on merits.
C. HARI SHANKAR, J.
OM PRAKASH SHUKLA, J.
MARCH 09, 2026/aky/yg
Signature Not Verified
Digitally Signed By:AJIT
KUMAR FAO(OS) (COMM) 204/2025 Page 34 of 34
Signing Date:09.03.2026
16:58:32
