Delhi High CourtIntellectual Property LawCivil Procedure and Evidence

Species patent is vulnerable to revocation if teachings in genus patent enable a person skilled in the art.

Novo Nordisk A/S v. Dr. Reddys Laboratories Limited & Anr. [FAO(OS) (COMM) 204/2025]

Species patent is vulnerable to revocation if teachings in genus patent enable a person skilled in the art.. Novo Nordisk A/S v. Dr. Reddys Laboratories Limited & Anr. [FAO(OS) (COMM) 204/2025]. Delhi High Court. LawLens
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In brief

The question

Whether the Respondents raised a "credible challenge" to the validity of the suit patent (IN’697) sufficient to justify the denial of an interlocutory injunction under Order XXXIX of the CPC

The court held

The Court dismissed the appeal and upheld the Single Judge’s refusal to grant an injunction

It also directed

It held that the Respondents successfully established a credible challenge to the validity of the suit patent under Section 64(1)(f) (obviousness)

The Court further emphasized that in cases where a patent is on the verge of expiry and a credible challenge is raised, the balance of convenience and the principle of avoiding "mini-trials" at the interim stage weigh against granting an injunction

The Respondents remain bound by their earlier undertaking not to sell in India until the patent expires

01Facts

The Appellant (Novo Nordisk) holds Indian Patent 262697 (IN’697) for "Semaglutide," an anti-diabetic drug

¶ 2, 35

In 2024, the Appellant discovered that the Respondents were importing Semaglutide and filed an infringement suit in 2025

¶ 2, 36

The suit patent is set to expire on March 20, 2026

¶ 3

The Respondents contested the suit by invoking Section 107(1) of the Patents Act, 1970, raising a "credible challenge" to the patent’s validity based on a prior Genus Patent, IN 275964 (IN’964)

¶ 38, 42

A Single Judge rejected the Appellant’s application for an interlocutory injunction on December 2, 2025, finding the patent vulnerable to revocation under Section 64

¶ 2

The Appellant appealed this rejection.

02Issues

i.Whether the Respondents raised a "credible challenge" to the validity of the suit patent (IN’697) sufficient to justify the denial of an interlocutory injunction under Order XXXIX of the CPC

¶ 14, 43

ii.Whether the suit patent was vulnerable to revocation under Section 64(1)(a) (prior claiming), 64(1)(e) (lack of novelty/prior publication), or 64(1)(f) (obviousness/lack of inventive step)

¶ 15, 41

iii.Whether the appellate court should interfere with the discretionary order of the Single Judge given the imminent expiry of the patent

¶ 11, 33

03Law Applied

The court applied the "Wander Standard" from Wander Ltd v. Antox (India) Pvt Ltd, which restricts appellate interference in discretionary interlocutory orders unless the lower court acted arbitrarily or perversely

¶ 33

Regarding patent law, Section 107(1) of the Patents Act, 1970 allows any ground for revocation under Section 64 to be a defense in an infringement suit

¶ 14

The court relied on F. Hoffmann-La Roche Ltd v. Cipla Ltd (Roche-I), establishing that a defendant need only show a "credible challenge" or "vulnerability" of the patent at the interim stage

¶ 14

For obviousness, the court referenced Section 2(ja) regarding "inventive step" and the "person skilled in the art" (PSITA) test as interpreted in Roche-II, while also applying the "person in the know" test for common inventors as established in AstraZeneca AB v. Intas Pharmaceuticals Ltd

¶ 26, 27, 61

Provisions in the judgment · 5 · Linked ones open on LawLens

Patents Act, 1970 Section 48Section 64Section 107Section 13Section 2

04Reasoning

The Court first noted the lack of "irreparable loss" to the Appellant, as the patent was only two months from expiry when judgment was reserved

¶ 4, 10

On the merits, the Court found that while the Single Judge slightly conflated "prior claiming" (Section 64(1)(a)) with "obviousness" (Section 64(1)(f)), the factual findings strongly supported a credible challenge under the latter

¶ 42, 56

The Appellant admitted that the only difference between Example 61 of the prior Genus Patent (IN’964) and Semaglutide was the substitution of the amino acid 'Ala' with 'Aib' at the 8th position

¶ 48, 51

The Court reasoned that since Claim 16 of the Genus Patent specifically taught that 'Aib' was a preferred substitution at that position, a "person in the know" (given five inventors were common to both patents) would find the transition to Semaglutide obvious

¶ 52, 61, 62

Thus, the suit patent was prima facie vulnerable to revocation for lack of an inventive step.

05Holding

The Court dismissed the appeal and upheld the Single Judge’s refusal to grant an injunction

¶ 65, 66

It held that the Respondents successfully established a credible challenge to the validity of the suit patent under Section 64(1)(f) (obviousness)

¶ 62, 63

The Court further emphasized that in cases where a patent is on the verge of expiry and a credible challenge is raised, the balance of convenience and the principle of avoiding "mini-trials" at the interim stage weigh against granting an injunction

¶ 10, 28, 30

The Respondents remain bound by their earlier undertaking not to sell in India until the patent expires

¶ 37
Delhi High Court

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Novo Nordisk A/S v. Dr. Reddys Laboratories Limited & Anr. [FAO(OS) (COMM) 204/2025]

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