The Semaglutide Battle: Why Drl Won the Right to Manufacture Despite Novo’s Patent

On 2^nd December 2025, the Delhi High Court declined to grant an interim injunction restraining Dr. Reddy’s Laboratories from manufacturing semaglutide in India for export, notwithstanding Novo Nordisk’s assertion of infringement of Indian patent IN 262697 (IN’697). The Court’s order, rendered at the interlocutory stage, did not adjudicate the final validity of the patent but turned on the application of settled principles governing interim relief under Indian patent law. The dispute is emblematic of a larger structural tension between high-value pharmaceutical patent protection, allegations of evergreening, and India’s position as a global manufacturing hub for export -oriented generics.

Against this technical and legal backdrop, the decision assumes significance for three distinct but interconnected reasons:

i. First, it illustrates judicial scrutiny of genus–species patenting strategies in high-value biologics and pharmaceuticals;

ii. Second, it clarifies the treatment of export-oriented manufacture and how courts approach export-only manufacture near patent expiry, and

iii. Creates an unresolved tension between prima-facie invalidity and protection of the domestic market during pendency.

What the Patent Actually Claims

To understand why the Court was unconvinced at the interim stage, it is necessary to examine what IN’697 actually claims. The patent at issue – published specification for acylated GLP-1 analogues, claims acylated GLP-1 peptides that include at least one non-proteogenic amino-acid residue (notably Aib at position 8) and an albumin-binding acyl moiety attached (commonly via Lys26) to prolong half-life and provide DPP-IV resistance and prolonged in-vivo action. The specification sets out broad formulae (Formula I/II), enumerates specific substitutions (sequence embodiments), and supplies multiple chemical examples and linkers. These concrete embodiments (including Aib substitution and Lys26 acylation) are the technical basis for both Novo’s species patent claim and DRL’s prior-claiming/obviousness counter arguments.

The Narrow Procedural Issue the Court Decided

Despite the breadth of the patent claims and the competing assertion on validity, the Court was concerned only with a limited procedural question at the interlocutory stage. The parties agreed (and the court recorded) that DRL would not sell semaglutide in India; DRL’s activity was manufacture for export only. Thus, the sole question on the interim application was: should DRL be restrained from manufacturing semaglutide in India until IN’697 expires / the suit is finally decided?

The court answered no.

How the Court Reached That Conclusion

A. The defendant’s multi-ground attack (Section 64)

DRL pressed four principal invalidity arguments:

i. Prior claiming from Novo’s earlier genus patent (IN’964)

ii. Anticipation / prior publication

iii. Lack of inventive step

iv. Alleged false suggestion in patent procurement

The relevance of these grounds lay not in their final adjudication, but in whether they were substantial enough to cast doubt on the presumption of prima facie validity at the interim stage. The court examined each strand and treated the overall challenge as credible enough to undermine the “prima facie validity” required for interim relief. The order carefully compares Example 61 of the genus patent with the semaglutide embodiments (Aib substitution; acylation at Lys26) described in IN’697, and finds that a straightforward mechanical leap from genus to the specific species requires selection and combination steps not plainly taught by the earlier disclosure.

B. Interim relief test applied

Having found the validity challenge to be credible, the Court proceeded to apply the settled principles governing the grant of interim injunctions under Indian patent law.

The Court applied the threefold test:

i. Prima facie case: because DRL’s validity challenge raised substantial, arguable issues, Novo could not show an unassailable prima facie case.

ii. Balance of convenience: DRL had committed not to sell in India, had made substantial capital investment in manufacturing facilities for export, and only a short period remained before IN’697’s expiry. Conversely, Novo had not shown an immediate domestic commercial displacement. The balance favored DRL.

iii. Irreparable harm: the court found Novo’s claimed injuries to be compensable in damages and not of the irreparable kind demanded for an injunction.

C. Operative result

i. DRL may manufacture and export semaglutide to markets where Novo has no patent.

ii. DRL remains prohibited from selling in India pursuant to its undertaking.

iii. The Court did not make a final finding on validity; it took a prima facie view sufficient to deny interim relief.

Why this decision is legally significant

Beyond its immediate effect on the parties, the order carries broader doctrinal and commercial implications for pharmaceutical patent enforcement in India.

A. Genus vs species: scrutiny, not deference

The court’s line-by-line comparison of genus disclosures and the later species patent shows a willingness to interrogate how a species was arrived at from a genus. It does not accept facile assertion that a species necessarily falls within a genus disclosure; rather, it looks for clear teaching or motivation to make the specific choices that produce the claimed species (Aib substitution + particular acylation patterns.) That approach tightens the scrutiny on layered patenting strategies in chemical/peptidic inventions.

Practical effect: Innovators relying on successive patent filings must ensure the later patent demonstrates concrete technical advance (not merely an arguable optimization) over the genus. The court’s careful parsing signals higher risk for “evergreening’ attempts.

B.     Export-only manufacture is not per se injunctive conduct

By permitting manufacturing for export, subject to the sales undertaking, the court distinguishes manufacturing per se from market entry. Where manufacturing is targeted at non-patent jurisdictions and the defendant’s invalidity challenge is substantial, courts may refrain from injunctive interference. This pragmatic stance recognizes global supply chains and the reality that India is a major API/finished dosage manufacturer for export markets.

Practical effect: Generic manufacturers may proceed with export-oriented production under legal risk calculated against likely compensatory relief, but not necessarily an automatic injunction; especially near expiry.

C. The residual sales ban: a doctrinally awkward compromise

Restraining the domestic sales bar while allowing manufacture/export is the most contentious element. It reflects the Court’s attempt to preserve the patentee’s domestic exclusivity pending final adjudication while not imposing an arguably disproportionate commercial burden on DRL. Yet it creates a doctrinal tension: if validity concerns are strong enough to deny an injunction against manufacture, why maintain a sales ban that effectively preserves exclusivity? This tension stems directly from the Court’s prima facie assessment of vulnerability without a corresponding willingness to disturb domestic market exclusivity pending trial. The order does not fully reconcile this tension.

Practical effect: Defendants must exercise caution; export permissions may come alongside attendant limitations on domestic market entry, and the sequencing of revocation proceedings relative to manufacturing commencement matters.

CRITIQUE

While the Court’s reasoning is largely consistent with settled injunction jurisprudence, certain aspects of the order invite closer scrutiny when examined against its own factual findings. The Court’s decision is defensible on statutory and equitable grounds; it adheres to the injunction test and recognizes the commercial reality of export markets. Nevertheless, two points merit critical attention; both drawn from the judgement’s facts and doctrine.

A. Timing and the “last months” problem

The order was issued when the patent term was close to expiry (March 2026). The tight remaining term influenced the balance-of-convenience analysis. This raises a systemic issue: patentees will increasingly litigate late in the term to squeeze relief; courts may increasingly need to consider whether injunctions remain an appropriate remedy in the final months of exclusivity. The judgement accommodates that reality, but the approach may incentivize strategic timing; either by patentees seeking last-minute relief or by generic entrants aligning manufacture with expiry. The Court’s analysis is cautious but opens a broader policy question about managing end-of-term disputes.

B. The “clearing the way” paradox

By endorsing a domestic sales ban while allowing export manufacture, the Court effectively split the legal consequences of the prima-facie finding. If a species patent is prima facie vulnerable, maintaining domestic exclusivity appears protective of the patentee in a way that undercuts the force of the non-injunction for manufacture. The judgement justifies this by reference to the sequencing of revocation proceedings and the defendant’s undertaking; yet the result is a half-measure: markets abroad may benefit from lower costs; Indian patients must wait. This tension is real and, critically, fully factual in origin (undertakings, timing of revocation, investment by DRL).

These doctrinal choices and procedural compromises translate into concrete strategic lessons for both originator companies and generic manufacturers.

Practical Takeaways

A.  Genus disclosures require precise parsing.

When drafting species patent, ensure the specification explains why a particular substitution or acylation is non-obvious and how it yields a technical advantage. Use explicit comparative data.

B. If manufacturing for export, file revocation early.

Courts expect defendants seeking market entry to “clear the way”; commencing manufacturing before a revocation challenge may complicate domestic entry positions.

C. Near-expiry litigation will alter injunction calculus.

Parties should plan time effects: costly injunctions are less probable when only months remain on the patent.

D. Export strategy is viable but not risk-free.

Export-only manufacture can proceed where validity is credibly challenged; but domestic launch may be restrained by undertakings or judicial caution.

Conclusion

The Delhi High court’s order in Novo Nordisk v. Dr. Reddy’s is consequential precisely because it is narrow; it does not decide ultimate validity, but it supplies principled guidance on interim relief when species patents are contested and manufacturing is export-oriented. The judgment tightens the analytical lens on genus-species relationships, privileges a fact-sensitive balance between commercial reliance and lawful exclusivity, and leaves open, for final hearing, the larger question of whether IN’697 ultimately survives statutory scrutiny.

For innovators, the message is clear: “patent layering” without demonstrable technical advance is risky. For generics, the message is cautious: export manufacture is feasible but must be handled strategically to avoid entanglement with domestic market constraints.

Author: Vaishnavi Shukla, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at  Khurana & Khurana, Advocates and IP Attorney.