Case Name: Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. 

Citation: CS (COMM) 565/2025 dated 2 December 2025

Court: Delhi High Court

Coram: Justice Manmeet Pritam Singh Arora

Abstract 

The Honourable Delhi High Court’s recent decision refusing an injunction to Novo Nordisk over its blockbuster diabetes drug “Semaglutide,” marketed globally as Ozempic, marks a turning point in the Indian approach to genus–species patenting. The judgment holds that Novo’s species patent was already disclosed, taught and enabled in its own earlier genus patent and therefore vulnerable to revocation. While the reasoning appears straightforward at first glance, the decision raises deeper doctrinal questions about the boundary between legitimate incremental innovation and prohibited evergreening. This comment explores whether the Court’s analysis, particularly on disclosure, enablement, obviousness and the evidentiary weight accorded to Form 27, strikes the correct balance between statutory interpretation and judicial innovation or whether it stretches patent doctrine beyond legislative intent. It also examines the Court’s treatment of export permissibility, which distinguishes between domestic exclusivity and international supply chains, and considers whether this approach coherently aligns with India’s patent framework or risks creating practical inconsistencies in enforcement, manufacturing strategy and global market access.

Introduction

Cognizant as it is of the powerful symbolism, only a few pharmaceutical cases in recent times have had a kind of symbolic resonance more than what Novo Nordisk v. Dr. Reddy’s held. It is hard to overestimate semaglutide’s worldwide profile as the new poster child of modern metabolic therapy, and with censorship reports mounting across markets about its unprecedented effectiveness, the legal framework that underpins its protection is a topic of considerable commercial and public interest. As a major diabetes hub and global centre for generic pharmaceutical supply, it was inevitable that India would become the focal point of this patent battle. The refusal by the Court to order Dr. Reddy’s to make Semaglutide for export represents an aggressive judicial stance towards the potential of evergreening, to be sure, but it raises some analytical challenges that warrant a bit more scrutiny.

Factual Background

The dispute revolves around two patents belonging to Novo Nordisk. While the first one, IN ‘964, was a broad genus patent filed in 2004 covering a wide Markush structure of GLP-1 analogues,  the second one, IN’697, which was filed in 2006 and granted in 2014, specifically claimed the Semaglutide molecule. After the expiry of the genus patent in 2024, Dr. Reddy’s began manufacturing Semaglutide in India for export to jurisdictions where the compound was not patent-protected. Novo, contending this constituted infringement, sought an interim injunction. To this, Dr. Reddy’s responded that Semaglutide was already taught and claimed within IN’964, invoking the Gillette defence and challenging the validity of IN’697.

Issues:

• Whether Semaglutide was already disclosed, taught, or enabled within Novo’s earlier genus patent, IN ‘964, thereby rendering the later species patent, IN’697, vulnerable to invalidity for prior claiming and anticipation under Section 64(1)(a)?
• Whether applying the “person in the know” standard and the scientific literature on GLP-1 analogues, the substitution of alanine with Aib at position 8 made Semaglutide obvious to a skilled person under Section 64(1)(f)?
• Whether Novo’s Form 27 disclosures and commercial working statements could be treated as admissions linking the genus and species patents, and what implications this has for allegations of evergreening and the grant of interim injunctions?

Court’s Reasoning

The ratio in Novo Nordisk v. Dr. Reddy’s is noteworthy, both for its structural neatness, but also the way it travels through technical analysis, patent specification examination, prior art and statutory concepts with apparent ease. The analysis starts with the interpretive separation imposed by the ‘964 ancestor genus patent, which is not to be interpreted as a mere hollow or ornamental document. Rather, it should be given full pretension as a technical teaching to the person skilled in art. This interpretive filter colours the rest of the opinion. 

The Court first establishes the proximity between Example 61 of IN’964 and Semaglutide. Relying on scientific papers, particularly the Lau (2015) and Deacon (1998) studies, it accepts that the only difference between Example 61 and Semaglutide lies in the amino acid present at the 8th position, i.e., alanine in Example 61 and Aib (α-aminoisobutyric acid) in Semaglutide. It is emphasised that Aib substitution was not only known in the relevant period but was repeatedly highlighted in scientific literature as a reliable and predictable method of improving resistance to DPP-IV, the enzyme that rapidly degrades GLP-1 analogues. Thus, when the genus patent openly invites substitutions including Aib within the same structural skeleton, it is to be read as a prover of a roadmap rather than being a mere broad placeholder. In other words, the Court concludes that the genus does not merely allow Semaglutide; it materially points towards it.

The Court goes on to invoke the “person in the know” standard, a concept earlier articulated by the Delhi High Court’s Division Bench in AstraZeneca and later applied in Roche v. Natco. This framework becomes relevant when the genus and species patents share common inventors. In such circumstances, the Court does not rely solely on the conventional POSITA benchmark. Instead, it considers that the inventors themselves, as individuals presumed to have full awareness of the genus disclosure, form the appropriate reference point for evaluating obviousness. Applying this logic to Novo’s patents, the Court reasons that the inventors, being very familiar with the structural options and substitutes in IN ‘964, would naturally be led to Semaglutide. As a result, the “person in the know” construct supports the Court’s conclusion that the species patent does not represent a meaningful inventive advance over the genus patent. Although formally introduced within the context of obviousness under section 64(1)(f), the Court appears to rely on the same reasoning when assessing prior claiming and anticipation, thereby allowing the standard to influence multiple doctrinal findings.

The judgment becomes more assertive when it treats Novo’s Form 27 disclosures as an admission against Novo’s own interest. Novo had declared that IN’964 was worked commercially through products containing Semaglutide. If IN ‘964 is being commercially worked through Semaglutide-based products, the patentee itself appears to acknowledge that the earlier genus patent covers the later species. The Court interprets this as confirmation that IN’964 taught Semaglutide. This approach in particular allows the Court to bridge any remaining gap between disclosure and enablement, assuming that if the patentee itself linked the two patents in practice, the teaching must have been adequate.

Having established anticipation and enablement, the Court then turns to the allegation of evergreening. Where it holds that Novo, being fully aware of the advantages of Arab substitution in 2004, deliberately withheld Semaglutide from the genus patent to file a later, narrower, and more commercially potent species patent. By doing so, Novo attempted to extend its period of exclusivity unlawfully. The judgment concludes that granting an injunction in such circumstances would directly reward the conduct that the Patents Act and long-standing Indian policy seek to deter.

Critique

Although the Court’s reasoning is compelling at first glance, a closer examination reveals serious jurisprudential, scientific and procedural weaknesses. The central flaw arises from the Court’s conflation of structural similarity with specific disclosure. Indian patent law, echoing the UK House of Lords in Synthon v. SmithKline Beecham and the Supreme Court of India in Bishwanath Prasad, requires that anticipation must provide a clear, unmistakable, enabling teaching of the claimed invention. Although Structural proximity as well as the existence of permissible substitutions. They are common in peptide chemistry; the proximity is not disclosed. One molecule may differ from another by a single residue but produce dramatically different therapeutic outcomes, and that is why species patents exist in the first place. By treating Example 61 as essentially the same as Semaglutide, the Court compresses the entire scientific space of peptide drug development into a linear, foreseeable path, which, chemically speaking, is rarely the case.

Another doctrinal concern arises from the reliance on Aib substitution as an automatic signpost to Semaglutide. The Court assumes that because Aib substitution was known to confer DPP-IV stability, the skilled person would inevitably arrive at Semaglutide. This reasoning mirrors the hindsight bias criticised in KSR v. Teleflex, the assumption that because scientific advances now appear straightforward, they must have been obvious ex ante. In reality, the literature preceding Semaglutide was filled with attempted analogues, many of which failed in clinical or pre-clinical settings. Semaglutide’s breakthrough value lies not only in its structure but in the magnitude of its half-life extension and its once-weekly dosing, an improvement far beyond the predictable effects of known substitutions. By ignoring this, the Court reduces a genuine scientific achievement to a routine optimisation.

The treatment of Form 27 presents another significant concern. Patent working statements are meant to serve public transparency, not evidentiary confession. Many patentees list multiple patents together to reflect broad product families without implying that each patent covers every product. Courts have long recognised that administrative disclosures require contextual reading; the Delhi High Court itself acknowledged this in Telefonaktiebolaget LM Ericsson v. Intex. By elevating Form 27 to a quasi-admission of claim overlap, the Court weaponises a transparency tool, thereby discouraging patentees from candid reporting. This undermines the public objective of the working requirement and increases the risk of strategic under-disclosure.

The Court’s reliance on the “person in the know” standard raises multiple problems. Even though the doctrine originates in AstraZeneca and Roche, its deployment in Novo unsettles a foundational principle of patent law: that obviousness must be assessed through the eyes of a neutral, uninventive POSITA. The shift to an inventor-centric viewpoint introduces a level of subjective knowledge that the law has historically guarded against. This doctrinal move risks erasing the boundary between what the patent actually teaches and what the inventors privately understand. In practical terms, it equips the hypothetical evaluator with insights that only the inventors possessed, thereby making the inventive step appear retrospectively more predictable than it truly was. Such hindsight reasoning is precisely what the UK Court of Appeal cautioned against in Windsurfing International v. Tabur Marine, where it warned that the skilled person must not be reconstructed with the inventor’s foresight or motivations. Applied to a field like peptide therapeutics, where optimisation is empirical, uncertain, and often counterintuitive, the “person in the know” standard substantially lowers the threshold for invalidating species patents. It risks collapsing legitimate incremental innovation into a narrative of inevitable progression, thereby narrowing the space for patent protection in areas where innovation typically proceeds stepwise.

Finally, the Court’s finding of evergreening rests on conjecture rather than evidence. The assumption that Novo deliberately concealed Semaglutide in 2004 presupposes that the molecule was fully developed, tested and recognised as commercially superior at that time. This is scientifically implausible. Drug discovery is iterative, expensive and deeply empirical. Semaglutide emerged only after years of refinement, comparative analysis and stability studies. To infer concealment without documentary evidence risks transforming a legitimate species invention into a legal presumption of bad faith. Even jurisdictions with far stricter anti-evergreening standards, such as the EPO in its GLP-1 opposition decisions, have never held that Semaglutide was inherently disclosed in earlier genus patents.

For these reasons, while the judgment aligns with India’s long-standing scepticism of patent thickets, it fails to appreciate the nuanced, empirical reality of peptide drug development and blends multiple patent doctrines in a way that creates uncertainty for innovators and generics alike.

Impact

Treatment for diabetes and obesity has emerged as an extremely lucrative global market for pharmaceutical manufacturers. The new class of GLP-1 drugs, particularly semaglutide developed by Novo Nordisk and tirzepatide developed by Eli Lilly and marketed as Mounjaro and Zepbound, has reshaped this therapeutic landscape. Their extraordinary commercial success has triggered a worldwide battle over the rights to manufacture and sell these molecules. While originator companies have sought to enforce and extend their patent portfolios to safeguard their bottom line, other manufacturers, including generic producers, are attempting to secure a share of this rapidly expanding market.

In this context, the Delhi High Court’s ruling represents a setback for Novo Nordisk and a strategic opening for competing drug makers. Apart from Dr. Reddy’s Laboratories, companies such as Cipla and Sun Pharma have publicly signalled their intention to enter the GLP-1 space. Cipla, in its October earnings call, described “big volume opportunities” in the semaglutide segment, while Sun Pharma referred to the GLP-1 market as “exciting” and expressed a desire to participate “whenever the first opportunity is available.” According to an August IQVIA report, more than ten companies have already filed Subject Expert Committee submissions in India to conduct Phase III studies for semaglutide. With Novo Nordisk’s patents over semaglutide set to expire soon in major markets such as Canada, China, Brazil, India and Turkey, significant opportunities are likely to open up for generic manufacturers who can offer lower-cost options. The same IQVIA report notes that these jurisdictions together account for roughly 40 per cent of the world’s population and an estimated one-third of all adults living with obesity. In such regions, the availability of lower-priced, off-patent semaglutide could dramatically expand patient access. With over a dozen manufacturers developing non-proprietary versions of semaglutide, analysts expect a surge in demand and a substantial expansion of the private market once exclusivities are lifted.

The decision carries important consequences for market dynamics, regulatory behaviour and patient access in India. By restraining domestic sale even after holding the suit patent prima facie invalid, the Court has created a precedent that may delay the entry of generics in situations where patent vulnerability is already established. This elevates the requirement of clearing the way into a decisive factor, while giving limited attention to the scope of Section 107A, which is designed to facilitate early preparation and ensure swift post expiry availability of medicines. Such an approach may discourage manufacturers from investing in advanced production capabilities for essential drugs and could introduce uncertainty into India’s pro-competitive pharmaceutical environment.

On the access front, the impact is immediate. Novo is set to launch Ozempic in India at prices likely to remain high until the patent expires, and the absence of domestic manufacture may further restrict affordability. With generics unable to enter the Indian market, parallel imports may emerge as the only short-term avenue to expand availability, since products exported by Dr Reddy qualify as duly authorised under Section 107A(b). While the ruling strengthens India’s position as an export-oriented manufacturing hub by permitting outbound supply to non-patent jurisdictions, it simultaneously risks constraining domestic access to a WHO-listed essential medicine during a period of unprecedented demand.

On the generics side, the judgment raises confidence in challenging species patents aggressively based on broad genus structures. It also strengthens India’s access-driven patent culture but risks reinforcing an environment where follow-on innovation does not receive adequate protection. In an industry where many clinically transformative drugs like oncology peptides, biologics and next-generation analogues are the product of species-level refinement rather than de novo discovery, this could have long-term consequences for investment and R&D flows into India.

The decision also becomes part of India’s evolving reputation within global IP ecosystems. Other jurisdictions, particularly in the EU and US, have approached Semaglutide-related patents with far greater nuance, distinguishing between priority issues, disclosure boundaries and true inventiveness. India’s comparatively harsh view may strengthen its access narrative, but at the cost of aligning itself further from innovation-oriented patent cultures.

Conclusion

Novo Nordisk v. Dr. Reddy’s is a landmark judgment not because it shuts the door on an injunction in the final months of a patent term, but because it articulates a judicial philosophy that treats broad genus disclosures as inherently capacious. The Court is rightly vigilant against evergreening, a principle that sits at the heart of Indian pharmaceutical patent strategy, but its reasoning stretches several doctrinal threads: disclosure, enablement, obviousness and admissions beyond traditional contours.

In its pursuit of preventing monopoly extension, the Court risks eroding the thin but crucial line between illegitimate evergreening and legitimate incremental innovation. Semaglutide is widely regarded as a breakthrough molecule precisely because its efficacy far exceeded the predictable advantages of Aib substitution. To treat such a leap as obvious, merely because the structural modification is conceptually simple, collapses the complex empirical journey of drug discovery into a mechanical exercise. Patents exist to reward not just molecular sketches but the arduous transformation of chemical insight into therapeutic reality. If every trivial structural difference becomes legally trivial, the incentive to undertake costly experimentation may diminish.

The judgment’s legacy, therefore, will depend on whether appellate courts refine its reasoning or allow its broad genus-dominant logic to stand. India must continue to balance public access with innovation incentives. This case shows that in maintaining that balance, courts must be careful not to let doctrinal shortcuts obscure the scientific and commercial realities of modern drug development.

References:

1. Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd., CS (COMM) 565/2025 (Delhi High Court, Judgment dated 2 December 2025).
2. Synthon B.V. v. SmithKline Beecham plc, [2005] UKHL 59.
3. Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511.
4. AstraZeneca AB v. Intas Pharmaceuticals Ltd., 2020 SCC OnLine Del 1446.
5. F. Hoffmann-La Roche AG v. Natco Pharma Ltd., CS (COMM) 567/2024 (Delhi High Court, 24 March 2025).
6. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
7. Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] RPC 59 (CA).
8. Telefonaktiebolaget LM Ericsson v. Intex Technologies (India) Ltd., CS (OS) 1045/2014 & I.A. 6735/2014 (Delhi High Court, 13 March 2015).
9. IQVIA, “Off-Patent Semaglutide in 2026: The Next Revolution in Anti-Obesity Medications” (July 2025), available at: https://www.iqvia.com/locations/emea/blogs/2025/07/off-patent-semaglutide
10. Reuters, “India’s Sun Pharma aims to launch its obesity drug in five years, managing director says” (February 28, 2025), available at: https://www.reuters.com/business/healthcare-pharmaceuticals/indias-sun-pharma-aims-launch-its-obesity-drug-five-years-managing-director-says-2025-02-28/
11. Cipla Limited, “Q2 FY26 Earnings Conference Call” (October 30, 2025), available at: https://www.cipla.com/sites/default/files/Cipla-Earnings-Oct30-2025.pdf
12. Yogesh Byadwal, “Part I – Novo v. Dr. Reddy: Clear the Way or Else Block The Way,” SpicyIP (December 4, 2025), available at: https://spicyip.com/2025/12/part-i-novo-v-dr-reddy-clear-the-way-or-else-block-the-way.html