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Introduction

On 2 December 2025, the Delhi High Court delivered its judgment in Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. & Anr., CS(COMM) 565/2025. The case concerned an application for interim injunction filed by Novo Nordisk A/S, a global healthcare company, seeking to restrain the defendants from infringing its Indian Patent No. 262697(IN’697). The patent covers the compound Semaglutide, a GLP-1 analogue used in the treatment of Type 2 Diabetes and obesity. The dispute raised important questions about prior claiming, inventive step, obviousness, and the scope of patent rights under the Patents Act, 1970.

Facts of the Case

Patent No. 262697, titled “Acylated GLP-1 analogs comprising non-proteogenic amino acid residue,” was granted to Novo Nordisk on 5 September 2014, with a term expiring on 20 March 2026. The compound claimed is Semaglutide, marketed globally under brand names such as Ozempic, Wegovy, and Rybelsus. In late 2024, Novo Nordisk discovered that Dr. Reddy’s Laboratories and OneSource Specialty Pharma were importing and exporting Semaglutide in significant quantities. On 5 May 2025, Novo Nordisk issued a cease-and-desist notice to the defendants. The defendants responded by filing a revocation petition (C.O. (COMM.-IPD-PAT) No. 9/2025) against this patent. Novo Nordisk then filed the infringement suit on 26 May 2025.

On 29 May 2025, the Court recorded the defendants’ undertaking not to sell the drug in India but allowed them to export to countries where Novo Nordisk did not hold patents. Novo Nordisk challenged this order before the Division Bench, which directed the Single Judge to decide the interim injunction application (I.A. 14076/2025).

Argument in Favour

Novo Nordisk argued that Semaglutide was a novel and inventive compound under Section 64(1)(f) of the Patents Act. It exhibited a prolonged half-life of approximately 165 hours in humans, enabling convenient once-weekly administration. This fulfilled a long-felt need for diabetes treatment. Reliance was placed on F. Hoffmann-La Roche v. Cipla Ltd., 2015 SCC OnLine Del 13619, where the Court held that fulfilling a long-felt need is relevant to inventive step.

On the issue of prior claiming under Section 64(1)(a), Novo Nordisk contended that the defendants’ reliance on the earlier Genus Patent was misplaced. Prior claiming requires disclosure of the invention as a whole, not just its components. They cited Novartis AG v. Natco Pharma Ltd., 2023 SCC OnLine Del 106, and FMC Corporation v. Best Crop Science LLP, 2021 SCC OnLine Del 3647, to argue that mere coverage does not amount to disclosure.

Novo Nordisk also rejected the Section 3(d) objection, stating that Semaglutide was a new compound, not a new form of a known substance. Section 3(d) excludes patentability of new forms of known substances unless they show enhanced efficacy. Since Semaglutide itself was novel and showed enhanced efficacy, Section 3(d) was not applicable.

The company further argued that the patent had remained unchallenged for nearly 19 years, suggesting prima facie validity. Reliance was placed on Kudos Pharmaceuticals Ltd. v. Natco Pharma Ltd., 2024 SCC OnLine Del 1439, and Strix Ltd. v. Maharaja Appliances Ltd., 2009 SCC OnLine Del 2825. Finally, Novo Nordisk maintained that manufacturing in India, even for export, amounted to infringement under Section 48 of the Patents Act. They relied on Merck Sharp & Dohme Corp. v. Sanjeev Gupta, 2019 SCC OnLine Del 11167, and Merck Sharp & Dohme Corp. v. Glenmark Pharmaceuticals, 2015 SCC OnLine Del 8227.

Argument Against

The defendants argued that Semaglutide was already disclosed in the Genus Patent (IN’964). Example 61 of IN’964 covered the compound, differing only by substitution of Alanine (Ala) with Aib at the 8th position. Claim 16 of IN’964 expressly enabled this substitution. They contended that the substitution was obvious to a “person in the know,” especially since five inventors were common to both patents. Reliance was placed on AstraZeneca AB v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746. Prior art such as Deacon (1998) and Knudsen (2004) taught that Aib substitution conferred stability and resistance.

The defendants accused Novo Nordisk of evergreening, arguing that the company withheld Semaglutide during the filing of the Genus Patent to later claim it separately. They relied on Novartis AG v. Union of India, (2013) 6 SCC 1, which prohibits evergreening. They also pointed to admissions by Novo Nordisk, such as filing common Form 27s for both patents and seeking foreign Patent Term Extensions (PTEs) based on Semaglutide, which they argued proved that Semaglutide was covered by IN’964.

On the balance of convenience, the defendants highlighted their investment of Rs. 1,000 crores in manufacturing facilities for export. They argued that Novo Nordisk relied only on imports and did not work the patent in India, making damages an adequate remedy. 

Court’s Decision

The Court dismissed Novo Nordisk’s application for interim injunction. It held that the defendants had raised a credible challenge to the validity of IN’697.

On presumption of validity, the Court noted that Section 13(4) of the Patents Act states that grant of a patent does not guarantee validity. It cited Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511, and Mold Tek Packaging Ltd. v. Pronton Plast Pack Pvt. Ltd., 2025 SCC OnLine Del 4883, to emphasize that validity must be tested against credible challenges.

On prior claiming under Section 64(1)(a), the Court found that Semaglutide was prior claimed in IN’964. Example 61 and Claim 16 enabled the substitution of Ala with Aib, leading directly to Semaglutide. On obviousness under Section 64(1)(f), the Court held that the substitution was obvious to a “person in the know.” Prior art such as Deacon (1998) and Knudsen (2004) taught the benefits of Aib substitution. The Court applied the reasoning in AstraZeneca AB v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746.

The Court also inferred evergreening, noting that Novo Nordisk invented Semaglutide in 2004 but withheld it to file a later patent, amounting to double patenting. Reliance was placed on Novartis AG v. Union of India, (2013) 6 SCC 1. On balance of convenience, the Court permitted the defendants to continue manufacturing and exporting Semaglutide to countries where Novo Nordisk did not hold patents, but restrained them from selling in India until expiry of IN’697. The Court cited Merck Sharp & Dohme Corp. v. Glenmark Pharmaceuticals, 2015 SCC OnLine Del 8227, to emphasize the need to “clear the way” before commencing manufacture.

Conclusion

The Delhi High Court refused to grant an interim injunction to Novo Nordisk, holding that the defendants had raised a credible challenge to the validity of IN’697. The Court found that Semaglutide was prior claimed in the Genus Patent and that its development was obvious to a skilled person. The judgment underscores the principle that patents cannot be extended through minor modifications of known compounds, a practice often termed “evergreening.”

By allowing export but restraining domestic sales, the Court balanced the interests of both parties. For pharmaceutical companies, the case highlights the importance of avoiding double patenting and ensuring genuine novelty and inventive step. For the public, it reinforces that patent law seeks to prevent unjustified extensions of monopoly, ensuring timely access to medicines.