A Weighty Dispute: Novo Nordisk’s Semaglutide Patent Clash in Delhi High Court

Introduction

A major patent battle [1] has erupted in India between pharmaceutical giants Novo Nordisk and Dr. Reddy’s Laboratories over the popular weight loss and diabetes drug semaglutide. Novo Nordisk sued Dr. Reddy’s for manufacturing and exporting its patented drug without consent. This case is significant for the Indian pharmaceutical industry, as its outcome will influence availability of generic versions of the drug in Indian and help shape the future of patent enforcement. The case is listed for hearing on August 19, 2025 after pleadings in the application are complete.

This blog provides an insight into the ongoing patent dispute between Novo Nordisk and Dr. Reddy’s Laboratories concerning semaglutide.

Facts and Background

Key Players in the Dispute

Plaintiff: Novo Nordisk, the Danish pharmaceutical company behind type 2 diabetes and weight-loss medications such as Ozempic (injectable semaglutide), Wegovy (higher-dose semaglutide for obesity), and Rybelsus (oral semaglutide)
Defendant 1: Dr. Reddy’s Laboratories, a leading Indian pharmaceutical company that has obtained CDSCO regulatory licences to manufacture semaglutide.
Defendant 2: OneSource Specialty Pharma Ltd., a contract manufacturer engaged by Dr. Reddy’s to produce semaglutide formulations.

Patents in Play

Novo Nordisk’s semaglutide products are covered by three main Indian patents:

Indian Patent No. 275964, covering the composition of semaglutide itself. This patent expired in September 2024.
Indian Patent No. 262697, filed in March 2007 and granted in March 2014, covering specific formulations and delivery devices designed to improve stability and administration. This patent is scheduled to expire on 20 March 2026 and is the primary patent asserted in this litigation.
Pending Indian patent application 202047010224, filed in 2020, for a specific formulation of semaglutide, described as “Semaglutide liquid formulations (no more than 0.01% (w/w) phenol.”

The expiry of the basic composition patent in 2024 has opened the door to potential generic development. However, the formulation patent remains in force and continues to confer exclusive rights on Novo Nordisk.

Core of the Dispute

Novo Nordisk filed a patent infringement suit in the Delhi High Court against Dr. Reddy’s and OneSource Specialty Pharma Ltd. alleging that the defendants imported substantial quantities of semaglutide API and manufactured finished formulations without its permission thereby infringing Indian Patent No. 262697.

Semaglutide is a GLP-1 receptor agonist widely prescribed for type 2 diabetes and increasingly used off-label for weight loss, driving a surge in global demand.

Separately, Dr. Reddy’s has filed a revocation petition under Section 64 of the Indian Patents Act, 1970 contending that Patent No. 262697 lacks novelty and inventive step. According to Dr Reddy’s, the claimed improvements—principally relating to stabilised forms and improved enzyme resistance—were already disclosed or obvious in light of Novo’s earlier patent and established prior art, and therefore amount to “evergreening.”

Dr. Reddy’s Standpoint and Novo Nordisk’s Arguments

Dr. Reddy’s confirmed before the Delhi High Court that it holds a CDSCO licence solely to manufacture the impugned drug and does not have permission to market or sell the product in India. The company provided an undertaking that it would not offer the product for sale domestically. This position reflects its current operational boundary -manufacturing exclusively for export to jurisdictions where Novo Nordisk’s patent rights either do not exist or have expired.

Novo Nordisk, however, contends that even such export constitutes infringement. Specifically, Novo relies on Section 48 of the Patents Act, 1970, which grants the patentee the exclusive right to prevent third parties, without its consent, from the act of making, using, offering for sale, selling, or importing the patented product in India. Novo argues that large-scale commercial manufacturing, even if destined for foreign markets, undermines the exclusivity conferred by the patent.

In response, Dr. Reddy’s invokes Section 107A(b)—India’s version of the Bolar exemption—which provides that certain acts, including making or selling a patented invention solely for uses reasonably related to the development and submission of information required under any law regulating manufacture, use, or sale of the product in India or abroad, do not constitute infringement. Dr. Reddy’s maintains that its exports are for regulatory and commercial supply in countries where no Novo patents are in force and that the exemption fully applies.

Balancing Act of the Delhi High Court

After hearing the parties, the Delhi High Court issued an interim injunction on 29 May 2025, restraining Dr. Reddy’s and OneSource from selling semaglutide within India, as neither held a licence to market the product domestically. Accordingly, semaglutide manufactured by Dr. Reddy’s will not be made available in India while the injunction remains in force.

However, the Court declined to restrain Dr. Reddy’s from manufacturing and exporting the drug to foreign jurisdictions. The Court recorded Dr. Reddy’s formal undertaking not to sell in India and noted that the question of whether such export infringes the patent under Section 48, or qualifies for the exemption under Section 107A, requires further adjudication. The Court directed that all remaining submissions, including arguments on novelty, inventive step, and statutory defences, will be considered on the next date of hearing after completion of pleadings.

Our Analysis and Conclusion

The ongoing patent dispute between Novo Nordisk and Dr. Reddy’s Laboratories highlights in light critical issues of patent evergreening, the interpretation of India’s Bolar exemption, and access to affordable generic medicine. The Delhi High Court’s nuanced approach to restrict sale of the impugned drug in India without restraining its export may set a precedent, not only for semaglutide but also for how India navigates the tension between patent protection and public interest in healthcare.

The final outcome is likely to turn on the resolution of Dr. Reddy’s revocation petition and the deeper scrutiny of the formulation patent’s novelty and inventiveness. If the Court holds that the patent is invalid, or that manufacturing for export falls squarely within the Section 107A exemption, it could accelerate the availability of generic semaglutide and create clarity for Indian exporters. Conversely, if Novo Nordisk prevails, it could strengthen innovator control over manufacturing pipelines in India even when products are not sold domestically.

Given that India hosts one of the world’s largest diabetes populations and the domestic GLP-1 market is projected to grow sharply beyond ₹6 billion annually, this decision will have substantial implications for patients, payers, and industry stakeholders.

All eyes are now on August 19, 2025, when the High Court will hear the parties’ full arguments and potentially clarify the boundaries of Section 107A and the patentee’s exclusive rights under Section 48.