Delhi High Court Rejects Novo Nordisk's Injunction Plea, Allows Dr. Reddy's to Manufacture and Export Semaglutide

The Delhi High Court on Tuesday refused to grant Novo Nordisk an interim injunction against Dr. Reddy's Laboratories Ltd. and OneSource Specialty Pharma Ltd. over semaglutide, the active ingredient used in its anti-diabetic and weight-loss drugs Ozempic and Wegovy. It held that the Danish company had failed to establish a prima facie case of infringement of its species patent IN'697. A single bench of Justice Manmeet Pritam Singh Arora refused interim relief, holding that Novo Nordisk had failed to establish a prima facie case in view of the strong and credible challenge raised by the Indian companies to the validity of its patent. The court, however, continued the companies' earlier undertaking that they would not sell the disputed semaglutide drugs in India until the expiry of Novo's patent on March 20, 2026 and would confine their activities to export to countries where Novo does not hold patent rights."Since the Plaintiff (Novo Nordisk) is not manufacturing in India and only importing to India, this Court accepts the undertaking by the Defendants and permits them to manufacture the impugned drug in India and export it to countries where the Plaintiff does not have a Patent registration", it said. Novo argued that despite its subsisting patent, the companies had begun manufacturing semaglutide-based formulations and sought to restrain all manufacture, sale and export. The Indian companies countered that semaglutide was already claimed in Novo's earlier genus patent IN'964, rendering IN'697 invalid for lack of novelty and inventive step. They relied on prior-art documents and on Novo's own Form-27 filings to show the compound had been commercially worked under the genus patent.Comparing IN'964 and IN'697, the court found semaglutide was disclosed in the genus patent and that a skilled person could easily arrive at the compound based on earlier disclosures. It also relied on Novo's admissions before the Patent Office that semaglutide products were worked under the genus patent, citing Boehringer Ingelheim Pharma v. Vee Excel Drugs that such admissions bind the patentee. On anticipation, the court held that IN'964, published before IN'697, enabled a skilled person to reproduce semaglutide “without undue experimentation.”On obviousness, the court observed that because the same inventors filed both patents, the assessment had to be made from the perspective of a “person in the know.” It noted that the prior art taught the key modifications that led to semaglutide, and that Novo had developed the compound around the time of filing the genus patent in 2004 but withheld it to seek a later species patent amounting, the court said, to “double patenting” and evergreening. While the Court accepted that the defendants had raised a credible challenge to validity, it criticised their failure to “clear the way” before commencing manufacture despite being aware of Novo's patent, calling the conduct procedurally improper. Their undertaking not to sell the drug in India was therefore continued. Dismissing Novo Nordisk's application for interim relief, the court clarified that all observations were prima facie and would not affect the final adjudication. Case Title: Novo Nordisk v. Dr. Reddys Laboratories Limited & Anr.Citation: 2025 LiveLaw (Del) 1660 Case Number: CS(COMM) 565/2025 For Plaintiff: Advocates Hemant Singh, Mamta Jha, Siddhant Sharma, Rishabh Paliwal, Abhay Tandon and Shreyansh Gupta For Defendants: Senior Advocates Gopal SubramaniuM and J.Sai Deepak with Advocates Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Kartikeya Tandon, Pavan Bhushan and Avinash K SharmaClick Here To Read/Download Order

Delhi High Court Rejects Novo Nordisk's Injunction Plea, Allows Dr. Reddy's to Manufacture and Export Semaglutide

Ayushi Shukla

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