Dr. Reddy’s informs Delhi High Court it will manufacture and export, but not market or sell, its Ozempic-like drug in India amid Novo Nordisk’s lawsuit.

Dr. Reddy’s informs Delhi High Court it will manufacture and export, but not market or sell, its Ozempic-like drug in India amid Novo Nordisk’s lawsuit.

Delhi High Court Records Dr. Reddy’s Undertaking Not to Sell Ozempic-like Drug in India Amid Patent Dispute

On May 29, the Delhi High Court recorded an undertaking from Dr. Reddy’s Laboratories stating that it will not market or sell its Ozempic-like drug in India, in light of an ongoing patent infringement lawsuit filed by Novo Nordisk A/S concerning the diabetes drug Semaglutide.

Representing Dr. Reddy’s, Senior Advocates Abhishek Manu Singhvi and Mukul Rohatgi informed the court that the company had received a manufacturing licence for the drug in December 2024 and began production in April 2025. However, they clarified that Dr. Reddy’s does not currently possess a licence to sell the drug in India.

Accordingly, the company undertook not to sell the drug domestically, while reserving the right to export it to countries where Novo Nordisk does not hold a patent. These submissions were recorded by Justice Amit Bansal, who ordered that they would remain binding on Dr. Reddy’s until the next hearing, scheduled for August 19.

Senior Advocate Sandeep Sethi, appearing for Novo Nordisk, raised objections to the proposed export of the drug. He argued that under the Patents Act, 1970, even exporting a product that infringes on a patent constitutes infringement. The court noted this argument and stated it would be considered once the pleadings are complete.

Novo Nordisk has alleged that Dr. Reddy’s and its affiliate have infringed its patent by manufacturing and dealing in formulations containing Semaglutide without proper authorization. Semaglutide is the active ingredient in the globally marketed diabetes and obesity medications Ozempic, Wegovy, and Rybelsus.

Earlier in May, Dr. Reddy’s filed a revocation petition challenging the validity of Novo Nordisk’s Indian patent on Semaglutide. The company argued that the patent lacks novelty and inventive step, is insufficiently disclosed, and was obtained through misrepresentation. They contended that the molecule was already disclosed in Novo Nordisk’s earlier Indian patent, and that the only modification — substituting Alanine with Aib at the 8th position — is a routine chemical adjustment aimed at enhancing stability and enzymatic resistance.

Dr. Reddy’s also accused Novo Nordisk of engaging in evergreening, a practice where patent holders make minor changes to extend monopoly protection and delay generic competition.

Novo Nordisk had initially filed a national phase application in India in March 2006 based on a prior international patent. A second national phase application followed in July 2007. The first patent was granted in 2016 and expired in September 2024. The second, which is currently under challenge, was granted in 2014 and is due to expire in March 2026.

Novo Nordisk was represented by Senior Advocate Sandeep Sethi, along with advocates Sanjeev Kumar Tiwari, Deepa K. Tiku, Amrish Tiwari, Abhishek Jan, Shatadal Ghosh, and Pramod Kumar.

Dr. Reddy’s was represented by Senior Advocates Abhishek Manu Singhvi, Mukul Rohatgi, Gaurav Pachnanda, Chander M. Lall, and J. Sai Deepak, along with advocates Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Kartikeya Tandon, Amit Sharma, T. Lawrence, Avinash K. Sharma, Keshav, and Annanya Mohan from Sim & San.

Author : Krish Chandna

Posted on : 31,May,2025

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