The Delhi High Court on May 29 recorded an undertaking from Dr. Reddy’s Laboratories that it will not sell the Ozempic like drug in India, amid an ongoing patent infringement suit filed by Novo Nordisk A/S over the patent of blockbuster diabetes medication.
Appearing for Dr. Reddy's, Senior Advocates Abhishek Manu Singhvi and Mukul Rohatgi submitted that Dr. Reddy’s had obtained a licence to manufacture the drug in December 2024 and had begun manufacturing the drug in April 2025.
However, they clarified that the company “does not have a licence to sell the impugned drug in India till date.”
Accordingly, they will not sell the drug in India. However, they reserve their right to export the drug to countries where the plaintiff has not been granted a patent yet, it was submitted.
Justice Amit Bansal recorded these submissions and directed that they “shall bind the defendants (Dr. Reddy's) till the next date of hearing.” The matter is next listed for hearing on August 19.
Senior Advocate Sandeep Sethi, appearing for Novo Nordisk, objected to the proposed export of the drug.
He submitted that as per the scheme of the Patents Act, 1970, even the export of an infringing product amounts to infringement.
The Court noted this contention and said it would be considered on the next date once pleadings are complete.
Novo Nordisk alleged that Dr. Reddy’s and its affiliate have infringed its patent by manufacturing and dealing in semaglutide formulations without authorisation. Semaglutide is the key component in Ozempic, Wegovy, and Rybelsus, marketed globally for the treatment of type 2 diabetes and obesity.
Earlier in May, Dr. Reddy's filed a revocation petition challenging Indian Patent granted to Novo Nordisk A/S for Semaglutide — the active ingredient in the anti-diabetes drug Ozempic.
Ozempic, launched in 2017, is a once-weekly injectable GLP-1 receptor agonist widely prescribed for the treatment of type 2 diabetes. In recent years, it has also seen rising global demand for off-label use as a weight-loss drug. Its active compound, Semaglutide, is considered one of the most commercially successful molecules in the pharmaceutical market today, making the underlying patent a critical commercial asset for Novo Nordisk.
Dr. Reddy’s contended that Nordisk's patent lacks novelty and inventive step, is insufficiently disclosed, and was obtained by misrepresentation. They said that Semaglutide was already disclosed in Novo Nordisk’s earlier Indian patent and that the only difference — substitution of Alanine with Aib at the 8th position — is a standard, well-known modification used to improve molecular stability and resistance to enzymatic degradation.
Dr. Reddy's also accused Novo Nordisk of attempting to extend its monopoly by way of evergreening, a strategy where patent holders make minor modifications to existing products or processes to extend their market exclusivity.
In India, Novo Nordisk filed its first national phase application in March 2006 based on an earlier international patent filing. A second national phase application was filed in July 2007 following another international application made in March 2006. The first patent was granted in 2016 and expired in September 2024. The second, which is now 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 with advocates Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Kartikeya Tandon, Amit Sharma, T. Lawrence, Avinash K. Sharma, Mr. Keshav and Annanya Mohan from Sim & San.
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