NEW DELHI| 31ST MAY 2025
In a key development in the ongoing pharmaceutical patent battle, Dr. Reddy’s Laboratories Ltd has submitted before the Delhi High Court that it will not sell its semaglutide-based drug in India, amid a patent infringement suit filed by Novo Nordisk A/S, the Danish pharmaceutical giant behind blockbuster diabetes and weight-loss medications such as Ozempic, Wegovy, and Rybelsus.
DR. REDDY’S TO HALT DOMESTIC SALES, MAY EXPORT THE DRUG
“The company does not have a licence to sell the impugned drug in India till date.”
Appearing for Dr. Reddy’s, Senior Advocates Abhishek Manu Singhvi and Mukul Rohatgi informed the court that the company had obtained a licence to manufacture the drug in December 2024 and began production in April 2025. However, they clarified: Accordingly, they submitted that the drug will not be sold within India. However, Dr. Reddy’s reserves the right to export the product to countries where Novo Nordisk does not have a valid patent.
Justice Amit Bansal recorded the undertaking and directed:
“These submissions shall bind the defendants (Dr. Reddy’s) till the next date of hearing.”
The matter is next scheduled for hearing on August 19, 2025.
NOVO NORDISK RAISES OBJECTION ON EXPORT PLAN
Representing Novo Nordisk, Senior Advocate Sandeep Sethi strongly objected to the proposed export, arguing:
“As per the scheme of the Patents Act, 1970, even the export of an infringing product amounts to infringement.”
The court took note of this argument and stated it will be considered on the next date once pleadings are complete.
PATENT DISPUTE OVER SEMAGLUTIDE: A BILLION-DOLLAR MOLECULE
At the heart of the dispute is semaglutide, the active ingredient in Ozempic, a GLP-1 receptor agonist approved for type 2 diabetes and now in high demand globally for off-label weight loss use. Novo Nordisk has accused Dr. Reddy’s of infringing its Indian patent by manufacturing semaglutide-based formulations without authorisation.
In turn, Dr. Reddy’s has filed a revocation petition, challenging the validity of Novo Nordisk’s patent. The company argues that the patent:
Lacks novelty and inventive step Is insufficiently disclosed
Was obtained by misrepresentation
Dr. Reddy’s maintains:
“Semaglutide was already disclosed in Novo Nordisk’s earlier Indian patent and 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.”
They also accused Novo Nordisk of “evergreening”, a strategy to extend monopoly rights by making minor, obvious modifications to an existing drug.
BACKGROUND ON INDIAN PATENT TIMELINE
Novo Nordisk filed its first national phase application in March 2006, granted in 2016, which expired in September 2024.
The second application, filed in July 2007 and granted in 2014, is currently under legal challenge and is set to expire in March 2026.
LEGAL TEAMS
Novo Nordisk was represented by:
Senior Advocate Sandeep Sethi
Advocates Sanjeev Kumar Tiwari, Deepa K. Tiku, Amrish Tiwari, Abhishek Jan, Shatadal Ghosh, and Pramod Kumar
Dr. Reddy’s Laboratories was represented by:
Senior Advocates Abhishek Manu Singhvi, Mukul Rohatgi, Gaurav Pachnanda, Chander M. Lall, and J Sai Deepak
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
