Delhi HC Allows Dr Reddy’s to Manufacture and Export Semaglutide, Rejects Novo Nordisk’s Injunction Plea

The Delhi High Court has allowed Dr. Reddy’s Laboratories to continue manufacturing and exporting the diabetes and weight-management drug Semaglutide, while dismissing Danish pharmaceutical company Novo Nordisk’s plea seeking an interim injunction to halt production.

Justice Manmeet Pritam Singh Arora held that Dr. Reddy’s had raised a credible challenge to the validity of Novo Nordisk’s patent on the grounds of prior claiming, double patenting and obviousness.

Semaglutide, sold internationally under the brand names Ozempic, Wegovy and Rybelsus, is a GLP-1 analogue prescribed for type-2 diabetes and obesity and is known for its once-weekly injectable dosage regimen.

Novo Nordisk had approached the Court alleging infringement and seeking to block Dr Reddy’s from manufacturing or exporting the product until its patent expires in March 2026.

The company told the Court that it became aware in late 2024, through due diligence and an investigator’s report, that Dr. Reddy’s Laboratories and OneSource Speciality Pharma were importing and exporting Semaglutide in significant quantities, indicating commercial use.

Dr Reddy’s opposed the injunction, arguing that Novo Nordisk’s patent was neither novel nor inventive, as the compound had already been disclosed under the company’s earlier genus patent, which has now expired. The defendants argued that the later “species” patent was merely an attempt to extend monopolistic rights.

Agreeing with the defendants’ position, the Court observed, “The Suit Patent/IN’697 is vulnerable on the ground of obviousness on account of the claims and compounds disclosed in the Genus Patent/IN’964, as well as the teaching in the prior art in Deacon (1998) and Knudsen (2004).”

Court held that the later patent merely attempted to extend monopoly protection already enjoyed under the earlier patent, noting, "Thus, from the aforesaid factors, this Court infers that the Plaintiff invented the Semaglutide compound in 2004, which is contemporaneous to the time of filing the Genus Patent IN’964, but wilfully withheld the Semaglutide compound from the Patent Office and artificially created a second patent [Suit Patent/IN’697] that were filed at a later filing date afterthe Genus Patent/IN’964, to extend the monopoly already granted with the acceptance of the Genus Patent/IN’964.

It added that Novo Nordisk had obtained two patents for minor variants of the same compound, a practice known as double patenting, which resulted in “evergreening.”

“Therefore, it can be concluded that the Genus Patent/IN’964, which discloses the Semaglutide compound has enjoyed protection for a period of twenty [20] years; however, the protection for the same remains extended due to the Suit Patent/IN’697, resulting in double patenting and, thereby, evergreening," the Court said.

The Court further found the invention lacked inventiveness, holding, “Thus, this Court is satisfied that the single substitution made to the GLP-1 analogue of Example 61 compound of the Genus Patent/IN’964 to arrive at the Semaglutide compound in the Suit Patent/IN’697 were obvious to try for a ‘person skilled in the art’, or in this case, the ‘person in the know’ with a reasonable expectation of success, i.e. to obtain GLP-1(7-37) analogue with increased half-life for effective treatment of Type 2 Diabetes.

Since Novo Nordisk does not manufacture Semaglutide in India and relies solely on imports, the Court permitted Dr. Reddy’s to continue manufacturing the drug solely for export to jurisdictions where Novo Nordisk does not hold a patent. The Court also directed the company to disclose quantities produced and exported.

Dismissing the injunction, the Court held, “Accordingly, the Plaintiff has failed to make out a prima facie case for the grant of an interim injunction… any damages suffered by the Plaintiff can be adequately compensated… after the trial has been concluded.”

The Court clarified that its findings are prima facie and limited to the determination of the interim application, and that the main infringement suit will proceed on its merits.

For Plaintiff: Mr Hemant Singh, Ms. Mamta Jha, Mr. Siddhant Sharma, Mr. Rishabh Paliwal, Mr. Abhay Tandon and Mr. Shreyansh Gupta, Advs.

For Defendant: Mr. Gopal Subramanium, Sr. Adv. and Mr J. Sai Deepak, Sr. Adv. with Mr. Mohit Goel, Mr. Sidhant Goel, Mr. Aditya Goel, Mr. Deepankar Mishra, Mr. Kartikeya Tandon, Mr. Pavan Bhushan and Mr. Avinash K. Sharma, Advs.

Case Title: NOVO NORDISK AS versus DR. REDDYS LABORATORIES LIMITED & ANR.

Bench: Justice Manmeet Pritam Singh Arora

Order Date: 1 December 2025