Delhi HC Rejects Interim Injunction To Novo Nordisk in Semaglutide Patent Case Against Dr. Reddy’s [Read Judgment]

New Delhi: The High Court of Delhi, in a significant patent infringement dispute concerning the blockbuster anti-diabetes drug Semaglutide, dismissed the application for an interim injunction filed by Novo Nordisk A/S against Dr. Reddy’s Laboratories Limited and OneSource Specialty Pharma Limited. The judgment, delivered by Justice Manmeet Pritam Singh Arora on December 02, 2025, permitted the defendants to continue manufacturing the drug for export to non-patented territories while barring domestic sales.

Novo Nordisk, the plaintiff, sought to restrain the defendants from infringing its Patent No. 262697 (“Suit Patent/IN’697”), which claims the compound Semaglutide, marketed under brands such as Ozempic and Rybelsus. The plaintiff argued that the manufacturing of the impugned drug in India for export itself amounts to infringement of the Suit Patent/IN’697, which is set to expire on March 20, 2026.

The defendants countered the infringement claim by raising a credible challenge to the validity of the Suit Patent/IN’697, primarily employing the “Gillette Defence” and arguing that the invention was anticipated by prior claiming and lacked an inventive step. This challenge hinged on the earlier “Genus Patent” (Patent No. 275964, “IN’964”), which the defendants contended had already claimed or disclosed the Semaglutide compound.

The Court noted the minimal difference between the compound claimed in the expired Genus Patent and the Semaglutide compound, stating that the sole distinction was the presence of “Aib” instead of “Ala” at the 8th position of the GLP-1 analogue. Crucially, the Court found merit in the defendants’ argument on prior claiming and obviousness, observing:

“In view of Section 13(4) of the Patents Act, there is no guarantee to the validity of the patent, and in case the defendant raises a Section 107(1) defence, the Court has to examine whether the defendant has raised a credible challenge of vulnerability of the suit patent to revocation on one or more grounds envisaged in Section 64 of the Patents Act.”

Furthermore, the Court pointed to consistent representations made by the plaintiff to the Indian Patent Office in Statutory Form 27 and in foreign jurisdictions regarding Patent Term Extensions (PTEs) and Supplementary Protection Certificates (SPCs). These disclosures were viewed as admissions that the Semaglutide compound was disclosed in the earlier Genus Patent. The judgment held:

“The plaintiff is bound by its declarations made to patent offices in India and abroad in light of the law settled in Novartis AG v. Union of India.”

Addressing the timeline of the Semaglutide invention, the Court noted the plaintiff’s own pleadings that Semaglutide was invented in 2004, around the same time the Genus Patent was filed. This led the Court to prima facie conclude that the Suit Patent was a result of evergreening, stating:

“This Court infers that the plaintiff invented the Semaglutide compound in 2004, which is contemporaneous with the filing of 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], filed at a later date after the Genus Patent/IN’964, to extend the monopoly already granted with the acceptance of the Genus Patent/IN’964.”

While acknowledging that the defendants had established a credible challenge to the patent’s validity, the Court also accepted the defendants’ undertaking not to sell the impugned drug in India until the expiry of the Suit Patent. However, the Court censured the defendants’ conduct for failing to “clear the way” by challenging the Suit Patent before commencing manufacturing, stating:

“The defendants have a history of litigation vis-à-vis the Semaglutide compound in the USA and therefore were well aware of the plaintiff’s proprietary claims. The defendants, however, chose to set up manufacturing facilities in India and commence manufacturing without challenging the Suit Patent/IN’697.”

Ultimately, finding that the plaintiff failed to establish a prima facie case and that any potential damages could be compensated monetarily, the Court dismissed the interim injunction application, permitting manufacturing and export to non-patented countries, provided the defendants maintain proper accounts.

Case Details:

Case Name: Novo Nordisk A/S v. Dr. Reddy’s Laboratories Limited & Anr.

Case No.: CS(COMM) 565/2025 & CRL.M.A. 21608/2025; I.A. 14076/2025; I.A. 17699/2025; I.A. 17802/2025; I.A. 18374/2025; I.A. 19205/2025; I.A. 19361/2025

Reserved on: 15 September 2025

Date of Decision: 02 December 2025

Coram: Hon’ble Ms. Justice Manmeet Pritam Singh Arora

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

Advocates for Defendants:
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

[Read Judgment]