The Delhi High Court dismissed Novo Nordisk’s application for interim injunction restraining Dr. Reddy’s Laboratories and OneSource Specialty Pharma from manufacturing and exporting Semaglutide, holding that the patent is prima facie vulnerable to challenge on grounds of obviousness and prior claiming.
The plaintiff, a global healthcare company, owns Suit Patent IN697 related to acylated GLP-1 analogues for treating type 2 diabetes, specifically the compound Semaglutide, which is the Active Pharmaceutical Ingredient (API) in the drug marketed under the brand names Ozempic, Wegovy, and Rybelsus. The company alleged that the defendants infringed this patent by manufacturing and exporting Semaglutide without authorization.
The suit patent claims the innovative compound Semaglutide with a weekly dosage regime, contrasted with prior GLP-1 drugs requiring more frequent doses. The plaintiff sought an interim injunction to prevent the defendants’ manufacture and export of the compound in India.
The defendants, following expiry of an earlier patent IN964, commercially manufactured the compound without clearance, sparking patent infringement proceedings. They also filed a revocation petition challenging the validity of the Suit Patent IN697, contending that Semaglutide is covered in the earlier Genus Patent IN964, which disclosed a broad range of GLP-1 analogues including structurally close compounds.
They highlighted that the earlier patent enabled a skilled person to synthesize Semaglutide by substituting an amino acid in a known compound, negating novelty and inventive step. The defendants, however, gave an undertaking to not sell the drug in India, but reserved the right to export where the plaintiff does not hold a patent.
The Bench comprising Justice Manmeet Pritam Singh Arora observed that the prior art disclosure in the Genus Patent IN964 anticipated the claimed invention in the Suit Patent IN697, rendering it non-innovative and obvious. The court emphasized the fundamental patent law principle preventing evergreening of pharmaceutical patents through minor modifications.
However, the defendants’ failure to clear the way before manufacturing commercially in India further was interpreted as procedurally improper and influenced the court’s caution in granting interim injunctions.
The court accepted the defendants’ undertaking to not sell the product in India but allowed manufacture and export until the expiry of the patent in March 2026, balancing the plaintiff’s patent rights with market realities.
In result, the court dismissed the interim injunction application, concluding that the plaintiff failed to establish a prima facie case for patent validity or irreparable harm. The ruling clarified that damages are an adequate remedy for alleged infringement, and that the defendants’ activities are restricted to export markets without patents held by the plaintiff.
The defendants are instructed to submit records of details, quantity, and value of the products manufactured and sold. The court clarified that the ruling is confined to the present interim application and does not have any bearing on the full trial.
Cases relied on:
1. Boehringer Ingelheim Pharma v. Vee Excel Drugs, 2023 SCC OnLine Del 1889
2. Novartis AG v. Union of India, (2013) 6 SCC 1[Paragraph Nos. 101, 102, 105]
3. Bayer Healthcare LLC v. NATCO Pharma Limited, 2023 SCC OnLine Del 3921
4. LAVA International Limited v. Telefonaktiebolaget LM Ericsson, 2024 SCC OnLine Del 2497
5. Hoffmann-La Roche Ltd. v. Cipla Ltd., 2015 SCC OnLine Del 13619
6. AstraZeneca AB and Another v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746
7. Hoffmann -LA Roche AG and Another v. Natco Pharma Limited, 2025 SCC OnLine Del 6390
8. Merck Sharp and Dohme Corporation & Another Vs. Glenmark, 2015 SCC OnLine Del 8227
9. FMC Corporation & Ors. v Natco Pharma Limited, 2025 SCC OnLine 8582
Appearances:
For the Plaintiff(s): Mr. Hemant Singh, Ms. Mamta Jha, Mr. Siddhant Sharma, Mr. Rishabh Paliwal, Mr. Abhay Tandon and Mr. Shreyansh Gupta, Advs.
For the Defendant(s): 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.
