Delhi High Court refuses to restrain Dr Reddy's from manufacturing, exporting Ozempic like drug

The Delhi High Court on Tuesday dismissed Novo Nordisk's application to restrain Dr. Reddy's Laboratories Limited and OneSource Specialty Pharma Limited from manufacturing and exporting diabetes and weight management drug Semaglutide [Novo Nordisk v. Dr Reddy's]..Semaglutide is marketed under brand names like Ozempic, Wegovy and Rybelsus by Novo Nordisk..Justice Manmeet Pritam Singh Arora found that Dr. Reddy's (defendant) raised a credible challenge to the validity of the suit patent by Novo Nordisk on grounds of prior claiming and obviousness.Dr. Reddy's was permitted to continue manufacturing the drug in India for export to non-patented territories, subject to maintaining accounts."Since the Plaintiff (Novo Nordisk) is not manufacturing in India and only importing to India, this Court accepts the undertaking by the Defendants and permits them to manufacture the impugned drug in India and export it to countries where the Plaintiff does not have a Patent registration.".The order further stated,"The Plaintiff has failed to make out a prima facie case for the grant of an interim injunction. On the basis of the discussion above, this Court is of the view that any damages suffered by the Plaintiff can be adequately compensated, if deemed appropriate, after the trial has been concluded in accordance with law.".Patents in question: The suit involved a 'species' patent held by Novo Nordisk, which claims the compound Semaglutide7777. This patent was granted on September 5, 2014, and is set to expire on March 20, 2026. Dr Reddy's relied heavily on Novo Nordisk's earlier 'genus' patent, which expired on September 17, 2024.The compound: Semaglutide, the active pharmaceutical ingredient in products like Ozempic, is a GLP-1 analogue used for treating diseases like Type 2 diabetes and obesity. It is noted for its once-weekly subcutaneous dosage, a significant improvement over earlier analogues like Exenatide (twice a day) and Liraglutide (once a day). The infringement claim: Novo Nordisk filed the suit in May 2025 alleging infringement after discovering in late 2024 that Dr. Reddy's was importing and dealing in the Semaglutide compound.Dr Reddy's undertaking: The defendant provided an undertaking to the Court on May 29, 2025 that it would not sell the impugned drug in India until the expiration of the suit patent. Foreign admissions and Form 27: Novo Nordisk filed a common statutory Form 27 with the Indian Patent Office for both the Suit Patent/IN'697 and the Genus Patent/IN'964 for the years 2020-2023, declaring the commercial working of both patents based on the Semaglutide product..The Court dismissed the application for a ban on manufacturing Semaglutide for export because it believed that the defence had presented a strong case that the patent was likely invalid. The core reasons for this potential invalidity were:1. Prior claiming (double patenting)The Court found that the specific Semaglutide compound was essentially already claimed in Novo Nordisk's earlier, expired 'Genus Patent'.The Semaglutide compound differs from a compound in the earlier patent (Example 61) only by substituting Alanine ('Ala') with a different amino acid, aminoisobutyric acid ('Aib').The earlier Genus Patent explicitly listed this specific substitution ('Aib' at the 8th position), making it part of the original claim.Novo Nordisk's repeated filings (Form 27) with the Indian Patent Office, linking the commercial drug Semaglutide to both the old and new patents, served as an admission that the product was covered by the earlier patent..The Court thus concluded that Novo Nordisk was trying to get a second patent for an invention already covered by the first, a practice known as evergreening..2. Obviousness (lack of inventive step)The Court determined that the slight modification made to create Semaglutide was obvious and did not require an inventive step.Since the inventors of both the earlier and later patents were the same, the Court applied a high standard, treating them as a 'person in the know'.Scientific literature already taught that substituting 'Ala' with 'Aib' was a known strategy to make GLP-1 drugs more stable and last longer.For a 'person in the know,' experimenting with this established substitution on the already potent Example 61 compound was an obvious step with a reasonable expectation of success."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. 130. Therefore, this Court is of the prima facie opinion that 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].".The final order permits Dr. Reddy's to continue manufacturing the Semaglutide compound and export it to countries where Novo Nordisk holds no patent registration, provided they maintain accounts of the stock manufactured and exported until the patent's expiry..Novo Nordisk was represented by Advocates Hemant Singh, Mamta Jha, Siddhant Sharma, Rishabh Paliwal, Abhay Tandon and Shreyansh Gupta..Dr. Reddy's was represented by Senior Advocates Gopal Subramanium and J Sai Deepak, with Advocates Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Kartikeya Tandon, Pavan Bhushan and Avinash K Sharma. .[Read Judgment].Follow Bar and Bench channel on WhatsAppDownload the Bar and Bench Mobile app for instant access to the latest legal news.