The Delhi High Court allowed Dr. Reddy’s to manufacture semaglutide in India and export it internationally but barred domestic sales until March 2026, when Novo Nordisk’s secondary patent expires.
Novo Nordisk alleges that Dr. Reddy’s and OneSource infringed the patent by importing the active ingredient and producing finished formulations without consent, while Dr Reddy’s claims the patent is invalid and its production is solely for export.
The court’s interim order permits exports under the Bolar exemption but maintains restrictions on Indian sales, with the final determination on patent infringement and statutory exemptions pending further hearings.
The Delhi High Court on Tuesday permitted Dr. Reddy’s Laboratories to manufacture their version of diabetes and anti-obesity drug semaglutide in India and export it to international markets, even as Novo Nordisk continues to pursue a patent infringement case against the company. The court has, however, prohibited Dr. Reddy’s from selling the drug within India until March 2026, when Novo Nordisk’s patent is due to expire.
The decision was delivered by Justice Manmeet Pritam Singh Arora. This order is in pursuance of the Delhi High Court’s finding that there is credible challenge to the validity of Novo Nordisk patent for their diabetes medicine semaglutide, sold as Wegovy. The ruling affirms that production for export may continue uninterrupted, but any domestic commercial activity involving semaglutide remains off-limits until the end of the patent term, which is March 2026.
When Outlook reached out to Dr. Reddy’s Laboratories, the company said it was awaiting the official order copy. “We will provide our comments once we have carefully reviewed the order,” said Dr. Reddy's spokesperson.
This is particularly important in India because, according to Lancet, there are estimated 8.98 crore (89.8 million) people above the age of 18 years are suffering from diabetes (type 2) and according to the World Health Organisation nearly 25 million are prediabetics (at a higher risk of developing diabetes in near future). More than 50 per cent of people are unaware of their diabetic status which leads to health complications if not detected and treated early. India has the second highest number of adults (20-79 years) with diabetes in the world.
This dispute follows an earlier order issued in May 2025 by a single-judge bench led by Justice Amit Bansal. At that stage, Dr Reddy’s Laboratories and OneSource Specialty Pharma informed the court that they were selling in countries where there was no patent and they were manufacturing in India. This came after after Novo Nordisk sought an injunction claiming infringement. The Judge had posted the case for hearing in august. The bench chose to continue hearing the company’s application, maintaining the restriction pending further examination of the patent issues.
Novo Nordisk entered the Indian market with Wegovy in June 2025, pricing the drug between Rs 17,000 and Rs 25,000 per month. Although the firm’s primary composition patent for semaglutide (Patent No. 275964) expired in September 2024, it still holds secondary patents in India. The key among them is Patent No. 262697, which covers the drug’s manufacturing process and delivery mechanism and remains valid until March 2026. These secondary patents form the basis of the Danish company’s infringement claim. Patent No. 262697 is a product patent and not a process patent.
The pharmaceutical company alleges that Dr Reddy’s and its affiliate imported semaglutide active pharmaceutical ingredient (API) and produced finished formulations without permission, thereby infringing Patent No. 262697. Semaglutide is used in several of Novo Nordisk’s leading GLP-1 therapies, including Ozempic, Wegovy and Rybelsus, which are widely prescribed for type-2 diabetes and for weight management. GLP-1 therapy is a class of medications that help manage type 2 diabetes and obesity.
Dr. Reddy’s received regulatory approval to manufacture semaglutide in December 2024 and began production in April 2025. Shortly afterwards, Novo Nordisk issued a cease-and-desist notice, prompting Dr. Reddy’s to file a petition in the Delhi High Court on May 14 seeking revocation of the patent. Novo Nordisk responded by filing a detailed infringement suit on May 26 against both Dr. Reddy’s and OneSource. The company claimed that the two firms were importing significant quantities of semaglutide API and exporting both the API and finished injections in contravention of the Patents Act.
Dr. Reddy’s countered that the patent lacked novelty and amounts to an attempt at evergreening to extend exclusivity beyond the expiry of the primary patent. The company emphasises that while it holds a licence from the Central Drugs Standard Control Organisation (CDSCO) to manufacture the drug, it has no approval to sell it within India. Its present production is solely for export to countries where Novo Nordisk’s patent rights have expired.
Novo Nordisk argues that even such export activity constitutes infringement under Section 48 of the Patents Act, which grants the patentee exclusive rights over making, using and exporting the patented invention. Dr. Reddy’s, in contrast, relies on the Bolar exemption under Section 107A, which protects certain forms of manufacture and export undertaken for regulatory purposes or for lawful commercial supply in markets where the patent does not apply.
On May 29, DRL and OneSource Specialty Pharma gave a statement on record to the High Court that they were manufacturing in India and exporting to non patent countries. The matter was then posted for hearing in August 2025.
The latest order reinforces this interim arrangement, allowing Dr. Reddy’s to maintain its export operations while ensuring that Novo Nordisk’s patent rights in the Indian market remain intact until their scheduled expiry in March 2026.
