A single-judge bench of Delhi high court had allowed Dr Reddy’s to continue manufacturing and exporting semaglutide to non-patent jurisdictions, while restraining domestic sales until the patent expires in March 2026.
The Delhi High Court’s division bench on Monday reserved its verdict on Danish drugmaker Novo Nordisk’s appeal against a single-judge order that allowed Dr Reddy’s Laboratories to manufacture semaglutide in India and export it to countries where the blockbuster diabetes and weight-loss drug is not under patent protection.
A bench of Justice C. Hari Shankar and Justice Om Prakash Shukla heard arguments from both sides.
Semaglutide is used to treat type-2 diabetes and obesity. It works by mimicking the GLP-1 hormone to control blood sugar, suppress appetite and promote weight loss.
Novo Nordisk markets it as Ozempic for diabetes and Wegovy for weight management. The drug is currently among the world’s most valuable and closely contested pharmaceuticals, as Indian companies prepare to enter the market with generic versions once Novo’s patent expires.
The appeal challenges a 2 December 2025 order of Justice Manmeet Pritam Singh Arora, who held, on a prima facie basis, that semaglutide was not clearly distinct from earlier inventions covered by a broad “genus” patent.
The single judge ruled that Novo had failed to make out a strong case for an interim injunction to restrain Dr Reddy’s from exporting the drug to countries where no patent exists.
That ruling allowed Dr Reddy’s to continue manufacturing and exporting semaglutide to non-patent jurisdictions, while restraining domestic sales until the patent expires in March 2026.
The same relief was extended on 10 December 2025 to Sun Pharmaceutical Industries, permitting it to export semaglutide to countries without patent protection while blocking sales in India.
Justice Arora’s findings have tilted the balance in favour of Indian manufacturers, particularly on the issue of exports.
Novo has now challenged these orders before the division bench, arguing that the single judge erred in holding that semaglutide lacked novelty. During the hearing, Novo said the earlier patent relied upon by generic companies covered only a broad class of GLP-1 molecules and did not specifically disclose or teach semaglutide, which, it contended, has a unique chemical structure and long-acting properties.
Novo further argued that merely falling within a broad chemical family does not mean a drug was already invented, and that the court had relied on hindsight to reach that conclusion. Allowing exports during the life of the patent, it said, would cause serious and irreparable harm to its global business and weaken its patent rights.
Queries sent to Novo Nordisk and Dr Reddy’s were not answered till press time.
The division bench’s ruling is expected to be significant for the pharmaceutical industry. It will affect not only Dr Reddy’s and Sun Pharma but also other companies such as Natco that are preparing to launch generic versions of semaglutide once Novo’s Indian patent expires in 2026.
While most Indian players are still awaiting regulatory approvals, Sun Pharma, Dr Reddy’s Laboratories and Alkem Laboratories are among those that have already received clearance from the drug regulator to market semaglutide.
The dispute comes at a time when India’s market for diabetes and weight-loss drugs is expanding rapidly. According to Pharmarack, the GLP-1 segment has grown from ₹186 crore in November 2022 to over ₹1,000 crore in November 2025. Eli Lilly’s tirzepatide (Mounjaro) currently dominates the category, while Novo’s Wegovy has gained market share following a recent price cut.
Novo Nordisk also recently launched its blockbuster brand Ozempic in India for the treatment of type-2 diabetes and is seeking to maximise its market presence before semaglutide loses patent exclusivity.
The division bench is expected to pronounce its ruling in the case before Novo’s semaglutide patent expiry on 20 March 2026.
Source: Mint
