The Delhi High Court's division bench has reserved its verdict in a crucial pharmaceutical patent case. On Monday, the bench heard arguments from Danish drugmaker Novo Nordisk and Indian pharmaceutical companies regarding the manufacturing and export of semaglutide.
Court Proceedings and Key Arguments
A bench comprising Justice C. Hari Shankar and Justice Om Prakash Shukla listened to detailed submissions from both sides. Novo Nordisk appealed against a single-judge order that permitted Dr Reddy's Laboratories to produce semaglutide in India and export it to countries where the drug lacks patent protection.
Background of the Dispute
Justice Manmeet Pritam Singh Arora issued the original order on December 2, 2025. The judge ruled on a prima facie basis that semaglutide did not show clear distinction from earlier inventions covered by a broad "genus" patent. This decision denied Novo Nordisk's request for an interim injunction to stop Dr Reddy's from exporting the medication to non-patent jurisdictions.
The ruling specifically allowed Dr Reddy's to continue manufacturing and exporting semaglutide to countries without patent protection. However, it restrained domestic sales in India until the patent expires in March 2026. On December 10, 2025, the court extended similar relief to Sun Pharmaceutical Industries.
Novo Nordisk's Legal Challenge
Novo Nordisk challenged these orders before the division bench, arguing that Justice Arora made an error in determining that semaglutide lacked novelty. The company maintained that earlier patents relied upon by generic manufacturers covered only a broad class of GLP-1 molecules. These patents did not specifically disclose or teach semaglutide, according to Novo's legal team.
The pharmaceutical giant contended that semaglutide possesses a unique chemical structure with long-acting properties. Novo Nordisk argued that merely belonging to a broad chemical family does not mean the drug was already invented. The company expressed concern that allowing exports during the patent's life would cause serious and irreparable harm to its global business operations.
Understanding Semaglutide
Semaglutide treats type-2 diabetes and obesity effectively. The medication works by mimicking the GLP-1 hormone to control blood sugar levels. It suppresses appetite and promotes weight loss through this mechanism.
Novo Nordisk markets the drug under two brand names. Doctors prescribe Ozempic for diabetes management, while Wegovy addresses weight management needs. This pharmaceutical product ranks among the world's most valuable and closely contested drugs currently.
Impact on Indian Pharmaceutical Industry
The division bench's upcoming ruling will significantly affect India's pharmaceutical sector. The decision will impact not only Dr Reddy's and Sun Pharma but also other companies like Natco that plan to launch generic versions of semaglutide after Novo's Indian patent expires.
Most Indian pharmaceutical players still await regulatory approvals for their generic versions. However, several companies have already received clearance from India's drug regulator. Sun Pharma, Dr Reddy's Laboratories, and Alkem Laboratories count among those with regulatory approval to market semaglutide.
Market Context and Growth
This legal dispute unfolds during rapid expansion of India's diabetes and weight-loss drug market. According to Pharmarack data, the GLP-1 segment has shown remarkable growth. The market expanded from ₹186 crore in November 2022 to over ₹1,000 crore in November 2025.
Eli Lilly's tirzepatide, marketed as Mounjaro, currently dominates this category. Novo Nordisk's Wegovy has gained market share following a recent price reduction. Novo Nordisk recently launched its blockbuster brand Ozempic in India for type-2 diabetes treatment. The company seeks to maximize its market presence before semaglutide loses patent exclusivity.
What Comes Next
The Delhi High Court might pronounce its order before Novo's patent expires in March 2026. Justice Arora's findings have already tilted the balance in favor of Indian manufacturers, particularly regarding export permissions. Both Novo Nordisk and Dr Reddy's did not respond to queries until press time.
This case represents a critical juncture for patent law interpretation in India's pharmaceutical industry. The verdict will establish important precedents for future disputes involving innovative drugs and generic manufacturers.
