The Delhi High Court today delivered a split verdict. It allowed Sun Pharmaceutical Industries to manufacture and export its version of the blockbuster drug semaglutide. However, the court strictly barred the company from selling the product in the domestic Indian market.
Court Upholds Patent Expiry Timeline
The decision is a major development in the pharmaceutical patent battle. Danish giant Novo Nordisk markets semaglutide globally. It is the active ingredient in its widely-used diabetes and weight-loss drugs, Ozempic and Wegovy.
Novo Nordisk sued Sun Pharma for patent infringement. The Danish company seeks to protect its secondary patent. This patent covers specific formulations and the delivery system of the drug. The patent remains valid until March 2026.
The court’s ruling respects this expiration date. It ordered Sun Pharma to refrain from all sales within India until the patent lapses.
Exports Allowed: A Win for Generics
Crucially, the court granted Sun Pharma permission to continue manufacturing. It also allowed exports to countries where Novo Nordisk does not hold patent protection.
This order mirrors a recent ruling against Dr. Reddy’s Laboratories (DRL). Justice Manmeet Pritam Singh Arora heard both cases. She had previously allowed DRL similar manufacturing and export rights.
Sun Pharma provided a formal undertaking to the court. The company will comply with the domestic sales ban. It will also provide the court with full details of its manufacturing and export accounts.
Evergreening Challenge Cited
The ongoing dispute centers on the validity of Novo Nordisk’s secondary patent. Generic makers argue the patent constitutes evergreening.
Evergreening is a common practice. Companies attempt to extend their patent monopoly. They secure new patents on minor modifications to an existing drug.
The Indian Patents Act, specifically Section 3(d), prohibits this. This section denies patents for new forms of a known substance. The new form must show a significant enhancement in therapeutic efficacy.
The court noted that Sun Pharma and DRL raised a “credible challenge” to the secondary patent’s validity. This legal challenge bolstered the generic companies’ position.
Market Impact: A Race for 2026
The ruling is a clear signal. It encourages Indian generic companies to prepare for market entry.
The global market for GLP-1 drugs like semaglutide is massive. Indian drug makers are now lining up to launch their generic versions.
The ban on domestic sales protects Novo Nordisk’s current market exclusivity. Yet, the export green light allows generic firms to gain a foothold. This prepares them for a competitive domestic launch in March 2026.
Novo Nordisk still holds an advantage in the Indian market. It recently cut the price of its product, Wegovy. This move increases competition against rivals like Eli Lilly’s Mounjaro.
Novo Nordisk has indicated it intends to appeal the court’s earlier decision in the DRL case. The legal battle for the lucrative weight-loss drug market will continue.
