- Delhi HC Clears

DRREDDY

’s Semaglutide Exports

In a significant legal development, the Delhi High Court upheld a previous ruling allowing

’s Laboratories to manufacture and export semaglutide, a diabetes and weight-loss drug, to countries where Novo Nordisk does not hold a patent. The decision, delivered just days before semaglutide’s patent exclusivity expires in India on 20 March 2026, paves the way for domestic generics and reinforces the court’s stance on broad patent interpretation. Legal Highlights - A division bench dismissed Novo Nordisk’s appeal against a 2 December 2023 single-judge order. - The court ruled that semaglutide was not clearly distinct from earlier inventions covered under a broad “genus” patent (IN’964). - The judgment cited Section 64(1)(f) of the Indian Patents Act, noting a credible challenge to the validity of Novo’s suit patent. - The same export relief was extended to Sun Pharmaceutical Industries on 10 December 2025. Implications for Dr. Reddy’s - The company can continue exporting semaglutide to non-patent jurisdictions, unlocking near-term revenue potential. - Domestic manufacturing and marketing of generics will be permitted post 20 March 2026, once exclusivity lapses. - The ruling strengthens India’s position as a global supplier of affordable generics, especially in therapeutic areas like diabetes and obesity. Novo Nordisk’s Position - Novo argued that semaglutide’s unique chemical structure and long-acting properties were not disclosed in the genus patent. - The court disagreed, stating that semaglutide would be obvious to a skilled person based on the teachings of the broader patent. - The bench declined to examine other aspects, affirming the lower court’s decision on this ground alone. Outlook With semaglutide’s patent expiry imminent, Indian pharma players are poised to enter the domestic market. The ruling sets a precedent for patent interpretation and export rights, potentially influencing future litigation in high-value drug categories.