The patent in question is due to lapse in March next year. The court is scheduled to take up Natco’s challenge for further hearing in February. Novo Nordisk confirmed the filing of the plea.
“Yes, we confirm this. The matter is sub judice, and we wish to refrain from any comment on this,” Novo Nordisk India told Business Standard.
Semaglutide is widely prescribed for the treatment of type 2 diabetes and is also approved for chronic weight management in select adult and adolescent patients. GLP-1 (glucagon-like peptide-1) medications, or agonists, are a class of drugs that mimic a natural hormone to help manage blood sugar in type 2 diabetes and promote significant weight loss by regulating appetite, slowing digestion and increasing insulin release.
Novo Nordisk currently markets the drug in India and globally under brand names such as Wegovy, Rybelsus and Ozempic, the last of which was recently introduced in the Indian market as a once-weekly injectable therapy for diabetes. While Novo Nordisk’s primary product patent over the semaglutide compound expired in September 2024, the company continues to enjoy protection in India through a secondary patent relating to the drug’s manufacturing process and delivery mechanism, which remains valid until March 2026.
Natco has questioned the legality of this secondary patent, arguing that it unlawfully extends monopoly rights over an invention whose core protection period has already ended. Earlier, on December 2, the Delhi High Court declined to grant interim relief to Novo Nordisk and permitted Dr Reddy’s Laboratories to manufacture semaglutide for export to jurisdictions where Novo Nordisk does not hold patent protection.
The Delhi High Court division bench had declined to interfere with a single-judge decision permitting Dr Reddy’s Laboratories to manufacture and export the diabetes and weight-loss drug semaglutide to countries where Novo Nordisk, the maker of the weight-loss drug Ozempic, does not hold a patent.
However, the court made it clear that domestic sales in India would remain barred until the expiry of the secondary patent in March 2026. Similar permissions were extended to Zydus Lifesciences and Sun Pharmaceutical Industries.