Sun will require HC nod for Semaglutide tablet launch

New Delhi: The Delhi High Court on Tuesday asked a subsidiary of Sun Pharmaceutical Industries to take its approval before launching semaglutide tablets in the market, a plea sought by Danish drugmaker Novo Nordisk that claims to have a new patent for the tablet form of the diabetes and weight-management drug.

Justice Anup Jairam Bhambhani directed Sun Pharma Laboratories that as and when it is granted a licence for commercial manufacturing of semaglutide tablets, it must inform and take approval of the court before taking any steps for launching the product in the market.

The court also sought a response from Sun Pharma on Novo Nordisk's patent infringement petition. Novo Nordisk alleged that the approval that the Indian company received from the subject expert committee of the regulator for the manufacturing of semaglutide tablets in 3-milligram, 7-milligram and 14-milligram strengths violated its existing patent for the tablets.


Novo Nordisk sought a restraint order, saying that Sun Pharma was ready to launch the tablets in the market the moment it would have the marketing approval. And once the drug is launched, it would be difficult to withdraw it, the Danish drugmaker said. It claimed that while its latest patent related to semaglutide tablets, the primary patent that expired in India in March was for the injectable variant of the drug.

Sun Pharma argued that the Delhi High Court did not have territorial jurisdiction to hear the case as the Indian company was based in Maharashtra. Besides, Novo Nordisk must show similarity in the products as its earlier patent expired, it said, adding that Sun Pharma's product was being compared against an expired patent.

Novo Nordisk said Sun Pharma Laboratories was working with a Delhi address and was carrying out business in the union territory. It sold its products both online and offline in Delhi, and will also sell semaglutide tablets in Delhi soon after getting the approval, it said.