Sun Pharma will Need HC Nod for Semaglutide Tablet Launch

Novo Nordisk submitted that a restraint order was required as Sun Pharma was ready to launch semaglutide tablets in the market the moment it would have marketing approval. And once the drug is launched, it would be difficult to withdraw it.

New Delhi: The Delhi High Court on Tuesday asked Sun Pharma Laboratories to take its prior approval before launching semaglutide tablets, an oral diabetes and weight-management drug, in the market, a plea sought by Danish drugmaker Novo Nordisk, which claims to have a new patent for the same tablet.

Justice Anup Jairam Bhambhani directed that as and when Sun Pharma is granted a licence for commercial manufacture of semaglutide tablets, it is required to inform the court and take its prior approval before taking any further steps for launching these tablets in the market.

The court also sought response from Sun Pharmaceutical Industries, a subsidiary of Sun Pharma Laboratories, on a Novo Nordisk’s patent infringement petition alleging that the former had received approval from the subject expert committee for manufacture of semaglutide tablets in 3 milligram, 7 milligram and 14 milligram, and this violated its existing patent for semaglutide tablets.

Novo Nordisk submitted that a restraint order was required as Sun Pharma was ready to launch semaglutide tablets in the market the moment it would have marketing approval. And once the drug is launched, it would be difficult to withdraw it, the Danish drugmaker said. It further claimed that while its latest patent related to semaglutide tablet, the previous patent was in respect of semaglutide that was injectable.

Sun Pharma opposed Nova’s petition, arguing that the Delhi HC did not have territorial jurisdiction to hear the case as Indian company was based out of Maharashtra. Novo Nordisk must show similarity in products as its earlier patent had expired, it said, adding that Sun Pharma’s product was being compared against an expired patent.

But Novo said that Sun Pharma Labs 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 post licencing nod, the Danish company said.

 

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