Litigation Update: Novo Nordisk vs Sun Pharma on Semaglutide

The Delhi High Court has passed a crucial order in the ongoing patent battle between Danish pharmaceutical giant Novo Nordisk and Indian major Sun Pharma regarding the manufacture and sale of Semaglutide.

Key Takeaways from the Order

• Export Allowed: Sun Pharma has been permitted to manufacture and export Semaglutide to countries where Novo Nordisk does not hold a valid patent.
• Domestic Sales Barred: The court has restrained Sun Pharma from selling the drug in the Indian market until the expiry of Novo Nordisk's specific patent in March 2026.
• Undertaking Recorded: Justice Manmeet Pritam Singh Arora recorded Sun Pharma's undertaking that it would not commercialize the product in India during the patent term.

Background of the Dispute

Semaglutide is a GLP-1 receptor agonist used for the treatment of Type 2 Diabetes and obesity, marketed globally under brand names like Ozempic, Wegovy, and Rybelsus. Novo Nordisk alleged that Sun Pharma's proposed generic version would infringe its existing patents.

While Novo Nordisk's primary patent for the molecule expired in 2024, the company holds a secondary patent covering specific formulations and delivery mechanisms that is valid until March 2026.

Industry Impact

This ruling mirrors a similar recent order involving Dr. Reddy’s Laboratories, setting a precedent for Indian generic manufacturers. It strikes a balance by protecting the innovator's patent rights within India while allowing domestic companies to tap into global export opportunities where such patent barriers do not exist.

For more updates on pharmaceutical litigations and patent news, check out my earlier posts on e-Pharmatimes.