Delhi High Court allows Dr Reddy's to make semaglutide for export

The Delhi High Court has upheld an order permitting Dr Reddy's Laboratories to manufacture semaglutide in India solely for export, rejecting Novo Nordisk's appeal in the ongoing patent dispute

A division Bench of the Delhi High Court on Monday affirmed a single-judge Bench’s order allowing pharmaceutical company Dr Reddy’s Laboratories to manufacture the diabetes and weight-management drug semaglutide in India for export to jurisdictions where Danish drugmaker Novo Nordisk does not have patent protection.

 

The Bench of Justices C Hari Shankar and Om Prakash Shukla dismissed Novo Nordisk’s appeal against a single-judge ruling that had permitted export-only manufacture of the drug. The division Bench held that it saw no grounds to interfere with the earlier order.

 

The court noted that the single-judge Bench had found prima facie merit in Dr Reddy’s challenge to Novo Nordisk’s patent, observing that the species patent covering semaglutide appeared susceptible to revocation on the grounds of obviousness.

 

 

The court clarified that even if certain statutory provisions might have been combined in the earlier analysis, the finding on obviousness by itself was sufficient to sustain the initial order.

 

At the same time, the division Bench emphasised that its observations were only tentative and would not affect the final determination of the patent dispute. A detailed copy of the order is awaited.

 

Semaglutide is sold by Novo Nordisk under brands such as Ozempic, Wegovy, and Rybelsus. The company holds a species patent for the compound, granted in 2014.

  Novo Nordisk had approached the high court last year, alleging infringement, and seeking to restrain Dr Reddy’s from manufacturing the drug in India. Dr Reddy’s contested the claim, arguing that the patent lacked novelty and inventive step in view of Novo’s earlier genus patent, which expired in 2024.

 

Genus patents cover a broad group of related chemical compounds (a “superset” or family), while species patents protect a specific compound, molecule, or formulation within that broader group.

 

In an order dated December 2, 2025, a single judge of the high court had observed that the modification leading to semaglutide appeared obvious in light of prior art, including the earlier genus patent and existing scientific literature. On that basis, the court permitted Dr Reddy’s to manufacture the drug in India solely for export while refusing Novo’s request for an injunction.

 

Novo subsequently challenged the interim ruling before a division Bench. On December 12, 2025, the appellate Bench declined to stay the order, noting that the single judge had delivered a detailed analysis comparing the patent with prior art and had found substance in the validity challenge raised by Dr Reddy’s. It also observed that since the relief granted was limited to export-only manufacture, no interim restraint was warranted.

 

With Monday’s decision, the division Bench has now rejected Novo’s appeal against the interim order.