Delhi HC refuses to halt order allowing Dr Reddy's to export Semaglutide

The Delhi High Court refused to stop an earlier order that lets Dr Reddy's make Semaglutide in India only for export, saying Novo Nordisk's patent challenge needs a full hearing before any decision

The Delhi High Court on Friday declined to stay a single judge’s order that allowed Dr Reddy’s Laboratories to manufacture Semaglutide in India for export to countries where Danish drugmaker Novo Nordisk does not hold a patent, Bar and Bench reported.

 

Semaglutide is sold globally under the brand names Ozempic, Wegovy, and Rybelsus.

 

Novo Nordisk had appealed against this decision, arguing that Dr Reddy’s should not be allowed to make the drug at all.

Bench decides to hear appeal fully, not grant interim stay

 

A Division Bench of Justices Hari Shankar and Om Prakash Shukla said it would hear the appeal in full instead of passing an interim injunction at this stage. The judges noted that the single judge had accepted Dr Reddy’s argument that Novo Nordisk’s specific patent appeared “vulnerable to revocation” under Section 64 of the Patents Act, the news report said.

 

 

“The learned single judge has, in a detailed judgment, found substance in this contention of the respondent on various considerations,” the Bench said. 

Prior art comparison central to the dispute

 

The Bench pointed out that the core reasoning of the single judge lay in paragraphs 36 to 46 of the earlier order, where the suit patent was compared with prior art.

 

This comparison showed that “the claim in the suit patent is obvious from the claim in the prior art... [with] only one radical which would be obvious to a person skilled in the art".

 

The judges said these findings could “prima facie suffice to uphold the impugned order", even though Novo Nordisk’s lawyers strongly disagreed. The Bench added that such disagreements cannot be settled on the first day of the appeal and must be examined when the appeal is finally heard, the news report said.

Patent fight centres on Semaglutide’s novelty

 

The case stems from Novo Nordisk’s claim that Dr Reddy’s infringed its 2014 species patent for Semaglutide, the active ingredient in its blockbuster diabetes and weight-loss drugs.

 

The company argued that this patent prevents any manufacture of Semaglutide in India. Dr Reddy’s countered that the patent lacked novelty and an inventive step because Novo Nordisk’s own earlier genus patent -- now expired -- already disclosed the same peptide backbone. The single judge agreed that the structure in the genus patent anticipated Semaglutide.

 

In the December 2 ruling, the single judge also pointed to Novo Nordisk’s Form-27 filings, which showed the company declaring Semaglutide as commercially worked under both the genus and species patents. This, the judge held, supported Dr Reddy’s claim of prior disclosure.  ALSO READ | Novo Nordisk moves HC to stop Sun Pharma's weight-loss drug launch

Export-only permission continues

 

Novo Nordisk argued before the Division Bench that allowing any manufacture of Semaglutide would undermine the patent framework. But the Bench highlighted that the order only permits export, not sale within India, and is therefore limited in scope. It reiterated that the validity of the patent cannot be decided immediately and requires a full hearing, Bar and Bench reported.

 

The Bench has now issued notice and listed the appeal for final disposal. Until then, the single judge’s order remains in force, meaning Dr Reddy’s can continue to manufacture Semaglutide for export only.