Delhi High Court refuses to stay order allowing Dr Reddy’s to manufacture and export Ozempic-like drug

A Division Bench of Delhi High Court on Friday declined to stay a Single Judge’s order that had allowed Dr Reddy’s Laboratories to manufacture Semaglutide in India for export to countries where Novo Nordisk does not hold patent protection over its manufacture and sale under brand names like Ozempic [Novo Nordisk Vs Dr. Reddy's].

Semaglutide is marketed under brand names such as Ozempic, Wegovy and Rybelsus by Novo Nordisk.

Novo Nordisk has filed an appeal before the High Court challenging a single judge's decision to allow Dr Reddy’s Laboratories to manufacture the drug for export out of India.

A Division Bench of Justices Hari Shankar and Om Prakash Shukla today found it fit to decide the appeal finally, rather than hearing a plea for an interim injunction of the order.

The Bench recorded that the single judge had accepted the respondent’s contention that the suit patent (Novo Nordisk's patent) appeared vulnerable to revocation under Section 64 of the Patents Act.

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

The Bench highlighted that the heart of the order under challenge lay in paragraphs 36 to 46, where the single judge compared the suit patent with prior art.

The comparison showed “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.”

These findings, the Bench noted, could "prima facie suffice to uphold the impugned order.”

Novo Nordisk’s counsel disputed these preliminary conclusions, but the Court held that such issues cannot be decided on the very first day of hearing and required detailed analysis at the stage of final disposal.

The underlying litigation arises from Novo Nordisk’s suit alleging infringement of its 2014 species patent covering Semaglutide, the active ingredient in its globally marketed drugs Ozempic, Wegovy and Rybelsus.

The company relied on this patent to prevent any manufacture of the compound in India. Dr Reddy’s, however, argued that the suit patent lacked novelty and inventive step in light of Novo Nordisk’s own earlier genus patent, which expired in 2024. This earlier patent disclosed the same peptide backbone and, according to the single judge, anticipated the essential structure of Semaglutide.

In its December 2 order, the single judge held that the modification leading to Semaglutide appeared to be obvious in light of prior art, including the genus patent and scientific literature. The Court also noted Novo Nordisk’s Form-27 filings, which declared Semaglutide’s commercial working under both the species and the genus patents—an admission that supported the defence of prior claiming.

While Novo Nordisk argued before the Division Bench that permitting any manufacture of Semaglutide undermines the statutory scheme, the Bench emphasised that the single-judge order permitted only export, not domestic sale, and that its scope was narrow.

It added that determining whether the suit patent is indeed invalid cannot be done on day one of the appeal hearing.

The Bench has now issued notice and fixed the appeal for final disposal, while declining to grant any interim protection. As a result, the export-only permission granted by the single judge continues to operate.

Novo Nordisk was represented by Advocates Hemant Singh and Mamta Rani Jha from Inttl Advocare.

Dr. Reddy's was represented by Senior Advocate Sai Deepak with Advocates Siddhant Goel and Mohit Goel from Sim & San.