Delhi HC Rejects Stay on Order Permitting Dr. Reddy's Semaglutide Export

The Delhi High Court has declined to suspend a single judge's ruling that permits Dr. Reddy's Laboratories to produce Semaglutide in India for export. This is applicable to countries where Novo Nordisk, the Danish drugmaker, does not possess a patent, according to reports. Semaglutide is globally marketed under the brand names Ozempic, Wegovy, and Rybelsus, used in diabetes and weight management. Novo Nordisk had appealed the decision, asserting that Dr. Reddy's should be prohibited from manufacturing the drug entirely.

Bench to Hear Appeal, Denies Interim Stay

A Division Bench, consisting of Justices Hari Shankar and Om Prakash Shukla, stated it would conduct a full hearing of the appeal instead of issuing an interim injunction at this point. The judges highlighted that the single judge had acknowledged Dr. Reddy's argument that Novo Nordisk's specific patent appeared "vulnerable to revocation" as per 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 Bench stated.

Dispute Focuses on Prior Art Comparison

The Bench emphasized that the single judge's primary reasoning was detailed in paragraphs 36 to 46 of the preceding order, which compared the suit patent with prior art. This comparison revealed 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 indicated that these findings could "prima facie suffice to uphold the impugned order," despite strong disagreement from Novo Nordisk's lawyers. The Bench added that such disagreements require thorough examination during the final appeal hearing.

Patent Battle Revolves Around Semaglutide's Novelty

The core of the matter lies in Novo Nordisk's allegation that Dr. Reddy's violated its 2014 species patent for Semaglutide, the key ingredient in its widely successful drugs for diabetes and weight loss. Health tracking apps like Shotlee can help monitor the effects of these drugs, but the legal battle is about patent rights. The company contended that this patent prevents any Semaglutide production in India. Dr. Reddy's countered that the patent lacked novelty and an inventive step, as Novo Nordisk's earlier genus patent – now expired – had already disclosed the same peptide backbone. The single judge concurred that the structure in the genus patent anticipated Semaglutide. In the December 2 ruling, the single judge also referenced Novo Nordisk's Form-27 filings, which indicated the company had declared Semaglutide as commercially worked under both the genus and species patents. The judge determined that this supported Dr. Reddy's claim of prior disclosure.

Export-Only Permission Remains

Novo Nordisk argued before the Division Bench that allowing any Semaglutide manufacture would compromise the patent system. However, the Bench emphasized that the order only authorizes export, not domestic sale within India, thus limiting its scope. It reiterated that the patent's validity cannot be determined immediately and necessitates a full hearing. The Bench has now issued a notice and scheduled the appeal for final resolution. Until then, the single judge's order remains effective, allowing Dr. Reddy's to continue manufacturing Semaglutide solely for export.