No relief for Novo Nordisk: HC refuses interim stay on order letting Dr Reddy’s make, export weight-loss drug

Novo Nordisk had appealed against a single judge’s order from December 2 which had refused to restrain DRL from manufacturing and exporting the drug. The court had drawn a prima facie conclusion that DRL has put up a credible challenge to the validity of the patent over semaglutide held by Novo Nordisk in India until March 2026. It, however, had barred DRL from selling it in India until the patent held by Novo Nordisk expired.

Its plea against DRL was taken up by a bench of Justices C Hari Shankar and Om Prakash Shukla. On Friday, Justice Shankar, addressing Novo Nordisk’s counsel, Hemant Singh, orally opined that the company has not made out a compelling case for granting an ex-parte stay at this stage.

“The single judge has not refused the interim exemption you sought and has granted a very very limited relief to DRL which is, that you can export to countries where you [Novo Nordisk] don’t have a patent. We are aware that even manufacturing constitutes infringement, nonetheless, it is just an interim arrangement… they’ve not been allowed to sell in India, or export to countries where you have a patent. So on irreparable loss and balance of convenience, it is a very weak case today…,” Justice Shankar said orally to Nordisk’s counsel.

“… the single judge has actually gone on to examine by comparing the claim in the suit patent vis-a-vis the claim in the prior art… She has compared the two compounds and said that there is only one point where there is a difference and for a person skilled in the art, it is obvious. Now whether it is obvious or not is not an issue that needs examination, we cannot decide on the first day… This single observation, if we find it to be correct, is sufficient to uphold the order. So given this position… we are of the view that it is not a case for ex-parte stay, we are just telling you that,” Justice Shankar said orally.

Singh countered, “The prejudice point comes here: that after this order, there are others who are now manufacturing.” Justice Shankar, however, responded that this cannot be a ground to press for ex-parte immediate stay against DRL at this point.

The bench recorded in its order that “in view of the limited relief granted to respondents (DRL) in this case, we are inclined, instead of granting any interim orders today, to set down the appeal for final disposal on a short date”.

With Novo Nordisk conceding their request for immediate stay on the December 2 judgment, the bench has now kept its appeal for final hearing on January 15. The court issued notice to DRL in the stay application while directing the parties to file short notes on their submissions before the next date of hearing.

Following the December 2 order, Novo Nordisk had also moved Delhi HC against Sun Pharma and Alkem Laboratories seeking the court’s direction that they be restrained from directly or indirectly dealing in Active Pharmaceutical Ingredient (API), pharmaceutical products or formulations containing Semaglutide by itself or Semaglutide, either alone or as injections or as tablets in any form or in combination with other API.

Sun Pharma, on December 10, told Delhi HC that it is already manufacturing the drug, and relying on the December 2 order, gave an undertaking that the company shall not sell the drug in India until the expiry of the suit patent of Novo Nordisk, and shall continue to export it to countries where Novo Nordisk does not hold patent over the drug.

Behind the Novo Nordisk case

Novo Nordisk’s semaglutide products are covered by two main Indian patents:

• Indian Patent No. 275964 covers the composition of semaglutide itself, which was filed in March 2006 and expired in September 2024.
• Indian Patent No. 262697, covers specific formulations and delivery devices designed to improve stability and administration. It was filed in March 2007, and is scheduled to expire in March 2026.

The expiry of the basic composition patent in 2024 opened the door to potential generic development.

The Delhi HC, on December 2, had held that prima facie, there is no novelty in the second patent under Novo Nordisk for semaglutide and concluded that the company had obtained two patents for a nearly similar compound with minor tweaks, which any domain expert can formulate.

The HC’s ruling in Novo Nordisk’s case against DRL indicates a victory for other generic drug makers. Apart from DRL, companies like Mankind Pharma, Cipla and Sun Pharma are contemplating introducing GLP-1 products in India.