Danish pharma giant says in process of challenging earlier verdict, where court allowed Dr Reddy’s to make and export weight-loss drug
Danish pharma giant Novo Nordisk has moved the Delhi High Court seeking to restrain Indian company, Sun Pharmaceutical, from directly or indirectly dealing in semaglutide, an active pharmaceutical ingredient in the blockbuster drug Ozempic, or any product derived from it.
The fresh plea comes on the heels of the HC allowing Dr Reddy’s Laboratories (DRL) to continue manufacturing and exporting its version of the GLP-1 drug that contains semaglutide. The drug, marketed globally by Novo Nordisk as Ozempic for Type 2 diabetes and for obesity, has been at the centre of a patent dispute in India.
Last week, a single judge bench had refused to grant any interim injunction in favour of Novo Nordisk, while making 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.
The court had thus allowed DRL to continue manufacturing and exporting the drug, while barring DRL from selling it in India until the patent held by Novo Nordisk expires.
On Tuesday, Novo Nordisk told the Delhi HC that it is in the process of challenging the single judge’s order.
The fresh suit by Novo Nordisk against Sun Pharma was taken up before Justice Tejas Karia. The counsel appearing for the Danish pharma giant told the court, “[in single judge’s order from December 2]… to balance equities, the court maintained the status quo — that is, whatever you’re doing, the defendant (DRL) in that case was permitted to do [manufacture and export], whatever they were not doing [sell in India], they were asked to hold on… I’m only requesting that [for Sun Pharma as well]. I’m not challenging the findings [of the December 2 verdict in this suit]…”
“The suit is pending… we’re in the process of challenging it [the December 2 verdict],” the counsel said.
Sun Pharma, in a November earnings call, termed the GLP-1 market — the class of drugs to which semaglutide belongs — as “exciting”, adding that it wants to “participate in the market whenever the first opportunity is available”.
Justice Karia, noting that the subject matter is already being dealt with by the court of Justice Manmeet Pritam Singh Arora, transferred the suit for hearing by the same court.
The suit is expected to be heard by Justice Arora on Wednesday.
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’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.
