New Delhi: In a setback for Novo Nordisk, the Delhi High Court on Monday upheld an order permitting Dr. Reddy’s Laboratories to manufacture diabetes and weight-loss drug semaglutide in India for export to countries where the innovator doesn’t hold a patent, dismissing the Danish drugmaker’s appeal.
A division bench of justices C. Hari Shankar and Om Prakash Shukla said that it did not find reason to interfere with a previous single-judge bench’s order that allowed Dr. Reddy’s to manufacture semaglutide and export it to non-patent countries.
The ruling comes just days before semaglutide loses its patent exclusivity in India on 20 March, which would allow generics to be manufactured and marketed domestically.
The division bench had reserved its order after a January 19 hearing. Novo’s appeal challenges a 2 December 2025 order of justice Manmeet Pritam Singh Arora, who held, on a prima facie basis, that semaglutide was not clearly distinct from earlier inventions covered by a broad “genus” patent.
The single-judge bench ruled that the innovator had failed to make out a strong case for an interim injunction to restrain Dr. Reddy’s from exporting the drug to countries where no patent exists. The same relief was extended on 10 December 2025 to Sun Pharmaceutical Industries.
Novo Nordisk and Dr. Reddy’s did not respond to Mint’s queries.
The challenge
Novo challenged the single-judge ruling, arguing that the order erred in holding that semaglutide lacked novelty. During the hearing, Novo said the earlier patent relied upon by generic companies covered only a broad class of GLP-1 (glucagon-like peptide-1) molecules and did not specifically disclose or teach semaglutide, which, it contended, has a unique chemical structure and long-acting properties.
Viewed from the perspective of a person in the know, it is prima facie clear that semaglutide would be obvious from the teachings contained in the Genius Patent IN’964 and that, therefore, a credible challenge to the validity of the suit patent, under Section 64(1)(f), is made out, the division bench said in its order.
“Even on this sole ground, as the impugned judgment is liable to be affirmed, we do not deem it necessary to enter into any other aspect of the matter,” the order said.
Section 64(1)(f) of the Indian Patent Act, 1970 allows for revocation of a patent if the invention is obvious or does not involve an inventive step.
There are two ways this could move forward. “Novo Nordisk now has the right to file an appeal to the Supreme Court against the division bench’s order. And secondly, the main suit which is still pending for the single judge will continue on its own merits,” a legal expert said on the condition of anonymity.
If Novo wins
Should Novo Nordisk win the case even after the patent expires, it would be liable to collect damages from the other party.
The main dispute centres on semaglutide’s patent structure. The primary patent for the molecule expired in September 2024, while a second formulation patent is valid until March 2026. On 12 May 2025, Dr. Reddy’s challenged the validity of Novo’s second patent in the Delhi High Court, saying that it lacks novelty. Soon after, Novo Nordisk filed a patent infringement suit against Dr. Reddy’s.
Dr. Reddy’s has challenged this under Section 64 of the Patent Act, 1970, calling it an attempt at “evergreening” to extend monopoly protection.
The high court’s ruling comes as Indian companies rush to prepare for the launch of copycat generics of the blockbuster weight-loss drug this month, while innovators like Novo Nordisk will try to hold on to their market share. The market for GLP-1s was worth ₹1,446 crore on a moving annual total basis as of February 2026, according to Pharmarack. Over 50 branded generic versions of semaglutide are expected to hit the market as the patent expires, Pharmarack said in a report dated 7 March.
