Delhi High Court Upholds Order Refusing Interim Relief To Novo Nordisk In Semaglutide Patent Dispute With Dr Reddy's

The Delhi High Court on Monday dismissed Danish Pharma Company Novo Nordisk's appeal seeking an interim injunction against Dr Reddy's Laboratories Ltd in a patent infringement dispute over the anti-diabetic drug Semaglutide.

The drug is the active ingredient in Novo Nordisk's blockbuster diabetes medicine Ozempic, which has also gained global attention for its weight loss effects.

A Division Bench of Justice C. Hari Shankar and Justice Om Prakash Shukla upheld a Single Judge's order refusing to grant interim relief restraining Dr. Reddy's from dealing in Semaglutide, holding that the defendants had raised a credible challenge to the validity of the patent.

Novo Nordisk holds Indian Patent No. 262697 for an invention titled “Acylated GLP-1 Analogs Comprising Non-Proteogenic Amino Acid Residue," with a priority date of March 18, 2005.

Novo Nordisk's patent covers Semaglutide, a GLP-1 analogue used to treat diabetes. The drug is sold in India under the brand names Wegovy and Rybelsus.

The company told the court that it first became aware in December 2024 that Dr. Reddy's Laboratories Ltd was importing and exporting Semaglutide. Viewing this as an infringement of its patent, Novo Nordisk issued a cease-and-desist notice on May 5, 2025. When the dispute remained unresolved, it moved the Delhi High Court later that month, filing a patent infringement suit against the pharmaceutical major.

While the defendants did not dispute importing and exporting the drug, they challenged the validity of the suit patent under Section 107(1) of the Patents Act, contending that it was vulnerable to invalidity under Sections 64(1)(a), (e), (f) and (k).

The single judge had refused to grant an interim injunction after holding that Dr Reddy's had raised a credible challenge to the validity of the suit patent under Sections 64(1)(a), (e) and (f) of the Patents Act, prompting Novo Nordisk to file the present appeal. During the appeal proceedings, Dr. Reddy's undertook that it would not sell Semaglutide in India.

Section 64 of the Patents Act sets out grounds on which a patent may be revoked. Section 64(1)(a) applies where the invention was already claimed in an earlier patent, Section 64(1)(e) where the invention is not new in light of prior knowledge or publication, and Section 64(1)(f) where the invention is obvious or lacks an inventive step.

The division bench said it differed from the Single Judge only with respect to the finding that the challenge fell under Section 64(1)(a).

“It appears, to us, that though a credible challenge to the validity of the suit patent is thereby made out, the challenge would be relatable, not to Section 64(1)(a), but to Section 64(1)(e) and (f),” the Court said.

The Bench observed that the Single Judge had slightly erred in conflating the concept of obviousness under Section 64(1)(f) with anticipation by prior claiming under Section 64(1)(a).

“The findings returned by the learned Single Judge, for holding a prima facie case to have been made out under Section 64(1)(a), in fact make out a prima facie credible challenge to the validity of the suit patent under Section 64(1)(f),” the Court observed.

The Court further noted that the analysis undertaken by the Single Judge effectively demonstrated a case of obviousness under Section 64(1)(f), even though it had been conducted in the context of Section 64(1)(a).

It also observed that, from the perspective of a “person in the know,” Semaglutide appeared prima facie obvious from the teachings of the earlier genus patent IN'964, thereby establishing a credible challenge to the validity of the suit patent.

Accordingly, the bench dismissed the appeal against the interim order.

For Appellant: Advocates Hemant Singh, Mamta Jha, Rishabh Paliwal, Shreyansh Gupta and Sanchit Sharma

For Respondent: Senior Advocates Gopal Subramanium, J. Sai Deepak, Advocates Mohit Goel, Sidhant Goel, Aditya Goel, Deepankar Mishra, Kartikeya Tandon, Pavan Bhushan, Avinash Sharma, Raghav Kohli, Adnan Yousuf and Ankit Malhotra,