Delhi High Court Directs Sun Pharma To Seek Prior Approval Before Launching Semaglutide Tablets

The Delhi High Court on 11 August directed Sun Pharma Laboratories Limited to seek prior approval from the Court before commercially manufacturing or launching its Semaglutide Tablets, in a patent infringement suit filed by Novo Nordisk A/S.

Justice Anup Jairam Bhambhani did not grant an interim injunction at this stage, but observed:

“As and when a manufacturing license is granted to the defendant for the manufacture of Semaglutide Tablets, before taking any steps towards commercial manufacturing or launch of the said product, the defendant shall move an appropriate application before this court seeking prior approval for that purpose.”

Novo Nordisk approached the Delhi High Court alleging that Sun Pharma's proposed Semaglutide Tablets in 3 mg, 7 mg and 14 mg dosages would infringe its patent. It relied on recommendations made by the Subject Expert Committee at its meeting on 24 June 2026, which recommended permission for Sun Pharma to manufacture and market the tablets.

Senior Counsel Amit Sibal, appearing for Novo Nordisk, submitted that Sun Pharma had completed clinical trials and was on the verge of launching the drug. He placed certain supporting documents before the Court.

Senior Counsel Rajeshwari Hariharan, appearing for Sun Pharma, raised a preliminary objection to the maintainability of the suit, submitting that the Delhi High Court lacked territorial jurisdiction since none of the parties was based in Delhi. She also argued that the suit was premature as Sun Pharma had not yet applied for a commercial manufacturing licence, a process which would take some time.

The Court noted an ambiguity in Sun Pharma's position regarding the composition of its product. It observed:

“It appears there is ambiguity as to the defendant's stand, in particular as to whether their pharmaceutical product contains Salt of NAC alongwith Semaglutide; and if so, in what proportion/range; and whether the quantity of SNAC contained in the defendant's product maps onto the plaintiffs' patent claim(s).”

In view of this ambiguity and the fact that Sun Pharma had not yet obtained a manufacturing licence, the Bench declined to grant an interim injunction at this stage. It clarified that it would consider Novo Nordisk's plea for interim relief after Sun Pharma moves an application seeking approval to commercially manufacture or launch the product. It kept Sun Pharma's objection regarding the Court's territorial jurisdiction open for adjudication at a later stage.

The matter is next listed before the Joint Registrar on 4 November 2026.