Sun Pharma Can Manufacture Ozempic-Like Drug Only for Export, Rules Delhi HC
The Delhi High Court in Novo Nordisk Vs Sun Pharma has allowed Sun Pharma to manufacture and export its semaglutide formulation (a drug similar to Novo Nordisk’s Ozempic) but has made it clear that the company cannot sell it in India until Novo Nordisk’s patent expires.
The Court recorded Sun Pharma’s undertaking that the product will only be supplied to countries where Novo Nordisk does not have an active patent. This assurance became the basis for permitting Sun Pharma to continue production solely for export purposes.
Semaglutide, the active ingredient in Novo Nordisk’s well-known drugs Ozempic and Wegovy, has become the centre of global patent battles due to increasing demand for diabetes and weight-loss treatment.
Novo Nordisk had approached the Court alleging that Sun Pharma’s version of semaglutide infringed its patent. Sun Pharma, however, referred to a December 2 ruling in a similar matter involving Dr Reddy’s Laboratories. Justice Manmeet Pritam Singh Arora clarified that the benefit of that earlier ruling came with strict compliance requirements.
The Court noted Sun Pharma’s commitment that exports will be made only to jurisdictions where no patent conflict exists. The company has been directed to file an affidavit within two weeks confirming this undertaking.
Sun Pharma also informed the Court that it has already started manufacturing the drug. The Court instructed the company to submit quarterly statements of accounts, including export details, until March 2026. This mirrors conditions previously imposed on Dr Reddy’s Laboratories.
In the earlier ruling on December 2, the Delhi High Court had refused to stop Dr Reddy’s Laboratories and OneSource Specialty Pharma from manufacturing and exporting semaglutide. The Court held that Dr Reddy’s had raised credible questions on the validity of Novo Nordisk’s patent, including prior claiming and obviousness.
As a result, Dr Reddy’s was allowed to continue producing the drug for export to markets where Novo Nordisk does not hold patent protection, subject to filing detailed accounts.
