Takeaway: the Fourth Panel of the Superior Court of Justice (STJ) unanimously denied Novo Nordisk’s request to extend the term of the semaglutide patent in Brazil, the active ingredient in Ozempic and Rybelsus. As a result, the original term of protection remains unchanged, with expiration set for March 2026.

The case concerned Novo Nordisk’s attempt to obtain a judicial extension of patent protection based on alleged delays by the Brazilian Patent and Trademark Office (INPI) in examining and granting the application. The company argued that the administrative backlog should be offset through a corresponding extension of the exclusivity period This extension would, in practical terms, have postponed the entry of generic competitors into the Brazilian market for more than a decade.

The reporting justice emphasized that the Brazilian courts may not create compensatory mechanisms for administrative delay absent express statutory authorization. The Court declined to engage in a case-specific recalculation of the patent term or to introduce, by judicial interpretation, a form of patent term adjustment not provided for under Brazilian law.

The ruling also dismissed Novo Nordisk’s argument that it had suffered prejudice as a result of the examination delay. The Court noted that Brazil’s patent system affords meaningful legal protection from the filing stage, including the right to seek damages for unauthorized exploitation occurring between publication of the application and grant of the patent.

As a result of the decision, the semaglutide patent remains set to expire in March 2026, clearing the way for generic entry into the Brazilian market thereafter.

Click here to access the full decision.

The MAC Advogados team closely monitors case law from Brazil’s higher courts and advises pharmaceutical companies and investors on strategic litigation.

Authors: Mateus Carreteiro, Igor Castro and Barbara Gaudencio