Brasília – A legal dispute in Brazil over a patent extension for Ozempic (semaglutide) could establish a precedent with major implications for the pharmaceutical industry. The case, currently before the Superior Court of Justice (STJ), will determine whether delays by the Brazilian Patent Office (INPI) justify an extension of exclusivity for Novo Nordisk’s drug, whose protection is set to expire in 2026.

Novo Nordisk argues that administrative backlogs at INPI have unfairly shortened its period of patent protection and seeks “recomposition” of the lost time. Legal experts, however, point out that the Supreme Federal Court (STF) ruled in 2021 against automatic patent extensions under Article 40 of the Industrial Property Law, which may restrict the company’s chances of success.

According to specialists, if the court grants the extension, it could open the door for similar claims from other pharmaceutical companies and delay the entry of generics or biosimilars into the Brazilian market. Conversely, a decision upholding the original expiration date would reinforce the precedent that patent terms cannot be prolonged due to bureaucratic inefficiencies.

The outcome of this case is expected to shape future discussions on innovation, competition, and access to medicines in Brazil, particularly for chronic conditions like obesity and diabetes, for which semaglutide is widely prescribed.

Source: Panorama Farmacêutico

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