Brazil’s Superior Court of Justice (STJ), through its Fourth Panel, has ruled against extending the term of the patents covering the medicines Ozempic and Rybelsus. The decision was issued in a case brought by Novo Nordisk and Novo Nordisk Farmacêutica do Brasil Ltda. against the National Institute of Industrial Property (INPI). The companies argued that administrative delays in examining the patent applications justified an extension of the patent term. Lower courts had already dismissed the claim, relying on the precedent set by the Federal Supreme Court in Direct Action of Unconstitutionality No. 5,529, which established that invention patents are valid for a non-extendable period of twenty years counted from the filing date.

In her opinion, Justice Isabel Gallotti emphasised that the Supreme Court’s precedent seeks to prevent adverse effects on public access to medicines and on public healthcare services by preserving the temporary nature of patent exclusivity. She further noted that, although the patent term cannot be extended, patent holders are afforded legal protection during the administrative review process, including the right to compensation for any unauthorised use of the invention from the date of publication of the application, as provided by law. According to the justice, it is not for the judiciary to introduce case-by-case adjustments in the absence of clear statutory criteria.

Link to the Court Decision Julgamento Eletrônico

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