Life Sciences and Pharma IP Litigation 2025

BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello

can better assess the case and render a deci - sion on whether or not to grant the preliminary injunction request. It is important to highlight that jurisdictional rem - edies are not only available to the party whose right has been infringed, but also to the party whose right is about to be infringed, aiming to prevent damage from occurring. It is therefore possible for a patentee to file an inhibitory lawsuit combined with a preliminary injunction request, aiming to prevent the defendant from commit - ting the infringement and the material damages arising therefrom. However, such lawsuits are analysed on a case-by-case basis, taking into consideration the background to the discussion, as well as the practices provided by Article 43 of the Brazilian Industrial Property Act, which are considered exemptions of infringement or threat of infringement, such as the Bolar exemption and the market authorisation application. Should the preliminary injunction be granted on an ex parte basis, the defendant will be sum - moned via post or by the clerk of the court. As soon as the confirmation receipt is filed in the court’s files, both the defence brief and potential interlocutory appeal deadlines will start. 1.4 Structure of Main Proceedings on Infringement/Validity Bifurcation of Infringement and Validity Proceedings: Legal Provisions and Discussions on the Case Law Infringement actions must be filed before a state court, while nullity actions must be filed before a federal court, since the participation of the BPTO (a federal autocracy) as a co-defendant is man - datory, as it is responsible for granting the chal - lenged patent, in accordance with Article 57 of the Brazilian Industrial Property Act.

There is currently a discussion in the main Bra - zilian courts regarding the possibility of arguing the invalidity of a patent in an incidental manner, as a way of defence in an infringement action, based on the provision set forth by Article 56, § 1o of the Brazilian Industrial Property Act (“the nullity of a patent may be argued, at any time, as a matter for defence”). For some judges, it would not be possible to dis - cuss the nullity of a patent during an infringement action, since Article 57 of the Brazilian Industrial Property Act provides that the BPTO must figure as a mandatory co-defendant (and its participa - tion is only possible before the federal courts, due to a competence rule established by the Brazilian Federal Constitution). For this reason, Article 56, § 1o of the Industrial Property Act cannot be interpreted on its own. However, for other judges, it would indeed be possible to dis - cuss the nullity of a patent in an incidental man - ner in an infringement proceeding, although the decision on the merits rendered in this respect would have inter partes effects but would not affect third parties outside the lawsuit. There is currently no uniformity in Brazilian case law with respect to this subject and each judge can adopt their own position regarding the matter. Most recently (EREsp 1332417/RS, Motion for Reconsideration in Special Appeal – 2012/0137220-6), the STJ considered whether it is possible to claim the nullity of patents and/ or industrial designs as a matter of defence. On 12 June 2024, the Second Panel of the STJ unanimously reaffirmed such understanding by authorising the claim of nullity by the defendant in an infringement lawsuit. The nullity of patents and industrial designs by the state courts is of an incidental nature, operating inter partes effects, and may serve, exclusively, as a guiding basis

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