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

the provision of Article 57 of the Brazilian Indus - trial Property Act, since the BPTO is the federal agency responsible for the administrative act that granted the targeted patent. 1.3 Preliminary Injunction Proceedings Preliminary injunctions are available in the Bra - zilian legal system and are regulated by Article 300 and the following articles of the Brazilian Code of Civil Procedure, as well as Article 209, § 1o of the Brazilian Industrial Property Act, which establishes that the judge may grant an injunc - tion to cease the infringement, aiming to avoid irreparable damages. Usually requested on an ex parte basis within the initial brief of the infringement or nullity actions, the plaintiff must attest the: • likelihood of success on the merits; and • risk of irreparable harm, and if one such requirement is not fulfilled, the preliminary injunction request will not be granted by the trial court judge. Although ex parte injunctions are allowed in Bra - zil for patent infringement cases, in the São Pau - lo State Court, judges generally allow defend - ants to submit a short defence within five days of the summoning, before the official deadline for a formal reply, so as to provide initial inputs to the court. In addition, in 2024 it was apparent that in patent infringement claims in the Rio de Janeiro State Court, judges were also ordering a concise unbiased expert opinion, before the issuance of the preliminary injunction, so as to clarify to the court the main aspects of the infringement. The Usefulness and Necessity of the Claim For both patent infringement and patent invalid - ity actions, the existence of a granted patent is

an indispensable prerequisite of the lawsuit, as it attests the procedural interest of the plaintiff. According to a recent decision rendered by the Brazilian Superior Court of Justice on Special Appeal No 2.001.226, the procedural interest requires the confluence of two elements: the usefulness and necessity of the claim submit - ted to the court. While the former will be attest - ed if the lawsuit can provide the plaintiff with the favourable result sought, the need for the state to act will be attested if it is found that the opposing party resists the claim formulated by the plaintiff. Thus, it is inferred that the existence of a patent itself should not be used as an exclusive argu - ment to attest to the likelihood of success on the merits, but as an argument to attest the proce - It is also the case that the sooner the patentee adopts the necessary and relevant measures to prevent the ongoing infringement practices, the better the chance that the judge will understand the real urgency of the matter, as well as the risk of irreparable harm. On the other hand, the judge must also weigh the risk of reverse dam - age to the counterparty, before deciding on the balance whether or not to grant the preliminary injunction. Judges are used to rendering such decisions on an ex parte basis, but during the past few years, a specific court specialised in IP has been adopting a different practice: the São Paulo State Court – one of the major courts concentrating on IP litigation discussions in Brazil – has been summoning the defendant to present a prelimi - nary response regarding the plaintiff’s prelimi - nary injunction request, aiming to promote the least adversarial proceeding so that the judge dural interest of the plaintiff. Assessing the Pros and Cons

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