BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello
Among the 24 preliminary injunction claims, there are more rejections than grants of prelimi - nary relief when analysing the decisions handed down with regard to requests for preliminary injunctions. Regarding the merits of these lawsuits, all the judgments handed down in 2024 have dismissed requests for a patent adjustment term. The rea - sons behind such conclusions are similar to the arguments accepted for the denial of the pre - liminary injunctions. In particular, four key points have grounded the dismissal of the requests: • the adjustment of the deadline would go against the unconstitutionality decision handed down by the STF in ADI 5529; • the adjustment of the patent term depends on there being prior legislative activity expressly authorising this; • by virtue of Article 44 of the LPI, companies could benefit from the lengthy patent exami - nation; and • social interest should guide the patent protec - tion system and society would be harmed by the prolonged validity of pharmaceutical patents. The only judgment that does not men - tion such arguments (Case No 1074941- 83.2021.4.01.3400) is based exclusively on the application of the statute of limitations of the claim filed. Therefore, it is clear that judges are hesitant to address the issue without clearer instructions from the higher courts on the admissibility of the case-by-case adjustment in view of the under - standing established at the time of ADI 5529. As a direct result of the decisions of dismissal in the first instance, appeals have been filed and it
is expected that the position of the TRF-1 in the appeals stage will shape the near future of PTA actions in Brazil. 4.2 Paediatric Extensions In Brazil, there is no division in PTA lawsuits based on a certain field of medical specialisa - tion, nor any provision of extension based on special groups of patients or diseases. 4.3 Paediatric-Use Marketing Authorisations See 4.2 Paediatric Extensions . 4.4 Orphan Medicines Extensions See 4.2 Paediatric Extensions . The Brazilian legal system does not differentiate between injunctions in the area of life sciences from others aimed at other technologies, as they are treated as a whole within the industrial prop - erty law and also by the Brazilian Code of Civil Procedure. The general rules for granting injunc - tions in patent matters are set out in Article 209, According to Article 209, Section 1o of the Bra - zilian Industrial Property Act, the judge may, during the course of proceedings and in order to avoid damage that is irreparable or difficult to repair, provisionally order the suspension of the violation, or of the act that gives rise to it, prior to summoning the defendant, and where necessary, order the posting of a cash bond or a bank guarantee. 5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief §1 of the Industrial Property Law. Provisional Order of Suspension
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