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

7. Appeal 7.1 Timeframe to Appeal Decision Regarding the Preliminary Injunction

labels or packages that may cause error, confu - sion or undue association among consumers. For instance, Orientation No 43/2017 of Anvisa establishes the complementary details to guide the agency when evaluating and deciding on third party’s requests to register the name of a certain drug. Among other things, an analysis to decide on the approval of the name of a drug product must include research of Anvisa’s and the BPTO’s databases, evaluation of graphic and phonetic resemblances, assessment of potential errors, assessment of the safety of the proposed name, based on assumptions of risk of error in cases of prescriptions, dispensing and/or administration or use. In the pharma and life sciences field, the judges tend to be extra-careful in court discussions about trade marks and trade dress which are possibly confusingly similar to a third party’s prior-registered trade marks or trade dress, as the case concerns human health. 6.2 Copyright Copyright disputes in the life sciences and phar - ma sector are not common in Brazil. 6.3 Trade Secrets In Brazil, life sciences and pharma cases fall under the data package discussion on the grounds of unfair competition practices. According to Article 195, XIV of the Brazilian Industrial Property Act, a crime of unfair com - petition is perpetrated by anyone who divulges, exploits or utilises, without authorisation, results of tests or other undisclosed data, the prepara - tion of which involved considerable effort and was submitted to government agencies as a condition for obtaining approval to commercial - ise products.

After the trial court decision is published, the parties that do not agree with it can file a motion for clarification within five days in order to chal - lenge omissions, contradictions, obscurities and oversights. From the motion for clarifica - tion decision, the parties will have 15 days to file an interlocutory appeal and it is possible to claim an injunction to suspend the preliminary injunction decision. The interlocutory appeal will be addressed to a rapporteur judge who will analyse the injunction claim and serve the counterparty to respond to the appeal within 15 days. Generally, it will take a couple of months to have the judgment session, which is not a hearing, but the attorneys will be able to present oral arguments before the panel as a preliminary injunction discussion allows such oral debates. It is possible to re-analyse the trial court decision and for the matter to be considered de novo. Once the panel has issued the vote, the decision will be published and the parties can file motions for clarification within five days of the publica - tion and/or file special appeals to the Superior Court of Justice questioning the applicability of the federal law. If constitutional matters are involved, it is possible to offer an extraordinary appeal to the Supreme Court. However, this is unusual for patent matters. First Instance Main Action Decision for Infringement and Nullity Actions The timing to file an appeal against a first instance main action decision is 15 days from date of publication onwards. It is also possible to question the decision by filing a motion for clari - fication. The timing in a main action appeal judg - ment session will depend on the court’s back - log, but it can take one to two years for a final

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