BRAZIL Law and Practice Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys
To ensure compliance, ANVISA has established an examination procedure to approve commercial names for regulated products. This procedure is regulated by a few internal rules, the most important of these being Collegiate Directorate Ordinance (RDC) #59/14, further clarified by Service Ordinance (OS) #43/17. The steps carried out by ANVISA in this examination involve checking many criteria, with the overall goal of preventing consumer error. 6.2 Copyright Copyright disputes are rare in the life sciences indus ‑ try in Brazil, and they are often presented in conjunc ‑ tion with unfair competition claims. 6.3 Trade Secrets Usually, trade secrets in the life sciences industry are handled by Brazilian law through one of two path ‑ ways: (i) rules against unfair competition or (ii) RDP rules. In the first case, the violation of a trade secret must fall within one of the 14 hypotheses established in Article 195 of the BPS. The most common grounds raised in such cases are: • using fraudulent means to garner another’s clien ‑ tele (Article 195, III); or • disclosing, exploiting or using, without authorisa ‑ tion, any knowledge that was attained through employment or a contractual relationship (Article 195, XI) or through fraud or other illegal means (Article XII). See 2.2 Regulatory Data and Market Exclusivity for a more thorough analysis of the role of RDP in protect ‑ ing trade secrets.
Federal District), while invalidity lawsuits are directed to a federal court of appeals (which is divided into six circuits). A final decision on the merits may be appealed with ‑ in 15 business days from publication. Timelines for judging this appeal may vary by case and court. A very quick decision may be rendered in three months from appeal; but slower cases may take as long as 11 months or more. Generally, appeals are heard by a panel of three judg ‑ es. If the court is split, an expanded judgment is called for. In this scenario, new appellate judges are called on to hear the appeal and aid in reaching a definitive result. Furthermore, no new issues of law or fact may be presented on appeal if they were not presented in the earlier trial (except if the issue is new or could not have been previously known). Interlocutory Appeals Interlocutory appeals are also allowed against deci ‑ sions rendered during trial (eg, when a preliminary injunction is granted or rejected). These interlocu ‑ tory appeals may be lodged within the same 15-day timeframe. Timelines for interlocutory appeals also vary widely. A quick decision may come within three months, while a slower ruling can take six months or more. If there is urgency, an appellant may request a stay of the appealed decision while the parties await the decision of the appellate court. If an interlocutory appeal is filed against a decision granting/rejecting a preliminary injunction, an appel ‑ lant must demonstrate that the statutory criteria are met (see 1.3 Preliminary Injunction Proceedings ). If a patent is revoked by a decision that is effective immediately, the grounds for injunction are removed. Nevertheless, it is good practice to inform the court of the revocation and arrange a meeting with the judge to confirm that the injunction is no longer in place. 7.2 Appeal Court(s) Arbiter As discussed in 7.1 Timeframe to Appeal Decision , the panel of appellate judges that will hear a given case may vary according to the nature of the dispute (ie, infringement or invalidity) and the territorial juris ‑ diction.
7. Appeal 7.1 Timeframe to Appeal Decision
A final decision on the merits issued by a trial court is always appealable. However, further appeals to the superior courts are not automatically admitted and are subject to strict criteria for evaluating appealabil ‑ ity. Appeals in infringement lawsuits are assessed by a state court of appeals (one for each state and the
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