BRAZIL Law and Practice Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys
den of proving their claims, and the defendant bears the burden of proving their defences. Nevertheless, under certain conditions, judges may shift the burden of proof onto the defendant. For example, when a patent covers a process, the BPS (Article 42, Section 2) dictates that it is the burden of the defendant to prove that their process differs from the one protected by the patent. Moreover, under the CPC (Article 373, Section 1), the burden of proof may be shifted onto the defendant if the judge finds that it would be impossible or unduly difficult for the claimant to produce this evidence. A judge may also shift the burden of proof if he or she deems that it would be easier for the evidence to be produced by the defend ‑ ant than the plaintiff. 1.15 Defences and Exceptions to Patent Infringement Article 43 of the BPS provides a set of seven excep ‑ tions that serve as affirmative defences to patent infringement. These exceptions cover: • private and non-commercial uses that are not harmful to the legitimate interests of the patentee; • experimental uses for technological/scientific research; • preparing medication according to medical pre ‑ scriptions for individual cases; • products placed in the internal market directly by the patentee or with their authorisation (ie, exhaus ‑ tion); • third parties that, in the case of patents related to living matter, use the patented product as the initial source of variation or propagation for obtaining other products, without economic ends; • third parties that, in the case of patents related to living matter, use, place in circulation or commer ‑ cialise a patented product that has been intro ‑ duced lawfully onto the market by the patentee or authorised parties, provided that the patented product is not used for commercial multiplication or propagation of the living matter; and • acts practised by unauthorised third parties relating to the patented invention carried out exclusively to produce information, data and test results to seek market approval in Brazil or abroad, in order to
exploit or commercialise the patented product after expiry of the patent term (ie, Bolar exception). The law also provides a few other exceptions to pat ‑ ent protection, such as the prior use exception (Article 45 of the BPS) and the opportunity to claim patent invalidity as a means of defence (Article 56, Section 1º of the BPS). Compulsory licences are also available (per Article 68 et seq of the BPS) if statutorily set criteria are met (eg, if the patentee engages in patent misuse, or if the commercialisation is not sufficient to meet mar ‑ ket needs) and after a specific process is started at the discretionary authority of the chief of the Execu ‑ tive Branch. Nevertheless, the award of compulsory licences is exceedingly rare and may be dismissed if the patentee provides one of the following three jus ‑ tifications: • lack of use occurs for legitimate reasons; • there are serious and effective efforts in place to prepare for commercialisation; or • lack of manufacture/commercialisation is due to a legal impediment. 1.16 Stays and Relevance of Parallel Proceedings State court judges have discretion on whether to stay infringement proceedings when parallel patent nullity proceedings are initiated before federal courts. Recent rulings by the Superior Court of Justice seem to favour the stay of infringement discussions while nul ‑ lity proceedings are underway (unless the finding for infringement has already been issued when the stay is requested – per Motion for Clarification on Appeal #1,558,149/SP), but this guidance is not binding on lower courts. Therefore, state judges’ discretion on the issue is still wide. Nevertheless, there is no stay if the invalidity proceed ‑ ings are underway in foreign courts referring to foreign counterparts of national patents. According to Article 24 of the CPC, foreign lawsuits do not constitute lis pendens unless a treaty demands local cases to be halted while foreign proceedings are ongoing.
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