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

1.17 Patent Amendment It is possible for a patent to be declared partially invalid with respect to a specific claim, during litigation. When this happens, the trial court decision should also be considered part of the letter patent, as the BPTO will not issue a new letter patent and there are no provisions binding the BPTO to do so. As to actions that challenge the rejection of pat - ent applications, seeking for them to be granted in the judicial sphere, recent Brazilian case law has admitted the amendment of a set of claims as long as this is to restrict and limit it, according to Article 32 of the Brazilian Industrial Property Act. 1.18 Court Arbiter Regarding infringement actions, the São Paulo and Rio de Janeiro state courts are the main courts when it comes to IP matters, as both have specialised judges. However, in order to file this type of action in one of them, the plaintiff must demonstrate that it has its headquarters in one of these cities, or that the infringement practice has occurred in one of these jurisdictions, since this is a prerequisite set forth by Article 53, V of the Brazilian Code of Civil Procedure. Regarding nullity actions, Article 57 of the Brazilian Indus - trial Property Act requires these to be filed in a federal court – and the Rio de Janeiro court is the major one with specialised judges in IP mat - ters, since the BPTO headquarters are located in the city.

proof must first be attested in the defence brief, and can be corroborated by a technical assistant hired by the party, or by a specific employee of the defendant’s company. Once the defendant provides the court with the necessary proof, the unbiased expert appointed by the court will be responsible for analysing, during the technical evidence phase, the patented method versus the method allegedly used by the defendant. Where necessary, the expert may reproduce, through an experiment in a laboratory, the alleged meth - od used by the counterparty, in order to attest not only to the potential differences between the methods, but also, whether the defendant’s method is really effective. 1.14 Discovery/Disclosure See 1.7 Pre-Action Discovery/Disclosure . 1.15 Defences and Exceptions to Patent Infringement Prosecution history estoppel, references from the state of the art, and Bolar exemption, and most recently invalidity arguments (see 1.4 Structure of Main Proceedings on Infringe- ment/Validity ) are common defence strategies used by defendants accused of equivalence infringement or literal infringement. The disclo - sure-dedication doctrine can also be used as defence to the doctrine of equivalents, although the Brazilian system has not adopted such des - ignations directly in the Brazilian Industrial Prop - erty Act. 1.16 Stays and Relevance of Parallel Proceedings See “Staying of the Infringement Proceeding” in 1.4 Structure of Main Proceedings on Infringe- ment/Validity .

2. Generic Market Entry 2.1 Infringing Acts

The Brazilian IP Law confers the right to pre - vent third parties that do not have consent from

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