BRAZIL Law and Practice Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys
2. Generic Market Entry 2.1 Infringing Acts
1.17 Patent Amendment After being granted, patents may not be voluntarily amended, but they may undergo amendments as a result of administrative or judicial nullity proceedings. When a court or a reviewing body of the BRPTO finds that a patent is partially valid, the decision will pro ‑ pose amendments restricting the scope of the patent in order to meet patentability requirements. 1.18 Court Arbiter While forum shopping is not allowed under Brazilian law, patent litigants have some leeway to direct their cases to specialised judges. In infringement proceedings, lawsuits must be direct ‑ ed to the place of the defendant’s domicile (per Article 46 of the CPC) or to the place where infringement occurred (per Article 53 of the CPC). If infringement is widespread throughout Brazil, some courts welcome plaintiffs’ choice in where to hold lawsuits. Regarding nullity disputes, lawsuits may be filed in the place of the plaintiff’s headquarters, but it is far more common to direct lawsuits to the federal courts of Rio de Janeiro or Brasília, where the BRPTO has standing offices and the courts are used to hearing complex IP cases. Sophisticated patent litigants tend to prefer the spe ‑ cialised state courts found in São Paulo or Rio de Janeiro for infringement litigation. Both jurisdictions have trial courts specialised in business law, with judges who are veterans in intellectual property mat ‑ ters. São Paulo also boasts two specialised appel ‑ late panels for business law that hear appeals in IP infringement cases. For nullity proceedings, patent litigants mostly choose Rio de Janeiro or Brasília’s federal courts. Both juris ‑ dictions have trial courts specialising in IP issues, with Brasília being a more recent venue in specialising. Rio de Janeiro also has two specialised appellate panels for IP nullity cases.
Articles 42, 183 and 184 of the BPS award paten ‑ tees the right to enjoin unauthorised third parties from engaging in many infringing acts, such as: • making; • using; • offering for sale; • selling;
• importing; • exporting; • maintaining stock; or • receiving for commercial purposes.
Some acts of infringement (eg, preparatory acts for attaining market authorisation) are exempt under Arti ‑ cle 43 of the BPS (see 1.15 Defences and Exceptions to Patent Infringement ). Nevertheless, market authorisations attained well before patent expiry may be targeted for enforcement, as the renewal of market authorisation requires actual commercialisation of the product. Other commercial acts – such as offers for tender/supplying patented products – constitute acts of infringement that may be enjoined by a patentee. The possibility of skinny labelling in Brazil is still uncertain. While the Brazilian Food and Drug Author ‑ ity (ANVISA) has authorised the practice, some court decisions have noted that skinny labelling does not excuse the practice of infringing acts. This discussion is ongoing in the Judiciary. 2.2 Regulatory Data and Market Exclusivity Regulatory Data Protection (RDP) is applicable in Bra ‑ zil under Article 39.3 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Moreover, Statute #10,603/02 institutes specific rules governing RDP under Brazilian law, albeit expressly excluding pharmaceutical products for human use (which means the enforcement and implementation thereof currently lack regulation in Brazil). Under Statute #10,603/02, RDP may be awarded to pharmaceutical products for veterinary use, agro ‑
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