BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Isabella Bonisolo and Juliana Castelo Branco, Licks Attorneys
In May 2021, the STF declared that the sole par - agraph of Article 40 of the BPS was unconstitu - tional (ADI # 5,529). Previously, the law assured patent protection of up to 20 years from the filing date, with at least ten years of protection after the granting, due to a possible backlog at the BPTO. From 12 May 2021 onwards, all patents granted, no matter the BPTO delay, are valid for 20 years from the date of the deposit. In addi - tion, the decision immediately determined that certain granted patents would lose the ten-year period of protection after the granting, namely: (i) patents under discussion in invalidity lawsuits filed up to 7 April 2021; and (ii) patents related to pharmaceutical treatments and products. Until the end of 2024, it was possible to identify 64 PTA-like lawsuits: • Among these cases, 26 had requests for preliminary injunctions (PIs) – four PIs were granted and three are still in force (in one, the PI was granted at trial court level but was revoked in an appeal filed by the Brazilian National Health Surveillance Agency ( Agência Nacional de Vigilância Sanitária , or Anvisa) after the original term of protection reinstated by the PI expired) and 22 PIs were denied. • So far, 21 cases have been decided on the merits at trial level, all of which received unfavourable decisions rejecting the PTA-like claims. The plaintiffs filed appeals against 18 of these decisions. The Federal Court of Appeals for the First Circuit (TRF-1) has decided two appeals on the merits and upheld the trial-level decisions. Both appel - late decisions were challenged, and the appeals are pending before the superior courts. • Several constitutional complaints on the ADI # 5,529, filed by the BPTO and/or life scienc - es and pharma companies, pending before
the STF, discussed the PIs granted by the federal courts, all of them deciding against granting compensation in patent terms due to delays in the BPTO’s examinations. • On this same matter, with Bill # 2,056/22, Congress proposes to amend Law # 5,648/1970 (which established the BPTO) to foster better management and governance practices at the BPTO, and to amend the BPS to: (a) allow divisional applications after the decision that granted the patent applica - tion and, in case of rejection, until the final decision (including the appeal phase); (b) allow claim modifications until the end of the examination phase; (c) declare that the end of the examination phase includes the appeal phase; and (d) establish a PTA mechanism for BPTO delays. São Paulo Court of Appeals Sets Precedent for Technical Examination in Pharma Patent Case In an infringement lawsuit (Case # 1002787- 10.2022.8.26.0100) a decision on the merits in 2023 focused on certain invalidity aspects of the patent raised by the defendant (with no court ratification in the appropriate proceed - ing) and ignored infringement issues, without any technical examination. In June 2024, the First Reserved Chamber of Business Law of the São Paulo State Court of Appeals voided the trial decision, reasoning that the synthesis of a chemical component within the human body involves significant complexity, which requires technical examination, with a knowledge of bio - chemistry or organic chemistry, to determine whether there is illicit activity. The decision established a significant prec - edent for pharma patent owners, ensuring the
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