Brazil Weighs Patent Term Adjustment Legislation as Pharmaceutical Innovation Faces Uncertainty
核心洞察
Nearly 100 lawsuits have been filed since Brazil's Supreme Court struck down automatic patent term extensions in May 2021, with most appellate decisions ruling against patent holders.
Two bills in Brazil's Chamber of Deputies propose Patent Term Adjustment mechanisms to compensate for INPI (搜索) examination delays, though no votes have been scheduled.
A UFRJ study commissioned by FarmaBrasil (搜索) estimates that extending pharmaceutical patent terms could cost Brazil's public health system up to R$1.1 billion and consumers R$7.6 billion.
Brazil's pharmaceutical patent landscape is approaching a critical juncture as lawmakers consider new legislation that would introduce Patent Term Adjustment (PTA) mechanisms, five years after the Federal Supreme Court (STF) eliminated the country's previous safeguard against excessive examination delays.
The STF's May 2021 ruling in Constitutional Challenge No. 5529 (ADI 5529) declared unconstitutional the sole paragraph of Article 40 of the Brazilian Patent Statute, which had guaranteed a minimum 10-year patent term from grant date when INPI (搜索) examination exceeded a decade. The justices based their decision solely on the Industrial Property Law (No. 9279 of 1996), establishing that patents must be granted for a term of 20 years counted from the filing date. The decision was applied retroactively to pharmaceutical patents, leading the Brazilian patent and trademark office to reduce protection terms on 3,341 patents.
Since that ruling, nearly 100 lawsuits have been filed by patent holders seeking term adjustments based on broader legal principles including state liability, reasonable duration of administrative proceedings, and the duty of administrative efficiency. According to specialists, practically all appellate-level and higher-court decisions have been unfavorable to patent holders.
"The current lawsuits do not seek to relitigate what was decided by the STF. What is being sought now is a case-by-case analysis. They argue that there is a need for compensation for INPI (搜索)'s delay," said Thiago Ruschi of Bhering Advogados, noting that while the court rejected one line of argument, this alternative approach still lacks a settled understanding.
Legislative Proposals Under Consideration
In the Chamber of Deputies, two primary proposals have emerged: Bill 5810 of 2025 and Supplementary Bill 32 of 2026. Both would create a Patent Term Adjustment mechanism, though neither has been scheduled for a vote. Lawmakers entered recess on July 18 and are expected to focus on October elections before returning to legislative business.
Bill 5810 of 2025, authored by lawmakers Capitão Alberto Neto (PL-AM), Dr. Zacharias Calil (União Brasil-GO), and Mersinho Lucena (PP-PB), provides for a 20-year term for invention patents and 15 years for utility models from the filing date, but establishes that in the event of delay, an adjustment "will never exceed a term of five years and will always be established in proportion to the delay in the patent-approval process."
The bill's authors argue that the absence of a legal instrument to compensate for INPI (搜索) delays compromises "legal certainty, predictability, and the investment environment for Research and Development (R&D), abruptly reducing the effective period of exclusivity below the internationally adopted 20-year standard." The proposal is currently before the Committee on Industry, Commerce, and Services, where rapporteur Congresswoman Adriana Ventura (NOVO-SP) has not yet presented an opinion.
Supplementary Bill 32 of 2026 establishes a proportional mechanism to adjust patent terms when delays are caused exclusively by the public administration. Rapporteur Congressman Beto Richa (PSDB-PR) has already presented his opinion, though no vote has been scheduled.
Economic Stakes and Industry Divide
A study by the Institute of Economics at the Federal University of Rio de Janeiro (UFRJ), commissioned by FarmaBrasil (搜索), indicates that extending pharmaceutical patent terms could generate additional costs of up to R$1.1 billion for the Unified Healthcare System (SUS), plus R$7.6 billion for consumers.
Renato Porto, president of the Brazilian Association of the Research-Based Pharmaceutical Industry (Interfarma (搜索)), which represents foreign companies, emphasized that the debate concerns compensation for administrative delays rather than patent extension per se. "No company puts a product on the market without having the patent granted. That is the standard," Porto said, adding that Interfarma's primary objective is for INPI (搜索) to review applications within a reasonable period.
"We are clear that the bills do not run counter to the STF decision. Justice Dias Toffoli's vote says the problem is that [renewal] was automatic and that the extra term was fixed at 10 years," Porto stated.
The domestic generics and biosimilars industry, however, opposes the initiatives. Grupo FarmaBrasil (搜索), the Brazilian Association of Fine Chemicals, Biotechnology, and Specialty Industries (Abifina (搜索)), and the Association of National Pharmaceutical Laboratories (Analac (搜索)) have all expressed support for maintaining the STF's understanding, arguing that strengthening the intellectual property system should occur through investments in modernizing INPI (搜索) and improving its efficiency.
Guilherme Takeishi, FarmaBrasil (搜索)'s lawyer and a partner at Reis, Souza, Takeishi e Arsuffi Advogados, warned that possible approval of bills creating patent extension mechanisms "would send a worrying signal of legal uncertainty."
Judicial Precedent and Examination Timelines
Court decisions have favored maintaining regular patent terms without extensions. A notable case from the Superior Court of Justice (STJ) involved semaglutide, the active ingredient in Ozempic, where the patent was not extended and the first generic version has already been approved by health regulator Anvisa.
Aline Ferreira, a partner at Souto Correa Advogados, noted that according to INPI (搜索) data, the average time to grant biopharmaceutical patents is the longest at 6.4 years, while the fastest category—polymers and related products—averages 3.5 years. "The bills take into account what exists in other countries for extensions. They are one possible response to the boom in lawsuits. Another is the end of task forces. The delay leads industries to seek some way to press for faster approvals," Ferreira said.
A separate legislative proposal, Bill 3676/2026, moves in the opposite direction by proposing a reduction in protection terms specifically for pharmaceutical patents. This proposal has raised concerns under Article 33 of the TRIPS Agreement, which provides that patent protection "shall not end before the expiration of a period of twenty years counted from the filing date."
The debate ultimately centers on an unresolved question: who should bear the cost of excessive administrative delays—the state or the innovators who have no control over them. Five years after ADI 5529, Brazil's National Congress has yet to adopt a mechanism capable of restoring confidence in the country's innovation ecosystem.