巴西药品专利期限延长争议升温，中资药企需关注成本传导

Guilherme Takeishi Divulgação Foreign pharmaceutical companies are acting on two fronts to extend the patent terms of medicines. In addition to intensifying litigation, they have begun betting on a push in Brazil’s Congress to approve legislative proposals that would create a mechanism to compensate for delays by the National Institute of Industrial Property (INPI) in reviewing applications. Nearly 100 lawsuits have been filed since the Federal Supreme Court (STF) settled the issue in May 2021 in a decision unfavorable to foreign companies. In their requests, they argue that patent terms should be adjusted and extended based on certain mechanisms that exist abroad and were cited in votes at the STF, but did not form the basis of the decision. The justices’ understanding was based solely on the Industrial Property Law (No. 9279 of 1996). They declared unconstitutional a provision of the law that established a minimum term of 10 years in cases of INPI delays, counted from the date the registration was granted (ADI 5529). They also defined that patents must be granted for a term of 20 years, counted from the date the application is filed—which, in practice, reduces the period of protection. The lawsuits began to be filed in July 2021, according to specialists heard by Valor. Among those already judged, practically all appellate-level and higher-court decisions have been against extending patents. A study carried out by the Institute of Economics at the Federal University of Rio de Janeiro (UFRJ) after the STF decision, commissioned by FarmaBrasil, an entity that brings together 12 national laboratories, indicated that extending pharmaceutical patent terms in the country could generate additional costs of up to R$1.1 billion for the Unified Healthcare System (SUS), in addition to R$7.6 billion for consumers. The figure accounted for this new industry push in court. At the same time, in the Chamber of Deputies (Brazil’s Lower House), foreign companies are betting on two proposals: Bill 5810 of 2025 and Supplementary Bill 32 of 2026. Both create a mechanism called Patent Term Adjustment (PTA). No vote on the texts has been scheduled yet. Lawmakers go into recess on the 18th. After that, they will return to their home bases to focus on the elections. As a result, new votes will take place only after the first round of the October elections. Bill 5810 of 2025 provides for a 20-year term for invention patents and a 15-year term for utility models, counted from the filing date, but establishes that, in the event of a delay, there will be an adjustment that “will never exceed a term of five years and will always be established in proportion to the delay in the patent-approval process.” For the lawmakers who authored the proposal—Capitão Alberto Neto of the Liberal Party (PL) of Amazonas, Dr. Zacharias Calil of União Brasil of Goiás, and Mersinho Lucena of the Progressive Party (PP) of Paraíba—the absence of a legal instrument to compensate for INPI 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 bill is being processed in the Chamber’s Committee on Industry, Commerce, and Services. The rapporteur, Congresswoman Adriana Ventura of the New Party (NOVO) of São Paulo, has not yet presented an opinion. For now, there is no forecast for the text to be placed on the agenda. Supplementary Bill 32 of 2026 establishes a proportional mechanism to adjust the patent term when the delay is caused exclusively by the public administration. The broader text also prohibits the withholding of INPI expenses. The proposal is also being processed in the Committee on Industry, Commerce, and Services, but no vote has been scheduled. The rapporteur, Congressman Beto Richa of the Brazilian Social Democracy Party (PSDB) of Paraná, has already presented his opinion. Renato Porto, president of the Brazilian Association of the Research-Based Pharmaceutical Industry (Interfarma), which represents foreign companies, stresses that the debate is not about extending patents, but about compensating for the time the public administration takes to grant them. Porto explains that companies usually wait to bring a product into the country until the patent is granted, which, in practice, due to delays, results in a validity period shorter than the 20 years provided by law. “No company puts a product on the market without having the patent granted. That is the standard,” he says. Interfarma’s main objective is for INPI to review applications within a reasonable period, according to Porto. The bills, he adds, are intended to ensure that a delay considered inappropriate or excessive justifies compensation in the patent term. “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,” he said. The domestic generics and biosimilars industry, however, opposes the initiatives in Congress. Grupo FarmaBrasil argues that strengthening the intellectual property system should occur through investments in modernizing INPI and improving its efficiency. The Brazilian Association of Fine Chemicals, Biotechnology, and Specialty Industries (Abifina) and the Association of National Pharmaceutical Laboratories (Analac) have also expressed the same position in favor of maintaining the STF’s understanding. According to Guilherme Takeishi, FarmaBrasil’s lawyer and a partner at Reis, Souza, Takeishi e Arsuffi Advogados, there is an attempt to obtain in the Legislative Branch an outcome that Brazilian courts have already rejected. In his view, the possible approval of bills that would create mechanisms to extend patents would send a worrying signal of legal uncertainty. Court decisions, he adds, have favored maintaining the regular patent term, without extensions. One of them came from the Superior Court of Justice (STJ), in a case involving semaglutide, the active ingredient in Ozempic. The patent was not extended, and the first generic medicine with this active ingredient has already been approved by Brazil’s health regulator Anvisa. Aline Ferreira, a partner at Souto Correa Advogados, notes that patents are granted on time when INPI conducts task forces for approvals, but that under the normal pace, the interval begins to increase again. She recalls that, according to INPI’s own information, the average time to grant biopharmaceutical patents is the longest at 6.4 years. The fastest, for polymers and related products, is 3.5 years. The bills take into account what exists in other countries for extensions, the lawyer says. “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.” According to Thiago Ruschi, of Bhering Advogados, the first wave of lawsuits, before the STF decision, had structural grounds, based on the need for mechanisms to protect patent holders in Brazil that were compatible with the investments made, and the court rejected them. “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’s delay,” he says. “The court rejected one line of argument, but this other one still does not have a settled understanding,” he adds, stressing that there is a precedent accepting this argument. He considers it important that there be some compensation for a delay not caused by the patent holder. Jéssica Sant’Ana contributed reporting. Translation: Todd Harkin