ABPI Advocates for Brazil’s Removal from the USTR Watch List

ABPI has been advocating for Brazil’s removal from the United States Trade Representative (USTR) “Watch List,” which includes countries that fail to provide adequate protection for Intellectual Property rights or that hinder fair and equitable access to the U.S. market. By late April, when the USTR publishes the 2025 Special 301 Report on “Identification of Countries under Section 182 of the Trade Act of 1974,” Brazil could be classified as a “Priority” country, placed on the “Priority Watch List” or “Watch List,” or, as ABPI argues, be excluded from the list entirely.

Brazil has been on the USTR’s list since 1999, but ABPI maintains that the country now values and respects Intellectual Property rights. “Brazil has had a highly effective legal system for ensuring the protection and enforcement of Intellectual Property rights for many years,” stated ABPI President Gabriel Leonardos, who signed the official letter addressed to the USTR.

In the document, ABPI highlights that Brazilian authorities, committed to protecting Intellectual Property owners and fostering a fair and innovative environment, have launched major anti-piracy initiatives. The letter also acknowledges the implementation of effective enforcement campaigns against online piracy, aligning with the objectives of the National Intellectual Property Strategy, established by the Ministry of Development, Industry, Commerce, and Services (MDIC), which aims to enhance security in Brazil’s Intellectual Property landscape.

The document further underscores that “The Brazilian Judiciary plays a crucial role in the protection and enforcement of Intellectual Property rights in Brazil. Its independence enables judges to take swift action to prevent IP infringements, thanks in part to a highly effective system of precautionary measures.” As for the Brazilian Patent and Trademark Office (BPTO), it “conducts independent examinations of patent applications and ensures legal certainty by regularly issuing and updating its examination guidelines, which are aligned with various international Patent Offices.” ABPI also points out that Brazil is a signatory to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, the Hague Agreement on the International Registration of Industrial Designs, and the Madrid Protocol on the International Registration of Trademarks.

However, despite significant progress, the document notes that there is still room for improvement in the system:

. Modernization of BPTO’s internal rules on application amendments: The BPTO needs to revise its internal regulations, which still unduly restrict applicants’ rights to make modifications during the process and to file divisional applications.

. Patent Term Adjustment (PTA): Brazil’s IP legislation needs modernization to include a provision allowing the BPTO to adjust the term of a patent if there is an unjustified delay in its granting process.

. Data Package Exclusivity (DPE): A critical gap remains in Brazil’s data protection framework: pharmaceutical products for human use lack explicit protection under federal law. While Federal Law No. 10,603/2022 protects data related to veterinary products, fertilizers, and agrochemicals, this creates an inconsistency, raising concerns about potential discriminatory treatment. Unlike the TRIPS Agreement (Article 39), Brazil continues to allow government authorities to grant marketing approval for pharmaceutical products to competitors based on test data submitted by innovators to prove the safety and efficacy of their products. Additional efforts are needed to ensure that test data and other related information are fully protected against unauthorized use, safeguarding marketing approval for a fixed period.

. BPTO’s backlog: Since 2018, the BPTO has implemented measures to accelerate patent examination, significantly reducing the backlog of pending applications. However, in the past four years, the number of substantive decisions issued by the BPTO—such as approvals and rejections—has steadily declined due to a shortage of examiners and a lack of investment in IT infrastructure at the institute. This is largely due to the diversion of official fees collected by the BPTO to fund unrelated federal government expenses.