Submission of Comment to US Trade Representative on the Section 301 Investigation of Acts, Policies, and Practices of Brazil Related to Intellectual Property Protection

Comment filed and attachment available at: https://comments.ustr.gov/s/commentdetails?rid=8VX64YG6Q8

18 August 2025

We, professors of intellectual property law based in the United States, United Kingdom and Brazil, hereby submit our response to the USTR’s request for comments on the initiation of its Section 301 investigation.

Specifically we address the following issue on which comments have been invited:

“Intellectual Property Protection
• The acts, policies, and practices of Brazil that deny adequate and effective protection and enforcement of intellectual property rights.”

We submit that Brazil provides adequate and effective protection and enforcement of intellectual property rights within its rights and obligations as detailed in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

We would like to remind the US Trade Representative (USTR) of Article 1.1 of TRIPS, which states that countries “shall not be obliged to implement in their law more extensive protection than is required by this Agreement”. As such, there is no legal obligation for Brazil to exceed the implementation and protection of TRIPS provisions. Accordingly, Brazil is also under no legal obligation to implement TRIPS-plus policies, such as data exclusivity or patent term extensions. Any USTR requests for the implementation and protection of TRIPS-plus policies represent extra-legal interferences with no basis in Brazil’s existing legal obligations.

Intellectual property rights and data exclusivity provisions are artificial regulatory barriers, which can create oligopolistic markets and hinder competition. They have real life consequences, especially on peoples’ access to medicines. There is much evidence indicating likely harms of TRIPS-plus policies by hindering access to medicines. TRIPS-plus policies impede competition in both developing and industrialized nations by delaying market entrance of generic medicines and leading to wasteful duplication of research, investment, and labor.

Rather than Brazil not fulfilling its TRIPS obligations, we submit that it has refrained from fully exercising the discretion it is legally entitled to under TRIPS. Member states have the legal right to use, to the full, flexibilities to implement measures to protect public health under TRIPS and the 2001 Doha Declaration on TRIPS and Public Health, which the United States itself agreed to in full. Brazil did not implement many such flexibilities, such as compulsory licensing, even in times of a global crisis, as in the early days of the COVID-19 pandemic.

Regarding the issue of patent pendency, TRIPS provides member states with flexibility in the way its provisions will be implemented. Brazil has traditionally had a high standard of patent examination, which is necessary to maintain high quality patent grants and avoid anti-competitive abuse of the patent system. We are aware that Brazil has put new procedures in place to streamline and expedite patent prosecution. Our hope is that the quality of its examination will be maintained with this reform.

In passing, we note that in June 2025, Brazil ratified the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. This is likely to enhance legal certainty and international cooperation in the field of biotechnological inventions.

Thank you for your consideration.

Yours sincerely,

Dr Hyo Yoon Kang
Associate Professor/Reader in Law, Warwick Law School, University of Warwick, United Kingdom

Dr Graham Dutfield
Professor of International Governance, University of Leeds, United Kingdom

Dr Vitor Henrique Pinto Ido
Professor of Commercial Law, University of São Paulo, Brazil

Amy Kapczynski
John Thomas Smith Professor of Law, Yale Law School, New Haven, CT, USA

Dr Luke McDonagh
Associate Professor, LSE Law School, London School of Economics, United Kingdom

Dr Christopher J Morten
Associate Professor of Law, New York University School of Law, New York, NY, USA