<div dir="ltr"><table border="0" cellpadding="0" cellspacing="0" width="100%" role="presentation" style="border-collapse:collapse"><tbody><tr><td valign="top" id="m_-7519615131838464393gutterContainerId-6" style="word-break:break-word;padding:0px"><table border="0" cellpadding="0" cellspacing="0" width="100%" role="presentation"><tbody><tr><td valign="top" id="m_-7519615131838464393b6" style="word-break:break-word;padding:0px;border:0px;border-radius:0px"><table width="100%" style="border:0px;border-radius:0px"><tbody><tr><td class="m_-7519615131838464393mceTextBlockContainer" style="word-break:break-word;padding:12px 24px"><div class="m_-7519615131838464393mceText" id="m_-7519615131838464393d6" style="font-family:"Helvetica Neue",Helvetica,Arial,Verdana,sans-serif;color:rgb(0,0,0);width:608px"><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;letter-spacing:0px;direction:ltr"><em><strong><span style="font-size:20px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">SouthNews No. 535, 17 September 2025</span></span></strong></em></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:center;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:center;letter-spacing:0px;direction:ltr"><strong><span style="font-size:25px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Brazil’s Right to Balance IP and Public Health</span></span></strong></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:center;letter-spacing:0px;direction:ltr"><em><span style="font-size:23px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Submission to USTR defends Brazil’s lawful use of TRIPS flexibilities</span></span></em></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:center;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;letter-spacing:0px;direction:ltr"><strong><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">By Nirmalya Syam</span></strong></p></div></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td valign="top" id="m_-7519615131838464393gutterContainerId-31" style="word-break:break-word;padding:0px"><table border="0" cellpadding="0" cellspacing="0" width="100%" role="presentation"><tbody><tr><td valign="top" id="m_-7519615131838464393b31" style="word-break:break-word;padding:0px;border:0px;border-radius:0px"><table width="100%" style="border:0px;border-radius:0px"><tbody><tr><td class="m_-7519615131838464393mceTextBlockContainer" style="word-break:break-word;padding:12px 24px"><div class="m_-7519615131838464393mceText" id="m_-7519615131838464393d31" style="font-family:"Helvetica Neue",Helvetica,Arial,Verdana,sans-serif;color:rgb(0,0,0);width:608px"><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">In response to the United States Trade Representative's (USTR)<span class="gmail-Apple-converted-space"> </span></span></span><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=d0f4f35622&e=4b8d039b1d" target="_blank" style="color:rgb(255,171,1);word-break:break-word;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Section 301 investigation into Brazil's intellectual property (IP) policies</span></span></a><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">, Prof. Carlos Correa, Executive Director of the South Centre, submitted written comments defending Brazil's IP framework and its use of public health safeguards.<span class="gmail-Apple-converted-space"> </span></span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">The submission affirms that Brazil’s IP regime is fully consistent with its international obligations — and that its approach to public health and innovation reflects a legitimate, lawful policy balance under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">The USTR alleges that Brazil fails to provide “adequate and effective” protection of IP rights. However, Brazil has implemented a patent framework that meets — and in some respects exceeds — its obligations under the World Trade Organization’s (WTO) TRIPS Agreement. This includes provisions such as pipeline patent revalidation and patent term extensions.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Brazil’s IP system also incorporates public health safeguards that TRIPS explicitly allows. These include compulsory licensing, rigorous patent examination to avoid unjustified monopolies, and the use of legal exceptions like the Bolar and experimental use clauses. The submission emphasizes that Brazil’s exercise of these flexibilities is both legally sound and rooted in its constitutional duty to ensure access to healthcare.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Brazil’s universal public health system (SUS) has played a vital role in responding to major public health challenges such as HIV/AIDS and hepatitis C. Measures to ensure access to affordable medicines — including price negotiations and, in one case, a compulsory license — have helped fulfill that mandate while remaining firmly within the legal space TRIPS provides.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Importantly, Prof. Correa notes that there is no evidence of systemic bias or discrimination against patent holders in Brazil. Judicial and administrative mechanisms remain fully available for enforcement of IP rights, and Brazil’s legal system has ruled against certain TRIPS-plus provisions in favour of constitutional protections.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">What is concerning, however, is the use of Section 301 — a unilateral trade tool — to pressure countries into adopting standards beyond their WTO obligations. As we note in the comments, this practice risks undermining the credibility of the multilateral trading system and the balance that TRIPS was designed to achieve. A WTO panel has previously cautioned that even the threat of such action can disrupt the equal footing that WTO rules are meant to provide.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Hence, it is critical to stress that Brazil is operating within the bounds of international law. It is using the policy space allowed under TRIPS to pursue its health and development objectives. These actions are not trade violations — they are lawful, necessary, and aligned with the Doha Declaration on Public Health and the TRIPS Agreement.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">The USTR should reconsider its approach and recognize that development-oriented IP policies, especially those supporting public health, are not only legitimate — they are vital. All WTO members, including Brazil, should be able to exercise their rights under TRIPS without facing undue pressure or unilateral sanctions.</span></span></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><br></p><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><em><strong><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">Author: Nirmalya Syam is Senior Programme Officer of the Health, Intellectual Property and Biodiversity Programme (HIPB) at the South Centre.<span class="gmail-Apple-converted-space"> </span></span></span></strong></em></p></div></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td valign="top" id="m_-7519615131838464393b8" style="word-break:break-word;padding:20px 24px;border:0px;border-radius:0px"><table align="center" border="0" cellpadding="0" cellspacing="0" width="100%" role="presentation" class="m_-7519615131838464393mceDividerContainer" style="border-collapse:collapse;width:612px"><tbody><tr><td valign="top" class="m_-7519615131838464393mceDividerBlock" style="word-break:break-word;min-width:100%;border-top-width:1px;border-top-style:solid;border-top-color:rgb(0,0,0);line-height:0;font-size:0px"> </td></tr></tbody></table></td></tr><tr><td valign="top" id="m_-7519615131838464393gutterContainerId-9" style="word-break:break-word;padding:0px"><table border="0" cellpadding="0" cellspacing="0" width="100%" role="presentation"><tbody><tr><td valign="top" id="m_-7519615131838464393b9" style="word-break:break-word;padding:0px;border:0px;border-radius:0px"><table width="100%" style="border:0px;border-radius:0px"><tbody><tr><td class="m_-7519615131838464393mceTextBlockContainer" style="word-break:break-word;padding:12px 24px"><div class="m_-7519615131838464393mceText" id="m_-7519615131838464393d9" style="font-family:"Helvetica Neue",Helvetica,Arial,Verdana,sans-serif;color:rgb(0,0,0);width:608px"><p style="margin:0px;padding:0px;word-break:break-word;font-size:16px;line-height:1.5;text-align:justify;letter-spacing:0px;direction:ltr"><strong><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">SouthNews is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.<br><br>To view other articles in SouthNews, please click </span></span></strong><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=986d3a3df3&e=4b8d039b1d" target="_blank" style="color:rgb(0,0,0);word-break:break-word;direction:ltr"><strong><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">here</span></span></strong></a><strong><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">.<br><br>For more information, please contact Anna Bernardo of the South Centre: Email </span></span></strong><a href="mailto:abernardo@southcentre.int" target="_blank" style="color:rgb(0,0,0);word-break:break-word;direction:ltr"><strong><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">abernardo@southcentre.int</span></span></strong></a><strong><span style="font-size:14px"><span style="font-family:Arial,"Helvetica Neue",Helvetica,sans-serif">.</span></span></strong></p></div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></div>