President Donald Trump has a new opportunity to secure intellectual property victories in the upcoming U.S.-Mexico-Canada Agreement (USMCA) review process, following a shift in Congress. During his first term, as under secretary of Commerce for Intellectual Property and director of the U.S. Patent and Trademark Office, the author played a key role in shaping the intellectual property aspects of the trade pact that replaced the North American Free Trade Agreement (NAFTA). The agreement initially included provisions to strengthen protections for American biotech companies, including a requirement for Mexico and Canada to provide 10 years of ‘regulatory data protection’ for biologic medicines. However, this key provision was excluded from the final agreement at the last minute due to pressure from then-House Speaker Nancy Pelosi, despite the original draft text having included it.
Regulatory data protection is designed to prevent foreign competitors from using the clinical trial data of biologic medicine developers to create knockoff products, which can take years of research and often billions of dollars to develop. This measure gives innovators a better chance to recoup their investments, incentivizing further research and development, and creating jobs in the process. The United States already provides 12 years of data protection for biologics, and the USMCA would have brought Canada and Mexico closer to that standard. However, the final agreement left this critical provision out, which many argue undermines the potential for lower drug prices in the U.S.
Nancy Pelosi’s influence on the final agreement has drawn criticism, with some arguing that her opposition to the provision contributed to its exclusion. The Trump administration, now with a new Congress, is seen as having a greater opportunity to push for the original terms during the upcoming USMCA review. This review is expected to give the administration a chance to hold Mexico and Canada accountable for their commitments under the trade pact. Mexico, in particular, has been placed on the Special 301 Priority Watch List for failing to meet its intellectual property enforcement commitments, including weak patent-enforcement systems and rampant trademark counterfeiting and copyright piracy.
Strengthening these protections is expected to have a significant impact on U.S. innovation and competitiveness. It could lead to more new treatments for patients, more high-paying jobs in the industries of the future, and continued leadership in critical 21st-century industries. The Trump administration is likely to focus on these goals during the review, emphasizing the importance of protecting American innovators and ensuring that U.S. companies can compete effectively in a global market.