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Dorchester Center, MA 02124

President Donald Trump stands on the verge of a significant political and economic triumph that eluded him during his first term. The upcoming joint review of the U.S.-Mexico-Canada Agreement presents a crucial opportunity. This trade deal, which replaced the North American Free Trade Agreement, is set to undergo discussions that could reshape future economic relations between the three nations.
During my tenure as the under secretary of Commerce for Intellectual Property and director of the U.S. Patent and Trademark Office in the Trump administration, I had the privilege of contributing to the intellectual property aspects of this vital agreement. Alongside the president and U.S. Trade Representative Bob Lighthizer, we successfully secured essential concessions from Canada and Mexico aimed at strengthening intellectual property protections.
Intellectual property protections play a pivotal role in maintaining the competitive edge of American businesses. These measures help prevent foreign competitors from unfairly capitalizing on the innovations developed by American companies. The benefits of robust IP protections extend beyond merely safeguarding technologies and designs; they also encourage American firms to allocate more resources towards research and expansion into international markets.
Regrettably, one of the critical concessions — a ten-year requirement for Mexico and Canada to provide regulatory data protection for innovative biologic medicines — was omitted from the final version of the agreement at a critical moment. This provision is vital as it prevents rival companies from utilizing the clinical trial data of a biologic developer to develop their own generic products. The innovation of a new biologic medicine demands vast resources and can take years of research.
Regulatory data protection is necessary for innovators to recoup their significant investments and attracts them to invest further in research and development. Such investments lead to job creation, especially within research and manufacturing sectors.
The United States currently offers twelve years of regulatory data protection for biologics. The original draft of the USMCA aimed to elevate Canada and Mexico’s standards to match those of the United States, thereby creating a fairer competitive environment.
The objective was straightforward: enhance protections abroad to ensure that foreign manufacturers do not exploit American biotech innovators by introducing generic products prematurely. Such measures would allow American inventors to recover their investments more effectively, potentially leading to reduced drug prices domestically.
Ultimately, this highly beneficial provision was removed from the agreement primarily due to pressures from then-House Speaker Nancy Pelosi. Her support was deemed crucial to pass the USMCA’s implementing legislation through the House of Representatives.
Looking ahead, the new Congress presents an opportunity for the Trump administration to advocate for the original terms of the agreement. Both Canada and Mexico had previously consented to these terms. Strengthening regulatory data protections in these countries would curtail the freeloading and ultimately help bring down prescription prices for American consumers.
The upcoming joint review also enables the administration to hold Canada and Mexico accountable to their previously agreed commitments. Particularly concerning is Mexico’s placement on the Special 301 Priority Watch List for its ongoing intellectual property violations. This list includes countries that chronically undermine American intellectual property rights.
Mexico has a troubling history of failing to enforce patent protections, adhere to patent-term restoration standards and adequately address copyright infringement. Furthermore, trademark counterfeiting and copyright piracy have proliferated. These issues have substantially weakened the protections American creators were supposed to benefit from through the trade agreement.
Enhancing intellectual property protections within the USMCA could yield profound benefits for American consumers and innovators alike. Stronger protections would pave the way for more new treatments at lower costs for American patients. Additionally, these changes would support the growth of high-paying jobs in industries poised for future innovation.
Ultimately, reinstating and strengthening these protections remains crucial for the United States to maintain its leadership in the rapidly evolving landscape of 21st-century industries.
The forthcoming review of the USMCA is not just a routine administrative process; it is a defining moment for the Trump administration and its commitment to revitalizing American innovation and competitiveness. By pushing for stronger regulatory data protections and ensuring compliance from our trading partners, the administration can lay the groundwork for a more equitable and successful economic future.
In summary, through diligent negotiation and commitment to strengthening trade agreements, the Trump administration has a unique opportunity. By taking decisive action now to foster innovations, protect intellectual property, and enhance economic ties with neighbors, we can secure a prosperous future for American businesses and consumers.