President Donald Trump has a renewed opportunity to address the intellectual property (IP) shortcomings in the U.S.-Mexico-Canada Agreement (USMCA) during its upcoming review process. The agreement, which replaced the North American Free Trade Agreement (NAFTA), was nearly finalized with robust IP protections, but key provisions, such as the requirement for Mexico and Canada to offer 10 years of regulatory data protection for cutting-edge biologic medicines, were excluded at the eleventh hour due to political pressures. Now, the Trump administration could potentially revisit these terms during the review, aiming to ensure a level playing field and potentially lower drug prices in the U.S. as part of the ongoing evaluation of the trade pact’s effectiveness.
The IP provisions were a cornerstone of the original USMCA negotiations, with the Trump administration and U.S. Trade Representative Robert Lighthizer pushing for stronger protections to prevent foreign competitors from exploiting the innovations of American companies. Regulatory data protection for biologics, in particular, was critical because it prevents rival firms from using the clinical trial data of a biologic developer to create knockoff products. This provision was seen as a way to incentivize innovation, recoup investments, and ultimately lower drug prices in the U.S.
However, the provision was removed from the final agreement at the insistence of then-House Speaker Nancy Pelosi, whose support was essential for passing the USMCA’s implementing legislation through Congress. Despite this setback, the Trump administration is now positioned to push for the original terms during the upcoming review, which offers an opportunity to strengthen IP protections and address the shortcomings in Mexico and Canada. The administration has already placed Mexico on the Special 301 Priority Watch List due to its failure to uphold its IP commitments, highlighting the importance of securing these provisions for the benefit of U.S. innovators and patients.
The review process also presents an opportunity to hold Mexico accountable for its failure to implement the patent-enforcement systems and copyright protections it agreed to under the trade pact. Strengthening these protections could lead to more affordable treatments for American patients and more high-paying jobs in the future, reinforcing the U.S.’s position as a leader in critical 21st-century industries. As the Trump administration seeks to leverage the USMCA review, the focus remains on addressing past weaknesses and ensuring that the agreement serves the interests of American innovation and economic growth.