Trump’s Upcoming Opportunities in USMCA Review
President Donald Trump is poised to pursue political and economic wins that he nearly secured during his first term, though these were notably hindered by Congress. A significant opportunity lies ahead with the forthcoming joint review of the United States-Mexico-Canada Agreement (USMCA)—the trade pact that replaced the North American Free Trade Agreement (NAFTA). The three countries are set to convene soon to assess the agreement’s effectiveness and provide updates.
In my previous role during the first Trump administration, I worked on the intellectual property provisions of this agreement as Under Secretary of Commerce for Intellectual Property and Commissioner of the United States Patent and Trademark Office. Together with the President and U.S. Trade Representative Bob Lighthizer, we managed to secure several concessions from both Mexico and Canada aimed at bolstering protections for intellectual property (IP). These protections are crucial in preventing foreign competitors from appropriating technology and designs from innovative U.S. firms, as well as encouraging American companies to ramp up their research efforts and expand into international markets.
However, it’s unfortunate that a major concession—a stipulation requiring Mexico and Canada to provide 10 years of “regulatory data protection” for advanced biologics derived from living cell cultures—was eliminated at the last minute.
During those regulatory data protection periods, competitors are prohibited from utilizing the clinical trial data of biologics developers to manufacture their own counterfeit products. Developing a new biological drug, as you might imagine, is a lengthy process that can take years and cost billions of dollars.
This regulatory data protection essentially provides innovators with a better shot at recouping their investments, encouraging them to allocate more resources to research and development—which, in turn, creates jobs in research and manufacturing.
The United States currently offers 12 years of data protection for biologics, and the original USMCA draft was intended to align Canada and Mexico more closely to this standard, thereby leveling the playing field.
The objective was to enhance protections abroad, preventing foreign manufacturers from capitalizing on American biotech innovations through premature counterfeit product launches. This could help U.S. inventors recover their investments more effectively in Mexico and Canada, ultimately leading to lower drug prices in the United States.
But this provision meant to curb freeloading was taken out at the behest of then-Speaker Nancy Pelosi, who required support to pass USMCA enforcement legislation.
Now, with a new parliament in session, a second Trump administration should consider revisiting those original terms agreed upon by Canada and Mexico during the upcoming USMCA review. Strengthening data protection regulations in neighboring countries could disrupt freeloading and potentially lower prices for American patients.
This upcoming review also presents an opportunity for the administration to hold Mexico accountable for unfulfilled promises regarding IP protections.
Recently, Mexico was added to the Special 301 Priority Watch List, which identifies serial intellectual property infringers, due to longstanding concerns. Mexico has yet to establish the promised patent enforcement system, and issues with patent term restoration regulations and copyright enforcement have allowed widespread trademark counterfeiting and copyright violations. Such failures have eroded the protections American innovators expected from trade agreements.
Enhancing intellectual property protections will mean more new treatments for patients, decreased prices for Americans, creation of good-paying jobs in emerging industries, and sustained leadership in critical sectors for the 21st century.
