November Highlights: The Upcoming Review of the USMCA
This fall marked the beginning of the first scheduled Joint Review process for the United States-Mexico-Canada Agreement (USMCA), the 2020 trade pact that governs trade across North America. The joint review is a built-in mechanism requiring the three countries to assess whether the agreement is functioning as intended and whether its provisions should be renewed, amended, or renegotiated. In September, the Office of the U.S. Trade Representative opened a public docket for input on the agreement’s operation in advance of the official Joint Review, which will take place in July 2026. In November, the agency prepared for a public hearing on the Joint Review, taking place December 3-5.
Because the USMCA governs trade rules across life sciences, advanced manufacturing, clean energy, digital commerce, creative industries, and other IP-intensive sectors, the outcome of this review will have far-reaching consequences for U.S. prosperity and competitiveness. It also presents an unprecedented opportunity. For the first time since the agreement took effect in 2020, U.S. negotiators will have the opportunity to directly confront Canada’s and Mexico’s violations of certain IP provisions, strengthen enforcement mechanisms, and restore important IP protections — such as robust regulatory data protection — that were originally negotiated into the agreement but ultimately removed before ratification.
However, if negotiators allow the USMCA’s IP provisions to erode or go unenforced, the consequences could be particularly harmful to the United States. U.S. innovators will face much greater difficulty competing in two of America’s largest export markets — and rivals like China will be well-positioned to fill the gap.
For these reasons, urging USTR to renew and strengthen the USMCA, securing comprehensive, enforceable IP protections, was a priority for C4IP throughout the month of November:
- C4IP Executive Director Frank Cullen submitted a comment letter urging USTR to use the upcoming joint review to press Mexico and Canada to fully implement their IP commitments, crack down on currently widespread violations of the USMCA’s counterfeiting and piracy provisions, and strengthen regulatory data protection for medicines to better support U.S. innovation.
- C4IP’s comment was highlighted in IPWatchdog’s weekly “Barks & Bites” news roundup, which also highlighted the specific IP problems in copyright, piracy, and industrial policy facing Mexico and Canada that were identified by C4IP.
Additional Coalition Updates
- On November 19, C4IP Chief Policy Officer and Counsel Jamie Simpson gave a presentation on the shifting balance between patents and trade secrets in the United States after the passage of the Defend Trade Secrets Act of 2016 at the Presidential Council on Intellectual Property and the Supreme Court of Korea’s 2025 International Forum on Intellectual Property in Seoul, South Korea.
- On November 17, C4IP published a fact sheet comparing the PREVAIL Act of 2025’s proposed PTAB framework with prior and current USPTO approaches, highlighting how the bill would end the cycle of policy shifts between administrations by eliminating duplicative and repetitive proceedings as well as harmonizing standards for challenging patents between PTAB, district courts, and the International Trade Commission (ITC).
- On November 17, C4IP Executive Director Frank Cullen was interviewed by KTNV Las Vegas in a news segment about the danger posed by counterfeit holiday gifts, which not only violate the IP rights of legitimate creators and sellers but can cause physical harm to unsuspecting recipients.
- On November 14, C4IP published a blog post detailing the economic and consumer harms posed by counterfeit goods, which are particularly prevalent during the holiday season, and urging Congress to pass the SHOP SAFE Act to incentivize e-commerce platforms to better police counterfeit products being sold by third parties through their sites.
- On November 13, C4IP’s support for the Patent Eligibility Restoration Act (PERA) was cited in a Mondaq article on the bill, which concluded that there is a broad consensus between “[j]udges, industry leaders, investors, USPTO personnel and many others” on the need for patent subject matter eligibility reform.
- On November 10, C4IP Executive Director Frank Cullen issued a statement commending six members of Congress for introducing the Restoring America’s Leadership in Innovation Act of 2025 and four members for introducing the Balancing Incentives Act of 2025, both of which recognize the problems that have faced innovators by the operations of the PTAB’s post grant review proceedings.
- On November 6, C4IP Executive Director Frank Cullen submitted a comment letter to India’s Central Drugs Standard Control Organization, responding to its recent invitation to comment on India’s drug approval regime and recommending that India adopt robust regulatory data protection and data exclusivity to reward first movers, attract investment, and expand patient access to innovative medicines.
- On November 5-7, C4IP Chief Policy Officer and Counsel Jamie Simpson spoke on a panel at the 12th Annual IP Dealmakers Forum in Austin, Texas, about trends and developments in the PTAB.
- On November 3, C4IP published a blog post on the FDA’s recent approval of a new, subcutaneous formulation of the cancer drug Keytruda, explaining how this exemplifies the value to patients of follow-on innovation and rebutting critics’ assertions that the new formulation constitutes an unnecessary “product hop.”