On behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), we hereby submit comments on the Draft Resolution related to collaboration between the Mexican Institute of Industrial Policy (IMPI) and the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) (Draft Resolution) as published on February 26. While the Draft Resolution has the potential to improve the collaboration between IMPI and COFEPRIS, it falls short of the commitments that Mexico made in Annex 20-A of the U.S.-Mexico-Canada Agreement (USMCA) to improve its patent linkage system. It remains critical for Mexico to issue secondary regulations that revise its patent linkage system ahead of the Joint Review of the USMCA next year. Last summer we submitted a joint letter with the Mexican Association of Pharmaceutical Research Industries (AMIIF) to IMPI and COFEPRIS in which we identified key aspects of Mexico’s Patent Linkage system that must be revised to bring Mexico into compliance with its USMCA commitments: First, Mexico’s system must be amended to ensure that all “patents claiming that product” are covered by its patent linkage mechanism. In the United States, parties can list all relevant patents in the Orange Book, including compound, formulation and method of use patents. Conversely, in Mexico, parties must seek court orders on a case-by-case basis for their method-of-use patents to be included in the Patent Linkage Gazette (hereafter Gazette). Promisingly, the Draft Resolution (Article 7) indicates that only process patents are expressly excluded from listing in the Gazette. However, in light of the historical difficulties faced by innovators in listing their use patents in the Gazette, it is essential that Mexico issue secondary regulations that explicitly identify all types of patents – including use patents – that are eligible for inclusion in the Gazette. Second, Mexico must ensure that the innovator is notified of the generic application and afforded “a reasonable opportunity to present facts and arguments in support of that [innovator’s] position before any final administrative action.” Under the U.S. patent linkage system, the innovator receives direct notice of the generic application from the applicant and can assess the basis for the generic applicant’s certification before deciding whether to initiate a court challenge. Consistent with its USMCA commitments, Mexico needs to develop a corresponding mechanism whereby the innovator is notified of IMPI’s preliminarily determination of whether the generic infringes the innovator’s patents and is allowed to present facts or arguments in support of the innovator’s position before IMPI issues its final decision to COFEPRIS. While Article 9 helpfully formalizes COFEPRIS’s current practice of publishing notice of generic or biosimilar marketing authorization applications, that notice alone is not sufficient to meet Mexico’s USMCA commitments. We look forward to further engagement with the Mexican government on the implementation of secondary regulations that reflect Mexico’s USMCA commitments to revise its patent linkage mechanism.