On April 3, 2026, amendments to the Federal Law for the Protection of Industrial Property (LFPPI) were published in the Official Gazette of the Federation (DOF), entering into force on April 4, 2026. In general terms, the amendments introduce measures aimed at streamlining and improving the efficiency of various procedures set forth in the law. At the same time, they strengthen legal certainty for holders of patents, registrations, and other protected exclusive rights.
Among other aspects discussed separately at OLIVARES, a key provision relates to patent term compensation certificates arising from delays in the regulatory approval of pharmaceutical products.
Under the reform, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) would notify the Mexican Institute of Industrial Property (IMPI) of any regulatory delay, as well as the corresponding compensatory period. IMPI would then inform the patent holder, who would be responsible for covering the costs associated with the issuance of the compensatory certificate.
This new provision seeks to comply with Article 20.46 of the USMCA; however, it only addresses the obligations of IMPI. To date, there is no legal or regulatory framework establishing the criteria to determine whether a regulatory delay exists or how the corresponding patent term compensation will be granted. Therefore, this constitutes a partial or incomplete implementation of the referenced USMCA provision.
Accordingly, it will be necessary to await the issuance of the corresponding regulations establishing clear rules and guidelines to define what constitutes an “unreasonable delay,” taking into account the different types of products subject to regulatory approval procedures before the health authority, as well as the rules, parameters, or formulas to determine the appropriate patent term compensation. Without such framework, it cannot be concluded that Mexico is fully compliant with its USMCA obligations regarding patent term compensation for regulatory delays.
The transitory provisions of the reform establish that ongoing proceedings shall be resolved in accordance with the legal framework in force at the time they were initiated. In that sense, an initial interpretation could suggest that the reforms apply only to those patents that were filed, prosecuted, and granted after the entry into force of the amendments, i.e., April 4, 2026.
Beyond a literal interpretation, cases could be assessed under a case-by-case approach, also taking into account the potential interpretation of the provisions of the USMCA based on the corresponding hierarchy of the international treaties in accordance with the Mexican legal system and their interaction with the new regulatory framework, including the forthcoming provisions that may be issued by the health authority in connection with this patent term compensation mechanism for regulatory delays.
Further contributions to this article by Alonso Camargo, Rommy Morales, Jaime Rodriguez, Luz Elena Elias, Karla Olvera, and Ingrid Ortíz.
