After three years after the entry into force of the United States-Mexico-Canada Agreement (USMCA), Mexico has taken positive steps toward complying with its Intellectual Property (IP) commitments. For instance, in 2020, a package of legal reforms was passed by the Federal Congress, including a new Industrial Property Law and amendments to the Copyright Law and Criminal Code, with both substantive and procedural provisions strengthening IP rights in the fields of patents, trademarks, copyright, trade secrets, and enforcement. However, further efforts are needed for a full and timely alignment. Here, we list outstanding obligations on plant breeder’s rights and pharmaceutical exclusivities that should be effectively implemented in the following years.
- Accession to UPOV 1991. Mexico has committed to ratifying or acceding to UPOV 1991, which will enhance the protection of plant breeders’ protection by July 1, 2024, at the latest. While prior attempts to update the current Federal Law of Plant Varieties have not matured due to political resistance, the 2024 deadline should provide additional pressure to expedite parliamentary discussions and bring Mexico’s system in line with international standards.
- Patent Term Extension. USMCA mandates the availability of Patent Term Extension (PTE) for patents covering a pharmaceutical product to compensate for unreasonable curtailment due to the marketing approval process. Creating detailed PTE regulations at the domestic level will require an amendment to Federal laws and close cooperation between the regulatory and patent authorities. The associated transition period ends on January 1, 2025, so full implementation should occur before said date. There has been no legislative activity so far in this respect.
- Test data protection. Previous obligations on the protection of test data for pharmaceutical and agrochemical products have been further specified in the USMCA. This will allow for effective preclusion of unauthorized reliance on approved innovator products’ safety and efficacy data, during a term of 5 years (pharmaceuticals) and ten years (agrochemicals) after approval. No local laws on this type of regulatory exclusivity exist, and no records of related legislative initiatives exist. The deadline is July 1, 2025, to update the legal system accordingly.
- Patent linkage system. Per the USMCA, the existing linkage system to prevent the regulatory approval of products covered by a patent without the patent holder’s consent requires review. Specifically, Mexico’s authorities are bound to notify the patent holder whenever an unauthorized party files a marketing application and to provide a reasonable opportunity to present facts and arguments regarding said marketing application. Even though the corresponding measures were supposed to be in place since July 1, 2020, Mexico just complied in 2023, partially and with a big room for improvement. Proper amendments to the regulations are needed with increasing urgency as patent owners’ resort to alternative legal strategies to protect their rights.
Enhanced plant breeder’s rights and pharmaceutical exclusivities have involved intense debate in the country, so, most likely, implementation of the above-listed USMCA obligations will face significant delays. Nevertheless, given Mexico’s overall commitment to reinforce and improve its protection and enforcement systems, discussions in Congress should have significantly progressed by 2025.