MEXICO Trends and Developments Contributed by: Roxana Aispuro and Mónica Sánchez, BC&B Law & Business
introduced to ensure consistency with the treaty’s obligations. As a result of the USMCA negotiations, and particularly in the area of intellectual property, significant amend- ments to the Mexican legal framework became neces- sary. Accordingly, on 1 July 2020, Mexico enacted the Federal Law for the Protection of Industrial Property ( Ley Federal de Protección a la Propiedad Industrial – LFPPI), which replaced the industrial property statute that had been in force for nearly three decades. This new legislation introduced several mechanisms aimed at strengthening patent protection. Notwithstanding the enactment of the LFPPI, certain aspects of the legal framework have continued to evolve in order to address practical implementation issues and emerging regulatory needs. In this regard, on 10 March 2026, the Mexican Senate approved new amendments to the LFPPI. Considering these recent developments, as well as previous reforms, the following sections provide a summary and analysis of the key issues of relevance to the pharmaceutical industry. In particular, the analy- sis will address recent developments related to pat- ent prosecution, patent term adjustments (PTAs), the interaction between the patent system and the regu- latory framework for pharmaceutical products, and other regulatory mechanisms that may impact the protection and commercialisation of pharmaceutical innovations in Mexico. Patent prosecution In addition to the proposed amendments to the LFPPI, on 11 March 2026, the Official Gazette of the Federa- tion published a new agreement amending the provi- sions that establish the response deadlines for various procedures before IMPI. The amendment introduces a limitation on the number of official actions that may be issued during the substantive examination of a patent application. Under the previous framework, during substan- tive examination, IMPI could issue up to four official actions, allowing applicants multiple opportunities to submit arguments and amendments to address the objections raised by the examiner. However, under the
recently published amendment, the number of offi- cial actions has been reduced to two. This modifica- tion applies to applications filed on or after 12 March 2026 and may therefore affect all applicants, including pharmaceutical companies, where the complexity of the technologies involved may require more than two official actions. From a policy perspective, the reduction in the num- ber of office actions appears to be aimed at stream- lining patent prosecution and reducing examination timelines. However, this measure may also raise con- cerns regarding its potential impact on the quality and depth of substantive examination, particularly in highly technical fields such as pharmaceuticals and biotech- nology. Given the complexity of these inventions, the examination process often requires detailed techni- cal exchanges between applicants and examiners in order to properly assess patentability requirements, including novelty, inventive step and sufficiency of dis- closure. Limiting the opportunities for such exchanges may increase the likelihood of premature rejections or, alternatively, lead applicants to pursue additional administrative or judicial mechanisms to defend their patent rights. Consequently, the practical effects of this reform will likely become clearer as the new framework is imple- mented and interpreted in practice by both IMPI and the courts. Patent term adjustment in Mexico: scope and practical challenges The LFPPI introduced, for the first time in Mexican legislation, an explicit mechanism allowing patent holders to request an adjustment to the patent term in cases where the granting procedure has been sub- ject to unreasonable delays attributable to the patent office. This mechanism seeks to ensure that patent holders are not unduly deprived of the effective period of exclusivity guaranteed under the patent system. Under the LFPPI, a PTA may be requested when the prosecution of a patent application exceeds a speci- fied period due to delays attributable to the authority responsible for examination. In such circumstances, the patent holder may request an extension of the
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