MEXICO Trends and Developments Contributed by: Roxana Aispuro and Mónica Sánchez, BC&B Law & Business
patent term to compensate for the time lost during the examination process. Additionally, the USMCA contemplates the possibility of PTAs resulting from delays by the health author- ity in granting marketing authorisations for pharma- ceutical products. This provision acknowledges that even when patents are granted in a timely manner, the commercialisation of a drug can be delayed due to extended regulatory review periods, potentially reduc- ing the effective market exclusivity for the innovator. To provide a clearer and more predictable regulatory framework for this mechanism, proposed legislative amendments in Mexico envisage the incorporation of a new article under which the COFEPRIS would be responsible for determining the compensatory period attributable to such regulatory delays. Under this system, once COFEPRIS establishes the length of the delay, the patent holder may request IMPI to issue a complementary certificate reflecting the corresponding extension of the patent term. This approach aligns with international practices, ensur- ing that innovators are not penalised for delays that are beyond their control, particularly in sectors such as biopharmaceuticals, where regulatory evalua- tions are often complex and time-intensive. Moreo- ver, it strengthens Mexico’s compliance with USMCA obligations, harmonising domestic procedures with standards applied in the United States and Canada, where PTAs for regulatory delays are already recog- nised. The introduction of this co-ordinated system has sev- eral expected benefits. First, it mitigates the risk of reduced effective patent life caused by lengthy mar- keting authorisation processes. Second, it creates a transparent and standardised methodology for calcu- lating compensatory periods, reducing ambiguity and potential disputes between patent holders and regu- latory authorities. Finally, it enhances Mexico’s posi- tion as an attractive jurisdiction for pharmaceutical innovation, by ensuring that the economic incentives provided by patent protection are fully realised even in the presence of unavoidable administrative delays. However, despite the introduction of this mechanism in the LFPPI, several practical and interpretative issues
have emerged regarding its implementation. These include, among others, the criteria used to determine what constitutes an “unreasonable delay”, the meth- odology for calculating the corresponding adjustment period, and the procedural requirements for request- ing such adjustments before IMPI. Addressing these issues will be essential to ensure legal certainty for patent holders and to guarantee the effective applica- tion of the PTA system in Mexico. The pharmaceutical patent linkage system in Mexico: interaction between IMPI and COFEPRIS The USMCA establishes a comprehensive framework for the protection of pharmaceutical patents across its member countries. Under the agreement, patent protection must be available not only for the active ingredient of a drug but also for new uses, formu- lations or methods of administration. Patent holders are granted enforceable rights to prevent unauthor- ised manufacture, use or sale of patented medicines, thereby strengthening incentives for innovation within the pharmaceutical sector. The patent linkage system establishes a formal co- ordination mechanism between IMPI and COFEPRIS to prevent the granting of marketing authorisations that could potentially infringe valid patent rights. This system has been in place in Mexico for several years and has recently undergone practical modifications aimed at aligning it with the USMCA. Notably, these changes facilitate the inclusion of second-use pat- ents in the Linkage Gazette, which were previously not incorporated automatically and often required litiga- tion if IMPI initially denied their inclusion. Under this system, IMPI periodically publishes a list of patents that may be used in allopathic medicines. The publication, known as the Linkage Gazette, includes patents covering active pharmaceutical ingredients, pharmaceutical compositions or formulations, and medical use patents, which were recently included in the October 2025 edition of the Gazette. During the evaluation of marketing authorisation applications, COFEPRIS consults the Linkage Gazette to ensure that authorisations are not granted to third parties for products potentially covered by valid patents.
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