MEXICO Trends and Developments Contributed by: Roxana Aispuro and Mónica Sánchez, BC&B Law & Business
Conclusions and perspectives In response to the implementation of the USMCA, and its mandated six-year comprehensive review – which is scheduled to begin in 2026 – as well as recent amendments to the LFPPI and other regula- tions, Mexico has introduced several regulatory and administrative practices aimed at aligning its pharma- ceutical intellectual property framework with interna- tional standards. The evolution of Mexico’s intellectual property and regulatory framework for pharmaceutical products reflects a broader effort to align national legislation with international standards and commitments. Mech- anisms such as PTA, marketing authorisation opposi- tion and regulatory data protection are intended to strengthen the incentives for innovation by providing additional safeguards for investments in research, development and regulatory approval processes. Nevertheless, the effective implementation of these mechanisms still presents practical and interpretative challenges, including the determination of regulatory delays, the co-ordination between IMPI and COFE- PRIS, and the definition of clear procedural criteria for granting compensatory protection. Looking forward, continued regulatory clarification and institutional co-ordination will be essential to ensure legal certainty for innovators while maintaining a balanced framework that also promotes competition and access to medicines in the Mexican pharmaceuti- cal market.
be relied upon by third parties seeking approval for equivalent products. In practice, this mechanism functions as a form of regulatory exclusivity that operates independently from patent protection. While patents protect the underlying invention, data protection prevents regula- tory authorities from relying on the originator’s clinical data to approve generic or follow-on products for a defined period. As a result, even in cases where pat- ent protection may have expired or is not available, data protection may still provide an additional layer of market exclusivity for innovative pharmaceutical products. Clinical data protection is particularly significant for products requiring extensive clinical development, such as new chemical entities and biotechnologi- cal medicines. The generation of clinical evidence for these products often requires substantial finan- cial investment and long development timelines. For this reason, data protection mechanisms are widely regarded as an important incentive to promote contin- ued research and development in the pharmaceutical sector. From a policy perspective, the protection of clinical data in Mexico has also been influenced by interna- tional commitments and trade agreements, particu- larly the USMCA. This agreement includes provisions aimed at ensuring adequate protection of undis- closed tests or other data submitted for the purpose of obtaining marketing approval. In line with these commitments, proposed amendments to the LFPPI contemplate the incorporation of an article establish- ing that safety and efficacy data submitted for the approval of innovative pharmaceutical products may not be disclosed or relied upon by third parties for a period of five years. These developments illustrate the ongoing effort to strengthen the regulatory framework governing phar- maceutical innovation in Mexico while balancing the interests of originator companies, generic manufactur- ers and public health considerations.
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