MEXICO Trends and Developments Contributed by: Roxana Aispuro and Mónica Sánchez, BC&B Law & Business
with international benchmarks facilitates greater inte- gration with global markets and supports innovation within the industry. The protection of pharmaceutical inventions in Mexico plays a crucial role in shaping the development and competitiveness of the sector. Patents grant innova- tors exclusive rights to manufacture and commer- cialise their products for a defined period, providing incentives for research and development and attract- ing investment in high-value biotechnology and phar- maceutical innovation. Looking ahead, the expectation is that the national pharmaceutical industry will strike a balance between encouraging innovation through strong patent protec- tions and fostering the growth of generic medicines. By streamlining patent procedures and supporting the domestic generics sector, Mexico can maintain a competitive pharmaceutical market that both drives innovation and meets the needs of public health. Mexico possesses many of the conditions required to strengthen its role in the global healthcare manu- facturing landscape. Its strategic geographical loca- tion established industrial infrastructure, and a highly skilled workforce provides a solid foundation for fur- ther development in the pharmaceutical and medical technology sectors. Nevertheless, fully realising this potential will depend on co-ordinated action between the public and private sectors. Reducing operational risks, improving regula- tory efficiency and implementing clear and consistent public policies that encourage innovation and invest- ment will be essential. Regulatory framework and international treaties governing innovation and intellectual property in Mexico The pharmaceutical industry, by its nature, operates within a complex and highly regulated environment. In Mexico, the Federal Commission for the Protec- tion against Sanitary Risks ( Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS), the health authority, is responsible for ensuring the safety, quality and efficacy of medical products. This objec- tive is achieved through the evaluation of regulatory
dossiers and the granting of marketing authorisations once applicants demonstrate compliance with the requirements established in the applicable laws and regulations. At the same time, the pharmaceutical sector is char- acterised by continuous innovation, including the development of new molecules, pharmaceutical com- positions, therapeutic indications and drug delivery technologies. To protect these innovations and ensure the enforceability of the corresponding exclusive rights, while also preventing potential infringement of third-party rights, pharmaceutical companies must comply with the intellectual property framework. In Mexico, this system is administered by the Mexican Institute of Industrial Property ( Instituto Mexicano de la Propiedad Industrial – IMPI), which is responsible for granting and enforcing industrial property rights, including patents. Over time, the Mexican regulatory and intellectual property frameworks have undergone several reforms aimed at strengthening the protection of innovation, improving regulatory efficiency and ensuring compli- ance with obligations arising from international agree- ments. In this context, 2020 represented a year of signifi- cant international and domestic developments. The United States–Mexico–Canada Agreement (USMCA) entered into force on 1 July 2020, replacing the North American Free Trade Agreement (NAFTA), which had governed trade relations among the United States, Mexico and Canada since 1994. The renegotiation of NAFTA began in 2017 with the objective of modern- ising the agreement to address evolving economic realities, including digital trade, enhanced regulatory co-operation and updated standards for intellectual property protection. Overall, the USMCA reflects an effort to align the intel- lectual property frameworks of North America with contemporary global standards, providing greater legal certainty for innovators and companies operat- ing in the region. At the same time, the agreement prompted legislative reforms in the member countries, particularly Mexico, where several amendments were
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