MEXICO Trends and Developments Contributed by: Roxana Aispuro and Mónica Sánchez, BC&B Law & Business
When an applicant seeks marketing authorisation for a generic medicine, COFEPRIS may request an opinion from IMPI regarding the potential infringement of the relevant patent rights. Applicants requesting a marketing authorisation should demonstrate that the proposed product does not infringe any valid patent in Mexico related to the product to be commercialised, that they are the assignees or registered licensees of the relevant patent rights, or alternatively that the reg- ulatory submission was made within the period per- mitted under the Bolar exemption, which allows the filing of regulatory applications prior to patent expira- tion (three years before the expiration of a patent for allopathic medicines and six years before the expira- tion of patents covering biotechnological products). The patent linkage system in Mexico is valuable for patent protection because it prevents the marketing of pharmaceutical products that could infringe valid pat- ents, ensuring that patent holders can fully exercise their rights. By co-ordinating the review of marketing authorisation applications with the registry of active patents, the system provides legal certainty, reduces the risk of unauthorised generic entry and strengthens incentives for innovation in the pharmaceutical sector. Opposition process for marketing authorisations in Mexico In Mexico, the opposition process for marketing authorisations provides a mechanism for third parties to challenge the approval of a pharmaceutical prod- uct before it is granted by COFEPRIS. This process plays a crucial role in ensuring that new pharmaceuti- cal products comply with regulatory standards and respect existing intellectual property rights. Typically, any interested party – including patent holders, com- petitors or other stakeholders – may file an opposition, particularly when a pending application could infringe a valid patent or clinical data exclusivity. Oppositions must be submitted within ten working days, usually following the publication of the pend- ing marketing authorisation in the Official Gazette or notification by COFEPRIS, and must be supported by evidence demonstrating potential infringement or non-compliance. Upon receiving an opposition, COFEPRIS evaluates the claims, may request addi- tional documentation from both the opposer and the
applicant and, in cases involving patents, consults the Linkage Gazette in co-ordination with IMPI to verify patent status. Depending on the findings, COFEPRIS may reject the opposition, allowing the marketing authorisa- tion to proceed, or sustain it, which could result in suspension, amendment or denial of the application. However, in practice, participation in this procedure may be limited due to administrative requirements of COFEPRIS, as the filing of an opposition generally requires the involvement of a legal representative with an operational notice in Mexico. Consequently, patent holders without an established regulatory presence in the country may face practical limitations when attempting to intervene in these proceedings. The opposition process thus serves multiple purpos- es: it protects intellectual property rights, prevents unauthorised entry of generic products, ensures reg- ulatory compliance and promotes transparency and legal certainty in the pharmaceutical market. By com- plementing the patent linkage system, this mechanism reinforces the integrity of Mexico’s pharmaceutical regulatory framework and provides additional safe- guards for innovation and investment in the sector. Protection of clinical data in Mexico Another relevant aspect within the regulatory frame- work governing pharmaceutical products in Mexico is the protection of clinical data submitted in support of marketing authorisation applications. Clinical trial data represents a significant investment in research and development and constitutes a key component of the regulatory dossier required to demonstrate the safety, quality and efficacy of pharmaceutical products. Con- sequently, the protection of such data has become an important element of the broader system designed to encourage pharmaceutical innovation. In Mexico, the protection of clinical data is primarily regulated through provisions contained in the Regu- lation of Health Supplies and related administrative practices of the Health Authority (COFEPRIS). These provisions establish a period of regulatory data pro- tection during which the clinical and preclinical infor- mation submitted by the originator company may not
210 CHAMBERS.COM
Powered by FlippingBook