Introduction
The relationship between the protection of industrial property and health regulation is one of the most complex and relevant axes of contemporary pharmaceutical law. In legal systems where the authorization of generic medicines depends on the prior verification of current patent rights, the institutional articulation between industrial property authorities and health agencies is decisive to guarantee both legal certainty and timely access to medicines.
In this context, the launch of the Portal of the Linkage System between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) represents an institutional milestone of the first order. The platform, put into operation, materializes an effort of technical, operational and regulatory coordination between both institutions, with the declared purpose of facilitating public access to information on marketing authorization and patents related to inventions that can be used in medicines.
The patent linkage system in the Mexican legal system
The concept of patent linkage refers to the mechanism by which the health authority conditions or links the granting of marketing authorization of medicines to the verification of the status of patents associated with the active ingredient, formulation or use of the product in question. This model seeks to balance two legitimate interests in permanent tension: the protection of the exclusive rights of the patent holder and the need to speed up the market entry of generic medicines that expand access to health.
In Mexico, the IMPI-COFEPRIS linkage system operates through a technical cooperation scheme in which COFEPRIS requests IMPI to pronounce on the existence of patents in force that could be affected by the granting of a specific marketing authorization. This mechanism, which has been operating progressively, now acquires an unprecedented dimension of transparency and accessibility with the launch of the digital portal.
The creation of this platform is also part of the fulfillment of international commitments, particularly those derived from the USMCA, as well as in the attention to observations made in evaluations such as the Special 301 Report of the Office of the United States Trade Representative, which has historically pointed out deficiencies in the effectiveness of the Mexican linkage system.
Functional scope of the portal: available information and regulatory traceability
One of the most significant aspects of the new tool is the breadth of information it makes available to the public. The portal will allow you to consult:
- current marketing authorization,
- applications for marketing authorization in process,
- third-party oppositions filed with respect to such applications.
This last functionality is particularly relevant, as it gives visibility to a procedural mechanism that, until now, lacked a systematized public consultation channel.
In addition, the platform incorporates patent search engines related to inventions that can be used in medicines, differentiating between patents in force, expired, in the public domain or close to expire. The possibility of verifying in real time the validity of a specific patent is a tool of enormous practical value for pharmaceutical laboratories, generic manufacturers and industrial property law professionals, since it reduces the uncertainty associated with decision-making on the development, investment and commercialization of products.
The system will also make it possible to review the responses issued by the IMPI to COFEPRIS within the framework of technical cooperation, the copies of the gazette with lists of patents linked to allopathic medicines, and the regulatory framework applicable to the linkage system. This component of regulatory traceability significantly expands the principle of transparency, by allowing any interested party to reconstruct the institutional logic that supported a given resolution.
Technical cooperation statistics
During 2025, IMPI received 900 requests for technical cooperation and issued 799 responses. Of this universe, in 572 cases it was determined that there were no patents that could be invaded with the granting of the corresponding marketing authorization, while in 72 responses it was concluded that there would be patent invasion. To these figures are added 155 cases in which the IMPI did not issue a final pronouncement due to lack of sufficient technical information.
For the beginning of 2026, at the end of February, the IMPI reported 201 responses issued: 152 indicated the absence of potentially invaded patents, 9 determined the existence of invasion and in 40 cases it was not possible to issue a final pronouncement.
These statistics are of particular legal interest. On the one hand, the majority proportion of responses ruling out patent invasion suggests that the system operates as an efficient filtering mechanism that clears the way for generic authorization without apparent conflict. On the other hand, the persistence of a significant percentage of cases without a definitive pronouncement – due to insufficient technical information – shows areas of opportunity in the quality of the files that are submitted for technical cooperation, an aspect that the portal could contribute to remedying by facilitating early access to relevant information.
International Dimension: the USMCA and the Special Report 301
The portal cannot be understood in isolation from the international commitments assumed by Mexico. Chapter 20 of the USMCA establishes specific intellectual property obligations applicable to the pharmaceutical sector, including provisions on the protection of test data, exclusivity periods, and mechanisms for linking the patent authority and the health authority.
The portal responds to areas of opportunity identified in international assessments, including the USMCA and the Special Report 301, particularly in relation to the effectiveness of the linkage system. This tool not only shows an exercise in internal modernization, but also a measure of compliance with treaty obligations that, if not addressed, could lead to disputes under the dispute settlement mechanisms of the treaty itself.
In this sense, the launch of the portal represents a tangible advance in aligning Mexico with the best global practices in patent linkage, contributing to strengthening the country’s perception as a reliable destination for investment in clinical research and development of new pharmaceutical products.
Critical reflections and perspectives
While acknowledging the importance of the portal as an instrument of transparency and modernization, it is pertinent to formulate some critical considerations. Firstly, the effectiveness of the system will depend to a large extent on the quality, updating and completeness of the information hosted on the platform. A portal that does not reflect in real time the changes to the status of patents or marketing authorization would quickly lose its usefulness as a tool for legal certainty.
Secondly, the question remains about the procedural treatment of oppositions by third parties against applications for marketing authorization. Although the portal announces the possibility of consulting such oppositions, the deadlines, requirements and legal effects of this mechanism remain to be clearly defined, particularly with regard to the hearing rights of the registrant and the patent holder.
Conclusions
The Portal of the IMPI-COFEPRIS Linkage System constitutes a significant institutional advance in the articulation between industrial property and health regulation in Mexico. Its implementation responds both to internal modernization needs and to international commitments derived from the USMCA and other multilateral evaluations.
By making information on pharmaceutical patents, marketing authorization and technical cooperation between both institutions transparent, the platform has the potential to reduce legal uncertainty, speed up the entry of generic drugs into the market and strengthen the competitiveness of the Mexican pharmaceutical sector. However, its long-term success will depend on the quality of the information, the robustness of the associated procedures, and the institutional will to maintain a genuine balance between intellectual property protection and access to public health. Intellectual property professionals in Mexico and the region should closely follow the evolution of this tool and its impact on regulatory and litigation practice in the pharmaceutical sector.
References
https://vinculacioncofepris.impi.gob.mx/
By: Janett Lumbreras
