New opportunities and challenges in the IMPI–COFEPRIS Linkage System

In 2003, a linkage system between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was formally established within the Mexican regulatory framework. This system is aimed at coordinating the protection of patent rights with the granting of marketing authorizations in the pharmaceutical and biotechnological fields for the same patent holder.

This system has evolved significantly, expanding both its scope and effectiveness. In particular, it has strengthened patent protection against third parties seeking to obtain marketing authorizations for products covered by valid patent rights. It is also aligned with international commitments such as the USMCA (United States–Mexico–Canada Agreement) and the domestic legal framework, namely the Federal Law for the Protection of Industrial Property (LFPPI). Among the most relevant developments are the following:

• The publication of the Gazette of Medicines —issued every six months—which not only discloses lists of patents in force for allopathic medicines, but more recently also includes biotechnological products, compositions, and uses, thereby providing a broader scope of protection and linkage for various types of inventions in the health sector that may be subject to marketing authorizations.

The issuance of the Agreement between the IMPI and the COFEPRIS, which establishes the following:

• Regulates the manner in which IMPI and COFEPRIS share technical information for the evaluation of marketing authorization applications, on a confidential basis.
• Provides information regarding allopathic and biotechnological medicines disclosed in the Gazette of Medicines, such as active ingredient, patent term, holder(s), etc.
• Establishes the type of technical assistance that COFEPRIS may request from IMPI and the conclusions that may be derived therefrom.
• Introduces the possibility for a patent holder to file an opposition against a marketing authorization application that may affect the scope of its patent rights, upon its publication in COFEPRIS listings of generic or biosimilar applications. Such opposition must be filed within a 10-day period from the date of publication, through the Third Party Opposition Form (FOT).

During 2026, and as part of the continued efforts to strengthen the IMPI–COFEPRIS linkage system, two additional developments have been introduced which further enhance transparency, accessibility, and the potential for compensation to patent holders who have applied for a marketing authorization:

1. The launch of the “IMPI–COFEPRIS Linkage System Portal”, which centralizes relevant information in a single platform, presented in an organized, intuitive, and user-friendly manner, including:

1. Granted marketing authorizations
2. Pending marketing authorization applications
3. Third-party oppositions
4. Patents in the public domain
5. Patents nearing expiration (within 3, 5, or 10 years)
6. Patents associated with medicaments
7. COFEPRIS responses
8. Gazette of Medicines
9. Regulatory framework
10. Various forms

2. An amendment to the LFPPI establishing the possibility of patent term adjustment in favor of the patent holder in cases of unreasonable delays attributable to COFEPRIS in the granting of a requested marketing authorization. However, this mechanism still requires further regulatory development within the health framework for its effective implementation.

Notwithstanding the foregoing, the IMPI–COFEPRIS linkage system still faces challenges, particularly in reducing processing times, strengthening institutional coordination, and achieving a proper balance between patent protection and access to generic and biosimilar medicines.

At H&A, we would be pleased to provide further information and tailored advice on this matter.