A New Mechanism for Contesting Sanitary Registrations in Mexico

Mexico has recently introduced a mechanism that empowers medical patent owners to contest sanitary registration application procedures. This system is particularly noteworthy because it allows applications to be contested and rejected before undergoing formal registration, thereby avoiding the need for litigation.

Pharmaceutical formulas for medications are considered intellectual property and therefore subject to patent protection. These patents are filed with the Mexican Institute of Industrial Property (IMPI). Interestingly, the process of obtaining a patent operates in its own sphere, independent from the legal framework required for acquiring sanitary authorisation.

Sanitary authorisations, on the other hand, are granted by another body altogether – the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). COFEPRIS’s criteria for authorisation are primarily based on the safety and efficacy of the medication in question, with no direct relation to the patent procedure.

In the past, a lack of communication between these two legal bodies led the issuance of sanitary registrations for medications to third parties who did not hold active patents. To address the need for improved communication and collaboration, the Mexican authorities are establishing a system of collaboration, cooperation and communication between the two bodies.

In 2010, the Mexican Supreme Court ruled that formulation patents must be included in the Gazette of Allopathic Medicinals, as they pertain to medicines containing an active ingredient. This led to the inclusion of pharmaceutical formulation patents in the Gazette from 2012 onwards.

COFEPRIS verifies the safety and efficacy of pharmaceutical formulas for the treatment and prevention of specific diseases and conditions. Simultaneously, IMPI has taken steps to enhance the implementation of the collaboration system to prevent violations of exclusive rights. The collaboration system aims to delineate the responsibilities of both authorities, with IMPI publishing a Gazette containing information on active patents for allopathic medicinal products.

Although the Mexican Supreme Court’s ruling focused on the responsibilities of IMPI, the collaboration system should be understood as a unified system, involving both IMPI and COFEPRIS. COFEPRIS, for its part, is responsible for reviewing the list of product patents and making rulings to deny or suspend any sanitary registrations for active ingredient patents published in the Gazette until the patents expire. COFEPRIS is also required to assess any products listed in the Gazette based on their active ingredient.

However, the efficacy of this system hinges on COFEPRIS performing its duties with precision and diligence. If COFEPRIS fails to perform its duties, patent owners are forced to approach different authorities to ensure that their rights are respected.

In 2022, to address these concerns and further enhance the system, a mechanism was introduced empowering patent owners to formally contest sanitary registration application procedures before they are granted, without having to resort to litigation.

The collaboration system is expected to evolve and improve. In the past, sanitary registrations were granted for products that infringed on active patents. Under the new system, unfair sanitary registration applications can be rejected before being granted.

A truly effective collaboration system requires active participation from patent owners and a greater commitment from administrative authorities to respect judicial precedents, thereby discouraging the practice of pharmaceutical patent infringement.