Ten years of the linkage system

The linkage system is defined as an exchange information system between the COFEPRIS, the entity responsible for the granting of health registrations for drugs, and the IMPI, the one responsible for granting a patent right to a product.

The linkage system is defined as an exchange information system between the Federal Commission for Protection against Health Risks (COFEPRIS), the entity responsible for the granting of health registrations for drugs, and the Mexican Institute of Industrial Property (IMPI), the one responsible for granting a patent right to a product.

Article 167-bis of the Health Law Regulations (RIS) establishes some guidelines with the purpose of regulating the exchange of information, including:

• Requiring evidence of the ownership or licensee of an active substance patent;
   
• The obligation of IMPI to issue a list of products covered by a patent in force; and
   
• The possibility that a third party interested in obtaining a health registry for a patented active substance of an allopathic medicinal product may be able to perform the studies, tests and corresponding experimental production, within three years prior to patent expiry, even though the health registration will be granted until the patent expires.

However, almost 10 years after this system came into effect, there are still certain peculiarities related to its application and interpretation.