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The Mexican Linkage System

The main objective of this Linkage System is to establish an inter-authority communication channel between the Mexican Institute of Industrial Property (“IMPI”), the Mexican authority responsible for evaluating and granting patents, and the Federal Commission for Protection against Sanitary Risks (“COFEPRIS”), the regulatory authority responsible for granting marketing authorizations for medicaments in Mexico.

This communication channel, unique in Latin America, was established in order to enforce the rights of exclusive commercial exploitation granted to a patent holder, and prevent the issuance of marketing authorizations that overlap with the scope of protection granted to a medicament related patent, thereby creating a mechanism that guarantees the rights for both the applicants requesting a marketing authorization and the owners of medicament related patents.

The United Nations has established that the protection of intellectual property is a basic human right, and one of the goals to achieve with this Linkage System is to exercise the rights conferred by a medicament related patent.

It is known that the assertion of the rights granted by a patent may result in lengthy and costly procedures, regardless of whether the patentee is a large, medium, small, domestic or foreign company.

Hence, this linkage system in principle sets for an equal exercise of these rights for the holder of a patent related to a medicament.

Clarke Modet & Co., as a GLOCAL company, is committed to encourage and integrally assist foreign and national industries in the acquisition and assertion of intellectual property rights, through the different figures of protection such as patents, trademarks, industrial secrets, plant varieties, etc., including the best ways of using tools such as Linkage System, in order to maximize the protection of their intangible assets.

Since its implementation in 2004, the Mexican Linkage System has slowly been established as a useful tool in the exercise of rights granted to a medicament patent.

At the beginning, the system was restricted to patents covering active pharmaceutical compounds, nowadays this system also applies to patents related to formulations, therapeutic indications, polymorphs, salts, among others.

Nonetheless the above, a long journey still awaits to reach an optimal system: A harmonized patentability criteria will be needed in order to prevent the granting of patents that do not fulfill the minimum patentability requirements, the implementation of an effective opposition system, additional figures of protection such as patent term extensions, more comprehensive clinical data protection, and others, in order to provide the innovative industry with more incentives to continue their search for new technologies.

The signing of international treaties such as The Trans Pacific Partnership Agreement (TPP), bring new edges that pose a light in reaching the goals for the establishment of better instruments for IP prosecution and enforcement in Mexico.

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Carmen Sánchez-Puelles