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It is expected that on November 5, 2020, Mexico’s new Federal Law on Protection of Intellectual Property (LFPPI) will take effect.  Pursuant to the LFPPI, the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (namely, the regulatory agency known as COFEPRIS), will participate jointly in the design and implementation of a new patent linkage system for allopathic medicines.

It is expected that by approximately December 17, 2020: (i) a regulation will be issued by the Executive branch of the Mexican Government; and/or (ii) General guidelines will be issued by COFEPRIS and IMPI, that will provide the rules regarding this new patent linkage system.

The current patent linkage system requires: (1) bi-annual publication in the IMPI Gazette of a list of allopathic medicine patents; and (2) that intra-governmental communications between COFEPRIS and IMPI occur prior to the granting of any sanitary registrations for allopathic medicines.  The current linkage system is regulated by regulations under the current Industrial Property Law and the Health Supplies Regulation.

Under the new LFPPI, support of the patent linkage system will be elevated to that of Federal law instead of merely legislation (under the Mexican legal system, laws, such as Federal laws, have a higher hierarchy than regulations).  Thus, the new patent linkage system will require,  somewhat similarly to the current linkage system, the following:  (1) bi-annual publication in the IMPI gazette of the list of allopathic medicine patents; and (2) that such publication occur as a result of a coordinated effort between IMPI and COFEPRIS in the operation of the linkage system.

The LFPPI also establishes that publication of the list be carried out in accordance with the current Health regulations, which may trigger different interpretations from those already made in the past by the Mexican courts.

It is expected that the scope of the linkage system will be modified based on the new regulations to be issued.  For example, it is anticipated that the linkage system will include new requirements or obligations, such as a requirement that notice be provided to the patent owner, or that the patent owner be permitted to conduct a hearing, as established by the U.S.-Mexico-Canada Trade Agreement (USMCA)/El Tratado entre México, Estados Unidos y Canadá (TMEC).

Currently, there are several legislative initiatives currently being studied and under discussion in advance of the LFPPI coming into effect.  These legislative initiatives seek to provide limitations on the scope of the new linkage system.  These efforts demonstrate that there are lobbing efforts underway by various stakeholders and associations to define certain inclusions or limitations into the final version of the new linkage system.  In fact, on August 19, 2020, an announcement was made that COFEPRIS: (i) is no longer considered to be an autonomous government entity (up until August 19, 2020, COFEPRIS was a decentralized agency of the Ministry of Health and in charge of the control and surveillance of all aspects related to sanitary regulations (i.e., drugs, medical devices, health services, food supplements, food and beverage, cosmetics, pesticides, clinical studies, etc.), with administrative, technical and operational autonomy), but instead is now dependent on the Undersecretary for Prevention and Promotion of Health); and (ii) issued new rules “announcing” that “use” patents will no longer be considered under the patent linkage system.  The formal rules for items (i) and (ii) have not yet been published, thus, we are unable to know the basis or rational behind this announcement; however, this is an example of the trend of the Mexican government to limit the patent linkage system to compound patents only.

Please continue to watch BRICS & Beyond for updates on the new patent linkage system in Mexico.

This post was written by Lisa Mueller and José Alejandro Luna Fandiño of Olivares.

 

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