As informed in our Newsletter No. 109, it is expected that the new Federal Law on Protection of Intellectual Property (LFPPI) will enter in force in November of this year.
The LFPPI establishes that the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (regulatory agency / COFEPRIS), participate jointly in the design and implementation of the patent linkage system related to allopathic medicines.
The law has granted a term of 120 business days after publication of the law, thus by December of this year, through the issuance of the respective regulation by the Executive and / or through the issuance of General guidelines by of COFEPRIS and IMPI the rules of the patent linkage will be issued in the regulation.
The current patent linkage system consists on the biannual publication in the IMPI Gazette of the list of drug patents, as well as the intra-governmental communication that must exist between COFEPRIS and IMPI, prior to granting sanitary registrations for allopathic medicines, is currently regulated at the regulatory level, both by the regulations of the current Industrial Property Law and the Health Supplies Regulation.
In the new LFPPI, the support of the linkage system has been elevated to the rank of Federal legislation, establishing, in similar terms to the current ones, that the publication in the gazette of the list of allopathic medicine patents must be biannual and that it should occur coordination between IMPI and COFEPRIS for the operation of said linkage system.
The LFPPI establishes that the publication of said list must 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.
The scope of the linkage system will surely be modified in the new regulation of the LFPPI, and it is expected that new phases will be included such as the notice or hearing to the patent owner, as established by the USMCA/TMEC, a situation that had left the system in debt since its implementation in Mexico.
Whatever would be the format and regulation of the new linkage system, it is expected and OLIVARES will promote that the system fulfills its original function and nature which is to avoid the violation of exclusive rights of allopathic drug patents, including active ingredients, formulations and its medical uses.
We will be attentive to the implementation process of the new linkage system and we will be sending our communications about it.
Originally published by Olivares, August 2020
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.