THE MEXICAN LINKAGE SYSTEM


To understand the patent linkage system in Mexico, it is essential to refer to the provisions of Article 25 of the Industrial Property Law, which indicates that to be included in the programme the patent must be for the nature of a product or a process. Tis means the exclusion of formulation and new-use patents.


Te main problem with the patent linkage system in Mexico is that Article 47 Bis of the regulations was ambiguous and subject to interpretation as to which patents were to be included in the Gazette. Taken literally, Article 47 Bis excludes only patents that solely claim a new process. However, in


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practice, the Mexican authorities adopted another interpretation and, to date, the IMPI allows only patents that claim compounds (that is the active substance of a medicine) per se and not patents that claim formulations (that is the mix of components in a medication) or its uses (the specific therapeutic indications of a medicine).


Supreme Court’s decision


Aſter several proceedings before federal courts, the Supreme Court of Justice (the supreme judicial authority in Mexico) looked at the matter of interpretation and at how to decide on the proper


interpretation of the provisions of Article 47 Bis of the regulations.


Te Supreme Court issued a majority decision, supporting the broad interpretation: that it includes not only compound patents but also patents claiming pharmaceutical formulations. Te justices claimed that the spirit of the linkage system is to provide a simple channel of communication between IMPI and COFEPRIS to avoid the issuance of MAs to products that infringe patents. It further ruled that pharmaceutical products (drugs) are not comprised solely of their active substance but also of


the entirety of ingredients that World Intellectual Property Review Annual 2014


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