iRecently, the Mexican regulatory agency empowered to approve drugs, medicines, and other regulated products and services in Mexico, COFEPRIS, published the following on its website, in connection with Patent Linkage Regulation in Mexico:
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An updated list of generic and biosimilar applications, including general information, such as the date of application, applicant name, generic name, pharmaceutical form, and publication date; and
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A format to oppose the generic or biosimilar applications based on an existing patent or patents in force.
It is encouraging to see the regular updating of the list of generic and bio-comparable applications, a practice which had been on pause over the last couple of years. It is considered a positive development that COFEPRIS resumed this activity, in compliance with its publicity and transparency obligations established in the legislation, mainly in the Health Law.
Regarding the second publication, the “opposition format”, COFEPRIS appears to be exploring ways to comply with the notice requirement established in the USMCA as a condition of the Mexican Patent Linkage Regulation.
It was not until now that the Mexican Patent Linkage Regulation even contemplated the notice of the patent holder during the patent linkage process. Read more about this here.
COFEPRIS seems to be demonstrating good will with the new opposition process currently under comment, and it appears to be attempting to comply with the USMCA notice obligation in linkage regulation. However, when analyzed, it seems that the publication of the process on its website does not comply with the required administrative and legal formalities to be valid and have legal effect.
In addition, on-depth review, the publications would not fulfill the legal standard of proper notice, as these publications carry the burden of detecting and alerting COFEPRIS of an eventual patent violation to the patent holder. Whereas, in the patent linkage system, COFEPRIS has the obligation to observe the patents listed in the linkage gazette and initiate the preventive administrative mechanism of patent linkage.
The obligation provided in the USMCA in connection with patent linkage should consist of the proper notification by the authorities (COFEPRIS and/or the Mexican Patent Office) to the patent holders, prior to the approval of the generic or biosimilar application. That is, the authority is the one who has the obligation to notify the patent holder, not the other way around.
In essence, the publications suggest an opposition system. The patent holder has the high burden to detect and alert COFEPRIS in 10 working days of an eventual violation of the patent listed in the linkage gazette, by comparing a list of generic and bio-comparable applications with limited information regarding the formulation and specifics of the approval application to have enough elements to claim an eventual patent violation. Certainly, this is not a notification system wherein a proceeding impacting an interested party has been initiated by the authority, which would appear to be the rationale behind the notice obligation provided in the USMCA.
