In Mexico, COFEPRIS announces new rules for the authorization of generic drugs

August 24, 2020

On August 19, 2020, the regulatory agency in Mexico (COFEPRIS), which as we have indicated in a previous newsletter, will soon be incorporated into the Ministry of Health, losing its status as an autonomous entity, announced new operating rules for the approval of generic drugs in Mexico, based on the following guidelines:

• COFEPRIS will have a special procedures window for the generic pharmaceutical products.
• These applications for approvals of generics could be filed, the day after the granting of the patent related to the innovative medicine.
• The respective applications would be decided at any time, prior to the expiration of the patent, if the registration or approval is given, COFEPRIS will provide a provisional official communication, which would be exchanged for the definitive sanitary registration or approval, the day after the expiration or the validity of the patent.

COFEPRIS indicates that they are complying with the elimination of the temporality of 3 years (for chemically synthesized drugs) and 8 years (for biotechnological) to research and develop generics or biocomparables, according to the reforms to the so-called Bolar Exception in the new Federal Law for the Protection of Industrial Property (New IP Law) which will enter in force by November 2020.

The communication also mentions that the rules for granting sanitary registrations of generic drugs, “second-use patents, which refer to the therapeutic indication, are no longer allowed,” which seems to mean that the patents of new uses will not be considered as part of the linkage system.

We consider that these rules announced by COFEPRIS, are only a statement on its official website, still without legal basis. Likewise, it represents a statement contrary to the patent system, the patent linkage system, the Mexican Constitution and international treaties. It will be necessary to analyze the complete and legal contents and their scope to confirm, if these rules indeed contradict the law.

OLIVARES is monitoring the implementation of these rules and analyzing the scope of the content of this communication.