By Marco Tena
On March 6, 2025, the new collaboration mechanism between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation in order to strengthen patent protection in the pharmaceutical industry.
This agreement establishes guidelines on the transmission of information to be handled in sanitary registration applications to guarantee the observance of industrial property rights, a matter that COFEPRIS did not previously do during the procedures at the time of granting a sanitary registration for the commercialization of pharmaceuticals.
The agreement creates a formal procedure for the evaluation of patents applicable to medicines. COFEPRIS will make a publication to the general public of the applications for sanitary registration of generic or biocomparable medicines, so that any third party that considers its granting could violate any patent right by means of the Form of Opposition of Affected Third Party (FOT) within 10 working days, which will be sent with the application to IMPI for its study. IMPI will issue a resolution based on
This new collaboration scheme between IMPI and COFEPRIS represents an important advance in the protection of pharmaceutical patents, provides greater legal certainty to holders and allows them to act in the event of possible infringements. However, it may also imply challenges in terms of time and additional procedures in the authorization of new drugs.
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