Mexico City, March 10 2025
On March 6, 2025, the Official Gazette of the Federation (DOF) published an agreement (the “Agreement”) outlining the provisions for collaboration between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Health Risks (COFEPRIS). The Agreement formalizes and details the technical cooperation mechanism between both institutions regarding patents for allopathic and biotechnological medicines.
IMPI will continue to publish a biannual list in the Industrial Property Gazette of valid patents applicable to allopathic and biotechnological medicines (Linkage Gazette). This list will include:
- The generic name or internationally recognized name of the active principla, biopharmaceutical, or active substance.
- The specific description.
- The chemical name of the active principle or biopharmaceutical, or the active substance.
- The patent number.
- The patent validity period.
- The payment of annuities at the time of publication of the list.
- The patent holder.
- The license(s) and sublicense(s), if applicable.
- The protection category.
- Any relevant observations, if applicable.
- The electronic link to the patent title or file.
In this case, it is new that the protection category is included.
IMPI may issue extraordinary publications in the Gazette, which will be incorporated into the most recent biannual list. The latest publication of the list in the Gazette will replace the previous one. The list will not include patents protecting only processes. Additionally, certain information will be kept confidential in accordance with the Federal Law on Transparency and Access to Public Information.
For its part, COFEPRIS may request IMPI to provide information on valid patents related to medicines undergoing sanitary registration. To do so, it must submit a request including:
- Date and sequential reference number of the request.
- Generic name or salts of the active principle.
- Chemical name and chemical structure.
- Medicine formulation, including additives.
- Pharmaceutical form and route of administration.
- Usage considerations and therapeutic indication.
- Characteristics of the active principle or biopharmaceutical.
- Relevant observations and annexed documents.
- Third-Party Affected Opposition Form (FOT), if applicable.
Additionally, COFEPRIS will publish lists of applications for the sanitary registration of generic or biocomparable medicines, granting a 10-business-day period for third parties to submit oppositions through the FOT. IMPI will then respond to COFEPRIS’s requests by providing information on valid patents that may be related to the medicine in question.
IMPI, in turn, will provide a response that, where applicable, will include:
- The date and sequential reference number of the response issued by IMPI.
- The valid patents directly related to the formulation of medicines and additives, or, if applicable, a statement that no valid patents providing protection to the compound with the consulted generic name, nor significantly related to the formulation of medicines and additives stated in the request, were found.
- Any observations IMPI deems necessary, if applicable.
- The technical analysis of the valid patents directly related.
- The valid patents related to the formulation of medicines or biopharmaceuticals and additives subject to the request, but for which the analysis concludes that they are not related to the compound or the formulation of medicines and additives stated in the request.
- In cases where IMPI cannot reach a conclusion due to insufficient technical information to determine the correlation between a patent and the information provided in the request, this situation will be specified in the conclusion section of the response to COFEPRIS.
The Agreement represents progress in inter-institutional coordination and provides greater clarity on patent protection in the pharmaceutical sector, as it establishes a more transparent exchange of information between IMPI and COFEPRIS. The inclusion of the therapeutic indication in the information COFEPRIS sends to IMPI is a significant step, as it allows for a more precise evaluation of pharmaceutical use patents.
It still does not, however, fully align with article 20.50 of the USMCA (United States-Mexico-Canada Agreement). This article requires a system that notifies the patent holder before a pharmaceutical product is marketed, giving them the opportunity to take legal action if they believe their patent rights are being infringed. Although the Agreement improves transparency and technical cooperation, it does not establish a pre-commercialization notification mechanism, which is a key requirement of the USMCA.
The Agreement will come into effect 60 business days after its publication in the DOF.
Sincerely,
Claudio Ulloa
culloa@basham.com.mx
Mariana González
mgonzalezv@basham.com
