Mexico City, February 18th 2025.
The Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) have presented a draft agreement aimed at establishing a technical collaboration framework to strengthen the protection of patents related to allopathic and biotechnological medicines. This draft was published, February 12, 2025, in the National Commission for Regulatory Improvement (CONAMER).
The draft establishes that IMPI will publish a semi-annual list of invention patents that may be used in allopathic and biotechnological medicines and that remain in force at the time of their publication in the Industrial Property Gazette. This list will include detailed information such as the generic name or internationally recognized name of the drug or biopharmaceutical, the specific description of the drug, the chemical name, the patent number, its validity, the payment of annuities, the patent holder, licenses and sublicenses, the protection category, relevant observations, and an electronic link to the patent title or file. The inclusion of the protection category is a new feature.
Additionally, the draft establishes a technical cooperation mechanism between IMPI and COFEPRIS. When COFEPRIS receives a marketing authorization application for a medicine, it may request information from IMPI regarding active patents related to the medicine in question. The request from COFEPRIS must include at least the following:
I. The date and progressive file number of the application assigned by the Commission;
II. The generic name or active ingredient(s);
III. The chemical name;
IV. The chemical structure;
V. The formulation of drugs or biopharmaceuticals and additives;
VI. The pharmaceutical form;
VII. The route of administration;
VIII. The intended use;
IX. The therapeutic indication;
X. The characteristics of the drug, biopharmaceutical, or active substance;
XI. Any observations deemed necessary by the Commission, when applicable;
XII. Any supporting documents deemed necessary by the Commission; and
XIII. The Third-Party Opposition Form (FOT) for a Marketing Authorization Application for a Generic or Biocomparable Medicine before COFEPRIS, if applicable.
The information contained in sections V, IX, X, and XII may be classified as confidential, in accordance with Articles 167 bis of the Regulations, 168 of the Law, and 113 of the Federal Law on Transparency and Access to Public Information.
IMPI, in turn, will provide a response that will include, when applicable, the following information:
- The date and progressive file number of IMPI’s response.
- The active patents that are significantly related to the formulation of drugs and additives; or, if none are found, a statement indicating that no active patents were identified that protect the compound under the consulted generic name, nor any significantly related to the formulation of drugs and additives mentioned in the request.
- Any observations deemed necessary by IMPI, when applicable.
- The technical analysis of the active patents that are significantly related.
- The active patents related to the formulation of drugs or biopharmaceuticals and additives mentioned in the request, but which, upon analysis, are determined not to correspond with the compound or the formulation of drugs and additives indicated in the request.
- In cases where IMPI is unable to issue a conclusion due to a lack of sufficient technical information to determine the correspondence between a patent and the information provided in the request, this circumstance will be specified in the conclusion section of the response to COFEPRIS.
This draft represents progress in the protection of intellectual property rights in the pharmaceutical sector, as it more clearly defines the information that will be exchanged between IMPI and COFEPRIS. The inclusion of the therapeutic indication in the information that COFEPRIS submits to IMPI is an important step, as it allows for a more precise evaluation of pharmaceutical use patents.
However, it is important to note that this draft is not yet fully aligned with Article 20.50 of the USMCA (United States-Mexico-Canada Agreement). This article establishes the need for 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. While the current draft improves transparency and technical cooperation, it does not establish a pre-marketing notification mechanism, which is a key requirement of the USMCA.
In conclusion, while this draft is a positive step toward greater clarity and protection of intellectual property rights in the pharmaceutical sector, further work is needed to fully align Mexican practices with the international obligations established in the USMCA.
Sincerely,
Claudio Ulloa
culloa@basham.com.mx
Mariana González
mgonzalez@basham.com.mx
