New IMPI–COFEPRIS Collaboration Agreement

Mexico’s IMPI and COFEPRIS are launching a new technical collaboration to improve coordination around the authorization of generic drugs and biosimilars.

On June 3, 2025, the new Agreement establishing a technical collaboration mechanism between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of Mexico will enter into force. This agreement aims to exchange information related to the marketing authorization (MA) of generic drugs and biosimilars. The forms for exchanging this information will be available on the IMPI and COFEPRIS websites. The Agreement guarantees that the MA process is carried out correctly, protecting the confidentiality of the information involved.

Key points of the agreement are:

The IMPI will publish a semi-annual list (and extraordinary updates if necessary) of patents for inventions related to allopathic and biotechnological medicines that are in force, excluding patents that protect a process. This list will include details about the patents, such as the chemical name of the active ingredient, its ownership, validity, patent number, and other relevant characteristics.

COFEPRIS will inform the general public of applications for MA of generic drugs and biosimilars so that, if an interested party believes their patent rights are being infringed by a MA application, they may file an “Affected Third Party Opposition” (FOT) to said MA with COFEPRIS within 10 business days.

When COFEPRIS requires technical cooperation from IMPI, it will send a detailed request that must include information on the active ingredient, formulations, therapeutic indications, and other related details, and, where applicable, the FOT. Some of this information may be classified as confidential.

IMPI will respond to the COFEPRIS request, providing information on the patents related to the requested medicament, indicating whether or not there are patents protecting the compound in question, or related to the formulation of drugs and additives, and providing a technical analysis if necessary. In cases where the IMPI cannot determine the correspondence between the information indicated in an request and a patent, this circumstance will be indicated in the conclusions section of the response to COFEPRIS.

This agreement seeks better coordination and transparency among authorities to ensure that medicines entering the market are properly registered and do not infringe existing patents.