New Decree for Patent Linkage by the Mexican Government.

March 24, 2025

On March 6, 2025, a Decree providing guidelines about the technical collaboration between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for Protection against Health Risks (COFEPRIS) was published in the Federal Official Gazette. This Decree follows the draft published on February 12, 2025, noted in our newsletter dated February 19, 2025. https://www.olivares.mx/draft-of-decree-for-patent-linkage-by-the-mexican-government/.

In brief, the key points of the Decree under report are the following:

• Establishing the rules for communications between IMPI and COFEPRIS.
• Guidelines for new “forms,” which will be published on the official web site of both authorities. Up to the date of circulation of this newsletter, these “forms” have not been published yet.
• The information that should be included in the Allopathic Medicines Gazette and the corresponding technical communications between COFEPRIS and IMPI.
• COFEPRIS will publish a list of Marketing Authorizations (MA) Applications for generics and biosimilars. This list (with no rules on temporality and forms) will be considered as a warning to the public for purposes of detecting potential harm to patent rights.
• In case of potential harm to patent rights, an opposition “form” can be filed by the patent owner or its licensee and/or sublicensee before COFEPRIS within the statutory term of 10 working days after the publication date of such list.
• The communication rendered by COFEPRIS to IMPI, concerning the technical communication should attach the “opposition form”, along with the information provided by the patent owner or its licensee and/or sublicensee.

The most relevant provisions included within the decree are the publication of the list of MA applications and the “opportunity” to file an opposition by the patent owner if he considers that a patent right is affected by the MA applications.

The Decree is legally founded on certain provisions of the IP Law, Health Regulations, and the USMCA. It seems that the decree intends to comply with the provisions of the USMCA, where it is provided that if a person/company (patent owner) is directly affected by a proceeding, in this case, the MA applications, they must be given with a reasonable opportunity to present facts and arguments, prior to issuing the corresponding decision on the MA application.

In OLIVARES, we consider that the USMCA establishes the burden to the State Party to provide the corresponding notice to the patent holder who would be directly affected by the marketing authorization application proceeding, on the contrary, this Decree imposes on the patent holders the burden of identifying themselves as affected parties without being personally notified by COFEPRIS or IMPI.

In addition, it seems that the opposition opportunity will take place before COFEPRIS and not IMPI, even though IMPI is the patent office, i.e., the authority that handles the information related to the owner or its licensee and/or sublicensee, namely, those who could be directly impacted by the patent linkage mechanism. Nevertheless, it is expected that the details of this matter should be described later, through other official texts.

The guidelines provided are a step forward in the Mexican Linkage System, as it clarifies the information to be exchanged by these authorities. Nonetheless, for the reasons commented, we consider that the Decree does not observe the obligations of proper notice established in the USMCA for the Mexican Patent Linkage. This conclusion could be summarized in the sense that the legal burden, obligations, and formalities of a notice process are different from an opposition system.

The Decree will come into force within the next 60 working days of its publication; namely, it will enter into force on June 3, 2025.

At OLIVARES, we will continue to follow up on the upcoming changes and application of this Decree, and we will keep our clients closely informed on this matter, monitoring how the decree will be implemented within practice.