Adjustment of Patent validity due to COFEPRIS delays

June 17, 2026

In a previous article published on April 10, 2026 of this newsletter, we reviewed the amendment to the Federal Law for the Protection of Industrial Property (LFPPI) published on April 3, 2026, which introduced Article 136 Bis. This article, for the first time in Mexico, incorporates the possibility of adjusting the term of a patent when there are unreasonable delays in the granting of a health registration processed by the Federal Commission for the Protection Against Health Risks (COFEPRIS). This marks an important step toward fulfilling Mexico’s international commitment under the USMCA (Article 20.46).

We had pointed out, however, that this mechanism was incomplete in that previous publication. The law established the “what,” but not the “how.” Specifically, regulatory adjustments were lacking within the health authority that would allow the COFEPRIS to determine the compensatory time as a result of such delays. This is an essential first step so that the Mexican Institute of Industrial Property (IMPI) could, in turn, issue the corresponding supplementary certificate.

These regulatory adjustments were not long in coming. On April 24, 2026, an amendment to the Health Supplies Regulation was published in the Official Gazette of the Federation, which added Article 166 Bis 1 through Article 166 Bis 5. With these additions, the compensation mechanism for health authority-related delays now has clear procedural guidelines, marking an important step toward its practical implementation.

Based on a combined reading of Article 136 Bis of the LFPPI and these new regulatory provisions, the procedure for obtaining a supplementary certificate due to health authority-related delays can be summarized as follows:

1. Once a health registration has been obtained, the registrant has 60 business days from the date of notification to file an application for compensation with the COFEPRIS for unreasonable delays.

• The application must include the dates of the proceedings, arguments accrediting the unreasonable delay, and must identify the affected patent, which should have been specified from the outset of the procedure.

2. COFEPRIS will review the request and may request clarifications, if necessary, on a one-time basis. These must be provided within a period of 5 business days. The application will be dismissed if the request is not complied with.
3. Once the request for compensation has been analyzed, the COFEPRIS will determine if there are attributable, unreasonable delays. If the determination is favorable, the patent holder and the IMPI will be notified of the decision in order to issue the supplementary certificate, excluding any periods considered as reasonable delays.

This is where the scope of the Health Supplies Regulation ends. Once the IMPI has been notified of a favorable decision for the compensation request, Article 136 bis of the LFPPI comes into effect. The steps that follow are:

4. The IMPI will notify the patent holder to pay the corresponding fees within one month.
5. If the patent holder fails to make the payment, the term extension will be deemed as waived.
6. Once payment is made, the IMPI will issue a supplementary certificate acknowledging the extension of the patent’s term. (This extension will take effect at the end of the patent’s original term and may not exceed five years.)

As can be observed, this procedure is structured as a two-stage process: the first technical stage, handled by the COFEPRIS, and the second formal stage, handled by the IMPI.

This regulatory development corrects one of the main shortcomings of the original intent: the absence of a mechanism allowing the patent holder to initiate the process. Now the holder of a health registration has a direct avenue to request compensation for the term of a patent whose term of exploitation was limited by the COFEPRIS’s unreasonable delay, which undoubtedly strengthens the system’s applicability and provides tools to enforce it.

It is important to highlight the following:

First, although the regulation does not specifically define what constitutes an “unreasonable delay,” it does incorporate a significant step forward by establishing in Article 166 Bis 4 what can be considered a reasonable delay. In general terms, such delays may include periods attributable to the applicant themself, including the time taken to address the authority’s requests (notices), delays resulting from unsuccessful appeals, as well as those caused by force majeure or unforeseeable circumstances.

On this basis, the concept can be defined through a process of elimination, i.e., any time not included within these circumstances and that can be attributed to the authority may be considered an “unreasonable delay,” provided that it exceeds the maximum response time applicable for each procedure (see Article 166 of the RIS). While this approach does not completely eliminate the ambiguity or vagueness of the concept of “unreasonable delay,” it does significantly narrow its scope.

Nevertheless, the practical application of these criteria will still depend on how the authority interprets and codifies them into internal guidelines and criteria, which leaves some room for uncertainty.

Finally, it must not be overlooked that the decree itself establishes, in the third transitional article, that the Secretary of Health must make additional regulatory and administrative adjustments for the proper implementation of this system, such as the issuance of guidelines, technical criteria, and operational rules, to ensure its consistent application in practice. In this context, to ensure that the mechanism is fully operational and to prevent potential challenges to it, it is necessary for these adjustments to include the strengthening of COFEPRIS’s jurisdictional framework by expressly incorporating powers into its regulations that allow it to issue this type of determination. This will inevitably involve aspects of industrial property that, by their nature, exceed the COFEPRIS’s natural scope of jurisdiction.

In this context, the adjustment of a patent term due to health authority-related delays ceases to be purely declaratory and becomes an operational system whose effectiveness will depend, to a large extent, on how the supplementary provisions are developed and how both the COFEPRIS and the IMPI apply them in specific cases.