Adjusting Patent Terms Due to Health Authority Delays: A Necessary but Still Inecffective Mechanism in Mexico

April 10, 2026

It is a constant feature of the Mexican legal system—and of many other systems—that domestic regulations evolve at a slower pace than the obligations arising from international treaties, which typically establish minimum standards that the member States must implement in their domestic law, adapting them to their own regulatory context. In the field of intellectual property, this dynamic is particularly evident.

Under the Treaty between the United Mexican States, the United States of America, and Canada (USMCA), specifically in Chapter 20 on intellectual property rights, clear obligations are established to compensate patent holders for losses in effective protection time resulting from unreasonable delays attributable to their home authorities. Thus, Article 20.44 provides for adjustments for delays in the grant of patents, while Article 20.46 extends this logic to delays incurred within the process of granting marketing authorizations (MA), particularly relevant for pharmaceutical products.

This concern is not new. Since the North American Free Trade Agreement (NAFTA), Article 1709.12 already contemplated the possibility of extending patent protection to compensate for administrative delays; however, that provision was precisely that: “a possibility,” which, naturally, allowed the member States to freely decide whether or not to grant such compensation. In that context, Mexico chose not to exercise this power, maintaining a system without mechanisms to compensate for such delays.  It was not until the entry into force of the USMCA that this approach became an inescapable legal obligation, as it expressly established that the States must provide for means to adjust the term of patents in the face of unreasonable delays—now not only in their grant but also for delays incurred within the processes for granting MA.

In Mexico, the Federal Law on the Protection of Industrial Property (FLPIP) of 2020, partially incorporated these obligations by introducing the system of supplementary certificates. However, in its original version, this mechanism was limited to compensating for delays attributable to the Mexican Institute of Industrial Property (IMPI) during the patent application process, excluding those resulting from the actions of the Federal Commission for the Protection against Health Risks (COFEPRIS).

However, this omission was partially corrected through the amendment to the FLPIP published on April 3, 2026, which added Article 136 Bis, introducing a new ground for a complementary certificate; allowing the term of a patent to be adjusted when there is an unreasonable delay in the granting of the corresponding MA by the health authority, that is, COFEPRIS.

Thus, Article 136 Bis establishes a mechanism in which the health authority plays a central and catalytic role. Indeed, it follows from the legal text itself that, once said authority determines the compensatory period resulting from an unreasonable delay in the granting of the MA, it will be the authority itself that requests IMPI to issue the supplementary certificate. Subsequently, the new article provides that the IMPI will notify the patent holders so that, within one month, they make the corresponding payment, after which, if applicable, the certificate adjusting the patent’s term for up to a maximum of five years will be issued.

On paper, the design appears consistent with Mexico’s international commitments. However, in my view, its implementation faces technical, legal, and operational obstacles that seriously compromise its effectiveness and applicability.

The first of these concerns the activation of the mechanism itself. Based on a literal interpretation of the provision in question, the issuance of the supplementary certificate does not depend on the patent holder or the holder of the relevant health registration, but rather on the health authority itself. That is to say, under the new Article 136 Bis, it is not the individual who directly requests the certificate, but rather the entire procedure is triggered by an action on the part of COFEPRIS, consisting of determining the compensatory period and subsequently requesting IMPI to issue the certificate.

This design poses an obvious practical problem: it is highly unlikely, if not impossible, that the authority, on its own initiative, would acknowledge the existence of unreasonable delays in its own procedures and, consequently, promote the issuance of a compensatory mechanism resulting from such delays. This is not only due to its already standard excessive workload, but also to the very fact that, if such a request were issued, COFEPRIS would be expressly acknowledging, under no uncertain terms, the commission of punishable administrative offenses.

Added to this is a second problem: the lack of a legal mechanism allowing an individual to urge the health authority to issue such a determination. Currently, there is no procedure in Mexican health regulations that allows for a formal request for the determination of compensatory time due to unreasonable delay, much less compels the authority to rule on the matter.

Even if, hypothetically, a mechanism for private individuals to make such a request existed, the wording of Article 136 Bis suggests that the final decision on whether or not to issue the supplementary certificate rests with the health authority itself, which introduces a wide margin of discretion and reinforces the system’s structural dependence on the regulatory Authority’s will.

Finally, and as a third issue, two even more serious problems remain in terms of legal technique: (i) the absence of a procedure to determine unreasonable delay and (ii) the lack of a regulatory framework that grants express powers to the health authority to issue such determinations and requests. In a system governed by the principle of legality, under which authorities may only act within the scope of powers conferred upon them by law, this absence of regulations is, in my view, insurmountable.

Consequently, the mechanism provided for in Article 136 Bis, although laudable in its purpose and aligned with international standards, currently lacks the minimum conditions for operability. Without a clear and direct procedural pathway for individuals to access this compensatory benefit and without clear powers on the part of COFEPRIS to initiate the procedure before IMPI, the system is, in fact, incomplete.

Thus, unless the applicable health regulations are amended to provide COFEPRIS with a clear procedural and discretionary framework to assist in this new procedure, or the design of the mechanism itself provided for in Article 136 Bis of the FLPIP is not rethought—so that access to the supplementary certificate can be requested directly by the patent holder, without depending on the health authority—the adjustment of the term of validity due to regulatory delays runs the risk of becoming what we know in legal jargon as “dead letter”.