The Term the State Consumed

Three Collegiate Circuit Courts of Mexico's First Circuit ordered compensation this year for the time the Mexican Institute of Industrial Property (IMPI) — Mexico's patent and trademark office — took to grant. I have read some coverage describing this as patents coming back from the dead. What happened is rather more complicated and rather less novelistic: the legislature created the remedy in 2020 and then withheld it from the patents that had already suffered the harm, which left constitutional litigation as the only door still open.

As I have noted before, my professional practice centres on representing patent holders, a substantial part of it in the pharmaceutical field, so these rulings reach matters of the kind I handle.

Three rulings

On 16 April 2026 the Sixteenth Collegiate Court in Administrative Matters of the First Circuit decided amparo review 386/2025 and upheld the grant of an amparo — Mexico's constitutional protection action — against IMPI's refusal to compensate the time lost from a patent's term. On 3 July the Twenty-Second Collegiate Court did the same in amparo review 818/2025, and that same day the Second Collegiate Court reached an identical result in 175/2026. All three rulings were unanimous.

All three also apply the same criterion of the now-dissolved Second Chamber of the Mexican Supreme Court (Suprema Corte de Justicia de la Nación, SCJN), the country's highest court, handed down in amparo review 257/2020 (the Bayer Healthcare case) on 14 October 2020, from which three isolated theses derived. The central one holds that where delays attributable to the administrative authority arise in granting a patent, its term may not be shorter than seventeen years counted from grant, on a systematic reading of Article 23 of the repealed Industrial Property Law (Ley de la Propiedad Industrial, LPI) together with Article 1709(12) of the North American Free Trade Agreement (NAFTA).

The arithmetic that has caused so much alarm follows from the dates in file 386/2025. The patent issued on 5 September 2012 on an international application filed on 21 December 2005, so twenty years from filing placed expiry in December 2025, while seventeen years from issuance places it in 2029. The gap between those two dates was produced by the six years and eight months IMPI took to decide the file in front of it.

Four regimes and a transitory provision

Understanding how these patents ended up in constitutional litigation requires reviewing four regimes that accumulated over them, none of which reached far enough to cover them. NAFTA, in Article 1709(12), provided that a Party may extend the term of protection to compensate for administrative delays, and that permissive form was always read as a state power rather than a duty — as both the First Chamber held in 2015 and the Second Chamber held in 2020, the latter by five votes and in the very case from which today's doctrine emerged.

On the two later treaties — the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and the United States-Mexico-Canada Agreement (USMCA) — the argument was built by IMPI itself. The authority contended, in amparo review 386/2025, that in implementing both treaties domestically the Mexican State became obliged to create a means of adjusting patent term, unlike under NAFTA, and that such compensation reaches only applications filed after each instrument entered into force, “pursuant to footnotes 08 and 34 respectively”. None of the three courts ruled on that submission, since all three decided the cases under Article 23 of the LPI read with NAFTA.

Footnote 34 to Article 20.44 of the USMCA does say what the authority says it says. As to the CPTPP, however, it bears noting that the decree by which Mexico promulgated it — published in the Federal Official Gazette on 29 November 2018 — carries an Annex whose item 7 suspends the application of Article 18.46, the provision on adjustment for unreasonable granting authority delays, in its entirety and together with its four footnotes, alongside the provisions on test data and biologics.

The Federal Law for the Protection of Industrial Property (Ley Federal de Protección a la Propiedad Industrial, LFPPI) of 2020 finally introduced Chapter VIII, on the supplementary certificate, and with it the administrative remedy was written into Mexican statute for the first time. And the Sixth Transitory Article of the enacting decree expressly excluded from that chapter the patents granted under the repealed statute.

Patents granted under the LPI are precisely the ones now expiring; they are the ones that suffered IMPI's delays at a time when the statute set the office no deadline at all for substantive examination; and they are the only ones the legislature denied the very instrument designed to compensate that delay. The earlier treaty gave a power Mexico never exercised through legislation, the treaty that turned it into an obligation was suspended, the treaty that binds today looks only forward, and the new statute placed a transitory wall in the middle.

It should also be said that the certificate would not have delivered what the courts are now granting. The discussion the transitory provision foreclosed would have been a good deal more modest, since the chapter requires more than five years of prosecution before it applies at all, caps the certificate at five years, and grants one day of term for every two days of unreasonable delay. What was closed to these patents was a door that in any event led to a smaller room — one with rules and a fee schedule.

When IMPI invoked the Sixth Transitory Article in amparo review 175/2026, the Second Collegiate Court dismissed the point because that was not the legal basis the trial judge had relied on. Compensation was granted not under the supplementary certificate regime but under Article 23 of the LPI read with the treaty, which means these matters are now resolved outside the chapter the legislature wrote for them and with the tools of the statute it repealed.

Not an extension, a restoration

Article 53 of the LFPPI, and Article 23 of the LPI before it, provides that a patent has a non-extendable term of twenty years, and a Collegiate Court held, deciding direct amparo 420/2009 brought by a generic manufacturer, that term extension is a figure not provided for in the statute and that the term is non-extendable.

This is precisely where I consider the argument to be mistaken, because the compensation mechanism is not extending a patent, which cannot run beyond twenty years; what it does is bring the patent's protection closer to that statutory term.

The reason is that those twenty years run from the filing date, when the right cannot yet be asserted against anyone, so the holder has only the period remaining once the patent issues. The Second Collegiate Court put it this way in 175/2026: the full exclusive right conferred by a patent is enforceable only upon grant. The holder in file 386/2025 was recognised twenty years by statute, and the office's delay left thirteen years and three months of enforceable right.

Article 1709(12) captures both ways of measuring, since it guarantees a term of protection of at least twenty years from filing, or in the alternative seventeen years from grant. On that basis the Second Chamber held, in thesis 2a. LIV/2020 approved by five votes, that the provision implies recognition of a right in favour of the patent applicant that delays be compensated.

The 2020 legislature understood it the same way when it avoided calling its figure an extension and named it a supplementary certificate, and when Article 134 provided that the certificate takes effect the day after the twenty-year term expires, as a separate title.

The criterion in direct amparo 420/2009, with which this section opened, in fact decided whether Mexico had to recognise a term extension granted in the patent's country of origin, over a registration issued under the Twelfth Transitory Article of the 1991 statute, which itself carried a twenty-year cap; the Collegiate Court held that the transitory provision governs the moment of registration and does not authorise extending it afterwards.

Nominal term and effective term

The twenty years of a pharmaceutical patent are a nominal figure, as anyone who has worked on the industry side knows and as the Mexican State itself documented twenty years ago in Toward a Comprehensive Pharmaceutical Policy for Mexico, published by the Ministry of Health, which devotes a section to the costs and risks of investing in research and development. That document also records the opposing position, held by those who argue the industry's figures are inflated, which does not diminish its value, since no one there disputes the risk.

A patent's clock runs from the filing date, which comes early, when the molecule has not yet been through clinical phases; then come the trials, the regulatory dossier and the marketing authorization, so the possibility of selling appears only at the end. Effective exploitation is what remains once science and the regulator have finished their work, and to that structural discount — which no one disputes, because it is inherent to the system — these cases add a different one: the time the authority took to decide.

A day of pharmaceutical patent term carries real economic value, which is why the argument is so sharp. The legal question, however, is soberer than the economic one. Should the holder absorb the cost of the authority's delay, or should it be absorbed by whoever caused it?

I would summarise the patent system as a bargain, disclosure in exchange for a period of exclusivity, and if the State collects full disclosure and delivers an exclusivity shortened by its own delay, it has not held up its end.

Access to medicines and the right to health (no innovation, no generics)

The access-to-medicines argument is usually presented as though the patent were the obstacle and the generic its solution, which is a short reading. The generic medicine exists because someone patented a molecule, disclosed it in terms sufficient for a third party to reproduce it, and waited for the term to end, so whoever defends the generics industry is also defending, without saying so, the patent architecture that makes it possible. What is in dispute is the date on which its turn begins, which is a legitimate and entirely separate question.

On the balance with the right to health under Article 4 of the Mexican Constitution, it matters who the duty binds. The patent holder is not the principal duty-bearer of that right; the State is, and the State has its own instruments to satisfy it, from consolidated procurement and price negotiation to the public-interest licence under Article 153 of the LFPPI, designed precisely for emergencies and for serious diseases that the General Health Council declares to be of priority attention. Shifting that burden onto a private party by cutting back its title substitutes a public policy with an expropriation that has no basis.

It is worth adding that a system which compensates the regulator's delay is a system that puts a price on its own inefficiency, and that price is the best incentive there is for IMPI to decide on time. The April 2026 reform aims at that, and it is one of the answers to the problem, since for the first time the deadline sits in the statute — one year from the start of substantive examination — and for the first time there is a procedure to enforce it when it lapses. It arrives late for the generation of patents now in litigation, and it arrives with a gap, because no provision sets a deadline for starting that examination, which is exactly the stretch where the six years and eight months of file 386/2025 accumulated.

IMPI's argument, in its own words

It would be easy to caricature the authority, and there is no need, because its grievance on appeal in amparo review 818/2025 strikes me as well built, and I take it as the court recorded it in its ruling, which is the public source.

IMPI argued that there exists de facto “a paralegal mechanism which, without guarantees of legal certainty and security, abuses the ruling in amparo review 257/2020”, and that the lack of clarity “on matters such as the period for claiming a delay, the fee, the burden of proof, the relationship between the compensation period and the delay, and situations not counted as delay, has fostered an abuse of right, in many cases without even proving the delays claimed”. It added that the outcome runs against “the legal certainty and security imposed by Article 28 of the Constitution, since it prevents the invention at issue from being freely used by any person as the Constitution commands”, with the resulting effect on the price of an essential good and on the right to health.

Without conceding that it is sound, the constitutional argument is at least interesting, since Article 28, in its tenth paragraph, authorises inventors' privileges precisely as a temporary exception to the prohibition of monopolies, from which it follows that temporariness is a condition of the regime's legitimacy. All three courts dismissed it because the Second Chamber's criterion had already examined the constitutional regularity of the figure, and thesis 2a. LIV/2020 holds that compensating delays does not violate legality, equality, access to impartial justice or legal certainty.

The part of the grievance that no existing criterion answers, however, is the first, and it is the one I could agree with, because there are indeed no rules on the period for claiming, the burden of proof, the fee or the catalogue of delays that do not count. Yet the four things IMPI misses are today provided for in the statute. The period and the exact moment to request it are in Article 129, the burden of arguing admissibility in Article 130(II), the fee in Article 130(III), and the catalogue of delays that do not count — what the legislature called reasonable delays — in Article 132. All of them sit in the chapter the Sixth Transitory Article closed to patent holders, so IMPI is describing with precision a vacuum it did not create, one the statute resolved for everyone except these files, and against which it defends itself case by case.

The good-faith third party and the cautionary entry

The objection to these rulings is practical. A third party that entered the market holding a valid marketing authorization, looking at a gazette that showed the patent as expired, later finds that the term was different. The National Association of Drug Manufacturers complained on 28 July that domestic laboratories were not summoned as interested third parties to those proceedings despite holding marketing authorizations for the same products, and the complaint deserves a hearing.

That problem, however, is not solved by denying compensation but by publishing it, and on that there is binding precedent from the Second Chamber itself. Thesis 2a./J. 7/2010, arising from conflicting-precedent proceeding 386/2009, requires that patents on allopathic medicines be included in the publication under Article 47 bis of the then Regulations to the Industrial Property Law, in a listing that, the criterion says, shall specify the term of the patent concerned. A Collegiate Court later held that granting an amparo on that ground may go so far as to require the authority to specify, in the observations section of that publication, the real scope of what is protected.

If an amparo can order the gazette to specify what a patent covers, it can also order it to note that a compensation request is pending. That is the concrete proposal: a cautionary entry in the Industrial Property Gazette and in the medicines gazette from the moment the request is filed, showing its date and the term claimed. No one commits a production line against a registration that reads “compensation pending”, and no court would have to decide, years later, between a legitimate right and an equally legitimate expectation.

Registry publicity, seen this way, is what allows the holder to assert a right without the outcome looking like an abuse, rather than a benefit handed to the third party against it. It is the opacity of the register that turns a restoration into something that reads as a resurrection.

I will close by noting that the consequences of resolving this through constitutional litigation are already visible. The holder must litigate for years what an administrative filing should resolve in months, and litigates without knowing what period governs, what must be proved, or which delays count in its favour, when those rules exist in writing and were withheld from it. The third party that committed a production line looking at a gazette learns too late that the date was different. And IMPI complains in court of an absence of rules it did not create, while launching a committee to hold itself to deciding on time — a committee whose guidelines, as I noted when I reviewed them in June, do not define what an unjustified delay is.

It is the same fracture I described in relation to the patent register: a State that acts through agencies rather than as a single body, where what one office recognises another disregards. Here the fracture runs between the State that granted the patent late and the State that now refuses to answer for that lateness, and the result is the same — a private party paying, in years of exclusivity, for a delay it did not cause.