Each new drug created to heal, loses meaning when it becomes a symbol of inequality

December 10, 2025

In a session on August 6, 2025, the Second Chamber of the Supreme Court of Justice of the Nation (SCJN) consolidated transcendental criteria regarding administrative delays in granting patents in the field of industrial property via a systematic interpretation of both the Mexican Industrial Property Law and the North American Free Trade Agreement (NAFTA)

The Second Chamber of the SCJN ruled on compensating time towards the expiration date of a patent in this case, filed under Administrative Appeal for Review 1/2025, in relation to a drug for the prevention and treatment of the human immunodeficiency virus (HIV).

In accordance with the judgment, the following rule was established to calculate compensation of time towards the expiration of a patent:

• On the one hand, the term of a patent may not exceed twenty years, counted from the date of its filing. However, this date is subject to the conclusion of the formal examination of the application and compliance with the other established requirements.
• On the other hand, the effective period of protection for a patent may not be less than seventeen years, counted from the date on which it is granted.

This criterion complements that established by the Second Chamber of the SCJN itself in the Amparo for Review 257/2020, in which the protection period of at least seventeen years must be guaranteed from the date of the patent granting, which has led to more than 150 applications being filed with the Mexican Institute of Industrial Property (IMPI) for compensation towards the expiration of patents.

It should be noted that these criteria cannot be applied to more than 75% of the compensation requests pending resolution, as it is impossible to comply with the two established parameters.

That is to say, in most cases in which a final decision is pending regarding the possible compensation towards the term of a patent, the minimum period of seventeen years as of the date of granting cannot be satisfied without at the same time exceeding the maximum period of twenty years as of the conclusion of the formalities examination of the patent application; it is mathematically impossible.

Imagine a patent which had the formalities examination completed on June 20, 2018, and was granted by the IMPI on June 20, 2022. According to the criteria, this patent cannot be valid after June 20, 2038 (formalities examination +20 years) but cannot be valid for less time than the date of June 20, 2039 (granting +17 years).

Therefore, it would be impossible to comply with the two parameters at the same time, since it is impossible to guarantee the minimum term without exceeding the maximum term, as established by the Second Chamber of the SCJN. It is worth adding that, by exceeding the maximum term, an extension would be granted that is not legally possible.

In a similar way to the hypothetical case raised, more than 75% of the requests for compensation are awaiting a decision in which the Courts and Tribunals will have to decide case by case if the administrative delay can be accredited, and consequently if it is appropriate to compensate the term of a patent without an extension.

Science is a bridge to life, not a wall to enclose it

According to the historical HIV report for the second quarter of 2025, published by the General Directorate of Epidemiology[1], at least 180,319 cases were diagnosed in Mexico as of July 14, 2025.

On the other hand, according to data from the National Institute of Statistics and Geography (INEGI),[2] 44.5 million people lacked access to health services in 2024.  Meanwhile, according to the U.S. Food & Drug Administration[3], a generic drug can generally be sold for around 80-85% less than the price of the original drug.

In Mexico, there are currently more than 55 pharmaceutical patents protecting drugs for different types of conditions that are awaiting a decision as to whether or not time should be compensated to their patent term. These new criteria only generate more uncertainty regarding the date on which a generic drug may obtain health registration, and consequently, begin commercialization.

[1] Government of Mexico. (2025). DVEET Historical HIV Report 2025: 2nd Quarter [PDF Report]. https://www.gob.mx/cms/uploads/attachment/file/1023130/DVEET_InformeHistorico_VIH_2025_2DOTRIM.pdf

[2] INEGI (2025, August 13). Press Release 118/25: Multidimensional Poverty [PDF]. https://www.inegi.org.mx/contenidos/saladeprensa/boletines/2025/pm/pm2025_08.pdf

[3] U.S. Food and Drug Administration. (n.d.). Generic Drugs: Questions and Answers [PDF]. https://www.fda.gov/media/112590/download