Mexico Amends Health Supplies Regulations: Patent Term Compensation and Data Exclusivity Now in Effect

Mexico has enacted significant amendments to its Regulations on Health Supplies (Reglamento de Insumos para la Salud, RIS), published in the Official Gazette of the Federation on April 24, 2026, and effective as of April 25, 2026. The reform introduces long-awaited intellectual property protections aligned with the United States–Mexico–Canada Agreement (USMCA), including a patent term compensation mechanism for regulatory delays and a clinical data exclusivity framework for innovative pharmaceutical products.

Patent Term Compensation for Unreasonable Delays

The amended RIS establishes a procedure for patent term compensation when "unreasonable delays" attributable to COFEPRIS (search)Search term, Mexico's health regulatory authority, occur during the marketing authorization process. The mechanism, previously incorporated through amendments to the Federal Law for the Protection of Industrial Property (FLPIP), must be initiated at the request of the interested party within sixty days following notification of the sanitary registration.

Eligibility requires that the patent be expressly cited in the sanitary registration application. Compensation is inadmissible where the patent relates to an allopathic medicine that previously obtained a sanitary registration, was previously included in another registration, was not identified at the initiation of the procedure, or where the product was commercialized prior to obtaining registration.

The regulation identifies certain periods that must be excluded from delay calculations, including time taken to respond to official requests for information, judicial proceedings or adverse legal challenges, and periods resulting from force majeure or acts of God. Legal analysts at Basham have noted that the breadth of the force majeure exception "grants the authority wide and discretionary latitude to determine which periods should be excluded, which could be grounds for a challenge on the grounds of unconstitutionality."

Any compensation awarded is capped at a maximum of five years, and only one patent per product may benefit from the extension. According to the transitory provisions, these rules apply exclusively to sanitary registrations filed after the April 25, 2026 entry into force.

Clinical Data Protection Exclusivity

Article 167 Bis now expressly recognizes clinical data protection. Where an allopathic medicine contains a new molecule, the technical and scientific information submitted regarding its safety, quality, and efficacy will be protected for a period of five years from notification of the sanitary registration. During this period, third parties may not use such information without the express authorization of the holder.

Notably, the protection does not extend specifically to new indications or pediatric indications, nor does it provide an additional protection period for biologics. An open question remains as to whether data protection covers second therapeutic uses, which Mexican legislation treats as "new molecules." Legal experts anticipate this ambiguity will likely be resolved through future contentious proceedings.

Redefinition of "New Molecule"

The definition of "new molecule" under Article 2, Section XV has been amended. Previously defined as a substance of natural or synthetic origin not previously used in the country, the new definition limits the concept to drugs, biologics, or substances with therapeutic, preventive, or rehabilitative activity that do not hold a sanitary registration in Mexico. This clarification narrows the regulatory scope and explicitly incorporates biopharmaceuticals.

Additional Regulatory Changes

The reform introduces new requirements for obtaining sanitary registrations, including the obligation to submit documentation from the Mexican Institute of Industrial Property (IMPI (search)Search term) evidencing patent ownership or a corresponding license. For generic medicines, when an interchangeability report relies on safety and efficacy information from a new molecule, the express written consent of the information holder must be submitted if no more than five years have elapsed since the registration notification.

Regarding biotechnological products and biosimilars, the opinion of the New Molecules Committee is now only required when a risk associated with the comparable biotechnological medicine is identified, particularly for applications supported by prior authorization from a recognized foreign regulatory authority. The reform also clarifies that preclinical and clinical studies for comparable biotechnological medicines must use the corresponding reference product.

In a development welcomed by the pharmaceutical industry, the term of sanitary registrations has been extended from five to ten years.

Implementation and Anticipated Challenges

The reform applies to matters filed after April 25, 2026, while pending matters continue under previously effective provisions. The Ministry is required to carry out necessary regulatory and administrative adjustments, creating some uncertainty regarding implementation, particularly for sanitary registrations granted prior to the reform's entry into force.

Industry observers anticipate judicial challenges on several fronts. Innovators are expected to contest the limitation that only a single patent may benefit from term compensation, as well as the absence of specific protections for new indications and the limited protection period for biologics. Additionally, a pending review of the current patent linkage system was not addressed in this reform, leaving unresolved tensions between innovative and generic pharmaceutical companies regarding hearing rights during generic product application reviews.

The amendments represent Mexico's effort to comply with obligations under Articles 20.46 and 20.48 of the USMCA, which is itself currently undergoing a renegotiation process.