Mexico Updates Health Regulations to Align IP Rules With USMCA

On April 24, 2026, a decree was published in the Official Gazette of the Federation modifying several articles of the Regulations for Health Supplies (Reglamento de Insumos para la Salud).  Several modifications took place, including an update of the definition of “New Molecule” to include a reference to biopharmaceuticals and adjustments to clearances by the New Molecules Committee, making them optional for products that have been previously approved by a recognized foreign regulatory authority. 

The modifications also included two IP-related protections for innovative pharmaceutical products, seeking compliance with the obligations deriving from Articles 20.46 and 20.48 of the USMCA, as follows:  

Patent Term Adjustment to compensate for Regulatory Approval Delays

The regulations establish the possibility of requesting patent term compensation, when the following conditions occur:

• Unreasonable delays take place during the marketing authorization issuance process, attributable to the regulatory authority. 
• The patent intended for compensation was mentioned as relevant to the pharmaceutical product in the relevant marketing authorization application.
• The patent does not cover a previously authorized pharmaceutical product. 
• The product was not previously marketed in the country

As a relevant note, several companies have filed constitutional actions against COFEPRIS seeking decisions on approval proceedings for drugs and devices. The regulations recognize these actions by indicating that, if litigation is pursued, delays will only be considered unreasonable if the result of said litigation is unfavorable to the applicant.

Data Protection Exclusivity/Regulatory Exclusivity

The regulations also included a modification to the last paragraph of article 167 bis, to incorporate regulatory data exclusivity, with the following relevant notes:

• When a product is approved with a New Molecule (which includes small molecules and biologics), protection will be granted for a period of five years from the date of notice of the marketing authorization.
• During that period, no third party can use the innovator’s safety quality and efficacy information to support approval of another marketing authorization. 
• There is no specific protection granted to new indications, pediatric indications, nor an additional protection period for biologics.

What’s Next?

On patent term extensions to compensate for regulatory delays, we anticipate that innovators will challenge the limitations included in the regulations, specifically the fact that only a single patent can be subject to term compensation. 

On the regulatory exclusivity site we also anticipate that the lack of specific protection for new indications, and a limited protection period for biologics will be subject to judicial challenges. 

A pending item in these reforms was a review of the current patent linkage system, which prevents COFEPRIS from granting a marketing authorization until a clearance opinion is provided from the patent office;  innovation based companies have argued — both in policy positions and through judicial actions — that the system should grant them a right of hearing during the review of the generic product application, and generic companies have requested a rebalancing of the system, to reflect incentives granted in the United States to seek quicker approvals, such as the possibility to claim patent invalidity, recover damages if successful in litigation, and the implementation of an exclusivity period for a first generic.