Mexican Antitrust Commission Concludes Study On Expired-Patent Drug Market

As reported in our previous newsletter No. 17/2016, the Mexican Antitrust Commission (known by its Spanish acronym, COFECE) in mid-2016 announced that it would conduct a study regarding competition concerns over pharmaceutical products with lapsed patents. This was the first analysis of its kind in Mexico. Justifications for the study were flawed and demonstrated confusion on a number of concepts.

On August 9, 2017, COFECE published its study, concluding that there are some competition flaws in the expired-patent drug market, derived essentially from lack of development on regulations and public policies.

COFECE identified, among other issues, the following:

– The linkage system between patents and approvals of generics is not fully transparent;

– data on approvals and applications for healthcare products is not up-to-date and complete;

– incomplete and poor knowledge of the Bolar exemption delays generics approvals;

– “several patents are granted for the same active substance” (SIC); and

– Over-litigation.

COFECE issued some helpful recommendations, such as improving access, quality, and transparency of public data of approvals and applications for healthcare products; however, they made various harmful recommendations, such as their suggestion to establish restrictions on granting some types of patents.

Olivares considers that the COFECE study has several inaccuracies in its contents and methodology. COFECE incorrectly or ambiguously interpreted and referred to concepts, provisions, and practices of the international and national patent system, such as patentability standards, linkage system, the Bolar exemption, and patent infringement.

It is important to note that COFECE recommendations are not binding; however, the study wholly fails to accurately represent the patent law and contradicts the Mexican Constitution and International Treaties, which sets the stage to contest the study through a constitutional action-even if only for illustrative and corrective purposes.

Partners and Associates of our law firm, through the various industry associations in which we participate, will follow up with COFECE on this study and emphasize that a proper understanding of the intersection of regulations for healthcare products, patent rights, and competition is needed to appropriately encourage competition.


This newsletter is intended only as a general discussion of the addressed issues, and should not be regarded as legal advice.

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