Enforcement of use patents in the Mexican Linkage System

June 10, 2020

The patent linkage system between COFEPRIS and the Mexican Institute of Industrial Property (IMPI) aims to prevent the granting of marketing authorizations in violation of patent rights. According to the linkage regulation established in article 147bis of the Industrial Property Law Regulation (RLPI) and article 167bis of the Health Supplies Regulation (HSR), IMPI must publish a “Linkage Gazette” every six months. Besides expressly stating that patents protecting allopathic medicines (products) must be included, the only patents that are explicitly excluded by these regulations are those that protect production and formulation processes of medicines. Therefore, formulation and use patents should also be included in the Linkage Gazette, as confirmed by the jurisprudence issued on this matter by the Mexican Supreme Court in 2010.

However, in contravention of the above, COFEPRIS still considers that in accordance with the Linkage System provided by article 167bis of the Health Medical Supplies Regulation, it is exclusively bound to observe the existence of active ingredients patents when processing a marketing authorization application for a pharmaceutical product, expressly disregarding formulation and use patents published in the Linkage Gazette.

OLIVARES has already processed several successful litigations related to the enforcement of formulation and use patents by COFEPRIS. However, in a related litigation through which the granting of a marketing authorization was challenged, the Circuit Courts recently issued a relevant decision in which it clearly established that COFEPRIS is not entitled to make a distinction about the applicability of the Linkage System for use patents, and therefore, should always guarantee the exclusivity of all patents (compound, formulation and use) published in the Gazette. In compliance with this decision, COFEPRIS was obliged to revoke the granting of a marketing authorization for a pharmaceutical product that infringed valid use patents published in the Linkage Gazette.

It is important to take into consideration that on April 2019, members of the ruling political party submitted for consideration of the Senate an initiative aimed at restricting the application of the Linkage System to active ingredient patents; however, such initiative has not been included in the Senate´s study agenda and its analysis is not expected in the short term.