Mexico backs innovators in pharmaceutical debate


Rodrigo Calderon Ponce

Mexico’s Supreme Court has ruled on the interpretation of a long-standing and controversial patent debate: marketing authorisation linkage regulations.

The ruling provides that formulation patents, and not just compound (or active substance) patents, should be included as part of the linkage system, says Rodrigo Calderon Ponce.

Mexico introduced the patent/marketing authorisation linkage system for pharmaceutical products in 2003. This system involves the interparty collaboration of two Mexican authorities: the Mexican Patent and Trademark Office (IMPI) and the Mexican Commission for the Protection Against Health Risks (COFEPRIS). The linkage system provides that IMPI publishes a so-called Linkage Gazette, listing all patents granted and valid that cover allopathic drugs.

COFEPRIS in turn must observe the referenced gazette and deny marketing authorisation for a drug that infringes any of the listed patents. The regulatory template for this system is provided by two articles: Article 47 Bis of the Regulations of the Law of Industrial Property (MLIPR), which states the rules for including patents in the Linkage Gazette, and Article 167 Bis of the Health Products Regulations, which sets out the rules for issuing and obtaining marketing authorisation for a new drug.

Mexico Supreme Court, pharmaceuticals, linkage system, IMPI, COFEPRIS