Mexico’s patent linkage system: current state, effects and flaws

The Mexican linkage system for patents related to the drug approval process was enacted on September 19, 2003. The main purpose was to improve the communication between the Federal Commission for Protection against Health Risks (COFEPRIS), which is the regulatory agency in Mexico, and the Mexican Institute of Industrial Property (IMPI), in order to prevent the granting of marketing authorisations (MAs) for generic versions of pharmaceutical drugs which might fall within the scope of valid patents. This system has also served as a tool for public health institutions to verify patent ownership in order to assign direct purchases.