The Patent Linkage System For Allopathic Medicines In Mexico

The decree published in the Official Gazette of the Federation on Sept. 19, 2003, added section IV of article 167 and article 167 bis of the Health Supplies Regulation were added, as well as article 47 bis of the Industrial Property Law Regulation. As a result, a mechanism for preventing violation of patent rights, known as the linkage system, was established in Mexico between the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), in charge, among other issues of a regulatory nature, of granting marketing authorizations for allopathic medicines, and the Mexican Institute of Industrial Property (IMPI), which is responsible for protecting industrial property rights through the granting of patents, through the publication in the gazette by the IMPI of patents in force for allopathic medicines that must be observed by COFEPRIS. As such, prior to granting a marketing authorization and taking into consideration the technical opinion issued by the IMPI,