Sanitary Regulation of Pharmaceutical Products in Mexico (Sanitary Registration-Board Arrangement-Patent)—Monoclonal Antibody Case Study

The Federal Commission for Protection against Health Risks in Mexico (COFEPRIS) is responsible for the regulation and health promotion of the production, commercialization, import, export, publicity or involuntary exposure of medicines and technologies for health. For its part, the Mexican Institute of Industrial Property (IMPI) is a decentralized public body with legal personality, own property and legal authority to administer the industrial property system in our country. In the year 2000, on September 19, the official journal published the linking of patents related to allopathic medicines and the sanitary registry. Objectives: To publicize the process of linking the Sanitary-Patent Registry as a case study to delimit the scope of the new pharmaceutical products. Methodology: Request the information to COFEPRIS for the registration of a new pharmaceutical product; Establish flow diagrams for the registration of: innovative products, generic products, biotech products and bio similar products; Integrate the documents in the dossier of the pharmaceutical product for sanitary registration; Elaborate sworn letter of non-invasion of patents and study of patents; Submit the Health Registry; Intergovernmental consultation. Sanitary Registry Results: Search of patents in databases to elaborate state of the art, to write letter under protest to say truth that is not invading any patent, when developing a composition of cetuximab, as generic product since the patent molecule expired in 2016 and 11 patents related to compositions, preparations and finished product preparation processes. Conclusions: COFEPRIS will determine through intergovernmental consultation with the IMPI whether or not a patent is invaded, according to the case it will grant the registration or send the corresponding prevention for cetuximab, in case that invading can also be a refusal of grant.