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Federal Administrative Trial 847/14-EPI-01-7 decided by the Specialized Chamber on Intellectual Property of the Federal Court of Administrative Justice, in session of February 17, 2016. Unanimity of votes. Rapporteur Judge: Luz María Anaya Domínguez. Secretary: Ivett Nazdihely Galicia Rendón

Los datos clínicos de medicamentos biotecnológicos son meritorios de protección contra toda divulgación y contra todo uso comercial desleal, por lo que debe otorgarse un reconocimiento de confidencialidad por un periodo razonable no menor de cinco años, y ninguna persona distinta a la que presentó dicha información ante la Comisión Federal para la Protección contra Riesgos Sanitarios puede, sin autorización de la titular del registro sanitario, contar con tales datos en apoyo a una solicitud para aprobación de un producto que involucre el mismo principio activo. Lo anterior sobre la base de considerar que los medicamentos biotecnológicos sí pueden calificarse como “nuevas entidades químicas” para los efectos del Reglamento de Insumos para la Salud.