Asunto C-617/12: Auto del Tribunal de Justicia (Sala Octava) de 14 de noviembre de 2013 [petición de decisión prejudicial planteada por la High Court of Justice (Chancery Division) — Reino Unido] — Astrazeneca AB/Comptroller General of Patents [Medicamentos para uso humano — Certificado complementario de protección — Reglamento (CE) no 469/2009 — Artículo 13, apartado 1 — Concepto de «primera autorización de comercialización en la Comunidad» — Autorización expedida por el Instituto suizo de productos terapéuticos (Swissmedic) — Reconocimiento automático en Liechtenstein — Autorización expedida por la Agencia Europea de Medicamentos — Duración de la validez de un certificado]
Lengua de procedimiento: inglés
High Court of Justice (Chancery Division)
Demandante: Astrazeneca AB
Demandada: Comptroller General of Patents
Petición de decisión prejudicial — High Court of Justice, Chancery Division, Patents Court — Reino Unido — Interpretación del artículo 13, apartado 1, del Reglamento (CE) no 469/2009 del Parlamento Europeo y del Consejo, de 6 de mayo de 2009, relativo al certificado complementario de protección para los medicamentos (DO L 152, p. 1) — Concepto de primera autorización de comercialización — Autorización suiza reconocida automáticamente por Liechtenstein, pero que no ha sido concedida siguiendo el procedimiento administrativo previsto por la Directiva 2001/83/CE, por la que se establece un código comunitario sobre medicamentos para uso humano.
En el marco del Espacio Económico Europeo (EEE), el artículo 13, apartado 1, del Reglamento (CE) no 469/2009 del Parlamento Europeo y del Consejo, de 6 de mayo de 2009, relativo al certificado complementario de protección para los medicamentos, debe interpretarse en el sentido de que una autorización administrativa, expedida para un medicamento por el Instituto suizo de productos terapéuticos (Swissmedic) y reconocida automáticamente en Liechtenstein, debe considerarse la primera autorización de comercialización de dicho medicamento en el Espacio Económico Europeo en el sentido de esta disposición, cuando esta autorización es anterior a las autorizaciones de comercialización expedidas para este medicamento, bien por la Agencia Europea de Medicamentos (EMA), bien por las autoridades de los Estados miembros de la Unión Europea con arreglo a los requisitos que figuran en la Directiva...
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