Spain: Patentes Farmacéuticas ¿Hacia Dónde Vamos?

Last Updated: 1 November 2017
Article by Fátima Mateos

La industria farmacéutica se encuentra en un momento de transición, marcado por la expiración de los derechos de patente de medicamentos que han sido grandes ventas, el rápido crecimiento de los genéricos y las oportunidades de los mercados emergentes.

Estos aspectos darán lugar a la configuración de un nuevo entorno que hace que se reformulen las inversiones en I+D, se produzca un cambio de enfoque hacia los fármacos de origen biológico y que exista una caída del número de patentes. Es por ello que algunas compañías ya han apostado por un nuevo modelo de innovación de I+D que les permitirá definir un nuevo modelo de ventas.

Los costes asociados al desarrollo de un medicamento cada vez son más altos debido a los gastos en numerosos ensayos clínicos y las fuertes medidas legislativas actuales que, si bien mejoran la seguridad de los pacientes, hace que los nuevos medicamentos tengan que superar unas barreras mayores que sus antecesores.

 Según la Asociación Nacional Empresarial de la Industria Farmacéutica (FarmaIndustria), en 2014 la investigación y desarrollo de un nuevo medicamento suponía un total de 2.425 millones de euros (2.558 millones de dólares), trece veces más que en 1979. La inversión global de la industria farmacéutica en actividades de I+D fue de 142.000 millones de euros en 2016, 30.000 de ellos en Europa.

 Más de la mitad de esta inversión (el 57,6%) se destina al diseño, desarrollo y evaluación de ensayos clínicos de fase 1, 2 y 3. El resto, a investigación básica (24,8%), procesos de aprobación (6,1%) y tareas de farmacovigilancia (9,5%).

"En 2015, de más de 7.262 moléculas en desarrollo, sólo fueron autorizadas 44 nuevas medicinas, lo que refleja una tasa de éxito de alrededor del 0,6% en todos los procesos de I+D que emprende la industria farmacéutica. Sólo 1 de cada 5 medicamentos comercializados generan ingresos que superan los costes medios de I+D."

 Para las empresas farmacéuticas, las patentes son un seguro para recuperar la inversión realizada en el descubrimiento y puesta en el mercado de nuevos fármacos. Una patente concede a su titular el derecho a excluir de la explotación comercial de la invención a quienes carezcan de su consentimiento. Esto incluye el derecho a impedir a otros que fabriquen, utilicen, vendan, ofrezcan para la venta o importen la invención patentada sin la autorización previa del titular.

En la industria farmacéutica, el derecho a excluir a otros del uso de la invención no otorga el derecho a comercializar un nuevo medicamento dado, puesto que este último todavía tendrá que someterse a determinadas pruebas (por ejemplo, los ensayos clínicos) y obtener la autorización para la comercialización, independientemente de que haya sido patentado. En resumen, al obtener una patente sobre un producto farmacéutico no se obtiene el derecho a ponerlo en el mercado.

 En muchos países, son patentables las mejoras realizadas en los productos existentes, al igual que los nuevos usos de un producto patentado, siempre y cuando se satisfagan todos los requisitos de patentabilidad. En la industria farmacéutica, no es extraño que las empresas presenten solicitudes de patente para nuevas indicaciones terapéuticas de un medicamento conocido. Sin embargo, no está prevista dicha protección en todas las jurisdicciones. Además, con frecuencia las empresas presentan solicitudes relacionadas con nuevas preparaciones o métodos de aplicación de un medicamento, nuevos procedimientos de fabricación o procedimientos perfeccionados, regímenes de dosificación reducida, nuevas versiones de compuestos activos u otras variantes que satisfacen los requisitos de patentabilidad.

No hay un marco especial para tratar las invenciones químicas o farmacéuticas, aunque los requisitos regulatorios sí suponen un marco especial para su comercialización. Hoy en día la costosa y extensa fase de ensayos clínicos a la que debe ser sometida un medicamento antes de su comercialización, para que pueda reunir los criterios de eficacia, seguridad y calidad necesarios, disminuye el tiempo de protección de mercado otorgado por la patente.

 Se requiere una media de entre 10 y 12 años de trabajo antes de poder comercializar un fármaco, lo que ha supuesto una disminución de los beneficios de la industria farmacéutica y el tiempo de protección ha quedado reducido a un periodo efectivo de ocho años. Por todo ello, se estableció un Certificado complementario de protección (CCP), un título de propiedad industrial, por el cual se permite ampliar el periodo de patentabilidad hasta un máximo de 5 años tras la caducidad de la patente base del medicamento. Este certificado otorga los mismos derechos que la patente, con lo cual, si la patente cubriese el principio activo y sus derivados, también lo hará el certificado, pero en caso de que cubra a un conjunto de productos el certificado solo confiere protección al que se encuentre amparado por la autorización de comercialización.

El CCP pretende compensar esta reducción en el tiempo efectivo de protección y confiere los mismos derechos que la patente, estando sujeto a las mismas limitaciones y obligaciones que ésta.  

"Tanto la patente y el certificado complementario de protección de los medicamentos de uso humano y fabricación industrial son instrumentos esenciales en la protección de la innovación, siendo indispensables para que exista una inversión en la investigación y el desarrollo de nuevos medicamentos."

Es por ello, que, dada la actual necesidad y relevancia de la protección de las patentes farmacéuticas, en nuestra jornada "Patentes Farmacéuticas y Biotecnológicas ¿hacia dónde vamos?" del próximo día 27 de Octubre de 2017 se analizará el marco legal y la problemática existente, así como las últimas decisiones y novedades.


Clarke, Modet & Co - SPAIN


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