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La excesiva ampliación de la cláusula Bolar en el «paquete legislativo sobre medicamentos» - Despacho de abogados Gómez-Acebo & Pombo
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La excesiva ampliación de la cláusula Bolar en el «paquete legislativo sobre medicamentos»

icon 14 de enero, 2026

La cláusula Bolar permite realizar estudios y ensayos necesarios para obtener autorizaciones de medicamentos sin infringir patentes. Su alcance ha ido creciendo durante la tramitación del paquete legislativo sobre medicamentos, incorporando más actores y más actividades, hasta incluir la participación en licitaciones públicas antes de expirar la patente. Esta ampliación plantea dudas de compatibilidad con el Acuerdo ADPIC, que solo permite excepciones limitadas a los derechos de patente. La participación en licitaciones podría considerarse una oferta de venta, vulnerando así los límites fijados por dicho acuerdo.

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Autor/es

Ángel García Vidal – Consejero Académico

Rais Amils – Socia

Tipología

Análisis

Áreas y sectores

Propiedad Industrial e Intelectual

Farmacéutico y Sanitario