Publication: La estructura de la protección jurídica de los certificados complementarios de protección para medicamentos
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Date
2024-05
Authors
Massaguer Fuentes, José
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Publisher
Editorial La Ley
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DOI
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info:eu-repo/semantics/article
Description
Abstract
El certificado complementario de protección para medicamentos de uso humano y veterinarios («CCP») es un título de propiedad industrial de Derecho de la UE dirigido a incentivar las inversiones y esfuerzos en I+D+i requeridos para desarrollar y poner en el mercado nuevos medicamentos por medio, dicho en términos poco precisos, de la prolongación de la duración de la protección jurídica sobre los principios activos de medicamentos para los que se ha obtenido la necesaria autorización administrativa de comercialización («AC») más allá de la duración de las patentes que los protegen inicialmente. En las líneas que siguen abordaré el estudio de la estructura esta modalidad de protección jurídica. Trataré, en particular, el objeto para el que se concede el CCP o producto protegido, el alcance de la protección que confiere el CCP, el contenido sustantivo o ius prohibendi que encarna la tutela material que concede el CCP, incluidas sus limitaciones y excepciones, la duración de ese derecho de exclusión y, en fin, su extinción y la del propio CCP. ---------------------------------------
The supplementary protection certificate for medicines for human and veterinary use («SPC») is an industrial property title under EU law aimed at encouraging investments and efforts in R&D&I required to develop and put on the market new medicines by means of prolonging the duration of legal protection on the active ingredients of medicines for which the necessary administrative marketing authorization has been obtained («MA») beyond the duration of the patents that initially protect them. In the lines that follow, I will address the structure of this sui generis legal protection system. Specifically, I will discuss the subject-matter for which the SPC is granted (the «protected product»), the scope of the protection conferred by the SPC over the protected product, the substantive content or ius prohibendi that embodies its protection, including its limitations and exceptions, the duration of this IP right and, finally, its expiry and that of the CCP itself.
The supplementary protection certificate for medicines for human and veterinary use («SPC») is an industrial property title under EU law aimed at encouraging investments and efforts in R&D&I required to develop and put on the market new medicines by means of prolonging the duration of legal protection on the active ingredients of medicines for which the necessary administrative marketing authorization has been obtained («MA») beyond the duration of the patents that initially protect them. In the lines that follow, I will address the structure of this sui generis legal protection system. Specifically, I will discuss the subject-matter for which the SPC is granted (the «protected product»), the scope of the protection conferred by the SPC over the protected product, the substantive content or ius prohibendi that embodies its protection, including its limitations and exceptions, the duration of this IP right and, finally, its expiry and that of the CCP itself.
Citation
LA LEY mercantil, 2024, N. 113, pp. 1-29
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