The extension of the exclusive right to pharmaceuticals under the European law: The Supplementary Protection Certificate

Article type: Research Article

Authors: de la Rosa, Fidel Porcuna

Affiliations: Associate Bird & Bird LLP, Madrid, Spain. E-mail: Fidel.Porcuna@twobirds.com

Abstract: The interplay of the exclusive right conferred by patents to innovative pharmaceutical products and the regulatory rules for their marketing approval seemed to be solved 1993 with the creation of the Supplementary Protection Certificate, which allowed patent owners to extend on a timely basis their exclusive rights upon expiration of the patent, thus mitigating, at least partially, the negative effects of lengthy administrative marketing approvals. The development of this new IP right through the years has revealed deficiencies in the system and resulted in a rich body of European case law, notably as to what constitutes a 'basic patent', 'marketing authorisation' or 'product', which provide key concepts for the requirements of the Supplementary Protection Certificate. The successive amendments of the Regulation concerning the Supplementary Protection Certificate for Medicinal Products include the extension of the original duration of this right upon new requirements concerning the inclusion of paediatric plans in the marketing authorisation which form the basis of a SPC application.

Keywords: Supplementary protection certificate, basic patent, marketing authorisation, european union, pharmaceuticals, medicinal product, active ingredients, regulation

DOI: 10.3233/PPL-2011-0310

Journal: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 61-71, 2011