Patent Term Extension in Europe – SPCs for Combination Products [in Japanese]

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K. Kamprath, A. Bieberbach, K. Hinkelmann, in Journal of the Japanese Group of AIPPI, Vol. 57, No. 2, 2012, pages 2-14

On November 24, 2011 a landmark ruling of the European Court of Justice (ECJ) with important implications for the manufacturers of medicinal products was delivered in the field of supplementary protection certificates (SPCs) and combination products. The SPC system, which is based on the SPC Regulation of the European Union, provides an extension of the patent term for medicinal products in Member States of the European Union. The present article provides a review on respective developments in Europe, the problems which arose, the solution proposed by the Advocate General and the judgment which had been finally rendered by the ECJ as well as comments thereon.