Decision on calculation of SPC-term in favour of Pharmaceutical companies where every day counts

The Court of Justice of the European Union (CJEU) has confirmed the Advocate General’s Opinion Case C-471/14 Seattle Genetics Inc.

In last months Awa Review Newsflash we reported the Advocate General’s Opinion on the Court of Justice of the European Union (CJEU) referral in Case C-471/14 (Seattle Genetics). The CJEU has now confirmed the AG’s opinion settling that it is the Community law which should be used to determine the SPC term for medicinal products and therefore it is the date of notification which should be applied when interpreting Article 13 for the calculation of the SPC term.

With the same reasoning as the AG, the CJEU based its decision on the original intention of a joint SPC legislation to promote free market movement of pharmaceutical products. The CJEU stated that a regulation is the most appropriate legal instrument to provide a uniform solution at the community level in order to prevent heterologous development of national laws.

With respect to the question concerning the relevant date for determining the SPC term, the CJEU based its opinion on the general legal principle of TEUF that the decision will take effect upon notification of the addressee. The CJEU further based its decision in the light of the overall objective of Article 13, namely to provide adequate effective protection to the holder of an SPC.

The original article can be found here.

9 October 2015