CJEU about the concept 'date of the first authorisation to place the product on the market in the European Union’
06-10-2015 Print this page
The ‘date of the first authorisation to place the product on the market in the European Union’ of Article 13(1) SPC Regulation is determined by EU law. The ‘date of the first authorisation to place the product on the market in the European Union’ is the date on which notification of the decisions granting marketing authorisation was given to the addressee of the decision.
The request for a preliminary ruling concerns the interpretation of the concept 'date of the first authorisation to place the product on the market in the European Union' in Article 13(1) of the SPC Regulation Regulation. The Oberlandesgericht Wien has, with regard to the action brought by Seattle Genetics, stated that it would appear that the patents offices of Member States differ in their practice with regard to the determination of the period covered by SPCs referred to in Article 13(1). That is why two preliminary questions have been asked. The CJEU answers the questions as follows:
1. Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.
2. Article 13(1) of Regulation No 469/2009 is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.
IPPT20151006, CJEU, Seattle Genetics v Patentamt
