Generics v. Synaptech, Court of Appeal Civil Division (Court of Appeal Civil Division), 16 October 2009

In view of the need for a consistent approach to interpretation of Council Regulation (EEC) 1768/92, the Court of Appeal has referred to the European Court of Justice (ECJ) questions on the meaning of the term ‘the first authorisation to place the product on the market’ in Article 13(1); in particular whether the first authorisation must be issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC). The answer to this question will determine the correct expiry date of SPC/GB00/033. In making this referral, the Court of Appeal requested that the ECJ join this reference with the reference pending in Synthon v. Merz ([2009] EUECJ C-195/09).

A full summary of this case has been published on Kluwer IP Law.