C-427/09

Generics (UK) Limited v Synaptech Inc

The case raises the following questions which have been sent to the European Court of Justice for a preliminary ruling:

1. In view of the need for a consistent and certain approach to questions of interpretation of Regulation 1768/92 (and by implication its successor Regulation 469/2009), the court of Appeal, pursuant to Article 234 EC, requests the Court of Justice of the European Communities to make a preliminary ruling on the following questions of Community law:

a) For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, is the "first authorisation to place the product on the market in the Community" the first authorisation to place the product on the market in the community which was issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

b) If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?

2. In the light of the overlap between the legal issues raised by this reference and those raised in Case C-195/09 Sython v Merz, the Court of Appeal also respectfully requests that this case be joined with Case C-195/09 for the purposes of the oral hearing and final judgement, pursuant to Article 43 of the Rules of Procedure of the Court of Justice.