Today the Courts Service has released this order of the Court of Appeal (Lords Justices Jacob and Rimer and Mr Justice Kitchin):
"UPON APPEAL from the order of Mr Roger Wyand QC, Deputy High Court Judge dated 9 June 2009The Schedule to this order can be read in full here. In short, the questions referred -- which overlap with those in Synthon v Merz, are as follows:
AND UPON HEARING Counsel for the Appellant and Counsel for the Respondent
IT IS ORDERED that
1) the questions set out in the Schedule to this Order concerning the interpretation of Regulation (EEC) 1768/92 be referred to the Court of Justice of the European Communities for a preliminary ruling in accordance with Article 234 of the Treaty establishing the European Community
2) this Court will request that the Court of Justice of the European Communities join this reference with the reference in pending Case C-195/09 Synthon v Merz, referred by Floyd J on 29 May 2009 [on which, see The SPC Blog here]
3) all further proceedings in this appeal be stayed until the Court of Justice of the European Communities has given its ruling on the said questions or until further order
4) the Senior Master shall forthwith, and without waiting for time to appeal against this Order to expire, transmit to the Registrar of the ECJ, pursuant to CPR Pt 68, this Order and the Schedule thereto
5) costs be reserved
6) there be liberty to apply".
"(1) 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?
(2) 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requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"