Synaptech: here comes the Hearing

Mark your diaries! Next Thursday, 17 February, is a big day for SPCs in the European Union. That's the day that the Court of Justice of the European Union is hearing Case C-427/09, Generics (UK) Ltd v Synaptech Inc, a reference for a preliminary ruling from Court of Appeal, England and Wales, on 28 October 2009.  The reference was made just days before Generics (UK) Ltd rebranded as Mylan.

The questions that the Court has been asked to give its ruling on are these:

"For the purposes of Article 13(1) of Council Regulation 1768/92 [concerning the creation of a supplementary protection certificate for medicinal products OJ L 182, p. 1], 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 [on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products OJ 22, p. 369] (now replaced with Directive 2001/83 [on the Community code relating to medicinal products for human use OJ L 311, p. 67]) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

If, for the purposes of Article 13(1) of Council Regulation 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65 (now replaced with Directive 2001/83), 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with the requirements of Directive 65/65) and that was never amended to comply with Directive 65/65 and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"

This blog notes that it has taken 18 months to get from the reference to the Hearing. In better times, by 18 months we might have expected to be well beyond that, taking delivery of the Advocate General's Opinion.