Synthon v Merz: questions for the ECJ

The questions referred to the Court of Justice of the European Communities for a preliminary ruling in Synthon v Merz by Mr Justice Floyd (Patents Court, England and Wales) -- reported by the SPC Blog here -- have just been posted on the Curia website for all to see. The case is now Case C-195/09 Synthon BV v Merz Pharma Gmbh & Co KG. The questions referred read as follows:

"1. For the purposes of Articles 13 and 19 of Council Regulation ... 1768/92, is an authorisation a "first authorization to place ... on the market in the Community", if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that Directive?

2. For the purposes of Articles 13 and 19 of Council Regulation ... 1768/92, does the expression "first authorization to place ... on the market in the Community", include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?

3. Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation ... 1768/92 as defined by Article 2?

4. If not, is an SPC granted in respect of such a product invalid?"

We await the answers with excitement and trepidation ...