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 ...

BREAKING NEWS: Synthon v Merz ruling just given

Mr Justice Floyd (Patents Court, England and Wales) has just given judgment this morning in Synthon BV v Merz Pharma GmbH & Co KGaA (no neutral citation has yet been allocated and the judgment is still subject to editorial corrections).

What is this case about? The judge succinctly summarises the dispute:

"1. The question which arises in this action is: can one obtain an SPC in circumstances where the product has been placed on the market in the Community without the need to do safety and efficacy testing as prescribed in 65/65, or indeed at all? The defendant Merz Pharma GmbH & Co. KGaA (“Merz”) says that you can. The claimant Synthon B.V. (“Synthon”) says that you cannot.

2. Merz is the proprietor of SPC No GB 02/046 (“the SPC”) granted on 14th August 2003 in respect of a compound called memantine. Although the SPC was granted on the basis of EU wide marketing authorisations granted in 2002, memantine had already been on the market in Germany (but not in the UK) for a quarter of a century. By this action Synthon seek revocation of the SPC on a number of grounds, or a declaration that it has zero term".

Who is right? It seems we may have to wait a while to find out, since the judge concludes as follows:

"85. ... I will exercise my discretion to refer the questions of law which arise on the interpretation of the SPC Regulation to the ECJ. I invite the parties to make submissions as to the wording of the reference, following which I will make an order directing a reference to the Court".

The SPC Blog will provide a note on this decision soon. In the meantime, since it's not yet available on the excellent BAILII website, you can read it via the blog here.  The blog will also keep track of this case as it travels to Luxembourg and back.

Finally, a word of thanks to Alison Hall (Clerk to Mr Justice Floyd) for sending this to The SPC Blog so speedily.