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