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.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.
1 comment:
The same SPC was revoked in Germany in what appears to be an identical submission.
The old product "Akatinol" sold in Germany contains the same active ingredient - memantine - in the same quantitative amount. It was approved prior to Germany joining the EU. Akatinol was deemed to have been approved under 65/65 EEC under German Arzneimittelgesetz (AMG) of 24 Aug 1976, the national law implementing Council Directive 65/65/EEC. All authorisations under AMG 1976 fulfil the requirements of 65/65/EEC. The transitional provision (Überleitungsvorschrift) in Art. 3 Section 7 (1) (which became later Section 105(1) of the current AMG) stipulates that earlier "finished medical products" are deemed to be authorised for marketing under AMG 1976; i.e. 65/65/EEC.
It seems very clear that the SPC must fall since it does not refer to the first approval in the EU under 65/65.
Should the patentee, who sold Akatinol, benefit from the transitional provisions that allowed sales to continue in the EU and also benefit from an SPC? Surely it is one or the other and not both?
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