On 10 May 2009, the High Court handed down its judgment in Generics (UK) Limited v Synaptech Inc holding that the “first authorisation to place the product on the market in the Community” in Article 13 of the EC Council Regulation 1768/92 (the “SPC Regulation”) referred only to marketing authorisations granted in accordance with Directive 65/65/EEC.
Synaptech obtained European Patent EP (UK) 0 236 684 protecting galantamine for the treatment of Alzheimer’s disease, which expired on 16 January 2007. Synaptech applied for, and was granted, an SPC for this product in the UK which is due to expire on 15 January 2012. In its application for this SPC, Synaptech cited the Swedish marketing authorisation granted in 2000 (and not the earlier Austrian or German authorisations) as the first authorisation to place the product on the market in the Community within the meaning of Article 13 of the Regulation. Accordingly, the SPC was granted with the maximum term of five years.
On 16 October 2009, the Court of Appeal decided to refer questions to the ECJ which to a degree overlap with those referred earlier in 2009 by the English High Court in Synthon v Merz in a similar case concerning memantine (Case C-195/09). The Court of Appeal has requested that these cases be joined.