A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 23 October 2009

Synaptech for ECJ reference: to join with Synthon v Merz?

In Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), Roger Wyand QC, sitting as a Deputy Judge in the Patents Court (England and Wales), held that the term "the first authorisation to place the product on the market" should be interpreted wherever it occurs in the European supplementary protection certificate (SPC) Regulation as referring to the first authorisation compliant with Directive 65/65/EEC. On this basis the Intellectual Property Office had correctly granted an SPC with a term calculated on the basis of a first Directive 65/65/EEC authorisation in 2000, rather than earlier non-compliant authorisations (see The SPC Blog here for comments on that decision).

Today the Courts Service has released this order of the Court of Appeal (Lords Justices Jacob and Rimer and Mr Justice Kitchin):
"UPON APPEAL from the order of Mr Roger Wyand QC, Deputy High Court Judge dated 9 June 2009

AND UPON HEARING Counsel for the Appellant and Counsel for the Respondent

IT IS ORDERED that

1) the questions set out in the Schedule to this Order concerning the interpretation of Regulation (EEC) 1768/92 be referred to the Court of Justice of the European Communities for a preliminary ruling in accordance with Article 234 of the Treaty establishing the European Community
2) this Court will request that the Court of Justice of the European Communities join this reference with the reference in pending Case C-195/09 Synthon v Merz, referred by Floyd J on 29 May 2009 [on which, see The SPC Blog here]
3) all further proceedings in this appeal be stayed until the Court of Justice of the European Communities has given its ruling on the said questions or until further order
4) the Senior Master shall forthwith, and without waiting for time to appeal against this Order to expire, transmit to the Registrar of the ECJ, pursuant to CPR Pt 68, this Order and the Schedule thereto
5) costs be reserved
6) there be liberty to apply".
The Schedule to this order can be read in full here. In short, the questions referred -- which overlap with those in Synthon v Merz, are as follows:
"(1) For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, is the “first authorisation to place the product on the market in the Community” the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?
(2) If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an “authorisation to place the product on the market in the Community” must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"

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