The Court of Appeal has now referred various questions about Marketing Authorisations to the ECJ.

In Generics v Synaptech, [2009] EWCA Civ 1119 the court considered an appeal from a decision by Roger Wyand QC, sitting as a deputy High Court judge, in which he determined that a Supplementary Protection Certificate (SPC) for galantamine had a term expiring in January 2012. Roger Wyand QC pointed out that such a certificate can be granted where the product is protected by an in force patent, and where a valid authorisation to place the product on the market has been granted in accordance with Directive 65/65/EEC. In coming to this conclusion, earlier marketing authorisations for galantamine, which had been on sale in Europe for more than 40 years as a medicine, were effectively ignored as they were not Directive 65/65 compliant.

The Appeal Court has now referred the question as to whether a marketing authorisation has to be compliant with Directive 65/65 to the ECJ. The actual questions referred are:

"In view of the need for a consistent and certain approach to questions of interpretation of Regulation 1768/92 (and by implication its successor Regulation 469/2009), the Court of Appeal, pursuant to Article 234 EC, requests the Court of Justice of the European Communities to make a preliminary ruling on the following questions of Community law:

  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requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"

The Court of Appeal also asked the ECJ to join this reference with the earlier reference made by Floyd J in Synthon v Merz, [2009] EWHC 656 (Pat). In this earlier case the issue was whether an SPC could be granted at all where a product had been authorised for marketing prior to the coming into force of Directive 65/65.

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