The Court of Appeal has recently considered a High Court decision of January 2010 that rejected Medeva's application for a Supplementary Protection Certificate (SPC) in relation to its combined vaccine product. The High Court's reason for rejecting the application was that the vaccine contained more active ingredients than were protected by the basic patent (see previous Law Now). The case turned on the correct test to be used to determine whether the basic patent protected the "product" that was the subject of the marketing authorisation.  The High Court rejected Medeva's argument that the correct test was to consider whether the "product" would infringe the patent, the "infringement test".

In its decision of 23 June, the Court of Appeal concluded that the following questions should be referred to the ECJ, in summary:

1.What is the test by which to determine whether "the product is protected by a basic patent in force" for the purposes of Article 3(a)?

2.Should a different test be applied in cases where the product is a multi-disease vaccine?

3. Is it sufficient for the purposes of Article 3(a), in the context of a multi-disease vaccine, that the basic patent in force protects one aspect of the product?

4. For the purposes of Article 3(b) may the product be limited to that part of a multi-disease vaccine as is protected by the basic patent in force?

The ruling of the ECJ will be of great interest to innovator companies, especially those who market combination products and/or multi-disease vaccines.

For full details regarding the questions referred please refer to the sealed order of the Court of Appeal here.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 28/06/2010.