Glaxosmithkline Biological SA v Comptroller-General of Patents Designs and Trade Marks, Patents Court, London, UK, 21 March 2013, Case No.  EWHC 619 (Pat)
The UK Patents Court has made a further reference to the Court of Justice of the European Union, requesting that Article 1(b) of Regulation 469/2009/EC (the SPC Regulation) be clarified, and in particular the meaning of “active ingredient” and “combination of active ingredients”.
Glaxosmithkline Biological SA (“GSK”) filed two Supplementary Protection Certificate (“SPC”) applications, one for an adjuvant known as AS03, and one for a vaccine comprising an antigen and AS03. In both applications, GSK relied upon a marketing authorisation for a influenza vaccine, sold under the trade mark, Prepandrix. Acting on behalf of the Comptroller, the Deputy Director of the UK Intellectual Property Office, decided that neither application was allowable since AS03 was not an “active ingredient” of Prepandrix, within the meaning of the SPC Regulation. GSK appealed this decision.
Both parties agreed that this issue should be referred to the CJEU for a preliminary ruling. Mr Justice Arnold, hearing the case, agreed that this was necessary for three reasons: (1) the answer in this case was not acte clair; (2) there was a lack of consistent interpretation between different national authorities on this point; and (3) the present case raised a similar issue to the issue in a previous SPC related case, Bayer CropScience.
Accordingly, the following questions have been referred to the Court of Justice:
1. Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an “active ingredient” within the meaning of Article 1(b) of Regulation 469/2009/EC?
2. If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a “combination of active ingredients” within the meaning of Article 1(b) of Regulation 469/2009/EC?
Mr Justice Arnold added that in his view, a strict interpretation of Regulation 469/2009/EC was necessary to avoid uncertainty and inconsistency. Accordingly, he suggested that both questions should be answered, “No”. The judge also expressed some exasperation with the number of referrals to the CJEU that had been necessitated by the SPC Regulation, describing the present state of the SPC system as “dysfunctional”.
Read the entire decision (in English) here.
Head note: Claudia Rabbitts, Graham Burnett-Hall