Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks

For supplementary protection certificates, the concept of a “product” in Article 1(b) of the SPC Regulation is to be interpreted strictly. An adjuvant which has no therapeutic effect of its own is not an active ingredient merely because it enhances the therapeutic effect of an antigen. Nor does combining the adjuvant with that antigen necessarily create a combination of active ingredients. The need for clear, predictable and uniform administration by national authorities supports a bright-line approach, even where the invention reflects substantial research.

GSK appealed against the Comptroller’s decision that two applications for supplementary protection certificates relating to the AS03 adjuvant and an AS03-adjuvanted influenza vaccine were not allowable as drafted. The applications relied on the marketing authorisation for Prepandrix and concerned whether AS03 was an “active ingredient” under Article 1(b) of the SPC Regulation, alone or in combination with the vaccine antigen.

The parties agreed that the issue required a preliminary ruling from the Court of Justice of the European Union. The central questions were whether an adjuvant with no therapeutic effect of its own, but which enhanced an antigen’s therapeutic effect, was an active ingredient, and whether its combination with the antigen could constitute a combination of active ingredients.

The appeal was not finally determined on the substantive classification of AS03. The court referred two questions to the Court of Justice for a preliminary ruling.

1. The earlier authorities supported a strict and predictable interpretation of Article 1(b). In particular, Massachusetts Institute of Technology [2006] ECR I-4089 treated a substance without a therapeutic effect of its own as outside “active ingredient”, even where it enabled a pharmaceutical form necessary for therapeutic efficacy.

2. Pharmacia Italia SpA [2004] ECR I-10001, Massachusetts Institute of Technology [2006] ECR I-4089 and Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents [2007] ECR I-2839 supported the view that the Regulation should be interpreted by bright-line rules.

3. Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents [2012] ECR I-0000 appeared to depart from, or qualify without explanation, the earlier authorities. The court therefore considered that the answer was not acte clair.

4. In his provisional view, Arnold J considered the Comptroller’s arguments more convincing. The Regulation was intended to provide a simple, predictable and uniform system. Article 1(b) therefore required strict interpretation. He would have answered both referred questions in the negative.

5. The questions were referred because of the absence of acte clair, divergent interpretations among national patent offices, and the similarity with the issue in Bayer CropScience Case C-11/13.

High Court (Patents Court): GSK appealed against the Deputy Director’s decision dated 19 December 2012 (BL O/506/12). Arnold J referred questions to the Court of Justice for a preliminary ruling; the substantive appeal was not finally disposed of in this judgment.