In short, GSK applied for a supplementary protection certificate for "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03 protected by European Patent (UK) No 0 868 918. Later, GSK applied for a supplementary protection certificate for "an adjuvanted influenza vaccine comprising an influenza virus component which is an influenza virus antigen from an influenza virus strain that is associated with a pandemic outbreak or has the potential to be associated with a pandemic outbreak, wherein the adjuvant is an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", a vaccine comprising an antigen and AS03 protected by European Patent (UK) No 1 618 889. In both cases GSK relied upon marketing authorisation EU/1/08/453/001 for a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A virus marketed by GSK under the trade mark Prepandrix. In decision BL O/506/12 the UK IPO decided that neither application was allowable: AS03 was not an "active ingredient" of Prepandrix. GSK appealed to the Patents Court and Arnold J decided to refer the following questions 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?Andrew Waugh QC (3 New Square) and Emma Fulton (Hogan Lovells International LLP) both emailed to draw the attention of this blogger to the text which we have reproduced in bold type.
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?"
84. In case it assists, I shall state my own view on these questions. While I acknowledge the force of counsel for GSK's argument that the primary purpose of the SPC Regulation is to reward innovative research of the kind that led to the development of AS03 and Prepandrix, I find the arguments presented by counsel for the Comptroller more convincing. In particular, I consider that the SPC Regulation was intended to provide a simple and predictable system that could be operated by the competent authorities of the Member States, and in particular the national patent offices, in a uniform manner. To achieve those objectives, it is necessary to have bright-line rules. Article 1(b) is such a rule. In my view the Court of Justice was correct to hold in Pharmacia, MIT and Yissum that it should be strictly interpreted. The result of a strict interpretation is to deny extended protection for what may well be meritorious inventions, but the price of not adopting a strict interpretation is a level of uncertainty and inconsistency which in my opinion is unacceptable. Accordingly, I would answer both questions no.This blogger is fully in agreement with the judge's comments.
85. It is worth adding that, as counsel for the Comptroller pointed out, GSK may be able to obtain an SPC for the antigen contained in Prepandrix based on the 889 patent and the marketing authorisation for Prepandrix. Thus refusal of the appeal would not necessarily leave GSK bereft of protection.
86. Finally, I would observe that this is the third time in six months that I have had to refer questions of interpretation of the SPC Regulation to the CJEU. I do so with considerable regret. That this should be necessary demonstrates the dysfunctional state of the SPC system at present. This is primarily due to the poor drafting of the SPC Regulation and to the failure of the European Commission, Council and Parliament to revise it to address the problems which have emerged. Matters have not been assisted, however, by the fact that the Court of Justice's recent case law interpreting the SPC Regulation has not provided the level of clarity and consistency that is required.
