The Patents Court of England & Wales has requested that the CJEU clarifies the meaning of "product" in the SPC Regulation (Regulation 469/2009). In particular, the Court has asked whether an adjuvant for a vaccine can be a "product" and therefore the subject of an SPC.

Although the Patents Court is of the opinion that a narrow interpretation should be followed (such that only active ingredients in the strict sense are included), it requested clarification given the different interpretations by national authorities and the existing case law of the CJEU. (GlaxoSmithKline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks [2013] EWHC 619 (Pat)).

Business Impact

Previously it was thought following the CJEU's decision in MIT (Case C-431/04) that substances which did not have therapeutic effects of their own but which were used to obtain a certain pharmaceutical form were outside the meaning of "product". However, if the CJEU decides to adopt a more teleological interpretation of the SPC Regulation so as to reward and encourage pharmaceutical research (consistent with the approach adopted by the CJEU in Neurim (Case C-130/11)), this opens up the possibility that an SPC could be obtained for a wider range of ingredients or constituents than previously thought possible.

Background

The case concerned two SPC applications made by GSK. Both SPC applications were based on GSK's marketing authorisations (MAs) for Prepandrix, a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A virus. However, the SPC applications were based on two different GSK patents. The first protected an adjuvant known as AS03, whereas, the second patent protected a vaccine comprising an antigen and AS03. Whether GSK is able to obtain SPCs based on its applications turns on whether the adjuvant AS03 falls within the definition of "product" in the SPC Regulation. Article 1(b) of the SPC Regulation provides that "‘product’ means the active ingredient or combination of active ingredients of a medicinal product".

Further Analysis

Arnold J considered the earlier case law of the CJEU in Pharmacia (Case C-31/03), MIT and Yissum (Case C-202/05). When considering this case law, Arnold J held that this supported a strict interpretation of the meaning of "product" as excluding from the definition substances that did not have any therapeutic effect on their own and that this definition did not depend upon the therapeutic use of the active ingredient. Arnold J then considered the CJEU's decision in Neurim as indicating an intention by the CJEU to depart from this strict definition, but that this was not clear as Neurim did not refer to the above case law. In Neurim the CJEU permitted the grant of an SPC for a second medical use of an active ingredient despite the fact that the same active ingredient had already been the subject of an MA, which on a literal interpretation of the SPC Regulations would have been precluded. Arnold J also highlighted that he could not reconcile Neurim with further earlier decisions of the CJEU in Synthon v Merz (Case C-195/09) and Generics v Synaptech (Case C-427/09), even though Synthon v Merz was referred to in Neurim.

In light of this case law, the differing approaches of the national authorities to GSK's SPC applications and the pending reference in Bayer CropScience (Case C-11/13) that concerns similar provisions in the SPC Regulation for Plants (Regulation 1610/96), Arnold J agreed to refer two questions to the CJEU. The referred questions are:

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?

Arnold J gave his own view on how these questions should be answered. Although recognising that the primary purpose of the SPC Regulation is to reward innovative research (including that which resulted in GSK's development of AS03), Arnold J preferred a strict interpretation of the meaning of "product". Arnold J preferred this interpretation as it provides a simple and predictable system for national authorities when granting SPCs, resulting in the uniform decisions by different member states envisaged under SPC regime. In reaching this view, Arnold J recognised that this interpretation would exclude some meritorious inventions from the SPC Regime.

In concluding his judgement, Arnold J expressed his concerns over the current "dysfunctional state of the SPC system", which he primarily attributed to the poor drafting of the SPC Regulation and the absence of revision, but also to the "level of clarity and consistency" of the recent case law of the CJEU.