Recently the CJEU gave a reasoned order in relation to questions arising from the UK Patent Comptroller-General's refusal to grant GSK two supplementary patent certificates ("SPCs").
GSK sought two SPCs from the UK Patent Comptroller-General for (i) an adjuvant and (ii) an adjuvanted influenza vaccine. Both medicinal products for which GSK sought the SPCs related to GSK's marketing authorisation for a pre-pandemic vaccine against the H5N1 subtype of influenza, marketed by GSK as Prepandrix.
SPCs are granted in relation to the product for which the MA was granted and which in practice embodies the underlying patent. Under Regulation (EC) 469/2009 which governs the granting of SPCs, a "product" is the active ingredient or combination or active ingredients of a medicinal product (which is a substance for treating or preventing diseases in human beings).
The issue in the GSK case was whether the adjuvant used in both products was an "active ingredient". The adjuvant did not have a therapeutic effect on its own, but rather enhanced the therapeutic effect of the antigen in product (ii).
Therefore, while the Comptroller-General accepted that the adjuvant could be a medicinal product that did not mean that it was an active ingredient such that it amounts to a "product" for which an SPC could be granted.
GSK appealed the decision to the High Court which referred certain questions to the CJEU. The CJEU was asked to determine whether an adjuvant which has no therapeutic effect on its own but which, when combined with an antigen, enhances the therapeutic effect of the antigen, is an "active ingredient" pursuant to Art 1(b) of Regulation 469/2009 (referring to product (i) above)? And if not, could the combination of the adjuvant with the antigen be a combination of active ingredients under Art 1(b) (referring to product (ii) above)?
Given that there is no definition of "active ingredient" in the Regulations, the CJEU said it was necessary to look at the context in which the term is used and its meaning in everyday language. The CJEU found that in general in pharmacology "active ingredients" do not include substances within a medicinal product which do not have an effect of their own.
The CJEU also referred to the explanatory memorandum to the proposal for the Regulation which said that "product" should be interpreted to mean the active substance(s) in the strict sense and that excipients or other minor changes to it (e.g. new doses, salts, etc) were not to form the basis for granting an SPC.
As a result an ingredient without any therapeutic effect was not an "active ingredient" and the combination of that ingredient with an ingredient which does have therapeutic effect does not make the combination "a combination of active ingredients". Accordingly an SPC cannot be granted for either (i) or (ii).
In coming to its decision the CJEU reviewed its decision in Case C-431/04 Massachussets Institute of Technology and its more recent decision in Case C-130/11 Neurim Pharmaceuticals (which GSK sought to rely upon) but it concluded that the CJEU did not, in the Neurim judgment, cast doubt on the principle that Article l(b) of Regulation No 46912009 is to be interpreted narrowly, as held in the judgment in Massachusetts Institute of Technology, to the effect that the term 'product' cannot cover a substance which does not correspond to the definition of 'active ingredient' or that of 'combination of active ingredients'.
This article is part of the International Life Sciences Update for February 2014