Patented pharmaceutical products which usually go through a tedious marketing authorisation procedure may on request and based on a basic patent obtain protection for a further maximum period of 5 years by the means of supplementary protection certificates (“SPC”). One of the prerequisites for SPCs issued in Europe on a national level is that a product has to be an “active ingredient” or a “composition of active ingredients” [Article 1(b) of Regulation (EG) 469/2009].
In the absence of definitions of the terms “active ingredients” and “composition of active ingredients” in the Regulation, the European Court of Justice (ECJ) regularly receives questions concerned with interpretation of the disputed terms referred to it for a preliminary ruling from national offices or courts responsible for granting of SPCs . Most recently, the ECJ clarified in its judgement of Mai 4, 2006, C-431/04 (see News of May 24, 2006) that a carrier which does not have a pharmaceutical effect of its own and which merely serves to achieve a certain pharmaceutical form of the product, cannot be seen as the “active ingredient”. Furthermore, according to that judgment, a combination of two components cannot be seen as the “composition of active ingredients” in the sense of the regulation, if only one of the ingredients possesses a pharmaceutical effect.
The ECJ confirmed such a narrow interpretation of the definitions in relation to two SPCs requested by GlaxoSmithKline for a product approved under a name “Prepandrix”. The SPC applications were based on two respective basic patents (judgment of November 14, 2013, C-210/13). The first basic patent protects a specific adjuvant (AS03), the second basic patent protects the adjuvant in combination with an active ingredient against the avian flu (antigen against the H5N1-strain of the Influenza-A-virus).
In this special case it had to be considered that, in contrast to an inert carrier (C-431/04), the adjuvant enhances the effect of the pharmaceutically active antigen. Accordingly, the adjuvant has a physiological effect of its own on the body.
However, such a subtle difference did not affect the ECJ’s decision C-210/13, as the adjuvant itself still does not have any therapeutical effect of its own. Therefore, the adjuvant cannot be seen as the “active ingredient” in the sense of Article 1(b) of the SPC-regulation 469/2009. Furthermore, the ECJ asserted that “Prepandrix” cannot be considered as the “composition of active ingredients”, as the adjuvant component of the medicament is not an independent “active ingredient”. In contrast to “active ingredients”, adjuvants are merely listed as additives in section 18.104.22.168 of the Annex I of the Part I “Standardised marketing authorisation dossier requirements” of the EU-regulation 2003/63 of May 25, 2003.