In a case relating to an ‘adjuvant’ used in a vaccine product, the Court of Justice of the European Union (CJEU) has issued a decision (Case C-210/13) on the interpretation of Article 1(b) of Regulation (EC) No 469/2009 concerning supplementary protection certificates (SPCs) for medicinal products in EU member states.
A condition for obtaining an SPC is that the ‘product’ must be protected by a basic patent in force and, according to Article 1(b) of the Regulation, ‘product’ means the ‘active ingredient’ or ‘combination of active ingredients’ of a medicinal product. In its decision, the CJEU held that an ‘adjuvant’, having no therapeutic effect of its own, is not an 'active ingredient' within the meaning of Article 1(b), and therefore cannot form the basis of an SPC.
In this case, GlaxoSmithKline Biologicals SA (GSK) had filed two SPC applications at the UK Intellectual Property Office (UKIPO), the first in respect of an adjuvant known as AS03, which was protected by a basic patent, and the second in respect of an influenza vaccine comprising the adjuvant AS03 and an influenza virus antigen, the vaccine being protected by another basic patent. For both SPC applications, GSK relied on a marketing authorisation issued for the influenza vaccine Prepandrix®, containing the virus antigen and the AS03 adjuvant. The AS03 adjuvant did not confer any immunity on its own, but it had physiological effects that improved the body’s general immune response to antigens, thereby enhancing the therapeutic effects of the influenza virus antigen.
The UKIPO rejected both of GSK’s applications on the ground that the adjuvant AS03 was not considered to be an ‘active ingredient’. This followed an earlier CJEU judgement, in Massachusetts Technology Institute (MIT) [CJEU Case C-431/04], in which a polymeric excipient, used in combination with a cytotoxic active agent for treating brain tumours, was held not to be an ‘active ingredient’ according to Article 1(b). The excipient had no therapeutic effect of its own, but contributed to the medicinal product by acting as a bioerodible matrix for the gradual release of the active agent in the brain.
GSK appealed the UKIPO’s decision to the UK High Court, and the question put to the CJEU by Mr Justice Arnold, in a reference for a preliminary ruling, was, in essence, whether the term ‘active ingredient’ in Article 1(b) of the Regulation would encompass a substance which has no therapeutic effect of its own but which, in a combination with a second substance, enhances the therapeutic effects of the second substance.
The CJEU considered the case at hand in the light of the MIT decision. The considerations applying to MIT’s excipient were held to apply also in the case of GSK’s adjuvant which, as it had no therapeutic effects of its own, could therefore not be regarded as falling within the concept of ‘active ingredient’. It followed that an SPC cannot be granted in respect of that adjuvant, since the adjuvant cannot be regarded as a ‘product’ within the meaning of Article 1(b) of the Regulation.
The CJEU also referred to the Neurim judgment (CJEU Case C-130/11), which held that a patent protecting a new application of a new or known product may now enable an SPC to be granted and, in that case, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product. The CJEU concluded that the Neurim judgment did not cast doubt on the principle that Article 1(b) should be interpreted narrowly, as held in the judgment in MIT, to the effect that the term ‘product’ cannot cover a substance which does not correspond to the definition of ‘active ingredient’ or ‘combination of active ingredients’.
Thus, the CJEU has confirmed that Article 1(b) of the Regulation is to be interpreted narrowly whereby, in a medicinal product, only a substance that has therapeutic effects of its own can be regarded as an ‘active ingredient’ and thus form the basis of an SPC.