Following a reference from the Patents Court of England & Wales, the CJEU has issued a Reasoned Order in Glaxosmithkline Biologicals SA v Comptroller-General of Patents (Case C-210/13) clarifying the meaning of "product" in the SPC Regulation (Regulation 469/2009). The CJEU has affirmed its decision in MIT (Case C-431/04) and adopted a narrow definition of "product", such that only active ingredients or a combination of active ingredients in the strict sense are included. As a consequence, even if adjuvants or excipients influence the therapeutic effect of an active ingredient, as they have no therapeutic effect of their own, they cannot be the subject of an SPC either alone or in conjunction with antigens.
By maintaining the strict definition of "product" from the CJEU's decision in MIT, the door has been closed on SPCs being obtained on a wider range of ingredients or constituents.
The reference to the CJEU concerned two SPC applications made by GSK. Both SPC applications were based on GSK's marketing authorisations 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 was able to obtain SPCs based on its applications turned on whether the adjuvant AS03 fell 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".
In light of the existing case law and MIT in particular, the CJEU felt able to determine the reference by Reasoned Order. In the absence of a definition of "active ingredient" in the SPC Regulation, the CJEU approached its meaning by reference to the general context in which the term was used and its usual meaning in everyday language. The CJEU considered that the pharmacological use of the term ingredient and the regulatory distinction between active ingredients and adjuvants pointed away from adjuvants falling within the meaning of active ingredient in the SPC Regulation. As a consequence, the CJEU held that an adjuvant cannot be an active ingredient nor form part of a combination of active ingredients and thus could not be included within the meaning of "product" under Article 1(b) of the SPC Regulation.
The CJEU also affirmed that its decision in Neurim (Case C-130/11) did not cast doubt on a narrow interpretation of "product" under Article 1(b) of the SPC Regulation. Even under this narrow interpretation an SPC can be granted on the basis of a patent protecting a new application of a new or known product.