SPCs on adjuvants??

The SPC blog has found out that a couple of patent offices, Italy and Slovenia, have granted SPCs on vaccine adjuvants (generally vaccine components that modify the immune response to an antigen). We recall from the SPC blog event in January that France had refused such claims, and it wasn't looking too good elsewhere for those seeking this sort of protection.

The medicinal product in question was a combination of antigen + adjuvant, and SPCs were granted to both the adjuvant per se and to the (antigen + adjuvant) as a combination of active substances.

All of this must be considered within the context of the decision in the ECJ Case C-431/04 (MIT) which related to a combination of an active plus a bioerodible matrix that enabled the active to be administered in a therapeutically relevant way. The ECJ decided that:

Article 1(b) of Council Regulation No 1768/92 of 18 June 1992 ...must be interpreted so as not to include in the concept of ‘combination of active ingredients of a medicinal product’ a combination of two substances, only one of which has therapeutic effects of its own for a specific indication.

Does a vaccine adjuvant have a therapeutic effect of its own for a specific indication? A vaccine adjuvant, which itself has some immunological/ physiological effect on a host, might at least be considered to be more of an active substance than a matrix to allow slow release.

Let's throw into the mix (not literally) that some adjuvants for vaccines are being considered as monotherapies in their own right, such as CpG for cancer ...

Moreover, it's an interesting one for patent attorneys and their regulatory teams. Do you argue that an adjuvant is an active, which may be necessary if trying to obtain an SPC on a combination of an old active with new adjuvant, for example. Or do you argue that the adjuvant is a mere excipient to assist in the regulatory process?

If anyone has any other SPC related information on SPCs granted or refused on adjuvants, please do share them with us.