SPC protection based on "subject-matter of the invention"

In Actavis and Boehringer Ingelheim (Case C-577/13) the CJEU ruled on 12 March 2015 that where a basic patent includes a claim to an active ingredient which "constitutes the sole subject-matter of the invention", and the holder of that patent has already obtained an SPC for that active ingredient, the holder may not obtain a second SPC for a combination of that ingredient with another active ingredient. On the facts of the case, it was not permissible to have an SPC for the combination of telmisartan and hydrochlorothiazide (HCTZ) in circumstances where it is the telmisartan component that is inventive, but not the combination – the combination must embody a separate inventive advance if it is also to be protected.

eyewear on notebookBy requiring the product protected by an SPC to be within the "subject-matter of the invention" the CJEU appears to be importing the patent law concept of invention into SPC considerations. However, the subject matter claimed by the basic patent in force that underlies an SPC should be inventive in any case. It is therefore not currently clear whether this ruling has repercussions beyond focussing scrutiny on combination SPCs in which one active ingredient has already been the subject of protection. Indeed, the CJEU states that:

if it were accepted that all subsequent marketing of an active ingredient in conjunction with an unlimited number of other active ingredients which do not constitute the subject-matter of the invention covered by the basic patent would confer entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs

The CJEU ruling

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.


Paul England

Paul is a senior associate and professional support lawyer in the Patents group based in our London office.