The level of definition required for an active ingredient to be considered "protected by a basic patent" under Article 3(a) of the SPC regulation has long been disputed, particularly insofar as this relates to combination products wherein one of the active ingredients is explicitly identified and the basic patent merely mentions the possibility that another active ingredient may be present.
In applying the CJEU's decision C121/17, the UK High Court has now confirmed that merely reciting the optional presence of additional therapeutic ingredients is not enough for a specific combination to be considered to be protected by a basic patent under Article 3(a) of the SPC regulation. This decision applied both of the tests recited in C-121/17 and indicated that a combination product cannot be considered to fall under the invention covered by a patent where the patent merely states that other therapeutic ingredients may be present, and that a second active ingredient cannot be specifically identifiable if it is not mentioned in the patent even if it was known at the priority date.
This decision will not come as a surprise to the SPC community, but it does appear to once and for all exclude SPC protection for a combination product on the basis of a basic patent which merely recites a single active ingredient in combination with further undefined therapeutic ingredients. We await a further application of C-121/17 in a situation where the second active ingredient is specified in generic terms, which may be expected to cause more controversy.
The first test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, the combination of active ingredients must necessarily, in the light of the description and drawings of the patent, fall under the invention covered by that patent. As explained above, this is not a simple extent of protection test. Rather, the combination must be one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, to embody the technical contribution made by the patent.