In order to gain time for the amortization of research investments on patented pharmaceutical products, the pharmaceutical industry may use supplementary protection certificates (“SPC’s”). Prerequisite for the issuance of an SPC on an approved pharmaceutical product is that the product is protected by a base patent in terms of an active ingredient or a composition of active ingredients [Art. 3(a) and (b) of Regulation (EG) 469/2009] and that the active ingredient or the composition of active ingredients are recited in the claims of the base patent (cf. ECJ judgment C-322/10 of November 24, 2011).
Up to now it was unclear, if a functional definition of the active ingredient in the claim of the base patent also fulfils this prerequisite. As an example, a claim directed to an antibody active ingredient shall be mentioned: “isolated antibody, binding the domain X of peptide Y”. The advantages of a functional definition of an antibody with respect to a structural definition are obvious: any suitable antibodies are covered, even those which will only be available in the future. The other side of the coin is the above-mentioned uncertainty about the question, if an SPC based on a functionally defined patent claim is allowable.
With his judgment C-493/12 of December 12, 2013 the ECJ clarified that it is not mandatory to define the active ingredient in the claims of the base patent by using a structural formula. A functional definition (for instance in accordance with the above-mentioned claim example, as commonly accepted by the European Patent Office) is also acceptable, as far as the claim as directed to the relevant active ingredient.
In detail, the headnote says the following: “Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.”