CJEU Decides (or not?) on How Much "Identification" of Active Pharmaceutical Ingredient Is Required in Claims of Basic Patent
On December 12, the Court of Justice of the European Union ("CJEU") issued its decision in the case C-493/12 Eli Lilly and Company Ltd vs. Human Genome Sciences Inc. regarding the question to what extent an active pharmaceutical ingredient ("API") has to be specified in a basic patent in order to obtain a supplementary protection certificate ("SPC").
The requirements for the grant of an SPC are laid down in Art. 3 and 13 (1) of EU Regulation 469/2009 (the "SPC Regulation"). According to Art. 4 of the SPC Regulation, a product has to be protected by a basic patent in force to be eligible for an SPC.
In a previous decision of the CJEU, C-322/10 (Medeva), the Court stated that it was possible to obtain an SPC for "active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on." In another decision, C-630/10 (Queensland), the Court discussed whether the API was identified in the wording of the claims.
This left patentees wondering how "specific" the API had to be "identified" or "specified" in the claim. It is worth recalling that the approach of the CJEU was the result of a balance between an infringement test advocated by some, which would have left the answer to the national courts, and some sort of autonomous test under the SPC Regulation, which allowed for some harmonization.
In the case referred to the CJEU, Human Genome Sciences Inc. ("HGS") is a holder of a patent that covers antibodies that bind specifically to a specific protein, without explicitly defining an antibody. Eli Lilly and Company Ltd ("Eli Lilly") has opposed the HGS application for an SPC on the basis of an antibody (which falls within the scope of the claim of the HGS) by arguing that the specific antibody for which the marketing authorization was granted is not covered by a "basic patent" within the meaning of Article 3 of the SPC Regulation, insofar as the relevant claim of HGS's patent is too broadly drafted for it to be possible for that antibody to be regarded as being "specified," for the purpose of the test set out in the Medeva decision of the Court.
The High Court of Justice (England and Wales) referred the following question to the CJEU: "In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?"
Ruling of the CJEU
The Court reached the conclusion that the extent of protection is conferred by the patent claims and they should be interpreted, inter alia, in light of the description of the invention, as required by Article 69 of the EPC.
Art. 69 EPC stipulates that "[t]he extent of the protection conferred by a European patent … shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims."
The Court held that, for the present case, in order for an API to be regarded as "protected by a basic patent in force" within the meaning of Article 3(a) of the SPC Regulation, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula, and that it is sufficient that an API is covered by functional terms.
However, the Court stated that where the API is covered by a functional formula in the claims, an SPC for that API can be granted, on the condition that the claims relate, "implicitly but necessarily and specifically," to the API in question, which is a matter to be determined by the referring court.
The upside of the decision is that the Court does not impose too strict requirements for an API to be "identified" or "specified" in the claims of the basic patent. In particular for complex biologics, it is not absolutely necessary to include picture claims, sequences claims, or other structural descriptions in the claims.
At least on the basis of this decision, the CJEU provides patent holders with a legal certainty that any embodiments that are considered to be within the scope of a claim (according to the national law of the Member State of the EU) should also be considered as being specified within the wording of a claim and that an SPC can be granted for any active ingredients falling within the scope of a claim even if the active ingredient is not specifically mentioned.
Nevertheless, some degree of uncertainty remains, as the CJEU requires that a claim of the basic patent has to relate to an active ingredient "implicitly but necessarily and specifically." Whether or not this is the case is left entirely to the national courts. This will inevitably lead to conflicting decisions by the national courts, which will then have to refer the matter again to the CJEU.
Accordingly, patentees remain well advised, in particular with regard to biologics, to include as many structural references in the claims of a basic patent as possible at the time of the filing.