Germany: CJEU asked to clarify functional definition issue

January 29 2018

Recently, the 14th Senate of the German Federal Patent Court referred new questions to the CJEU on the criteria for Article 3(a) of the SPC Regulation (EC) No. 469/2009 (decision 14 W (pat) 12/17; CJEU: C-650/17) to clarify when a functional definition refers to the product in question.

In this case, the claims of the basic patent EP 1 084 705 B1 refer to treatment of Diabetes mellitus by administration of DPIV-inhibitors based on the inventors' recognition that inhibition of the enzyme DPIV generally allows for lowering of blood glucose. The SPC was requested for sitagliptin, a DPIV-inhibitor marketed for treatment of Diabetes mellitus. The basic patent refers to DPIV inhibitors and points out that other DPIV inhibitors may be used as well, however does not disclose sitaglipin individually. Sitagliptin is protected by a later filed composition of matter patent.

The situation is thus comparable with the CJEU Eli Lilly decision (C-493/12) where the claims were directed to the genus of Neutrokine-alpha antibodies, but the product in question, tabalumab being a Neutrokine-alpha antibody was not individually disclosed in the claims or the specification and had been developed after the filing date of the basic patent. In this case the CJEU had ruled that functional features can protect a product under Article 3(a) if the claim refers implicitly, necessarily and specifically to the product. However, courts and patent offices have struggled with this test. The UK, for example, has taken a rather generous approach, whilst authorities in the Netherlands, France and Germany seem to require an individualized disclosure of the product in the description or consider Eli Lilly to be limited to biologics.

In its referring decision the Senate acknowledges that sitagliptin is a DPIV-inhibitor and would thus be within the extent of protection conferred by Article 69 EPC. However, according to the Senate's interpretation following the rejection of the infringement test by Medeva (CJEU C332/10) it would not be sufficient for the purpose of Article 3 (a) that the product in question, namely sitagliptin, falls within the extent of protection (Schutzbereich) conferred by the claims. It would rather be required that the product is disclosed specifically enough to form the subject matter (Schutzgegenstand) of the claims, which in the absence of an individualized disclosure of sitagliptin in the basic patent would not be the case.

In view of the divergent interpretation of the CJEU's case law by the national courts and patent offices, the Senate referred the questions whether the product is protected by a basic patent in force only if it belongs to the protected subject-matter as defined by the claims and whether it is not sufficient that the product in question meets the functional definition in the claims, but is not individualized in the basic patent. The outcome of this referral together with the pending referral (C121/17) hopefully will bring more clarity for the interpretation of Article 3(a).