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).
Maiwald Patentanwalts GmbH
Elisenhof, Elisenstr 3
D-80335, Munich, Germany
Tel: +49 89 74 72 660
Fax: +49 89 77 64 24