Managing IP is part of the Delinian Group, Delinian Limited, 8 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2023

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Germany: CJEU asked to clarify functional definition issue

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).

Annelie Wünsche

Dirk Bühler

Maiwald Patentanwalts GmbHElisenhof, Elisenstr 3D-80335, Munich, GermanyTel: +49 89 74 72 660 Fax: +49 89 77 64

more from across site and ros bottom lb

More from across our site

Counsel from BMW and Finnegan explain how they got an NPE to sign a covenant agreeing not to sue the automaker ever again
The blue checkmark could be a good tool, but it’s unclear how widespread its adoption will be, say in-house sources
Sarah Harris, partner at Williams & Connolly, reveals how her team secured a copyright victory at SCOTUS and reflects on why the case matters
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
A Court of Appeal judge demanded respect for solicitor-judges after reprimanding a barrister for his 'unwise' words
Speeches at the UPC inauguration highlighted the gap between the unitary patent dream and the reality today
Sources with experience on both sides of the Atlantic believe hugely profitable US law firms may still take some convincing before agreeing to partner with a UK outfit
IP counsel urge the government to restrict safe harbour exceptions available to intermediaries and clear up doubts with the existing law
A New York lawyer could face sanctions after citing fake judgments generated by ChatGPT, but that doesn’t mean practitioners should shy away from AI
Klaus Grabinski told delegates at a UPC inauguration event that the proposed SEP regulation would limit access to justice