Germany: SPCs for medical devices

Managing IP is part of Legal Benchmarking Limited, 4 Bouverie Street, London, EC4Y 8AX

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

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

Germany: SPCs for medical devices

While SPCs can be granted for medicinal products in accordance with Regulation (EC) No 469/2009, it has been questioned whether medical devices that are also subject to a lengthy product approval process similar to medicinal products could be eligible for SPC protection in the absence of an explicit Regulation in this respect. In the past, the German Federal Patent Court (Bundespatentgericht or BPatG) adopted a relatively liberal approach in deciding that SPCs for an implantable medical device comprising a pharmaceutically active substance are allowable (14 W (pat) 12/07). A recent case may signal that the German Federal Patent Court may apply a stricter approach in the future.

The 14th Senate of the BPatG held in decision 14 W (pat) 45/12 that SPCs cannot be granted for medical devices under the Regulation and the corresponding case law of the CJEU. The Leibniz-Institut für Neue Materialien gGmbH filed an SPC application for aminosilane-coated iron oxide nanoparticles, which are directly introduced into a tumour and then heated by the application of an external magnetic field. This treatment results in the destruction or in the sensitisation of the tumour cells for further treatment. The application was based on an EC design-examination certificate in accordance with Directive 93/42/EEC on Medical Devices.

According to Article 1(b) of the Regulation, "product" means the active ingredient or combination of active ingredients of a medicinal product. Since the term "active ingredient" is not defined in the Regulation, the BPatG referred to the CJEU decision Forsgren (C-631/13), which held that active ingredients must have pharmacological, immunological or metabolic action of their own. The BPatG concluded that the therapeutic effect of the aminosilane-coated iron oxide particles, which are inactive on their own, is purely physical, and therefore the particles do not fall under the definition of the term "product" as defined by Article 1(b) of the Regulation, thus ruling out the application of the Regulation.

While the BPatG indicated that it favours the grant of SPCs for medical products, it made clear that it will be up to the legislator to implement corresponding legal frameworks. It remains to be seen whether the recent decision marks a new era of stricter rulings on SPCs to medical devices in Germany, or whether it only precludes the grant of SPCs for medical devices that do not have a therapeutic effect on their own.

Wunsche

Annelie Wünsche


Maiwald Patentanwalts GmbHElisenhof, Elisenstr 3D-80335, Munich, GermanyTel: +49 89 74 72 660 Fax: +49 89 77 64 24info@maiwald.euwww.maiwald.eu

more from across site and SHARED ros bottom lb

More from across our site

David Aylen, who spent more than 20 years at Gowling WLG, has joined United Trademark and Patent Services as of counsel in the UAE
Europe is among the most lucrative legal markets for PE firms to bet on, but clients’ reactions will decide whether external investment drives success
Rulings of note covered pre-June 2023 infringements and jurisdiction over non-UPC states, while winners of Managing IP’s EMEA Awards acted in multiple cases
Jason Blair, a former special marks examiner, said Dykema’s Texas presence will help him build deeper connections with clients
Lee Curtis and Rachel Platts at HGF discuss the rise of the ‘intention economy’ and its impact on trademark law
Martin Wintermeier discusses taking a hit for clients, not letting stress get to you, and why being a criminal defence lawyer might have been fun
Exclusive data and analysis reveal why clients feel external legal teams aren’t providing business-centric advice
The head of the soft IP team at engineering group Sandvik, winner of the in-house team of the year award, reveals why a flurry of M&A activity led to a busy 2024
Lawyers at Herbert Smith Freehills outline what rights owners should be doing ahead of sweeping changes to EU design law
Deals between five more law firms and President Trump and an antitrust lawsuit against Amgen were also among the top talking points this week
Gift this article