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SPCs and Medical Devices: Regulation 469/2009 requires a pharmacological, immunological or metabolic action of the product of its own: BPatG Decision 14 W (pat) 45/12

Summary of a decision of the German Federal Patent Court of December 8, 2015 concerning the application of Regulation 469/2009 to medical devices. Isenbruck Bösl Hörschler LLP (Ulrike Herr and Raphael Bösl) represented the Leibniz-Institut für Neue Materialien gemeinnützige GmbH in the proceedings.

The German Federal Patent Court has handed down recently the decision for the SPC case Leibniz-Institut für Neue Materialien gemeinnützige GmbH (14 W (pat) 45/12). This decision of December 8, 2015 concerns the application of Regulation 469/2009 to medical devices.

In Short

The BPatG emphasised that an SPC is not granted for a medicinal product as such (or as in the present case: for a medical device), but only for an active ingredient or for a combination of active ingredients, respectively, of a medicinal product. The term “active ingredient” means that the product exerts a pharmacological, immunological or metabolic action of its own. Moreover,currently, the BPatG does not seem to grant SPCs for medical devices based on Regulation 469/2009 at all.

The Case

The Leibniz-Institut für Neue Materialien gemeinnützige GmbH (“Leibniz”) filed an SPC application in Germany for the medical device product “aminosilane-coated iron oxide nanoparticles” based on EC Design Examination Certificate no. 11870GB411100614 granted under the Medical Device Directive (MDD) 93/42/EEC. Aminosilane-coated iron oxide nanoparticles are used for the local treatment of solid brain tumours. The method is based on the principle of introducing the magnetic nanoparticles directly into a tumour and then heating them in an alternating magnetic field. As a result of the treatment, tumour cells are either irreparably damaged or sensitized for additional therapies. The therapeutic effect is achieved by physical means.

The GPTO German Patent and Trademark Office rejected the SPC application essentially on the grounds that the product is not a medicinal product but a medical device and that the EC Design Examination Certificate which is governed by MDD 93/42/EEC is allegedly not a valid marketing authorisation under Article 3 (b) of Regulation 469/2009. The GPTO excluded also application of Regulation 469/2009 to medical devices by analogy. In the UK, the corresponding SPC application was rejected for similar reasons. The Hearing Officer held that a product, which had not been subject to an administrative authorisation procedure, is excluded by Article 2 of Regulation 469/2009 (see post dated 8 August 2014).

In Germany, Leibniz appealed against the rejection decision and argued inter alia that, on one hand, the product is a medical device according to Article 1(2) (a) of MDD 93/42/EEC owing to its physical effect, on the other hand, the product is a medicinal product according to Article 1(a) of Regulation 469/2009, since the product is administered in view to restoring or improving physiological functions in humans. The appellant pointed out that according to Regulation 469/2009, the term “active ingredient” is not limited to products having a pharmacological, immunological or metabolic action.

Grounds for the BPatG’s Decision

The BPatG did not share Leibniz’s view. It held that it must be assessed first, if the scope of Regulation 469/2009 is opened. The BPatG mentioned that according to Article 2, application of Regulation 469/2009 requires inter alia that the “aminosilane-coated iron oxide nanoparticles” constitute a product in terms of Article 1(b) of Regulation 469/2009. The BPatG admitted that the term “active ingredient” is not defined in the Regulation. Therefore, the Court reviewed relevant CJEU case law including the recent decision Forsgren, C-631/13 of 15 January 2015, concerning the interpretation of Article 1 (b) of Regulation 469/2009 with respect to an active ingredient that is covalently bound to other active ingredients forming part of a medicinal product. The BPatG is of the opinion that in Forsgren, the CJEU has finally clarified that only substances producing a pharmacological, immunological or metabolic action of their own are active ingredients in terms of Regulation 469/2009 (cf. CJEU, Forsgren, C-631/13 of 15 January 2015, paragraph 25).

As outlined above, the therapeutic effect of the product “aminosilane-coated iron oxide nanoparticles” is achieved by physical means. Thus, under consideration of Forsgren, the BPatG concluded that aminosilane-coated iron oxide nanoparticles are not a product according to Article 1 (b) of Regulation 469/2009, since said nanoparticles are not substances producing a pharmacological, immunological or metabolic action of their own. As a result, the BPatG decided that in the present case, already for this reason the scope of Regulation 469/2009 is not opened. Consequently, any remaining questions were not assessed and the appeal was rejected.

It is important to note that ground 6 of the decision seems to reflect the current position of the BPatG concerning the grant of SPCs for medical devices based on Regulation 469/2009. The BPatG indicates that, in principal, section 16a paragraph 1 of the German Patent Act includes the option of extending the type of products for which an SPC may be granted by additional regulations. The Court acknowledges that the effective patent protection for medical devices is insufficient for recovering the investment put into research owing to the necessary preclinical and clinical studies and the authorisation procedure. Both aspects led to the introduction of SPCs for medicinal products for human use and for veterinary medicinal products. However, the Court points out that only the legislators are competent to create a similar regulation for medical devices. In contrast, the Courts are barred from extending supplementary protection to medical devices. Thus, at present, at least the 14th division of the BPatG does not seem to be willing to grant SPCs for medical devices based on Regulation 469/2009.

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