The SPC Blog is grateful to Ulrike Herr and Raphael Bösl at Isenbruck Bösl Hörschler LLP for providing a recently published decision of the German Federal Patent Court regarding SPCs and medical devices, here. Ulrike and Raphael represented the Leibniz-Institut für Neue Materalien gemeinnützige GmbH in the proceedings and have kindly provided the following summary of the decision:
"The German Federal Patent Court
(BPatG) 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 German Patent and Trademark
Office (GPTO) 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."
Many thanks to Ulrike and Raphael for sharing this decision!
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Friday 11 March 2016
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment