No Supplementary Protection Certificates for Medical Devices
The German Federal Patent Court refused to grant a Supplementary Protection Certificate (SPC) for aminosilane-coated iron oxide nanoparticles which were authorized for the European market as a medical device. Although the decision clearly refuses an analogous use of the SPC regulation for most medical devices – only the EU legislator could introduce a new medical device SPC – the court still leaves open whether at least implantable medical devices containing active pharmaceuticals might be subject of an SPC under the current regulations.
Supplementary Protection Certificates (SPCs) provide additional patent term for medicines or plant protection agents after the expiry of the basic patent. Since gaining approval to place a new medicament on the European market requires a cumbersome and time consuming administrative procedure, a large proportion of the standard 20 year patent term passes by without providing any benefit for the patent owner. With the regulation (EC) No. 469/2009 (“SPC regulation”) the European Union (EU)-legislator intended to compensate the loss in effective patent term and to allow companies to recoup their investment in clinical trials and administrative procedures. SPCs grant up to 5 additional years of patent protection for approved medicines or plant protection agents. Up to the present day many SPCs have been granted in Europe for medicinal products containing chemical compounds as active ingredients. Still unclear is, however, whether therapeutic medical devices, or devices containing therapeutically active ingredients, can also be subject of an SPC.
The market authorization procedure for medical devices is regulated in Directive 93/42/EEC and Directive 90/385/EEC (the latter for active implantable medical devices), whereas medicines are approved according to Directive 2001/83/EC. Although approval of medical devices, in particular if they are implantable and contain pharmacological active ingredients, also involves extensive preclinical and clinical testing, the authorization procedure is not identical to medicines. For example the responsible institutions for granting a market approval for medicines are public institutions such as the European Medicines Agency (EMA), whereas medical devices are approved by specialized qualified private organizations.
The German Federal Patent Court now decided on an appeal filed by an applicant for an SPC for the medical device “aminosilane-coated iron oxide nanoparticles” (case no. 14W (pat) 45/12). The SPC was filed on basis of the European patent EP 0 636 111 and an EC design examination certificate as first market authorization granted for the product NanoTherm AS1. The German Patent Office had previously rejected the SPC application with the argument that the nanoparticles are not a medicinal product in the sense of Article 1 of the SPC regulation, but a medical device according to EU Directive 93/42/ECC. In appeal proceedings the applicant explained that although the nanoparticles are a medical device, they are likewise a medicinal product according to the SPC regulation as they provide a therapeutic effect. The appellant further stated that the EC design examination involved extensive clinical testing which lasted for about 11 years until the product could be placed on the market. The patent owner thus suffered from a loss of effective patent term comparable to the situation of innovative medicines, and that therefore an analogous application of the SPC regulation for medical devices is justified.
The 14th senate of the German Federal Patent Court in the decision 14 W (pat) 45/12 did not share the view of the applicant. With reference to the recent decision of the Court of Justice of the EU (CJEU) in Forsgren (C-631/13 dated 15 January 2015) the senate argued that SPCs may only be granted for medicinal products containing an active ingredient or combination of active ingredients with own pharmacological, immunological or metabolic effects. Thus the senate analyzed the question whether the nanoparticles have a pharmacological, immunological or metabolic effect on their own. During a cancer therapy the nanoparticles are administered to cancerous tissue in a patient and then activated by applying an alternating electromagnetic field which induces heat locally at the targeted site to destroy or weaken tumor tissue. The therapeutic effect of the nanoparticles is therefore produced solely by physical means and is not of a pharmacological, immunological or metabolic nature.
Following the senate’s understanding of the CJEU decision in Forsgren with respect to the interpretation of the term “active ingredient” in Article 1b of the SPC regulation, the patent court’s negative decision is probably not very surprising. Interesting is, however, that the judges still comment on the possibility of an analogous application of the SPC regulation for medical devices. The judges specifically deny analogy for “medical devices that t in the sense of regulation (EC) No. 469/2009” (emphasis added). Applying the SPC regulation to medical devices would constitute an inadmissible expansion of the scope of the regulation. Although the judges agree with the applicant’s argument that the marketing of medical devices requires extensive clinical testing, only the European legislator and not the courts could provide relief to the unsatisfactory situation. The senate indicates that the legal SPC framework does not exclude additional regulations allowing SPCs for medical devices.
Here the 14th senate specifically rejected an analogous use of the SPC regulation for medical devices without active ingredients. The question thus remains whether there is a possibility for an analogous use of the SPC regulation for a medical device containing an active ingredient. But even if the question could be answered in the affirmative, there is unfortunately another hurdle in Article 2 of the SPC regulation. Market authorizations for medical devices are exclusively granted under the European medical device directive and not via the administrative procedures for the authorization of medicines under EU directives 2001/83 and 2001/82. In the case Hylan A and Hylan B (15 W (pat) 28/08) the 15th senate of the German Federal Patent Court previously rejected an SPC for a medical device on the ground that Article 2 of the SPC regulation would require a market authorization by an “administrative” procedure, which the senate did not recognize in the procedures for the authorization under the medical device directive. As mentioned before, it is currently mandatory to apply for market authorization for a medical device under the medical device directive and thus the Hylan A and Hylan B decision shuts the door for any analogous use of the SPC regulation for medical devices. Although the case was open to a legal revision by the Federal Supreme Court, the applicant did not file an appeal.
Contrary thereto, other European courts granted SPCs to medical devices containing active ingredients in the past. The Dutch court in the case Genzym vs. Bureau voor de Industriele Eigendom decided that an analogy between the procedures for market authorization for active implantable medical devices and medicines is fully justified. Even the 14th senate of the German Federal Patent Court – then in a different composition – granted an SPC in the case Yttrium-90 glass microspheres (14 W (pat) 12/07) on the basis of an authorization pursuant to the medical device directives. Obviously the national case law is not harmonized and one may hope that this question will finally find its way up to the CJEU for a clarification whether active implantable medical devices can be subject of an SPC under the current regulations.