Patent decision

BL number
Concerning rights in
Hearing Officer
Dr L Cullen
Decision date
29 July 2014
Person(s) or Company(s) involved
Leibniz-Institut für Neue Materialien Gemeinnützige GmbH
Provisions discussed
Regulation (EC) No. 469/2009, Articles 2 and 3; Directive 2001/83/EC on the Community code relating to medicinal products for human use; Directive 93/42/EEC concerning medical devices
Supplementary Protection Certificates
Related Decisions


EC Design Examination Certificate No. 11870GB411100614, dated 14 June 2010 was filed in support of SPC application SPC/GB/10/051 for “Aqueous dispersion of iron oxide nanoparticles”. This product acts through physical means: the nano-sized particles are introduced directly into a cancer tumour and subjected to an alternating magnetic field which causes the particles to heat up and this results either in irreparable damage to the tumour cells or their sensitization to additional treatment. The applicant argued that the procedure for obtaining the EC Design Examination Certificate under Directive 93/42/EEC for this device product is, at least, as onerous as that for obtaining an authorisation under Directive 2001/82/EC for a veterinary medicinal product and thus analogous to procedures in Directive 2001/83/EC for a human medicinal product.

The hearing officer reviewed the SPC regulation and the relevant parts of the Medical Devices Directive (Directive 93/42/EEC) and the Medicinal Products Directives (Directive 2001/83/EC). He took account of the previous decision in Cerus Corporation (BL O/141/14) as well as the purpose of both Directives, the means by which medicinal products and medical devices deliver their principle mode of action, relevant guidance and the actual procedure that is being assessed under both Directives. He concluded that the SPC Regulation does not merely provide for all products which have to have an authorisation before being placed on the market as being worthy of having an SPC but those requiring authorisation under Directive 2001/83/EC or 2001/82/EC. He did not consider that the assessment criteria used to obtain an EC Design Examination Certificate under Directive 93/42/EEC is the same as to obtain a marketing authorisation under Directive 2001/83/EC or Directive 2001/82/EC partly because the objectives of the systems are different given the differing uses of products and devices. In this case the product exercised its action by physical means as opposed to by pharmacological, immunological or metabolic means and therefore does not fall within the scope of the Medicinal Products Directive (Directive 2001/83/EC).

As a consequence, the SPC application was found not to meet the requirements of Article 2 of the SPC Regulation and was rejected under Article 10(2) of this Regulation.

The Hearing Officer, in this instance, did not need to go on and decide whether or not the EC Design Examination Certificate was a valid authorisation for the purposes of Article 3(b).

Full decision O/328/14 PDF document271Kb