Taxol eluting stent decision from the Swiss Federal Administrative Court

The SPC Blog has received news from Tarik Kapic of Bovard of a decision from the Swiss Federal Administrative Court that will force the Swiss Institute of Intellectual Property to decide whether an SPC can be granted on a stent eluting an active ingredient.  An application was filed in 2014 but the Institute refused completely to enter into the matter and the Court has now accepted the appeal based on a “denial of justice” (Rechtsverweigerung). 

A copy of the decision can be found here.  Unfortunately no English translation is available at the moment.

Many thanks to Tarik for passing this on!

Medical Devices Directive authorisation no good for SPC

In Leibniz-Institut für Neue Materialien Gemeinnützige GmbH, BL O/328/14, a UK Intellectual Property Office decision of 29 July, hearing officer Lawrence Cullen held that a medical device, the marketing authorisation for which was governed by Directive 93/42 -- the Medical Devices Directive -- was not a basis for granting an application for an SPC under Regulation 469/2009 in respect of the “aqueous dispersion of iron oxide nanoparticles” . According to the Institute the authorisation procedure under the Medical Devices Directive was the equivalent of an authorisation to place the product on the market as a medicinal product, granted under the administrative procedure laid down in Directive 2001/83 (the Medicinal Products Directive). Following a careful examination of all the relevant legislation and case law, the hearing officer held that a product which had not been subject to the administrative procedure in the Medicinal Products Directive is actually excluded by Article 2 of the SPC Regulation from being granted an SPC.

The 45 page ruling can be read in its entirety here.

SPCs and medical devices: disappointment for Cerus

Via this post by Darren Smyth (EIP) on the IPKat weblog comes news of two SPC applications in the name of Cerus Corporation: SPC/GB/07/043 and SPC/GB/07/044.  The outcome of both applications was that authorisation to place a product on the market as a medical device under Directive 93/42 cannot be considered equivalent to authorisation under the medicinal products Directive, Directive 2001/83.  Accordingly, the two applications were held not to comply with Article 3(b) of the SPC Regulation, which requires "a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate".  Darren observes that this appears to be the majority view around Europe, though there are some conflicting cases in the Netherlands and Germany where the assessment processes were held to be equivalent and SPCs were allowed.  

The Cerus Corporation decision, dated 31 March, is summarised on the UK IPO website as follows:

EC Design Examination Certificate No. G7 02 05 16178 063 was filed in support of SPC application SPC/GB/07/043 for “Platelet preparation obtainable by addition, and subsequent photoactivation, of amotosalen or its salt, to a suspension of platelets in plasma”. EC Design Examination Certificate No. G7 06 09 60562 004 was filed in support of SPC application SPC/GB/07/044 for “Platelet preparation obtainable by addition to plasma, and photoactivation, of amotosalen or its salt”. These EC Design Examination Certificates relate to medical devices that meet the criteria of Article 1(4) of Directive 93/42/EEC because they relate to a device that incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which acts upon the body with action ancillary to that of the device. As a consequence, they fall within class III medical devices and the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in the medicinal products legislation (Directive 2001/83/EC). Class III devices have the highest risk potential in terms of the vulnerability of the human body (taking account of the potential risks associated with the technical design and manufacture of the device). Explicit prior authorization with regard to conformity is required for such devices to be placed on the market. As a consequence of the need to assess the substance as part of the assessment of the device overall, the applicant argued that these EC Design Examination Certificates can, as a consequence, be considered to meet the requirements of Art 3(b) of the SPC regulation, i.e. they represent a valid authorization to place, on the market as a medicinal product, the product for which an SPC has been applied for.

The hearing officer reviewed the SPC regulation and the relevant parts of the medical devices and medicinal products directives. He took account of the purpose of both codes, the means by which medicinal products and medical devices deliver their principle mode of action, and the actual performance that is being assessed under both codes. He concluded that the assessment carried out in relation to the substance, i.e. the safety, quality and usefulness of the substance, when considered in light of the means by which the medical device delivers its action and considering the process by which a device is approved, including the roles of notified bodies and competent bodies, means that the conformity assessment procedure for a class III medical device is not the same as or equivalent to the process carried out to authorise a medicinal product for human use.

As a consequence, the SPC applications were found not to meet the requirements of Article 3(b) and were rejected under Article 10(2) of the SPC Regulation. 

As ever, readers' comments are invited and appreciated.