The SPC Blog has received two questions from readers. Can you help them?1. "Are the travaux préparatoires for the SPC Regulation available online -- I've tried finding them on the European Commission's website but have had no luck so far".
2. "Does anyone know whether patent extensions were ever considered for medical devices? And why were they not included within the SPC provisions?"
If you have anything to offer, can you please post your information as a Comment below.
5 comments:
I haven't found the travaux préparatoires online, but I have a copy which I'd be happy to scan in and send. Email me at adrian.bradley@fjcleveland.co.uk
Two quick answers:
Ad 1) The European Parliament has put the main travaux préparatoires regarding Regulation 1901/2006 online at http://www.europarl.europa.eu/oeil/file.jsp?id=5210532.
There are also dossiers on Regulations 1768/92 and 1610/96, but most of the documents listed are not available. Probably have never been scanned.
Ad 2) The Netherlands Patent Office decided that in principle medical devices could form the basis for an SPC but only if the medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, 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 Directive 75/318/EEC.
This opinion has been confirmed by the Court of The Hague in 2004, which decision (in Dutch) can be found at http://www.boek9.nl/index.php?//Een+belastende+en+langdurige+procedure////21736/.
Interestingly the applicant also decided to appeal this decision to the "Raad van State" (High Court for Adminstrative Law). A hearing was held after which the Court was on the verge of referring questions to the European Court of Justice, which would have been very helpful to everybody in Europe, but at that point the applicant dropped the appeal.
Over the years we have received only a couple of applications based on an authorization for a medical device. Perhaps that is due to the fact that the active substances that are incorporated in medical devices usually have been the subject of previous authorizations as medicinal products.
Dr. Martijn de Lange
Patent examiner
Netherlands Patent Office
Re Question 2: They were not.
In part this is simply because the harmonisation in Europe of the regulatory regime applying to medical devices, unlike that for medicinal products, to a large degree postdates the SPC Regulation. But more fundamentally it is hard to envisage how one could establish an SPC type scheme for them, as they do not receive marketing authorisations in the same way as medicinal products, and indeed the degree of regulation varies enormously depending on the nature of the device. Moreover from a policy point of view the regulatory barrier to entry, and consequential delay in commercialisation is for most medical devices lower than that for medicinal products. My impression is also that the commercial life cycles of medical devices are relatively short. Of course, were we still to have the Patents Act 1949 provisions for patent extension on grounds of inadequate remuneration, deserving cases in medical devices (and in any other area of technology) could be addressed. But that was a casualty of the EPC and the 1977 Act.
Dear SPC Blog reader,
Regarding your query as to where to find a copy of the "travaux preparatoires", please try the following link as I believe that is what you are looking for.
http://documents.epo.org/projects/babylon/eponet.nsf/0/43F40380331CE97CC125727A0039243C/$File/00002a_en.pdf
Kind Regards,
Dr. Benoit Lienard
IPASSET LLP
1. Most travaux préparatoires are available via EU Helpdesk, this is the way I have received some of them. Please email me at kzbier@web.de should you still need any.
2. Interestingly, according to “The Supplementary Protection Certificate. Guide for Applicants” (p.15), published by the UK Patent Office,available at http://www.ipo.gov.uk/spctext.pdf, it is possible to apply for the SPC for a medical device, “Regulation 1768/92 concerning certificates for medicinal products states that a marketing authorisation in accordance with Directive 65/65/EEC or Directive 81/851/EEC (now to be interpreted as Directive 2001/83/EC and Directive 2001/82/EC) needs to have been granted to obtain a certificate. However, this does not guarantee that a certificate will be granted. An important point to consider is whether the medical device essentially incorporates an active substance which can be defined as the product in a suitable way for the certificate and which is authorised in accordance with the Directives 65/65 and 81/851” .
Katarzyna Zbierska LL.M IP
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