For the half-year to 31 December 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Rebecca Gulbul, Lucas Michels and Marie-Andrée Weiss.

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Wednesday, 2 April 2014

Fresh from the UK IPO - No SPCs for medical devices, says Hearing Officer

This Kat just noticed a decision in relation to two SPC applications in the name of Cerus CorporationSPC/GB/07/043 and SPC/GB/07/044 - in which it is confirmed that, as might be expected, authorisation to place a product on the market as a medical device pursuant to Directive 93/42/EEC cannot be considered equivalent to authorisation pursuant to the medicinal products Directive 2001/83/EC.  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
This Kat understands this to be the majority view around Europe, but that there are some conflicting cases in the Netherlands and Germany where the assessment processes were held to be equivalent and SPCs were allowed.  The Decision is dated 31 March and is not yet apparently posted to BAILII, but the summary on the IPO website is excellent, and seems worth reproducing in full:
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. 
Merpel wonders, exhausted, whether this means that another referral to the CJEU is to be expected, if the applicant appeals to the Patents Court or higher.

6 comments:

Anonymous said...

Your title says 'No SPCs for medical devices'. However in the present case the SPC applications were refused due to the type of authorisation required, rather than the fact the product was a medical device. Presumably if you got the usual authorisation for a medicinal product for the medicinal product part of the device the fact the product was in a device would not stop an SPC being granted based on that.

Darren Smyth said...

Dear Anonymous at 9:53

Thank you for your comment, which I fear has left me a little bewildered. “Medical Device” and “Medicinal Product” are legally defined terms in the two Directives 93/42/EEC and 2001/83/EC respectively. In my blogpost, therefore, “medical device” means “something authorised pursuant to Directive 93/42/EEC”, and “medicinal product” means “something authorised pursuant Directive 2001/83/EC”. I think that this is standard and self-evident, and most authors would take this approach. So in your contrafactual “if you got the usual authorisation for a medicinal product for the medicinal product part of the device”, then what you have is a medicinal product, and any SPC is in respect of that medicinal product.

Best wishes

Darren

Anonymous said...

Thanks Darren. You are correct and apologies for not being clear. I'm basically saying that where a product is 'Drug X within device Y' then presumably this could be a product under Directive 2001/83/EC and so someone could get an SPC to it.

Anonymous said...

The directives are clear as to which one is to be applied in each circumstance. There is no overlap or user-choice. 2001/83/EC applies in a particular drug/device combination, which is mentioned several times in the decision.

Darren Smyth said...

Dear Anonymous at 13.26 who I assume is same as Anonymous at 9:53

Thank you for your comment and clarification.

Intervening anonymous at 15:37 is not me, but their comment, although brief, is on point. For my part, I think I am going to have to be nit-picky, because precision is important in SPCs. Your comment is, I think, possibly correct up to the final “it”. Someone could get an SPC to the Drug X, but the SPC protects the “product”, which in the parlance of the SPC regulation means the active ingredient. It would not be an SPC to a medical device (in any sense of the term). It is not ruled out under the SPC regulation or the Directive 2001/83/EC that the medicinal product under Directive 2001/83/EC may include some device-type elements, but I think the only sensible way to view that situation is that by definition it is a medicinal product, not a medical device. The language of the three regulations is head-hurty enough without using it informally to mean something other than the defined meaning.

Best wishes

Darren

Anonymous said...

The full IPO decision may be found here:
http://www.ipo.gov.uk/pro-types/pro-patent/pro-p-os/o14114.pdf

What I find surprising in this decision is that the granted patent
https://data.epo.org/publication-server/pdf-document?pn=0707476&ki=B1&cc=EP
only includes method claims which I would have thought would lead to a fundamental bar for an SPC but then this is not my field. Perhaps the hearing officer wanted to set the record straight.

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