A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Sunday 25 October 2015

Paclitaxel: when Design Examination Certificates are not enough

Our attention has been drawn to a very recent decision of the UK Intellectual Property Office (IPO) on 6 October: it's BL O/466/15 Angiotech & UBC, a decision of Hearing Officer Dr L. Cullen.

According to the IPO's summary (to which we have added some handy links and emboldened text):
EC Design Examination Certificate no. ID 60004045 0001, dated 21 January 2003, was filed in support of SPC applications, SPC/GB/14/030 for the product “Taxol®” and SPC/GB/14/031 for the product “Taxol®-eluding stent”. These SPC applications concern the use of paclitaxel (referred to by its trade mark, Taxol®) for preventing restenosis. The stent prevents restenosis by physically keeping the blood vessel open while a paclitaxel coating on the stent hinders cell division so preventing the formation of new blood tissue that would block the open blood vessel. The applicant argued that the procedure for obtaining an EC Design Examination Certificate under Directive 93/42/EEC for this device is sufficiently identical to the procedure under Directive 2001/83/EC for the approval of a medicinal product for human use and, as such, it can be used in support of an SPC application under article 3(b) of the SPC Regulation.

The Hearing Officer (HO) reviewed the SPC regulation, the relevant parts of the Medical Devices Directive (Directive 93/42/EEC) and of the Medicinal Products Directive (Directive 2001/83/EC). He took account of the purpose and the actual procedure that is being assessed under both Directives, as well as relevant guidance on both Directives. He reviewed relevant CJEU case law including the recent decision in Laboratoires Lyocentre, C-109/12 and also considered the relevance of previous IPO decisions concerning medical devices Cerus (BL O/141/14) and Leibniz (BL O/328/14). The HO concluded that the SPC Regulation does not provide for all products which have to have some form of authorisation before being placed on the market as being worthy of an SPC but only those authorised under the directives referred to in Article 2 of this Regulation, including Directive 2001/83/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 that to obtain a marketing authorisation under Directive 2001/83/EC. The objectives of both of these systems are different given the differing uses of medicinal products and medical devices and the different means used to approve their use in humans. As a consequence, the SPC applications were found not to meet the requirements of the SPC Regulation and were rejected under Article 10(2) of this Regulation.
This is the third decision of the IPO since March 2014 on whether an SPC can be obtained based on the approval for a class III medical device. Of interest here is that fact that there was a significant difference between the date when the device was approved and the date when the patent was granted. This made it necessary to consider which was the relevant version of the legislation with regard to approval of medical device or approval of medicinal products: was it the version in force when the device approval was granted or the version in force when the patent was granted for a medical device?

The decision also considered the relevance of CJEU Case C-109/12 Laboratoires Lyocentre where the CJEU was asked whether the classification of a capsule as a medical device under Directive 93/42 in some Members States prevented it being classified as a medical product under Directive 2001/83 in others.

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