Precis

In its decision of 6 October 2015 in Angiotech Pharmaceuticals Ltd and the University of British Columbia (BL/ O/466/15), the UK Intellectual Property Office (the “IPO”) considered whether a Supplementary Protection Certificate (“SPC”) could be granted for a Taxol®-coated stent (which is classified in the EU as a Class III medical device, rather than a human medicinal product). The applicants argued that the Design Examination Certificate and Declaration of Conformity required under Directive 93/42/EC concerning Medical Devices (the “Medical Device Directive”) before the product could be put on the market in the EU was equivalent to a marketing authorisation for a human medicinal product granted under Directive 2001/83 (the “Medicinal Product Directive”).

The German Courts and Dutch Courts have each, in at least one case apiece, allowed the grant of an SPC in these circumstances. The IPO had itself granted such SPC applications in the past. However, confirming its more recent practice established last year in its decisions in Cerus (BL O/141/14) and Leibnitz (BL O/328/14), the IPO decided that an SPC cannot be granted in this circumstances, and rejected the application.

What?

Angiotech Pharmaceuticals Inc. and the University of British Columbia (“the Applicant”) applied for two Supplementary Protection Certificates (“SPC”) SPC/GB/14/030 for “Taxol®” and SPC/GB/14/031 for “Taxol®-eluting stent” on 31 March 2014. Both SPC applications were based on the patent EP(UK)2226085 B1 which is entitled “Anti-angiogenic compositions and methods of use.” The expiry date of the patent at the European Patent Office was 8 July 2014.

The SPC applications in question refer to the use of Taxol®(paclitaxel) for treating or preventing restenosis. Taxol®-coated stents treat restenosis by physically keeping the blood vessel open, and over time prevent the formation of new blood vessels around the stent.

A Design Examination Certificates (No. ID 60004045 0001) dated 21 January 2003 (“the Certificate”) was identified by the Applicants as the relevant Marketing Authorisation for the purpose of the SPC application. The Certificate was issued by TUV Rheinland Product Safety GmbH, which is a Notified Body under Directive 93/42 EC. The Certificate confirms that the design of the medical device identified as a “Coronary Stent with delivery system products: see attachment” fulfils the requirements of Annex II, Article 4, of Directive 93/42/EEC.

The law

The scope of Regulation 469/2009 concerning the supplemetnary protection certificate for medicinal products (the “SPC Regulation”) is specified in Article 2. It provides that:

“Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC … may be the subject of a certificate”.

Product is defined as “the active ingredient or combination of active ingredients of a medicinal product.”

The repeated references to “medicinal product”, rather than “medical device”, appear to be unequivocal, and at first sight do not hold out much prospect that a medical device could qualify for an SPC.

However, the applicant argued that:

  • the fundamental objective of the SPC Regulation is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health. The raison-d’etre of the SPC Regulation is the fact that the period of effective protection under a patent is insufficient to cover the investment put into pharmaceutical research and the SPC Regulation thus sought to make up for that insufficiency by creating an SPC for medicinal products.
  • The same rationale applies to medical devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices. Such products are classified as medical devices in Class III (Rule 13 of Annex IX of Directive 93/43/EEC), rather than medicinal products. Explicit prior authorisation with regard to conformity to the essential requirements of the Medical Devices Directive is required in order for them to be placed on the market.
  • Furthermore, Annex I of Directive 93/43/EEC provides that:

“Where a 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 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.”

Moreover, the Notified Body is required to obtain a scientific opinion from one of the competent authorities designated by the Member States under the Medicinal Product Directive (such as the Medicines and Healthcare Products Regulatory Agency) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the medical device.

  • The safety, quality and useful testing carried out is equivalent to the safety and efficacytesting required for medicinal products under the Medicinal Products Directive. Taking a purposive approach to legislative interpretation, as required by EU law, this type of Class III medical device should properly fall within the scope of the SPC Regulation.

The applicant supported its arguments with evidence setting out how difficult, time consuming and arduous it had been to obtain an authorisation under the Medical Device Directive. The product had undergone pre-clinical and clinical trials and it had taken 8 to 10 years to get from concept to market.

However, the IPO hearing officer disagreed, concluding that an assessment of “safety, quality and usefulness” under the Medical Device Directive is not the same as an assessment of “safety and efficacy” under the Medicinal Product Directive.

So what?

Decisions of the IPO are not of high authority in the English legal system and, as such, are not reported widely. However, this decision is instructive as it illustrates the current policy of the IPO in an important area of SPC law.

The Applicant pointed out that refusing SPC protection for the Taxol®-coated stent would discourage the incorporation of medicinal products into devices, which would be to the detriment of patients. However, such arguments did not sway the IPO enough to outweigh its assessment of the wording of the Regulation and of the nature of the authorisation process.

In this case, the commercial importance of SPC protection was particularly stark. The patent was only granted by the European Patent Office (EPO) on 27 November 2013, despite having been filed on 9 July 1994, with a priority date of 19 July 1993. The extraordinarily long examination stage (19 years), meant that the period of effective patent protection was less than 1 year. Had a SPC been granted, its duration would have been approximately 3.5 years, a highly desirable extension to the term of patent protection.

In light of the divergent practices between the different member states, a reference to the CJEU may be required at some point to establish consistency. The IPO does not make such references. If the decision is appealed, the appeal will be heard by the English Patents Court, which has the power to make a reference to the CJEU and has done so in the field of SPC law on several occasions.