On 31 March 2014 two applications for Supplementary Protection Certificates (“SPCs”) SPC/GB/07/043 (“043”) and SPC/GB/07/044 (“044”) (together “the applications”) for medical devices came before Dr Laurence Cullen, Deputy Director (sitting as a Hearing Officer) of the UK Intellectual Property Office (“UKIPO”).
Both applications were filed by Cerus Corporation (“Cerus”) on 9 August 2007 and were based on European Patent 0 707 476 entitled “Compounds for the photodecontamination of pathogens in blood” (“the Patent”). The Patent discloses new in vitro methods of inactivating pathogens in blood products using the active ingredient amotosalen in the presence of UV light. As the methods have shorter irradiation times, and no need to limit the concentration of molecular oxygen present, they do not significantly affect blood function or cause mutation.
The applications, though, related to Class III medical devices, the highest risk in terms of the vulnerability of the human body and therefore the most tightly regulated. Despite amotosalen being an integral part of the devices, and the fact that, if used separately, amotosalen would be considered a medicinal product, its action was ancillary to that of the device. Accordingly, the devices were regulated under the Medical Devices Directive 93/42/EEC (“MDD”) rather than the medicinal products regime. This meant that each application was supported by an EC Design Examination Certificate (“DEC”) and not by a marketing authorisation.
Although the medical devices and medicinal products regimes share a number of similarities, such as the requirement for clinical tests, and notwithstanding the fact that the MDD regime required a clinical assessment of the amotosalen, the two regimes have different purposes and make assessments in accordance to different criteria. Cerus nonetheless had argued that the DECs were also valid authorisation to place the product on the market as a medicinal product as required by Article 3(b) of the SPC Regulation, and that accordingly SPCs should be granted for its devices.
At first instance the UKIPO disagreed with Cerus; applying a literal construction to Article 3(b) and finding that the valid authorisation must be granted under Directive 2001/83/EC (human medicinal products) or 2001/82/EC (veterinary medicinal products). Cerus appealed and, indicating the importance given to the issue, that appeal was heard by Dr Cullen, Deputy Director of the UKIPO.
Although Dr Cullen saw the attraction of taking a literal construction, he could not decide the issues on that basis alone. It is an established principle of EU law that, in order to properly interpret EU legislation, it is necessary to take into account its purpose and the objectives behind it (“the teleological approach”). Dr Cullen therefore followed that approach and, having reviewed the MDD and the MPD, found it clear that a device of the type in issue should only be assessed under the MDD and not any other regulatory regime. He also reviewed the DECs and the technical reports attached to them. He concluded from these documents that the opinion of the competent body required by the MDD for Class III devices was based on what was required to approve a medical device under the MDD and not on what was necessary to approve a medicinal product under the MPD. The assessment of safety, quality and usefulness required by the MDD could not be considered to be the same as or equivalent to the assessment of quality, safety and efficacy of a medicinal product under the MPD; thus the two procedures could not be considered equivalent.
Consequentially, Dr Cullen found that the DECs for the applications could not be deemed to meet the conditions of Article 3(b) of the SPC Regulation nor to have been subject to an administrative procedure under the MPD as required by Article 2 of the SPC Regulation. The Applications were therefore rejected under Article 10(2) for not meeting the conditions required for the grant of an SPC. He also noted that the product definitions provided in the applications were deficient as they did not specify an active ingredient as required by the SPC Regulation.
Notwithstanding the fact that the meaning of a “valid authorisation” has previously been explored extensively by the CJEU in decisions such as Novartis (C-207/03) and Pharmacia Italia (C-31/03) and more recently Neurim (C-130/11) and Astrazeneca (C-617/12), the question of whether it is possible to obtain an SPC for a medical device would appear to be too important for Cerus to not challenge this decision. The appeal would be to the Patents Court and thereafter, if past SPC cases are anything to go by, a reference to the Court of Justice of the European Union - as recently noted by Mr Justice Arnold almost anything to do with the SPC Regulation has ultimately required such a reference.