On 25 October 2018, the Court of Justice of the European Union (CJEU) handed down a judgment in Boston Scientific (C-527/17) concerning Supplementary Protection Certificates (SPCs) for medicinal products in the context of medical devices.
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a market authorisation (MA), compensating for delay to market entry. The relevant MAs for medicinal products are identified in the SPC legislation as those granted in accordance with the Medicinal Products Directives (Directives 2001/83/EC or 2001/82/EC).
Medical devices per se are not considered eligible for SPC protection and these have a separate authorisation procedure for bringing them to market under the Medical Devices Directive (Directive 93/42/EC).
However, medical devices that incorporate a medicinal product must be categorised as either a medical device or a medicinal product. This categorisation depends on whether the combination medical device and medicinal product is intended to be used exclusively in that combination in a non-reusable way (in which case the product is treated, and authorised, as a medicinal product) or whether the medicinal product component acts on the human body by an action ancillary to that of the medical device itself (in which case the product is treated, and authorised, as a medical device).
Until now there was uncertainty whether an MA granted for a medical device that nevertheless comprises a medicinal product, under the Medical Device Directive, could qualify to provide basis for an SPC.
DECISION OF THE CJEU
The present judgment relates to an SPC application for paclitaxel for the treatment of restenosis. Instead of a MA for paclitaxel itself, the application was based on an authorisation for a stent into which paclitaxel was incorporated (TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System). This authorisation was granted in accordance with the Medical Devices Directive but still required the provision of quality, safety and usefulness data, by analogy with the provisions of the Human Medicinal Products Directive.
The CJEU ruled that an authorisation granted in accordance with the Medical Devices Directive for a device incorporating a medicinal product as an integral part, cannot be treated in the same way as an authorisation for that medicinal product granted under the Human Medicinal Products Directive, even if there was a similar quality, safety and usefulness assessment.
In particular, the court emphasised that the two types of products (medical devices and medicinal products) are mutually exclusive and hence their authorisation processes are not cross-applicable. Products which are combinations of a medical device and medicinal products are either considered a medical device authorised under the Medical Devices Directive or a medicinal product authorised under the Human Medicinal Products Directive. It is for competent authorities to categorise products as one or the other, taking into account the “principal mode of action of the product” as set out in the Medical Devices Directive. Hence, for products that are considered as medical devices, it is not possible to classify the medicinal product independently from the device.
Further, the court highlighted the importance of the context of the authorisation procedure, and did not accept that the assessment of quality, safety and usefulness for component medicinal products under the Medical Device Directive was equivalent to that under the Human Medicinal Products Directive. In particular, the court considered that the assessment would be different when a medicinal product is being assessed on its own as opposed to when it is incorporated in a medical device.
The CJEU’s judgment has confirmed the general consensus that an MA granted under the Medical Devices Directive for a medical device incorporating a medicinal product does not qualify for an SPC.
The ruling will no doubt be a disappointment for innovators who were hoping to rely on the SPC regime to extend the exclusivity for medical devices in Europe.
Currently, the only option available to such innovators remains to develop standalone medicinal products or devices incorporating medicinal products where the medicinal product has the principal mode of action such that they are authorised under the Medicinal Products Directive.
Looking to the future, it will be interesting to see if the European Commission decides to reform the SPC legislation to provide supplementary protection for medical devices. Following the Commission’s public consultation on SPCs, a report published by the Max Planck Institute suggests that, although most stakeholders do not favour extending the coverage of SPCs to other fields, if protection were to be extended, the greatest support would be for medical devices.
Please contact us if you are interested in filing or challenging SPCs, particularly where the authorised product is a combined medical device and medicinal product. If you require any further information, please contact Michael Pears of our SPC and Regulatory group.