The Court of Justice of the European Union (CJEU) has handed down a decision in Boston Scientific (C‑527/17) clarifying that Supplementary Protection Certificates (SPCs) cannot rely on a medical device authorisation. Consequently, a product categorised as a 'medical device' cannot benefit from an SPC, regardless of whether or not it incorporates an active ingredient
SPCs were introduced to compensate patent holders for the effective loss in patent term through delays in receiving marketing authorisation. The legislative intent was that the SPC system should be applicable to any pharmaceutical research that leads to a new patentable invention.
However, the SPC Regulation sets out that SPCs are only available for products that have been approved in accordance with the Medicinal Products Directives (2001/83/EC or 2001/82/EC). Medicinal or plant protection products can receive a marketing authorisation (MA) in accordance with these Directives, whereas medical devices are subject to a different authorisation procedure.
Medical devices must undergo an assessment according to the Medical Devices Regulation (EU) 2017/745 (which recently replaced the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC) in order to receive a CE certification.
However, where a medical device incorporates a medicinal product, it must be assessed whether the medical device/drug combination should be categorised as a medical device or as a medicinal product. Where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the combination product is categorised as a medicinal product. Consequently, a MA must be obtained in accordance with the Medicinal Products Directive.
By contrast, where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device, the combination product is categorised as a medical device. However, such a combination must nevertheless undergo a stringent approval procedure to establish the quality, safety and usefulness of the drug component of the medical device/drug combination.
Accordingly, some patent offices have taken the position that a CE certification for such a combination product should be treated as being equivalent to an MA issued in accordance with the Medicinal Products Directives. Other patent offices have applied the SPC Regulation more strictly, ruling that an SPC may only be granted on the basis of an MA that has truly been issued in accordance with the Medicinal Products Directives.
The resulting legal uncertainty resulted in a referral to the CJEU (as reported here) and has now been resolved via decision C‑527/17. The CJEU ruled that Article 2 of the SPC Regulation must be interpreted to the effect that a CE-mark approval for a medical device comprising an active ingredient as an integral part cannot be equated to an approval in accordance with the Medicinal Products Directives, even if the active ingredient has been analogously assessed by way of the consultation process.
In reaching its conclusion, the court emphasised that ‘medicinal product’ and ‘medical device’ are mutually exclusive such that if a product that falls within the definition of a ‘medicinal product’, it may not be classified as a ‘medical device’ within the meaning of the relevant Directives. It is for the competent authorities to categorise a product as one or the other, and this categorisation determines the appropriate authorisation process.
Thus, under the current SPC regime, products classified as medical devices are not eligible for SPCs. Of course, the European Commission is currently considering a reform of the SPC system (discussed here), so it remains to be seen whether at least certain types of medical devices may become eligible for SPC protection in the future.
An SPC cannot therefore be granted for a product which has been the subject of prior authorisation not as a medicinal product, but as a substance forming an integral part of a medical device.