SPCs for medical devices

Can patents for medical devices be extended via Supplementary Protection Certificates?

Ulla Klinge reports.

For more than 20 years an EU-based system has been in place extending the effective patent life for patents for medicinal products and for plant protection products via a so-called Supplementary Protection Certificate (SPC). The system was put in place in order to compensate the innovative pharmaceutical or plant protection product industry for the long delay between filing of a patent application and the issuance of a marketing authorisation for the medicinal/plant protection product protected by the patent.

The legislation governing SPC’s referred expressly to medicinal products and plant protection products, respectively, and made no reference to medical devices. Furthermore, in the respective SPC regulations, reference was made to specific EU directives governing the authorisation of medicinal products/plant protection products, whereas no such corresponding EU directives for medical devices were in place at that time.

However, since then legislation governing medical devices have become stricter and more harmonised across Europe. The result has been that it takes longer to obtaining marketing authorisation for medical devices, much in the same vein as with medicinal products. Patentees for medical devices have thus sought to have their effective patent life extended by applying for an SPC, arguing that the authorisation procedure is analogous to the authorisation procedure for medicinal products.

Until now patentees have been largely unsuccessful in obtaining SPC protection for medical devices. A number of patent authorities have argued that the SPC Regulation strictly precludes products that have not been authorised under the Medicinal Products Directive, even where the quality, safety and other test procedures have been performed in analogy with the Medicinal Products Directive. Only in a few instances have SPC’s been granted on medical devices, and the approach of individual states has not been consistent.

However, there may be light at the end of the tunnel. In a recent referral to the Court of Justice of the European Union (C-527/17) it is asked whether an authorisation under the Medical devices Directive for a drug-device combination must be considered equivalent to an authorization under the medicinal product directive and thus whether such drug-device combinations may be eligible for SPC protection.

If the above question is answered in the affirmative, it may become easier in the future to get SPC’s for certain medical devices.