Is there a future for medical device SPCs? Past, present and future perspectives

This article reviews UK and European cases on the ability of the SPC system to be applied to medical devices and considers the main issues faced by such applications. It also considers whether now might be the time to introduce a new system for "medical device SPCs".

This article was first published by Lawtext Publishing Ltd in the BioScience Law Review vol 16 issue 3, pp143-152 who have agreed to Simmons & Simmons making it available on elexica.

Supplementary Protection Certificates (SPCs) have on occasion been sought for medical devices, forcing granting authorities and courts across Europe to consider the question: are medical devices included within the scope of the SPC system? These cases have produced inconsistent outcomes. The European Commission's study into the SPC system and the new EU medical device regulations bring into the spotlight the scope of the SPC system and the regulatory regime relating to medical devices.

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