New medical uses of known medical devices – A new prespective on purpose-limited product protection for medical devices in Europe

Abstract

Abstract Medical products/devices belong to a technical field attracting increasing importance in recent years in view of a growing number of applications. However, according to the prevailing jurisprudence of the Boards of Appeal of the European Patent Office (EPO), they generally do not enjoy the novelty privilege provided by Art. 54(4) und (5) EPC, as this is said to be applicable only to classical medicaments. According to the current approach, it is decisive whether the subject is a substance or a composition. Although these terms may be interpreted broadly, obtaining patent protection for new uses of known med-tech products was successful only in narrowly-defined and limited cases. In a recently published decision, a Board of Appeal for the first time gave a detailed explanation of the narrow interpretation of the aforementioned terms and further refined the jurisprudence with respect to medical products/devices. This article reviews the legal development and summarizes the current status on the subject. It then critically deals with the current considerations of the EPO Boards of Appeal regarding the narrow interpretation of Art. 54(4) and (5) EPC and presents arguments in favor of a broader interpretation. Finally, the article discusses whether a clarification of the outstanding questions on this important topic can reasonably be expected and how this could evolve.