Intellectual property rights over 'integrated' medical devices: the potential health impacts and bioethical implications of rightsholders' control.

Abstract

Despite extensive literature examining intellectual property rights (IPRs) and access to health, there has been limited examination of how IPRs can potentially impact the development, access to, delivery of, and use of medical devices. This article fills this gap, focusing on patent and copyright protections applicable to elements of medical devices that are attachable to or implanted into the human body, such as prostheses or pacemakers. Although the human body itself is not patentable in Europe (Article 5, Biotechnology Directive), elements of medical devices created outside the body are patentable. Moreover, certain aspects of such medical devices can be subject to copyright, and other types of IPRs. This article provides an overview of the types of IPRs that can apply over attachable and implantable medical devices. Following this, and focusing specifically on copyright and patent rights, it argues that such IPRs, alongside incentivizing technological development in certain contexts, also give rightsholders significant control over key aspects of how individuals use and access IP-protected elements of such devices, with the potential for health-related impacts and bioethical implications. Accordingly, the article argues that greater understanding and scrutiny are needed within the health law and bioethics communities around the potential impacts of IPRs over medical devices.