Phoebe Li

3D Bioprinting Technologies: Patents, Innovation, and Access

Following on from digitisation in production which transforms traditional business models of manufacturing, 3D printing has been extending its application into biotechnology by means of regenerative medicine and tissue engineering. The practice of printing living human cells challenges existing legal frameworks of bioethics, product liability and intellectual property. This article examines the impacts and implications of associated patents arising from 3D bioprinting, specifically by examining the patentability, the morality test, and the medical treatment exception. It considers the consequences of granting 3D bioprinting product and process patents and examines the corresponding rights and responsibilities of stakeholders. In order to implement the benefit-sharing responsibility embedded in international law, this paper proposes a portfolio approach to innovation, with a view to avoiding inequality and disparities in access to 3D bioprinting technologies.

3D bioprinting: regulation, innovation, and patents

Abstracts This chapter begins by introducing the challenges that three-dimensional (3D) bioprinting poses to the existing legal regime across a wide range of issues such as bioethics, safety, regenerative medicine, tissue engineering, and intellectual property (IP). The topics include issues arising from customization which will likely challenge the definitions of “manufacturer” and “placed on the market” in the regulatory sphere. The first part of the chapter briefly introduces the 3D bioprinting technology. The second part looks into the relevant regulatory instruments in preprinting, printing, and postprinting stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products (ATMP) Regulation and the new Medical Device Regulation. The third part addresses the relevant IP issues associated with the bioprinting technologies, particularly in relation to the role of patents as an actor for regulation. It introduces the scope of protection by examining patentability criteria, followed by examples of 3D bioprinting patents on a bioprinter, a computer software system for medical imaging, and on “multilayered vascular tubes.”