Abstract

A combination of 3D printing techniques and synthetic biology, 3D bioprinting is a promising field. It is expected that 3D bioprinting technologies will have applications across an array of fields, spanning biotechnology, medical surgery and the pharmaceutical industry. Nonetheless, the progress of these technologies could be hindered, unless there is adequate and effective protection for related applications. In this article, the authors examine the patent eligibility of 3D bioprinting technologies. This issue raises concern given that existing patent systems are generally averse to nature-derived inventions and many of them exclude products of nature or discoveries from patentability. This qualitative study analyses the current patent systems in key jurisdictions, particularly, the U.S. and the EU, and their applicability, as well as effectiveness, in the context of 3D bioprinting. The study argues that the main reason for the apathy of existing patent systems towards bio-inventions is that they were designed to deal with mechanical inventions. It suggests an innovation framework that encompasses both mechanical and biological inventions to cater adequately to emerging technologies.

Highlights

  • The novel technology of 3D bioprinting aims to synthetically produce tissues and other biological constructs by using 3D bioprinters [1]

  • This issue raises concern given that existing patent systems are generally averse to nature-derived inventions and many of them exclude products of nature or discoveries from patentability

  • “product of nature” doctrine is discussed under the U.S patent system, while the discovery exclusion is examined under the European patent system

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Summary

Introduction

The novel technology of 3D bioprinting aims to synthetically produce tissues and other biological constructs by using 3D bioprinters [1] This technology has application mainly in the area of medical surgery, where it is used to transplant synthetically printed tissues into patients [2]. According to Bicudo and others, it is hard to pinpoint the precise beginning of bioprinting technologies, there were some experiments in this area in the middle of the 1980s. It seems that the real emergence of these technologies was in the 1990s, while the vast majority of bioprinting companies were established in the present century [1]. Future research in this field is expected to enhance the ability to print whole organs and the value of 3D bioprinting will eventually rise to an estimated USD 3 billion in the near future [5]

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