Intellectual Property and Bioprinting: the battle royale between BICO and Organovo

Abstract

This article has several parts. Part 2 will chart the landscape for patents in respect of bioprinting. This data analysis will look at the databases of the World Intellectual Property Organization (WIPO), IP Australia, the United States Patent and Trademark Office (USPTO), the United Kingdom Intellectual Property Office (UKIPO), the European Patent Office (EPO), and the Japanese Patent Office (JPO). The study will seek to illuminate patent trends in the field. Moreover, it will seek to analyse patent thickets and white spaces in the field of bioprinting. This will be of considerable importance in determining the freedom to operate for researchers and scientists working in the field. Part 3 considers questions of patent infringement and enforcement. In particular, it analyses the conflict between United States company Organovo and Swedish company Cellink (now part of the BICO corporate group) over bioprinting patents. 3D printing and bioprinting also raises larger questions about the nature of patent infringement, and the role and scope of patent exceptions. Part 4 looks at patent defences, exceptions, and limitations – such as the defence of experimental use – and their application in the context of 3D printing and bioprinting. There has been interest in public licensing, research exchanges, patent pools, in respect of bioprinting. There has also been discussion of compulsory licensing, Crown Use, and government acquisition. The conclusion considers the issues raised under patent law by bioprinting. It also notes secondary forms of intellectual property protection – such as trade marks, trade secrets, and copyright protection. The conclusion considers the inter-relationship between intellectual property and regulation in the context of bioprinting.

It should be noted that scope of this article is limited to patent law and bioprinting. A number of topics are beyond the circumference of this article due to space considerations – given the expanding literature in the field. The topic of patentable subject matter in the context of 3D printing and bioprinting deserves separate consideration (especially given the growing policy debate around the topic). The author hopes to consider how other forms of intellectual property (such as copyright law, trade mark law, and database protection) impinge upon the bioprinting in the future. There is scope for further work in the future on open source bioprinting projects; the regulation of bioprinting; and product liability in the fields of medical 3D printing and bioprinting.