Patenting Bioprinting-Technologies in the US and Europe – The 5th Element in the 3rd Dimension

Abstract

The opportunities and the broader implications of bioprinting raise a wide variety of crucial legal issues. These may range from the regulation of the science and its’ societal effects to questions regarding the commercialization of the technology. Regarding commercialization aspects, one issue that must be addressed concerns the question of what types of products and uses should be regarded as protectable subject matter under the relevant intellectual property right (IPR) frameworks. Considering that the availability IPRs is one of the factors that might have a great impact on where the greatest investments and scientific efforts in this technology will be made, this is an utterly important question. In addition to trade secrets, copyrights, trademarks and other IPR-related rights, patents will most likely play a major role in that respect and will be at the focus of this paper.

In this paper, we examine and discuss what sorts of bioprinting - inventions are being patented or would be - protectable under European and US patent laws. Rather than focusing on the highly relevant questions that 3D printing poses for patent infringement doctrines, IP governance, user-generated solutions and research exemptions, this paper concentrates on the question of patentable subject matter and patentability. To this end, we start out by (1) briefly describing the relevant state of the art in bioprinting. This allows us to better describe and understand the current bioprinting patent landscape (2), and to examine in how far any future inventions stemming from such technology would meet the most basic U.S. and European patent requirements (3). A related question is of course, if some bioprinting technologies should be categorically excluded from patentability, i.e. even when meeting the most basic patent criteria. We address this specific issue by discussing patent-limitations and morality exclusions from patent law (4), which will allow us to complete the paper with some concluding remarks (5).