Intellectual property (IP) protection is a major feature of the additive manufacturing (AM) sector, with the registration of IP rights covering new AM processes, hardware, materials and end products as well as copyright issues over digital files all commonplace.

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Yet, while existing IP laws are generally viewed as adequate for current needs, new technological developments have exposed a number of grey areas in the industry, specifically around subsistence of IP rights, infringement and enforceability.

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Bioprinting 3D bioprinting is increasingly used to fabricate tissue models for in vitro testing and research, but the long-term goal lies in its application to the field of regenerative medicine. Although many aspects of 3D bioprinting are patentable, bioprinted tissues and organs may face barriers to patentability in the form of excluded subject matter, medical exclusion and public policy.

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European and US patent laws exclude a human organism from patent eligibility but conversely do not explicitly rule out patent protection for human organism parts such as tissue and organs. Furthermore, non-human subject matter constitutes patentable subject matter as long as it is synthetic or modified to an artificial state. Accordingly, 3D bioprinted tissue and organs will remain patentable so long as they are distinguishable from natural tissue and organs.

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