[Guest Book Review] Bioinked Boundaries
Jocelyn Bosse
[Guest Book Review] Bioinked Boundaries
Jocelyn Bosse Thursday, November 20, 2025 - Aislinn Fanning, Australia, Book review, European patent law, patents, USA
The IPKat has received and is pleased to host this review of Bioinked Boundaries by Pratap Devarapalli. This book review has been prepared by Aislinn Fanning, who is a Postdoctoral Researcher on the ERC PatentsInHumans Project at Maynooth University, Ireland. Here’s what Aislinn writes:
This is a review of the book, Bioinked Boundaries. Patenting 3D Bioprinted Tissues, Organs and Bioinks: An US, European and Australian Patent Law Perspective (Springer 2025), by Pratap Devarapalli.
The book uses a comparative analysis across three jurisdictions (the US, Europe and Australia) to investigate the key question of what is, or may be, patentable subject matter in relation to bioprinting innovation. 3D bioprinting involves using bioinks (which are composed of living stem cells) to print complex organic structures that mimic living tissues. Bioprinted materials involve both natural biological materials as well as a level of human and scientific intervention. Thus, the prospect of patents over bioprinting innovation raises a range of topical legal, ethical and societal questions.
Overall argument of the book
The question at the heart of this book relates to how the patent system can respond to the development of technologies that blur the distinction between the ‘natural’ (in this context, related to the human body) and the artificial. One of the book’s key arguments is that the role of patent law in the bioprinting field is multi-faceted. On one hand, patents provide protections that incentivise investment and research. This is particularly necessary in the field of biotechnology, where the development and commercialisation of emerging technologies is costly. On the other hand, the patent system must balance incentivising innovation with ensuring accessibility of technologies under patent.
Through a detailed comparative doctrinal analysis of approaches to patentable subject matter in the US, Europe and Australia, coupled with an empirical analysis of patent prosecution data in each of those jurisdictions, the book grapples with the complex issues these technologies pose within patent systems. In comparing how each jurisdiction handles the patentability of bioinks and bioprinted tissues, the book identifies patterns, similarities and divergences between the three jurisdictions and potential areas for reform. It is divided into five substantive chapters, plus an introduction and conclusion.
Setting up the argument
The introductory chapter introduces the key problems the book grapples with and sets the scene for the forthcoming analysis. As a precursor to the analysis, Chapter 2 of the book traces the history and development of bioprinting and bioinks, clearly setting out the steps involved in the bioprinting process and the historical development of the technology. This introduction to 3D bioprinting is useful given that not everyone who reads this book will be familiar with the particularities of the bioprinting process. An understanding of how bioprinting processes typically operate, and what it entails, also lays a critical foundation for later chapters which examine a range of patentability issues associated with these technologies. Following this overview, the chapter looks to the future to highlight the significance of this technology in the health space, where (for example) the development of functional human-scale 3D tissues and organs is progressing. Such ongoing bioprinting research and development could have transformative potential for human health, particularly given the global shortages of organs for transplant.
Chapters 3, 4 and 5 then offer a doctrinal analysis of patentable subject matter requirements in Australia, the US and Europe (respectively) in relation to claims directed towards bioprinted tissues and bioinks. In essence, although patent law in each jurisdiction must comply with the minimum standards under the World Trade Organization’s Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS), there are some interpretative differences and variations as to what constitutes patentable subject matter in the three jurisdictions. These chapters discuss the patent law frameworks in the US, Europe and Australia with reference to how they are being applied, and may be applied in future, to applications related to bioprinting and bioinks. For instance, the book argues that assessments in the US, Australia and Europe around patentability in this context may focus on the extent of human intervention and modifications to the biological material to produce a bioprinted product (or process of doing so) that is markedly different from its naturally occurring counterpart. However, in the European context, it highlights that assessments about whether bioprinted tissues and bioinks are patentable may also involve greater scrutiny around exceptions to patentability on grounds of morality or ordre public, or as a method of treatment (under Art 53 of the European Patent Convention).
The book makes the case that bioprinted tissues and bioinks may be considered patentable subject matter, in certain contexts, in each of the jurisdictions examined. However, it also argues that those drafting patent applications should draft them carefully, paying attention to patentable subject matter requirements and exceptions from patentability in each respective jurisdiction.
The empirical comparison
Chapter 6, then, offers an empirical analysis of patent prosecution data (in other words, patent applications with claims directed to bioprinted tissues and bioinks) in those three jurisdictions. The chapter draws out the divergence in approaches across the jurisdictions (e.g., in terms of the types of claims made, where there are more ‘process’ claims in Australia) as well as the commonalities between them. Empirically, the book suggests that the patentable subject matter requirement may be a bigger hurdle to patent claims related to bioprinted tissues and bioinks in Europe than in the US or Australia. The book also suggests that although patentable subject matter requirements can be a hurdle in this context, that hurdle is being overcome through careful drafting of patent claims prior to examination or through amending objected claims after they have been examined.
Concluding thoughts
With biotechnology evolving and progressing rapidly, this book is a timely and important contribution which highlights some of the problems and conundrums that arise in the context of patenting bioprinting and bioinks. The book will be of interest to patent practitioners, academics and policymakers alike. Alongside its doctrinal and empirical analyses, it also offers a series of recommendations to those who may be drafting patent claims directed at bioprinted tissues or bioinks in each jurisdiction.
Patent and intellectual property law scholarship must continue to grapple with emerging biotechnologies and how patent systems across the globe can and should respond to developments in that space. Questions about how the patent system responds to the ever-evolving landscape of biotechnological advancement are central to striking an appropriate balance between fostering innovation in the health space and ensuring global access to lifesaving and life-altering technologies.
Beyond thinking about how the patent system as it is now will respond to the developments in bioprinted tissues and bioinks, scholarship in this area must also ask normative questions of patent law as these technologies develop. For example, should bioprinted tissues, organs and bioinks be patentable? And if they are, to what extent do patents over these technologies raise concerns about access to, and the development of such technologies? Relatedly, what are the (bio)ethical issues posed around how such patents are granted and could be used in future? And how should patent law engage with such ethical issues? As advancements in biotechnology like 3D bioprinting develop, with transformative potential for human health, it is imperative that the patent system balances incentives for innovation with the ethical issues posed by these technologies.
Details
Publisher: Springer
Extent: 193 pages
Format: Hardback and eBook
ISBN: 978 981 96 2590 1
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