Patenting aspects of 3D bioprinted tissues and bioinks

This thesis explores the current application of the patentability requirements in relation to bioprinted tissues and bioinks, with a detailed examination of the patentable subject matter requirement. The patentable subject matter requirement has been in a state of turmoil over the past two decades due to the fact courts have had to grapple with emerging technologies in the fields of life sciences, computational technology and technology involving or directly related to treatment of the human body. A body of case law has emerged in each of these respective areas that highlights the difficulty courts have had in determining whether innovations in these areas satisfy the fundamental threshold of patentability. The scope of patentable subject matter has seemingly been narrowed as a result of a series of cases in each jurisdiction pertaining to the each of the areas identified above. However, the approaches to the subject matter requirement vary between jurisdictions, with Australia, the European Union (EU) and the United States of America (US) exemplifying these different approaches. Three dimensional (3D) bioprinting is a technology that represents the combination of the above-mentioned areas of technological innovation (i.e., life sciences, computation, and treatment of the human body). Specifically, the types of subject matter related to 3D bioprinted tissues and bioinks are the most complex, as they are composed of naturally available elements such as living stem cells in combination with natural and/or synthetic bioactive molecules and other biomaterials that are 3D bioprinted in the form of a specific structure or scaffold. Considering this, this thesis addresses the overarching research question, ‘Is the patentable subject matter requirement a hurdle to patenting bioprinting inventions, specifically bioinks and bioprinted tissues?’
In addressing the research questions of this thesis, this thesis employs a two-phase analysis, the former being doctrinal and the latter being empirical. The doctrinal analysis is focused on analysing the patentable subject matter requirements and patent jurisprudence in Australia, the US, and the EU (some of the major bioprinting technology hubs) and applying this analysis to subject matter related to 3D bioprinted tissues and bioinks. The empirical analysis is focused on analysing patent prosecution data from patent applications filed in Australia, the US and the EU with patent claims directed towards bioprinted tissues and bioinks. The analysis of patent prosecution data specifically identifies how patent examiners are applying the patent provisions to accept or object to specific patent claims directed towards bioprinted tissues and bioinks.
The conclusion of the doctrinal analysis reveals that the present subject matter requirements, and specifically the doctrinal limits as provided by Australian, the US and the EU patent laws and jurisprudence, are useful to examine subject matter directed towards bioprinted tissues and bioinks. However, this doctrinal analysis does not fully answer questions relating to issues such as ‘identifying the level of human intervention’ that is required for subject matter to be considered patentable, and how a bioprinted tissue or organ having ‘markedly different characteristics’ would replace a natural tissue or organ’. The analysis of the patent prosecution data provides guidance on the approaches taken by patent examiners with regard to these and other issues.
The outcomes of the two-phase analysis conducted in this thesis identifies that the patentable subject matter requirement is more of a hurdle in the EU than the other jurisdictions, followed by Australia and the US, in respect of patent applications with claims directed towards bioprinted tissues and bioinks. However, the claim analysis in the empirical phase identified that this hurdle is apparently being overcome either through drafting of patent claims before examination, or through amendment of the objected claims after examination. In light of the findings based on the doctrinal and empirical analysis, this thesis proposes patenting framework models for Australia, the US, and the EU specifically applicable for bioprinting inventions. The proposed patenting framework models will assist patent applicants to identify the types of bioprinting patent claims that would be considered patentable and non-patentable in respective jurisdictions. In addition, this thesis also provides guidance on how to overcome patentable subject matter objections at different stages of patent prosecution.