Patenting bioprinting : an ethical dilemma in the provision of accessible health technologies

For decades, researchers in the tissue engineering and regenerative medicine sphere have continuously worked to replicate naturally occurring tissues and organs for research and transplantation purposes. Whilst this has been met with a certain degree of success, it would appear that many engineered tissue products lack the structural and functional complexity found in their naturally occurring counterparts. To this end, the emergence of bioprinting with its promises to reproduce the complexity and intricacy of native tissues through precise placement of cells marks an important milestone not only in the advancement of tissue engineering, but also for the future of healthcare. In simple terms, bioprinting involves the use of a combination of living biological cells, and other living and non-living materials to print three-dimensional functional living tissue constructs such as breast, liver, kidney and skin tissue. It is anticipated that such bioprinted constructs1 will be used in the areas of disease modelling and research; drug discovery and animal testing; as well as treatment of chronic diseases and tissue/organ transplantation. Given these potential applications of bioprinting, it is pertinent that ethical, legal and socio-economic concerns regarding the technology are fully explored as the technology advances. This is especially so in light of the developing patent landscape for bioprinted constructs which are generally designed to replicate their naturally occurring counterparts - the latter being unpatentable subject matter. Accordingly, this thesis examines the law on patentability of bioprinted constructs (which are combinations of living and non-living materials) and questions whether they ought to be patentable given the implications of monopolising body parts. In particular, this thesis focuses on three jurisdictions with disparate approaches to patentability ‚Äö- Australia, Europe (under the European Patent Convention) and the United States of America. It considers whether the disparate approaches to patentable subject matter and morality of patenting yield similar or different results. Noting that the differences in legislative provisions appear to have limited impact on patentability, this thesis also considers the parameters of access to patented bioprinted constructs. It examines matters pertaining to access to bioprinted constructs in themselves, as well as access to the technology. In this regard, this thesis concludes that patent flexibilities in their current form are not particularly suited to the nature of bioprinted constructs. Accordingly, ensuring technological access is especially important in order to ameliorate the effects of a patent grant and ensure equitable access for all.