Pheh-Hoon Lim (Auckland University of Technology) & Phoebe Li (University of Sussex Law School) have posted Patentability of Biofabricated Human Organs: ‘Products of Nature’ or ‘Products Derived from Nature’ Revisited (in Hawkins N (ed) Patenting Biotechnological Innovation: Eligibility, Ethics and Public Interest (Edward Elgar, 2022) 69-89) on SSRN. Here is the abstract:
Concerns over the blurring of the distinction between ‘discoveries’ and ‘inventions’ raise a question on whether biofabricated human organs created by additive multilayering of naturally occurring cells are man-made inventions. Or, arguably, are they non-patentable products of nature despite the need for human intervention to create them? This chapter revisits the ‘product of nature’ versus ‘product derived from nature’ debate to consider this question based on case law reasoning presented in the scenarios on bioproducts in the Oncomouse and Dolly the sheep and the further controversy on ‘isolated genes’ in Myriad. The authors draw a parallel between isolated DNAs (and bioproducts of higher life forms/mammals) and a bioprinted human organ to examine whether the latter could satisfy the patent-eligibility threshold when the essential elements of the claimed biological compositions do not alter the fundamental quality of an organ as it exists in the body.