Whither Gene Patenting and the Patenting of Diagnostic Methods Post-Mayo and Myriad? The Need for Certainty in Navigating the High Seas of Policy

Abstract

This paper is prompted by a series of recent high-profile decisions emanating from the apex courts in the US and Australia – namely, Mayo and Myriad – on the patent eligibility of gene-based inventions. Adopting a comparative approach, this paper critically examines whether isolated gene sequences and diagnostic methods qualify as patentable subject matter in several leading jurisdictions, including the US, Australia, Europe and the UK. An attempt will also be made, after carefully considering various arguments on both sides of the policy debate, at predicting what the future might hold (or, perhaps more accurately, at suggesting what the future ought to be) for gene patenting and the patenting of diagnostic methods in the global biotechnology landscape.

Keywords: Biotechnological Inventions, Human Genetics, Molecular Diagnostics, Public Health, Comparative Law, Patentable Subject Matter, Patent Eligibility, Discovery-Invention Distinction, EU Biotech Directive