Life after Myriad: The Uncertain Future of Patenting Biomedical Innovation & Personalized Medicine in an International Context

Abstract

In a unanimous judgment the US Supreme Court held in the 2013 Myriad gene patent case that patent claims directed to isolated genomic DNA are identical to the naturally occurring sequence and thus not patent eligible "products of nature". It appears therefore that for a new biological composition of matter to be patent eligible, it must not be identical to the naturally occurring biological composition. This decision affects all isolated "products of nature", including genes, gene fragments, and other naturally occurring nucleotide sequences, as well as naturally occurring amino acid sequences, including peptides, ligands, and proteins. Consequently, Myriad has a severe impact on many patent portfolios. Although Myriad does not directly affect the patentability of cDNA or sufficiently modified compounds, and the most recent USPTO guidance provides some hints on how the new eligibility standard can be met, it is still not entirely clear how much modification is required to render a molecule sufficiently distinct from naturally occurring counterparts. Moreover, when combined with the US Supreme Court decisions in Prometheus and Alice, Myriad may affect method claims which depend upon unmodified biological materials. The USPTO guidance, however, still leaves much uncertainty over the patentability of such methods and diagnostics. The substantial impact of these decisions on the biomedical sector and personalized medicine, as recently demonstrated by the 2015 CAFC decision in Ariosa, as well the methodology used by the generalist Supreme Court in reversing a specialized CAFC judgment is particularly interesting from a comparative perspective. This paper analyses and discusses these U.S. developments, and compares them with the situation in Australia and in the EU.

Keywords: Biotechnology, US, Europe, Australia, Comparative Law, DNA, Myriad, patent-eligibility, personalized medicine, genetic diagnostics, USPTO 2014 Guidelines, methods, innovation, Unified Patent Court