Replacing judicial exceptions is controversial – previous bills have been rated at a less than 2% chance of passage

Four US Supreme Court decisions handed down from 2010 to 2014 changed decades-long understandings about what can be patented in the USA. The decisions directly affected practices in molecular diagnostics. Two decisions—Mayo v. Prometheus (2012) and Myriad v. Association of Molecular Pathology (2013)—directly addressed diagnostics. They eliminated patent-eligibility for many diagnostic method claims (Mayo) and isolated DNA corresponding to sequences found in nature (Myriad). This created significant uncertainty about what could be patented in molecular diagnostics (and other fields). The decisions disrupted genetic-testing service monopolies on testing one or a few patented genes for various clinical conditions, including inherited risk of breast and ovarian cancer. Before Mayo and Myriad, patented genes had been excluded from many tests for the fear of patent infringement liability. The Supreme Court opened the door to widespread, multigene testing by relieving that threat, so formerly patented genes were included in molecular tests, which became available at a lower cost at many more labs. After the Supreme Court decisions were handed down, several organizations concerned with patent law called upon Congress to abrogate the decisions by revising the definition of patentable subject matter in §101 of the US Patent Act. These efforts were fueled in part by claims that the decisions dampened investment, and therefore innovation, in clinical genomics. Responding to these claims, Senators Thom Tillis (R-NC) and Chris Coons (D-DE) introduced bills in the US Senate to amend §101 of the Patent Act—most recently S. 2140, the , which would eliminate judicial exceptions to patent-eligibility and replace them with a limited number of statutory exceptions. It is unclear whether the bill will become law. At the time of its introduction, GovTrack assessed its odds of enactment at 2 per cent. Yet, S. 2140 indicates that interest in a legislative remedy to the uncertainty created by patentable subject matter jurisprudence has not dissipated. It is an appropriate time to examine the practical consequences of statutory replacement of Supreme Court decisions with a more permissive doctrine of patent-eligibility. Here, we do so with a focus on consequences for molecular diagnostics, in particular the implications of the Myriad and Mayo decisions. The paper thus addresses doctrines of patent law but also traces real-world effects on molecular diagnostics.