This Comment discusses the ways that patent law jurisprudence falls short in promoting innovation in precision medicine. Section II provides an overview of the diagnostic field and the patent eligibility of diagnostics as well as suggestions for drafting patent-eligible claims for diagnostics. Section III discusses the doctrine of divided infringement, when more than one entity performs steps in a patented method. Section III then argues the limitations placed on patent eligibility for diagnostic method claims render many of these patents unenforceable against infringement. Thus, this Comment suggests that the courts have created a problem where, in order to obtain a patent for a diagnostic, an inventor must include limitations that then make the claims unenforceable. This Comment further argues—in direct conflict with the Precision Medicine Initiative—this problem is specific to diagnostics that diagnose either the risk for developing a disease or untreatable diseases.
Alison Slaughter, Ph.D., is a J.D. Candidate, Temple University Beasley School of Law, 2021.