Patent Eligibility as a Policy Lever to Regulate the Patenting of Personalized Medicine

Abstract

This book chapter considers the implications of a recently reinvigorated patent eligibility doctrine for innovation in personalized medicine. Section I begins with a brief overview of personalized medicine, followed in Section II by a discussion of the critical role molecular diagnostic method claims will likely play in providing effective patent protection for inventions relating to personalized medicine. Section III reviews recent developments in patent law that have breathed new life into the previously moribund doctrine of patent eligibility, most notably the Supreme Court's 2010 Bilski v. Kappos (Bilski II) decision and the Federal Circuit’s decision in Prometheus v. Mayo (Prometheus III) applying Bilski II to claims reciting a method for practicing personalized medicine. In Section III, I argue that by declining to set forth any clear criteria for assessing compliance with the doctrine, the Supreme Court has in effect sanctioned the use of patent eligibility as a wildcard to invalidate patent claims deemed unworthy of patent protection. Section IV discusses how the lower courts, particularly the Federal Circuit, and US Patent and Trademark Office (PTO) might leverage the discretion inherent in the Bilski II fundamental test for patent eligibility as a policy lever to regulate the scope of patent claim coverage available for inventions relating to molecular diagnostics and personalized medicine. Section V offers some concluding thoughts on the implications of these developments for the availability of adequate patent protection for personalized medicine innovations.