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

Christopher M. Holman, Patent Eligibility as a Policy Lever to Regulate the Patenting of Personalized Medicine, book chapter in PERSPECTIVES ON PATENTABLE SUBJECT MATTER, edited by Michael Abramowicz, F. Scott Kieff and James E. Daily, Cambridge University Press (2014).

32 Pages Posted: 20 Feb 2015

See all articles by Christopher M. Holman

Christopher M. Holman

University of Missouri - Kansas City School of Law

Date Written: February 18, 2015

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.

Keywords: Patent eligibility, Prometheus, Mayo, Bilski, personalized medicine, diagnostics, diagnostic testing, molecular diagnostics, genetic testing, patentable subject matter

Suggested Citation

Holman, Christopher M., Patent Eligibility as a Policy Lever to Regulate the Patenting of Personalized Medicine (February 18, 2015). Christopher M. Holman, Patent Eligibility as a Policy Lever to Regulate the Patenting of Personalized Medicine, book chapter in PERSPECTIVES ON PATENTABLE SUBJECT MATTER, edited by Michael Abramowicz, F. Scott Kieff and James E. Daily, Cambridge University Press (2014). , Available at SSRN: https://ssrn.com/abstract=2566924

Christopher M. Holman (Contact Author)

University of Missouri - Kansas City School of Law ( email )

5100 Rockhill Road
Kansas City, MO 64110-2499
United States

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