Case Western Reserve Journal of Law, Technology, and the Internet, Forthcoming


For a quarter century following the landmark 1980 decision of the Supreme Court in Diamond v. Chakrabarty, inventions and discoveries in biotechnology research appeared to be eligible for patent protection, assuming they meet the statutory standards for patent protection. The Supreme Court reopened the issue of patentable subject matter in 2005 when it granted certiorari in Laboratory Corporation v. Metabolite on the question of whether a method of diagnosing vitamin deficiency by observing a biomarker was unpatentable as a “basic scientific relationship.” Although the Court later dismissed the case without reaching a decision on the merits, since that time the Court of Appeals for the Federal Circuit has struggled to discern the limits of patentable subject matter for diagnostic methods in old Supreme Court decisions that had previously seemed destined to languish on library shelves. The Supreme Court reaffirmed the authority of these decisions without explanation in Bilski v. Kappos, thereby demanding formal adherence to stare decisis without following the discipline of common law reasoning. To make sense of these decisions as a guide to the subject matter boundaries of the patent system in the context of contemporary technologies, it is necessary to begin with an account of the functions of subject matter boundaries in patent law. In Mayo Collaborative Services v. Prometheus Laboratories, the Supreme Court has another opportunity not only to clarify the boundaries of patentable subject matter, but to explain what the doctrine of patentable subject matter is all about. This article reviews developments on the issue of patentable subject matter and considers alternative accounts of the work that patentable subject matter doctrine might do for the patent system in the hope of clarifying the application of that doctrine to new technologies with a focus on diagnostic method claims.


Intellectual Property Law

Date of this Version

January 2012