Diagnosing Patentable Subject Matter

Holders of diagnostic method patents attempt to claim an exclusive right to the correlation between a patient's medical data and a medical prognosis. These patents are a major source of controversy in the courts, with three prominent unresolved cases currently in litigation. The key question is whether diagnostic correlations are patentable subject matter under 35 U.S.C. 5 101. Although the ultimate resolution of these cases is unclear, this Note argues that in light of recent scientific advances, the public interest supports granting patents on diagnostic correlations. Part I reviews the origins of patentable subject matter doctrine and the basis for the current controversy. Part II provides a tutorial on modern diagnostic medicine and explains that data gathering is becoming increasingly standardized and affordable. Part III discusses the public policy concerning patents on diagnostic correlations. Finally, Part IV concludes that granting patents on diagnostic correlations is in the public interest.