Naresh Sritharan | Bloomberg Law For the second time, the U.S. Supreme Court has granted certiorari in Mayo Collaborative Services v. Prometheus Laboratories, Inc.1 to review the patentability of methods for optimizing the dosage of a therapeutic drug. The Court's decision will likely impact the burgeoning field of personalized medicine, which seeks to customize healthcare by tailoring decisions and practices to the individual patient. Mayo Collaborative Services, the petitioner, has argued that the patents at issue, which have twice been found not invalid by the Federal Circuit, claim ineligible subject matter. Prometheus maintains that its patents represent innovation and has asserted that Mayo's claims "ring particularly hollow."2 This article will review the case's lengthy proceedings and consider the future of medical diagnostic patent claims.
Defining Patentable Subject Matter
District Court Finds Prometheus's Patents Invalid
administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 indicates a need to decrease the amount of said drug subsequently administered to said subject.
Federal Circuit Applies Machine-or Transformation Test, Finds Patents Claimed Eligible Subject Matter
Federal Circuit Upholds Validity of Prometheus's Patents Under Transformation and Preemption Tests
The Labcorp Dissent
Stage Set for the Supreme Court
Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry.30
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