Mayo Collaborative Services v. Prometheus Laboratories: Supreme Court Limits the Scope of Patent Claims to Diagnostic Methods

This morning, the Supreme Court of the United States handed down its unanimous opinion in Mayo Collaborative Services et al. v. Prometheus Laboratories, Inc., reversing the Federal Circuit’s earlier ruling that the diagnostic-method patent claims at issue are patentable subject matter under 35 U.S.C. Sec. 101.

In making this ruling, the Court reaffirmed the guidance from its case law that although “an application of a law of nature . . . to a known structure or process may [deserve] patent protection,” “a patent must do more than simply state the law of nature while adding the words ‘apply it.'” (Citing Diamond v. Diehr, 450 U. S. 175, 185 (1981), and Gottschalk v. Benson, 409 U. S. 63, 71–72 (1972)) (emphasis in original).  “[The patent] must limit its reach to a particular, inventive application of the law.”  Opinion at 1 (Syllabus).  In the end, the Court held Prometheus’s claims to be unpatentable subject matter because (1) the claims inform the audience about a law of nature; (2) the steps of implementing the law of nature are “understood, routine, conventional activity”; and (3) the steps, even when viewed as a whole, “add nothing significant beyond the sum of their parts taken separately.”  Opinion at 11.