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A unanimous U.S. Supreme Court has just ruled in Mayo Collaborative Services v. Prometheus Laboratories, Inc., that the diagnostic method claims involved there were not patent eligible subject matter. The U.S. Court of Appeals for the Federal Circuit had previously held that using the “machine or transformation” test told you whether you were impermissibly claiming an “excluded law of nature.”

In reversing the Federal Circuit’s decision, the Supreme Court, in an opinion by Justice Breyer, did not dispute the Federal Circuit’s application of the machine or transformation test. Rather, the Court held that “the law of nature exclusion” trumps that test. In doing so, it has taken away a standard that the diagnostic method field has been using to determine what is and is not patentable subject matter, thereby casting a cloud over the entire field of “personalized medicine.”

Join Ronald I. Eisenstein and David S. Resnick from Nixon Peabody LLP for a discussion of Mayo v. Prometheus, its implications, and strategies for minimizing its impact. They have been following this issue since it first began developing six years ago in LabCorp v. Metabolite.