In Mayo v. Prometheus, the U.S. Supreme Court held that claims directed to a diagnostic method were unpatentable, not simply because the subject matter of the claims was not novel or obvious, but rather because the subject matter covered by the claims was the mere application of the laws of nature - the discovery of facts of nature - and therefore not patentable on a more fundamental basis under Section 101 of the Patent Act.
As the Court stated:
"Because the laws of nature recited by Prometheus' patent claims-the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm-are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims. The 'administering' step simply identifies a group of people who will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders. Doctors had been using these drugs for this purpose long before these patents existed ... The 'wherein' clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions ... The 'determining' step tells a doctor to measure patients' metabolite levels, through whatever process the doctor wishes to use."
For those in the diagnostic business, e.g., Quest subsidiary Athena Diagnostic, the Mayo case should have a sobering effect as it may well be the basis for the invalidation of broad patent claims and the renegotiation of royalties on patents licensed. Thus the Mayo case should ultimately free up more development in the diagnostic field as broad blocking patents will be scrutinized carefully for invalidity.
The implications of the Mayo decision on whether the Supreme Court will grant cert in the Myriad gene case is unclear. Recall that in Myriad the ACLU and the Public Patent Foundation filed a writ of certiorari challenging the Federal Circuit's decision to uphold the patentability of claims directed to isolated sequences of DNA in patents owned by Myriad Genetics. The petition for cert was not directed to other of the claims at issue including drug screening claims and diagnostic method claims.
Nevertheless, the Supreme Court could decide to require briefing on all of the claims. It could decide that the drug screening claims are different from the mere application of a law of nature to pass the Section 101 subject matter test for the issuance of a patent, but it would seem unlikely that the Supreme Court would treat the diagnostic claims in Myriad any differently than it treated those in Mayo. But given that it just issued a unanimous decision in Mayo, it seems unlikely that the Court would want to decide another case directed to diagnostic method claims.
The Mayo decision appears broad enough to encompass the Myriad claims directed to the isolated gene sequences as they exist in nature. So the Supreme Court could grant the petition and thereafter set a briefing schedule. However, it is also quite possible that the Supreme Court will simply remand the case to the Federal Circuit for reconsideration in light of the Mayo case.
It is noteworthy that Myriad's stock fell by 5% after the Court's decision in Mayo was announced.