This morning, the Supreme Court denied the petitions for cert. filed in the Vanda, Berkheimer and Athena appeals. While the Court had requested and received amici briefs from the Solicitor General that opined that the Court should not grant cert. in Vanda (genotyping to identify appropriate amounts of drug to administer and then administering it) and Berkheimer (Is patent eligibility, e.g., “inventive step” a question of law or fact?), because they were correctly decided, the briefs also strongly suggested that the Court should revisit Prometheus v. Mayo and the patent eligibility of diagnostic tests. Of course, this is not the question that the Court asked the SG to opine on, but the patent bar had some hope that Athena might provide a vehicle for the Court to distinguish Mayo.
No such luck, but even if the Court had granted cert., Athena posed the question so narrowly that the Court would have been forced to distinguish it from Mayo on the basis that Mayo was not sufficiently “novel” as that term is used in s. 101. Ignoring the precise range of metabolite concentrations recited in the claims, the fact of the matter is that the Prometheus ‘623 patent discloses that the determination of 6-MP metabolites can be conducted by a variety of known assay techniques, such as reverse-phase HPLC. However, unlike Athena, no novel compounds were asserted to be formed during the analyses. See Col. 8, lines 37-46 of the ‘632 patent. Athena was using standard ELISA techniques to measure the presence or absence of autoantibodies to MuSK that were only novel because the complexes that formed during the ELISA assays where themselves novel. For a majority of the Fed. Cir., this was a difference that failed to distinguish Athena’s diagnostic claims from the “optimized therapeutic efficacy” that was a goal of the Prometheus assay.
For those of us who want simple “If A, then B” diagnostic assays, there is little to celebrate here. At least the Court indirectly endorsed method-of-treatment claims that also recite a diagnostic method to put patients into “treat” and “don’t treat” pools. If the best lawyering cannot convince the Court that Athena’s claims are not an attempt to patent a natural law, we have only Congress to look to for help. As the S. Ct. said in Mayo: “ [W]e must recognize the role of Congress in crafting more finely tailored rules where necessary…We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.”