“The court of appeals majority reached the correct result in concluding that the method of medical treatment claimed in Vanda’s patent is patent-eligible subject matter. A decision from this Court resolving the internal tension within Mayo and reaffirming that Section 101 encompasses methods of medical treatment would have little practical effect in this case.” – Solicitor General’s brief
The United States Office of the Solicitor General (SG) has filed its brief in response to the Supreme Court’s March request for views in Hikma Pharmaceuticals v. Vanda Pharmaceuticals. The December 6 brief says that the Federal Circuit correctly held the relevant claims of Vanda’s patent-in-suit eligible, and that the case is therefore “not an optimal vehicle for bringing greater clarity” on the topic of Section 101 law. Instead, said the SG, the High Court should grant certiorari in a case like Athena Diagnostics v. Mayo Collaborative Services, in which the order denying en banc rehearing “was accompanied by multiple separate opinions articulating different understandings of Mayo and seeking clarification from this Court.”
Granting Vanda Would Have “Little Practical Effect”
In Vanda, the Federal Circuit found at step one of the Mayo/Alice framework that the claims of Vanda Pharmaceuticals’ U.S. Patent No. 8,586,610, which discloses a method of treating schizophrenia using the antipsychotic drug iloperidone, were patent eligible under Section 101. The Court distinguished Vanda’s claims from those at issue in Mayo Collaborative Services v. Prometheus Laboratories, holding that Mayo’s claims merely recited the natural relationship between an individual’s ability to metabolize a drug and the proper dosage of that drug, while Vanda’s claims recited “an application of that relationship.”
Chief Judge Prost dissented, arguing that the claims “set forth a natural relationship—namely, the relationship between the CYP2D6 genotype and the likelihood that a dosage of iloperidone will cause QTc prolongation” and thus lacked any inventive concept.
In the Solicitor General’s brief, the government explains that, historically, claims like the ones at issue in Vanda were “well understood” to be patent eligible, “[b]ut the Court’s recent Section 101 decisions leave the proper analysis of such claims unclear.” As highlighted by Chief Judge Prost’s dissent in Vanda, “it is arguably unclear how the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible can be reconciled with mechanical application of Mayo’s two-step framework.” Thus, while the analysis and precedent needs to be reviewed, the Court should address the issue in a more appropriate case, like Athena, said the SG. The brief continued:
The court of appeals majority reached the correct result in concluding that the method of medical treatment claimed in Vanda’s patent is patent-eligible subject matter. A decision from this Court resolving the internal tension within Mayo and reaffirming that Section 101 encompasses methods of medical treatment would have little practical effect in this case. Nor does the decision below cast doubt on the patent-eligibility of a wide swath of medical technologies.
Hope for Athena
In Athena Diagnostics v. Mayo Collaborative Services, the Federal Circuit issued an 86-page order denying en banc rehearing that included eight separate opinions—four concurring with the en banc denial and another four dissenting from the decision. The separate opinions reflected a Federal Circuit that remains deeply divided on the proper application of the U.S. Supreme Court’s Section 101 jurisprudence under Mayo Collaborative Services v. Prometheus Laboratories (2012). Throughout the opinions, it seemed clear that the Federal Circuit was eager to have the Supreme Court take this case up on appeal in order to clarify Mayo’s judicial exception to laws of nature and its impact on patent claims covering medical diagnostics. Athena filed its petition for certiorari with the Supreme Court in early October, warning the Court that failure to clarify the law in favor of finding claims like the ones at issue in the case patent eligible will be a death-knell for medical diagnostics. The brief highlighted five main points of confusion that have emerged in the High Court’s precedent and implored the Court to resolve the mess.
In reactions to Athena’s petition at the time, industry experts were hopeful that the Supreme Court would grant cert. Former USPTO Director and Senior Partner at Polsinelli, Todd Dickinson, agreed with the SG’s view in its Vanda brief that Athena represents a much better vehicle for clarity. “In Athena you have the entire CAFC involved, considering and denying en banc review, and splitting 7-5 on §101 eligibility under Mayo,” Dickinson told IPWatchdog in October. “These two cases present very different ways for the Supreme Court to approach this issue, which might even affect the outcome relative to Mayo. In Vanda, they are being asked to revisit a fairly recent precedent in which the CAFC drew a distinction with that precedent and upheld patentability in the face of Mayo. In Athena they would basically be affirming the CAFC’s views interpreting the Supreme Court in Mayo/Myriad, finding in the Supreme Court’s favor, but they would have the opportunity to adjust their precedent to fit medical diagnostics as eligible and address those eight other opinions, if they chose.”
While the Supreme Court does not necessarily have to take the government’s advice, the SG’s opinion that methods of treatment should be considered patent eligible as a rule, that there is serious and harmful confusion in this area of the law, and that the Athena case is a more appropriate vehicle for resolving that confusion than Vanda, could go a long way toward convincing SCOTUS to grant the petition in Athena.
Athena’s reply brief is expected to be filed tomorrow and the case will go to Supreme Court conference January 10.