In a much-anticipated decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the US Court of Appeals for the Federal Circuit on April 13 affirmed the district court’s holding that Vanda’s patent claims directed to a method of treating patients with schizophrenia are both valid and infringed.
The split panel in Vanda held that claims relating to treating schizophrenia patients with the drug iloperidone, where the dosage range is based on the patient’s genotype, were not directed to an abstract idea.
Following a bench trial, Judge Gregory Sleet of the US District Court for the District of Delaware held that the asserted claims were not invalid under 35 USC § 101, despite concluding that “the asserted claims depend upon laws of nature,” specifically, “the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation.”
The district court explained that the asserted patent “addresses natural relationships to which the claims add conducting CYP2D6 genotyping tests to determine the appropriate dose of iloperidone to reduce QTc-related risks.” The court found that “while it may have been conventional to investigate for side-effects, [West-Ward] has not proven by clear and convincing evidence that the precise test and the discovered results were routine or conventional.”
The Federal Circuit’s majority opinion, authored by Judge Alan Lourie and joined by Judge Todd Hughes, affirmed the district court but concluded that the asserted claims were not directed to a law of nature at Mayo/Alice’s step one, which requires determining “whether the claims at issue are directed to one of those patent-ineligible concepts.” “If the claims are not directed to a patent ineligible concept at step one, [the court] need not address step two of the inquiry.”
West-Ward contended that the US Supreme Court held that similar claims were patent ineligible in Mayo. The patent in Mayo claimed a method for “optimizing” the dosage of thiopurine drugs by administering them to a patient and measuring the level of certain metabolites in the blood, “wherein the level of metabolites indicates whether to adjust the dosage.” The Supreme Court held that the claims recited a natural law and did not include any “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.”
The majority observed that the claims in Mayo were not directed to a novel method of treating a disease, but instead “a diagnostic method based on the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.”
Conversely, the majority explained that the claims in Vanda are “directed to a method of using iloperidone to treat schizophrenia”:
The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship. Unlike the claim at issue in Mayo, the claims here require a treating doctor to administer iloperidone in the amount of either (1) 12 mg/day or less or (2) between 12 mg/day to 24 mg/day, depending on the result of a genotyping assay.
The majority also found that preemption was not a concern because unlike “[i]n Mayo, [where] ‘a doctor . . . could violate the patent even if he did not actually alter his treatment decision in  light of the test,’” the claims here do not “tie up the doctor’s subsequent treatment decision.”
In summary, the majority wrote:
At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. . . . They recite more than the natural relationship between CYP2D6 metabolizer genotype and the risk of QTc prolongation. Instead, they recite a method of treating patients based on this relationship that makes iloperidone safer by lowering the risk of QTc prolongation.
The majority opinion also contains a discussion regarding jurisdiction, induced infringement, written description, and injunctive relief.
In her dissent, Chief Judge Sharon Prost stated that she would have found the Vanda claims patent ineligible, and accused the majority of conflating the Mayo/Alice step one and step two inquiries.
Chief Judge Prost noted that in Mayo, the patent “set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” In this case, she opined, the representative claim “also sets forth a natural relationship—namely, the relationship between the CYP2D6 genotype and the likelihood that a dosage of iloperidone will cause QTc prolongation.” Chief Judge Prost criticized the majority for drawing a distinction based on the specific metes and bounds in the claim at step one: “But reciting specific metes and bounds in the claims did not prevent the Supreme Court from concluding those claims set forth a natural law in Mayo.”
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors, Michael J. Abernathy (Chicago) or Julie S. Goldemberg (Philadelphia), or any of the following lawyers from Morgan Lewis’s IP Life Sciences Practice:
Jeffry S. Mann, Ph.D.
Robert Smyth, Ph.D.
 Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., Nos. 2016-2707, 2016-2708 (Fed. Cir. Apr. 13, 2018) (Slip Op.).
 Id. at 7.
 Id. at 28 (quoting Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014)).
 Id. at 28-29.
 Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 74-75 (2012).
 Id. at 77.
 Slip. Op. at 29.
 Id. at 30.
 Id. (citing Mayo, 566 U.S. at 86).
 Id. at 32.
 Dissent of Chief Judge Prost in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., Nos. 2016-2707, 2016-2708 (Fed. Cir. Apr. 13, 2018) (Dissent) at 1-2.
 Id. at 3 (citing Mayo, 566 U.S. at 77).
 Id. at 4.
 Id. at 5.