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ARTICLE · 30 MAY 2018

Personalized Medicine Claims Make It Past § 101 Invalidity Challenge

The US Court of Appeals for the Federal Circuit affirmed a district court finding that a patented method for treating schizophrenia was not subject matter ineligible under 35 USC § 101.

United StatesIntellectual Property

The US Court of Appeals for the Federal Circuit affirmed a district court finding that a patented method for treating schizophrenia was not subject matter ineligible under 35 USC § 101. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Intl. Ltd., Case No. 16-2707; -2708 (Fed. Cir., Apr. 13, 2018) (Lourie, J) (Prost, CJ, dissenting).

Vanda Pharmaceuticals owns a patent relating to a method of treating schizophrenia patients with iloperidone. The cytochrome P450 2D6 gene (CYP2D6) encodes an enzyme known to metabolize iloperidone. Expression of this gene varies among individuals, and thus some patients with lower than normal CYP2D6 are poor metabolizers of iloperidone. These patients are more at risk for a side effect known as QTc prolongation—a life-threatening ventricular arrhythmia. The patent teaches that treatment of a patient who has lower CYP2D6 activity with iloperidone can be accomplished more safely by administering a lower dose of the drug than would

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