On April 13, 2018, the Federal Circuit issued a new decision in its recent line of cases analyzing whether generic drug labels may be evidence of induced infringement of method of treatment claims in Hatch-Waxman cases. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the Court, in upholding the District Court’s finding of induced infringement, held that proposed instructions to physicians can satisfy the specific-intent element of induced infringement. 887 F.3d 1117 (Fed. Cir. 2018) (Judges Lourie and Hughes, Chief Judge Prost dissenting on other issues). This decision follows and builds upon the Federal Circuit’s 2017 decisions in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) and Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).
In Vanda, the claims of the patent at issue required treatment of schizophrenia with iloperidone to be performed with different dosing ranges depending on whether the patient was a poor metabolizer of CPY2D6. Because the claims at issue related to a method of treatment, for West-Ward to be liable for infringement, West-Ward must induce the physicians to practice the method. According to the Federal Circuit, a “proposed label [that] ‘recommends’ that physicians perform the claimed steps” was sufficient to establish specific intent and support liability for induced infringement. Vanda, 887 F.3d at 1130-33.
Various portions of the label were relevant to the Federal Circuit’s analysis. First, the Court noted that the Dosage and Administration portion of the label taught physicians to titrate the dose from a low starting dose, and stated that “[d]osage adjustment for patients taking iloperidone who are poor metabolizers of CPY2D6: Iloperidone dose should be reduced by one-half for poor metabolizers of CYP2D6 [see Pharmacokinetics (12.3)].” Id. at 1131. The Pharmacokinetics section noted, inter alia, that poor metabolizers “should have their dose reduced by one-half. Laboratory tests are available to identify CYP2D6 [poor metabolizers].” Id. (emphasis omitted). The Federal Circuit found these recitations supported the District Court’s finding that the label “recommends that practitioners perform or have performed a genotyping assay to determine whether patients are CYP2D6 poor metabolizers.” Id. (quoting Vanda Pharm. Inc. v. Roxane Labs., Inc., 203 F. Supp. 3d 412, 432 (D. Del. 2016)).
Next, the Court noted that the label recommends a “‘[u]sual’ target dose range (12 to 24 mg/day) and maximum dose (24 mg/day)” along with a recommendation to “reduce” the dose for poor metabolizers. Id. at 1132. The Federal Circuit stated this supported the District Court’s finding that “[t]he label recommends oral administration of iloperidone tablets at 12 to 24 mg/day to non-genotypic CYP2D6 poor metabolizers and 12 mg/day or less to genotypic CYP2D6 poor metabolizers.” Id. (quoting Vanda Pharm., 203 F. Supp. 3d at 432).
Focusing on these specific findings, and noting that regardless of any substantial noninfringing uses, the Federal Circuit upheld the District Court’s finding that the label supported liability for induced infringement.