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Vanda Pharmaceuticals Inc. et al. v. Roxane Laboratories, Inc.

Representative Claim

  1. A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:

determining whether the patient is a CYP2D6 poor metabolizer by:

obtaining or having obtained a biological sample from the patient; and

performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and

if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and

if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,

wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.

Posture:

Bench Trial – final ruling on parties’ post-trial briefs pursuant to FRCP 52(c).

Abstract Idea: Yes

The Court determined that the claims fundamentally depend on laws of nature, particularly “the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation.” In so finding, the Court rejected Plaintiffs’ arguments based on Enfish that while the claims “involve a patent eligible concept” they are not “directed to” it. Ultimately, the Court was persuaded to the contrary by the disclosure of the ’610 Patent itself which described the natural relationships as follows:

“The present invention describes an association between genetic polymorphisms in the CYP2D6 locus, corresponding increases in the concentrations of iloperidone or its metabolites, and the effect of such increases in concentrations on corrected QT (QTc) duration relative to baseline.”

Something More: Yes

On step two of the Alice/Mayo test, the Court found as follows:

“[W]hile it may have been conventional to investigate for side-effects, [Defendant] has not proven by clear and convincing evidence that the precise test and the discovered results were routine or conventional. The court finds it persuasive that the dosage step in the ’610 Patent does not apply to all patients, but only a specific patient population based upon their genetic composition. The dosage step requires applying genetic tests in a highly specified way. Moreover, the process of using this genetic test to inform the dosage adjustment recited in the claims was not routine or conventional and amounted to more than a mere instruction to apply a natural relationship. This combination of elements is sufficient to ensure that the claims amount to significantly more than just a natural law.”