A Different Lesson from Vanda v. West-Ward

August 20, 2018 – Article

      Last week the Federal Circuit denied West-Ward’s petition for rehearing en banc.  At the time of the original Federal Circuit decision (Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the case generated substantial commentary in regard to its patent eligibility context.  West-Ward’s petition focused on the question of whether “adjusting a dose of an old drug based on a patient’s genetic risk of poorly metabolizing it” is patent eligible subject matter, so the pro-patent crowd will no doubt be pleased.  There is another aspect of the case, however, which is worthy of consideration.

The independent claims of Vanda’s ‘610 patent all required a “genotyping” step:

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

The finding of inducement of infringement hinged on the tricky question of whether West-Ward’s proposed ANDA label induced this genotyping step.  The proposed label did not mention genotyping, and there was conflicting testimony of whether the label’s reference to “laboratory tests” would lead to genotyping or phenotyping to determine if the patient was a CYP2D6 poor metabolizer.

      In finding Vanda’s claims patent eligible, the Federal Circuit distinguished the situation from Mayo on the ground that the claims of the ‘610 were directed to a novel method of treating a disease, not a diagnostic method.  The Federal Circuit further noted that unlike the claims in Mayo, the claims of the ‘610 patent require the 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 the genotyping assay.”

      Since it is the administration step which appears to confer patentability on the ‘610 claims, and since the genotyoping step appears to have raised a close question of infringement, one should wonder whether the genotyping step was necessary.  Instead, would a claim without the genotyping step be just as patentable and more likely to be found infringed.  For example, imagine the following new version of Claim 1 of the ‘610 patent:

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

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

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

This claim should also be patent eligible and should be much easier to be found infringed.