Vanda and Patent Eligibility for Diagnostics

Guest Post by Jennifer Johnson

Part I of a two-part post

On April 13, 2018, the Federal Circuit released a decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd (citation), affirming the district court’s ruling that the claims at issue are directed to patent-eligible subject matter. Vanda owns U.S. Patent 8,586,610 (hereinafter “the ‘610 patent”), which was challenged by West-Ward on validity grounds following a decision by the district court that West-Ward’s proposed products induce infringement of the asserted claims of the ’610 patent.  Claim 1 of the ‘610 patent recites:

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.


In the decision, the federal court drew upon reasoning set forth in Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016) to conclude that the claims are not directed to a patent-ineligible concept (“it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’”), contending that the while the claims rely upon relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, “that is not what they claimed. They claimed an application of that relationship.”  The court further reasoned that, unlike the claims in Mayo (Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012)), the claims do not “tie up the doctor’s subsequent treatment decision.”  In summary, the court concluded “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” and thus are patent eligible.

So what is the take-away?  From a practical standpoint, the Federal Circuit has now provided a clearer path forward, together with the decision in CellzDirect, in how to avoid ineligibility rejections when drafting diagnostic claims that rely on naturally-occurring relationships.  Namely, the Federal Circuit has emphasized the need to claim use of the naturally-occurring relationship in specific patients to achieve a specific outcome.  And more specifically, even stating this use in the preamble might be enough!