In a memorandum distributed to the patent examining corps last month by Robert W. Bahr, Deputy Commissioner for Patent Examination Policy at the U.S. Patent and Trademark Office, the Office addresses a recent decision by the Federal Circuit in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals.  The memorandum notes that claims at issue in Vanda "recite a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart's normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism," and sets forth the following representative claim:

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 [emphasis in memorandum].

The memorandum explains that in Vanda, the Federal Circuit determined that the claims at issue are "patent eligible under 35 U.S.C. § 101 because they are not 'directed to' a judicial exception" (emphasis in memorandum).

According to the memorandum, "[t]he Federal Circuit's decision in Vanda illustrates several important points regarding the subject matter eligibility analysis."  The memorandum sets forth three such points:

• "[T]he Federal Circuit evaluated the claims as a whole, including the arguably conventional genotyping and treatment steps, when determining that the claim was not 'directed to' the recited natural relationship between the patient's genotype and the risk of QTc prolongation."

• "[T]he Federal Circuit cited the Supreme Court '[t]o further underscore the distinction between method of treatment claims and those in Mayo.' . . . Method of treatment claims (which apply natural relationships as opposed to being 'directed to' them) were identified by the Supreme Court as not being implicated by its decisions in Mayo and Myriad because they 'confine their reach to particular applications'" (emphasis in memorandum).

• "[T]he Federal Circuit did not consider whether or not the treatment steps were routine or conventional when making its 'directed to' determination" (emphasis in memorandum).

The memorandum concludes by stating that:

The USPTO's current subject matter eligibility guidance and training examples are consistent with the Federal Circuit's decision in Vanda, with the understanding that: (1) "method of treatment" claims that practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance; and (2) it is not necessary for "method of treatment" claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S .C. § 101.  For example, claims 5 and 6 of USPTO Example 29 (Diagnosing and Treating Julitis) should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance in light of the Federal Circuit decision in Vanda.