USPTO issues guidance on patent eligibility of method of treatment claims in light of Vanda Pharmaceuticals

On June 7, 2018, the USPTO issued new guidance to its examining corps in the form of a memorandum discussing the Federal Circuit’s April 13, 2018 decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Circ. 2018).

On patent eligibility, Vanda itself held that the claims at issue were not merely directed to a natural relationship of an individual’s ability to metabolize a drug with the proper dosage for that individual, which would have seen the claims rendered patent ineligible under Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). Rather, the Federal Circuit held that Vanda’s claims were directed to “an application of that relationship” and that the recitation of specific dosages as well as the specification’s explanation of the significance of those specific dosages distinguished Vanda’s claims from Mayo and Myriad.

As for the USPTO memo, it begins by highlighting the representative claim from Vanda, which is directed to treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a potentially serious disruption of the heart’s normal rhythm) in patients having a particular genotype associated with poor drug metabolism. The representative claim reads as follows, with the bolded portions being emphasized in the memo itself:

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.

The memo first observes that the “primary” steps of the claim include “determining” a metabolizer genotype with a genotyping assay, and then “administering” a certain quantity of drug based on that determination in order to “treat a particular disease.”


The memo then dives into the Federal Circuit’s holding, noting that “[t]he Federal Circuit distinguished Mayo, stating: ‘The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship. Unlike the claim at issue in Mayo, the claims here require a treating doctor to administer iloperidone.’…As a result, the Federal Circuit held the claims in Vanda patent eligible under the first step of the Alice/Mayo framework…because the claims ‘are directed to a method of using iloperidone to treat schizophrenia,’ rather than being ‘directed to’ a judicial exception.”

Thereafter the memo states that Vanda illustrates several important points regarding the subject matter eligibility analysis. First, the Federal Circuit evaluated the claims as a whole, including arguably conventional genotyping and treatment steps, when determining that the claim was not “directed to” the natural relationship between a patient’s genotype and the risk of QTc prolongation.

The second important point is that the Federal Circuit cited the Supreme Court to, in the Federal Circuit’s own words, “further underscore the distinction between method of treatment claims and those in Mayo.” Thus, the memo reads, “[m]ethod 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 original].’”

Further distinguishing from Mayo, the memo then states that the third important point illustrated by Vanda is that while the Mayo claims recited a step of administering a drug to a patient, that step was performed in order to gather data about the natural relationships and thus was ancillary to the overall diagnostic focus of the claims. Accordingly, “[t]he Mayo claims were not ‘method of treatment’ claims that practically apply a natural relationship.”

Next, the USPTO’s memo proclaims that “[t]he 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 [emphasis original].”

Then, in conclusion, the memo indicates that it is intended to “addresses the limited question of how to evaluate the patent eligibility of ‘method of treatment claims’ in light of the Federal Circuit decision in Vanda” and also states, perhaps in a nod to the leadership of new USPTO Director Andrei Iancu, that “[t]he USPTO is determined to continue its mission to provide clear and predictable patent rights in accordance with this rapidly evolving area of the law, and to that end, may issue further guidance in the area of subject matter eligibility in the future.”


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Join the Discussion

3 comments so far.

  • [Avatar for Babak Nouri]
    Babak Nouri
    August 30, 2018 05:58 pm

    Agree with Paul Cole, although this is not necessarily a new development – the same (or very similar) scenario was presented in the Rapid Litigation v. Cellzdirect case (2016) – same type of analysis was applied by the Federal Circuit and same conclusion based on the same reasoning was ultimately reached.

    All clinical/biological diagnostic or treatment methods are based on some underlying natural relationship. The distinction between 101 validated (Cellzdirect and Vanda) and 101 invalidated (Mayo and Sequenom) Diagnostic/Treatment methods is subtle ! .. but quantifiable, if evaluated objectively.

  • [Avatar for Anon]
    June 19, 2018 11:24 am

    All of the operative verbs here are one of two types:

    Further, one could (easily/consistently) use the “extra-solution” parsing to show the “apply” steps do not add that (admittedly undefined) “substantially more.”

    There really is no distinction (at least on a meaningful level) between the opposite outcomes of this case and the Supreme Court directions (with deference to Mr. Cole, this is very much a Supreme Court created problem, and here you have a lower court NOT following what the Supreme Court wrote).

  • [Avatar for Paul Cole]
    Paul Cole
    June 19, 2018 06:29 am

    A very favourable development, indicating leadership by the USPTO as a legitimate expert body in these matters, as the public would be entitled to expect. The USPTO has legal teams and is in a good position both from unrivalled experience in handling real cases and from the opportunities for in-house analysis to perform this role. It is also gratifying to see not mere parroting words e.g. from Mayo v Prometheus but coming to grips with the task of legally analysing the decision to see what it really means, guided by a useful Federal Circuit opinion