In a memorandum dated June 7, 2018 (Memo), the U.S. Patent and Trademark Office (USPTO) set out new guidance concerning method-of-treatment claims, which should be welcome news for patentees. The memo addressed the decision by the U.S. Court of Appeals for the Federal Circuit in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018). In particular, the guidance suggests that claims directed to methods of treating a disease will typically meet patent eligibility standards under step one of the U.S. Supreme Court’s Mayo test.[1]

The claims in Vanda were directed to a method of treating a patient with schizophrenia by using iloperidone. Iloperidone is a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to health problems) in patients having a particular genotype associated with poor drug metabolism. Memo at 1. The primary steps of the claims include “determining” with a genotyping assay, and then “administering” a certain quantity of drug based on that determination in order to “treat a particular disease.” Id. at 2. The USPTO noted that the Federal Circuit distinguished Mayo as follows: “The inventors recognized 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.” Id., citing Vanda at 1135 (emphasis added).

The USPTO stressed three main aspects of the Vanda decision. First, claims are to be evaluated as a whole, including arguably conventional genotyping and treatment steps, when determining whether or not the claims are “directed to” a recited natural relationship. Memo at 2. Second, method-of-treatment claims that apply natural relationships as opposed to being “directed to” them are not implicated by Supreme Court decisions in Mayo and Myriad because they “confine their reach to particular applications.” Id. Third, the second step of the Mayo test, i.e., whether or not the treatment steps were routine or conventional, is not necessary once a claim is found not to be directed to patent-ineligible subject matter under step one. Id.

Accordingly, the USPTO provides patentees with helpful guidance when defending method-of-treatment claims under 35 U.S.C. § 101. Although not mentioned in the Memo, the Vanda decision included a dissent by Chief Circuit Judge Sharon Prost that found the claims to be more consistent with Mayo. So despite the helpful views expressed by the majority in Vanda and subsequently adopted by the USPTO, patentees still need to be careful in drafting method-of-treatment claims and should remain prepared to defend the eligibility of such claims under Section 101.

[1] Mayo Collaborative Serv. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). Under the Supreme Court’s two-step framework, the Section 101 analysis considers (1) whether the claims at issue are directed to a patent-ineligible concept, i.e., a law of nature, abstract idea or natural phenomenon, and if so, (2) whether additional elements transform the nature of the claims into a patent-eligible concept, i.e., something more than routine or conventional steps.