USPTO Memo Addresses Federal Circuit Authority On Patent Eligibility Of Some Treatment Methods

In Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals, Ltd., Nos. 2016-2707, 2016-2708 (Fed. Cir. April 13, 2018), the court held that claims to methods of treatment were patent eligible. At issue was the eligibility of methods of treating schizophrenia with iloperidone, in which the dosage of the pharmaceutical was adjusted based on the patient's genotype. Patients with genotypes indicating they would be poor metabolizers of the therapeutic would be given lower doses to avoid heart-related side effects of the drug. The parties argued the two-step Mayo test for patent eligibility, i.e., whether an exception to eligibility is recited and, if so, whether substantially more is recited to overcome the exception. Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). The exceptions to patent eligibility, elaborated in a series of recent Supreme Court cases, include laws of nature, natural phenomena, and abstract ideas. The Federal Circuit distinguished Mayo as drawn to a diagnostic method concerning the relationship between thiopurine metabolites and efficacy/toxicity that did not require administration of a recognized dosage. In contrast, Vanda's claims to treating schizophrenia required administration of specific dosage ranges, thereby amounting to an application of the relationship between the drug, the metabolizer status of the patient, and heart-related side effects.

Following consideration of Vanda and two other decisions on patent eligibility (Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299 (Fed. Cir. 2018) and Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc., 880 F.3d 1356 (Fed. Cir. 2018)), the USPTO issued a memo on June 7, 2018, noting that claims as a whole are to be examined and outlining an analytical framework for method of treatment claims that should enable appropriate claims to pass the eligibility threshold in a streamlined fashion. Based on its interpretations of the cited cases, the USPTO stated that the Federal Circuit held treatment method claims patent eligible because they applied natural relationships, thereby avoiding the potentially messy second step of the Mayo test where the claims would be analyzed to determine if they recited substantially more than the exception, e.g., unconventional or non-routine steps. In view of this position, applicants seeking patents on treatment methods now have helpful guidance on drafting claims that the USPTO will consider to be patent eligible.

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