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

In Vanda the patent’s claims recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation in patients having a particular genotype associated with poor drug metabolism.  The Federal Circuit held that the claims at issue were patent eligible under 35 U.S.C. § 101 and not "directed to" natural phenomena, a judicial exception to patentability.

The memo began by highlighting a representative claim and noting that the “primary” steps 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 discussed the holding, noting that Vanda was distinguished from Mayo Collaborative Services v Prometheus Laboratories, Inc, 566 US 66 (2012) on the basis that the inventors claimed an application of the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation, and not the relationship itself.  Finally, the memo highlighted several key points regarding the subject matter eligibility analysis illustrated by Vanda and concluded by noting that current USTPO guidance and training examples are consistent with the decision.

The guidance can be found on the USTPO website here.

Summary By: Jae Morris


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