USPTO issues Memo on Patent Eligibility of Method of Treatment Claims

The United States Patent and Trademark Office (USPTO) recently issued a memo providing examination guidance on the subject matter eligibility of the method of treatment claims. The memo discussed the recent Federal Circuit decision in Vanda Pharmaceutical Inc. v. West-Ward Pharmaceuticals, 887 F. 3d 1117 (Fed. Cir. 2018) and addressed the question of how to evaluate the patent eligibility of method of treatment claims in view of Vanda.

The claims at issue in Vanda were directed to a method of treating a patient with iloperidone. The claimed treatment method includes the steps of (1) determining with an assay whether the patient has a CYP2D6 poor metabolizer genotype; and (2) administering a certain quantity of drug based on the genotype determination. The Federal Circuit held the method of treatment claims patent eligible under the Alice/Mayo framework and distinguished Vanda from Mayo. Id. at 1135. The Federal Circuit reasoned that the inventors claimed an application of natural relationship and “unlike the claim at issue in Mayo, the claims here require a treating doctor to administer iloperidone.” Id.

The USPTO memo noted three important points in Vanda: (1) the Federal Circuit evaluated a claim as a whole when determining the claim was not “directed to” the natural law; (2) the Mayo claims were not “method of treatment” claims that practically apply a natural relationship because the step of administering a drug to the patient was performed to gather data about the natural relationship and was ancillary to the overall diagnostic focus of the claims; and (3) The Federal Circuit did not consider whether or not the treatment steps were routine or conventional because the claims was determined eligible under the first part of the test and there was no need to conduct the second part of the analysis.

The USPTO concluded in the memo that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under the first step of the 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.”

Another blog article published earlier this year also discussed the patent eligibility determination in several district court cases that found personized treatment method claims patent ineligible. The Federal Circuit’s decision in Vanda overruled the district court. Following the Vanda decision, West-Ward filed a petition for rehearing en banc on the subject matter eligibility question. Given that Vanda was a 2-1 decision with Judge Laurie and Judge Hughes in the majority and Chief Judge Prost in dissent, it will be interesting to see whether the Federal Circuit would order a rehearing en banc.