USPTO's memo on Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals

On Jun 7, 2018, The United States Patent and Trademark Office (USPTO) issued memo on recent decision of the U.S Court of Appeals for the Federal Circuit for patent eligible under 35 U.S.C. § 101 in case of Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals.

The USPTO's memo begins with highlighting representative claims of Vanda's Patent Number US8,586,610. Representative claim of US8,586,610 is as below:

Claim 1: 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. 

Here below is the details of memo:

The primary steps 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 1134. The 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." Id. at 1135 (emphasis added). As a result, the Federal Circuit held the claims in Vanda patent eligible under the first step of the Alice/Mayo framework (Step 2A in the US PTO' s subject matter eligibility guidance), because the claims "are directed to a method of using iloperidone to treat schizophrenia," rather than being "directed to" a judicial exception. 

The Federal Circuit's decision in Vanda illustrates several important points regarding the subject matter eligibility analysis. First, the Federal Circuit evaluated the claims as a whole, including the arguably conventional genotyping and treatment steps, when determining that the claim was not "directed to" the recited natural relationship between the patient's genotype and the risk of QTc prolongation. The importance of evaluating the claims as a whole in Step 2A was also emphasized by the Federal Circuit in previous cases, such as 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 two prior cases are discussed in a memorandum dated April 2, 2018 to examiners titled "Recent Subject Matter Eligibility Decisions." 

Second, the Federal Circuit cited the Supreme Court "[t]o further underscore the distinction between method of treatment claims and those in Mayo." Id. at 113 5. Method 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." Id. The Federal Circuit noted that while the "claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease." Id. at 1134. That is, 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. The Mayo claims were not "method of treatment" claims that practically apply a natural relationship. 

Lastly, the Federal Circuit did not consider whether or not the treatment steps were routine or conventional when making its "directed to" determination. Since the claim was determined eligible in the step 2A "directed to" part of the test, there was no need to conduct a step 2B analysis. 

The US PTO' 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. For example, claims 5 and 6 of USPTO Example 29 (Diagnosing and Treating Julitis) should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance in light of the Federal Circuit decision in Vanda. 

This memorandum 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. The USPTO is determined to continue its mission to provide clear and predictable patent rights in accordance with this rapidly evolving area ofthe law, and to that end, may issue further guidance in the area of subject matter eligibility in the future.

1. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).