In a decision issued on August 25, 2016, Judge Sleet weighed in on the ongoing debate about whether a claim directed to a method of treatment is patent eligible subject matter under 35 U.S.C. § 101.

Vanda’s claims at issue were directed to methods of treating patients with schizophrenia or a schizoaffective disorder by administering a particular dose of the compound iloperidone, where the correct dose is determined based on the results of genetic testing. During development of iloperidone, Vanda discovered that patients with a certain genetic mutation in an enzyme called CYP2D6 poorly metabolize iloperidone, and those patients therefore have increased concentrations of iloperidone in their blood. Increased concentrations of iloperidone can lead to serious side effects, including a type of abnormal heart rhythm that can result in sudden death. Vanda’s method claims are based on this discovery and require that genetic testing be performed on a patient before the patient is administered iloperidone to determine whether the patient has a genetic mutation in CYP2D6. If the patient does not have the genetic mutation, the patient receives the maximum dose of the drug. If the patient does have the genetic mutation and is thus a poor metabolizer of the drug, the dose of the drug is reduced by half (thereby reducing the likelihood of experiencing serious side effects).

Roxane argued that Vanda’s method claims are directed to patent-ineligible subject matter because the claims cover a law of nature applied in a routine and conventional way. To decide this issue, the court applied the two-step analysis of Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014). First, the court determined whether the asserted method claims depend on laws of nature. According to the court, the claims depend on the natural relationship among iloperidone, mutations in CYP2D6 that cause poor metabolism of iloperidone and raise the concentration of the drug in the blood, and the effect of the increased concentration of iloperidone on normal heart rhythms. Thus, the court found that the claims do depend on laws of nature. Second, the court analyzed whether the claims incorporate some additional non-routine or non-conventional step to transform the nature of the claims into patent eligible subject matter. Vanda’s method claims require genetic testing to determine whether a patient has a CYP2D6 mutation, and, based on the results of that testing, determining the appropriate dose of the administered drug. Relying on competing expert testimony, the court found that Roxane failed to prove that the genetic testing required by the claims and the results of that testing were routine or conventional. The court also noted that it found persuasive that the step of adjusting the dose of the drug does not apply to all patients, but only to those with the genetic mutation, such that the dosage step requires applying genetic testing in a highly specified way. The court thus concluded that the combination of elements recited in the claims is sufficient to ensure that the claims are directed to significantly more than just a natural law.

Vanda Pharma. Inc. v. Roxane Labs, Inc., 13-1973, 14-757-GMS (D. Del. August 25, 2016) (Judge Sleet).