A recent Federal Circuit decision provides patent holders and applicants some guidance as to when patent claims that include methods of treatment may be eligible for patenting.
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd. (Fed. Cir. Apr. 13 2018), the decision involved U.S. Patent 8,586,610, which is directed to a method of trating a patient who is suffering from schizophrenia with iloperidone. The representative claims included the steps of performing a genotypic assay on the patient, and administering one of multiple dosages of iloperidone to the patient depending on the results of the assay.
The defendant argued that the claims were not patent-eligible “because they are directed to a natural relationship between iloperidone, CYP2D6 metabolism, and QT prolongation, and add nothing inventive to those natural laws and phenomena.” The patent holder argued that while the claims may “touch upon” laws of nature, they are not directed to any law of nature.
The court agreed with the patent holder, nothing that while the “inventors recognized the relationships between iloperidone [and certain natural phenomena,] that is not what they claimed. They claimed an application of that relationship. Unlike the claim at issue in Mayo [v. Prometheus], the claims here require a treating doctor to administer iloperidone in the amount of either (1) 12 mg/day or less or (2) between 12 mg/day to 24 mg/day, depending on the result of a genotyping assay.” Thus, the court found that the “patent claims are ‘a new way of using an existing drug’ that is safer for patients because it reduces the risk of QTc prolongation,” rather than purely a law of nature.
The Vanda decision can be a useful reference point for applicants who seek to claim personalized medicine delivery methods. The court’s discussion of claims that touch on, but are not directed to, laws of nature may be helpful for those who are inventing new and useful methods that rely on laws of nature, but which aren’t inherently laws of nature on their own.