A recent case from the United States Federal Circuit indicates that patent claims directed to methods of medical treatment can be found to be patentable even if the method steps recite subject matter related to a natural phenomenon.
The Federal Circuit affirmed a ruling of a United States District Court that claims to a method for treating a schizophrenia patient using the drug iloperidone in a dosage range based on a genotype indicating the patient’s ability to metabolize iloperidone are infringed and not invalid (Vanda Pharm., Inc. v. West-Ward Pharm. Int’l Ltd, Appeal No. 2106-2707, -08 (Fed. Cir., April 18th 2018).
The issue of patent eligibility was addressed by the Court using the prescribed “Alice/Mayo test” which, in brief includes the following steps:
(1) determine whether the claims are directed to a patent-ineligible concept (such as a natural phenomenon); and
(2) determine whether the claim’s elements, considered both individually and as an ordered combination, transform the nature of the claims into a patent-eligible application.
Claim 1 of U.S. Patent No. 8,586,610 recites:
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.
The Court first drew the distinction that this claim is directed to a method of treating a disease whereas the claims of Mayo (which contributed to the formulation of the Alice/Mayo test) were directed to a diagnostic method. It was then stated that while the inventors recognized the relationship between iloperidone CYP2D6 metabolism and a biological effect, they did not claim the relationship, but instead claimed an application of the relationship. Therefore the claim is addressed to a new way of using an existing drug. The decision also included an analysis of preemption with the result being that the patent ineligible claims of Mayo tie up the doctor’s treatment decision by “indicating” a need for treatment without prescribing a specific dosage regimen. In contrast, claim 1 of the ‘610 Patent recites a specific dosage regimen and therefore does not tie up all possible methods of treatment.
It therefore appears that claim drafting practice in situations where a natural phenomenon is involved in a method of medical treatment, reciting one or more “administering” steps will likely be helpful in ensuring that claims are not found to be ineligible under the Alice/Mayo test.
For more information, please contact Mark Roach.