For those of you who may have lost hope regarding the patentability of personalized medicine discoveries, here’s some encouragement. Recently the Federal Circuit affirmed the validity of a patent directed to a method of treating schizophrenia, which is based on genetic testing of the patient. Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., Nos. 2016-2707, 2016-2708, 2018 WL 1770273, —F.3d — (Fed. Cir. Apr. 13, 2018). The Court found that the claims of U.S. Patent No. 8,586,610 were patent eligible and not drawn to a law of nature under 35 U.S.C. § 101. Claim 1 is representative and is shown below:
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 the patent claims recite a method of treatment based on the results of genetic testing, i.e., whether the patient is of a CYP2D6 poor metabolizer genotype or not. As an aside, the abbreviation “CYP2D6” refers to the cytochrome P450 2D6 gene, which encodes an enzyme that is known to metabolize a large number of drugs, including the one to be used here, iloperidone (FANAPT®). A patient who is a poor metabolizer has lower than normal CYP2D6 enzyme activity, which means that iloperidone is inefficiently metabolized and persists in the body longer. The increased drug exposure in these patients can lead to a risk of serious physiological effects, such as a disturbance in heart rhythm (QTc prolongation). Truly, it is useful to not only know which drugs will be helpful in treatment, but also to know how to mitigate potentially serious side effects of the chosen drugs—before treatment begins. This is one remarkable benefit of personalized medicine and the study of genetics.
The Federal Circuit explained, that unlike Mayo, the patent claims here recite the steps of carrying out a dosage regimen based on the results of genetic testing. “At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Id. at *15.
The Court also mentioned that the case of Myriad noted that “method claims” and “patents on new applications of knowledge about [particular] genes” were “not implicated by [its] decision.” Id. (quoting Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013)).
There was a dissent however, by Chief Judge Proust, who characterized the asserted patent claims to be directed to a law of nature along the lines of Mayo. Id. at *18.
This is an interesting case to keep in mind when considering the patentability of Personalized Medicine breakthroughs in the future. The holding here highlights the importance of effective claim drafting to present your patent application in such a manner that conveys subject matter eligibility to the USPTO and the courts.