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Vanda Pharmaceuticals Vs. West-Ward Pharmaceuticals International

Representative Claim(s)

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.

Posture:

Appeal from Hatch-Waxman litigation in the United States District Court for the District of Delaware. The District Court found that claims were directed to patent-eligible subject matter.

Exception Category: None

“Consistent with Supreme Court precedent, we agree with Vanda that the asserted claims are not directed to patent-ineligible subject matter. … Claim 1 requires specific steps: (1) determining the patient’s CYP2D6 metabolizer genotype by (a) obtaining a biological sample and (b) performing a genotyping assay; and (2) administering specific dose ranges of iloperidone depending on the patient’s CYP2D6 genotype.”

“Although the representative 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. [citation omitted.]  Importantly, the Supreme Court explained that the administering step was akin to a limitation that tells engineers to apply a known natural relationship or to apply an abstract idea with computers. [citation omitted.] (comparing the claim in Mayo to “Einstein telling linear accelerator operators about his basic law and then trusting them to use it where relevant”). To further underscore the distinction between method of treatment claims and those in Mayo, the Supreme Court noted that “[u]nlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.”

“In this case, the ‘610 patent claims are directed to a method of using iloperidone to treat schizophrenia. 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 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 assays.”

“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. They are different from Mayo. They recite more than the natural relationship between CYP2D6 metabolizer genotype and the risk of QTc prolongation. Instead, they recite a method of treating patients based on this relationship that makes iloperidone safer by lowering the risk of QTc prolongation. Accordingly, the claims are patent eligible”

Significantly More: Not Decided

Judge Prost Dissented

“I would find the asserted patent claims to be directed to a law of nature. The majority finds the claims herein are not directed to a natural law at step one of the § 101 analysis, but its efforts to distinguish Mayo cannot withstand scrutiny. The majority relies on the claims’ recitation of specific applications of the discovery underpinning the patent to find no natural law is claimed. But it conflates the inquiry at step one with the search for an inventive concept at step two. Once the natural law claimed in the ‘610 patent is understood in a manner consistent with Mayo, what remains fails to supply the requisite inventive concept to transform the natural law into patent-eligible subject matter.”

“While the claims here do not solely state a law of nature, they do no more than simply direct the relevant audience to apply it.”

“As the majority notes, the ‘610 patent claims a method of treating schizophrenia with iloperidone ‘that is safer for patients because it reduces the risk of QTc prolongation.’ [Citation omitted.] This is no more than an optimization of an existing treatment of schizophrenia, just as the claims in Mayo concerned “optimizing therapeutic efficacy” of thiopurine drugs. Mayo warned against “drafting effort[s] designed to monopolize the law of nature itself.” [Citation omitted.] The majority does not heed that warning.”

“The majority fails to reconcile this substantive similarity between our case and Mayo. Instead, it points to the specific dosages as a distinction between the administering step here and that in Mayo. But Mayo examined the significance of the “administering” step in its search for an inventive concept, not as part of the determination whether the claims were directed to a natural law at the threshold. And the specific dosage adds nothing inventive to the claims beyond the natural law.”

“Whatever weight can be ascribed to the foregoing statements about methods of treatment, we remain beholden to the holding of Mayo, which, in my view, requires us to find the claims directed to a natural law at step one. (And I find no inventive concept in the claims once the natural law at issue is properly understood in view of Mayo.)”