Source: http://mwzb.com/if-you-vanda-patent-a-genetic-test-induce-the-doctor-to-infringe.html
Timestamp: 2019-04-23 02:52:04+00:00

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September 19, 2018 — As summer vacations end, school for kids and big kids starts up, and we return to the reality that is September, we present a little big kid patent school and some good news for holders of pharmaceutical method patents – in the form of the Federal Circuit’s Vanda decision. Vanda gives patentees some strength in resisting a challenge to patentable subject matter under 35 USC §101 and also some confidence in asserting infringement against a deep-pocket infringer.
Vanda’s patent relates to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient’s genotype.
In short, the claims of the patent at issue required treatment of schizophrenia with iloperidone to be performed with different dosing ranges depending on whether the patient was a poor metabolizer of CPY2D6. Because the claims at issue related to a method of treatment, for West-Ward to be liable for infringement, West-Ward must induce the physicians to practice the method.
Akamai Techn. Inc. v. Limelight Networks (797 F.3d 1020, 116 U.S.P.Q.2d 1344 (Fed. Cir. 2015, en banc) confirmed that an act of direct infringement must be proven before there can be a finding of indirect infringement and that direct infringement requires all the steps of the claimed method to be performed by, or attributable to, a single entity. In the real world, at least the steps of “assaying” and “administering” are seldom performed by a single actor, and if they are, that actor is most likely to be a doctor. That was the case here, where the plaintiff put forth evidence below of direct infringement in the form of physician testimony and corroborating patient records showing that a doctor had performed or caused to be performed, all of the active steps. These steps included obtaining a biological sample, performing the claimed genotyping steps, and administering an adjusted dose of iloperidone to a patient based on genotype in accordance with Vanda Pharma’s claim.
Doctors are seldom the target of enforcement actions, for a variety of practical reasons. First and foremost, 35 U.S.C. § 287(c) bars a medical procedure patent owner from enforcing that patent by obtaining an injunction, monetary damages, and attorney fees, against a medical practitioner and a related health care entity based on the medical practitioner’s performance of a medical activity. Moreover, even for patents on devices such as a diagnostic kit, patentees would prefer to sue the manufacturer of such an infringing diagnostic kit or the laboratory performing the tests – not only because one suit in one jurisdiction (or at least a few suits in a limited number of jurisdictions) would stop the infringement instead of pursuing doctors in multiple actions, but because in terms of damages the award would cover all or most infringing items, not just those few used by an individual physician . As a result, in addition to proof of direct infringement, a theory of indirect infringement is necessary to get at the target defendant, typically the entity performing the “assaying” step of the claimed method or the entity marketing the assay test kit.
Nevertheless, the court agreed with Vanda that this language was sufficient to support the finding below that the label recommends practitioners perform or have performed a genotyping assay. The court took note of the finding below, based on expert testimony for both parties, that the “laboratory tests” referred to in the label are “genotyping tests.” In addition, the court rejected the defendant’s argument that the existence of substantial non-infringing uses precluded a finding of specific intent as a matter of law. Unlike contributory infringement, inducement under Section 271(b) does not include any language regarding non-infringing substitutes. Thus, a finding of induced infringement can still occur even if the actions of some, but not all physicians, are infringing. The defendant also argued that there was no inducement because there is no label instruction satisfying the claim element of “obtaining a biological sample.” But the court rejected this argument and agreed with the finding below that the label implicitly recommends obtaining a biological sample, since a sample is required in order to perform the genotyping test.
According to the Federal Circuit, a “proposed label [that] ‘recommends’ that physicians perform the claimed steps” was sufficient to establish specific intent and support liability for induced infringement. Vanda, 887 F.3d at 1130-33.
Focusing on these specific findings, and noting that regardless of any substantial non-infringing uses, the Federal Circuit upheld the District Court’s finding that the label supported liability for induced infringement.
In a second positive development, the Vanda court confirmed that the diagnostic method claim satisfied the patentable subject matter requirement of 35 USC §101.
Vanda’s asserted claims were directed to a “method of treating” a patient suffering from schizophrenia with a drug called iloperidone. Iloperidone is metabolized by the liver cytochrome P450 enzyme, CYP2D6, and high levels of iloperidone or its metabolites were known to cause a serious side effect in the form of a heart arrhythmia, QT prolongation, which is referred to as QTc when corrected for the patient’s heart rate.
According to the specification of the ‘610 Patent, the inventors discovered “an association between genetic polymorphisms in the CYP2D6 locus, corresponding increases in the concentrations of iloperidone or its metabolites, and the effect of such increases in concentrations on corrected QT (QTc) duration relative to baseline.” The asserted claims recite active steps relating to determining whether a patient is a CYP2D6 poor metabolizer and administering an appropriate dose based on metabolizer status. In brief, the active steps recited in the claim are “determining” whether the patient is a poor metabolizer by “obtaining” a biological sample and “performing” a genotyping assay followed by “administering” to the patient a specific dose of “12 mg/day or less” for poor metabolizers or “an amount that is greater than 12 mg/day, up to 24 mg/day” for a patient that lacks a CYP2D6 poor metabolizer genotype.
The Federal Circuit recalled the Supreme Court’s two step inquiry for determining subject matter eligibility, commonly referred to as “the Mayo/Alice inquiry ( Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 132 S. Ct. 1289,182 L. Ed. 2d 321, 101 U.S.P.Q.2d 1961, 80 U.S.L.W. 4225 (2012) / Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347, 110 USPQ2d 1976 (2014)).” Under Step 1, the question is whether the claimed subject matter is “directed to” a judicial exception, such as a law of nature, a natural product, or an abstract idea. If it is not, then the inquiry ends there and the claim is deemed patent eligible. However, if the claim is found to be “directed to” a judicial exception, then the inquiry proceeds to Step 2, in which the claim is examined to determine whether or not it adds “significantly more” to the judicial exception, or is merely an attempt to claim the law of nature, natural product, or abstract idea itself. In the vast majority of diagnostic method cases finding claims lacking in patentable subject matter under §101, the courts have found that the subject matter was directed to an exception, typically a law of nature (e.g., the “natural” correlation between CYP2D6 and metabolization of iloperidone) and the case has focused on the “significantly more” aspect – which has proved hard to satisfy.
Here, claims directed to treating a specific disease (schizophrenia) with a specific drug (iloperidone) in a specific patient population (CYP2D6 poor metabolizers, or not) in a specific way (by administering a defined dose to each patient population) to achieve a specific result (lower risk of a serious side effect) were patent eligible at Step 1 of the Mayo/Alice inquiry.
West-Ward’s motion for rehearing en banc was denied by the Federal Circuit in August. Thus, for the moment, Vanda provides a ray of hope for diagnostic method claims of similar nature, where assaying of a specific factor provides information which is then used to adjust treatment – for not only are such claims directed to patentable subject matter under this decision, but are infringed by a viable target defendant enabling enforcement in a reasonable manner.

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