April 16, 2018
On April 13 the Federal Circuit affirmed the lower court decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l. Ltd., appeal Nos. 2016-2707 and 2016-2708. The opinion addresses a number of concerns in ANDA litigation including whether jurisdiction exists under 35 U.S.C. § 271(e)(2) for a “late listed” Orange Book patent (it does), the availability of an injunction to prevent inducement of infringement by a label (it is available), and the patent eligibility of a claim to using a drug based upon the results of a diagnostic technique. It is this latter point which is of significant importance. Claim 1 of the patent (USP 8,586,610 (‘610)):
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.
In addressing the patent eligibility question, the district court had found the claim patent eligible, the Court, like the district court, quoted freely from the leading Supreme Court decisions Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). The analysis began with a discussion of the two-step process set forth in Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014). In particular the Court noted on page 28 of the slip opinion:
Step one requires determining “whether the claims at issue are directed to one of those patent-ineligible concepts.” Id. (emphasis added); see Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, (Fed. Cir. 2016). The Supreme Court has cautioned that “too broad an interpretation of” ineligible subject matter “could eviscerate patent law” because “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Mayo, 566 U.S. at 71. Accordingly, at step one, “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016). If the claims are not directed to a patent ineligible concept at step one, we need not address step two of the inquiry. See Enfish, 822 F.3d at 1339. That is the case here.
The Court went on to find the claim was not directed to patent-ineligible subject matter because Claim 1 recites “[a] method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia” comprising the following steps:
(1) (1) deter- mining 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.
The Court distinguished over Mayo for several reasons. First, Mayo’s claims were not directed to a method of treating a disease but to a diagnostic technique. The diagnostic method based on the “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. This “relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.” Id. (Slip op. at 29)
The second, and most important, was that unlike the claim in Mayo
to the extent that preemption is a concern, the ’610 patent claims do not “tie up the doctor’s subsequent treatment decision.” Id. at 86. The claim in Mayo did not go beyond recognizing (i.e., “indicates”) a need to increase or decrease a dose. Id. at 75. In Mayo, “a doctor . . . could violate the patent even if he did not actually alter his treatment decision in the light of the test.” Id. The claim was not a treatment claim. It was “not limited to instances in which the doctor actually decreases (or increases) the dosage level where the test results suggest that such an adjustment is advisable.” Id. at 76. Thus, the claim in Mayo did not involve doctors using the natural relationship between the metabolite level and lessening “the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. at 77. The claims in Mayo therefore “tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations. And they threaten to inhibit the development of more refined treatment recommendations . . ..” Id. at 86–87. (Bolding added)
Slip opinion at 31
The court noted on Slip Opinion at page 32 that the Supreme Court in Myriad noted “that “method claims” and “patents on new applications of knowledge about [particular] genes” were “not implicated by [its] decision.” Id. 595–96 (emphasis in original).”
The Court concluded at slip opinion page 32:
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.
This opinion represents an important step in a more rational application of the patent-ineligibility doctrine.