Method of Treatment Claims Patent Eligible Even without Reciting Dosages
It appears that Judge William C. Bryson, U.S. Appellate Court Judge on the Federal Circuit bench, is riding the circuit these days, peripatetically ruling on the St. Regis Mohawk Tribe's motion to join ANDA litigation in the Eastern District of Texas last October and, last week, denying Defendant's motion to reconsider his grant of summary judgment that the claims at issue in Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd. were not invalid for being patent-ineligible subject matter under 35 U.S.C. § 101. The significance of this decision, and more importantly the reasoning behind it, are important because "method of treatment" claims may be the last refuge against the pernicious stain of patent invalidation caused by inferior court's (and the USPTO's) implementation of the U.S. Supreme Court's questionably recent patent eligibility jurisprudence.
The litigation arose over alleged infringement of claims 12, 17, and 19 of U.S. Patent No. 9,265,760 and claim 1 of U.S. Patent No. 9,339,499 related to methods for treating pain in certain hepatically impaired subjects:
'760 patent:
12. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, wherein the dosage unit provides a release profile of hydrocodone that: (1) does not increase average hydrocodone AUC0-∞in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%; (2) does not increase average hydrocodone AUC0-∞in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%; (3) does not increase average hydrocodone Cmax in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 9%; and (4) does not increase average hydrocodone Cmax in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%.
17. The method of claim 12, wherein the dosage unit provides a release profile of hydrocodone such that: (1) the average hydrocodone AUC0-∞ per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 300 ng*h/mL to about 500 ng*h/mL; (2) the average hydrocodone AUC0-∞ per 20 mg of hydrocodone bitartrate dosed to subjects suffering from mild hepatic impairment is in the range of about 300 ng*h/mL to about 570 ng*h/mL; and (3) the average hydrocodone AUC0-∞ per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 300 ng*h/mL to about 700 ng*h/mL.
19. The method of claim 17, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone AUC0-∞ per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 352 ng*h/mL to about 666 ng*h/mL.
'499 patent:
1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, wherein the dosage unit provides a release profile of hydrocodone that: does not increase average hydrocodone AUC0-∞ in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%; and does not increase average hydrocodone AUC0-∞ in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%.
(Another set of '760 patent claims, comprising claims 1-4 and 11, was not at issue in the District Court's decision.)
Judge Bryson previously denied (on May 15, 2018) Alvogen's summary judgment motion that claims 12, 17, and 19 of the '760 patent and claim 1 of the '499 patent were invalid under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter, and part of the basis for Judge Bryson's denial of the Alvogen's motion for rehearing rests on District of Delaware precedent that such motions should be granted "sparingly" under local rule 7.1.5.
On the merits, Alvogen argued that the District Court misapprehended the difference between claims reciting specific dosages and claims reciting the pharmacokinetic parameters produced by administration of dosages not recited with specificity in the claims. The basis for Alvogen's argument of misapprehension stems from the statement in Judge Bryson's original opinion (denying Alvogen's summary judgment motion) that "the claims asserted in this case describe a specific dosing regimen to treat a specific condition based on the patient's medical status" like the claims the Federal Circuit found patent-eligible in Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International, Ltd., 887 F.3d 1117 (Fed. Cir. 2018). The absence of limitations in the claims at issue here (and thus lacking "a specific dosing regimen" according to Alvogen) was the lynchpin of this argument, which Judge Bryson rejected. He understood the claims, while not containing a dosing regimen "in [] conventional form" to be the same as regimens recited in claims that did contain such expressly recited dosages, because the resulting pharmacokinetic parameters were produced in each type of claim. In a footnote Judge Bryson set forth his reasoning:
While the dosing regimens in the "PK-only" claims are set forth in an unconventional manner, that is not unusual, as dosing regimens can be measured and designated in many ways other than simply by reference to the amount and frequency of administration of a drug. For example, a direction to administer drug from a bronchial inhaler for short-term relief "until normal breathing is restored," but not for long-term relief, is a dosing regimen, as is a direction to reduce the dosage of a drug administered to a patient from a particular starting amount to the minimum amount necessary to achieve the desired efficacy.
And more generally, and having significance for claims other than the ones at issue here:
A claim to a method of treating an illness is typically more than an expression of a natural law; if it were otherwise, pharmaceutical patents would be hard to come by, as most methods of treatment using pharmaceuticals consist simply of the administration of a drug that affects the human body in a manner that is dictated by laws of nature.
Judge Bryson's opinion also provides an illustrative example of a patent-eligible claim in this context (albeit one that "might have other infirmities, such as failing to pass muster under sections 102, 103, or 112 of the Patent Act). Such a claim would be one that merely recited "a method for treating pain in subjects with mild or moderate hepatic impairment comprising administering an oral dosage of hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate." This is enough, in his view, to pass muster as being something more than a claim reciting a natural law. Accordingly (or "[a] fortiori" in the opinion), here the claims have additional limitations that describe the claimed dosage forms with reference to specific pharmacokinetic properties. "Adding limitations to a claim that satisfies section 101 does not convert the claim into one that is directed to unpatentable subject matter," Judge Bryson writes.
The opinion once more rejects Alvogen's argument that the claims at issue here are akin to the patent-ineligible claims in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). Those claims were ineligible for reciting the relationship between blood metabolite concentration and effectiveness of drug treatment. Here, as in Vanda, the claims affirmatively recite "treatment steps," "that is, directed at a new and useful method of treating pain in a certain population of patients using a specific set of hydrocodone bitartrate formulations" and thus, are patent eligible.
Finally, Judge Bryson counters Alvogen's argument that a section 101 analysis "requires consideration of 'the claimed advance over the prior art," relying on language from Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016). He states that "Alvogen would be wrong to read a strong novelty inquiry into section 101 analysis," on the basis of the distinction that "the section 101 inquiry evaluates 'the focus of the claimed advance over the prior art to determine if the claim's character as a whole is directed to excluded subject matter,'" citing the Federal Circuit's reliance on Affinity Labs of Texas, LLC v. DIRECTV Dig. LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016), in its decision in Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1325 (Fed. Cir. 2017).
It is important not to read too much into this decision, it being denial of a motion for rehearing of a decision on summary judgment. However, it is important to note that decisions such as this one have increased relevance in light of the Supreme Court's refusal to recognize that there may be solid grounds to reconsider their thinking on patent eligibility, as illustrated by their most recent refusal (yesterday) to grant certiorari in Cleveland Clinic Foundation v. True Life Health Diagnostics. The Supreme Court may have intended the Federal Circuit and the district courts to "flesh out" the application of the principles and concerns it voiced in Bilski, Mayo, Myriad, and Alice. After a certain period of apparently sheepish acquiescence it is possible that the inferior courts are beginning to fulfill the Court's expectations.
Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd. (D. Del. 2018)
Memorandum Opinion and Order by Judge Bryson
