Since the Mayo v. Prometheus decision in 2012, patent eligibility challenges have skyrocketed, and pharmaceutical patents claiming methods of treatment have not been spared scrutiny. Two recent cases decide the eligibility issue in favor of patentees. Earlier this year the Federal Circuit upheld method of treatment claims in Vanda Pharmaceuticals Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). And more recently, Judge Bryson, sitting by designation in the District of Delaware, ruled on summary judgment that a set of claims covering methods of treatment were not directed to patent ineligible concepts. Pernix Ir. Pain DAC v. Alvogen Malta Ops., LTD, 2018 U.S. Dist. LEXIS 81419 (D. Del. May 15, 2018), motion for reconsideration denied, 2018 U.S. Dist. LEXIS 96634 (D. Del. June 8, 2018). Though neither case pronounces a per se rule that methods of treatment are patent eligible, they do provide some guidance about how to frame the eligibility argument for success, and how to draft strong claims.
In Vanda, a representative claim recited “[a] method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia,” and included these 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.” Vanda, 887 F.3d at 1134. The Federal Circuit ruled that the claims “are directed to the method of using iloperidone to treat schizophrenia,” and not a natural law. Id. It viewed those claims as covering “‘a new way of using an existing drug’ that is safer for patients because it reduces the risk of QTc prolongation,” a heart rhythm condition. Id. The Federal Circuit distinguished the claimed methods, which involved distinct treatment steps, from those in Mayo, which as a whole were “not directed to the application of a drug to treat a particular disease.” Id. at 1134-35. And it noted that the Mayo Court itself distinguished the invalid claims there from patents claiming new ways of using an existing drug. Id. at 1135.
Succinctly stated, the Court’s rationale for finding eligibility is as follows:
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 rationale suggests that at least claims directed to “specific” methods of treatment—i.e., those that articulate the relevant patient population, some aspect of a dosing regimen, and the condition to be treated—may pass muster under Mayo.
Though Judge Bryson was not part of the Vanda panel, he built off it in ruling, in a district court litigation sitting by designation, that claims covering methods of treating pain in patients with compromised liver function by administering an extended-release dosage form were patent eligible. Pernix, 2018 U.S. Dist. LEXIS 81419 at *66-72. Like the Vanda court, Judge Bryson distinguished the claims from those at issue in Mayo. He found that while the inventions may have been based on a natural law—the physiological response to hydrocodone in individuals with or without mild or moderate hepatic impairment—the claims do more than merely report those physiological responses . . . [they] describe a specific dosing regimen to treat a specific condition based on the patient’s medical status.” Id. at *70-71. Thus, they are not directed to a natural law, and are eligible.
Judge Bryson further explained his eligibility rationale in denying the defendant’s motion for reconsideration of the eligibility issue as applied to a subset of claims – the “PK-only” claims. Those claims required that upon administration, the dosage form give rise to certain pharmacokinetic (PK) parameters. He first broadly explained that “[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.” Pernix, 2018 U.S. Dist. LEXIS 96634, at *4-5. Then he drilled down on the language in the “PK-only” claims, pointing out that they involve administering an extended-release dosage form containing an active drug. Id. at *5. Because of this, the claims were eligible. This suggests that treatment claims reciting a pharmaceutical composition containing an active ingredient will guard against ineligibility.
The PTO, too, has weighed in on the impact of Vanda on how treatment claims should be evaluated for eligibility during prosecution. In a June 7, 2018 memoranda, the PTO reiterated that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible . . .; and (2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S.C. § 101.”
Although the outcomes of Vanda and Pernix suggest a positive trend for pharmaceutical patentees, they do not signal the end of eligibility challenges in this field. Indeed, Chief Judge Prost dissented in Vanda, disagreeing with the majority that those claims were not directed to ineligible subject matter. In the Chief Judge’s view, “the end result of the claimed process is no more than the conclusion of a natural law,” and “[t]he recitation of specific dosages adds no more than a conventional application of that natural law.” Vanda, 887 F.3d at 1143 (Prost, C.J., dissenting). Pharmaceutical patentees should continue to expect to see section 101 challenges, but at least now have some decisions deciding the eligibility issue in their favor, and tools to consider in drafting claims going forward.
Betsy Flanagan is a Principal in the Twin Cities office of Fish & Richardson. Her practice focuses on complex patent litigation, with an emphasis on life sciences, biotechnology and pharmaceutical litigation, including Hatch-Waxman litigation. Betsy has worked on a variety of...