Docket No. 2017-1240, -1455, -1887
WALLACH, CLEVENGER, STOLL
March 28, 2019
Brief summary: DC dismissal under Rule 12(b)(6) for ineligibility under § 101 reversed since “the claims are directed to a patent-eligible method of using oxymorphone…to treat pain in a renally impaired patient”, similar to the claims in Vanda (FC 2018).
Summary: Endo appealed DC dismissal under Rule 12(b)(6) (failure to state a claim; in Actavis, Endo stipulated in Teva) finding the claims of US 8,808,737 directed to “providing” oxymorphone to “a renally impaired patient” (preamble), “measuring a creatine clearance rate…and determining it to be” within four claimed ranges, and “orally administering…a lower dose” of oxymorphone “depending on which creatine clearance rate is found” resulting in a 12-hr AUC of less than about 21 ng hr/mL to be patent ineligible under § 101. The DC (which adopted the magistrate judge’s recommendation) reasoned “that the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment” and did not “add enough to qualify as a patentable method that applies the law of nature” (Alice, US 2014 (steps one and two); Mayo, US 2012). The DC determined that “the ‘providing’ step is similar to the administering step in Mayo because it ‘merely identifies the specific drug for administration’”, “the measuring/determining step, like Mayo, ‘just directs one to use a well-known method to measure creatine levels to obtain the necessary information to apply a law of nature’”, and “the ‘administering step’ is indistinguishable from Mayo’” (e.g., administering step “simply limits the relevant audience to patients and prescribing physicians…utilizing the natural law to manage the dosage”). In addition, the DC concluded, “the claims are directed to the connection between the severity of renal impairment and the bioavailability of oxymorphone,’ or, in other words, the reaction of the human body of a renally impaired individual to oxymorphone, which is unquestionably a natural law.” The FC panel explained that “[t]o survive a motion to dismiss for failure to state a claim, a complaint must allege ‘enough facts to state a claim to relief that is plausible on its face’” (Bell Atl., US 2007), and that a DC’s determination under § 101 “is an issue of law, which we review de novo, and may contain underlying issues of fact” (Berkheimer, FC 2018). The FC panel disagreed with the DC’s § 101 eligibility determination, finding that “the claims are directed to a patent-eligible method of using oxymorphone…to treat pain in a renally impaired patient”, acknowledging in FN4 that the DC “did not have the benefit of considering Vanda” (FC 2018), Cellz Direct (FC 2016 (eligible claims to “a method of freezing hepatocytes”), and Natural Alt. (FC 2019; see also Ariosa, FC 2015 (ineligible “method for detecting paternally inherited cell-free fetal DNA”) and Athena, FC 2019 (“recite[d] a natural law and conventional means for detecting it”)). The FC panel wrote that it “held similar claims patent-eligible in Vanda” (treating schizophrenia with iloperidone “adjusted based on whether or not the patient is a ‘CYP2D6 poor metabolizer’”) since “[b]oth claims recited a method for treating a patient”, “require specific treatment steps”, and “differ from those in Mayo” since “as a whole was not directed to the application of a drug to treat a particular disease” (e.g., “the inventor here recognized the relationship between oxymorphone and patients with renal impairment, but that is not what he claimed”, “the claims here do not” “tie up the doctor’s subsequent treatment decision”).