The third treatment method case in the last year that was challenged as patent-ineligible subject matter under 35 U.S.C. §101 has been found eligible by the Court of Appeals for the Federal Circuit, in a recent case, Endo Pharms. Inc. v. Teva Pharms. USA, Inc.,[1] decided March 28, 2019.
Endo owns U.S. Patent No. 8,808,737 (‘737), entitled “Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment.” The claims are directed to a personalized treatment method of using oxymorphone to treat patients with impaired kidney function. The improvement stated in the specification is the pharmacokinetics of oxymorphone treatment for pain in renal patients differed than with other patients; as such, the claimed invention is directed to that method of providing pain treatment for renal patients notwithstanding their impaired renal functions.
Claim 1 of the ‘737 patent recites:
1. A method of treating pain in a renally impaired patient, comprising the steps of:
a. providing a solid oral controlled release dosage form, comprising:
i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and
ii. a controlled release matrix;
b. measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 mL/min; and
c. orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;
wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 ng·hr/mL.
Endo sued Actavis for patent infringement of the ‘737 patent. Actavis then moved to dismiss for lack of patent-eligibility under §101, which was granted by the district court. The district court noted that that the “administering” step of Claim 1 of the ‘737 patent was “indistinguishable” from Mayo, and therefore, was merely a process to use natural law to manage a particular dosage.[2] Endo appealed.
The Fed Circuit panel was composed of Judges Wallach, Clevenger, and Stoll, with Judge Stoll writing for a unanimous court.
Judge Stoll opened:
[W]e conclude that the asserted claims are not directed to patent-ineligible subject matter. On the contrary, the claims are directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient. Our conclusion is supported by the claim language itself and confirmed by the specification. The claims recite “a method of treating pain in a renally impaired patient.” Claim 1 also requires specific steps: (a) providing a pharmaceutical [], (b) testing the patient for a disease state [], and then (c) administering the pharmaceutical [] based on the creatinine clearance rate to achieve an average AUC of oxymorphone over a 12-hour period of less than 21 ng hr/mL.
She drew quick comparison with the recently-decided Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd.,[3] case decided in 2018. The Vanda claims-at-issue were directed to a method of treating schizophrenia patients with a personalized dosage of iloperidone based on that patient’s poor metabolizing of a particular enzyme (C7P2D6). Similarly, she noted, the Endo claims here are indistinguishable with the Vanda claims. The Endo claims recite specific steps to carry out a particularized dosage regimen based on renal function of that particular patient. In other words, both Vanda and Endo focus on the specific, particular treatment steps required to treat a specific problem:
Like the claims in Vanda, 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.”
This case is the third recent treatment method case which were found patent-eligible by the Fed Circuit, following Vanda Pharms., and Natural Alts. Int’l, Inc. v. Creative Compounds, LLC decided this past March.[4] The Fed Circuit is drawing hard lines determining that methods of treatment (e.g., preamble reciting “method for treating [illness]”) fall within patent-eligible under §101, as opposed to the abstract idea claims in Mayo, where the U.S. Supreme Court found ineligible (e.g., preamble reciting “method for optimizing efficacy”).[5] This is promising for pharmaceutical and drug therapy companies seeking to protect their research investments by providing a level of predictability in the patenting process.
[1] ___F.3d___ (Fed. Circ. 2019) (slip op.), reversing Endo Pharms. Inc. v. Actavis Inc., 2015 WL 7253674 (D. Del. Nov. 17, 2015).
[2] See Mayo Collaborative Servs. v. Prometheus Labs, Inc., 566 U.S. 66, 78 (2012).
[3] 887 F.3d 1117 (Fed. Cir. 2018).
[4] ___F.3d___ (Fed. Cir. 2019) (slip op.).
[5] 566 U.S. 66, 132 S. Ct. 1289, 1297-99 (2012).