March 28, 2019
Case Name: Endo Pharms. Inc. v. Teva Pharms. USA, Inc., C.A. No. 17-1240, 1455, 1887, 2019 U.S. App. LEXIS 9189 (Fed. Cir. Mar. 28, 2019)
Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone hydrochloride); U.S. Pat. No. 8,808,737
Nature of the Case and Issue(s) Presented: The Federal Circuit reversed the district court’s holding that the claims of the ’737 patent were ineligible under 35 U.S.C. § 101.
Why Endo Prevailed: The Federal Circuit held that the district court incorrectly concluded that the claims at issue were directed to a natural law, and therefore reversed.
The ’737 patent covers a method of treating pain in patients with impaired kidney function. The inventor of the ’737 patent discovered that patients with renal impairment need less oxymorphone than usual to manage their pain. This is because a patient with renal impairment has higher blood levels of oxymorphone than a healthy patient receiving the same dose. The inventor therefore developed a new method of using oxymorphone to treat patients with renal impairment, and claimed the method in the ’737 patent. Claim 1 of the ’737 patent is representative:
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.
In the district court, Actavis moved to dismiss Endo’s infringement claims for the ’737 patent on the basis that the claims were ineligible under § 101. The magistrate judge concluded that the claims were directed to the natural law that “the bioavailability of oxymorphone is increased in people with severe liver impairment.” Further, the magistrate judge reasoned that the “providing” step was similar to the administering step in Mayo because it “merely identifies the specific drug for administration.” Mayo Collaborative Servs. v. PrometheusLabs., Inc., 566 U.S. 66 (2012). The magistrate judge concluded that the measuring/determining step directed use of a well-known measurement method to obtain the information necessary to apply the natural law. Finally, the magistrate judge concluded that the “administering step” merely instructed physicians to utilize the natural law in managing the dose of oxymorphone. The magistrate judge therefore recommended that the district court grant the motion to dismiss based on a finding of patent ineligibility. The district court adopted the magistrate judge’s recommendation and granted Actavis’s motion. After the dismissal in the Actavis case, Endo stipulated that the ’737 patent claims were ineligible, subject to appeal, in the Teva case. Endo appealed.
The Federal Circuit began by stating that it must apply a two-part test in determining subject matter eligibility under § 101. First, it must determine “whether the claims at issue are directed to one of those patent-ineligible concepts.” (quoting Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208, 217-18 (2014)). The court explained that if the answer to step one was no, it need not address step two. The court determined that the asserted claims were not directed to patent-ineligible subject matter, but that the claims were directed to a “patent-eligible method of using oxymorphone . . . to treat pain in a renally impaired patient.”
The...
