919 F.3d 1347
Fed. Cir.2019Background
- Endo owns U.S. Pat. No. 8,808,737 claiming a method of treating pain in patients with renal impairment by using oral controlled‑release oxymorphone (5–80 mg) and adjusting dose based on measured creatinine clearance to achieve an average 12‑hour AUC < ~21 ng·hr/mL.
- Inventor discovered a correlation between renal impairment (creatinine clearance) and oxymorphone plasma AUC: patients with moderate/severe impairment show substantially higher AUCs, necessitating lower doses.
- Representative claim 1 recites: (a) providing a specified controlled‑release oxymorphone formulation, (b) measuring creatinine clearance and categorizing impairment, and (c) orally administering a lower dosage depending on category, with a wherein clause limiting post‑dose average AUC.
- Actavis and Teva moved to dismiss for patent‑ineligible subject matter under 35 U.S.C. § 101; the magistrate and district court held the claims ineligible as directed to a natural law (the relationship between renal impairment and oxymorphone bioavailability) and dismissed.
- On appeal the Federal Circuit reviewed eligibility under the Alice/Mayo framework (step one only), analyzed claim language and specification, and compared the claims to precedent (notably Vanda), concluding the claims are directed to a specific treatment method and are patent‑eligible.
Issues
| Issue | Endo's Argument | Actavis/Teva's Argument | Held |
|---|---|---|---|
| Whether claims of the ’737 patent are directed to patent‑ineligible subject matter under 35 U.S.C. § 101 (Alice/Mayo step one) | Claims are directed to a specific method of treating renally impaired patients using a particular drug, testing, and dosing steps to achieve a concrete pharmacokinetic outcome (AUC < ~21) — thus an application, not a law of nature | Claims merely recite the natural correlation between renal impairment and oxymorphone bioavailability and add routine steps (provide drug, measure creatinine, administer) akin to Mayo, thereby claiming a natural law | Reversed: claims are directed to a patent‑eligible method of treatment — a specific dosing regimen tied to testing and a pharmacokinetic target, like claims upheld in Vanda |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (Sup. Ct.) (established two‑step framework for § 101 and held claims tying metabolite levels to dosing were patent‑ineligible)
- Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (Sup. Ct.) (clarified Mayo test and directed‑to inquiry)
- Diamond v. Diehr, 450 U.S. 175 (Sup. Ct.) (recognized implicit exception for laws of nature but upheld applications of such laws)
- Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir.) (step one: claims not directed to abstract idea where they are specific improvements)
- Vanda Pharm. Inc. v. West‑Ward Pharm. Int'l Ltd., 887 F.3d 1117 (Fed. Cir.) (upheld method‑of‑treatment claims that adjust dosing based on genetic testing)
- CellzDirect, Inc. v. Trophy Skin, Inc., 827 F.3d 1042 (Fed. Cir.) (upheld method claims that produce a new, useful preparation despite relying on natural properties)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir.) (held claims directed to natural phenomenon and relying on routine techniques were ineligible)
- Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir.) (distinguished detection claims from treatment claims; detection of natural cause with conventional means can be ineligible)