In Endo Pharmaceuticals Inc., v. Teva Pharmaceuticals USA, Inc., [ 2017-1240, 2017-1455, 2017-1887](March 28, 2019), the Federal Circuit reversed the district court’s determination that the claims of U.S. Patent No. 8,808,737 ineligible under 35 U.S.C. § 101.
The ’737 patent, entitled “Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment” covers a method of using oxymorphone to treat pain in patients with impaired kidney function. The method adjusted the level of oxymorphone administered based upon the severity of the renal impairment.
The magistrate judge first analyzed step 1 of the Alice/Mayo test, reasoning that the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment. The district court adopted the magistrate judge’s recommendation, finding the patent claims ineligible.
At step one of the Alice/Mayo, the Federal Circuit said “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Applying this law, the Federal Circuit concluded that the asserted claims are not directed to patent-ineligible subject matter. On the contrary, the Federal Circuit found that the claims were directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient. This conclusion was supported by the claim language itself and confirmed by the specification, the claims, the abstract, patent title, and summary of the invention all describe the invention as a “method of treating pain” in patients with renal impairment.
The claims at issue here are legally indistinguishable from the representative claim in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018). Both claims recite a method for treating a patient. The Vanda patent claims recite the steps of carrying out a dosage regimen based on the results of genetic testing, while in the instant case the claims similarly recite the steps of carrying out a dosage regimen, though the steps are based on the results of kidney function testing. Additionally, the claims in both cases require specific treatment steps.
The Federal Circuit distinguished Mayo in part because the claims as a whole were not directed to the application of a drug to treat a particular disease. The Federal Circuit noted that the inventor here recognized the relationship between oxymorphone and patients with renal impairment, but that is not what he claimed. Rather, he claimed an application of that relationship—specifically, a method of treatment including specific steps to adjust or lower the oxymorphone dose for patients with renal impairment. The claims are thus directed to more than just reciting the natural relationship.
The Federal Circuit concluded that the ’737 patent claims are like those in Vanda. They are eligible because they are “directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Finding “[o]ur precedent leaves no room for a different outcome.”