Endo Pharms. Inc. v. Teva Pharms. USA, Inc.

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 court explained that the claims of the ’737 patent were similar to claims that it had recently upheld as patent-eligible in Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). At issue in Vanda were claims to a method of treatment of schizophrenia using a drug where the dose was adjusted based on whether the patient was a “CYP2D6 poor metabolizer.” Id. at 1121. The court explained that the ’737 claims and the Vanda claims both recited a method for treating a patient based on results of testing – in Vanda, genetic testing, and in the ’737 patent, kidney function testing. Additionally, both sets of claims required specific treatment steps.

The court further explained that, like the claims in Vanda, the ’737 patent claims were different from the ones at issue in Mayo. First, the Mayo claims were not directed to the application of a drug for treating a specific disease. Next, the administering step of Mayo was distinguishable from the “providing” step of the ’737 patent because it merely directed giving the drug to a patient with a certain disorder, whereas the ’737 directed administration of a specific dose based on the results of a kidney test. The court explained that, like in Vanda, the ’737 patent inventor recognized a relationship between oxymorphone and patients with renal disfunction – but that is not what he claimed. Instead, he claimed an application of that relationship, i.e., specific steps to adjust the dose for patients with renal impairment.

The court also stated that preemption was not a valid concern because the claims of the ’737 patent did not “tie up the doctor’s subsequent treatment decision.” The claims at issue in Mayo simply noted that the level of metabolite indicated a need to increase or decrease dosage without setting out a specific dosing regimen or steps to take as a result of the indication. By contrast, the ’737 claims set out specific treatment steps to be taken based test results.

The court then addressed Actavis’s arguments that the ’737 patent claims were distinguishable from the Vanda claims. First, Actavis argued that unlike the Vanda claims, the ’737 patent claims did not include any specific way that the biological sample should be obtained or assayed. The court stated that this was a “distinction without a difference” and that it was not enough to persuade the court that the claims should be treated differently than the Vanda claims.

Next, Actavis argued that the ’737 claims did not provide an amount or frequency of oxymorphone administration. The court disagreed, explaining that the “wherein” clause specified the dose and schedule of administration based on how much oxymorphone is in a patient’s system. Taken together, the administering step and the wherein clause made the claims as specific as the Vanda claims and specified more than just a recognition of the need to lower the dose of drug.

Finally, the court discussed the § 101 case law. The court explained that CellzDirect supported its decision because the claims in CellzDirect were directed to “a new and useful method of preserving hepatocyte cells,” not just an observation of the ability of hepatocytes to survive multiple freeze-thaw cycles. Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1046-48 (Fed. Cir. 2016). Similarly, the claims of the ’737 were directed, not just to observation, but to “a new and useful method of treating pain in patients with impaired renal function.” Next, the court discussed Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). In that case the court held that “where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are convention, routine and well understood applications in the art.” Id. at 1378. The court determined that claims at issue in Ariosa only directed doctors to apply conventional techniques to detect the natural phenomenon and were therefore ineligible. By contrast, the court explained that the ’737 patent claims were directed to more, i.e., a specific method of treatment based on recognition that patients with renal impairment have higher oxymorphone blood levels than healthy patients. The court held that Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019) was distinguishable for similar reasons.

Thus, the court reversed the district court’s judgment that the ’737 patent claims were ineligible under § 101.