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Endo v. Teva

Representative Claim(s)

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.

Posture:

Appeal from decision of the District Court

Exception Category: None

“… 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.”

“The specification predominantly describes the invention as a method that treats renally impaired pain patients with less oxymorphone while still treating their pain. Indeed, the specification explains that the method ‘avoid[s] possible issues in dosing’ and allows for treatment with ‘the lowest available dose’ for patients with renal impairment.”

The Court found the claims to be legally indistinguishable from the claims held to be eligible in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018), which recited a method of treating schizophrenia with iloperidone, where administration is adjusted based on whether or not the patient is a “CYP2D6 poor metabolizer.”

“Also like the claims in Vanda, the claims here differ from those in Mayo in material respects. Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease. [Citation omitted.] Furthermore, the administering step in Mayo is distinguishable from the administering step in the ’737 patent because the administering step in Mayo is the first step in the method that simply describes giving the drug to a patient with a certain disorder. By contrast, the administering step in the ’737 patent is the step that describes giving a specific dose of the drug based on the results of kidney function testing. … In Vanda, the inventors recognized the relationship between iloperidone dosage and the patient’s CYP2D6 poor metabolizer genotype, but that was not what they claimed. Similarly, 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.”

Significantly More: Not Decided

N/A