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Endo Pharmaceuticals, Inc. v. Actavis, Inc.

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 m[L]/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 nghr/mL.

Posture:

Motion to Dismiss

Exception Category: Law of Nature

“The [claims] cover the natural law that the ‘bioavailability of oxymorphone is increased in people with impaired kidney function.’”

“The ’737 Patent, however, explains that oxymorphone is ‘widely used’ for acute and chronic pain relief, thus showing that the utilization of oxymorphone is not the invention.”

“Therefore, the connection between the severity of renal impairment and the bioavailability of oxymorphone, which the ‘737 Patent sets forth in detail, is the subject matter of the invention.”

Significantly More: No

“The providing step is insufficient to make the claim patentable because it simply informs patients and prescribing physicians of the relevant drug to be administered.”

“The measuring/determining step…only instructs the physician to measure the patient’s creatinine level to determine the level of renal impairment using a previously recognized method.”

“[A]nalyzing claim 1 as a whole, the steps in combination do not transform the natural law into a patentable application of that law.”

“The administering step merely instructs physicians to dispense oxymorphone for the treatment of pain in a well-known manner, while utilizing the natural law to manage the dosage.”

The court also noted a preemption issue, stating: “A patent covering the application of a well-known natural law [this] broadly clearly restricts further advancement in this area of treatment.”