The Disctrict Court for the District of Delaware in Endo Pharmaceuticals Inc. v. Actavis Ind (D. Del. 2015) casts doubt as to whether the 2011 Federal Circuit case of Classen discussed earlier in this Blog has any precedential value in light of Mayo. In particular, the Court dismissed the argument that a mandatory application step is sufficiently transformative so as to save claims which are otherwise unpatentable under 35 USC 101. As stated in Mayo, one must do more than simply state the law of nature while adding the words “apply it”.
The claims in issue had a step (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”
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 ot about 80 mg of oxymorphone or a pharmaceutically acceptable sale 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 aobut 30 m [L]/min, (b) aobut 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 adminsitering to said patient, in dependence on which creatnine 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.