Federal Circuit Doubles-Down on Vanda, Highlighting Limitations of § 101 Defense

Last week, the Federal Circuit reversed a decision from the District of Delaware that held that a method of treatment patent invalid under 35 U.S.C. § 101.  Endo Pharms. Inc. et al. v. Teva Pharms. USA et al. The claim at issue recited:

  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.

The district court held this claim was invalid under 35 U.S.C. § 101 because the claims were directed to “the connection between the severity of renal impairment and the bioavailability of oxymorphone,’ or, in other words, the reaction of the human body of a renally impaired individual to oxymorphone, which is unquestionably a natural law.”  The district court analogized the patent claims to the representative claim the Supreme Court held invalid in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).

The Federal Circuit disagreed, distinguishing the claim in Mayo by stating that “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.”  More specifically, the Federal Circuit distinguished the administering step of relevant claim from the one in Mayo by stating the step in Mayo “simply describes giving the drug to a patient with a certain disorder,” while the step in the claim at issue “describes giving a specific dose of the drug based on the results of kidney functioning testing.”

The Federal Circuit’s decision in this case relied heavily on its previous decision in Vanda Pharms Inc. v. West-Ward Pharms. Int’l Ltd. which dealt with a similar patent claim as the one listed above.  Petition for a writ of certiorari was filed in that case, and the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States.  Therefore, the Supreme Court may well hear the case and provide new guidance regarding whether the Federal Circuit’s decisions since Mayo have correctly applied the Supreme Court’s decisions.

Until the Supreme Court does weigh in, however, the Federal Circuit has limited the strength of 35 U.S.C. § 101 defenses for method of treatment claims requiring the administration of a drug at a specified dose.