In 2009, I filed an amici brief on behalf of myself and several other law professors in Prometheus v. Mayo, which was the first time the Federal Circuit heard the case. In the decision below, the district court held that the interaction of a synthetic, non-naturally occurring pharmaceutical compound with the human body is a “natural phenomenon.” In our brief, we basically argued that the interaction of a synthetic compound with the human body is not a natural phenomenon, but that if the definition of “natural phenomena” is interpreted so broadly as to encompass the interaction of human-made drugs with the human body, then by implication drug method of treatment claims seemed vulnerable to invalidation under 101 for encompassing patent ineligible subject matter.
Nonetheless, the Federal Circuit and the Supreme Court invalidated the Prometheus claims based on an assumption that the interaction of the pharmaceutical agent (the metabolic breakdown product of a drug) with the human body is a natural phenomenon. In the Supreme Court’s decision, Mayo v. Prometheus, Justice Breyer seemed cognizant of this concern, and affirmatively stated that drug method of treatment claims should not be threatened by the holding in Mayo. Still, I have continued to wonder how secure drug method of use claims are post-Mayo, particularly given the expansive interpretation of the Mayo/Alice by the district court’s and the Federal Circuit in decisions such as Ariosa (discussed in a previous post).
Thus, it came as no surprise when I saw a September 23, 2015 Report and Recommendation from a magistrate judge in the District of Delaware recommending invalidation of a drug method of treatment patent for patent ineligibility on a motion to dismiss under Rule 12(b)(6). The case, Endo Pharmaceuticals v. Actavis, is an ANDA litigation brought by Endo Pharmaceuticals against Actavis in connection with a Generic Oxymorphone ER Tablets. The Report and Recommendation is available here.
The patent is US Patent Number 8,871,779, and representatives of claim one recites:
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 nghr/mL.
The magistrate judge applied the Mayo/Alice two-part test for patent eligibility. The first step is to determine whether the claims at issue are “directed to a patent-eligible concept,” in this case a natural law. The magistrate judge notes that the “Mayo court provided a broad definition for a law of nature: ‘[a] patent that… describes a relationship that is the consequence of entirely natural processes sets forth a natural law.’” The judge went on to conclude that “the connection between the severity of renal impairment and the bioavailability of oxymorphone” was the relevant natural law to which the claims are directed.
The second step is to determine whether the claims “add enough” to the “natural law” to render the claim patent eligible. The magistrate judge essentially determined that the “providing,” “measuring,” and “administering” steps were analogous to the steps in the claims held to be patent ineligible in Mayo, and thus did not provide “enough” extra.
The claims at issue in Mayo essentially recited a method of performing a diagnostic test and determining the optimal dosage of drug for a patient. The claim did not recite a step of actually administering the optimized dosage to a patient, and many have held out the hope that in the future a claim that included this additional step of actually applying the information derived from the diagnostic test would be found patent eligible.
But note that Endo’s claim does expressly recite administering a lower dosage of drug to a patient based on the results of the diagnostic test, i.e., the claim does include the extra step that many thought would have rendered the claims in Mayo patent ineligible. But, at least in the view of this magistrate judge, the inclusion of this extra step was not sufficient to render the claim patent eligible. And given the sweeping language of Mayo, particularly as interpreted by the Federal Circuit in Ariosa, it is not hard to see how the magistrate judge came to this conclusion.
It is important to note that the Endo claim is not a straightforward method of treatment claim, i.e., “a method of treating disease X by administering drug Y,” and does not necessarily indicate that the magistrate judge would have ruled such a claim patent ineligible. The decision does explicitly note that “oxymorphone is ‘widely used’ for acute and chronic pain relief, the showing that the utilization of oxymorphone is not the invention.” Thus, the magistrate judge seemed to imply that in a case where the “invention” is the discovery of a new pharmaceutical agent for the treatment of some medical condition a method of treatment claim could still be patent eligible under Mayo.
It seems inevitable that before long we will be seeing a decision involving an allegation that a more conventional method of treatment claim is patent ineligible. It will be interesting to see how the courts handle that case, and also how the district court judge in Endo v. Actavis (and perhaps the Federal Circuit eventually) responds to the magistrate judge’s recommendation.