Judge Andrews Adopts Report and Recommendation Invalidating Patent on Section 101 Grounds
December 1, 2015
Publication| Intellectual Property
In Endo Pharmaceuticals Inc. v. Actavis Inc., C.A. No. 14-1381-RGA (D. Del. Nov. 17, 2015), Judge Andrews overruled objections to a report and recommendation concluding that the patent-in-suit should be found invalid due to lack of patent-eligible subject matter. The patent was directed to a method for treating renally impaired patients with a dosage of oxymorphone. The magistrate judge, likening the claims of the patent-in-suit with those at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), had concluded in the report and recommendation that the patient-in-suit stated a law of nature (the effect of a compound on a person with renal impairment) and simply instructed doctors how to apply the law when treating patients. According to the plaintiffs, the patent-in-suit was “directed to a new and useful process (the altered treatment regimen) that provides a practical, tangible benefit (relief of pain) in a particular patient population,” and the claims differed from those at issue in Mayo because the patent-in-suit required the doctor to “act or apply the method in a tangible way.”
Judge Andrews found that the patent-in-suit did not satisfy Mayo’s “inventive concept” requirement, noting that both the specification of the patent as well as the plaintiffs’ briefing acknowledged that the claims were directed to the natural law that “the bioavailability [of the compound covered by the patent-in-suit] is increased in patients with renal impairment.” Thus, Judge Andrews concluded that the subject matter of the patent-in-suit merely covered the natural law of how a renal-impaired individual would react to the pharmaceutical compound, and declared the patent to invalid under Section 101. Judge Andrews also agreed with the magistrate judge that the patent-in-suit was analogous to the patents in Mayo, finding that the differences between the two patents (the “need” to increase or decrease a drug versus directing the doctor to “orally administer” the drug) were immaterial.
Analysis: This is just one in a continuing line of cases invalidating patents on 35 U.S.C. § 101 grounds in the wake of Mayo and Alice in the District of Delaware, including pharmaceutical patents.