Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd.

Case Name: Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., Civ. No. 16-139-WCB, 2018 U.S. Dist. LEXIS 81419 (D. Del. May 15, 2018) (Bryson, C.J.)

Drug Product and Patent(s)-in-Suit: Zohydro® (hydrocodone bitartrate); U.S Patents Nos. 9,265,760 (“the ’760 patent”) and 9,339,499 (“the ’499 patent”)  

Nature of Case and Issue(s) Presented: At issue were two patents claiming methods of treating pain in patients with hepatic impairment (i.e., compromised liver function). Because the liver was primarily responsible for metabolizing opioids, patients with hepatic impairment were often prescribed reduced dosages of opioids in order to avoid the build-up of unsafe levels in the bloodstream. The patented inventions encompassed formulations of extended release-hydrocodone that had release profiles that were similar for both healthy and hepatically impaired patients. The court denied Pernix’s motion for summary judgment of infringement, denied Alvogen’s motion for summary judgment of invalidity based on anticipation, and granted Pernix’s motion for summary judgment of patent eligibility.

Why Pernix Prevailed: Pernix’s summary-judgment of infringement. Pernix advanced two theories of direct infringement: (i) single-party direct infringement by the patient alone; and (ii) joint direct infringement by the physician and the patient. As to the former, the court granted Alvogen’s motion to strike because Plaintiff had failed to advance the “patient only” theory in its infringement contentions and expert reports. As to the latter, the court held that the issue presented an issue of fact for trial that could not be resolved on summary judgment. More particularly, the court agreed that there was no evidence that physicians will “condition” continued treatment on the patients’ administering the ANDA product as prescribed, and, without more, it was not clear that Alvogen’s label would induce hepatically impaired patients to use the ANDA product for the treatment of pain.

Alvogen’s summary-judgment motion for invalidity based on anticipation. As to Alvogen’s first reference—Huang—the court concluded that it was unclear whether it even qualified as prior art because there was a fact question as to whether the inventors reduced to practice prior to the publication of Huang. As to Alvogen’s second reference—Devane—the court explained that it was not possible to determine whether Devane inherently disclosed either treating hepatically impaired individuals for pain, or administering an extended release hydrocodone composition to patients with mild to moderate hepatic impairment without adjusting the starting dose relative to patients without hepatic impairment. In support, the court noted that Devane dosed healthy, not hepatically impaired, patients.

Pernix’s summary-judgment motion for patent eligibility. Alvogen argued that the patents-in-suit were ineligible for protection under § 101 because they were premised on the relationship between hepatic impairment and bioavailability after administration of extended-release hydrocodone. The court agreed that the inventions were based on a natural law—the physiological response to hydrocodone in an individual with or without mild to moderate hepatic impairment—but concluded that the claims did more than merely report those physiological responses. The claims described a specific dosing regimen to treat a specific condition based on the patient’s medical status.