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Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.

United States Court of Appeals, Federal Circuit

December 27, 2019

PERSION PHARMACEUTICALS LLC, Plaintiff-Appellant
v.
ALVOGEN MALTA OPERATIONS LTD., Defendant-Appellee

          Appeal from the United States District Court for the District of Delaware in No. 1:16-cv-00139-WCB, Circuit Judge William C. Bryson.

          Dominick A. Conde, Venable LLP, New York, NY, argued for plaintiff-appellant. Also represented by Christopher P. Borello, Joshua Daniel Calabro, Zachary Garrett.

          Chad A. Landmon, Axinn Veltrop Harkrider, LLP, Hartford, CT, argued for defendant-appellee. Also represented by Matthew Becker, Thomas K. Hedemann, David Keeler Ludwig, Edward M. Mathias; Christopher Michael Gallo, Washington, DC.

          Before O'Malley, Reyna, and Chen, Circuit Judges.

          REYNA, CIRCUIT JUDGE

         Persion Pharmaceuticals LLC appeals from a decision of the U.S. District Court for the District of Delaware finding the asserted claims of U.S. Patent Nos. 9, 265, 760 and 9, 339, 499 invalid as obvious and lacking adequate written description. Because we find no reversible error in the district court's obviousness determination, we affirm on that basis and do not reach the written description issue.

         Background

         I. The Asserted Patents

         Persion Pharmaceuticals LLC ("Persion")[1] owns U.S. Patent Nos. 9, 265, 760 ("the '760 patent") and 9, 339, 499 ("the '499 patent"), both entitled "Treating Pain in Patients with Hepatic Impairment." Both patents share a common written description[2] and priority date and are directed to methods of treating pain in patients with mild or moderate hepatic impairment using extended-release hydrocodone-only formulations. Hepatic impairment is compromised liver functionality.

         Hydrocodone is an opioid that is widely used to treat pain and has been FDA approved since 1943. It is marketed in both extended-release and immediate-release formulations and is often combined with other active ingredients. Like many opioids, hydrocodone is primarily metabolized in the human liver. If liver function is impaired, metabolism of opioids is slowed. Thus, the same dose of hydrocodone may pose a higher risk of overdose in a patient with hepatic impairment than in a healthy patient due to potential build-up of the drug in the patient's bloodstream.

         The '760 and '499 patents cover the formulation for Zo-hydro ER, Persion's extended-release hydrocodone-only drug product. When Zohydro ER's prior owner sought approval to market the drug from the U.S. Food and Drug Administration ("FDA"), the FDA required the owner to conduct a clinical study to determine the potential effect of the drug on patients with hepatic impairment. The study showed that use of Zohydro ER did not result in substantially higher concentrations of hydrocodone in the bloodstream of subjects with mild and moderate hepatic impairment than in subjects without hepatic impairment.

         Following this study, the researchers filed patent applications directed to their discovery, which later issued as the '760 and '499 patents. Example 8 of the patents describes the Zohydro ER clinical study and its results. Id. col. 22 l. 52-col. 23 l. 48. However, the patent claims are not limited to the use of the Zohydro ER formulation but instead cover methods of using any extended-release formulation with "hydrocodone bitartrate as the only active ingredient" to treat pain in patients with mild or moderate hepatic impairment.[3] '760 patent col. 24 ll. 1-5, col. 25 ll. 13-17, '499 patent col. 24 ll. 1-5, col. 26 ll. 9-13.

         The relevant claims of the '760 and '499 patents can generally be grouped into two sets: the "non-adjustment" claims and the "pharmacokinetic" claims. The non-adjustment claims are directed to administering a starting dose of hydrocodone to a patient having mild or moderate hepatic impairment without adjusting the dose relative to a patient with a healthy liver. Independent claim 1 of the '760 patent is representative of the non-adjustment claims, and recites:

1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.

'760 patent col. 23 l. 66-col. 24 l. 7.

         The pharmacokinetic claims recite pharmacokinetic parameters either as absolute values or in relation to values in a healthy patient. Independent claim 12 of the '760 patent is representative of the pharmacokinetic claims, and recites:

12. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate,
wherein the dosage unit provides a release profile of hydrocodone that:
(1) does not increase average hydrocodone AUC0-inf in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%;
(2) does not increase average hydrocodone AUC0-inf in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic ...

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