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Persion Pharms. LLC v. Alvogen Malta Operations LTD.

United States Court of Appeals for the Federal Circuit

December 27, 2019, Decided

2018-2361

Opinion

 [*1186]  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 description2 and priority date and are directed [**2]  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 Zohydro 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 [**3]  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  [*1187]  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.

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945 F.3d 1184 *; 2019 U.S. App. LEXIS 38562 **; 2019 U.S.P.Q.2D (BNA) 494084; 2019 WL 7202668

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

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

Pernix Ir. Pain DAC v. Alvogen Malta Operations Ltd., 323 F. Supp. 3d 566, 2018 U.S. Dist. LEXIS 144226 (D. Del., Aug. 24, 2018)

Disposition: AFFIRMED.

CORE TERMS

district court, hepatic, impairment, patients, hydrocodone, pharmacokinetic, prior art, patentable, moderate, skill, mild, dose, asserted claim, written description, ordinary person, formulations, labels, objective indicia, hydrocodone-only, acetaminophen, argues, extended-release, clear error, combine, pain, administering, parameters, suffering, products, asserts

Patent Law, Nonobviousness, Evidence, Fact & Law Issues, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, De Novo Review, Elements & Tests