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Purdue Pharm. Prods. L.P. v. Actavis Elizabeth LLC

United States District Court for the District of New Jersey

March 27, 2015, Decided; August 25, 2015, Filed

Civil Action No. 12-5311 (JLL) (JAD)

Opinion

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LINARES, District Judge.

This case involves the issues of infringement and validity of three patents covering Plaintiffs' product Intermezzo®. Intermezzo® is a drug manufactured for the treatment of insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep. After careful consideration of the evidence presented at a bench trial held December 1 -15, 2014, the Court finds as follows: As to the '131 patent, Defendants have met their burden of proving this patent is invalid as obvious, but failed to prove that the claim element "without residual sedative effects" is invalid as indefinite. Plaintiffs have proved by [*3]  a preponderance of the evidence that the asserted claims of the '131 patent are infringed by all Defendants. As to the '628 patent, Plaintiffs have failed to meet their burden of proving infringement as to Defendants, DRL and Actavis. Plaintiffs, however, have met their burden of proving that Novel infringes the '628 patent. While Defendants have failed to prove this patent is invalid as anticipated, the '628 patent is invalid as obvious. As to the '809 patent, Plaintiffs have met their burden of proving infringement as to Defendants, DRL and Novel. Defendants, on the other hand, have proved by clear and convincing evidence that the '809 patent is obvious and therefore invalid. This Opinion articulates the basis for each of these conclusions.

INTRODUCTION

This is an infringement action brought by Plaintiffs relating to the patents covering Intermezzo®. This action was commenced as a result of Defendants each filing an Abbreviated New Drug Application ("ANDA") pursuant to the Hatch-Waxman Act, seeking FDA approval to sell a generic version of Intermezzo® prior to the expiration of the relevant patents. This Court has subject matter jurisdiction over this action under 28 U.S.C. §§ 1331 and 1338(a). No party contests personal jurisdiction or venue for the purposes of this civil [*4]  action.

BACKGROUND1

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2015 U.S. Dist. LEXIS 112253 *

PURDUE PHARMACEUTICAL PRODUCTS L.P. et al., Plaintiffs, v. ACTAVIS ELIZABETH LLC, et al., Defendants.

Notice: NOT FOR PUBLICATION

Prior History: Purdue Pharm. Prods., L.P. v. Actavis Elizabeth, LLC, 2014 U.S. Dist. LEXIS 49857 (D.N.J., Apr. 9, 2014)

CORE TERMS

zolpidem, dose, infringement, sleep, insomnia, residual, buffer, patient, sedative, patent, pharmaceutical, transmucosal, delivery, Novel, night, composition, driving, invention, tartrate, label, concentration, plasma, saliva, hypnotic, tablet, dosage, comprising, minutes, vivo, waking