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Biotech / Medical : Avadel AVDL

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From: Paul Lee6/2/2016 11:00:23 AM
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Jazz Makes Deal In Xyrem IP Fight With Ranbaxy, Sun, Ohm By Kevin Penton


Law360, New York (May 13, 2016, 9:52 PM ET) -- Jazz Pharmaceuticals Inc. has agreed to drop its claims against generic-drug makers Ranbaxy, Sun and Ohm in a patent infringement case involving the narcolepsy drug Xyrem after the companies resolved their differences and struck a licensing agreement, the company told a New Jersey federal judge Thursday.

Ranbaxy Inc., Sun Pharmaceutical Industries Ltd. and Ohm Laboratories Inc. stipulated as part of the proposed order sent to U.S. District Judge Esther Salas that the abbreviated new drug applications they filed for a proposed generic version of Xyrem was a technical act of infringement of each of the asserted patents in the case and that their manufacturing and sales of the proposed generic would also infringe. The filing did not give details of the agreement.

Other than what the May 9 licensing deal allows, Ranbaxy, Sun and Ohm agreed not to manufacture or to sell the generic drug during the life of the patents, according to the letter.

Counsel for the parties could not be reached for comment on Friday.

Jazz began suing Ranbaxy and other drugmakers in 2013, alleging that their planned generic versions of Xyrem would infringe several of its patents, including those covering the composition of the drug and the method of distributing it. Other defendants include Amneal Pharmaceuticals, Par Pharmaceutical Inc. and Watson Laboratories Inc.

The suits came in response to ANDAs filed by each of the defendants seeking approval to commercially market a generic version of Xyrem before the expiration of various patents held by Jazz concerning the drug, which is used to treat daytime sleepiness and muscle weakness in narcolepsy patients.

The active ingredient in Xyrem is GHB, an intoxicant that the U.S. Drug Enforcement Agency has labeled a date-rape drug. Because of the risk of abuse, Xyrem is only available through one central pharmacy to patients who undergo special training on how to use it.

Several of the generics makers have alleged that the patents are invalid, saying they claim only the abstract idea of controlling access to a prescription drug to guard against potential abuse.

U.S. Magistrate Judge Joseph A. Dickson consolidated five related complaints in January.

Jazz is represented by Charles M. Lizza, William C. Baton and Sarah A. Sullivan of Saul Ewing LLP and Frank C. Calvosa, Brian J. Forsatz and Catherine T. Mattes of Quinn Emmanuel Urquhart & Sullivan LLP.

Ranbaxy, Sun and Ohm are represented by Karen A. Confoy, Christopher R. Kinkade and Kai W. Marshall-Otto of Fox Rothschild LLP and William Zimmerman, Carol Pitzel Cruz, Ben Anger, Karen Cassidy, and Christie Matthaei of Knobbe Martens Olson & Bear LLP.

The case is Jazz Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC et al., case number 2:13-cv-00391, in the U.S. District Court for the District of New Jersey.

--Additional reporting by Alex Wolf. Editing by Brian Baresch.
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