`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Sheila Raftery Wiggins
`DUANE MoRRIs LLP
`One Riverfront Plaza
`1037 Raymond Blvd., Suite 1800
`Newark, NJ 07 102-5429
`(973) 424-2000
`srwiggins@duanemorris.com
`
`Attorneysfor Plaintffs
`Jazz Pharmaceuticals, Inc.
`and Jazz Pharmaceuticals Ireland Limited
`
`Attorneysfor Defendant-Counterclaimants
`Wockhardt Bio AG, Wockhardt USA LLC, and
`Wockhardt Ltd.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No. 13-39 1 (ES)(JAD)
`(consolidated)
`
`(Filed Electronically)
`
`Civil Action No. 16-99 (ES)(JAD)
`
`(Filed Electronically)
`
`))))))))))))))))))))))))))))
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`Plaintiffs,
`
`V.
`
`AMNEAL PHARMACEUTICALS, LLC, et
`al.,
`
`Defendants.
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`Plaintiffs,
`
`V.
`
`WOCKHARDT BlO AG, WOCKHARDT
`LIMITED, and WOCKHARDT USA LLC,
`
`Defendants.
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 271 Filed 04/25/16 Page 2 of 5 PageID: 5019
`
`STIPULATION AND ORDER OF DISMISSAL
`
`The Court, upon the consent and request of Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz
`
`Pharmaceuticals Ireland Limited (collectively, “Jazz”) and Defendants Wockhardt Bio AG,
`
`Wockhardt Limited and Wockhardt USA LLC (collectively, “Wockhardt”), hereby enter into the
`
`record the following Stipulated Facts and issues the following Order of Dismissal:
`
`STIPULATED FACTS
`
`1.
`
`This Court has subject matter jurisdiction over these patent infringement actions
`
`(the “Actions”). This Court has personal jurisdiction over Jazz and Wockhardt, and venue is
`
`proper in this Court.
`
`2.
`
`In these Actions, Jazz has charged Wockhardt with infringement of certain claims
`
`of United States Patent Nos. 6,472,431, 6,780,889, 7,262,219, 7,851,506, 8,263,650, 8,324,275,
`
`8,461,203, 7,668,730, 7,765,106, 7,765,107, 7,895,059, 8,457,988, 8,589,182, 8,731,963,
`
`8,772,306, 8,859,619, 8,952,062, and 9,050,302 (“the Asserted Patents”) in connection with
`
`Wockhardt’s submission of Abbreviated New Drug Application (“ANDA”) No. 207526, directed
`
`to a generic 500 mg/mL sodium oxybate oral solution product for the treatment of cataplexy and
`
`excessive daytime sleepiness in narcolepsy (hereinafter, the “Generic Product”), to the U.S. Food
`
`and Drug Administration (“FDA”).
`
`3.
`
`Wockhardt has not, at this time, rebutted the statutory presumption that the
`
`Asserted Patents are valid and enforceable in this Action.
`
`4.
`
`Wockhardt admits that the submission of ANDA No. 207526 to the FDA for the
`
`purpose of obtaining regulatory approval to engage in the commercial manufacture, use andlor
`
`sale of the Generic Product within the United States prior to the expiration of the Asserted
`
`Patents was a technical act of patent infringement with respect to one or more claims of each of
`
`the Asserted Patents.
`
`2
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 271 Filed 04/25/16 Page 3 of 5 PageID: 5020
`
`STIPULATED ORDER OF DISMISSAL
`
`Accordingly, pursuant to the above Stipulated Facts, and upon the consent and request of
`
`Jazz and Wockhardt, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT:
`
`1.
`
`The filing of ANDA No. 207526 was a technical act of infringement of each of
`
`the Asserted Patents under 35 U.S.C. § 271(e)(2)(A).
`
`2.
`
`Wockhardt admits that the commercial manufacture, use, selling, offering for sale,
`
`or importing of the Generic Product would infringe each of the Asserted Patents.
`
`3.
`
`All claims, defenses, and counterclaims in this Action are hereby dismissed,
`
`without prejudice.’
`
`4.
`
`Wockhardt, its officers, agents, servants, employees and attorneys, and those
`
`persons in active concert or participation with them who receive actual notice of this Order by
`
`personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell or
`
`selling within the United States, or importing into the United States, the Generic Product during
`
`the life of the Asserted Patents, including any extensions and pediatric exclusivities, except only
`
`as expressly permitted by the License Agreement entered into between Jazz and Wockhardt on
`
`April 18, 2016, unless all of the asserted claims of the Asserted Patents are found invalid,
`
`unpatentable or unenforceable by a court or patent office decision from which no appeal has
`
`been or can be taken, other than a petition for a writ of certiorari to the U.S. Supreme Court, and
`
`any marketing of the Generic Product, except as allowed in this paragraph, would cause
`
`irreparable harm to Jazz.
`
`1 The dismissal of the parties’ claims, defenses, and counterclaims in Civil Action No.
`13-391 with respect to Wockhardt shall not result in the dismissal of claims, defenses, and
`counterclaims in that Action with respect to Amneal Pharmaceuticals LLC, Par Pharmaceutical,
`Inc., Sun Pharmaceutical Industries, Ltd., Ohm Laboratories Inc., Ranbaxy, Inc., Watson
`Laboratories, Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., and Lupin Inc.
`
`3
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 271 Filed 04/25/16 Page 4 of 5 PageID: 5021
`
`5.
`
`This Court retains jurisdiction over Jazz and Wockhardt for purposes of enforcing
`
`this Stipulation And Order Of Dismissal.
`
`6.
`
`The Clerk of the Court is directed to enter this final judgment forthwith.
`
`Dated: April 22, 2016
`
`Respectfully submitted,
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07 102-5426
`(973) 286-6700
`clizza@saul.com
`
`OfCounsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`QUINN EMANUEL URQUHART
`& SULLIVAN, LEP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Richard G. Greco
`RICHARD G. GREc0 PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`Attorneysfor Plaintffs
`Jazz Pharmaceuticals, Inc.
`And Jazz Pharmaceuticals Ireland Limited
`
`Respectfully submitted,
`
`By: 5/ Sheila Raftery Wiggins
`Sheila Raftery Wiggins
`DUANE MoRRIs LLP
`One Riverfront Plaza
`1037 Raymond Blvd., Suite 1800
`Newark, NJ 07102-5429
`Telephone: (973) 424-2000
`Fax: (973) 424-2001
`srwigginsduanemorris.com
`
`OfCounsel:
`
`Frederick R. Ball
`DUANE MoRRIs LLP
`100 High Street, Suite 2400
`Boston, MA 02110-1724
`
`Patrick C. Gallagher
`DUANE MoRRIs LLP
`190 South LaSalle Street, Suite 3700
`Chicago, IL 60603-3433
`
`Attorneysfor Defendant-Counterclaimants
`Wockhardt Bio AG, Wockhardt USA LLC,
`and Wockhardt Ltd.
`
`4
`
`
`
`Case 2:13-cv-00391-ES-JAD Document 271 Filed 04/25/16 Page 5 of 5 PageID: 5022
`
`SO ORDD:
`This ?) day of
`
`,2016
`
`TIcALAS
`7JASISTRICT JUDGE
`
`5
`
`