Case 2:13-cv-00391-ES-SCM Document 1 Filed 01/18/13 Page 1 of 17 PageID: 1
`
`
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`JAZZ PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`
`(Filed Electronically)
`
`
`
`
`
`
`
`Defendant.
`
`Plaintiff Jazz Pharmaceuticals, Inc. ((cid:147)Jazz Pharmaceuticals(cid:148)), by its undersigned
`
`attorneys, for its Complaint against defendant Amneal Pharmaceuticals, LLC ((cid:147)Amneal(cid:148)),
`
`alleges as follows:
`
`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C. §100, et seq., arising from Amneal(cid:146)s filing of an Abbreviated New Drug
`
`Application ((cid:147)ANDA(cid:148)) with the United States Food and Drug Administration ((cid:147)FDA(cid:148)) seeking
`
`approval to commercially market a generic version of Jazz Pharmaceuticals(cid:146) XYREMfi drug
`
`product prior to the expiration of United States Patent Nos. 6,472,431 (the (cid:147)(cid:146)431 patent(cid:148)),
`
`6,780,889 (the (cid:147)(cid:146)889 patent(cid:148)), 7,262,219 (the (cid:147)(cid:146)219 patent(cid:148)), 7,851,506 (the (cid:147)(cid:146)506 patent(cid:148)),
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`7,895,059 (the (cid:147)(cid:146)059 patent(cid:148)), 8,263,650 (the (cid:147)(cid:146)650 patent(cid:148)), and 8,324,275 (the (cid:147)(cid:146)275 patent(cid:148))
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`
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`owned by Jazz Pharmaceuticals (collectively, (cid:147)the patents-in-suit(cid:148)) owned by Jazz
`
`Pharmaceuticals.
`
`The Parties
`
`2.
`
`Plaintiff Jazz Pharmaceuticals is a corporation organized and existing under the
`
`laws of the State of Delaware, having a principal place of business at 3180 Porter Drive, Palo
`
`Alto, California 94304.
`
`3.
`
`On information and belief, defendant Amneal is a corporation organized under the
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`laws of the State of Delaware, having a principal place of business 440 U.S. Highway 22 East,
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`Suite 104, Bridgewater, New Jersey 08807.
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`Jurisdiction and Venue
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`4.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`5.
`
`This Court has personal jurisdiction over Amneal by virtue of, inter alia, its
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`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Amneal has purposefully availed itself of this forum by, among other things, operating its
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`headquarters in the State of New Jersey, making, shipping, using, offering to sell or selling, or
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`causing others to use, offer to sell, or sell, pharmaceutical products in the State of New Jersey
`
`and deriving revenue from such activities. Further, on information and belief, Amneal has
`
`customers in the State of New Jersey.
`
`6.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The Patent-In-Suit
`
`7.
`
`On October 29, 2002, the United States Patent and Trademark Office ((cid:147)USPTO(cid:148))
`
`duly and lawfully issued the (cid:146)431 patent, entitled (cid:147)Microbiologically Sound and Stable Solutions
`
`of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy(cid:148) to inventors Harry Cook,
`
`
`
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`2
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`
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`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. The (cid:146)431 patent
`
`was later assigned to Jazz Pharmaceuticals. A copy of the (cid:146)431 patent is attached hereto as
`
`Exhibit A.
`
`8.
`
`On August 24, 2004, the USPTO duly and lawfully issued the (cid:146)889 patent,
`
`entitled (cid:147)Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy(cid:148) to inventors Harry Cook, Martha Hamilton, Douglas Danielson,
`
`Colette Goderstad and Dayton Reardan. The (cid:146)889 patent was later assigned to Jazz
`
`Pharmaceuticals. A copy of the (cid:146)889 patent is attached hereto as Exhibit B.
`
`9.
`
`On August 28, 2007, the USPTO duly and lawfully issued the (cid:146)219 patent,
`
`entitled (cid:147)Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy(cid:148) to inventors Harry Cook, Martha Hamilton, Douglas Danielson,
`
`Colette Goderstad and Dayton Reardan. The (cid:146)219 patent was later assigned to Jazz
`
`Pharmaceuticals. A copy of the (cid:146)219 patent is attached hereto as Exhibit C.
`
`10.
`
`On December 14, 2010, the USPTO duly and lawfully issued the (cid:146)506 patent,
`
`entitled (cid:147)Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy(cid:148) to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`(cid:146)506 patent is attached hereto as Exhibit D.
`
`11.
`
`On February 22, 2011, the USPTO duly and lawfully issued the (cid:146)059 patent,
`
`entitled (cid:147)Sensitive Drug Distribution System and Method(cid:148) to Jazz Pharmaceuticals as assignee
`
`of the inventors Dayton Reardan, Patti Engle and Bob Gagne. A copy of the (cid:146)059 patent is
`
`attached hereto as Exhibit E.
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`
`
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`3
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`12.
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`On September 11, 2012, the USPTO duly and lawfully issued the (cid:146)650 patent,
`
`entitled (cid:147)Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy(cid:148) to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`(cid:146)650 patent is attached hereto as Exhibit F.
`
`13.
`
`On December 4, 2012, the USPTO duly and lawfully issued the (cid:146)275 patent,
`
`entitled (cid:147)Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy(cid:148) to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`(cid:146)275 patent is attached hereto as Exhibit G.
`
`The XYREM® Drug Product
`
`14.
`
`Jazz Pharmaceuticals holds an approved New Drug Application ((cid:147)NDA(cid:148)) under
`
`Section 505(a) of the Federal Food Drug and Cosmetic Act ((cid:147)FFDCA(cid:148)), 21 U.S.C. § 355(a), for
`
`sodium oxybate oral solution (NDA No. 21-196), which it sells under the trade name XYREMfi.
`
`The claims of the patents-in-suit cover, inter alia, pharmaceutical compositions containing
`
`sodium oxybate, and methods of use and administration of sodium oxybate or pharmaceutical
`
`compositions containing sodium oxybate. Jazz Pharmaceuticals owns the patents-in-suit.
`
`15.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the (cid:146)889, (cid:146)219,
`
`(cid:146)506, (cid:146)059, (cid:146)650, and (cid:146)275 patents are listed in the FDA publication, (cid:147)Approved Drug Products
`
`with Therapeutic Equivalence Evaluations(cid:148) (the (cid:147)Orange Book(cid:148)), with respect to XYREMfi.
`
`Acts Giving Rise to This Suit
`
`16.
`
`Pursuant to Section 505 of the FFDCA, Amneal filed ANDA No. 203631
`
`((cid:147)Amneal(cid:146)s ANDA(cid:148)) seeking approval to engage in the commercial use, manufacture, sale, offer
`
`
`
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`4
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`
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`for sale or importation of 500 mg/mL sodium oxybate oral solution ((cid:147)Amneal(cid:146)s Proposed
`
`Product(cid:148)), before the patents-in-suit expire.
`
`17.
`
`In connection with the filing of its ANDA as described in the preceding
`
`paragraph, Amneal has provided a written certification to the FDA, as called for by Section 505
`
`of the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) ((cid:147)Amneal(cid:146)s Paragraph IV Certification(cid:148)),
`
`alleging that the claims of the patents-in-suit are invalid, unenforceable, and/or will not be
`
`infringed by the activities described in Amneal(cid:146)s ANDA.
`
`18.
`
`No earlier than December 10, 2012, Jazz Pharmaceuticals received written notice
`
`of Amneal(cid:146)s Paragraph IV Certification ((cid:147)Amneal(cid:146)s Notice Letter(cid:148)) pursuant to
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`21 U.S.C. § 355(j)(2)(B). Amneal(cid:146)s Notice Letter alleged that the claims of the patents-in-suit
`
`are invalid, unenforceable, and/or will not be infringed by the activities described in Amneal(cid:146)s
`
`ANDA. Amneal(cid:146)s Notice Letter also informed Jazz Pharmaceuticals that Amneal seeks approval
`
`to market Amneal(cid:146)s Proposed Product before the patents-in-suit expire.
`
`Count I: Infringement of the ’431 Patent
`
`19.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-18 as though fully
`
`set forth herein.
`
`20.
`
`Amneal, through its submission of its Paragraph IV Certification as part of its
`
`ANDA to the FDA, has indicated that it seeks approval to engage in the commercial use,
`
`manufacture, sale, offer for sale, or importation of sodium oxybate oral solution, prior to the
`
`expiration of the (cid:146)431 patent. Amneal(cid:146)s actions with respect to its ANDA show that there is a
`
`substantial controversy, between the parties, of sufficient immediacy and reality to warrant the
`
`issuance of a declaratory judgment.
`
`21.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`5
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`prior to the expiration of the (cid:146)431 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`22.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)431 patent.
`
`23.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)431 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`24.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)431 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the (cid:146)431 patent and knowledge that its
`
`acts are encouraging infringement.
`
`25.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)431 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`Proposed Product is especially adapted for a use that infringes the (cid:146)431 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`26.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)431 patent is not enjoined.
`
`27.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
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`6
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`28.
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`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count II: Infringement of the ’889 Patent
`
`29.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-28 as though fully
`
`set forth herein.
`
`30.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`prior to the expiration of the (cid:146)889 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`31.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)889 patent.
`
`32.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)889 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`33.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)889 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the (cid:146)889 patent and knowledge that its
`
`acts are encouraging infringement.
`
`34.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)889 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`7
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`
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`Proposed Product is especially adapted for a use that infringes the (cid:146)889 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`35.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)889 patent is not enjoined.
`
`36.
`
`37.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’219 Patent
`
`38.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-37 as though fully
`
`set forth herein.
`
`39.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`prior to the expiration of the (cid:146)219 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`40.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)219 patent.
`
`41.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)219 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`42.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)219 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
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`encourage acts of direct infringement with knowledge of the (cid:146)219 patent and knowledge that its
`
`acts are encouraging infringement.
`
`43.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)219 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`Proposed Product is especially adapted for a use that infringes the (cid:146)219 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`44.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)219 patent is not enjoined.
`
`45.
`
`46.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count IV: Infringement of the ’506 Patent
`
`47.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-46 as though fully
`
`set forth herein.
`
`48.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`prior to the expiration of the (cid:146)506 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`49.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)506 patent.
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`50.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)506 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`51.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)506 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the (cid:146)506 patent and knowledge that its
`
`acts are encouraging infringement.
`
`52.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)506 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`Proposed Product is especially adapted for a use that infringes the (cid:146)506 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`53.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)506 patent is not enjoined.
`
`54.
`
`55.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count V: Infringement of the ’059 Patent
`
`56.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-55 as though fully
`
`set forth herein.
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`57.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`prior to the expiration of the (cid:146)059 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`58.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)059 patent.
`
`59.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)059 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`60.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)059 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the (cid:146)059 patent and knowledge that its
`
`acts are encouraging infringement.
`
`61.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)059 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`Proposed Product is especially adapted for a use that infringes the (cid:146)059 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`62.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)059 patent is not enjoined.
`
`
`
`
`11
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`
`
`63.
`
`64.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count VI: Infringement of the ’650 Patent
`
`65.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-64 as though fully
`
`set forth herein.
`
`66.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`prior to the expiration of the (cid:146)650 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`67.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)650 patent.
`
`68.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)650 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`69.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)650 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the (cid:146)650 patent and knowledge that its
`
`acts are encouraging infringement.
`
`70.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)650 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`12
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`
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`Proposed Product is especially adapted for a use that infringes the (cid:146)650 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`71.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)650 patent is not enjoined.
`
`72.
`
`73.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count VII: Infringement of the ’275 Patent
`
`74.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-73 as though fully
`
`set forth herein.
`
`75.
`
`Amneal(cid:146)s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral solution,
`
`prior to the expiration of the (cid:146)275 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`76.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)275 patent.
`
`77.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will infringe the (cid:146)275 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal(cid:146)s Proposed Product in the United States.
`
`78.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will induce infringement of the (cid:146)275 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal(cid:146)s ANDA, Amneal will intentionally
`
`13
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`
`
`encourage acts of direct infringement with knowledge of the (cid:146)275 patent and knowledge that its
`
`acts are encouraging infringement.
`
`79.
`
`Unless enjoined by this Court, upon FDA approval of Amneal(cid:146)s ANDA, Amneal
`
`will contributorily infringe the (cid:146)275 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal(cid:146)s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal(cid:146)s
`
`Proposed Product is especially adapted for a use that infringes the (cid:146)275 patent and that there is no
`
`substantial non-infringing use for Amneal(cid:146)s Proposed Product.
`
`80.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal(cid:146)s infringement of the (cid:146)275 patent is not enjoined.
`
`81.
`
`82.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff Jazz Pharmaceuticals respectfully requests the following relief:
`
`(A) A Judgment be entered that Amneal has infringed the patents-in-suit by
`
`submitting ANDA No. 203631;
`
`(B) A Judgment be entered that Amneal has infringed, and that Amneal(cid:146)s making,
`
`using, selling, offering to sell, or importing Amneal(cid:146)s Proposed Product will infringe one or
`
`more claims of the patents-in-suit;
`
`(C) An Order that the effective date of FDA approval of ANDA No. 203631 be a date
`
`which is not earlier than the later of the expiration of the patents-in-suit, or any later expiration of
`
`exclusivity to which Plaintiff is or becomes entitled;
`
`
`
`
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`
`
`(D)
`
`Preliminary and permanent injunctions enjoining Amneal and its officers, agents,
`
`attorneys and employees, and those acting in privity or concert with them, from making, using,
`
`selling, offering to sell, or importing Amneal(cid:146)s Proposed Product until after the expiration of the
`
`patents-in-suit, or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`(E) A permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B),
`
`restraining and enjoining Amneal, its officers, agents, attorneys and employees, and those acting
`
`in privity or concert with them, from practicing any methods as claimed in the patents-in-suit, or
`
`from actively inducing or contributing to the infringement of any claim of the patents-in-suit,
`
`until after the expiration of the patents-in-suit, or any later expiration of exclusivity to which
`
`Plaintiff is or becomes entitled;
`
`(F) A Declaration that the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Amneal(cid:146)s Proposed Product will directly infringe, induce and/or
`
`contribute to infringement of the patents-in-suit;
`
`(G) To the extent that Amneal has committed any acts with respect to the
`
`compositions and methods claimed in the patents-in-suit, other than those acts expressly
`
`exempted by 35 U.S.C. § 271(e)(1), that Plaintiff Jazz Pharmaceuticals be awarded damages for
`
`such acts;
`
`(H)
`
`If Amneal engages in the commercial manufacture, use, importation into the
`
`United States, sale, or offer for sale of Amneal(cid:146)s Proposed Product prior to the expiration of the
`
`patents-in-suit, a Judgment awarding damages to Plaintiff Jazz Pharmaceuticals resulting from
`
`such infringement, together with interest;
`
`(I)
`
`(J)
`
`
`
`
`Attorneys(cid:146) fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
`
`Costs and expenses in this action; and
`
`15
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`
`
`(K) Such further and other relief as this Court may deem just and proper.
`
`
`
`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`Dated: January 18, 2012
`
`
`
`
`
`
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`
`
`
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