Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 1 of 26 PageID: 1
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`
`
`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
`
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`
`
`(Filed Electronically)
`
`JAZZ PHARMACEUTICALS, INC.,
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`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`PAR PHARMACEUTICAL, INC.,
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`
`
`
`
`
`
`Defendant.
`
`Plaintiff Jazz Pharmaceuticals, Inc. ((cid:147)Jazz Pharmaceuticals(cid:148)), by its undersigned
`
`attorneys, for its Complaint against defendant Par Pharmaceutical, Inc. ((cid:147)Par(cid:148)), alleges as
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`follows:
`
`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
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`States, 35 U.S.C. §100, et seq., arising from Par(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)),
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`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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`8,263,650 (the (cid:147)(cid:146)650 patent(cid:148)), 8,324,275 (the (cid:147)(cid:146)275 patent(cid:148)), 8,461,203 (the (cid:147)(cid:146)203 patent(cid:148)),
`
`
`
`JAZZ EXHIBIT 2024
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
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`Page 1 of 26
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`

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`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 2 of 26 PageID: 2
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`
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`7,668,730 (the (cid:147)(cid:146)730 patent(cid:148)), 7,765,106 (the (cid:147)(cid:146)106 patent(cid:148)), 7,765,107 (the (cid:147)(cid:146)107 patent(cid:148)),
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`7,895,059 (the (cid:147)(cid:146)059 patent(cid:148)), 8,457,988 (the (cid:147)(cid:146)988 patent(cid:148)), and 8,589,182 (the (cid:147)(cid:146)182 patent(cid:148))
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`owned by Jazz Pharmaceuticals (collectively, (cid:147)the patents-in-suit(cid:148)).
`
`The Parties
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`2.
`
`Plaintiff Jazz Pharmaceuticals is a corporation organized and existing under the
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`laws of the State of Delaware, having a principal place of business at 3180 Porter Drive, Palo
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`Alto, California 94304.
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`3.
`
`On information and belief, defendant Par Pharmaceutical, Inc. is a corporation
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 300 Tice Boulevard, Woodcliff Lake, New Jersey.
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`4.
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`On information and belief, Par develops numerous generic drugs for sale and use
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`throughout the United States, including in this judicial district. Par has litigated patent cases in
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`this District in the past without contesting personal jurisdiction, and, in at least some of those
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`actions, Par has asserted counterclaims.
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`Jurisdiction and Venue
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`5.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`6.
`
`This Court has personal jurisdiction over Par by virtue of, inter alia, its systematic
`
`and continuous contacts with the State of New Jersey. On information and belief, Par has its
`
`principal place of business in Woodcliff Lake, New Jersey, conducts business in this District,
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`purposefully avails itself of this forum by, among other things, making, shipping, using, offering
`
`to sell or selling, or causing others to use, offer to sell, or sell, pharmaceutical products in the
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`State of New Jersey and deriving revenue from such activities. Also, on information and belief,
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`
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`2
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`
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`Par has customers in the State of New Jersey. Further, on information and belief, Par is
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`registered to conduct business in the State of New Jersey.
`
`7.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The Patent-In-Suit
`
`8.
`
`On October 29, 2002, the United States Patent and Trademark Office ((cid:147)USPTO(cid:148))
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`duly and lawfully issued the (cid:146)431 patent, entitled (cid:147)Microbiologically Sound and Stable Solutions
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`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)431 patent
`
`was later assigned to Jazz Pharmaceuticals. A copy of the (cid:146)431 patent is attached hereto as
`
`Exhibit A.
`
`9.
`
`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.
`
`10.
`
`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.
`
`11.
`
`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,
`
`
`
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`3
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`Page 3 of 26
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`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 4 of 26 PageID: 4
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`
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`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`(cid:146)506 patent is attached hereto as Exhibit D.
`
`12.
`
`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 E.
`
`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 F.
`
`14.
`
`On June 11, 2013, the USPTO duly and lawfully issued the (cid:146)203 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)203 patent is attached hereto as Exhibit G.
`
`15.
`
`On February 23, 2010, the USPTO duly and lawfully issued the (cid:146)730 patent,
`
`entitled (cid:147)Sensitive Drug Distribution System and Method(cid:148) to inventors Dayton Reardan, Patti
`
`Engle and Bob Gagne. The (cid:146)730 patent was later assigned to Jazz Pharmaceuticals. A copy of
`
`the (cid:146)730 patent is attached hereto as Exhibit H.
`
`16.
`
`On July 27, 2010, the USPTO duly and lawfully issued the (cid:146)106 patent, entitled
`
`(cid:147)Sensitive Drug Distribution System and Method(cid:148) to inventors Dayton Reardan, Patti Engle and
`
`
`
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`4
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`
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`Bob Gagne. The (cid:146)106 patent was later assigned to Jazz Pharmaceuticals. A copy of the (cid:146)106
`
`patent is attached hereto as Exhibit I.
`
`17.
`
`On July 27, 2010, the USPTO duly and lawfully issued the (cid:146)107 patent, entitled
`
`(cid:147)Sensitive Drug Distribution System and Method(cid:148) to inventors Dayton Reardan, Patti Engle and
`
`Bob Gagne. The (cid:146)107 patent was later assigned to Jazz Pharmaceuticals. A copy of the (cid:146)107
`
`patent is attached hereto as Exhibit J.
`
`18.
`
`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 K.
`
`19.
`
`On June 4, 2013, the USPTO duly and lawfully issued the (cid:146)988 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)988 patent is attached
`
`hereto as Exhibit L.
`
`20.
`
`On November 19, 2013, the USPTO duly and lawfully issued the (cid:146)182 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)182 patent is
`
`attached hereto as Exhibit M.
`
`The XYREM® Drug Product
`
`21.
`
`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.
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`The claims of the patents-in-suit cover, inter alia, pharmaceutical compositions containing
`
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`5
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`
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`sodium oxybate, and methods of use and administration of sodium oxybate or pharmaceutical
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`compositions containing sodium oxybate. Jazz Pharmaceuticals owns the patents-in-suit.
`
`22.
`
`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)650, (cid:146)275, (cid:146)730, (cid:146)106, (cid:146)107, (cid:146)059, (cid:146)988, and (cid:146)182 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.
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`Acts Giving Rise to This Suit
`
`23.
`
`Pursuant to Section 505 of the FFDCA, Par filed ANDA No. 205403 ((cid:147)Par(cid:146)s
`
`ANDA(cid:148)) seeking approval to engage in the commercial use, manufacture, sale, offer for sale or
`
`importation of 500 mg/mL sodium oxybate oral solution ((cid:147)Par(cid:146)s Proposed Product(cid:148)), before the
`
`patents-in-suit expire.
`
`24.
`
`On information and belief, in connection with the filing of its ANDA as described
`
`in the preceding paragraph, Par 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)Par(cid:146)s Paragraph IV
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`Certification(cid:148)), alleging that the claims of the (cid:146)889, (cid:146)219, (cid:146)506, (cid:146)650, (cid:146)275, (cid:146)730, (cid:146)106, (cid:146)107,
`
`(cid:146)059, and (cid:146)988 patents are invalid, unenforceable, and/or will not be infringed by the activities
`
`described in Par(cid:146)s ANDA.
`
`25.
`
`No earlier than November 20, 2013, Jazz Pharmaceuticals received written notice
`
`of Par(cid:146)s Paragraph IV Certification ((cid:147)Par(cid:146)s Notice Letter(cid:148)) pursuant to 21 U.S.C. § 355(j)(2)(B).
`
`Par(cid:146)s Notice Letter alleged that the claims of the (cid:146)889, (cid:146)219, (cid:146)506, (cid:146)650, (cid:146)275, (cid:146)730, (cid:146)106, (cid:146)107,
`
`(cid:146)059, and (cid:146)988 patents are invalid, unenforceable, and/or will not be infringed by the activities
`
`described in Par(cid:146)s ANDA. Par(cid:146)s Notice Letter also informed Jazz Pharmaceuticals that Par seeks
`
`approval to market Par(cid:146)s Proposed Product before the patents-in-suit expire.
`
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`6
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`
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`Count I: Infringement of the ’431 Patent
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`26.
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`Plaintiff repeats and realleges the allegations of paragraphs 1-25 as though fully
`
`set forth herein.
`
`27.
`
`Par, 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. Par(cid:146)s actions with respect to its ANDA show that there is a substantial controversy,
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`between the parties, of sufficient immediacy and reality to warrant the issuance of a declaratory
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`judgment.
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`28.
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`Par(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)431 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`29.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)431 patent.
`
`30.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)431 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`31.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)431 patent and knowledge that its acts are encouraging
`
`infringement.
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`7
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`32.
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`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
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`contributorily infringe the (cid:146)431 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(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 Par(cid:146)s Proposed Product.
`
`33.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)431 patent is not enjoined.
`
`34.
`
`35.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
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`of its reasonable attorneys(cid:146) fees under 35 U.S.C. § 285.
`
`Count II: Infringement of the ’889 Patent
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`36.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-35 as though fully
`
`set forth herein.
`
`37.
`
`Par(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).
`
`38.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)889 patent.
`
`39.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)889 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`
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`8
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`40.
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`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)889 patent and knowledge that its acts are encouraging
`
`infringement.
`
`41.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(cid:146)s 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 Par(cid:146)s Proposed Product.
`
`42.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)889 patent is not enjoined.
`
`43.
`
`44.
`
`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
`
`45.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-44 as though fully
`
`set forth herein.
`
`46.
`
`Par(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).
`
`
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`47.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)219 patent.
`
`48.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)219 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`49.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)219 patent and knowledge that its acts are encouraging
`
`infringement.
`
`50.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(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 Par(cid:146)s Proposed Product.
`
`51.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)219 patent is not enjoined.
`
`52.
`
`53.
`
`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.
`
`
`
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`Count IV: Infringement of the ’506 Patent
`
`54.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-53 as though fully
`
`set forth herein.
`
`55.
`
`Par(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).
`
`56.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)506 patent.
`
`57.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)506 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`58.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)506 patent and knowledge that its acts are encouraging
`
`infringement.
`
`59.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(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 Par(cid:146)s Proposed Product.
`
`
`
`11
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`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 12 of 26 PageID: 12
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`
`
`60.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)506 patent is not enjoined.
`
`61.
`
`62.
`
`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 ’650 Patent
`
`63.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-62 as though fully
`
`set forth herein.
`
`64.
`
`Par(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).
`
`65.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)650 patent.
`
`66.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)650 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`67.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)650 patent and knowledge that its acts are encouraging
`
`infringement.
`
`
`
`
`12
`
`Page 12 of 26
`
`

`
`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 13 of 26 PageID: 13
`
`
`
`68.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(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 Par(cid:146)s Proposed Product.
`
`69.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)650 patent is not enjoined.
`
`70.
`
`71.
`
`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 ’275 Patent
`
`72.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-71 as though fully
`
`set forth herein.
`
`73.
`
`Par(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).
`
`74.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)275 patent.
`
`75.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)275 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`
`
`
`13
`
`Page 13 of 26
`
`

`
`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 14 of 26 PageID: 14
`
`
`
`76.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)275 patent and knowledge that its acts are encouraging
`
`infringement.
`
`77.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par 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 Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(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 Par(cid:146)s Proposed Product.
`
`78.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)275 patent is not enjoined.
`
`79.
`
`80.
`
`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 ’203 Patent
`
`81.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-80 as though fully
`
`set forth herein.
`
`82.
`
`Par, 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)203 patent. Par(cid:146)s actions with respect to its ANDA show that there is a substantial controversy,
`
`14
`
`
`Page 14 of 26
`
`

`
`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 15 of 26 PageID: 15
`
`
`
`between the parties, of sufficient immediacy and reality to warrant the issuance of a declaratory
`
`judgment.
`
`83.
`
`Par(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)203 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`84.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)203 patent.
`
`85.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)203 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`86.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`induce infringement of the (cid:146)203 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)203 patent and knowledge that its acts are encouraging
`
`infringement.
`
`87.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`contributorily infringe the (cid:146)203 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par(cid:146)s Proposed Product is especially
`
`adapted for a use that infringes the (cid:146)203 patent and that there is no substantial non-infringing use
`
`for Par(cid:146)s Proposed Product.
`
`
`
`
`15
`
`Page 15 of 26
`
`

`
`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 16 of 26 PageID: 16
`
`
`
`88.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)203 patent is not enjoined.
`
`89.
`
`90.
`
`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 VIII: Infringement of the ’730 Patent
`
`91.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-90 as though fully
`
`set forth herein.
`
`92.
`
`Par(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)730 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`93.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)730 patent.
`
`94.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)730 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par(cid:146)s Proposed Product in the United States.
`
`95.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`induce infringement of the (cid:146)730 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par(cid:146)s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par(cid:146)s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the (cid:146)730 patent and knowledge that its acts are encouraging
`
`infringement.
`
`
`
`
`16
`
`Page 16 of 26
`
`

`
`Case 2:13-cv-07884-ES-JAD Document 1 Filed 12/27/13 Page 17 of 26 PageID: 17
`
`
`
`96.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s AN