Case 2:15-cv-01043-ES-JAD Document 1 Filed 02/06/15 Page 1 of 12 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 Plaintiffs
`Jazz Pharmaceuticals, Inc. and
`Jazz Pharmaceuticals Ireland Limited
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`Plaintiffs,
`
`v.
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant.
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited
`
`(collectively, “Jazz Pharmaceuticals”), by their undersigned attorneys, for their Complaint
`
`against defendant Amneal Pharmaceuticals, LLC (“Amneal”), allege 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’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
`
`approval to commercially market a generic version of Jazz Pharmaceuticals’ XYREM® drug
`
`product prior to the expiration of United States Patent Nos. 8,731,963 (the “’963 patent”),
`
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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 Plaintiffs
`Jazz Pharmaceuticals, Inc. and
`Jazz Pharmaceuticals Ireland Limited
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`JAZZ PHARMACEUTICALS, INC. and
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`Plaintiffs,
`
`v.
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant.
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited
`
`(collectively, “Jazz Pharmaceuticals”), by their undersigned attorneys, for their Complaint
`
`against defendant Amneal Pharmaceuticals, LLC (“Amneal”), allege 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’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
`
`approval to commercially market a generic version of Jazz Pharmaceuticals’ XYREM® drug
`
`product prior to the expiration of United States Patent Nos. 8,731,963 (the “’963 patent”),
`
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`8,772,306 (the “’306 patent”), and 8,859,619 (the “’619 patent”) owned by Jazz Pharmaceuticals
`
`(collectively, “the patents-in-suit”).
`
`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.
`
`Plaintiff Jazz Pharmaceuticals Ireland Limited is a corporation organized and
`
`existing under the laws of Ireland, having a principal place of business at One Burlington Road,
`
`Fourth Floor, Connaught House, Dublin, Ireland 4.
`
`4.
`
`On information and belief, defendant Amneal is a corporation organized under the
`
`laws of the State of Delaware, having a principal place of business at 440 U.S. Highway 22 East,
`
`Suite 104, Bridgewater, New Jersey 08807.
`
`Jurisdiction and Venue
`
`5.
`
`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 Amneal by virtue of, inter alia, its
`
`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
`
`headquarters in the State of New Jersey, making, shipping, using, offering to sell or selling, or
`
`causing others to use, offer to sell, or sell, pharmaceutical products in the State of New Jersey
`
`and deriving revenue from such activities. Amneal currently is litigating, and has litigated in the
`
`past, patent cases in this District without contesting personal jurisdiction. In at least some of
`
`those actions, Amneal has asserted counterclaims. Further, on information and belief, Amneal
`
`has customers in the State of New Jersey.
`
`2
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`
`7.
`
`8.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The Patent-In-Suit
`
`On May 20, 2014, the USPTO duly and lawfully issued the ’963 patent, entitled
`
`“Sensitive Drug Distribution System and Method.” A copy of the ’963 patent is attached hereto
`
`as Exhibit A.
`
`9.
`
`On July 8, 2014, the USPTO duly and lawfully issued the ’306 patent, entitled
`
`“Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters.”
`
`A copy of the ’306 patent is attached hereto as Exhibit B.
`
`10.
`
`On October 14, 2014, the USPTO duly and lawfully issued the ’619 Patent,
`
`entitled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy.” A copy of the ’619 patent is attached hereto as Exhibit C.
`
`The XYREM® Drug Product
`
`11.
`
`Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under
`
`Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for
`
`sodium oxybate oral solution (NDA No. 21-196), which it sells under the trade name XYREM®.
`
`The claims of the patents-in-suit cover, inter alia, methods of use and administration of sodium
`
`oxybate or pharmaceutical compositions containing sodium oxybate. Jazz Pharmaceuticals owns
`
`the patents-in-suit.
`
`12.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the patents-in-
`
`suit are listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (the “Orange Book”), with respect to XYREM®.
`
`13.
`
`The labeling for XYREM® instructs and encourages physicians, other healthcare
`
`workers, and patients to administer XYREM® according to the methods claimed in the patents-in-
`
`suit.
`
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`
`Acts Giving Rise to This Suit
`
`14.
`
`Pursuant to Section 505 of the FFDCA, Amneal filed ANDA No. 203631
`
`(“Amneal’s ANDA”) seeking approval to engage in the commercial use, manufacture, sale, offer
`
`for sale or importation of 500 mg/mL sodium oxybate oral solution (“Amneal’s Proposed
`
`Product”), before the patents-in-suit expire.
`
`15.
`
`In connection with the filing of its ANDA as described in the preceding
`
`paragraph, Amneal has provided written certifications to the FDA, as called for by Section 505
`
`of the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Amneal’s Paragraph IV Certifications”),
`
`alleging that the claims of the patents-in-suit and other Orange-Book-listed patents owned by
`
`Jazz Pharmaceuticals are invalid, unenforceable, and/or will not be infringed by the activities
`
`described in Amneal’s ANDA.
`
`16.
`
`No earlier than January 16, 2015, Jazz Pharmaceuticals received written notice of
`
`Amneal’s Paragraph IV Certification (“Amneal’s Notice Letter”) pursuant to
`
`21 U.S.C. § 355(j)(2)(B) with respect to the patents-in-suit. Amneal’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’s ANDA. Amneal’s Notice Letter also informed Jazz
`
`Pharmaceuticals that Amneal seeks approval to market Amneal’s Proposed Product before the
`
`patents-in-suit expire.
`
`Count I: Infringement of the ’963 Patent
`
`17.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-16 as though fully set
`
`forth herein.
`
`18.
`
`Amneal’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,
`
`4
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`prior to the expiration of the ’963 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`19.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’963 patent.
`
`20.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will infringe the ’963 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal’s Proposed Product in the United States.
`
`21.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will induce infringement of the ’963 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal’s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal’s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the ’963 patent and knowledge that its
`
`acts are encouraging infringement.
`
`22.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will contributorily infringe the ’963 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal’s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal’s
`
`Proposed Product is especially adapted for a use that infringes the ’963 patent and that there is no
`
`substantial non-infringing use for Amneal’s Proposed Product.
`
`23.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal’s infringement of the ’963 patent is not enjoined.
`
`24.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`5
`
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`
`25.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count II: Infringement of the ’306 Patent
`
`26.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-25 as though fully set
`
`forth herein.
`
`27.
`
`Amneal’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 ’306 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`28.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’306 patent.
`
`29.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will infringe the ’306 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal’s Proposed Product in the United States.
`
`30.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will induce infringement of the ’306 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal’s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal’s ANDA, Amneal will intentionally
`
`encourage acts of direct infringement with knowledge of the ’306 patent and knowledge that its
`
`acts are encouraging infringement.
`
`31.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will contributorily infringe the ’306 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal’s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal’s
`6
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`
`Proposed Product is especially adapted for a use that infringes the ’306 patent and that there is no
`
`substantial non-infringing use for Amneal’s Proposed Product.
`
`32.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal’s infringement of the ’306 patent is not enjoined.
`
`33.
`
`34.
`
`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’ fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’619 Patent
`
`35.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-34 as though fully set
`
`forth herein.
`
`36.
`
`Amneal’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 ’619 patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`37.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’619 patent.
`
`38.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will infringe the ’619 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Amneal’s Proposed Product in the United States.
`
`39.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will induce infringement of the ’619 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling Amneal’s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Amneal’s ANDA, Amneal will intentionally
`
`7
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`
`encourage acts of direct infringement with knowledge of the ’619 patent and knowledge that its
`
`acts are encouraging infringement.
`
`40.
`
`Unless enjoined by this Court, upon FDA approval of Amneal’s ANDA, Amneal
`
`will contributorily infringe the ’619 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Amneal’s Proposed Product in the United States. On
`
`information and belief, Amneal has had and continues to have knowledge that Amneal’s
`
`Proposed Product is especially adapted for a use that infringes the ’619 patent and that there is no
`
`substantial non-infringing use for Amneal’s Proposed Product.
`
`41.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Amneal’s infringement of the ’619 patent is not enjoined.
`
`42.
`
`43.
`
`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’ fees under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs Jazz Pharmaceuticals respectfully request 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’s making,
`
`using, selling, offering to sell, or importing Amneal’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 Plaintiffs are or become entitled;
`
`8
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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’s Proposed Product until after the expiration of the
`
`patents-in-suit, or any later expiration of exclusivity to which Plaintiffs are or become 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
`
`Plaintiffs are or become entitled;
`
`(F)
`
`A Declaration that the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Amneal’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 methods
`
`claimed in the patents-in-suit, other than those acts expressly exempted by 35 U.S.C. § 271(e)(1),
`
`that Plaintiffs 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’s Proposed Product prior to the expiration of the
`
`patents-in-suit, a Judgment awarding damages to Plaintiffs resulting from such infringement,
`
`together with interest;
`
`(I)
`
`(J)
`
`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
`
`Costs and expenses in this action; and
`
`(K)
`
`Such further and other relief as this Court may deem just and proper.
`
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`
`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 Plaintiffs
`Jazz Pharmaceuticals, Inc. and
`Jazz Pharmaceuticals Ireland Limited
`
`Dated: February 6, 2015
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Gabriel P. Brier
`Andrew S. Chalson
`Frank C. Calvosa
`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
`
`10
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`
`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`I hereby certify that the matters captioned, Jazz Pharmaceuticals, Inc. v. Roxane
`
`Laboratories, Inc., Civil Action No. 10-6108 (ES)(MAH), Jazz Pharmaceuticals, Inc. v. Amneal
`
`Pharmaceuticals, LLC, et al., Civil Action No. 13-391 (ES)(JAD), Jazz Pharmaceuticals, Inc. v.
`
`Amneal Pharmaceuticals, LLC, Civil Action No. 14-3235 (ES)(JAD), Jazz Pharmaceuticals, Inc.
`
`v. Ranbaxy Laboratories Ltd., et al., Civil Action No. 14-4467 (ES)(JAD), Jazz
`
`Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., Civil Action No. 14-5139 (ES)(JAD), Jazz
`
`Pharmaceuticals, Inc., et al. v. Par Pharmaceutical, Inc., Civil Action No. 14-6150 (ES)(JAD),
`
`Jazz Pharmaceuticals, Inc., et al. v. Ranbaxy Laboratories Ltd., et al., Civil Action No. 14-6151
`
`(ES)(JAD), Jazz Pharmaceuticals, Inc., et al. v. Watson Laboratories, Inc., Civil Action No. 14-
`
`7757 (ES)(JAD), Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., Civil Action No. 15-
`
`173 (ES)(JAD), and Jazz Pharmaceuticals, Inc. v. Ranbaxy Laboratories Ltd., et al., Civil
`
`Action No. 15-187 (ES)(JAD), are related to the matter in controversy because they involve
`
`defendants who filed Abbreviated New Drug Applications seeking to market generic versions of
`
`the same drug product.
`
`I further certify that, to the best of my knowledge, the matter in controversy is not the
`
`subject of any other action pending in any court or of any pending arbitration or administrative
`
`proceeding.
`
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`
`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 Plaintiffs
`Jazz Pharmaceuticals, Inc. and
`Jazz Pharmaceuticals Ireland Limited
`
`Dated: February 6, 2015
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Gabriel P. Brier
`Andrew S. Chalson
`Frank C. Calvosa
`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
`
`12
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