`
`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.,
`
`Civil Action No.
`
`Plaintiff:
`
`V.
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`PAR PHARMACEUTICAL, INC.,
`Defendant.
`
`
`(Filed Electronically)
`
`Plaintiff Jazz Pharmaceuticals, Inc. (“Jazz Pharmaceuticals”), by its undersigned
`
`attorneys, for its Complaint against defendant Par Pharmaceutical, Inc. (“Par”), 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 Par’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. 6,472,431 (the “’431 patent”),
`
`6,780,889 (the “’889 patent”), 7,262,219 (the “’219 patent”), 7,851,506 (the “’506 patent”),
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`8,263,650 (the “’650 patent”), 8,324,275 (the “’275 patent”), 8,461,203 (the “’203 patent”),
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`7,668,730 (the “’730 patent”), 7,765,106 (the “’106 patent”), 7,765,107 (the “’107 patent”),
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`7,895,059 (the “’059 patent”), 8,457,988 (the “’988 patent”), and 8,589,182 (the “’182 patent”)
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`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
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`Alto, California 94304.
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`3.
`
`On information and belief, defendant Par Pharmaceutical, Inc. is a corporation
`
`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.
`
`On information and belief, Par develops numerous generic drugs for sale and use
`
`throughout the United States, including in this judicial district. Par has litigated patent cases in
`
`this District in the past without contesting personal jurisdiction, and, in at least some of those
`
`actions, Par has asserted counterclaims.
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`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 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
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`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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`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 (“USPTO”)
`
`duly and lawfully issued the ’431 patent, entitled “Microbiologically Sound and Stable Solutions
`
`of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy” to inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. The ’431 patent
`
`was later assigned to Jazz Pharmaceuticals. A copy of the ’431 patent is attached hereto as
`
`Exhibit A.
`
`9.
`
`On August 24, 2004, the USPTO duly and lawfully issued the ’889 patent,
`
`entitled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy” to inventors Harry Cook, Martha Hamilton, Douglas Danielson,
`
`Colette Goderstad and Dayton Reardan. The ’889 patent was later assigned to Jazz
`
`Pharmaceuticals. A copy of the ’889 patent is attached hereto as Exhibit B.
`
`10.
`
`On August 28, 2007, the USPTO duly and lawfully issued the ’219 patent,
`
`entitled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
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`Treatment of Narcolepsy” to inventors Harry Cook, Martha Hamilton, Douglas Danielson,
`
`Colette Goderstad and Dayton Reardan. The ’219 patent was later assigned to Jazz
`
`Pharmaceuticals. A copy of the ’219 patent is attached hereto as Exhibit C.
`
`11.
`
`On December 14, 2010, the USPTO duly and lawfully issued the ’506 patent,
`
`entitled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
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`Treatment of Narcolepsy” to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
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`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
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`’506 patent is attached hereto as Exhibit D.
`
`12.
`
`On September 11, 2012, the USPTO duly and lawfully issued the ’650 patent,
`
`entitled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy” to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`’650 patent is attached hereto as Exhibit E.
`
`13.
`
`On December 4, 2012, the USPTO duly and lawfully issued the ’275 patent,
`
`entitled “Microbiologically Sound and Stable Solutions of Gamma—Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy” to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`’275 patent is attached hereto as Exhibit F.
`
`14.
`
`On June 11, 2013, the USPTO duly and lawfully issued the ’203 Patent, entitled
`
`“Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the
`
`Treatment of Narcolepsy” to Jazz Pharmaceuticals as assignee of the inventors Harry Cook,
`
`Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton Reardan. A copy of the
`
`’203 patent is attached hereto as Exhibit G.
`
`15.
`
`On February 23, 2010, the USPTO duly and lawfully issued the ’730 patent,
`
`entitled “Sensitive Drug Distribution System and Method” to inventors Dayton Reardan, Patti
`
`Engle and Bob Gagne. The ’730 patent was later assigned to Jazz Pharmaceuticals. A copy of
`
`the ’730 patent is attached hereto as Exhibit H.
`
`16.
`
`On July 27, 2010, the USPTO duly and lawfully issued the ’106 patent, entitled
`
`“Sensitive Drug Distribution System and Method” to inventors Dayton Reardan, Patti Engle and
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`Bob Gagne. The ’ 106 patent was later assigned to Jazz Pharmaceuticals. A copy of the ’106
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`patent is attached hereto as Exhibit 1.
`
`17.
`
`On July 27, 2010, the USPTO duly and lawfully issued the ’ 107 patent, entitled
`
`“Sensitive Drug Distribution System and Method” to inventors Dayton Reardan, Patti Engle and
`
`Bob Gagne. The ’ 107 patent was later assigned to Jazz Pharmaceuticals. A copy of the ’107
`
`patent is attached hereto as Exhibit J.
`
`18.
`
`On February 22, 2011, the USPTO duly and lawfully issued the ’059 patent,
`
`entitled “Sensitive Drug Distribution System and Method” to Jazz Pharmaceuticals as assignee
`
`of the inventors Dayton Reardan, Patti Engle and Bob Gagne. A copy of the ’059 patent is
`
`attached hereto as Exhibit K.
`
`19.
`
`On June 4, 2013, the USPTO duly and lawfully issued the ’988 patent, entitled
`
`“Sensitive Drug Distribution System and Method” to Jazz Pharmaceuticals as assignee of the
`
`inventors Dayton Reardan, Patti Engle and Bob Gagne. A copy of the ’988 patent is attached
`
`hereto as Exhibit L.
`
`20.
`
`On November 19, 2013, the USPTO duly and lawfully issued the ’182 patent,
`
`entitled “Sensitive Drug Distribution System and Method” to Jazz Pharmaceuticals as assignee
`
`of the inventors Dayton Reardan, Patti Engle and Bob Gagne. A copy of the ’182 patent is
`
`attached hereto as Exhibit M.
`
`The XYREM® Drug Product
`
`21.
`
`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®.
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`The claims of the patents—in-suit cover, inter al ia, pharmaceutical compositions containing
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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 ’889, ’219,
`
`’506, ’650, ’275,
`
`’730, ’106, ’107, ’059, ’988, and ’182 patents are listed in the FDA
`
`publication, “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange
`
`Book”), with respect to XYREM®.
`
`Acts Giving Rise to This Suit
`
`23.
`
`Pursuant to Section 505 of the FFDCA, Par filed ANDA No. 205403 (“Par’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 (“Par’s Proposed Product”), 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. § 3550)(2)(A)(vii)(IV) (“Par’s Paragraph IV
`
`Certification”), alleging that the claims of the ’889, ’219, ’506, ’650, ’275,
`
`’730, ’106, ’107,
`
`’059, and ’988 patents are invalid, unenforceable, and/or will not be infringed by the activities
`
`described in Par’s ANDA.
`
`25.
`
`No earlier than November 20, 2013, Jazz Pharmaceuticals received written notice
`
`of Par’s Paragraph IV Certification (“Par’s Notice Letter”) pursuant to 21 U.S.C. § 3550)(2)(B).
`
`Par’s Notice Letter alleged that the claims of the ’889, ’219, ’506, ’650, ’275,
`
`’730, ’106, ’107,
`
`’059, and ’988 patents are invalid, unenforceable, and/or will not be infringed by the activities
`
`described in Par’s ANDA. Par’s Notice Letter also informed Jazz Pharmaceuticals that Par seeks
`
`approval to market Par’s Proposed Product before the patents-in—suit expire.
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`Count I: Infringement of the ’431 Patent
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`26.
`
`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
`
`’431 patent. Par’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.
`
`28.
`
`Par’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 ’431 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`29.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’431 patent.
`
`30.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’431 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
`31.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
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`induce infringement of the ’431 patent under 35 U.S.C. § 271(b) by making, using, offering to
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`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
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`infringement with knowledge of the ’431 patent and knowledge that its acts are encouraging
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`infringement.
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`32.
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`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
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`contributorily infringe the ’431 patent under 35 U.S.C. § 271(c) by making, using, offering to
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`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
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`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’431 patent and that there is no substantial non-infringing use
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`for Par’s Proposed Product.
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`33.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par’s infringement of the ’431 patent is not enjoined.
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`34.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
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`35.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
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`of its reasonable attorneys’ 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’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 ’889 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(c)(2)(A).
`
`38.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’889 patent.
`
`39.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
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`infringe the ’889 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
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`and/or selling Par’s Proposed Product in the United States.
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`40.
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`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
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`induce infringement of the ’889 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’889 patent and knowledge that its acts are encouraging
`
`infringement.
`
`41.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
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`contributorily infringe the ’889 patent under 35 U.S.C. § 271(c) by making, using, offering to
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`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’889 patent and that there is no substantial non-infringing use
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`for Par’s Proposed Product.
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`42.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
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`Par’s infringement of the ’889 patent is not enjoined.
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`43.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`44.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
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`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count 111: Infringement 0f the ’219 Patent
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`45.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-44 as though fully
`
`set forth herein.
`
`46.
`
`Par’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 ’219 patent, constitutes infringement of one or more of the claims of that patent
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`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
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`of the ’219 patent.
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`48.
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`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
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`infringe the ’219 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
`49.
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`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’219 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’219 patent and knowledge that its acts are encouraging
`
`infringement.
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`50.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’219 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’219 patent and that there is no substantial non-infringing use
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`for Par’s Proposed Product.
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`51.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par’s infringement of the ’219 patent is not enjoined.
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`52.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`53.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
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`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
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`Count IV: Infringement of the ’506 Patent
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`54.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-5 3 as though fully
`
`set forth herein.
`
`55.
`
`Par’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 ’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 ’506 patent.
`
`57.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’506 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
`58.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’506 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’506 patent and knowledge that its acts are encouraging
`
`infringement.
`
`59.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’506 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’506 patent and that there is no substantial non-infringing use
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`for Par’s Proposed Product.
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`11
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`60.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
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`Par’s infringement of the ’506 patent is not enjoined.
`
`61.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`62.
`
`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 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’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 ’650 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(c)(2)(A).
`
`65.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’650 patent.
`
`66.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’650 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
`67.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’650 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’650 patent and knowledge that its acts are encouraging
`
`infringement.
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`68.
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`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’650 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’650 patent and that there is no substantial non-infringing use
`
`for Par’s Proposed Product.
`
`69.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par’s infringement of the ’650 patent is not enjoined.
`
`70.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`71.
`
`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 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’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 ’27 5 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(c)(2)(A).
`
`74.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’27 5 patent.
`
`75.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’275 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
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`and/or selling Par’s Proposed Product in the United States.
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`76.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’275 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’275 patent and knowledge that its acts are encouraging
`
`infringement.
`
`77.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’275 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’275 patent and that there is no substantial non-infringing use
`
`for Par’s Proposed Product.
`
`78.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par’s infringement of the ’275 patent is not enjoined.
`
`79.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`80.
`
`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 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
`
`’203 patent. Par’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.
`
`83.
`
`Par’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 ’203 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(c)(2)(A).
`
`84.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’203 patent.
`
`85.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’203 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
`86.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’203 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’203 patent and knowledge that its acts are encouraging
`
`infringement.
`
`87.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’203 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’203 patent and that there is no substantial non-infringing use
`
`for Par’s Proposed Product.
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`88.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par’s infringement of the ’203 patent is not enjoined.
`
`89.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`90.
`
`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 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’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 ’7 30 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(c)(2)(A).
`
`93.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’730 patent.
`
`94.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’730 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
`95.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’730 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’730 patent and knowledge that its acts are encouraging
`
`infringement.
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`96.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’730 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especially
`
`adapted for a use that infringes the ’730 patent and that there is no substantial non-infringing use
`
`for Par’s Proposed Product.
`
`97.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par’s infringement of the ’730 patent is not enjoined.
`
`98.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`99.
`
`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 IX: Infringement of the ’106 Patent
`
`100.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-99 as though fully
`
`set forth herein.
`
`101.
`
`Par’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 ’106 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(c)(2)(A).
`
`102.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’106 patent.
`
`103. Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe the ’106 patent under 35 U.S.C. § 271(a) by making, using, offering to sell, importing,
`
`and/or selling Par’s Proposed Product in the United States.
`
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`104. Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of the ’ 106 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, upon FDA approval of Par’s ANDA, Par will intentionally encourage acts of direct
`
`infringement with knowledge of the ’ 106 patent and knowledge that its acts are encouraging
`
`infringement.
`
`105. Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe the ’ 106 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, importing, and/or selling Par’s Proposed Product in the United States. On information and
`
`belief, Par has had and continues to have knowledge that Par’s Proposed Product is especia