Case 2:14-cv-05139-KM-MAH Document 1 Filed 08/15/14 Page 1 of 35 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
`
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`
`
`(Filed Electronically)
`
`JAZZ PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`PAR PHARMACEUTICAL, INC.,
`
`
`
`
`
`
`
`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
`
`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(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 No. 8,731,963 (the (cid:147)(cid:146)963 patent(cid:148) or the
`
`(cid:147)patent-in-suit(cid:148)) owned by Jazz Pharmaceuticals.
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`
`
`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 Par Pharmaceutical, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware, having a principal place of
`
`business at 300 Tice Boulevard, Woodcliff Lake, New Jersey.
`
`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.
`
`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,
`
`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
`
`State of New Jersey and deriving revenue from such activities. Also, on information and belief,
`
`Par has customers in the State of New Jersey. Further, on information and belief, Par is
`
`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).
`
`
`
`
`2
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`
`
`The Patent-In-Suit
`
`8.
`
`On May 20, 2014, the USPTO duly and lawfully issued the (cid:146)963 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)963 patent is attached
`
`hereto as Exhibit A.
`
`The XYREM® Drug Product
`
`9.
`
`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 patent-in-suit cover, inter alia, computer-implemented systems for the
`
`administration of sodium oxybate or pharmaceutical compositions containing sodium oxybate.
`
`Jazz Pharmaceuticals owns the patent-in-suit.
`
`10.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the (cid:146)963 patent
`
`is 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
`
`11.
`
`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
`
`patent-in-suit expires.
`
`12.
`
`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
`
`
`
`
`3
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`
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`Certification(cid:148)), alleging that the claims of the patent-in-suit are invalid, unenforceable, and/or
`
`will not be infringed by the activities described in Par(cid:146)s ANDA.
`
`13.
`
`No earlier than July 3, 2014, 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 patent-in-suit 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
`
`patent-in-suit expires.
`
`Count for Infringement of the ’963 Patent
`
`14.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-13 as though fully
`
`set forth herein.
`
`15.
`
`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)963 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`16.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the (cid:146)963 patent.
`
`17.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`infringe the (cid:146)963 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.
`
`18.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`induce infringement of the (cid:146)963 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
`
`4
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`
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`infringement with knowledge of the (cid:146)963 patent and knowledge that its acts are encouraging
`
`infringement.
`
`19.
`
`Unless enjoined by this Court, upon FDA approval of Par(cid:146)s ANDA, Par will
`
`contributorily infringe the (cid:146)963 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)963 patent and that there is no substantial non-infringing use
`
`for Par(cid:146)s Proposed Product.
`
`20.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Par(cid:146)s infringement of the (cid:146)963 patent is not enjoined.
`
`21.
`
`22.
`
`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 Par has infringed the patent-in-suit by submitting
`
`ANDA No. 205403;
`
`(B) A Judgment be entered that Par has infringed, and that Par(cid:146)s making, using,
`
`selling, offering to sell, or importing Par(cid:146)s Proposed Product will infringe one or more claims of
`
`the patent-in-suit;
`
`(C) An Order that the effective date of FDA approval of ANDA No. 205403 be a date
`
`which is not earlier than the later of the expiration of the patent-in-suit, or any later expiration of
`
`exclusivity to which Plaintiff is or becomes entitled;
`
`
`
`
`5
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`
`
`(D)
`
`Preliminary and permanent injunctions enjoining Par 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 Par(cid:146)s Proposed Product until after the expiration of the
`
`patent-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 Par, its officers, agents, attorneys and employees, and those acting in
`
`privity or concert with them, from practicing any systems as claimed in the patent-in-suit, or
`
`from actively inducing or contributing to the infringement of any claim of the patent-in-suit, until
`
`after the expiration of the patent-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 Par(cid:146)s Proposed Product will directly infringe, induce and/or
`
`contribute to infringement of the patent-in-suit;
`
`(G) To the extent that Par has committed any acts with respect to the systems claimed
`
`in the patent-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 Par engages in the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Par(cid:146)s Proposed Product prior to the expiration of the patent-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
`
`(K) Such further and other relief as this Court may deem just and proper.
`
`
`
`
`6
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`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`Dated: August 15, 2014
`
`
`
`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
`
`
`
`
`7
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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), and Jazz Pharmaceuticals,
`
`Inc. v. Ranbaxy Laboratories Limited and Ranbaxy Inc., Civil Action No. 14-4467 (ES)(JAD)
`
`are related to the matter in controversy because the matter in controversy involves the same
`
`plaintiff and related patents.
`
`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
`
`
`
`
`
`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.
`
`proceeding.
`
`Dated: August 15, 2014
`
`
`
`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
`
`8
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`
`EXHIBIT A
`
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`Case 2:14-cv-05139-KM-MAH Document 1 Filed 08/15/14 Page 10 of 35 PageID: 10
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US008731963B 1
`
`(12) United States Patent
`Reardan et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,731,963 Bl
`*May 20, 2014
`
`(54) SENSITIVE DRUG DISTRIBUTION SYSTEM
`AND METHOD
`
`(75)
`
`Inventors: Dayton T. Reardan, Shorewood, MN
`(US); Patti A. Engel, Eagan, MN (US);
`Bob Gagne, St. Paul, MN (US)
`
`(73) Assignee: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.c. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/592,202
`
`(22) Filed:
`
`Aug. 22, 2012
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 13/013,680, filed on
`Jan. 25, 2011, now abandoned, which is a continuation
`of application No. 121704,097, filed on Feb. 11, 201 0,
`now Pat. No. 7,895,059, which is a continuation of
`application No. 10/322,348, filed on Dec. 17, 2002,
`now Pat. No. 7,668,730.
`
`(51)
`
`(2012.01)
`
`Int. Cl.
`G06Q 10/00
`(52) U.S. Cl.
`USPC .................................... 70512; 705/3; 707/803
`(58) Field of Classification Search
`USPC ........................................... 707/803; 705/2, 3
`See application file for complete search history.
`
`(56)
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`ABSTRACT
`(57)
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`
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`Case 2:14-cv-05139-KM-MAH Document 1 Filed 08/15/14 Page 11 of 35 PageID: 11
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`"U.S. App!. No. 10/322,348, Non Final Office Action mailed Jun. 29,
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`"U.S. App!. No. 10/322,348, Notice of Allowance mailed Dec. 31,
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`"U.S. App!. No. 10/322,348, Preliminary Amendment mailed Sep.
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`"U.S. App!. No. 10/322,348, Response filed Mar. 29, 2006 to Final
`Office Action mailed Dec. 29, 2005", 11 pgs.
`"U.S. App!. No. 10/322,348, Response filed Aug. 8, 2006 to Non
`Final Office Action mailed Jun. 19, 2006", 10 pgs.
`"U.S. App!. No. 10/322,348, Response filed Sep. 29, 2005 to Non
`Final Office Action mailed Jun. 29, 2005", 19 pgs.
`"U.S. App!. No. 101731,915, Non Final OfficeActionmailedSug.12,
`2005", 22 pgs.
`"U.S. App!. No. 101731,915, Non Final Office Action mailed Oct. 5,
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`"U.S. App!. No. 101731,915, Non Final Office Action Response
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`"U.S. App!. No. 10/979,665, Non-Final Office Action mailed Nov.
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`"U.S. App!. No. 101979,665, Notice of Allowance mailed Apr. 30,
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`"U.S. App!. No. 101979,665, Preliminary Amendment filed Jun. 22,
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`"U.S. App!. No. 10/979,665, Preliminary Amendment mailed Nov. 2,
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`"U.S. App!. No. 10/979,665, Response filed Mar. 11,2010 to Non
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`"U.S. App!. No. 101979,665, Response filed Ju!. 14,2009 to Restric(cid:173)
`tion Requirement mailed Jun. 25, 2009", 8 pgs.
`"U.S. App!. No. 101979,665, Restriction Requirement mailed Jun.
`25, 2009", 7 pgs.
`"U.S. App!. No. 111097,651, Examiner Interview Summary mailed
`May 27,2010",3 pgs.
`"U.S. App!. No. 111097,651, Final Office Action mailed Nov. 12,
`2009", 14 pgs.
`"U.S. App!. No. 111097,651, Non-Final Office Action mailed Mar. 3,
`2010", 19 pgs.
`"U.S. App!. No. 111097,651, Non-Final Office Action mailed May
`27, 2009", 21 pgs.
`"U.S. App!. No. 111097,651, Notice of Allowance mailed Ju!. 23,
`2010",9 pgs.
`"U.S. App!. No. 111097,651, Preliminary Amendment mailed Apr. 1,
`2005", 6 pgs.
`"U.S. App!. No. 111097,651, Response filed Feb. 9, 2010 to Final
`Office Action mailed Nov. 12,2009", 11 pgs.
`"U.S. App!. No. 111097,651, Response filed Jun. 3, 2010to Non Final
`Office Action mailed Mar. 3, 2010", 12 pgs.
`"U.S. App!. No. 111097,651, Response filed Sep. 17,2009 to Non
`Final Office Action mailed May 29,2009", 10 pgs.
`"U.S. App!. No. 111097,985, Non Final Office Action mailed Sep. 14,
`2009", 22 pgs.
`"U.S. App!. No. 111097,985, Notice of Allowance mailed Mar. 10,
`2010", 11 pgs.
`"U.S. App!. No. 111097,985, Preliminary Amendment mailed Apr. 1,
`2005", 7 pgs.
`"U.S. App!. No. 111097,985, Response filed Nov. 3, 2009 to Non
`Final Office Action mailed Sep. 14,2009", 15 pgs.
`"U.S. App!. No. 111097,985, Supplemental Notice of Allowability
`mailed Jun. 29, 2010", 3 pgs.
`"U.S. App!. No. 121704,097, Non-Final Office Action mailed Sep. 24,
`2010",5 pgs.
`"U.S. App!. No. 121704,097, Notice of Allowance mailed Dec. 21,
`2010",8 pgs.
`"U.S. App!. No. 121704,097, Response filed Nov. 4, 2010 to Non
`Final Office Action mailed Sep. 24, 2010", 12 pgs.
`"U.S. App!. No. 13/013,680, Response filed Jun. 12,2012 to Restric(cid:173)
`tion Requirement mailed Dec. 14,2011",9 pgs.
`"U.S. App!. No. 13/013,680, Restriction Requirement mailed Dec.
`14,2011",7 pgs.
`"U.S. App!. No. 13/013,680, Preliminary Amendment filed Jun. 13,
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`
`PAR1026
`IPR of U.S. Patent No. 8,731,963
`Page 11 of 35
`
`

`
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`
`US 8,731,963 Bl
`Page 3
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