Case 2:10—cv—06108-SDW -MCA Document 1
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`Filed 11/22/10 Page 1 of 14 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
`
`
`
`Plaintiff,
`
`v
`
`JAZZ PHARMACEUTICALS, INC.,
`
`
`
`
`ROXANE LABORATORIES, INC.,
`
`Defendant.
`
`Civil Action No.
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiff Jazz Pharmaceuticals, Inc. (“Jazz Pharmaceuticals”), by its undersigned
`
`attorneys, for its Complaint against defendant Roxane Laboratories, Inc. (“Roxane”), alleges as
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`follows:
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`Nature of the Action
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`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 Roxane’s filing of an Abbreviated New Drug
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`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
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`approval to commercially market a generic version of Jazz Pharmaceuticals’ XYREM® drug
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`product prior to the expiration of United States Patent Nos. 6,780,889 (the “’889 patent”),
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`7,262,219 (the “’219 patent”), 7,668,730 (the “’730 patent”), 7,765,106 (the “’ 106 patent”),
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`and 7,765,107 (the “’107 patent”) owned by Jazz Pharmaceuticals (collectively, “the patents-
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`in-sui ”).
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`The Parties
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`2.
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`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.
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`On information and belief, defendant Roxane is a corporation organized under
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`the laws of Nevada, having a principal place of business at 1809 Wilson Road, Columbus,
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`Ohio 43228.
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`4.
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`On information and belief, Roxane is registered to do business in the State of
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`New Jersey, and maintains a registered agent for service of process in New Jersey. On
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`information and belief, Roxane regularly transacts business within this judicial district.
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`Further, on information and belief, Roxane develops numerous generic drugs for sale and use
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`throughout the United States, including in this judicial district. On information and belief,
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`Roxane has litigated patent cases in this district in the past without contesting personal
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`jurisdiction, and, in at least some of those actions, Roxane 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
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`6.
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`This Court has personal jurisdiction over Roxane by virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
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`Roxane has purposefully availed itself of this forum by, among other things, making, shipping,
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`using, offering to sell or selling, or causing others to use, offer to sell, or sell, pharmaceutical
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`products in the State of New Jersey and deriving revenue from such activities. Further, on
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`information and belief, Roxane has customers in the State of New Jersey.
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`7.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`The Patents in Suit
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`8.
`
`On August 24, 2004, the United States Patent and Trademark Office
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`(“USPTO”) duly and lawfully issued the ’889 patent, entitled “Microbiologically Sound and
`
`Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy” to
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`inventors Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton
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`Reardan. A copy of the ’889 patent is attached hereto as Exhibit A.
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`9.
`
`On August 28, 2007, the USPTO duly and lawfully issued the ’219 patent,
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`entitled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for
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`the Treatment of Narcolepsy” to inventors Harry Cook, Martha Hamilton, Douglas Danielson,
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`Colette Goderstad and Dayton Reardan. A copy of the ’219 patent is attached hereto as Exhibit
`
`B.
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`10.
`
`On February 23, 2010, the USPTO duly and lawfully issued the ’730 patent,
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`entitled “Sensitive Drug Distribution System and Method” to inventors Dayton Reardan, Patti
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`Engle and Bob Gagne. A copy of the ’730 patent is attached hereto as Exhibit C.
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`11.
`
`On July 27, 2010, the USPTO duly and lawfully issued the ’ 106 patent, entitled
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`“Sensitive Drug Distribution System and Method” to inventors Dayton Reardan, Patti Engle
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`and Bob Gagne. A copy of the ’ 106 patent is attached hereto as Exhibit D.
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`12.
`
`On July 27, 2010, the USPTO duly and lawfiilly issued the ’ 107 patent, entitled
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`“Sensitive Drug Distribution System and Method” to inventors Dayton Reardan, Patti Engle
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`and Bob Gagne. A copy of the ’ 107 patent is attached hereto as Exhibit E.
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`The XYREM® Drug Product
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`13.
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`Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under
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`Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a),
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`for sodium oxybate oral solution (NDA No. 21-196), which it sells under the trade name
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`XYREM®. The claims of the patents-in-suit cover, inter alia, pharmaceutical compositions
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`containing sodium oxybate, and methods of use and administration of sodium oxybate or
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`pharmaceutical compositions containing sodium oxybate. Jazz Pharmaceuticals owns the
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`patents-in-suit.
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`14.
`
`Pursuant to 21 U.S.C. § 355(b)( 1) and attendant FDA regulations, the ’889,
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`’219, ’730, ’ 106 and ’ 107 patents are listed in the FDA publication, “Approved Drug Products
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`with Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to XYREM®.
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`Acts Giving Rise to this Suit
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`15.
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`Pursuant to Section 505 of the FFDCA, Roxane filed ANDA No. 202-090
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`(“Roxane’s ANDA”) seeking approval to engage in the commercial use, manufacture, sale,
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`offer for sale or importation of 500 mg/ml sodium oxybate oral solution (“Roxane’s Proposed
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`Produc ”), before the patents-in-suit expire.
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`16.
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`In connection with the filing of its ANDA as described in the preceding
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`paragraph, Roxane has provided a written certification to the FDA, as called for by Section 505
`
`of the FFDCA, alleging that the claims of the patents-in-suit are invalid, unenforceable, and/or
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`will not be infringed by the activities described in Roxane’s ANDA.
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`17.
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`No earlier than October 14, 2010, Roxane sent written notice of its ANDA
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`certification to Jazz Pharmaceuticals (“Roxane’s Notice Letter”). Roxane’s Notice Letter
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`alleged that the claims of the patents-in-suit are invalid, unenforceable, and/or will not be
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`infiinged by the activities described in Roxane’s ANDA. Roxane’s Notice Letter also
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`informed Jazz Pharmaceuticals that Roxane seeks approval to market Roxane’s Proposed
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`Product before the patents-in-suit expire.
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`18.
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`In Roxane’s Notice Letter, it offered to provide access to certain confidential
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`information and materials within Roxane’s ANDA that would allow Jazz Pharmaceuticals to
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`confirm Roxane’s infringement of the patents-in—suit. In response, Jazz Pharmaceuticals wrote
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`to Roxane regarding the terms of this offer and requesting access. To date, Roxane has not
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`responded to this inquiry or provided any portion of its ANDA to counsel for Jazz
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`Pharmaceuticals.
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`Count I: Infringement of the ’889 Patent
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`19.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-18 as though fixlly
`
`set forth herein.
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`20.
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`Roxane’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
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`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 (e)(2)(A).
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`21.
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`There is a justiciable controversy between the parties hereto as to the
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`infringement of the ’889 patent.
`
`22.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will infringe the ’889 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Roxane’s Proposed Product in the United States.
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`23.
`
`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will induce infringement of the ’889 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, upon FDA approval of Roxane’s ANDA, Roxane will intentionally
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`encourage acts of direct infringement with knowledge of the ’889 patent and knowledge that its
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`acts are encouraging infringement.
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`24.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will contributorily infringe the ’889 patent under 35 U.S.C. § 271(c) by making, using, offering
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`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, Roxane has had and continues to have knowledge that Roxane’s
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`Proposed Product is especially adapted for a use that infringes the ’889 patent and that there is
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`no substantial non-infringing use for Roxane’s Proposed Product.
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`25.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
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`if Roxane’s infringement of the ’889 patent is not enjoined.
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`26.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`27.
`
`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 ’219 Patent
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`28.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-27 as though fully
`
`set forth herein.
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`29.
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`Roxane’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 under 35 U.S.C. § 271(c)(2)(A).
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`30.
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`There is a justiciable controversy between the parties hereto as to the
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`infringement of the ’219 patent.
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`31.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will infringe the ’219 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Roxane’s Proposed Product in the United States.
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`32.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
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`will induce infringement of the ’219 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, upon FDA approval of Roxane’s ANDA, Roxane 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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`33.
`
`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will contributorily infringe the ’219 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
`
`information and belief, Roxane has had and continues to have knowledge that Roxane’s
`
`Proposed Product is especially adapted for a use that infringes the ’219 patent and that there is
`
`no substantial non-infringing use for Roxane’s Proposed Product.
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`34.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
`
`if Roxane’s infringement of the ’219 patent is not enjoined.
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`35.
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`Jazz Pharmaceuticals does not have an adequate remedy at law.
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`36.
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`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 HI: Infringement of the ’730 Patent
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`37.
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`Plaintiff repeats and realleges the allegations of paragraphs 1-36 as though fully
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`set forth herein.
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`38.
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`Roxane’s submission of its ANDA to obtain approval to engage in the
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`commercial use, manufacture, sale, offer for sale, or importation of sodium oxybate oral
`
`solution, prior to the expiration of the ’730 patent, constitutes infringement of one or more of
`
`the claims of that patent under 35 U.S.C. § 271(c)(2)(A).
`
`39.
`
`There is ajusticiable controversy between the parties hereto as to the
`
`infringement of the ’730 patent.
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`40.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will infringe the ’730 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Roxane’s Proposed Product in the United States.
`
`41.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will induce infringement of the ’730 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Roxane’s ANDA, Roxane 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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`42.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will contributorily infiinge the ’730 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
`
`information and belief, Roxane has had and continues to have knowledge that Roxane’s
`
`Proposed Product is especially adapted for a use that infringes the ’730 patent and that there is
`
`no substantial non-infringing use for Roxane’s Proposed Product.
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`43.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
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`if Roxane’s infiingement of the ’730 patent is not enjoined.
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`44.
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`Jazz Pharmaceuticals does not have an adequate remedy at law.
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`45.
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`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 ’106 Patent
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`46.
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`Plaintiff repeats and realleges the allegations of paragraphs 1-45 as though fully
`
`set forth herein.
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`47.
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`Roxane’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).
`
`48.
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`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’ 106 patent.
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`49.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will infringe the ’ 106 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
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`importing, and/or selling Roxane’s Proposed Product in the United States.
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`50.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will induce infiingement of the ’ 106 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
`
`information and belief, upon FDA approval of Roxane’s ANDA, Roxane will intentionally
`
`encourage acts of direct infringement with knowledge of the ’ 106 patent and knowledge that its
`
`acts are encouraging infringement.
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`51.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will contributorily infringe the ’ 106 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, Roxane has had and continues to have knowledge that Roxane’s
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`Proposed Product is especially adapted for a use that infi'inges the ’ 106 patent and that there is
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`no substantial non-infringing use for Roxane’s Proposed Product.
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`52.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
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`if Roxane’s infringement of the ’ 106 patent is not enjoined.
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`53.
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`Jazz Pharmaceuticals does not have an adequate remedy at law.
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`54.
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`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 V: Infringement of the ’107 Patent
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`55.
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`Plaintiff repeats and realleges the allegations of paragraphs 1-54 as though fully
`
`set forth herein.
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`56.
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`Roxane’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
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`solution, prior to the expiration of the ’107 patent, constitutes infringement of one or more of
`
`the claims of that patent under 35 U.S.C. § 271(c)(2)(A).
`
`57.
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`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’ 107 patent.
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`58.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will infringe the ’ 107 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Roxane’s Proposed Product in the United States.
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`59.
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`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will induce infringement of the ’ 107 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
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`information and belief, upon FDA approval of Roxane’s ANDA, Roxane will intentionally
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`encourage acts of direct infringement with knowledge of the ’ 107 patent and knowledge that its
`
`acts are encouraging infringement.
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`60.
`
`Unless enjoined by this Court, upon FDA approval of Roxane’s ANDA, Roxane
`
`will contributorily infringe the ’ 107 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Roxane’s Proposed Product in the United States. On
`
`information and belief, Roxane has had and continues to have knowledge that Roxane’s
`
`Proposed Product is especially adapted for a use that infringes the ’107 patent and that there is
`
`no substantial non-infringing use for Roxane’s Proposed Product.
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`61.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed
`
`if Roxane’s infringement of the ’ 107 patent is not enjoined.
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`62.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`63.
`
`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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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff Jazz Pharmaceuticals respectfully requests the following relief:
`
`(A)
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`A Judgment be entered that Roxane has infringed the ’889, ’219, ’730, ’106 and
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`’ 107 patents by submitting ANDA No. 202-090;
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`(B)
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`A Judgment be entered that Roxane has infringed, and that Roxane’s making,
`
`using, selling, offering to sell, or importing Roxane’s Proposed Product will infringe one or more
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`claims of the ’889, ’219, ’730, ’ 106 and ’ 107 patents;
`
`(C)
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`An Order that the effective date of FDA approval of ANDA No. 202-090 be a
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`date which is not earlier than the later of the expiration of the ’889, ’219, ’730, ’ 106 and ’ 107
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`patents, or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
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`(D)
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`Preliminary and permanent injunctions enjoining Roxane and its officers, agents,
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`attorneys and employees, and those acting in privity or concert with them, from making, using,
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`selling, offering to sell, or importing Roxane’s Proposed Product until after the expiration of the
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`’889, ’219, ’730, ’106 and ’107 patents, or any later expiration of exclusivity to which Plaintiff is
`
`or becomes entitled;
`
`(E)
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`A permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B),
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`restraining and enjoining Roxane, its officers, agents, attorneys and employees, and those acting
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`in privity or concert with them, from practicing any compounds, methods or compositions as
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`claimed in the ’889, ’219, ’730, ’ 106 and ’ 107 patents, or from actively inducing or contributing
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`to the infringement of any claim of any of the patents-in-suit, until alter the expiration of the
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`patents-in-suit, or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`(F)
`
`A Declaration that the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Roxane’s Proposed Product will directly infringe, induce and/or
`
`contribute to infringement of the ’889, ’219, ’730, ’ 106 and ’ 107 patents;
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`(G)
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`To the extent that Roxane has committed any acts with respect to the compounds,
`
`methods or compositions claimed in the ’889, ’219, ’730, ’106 and ’107 patents, other than those
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`acts expressly exempted by 35 U.S.C. § 271(c)(1), that Plaintiff Jazz Pharmaceuticals be
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`awarded damages for such acts;
`
`(H)
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`If Roxane engages in the commercial manufacture, use, importation into the
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`United States, sale, or offer for sale of Roxane’s Proposed Product prior to the expiration of the
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`’889, ’219, ’730, ’ 106 and ’ 107 patents, a Judgment awarding damages to Plaintiff Jazz
`
`Pharmaceuticals resulting from such infringement, together with interest;
`
`(I)
`
`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
`
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`Case 2:10-cv-06108-SDW ~MCA Document 1
`
`Filed 11/22/10 Page 13 of 14 PagelD: 13
`
`(J)
`
`Costs and expenses in this action; and
`
`(K)
`
`Such further and other relief as this Court may deem just and proper.
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING
`
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneysfor Plaintifl
`Jazz Pharmaceuticals, Inc.
`
`Dated: November 22, 2010
`
`Of Counsel:
`
`F. Dominic Cerrito
`
`Daniel L. Malone
`JONES DAY
`222 East 41st Street
`
`New York, New York 10017-6702
`
`(212) 326-3939
`
`Richard G. Greco
`KAYE SCHOLER LLP
`425 Park Avenue
`
`New York, New York 10022-3598
`
`(212) 836-8500
`
`ROX 1024
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`Case 2:10-cv-06108-SDW -MCA Document 1
`
`Filed 11/22/10 Page 14 of 14 PageID: 14
`
`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`I hereby 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.
`
`Dated: November 22, 2010
`
`01 Counsel:
`
`F. Dominic Cerrito
`Daniel L. Malone
`
`JONES DAY
`222 East 41 st Street
`New York, New York 10017-6702
`
`(212) 326-3939
`
`Richard G. Greco
`KAYE SCHOLER LLP
`425 Park Avenue
`
`New York, New York 10022-3598
`
`(212) 836-8500
`
`By: 5/ 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
`
`Attorneysfor Plaintiff
`Jazz Pharmaceuticals, Inc.
`
`ROX 1024
`CBM of U.S. Patent No. 7,765,107
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`
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`

`«544 (ngggse 2:10-cv—06108—SDW "MCéI‘FiLCW SW 1/22/10 Page 1 of 1 PagelD: 15
`
`The 18 44 civil cover sheet and the information contained herein neither re lace nor sugplement the filing and service ofpleadings or othertgapers as reggredby law, except as provided
`by local rules ofcourt. This form, approved by the Judicial Conference 0 the United tates in September 1974, is requrred for the use of e Clerk of
`urt for the purpose of Initiating
`the civil docket sheet
`(SEE INSTRUCTIONS ON THE REVERSE OF THE FORM.)
`
`PLAINTIFFS
`
`Jazz Pharmaceuticals, Inc.
`
`DEFENDANTS
`
`Roxane Laboratories, Inc.
`
`Santa Clara: CA
`(b) County of Residence of First Listed Plaintiff
`(EXCEPT IN US. PLAINTIFF CASES)
`
`
`Franklin, OH
`County of Residence of First Listed Defendant
`(IN US. PLAINTIFF CASES ONLY)
`NOTE: m LAND CONDEMNATION CASES, USE THE LOCATION or THE
`LAND INVOLVED.
`
`(c) Attorney’s (Firm Name, Address, and Telephone Number)
`
`Attorneys (If Known)
`
`Charles M. Lizza, Esq., Saul Ewing LLP, One Riverfront Plaza,
`Newark, New Jerse 07102-5426, (973) 286-6700, cliz . t saul.com
`II. BASIS OF JURISDICTION (Place an “X" in One Box Only)
`III. CITIZENSHIP OF PRINCIPAL PARTIESGIace an “X" in One Box for Plaintiff
`(For Diversity Cases Only)
`and One Box for Defendant)
`PTF
`PTF
`DEF
`U 1
`D 4
`l3 4
`
`Citizen of This State
`
`DEF
`D 1
`
`Incorporated or Principal Place
`of Business In This State
`
`US. Government
`
`a 3 Federal Question
`(US. Government Not a Party)
`
`U 2 US Government
`
`CI 4 Diversity
`(Indicate Citizenship ofParties in Item III)
`
`Citizen of Another State
`
`U 2
`
`D 2
`
`Incorporated and Principal Place
`of Business In Another State
`
`D 5
`
`D 5
`
`IV. NATURE OF SUIT
`
` ' lace an “X" in One Box Onl
`
`
`
`Citizen or Subject of a
`Foreign Coun-
`
`D 3
`
`D 3
`
`Foreign Nation
`
`D 6
`
`D 6
`
`
`
`
`
`
`
`
`
`CI 152 Recovery of Defaulted
`
`(Excl. Veterans)
`D 153 Recovery of Overpayment
`of Veteran’s Benefits
`D 160 Stockholders’ Suits
`
`0 210 Land Condemnation
`
`D 230 Rent Lease & Ejectrnent
`
`0 245 Tort Product Liability
`D 290 All Other Real Property
`
`PERSONAL INJURY
`PERSONAL INJURY
`D 610 Agriculture
`U 362 Personal Injury -
`D 310 Airplane
`U 620 Other Food & Drug
`Med. Malpractice
`0 315 Airplane Product
`D 625 Drug Related Seizure
`D 365 Personal Injury -
`Liability
`D 140 Negotiable Instrument
`of Property 21 USC 881
`Product Liability
`D 150 Recovery of Overpayment D 320 Assault, Libel &
`D 630 Liquor Laws
`.
`D 368 Asbestos Personal
`& Enforcement of Judgment
`Slander
`D 640 RR. & Tmck
`D 820 Copyrights
`Injury Product
`D 330 Federal Employers’
`D 650 Airline Regs.
`U 830 Patent
`
`
`Liability
`Liability
`0 660 Occupational
`D 840 Trademark
`
`PERSONAL PROPERTY
`I: 340 Marine
`Safety/Health
`
`0 370 Other Fraud
`D 345 Marine Product
`0 690 Other
`
`
`0 371 Truth in Lending
`Liability
`,
`D 380 Other Personal
`0 350 Motor Vehicle
`0 710 Fair Labor Standards
`0 861 HIA (1395fi)
`
`
`
`
`Property Damage
`D 355 Motor Vehicle
`D 862 Black Lung (923)
`Act
`
`
`
`D 385 Property Damage
`Product Liability
`D 720 Labor/Mgmt. Relations D 863 DIWC/DIWW (405(g))
`
`
`
`D 730 Labor/Mgmt.Reporting D 864 SSID Title XVI
`El 195 Contract Product Liability D 360 Other Personal
`Product Liability
`D 865 RSI 405( 1
`In'
`& Disclosure Act
`
`0 740 Railway Labor Act
`
`
`
`
`D 441 Voting
`0 510 Motions to Vacate
`ID 870 Taxes (US. Plaintiff
`U 790 Other Labor Litigation
`
`
`
`
`D 791 Empl. Ret. Inc.
`or Defendant)
`D 442 Employment
`Sentence
`
`
`
`
`
`Security Act
`D 871 IRS—Third Party
`D 443 Housing/
`Habeas Corpus:
`
`
`
`
`
`26 USC 7609
`D 530 General
`Accommodations
`0 535 Death Penalty
`D 444 Welfare
`
`
`
`ID 540 Mandamus & Other
`0 445 Amer. w/Disabilities -
`
`
`
`D 550 Civil Rights
`Employment
`
`
`
`D 446 Amer. w/Disabilities -
`555 Prison Condition
`
`Other
`
`U 440 Other Civil Rights
`
`
`
`
`CI 422 Appeal 28 USC 158
`
`
`
`
`U 423 Withdrawal
`
`
`28 USC 157
`
`
`D 400 State Reapportionment
`D 410 Antitrust
`D 430 Banks and Banking
`D 450 Commerce
`D 460 Deportation
`D 470 Racketeer Influenced and
`Corrupt Organizations
`D 480 Consumer Credit
`I: 490 Cable/Sat TV
`0 810 Selective Service
`D 850 Securities/Commodities]
`Exchange
`D 875 Customer Challenge
`12 USC 3410
`D 890 Other Statutory Actions
`U 891 Agricultural Acts
`Cl 892 Economic Stabilization Act
`U 893 Environmental Matters
`U 894 Energy Allocation Act
`D 895 Freedom of Information
`Act
`0 900Appeal of Fee Determination
`Under Equal Access
`to Justice
`D 950 Constitutionality of
`State Statutes
`
`A133“! to District
`(Place an “X" in One Box Only)
`...
`1:17 1“ng“
`gsTmsfmdfr°m D6
`.
`1:12
`1:13
`Multidistnct
`Magistrate
`another district
`Remstated or
`Removed from
`Remanded from
`
`
`
`Liti ation
`Jud
`ent
`ci
`Re
`ed
`State Court
`A ellate Court
`
`
`
`
`'
`:
`'
`I
`'
`'
`i
`'
`it
`'
`t
`'
`'
`.
`'
`d whi
`
`
`ch you are filing (Do no c e jur sdrctronal statutes un ess drversrty)
`(a? 13%Eesdgyéltgéaatg(pg er
`
`
`_
`_
`_
`_
`_
`.
`Brief description _of cause:
`
`
`This IS an actIOn for patent Infringement ansmg out of the patent laws of the United States of Amenca.
`
`
`CHECK IF THIS IS A CLASS ACTION
`DEMAND 5
`CHECK YES only if demanded in complaint:
`VII. REQUESTED IN
`
`COMPLAINT:
`UNDER F.R.C.P. 23
`JURY DEMAND:
`CI Yes
`2! No
`
`VI. CAUSE OF ACTION
`
`1:14
`
`VIII. RELATED CASE(S)
`
`.
`_
`_
`S
`( °° ”mm”
`
`IUDGE
`
`n/a
`
`DOCKET NUMBER
`
`
`
`& ‘
`SIGNATURE OF ATTORNEY OF RECORD
`OWL &\
`
`FOR OFFICE USE ONLY
`
`ROX 1024
`CBM of U.S. Patent No. 7,765,107
`15 of 174
`
`

`

`Case 2:10-cv-06108-SDW -MCA Document 1-2
`
`Filed 11/22/10 Page 1 of 38 PagelD: 16
`
`EXHIBIT A
`
`ROX 1024
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`

`

`Case 2:10-cv-06108-SDW -MCA DocumenmlmllllllMflm mmmmmmmmm mm m : 17
`
`USOO6780889B2
`
`(12) Unlted States Patent
`(10) Patent No.:
`US 6,780,889 B2
`Cook et al.
`(45) Date of Patent:
`Aug. 24, 2004
`
`
`4,738,985 A
`4/1988 Kluger et al. ............... 514/533
`4,983,632 A
`1/1991 Gessa et al.
`514/557
`
`5,380,937 A
`1/1995 Koehler et al.
`.. 562/579
`..
`5,594,030 A ’
`1/1997 Conte et al.
`514/553
`5,840,331 A
`11/1998 Van Canter et al.
`424/464
`
`5,990,162 A
`11/1999 Scharf ................
`514/533
`6,472,431 B2 . 10/2002 Cook etal.
`................. 514/557
`FOREIGN PATENT DOCUMENTS
`
`(75)
`
`(54) MICROBIOIDGICALLY SOUNDAND
`smug SOLUTIONS OF GAMMA-
`HYDROXYBUTYRATE SALT FOR THE
`REQT
`T
`MENT 0F NARCOLEPSY
`.
`.
`.
`.
`Inventors- gym?aifi? giaEZMaélggg)
`Douglas Danielson, Otsogo. MI (US);
`Colette Goderstad, St. Paul, MN (US);
`Dayton Reardan, Excelsior, MN (US)
`-
`.
`-
`-
`(73) ASSIgncc' 33?;3Med'ca" Inc" Mmetonka’
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 195 days.
`
`(21) Appl. No.: 10/194,021
`.
`'
`(22) “ed
`(65)
`
`J"" 11’ 2002
`Prior Publication Data
`US 2003/0125385 A1 Jul. 3, 2003
`
`59
`EP
`EP
`EP
`GB
`
`W0
`
`0 B5 408
`0344704
`0616804
`0635265
`922029
`
`W0-96/40105
`OTHER PUB
`
`9/1987
`5/1989
`3/1994
`7/1994
`3/1963
`
`12/1996
`
`.......... A61Kf31/19
`.......... A61Kf31/19
`.......... A61K/31/19
`
`""""" A61Kf31/19
`ONS
`
`”CATI
`Arena, C., et al., “Absorption of Sodium Y—Hydroxybu-
`tyrate
`and
`its Prodrug Y—bntyrolactone:
`relationship
`between n vitro transport and in vivo absorption”, J. Phar-
`maceutical Sciences, 69(3), (1980), 356—358.
`.
`.
`(List continued on next page.)
`
`.
`Related US. Application Data
`-«
`-
`-
`-
`Drvrsron of a
`lrcatron No. 09/470,570, filed on Dec. 22,
`1999, now PagPNo. 6,472,431.
`ggxéisronal application No. 60/113,745, filed on Dec. 23,
`
`(62
`)
`(60)
`
`Primary Examiner—Zohreh Fay
`Assistant Examiner—Brian—Yong S. Kwon
`74) Attorney, Agent or Firm—Schwegman, Lundberg,
`(
`,
`Woossnor & K1uth,P.A
`(57)
`ABSTRACT
`
`(51)
`
`(52) us. Cl.
`
`Int. Cl.7 ...................... A61K 31/19; A61K 31/235;
`A61K 31/34; A61K 31/215
`....................... 514/557; 514/473; 514/533;
`514/529
`(58) Field of Search ................................. 514/557, 473,
`514533, 529
`
`(56)
`
`References Cited
`US. PATENT DOCUMENTS
`
`Disclosed are formulations of gamma-hydroxybutyrate in an
`aqueous medium that are resistant to microbial growth. Also
`disclosed are formulations of gamma-hydroxybutyrato that
`are also resistant to the conversion into GBL. Disclosed are
`methods to treat sleep disorders, including narcolepsy, with
`these stable formulations of GHB. The present invention
`also provides methods to treat alcohol and opiate
`withdrawal, reduced levels of growth hormone, increased
`intracranial pressure, and physical pain in a patient.
`
`4,393,236 A
`
`7/1983 Klosa ......................... 562/579
`
`1 Claim, 1 Drawing Sheet
`
`
`
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`—.a_—'
`=“t2tiJuumFm—dfiuih‘nlh"
`O uh—uhuy—‘Ht Hung-“mum.
`m*u~_-~u—a—
`
`V V sumo—un-
`.
`hfi-fl‘_‘n‘
`
`ROX 1024
`CBM of U.S. Patent No. 7,765,107
`17 of 174
`
`

`

`Case 2:10-cv-06108-SDW -MCA Document 1-2
`
`Filed 11/22/10 Page 3 of 38 PageID: 18
`
`US 6,780,889 B2
`Page 2
`
`OTHER PUBLICATIONS
`
`Bedard, M. A., “Nocturnal y—Hydroxybutyrate—Effect on
`Periodic Leg Movements and Sleep Organization of Narco-
`leptic