Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 1 of 65 PageID: 1
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`
`Attorneys for Plaintiffs
`Helsinn Healthcare S.A. and
`Roche Palo Alto LLC
`
`Of Counsel:
`
`Joseph M. O’Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`Angela C. Ni
`PAUL HASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`
`Attorneys for Plaintiff
`Helsinn Healthcare S.A.
`
`Mark E. Waddell
`LOEB & LOEB LLP
`345 Park Avenue
`New York, NY 10154
`(212) 407-4127
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
`
`Civil Action No. ____________________
`
`Plaintiffs,
`
`v.
`
`PAR PHARMACEUTICAL COMPANIES,
`INC. and PAR PHARMACEUTICAL, INC.,
`
`Defendants.
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiffs Helsinn Healthcare S.A. (“Helsinn”) and Roche Palo Alto LLC
`
`(“Roche”) (collectively, “Plaintiffs”), for their Complaint against Defendants Par Pharmaceutical
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 2 of 65 PageID: 2
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`Companies, Inc. (“Par Companies”) and Par Pharmaceutical, Inc., (“Par Inc.”) (collectively,
`
`“Defendants” or “Par”) hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Helsinn is a Swiss corporation having its principal place of business at Via
`
`Pian Scairolo, 9, CH-6912 Lugano-Pazzallo, Switzerland.
`
`2.
`
`Roche is a company, organized and existing under the laws of the State of
`
`Delaware, having a principal place of business at One DNA Way, South San Francisco,
`
`California 94080-4990.
`
`3.
`
`Upon information and belief, Par Companies is an entity organized and
`
`existing under the laws of the State of Delaware, with a principal place of business at 300 Tice
`
`Boulevard, Woodcliff Lake, New Jersey 07677. Upon information and belief, Par Companies
`
`manufactures, markets, and/or sells various generic drug products for sale and use in the State of
`
`New Jersey and throughout the United States.
`
`4.
`
`Upon information and belief, Par Inc. is an entity organized and existing
`
`under the laws of the State of Delaware, with a principal place of business at One Ram Ridge
`
`Road, Spring Valley, New York 10977. Upon information and belief, Par Inc. manufactures,
`
`markets, and/or sells various generic drug products for sale and use in the State of New Jersey
`
`and throughout the United States. Upon information and belief, Par Inc. is a wholly-owned
`
`subsidiary of Par Companies.
`
`5.
`
`Upon information and belief, the acts of Par Inc. complained of herein
`
`were done at the direction of, with the authorization of, and with the cooperation, assistance,
`
`and/or participation of Par Companies.
`
`-2-
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 3 of 65 PageID: 3
`
`NATURE OF THE ACTION
`
`6.
`
`This is a civil action concerning the infringement of United States Patent
`
`No. 7,947,724 (“the ’724 patent”), United States Patent No. 7,947,725 (“the ’725 patent”),
`
`United States Patent No. 7,960,424 (“the ’424 patent”), United States Patent No. 8,598,219 (“the
`
`’219 patent”), and United States Patent No. 8,729,094 (“the ’094 patent”). This action arises
`
`under the patent laws of the United States, 35 U.S.C. §§ 100 et seq., as well as the Declaratory
`
`Judgment Act, 28 U.S.C. §§ 2201-02.
`
`JURISDICTION AND VENUE
`
`7.
`
`This Court has jurisdiction over the subject matter of this action pursuant
`
`to 28 U.S.C. §§ 1331 and 1338(a) and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02.
`
`8.
`
`This Court may declare the rights and other legal relations of the parties
`
`pursuant to 28 U.S.C. §§ 2201-02 because this case is an actual controversy within the Court’s
`
`jurisdiction.
`
`9.
`
`Venue is proper in this Court as to each Defendant pursuant to 28 U.S.C.
`
`§§ 1391(b), (c), and/or (d), and 1400(b).
`
`10.
`
`This Court has personal jurisdiction over Defendants by virtue of the fact
`
`that, inter alia, both defendants have committed, aided, abetted, contributed to, and/or
`
`participated in the commission of a tortious act of patent infringement that has led to foreseeable
`
`harm and injury to Plaintiffs. This Court has personal jurisdiction over Defendants for the
`
`additional reasons set forth below, and for other reasons that will be presented to the Court if
`
`such jurisdiction is challenged.
`
`11.
`
`This Court has personal jurisdiction over Par Companies by virtue of the
`
`fact that, inter alia, it: (1) has a principal place of business in this Judicial District; (2) has
`
`purposely availed itself of the privilege of doing business in this Judicial District; (3) maintains
`
`-3-
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 4 of 65 PageID: 4
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`extensive systematic contacts with the State of New Jersey, including the marketing, distribution,
`
`and/or sale of generic pharmaceutical drugs to New Jersey residents; (4) has previously
`
`consented to this Court’s jurisdiction and taken advantage of the rights and protections provided
`
`by this Court; and (5) is registered to do business in New Jersey under Business I.D. No.
`
`0100946477.
`
`12.
`
`This Court has personal jurisdiction over Par Inc. by virtue of the fact that,
`
`inter alia, it: (1) has purposely availed itself of the privilege of doing business in this Judicial
`
`District; (2) maintains extensive systematic contacts with the State of New Jersey, including the
`
`marketing, distribution, and/or sale of generic pharmaceutical drugs to New Jersey residents; (3)
`
`has previously consented to this Court’s jurisdiction and taken advantage of the rights and
`
`protections provided by this Court; (4) is registered to do business in New Jersey under Business
`
`I.D. No. 0100071541; and (5) is a registered manufacturer and wholesaler of drugs in the State of
`
`New Jersey under Registration Nos. 5001143 and 5004032, respectively.
`
`THE PATENTS-IN-SUIT
`
`13.
`
`On May 24, 2011, the ’724 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the ’724 patent is attached as Exhibit A.
`
`14.
`
`On May 24, 2011, the ’725 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the ’725 patent is attached as Exhibit B.
`
`15.
`
`On June 14, 2011, the ’424 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the ’424 patent is attached as Exhibit C.
`
`-4-
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 5 of 65 PageID: 5
`
`16.
`
`On December 3, 2013, the ’219 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the ’219 patent is attached as Exhibit D.
`
`17.
`
`On May 20, 2014, the ’094 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the ’094 patent is attached as Exhibit E.
`
`18.
`
`Pursuant to 21 U.S.C. § 355(b)(l), the ’724 patent, the ’725 patent, the
`
`’424 patent, the ’219 patent, and the ’094 patent are listed in the United States Food and Drug
`
`Administration (“FDA”) publication titled Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (also known as the “Orange Book”) as covering Helsinn’s Aloxi®
`
`brand palonosetron hydrochloride intravenous solutions.
`
`ACTS GIVING RISE TO THIS ACTION
`
`COUNT I – INFRINGEMENT OF THE ’724 PATENT
`
`Plaintiffs reallege paragraphs 1-18 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted ANDA No. 207330 to
`
`19.
`
`20.
`
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`
`ANDA No. 207330 seeks the FDA approval necessary to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’ Orange Book
`
`listed patents that have the same expiration date as the ’724 patent. ANDA No. 207330
`
`specifically seeks FDA approval to market a generic version of Helsinn’s Aloxi® brand
`
`0.25 mg / 5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of the
`
`’724 patent.
`
`-5-
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 6 of 65 PageID: 6
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`21.
`
`Upon information and belief, ANDA No. 207330 includes a certification
`
`under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the
`
`’724 patent are invalid. Defendants notified Plaintiffs of their certification and provided a
`
`detailed statement of the alleged basis for the certification, but did not allege noninfringement of
`
`any claim of the ’724 patent, separate and apart from their assertions that those claims are
`
`allegedly invalid.
`
`22.
`
`Defendants’ submission to the FDA of ANDA No. 207330, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ’724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`23.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 207330 and the
`
`§ 505(j)(2)(A)(vii)(IV) certification constitutes infringement of the ’724 patent under 35 U.S.C.
`
`§ 271 (e)(2)(A).
`
`24.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer for sale, or sell their proposed generic versions of Helsinn’s Aloxi®
`
`brand products within the United States, import their proposed generic versions of Helsinn’s
`
`Aloxi® brand products into the United States, and/or induce or contribute to such conduct,
`
`Defendants will infringe the ’724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`25.
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`COUNT II – INFRINGEMENT OF THE ’725 PATENT
`
`26.
`
`Plaintiffs reallege paragraphs 1-25 as if fully set forth herein.
`
`-6-
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 7 of 65 PageID: 7
`
`27.
`
`Upon information and belief, Defendants submitted ANDA No. 207330 to
`
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`
`ANDA No. 207330 seeks the FDA approval necessary to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’ Orange Book
`
`listed patents that have the same expiration date as the ’725 patent. ANDA No. 207330
`
`specifically seeks FDA approval to market a generic version of Helsinn’s Aloxi® brand 0.25 mg
`
`/ 5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of the ’725
`
`patent.
`
`28.
`
`Upon information and belief, ANDA No. 207330 includes a certification
`
`under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the
`
`’725 patent are invalid. Defendants notified Plaintiffs of their certification and provided a
`
`detailed statement of the alleged basis for the certification, but did not allege noninfringement of
`
`any claim of the ’725 patent, separate and apart from their assertions that those claims are
`
`allegedly invalid.
`
`29.
`
`Defendants’ submission to the FDA of ANDA No. 207330, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ’725 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`30.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 207330 and the
`
`§ 505(j)(2)(A)(vii)(IV) certification constitutes infringement of the ’725 patent under 35 U.S.C.
`
`§ 271 (e)(2)(A).
`
`31.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer for sale, or sell their proposed generic versions of Helsinn’s Aloxi®
`
`-7-
`
`

`
`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 8 of 65 PageID: 8
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`brand products within the United States, import their proposed generic versions of Helsinn’s
`
`Aloxi® brand products into the United States, and/or induce or contribute to such conduct,
`
`Defendants will infringe the ’725 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`32.
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`33.
`
`34.
`
`COUNT III – INFRINGEMENT OF THE ’424 PATENT
`
`Plaintiffs reallege paragraphs 1-32 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted ANDA No. 207330 to
`
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`
`ANDA No. 207330 seeks the FDA approval necessary to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’ Orange Book
`
`listed patents that have the same expiration date as the ’424 patent. ANDA No. 207330
`
`specifically seeks FDA approval to market a generic version of Helsinn’s Aloxi® brand 0.25 mg
`
`/ 5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of the ’424
`
`patent.
`
`35.
`
`Upon information and belief, ANDA No. 207330 includes a certification
`
`under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the
`
`’424 patent are invalid. Defendants notified Plaintiffs of their certification and provided a
`
`detailed statement of the alleged basis for the certification, but did not allege noninfringement of
`
`any claim of the ’424 patent, separate and apart from their assertions that those claims are
`
`allegedly invalid.
`
`-8-
`
`

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`36.
`
`Defendants’ submission to the FDA of ANDA No. 207330, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ’424 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`37.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 207330 and the
`
`§ 505(j)(2)(A)(vii)(IV) certification constitutes infringement of the ’424 patent under 35 U.S.C.
`
`§ 271 (e)(2)(A).
`
`38.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer for sale, or sell their proposed generic versions of Helsinn’s Aloxi®
`
`brand products within the United States, import their proposed generic versions of Helsinn’s
`
`Aloxi® brand products into the United States, and/or induce or contribute to such conduct,
`
`Defendants will infringe the ’424 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`39.
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`40.
`
`41.
`
`COUNT IV - INFRINGEMENT OF THE ’219 PATENT
`
`Plaintiffs reallege paragraphs 1-39 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted ANDA No. 207330 to
`
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`
`ANDA No. 207330 seeks the FDA approval necessary to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’ Orange Book
`
`listed patents that have the same expiration date as the ’219 patent. ANDA No. 207330
`
`specifically seeks FDA approval to market a generic version of Helsinn’s Aloxi® brand
`
`-9-
`
`

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`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 10 of 65 PageID: 10
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`0.25 mg / 5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of the
`
`’219 patent.
`
`42.
`
`Upon information and belief, ANDA No. 207330 includes a certification
`
`under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the
`
`’219 patent are invalid. Defendants notified Plaintiffs of their certification and provided a
`
`detailed statement of the alleged basis for the certification, but did not allege noninfringement of
`
`any claim of the ’219 patent, separate and apart from their assertions that those claims are
`
`allegedly invalid.
`
`43.
`
`Defendants’ submission to the FDA of ANDA No. 207330, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ’219 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`44.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 207330 and the
`
`§ 505(j)(2)(A)(vii)(IV) certification constitutes infringement of the ’219 patent under 35 U.S.C.
`
`§ 271 (e)(2)(A).
`
`45.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer for sale, or sell their proposed generic versions of Helsinn’s Aloxi®
`
`brand products within the United States, import their proposed generic versions of Helsinn’s
`
`Aloxi® brand products into the United States, and/or induce or contribute to such conduct,
`
`Defendants will infringe the ’219 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`46.
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`-10-
`
`

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`
`COUNT V – INFRINGEMENT OF THE ’094 PATENT
`
`Plaintiffs reallege paragraphs 1-46 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted ANDA No. 207330 to
`
`47.
`
`48.
`
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`
`ANDA No. 207330 seeks the FDA approval necessary to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of generic 0.25 mg / 5 mL palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of certain of Plaintiffs’ Orange Book
`
`listed patents that have the same expiration date as the ’094 patent. ANDA No. 207330
`
`specifically seeks FDA approval to market a generic version of Helsinn’s Aloxi® brand 0.25 mg
`
`/ 5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of the ’094
`
`patent.
`
`49.
`
`Upon information and belief, ANDA No. 207330 includes a certification
`
`under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the claims of the
`
`’094 patent are invalid. Defendants notified Plaintiffs of their certification and provided a
`
`detailed statement of the alleged basis for the certification, but did not allege noninfringement of
`
`any claim of the ’094 patent, separate and apart from their assertions that those claims are
`
`allegedly invalid.
`
`50.
`
`Defendants’ submission to the FDA of ANDA No. 207330, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ’094 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`51.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 207330 and the
`
`§ 505(j)(2)(A)(vii)(IV) certification constitutes infringement of the ’094 patent under 35 U.S.C.
`
`§ 271 (e)(2)(A).
`
`-11-
`
`

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`
`52.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer for sale, or sell their proposed generic versions of Helsinn’s Aloxi®
`
`brand products within the United States, import their proposed generic versions of Helsinn’s
`
`Aloxi® brand products into the United States, and/or induce or contribute to such conduct,
`
`Defendants will infringe the ’094 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`53.
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs request that:
`
`A.
`
`A Judgment be entered declaring that Defendants have infringed the ’724,
`
`’725, ’424, ’219, and ’094 patents by submitting ANDA No. 207330;
`
`B.
`
`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any approval of ANDA No. 207330 be a date that is not earlier than the expiration dates
`
`of the ’724, ’725, ’424, ’219, and ’094 patents, or any later expiration of exclusivity for any of
`
`those patents to which Plaintiffs are or become entitled;
`
`C.
`
`An Order be issued that Defendants, their officers, agents, servants, and
`
`employees, and those persons in active concert or participation with either of them, are
`
`preliminarily and permanently enjoined from commercially manufacturing, using, offering for
`
`sale, importing, or selling the proposed generic versions of Helsinn’s Aloxi® brand products
`
`identified in this Complaint, and any other product that infringes or induces or contributes to the
`
`infringement of the ’724, ’725, ’424, ’219, and ’094 patents, prior to the expiration of any of
`
`those patents, including any extensions to which Plaintiffs are or become entitled; and
`
`-12-
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`

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`D.
`
`Plaintiffs be awarded such other and further relief as this Court deems just
`
`and proper.
`
`Dated: March 23, 2015
`
`Respectfully submitted,
`
`Of Counsel:
`
`Joseph M. O’Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`Angela C. Ni
`PAUL HASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`josephomalley@paulhastings.com
`brucewexler@paulhastings.com
`ericdittmann@paulhastings.com
`davidconca@paulhastings.com
`garyji@paulhastings.com
`angelani@paulhastings.com
`
`Attorneys for Plaintiff
`Helsinn Healthcare S.A.
`
`Mark E. Waddell
`LOEB & LOEB LLP
`345 Park Avenue
`New York, NY 10154
`(212) 407-4127
`mwaddell@loeb.com
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`wbaton@saul.com
`
`Attorneys for Plaintiffs
`Helsinn Healthcare S.A. and
`Roche Palo Alto LLC
`
`-13-
`
`

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`
`CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 & 40.1
`
`Pursuant to Local Civil Rules 11.2 and 40.1, I hereby certify that the matters captioned
`
`Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-
`
`3962 (MLC)(DEA) (Consolidated), Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories,
`
`Ltd., et al., Civil Action No. 12-2867 (MLC)(DEA), Helsinn Healthcare, S.A. et al. v. Dr.
`
`Reddy’s Laboratories, Ltd., et al., Civil Action No. 14-4274 (MLC)(DEA), Helsinn Healthcare
`
`S.A., et al. v. Teva Pharmaceuticals USA, Inc., et al., Civil Action No. 14-6341 (MLC)(DEA),
`
`and Helsinn Healthcare S.A., et al. v. GAVIS Pharma LLC, Civil Action No. 15-1228
`
`(MLC)(DEA) are related to the matter in controversy because the matter in controversy involves
`
`the same plaintiffs and the same patents, and because Defendants are seeking FDA approval to
`
`market a generic version of the same pharmaceutical product.
`
`I further certify that, to the best of my knowledge, the matter in controversy is not the
`
`subject of any other action pending in any court, or of any pending arbitration or administrative
`
`proceeding.
`
`-14-
`
`

`
`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 15 of 65 PageID: 15
`
`Dated: March 23, 2015
`
`Respectfully submitted,
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`wbaton@saul.com
`
`Attorneys for Plaintiffs
`Helsinn Healthcare S.A. and
`Roche Palo Alto LLC
`
`-15-
`
`Of Counsel:
`
`Joseph M. O’Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`Angela C. Ni
`PAUL HASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`josephomalley@paulhastings.com
`brucewexler@paulhastings.com
`ericdittmann@paulhastings.com
`davidconca@paulhastings.com
`garyji@paulhastings.com
`angelani@paulhastings.com
`
`Attorneys for Plaintiff
`Helsinn Healthcare S.A.
`
`Mark E. Waddell
`LOEB & LOEB LLP
`345 Park Avenue
`New York, NY 10154
`(212) 407-4127
`mwaddell@loeb.com
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`

`
`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 16 of 65 PageID: 16
`Case 3:l5—cv—O2078—MLC—DEA Document 1 Filed 03/23/15 Page 16 of 65 Page|D: 16
`
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`
`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 17 of 65 PageID: 17
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US00794 7724B2
`
`c12) United States Patent
`Calderari et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,947,724 B2
`*May 24, 2011
`
`(54) LIQUID PHARMACEUTICAL
`FORMULATIONS OF PALONOSETRON
`
`(75)
`
`Inventors: Giorgio Calderari, Rancate (CH);
`Daniele Bonadeo, Varese (IT); Roberta
`Cannella, Varese (IT); Enrico Braglia,
`Pazzallo (CH); Riccardo Braglia,
`Pazzallo (CH); Andrew Miksztal, Palo
`Alto, CA (US); Thomas Malefyt,
`Carmel Valley, CA (US); Kathleen M.
`Lee, Palo Alto, CA (US)
`
`(73) Assignees: Helsinn Healthcare S.A., Lugano (CH);
`Roche Palo Alto LLC, 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.: 11/186,311
`
`(22) Filed:
`
`Jul. 21, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2006/0069114 Al
`
`Mar. 30, 2006
`
`Related U.S. Application Data
`
`application
`of
`(63) Continuation
`PCT/EP2004/000888, filed on Jan. 30, 2004.
`
`No.
`
`(60) Provisional application No. 60/444,351, filed on Jan.
`30, 2003.
`
`(51)
`
`Int. Cl.
`AOJN 43152
`(2006.01)
`(52) U.S. Cl. ....................................................... 514/397
`(58) Field of Classification Search ................... 514/397
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`514/397
`4,695,578 A
`9/1987 Coates eta!.
`4,753,789 A
`6/1988 Tyers eta!. ..................... 424/10
`4,886,808 A
`12/1989 King
`514/299
`4,906,755 A
`3/1990 Gittos
`546/94
`4,929,632 A
`5/1990 Tyers eta!.
`514/397
`6/1990 King
`514/299
`4,937,247 A
`5,011,846 A
`4/1991 Gittos eta!.
`514/294
`5,034,398 A
`7/1991 King
`514/299
`5,202,333 A
`4/1993 Berger et al.
`514/296
`5,240,954 A
`8/1993 Tyers eta!.
`514/395
`5,272,137 A
`12/1993 Blase et al.
`5,344,658 A
`9/1994 Collin ........................... 424/489
`5,578,628 A
`1111996 Tyers eta!.
`514/397
`1111996 Tyers eta!.
`514/397
`5,578,632 A
`
`5,622,720 A
`5,854,270 A *
`5,922,749 A
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`6,284,749 B1 *
`6,287,592 B1 *
`6,294,548 B1
`200110020029 A1
`2003/0095926 A1
`
`4/1997 Collin ........................... 424/489
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`514/397
`7/1999 Tyers et al.
`514/397
`9/1999 Winterborn .
`514/399
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`514/397
`9/2001 Castillo eta!.
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`9/2001 Dickinson ..................... 424/450
`9/2001 James
`514/299
`9/2001 James
`514/299
`5/2003 Dugger, III ..................... 424/43
`
`FOREIGN PATENT DOCUMENTS
`12/2003
`WO 03/100091 A
`W0-2004/045615 A1 *
`6/2004
`W0-2004073714 A1 *
`6/2004
`2004067005
`8/2004
`
`wo
`wo
`wo
`wo
`
`OTHER PUBLICATIONS
`
`Chaitow, 1990, 3 pages.*
`Eglen, R. M. eta!., Pharmacological Characterization ofRS 25259-
`197, a Novel and Selective 5-HT3 Receptor Antagonist, in vivo,
`extracted from British Journal of Pharmacology, 1995, vol. 114, No.
`4, pp. 860-866.
`Chelly, Jacques eta!., Oral RS-25259 Prevents Postoperative Nausea
`and Vomiting Following Laparoscopic Surgery, extracted fromAnes(cid:173)
`thesiology, 1996, vol. 85, No. 3A, p. A21.
`Sorbe, Bengt, 5-HT3 Receptor Antagonists as Antiemetic Agents in
`Cancer Chemotherapy, extracted from Expert Opinion on Investiga(cid:173)
`tional Drugs, 1996, vol. 5, No.4, pp. 389-407.
`Gaster, Laramie M. and King, Frank D., Serotonin 5-HT3 and 5-HT4
`Receptor Antagonists, extracted from Medicinal Research Reviews,
`1997, vol. 17, No.2, pp. 163-214.
`Tang, Jun eta!., EfficacyofRS-25259, aNovel5-HT3 Antagonist, in
`the Prevention of Postoperative Nausea and Vomiting After Major
`Gynecologic Surgery, abstract extracted from Anesthesiology, 1997,
`vol. 85, No.3, suppl. p. A329.
`Tang, Jun et al., The Efficacy ofRS-25259, a Long-Acting Selective
`5-HT 3 Receptor Antagonist, for Preventing Postoperative Nausea and
`Vomiting After Hysterectomy Procedures, extracted fromAnesthesia
`and Analgesia, 1998, vol. 87, pp. 462-467.
`Adis R&D Profile, Palonosetron RS 25259, RS 25259 197, extracted
`from Drugs in R&D, Oct. 1999, vol. 2, No.4, pp. 251-252.
`Piraccini, Gaia et a!., An Interesting 5-HT 3 Receptor Antagonist
`Antiemetic for Patients Undergoing Chemotherapy-Based Condi(cid:173)
`tioning Regimens?, extracted from Blood, Nov. 16, 2001, vol. 98, No.
`11, part 2, p. 350b, abstract No. 5169.
`
`(Continued)
`
`Primary Examiner- Brandon J Fetterolf
`Assistant Examiner- Shirley V Gembeh
`(74) Attorney, Agent, or Firm- Arnall Golden Gregory
`LLP; Clark G. Sullivan
`
`ABSTRACT
`(57)
`The present invention relates to shelf-stable liquid formula(cid:173)
`tions of palonosetron for reducing chemotherapy and radio(cid:173)
`therapy induced emesis with palonosetron. The formulations
`are particularly useful in the preparation of intravenous and
`oral liquid medicaments.
`
`14 Claims, No Drawings
`
`

`
`Case 3:15-cv-02078-MLC-DEA Document 1 Filed 03/23/15 Page 18 of 65 PageID: 18
`
`US 7,947,724 B2
`Page 2
`
`OTHER PUBLICATIONS
`
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`ion in Investigational Drugs, Oct. 2002, vol. 3, No. 10, pp. 1502-
`1507.
`Navari, Rudolph M., Pathogenesis-Based Treatment of Chemo(cid:173)
`therapy-Induced Nausea and Vomiting-Two New Agents, extracted
`from Journal ofSupportive Oncology, 2003, vol. 1(2), pp. 89-103.
`Oppostion Brief filed by Dr. Reddy's Laboratories (UK) Limited,
`opposition to European Patent No. 1601359 Bl, Jul. 7, 2009.
`Photolytic and oxidative degradation of an antiemetic agent, RG
`12915 (Won C. M. Eta!, International Journal of Pharmaceutics 121
`(1995) 95-105 (1995).
`Palonosetron: a phase II dose ranging study to assess over a 7 day
`period the single dose pharmacokinetic profile of palonosetron in
`patients receiving highly emetogenic chemotherapy. Piraccini G et
`a!., Proc. Am. Soc. Clin. Oncol2002 21 Abs 449 (2002).
`Formulation and administration techniques to minimize injection
`pain and tissue damage associated with parenteral products. Larry A.
`Gatlin; Carol A Brister Gatlin, from Injectable Drug Development:
`Techniques to Reduce Pain and Irritation [Edited by Pramod K.
`Gupta, Gayle A. Brazeau; Published by Informa Health Care (origi(cid:173)
`nal copyright of 1999 by Interpharma Press), 1999; ISBN
`1574910957, 9781574910957)], p. 401-421.
`Parenteral Dosage Forms. Joanne Broadhead. from Part 11-Early
`drug development, Pharmaceutical preformulation and formulation:
`a practice guide from candidate drug selection to commercial dosage
`form [Edited by Mark Gibson; Published by Interpharma Press,
`2001; ISBN 1574911201, 9781574911206)], p. 331-353.
`Opposition Brief filed by Tecnimede Sociedade Tecnico-Medicinal
`S.A., opposition to European Patent No. 1601359 Bl, Jul. 8, 2009.
`Response brief filed by Helsinn Healthcare S.A. dated Jul. 13,2007,
`in response to the communication pursuant to Art. 96(2) EPC of Jan.
`3, 2007 regarding Serial No. 04 706 657.6-2123.
`European Patent Office official communication dated Jul. 19, 2006
`regarding Serial No. 04 706 657.6.
`Response ofHelsinn Healthcare S.A. dated Nov. 29, 2006 regarding
`EPO official communication dated Jul. 19, 2006.
`Lachman et a!., The Theory and Practice of Industrial Pharmacy,
`1986, third edition, pp. 652-784.
`Opposition Brief filed by Martin Paul White, opposition to European
`Patent No. 1601359 Bl, Jul. 8, 2009.
`
`Wong eta!. (1995), in British Journal of Pharmacology, vol. 114, pp.
`851-859 and Eglen et al. (1995), in British Journal of Pharmacology,
`vol. 114, pp. 860-866.
`Cover page and pp. 642-644 an