Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 1 of 24 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.
`Eric W. Dittmann
`Young J. Park
`Isaac S. Ashkenazi
`Gary Ji
`Angela C. Ni
`Dana Weir
`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.
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, 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 Dr. Reddy’s
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1003
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 2 of 24 PageID: 2
`
`Laboratories, Ltd. (“Reddy Ltd.”) and Dr. Reddy’s Laboratories, Inc. (“Reddy Inc.”)
`
`(collectively, “Defendants”), hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Helsinn is a Swiss corporation having its principal place of
`
`business at Via Pian Scairolo, 9, CH-6912 Lugano-Pazzallo, Switzerland.
`
`2.
`
`Plaintiff 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, Defendant Reddy Ltd. is an Indian
`
`corporation having a place of business at 7-1-27, Ameerpet, Hyderabad, Andhra Pradesh, India.
`
`Upon information and belief, Reddy Ltd., itself and through its wholly owned subsidiary and
`
`agent Defendant Reddy Inc., a New Jersey corporation, manufactures generic drugs for sale and
`
`use throughout the United States, including in this Judicial District. Reddy Ltd. has previously
`
`consented to personal jurisdiction in this Court, including in the related action Helsinn
`
`Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No. 12-2867
`
`(MLC)(DEA).
`
`4.
`
`Upon information and belief, Defendant Reddy Inc. is a corporation
`
`organized and existing under the laws of the State of New Jersey, having a place of business at
`
`200 Somerset Corporate Boulevard, Floor 7, Bridgewater, New Jersey 08807, and is a wholly
`
`owned subsidiary and agent of Defendant Reddy Ltd. Upon information and belief, Reddy Inc.
`
`is registered to do business in New Jersey and does business in this Judicial District. Reddy Inc.
`
`has previously consented to personal jurisdiction in this Court, including in the related action
`
`Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action
`
`No. 12-2867 (MLC)(DEA).
`
`-2-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 3 of 24 PageID: 3
`
`NATURE OF THE ACTION
`
`5.
`
`This is a civil action concerning the infringement of United States Patent
`
`No. 9,173,942 (“the ’942 patent”). This action arises under the patent laws of the United States,
`
`35 U.S.C. §§ 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02.
`
`JURISDICTION AND VENUE
`
`6.
`
`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.
`
`7.
`
`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.
`
`8.
`
`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).
`
`9.
`
`This Court has personal jurisdiction over each of the Defendants because,
`
`inter alia, each Defendant has committed, aided, abetted, contributed to, and/or participated in
`
`the commission of an 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.
`
`10.
`
`11.
`
`This Court has personal jurisdiction over Defendant Reddy Ltd.
`
`This Court has personal jurisdiction over Defendant Reddy Inc.
`
`THE PATENT
`
`12.
`
`On November 3, 2015, the ’942 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the ’942 patent is attached as Exhibit A.
`
`-3-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 4 of 24 PageID: 4
`
`13.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’942 patent has been 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 ’942 PATENT
`BY REDDY’S 505(b)(2) APPLICATION
`
`Plaintiffs reallege paragraphs 1-13 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted NDA No. 203050 to
`
`14.
`
`15.
`
`the FDA under § 505(b)(2) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(b)(2)).
`
`NDA No. 203050 seeks the FDA approval necessary to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of generic palonosetron hydrochloride intravenous
`
`solutions prior to the expiration of the ’942 patent. NDA No. 203050 specifically seeks FDA
`
`approval to market and sell generic versions of Helsinn’s Aloxi® brand palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of the ’942 patent.
`
`16.
`
`The ’942 patent had not issued at the time Defendants made their
`
`§ 505(b)(2)(A)(iv) certification regarding Plaintiffs’ other Orange Book-listed patents.
`
`17.
`
`The ’942 patent shares the same expiration date as Plaintiffs’ other Orange
`
`Book-listed patents. By seeking FDA approval of their NDA No. 203050 prior to expiration of
`
`Plaintiffs’ other Orange Book-listed patents, Defendants necessarily seek approval of that NDA
`
`prior to expiration of the ’942 patent.
`
`18.
`
`Upon information and belief, Defendants are required by law to either
`
`amend their NDA to contain a § 505(b)(2)(A)(iv) certification with respect to the ’942 patent, or
`
`must relinquish their request that the FDA approve NDA No. 203050 prior to the expiration of
`
`Plaintiffs’ Orange Book-listed patents.
`
`-4-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 5 of 24 PageID: 5
`
`19.
`
`Upon information and belief, Defendants continue to seek approval of
`
`NDA No. 203050 from the FDA and intend to continue in the commercial manufacture, use,
`
`sale, offer for sale, and/or importation of generic palonosetron hydrochloride intravenous
`
`solutions prior to the expiration of the ’942 patent.
`
`20.
`
`By seeking approval of their NDA to engage in the commercial
`
`manufacture, use, sale, offer for sale, and/or importation of generic palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the ’942 patent, Defendants have infringed that
`
`patent pursuant to 35 U.S.C. § 271(e)(2)(A).
`
`21.
`
`Defendants Reddy Ltd. and Reddy Inc. are jointly and severally liable for
`
`any infringement of the ’942 patent. This is because, upon information and belief, Defendants
`
`Reddy Ltd. and Reddy Inc. actively and knowingly caused to be submitted, assisted with,
`
`participated in, contributed to, and/or directed the submission of NDA No. 203050 to the FDA.
`
`22.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of NDA No. 203050 for the purpose
`
`of seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale,
`
`and/or importation of generic palonosetron hydrochloride intravenous solutions prior to the
`
`expiration of the ’942 patent constitutes infringement of the ’942 patent under
`
`35 U.S.C. § 271(e)(2)(A).
`
`23.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer to sell, 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
`
`would infringe the ’942 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`-5-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 6 of 24 PageID: 6
`
`24.
`
`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 Reddy Ltd. and Reddy
`
`Inc. have infringed the ’942 patent by submitting NDA No. 203050;
`
`B.
`
`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any approval of Defendants’ NDA No. 203050 be a date that is not earlier than the
`
`expiration date of the ’942 patent, or any later expiration of exclusivity for the ’942 patent to
`
`which Plaintiffs are or become entitled;
`
`C.
`
`An Order be issued that Defendants Reddy Ltd. and Reddy Inc., their
`
`officers, agents, servants, and employees, and those persons in active concert or participation
`
`with any of them, are preliminarily and permanently enjoined from commercially manufacturing,
`
`using, offering for sale, selling, or importing 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 ’942 patent, prior to the expiration of the ’942 patent,
`
`including any extensions to which Plaintiffs are or become entitled; and
`
`D.
`
`Plaintiffs be awarded such other and further relief as this Court deems just
`
`and proper.
`
`-6-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 7 of 24 PageID: 7
`
`Dated: December 15, 2015
`
`Respectfully submitted,
`
`Of Counsel:
`
`Joseph M. O’Malley, Jr.
`Eric W. Dittmann
`Young J. Park
`Isaac S. Ashkenazi
`Gary Ji
`Angela C. Ni
`Dana Weir
`PAUL HASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`josephomalley@paulhastings.com
`ericdittmann@paulhastings.com
`youngpark@paulhastings.com
`isaacashkenazi@paulhastings.com
`garyji@paulhastings.com
`angelani@paulhastings.com
`danaweir@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
`
`-7-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 8 of 24 PageID: 8
`
`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 Laboratories, Ltd., et al., Civil Action No. 11-3962
`
`(MLC)(DEA) (D.N.J. July 8, 2011) (Consolidated), Helsinn Healthcare, S.A., et al. v. Dr.
`
`Reddy’s Laboratories, Ltd., et al., Civil Action No. 12-2867 (MLC)(DEA) (D.N.J. May 11,
`
`2012), Helsinn Healthcare, S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No.
`
`14-4274 (MLC)(DEA) (D.N.J. July 7, 2014), Helsinn Healthcare, S.A., et al. v. Teva
`
`Pharmaceuticals USA, Inc., et al., Civil Action No. 14-6341 (MLC)(DEA) (D.N.J. Oct. 13,
`
`2014), Helsinn Healthcare, S.A., et al. v. Hospira, Inc., et al., Civil Action No. 15-2077
`
`(MLC)(DEA) (D.N.J. Mar. 23, 2015), Helsinn Healthcare, S.A., et al. v. Fresenius Kabi USA,
`
`LLC, et al., Civil Action No. 15-7015 (MLC)(DEA) (D.N.J. Sept. 22, 2015); Helsinn
`
`Healthcare, S.A., et al. v. Fresenius Kabi USA, LLC, et al., Civil Action No. 15-7378
`
`(MLC)(DEA) (D.N.J. Oct. 8, 2015); Helsinn Healthcare S.A., et al. v. Qilu Pharmaceutical Co.,
`
`Ltd., et al., Civil Action No. 15-8132 (MLC)(DEA) (D.N.J. Oct. 17, 2015); Helsinn Healthcare,
`
`S.A., et al. v. Hospira, Inc., Civil Action No. 15-264 (GMS) (D. Del. Mar. 25, 2015); and
`
`Helsinn Healthcare, S.A., et al. v. Exela Pharma Sciences LLC, et al., Civil Action No. 14-1444
`
`(GMS) (D. Del. Dec. 1, 2014) (currently stayed) are related to the matter in controversy because
`
`the matter in controversy involves the same plaintiffs and the same or related patents, and
`
`because Defendants are seeking FDA approval to market generic versions of the same
`
`pharmaceutical products.
`
`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.
`
`-8-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 9 of 24 PageID: 9
`
`Dated: December 15, 2015
`
`Respectfully submitted,
`
`Of Counsel:
`
`Joseph M. O’Malley, Jr.
`Eric W. Dittmann
`Young J. Park
`Isaac S. Ashkenazi
`Gary Ji
`Angela C. Ni
`Dana Weir
`PAUL HASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`josephomalley@paulhastings.com
`ericdittmann@paulhastings.com
`youngpark@paulhastings.com
`isaacashkenazi@paulhastings.com
`garyji@paulhastings.com
`angelani@paulhastings.com
`danaweir@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
`
`-9-
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 10 of 24 PageID: 10
`
`
`
`
`EXHIBIT A
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 11 of 24 PageID: 11
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US009173942B2
`
`c12) United States Patent
`Calderari et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 9,173,942 B2
`*Nov. 3, 2015
`
`(54) LfQUlD PHARMACEUTICAL
`FORMULATIONS OF PALONOSETRON
`
`(71) Applicants: Helsinn Bealthcare SA, Lugauo (CH);
`Roche Palo Alto LLC , Palo Alto, CA
`(US); Simone Macciocchi, Mel ide (CH);
`Giulio Macciocchi, Breganzona (CH)
`
`(72)
`
`Inventors: Giorgio Calderari, Rancate (CH);
`Dani.ele Bonadeo. Casalzuiguo (IT);
`Roberta Cannella. Varese (IT); Alberto
`Macciocchi, Me1ide (CH); Andrew
`Miksztal, Palo Alto, CA (US); Thomas
`Malefyt, Carmel VaUey, CA (US):
`Kathleen M Lee, Palo Alto, CA (US)
`
`(73) Assignees: HELSINN HEALTHCARE SA,
`Pambio-Noranco (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-
`c laimer.
`
`(21) Appl. No.: 13/901,830
`
`(22) Filed:
`
`May 24, 2013
`
`(65)
`
`Prior Publication Data
`Oct. 3. 2013
`US 2013/0261149 A 1
`
`Related U.S. Application Data
`(63) Continuation of application No. 13/901,437, filed on
`May 23, 2013, now Pat. No. 8,598,219, which is a
`continuation-in-part of application No. 13/087,012,
`filed on Apr. 14, 2011 , now Pat. No. 8,518,981, which
`is a continuation of application No. I 1/ 186,311 , filed
`on Jul. 21. 2005, now Pat. No. 7.947,724, which is a
`continuation of application No. PCT/EP2004/000888,
`filed on Jan. 30, 2004.
`(60) Provisional application No. 60/444.351. filed on Jan.
`30, 2003.
`
`(51)
`
`Int. Cl.
`A01N 43152
`A61K 47126
`A61K 47118
`A61K 47112
`A61K 47100
`A61K 31/473
`A61K 47102
`A61K 9100
`B65B 7116
`B65B 55102
`(52) U.S. C l.
`CPC ............... A61K 47126 (2013.01); A61K 910019
`(2013.0 I): A61K 910(195 (2013.01 ); A61 K
`311473 (2013.01 ); A61K 47100 (2013.01);
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`A61K 47102 (2013.01): A61K 47112 (2013.01):
`A61K 471183 (2013.01); B65B 7116 (2013.01);
`B65B 55102 (2013.01)
`Field of C lassification Search
`USPC .......................................................... 514/397
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`
`Primary Examiner - Shirley V Gembeh
`(74) Attorney, Agent, or Firm - Troutman Sanders LLP
`(57)
`ABSTRAC T
`The present invention relates to shelf·stable liquid formula-
`tions of palonosetron for reducing chemotherapy and radio-
`therapy induced emesis with palonosetron. The formulations
`are particularly useful in the preparation of intravenous and
`oral liquid medicaments.
`19 C laims, No llraw ings
`
`Exh. 1003
`
`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 12 of 24 PageID: 12
`
`US 9,173,942 B2
`Page2
`
`(56)
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`Exh. 1003
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`

`
`Case 3:15-cv-08662-MLC-DEA Document 1 Filed 12/15/15 Page 13 of 24 PageID: 13
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