Case 3:15-cv-08663-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,
`
`Plaintiffs,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC. and
`TEVA PHARMACEUTICAL INDUSTRIES,
`LTD.,
`
`Defendants.
`
`Civil Action No. _________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 2 of 24 PageID: 2
`
`Plaintiffs Helsinn Healthcare S.A. (“Helsinn”) and Roche Palo Alto LLC
`
`(“Roche”), for their Complaint against Defendants Teva Pharmaceuticals USA, Inc. (“Teva
`
`USA”), and Teva Pharmaceutical Industries, Ltd. (“Teva Ltd.”) (collectively, “Teva” or
`
`“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 Teva USA is a corporation
`
`organized and existing under the laws of the State of Delaware, having a place of business at
`
`400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677. Teva USA is a wholly owned
`
`subsidiary and agent of Defendant Teva Ltd. Upon information and belief, Teva USA has
`
`facilities in New Jersey, is registered to do business in New Jersey, and does business in this
`
`Judicial District. Teva USA 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., No. 11-3962 (MLC)(DEA) (Consolidated).
`
`4.
`
`Upon information and belief, Defendant Teva Ltd. is an Israeli corporation
`
`having a place of business at 5 Basel Street, Petah Tikva 49131, Israel. Upon information and
`
`belief, Teva Ltd., itself and through its wholly owned subsidiary and agent Defendant Teva USA,
`
`manufactures generic drugs for sale and use throughout the United States, including in this
`
`Judicial District. Teva Ltd. has previously consented to personal jurisdiction in this Court,
`
`-2-
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 3 of 24 PageID: 3
`
`including in the related action Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd.,
`
`et al., No. 11-3962 (MLC)(DEA) (Consolidated).
`
`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 each of the Defendants for the additional
`
`reasons set forth above and 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 Teva USA.
`
`This Court has personal jurisdiction over Defendant Teva Ltd.
`
`-3-
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 4 of 24 PageID: 4
`
`THE PATENT
`
`12.
`
`On November 3, 2015, the ’942 patent, titled “Liquid Pharmaceutical
`
`Formulations of Palonosetron,” was duly and legally issued to Helsinn and Roche as assignees.
`
`A copy of the ’942 patent is attached as Exhibit A.
`
`13.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’942 patent is 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 TEVA
`
`14.
`
`15.
`
`Plaintiffs reallege paragraphs 1-13 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted ANDA No. 090713 to
`
`the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
`
`ANDA No. 090713 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. ANDA No. 090713 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(j)(2)(A)(vii)(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 ANDA No. 090713 prior to expiration of
`
`Plaintiffs’ other Orange Book-listed patents, Defendants necessarily seek approval of that ANDA
`
`prior to expiration of the ’942 patent
`
`-4-
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 5 of 24 PageID: 5
`
`18.
`
`Upon information and belief, Defendants are required by law to either
`
`amend their ANDA to contain a § 505(j)(2)(A)(vii)(IV) certification with respect to the ’942
`
`patent, or must relinquish their request that the FDA approve ANDA No. 090713 prior to the
`
`expiration of Plaintiffs’ Orange Book-listed patents.
`
`19.
`
`Upon information and belief, Defendants continue to seek approval of
`
`ANDA No. 090713 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 ANDA 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 infringed that patent
`
`pursuant to 35 U.S.C. § 271 (e)(2)(A).
`
`21.
`
`Defendants Teva USA and Teva Ltd. are jointly and severally liable for
`
`any infringement of the ’942 patent. This is because, upon information and belief, Defendants
`
`Teva USA and Teva Ltd. actively and knowingly caused to be submitted, assisted with,
`
`participated in, contributed to, and/or directed the submission of ANDA No. 090713 to the FDA.
`
`22.
`
`Defendants’ active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 090713 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).
`
`-5-
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 6 of 24 PageID: 6
`
`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
`
`will infringe the ’942 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`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 Teva USA and Teva
`
`Ltd. have infringed the ’942 patent by submitting ANDA No. 090713;
`
`B.
`
`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any approval of Defendants’ ANDA No. 090713 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 Teva USA and Teva Ltd., 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
`
`-6-
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 7 of 24 PageID: 7
`
`D.
`
`Plaintiffs be awarded such other and further relief as this Court deems just
`
`and proper.
`
`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-
`
`

`

`Case 3:15-cv-08663-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-
`
`

`

`Case 3:15-cv-08663-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-
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 10 of 24 PageID: 10
`Case 3:15-Cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 10 of 24 PagelD: 10
`
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 11 of 24 PageID: 11
`case 3115'CV'08663'MLC'DEA Dowmmllllll 11111111 11111111111||||11|1111|||11|1|111||1|1|||1|111|1|l11|| 11
`
`L1300917394282
`
`[-121 United States Patent
`L'S 9.173342 32
`Calderari et a].
`145] Date of Patent:
`*Nov. 3, 2015
`
`1111] Patent No.:
`
`[541 LIQUIDPI{ARK-'1.“‘I‘ILJ'I'I(T.\I.
`151)R.\'IUI..\'1'II).VS()I’I’.\I.()N()SIC'1'R()N
`
`[7 1'1
`
`[721
`
`App]iu;11111::1|e|si1111 Ileiiltheare 5.11.1 11121111010111;
`Roche P11103110 I.I.( '. 1’21111.\1111.1'.-'\
`[1:8]: Simone N'Iaeeineehi. Melide [1‘1 1'1:
`GiulioMaceiuechi.11reg11111/01111112'111
`
`(58]
`
`(511]
`
`11111311111111: Giul'gin ('altlei'ari. Runeuie11‘11]:
`Daniele Bunatleu. (mail/11131111 (11]:
`Roberta ('anne]1n.\-111’ese [1'1"]: Alberto
`S-laccinuchi. Meiide 1(1 [1: Andrew
`311115161211. 1’111131 31111. 1' 'A 11:55]: Thomas
`311119111. (111111131 \1111e)‘.
`1
`'.-'\ [1.38).
`Kathleen 31 Lee. 12111131111. 1‘.-\ (1ij
`
`1731
`
`.-'\Hsignees: IIICIfiINN’IIIC.\1.'I‘II('.\RICSA.
`1’1111111ii1—N1'11‘11111311 {1'11}: Roche I’al:1.\|tu
`I.I.(.‘. 1’;1111_\1111.1'.\[115)
`
`[
`
`‘1:
`
`'1 Notice:
`
`Subieet 111 any diseiuimer. 111e ierm 11111115
`patent
`is exlended nr 1111.11151e11 under 35
`11.5.1". 154111} by 111111111.
`
`11115 patent
`elziimei‘.
`
`is 51111jee1 111
`
`11
`
`1131111111111
`
`1115—
`
`[21)
`
`.-\pp].1\'o.: 131901.830
`
`122)
`
`1-‘ile11:
`
`3-1111 2-1. 2013
`
`[(1:1)
`
`Prior Publication Data
`US 211137112111 14‘1_-\1
`Del. .3. 2111.3
`
`Related [1.8. Application Data
`
`[(13)
`
`(‘111111111111111111 111'21pplie11111111 Nu 1.3.-"9111.437. filed 1111
`May 23. 21113. 1111\1'
`11111. No. 8.595.219. which 1‘:
`11
`C111111111111111'111—111—1‘111r1
`111‘11111111011111111 N111. 13111571112.
`111edun.-\p1‘. 14. 2111 1.1111111’£1[.NL1_3.513.931.\1'111L51]
`isa1euniiniuiiion111‘z1ppiieaiiion No.
`1 171813.31 1. 1111311
`1111 .1111. 21. 211115.. 111m 1’111. No. 7.947.724. uhieh 1521
`
`1:1111111111111111111.11‘11pp11e11111111Nu. 1’( "17151’21111411111111'11'11‘1.
`111e11 1111 11111. 311. 211114
`
`111111
`
`19111151011111 11111111011111111 NU. 611-511-4435]. filed 1111 11111.
`511. 211113.
`
`[511
`
`‘Ju IJ
`
`Int. (‘1.
`.1 1’1 1 43/5 2
`.161K 47/26
`.461K-17'x’1’8
`.461K-1?x’12
`.461K 4711111
`.-’161K31‘/4?3
`.161K 421112
`.46111' 921111
`3658 .7716
`116.51355/112
`U.."i.(.‘1.
`(‘1’(‘
`
`121111111111
`{21111111111
`12110111111
`12011111111
`12111111111 '1
`121111111111
`{21111111111
`12110111111
`12011111111
`12111111111 '1
`
`116111 479612111311115-‘161'11 911011119
`[2111311111.161K 11/11119512(113.111];.-161K
`311/2173 [21113.11 1
`,1: 461111 4.7/111‘1121113111]:
`
`3116111472112121113.11112/16111: 43/11.? 121113.111 1'.
`31111111471983121113.111]:113651} 72111121113111}:
`315.513.55.412 [21113.01]
`I-‘ield of Classification Search
`1381’1‘
`............................... ..
`
`51—11397
`
`See application 11 e 1111'e11n1piele search 1115111119.
`
`References (‘ited
`
`1L8.1M1"N111110139113118
`
`
`
` 'x'x'k'r
`
`4.695.51.
`4.753.
`4.8565115
`4.9116755
`/
`4.929.032 .-
`11.11.11.247 .-\
`5.111 1.11411
`.\
`5.1134398 .\
`5.202.333 .-\
`5.2411954 .\
`5.272.137 .\
`5.344.65N .\
`.5.
`I521;
`.-\
`1132
`5.
`.\
`
`5.1122..-211 .\
`5.854.271)
`.-\
`5.922.749 .\
`5.95.458 .-\
`13.111113112
`.-\
`.-\
`
`111
`.
`(1237592 111
`(1.294.548 111
`(1.1199852 132
`7.109.339 132
`7.947.724 1.12
`7.947.725 1’12
`
`(miles c1111.
`91;?
`‘1
`iyerh' e1 :11.
`11 983
`12 959 King
`2“
`9911
`(11110::
`J
`._
`9911
`'['_\.-'1.‘1'.~' e1 :11.
`6
`11911 King
`-—1
`991
`(1111021 01:11.
`7
`9‘11 King
`4
`993
`13e1'ge1'eir11.
`S
`993
`'[')-'e1'.‘; e1 :11.
`12
`993 Binge e1 :11.
`11
`1194
`($011111
`11 9% '[yei's e1 :11.
`11
`991i
`'['_\'c1's e1 :11.
`—'1
`9‘1?
`('oliin
`12
`9‘13
`1111111111111
`7
`9‘19
`'1')-'e1'5 e1 :11.
`9
`9‘19
`\\"ii111:1'hu111
`5 2111111
`“111101110111
`11] 2111111
`\11111:1)’_\-'e1'1:1 :11.
`11211111
`(tisiiliu e1 :11.
`9 211111 Dickinson
`9 211111
`Jamex
`3 211114 Robiehnud
`‘1 2111111
`1.1x 1:1 :11.
`5 21111
`t.'111de1':11'ic1111.
`5 21111
`111111111111 c1111.
`
`[(‘ontinuedi
`
`1-'(1R]-'.11iN 1’.-\'['1-'1\"1'11111133112918
`
`['21)
`W11
`
`1151241111 .-\1
`\\"1 1—113 11111119 1
`
`4 1992
`12 211113
`
`[(‘11111111111‘111
`111111-111’11131.1('.-\'['[(1NS
`
`462-4117111311 1115-.”
`11111;: 01 211.. (3111:5111 .-\n:11;__! 199K;
`R.
`.\1.
`1 glen 1-1 111.. "1‘11:1imnmiegicnl c1111111c1e1'i7111ion 0111.9 2.5259-
`197.11 1111\'1:1111111SC1L'L‘11\'C 5-11'1'31ceuptu1 11111113101119.
`111 Vim.“ 1‘11'.
`.1
`1‘11;L1'111;1e:11:1g}-'
`1 14:8011-8611119951.
`1'he11y‘. Jacques e1 111.. 111111 118—25259 1‘1'e\'en1.~; Posiopemiive \niiseéi
`11nd
`\‘umiting i-ulimving 1.1111111'useupic Surgery.
`.-\11e:~111¢.‘xiuiu;.‘)-'.
`1‘1‘11’1_ 1'01. 85. \0. 3.-\. p. .'\21.
`Stal'he.13eng1.5-111-3 Recepior3111330111511; :11; .\n11e111e11e Agenis 111
`1'nnuei'(‘iiunivtiiernpyz extracted from 1..\'pe1't(1111111011uninvexliga-
`[11111111 Drugs. 19911. 1-111. 5 No. 4. pp. 359-4117.
`[( ‘unLinLiedj
`
`Shirley \‘ (.iemheh
`1’1'1'111111f1'111111111111?
`1'74]
`.-'111:)1‘1'1e_'.'. Jenn, r11‘1-1'1‘111
`11111111111111 Sanders 1.1.1’
`
`157]
`
`.\BS'1'R.\("I'
`
`The present 11111311111111 reluies 11'1 siielilsiubie liquid 111111111111—
`1111115 111‘1111111111'151311‘1111 1111'1‘e1111eing eheiiinthei‘apy 11nd 11111111—
`111erz1py induced emesis \1'1111 [1&111111115C11’1111.'1-11L‘ 1111111111111111111:
`are p111‘11e111111‘1y 1111111111 111 the prepan'aiiiim 111'111112111‘1111115 and
`111111 liquid 111ediean1ei1ts.
`
`19 (111111111. No Drawings
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 12 of 24 PageID: 12
`Case 3:15-cv-O8663-MLC-DEA Document 1 Filed 12/15/15 Page 12 of 24 PagelD: 12
`
`US 9,173,942 I32
`Page 2
`
`liuropean Patent Office ot'ticial communication dated Jul. 19. 211116.
`regarding Serial .\'o. 114 2116115711.
`Response ol'ileisinn 11ea1thcare S..-\. dated .\'o\-'. 29. 2111111. regarding
`l-IPt) olTicial communication date .1111. 19.211116.
`[achinan et al..
`the theory and Pr'actice of industrial Pharmacy.
`1931'). third edition. pp. 652—?S4.
`1'1ec1aration tut-Valentino .1. Stella. P111). dated Sep. 19. 211112.
`Opposition Briei'tiletl by Martin Paul White. opposition to 1:111opeatt
`’atcnt .\'o. 16111559 111.1111. 8. 211119.
`Wong et ai. [ 1995]. in British Journal ot'Pharmacology. \-'ol. 114. pp.
`851—359.
`1 he '1'1tcot3' and Practice
`{ 'ovci' page and pp. 642-644 and ?Ei.1-'1'S4 ol'
`111' industrial Pharmacy. '1 hir'd lidition. 1 ea and liebiger1198m.
`1'overpage and pp. 514-5 15 ot‘X-‘lodern Pharmaceutics. Second 1:111-
`tion..\-‘1arce1 1)ekker ( 199111.
`1'over page and pp. 142-1471 of Pharmaceutical Dosage l-orms:
`’arenteral
`.\-1edications vol.
`1. Second ldition. Marcel Dekker
`1 19921.
`Mitsuo Matsumoto et al.. "Yaku/aigaltu Manual".
`\an'xando to. ltd. [1989] 2 pages.
`Michael .1. 1‘ika1.“l ree'xe Drying“. l-Incyclopedia ol‘ Pharmaceutical
`'l'ecltrioiogy.'1hird lidition. .1an.21111?. pp. 1324—1825161}.lrilorma
`Pharmaceuticals and llealthcare.
`Daniele l1onadeo. “Supplemental Declaration of Daniele lionadeo
`1'nder'5?1'.1-.R. 1.1.12”. tiled in 1
`Appl. .Vo. 11 .188.2?11..111n.8.
`211119.
`Ki'anke et al.. 2111]? “Recent advances. trends. and economic consid-
`erations in .
`.
`. “ lispert Opinion Pitarmacotherp.. 8118): .12 11.1235.
`.\-1ort'o\\-'etal.. 1995. "Progress in reducing nausea and emesis: 1'om-
`parisons ot'ondansetron. granisetron. and tropiselron."1'ancer. vol.
`"1‘6. No. 3 pp. 345-5 5?.
`-\ppl.
`1.251.
`'Es'P'l'O Notice of -\11o\\':ittcc and ice; Due.
`1 588.2711. filed Mar. 24. 211116. Date Mailed Jan. 26. 211111.
`'SP'i'U 1111ice Action. 1
`Appl. No.
`1
`1 129.339. Date .\-1ailed.lan.
`15-. 211111.
`si'aili. Xat‘ar 11.. “1‘1i nical Pharmacology ot'Serotonin Receptor type
`15—11131Antagonists." 1"1trr. Med. 1'hem. 1'entrai Xen'ous System
`Agents. 211111: 1. 171—199.
`Barton 11‘itrate liaiTer1'alculalion1 2111111. 2 pages.
`'SP'l'f11)t'tice.-\ction. 1
`App]. .\'o. 11 2111.11.55. Date Mailed Aug.
`19. 211119.
`{esponse ot‘ ilelsinn llealthcare to opposition ol- lil‘ Serial No. 114
`2116 652.6. tialc‘ti 1c11. 11. 211111.
`Annex 1 (Statement ol'\\-'also Mossi. 1‘11.1'J.I to Response of] 1e1sinn
`leaithcare to 11p}msitionot‘1-.P Serial No. 114 21111115111 dated 1-e11.
`l 1. 211111.
`Annex 2 to Response ot‘ llelsinn llealthcai'e to Opposition ol‘ l'.P
`Serial No. 114 21166516 dated 1-e11. 11. 211111.
`Annex .1
`to Response 111' 11e1sinn ilealthcare to Opposition oi- 151‘
`.‘s‘erial \o.114 71166516tia1edleh. tt. 311111.
`Summary ot‘ Product 1'haracteristics 1'or .-\1o.si 25111211119].
`Scientific Discussion 1‘rom the lauropean Public Assessment Report
`for .-\losi (Palonoseteron Hydrochloride] 211116.
`6111
`ldition. Handbook of Pharmaceutical
`liscipients 12111191. pp.
`24T—25111RPS Publishing).
`Lewis. (iareth A 12111161 't1ptimi7ation Methods.‘ lincyclotmdia ot‘
`Pharmaceutical technology. 1:1. 2452-246?
`May 24. 2111] Para. 1\' notice li'om'i'eva Pharmaceuticals re ‘724 and
`‘T25 patents.
`May 24. 2111 l Para. l\-' notice from Sando/re ‘724 and ‘225 patents.
`May 24. 2111 l Para.
`[V notice from Dr. Retiti)-"s Fe 724 and '725
`patents.
`Aug. 9. 2111 l Para. l\-' notice from Dr. Reddy‘s re ‘424 patent.
`.\ttg. 19. 2111 1 Para. [V notice 1'rom leva Pharmaceuticals re ‘424
`patent.
`Sep. 22. 21111 Para. 1V notice from Sando/ re '224. .725 and '424
`palents.
`.1111. 8. 21111 1'omp1aint 1or patent
`111139112].
`Sep. 21. 211] l t.'ornplaint for patent infringement [D. 521. case .\'o.
`
`inli'ingement
`
`[1).
`
`.\'..1. case .\'o.
`
`
`
`1st edition.
`
`.\'o.
`
`1
`
`
`
`[.561
`
`References (iited
`
`11S. 1’.\'11"N'1‘ 11(11'111V111N1'S
`
`191111.424 1’32
`8.518.981 112
`8598.218 112
`8.598.219 112
`8.729.1194 112
`911669811 152
`211111 11112111129
`-\1
`21111.21 111195926 .\1
`21111411147511] A1
`2111.1 112111149 A1
`2111.1 1121111511 .A1
`2111.1 1128911115 .-'\1
`21114111139111111 A1
`2111511141454 -\1
`
`('alderari ct al.
`l
`6 211
`(‘alderari et al.
`.1
`N 211
`.1 1'aiderari et a1.
`12 211
`.1 1'aiderari et al.
`12 211
`5 211 4 1'aiderari et al.
`6 211
`5 K'altlei'ari et al.
`9 211111
`James
`5 21111.1 Hugger. 11]
`T 211114 Landau et al.
`111 211
`.1 1'aiderari et a1.
`111 211
`.1 1'aiderari et al.
`111 211 3 1'aiderari et al.
`2 211 4 K'altlei'ari et al.
`5 211 5 1'alderari et al.
`
`
`
`1-'()Ri{11iN PA'
`
`'1-IN'1'[)(11‘11M1-IN'1'S
`
`\\-"11
`\\-"11
`\\-'11
`
`“50211114045615
`MiG-21111411620115
`\\'1 1—21111471 21714
`
`6 211114
`8 211114
`9 211114
`
`('1'1'111iR1’1.3151.1(‘X1'111NS
`(iastct'. l ararnie M. and King. 1 rank 11.. Serotonin 5-11 13111111 5-1114
`Receptor' .-\ntagonists. estracted l‘rom Medicinal Research Reviews.
`1997 \-'ol. 1?. \o. 2. pp. 1621-214.
`tang. Jun et al.. “liliicacy ol'RS—25259. a Novel 5-11121.-\ntagonist.
`1n the Prevention ol‘l‘ostoperative Nausea and \-'omiting alier Major
`Gynecologic Surgery.“Anesthesiology. 199?. vol. 115. No. it supp]. p.
`.\329.
`
`111111;. .1un et al..'1'he1:111cacyot‘RS-25259. a 1.ong-.-\cting Selective
`5-1113 Receptor Antagonist. for Preventing Postoperative Nausea
`and \-'omiting After 1 ly'stet'ectotit_\.-' Procedures. Anesthesia and .-\nal-
`gesia. 1998. vol. 8?. pp. 462462.
`Adis Re'i'l) Profile. Palonosetron RS 25259 19?. Drugs in R&1).1Jct.
`1999. vol. 2. .\'o. 4. pp. 251-252.
`Piraccini
`(liaia et al..
`.\n interesting 5-111] Receptor .-\ntagonist
`Antiemetic tor Patients [Tndet'going 1'hemotheraphy-hased 1'ondi—
`tioning Regimens. Blood. Nov. 16. 211111. vol. 98. .\'o. 11. part 2. p.
`351111. abstract \o. 5169.
`St:tche1‘.1ieor'g. Paionosetron 11e1sinn. 1'111't'ent Opinion in investiga—
`Iional Drugs. 1 Jet. 211112. \'01. .1. .\'o. 111. pp. 15112—15111.
`.\'at-'ari. Rudolph M.
`’atliogeiiesis-l1ased treatment ol‘ (‘hemo-
`therapy-induced .\'ausea and Vomiting
`1\\-'o New Agents. Journal
`ot‘Suptwrtit-‘e Oncology. 2111121. \‘oi. 1121. pp. 89-111}.
`(Ihaitou. 19911.
`.1 pages.
`Opposition l1riet' tiled by Dr. Reddy‘s laboratories 11'K1 limited.
`opposition to lfuropean Patent .\'o. 16111559 131 dated .1111. 7. 211119.
`Photoiytie and osidative degradation 111' an antiemetic agent. R11
`l2915[\\'on1'..\"1.et al.. international.lournalo{Pharmaceutics 121.
`95—111511995].
`Palonosetron: .\ phase 11 dose ranging study to assess overa T day
`per'iod the single dose pharmacokinetic profile of palonosetron in
`patients receiving highly emetogenic chemotherapy. Pir'accini et al..
`1‘1'oc..\t‘r1.Soc. 1'1in. Uncol 211112 21 Abs 44912111121.
`liormulation and administration techniques to minimise injection
`pain and tissuedamageassociated with parenteral products. 1.111'1'}'.-\.
`(iatiin and 1'arol A. Brister (iatiin. ii'om injectahle 11mg Develop—
`ment: techniques to Reduce Pain anti irritation [ladited by PraJnod K.
`Gupta and Gayle A.
`lirayeau; published by lnt‘orma llealth ('are1
`191.19ng]5.\' 15149111957. 971K] 5749111952. p. 4111-421.
`11—1-..‘Li'1y
`Parenteral Dosage 1-orms.
`.1oanne 13roadhead. from Part
`drug development. pharmaceutical pret‘orrnulation and formulation:
`a practice guide from candidate drag selection to commercial dosage
`lorm (Edited by Mark (iibson; Published by 1nterpharma 1’ress.
`211111;1S13.\'15T 91 12111. ‘1?R]5749l 121161. p. 331-1521.
`Opposition lit'iefiilcd 11y lccnimedc Sociedade lecnico-Medicinal
`SA. in opposition to liuropean Patent .\'o. 1611 1.159 111.
`.1111. 8. 211119.
`Response briel'tiied 11y lielsinn 11eaithcare SA. da1ed .1111. 12‘. 211112.
`in responseto the cornnninication pursuant to .-\rt. 96121 l-IPt ' ol‘.lan.
`3. 21111? regarding Serial No. 11—1 T116 6516-2 12.1.
`
`

`

`Case 3:15-cv-08663-MLC-DEA Document 1 Filed 12/15/15 Page 13 of 24 PageID: 13
`Case 3:15-cv-O8663-MLC-DEA Document 1 Filed 12/15/15 Page 13 of 24 PagelD: 13
`
`US 9,173,942 I32
`
`Page 3
`
`[5(1)
`
`References (iited
`
`(111111111’11131.11‘;\'l'1(1NS
`
`.1. Hroadhetul. Parenteral Dosage 1"oims Pharmaceutical Prel‘ormula-
`tion and 1-ormulation: .’\ Practical Guide from 1'andidate Drug Selec-
`tion to 1'ommei'cial Dosage l orm. 1'11. k). pp.
`.1“ 1-354 11'rihson cd..
`1CR1'Pt'css 1st cd.211111].
`K..-\.1"onnors etal..1'l'temicalStabilityot‘Pharmaceuticals:.’\11and-
`
`book for Pharmach
`t.1ohn\\’i1ey& Sons 2d ed. 10818].
`Xoftan R.
`in lite Physician‘s DL‘sk ReILJ'ettce. op. 1511.1-11715111 ed.
`2111111.
`.-'\n'/emet in '1 he Physician‘s Desk Reference. pp. 11811-1183 [ith ed.
`2111111.
`11311111”. in 1'he Physician‘s Desk Reference. pp. 3 1114-31116 [5th ed.
`211111 1.
`in llandbook on lnjectable Drugs.
`1...\. 'l'rissel. 11ndansetron 1111.
`pp. 1133-13115 [.-\."1111’ 7111 ed. 1‘11121.
`\avohanli
`[tropisetron 111'1]
`.\-1alaysian Prescribing Information
`[Hep 21111111.
`Kytrillt' (granisetron 111'11 .‘s'outli African Prescribing Information
`[1)ec. 1111131.
`5. Motola and S. .-'\gharkar. Preformulation Research o 1‘ Parenteral
`Medications. Pharmaceutical Dosage 1-orms: Parenteral Medica-
`tions. vol.
`1. 1.11. 4. pp. 115-173 1.-\vis. 1.iehcrman.
`l.achrnan eds.
`Marcel Dekker 1nc. 2d ed. 1111121.
`'1'he Physicochemical
`.1. Wells. Phtn'maceutical 1’t'elht'rittttitlitrn:
`Properties of Drug .‘s‘uhstances. 1'11. 5: Drug Stability. pp. 152-191
`[1 lbs Eiom'od 1 111. 19821].
`.1. 5\\'a.i'brick anti Hoylan. l-ncyclopedia of Pharmaceutical lechnol-
`ogy. 1fxcipients1'hapter: 'l'heir Role in Parenteral Dosage 1-orms. \-'ol.
`19121131172 [Marcel 11ckket'. inc. 21111111.
`Handbook ofPlutrnutceutical ltxcipients. .111 15d..[1\'ibbe ed. Pharma-
`cetttical Press 2111111]; pp. 1411-143. 1811-194. 2124—2218.
`1}. Stacher.
`’alonosetron tllelsinn1.{'tn'ro. 11pin.
`[m-‘estig. 1)rugs.
`31111115112312111121.
`Handbook of Modern Pharmaceutical .-\nalysis. 15. .\hu_ia et al. ed..
`.-\c1tdcmic Press. 2111111.
`Jun. 8. 2111111 Bonadeo Declaration.
`.1111]. 8. 2111111 Bonadeo Declaration. l-xhibit 2.
`.1un. 8. 2111111 Bonadeo Declaration. l-xhibit 3.
`111"1.5§\111 122112-139 [2111181.
`.11"1.S.\'111172T11-3121211121.
`-eb.
`13.
`211117 Statutory Declaration of Daniele Bonadeo. with
`lisltilrit .\.
`Nov. 21. 21111? .‘s‘1atutoty 1)ec1aration of Giorgio 1‘alderari. Daniele
`1onadeo. Roberta 1'annella. l-.nrico Pn'aglia. and Riccardo 11i'aglia.
`{eddy‘s Paragraph 1V notice regarding all tltree patents 1 D. X1 1 'ase
`No. 12-2211'371. dated Mar. 311. 21112.
`May 1 1. 2111 2 1'omplaint for patent infringement 1iledb_\.-'
`{oche 1D. \..1. 1'ase No. 1232-81111.
`.1un.26. 21112 \oticeofRcddy‘smotion to dismiss [1). \..l. 1'ase. .\'o.
`12-281121.
`.1111]. 218. 21112 Dr. Reddy’s l.alioratories. ltd.‘s and Dr. Reddy’s
`.almratories. 1nc.’s memorandum oflavv in support oftheir motion to
`dismiss 111' for summary judgment of non-infringemcnt ol‘l
`Pat.
`Xo.1_‘)41_72:1[D.X..1.1'aseXo. 12-2‘1811 [including l-xliibits 1—1111.
`.-\ug. 111. 21112 \oticeol'Plaintil'ls’ cross-motion for partial summary
`_'ut1gment ofinl‘ringement [1). \..1. (me .\'o. 12-2sfiFi.
`.\ug. (r. 211 12 1‘1ainti11‘s‘ opposition to 11c1entlants‘ motion to dismiss
`or for summary iudgment of noninli'ingement and cross—motion for
`partial
`S1111]111:11'_\.'
`iudgment of infringement
`[1).
`\..l. 1.'ase .\'o.
`12181111 [including exhibits 1-4'].
`Schoneich declaration (D. \J. 1'ase .\'o. 12—231’17111nc1uding l'..\'hib-
`ils .-'\ anti
`1-2-—11. dated .-'\ug. 1']. 21112.
`Hep-'1. 21112 Reddy‘s briefin opposition to Plaintiffs cross-motion
`for partial summary judgment and t'cpl)‘ memorandum ot‘ lavv-
`in
`further support of Reddy's motion to dismiss or for summatyjutig-
`ment of non-infringement
`[1). NJ. 1.'ase \o.
`l2-2St'a?_1[1ncluding
`lisltilrits 1-41.
`Del ttca Declaration [D. \..1.1'ase No. 12-2H1’J?J[1ncluding exhibits
`.-'\—.11. dated Sep. :1. 21112.
`Hep. 111. 21112 PlaintilTs letter to Judge ('oopet' in response to Red-
`dy's combined opposition to Plaintifl's’ cross-motion for partial sum-
`mary iudgment and reply in support oi‘Reddy‘s motion to dismiss or
`for summary judgment of noninfringemcnt
`11.1.
`_\'..1. 1‘ase .\'o.
`12-2Xfi?][including exhibits .-\ and 13].
`
`l [elsinn attd
`
`
`
`.\'..1. case No.
`
`‘at.
`
`.-\nsv\'er and counterclaim of 1.11: 1{edd)-"s l.ahot'ato-
`.1 l. 2111]
`.-\ug.
`1.111. and Dr. Reddy's lalmratories inc.
`(1). N1. case .\'o.
`ries.
`11—112191112].
`Sep. 13. 2111 1 Sandor lnc.’s answer to complaint for patent infringe—
`ment and counter'claims 11). NJ. case No. 11-11191‘2].
`Sen 13.21111 1ev-aPharmaceuticalsESSA.1nc.and'levaPharmaceu-
`tical lndustries 1.td.‘s answer [1). X1 case No. 11-113111'12].
`(Jet.
`7'1. 21111 PlaintifPs reply to answer antl counterclaim of Dr.
`.{eddy‘sl.ahoratories.1.td.and1.1r.Retldylaboratories.1nc.[1).\..1.
`case .\'o.
`l 1-11111621.
`M. 21. 21111 Plaintifl‘s reply to Sandor 1nc.’s ansvver to complaint
`for patent
`infringement and cottnterclaims 1D.
`.\'..1. case No.
`141301321.
`1ct.24.2111 l Answerandcounterclaimof11r. Rcddy's] ahoratories
`Id. and Dr. Reddy‘s 1 aboratories. inc. [1). X1 case No. 11—55101.
`Jet. 24.21111 Hando/1nc.'sa