`
`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(cid:146)Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`PAUL, HASTINGS, JANOFSKY & WALKER 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
`
`
`
`
`Civil Action No. __________________
`
`
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`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 1005
`
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
`
`
`Plaintiffs,
`
`
`DR. REDDY(cid:146)S LABORATORIES, LTD.,
`DR. REDDY(cid:146)S LABORATORIES, INC.,
`SANDOZ INC., TEVA PHARMACEUTICALS
`USA, INC., and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.,
`
`
`v.
`
`Defendants.
`
`
`
`
`
`
`
`
`Exh. 1005, Page 1 of 131
`
`

`

`
`
`Plaintiffs Helsinn Healthcare S.A. ((cid:147)Helsinn(cid:148)) and Roche Palo Alto LLC
`
`((cid:147)Roche(cid:148)), for its Complaint against Defendants Dr. Reddy(cid:146)s Laboratories Ltd. ((cid:147)Reddy Ltd.(cid:148)),
`
`Dr. Reddy(cid:146)s Laboratories Inc. ((cid:147)Reddy Inc.(cid:148)), Sandoz Inc. ((cid:147)Sandoz(cid:148)), Teva Pharmaceuticals
`
`USA, Inc. ((cid:147)Teva USA(cid:148)), and Teva Pharmaceutical Industries Ltd. ((cid:147)Teva Ltd.(cid:148)), 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 8-2-337, Road No. 3, Banjara Hills, Hyderabad -
`
`500034, Andhra Pradesh, India. Upon information and belief, Reddy Ltd., itself and through its
`
`wholly owned subsidiary and agent Defendant Reddy Inc. (referred to collectively as (cid:147)Reddy(cid:148)),
`
`manufactures generic drugs for sale and use throughout the United States, including in this
`
`judicial district. Upon information and belief, Reddy Ltd. has appointed Lee Banks, Esq. of
`
`Reddy Inc., 200 Somerset Corporate Boulevard, Floor 7, Bridgewater, New Jersey 08807, as its
`
`agent in New Jersey authorized to accept service of process in this action. Reddy Ltd. has
`
`previously consented to personal jurisdiction in this Court.
`
`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.
`
`-2-
`
`Exh. 1005, Page 2 of 131
`
`

`

`
`
`is registered to do business in New Jersey and does business in this judicial district. Upon
`
`information and belief, Reddy Inc. has appointed Lee Banks, Esq. of Reddy Inc., 200 Somerset
`
`Corporate Boulevard, Floor 7, Bridgewater, New Jersey 08807, as its agent in New Jersey
`
`authorized to accept service of process in this action. Reddy Inc. has previously consented to
`
`personal jurisdiction in this Court.
`
`5.
`
`Upon information and belief, Defendant Sandoz is a corporation organized
`
`and existing under the laws of the State of Colorado, having a place of business at 506 Carnegie
`
`Center, Suite 400, Princeton, New Jersey 08540. Upon information and belief, Sandoz is
`
`registered to do business in New Jersey and does business in this judicial district. Upon
`
`information and belief, Sandoz has appointed Stephen R. Auten, Esq. of Sandoz, 506 Carnegie
`
`Center, Suite 400, Princeton, New Jersey 08540, as its agent in New Jersey authorized to accept
`
`service of process in this action. Sandoz has previously consented to personal jurisdiction in this
`
`Court.
`
`6.
`
`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. (referred to collectively as (cid:147)Teva(cid:148)). 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.
`
`7.
`
`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,
`
`-3-
`
`Exh. 1005, Page 3 of 131
`
`

`

`
`
`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.
`
`NATURE OF THE ACTION
`
`8.
`
`This is a civil action concerning the infringement of United States Patent
`
`No. 7,947,724 ((cid:147)the (cid:146)724 patent(cid:148)) and United States Patent No. 7,947,725 ((cid:147)the (cid:146)725 patent(cid:148)).
`
`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
`
`9.
`
`This Court has jurisdiction over the subject matter of this action pursuant
`
`to 28 U.S.C. §§ 1331 and 1338(a).
`
`10.
`
`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).
`
`11.
`
`This Court has personal jurisdiction over each of the Defendants by virtue
`
`of the fact that, inter alia, each Defendant has 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 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.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`This Court has personal jurisdiction over Defendant Reddy Ltd.
`
`This Court has personal jurisdiction over Defendant Reddy Inc.
`
`This Court has personal jurisdiction over Defendant Sandoz.
`
`This Court has personal jurisdiction over Defendant Teva USA.
`
`This Court has personal jurisdiction over Defendant Teva Ltd.
`
`-4-
`
`Exh. 1005, Page 4 of 131
`
`

`

`
`
`THE PATENTS
`
`17.
`
`On May 24, 2011, the (cid:146)724 patent, titled (cid:147)Liquid Pharmaceutical
`
`Formulations of Palonosetron,(cid:148) was duly and legally issued to Helsinn and Roche as assignees.
`
`A copy of the (cid:146)724 patent is attached as Exhibit A.
`
`18.
`
`On May 24, 2011, the (cid:146)725 patent, titled (cid:147)Liquid Pharmaceutical
`
`Formulations of Palonosetron,(cid:148) was duly and legally issued to Helsinn and Roche as assignees.
`
`A copy of the (cid:146)725 patent is attached as Exhibit B.
`
`ACTS GIVING RISE TO THIS ACTION
`
`COUNT I – INFRINGEMENT OF THE ’724 PATENT BY REDDY
`
`19.
`
`20.
`
`Plaintiffs reallege paragraphs 1-18 as if fully set forth herein.
`
`Upon information and belief, Defendant Reddy submitted ANDA
`
`No. 201533 to the United States Food and Drug Administration ((cid:147)FDA(cid:148)) under § 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)). ANDA No. 201533 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 and 0.075 mg / 1.5 mL palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)724 patent. ANDA No. 201533 specifically
`
`seeks FDA approval to market generic versions of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and
`
`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`the (cid:146)724 patent.
`
`21.
`
`ANDA No. 201533 alleges under § 505(j)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act that the claims of the (cid:146)724 patent are invalid.
`
`22.
`
`Reddy(cid:146)s submission to the FDA of ANDA No. 201533, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`-5-
`
`Exh. 1005, Page 5 of 131
`
`

`

`
`
`23.
`
`Reddy Ltd. and Reddy Inc. are jointly and severally liable for any
`
`infringement of the (cid:146)724 patent. This is because, upon information and belief, Reddy Ltd. and
`
`Reddy Inc. actively and knowingly caused to be submitted, assisted with, participated in,
`
`contributed to, and/or directed the submission of the ANDA No. 201533 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations to the FDA.
`
`24.
`
`Reddy(cid:146)s active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 201533 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`25.
`
`Plaintiffs are entitled to a declaration that, if Reddy commercially
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn(cid:146)s Aloxifi
`
`brand products within the United States, imports its proposed generic versions of Helsinn(cid:146)s
`
`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Reddy would infringe the (cid:146)724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`26.
`
`Plaintiffs will be irreparably harmed by Reddy(cid:146)s infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`COUNT II – INFRINGEMENT OF THE ’724 PATENT BY SANDOZ
`
`27.
`
`28.
`
`Plaintiffs reallege paragraphs 1-26 as if fully set forth herein.
`
`Upon information and belief, Defendant Sandoz submitted ANDA
`
`No. 202521 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
`
`§ 355(j)). ANDA No. 202521 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 and
`
`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`-6-
`
`Exh. 1005, Page 6 of 131
`
`

`

`
`
`the (cid:146)724 patent. ANDA No. 202521 specifically seeks FDA approval to market generic versions
`
`of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and 0.075 mg / 1.5 mL palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)724 patent.
`
`29.
`
`ANDA No. 202521 alleges under § 505(j)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act that the claims of the (cid:146)724 patent are invalid.
`
`30.
`
`Sandoz(cid:146)s submission to the FDA of ANDA No. 202521, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`31.
`
`Plaintiffs are entitled to a declaration that, if Sandoz commercially
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn(cid:146)s Aloxifi
`
`brand products within the United States, imports its proposed generic versions of Helsinn(cid:146)s
`
`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Sandoz would infringe the (cid:146)724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`32.
`
`Plaintiffs will be irreparably harmed by Sandoz(cid:146)s infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`COUNT III – INFRINGEMENT OF THE ’724 PATENT BY TEVA
`
`33.
`
`34.
`
`Plaintiffs reallege paragraphs 1-32 as if fully set forth herein.
`
`Upon information and belief, Defendant Teva 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 0.25 mg / 5 mL and
`
`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`the (cid:146)724 patent. ANDA No. 090713 specifically seeks FDA approval to market generic versions
`
`-7-
`
`Exh. 1005, Page 7 of 131
`
`

`

`
`
`of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and 0.075 mg / 1.5 mL palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)724 patent.
`
`35.
`
`ANDA No. 090713 alleges under § 505(j)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act that the claims of the (cid:146)724 patent are invalid.
`
`36.
`
`Teva(cid:146)s submission to the FDA of ANDA No. 090713, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`37.
`
`Teva Ltd. and Teva Inc. are jointly and severally liable for any
`
`infringement of the (cid:146)724 patent. This is because, upon information and belief, Teva Ltd. and
`
`Teva Inc. actively and knowingly caused to be submitted, assisted with, participated in,
`
`contributed to, and/or directed the submission of the ANDA No. 090713 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations to the FDA.
`
`38.
`
`Teva(cid:146)s active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 090713 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`39.
`
`Plaintiffs are entitled to a declaration that, if Teva commercially
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn(cid:146)s Aloxifi
`
`brand products within the United States, imports its proposed generic versions of Helsinn(cid:146)s
`
`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Teva would infringe the (cid:146)724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`40.
`
`Plaintiffs will be irreparably harmed by Teva(cid:146)s infringing activities unless
`
`those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law.
`
`-8-
`
`Exh. 1005, Page 8 of 131
`
`

`

`
`
`COUNT IV – INFRINGEMENT OF THE ’725 PATENT BY REDDY
`
`41.
`
`42.
`
`Plaintiffs reallege paragraphs 1-40 as if fully set forth herein.
`
`Upon information and belief, Defendant Reddy submitted ANDA
`
`No. 201533 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
`
`§ 355(j)). ANDA No. 201533 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 and
`
`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`the (cid:146)725 patent. ANDA No. 201533 specifically seeks FDA approval to market generic versions
`
`of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and 0.075 mg / 1.5 mL palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)725 patent.
`
`43.
`
`ANDA No. 201533 alleges under § 505(j)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act that the claims of the (cid:146)725 patent are invalid.
`
`44.
`
`Reddy(cid:146)s submission to the FDA of ANDA No. 201533, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the (cid:146)725 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`45.
`
`Reddy Ltd. and Reddy Inc. are jointly and severally liable for any
`
`infringement of the (cid:146)725 patent. This is because, upon information and belief, Reddy Ltd. and
`
`Reddy Inc. actively and knowingly caused to be submitted, assisted with, participated in,
`
`contributed to, and/or directed the submission of the ANDA No. 201533 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations to the FDA.
`
`46.
`
`Reddy(cid:146)s active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 201533 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations constitutes infringement of the (cid:146)725 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`-9-
`
`Exh. 1005, Page 9 of 131
`
`

`

`
`
`47.
`
`Plaintiffs are entitled to a declaration that, if Reddy commercially
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn(cid:146)s Aloxifi
`
`brand products within the United States, imports its proposed generic versions of Helsinn(cid:146)s
`
`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Reddy would infringe the (cid:146)725 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`48.
`
`Plaintiffs will be irreparably harmed by Reddy(cid:146)s infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`COUNT V – INFRINGEMENT OF THE ’725 PATENT BY SANDOZ
`
`49.
`
`50.
`
`Plaintiffs reallege paragraphs 1-48 as if fully set forth herein.
`
`Upon information and belief, Defendant Sandoz submitted ANDA
`
`No. 202521 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
`
`§ 355(j)). ANDA No. 202521 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 and
`
`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`the (cid:146)725 patent. ANDA No. 202521 specifically seeks FDA approval to market generic versions
`
`of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and 0.075 mg / 1.5 mL palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)725 patent.
`
`51.
`
`ANDA No. 202521 alleges under § 505(j)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act that the claims of the (cid:146)725 patent are invalid.
`
`52.
`
`Sandoz(cid:146)s submission to the FDA of ANDA No. 202521, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the (cid:146)725 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`-10-
`
`Exh. 1005, Page 10 of 131
`
`

`

`
`
`53.
`
`Plaintiffs are entitled to a declaration that, if Sandoz commercially
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn(cid:146)s Aloxifi
`
`brand products within the United States, imports its proposed generic versions of Helsinn(cid:146)s
`
`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Sandoz would infringe the (cid:146)725 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`54.
`
`Plaintiffs will be irreparably harmed by Sandoz(cid:146)s infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`COUNT VI – INFRINGEMENT OF THE ’725 PATENT BY TEVA
`
`55.
`
`56.
`
`Plaintiffs reallege paragraphs 1-54 as if fully set forth herein.
`
`Upon information and belief, Defendant Teva 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 0.25 mg / 5 mL and
`
`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`the (cid:146)725 patent. ANDA No. 090713 specifically seeks FDA approval to market generic versions
`
`of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and 0.075 mg / 1.5 mL palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)725 patent.
`
`57.
`
`ANDA No. 090713 alleges under § 505(j)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act that the claims of the (cid:146)725 patent are invalid.
`
`58.
`
`Teva(cid:146)s submission to the FDA of ANDA No. 090713, including the
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the (cid:146)725 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`-11-
`
`Exh. 1005, Page 11 of 131
`
`

`

`
`
`59.
`
`Teva Ltd. and Teva Inc. are jointly and severally liable for any
`
`infringement of the (cid:146)725 patent. This is because, upon information and belief, Teva Ltd. and
`
`Teva Inc. actively and knowingly caused to be submitted, assisted with, participated in,
`
`contributed to, and/or directed the submission of the ANDA No. 090713 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations to the FDA.
`
`60.
`
`Teva(cid:146)s active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of ANDA No. 090713 and the
`
`§ 505(j)(2)(A)(vii)(IV) allegations constitutes infringement of the (cid:146)725 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`61.
`
`Plaintiffs are entitled to a declaration that, if Teva commercially
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn(cid:146)s Aloxifi
`
`brand products within the United States, imports its proposed generic versions of Helsinn(cid:146)s
`
`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Teva would infringe the (cid:146)725 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`62.
`
`Plaintiffs will be irreparably harmed by Teva(cid:146)s 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., Reddy Inc.,
`
`Sandoz, Teva USA, and Teva Ltd. have infringed the (cid:146)724 and (cid:146)725 patents by submitting the
`
`aforesaid ANDAs;
`
`B.
`
`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any approval of any of Defendants(cid:146) ANDAs identified in this Complaint be a date that is
`
`-12-
`
`Exh. 1005, Page 12 of 131
`
`

`

`
`
`not earlier than the expiration dates of the (cid:146)724 patent and (cid:146)725 patent, or any later expiration of
`
`exclusivity for the (cid:146)724 patent or (cid:146)725 patent to which Plaintiffs are or become entitled;
`
`C.
`
`An Order be issued that Defendants Reddy Ltd., Reddy Inc., Sandoz, 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, importing, or selling the proposed generic
`
`versions of Helsinn(cid:146)s Aloxifi brand products identified in this Complaint, and any other product
`
`that infringes or induces or contributes to the infringement of the (cid:146)724 or (cid:146)725 patents, prior to
`
`the expiration of the (cid:146)724 or (cid:146)725 patents, 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.
`
`-13-
`
`Exh. 1005, Page 13 of 131
`
`

`

`
`
`
`Dated: July 8, 2011
`
`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
`
`
`
`
`Of Counsel:
`
`Joseph M. O(cid:146)Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`PAUL, HASTINGS, JANOFSKY & WALKER 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
`
`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
`
`
`-14-
`
`Exh. 1005, Page 14 of 131
`
`

`

`
`
`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 above-
`
`captioned action is not the subject of any other action pending in any court, or of any pending
`
`arbitration or administrative proceeding.
`
`
`
`
`
`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
`
`
`Dated: July 8, 2011
`
`
`
`Of Counsel:
`
`Joseph M. O(cid:146)Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`PAUL, HASTINGS, JANOFSKY & WALKER 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
`
`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
`
`
`Exh. 1005, Page 15 of 131
`
`

`

`
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`
`Attorneys for Plaintiffs
`Helsinn Healthcare S.A. and
`Roche Palo Alto LLC
`
`
`Of Counsel:
`
`Joseph M. O(cid:146)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,
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`
`
`Civil Action No. __________________
`
`
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`
`
`
`DR. REDDY(cid:146)S LABORATORIES, LTD.,
`DR. REDDY(cid:146)S LABORATORIES, INC.,
`SANDOZ INC., TEVA PHARMACEUTICALS
`USA, INC., and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.,
`
`
`v.
`
`Defendants.
`
`Exh. 1005, Page 16 of 131
`
`

`

`
`
`Plaintiffs Helsinn Healthcare S.A. ((cid:147)Helsinn(cid:148)) and Roche Palo Alto LLC
`
`((cid:147)Roche(cid:148)), for their Complaint against Defendants Dr. Reddy(cid:146)s Laboratories, Ltd. ((cid:147)Reddy
`
`Ltd.(cid:148)), Dr. Reddy(cid:146)s Laboratories, Inc. ((cid:147)Reddy Inc.(cid:148)), Sandoz Inc. ((cid:147)Sandoz(cid:148)), Teva
`
`Pharmaceuticals USA, Inc. ((cid:147)Teva USA(cid:148)), and Teva Pharmaceutical Industries, Ltd. ((cid:147)Teva
`
`Ltd.(cid:148)), hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Helsinn is a Swiss corporation having a 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 principal 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. (referred to collectively as (cid:147)Reddy(cid:148)), manufactures
`
`generic drugs for sale and use throughout the United States, including in this judicial district.
`
`Upon information and belief, Reddy Ltd. has appointed Lee Banks, Esq. of Reddy Inc., 200
`
`Somerset Corporate Boulevard, Floor 7, Bridgewater, New Jersey 08807, as its agent in New
`
`Jersey authorized to accept service of process in this action. 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. 11-3962
`
`(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 principal place of
`
`-2-
`
`Exh. 1005, Page 17 of 131
`
`

`

`
`
`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.
`
`Upon information and belief, Reddy Inc. has appointed Lee Banks, Esq. of Reddy Inc., 200
`
`Somerset Corporate Boulevard, Floor 7, Bridgewater, New Jersey 08807, as its agent in New
`
`Jersey authorized to accept service of process in this action. 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. 11-3962
`
`(MLC)(DEA).
`
`5.
`
`Upon information and belief, Defendant Sandoz is a corporation organized
`
`and existing under the laws of the State of Colorado, having a principal place of business at 506
`
`Carnegie Center, Suite 400, Princeton, New Jersey 08540. Upon information and belief, Sandoz
`
`is registered to do business in New Jersey and does business in this judicial district. Upon
`
`information and belief, Sandoz has appointed Alexandra Haner, Esq. of Sandoz, 506 Carnegie
`
`Center, Suite 400, Princeton, New Jersey 08540, as its agent in New Jersey authorized to accept
`
`service of process in this action. Sandoz 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. 11-3962 (MLC)(DEA).
`
`6.
`
`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. (referred to collectively as (cid:147)Teva(cid:148)). Upon
`
`information and belief, Teva USA has facilities in New Jersey, is registered to do business in
`
`-3-
`
`Exh. 1005, Page 18 of 131
`
`

`

`
`
`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., Civil Action No. 11-3962 (MLC)(DEA).
`
`7.
`
`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.
`
`NATURE OF THE ACTION
`
`8.
`
`This is a civil action concerning the infringement of United States Patent
`
`No. 7,960,424 ((cid:147)the (cid:146)424 patent(cid:148)). 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
`
`9.
`
`This Court has jurisdiction over the subject matter of this action pursuant
`
`to 28 U.S.C. §§ 1331 and 1338(a).
`
`10.
`
`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).
`
`11.
`
`This Court has personal jurisdiction over each of the Defendants by virtue
`
`of the fact that, inter alia, each Defendant has 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 each of the Defendants
`
`for the additional reasons set forth above a