Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 1 of 16 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(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
`
`
`Civil Action No. __________________
`
`
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
`
`Plaintiffs,
`
`v.
`
`DR. REDDY(cid:146)S LABORATORIES, LTD. and
`DR. REDDY(cid:146)S LABORATORIES, INC.,
`
`Defendants.
`
`
`
`Helsinn Healthcare Exhibit 2082
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
`
`Page 1 of 8
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 2 of 16 PageID: 2
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`Plaintiffs Helsinn Healthcare S.A. ((cid:147)Helsinn(cid:148)) and Roche Palo Alto LLC
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`((cid:147)Roche(cid:148)), for their Complaint against Defendants Dr. Reddy(cid:146)s Laboratories, Ltd. ((cid:147)Reddy
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`Ltd.(cid:148)) and Dr. Reddy(cid:146)s Laboratories, Inc. ((cid:147)Reddy Inc.(cid:148)), hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Helsinn is a Swiss corporation having a principal place of
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`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
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`State of Delaware, having a principal place of business at One DNA Way, South San Francisco,
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`California 94080-4990.
`
`3.
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`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
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`subsidiary and agent Defendant Reddy Inc. (referred to collectively as (cid:147)Reddy(cid:148)), manufactures
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`generic drugs for sale and use throughout the United States, including in this Judicial District. In
`
`its March 30, 2012 notice letter addressed to Helsinn and Roche, Reddy Ltd. 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 for purposes of
`
`the subject matter at issue in this action. Reddy Ltd. has previously consented to personal
`
`jurisdiction in this Court, including in the related actions Helsinn Healthcare S.A., et al. v. Dr.
`
`Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-3962 (MLC)(DEA), and Helsinn
`
`Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-5579
`
`(MLC)(DEA), the latter of which was consolidated with Civil Action No. 11-3962.
`
`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
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 3 of 16 PageID: 3
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`business at 200 Somerset Corporate Boulevard, Floor 7, Bridgewater, New Jersey 08807, and is
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`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.
`
`In its March 30, 2012 notice letter addressed to Helsinn and Roche, Reddy Inc. 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 for purposes of
`
`the subject matter at issue in this action. Reddy Inc. has previously consented to personal
`
`jurisdiction in this Court, including in the related actions Helsinn Healthcare S.A., et al. v. Dr.
`
`Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-3962 (MLC)(DEA), and Helsinn
`
`Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-5579
`
`(MLC)(DEA), the latter of which was consolidated with Civil Action No. 11-3962.
`
`NATURE OF THE ACTION
`
`5.
`
`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)). 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.
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`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).
`
`7.
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`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).
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`8.
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`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
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 4 of 16 PageID: 4
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`for the additional reasons set forth above and below, and for other reasons that will be presented
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`to the Court if such jurisdiction is challenged.
`
`9.
`
`This Court has personal jurisdiction over Defendant Reddy Ltd.
`
`10.
`
`This Court has personal jurisdiction over Defendant Reddy Inc.
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`THE PATENT
`
`11.
`
`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.
`
`ACTS GIVING RISE TO THIS ACTION
`
`INFRINGEMENT OF THE ’724 PATENT BY REDDY
`
`Plaintiffs reallege paragraphs 1-11 as if fully set forth herein.
`
`Upon information and belief, Defendants submitted NDA No. 203050 to
`
`12.
`
`13.
`
`the United States Food and Drug Administration ((cid:147)FDA(cid:148)) 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
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`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. NDA No. 203050 specifically seeks FDA
`
`approval to market and sell generic versions of Helsinn(cid:146)s Aloxifi brand 0.25 mg / 5 mL and
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`0.075 mg / 1.5 mL palonosetron hydrochloride intravenous solutions prior to the expiration of
`
`the (cid:146)724 patent.
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`14.
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`NDA No. 203050 alleges under § 505(b)(2)(A)(iv) of the Federal Food,
`
`Drug and Cosmetic Act that the claims of the (cid:146)724 patent are not infringed.
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 5 of 16 PageID: 5
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`15.
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`Defendants(cid:146) submission to the FDA of NDA No. 203050, including the
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`§ 505(b)(2)(A)(iv) allegations, constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`16.
`
`Defendants are jointly and severally liable for any infringement of the
`
`(cid:146)724 patent. This is because, upon information and belief, Defendants actively and knowingly
`
`caused to be submitted, assisted with, participated in, contributed to, and/or directed the
`
`submission of NDA No. 203050 and the § 505(b)(2)(A)(iv) allegations to the FDA.
`
`17.
`
`Defendants(cid:146) active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of NDA No. 203050 and the
`
`§ 505(b)(2)(A)(iv) allegations constitutes infringement of the (cid:146)724 patent under 35 U.S.C.
`
`§ 271(e)(2)(A).
`
`18.
`
`Plaintiffs are entitled to a declaration that, if Defendants commercially
`
`manufacture, use, offer for sale, or sell their 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, Defendants
`
`would infringe the (cid:146)724 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`19.
`
`Plaintiffs will be irreparably harmed by Defendants(cid:146) 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 (cid:146)724
`
`patent by submitting the aforesaid NDA;
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 6 of 16 PageID: 6
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`B.
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`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
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`date of any approval of any of Defendants(cid:146) NDA identified in this Complaint be a date that is not
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`earlier than the expiration date of the (cid:146)724 patent, or any later expiration of exclusivity for the
`
`(cid:146)724 patent to which Plaintiffs are or become entitled;
`
`C.
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`An Order be issued that Defendants, their officers, agents, servants and
`
`employees, and those persons in active concert or participation with any of them, are
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`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 patent, prior to the expiration of the (cid:146)724 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.
`
`Dated: May 11, 2012
`
`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
`
`-6-
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`
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`Page 6 of 8
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 7 of 16 PageID: 7
`
`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
`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
`
`-7-
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`Page 7 of 8
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`Case 3:12-cv-02867-MLC-DEA Document 1 Filed 05/11/12 Page 8 of 16 PageID: 8
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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 matter
`
`captioned Helsinn Healthcare S.A., et al. v. Dr. Reddy Laboratories, Ltd., et al., Civil Action No.
`
`11-3962 (MLC)(DEA), is related to the matter in controversy because the matter in controversy
`
`involves the same plaintiffs, the common defendants Dr. Reddy(cid:146)s Laboratories, Ltd. and Dr.
`
`Reddy(cid:146)s Laboratories, Inc. ((cid:147)Reddy(cid:148)), one of the same patents, and in both cases, Reddy is
`
`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.
`
`Dated: May 11, 2012
`
`Respectfully submitted,
`
`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
`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.
`
`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:
`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
`
`Page 8 of 8