Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 1 of 25 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
`
`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.
`
`
`
`
`
`
`
`
`
`Civil Action No. _______________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC (collectively,
`
`(cid:147)Plaintiffs(cid:148)), for their Complaint against Defendants Dr. Reddy(cid:146)s Laboratories, Ltd. and Dr.
`
`Reddy(cid:146)s Laboratories, Inc. (collectively, (cid:147)Reddy(cid:148) or (cid:147)Defendants(cid:148)), hereby allege as follows:
`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 1004
`
`-1-
`
`Exh. 1004, Page 1 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 2 of 25 PageID: 2
`
`THE PARTIES
`
`1.
`
`Plaintiff Helsinn Healthcare S.A. is a Swiss corporation having its
`
`principal place of business at Via Pian Scairolo, 9, CH-6912 Lugano-Pazzallo, Switzerland.
`
`2.
`
`Plaintiff Roche Palo Alto LLC 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 actions Helsinn
`
`Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-3962
`
`(MLC)(DEA), Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil
`
`Action No. 11-5579 (MLC)(DEA), and Helsinn Healthcare S.A., et al. v. Dr. Reddy’s
`
`Laboratories, Ltd., et al., Civil Action No. 13-5815 (MLC)(DEA), the latter two of which were
`
`consolidated with Civil Action No. 11-3962, and 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 actions
`
`-2-
`
`Exh. 1004, Page 2 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 3 of 25 PageID: 3
`
`Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., Civil Action No. 11-
`
`3962 (MLC)(DEA), Helsinn Healthcare S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al.,
`
`Civil Action No. 11-5579 (MLC)(DEA), and Helsinn Healthcare S.A., et al. v. Dr. Reddy’s
`
`Laboratories, Ltd., et al., Civil Action No. 13-5815 (MLC)(DEA), the latter two of which were
`
`consolidated with Civil Action No. 11-3962, and Helsinn Healthcare S.A., et al. v. Dr. Reddy’s
`
`Laboratories, Ltd., et al., Civil Action No. 12-2867 (MLC)(DEA).
`
`NATURE OF THE ACTION
`
`5.
`
`This is a civil action concerning the infringement of United States Patent
`
`No. 8,729,094 ((cid:147)the (cid:146)094 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
`
`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(cid:146)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 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 Defendants for the
`
`additional reasons set forth below and for other reasons that will be presented to the Court if such
`
`jurisdiction is challenged.
`
`-3-
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`Exh. 1004, Page 3 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 4 of 25 PageID: 4
`
`10.
`
`11.
`
`This Court has personal jurisdiction over Defendant Reddy Ltd.
`
`This Court has personal jurisdiction over Defendant Reddy Inc.
`
`THE PATENT
`
`12.
`
`On May 20, 2014 the (cid:146)094 patent, titled (cid:147)Liquid Pharmaceutical
`
`Formulations of Palonosetron,(cid:148) was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the (cid:146)094 patent is attached as Exhibit A.
`
`13.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the (cid:146)094 patent has been listed in the
`
`United States Food and Drug Administration ((cid:147)FDA(cid:148)) publication titled Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (also known as the (cid:147)Orange Book(cid:148)) as
`
`covering Helsinn(cid:146)s Aloxifi brand palonosetron hydrochloride intravenous solutions.
`
`ACTS GIVING RISE TO THIS ACTION
`
`COUNT I – INFRINGEMENT OF THE ’094 PATENT BY REDDY’S ANDA
`
`14.
`
`15.
`
`Plaintiffs reallege paragraphs 1-13 as if fully set forth herein.
`
`Upon information and belief, 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 palonosetron hydrochloride intravenous
`
`solutions prior to the expiration of the (cid:146)094 patent. ANDA No. 201533 specifically seeks FDA
`
`approval to market a generic version of Helsinn(cid:146)s Aloxifi brand palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the (cid:146)094 patent.
`
`16.
`
`The (cid:146)094 patent had not been issued at the time Reddy made its
`
`§ 505(j)(2)(A)(vii)(IV) certification regarding Plaintiffs(cid:146) other Orange Book-listed patents.
`
`17.
`
`The (cid:146)094 patent shares the same expiration date as Plaintiffs(cid:146) other Orange
`
`Book-listed patents. By seeking FDA approval of its ANDA No. 201533 prior to expiration of
`
`-4-
`
`Exh. 1004, Page 4 of 64
`
`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 5 of 25 PageID: 5
`
`Plaintiffs(cid:146) other Orange Book-listed patents, Reddy necessarily seeks approval of that ANDA
`
`prior to expiration of the (cid:146)094 patent.
`
`18.
`
`Upon information and belief, Reddy is required by law to either amend its
`
`ANDA to contain a § 505(j)(2)(A)(vii)(IV) certification with respect to the (cid:146)094 patent, or must
`
`relinquish its request that the FDA approve ANDA No. 201533 prior to the expiration of
`
`Plaintiffs(cid:146) Orange Book-listed patents.
`
`19.
`
`Reddy continues to seek approval of ANDA No. 201533 from the FDA
`
`and intends 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 (cid:146)094 patent.
`
`20.
`
`By seeking approval of its 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 (cid:146)094 patent, Reddy has infringed that patent
`
`pursuant to 35 U.S.C. § 271(e)(2)(A).
`
`21.
`
`Reddy Ltd. and Reddy Inc. are jointly and severally liable for any
`
`infringement of the (cid:146)094 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 ANDA No. 201533 to the FDA.
`
`22.
`
`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 constitutes
`
`infringement of the (cid:146)094 patent under 35 U.S.C. § 271(e)(2)(A).
`
`23.
`
`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
`
`-5-
`
`Exh. 1004, Page 5 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 6 of 25 PageID: 6
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`Aloxifi brand products into the United States, and/or induces or contributes to such conduct,
`
`Reddy would infringe the (cid:146)094 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`24.
`
`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 ’094 PATENT
`BY REDDY’S 505(b)(2) APPLICATION
`
`25.
`
`26.
`
`Plaintiffs reallege paragraphs 1-24 as fully set forth herein.
`
`Upon information and belief, Reddy submitted NDA No. 203050 to 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 (cid:146)094 patent. NDA No. 203050 specifically seeks FDA
`
`approval to market and sell generic versions of Helsinn(cid:146)s Aloxifi brand palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of the (cid:146)094 patent.
`
`27.
`
`The (cid:146)094 patent had not issued at the time Reddy made its
`
`§ 505(b)(2)(A)(iv) certification regarding Plaintiffs(cid:146) other Orange Book-listed patents.
`
`28.
`
`The (cid:146)094 patent shares the same expiration date as Plaintiffs(cid:146) other Orange
`
`Book-listed patents. By seeking FDA approval of its NDA No. 203050 prior to expiration of
`
`Plaintiffs(cid:146) other Orange Book-listed patents, Reddy necessarily seeks approval of that NDA prior
`
`to expiration of the (cid:146)094 patent.
`
`29.
`
`Upon information and belief, Reddy is required by law to either amend its
`
`NDA to contain a § 505(b)(2)(A)(iv) certification with respect to the (cid:146)094 patent, or must
`
`relinquish its request that the FDA approve NDA No. 203050 prior to the expiration of Plaintiffs(cid:146)
`
`Orange Book-listed patents.
`
`-6-
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`Exh. 1004, Page 6 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 7 of 25 PageID: 7
`
`30.
`
`Reddy continues to seek approval of NDA No. 203050 from the FDA and
`
`intends 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 (cid:146)094
`
`patent.
`
`31.
`
`By seeking approval of its 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 (cid:146)094 patent, Reddy has infringed that patent pursuant to 35
`
`U.S.C. § 271(e)(2)(A).
`
`32.
`
`Reddy Ltd. and Reddy Inc. are jointly and severally liable for any
`
`infringement of the (cid:146)094 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 NDA No. 203050 to the FDA.
`
`33.
`
`Reddy(cid:146)s active and knowing participation in, contribution to, aiding,
`
`abetting, and/or inducement of the submission to the FDA of NDA No. 203050 constitutes
`
`infringement of the (cid:146)094 patent under 35 U.S.C. § 271(e)(2)(A).
`
`34.
`
`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)094 patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`35.
`
`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.
`
`-7-
`
`Exh. 1004, Page 7 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 8 of 25 PageID: 8
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs request that:
`
`A.
`
`A Judgment be entered declaring that Defendants Reddy Ltd. and Reddy
`
`Inc. have infringed the (cid:146)094 patent by submitting the aforesaid ANDA;
`
`B.
`
`A Judgment be entered declaring that Defendants Reddy Ltd. and Reddy
`
`Inc. have infringed the (cid:146)094 patent by submitting the aforesaid NDA;
`
`C.
`
`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any approval of Defendants(cid:146) ANDA identified in this Complaint be a date that is not
`
`earlier than the expiration dates of the (cid:146)094 patent, or any later expiration of exclusivity for the
`
`(cid:146)094 patent to which Plaintiffs are or become entitled;
`
`D.
`
`An Order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any approval of Defendants(cid:146) NDA identified in this Complaint be a date that is not earlier
`
`than the expiration date of the (cid:146)094 patent, or any later expiration of exclusivity for the (cid:146)094
`
`patent to which Plaintiffs are or become entitled;
`
`E.
`
`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 either 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)094 patent, prior to the expiration
`
`of the (cid:146)094 patent, including any extensions to which Plaintiffs are or become entitled; and
`
`F.
`
`Plaintiffs be awarded such other and further relief as this Court deems just
`
`and proper.
`
`
`
`-8-
`
`Exh. 1004, Page 8 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 9 of 25 PageID: 9
`
`Dated: July 7, 2014
`
`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
`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
`mwaddell@loeb.com
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`
`
`
`
`
`
`-9-
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`Exh. 1004, Page 9 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 10 of 25 PageID: 10
`
`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) and Helsinn Healthcare S.A., et al. v. Dr. Reddy Laboratories, Ltd., et al.,
`
`Civil Action No. 12-2867 (MLC)(DEA) are 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)), and in all 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.
`
`
`
`
`
`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
`
`
`
`
`-10-
`
`Dated: July 7, 2014
`
`
`
`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.
`
`Exh. 1004, Page 10 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 11 of 25 PageID: 11
`
`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
`
`
`
`-11-
`
`Exh. 1004, Page 11 of 64
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`

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`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 12 of 25 PageID: 12
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`
`
`
`EXHIBIT A
`
`Exh. 1004, Page 12 of 64
`
`

`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 13 of 25 PageID: 13
`111111111111111111111111111111111111111111111111111111111111111111111111111
`US008729094B2
`
`c12) United States Patent
`Calderari et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,729,094 B2
`*May 20, 2014
`
`(54) LIQUID PHARMACEUTICAL
`FORMULATIONS OF PALONOSETRON
`
`(71) Applicants:Helsinn Healthcare SA, Lugano (CH);
`Roche Palo Alto LLC, Palo Alto, CA
`(US); Simone Macciocchi, Melide (CH);
`Giulio Macciocchi, Breganzona (CH)
`
`(72)
`
`Inventors: Giorgio Calderari, Rancate (CH);
`Daniele Bonadeo, Casalzuigno (IT);
`Roberta Cannella, Varese (IT); Alberto
`Macciocchi, Melide (CH); Andrew
`Miksztal, Palo Alto, CA (US); Thomas
`Malefyt, Carmel Valley, 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(cid:173)
`claimer.
`
`(21) Appl. No.: 13/902,132
`
`(22) Filed:
`
`May24, 2013
`
`(65)
`
`Prior Publication Data
`US 2013/0261150Al
`Oct. 3, 2013
`
`(63)
`
`Related U.S. Application Data
`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. 11/186,311, 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)
`
`(2006.01)
`
`Int. Cl.
`A61K 47100
`(52) U.S. Cl.
`USPC .......................................................... 514/296
`(58) Field of Classification Search
`USPC .......................................................... 514/296
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`EP
`wo
`wo
`wo
`wo
`
`0 512 400 A1
`W0-031 00091
`W0-2004045615
`W0-2004067005
`W0-2004703714
`
`4/1992
`12/2003
`6/2004
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`
`(Continued)
`
`Primary Examiner- Shirley V Gembeh
`(74) Attorney, Agent, or Firm- Clark G. Sullivan;
`Troutman Sanders LLP
`
`(57)
`
`ABSTRACT
`
`The present invention relates to shelf-stable liquid formula(cid:173)
`tions of palonosetron for reducing chemotherapy and radio(cid:173)
`therapy induced emesis with palonosetron. The formulations
`are particularly useful in the preparation of intravenous and
`oral liquid medicaments.
`
`30 Claims, No Drawings
`
`Exh. 1004, Page 13 of 64
`
`

`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 14 of 25 PageID: 14
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`706 657.6, dated Feb. 11, 2010.
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`Healthcare to Opposition ofEP Serial No. 04 706 657.6 dated Feb.
`11, 2010.
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`Serial No. 04 706 657.6 dated Feb. 11,2010.
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`Serial No. 04 706 657.6 dated Feb. 11,2010.
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`May 24, 2011 Para. IV notice from Teva Pharmaceuticals re '724 and
`'725 patents.
`May 24, 2011 Para. IV notice from Sandoz re '724 and '725 patents.
`May 24, 2011 Para. IV notice from Dr. Reddy's re '724 and '725
`patents.
`Aug. 9, 2011 Para. IV notice from Dr. Reddy's re '424 patent.
`Aug. 19, 2011 Para. IV notice from Teva Pharmaceuticals re '424
`patent.
`Sep. 22, 2011 Para. IV notice from Sandoz re '724, '725 and '424
`patents.
`Jul. 8, 2011 Complaint for patent infringement (D. N.J. case No.
`11-03962).
`Sep. 23, 2011 Complaint for patent infringement (D. N.J. case No.
`11-5579).
`Aug. 31, 2011 Answer and counterclaim of Dr. Reddy's Laborato(cid:173)
`ries, Ltd. and Dr. Reddy's Laboratories, Inc. (D. N.J. case No.
`11-03962).
`Sep. 13, 2011 Sandoz Inc.'s answer to complaint for patent infringe(cid:173)
`ment and counterclaims (D. N.J. case No. 11-03962).
`Sep. 13, 2011 Teva Pharmaceuticals USA, Inc. and Teva Pharmaceu(cid:173)
`tical Industries Ltd.'s answer (D. N.J. case No. 11-03962).
`Oct. 5, 2011 Plaintiffs reply to answer and counterclaim of Dr.
`Reddy's Laboratories, Ltd. and Dr. Reddy Laboratories, Inc. (D. N.J.
`case No. 11-03962).
`Oct. 21, 2011 Plaintiffs reply to Sandoz Inc.'s answer to complaint
`for patent infringement and counterclaims (D. N.J. case No.
`11-03962).
`Oct. 24, 2011 Answer and counterclaim of Dr. Reddy's Laboratories,
`Ltd. and Dr. Reddy's Laboratories, Inc. (D. N.J. case No. 11-5579).
`Oct. 24, 2011 Sandoz Inc.'s answer to complaint for patent infringe(cid:173)
`ment and counterclaims (D. N.J. case No. 11-5579).
`Oct. 27, 2011 Order consolidating the two cases (D. N.J. case No.
`11-5579).
`Nov. 17, 2011 Plaintiffs' reply to answer and counterclaim of Dr.
`Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (D.
`N.J. case No. 11-03962).
`Nov. 17, 2011 Plaintiffs' reply to Sandoz Inc.'s answer to complaint
`for patent infringement and counterclaims (D. N.J. case No.
`11-03962).
`
`Exh. 1004, Page 14 of 64
`
`

`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 15 of 25 PageID: 15
`
`US 8,729,094 B2
`Page 3
`
`(56)
`
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`OTHER PUBLICATIONS
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`Dec. 5, 2011 Teva Pharmaceuticals USA Inc. And Teva Pharmaceu(cid:173)
`ticals Industries Ltd.'s answer to complaint for patent infringement of
`the '424 patent (D. N.J. case No. 11-03962).
`May 21, 2012 Defendants' opening claim construction brief (includ(cid:173)
`ing exhibits 1-31 ).
`May 21, 20 12 Plaintiffs' opening claim construction brief (including
`exhibits 1-15).
`Jul. 20, 2012 Defendants' responsive claim construction brief
`(including exhibits 1-3).
`Jul. 20, 2012 Plaintiffs' responsive claim construction brief (includ(cid:173)
`ing Exhibits A and B).
`Sep. 7, 2012 CourttranscriptfromSep. 7, 2012 Markman hearing and
`Plaintiffs' Power Point presentation (D. N.J. case No. 11-03962).
`Dec. 1, 2011 Sandoz Inc.'s invalidity contentions pursuant to L. Pat.
`R. 3.6(c) (D. N.J. case No. 11-03962).
`Dec. 1, 2011 Teva Pharmaceuticals USA, Inc. and Teva Pharmaceu(cid:173)
`tical Industries, Ltd.'s invalidity contentions, pursuant to L. Pat. R.
`3.6(c)(D. N.J. case No. 11-03962).
`Dec. 1, 2011 Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Labo(cid:173)
`ratories, Inc.'s invalidity contentions pursuant to L.