`
`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.
`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 A venue
`New York, NY 10154
`(212) 407-4127
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
`
`Civil Action No. - - - - - -
`
`Plaintiffs,
`
`V.
`
`DR. REDDY'S LABORATORIES, LTD. and
`DR. REDDY'S LABORATORIES, INC.,
`
`Defendants.
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC (collectively,
`
`Reddy's Laboratories, Inc. (collectively, "Reddy" or "Defendar
`
`"Plaintiffs"), for their Complaint against Defendants Dr. Reddy's Laboratories, Ltd. and Dr.
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1006
`
`-1-
`
`
`
`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'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 A venue
`New York, NY 10154
`(212) 407-4127
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
`
`Civil Action No. - - - - - -
`
`Plaintiffs,
`
`V.
`
`DR. REDDY'S LABORATORIES, LTD. and
`DR. REDDY'S LABORATORIES, INC.,
`
`Defendants.
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC (collectively,
`
`"Plaintiffs"), for their Complaint against Defendants Dr. Reddy's Laboratories, Ltd. and Dr.
`
`Reddy's Laboratories, Inc. (collectively, "Reddy" or "Defendants"), hereby allege as follows:
`
`-1-
`
`Exh. 1006
`
`
`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 2 of 25 PageiD: 2
`
`THE PARTIES
`
`1.
`
`Plaintiff HeJsinn Healthcare S.A. is a Swiss corporation having its
`
`principal place of blllsiness at Via Pian Scairolo, 9, CH-6912 Lugano-Pazzal1o, 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., eta/., 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 SA., eta/. 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. 1006
`
`
`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 3 of 25 PageiD: 3
`
`Helsinn Healthcare S.A., eta!. v. Dr. Reddy's Laboratories, Ltd., et a!., 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., eta!. v. Dr. Reddy's
`
`Laboratories, Ltd., eta/., 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 conceming the infringement of United States Patent
`
`No. 8,729,094 ("the '094 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. §§ 2201-021because this case is an actual controversy within the Court's
`
`jmisdiction.
`
`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 jmisdiction 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-
`
`Exh. 1006
`
`
`
`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 jmisdiction over Defendant Reddy Inc.
`
`THE PATENT
`
`12.
`
`On May 20, 2014 the ' 094 patent, titled "Liquid Pharmaceutical
`
`Formulations of Palonosetron," was duly and legally issued to Plaintiffs as assignees. A copy of
`
`the '094 patent is attached as Exhibit A.
`
`13.
`
`Pursuant to 21 U.S.C. § 355(b)(l), the '094 patent has been listed in the
`
`United States Food and Drug Administration ("FDA") publication titled Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (also known as the "Orange Book") as
`
`covering Helsinn's Aloxi® brand palonosetron hydrochloride intravenous solutions.
`
`ACTS GIVING RISE TO THIS ACTION
`
`COUNT I - INFRINGEMENT OF THE '094 PATENT BY REDDY'S ANDA
`
`14.
`
`15.
`
`Plaintiffs reallege paragraphs 1-13 as if fully set forth herein.
`
`Upon infmmation 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 ' 094 patent. ANDA No. 201533 specifically seeks FDA
`
`approval to market a generic version of Helsinn' s Aloxi® brand palonosetron hydrochloride
`
`intravenous solutions prior to the expiration of the '094 patent.
`
`16.
`
`The '094 patent had not been issued at the time Reddy made its
`
`§ 505U)(2)(A)(vii)(IV) certification regarding Plaintiffs' other Orange Book-listed patents.
`
`17.
`
`The '094 patent shares the same expiration date as Plaintiffs' other Orange
`
`Book-listed patents. By seeking FDA approval of its ANDA No. 201533 prior to expiration of
`
`-4-
`
`Exh. 1006
`
`
`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 5 of 25 PageiD: 5
`
`Plaintiffs' other Orange Book-listed patents, Reddy necessarily seeks approval of that ANDA
`
`ptior to expiration of the '094 patent.
`
`18.
`
`Upon information and belief, Reddy is required by law to either amend its
`
`ANDA to contain a § 505U)(2)(A)(vii)(IV) certification with respect to the '094 patent, or must
`
`relinquish its request that the FDA approve ANDA No. 201533 prior to the expiration of
`
`Plaintiffs' 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
`
`imp01tation of generic palonosetron hydrochloride intravenous solutions prior to the expiration
`
`of the '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 '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 ' 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'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 ' 094 patent under 35 U.S.C. § 271(e)(2)(A).
`
`23.
`
`Plaintiffs are entitled to a declaration that, if Reddy commercilally
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn' s Aloxi®
`
`brand products withiin the United States, imports its proposed generic versions ofHelsinn's
`
`-5-
`
`Exh. 1006
`
`
`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 6 of 25 PageiD: 6
`
`Aloxi® brand products into the United States, and/or induces or contributes to such conduct,
`
`Reddy would infringe the '094 patent under 35 U.S.C. § 27l(a), (b), and/or (c).
`
`24.
`
`Plaintiffs will be irreparably harmed by Reddy's infringing activities
`
`unless those activities are enjoined by this Comt. Plaintiffs do not have an adequate remedy at
`
`law.
`
`COUNT II- INFRINGEMENT OF THE '094 PATENT
`BY REDDY'S 505(b)(2) APPLICATION
`
`Plaintiffs reallege paragraphs 1-24 as fully set forth herein.
`
`Upon information and belief, Reddy submitted NDA No. 203050 to the
`
`25.
`
`26.
`
`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 '094 patent. NDA No. 203050 specifically seeks FDA
`
`approval to market and sell generic versions of Helsinn's Aloxi® brand palonosetron
`
`hydrochloride intravenous solutions prior to the expiration of the '094 patent.
`
`27.
`
`The '094 patent had not issued at the time Reddy made its
`
`§ 505(b)(2)(A)(iv) certification regarding Plaintiffs' other Orange Book-listed patents.
`
`28.
`
`The '094 patent shares the same expiration date as Plaintiffs' other Orange
`
`Book-listed patents. By seeking FDA approval of its NDA No. 203050 prior to expiration of
`
`Plaintiffs' other Orange Book-listed patents, Reddy necessarily seeks approval of that NDA prior
`
`to expiration of the ' 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 '094 patent, or must
`
`relinquish its request that the FDA approve NDA No. 203050 prior to the expiration of Plaintiffs'
`
`Orange Book-listed patents.
`
`-6-
`
`Exh. 1006
`
`
`
`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 palonosetrorn hydrochloride intravenous solutions prior to the expiration of tlhe '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 ' 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
`
`inf1ingement of the ' 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'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 '094 patent under 35 U.S.C. § 271(e)(2)(A).
`
`34.
`
`Plaintiffs are entitled to a declaration that, if Reddy commerdally
`
`manufactures, uses, offers for sale, or sells its proposed generic versions of Helsinn' s Aloxi®
`
`brand products withEn the United States, imports its proposed generic versions ofHelsinn's
`
`Aloxi® brand products into the United States, and/or induces or contributes to such conduct,
`
`Reddy would infringe the '094 patent under 35 U.S.C. § 271 (a), (b), and/or (c).
`
`35.
`
`Plaintiffs will be irreparably harmed by Reddy's infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`-7-
`
`Exh. 1006
`
`
`
`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 '094 patent by submitting the aforesaid ANDA;
`
`B.
`
`A Judgment be entered declaring that Defendants Reddy Ltd. and Reddy
`
`Inc. have infringed tlhe '094 patent by submitting the aforesaid NDA;
`
`C.
`
`An Order be issued pursuant to 35 U.S.C. § 27](e)(4)(A) that the effective
`
`date of any approval of Defendants' ANDA identified in this Complaint be a date that is not
`
`earlier than the expiration dates of the '094 patent, or any later expiration of exclusivity for the
`
`'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' NDA identified in this Complaint be a date that is not earlier
`
`than the expiration date of the '094 patent, or any later expiration of exclusivity for the '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 prelimina1ily and permanently enjoined from commercially
`
`manufacturing, using, offering for sale, importing, or selling the proposed generic versions of
`
`Helsinn's Aloxi® brand products identified in this Complaint, and any other product that
`
`infringes or induces or contlibutes to the infringement of the '094 patent, plior to the expiration
`
`of the '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. 1006
`
`
`
`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 EWJNG LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@ saul. com
`wbaton@sau1.com
`
`Attorneys for Plaintiffs
`Helsinn Healthcare SA. and
`Roche Palo Alto LLC
`
`Of Counsel:
`
`Joseph M. O'Malley, Jr.
`Bruce M. Wexler
`Eric W. Dittmann
`David M. Conca
`Gary Ji
`Angela, C. Ni
`P AUL H ASTINGS LLP
`75 East 55th Street
`New York, NY 10022
`(212) 318-6000
`
`Attorneys for Plaintiff
`Helsinn Healthcare SA.
`
`Mark lE. Waddell
`LOEB & LOEB LLP
`345 Park A venue
`New York, NY 10154
`(212) 407-4127
`mwaddell @ loeb.com
`
`Attorneys for Plaintiff
`Roche Palo Alto LLC
`
`-9-
`
`Exh. 1006
`
`
`
`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 Ci vii Rules 11.2 and 40.1, I hereby ce1tify that the matters
`
`captioned Helsinn Healthcare SA., et al. v. Dr. Reddy Laboratories, Ltd., et al., Civil Action No.
`
`11-3962 (MLC)(DEA) and Helsinn Healthcare SA., eta/. v. Dr. Reddy Laboratories, Ltd., eta/.,
`
`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's
`
`Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. ("Reddy"), 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
`
`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
`
`administrative proceeding.
`
`Dated: July 7, 2014
`
`Of Counsel:
`
`Joseph M. O'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@ pau !hastings .com
`brucewexler@ paulhastings. com
`ericdittmann @paulhastings.com
`davidconca@paulhastings.com
`garyji @paulhastings.com
`angel ani@ paulhastings.com
`
`Attorneys for Plaintiff
`Helsinn Healthcare S.A.
`
`-10-
`
`Exh. 1006
`
`
`
`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 A venue
`New York, NY 10154
`(212) 407-4127
`mwaddell@ loeb.com
`
`Attorneysfor Plaintiff
`Roche Palo Alto LLC
`
`-11-
`
`Exh. 1006
`
`
`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 12 of 25 PageiD: 12
`
`EXHIBIT A
`
`Exh. 1006
`
`
`
`Case 3 : 14-cv-0427 4-M LC-DEA DocumenllDII
`
`n~lm~~~~~~~mlflltmlfllnmrml 13
`
`US008729094B2
`
`c12) United States Patent
`Calderari et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,729,094 B2
`*May 20, 2014
`
`(54) UQUID PHARMACEUTICAL
`FORMULATIONS OF PALONO SETRON
`
`(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 OT);
`Roberta Cannella, Varese (IT); Alberto
`Macciocchi, Melide (CH); Andrew
`Miksztal, Palo Alto, CA (US); Thomas
`Malcfyt, Carmel Valley, CA (US);
`Kathle~n M Lee, Palo Alto, CA (US)
`
`(73) Assignees: Belsinn Bealthcare SA,
`Pambio-Noranco (CH); Roche Pa lo Alto
`LLC, Palo Alto, CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjllSted under 35
`U.S.C. 154(b) by 0 days.
`This pa tent is subject to a tem1inal dis-
`claimer.
`
`(2 1) Appl. No .: 13/902,132
`
`(22) Filed:
`
`May24, 2013
`
`(65)
`
`Prior P ublication Oata
`Oct. 3, 2013
`US 2013/0261 150AJ
`
`Related U.S. Application ])ata
`(63) Continuation of application No. 13/901,437, filed on
`May 23, 2013, now Pat. No. 8,598,219, which is a
`continuation-in-part of application No. 13/087,012,
`filed on Apr. 14, 201 1, 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.
`
`(5 1)
`
`(2006.01)
`
`lnt. CI.
`A61K 47100
`(52) U.S. CI.
`USPC .......................................................... 5141296
`(58) Field of C lassification Search
`USPC .......................................................... 514/296
`See application file for complete search history.
`
`(56)
`
`Refe ren ces Cited
`
`U.S. PATENT DOCUMENTS
`
`4,695,578 A
`4,753,789 A
`4,886,808 A
`4,906,755 A
`4,929,632 A
`4,937,247 A
`
`9/1987 Coates et al.
`6!1988 Tyers et al.
`12/1989 King
`3/1990 Gittos
`5/1990 Tyers et al.
`611990 King
`
`4/1991 Gittos et al.
`5,011,846 A
`7/1991 King
`5,034,398 A
`4/1993 Berger el a.l.
`5,202,333 A
`8/1993 Tyers et al.
`5,240,954 A
`5,272,137 A
`J 2/1993 Blaseetal.
`911994 Collin
`5,344,658 A
`J 111996 Tyers et al.
`5,578,628 A
`J 111996 Tyers et al.
`5,578,632 A
`5,622,720 A
`4/1997 Collin
`J 211998 Gambhir
`5,854,270 A
`5,922,749 A
`711999 Tyers et al.
`5,955,488 A
`9/1999 Winterborn
`5/2000 Winterborn
`6,063,802 A
`10/2000 Munayyer et al.
`6,132,758 A
`9/2001 Castillo et al.
`6,284,749 Bl
`6,287,592 Bl
`9/2001 Dickinson
`6,294,548 B1
`9/200 I James
`3/2004 Robichaud
`6,699,852 B2
`9/2006 Lee etal.
`7,109,339 B2
`5/2011 Calderari et al.
`7,947,724 B2
`S/2011 Calderari et al.
`7,947,725 B2
`6/2011 Calderari el al.
`7,960,424 132
`812013 Calderari et al.
`8,518,981 B2
`9/200 I James
`200 110020029 A I
`5/2003 Dugger, lll
`2003/0095926 A 1
`2004/0147510 A 1 + 7/2004 Landau et al. .
`
`514/218
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`0 512 400 A l
`wo
`W0-03!00091
`wo
`W0-2004045615
`wo W0-2004067005
`wo
`W0-2004703714
`
`411992
`12/2003
`6/2004
`8/2004
`9/2004
`
`OTHER PUBLICATIONS
`
`COER (Clinical Pharmacology and Biopharmaceutics Review (Sep.
`2002).~
`Perez et al. (cancer J. Sci Am. { 1998) 4(1 ):52."
`R. M. Eglen et al., "Pharmacological characterization ofRS 25259-
`197, a novel and selective 5-HT3 receptor antagonist, in vivo," Br. J
`Phannacology 114:860-866 (1995).
`Chelly, Jacques et al., Oral RS-25259 Prevents Postoperative Nausea
`and Vorniting Following Laparoscopic Surgery, Anesthesiology,
`1996, vol. 85, No. 3A, p. A21.
`Sorbe, Bengt, 5-HT-3 Receptor Antagonists as Antiemetic Agents in
`Cancer Chemotherapy, extmct.ed from Expert: Opinion on Investiga-
`tional Dm gs, 1996, vol. 5 No.4, pp. 389-407.
`Gaster, Laramie M. and King, Frank D., Serotonin 5-HT3 and 5-HT4
`Receptor Antagonists. extracted from Medicinal Research Reviews,
`1997 vol. 17, No.2, pp. 163-214.
`(Continued)
`
`Primar)' Examiner - Shirley V Gembeh
`(74) Attorney, Agent, or Firm - Clark G. Sullivan;
`Troutman Sanders LLP
`
`(57)
`
`A US TRACT
`The present invention relates to shelf-stable liquid fonnula-
`tions of palonosetron for reducing chemotherapy and radio-
`therapy induced emesis with palonosetron. T he formulations
`are particularly useful in th e preparation of intravenous and
`oral liquid medicaments.
`
`30 C laims, No Drawings
`
`Exh. 1006
`
`
`
`Case 3:14-cv-04274-MLC-DEA Document 1 Filed 07/07/14 Page 14 of 25 PageiD: 14
`
`US 8,729,094 B2
`Page 2
`
`(56)
`
`Heferences Cited
`
`OTHER PUBLICATIONS
`
`Tang, Jun et al., "Efficacy of RS-25259, a Novel 5-HT3 Antagonist,
`in the Prevention of Postoperative Nausea and Vomiting after Major
`Gynecologic Surgery," Anesthesiology, 1997, vol. 85, No.3 suppl. p.
`A329.
`Tang, Jun et al., The Efficacy of RS-25259. a Long-Acting Selective
`5-HT3 Receptor Antagonist, for Preventing Postoperative Nausea
`and Vomiting After Hysterectomy Procedures, Anesthesia and Anal-
`gesia, 1998, vol. 87, pp. 462-467.
`Adis R&D Profile, Palonosetron RS 2 5259 197, Drugs in R&D, Oct.
`1999, vol. 2, o. 4, pp. 251-252.
`Piraccin i Gaia et al., An Interesting 5-HT3 Receptor Antagonist
`Antiemetic for Patients Undergoing Chemotheraphy-based Condi-
`tioning Regimens, Blood, Nov. 16, 200 I, vol. 98, No. II, part 2, p.
`350b, albstract No. 5169.
`Stacher, Georg, PalonoselTon Helsinn, Current Opinion in Investiga-
`tional Dmgs. Oct. 2002, vol. 3, o. 10, pp. 1502-1507.
`Navari, Rudolph M., Pathogenesis-Based Treatment of Chemo-
`therapy-Induced Nausea and Vomiting- Two New Agents, Journal
`of Supportive Oncology, 2003, vol. 1(2), pp. 89-103.
`Chaitow, 1990, 3 pages.
`Opposition Brief filed by Dr. Reddy's Laboratories (UK) Limited,
`opposition to European Patent No. 1601359 Bl dated Jul. 7, 2009.
`Photolytic and oxidative degradation of an antiemetic agent, RG
`12915 (Won C. M. et al., Intemationa.l Journal ofPhannaceutics 121.
`95-105 (1995).
`PalonoselTon: a phase II dose ranging study to assess over a 7 day
`period the single dose phannacokinetic profile of palonosetron in
`patients receiving highly emetogenic chemotherapy. Piraccini et al.,
`Proc. Am. Soc. Clin. Oncol 2002 21 Abs 449 (2002).
`Formulation and administrat ion techniques to minimize injection
`pain and tissue damageassocuat:ed with parenteral products. Larry A.
`Gatlin and Carol A. Brister Gatlin, from Injectable Dmg Develop-
`ment: Techniques to Reduce Pain and Irritatio n (Ed ited by Pramod K.
`Gupta and Gayle A. Brazeau; published by Infonna Health Cru·e)
`1999; ISBN 1574910957, 9781574910957, p. 401-421.
`Parente.ral Dosage Forms. Joanne Broadhead, from Part 11- Eru·ty
`dmg development, pharmaceut ical preformulation :md formulation:
`a practice guide from candidate dmg selection to commercial dosage
`fonn (Edited by Mark Gibson; Published by Interpharma Press,
`2001; ISBN 1574911201, 978157<19.1 1206), p. 33J-353.
`Opposition Brief filed by Tocnimede Sociedade Tecnico-Medicinal
`S.A. in opposition to Ettropean Patent No. 1601359 Bl , Jul. 8, 2009.
`Response brief filed by Helsinn Healthcru·e S.A. dated Jul. 13,2007,
`in response to the communication pursuant to Art. 96(2) EPC of Jan.
`3, 2007 regarding Serial No. 04 706 657.6-2123.
`European Patent Office of'ficial communication dated Jul. 19, 2006,
`regarding Serial No. 04 706 657.6.
`Respon se ofHelsinn Healthcare S.A. dated Nov. 29, 2006, regarding
`EPO official conununication date Jul. 19, 2006.
`Lachman et al., The Theory and Practice of Industrial Pharmacy,
`1986, third edition, pp. 652-784.
`Declaration of Valentino J. Stella, Ph.D. dated Sep. 19, 2007.
`Opposition Brief filed by Mrutin Paul White, opposition to European
`Patent No. 1601359 8 1, Jul. 8, 2009.
`Wong et al. (1995), in British Journal ofPhannacology, vol. l 14, pp.
`851-859.
`Cover page and pp. 642-644 and 783-784 of The Theory and Practice
`oflnduslTial Pharmacy, Third Edition, Lea and Febiger (1986).
`Cover page and pp. 514-515 of Modern Pharmaceutics, Second Edi-
`tion, Marcel Dekker (1990).
`Cover page and pp. 142-143 of Phru·maceutical Dosage Forms:
`Parenteral Medications vol.
`l , Second Edition, Marcel Dekker
`(1992).
`Mitsuo Matsumoto et a!., "Yakuzaigaku Manual", 1st edition,
`Nanza ndo Co., Ltd. ( 1989) 2 pages.
`Michael J. Pika!, "Freeze Drying", Encyclopedia of Pharmaceutical
`Technology, Third Ed ition, Jan. 2007, pp. 1824- 1825, vol. 3, In forma
`Pharmaceuticals :md Healthcare.
`
`Oaniele tlonadeo, "Supplemental Declaration ot Oaniele tlonadeo
`Under 37 C.F.R. 1.132", filed in U.S. Appl. No. 111388,270, Jun. 8,
`2009.
`Kranke et al., 2007 ''Recent advances, trends, and economic consid-
`erations in ... " Expert Opinion Pharmacotherp., 8(18): 3217-3235.
`Mo1Towetal., 1995, "Progress in reducing nausea an.demesis: Com-
`parisons of ondansetron, granisetron, and tropisetron." Cancer, vol.
`76, No.3 pp. 343-357.
`USPTO Notice of Allowance and Fees Due, U .S. Appl. No.
`11/388,270, filed Mar. 24, 2006, Date Mailed Jan. 26, 2010.
`USPTO Office Action, U.S. Appl. No. 1 I/ 129,839, Date Mailed Jan.
`15, 2010.
`Israili, Zaf."U H., "Clinical PharmacologyofSerotonin Receptor Type
`(5-HT3) Antagonists," Curr. Med. Chern. Central Nervous System
`Agents, 2001:1, 171-199.
`Barton (Citrate Buffer Calculation) 2000, 2 pages.
`USPTO Office Action, U.S. Appl. No. 11/201,035, Date Mailed Aug.
`19, 2009.
`Response of Helsinn Healthcare to opposition of EP Serial No. 04
`706 657.6, dated Feb. 1 I, 2010.
`Annex 1 (Statement ofWalso Mossi, Ph.D.) to Response of Helsinn
`Health care to Opposition of EP Serial No. 04 706 657.6 dated Feb.
`.II, 20.10.
`Annex 2 to Response of Helsinn Healthcare to Opposition of EP
`Serial No. 04 706 657 6 dated Feb. 1 J, 2010.
`Annex 3 to Response of Helsinn Healthcare to Opposition of EP
`Serial No. 04 706 657.6 dated Feb. 11 , 2010.
`Summary of Product Characteifistics for Aloxi 250 (2009).
`Scientific Discussion fTom rhe European Public Assessment Report
`for- Aloxi (Palono•ereron Hy<lrochlori<le) 2006.
`6th Edition, Handbook of Ph rumaceutical Excipients (2009), pp.
`247-250 (RPS Publishing).
`Lewis, Gareth A (2006) ·optimization Methods,' Encyclopedia of
`Pharmaceutical Technology, .I : 1, 2452-2467.
`May 24, 20 I I Para. IV notice from Teva Pharmaceuticals re '724 and
`'725 patents.
`May 24, 2011 Para. IV notice ti·om Sandoz re '724 :und '725 patents.
`May 24, 20 I J Para. IV notice from Dr. Reddy's re '724 and '725
`patents.
`Aug. 9, 201.1 Para. IV notice from Dr. Reddy's re '424 patent.
`Aug. 19, 201 1 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, 20 I J Complaint for patent infringement (D. N.J. case No.
`11-03962).
`Sep. 23, 2011 Complaint for patent infringement (D. N.J. case o.
`11-5579).
`Aug. 31, 201 1 Answer and counterclaim of Dr. Reddy's Laborato-
`ries, Ltd. and Dr. Reddy's Laboratories, Inc. (D. N.J. case No.
`11-03962).
`Sep. 13,2011 Sandoz Inc.'s ans wer to complaint for patent inlringe-
`ment and COlmterchLims (D. N.J. case No. 11-03962) .
`Sep. 13,2011 TevaPharmaceuticals USA, Inc. andTevaPharmaceu-
`tical Industries Ltd.'s answer (D. N.J. case No. ll-03962).
`Oct. 5, 201 J Plaintiff's reply to answer :md counterclaim of Dr.
`Reddy's Laboratories, Ltd. and Dr. Reddy Laboratories, Inc. (D. N.J.
`case No. 11-03962).
`Oct. 21 , 20 II Plaintiffs reply to Sandoz Inc.'s answer to complaint
`for patent infringement and counterclaims (D.
`.J. case No.
`ll-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-
`ment and counterclaims (D. N.J. case No. 11-5579).
`Oct. 27, 2011 Order consolidating the two cases (D. N.J. case No.
`ll-5579).
`Nov. J 7, 201 1 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. 1006
`
`
`
`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)
`
`Heferences Cited
`
`OTHER PUBLICATIONS
`
`Dec. 5, 201.1 Teva Phannaceuricals USA Inc. And Teva Phannaceu-
`ticals Industries Ltd.'s answeJrto complaint for patent infringement of
`the '424 parent (D. N.J. case No . .1 1-03962).
`May 21, 2012 Defendants' opening claim construction brief (includ-
`ing exhibits 1-31 ).
`May 21,2012 Plaintiffs' opening claim constmction brief (including
`exhibits 1-.15).
`Jul. 20, 2012 Defendants' responsive claim constmction brief
`(including exhibits 1-3).
`Jul. 20, 2012 Plaintiffs' responsive claim construction brief(includ-
`ing Exhibits A and B).
`Sep. 7,2012 CowttranscriptfromSep. 7, 20 12 Markman hearing and
`Plaintiffs' PowerPoint presentation (D. N.J. case No. 11-03962).
`Dec. I , 2011 Sandoz Inc.'s in validity contentions pursuant to L. Pat.
`R. 3.6(c) (D. N.J. case No. 1 J-03962).
`Dec. 1, 20 II Teva Phannaceuticals USA, Inc. and Teva Phannaceu-
`tical Industries, Ltd.'s invalidity contentions, pursuant to L. Pat. R.
`3.6(c)(D. N.J. case No. 11-03962).
`Dec. I, 20 II Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Labo-
`ratories, Inc.'s invalidity contentions pursuant to L. Pat. R. 3.6(c)(D.
`N.J. case No. J