`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`Civil Action No. 3:14-cv-07869(MAS)(LHG)
`Civil Action No. 3:14-cv-08082(MAS)(LHG)
`Civil Action No. 3:15-cv-02631(MAS)(LHG)
`
`
`
`
`
`
`FRESENIUS KABI USA, LLC,
`
`
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`Civil Action No. 3:14-cv-08079(MAS)(LHG)
`Civil Action No. 3:15-cv-02520(MAS)(LGH)
`
`v.
`
`
`
`
`
`
`ACCORD HEALTHCARE, INC.,
`
`
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`Civil Action No. 3:14-cv-08081(MAS)(LHG)
`Civil Action No. 3:15-cv-02521(MAS)(LHG)
`
`
`BPI LABS, LLC AND BELCHER
`PHARMACEUTICALS, LLC,
`
`Defendants.
`
`
`
`
`
`
`
`
`3512928-1
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`00001
`
`MYLAN - EXHIBIT 1031
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 2 of 12 PageID: 318
`
`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`Civil Action No. 3:15-cv-00287(MAS)(LHG)
`Civil Action No. 3:15-cv-01835(MAS)(LHG)
`
`v.
`
`
`
`
`
`
`APOTEX CORP. AND APOTEX, INC.,
`
`
`
`Defendants.
`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`Civil Action No. 3:15-cv-00289(MAS)(LHG)
`Civil Action No. 3:15-cv-01836(MAS)(LHG)
`
`
`
`
`
`
`BRECKENRIDGE PHARMACEUTICAL,
`INC.,
`
`
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`
`
`
`
`Plaintiffs,
`
`Civil Action No. 3:15-cv-00290(MAS)(LHG)
`Civil Action No. 3:15-cv-03392(MAS)(LHG)
`
`v.
`
`
`MYLAN LABORATORIES LTD.,
`
`Defendant.
`
`
`
`3512928-1
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`
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 3 of 12 PageID: 319
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`Civil Action No. 3:15-cv-00776(MAS)(LHG)
`Civil Action No. 3:15-cv-03107(MAS)(LHG)
`
`v.
`
`
`
`
`
`
`ACTAVIS LLC,
`
`
`
`Civil Action No. 3:15-cv-02522(MAS)(LHG)
`
`
`
`
`Civil Action No. 15-cv-02523(MAS)(LHG)
`
`
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`DR. REDDY’S LABORATORIES, INC. AND
`DR. REDDY’S LABORATORIES, LTD.,
`
`Defendants.
`
`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and SANOFI
`
`Plaintiffs,
`
`v.
`
`GLENMARK PHARMACEUTICALS, INC.,
`USA and GLENMARK
`PHARMACEUTICALS LTD.,
`
`
`Defendants.
`
`
`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
`
`Pursuant to Local Patent Rule 4.3 of the United States District Court for the
`
`District of New Jersey and the Court’s Pretrial Scheduling Order entered June 12, 2015 (C.A.
`
`No. 14-7869, ECF No. 23), plaintiffs Sanofi-Aventis U.S. LLC, Aventis Pharma S.A., and
`3
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`3512928-1
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 4 of 12 PageID: 320
`
`Sanofi (“Plaintiffs”) and defendants Fresenius Kabi USA, LLC (“Fresenius”); Accord
`
`Healthcare, Inc. (“Accord”); BPI Labs, LLC and Belcher Pharmaceuticals, LLC (collectively,
`
`“BPI-Belcher”); Apotex Corp. and Apotex Inc. (collectively, “Apotex”); Breckenridge
`
`Pharmaceutical, Inc. (“Breckenridge”); Mylan Laboratories Limited (“Mylan”); Actavis LLC
`
`(“Actavis”); Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively,
`
`“DRL”); and Glenmark Pharmaceuticals Inc., USA (formerly known as Glenmark Generics Inc.,
`
`USA) and Glenmark Pharmaceuticals Ltd. (collectively, “Glenmark”) (all collectively,
`
`“Defendants”) hereby provide their Joint Claim Construction and Prehearing Statement
`
`concerning U.S. Patent Nos. 5,847,170 (“the ’170 patent”), 7,241,907 (“the ’907 patent”), and
`
`8,927,592 (“the ’592 patent”) (collectively “Patents-In-Suit”).
`
`
`
`I.
`
`BACKGROUND
`
`This is a Hatch-Waxman Act patent action. Plaintiffs assert, among other things,
`
`that Defendants infringed the Patents-In-Suit by filing a New Drug Application (“NDA”) and/or
`
`an Abbreviated New Drug Application (“ANDA”) pursuant to 21 U.S.C. §§ 355(b)(2) and/or (j)
`
`(§ 505(b)(2) or § 505(j) of the Federal Food, Drug and Cosmetic Act) with the U.S. Food and
`
`Drug Administration seeking approval to market proposed drug products, which are as follows:
`
`a. For Fresenius: Cabazitaxel Injection, 60 mg/3 mL solution (“Fresenius’s NDA
`
`Product”) and Cabazitaxel Injection, 60 mg/1.5 mL solution (“Fresenius’s ANDA
`
`Product”);
`
`b. For Accord: Cabazitaxel Injection, 60 mg/1.5 mL (“Accord’s ANDA Product”) and
`
`Cabazitaxel Injection, 20 mg/mL, 3mL (“Accord’s NDA Product”);
`
`c. For BPI-Belcher: Cabazitaxel, 60 mg/1.5 mL solution for intravenous infusion (“BPI-
`
`Belcher’s ANDA Product”);
`
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 5 of 12 PageID: 321
`
`d. For Apotex: Cabazitaxel Injection, 60 mg/1.5 mL (“Apotex’s ANDA Product”);
`
`e. For Breckenridge: Cabazitaxel Solution, IV, 60 mg/1.5 mL (“Breckenridge’s ANDA
`
`Product”);
`
`f. For Mylan: Cabazitaxel Injection [60 mg/1.5 mL] [40 mg/mL] (“Mylan’s ANDA
`
`Product”);
`
`g. For Actavis: Cabazitaxel Injection, 10 mg/mL (40 mg/4 mL, 60 mg/6 mL)
`
`(“Actavis’s NDA Product”);
`
`h. For DRL: Cabazitaxel Solution for Infusion, 60 mg/1.5 mL (“DRL’s ANDA
`
`Product”); and
`
`i. For Glenmark: Cabazitaxel for Injection, 60 mg/1.5 mL (40 mg/mL) (“Glenmark’s
`
`ANDA Product”) (collectively “Defendants’ Cabazitaxel Products”).
`
`Plaintiffs also assert that Defendants will infringe the Patents-In-Suit if Defendants commercially
`
`make, use, offer to sell, or sell Defendants’ Cabazitaxel Products, or import Defendants’
`
`Cabazitaxel Products into the United States, or induce or contribute to any such conduct.
`
`Defendants allege that they do not and will not infringe the Patents-In-Suit and that the Patents-
`
`In-Suit are invalid.
`
`II.
`
`CONSTRUCTION OF TERMS
`
`A. Construction of Terms on Which the Parties Agree
`
`In accordance with Local Patent Rule 4.3(a), Plaintiffs and Defendants
`
`(collectively the “Parties”) have agreed to the construction of the following terms.
`
`With respect to claims 7 and 9 of the ’592 patent, the Parties agree that “AUC of
`
`about 991 ng·h/mL (CV 34%)” and “plasma clearance of 48.5 L/h (CV 39%)” do not need to be
`
`construed. The Parties do not thereby propose a construction for either of those terms.
`
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 6 of 12 PageID: 322
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`With respect to claims 1 and 27 of the ’592 patent, the Parties agree that “prostate
`
`cancer that has progressed during or after treatment with docetaxel” means “prostate cancer that
`
`has worsened during or after treatment with docetaxel.”
`
`With respect to claim 6 of the ’592 patent, the Parties agree that “in base form”
`
`means “having the formula set forth at col. 4:10-25 of the ‘592 patent and not in the form of a
`
`solvate or hydrate.”
`
`With respect to claim 8, the Parties agree that “Cmax of about 226 ng·h/mL (CV
`
`107%)” means “Cmax of about 226 ng/mL (CV 107%).”
`
`B. Each Party’s Proposed Construction of the Claim Terms in Dispute
`
`
`
`In accordance with Local Patent Rule 4.3(b), the Parties identify the disputed
`
`claim terms and proposed constructions in Exhibits A-C. The Parties request construction of
`
`these claim terms, phrases, or clauses by the Court. Exhibits A-C also include the intrinsic and
`
`extrinsic evidence that the Parties may rely on in support of their respective proposed
`
`constructions.
`
`C. Claim Terms Whose Construction Will Be Most Significant or Dispositive
`
`
`
`
`
`In accordance with Local Patent Rule 4.3(c), Plaintiffs do not believe any of the
`
`disputed terms will be case-dispositive or substantially conducive to promoting settlement. As
`
`argued by Defendants below, the construction of a few terms may be claim-dispositive pending
`
`resolution of applicable discovery in this case. This will not, however, resolve all claims of the
`
`’592 patent, and the ’907 patent is only asserted against a minority of Defendants.
`
`
`
`While all terms for construction are important to the resolution of this case, Defendants
`
`believe that the terms “acetone solvate” and “wherein the cabazitaxel is in the form of an acetone
`
`solvate” are claim dispositive with respect to claims 1-2 of the ’907 patent and claims 3-4 of the
`6
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 7 of 12 PageID: 323
`
`’592 patent, that the term “advanced metastatic disease” is claim dispositive with respect to
`
`claim 2 of the ’592 patent, and that the term “A method of increasing the survival of a patient” is
`
`claim dispositive with respect to claims 27-30 of the ’592 patent.
`
`D. Anticipated Length of Time Necessary for the Claim Construction Hearing
`
`
`
`
`
`In accordance with Local Patent Rule 4.3(d), the Parties provide the following
`
`estimates:
`
`The Scheduling Order provides for a half-day tutorial on February 18, 2016 (C.A.
`
`No. 14-7869, ECF No. 23), and for a full-day claim construction hearing on February 23, 2016.
`
`The Parties believe that both the tutorial and the claim construction hearing could be conducted
`
`on February 23, 2016 and estimate that the tutorial and the claim construction hearing together
`
`will require 4-6 hours total.
`
`The Parties further propose that the allotted time for the hearing and tutorial be
`
`divided equally between Plaintiffs and Defendants.
`
`E.
`
`Identification of Witnesses for the Claim Construction Hearing
`
`In accordance with Local Patent Rule 4.3(e), the Parties will call upon the
`
`following witnesses at the claim construction hearing:
`
`Plaintiffs expect to call Prof. Jerry Atwood and Dr. Daniel Petrylak1 in connection
`
`with the disputed claim terms in phrases listed in Exhibits A-C, to testify as to the definition of a
`
`person of ordinary skill in the art at the relevant time, to testify to the meaning of the disputed
`
`claim terms and phrases as they would be understood by a person of ordinary skill in the art
`
`
`1 Plaintiffs object to the extent Defendants state they expect to call “similarly qualified experts”
`not identified in the Joint Claim Construction Statement and Prehearing Statement. To the extent
`Defendants are able to utilize a heretofore unidentified expert, Plaintiffs reserve the right to
`identify and rely on testimony of an additional expert in rebuttal.
`7
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`
`including the ability of such a person to understand the scope of the claims, and to rebut
`
`arguments presented by Defendants and Defendants’ expert witnesses.
`
`Defendants expect to call Dr. Leonard Chyall, Dr. Edwin Posadas2, Dr. Jonathan
`
`Schiff, Dr. Scott Serels, and/or similarly qualified experts as expert witnesses in connection with
`
`the disputed claim terms and phrases listed in Exhibits A-C, to testify as to the definition of a
`
`person of ordinary skill in the art at the relevant time, to testify as to the meaning or
`
`indefiniteness of the disputed claim terms and phrases as they would be understood by a person
`
`of ordinary skill in the art, and to rebut arguments presented by Plaintiffs and Plaintiffs’ experts.
`
`Respectfully submitted,
`
`
`
`
`
`By: s/Liza M. Walsh_____________
`Liza M. Walsh, Esq.
`Tricia B. O’Reilly, Esq.
`Katelyn O'Reilly, Esq.
`CONNELL FOLEY LLP
`One Newark Center
`1085 Raymond Boulevard, 19th Floor
`Newark, New Jersey 07102
`(973) 757-1100
`(In Civil Action Nos. 14-7869, 14-8079, 14-
`8081, 14-8082, 15-287, 15-290, 15-1835, 15-
`2520, 15-2521, 15-2522, 15-2523, 15-2631,
`15-3392)
`
`
`
`
`
`
`
`October 2, 2015
`
`
`
`
`2 Plaintiffs have tentatively objected to Dr. Posadas serving as an expert for Defendants, and thus
`Defendants are identifying Dr. Posadas subject to that objection being resolved, withdrawn or
`otherwise overcome.
`
`3512928-1
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 9 of 12 PageID: 325
`
`
`
`By: s/Charles M. Lizza______________
`
`Charles M. Lizza, Esq.
`William C. Baton, Esq.
`SAUL EWING LLP
`One Riverfront Plaza
`1037 Raymond Blvd., Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6715
`(In Civil Action Nos. 15-776, 15-3107)
`
`Of Counsel:
`
`William E. Solander, Esq.
`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A., and SANOFI
`
`
`3512928-1
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 10 of 12 PageID: 326
`
`Attorneys FOR DEFENDANT
`Fresenius Kabi USA, LLC
`
`By: /s/Michael E. Patunas
`Michael E. Patunas
`Mayra V. Tarantino
`LITE DEPALMA GREENBERG,
`LLC
`570 Broad Street, Suite 1201
`Newark, NJ 07102
`(973) 623-3000
`mpatunas@litedepalma.com
`mtarantino@litedepalma.com
`
`GOODWIN PROCTER LLP
`Daryl L. Wiesen (pro hac vice)
`Eric T. Romeo (pro hac vice)
`53 State Street
`Exchange Place
`Boston, MA 02109
`(617) 570-1000
`dwiesen@goodwinprocter.com
`eromeo@goodwinprocter.com
`
`GOODWIN PROCTER LLP
`John P. Hanish, Ph.D. (pro hac vice)
`Brian J. Prew (pro hac vice)
`Aviv Zalcenstein (pro hac vice)
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`jhanish@goodwinprocter.com
`bprew@goodwinprocter.com
`azalcenstein@goodwinprocter.com
`
`Attorneys FOR DEFENDANT
`Accord Healthcare, Inc.
`
`By: /s/ Lisa J. Rodriguez
`Lisa J. Rodriguez
`SCHNADER HARRISON SEGAL
`& LEWIS LLP
`220 Lake Drive East, Suite 200
`Cherry Hill, NJ 08002-1165
`Tel: (856) 482-5741
`Fax: (856) 482-2578
`ljrodriguez@schnader.com
`
`Imron T. Aly
`SCHIFF HARDIN LLP
`
`233 S. Wacker Drive
`Chicago, IL 60606
`Tel.: (312) 258-5500
`Fax: (312) 258-5600
`
`ialy@schiffhardin.com
`
`Gina M. Bassi
`Brian Neff
`SCHIFF HARDIN LLP
`666 Fifth Avenue, Suite 1700
`New York, NY 10103
`Tel: (212) 745-9545
`Fax: (212) 753-5044
`gbassi@schiffhardin.com
`
`Alison Maddeford
`SCHIFF HARDIN LLP
`One Market, Spear Street Tower
`Thirty-Second Floor
`San Francisco, DA 94105
`Tel.: (415) 901-8700
`Fax: (415) 901-8701
`amaddeford@schiffhardin.com
`
`Attorneys FOR DEFENDANT
`Mylan Laboratories Ltd.
`
`By: /s/ Arnold B. Calmann
`Arnold B. Calmann
`(abc@saiber.com)
`Jeffrey Soos (js@saiber.com)
`Geri L. Albin (gla@saiber.com)
`SAIBER LLC
`One Gateway Center, 10th Floor,
`Suite 1000
`Newark, New Jersey 07102
`Telephone: (973) 622-3333
`
`
`Matthew R. Reed
`(mreed@wsgr.com)
`WILSON SONSINI GOODRICH &
`ROSATI
`
`650 Page Mill Road
`Palo Alto, California 94304
`Telephone: (650) 493-9300
`
`Wendy L. Devine
`(wdevine@wsgr.com)
`Clark Y. Lin (clin@wsgr.com)
`WILSON SONSINI GOODRICH &
`ROSATI
`12235 El Camino Real, Suite 200
`San Diego, California 92130
`Telephone: (858) 350-2300
`
`S. Brei Gussack
`(bgussack@wsgr.com)
`WILSON SONSINI GOODRICH &
`ROSATI
`1700 K Street, NW, Fifth Floor
`Washington, DC 20006
`Telephone: (202) 973-8800
`
`3512928-1
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`
`Attorneys FOR DEFENDANT
`Breckenridge Pharmaceutical, Inc.
`
`By: /s/ Robert Fettweis
`Robert Fettweis
`TRESSLER LLP
`744 Broad Street, Suite 1510
`Newark, NJ 07102
`(973) 848-2902
`
`C. Kyle Musgrove
`John W. Bateman
`Yongjin Zhu
`HAYNES AND BOONE, LLP
`800 17th Street, Suite 500
`Washington, DC 20006-3962
`(202) 654-4502
`
`Michael R. Ertel
`HAYNES AND BOONE, LLP
`30 Rockefeller Plaza, 26th Floor
`New York, NY 10112
`(212) 659-4973
`
`Robert F. Vroom
`BRECKENRIDGE
`PHARMACEUTICAL, INC.
`60 East 42nd Street, Suite 5210
`New York, NY 10165
`(646) 448-1309
`
`Attorneys FOR DEFENDANTS
`Apotex Corp. and Apotex Inc.
`
`
`
`By: /s/ Eric I. Abraham
`Eric I. Abraham
`Christina L. Saveriano
`HILL WALLACK, LLP
`202 Carnegie Center
`CN 5226
`Princeton, NJ 08543
`609-734-6358
`eia@hillwallack.com
`csaveriano@hillwallack.com
`
`Stephen R. Auten
`Andrew M. Alul
`Roger Kiley
`TAFT STETTINIUS &
`HOLLISTER LLP
`111 East Wacker Drive
`Suite 2800
`Chicago, IL 60601
`312-527-4000
`sauten@taftlaw.com
`aalul@taftlaw.com
`rkiley@taftlaw.com
`
`Attorneys FOR DEFENDANTS
`BPI Labs, LLC and Belcher
`Pharmaceuticals, LLC
`
`By: /s/ Christopher Casieri
`Christopher Casieri
`Gabriela Materassi
`MCNEELY HARE & WAR, LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`Tel.: (609) 731-3668
`Fax: (202) 478-1813
`chris@miplaw.com
`materassi@miplaw.com
`
`William D. Hare
`MCNEELY HARE & WAR, LLP
`5335 Wisconsin Avenue, Suite 440
`Washington, DC 20015
`Tel: (202) 640-1801
`Fax: (202) 478-1813
`bill@miplaw.com
`
`
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`
`Attorneys FOR DEFENDANTS
`Glenmark Pharmaceuticals, Inc.,
`USA and Glenmark Pharmaceuticals
`Ltd.
`
`By: /s/Gregory D. Miller
`Gregory D. Miller
`Nancy Del Pizzo
`RIVKIN RADLER
`21 Main Street - Court Plaza South
`West Wing - Suite 158
`Hackensack, NJ 07601-7021
`(201) 287-2460
`
`Jeffer Ali (pro hac vice)
`Jennell C. Bilek (pro hac vice)
`CARLSON, CASPERS,
`VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`(612) 436-9600
`jali@carlsoncaspers.com
`jbilek@carlsoncaspers.com
`
`
`Attorneys FOR DEFENDANTS
`Actavis LLC and Actavis Elizabeth
`LLC
`
`By: /s/Gregory J. Bevelock
`Gregory J. Bevelock
`LAW OFFICES OF GREGORY J.
`BEVELOCK, LLC
`12 Main Street, Suite 2
`Madison, NJ 07940
`(973) 845-2999
`
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8248
`
`Attorneys FOR DEFENDANTS
`Dr. Reddy’s Laboratories, Inc. and
`Dr. Reddy’s Laboratories, Ltd.
`
`By: /s/Frank D. Rodriguez
`Frank D. Rodriguez
`Dmitry Shelhoff
`Min Yang
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 379-4800
`frodriguez@buddlarner.com
`dshelhoff@buddlarner.com
`myang@buddlarner.com
`
`
`
`
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`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 1 of 24 PageID: 329
`EXHIBIT A
`
`The Parties’ Proposed Constructions and Evidence Regarding Disputed Claim Terms- U.S. Patent No. 8,927,592
`
`Defendants’ Proposed Construction2
`“A method for treating” is not limiting.
`
`If limiting, then:
`
` A
`
` method of attempting to cause a therapeutic
`effect in a patient
`
`Intrinsic Evidence:
`
`U.S. Patent No. 8,927,592, see, e.g., Abstract;
`Figures 1-5; col. 1:18-25; col. 1:35-67; col.
`2:11-35; col. 2:58-65; col. 3:6-30; col. 3:36-56;
`col. 5:33-67; col. 6:1-5; col. 6:28-34; col. 6:56-
`61; col. 7:8-14; col. 7:23-30; col. 7:61-65; col.
`8:8-11; col. 8:42-46; col. 8:51-56; col. 10:59-
`62; col. 16:43-45; col. 18:27-28; col. 20:25-30
`(claim 27); Examples 1-4; Tables 1-6.
`SA_JEV_0000033-54.
`
`’592 prosecution file history
`(SA_JEV_0001492-4908), including April 16,
`2014 Office Action (SA_JEV_0004261-283),
`July 10, 2014 Examiner Interview
`(SA_JEV_0004309-311).
`
`
`Claim(s) Plaintiffs’ Proposed Construction1
`1
`Limiting preamble
`
`Term
`A method for
`treating a
`patient
`
` A
`
` method that produces a therapeutic effect in a
`patient
`
`Intrinsic Evidence:
`
`’592 Patent: E.g.: Claims 1, 27; Abstract; col. 1,
`lns. 62-67; col. 2, lns. 18-24; col. 2, lns. 58-65;
`col. 3, lns. 6-10; col. 3, lns. 24-29; col. 3, lns. 33-
`34; col. 3, lns. 65-67; col. 5, lns. 32-35; col. 6, lns.
`1-9; col. 9, ln. 54-col. 10, ln. 26; Example 1, col.
`10, ln. 30-col. 17, ln. 32; Example 3, col. 17, ln.
`58-col. 18, ln. 29
`
`’592 File History: E.g.: Original claims 32-33
`(SA_JEV_0001545-1546); July 16, 2013 Reply to
`Office Action (SA_JEV_0001697-1702, 1721-23);
`March 17, 2014 Response Accompanying Request
`for Continued Reexamination (SA_JEV_0002275-
`2283); July 16, 2014 Declaration Under 37 C.F.R.
`§1.132 of Alton Oliver Sartor, MD
`(SA_JEV_0004332-4390); July 16, 2014 Reply to
`
`
`1 Plaintiffs reserve the right to rely on any evidence cited by Defendants in support of Defendants’ proposed constructions.
`2 Defendants reserve the right to rely on any evidence cited by Plaintiffs in support of Plaintiffs’ proposed constructions.
`
`
`
`A-1
`
`00013
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 2 of 24 PageID: 330
`EXHIBIT A
`
`Office Action (SA_JEV_0004391-4404) ; July 28,
`2014 Reasons for Allowance (SA_JEV_0004765-
`4766); November 6, 2014 Reasons for Allowance
`(SA_JEV_0004850-4851)
`
`Extrinsic Evidence:
`
`Defendants’ Preliminary Proposed Claim
`Constructions Pursuant to Local Patent Rule 4.2(a)
`
`Plaintiffs may rely on expert testimony from Dr.
`Daniel Petrylak as to the person of ordinary skill
`in the art at the time of the invention and to
`explain how a person of ordinary skill in the art
`would understand “a method for treating a patient”
`in the context of the ‘592 patent, including without
`limitation that the phrase would have the meaning
`proposed by Plaintiffs. Plaintiffs may also rely on
`expert testimony from Dr. Petrylak in rebuttal to
`expert testimony offered by Defendants with
`respect to this phrase.
`
`Pursuant to the Scheduling Order (C.A. No. 14-
`7869, ECF No. 23) and L. Pat. R. 4.5, Plaintiffs
`will provide any expert certifications and/or
`declarations with their opening and/or responding
`Markman briefs.
`
`March 17, 2014 Applicant Response
`Accompanying RCE at 2 and 8
`(SA_JEV_0002269-86); July 16, 2014
`Applicant Reply to Office Action at 2, 9, 12
`(SA_JEV0004391-404); Declaration Under
`C.F.R. § 1.132 of Alton Oliver Sartor, M.D. at
`5-9, 11, 13, and 27 (SA_JEV0004332-90).
`
`July 16, 2013 Applicant Reply to Office Action
`(SA_JEV_0001697-702); March 17, 2014
`Applicant Response Accompanying RCE
`(SA_JEV_0002269-86); July 16, 2014
`Applicant Reply to Office Action
`(SA_JEV0004391-404).
`
`Extrinsic Evidence:
`
`Prior art not previously before the United States
`Patent and Trademark Office cited in
`Defendants’ Joint Invalidity Contentions.3
`
`Plaintiffs’ Preliminary Disclosure of
`Infringement Contentions (August 4, 2015);
`Exhibit A at A-1.
`
`Random House Webster’s College Dictionary,
`2001 by Random House, Inc., p. 1393:
`Definition for “treat” (CabRef0005048-5050).
`
`
`
`3 Plaintiffs object to Defendants’ listing of prior art “cited in Defendants’ Joint Invalidity Contentions” as failing to describe the
`extrinsic evidence with sufficient particularity under Local Patent Rule 4.3(b) Plaintiffs reserve the right to strike any materials not
`expressly disclosed in this Joint Claim Construction and Prehearing Statement or heretofore not identified.
`
`
`
`A-2
`
`00014
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 3 of 24 PageID: 331
`EXHIBIT A
`
`One or more Defendants may also rely on
`expert testimony from Dr. Edwin Posadas4, Dr.
`Jonathan Schiff and/or Dr. Scott Serels about
`the level of ordinary skill in the art, the state of
`the relevant art, and how a person of ordinary
`skill in the art would understand the language
`“A method for treating a patient” in the context
`of the ’592 patent (and in view of the cited
`intrinsic and extrinsic evidence), including
`without limitation that the language (if it is a
`limiting preamble) would have the meaning
`proposed by Defendants. Drs. Posadas, Schiff
`and/or Serels and/or a similarly qualified
`expert5 may also rebut arguments presented by
`Plaintiffs’ experts. Pursuant to the Scheduling
`Order (C.A. No. 14-7869, ECF No. 23) and L.
`Pat. R. 4.5, Defendants will provide any expert
`certifications and/or declarations with its
`opening and/or responding Markman briefs.
`Delivering into the body of the patient
`
`Intrinsic Evidence:
`
`U.S. Patent No. 8,927,592, see, e.g., col. 1:57-
`59; 2:58-3:21; 4:40-41; 5:12-17; 5:30-53; 6:28-
`67; 7:43-54; 8:30-56; 13:1-67 (Table 3); 16:25-
`
`1, 27
`
`Administering
`to said patient
`
`Administering
`. . . to the
`patient
`
`Prescribing, supervising, or managing the formal
`taking of
`
`Intrinsic Evidence:
`
`’592 Patent: E.g.: Claims 1, 27; col. 1, lns. 57-59;
`col. 2, lns. 58-60; col. 2, ln. 67-col. 3, ln. 10; col.
`
`
`4 Plaintiffs have objected to Dr. Posadas serving as an expert for Defendants, and thus Defendants are identifying Dr. Posadas subject
`to that objection being resolved, withdrawn or otherwise overcome.
`5 Plaintiffs object to the extent Defendants state they expect to call “a similarly qualified expert” not identified in the Joint Claim
`Construction and Prehearing Statement or Exhibits A-C. Plaintiffs reserve the right to strike any expert testimony that is provided but
`not disclosed in this Joint Claim Construction and Prehearing Statement.
`
`
`
`A-3
`
`00015
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 4 of 24 PageID: 332
`EXHIBIT A
`
`5, lns. 12-54; col. 6, lns. 28-32; col. 6, lns. 48-53;
`col. 7, lns. 32-39; col. 8, lns. 42-46; col. 8, lns. 51-
`56; Table 3, col. 13, lines 1-67
`
`’592 File History: E.g.: January 16, 2013 Non-
`Final Office Action (SA_JEV_0001684-1695);
`July 16, 2013 Reply to Office Action
`(SA_JEV_0001697-1702); September 16, 2013
`Final Office Action (SA_JEV_0002128-2143);
`March 17, 2014 Response Accompanying Request
`for Continued Reexamination (SA_JEV_0002275-
`2283); April 16, 2014 Non-Final Office Action
`(SA_JEV_0004261-4283); July 16, 2014 Reply to
`Office Action (SA_JEV_0004391-4404); Tannock
`et al., Docetaxel Plus Prednisone or Mitoxantrone
`Plus Prednisone for Advanced Prostate Cancer,
`351 N. Eng. J. Med. 1502-12 (2004) (“Tannock
`2004”) (SA_JEV_0004576-4586, 4770)
`
`Extrinsic Evidence:
`
`Merriam Webster’s Collegiate Dictionary
`Eleventh Edition (2003) at 16 (SA_JEV-
`_0184061-184063)
`
`The Physician’s Desk Reference, Novantrone® pp.
`3158-63 (60th ed. 2006) (CabRef0002977-2983)
`
`Plaintiffs may rely on expert testimony from Dr.
`Petrylak with respect to the person of ordinary
`skill in the art and the meaning of this phrase in
`the context of the ’592 patent, including without
`limitation that it would have the meaning proposed
`
`42 (Table 4). SA_JEV_0000033-54.
`
`U.S. Patent Application No. 13/456,720, see,
`e.g., Dec. 11, 2012 Requirement for
`Restriction/Election (SA_JEV_0001578-85),
`including SA_JEV_0001580-82; Jan. 16, 2013
`Non-Final Office Action (SA_JEV_0001684-
`96), including SA_JEV_0001688-93; July 16,
`2013 Applicants Arguments / Remarks Made in
`an Amendment (SA_JEV_0001697-702),
`including SA_JEV_0001698-99; Sept. 16, 2013
`Final Office Action (SA_JEV_0002128-46),
`including SA_JEV_0002132-41; March 17,
`2014 RCE (SA_JEV_0002269-86), including
`SA_JEV_0002275-6; April 16, 2014 Non-Final
`Office Action (SA_JEV_0004261-86),
`including SA_JEV_0004266-76; July 16, 2014
`Amendment / Request for Reconsideration after
`Non-Final Office Action (SA_JEV0004391-
`404), including SA_JEV0004399-402.
`
`Extrinsic Evidence:
`
`SA_JEV_0005203 et seq., including
`SA_JEV_0005220-21, SA_JEV_0005226,
`SA_JEV_0005247, SA_JEV_0005261,
`SA_JEV_0005266, SA_JEV_0005329.
`
`SA_JEV_0005397 et seq., including
`SA_JEV_0005403, SA_JEV_0005415,
`SA_JEV_0005690.
`
`SA_JEV_0006137 et seq., including
`
`
`
`A-4
`
`00016
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 5 of 24 PageID: 333
`EXHIBIT A
`
`by Plaintiffs. Plaintiffs may also rely on expert
`testimony from Dr. Petrylak in rebuttal to expert
`testimony offered by Defendants with respect to
`this phrase.
`
`Pursuant to the Scheduling Order (C.A. No. 14-
`7869, ECF No. 23) and L. Pat. R. 4.5, Plaintiffs
`will provide any expert certifications and/or
`declarations with their opening and/or responding
`Markman briefs.
`
`
`SA_JEV_0006519.
`
`SA_JEV_0007358 et seq., including
`SA_JEV_0007369, SA_JEV_0007377,
`SA_JEV_0007411, SA_JEV_0007422.
`
`SA_JEV_0020143 et seq., including
`SA_JEV_0020180.
`
`Concise Dictionary of Modern Medicine, 2005
`by McGraw-Hill Companies, Inc., p. 18:
`Definition for “administer” (CabRef0005044-
`5047).
`
`One or more Defendants may also rely on
`expert testimony from Dr. Edwin Posadas, Dr.
`Jonathan Schiff and/or Dr. Scott Serels as to
`the level of ordinary skill in the art, the state of
`the relevant art, and how a person of ordinary
`skill in the art would understand the language
`“administering to said patient” and
`“administering. . . to the patient” in the context
`of the ’592 patent (and in view of the cited
`intrinsic and extrinsic evidence), including
`without limitation that the language would have
`the meaning proposed by Defendants.
`Drs. Posadas, Schiff and/or a similarly qualified
`expert may also rebut arguments presented by
`Plaintiffs’ experts. Pursuant to the Scheduling
`Order (C.A. No. 14-7869, ECF No. 23) and L.
`Pat. R. 4.5, Defendants will provide any expert
`certifications and/or declarations with its
`opening and/or responding Markman briefs.
`
`
`
`A-5
`
`00017
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 6 of 24 PageID: 334
`EXHIBIT A
`
`2
`
`advanced
`metastatic
`disease
`
`Castration resistant (hormone refractory),
`metastatic prostate cancer
`
`Intrinsic Evidence:
`
`’592 Patent: E.g.: Claim 1; col. 2, ln. 65-col. 3, ln.
`2; col. 4, lns. 4-5
`
`’592 File History: E.g: Pienta & Smith, Advances
`in Prostate Cancer Chemotherapy: A New Era
`Begins, 55(5) CA Cancer J. Clin. 300-18 (2005)
`(“Pienta & Smith”) (SA_JEV_0001938-1956,
`2148); Armstrong & George, New Drug
`Development in Metastatic Prostate Cancer, 26
`Urologic Oncol.: Seminars & Original
`Investigations 430-37 (2008) (SA_JEV_0004424-
`4431, 4768); Tannock 2004
`
`Extrinsic Evidence:
`
`Defendants’ Joint Invalidity Contentions (pp. 197-
`98)
`
`http://urologyhealth.org/urologic-
`conditions/advanced-prostate-cancer
`(CabRef0005016-17)
`
`FDA News Release: FDA Approves New
`Indication for Taxotere – Prostate Cancer (May
`19, 2004) (SA_JEV_0184064-65)
`
`Taxotere® Prescribing Information 2007
`(CabRef0003460-3516)
`
`Indefinite
`
`Intrinsic Evidence:
`
`U.S. Patent No. 8,927,592 (“the ’592 patent”)
`including: col. 2:1-10; col. 2:65 – col. 3:2; col.
`3:65 – col. 4:7; claims 1, 2, 17, and 20.
`SA_JEV_0000033-54.
`
`’592 prosecution file history
`(SA_JEV_0001492-4908), including: 1/16/13
`Office Action, including at 6
`(SA_JEV_0001684-95, including
`SA_JEV_0001690); 7/16/13 Reply to Office
`Action (SA_JEV_0001607-1702 and
`SA_JEV_0001720-23), including at 3
`(SA_JEV_0001721); 9/16/13 Office Action,
`including at 6 (SA_JEV_0002128-43, including
`SA_JEV_0002134); 4/16/14 Office Action,
`including at 10 (SA_JEV_0004261-83,
`including SA_JEV_0004271).
`
`Extrinsic Evidence:
`
`http://www.cancer.org/treatment/understanding
`yourdiagnosis/advancedcancer/advanced-
`cancer-what-is. CabRef0004281-83.
`
`http://urologyhealth.org/urologic-
`conditions/advanced-prostate-cancer.
`CabRef0005016-17.
`
`SA_JEV_0019474 et seq., including
`
`
`
`A-6
`
`00018
`
`
`
`Case 3:14-cv-07869-MAS-LHG Document 51-1 Filed 10/02/15 Page 7 of 24 PageID: 335
`EXHIBIT A
`
`
`Gulley et al., Phase I Study of a Vaccine Using
`Recombinant Vaccinia Virus Expressing PSA (rV-
`PSA) in Patients with Metastatic Androgen-
`Independent Prostate Cancer, 53(2) Prostate 109-
`17 (2002) (SA_JEV_0184066-74)
`
`Pfeifer et al., PC-SPES, a Dietary Supplement for
`the Treatment of Hormone-Refractory Prostate
`Cancer, 85 BJU Int’l 481-485 (2000)
`(SA_JEV_0184076-80)
`
`NCI Definition of Stage D Prostate Cancer,
`http://www.cancer.gov/publications/dictionaries/ca
`ncer-terms?cdrid=560344 (SA_JEV_0184075)
`
`Plaintiffs may rely on expert testimony from Dr.
`Petrylak as to the person of ordinary skill in the art
`at the time of the invention and to explain how a
`person of ordinary skill in the art would
`understand “advanced metastatic disease” in the
`context of the ’592 patent, including without
`limitation that the phrase would have the meaning
`proposed by Plaintiffs. Plaintiffs may also rely on
`expert testimony from Dr. Petrylak in rebuttal to
`expert testimony offered by Defendants with
`respect to this phrase.
`
`Plaintiffs may rely on expert testimony from Dr.
`Petrylak that a person of ordinary skill in the art
`would understand the scope of claim 2 of the ’592
`patent in light of the specification.
`
`
`SA_JEV_0019486.
`
`SA_JEV_0019499 et seq., including
`SA_JEV_00194517, SA_JEV_00194524.
`
`SA_JEV_0019651-62, including
`SA_JEV_0019651, SA_JEV_0019658, and
`SA_JEV_0019659.
`
`SA_JEV_0019672-79, including
`SA_JEV_0019672.
`
`SA_JEV_0019680-90, including
`SA_JEV_0019680.
`
`SA_JEV_0019913-18, including
`SA_JEV_0019913.
`
`SA_JEV_0021341 et seq., i