Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 1 of 12 PageID: 317
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`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
`
`
`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.
`
`
`
`
`
`
`
`
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`Plaintiffs,
`
`Civil Action No. 3:14-cv-08079(MAS)(LHG)
`Civil Action No. 3:15-cv-02520(MAS)(LGH)
`
`v.
`
`
`
`
`
`1
`
`AVENTIS EXHIBIT 2028
`Mylan v. Aventis
`IPR2016-00627
`
`

`
`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.
`
`
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`2
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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
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 4 of 12 PageID: 320
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`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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`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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`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
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 7 of 12 PageID: 323
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`’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.
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 8 of 12 PageID: 324
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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.
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 9 of 12 PageID: 325
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`
`
`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
`
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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 10 of 12 PageID: 326
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`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
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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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`Case 3:14-cv-07869-MAS-LHG Document 51 Filed 10/02/15 Page 12 of 12 PageID: 328
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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 19 of 24 PageID: 347
`EXHIBIT B
`
`The Parties’ Proposed Constructions and Evidence Regarding Disputed Claim Terms- U.S. Patent No. 5,847,170 7
`
`Defendants’ Proposed Construction
`“the product of the ‘replacing’ step
`does not need to be a compound of
`Formula (I)”
`
`Intrinsic Evidence:
`
`
`U.S. Patent No. 5,847,170 patent (“the
`’170 patent”) including: col. 5:48 – col.
`7:22, claims 3-15. SA_JEV_0000001-
`27.
`
`’170 prosecution file history, including:
`3/26/96 Application as Filed, including
`claims 5, 9, 13, 14, 26-28
`(SA_JEV_0000058-168, including
`SA_JEV_0000063-74, 84-98); 4/18/96
`Preliminary Amendment
`(SA_JEV_0000250-254); 10/29/97
`Amendment, including at 7-14, 24-40,
`43-44 (SA_JEV_0000612-666,
`including SA_JEV0000617-624, 634-
`650, 653-654); 4/23/98 Amendment,
`including at 1-25 (SA_JEV_0000684-
`711, including SA_JEV_0000684-708).
`
`
`
`Plaintiffs’ Proposed Construction
`Plain and ordinary meaning.
`
`Preamble of claim 8, i.e., “[a] process
`for preparing a taxoid of the following
`formula (I)” is limiting.
`
`Intrinsic Evidence:
`
`E.g., ’170 patent (SA_JEV_0000001-
`27) at e.g.: abstract; 1: 7-19; 4: 3-4, 24,
`34; 5: 36 – 7: 22; 9: 60-63; Example 1
`(12: 7 – 13: 33); Example 3 (18:57 –
`19: 49); Example 4 (22:41 – 23: 29);
`claim 8, claim 15.
`
`
`
`Claim
`8
`
`Term
`
`“replacing the
`protective group(s)
`of said ester of
`formula (V),
`represented by R7 or
`R6 and R7 together,
`by hydrogen atoms”
`
`
`
`
`
`
`
`
`7 Exhibit B includes the disputed term appearing in asserted claims by Plaintiffs as disclosed in Defendants’ Proposed Claim Terms
`for Construction for U.S. Patent No. 5,847,170 (“the ’170 Patent”), served August 12, 2015.
`
`
`
`B-1
`
`13