`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`C.A. No. 14-1453-LPS
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`Plaintiffs, v.
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`APOTEX INC and APOTEX CORP.,
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`Defendants.
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`PROPOSED JOINT PRETRIAL ORDER
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`PROCTOR HEYMAN ENERIO LLP
`Dominick T. Gattuso (# 3630)
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(302) 472-7300
`dgattuso@proctorheyman.com
`
`Attorneys for Defendants Apotex Inc. and
`Apotex Corp.
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`
`
`RICHARDS, LAYTON & FINGER, P.A.
`Frederick L. Cottrell, III (#2555)
`Selena E. Molina (#5936)
`920 North King Street,
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`molina@rlf.com
`
`Attorneys for Plaintiffs
`Meda Pharmaceuticals Inc. and Cipla Ltd.
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`
`
`Redacted: November 10, 2016
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`
`
`REDACTED
`PUBLIC VERSION
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`1
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`CIP2017
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 2 of 21 PageID #: 2959
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`On November 22, 2016, counsel for Plaintiffs1 and Apotex2 will participate in a pretrial
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`conference before this Court pursuant to Rule 16 of the Federal Rules of Civil Procedure, Local
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`Rule 16.3, and this Court’s June 04, 2015 Oral Order (D.I. 28). Pursuant to Local Rule 16.3,
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`Plaintiffs and Apotex hereby submit this proposed Joint Pretrial Order governing the bench trial
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`of Civil Action No. 14-1453-LPS for the Court’s approval. Trial is scheduled to begin on
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`December 12, 2016.
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`Plaintiffs are represented by: Mark Fox Evens (mevens@skgf.com), Uma N. Everett
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`(ueverett@skgf.com), Dennies Varughese
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`(dvarughe@skgf.com), Rami Bardenstein
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`(rbardenstein@skgf.com), Adam C. LaRock
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`(alarock@skgf.com),
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`Joshua
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`I. Miller
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`(jmiller@skgf.com),
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`Josephine
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`J. Kim
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`(joskim@skgf.com),
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`Stephanie Nguyen
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`(snguyen@skgf.com) of Sterne, Kessler, Goldstein & Fox PLLC, 1100 New York Ave., N.W.,
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`Washington, DC 20005-3934, and Frederick L. Cottrell, III (Cottrell@rlf.com) and Selena
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`Molina (molina@rlf.com) of Richards, Layton, Finger, 920 North King Street, Wilmington, DE
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`19801.
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`Apotex is represented by George C. Lombardi (glombard@winston.com), Samuel S. Park
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`(spark@winston.com), Kevin E. Warner (kwarner@winston.com), and Ryan B. Hauer
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`(rhauer@winston.com) of Winston & Strawn LLP, 35 W. Wacker Dr., Chicago, IL 60601,
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`Charles B. Klein (cklein@winston.com) and Ilan Wurman (iwurman@winston.com) of Winston
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`& Strawn LLP, 1700 K Street N.W., Washington, D.C., 2006, and Dominick T. Gattuso
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`(dgattuso@proctorheyman.com) of Proctor Heyman Enerio LLP, 300 Delaware Ave., Suite 200,
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`Wilmington, DE 19801.
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`1 “Plaintiffs” when used hereinafter with reference to C.A. No. 14-1453-LPS, shall mean the
`Plaintiffs in that action, namely Meda Pharmaceuticals Inc. and Cipla Ltd.
`2 “Apotex” when used hereinafter with reference to C.A. No. 14-1453-LPS shall mean Apotex
`Inc. and Apotex Corp.
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`2
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 3 of 21 PageID #: 2960
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`This Order will control the subsequent course of this action, unless modified by the Court
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`to prevent manifest injustice.
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`I.
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`A.
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`Nature of the Case – Civil Action No. 14-1453-LPS
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`Nature of the Action
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`1.
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`Plaintiffs brought this action for patent infringement against Apotex pursuant to
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`the Hatch-Waxman Act, codified as amended at 21 U.S.C. § 355(j) and 35 U.S.C. § 271(e).
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`Plaintiff Meda makes and sells the drug product Dymista®—approved by the Food and Drug
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`Administration for the relief of symptoms of seasonal allergic rhinitis—in the United States.
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`B.
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`Plaintiffs’ Complaints
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`2.
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`On December 2, 2014, Plaintiffs brought the instant action against Apotex (D.I. 1)
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`for infringing two patents—U.S. Patent Nos. 8,163,723 (“the ’723 patent”) and 8,168,620 (“the
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`’620 patent”)—based on Apotex’s filing of Abbreviated New Drug Application (“ANDA”) No.
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`207712 and accompanying certification pursuant
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`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`(“Paragraph IV certification”) that it intended to manufacture, sell or offer for sale its generic
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`version of Dymista® (“Generic Product”) prior to the expiration of those patents. In their
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`Complaint, Plaintiffs alleged that Apotex infringed, contributed to, aided and abetted, and/or
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`induced infringement of the ’723 patent and the ’620 patent pursuant to 35 U.S.C. § 271(e)(2)(A)
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`by submitting its ANDA and accompanying Paragraph IV certification. Plaintiffs further alleged
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`that Apotex would infringe, contribute to or induce infringement under 35 U.S.C. § 271(a)-(c) if
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`Apotex were to sell, offer for sale, manufacture, or import the products described in ANDA No.
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`207712.
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`3.
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`On February 26, 2016, Plaintiffs filed a First Amended Complaint (“Amended
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`Complaint”) against Apotex (D.I. 90) that asserted a claim for infringement of newly issued U.S.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 4 of 21 PageID #: 2961
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`Patent No. 9,259,428 (“the ’428 patent”) based on Apotex’s pending ANDA No. 207712. In their
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`Amended Complaint, Plaintiffs repeated all allegations from their original Complaint and also
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`alleged that Apotex infringed, contributed to, aided and abetted, and/or induced infringement of
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`the ’428 patent pursuant to 35 U.S.C. § 271(e)(2)(A) by submitting its ANDA. Plaintiffs further
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`alleged that Apotex would infringe, contribute to or induce infringement under 35 U.S.C. §
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`271(a)-(c) if Apotex were to sell, offer for sale, manufacture, or import the products described in
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`ANDA No. 207712.
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`4.
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`Plaintiffs are asserting claims 4, 29, and 42-44 of the '620 patent and claims 10,
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`11, 13, 15, 16, 23, 24, 26, and 29-30 of the ’428 patent.
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`C.
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`Apotex’s Answers and Counterclaims
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`5.
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`Apotex filed its Answer and Counterclaims to Plaintiffs’ original Complaint on
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`December 23, 2014 (D.I. 8) and to Plaintiffs’ Amended Complaint on March 9, 2016 (D.I. 93).
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`Apotex’s Answer and Counterclaims to the original Complaint and to the Amended Complaint,
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`taken together, assert defenses that each of the asserted patents—the ’723 patent, ’620 patent,
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`and ’428 patent—are invalid and not infringed, and that Plaintiffs’ allegations failed to state a
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`claim upon which relief can be granted. Apotex also alleged counterclaims for a declaration of
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`noninfringement and invalidity of the ’723 patent, the ’620 patent, and the ’428 patent.
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`D.
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`Plaintiffs’ Answers to Apotex’s Counterclaims
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`6.
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`On January 16, 2015, Plaintiffs filed their Answer to Apotex’s Counterclaims to
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`the Complaint (D.I. 12) and, on April 4, 2016, filed their Answer to Apotex’s Answer and
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`Counterclaims to the Amended Complaint (D.I. 93), denying that Apotex was entitled to any
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`relief as asserted in its Counterclaims or otherwise.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 5 of 21 PageID #: 2962
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`E.
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`Pending Motions
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`7.
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`There are no pending motions in this action.
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`F.
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`Stipulation to Infringement
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`8.
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`The parties have stipulated that Apotex’s Generic Product, described by ANDA
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`No. 207712, literally infringes claims 4, 29, and 42-44 of the ’620 patent; and claims 10, 11, 13,
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`15, 16, 23, 24, 26, and 29-30 of the ’428 patent. (D.I. 104.)
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`G.
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`Relief Sought by Plaintiffs
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`9.
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`Plaintiffs request the following relief from the Court: a judgment that the asserted
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`claims of the ’620 and ’428 patents are valid and enforceable; a judgment and order pursuant to
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`35 U.S.C. § 271(e)(4)(A) providing that the effective date of any FDA approval of Apotex’s
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`ANDA No. 207712 not be earlier than the latest of the expiration dates of the ‘620 and ’428
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`patents, inclusive of any extension(s) and additional period(s) of exclusivity; a permanent
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`injunction enjoining Apotex and its officers, agents, servants, and employees, and those persons
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`in active concert or participation with any of them, from making, using, selling, or offering to
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`sell in the United States, or importing into the United States, Apotex’s Generic Product for which
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`approval is sought in ANDA No. 207712; a declaration under 28 U.S.C. § 2201 that if Apotex,
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`their officers, agents, servants, employees, licensees, representatives, and attorneys, and all other
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`persons acting or attempting to act in active concert or participation with them or acting on their
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`behalf, engage in the commercial manufacture, use, offer for sale, sale and/or importation of
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`Apotex’s Generic Product prior to patent expiry, it will constitute an act of direct and/or indirect
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`infringement of the ’620 and ’428 patents; a finding that this is an exceptional case, and an award
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`of attorneys’ fees in this action pursuant to 35 U.S.C. § 285; an award of costs and expenses in
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`this action; and any further and other relief as this Court determines to be just and proper.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 6 of 21 PageID #: 2963
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`H.
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`Relief Sought by Defendants
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`10.
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`Defendants request the following relief from the Court: Dismissing Plaintiffs’
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`Complaints with prejudice; declaring that the manufacture, use, offer for sale, sale, and/or
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`importation of Defendants’ Generic Product does not and will not induce infringement of any
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`valid claim of the Patents-in-Suit; declaring that the manufacture, use, offer for sale, sale, and/or
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`importation of Defendants’ Generic Products does not and will not contribute to the infringement
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`of any valid claim of the Patents-in-Suit; declaring that the asserted claims of the Dymista
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`Patents are invalid; declaring that this is an exceptional case under 35 U.S.C. § 285 and/or other
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`applicable statute or rules and awarding Defendants their attorneys’ fees, costs, and expenses;
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`and; awarding to Defendants such further relief as to this Court may deem necessary, just and
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`proper.
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`II.
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`Jurisdiction
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`11.
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`Civil Action No. 14-1453-LPS is an action for patent infringement arising under
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`the patent laws of the United States, 35 U.S.C. § 271, et seq. This Court has subject matter
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`jurisdiction over these actions under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202. Venue is
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`proper under 28 U.S.C. §§ 1391(c) and 1400(b). Jurisdiction and venue are not disputed.
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`III.
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`Facts
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`A.
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`Uncontested Facts
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`12.
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`13.
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`The parties’ statement of uncontested facts is set forth in Exhibit 1.
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`These uncontested facts require no proof at trial and are part of the evidentiary
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`record in the case.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 7 of 21 PageID #: 2964
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`B.
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`Contested Facts
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`14.
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`Plaintiffs’ statement of issues of fact that they contend remain to be litigated is
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`attached as Exhibit 2.
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`15.
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`Apotex’s statement of issues of fact that it contends remain to be litigated is
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`attached as Exhibit 3.
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`16.
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`Should the Court determine that any issue identified in a party’s statement of
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`contested issues of fact to be litigated is more properly considered an issue of law, it should be so
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`considered.
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`IV.
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`Issues of Law
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`17.
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`Plaintiffs’ statement of issues of law that they contend remain to be litigated is
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`attached as Exhibit 4.
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`18.
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`Apotex’s statement of issues of law that it contends remain to be litigated is
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`attached as Exhibit 5.
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`19.
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`Should the Court determine that any issue identified in a party’s statement of
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`issues of law that it contends remain to be litigated is more properly considered an issue of fact,
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`it should be so considered.
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`V. Witnesses
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`20.
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`Presentation of evidence will follow the burden of proof. Nothing in this
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`paragraph precludes the right of a party to offer rebuttal testimony as appropriate.
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`21.
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`The parties agree that expert witnesses need not be sequestered. The parties agree
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`that fact witnesses shall be sequestered.
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`22.
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`Unless otherwise agreed between the parties, the parties will identify the
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`witnesses they expect to call for direct examination, and the order in which they expect to call
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 8 of 21 PageID #: 2965
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`said witnesses, by 6:00 p.m.3 two calendar days before4 the direct examination is expected to
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`take place.
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`23.
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`Beginning two nights before the start of trial, the parties will confer nightly to
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`update opposing counsel as to the expected day that the party intends to complete its presentation
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`of evidence.
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`A. Witnesses to Be Called
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`24.
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`Plaintiffs’ List of Witnesses to be Called Live or By Deposition is set forth in
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`Exhibit 6.
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`25.
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`Apotex’s List of Witnesses to be Called Live or By Deposition is set forth in
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`Exhibit 7. Apotex has recently learned that its commercial success expert, Glenn Newman, will
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`be unavailable for trial due to a sudden illness. The parties are discussing possible resolutions
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`and expect to update the Court at the pre-trial conference.
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`26.
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`The parties’ lists of witnesses indicate the witnesses they currently intend to call
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`and the witnesses they may call to testify at trial. This list also indicates whether a party intends
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`to introduce live testimony or deposition testimony for each witness. Any witness not listed will
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`be precluded from testifying absent good cause shown.
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`27.
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`In the event that a witness who was designated by a party to testify live at trial is
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`not available or otherwise cannot testify live due to unforeseeable circumstances beyond the
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`offering party’s control, upon a showing of good cause, the offering party may designate
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`deposition testimony in lieu of live testimony at trial. If a party is permitted by the Court to
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`3 All times in this Pretrial Order use Eastern Standard Time.
`4 For a direct examination expected to occur on a Monday, the parties will identify the witnesses
`they expect to call for direct examination by 6:00 p.m. on Saturday. Similarly, for a direct
`examination expected to occur on a Tuesday, the parties will identify the witnesses they expect
`to call for direct examination by 6:00 p.m. on Sunday.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 9 of 21 PageID #: 2966
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`designate testimony, the opposing party will have reasonable notice and an opportunity to
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`counter-designate deposition testimony.
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`28.
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`The parties further reserve the right to call: (1) one or more additional witnesses
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`whose testimony is necessary to establish authenticity or admissibility of any trial exhibit, if that
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`evidentiary status of the exhibit is challenged by an opposing party; (2) additional witnesses to
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`respond to any issues raised by the Court’s pretrial or trial rulings; (3) any witness live for
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`impeachment purposes to the extent permitted by applicable rules; and (4) any witness who
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`appears on the other party’s witness list.
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`B.
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`Testimony by Deposition
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`29.
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`Having exchanged testimony that will be offered by designation of deposition
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`testimony, and having met and conferred in an effort to resolve the objections set forth hereto:
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`a.
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`Deposition
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`testimony,
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`including Apotex’s objections and counter-
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`designations, and Plaintiffs’ objections thereto, that Plaintiffs may offer into evidence is set forth
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`in Exhibit 8.
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`b.
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`Deposition testimony, including Plaintiffs’ objections and counter-
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`designations, and Apotex’s objections thereto, that Apotex may offer into evidence is set forth in
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`Exhibit 9.
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`30. With respect to those witnesses the parties have identified in Exhibits 6 and 7 who
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`will be called to testify live at trial, no deposition designations or counter-designations are
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`required. Should a fact witness identified in Exhibits 6 and 7 as testifying live at trial become
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`unavailable, as that term is defined in the Federal Rules of Civil Procedure and Federal Rules of
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`Evidence, the parties may designate specific pages and lines of transcript that they intend to read
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`or play in lieu of the witness’s appearance, upon reasonable notice.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 10 of 21 PageID #: 2967
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`31.
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`For deposition testimony provided to the Court, the parties providing the
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`designated testimony shall serve the other parties with the transcript pages and line numbers of
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`the deposition testimony they intend to introduce by 6:00 p.m. three calendar days before such
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`testimony is to be introduced, and identify the manner in which the deposition will be used,
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`either by video or reading the transcript into the record. The opposing parties will identify any
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`objections to the designated deposition testimony and any specific pages and lines from that
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`deposition to counter-designate by 12:00 p.m. two calendar days before such testimony is to be
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`introduced, and identify the manner in which the deposition will be used, either by video or
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`reading the transcript into the record. The parties shall meet and confer to resolve any objections
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`to designated testimony by 3:00 p.m. two calendar days before such testimony is to be
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`introduced.
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`32.
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`If objections remain to be resolved, the party calling the witness by deposition
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`shall submit to the Court, no later than 10 p.m. two calendar days before the witness is to be
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`called at trial, on behalf of all parties: (i) a copy of the entire deposition testimony of the witness
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`at issue, clearly highlighting the designations, counter-designations, and pending objections; and
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`(ii) a cover letter clearly identifying the pending objections as well as a brief indication (i.e., no
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`more than one sentence per objection) of the basis for the objection and the offering party’s
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`response to it. Failure to comply with these procedures, absent an agreement by the parties and
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`approval by the Court, will result in waiver of the use of the deposition testimony or waiver of
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`objection to the use of the deposition testimony.
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`33.
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`All irrelevant and redundant material, including colloquy between counsel and
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`objections, will be eliminated when submitting the objections to the Court or when the
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`deposition is read or viewed at trial.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 11 of 21 PageID #: 2968
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`34. When the witness testifies by deposition at trial, the party calling the witness will
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`provide the Court with two copies of the transcript of the designations and counter-designations
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`that will be read or played. The parties will be charged for all time that elapses from the time the
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`witness is called until the next witness is called.
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`35. When deposition designation excerpts are introduced, all admissible deposition
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`counter-designations excerpts will be introduced simultaneously in the sequence in which the
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`testimony was originally given. The specific portions of the deposition shall be read or played in
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`page order. If an exhibit is referenced in a deposition designation, the exhibit is admitted into
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`evidence if it is included on the offering party’s trial exhibit list and is not otherwise objected to,
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`or is included on the joint trial exhibit list. Any deposition testimony, once designated and
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`introduced into evidence, may be used equally by any party for purposes of counter-designation
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`if consistent with the rule of completeness and the rules of evidence.
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`C.
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`Impeachment with Prior Inconsistent Statements
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`36.
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`Pursuant to Fed. R. Evid. 613, deposition and other testimony or statements not
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`specifically identified on a party’s deposition designation list or exhibit list may be used at trial
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`only for the purpose of impeachment, if otherwise competent for such purpose. The Court will
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`rule at trial on any objections based on lack of completeness and/or lack of consistency.
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`D.
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`Objections to Expert Testimony
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`37.
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`The parties request that the Court rule at trial on any objections to expert
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`testimony as beyond the scope of expert disclosures. Before each expert takes the stand, the
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`parties shall provide copies of that expert’s report(s) and deposition testimony to the Court.
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`However, unless expressly moved and accepted into evidence, the expert report(s) and deposition
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 12 of 21 PageID #: 2969
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`testimony shall be used only for the purpose of ruling on objections to expert testimony offered
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`at trial.
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`VI.
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`A.
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`Exhibits
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`Exhibits
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`38.
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`Plaintiffs’ list of exhibits that they may offer at trial, except demonstrative
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`exhibits and exhibits to be used solely for impeachment, and Apotex’s objections to Plaintiffs’
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`exhibits, are attached as Exhibit 10.
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`39.
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`Apotex’s list of exhibits that it may offer at trial, except demonstrative exhibits
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`and exhibits to be used solely for impeachment, and Plaintiffs’ objections to Apotex’s exhibits,
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`are attached as Exhibit 11.
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`40.
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`Plaintiffs’ trial exhibits will be identified with PTX numbers, starting at PTX 1.
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`Apotex’s trial exhibits will be identified with DTX numbers, starting at DTX 1.
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`41.
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`The parties agree that exhibits to be used solely for impeachment need not be
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`included on the lists of trial exhibits or disclosed in advance of being used at trial. Subject to the
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`remaining provisions of this Order, no party may use an exhibit not present on its exhibit list
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`(other than exhibits to be used solely for impeachment), unless the Court determines that good
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`cause has been shown.
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`42.
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`No exhibit will be admitted unless offered into evidence through a witness, who
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`must be shown the exhibit. Before the completion of the witness’ testimony, any party that has
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`used an exhibit with the witness and wishes that exhibit to be admitted into evidence must
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`formally move the exhibit into evidence, by exhibit number.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 13 of 21 PageID #: 2970
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`43.
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`The parties shall identify, by witness, the trial exhibits, including the exhibit
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`numbers, that they expect to use on direct examination by 6:00 p.m. two days before5 the direct
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`examination is expected to take place, and objections will be provided no later than 3:00 p.m.
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`the day before their intended use. The parties shall meet and confer in an attempt to resolve any
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`objections to the trial exhibits that are expected to be used during direct examination. If good
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`faith efforts to resolve the objections fail, the party objecting to the exhibits shall bring its
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`objections to the Court’s attention prior to the witness being called to the witness stand.
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`44.
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`Exhibits not objected to will be received into evidence by the operation of the
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`Final Pretrial Order without the need for additional foundation testimony, provided they are
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`shown to a witness. Nothing herein shall be construed as a stipulation or admission that the
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`document is entitled to any weight in deciding the merits of this case. The parties agree that any
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`description of a document on an exhibit list is provided for convenience only and shall not be
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`used as an admission or otherwise as evidence regarding the listed document or any other listed
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`document.
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`45.
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`Any party may use an exhibit that is listed on the other party’s exhibit list, to the
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`same effect as though it were on its own exhibit list, subject to all evidentiary objections. Any
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`exhibit, once admitted at trial, may be used equally by any party, subject to any limitations as to
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`its admission. The listing of a document on a party’s list is not an admission that such document
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`is relevant or admissible when offered by the opposing party for the purpose that the opposing
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`party wishes to admit the document. Each party reserves the right to object to the relevance of
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`5 For a direct examination expected to occur on a Monday, the parties shall identify the trial
`exhibits, by exhibit number, that they expect to use on that direct by 6:00 p.m. on Saturday.
`Similarly, for a direct examination expected to occur on a Tuesday, the parties shall identify
`the trial exhibits, by exhibit number, that they expect to use on that direct by 6:00 p.m. on
`Sunday.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 14 of 21 PageID #: 2971
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`any evidence offered by the other party, at the time such evidence is offered, in view of the
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`specific context in which such evidence is offered.
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`46.
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`On or before the first day of trial, counsel will deliver to the Courtroom Deputy a
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`completed AO Form 187 exhibit list for each party.
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`B.
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`Demonstrative Exhibits
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`47.
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`The parties agree that the demonstrative exhibits the parties intend to use at trial
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`do not need to be included on their respective lists of trial exhibits. Plaintiffs’ demonstratives
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`will be identified with PDX numbers, starting at PDX 1. Apotex’s demonstratives will be
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`identified with DDX numbers, starting with DDX 1.
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`48.
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`The parties will exchange demonstrative to be used in opening statements by 3:00
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`p.m. the night before opening statements. The parties will provide any objections to such
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`demonstratives by 8:00 p.m. the night before opening statements. The parties shall meet and
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`confer in an attempt to resolve any objections.
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`49.
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`The parties will provide demonstrative exhibits to be used in connection with
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`direct examination by 3:00 p.m. the night before their intended use. The parties will provide
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`any objections by 8:00 p.m. the night before their intended use. The parties shall meet and
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`confer in an attempt to resolve any objections.
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`50.
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`If good faith efforts to resolve the objections fail, the party shall bring its
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`objections to the Court’s attention prior to opening statements or prior to the applicable witness
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`being called into the witness stand.
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`51.
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`If any of the demonstratives change after the deadline, the party intending to use
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`the demonstrative will promptly notify the opposing counsel of the change(s).
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 15 of 21 PageID #: 2972
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`52.
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`The party seeking to use a demonstrative exhibit will provide a color
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`representation of the demonstrative to the other side in electronic PDF form. However, for video
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`or animations, the party seeking to use the demonstrative will provide it to the other side on a
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`DVD, CD, or via a secure file transfer protocol. For irregularly sized physical exhibits, the party
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`seeking to use the demonstrative will provide the other party a color representation as a color
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`PDF in electronic form as well as 8.5x11 copies of the exhibits.
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`53.
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`This provision does not apply to demonstratives created during testimony or
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`demonstratives used for cross-examination, neither of which need be provided to the other side
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`in advance of their use. This provision also does not apply to demonstratives consisting solely of
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`reproductions of trial exhibits that contain enlargements, or highlighting text or information.
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`VII. Damages
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`54.
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`This case currently does not involve any claims for damages. If Apotex launches
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`its Generic Product, the parties will inform the Court promptly.
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`VIII. Bifurcated Trial
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`55.
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`All issues will be tried without bifurcation.
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`IX. Motions in Limine
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`56.
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`Apotex’s First Motion in Limine to Exclude Testimony Regarding FDA’s State of
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`Mind, Plaintiffs’ opposition motion, and Apotex’s reply motion are attached as Exhibit 12.
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`57.
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`Apotex’s Second Motion in Limine to Exclude Hearsay Scientific Report and
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`Related Testimony, Plaintiffs’ opposition motion, and Apotex’s reply motion are attached as
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`Exhibit 13.6
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`6 Plaintiffs have identified Dr. Ying Long from Avomeen Analytical Services as a trial witness.
`Plaintiffs have also offered Dr. Long for deposition before trial.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 16 of 21 PageID #: 2973
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`58.
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`Apotex’s Third Motion in Limine to Exclude Evidence of Commercial Success,
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`Plaintiffs’ opposition motion, and Apotex’s reply motion are attached as Exhibit 14.
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`X.
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`Discovery
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`59.
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`Discovery is completed.
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`XI. Number of Jurors
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`60.
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`This is a non-jury trial.
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`XII. Non-Jury Trial/Post-trial Briefs
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`61.
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`62.
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`The parties request a detailed opinion from the Court post-trial.
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`Apotex’s opening post-trial brief on validity and objective indicia of non-
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`obviousness shall be limited to fifty (50) pages in length. Plaintiffs’ answering post-trial brief on
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`validity and objective indicia of non-obviousness shall be limited to fifty (50) pages. Apotex’s
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`reply post-trial brief on validity and objective indicia of non-obviousness shall be limited to
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`twenty-five (25) pages. Plaintiffs’ sur-repy on secondary considerations shall be limited to
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`twenty-five (25) pages.
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`63.
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`In addition to their opening post-trial briefs, each party will separately file their
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`proposed Findings of Fact comprising no more than fifty (50) pages in length each. The
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`proposed Findings of Fact, separately stated in numbered paragraphs, will constitute a detailed
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`listing of the relevant material facts the party believes it has proven, in a simple narrative form.
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`No separate proposed Conclusions of Law shall be filed.
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`64.
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`The parties propose the following post-trial briefing schedule:
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`a.
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`b.
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`c.
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`Both parties shall file Findings of Fact on January 06, 2017;
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` Apotex’s opening post-trial brief shall be due on January 20, 2017;
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`Plaintiffs’ answering post-trial brief shall be due on February 3, 2017;
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 17 of 21 PageID #: 2974
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`d.
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`e.
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`February 17, 2017.
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`Apotex’s reply brief shall be due February 10, 2017;
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`Plaintiffs’ sur-reply brief on secondary considerations shall be due
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`XIII. Motions for Judgment as a Matter of Law
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`65.
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`The parties have agreed to the following procedure: The parties reserve the right
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`to move for judgment on partial findings pursuant to Fed. R. Civ. P. 52(c). The parties agree that
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`either party making a motion pursuant to Fed. R. Civ. P. 52(c) will advise the Court of its motion
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`promptly and in accordance with that rule. If the Court requests more extensive argument on the
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`motion, such argument will be taken up at the Court’s first convenience. The parties will only
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`supplement the motion in writing upon request by the Court. Pursuant to Fed. R. Civ. P. 52(c),
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`the Court may decline to render any judgment until the close of evidence.
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`XIV. Length of Trial
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`66.
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`This case is currently set for a five-day bench trial on Dec. 12-16, 2016. The
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`parties propose that each side receive 13 hours for its trial presentations.
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`67.
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`Time will be charged to a party for its opening statement, direct and redirect
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`examinations of witnesses it calls (including by designation), cross-examination of witnesses
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`called by any other party (including by designation), its argument on any motions for judgment
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`as a matter of law, and all argument on objections a party raises to the opposing party’s exhibits
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`and demonstrative exhibits. The Courtroom Deputy will keep a running total of trial time used
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`by counsel.
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`XV. Amendment of the Pleading
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`68.
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`The parties are not seeking any amendments to the pleadings at this time.
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`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 18 of 21 PageID #: 2975
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`XVI. Additional Matters
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`A.
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`Notice of Commercial Launch of Apotex’s Generic Product
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`69.
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`. To date, Apotex has not agreed to provide Plaintiffs with notice of its
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`intended commercial launch date. For that reason, Plaintiffs respectfully request that the Court
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`order Apotex to provide Plaintiffs with notice no later than 45 days prior to its intended
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`commercial launch date. Plaintiffs intend to move for an injunction to prevent Apotex’s launch if
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`a decision from the Court has not issued and (1) Apotex has provided notice to Plaintiffs that it
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`intends to launch its Generic Product or (2) the 30-month stay will imminently expire. Apotex
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`believes that launch restrictions/notice provisions are premature at this time and can be revisited
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`after trial. However, if this Court requires notice of launch, then within three days from
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`Apotex’s notice, the parties will approach the Court with a briefing schedule for any motions for
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`injunctive relief. Alternatively, Plaintiffs request that the Court i