Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 1 of 21 PageID #: 2958
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
`
`Plaintiffs, v.
`
`APOTEX INC and APOTEX CORP.,
`
`Defendants.
`
`
`
`
`
`
`
`C.A. No. 14-1453-LPS
`
`
`
`
`
`
`
`
`
`
`
`
`PROPOSED JOINT PRETRIAL ORDER
`
`
`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.
`
`
`
`Redacted: November 10, 2016
`
`
`
`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.
`
`
`REDACTED
`PUBLIC VERSION
`
`1
`
`CIP2017
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`CIPLA LTD. EXHIBIT 2025 PAGE 1
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 2 of 21 PageID #: 2959
`
`
`On November 22, 2016, counsel for Plaintiffs1 and Apotex2 will participate in a pretrial
`
`conference before this Court pursuant to Rule 16 of the Federal Rules of Civil Procedure, Local
`
`Rule 16.3, and this Court’s June 04, 2015 Oral Order (D.I. 28). Pursuant to Local Rule 16.3,
`
`Plaintiffs and Apotex hereby submit this proposed Joint Pretrial Order governing the bench trial
`
`of Civil Action No. 14-1453-LPS for the Court’s approval. Trial is scheduled to begin on
`
`December 12, 2016.
`
`Plaintiffs are represented by: Mark Fox Evens (mevens@skgf.com), Uma N. Everett
`
`(ueverett@skgf.com), Dennies Varughese
`
`(dvarughe@skgf.com), Rami Bardenstein
`
`(rbardenstein@skgf.com), Adam C. LaRock
`
`(alarock@skgf.com),
`
`Joshua
`
`I. Miller
`
`(jmiller@skgf.com),
`
`Josephine
`
`J. Kim
`
`(joskim@skgf.com),
`
`Stephanie Nguyen
`
`(snguyen@skgf.com) of Sterne, Kessler, Goldstein & Fox PLLC, 1100 New York Ave., N.W.,
`
`Washington, DC 20005-3934, and Frederick L. Cottrell, III (Cottrell@rlf.com) and Selena
`
`Molina (molina@rlf.com) of Richards, Layton, Finger, 920 North King Street, Wilmington, DE
`
`19801.
`
`Apotex is represented by George C. Lombardi (glombard@winston.com), Samuel S. Park
`
`(spark@winston.com), Kevin E. Warner (kwarner@winston.com), and Ryan B. Hauer
`
`(rhauer@winston.com) of Winston & Strawn LLP, 35 W. Wacker Dr., Chicago, IL 60601,
`
`Charles B. Klein (cklein@winston.com) and Ilan Wurman (iwurman@winston.com) of Winston
`
`& Strawn LLP, 1700 K Street N.W., Washington, D.C., 2006, and Dominick T. Gattuso
`
`(dgattuso@proctorheyman.com) of Proctor Heyman Enerio LLP, 300 Delaware Ave., Suite 200,
`
`Wilmington, DE 19801.
`
`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.
`
`2
`
`CIPLA LTD. EXHIBIT 2025 PAGE 2
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 3 of 21 PageID #: 2960
`
`This Order will control the subsequent course of this action, unless modified by the Court
`
`to prevent manifest injustice.
`
`I.
`
`A.
`
`Nature of the Case – Civil Action No. 14-1453-LPS
`
`Nature of the Action
`
`1.
`
`Plaintiffs brought this action for patent infringement against Apotex pursuant to
`
`the Hatch-Waxman Act, codified as amended at 21 U.S.C. § 355(j) and 35 U.S.C. § 271(e).
`
`Plaintiff Meda makes and sells the drug product Dymista®—approved by the Food and Drug
`
`Administration for the relief of symptoms of seasonal allergic rhinitis—in the United States.
`
`B.
`
`Plaintiffs’ Complaints
`
`2.
`
`On December 2, 2014, Plaintiffs brought the instant action against Apotex (D.I. 1)
`
`for infringing two patents—U.S. Patent Nos. 8,163,723 (“the ’723 patent”) and 8,168,620 (“the
`
`’620 patent”)—based on Apotex’s filing of Abbreviated New Drug Application (“ANDA”) No.
`
`207712 and accompanying certification pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`(“Paragraph IV certification”) that it intended to manufacture, sell or offer for sale its generic
`
`version of Dymista® (“Generic Product”) prior to the expiration of those patents. In their
`
`Complaint, Plaintiffs alleged that Apotex infringed, contributed to, aided and abetted, and/or
`
`induced infringement of the ’723 patent and the ’620 patent pursuant to 35 U.S.C. § 271(e)(2)(A)
`
`by submitting its ANDA and accompanying Paragraph IV certification. Plaintiffs further alleged
`
`that Apotex would infringe, contribute to or induce infringement under 35 U.S.C. § 271(a)-(c) if
`
`Apotex were to sell, offer for sale, manufacture, or import the products described in ANDA No.
`
`207712.
`
`3.
`
`On February 26, 2016, Plaintiffs filed a First Amended Complaint (“Amended
`
`Complaint”) against Apotex (D.I. 90) that asserted a claim for infringement of newly issued U.S.
`
`
`
`- 2 -
`
`3
`
`CIPLA LTD. EXHIBIT 2025 PAGE 3
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 4 of 21 PageID #: 2961
`
`Patent No. 9,259,428 (“the ’428 patent”) based on Apotex’s pending ANDA No. 207712. In their
`
`Amended Complaint, Plaintiffs repeated all allegations from their original Complaint and also
`
`alleged that Apotex infringed, contributed to, aided and abetted, and/or induced infringement of
`
`the ’428 patent pursuant to 35 U.S.C. § 271(e)(2)(A) by submitting its ANDA. Plaintiffs further
`
`alleged that Apotex would infringe, contribute to or induce infringement under 35 U.S.C. §
`
`271(a)-(c) if Apotex were to sell, offer for sale, manufacture, or import the products described in
`
`ANDA No. 207712.
`
`4.
`
`Plaintiffs are asserting claims 4, 29, and 42-44 of the '620 patent and claims 10,
`
`11, 13, 15, 16, 23, 24, 26, and 29-30 of the ’428 patent.
`
`C.
`
`Apotex’s Answers and Counterclaims
`
`5.
`
`Apotex filed its Answer and Counterclaims to Plaintiffs’ original Complaint on
`
`December 23, 2014 (D.I. 8) and to Plaintiffs’ Amended Complaint on March 9, 2016 (D.I. 93).
`
`Apotex’s Answer and Counterclaims to the original Complaint and to the Amended Complaint,
`
`taken together, assert defenses that each of the asserted patents—the ’723 patent, ’620 patent,
`
`and ’428 patent—are invalid and not infringed, and that Plaintiffs’ allegations failed to state a
`
`claim upon which relief can be granted. Apotex also alleged counterclaims for a declaration of
`
`noninfringement and invalidity of the ’723 patent, the ’620 patent, and the ’428 patent.
`
`D.
`
`Plaintiffs’ Answers to Apotex’s Counterclaims
`
`6.
`
`On January 16, 2015, Plaintiffs filed their Answer to Apotex’s Counterclaims to
`
`the Complaint (D.I. 12) and, on April 4, 2016, filed their Answer to Apotex’s Answer and
`
`Counterclaims to the Amended Complaint (D.I. 93), denying that Apotex was entitled to any
`
`relief as asserted in its Counterclaims or otherwise.
`
`
`
`- 3 -
`
`4
`
`CIPLA LTD. EXHIBIT 2025 PAGE 4
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 5 of 21 PageID #: 2962
`
`E.
`
`Pending Motions
`
`7.
`
`There are no pending motions in this action.
`
`F.
`
`Stipulation to Infringement
`
`8.
`
`The parties have stipulated that Apotex’s Generic Product, described by ANDA
`
`No. 207712, literally infringes claims 4, 29, and 42-44 of the ’620 patent; and claims 10, 11, 13,
`
`15, 16, 23, 24, 26, and 29-30 of the ’428 patent. (D.I. 104.)
`
`G.
`
`Relief Sought by Plaintiffs
`
`9.
`
`Plaintiffs request the following relief from the Court: a judgment that the asserted
`
`claims of the ’620 and ’428 patents are valid and enforceable; a judgment and order pursuant to
`
`35 U.S.C. § 271(e)(4)(A) providing that the effective date of any FDA approval of Apotex’s
`
`ANDA No. 207712 not be earlier than the latest of the expiration dates of the ‘620 and ’428
`
`patents, inclusive of any extension(s) and additional period(s) of exclusivity; a permanent
`
`injunction enjoining Apotex and its officers, agents, servants, and employees, and those persons
`
`in active concert or participation with any of them, from making, using, selling, or offering to
`
`sell in the United States, or importing into the United States, Apotex’s Generic Product for which
`
`approval is sought in ANDA No. 207712; a declaration under 28 U.S.C. § 2201 that if Apotex,
`
`their officers, agents, servants, employees, licensees, representatives, and attorneys, and all other
`
`persons acting or attempting to act in active concert or participation with them or acting on their
`
`behalf, engage in the commercial manufacture, use, offer for sale, sale and/or importation of
`
`Apotex’s Generic Product prior to patent expiry, it will constitute an act of direct and/or indirect
`
`infringement of the ’620 and ’428 patents; a finding that this is an exceptional case, and an award
`
`of attorneys’ fees in this action pursuant to 35 U.S.C. § 285; an award of costs and expenses in
`
`this action; and any further and other relief as this Court determines to be just and proper.
`
`
`
`- 4 -
`
`5
`
`CIPLA LTD. EXHIBIT 2025 PAGE 5
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 6 of 21 PageID #: 2963
`
`H.
`
`Relief Sought by Defendants
`
`10.
`
`Defendants request the following relief from the Court: Dismissing Plaintiffs’
`
`Complaints with prejudice; declaring that the manufacture, use, offer for sale, sale, and/or
`
`importation of Defendants’ Generic Product does not and will not induce infringement of any
`
`valid claim of the Patents-in-Suit; declaring that the manufacture, use, offer for sale, sale, and/or
`
`importation of Defendants’ Generic Products does not and will not contribute to the infringement
`
`of any valid claim of the Patents-in-Suit; declaring that the asserted claims of the Dymista
`
`Patents are invalid; declaring that this is an exceptional case under 35 U.S.C. § 285 and/or other
`
`applicable statute or rules and awarding Defendants their attorneys’ fees, costs, and expenses;
`
`and; awarding to Defendants such further relief as to this Court may deem necessary, just and
`
`proper.
`
`II.
`
`Jurisdiction
`
`11.
`
`Civil Action No. 14-1453-LPS is an action for patent infringement arising under
`
`the patent laws of the United States, 35 U.S.C. § 271, et seq. This Court has subject matter
`
`jurisdiction over these actions under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202. Venue is
`
`proper under 28 U.S.C. §§ 1391(c) and 1400(b). Jurisdiction and venue are not disputed.
`
`III.
`
`A.
`
`Facts
`
`Uncontested Facts
`
`12.
`
`13.
`
`The parties’ statement of uncontested facts is set forth in Exhibit 1.
`
`These uncontested facts require no proof at trial and are part of the evidentiary
`
`record in the case.
`
`
`
`- 5 -
`
`6
`
`CIPLA LTD. EXHIBIT 2025 PAGE 6
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 7 of 21 PageID #: 2964
`
`B.
`
`Contested Facts
`
`14.
`
`Plaintiffs’ statement of issues of fact that they contend remain to be litigated is
`
`attached as Exhibit 2.
`
`15.
`
`Apotex’s statement of issues of fact that it contends remain to be litigated is
`
`attached as Exhibit 3.
`
`16.
`
`Should the Court determine that any issue identified in a party’s statement of
`
`contested issues of fact to be litigated is more properly considered an issue of law, it should be so
`
`considered.
`
`IV.
`
`Issues of Law
`
`17.
`
`Plaintiffs’ statement of issues of law that they contend remain to be litigated is
`
`attached as Exhibit 4.
`
`18.
`
`Apotex’s statement of issues of law that it contends remain to be litigated is
`
`attached as Exhibit 5.
`
`19.
`
`Should the Court determine that any issue identified in a party’s statement of
`
`issues of law that it contends remain to be litigated is more properly considered an issue of fact,
`
`it should be so considered.
`
`V. Witnesses
`
`20.
`
`Presentation of evidence will follow the burden of proof. Nothing in this
`
`paragraph precludes the right of a party to offer rebuttal testimony as appropriate.
`
`21.
`
`The parties agree that expert witnesses need not be sequestered. The parties agree
`
`that fact witnesses shall be sequestered.
`
`22.
`
`Unless otherwise agreed between the parties, the parties will identify the
`
`witnesses they expect to call for direct examination, and the order in which they expect to call
`
`
`
`- 6 -
`
`7
`
`CIPLA LTD. EXHIBIT 2025 PAGE 7
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 8 of 21 PageID #: 2965
`
`said witnesses, by 6:00 p.m.3 two calendar days before4 the direct examination is expected to
`
`take place.
`
`23.
`
`Beginning two nights before the start of trial, the parties will confer nightly to
`
`update opposing counsel as to the expected day that the party intends to complete its presentation
`
`of evidence.
`
`A. Witnesses to Be Called
`
`24.
`
`Plaintiffs’ List of Witnesses to be Called Live or By Deposition is set forth in
`
`Exhibit 6.
`
`25.
`
`Apotex’s List of Witnesses to be Called Live or By Deposition is set forth in
`
`Exhibit 7. Apotex has recently learned that its commercial success expert, Glenn Newman, will
`
`be unavailable for trial due to a sudden illness. The parties are discussing possible resolutions
`
`and expect to update the Court at the pre-trial conference.
`
`26.
`
`The parties’ lists of witnesses indicate the witnesses they currently intend to call
`
`and the witnesses they may call to testify at trial. This list also indicates whether a party intends
`
`to introduce live testimony or deposition testimony for each witness. Any witness not listed will
`
`be precluded from testifying absent good cause shown.
`
`27.
`
`In the event that a witness who was designated by a party to testify live at trial is
`
`not available or otherwise cannot testify live due to unforeseeable circumstances beyond the
`
`offering party’s control, upon a showing of good cause, the offering party may designate
`
`deposition testimony in lieu of live testimony at trial. If a party is permitted by the Court to
`
`
`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.
`
`
`
`- 7 -
`
`8
`
`CIPLA LTD. EXHIBIT 2025 PAGE 8
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 9 of 21 PageID #: 2966
`
`designate testimony, the opposing party will have reasonable notice and an opportunity to
`
`counter-designate deposition testimony.
`
`28.
`
`The parties further reserve the right to call: (1) one or more additional witnesses
`
`whose testimony is necessary to establish authenticity or admissibility of any trial exhibit, if that
`
`evidentiary status of the exhibit is challenged by an opposing party; (2) additional witnesses to
`
`respond to any issues raised by the Court’s pretrial or trial rulings; (3) any witness live for
`
`impeachment purposes to the extent permitted by applicable rules; and (4) any witness who
`
`appears on the other party’s witness list.
`
`B.
`
`Testimony by Deposition
`
`29.
`
`Having exchanged testimony that will be offered by designation of deposition
`
`testimony, and having met and conferred in an effort to resolve the objections set forth hereto:
`
`a.
`
`Deposition
`
`testimony,
`
`including Apotex’s objections and counter-
`
`designations, and Plaintiffs’ objections thereto, that Plaintiffs may offer into evidence is set forth
`
`in Exhibit 8.
`
`b.
`
`Deposition testimony, including Plaintiffs’ objections and counter-
`
`designations, and Apotex’s objections thereto, that Apotex may offer into evidence is set forth in
`
`Exhibit 9.
`
`30. With respect to those witnesses the parties have identified in Exhibits 6 and 7 who
`
`will be called to testify live at trial, no deposition designations or counter-designations are
`
`required. Should a fact witness identified in Exhibits 6 and 7 as testifying live at trial become
`
`unavailable, as that term is defined in the Federal Rules of Civil Procedure and Federal Rules of
`
`Evidence, the parties may designate specific pages and lines of transcript that they intend to read
`
`or play in lieu of the witness’s appearance, upon reasonable notice.
`
`
`
`- 8 -
`
`9
`
`CIPLA LTD. EXHIBIT 2025 PAGE 9
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 10 of 21 PageID #: 2967
`
`31.
`
`For deposition testimony provided to the Court, the parties providing the
`
`designated testimony shall serve the other parties with the transcript pages and line numbers of
`
`the deposition testimony they intend to introduce by 6:00 p.m. three calendar days before such
`
`testimony is to be introduced, and identify the manner in which the deposition will be used,
`
`either by video or reading the transcript into the record. The opposing parties will identify any
`
`objections to the designated deposition testimony and any specific pages and lines from that
`
`deposition to counter-designate by 12:00 p.m. two calendar days before such testimony is to be
`
`introduced, and identify the manner in which the deposition will be used, either by video or
`
`reading the transcript into the record. The parties shall meet and confer to resolve any objections
`
`to designated testimony by 3:00 p.m. two calendar days before such testimony is to be
`
`introduced.
`
`32.
`
`If objections remain to be resolved, the party calling the witness by deposition
`
`shall submit to the Court, no later than 10 p.m. two calendar days before the witness is to be
`
`called at trial, on behalf of all parties: (i) a copy of the entire deposition testimony of the witness
`
`at issue, clearly highlighting the designations, counter-designations, and pending objections; and
`
`(ii) a cover letter clearly identifying the pending objections as well as a brief indication (i.e., no
`
`more than one sentence per objection) of the basis for the objection and the offering party’s
`
`response to it. Failure to comply with these procedures, absent an agreement by the parties and
`
`approval by the Court, will result in waiver of the use of the deposition testimony or waiver of
`
`objection to the use of the deposition testimony.
`
`33.
`
`All irrelevant and redundant material, including colloquy between counsel and
`
`objections, will be eliminated when submitting the objections to the Court or when the
`
`deposition is read or viewed at trial.
`
`
`
`- 9 -
`
`10
`
`CIPLA LTD. EXHIBIT 2025 PAGE 10
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 11 of 21 PageID #: 2968
`
`34. When the witness testifies by deposition at trial, the party calling the witness will
`
`provide the Court with two copies of the transcript of the designations and counter-designations
`
`that will be read or played. The parties will be charged for all time that elapses from the time the
`
`witness is called until the next witness is called.
`
`35. When deposition designation excerpts are introduced, all admissible deposition
`
`counter-designations excerpts will be introduced simultaneously in the sequence in which the
`
`testimony was originally given. The specific portions of the deposition shall be read or played in
`
`page order. If an exhibit is referenced in a deposition designation, the exhibit is admitted into
`
`evidence if it is included on the offering party’s trial exhibit list and is not otherwise objected to,
`
`or is included on the joint trial exhibit list. Any deposition testimony, once designated and
`
`introduced into evidence, may be used equally by any party for purposes of counter-designation
`
`if consistent with the rule of completeness and the rules of evidence.
`
`C.
`
`Impeachment with Prior Inconsistent Statements
`
`36.
`
`Pursuant to Fed. R. Evid. 613, deposition and other testimony or statements not
`
`specifically identified on a party’s deposition designation list or exhibit list may be used at trial
`
`only for the purpose of impeachment, if otherwise competent for such purpose. The Court will
`
`rule at trial on any objections based on lack of completeness and/or lack of consistency.
`
`D.
`
`Objections to Expert Testimony
`
`37.
`
`The parties request that the Court rule at trial on any objections to expert
`
`testimony as beyond the scope of expert disclosures. Before each expert takes the stand, the
`
`parties shall provide copies of that expert’s report(s) and deposition testimony to the Court.
`
`However, unless expressly moved and accepted into evidence, the expert report(s) and deposition
`
`
`
`- 10 -
`
`11
`
`CIPLA LTD. EXHIBIT 2025 PAGE 11
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 12 of 21 PageID #: 2969
`
`testimony shall be used only for the purpose of ruling on objections to expert testimony offered
`
`at trial.
`
`VI.
`
`A.
`
`Exhibits
`
`Exhibits
`
`38.
`
`Plaintiffs’ list of exhibits that they may offer at trial, except demonstrative
`
`exhibits and exhibits to be used solely for impeachment, and Apotex’s objections to Plaintiffs’
`
`exhibits, are attached as Exhibit 10.
`
`39.
`
`Apotex’s list of exhibits that it may offer at trial, except demonstrative exhibits
`
`and exhibits to be used solely for impeachment, and Plaintiffs’ objections to Apotex’s exhibits,
`
`are attached as Exhibit 11.
`
`40.
`
`Plaintiffs’ trial exhibits will be identified with PTX numbers, starting at PTX 1.
`
`Apotex’s trial exhibits will be identified with DTX numbers, starting at DTX 1.
`
`41.
`
`The parties agree that exhibits to be used solely for impeachment need not be
`
`included on the lists of trial exhibits or disclosed in advance of being used at trial. Subject to the
`
`remaining provisions of this Order, no party may use an exhibit not present on its exhibit list
`
`(other than exhibits to be used solely for impeachment), unless the Court determines that good
`
`cause has been shown.
`
`42.
`
`No exhibit will be admitted unless offered into evidence through a witness, who
`
`must be shown the exhibit. Before the completion of the witness’ testimony, any party that has
`
`used an exhibit with the witness and wishes that exhibit to be admitted into evidence must
`
`formally move the exhibit into evidence, by exhibit number.
`
`
`
`- 11 -
`
`12
`
`CIPLA LTD. EXHIBIT 2025 PAGE 12
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 13 of 21 PageID #: 2970
`
`43.
`
`The parties shall identify, by witness, the trial exhibits, including the exhibit
`
`numbers, that they expect to use on direct examination by 6:00 p.m. two days before5 the direct
`
`examination is expected to take place, and objections will be provided no later than 3:00 p.m.
`
`the day before their intended use. The parties shall meet and confer in an attempt to resolve any
`
`objections to the trial exhibits that are expected to be used during direct examination. If good
`
`faith efforts to resolve the objections fail, the party objecting to the exhibits shall bring its
`
`objections to the Court’s attention prior to the witness being called to the witness stand.
`
`44.
`
`Exhibits not objected to will be received into evidence by the operation of the
`
`Final Pretrial Order without the need for additional foundation testimony, provided they are
`
`shown to a witness. Nothing herein shall be construed as a stipulation or admission that the
`
`document is entitled to any weight in deciding the merits of this case. The parties agree that any
`
`description of a document on an exhibit list is provided for convenience only and shall not be
`
`used as an admission or otherwise as evidence regarding the listed document or any other listed
`
`document.
`
`45.
`
`Any party may use an exhibit that is listed on the other party’s exhibit list, to the
`
`same effect as though it were on its own exhibit list, subject to all evidentiary objections. Any
`
`exhibit, once admitted at trial, may be used equally by any party, subject to any limitations as to
`
`its admission. The listing of a document on a party’s list is not an admission that such document
`
`is relevant or admissible when offered by the opposing party for the purpose that the opposing
`
`party wishes to admit the document. Each party reserves the right to object to the relevance of
`
`
`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.
`
`
`
`- 12 -
`
`13
`
`CIPLA LTD. EXHIBIT 2025 PAGE 13
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 14 of 21 PageID #: 2971
`
`any evidence offered by the other party, at the time such evidence is offered, in view of the
`
`specific context in which such evidence is offered.
`
`46.
`
`On or before the first day of trial, counsel will deliver to the Courtroom Deputy a
`
`completed AO Form 187 exhibit list for each party.
`
`B.
`
`Demonstrative Exhibits
`
`47.
`
`The parties agree that the demonstrative exhibits the parties intend to use at trial
`
`do not need to be included on their respective lists of trial exhibits. Plaintiffs’ demonstratives
`
`will be identified with PDX numbers, starting at PDX 1. Apotex’s demonstratives will be
`
`identified with DDX numbers, starting with DDX 1.
`
`48.
`
`The parties will exchange demonstrative to be used in opening statements by 3:00
`
`p.m. the night before opening statements. The parties will provide any objections to such
`
`demonstratives by 8:00 p.m. the night before opening statements. The parties shall meet and
`
`confer in an attempt to resolve any objections.
`
`49.
`
`The parties will provide demonstrative exhibits to be used in connection with
`
`direct examination by 3:00 p.m. the night before their intended use. The parties will provide
`
`any objections by 8:00 p.m. the night before their intended use. The parties shall meet and
`
`confer in an attempt to resolve any objections.
`
`50.
`
`If good faith efforts to resolve the objections fail, the party shall bring its
`
`objections to the Court’s attention prior to opening statements or prior to the applicable witness
`
`being called into the witness stand.
`
`51.
`
`If any of the demonstratives change after the deadline, the party intending to use
`
`the demonstrative will promptly notify the opposing counsel of the change(s).
`
`
`
`- 13 -
`
`14
`
`CIPLA LTD. EXHIBIT 2025 PAGE 14
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 15 of 21 PageID #: 2972
`
`52.
`
`The party seeking to use a demonstrative exhibit will provide a color
`
`representation of the demonstrative to the other side in electronic PDF form. However, for video
`
`or animations, the party seeking to use the demonstrative will provide it to the other side on a
`
`DVD, CD, or via a secure file transfer protocol. For irregularly sized physical exhibits, the party
`
`seeking to use the demonstrative will provide the other party a color representation as a color
`
`PDF in electronic form as well as 8.5x11 copies of the exhibits.
`
`53.
`
`This provision does not apply to demonstratives created during testimony or
`
`demonstratives used for cross-examination, neither of which need be provided to the other side
`
`in advance of their use. This provision also does not apply to demonstratives consisting solely of
`
`reproductions of trial exhibits that contain enlargements, or highlighting text or information.
`
`VII. Damages
`
`54.
`
`This case currently does not involve any claims for damages. If Apotex launches
`
`its Generic Product, the parties will inform the Court promptly.
`
`VIII. Bifurcated Trial
`
`55.
`
`All issues will be tried without bifurcation.
`
`IX. Motions in Limine
`
`56.
`
`Apotex’s First Motion in Limine to Exclude Testimony Regarding FDA’s State of
`
`Mind, Plaintiffs’ opposition motion, and Apotex’s reply motion are attached as Exhibit 12.
`
`57.
`
`Apotex’s Second Motion in Limine to Exclude Hearsay Scientific Report and
`
`Related Testimony, Plaintiffs’ opposition motion, and Apotex’s reply motion are attached as
`
`Exhibit 13.6
`
`
`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.
`
`
`
`- 14 -
`
`15
`
`CIPLA LTD. EXHIBIT 2025 PAGE 15
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 16 of 21 PageID #: 2973
`
`58.
`
`Apotex’s Third Motion in Limine to Exclude Evidence of Commercial Success,
`
`Plaintiffs’ opposition motion, and Apotex’s reply motion are attached as Exhibit 14.
`
`X.
`
`Discovery
`
`59.
`
`Discovery is completed.
`
`XI. Number of Jurors
`
`60.
`
`This is a non-jury trial.
`
`XII. Non-Jury Trial/Post-trial Briefs
`
`61.
`
`62.
`
`The parties request a detailed opinion from the Court post-trial.
`
`Apotex’s opening post-trial brief on validity and objective indicia of non-
`
`obviousness shall be limited to fifty (50) pages in length. Plaintiffs’ answering post-trial brief on
`
`validity and objective indicia of non-obviousness shall be limited to fifty (50) pages. Apotex’s
`
`reply post-trial brief on validity and objective indicia of non-obviousness shall be limited to
`
`twenty-five (25) pages. Plaintiffs’ sur-repy on secondary considerations shall be limited to
`
`twenty-five (25) pages.
`
`63.
`
`In addition to their opening post-trial briefs, each party will separately file their
`
`proposed Findings of Fact comprising no more than fifty (50) pages in length each. The
`
`proposed Findings of Fact, separately stated in numbered paragraphs, will constitute a detailed
`
`listing of the relevant material facts the party believes it has proven, in a simple narrative form.
`
`No separate proposed Conclusions of Law shall be filed.
`
`64.
`
`The parties propose the following post-trial briefing schedule:
`
`a.
`
`b.
`
`c.
`
`Both parties shall file Findings of Fact on January 06, 2017;
`
` Apotex’s opening post-trial brief shall be due on January 20, 2017;
`
`Plaintiffs’ answering post-trial brief shall be due on February 3, 2017;
`
`
`
`- 15 -
`
`16
`
`CIPLA LTD. EXHIBIT 2025 PAGE 16
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 17 of 21 PageID #: 2974
`
`d.
`
`e.
`
`February 17, 2017.
`
`Apotex’s reply brief shall be due February 10, 2017;
`
`Plaintiffs’ sur-reply brief on secondary considerations shall be due
`
`XIII. Motions for Judgment as a Matter of Law
`
`65.
`
`The parties have agreed to the following procedure: The parties reserve the right
`
`to move for judgment on partial findings pursuant to Fed. R. Civ. P. 52(c). The parties agree that
`
`either party making a motion pursuant to Fed. R. Civ. P. 52(c) will advise the Court of its motion
`
`promptly and in accordance with that rule. If the Court requests more extensive argument on the
`
`motion, such argument will be taken up at the Court’s first convenience. The parties will only
`
`supplement the motion in writing upon request by the Court. Pursuant to Fed. R. Civ. P. 52(c),
`
`the Court may decline to render any judgment until the close of evidence.
`
`XIV. Length of Trial
`
`66.
`
`This case is currently set for a five-day bench trial on Dec. 12-16, 2016. The
`
`parties propose that each side receive 13 hours for its trial presentations.
`
`67.
`
`Time will be charged to a party for its opening statement, direct and redirect
`
`examinations of witnesses it calls (including by designation), cross-examination of witnesses
`
`called by any other party (including by designation), its argument on any motions for judgment
`
`as a matter of law, and all argument on objections a party raises to the opposing party’s exhibits
`
`and demonstrative exhibits. The Courtroom Deputy will keep a running total of trial time used
`
`by counsel.
`
`XV. Amendment of the Pleading
`
`68.
`
`The parties are not seeking any amendments to the pleadings at this time.
`
`
`
`- 16 -
`
`17
`
`CIPLA LTD. EXHIBIT 2025 PAGE 17
`
`

`

`Case 1:14-cv-01453-LPS Document 137 Filed 11/21/16 Page 18 of 21 PageID #: 2975
`
`XVI. Additional Matters
`
`A.
`
`Notice of Commercial Launch of Apotex’s Generic Product
`
`69.
`
`
`
`. To date, Apotex has not agreed to provide Plaintiffs with notice of its
`
`intended commercial launch date. For that reason, Plaintiffs respectfully request that the Court
`
`order Apotex to provide Plaintiffs with notice no later than 45 days prior to its intended
`
`commercial launch date. Plaintiffs intend to move for an injunction to prevent Apotex’s launch if
`
`a deci