`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS INC.
`and EMS SI A,
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`_ _ _ _ _ _ D_e_fe_nd_an_t_s_. _ _ _ )
`NOVO NORDISK INC. and
`)
`NOVO NORDISK A/S,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`_ _ _ _ _ _ D_e_fe_nd_an_t_s. _ _ _ _ )
`NOVO NORDISK INC. and
`)
`NOVO NORDISK A/S,
`)
`)
`)
`)
`)
`)
`ZYDUS WORLDWIDE DMCC, ZYDUS )
`PHARMACEUTICALS (USA) INC. and )
`ZYDUS LIFESCIENCES LIMITED,
`)
`)
`)
`
`C.A. No. 22-294 (CFC)
`
`C.A. No. 22-296 (CFC)
`
`C.A. No. 22-297 (CFC)
`
`Plaintiffs,
`
`V.
`
`SUN PHARMACEUTICAL
`INDUSTRIES LTD. and SUN
`PHARMACEUTICAL INDUSTRIES,
`INC.,
`
`Plaintiffs,
`
`v.
`
`Defendants.
`
`MPI EXHIBIT 1082 PAGE 1
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`MPI EXHIBIT 1082 PAGE 1
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0001
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 2 of 38 PageID #: 1506
`
`NOVO NORDISK INC. and
`NOVO NORDISK NS,
`
`Plaintiffs,
`
`V .
`
`v.
`
`P la inti ffs,
`
`)
`)
`)
`)
`)
`)
`)
`DR. REDDY'S LABORATORIES, LTD. )
`and DR. REDDY'S LABORATORIES,
`)
`INC.,
`)
`)
`)
`Defendants.
`- - - - - - - - - -
`NOVO NORDISK INC. and
`)
`NOVO NORDISK NS,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 22-298 (CFC)
`
`C.A. No. 22-299 (CFC)
`
`AL VOGEN, INC.,
`
`Defendant.
`
`[~HEDlJLING ORDER
`
`This Jq~ ay of
`
`]..;AQ
`
`2022, pursuant to the Court's June 6,
`
`2022 Order directing the parties to confer about scheduling and discovery
`
`limitations, the parties have discussed pretrial management issues, have
`
`determined after discussion that the matter cannot be resolved at this juncture
`
`by settlement, voluntary mediation, or binding arbitration, and have prepared
`
`this proposed scheduling order;
`
`IT IS ORDERED that:
`
`2
`
`MPI EXHIBIT 1082 PAGE 2
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`MPI EXHIBIT 1082 PAGE 2
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0002
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 3 of 38 PageID #: 1507
`
`1.
`
`Case Consoldiation and Caption Modification. These actions are
`
`consolidated for all purposes, and all papers shall be filed in C.A. No. 22-cv-
`
`294-CFC. The Caption shall be modified to include the words "ANDA
`
`CASE" immediately below the Civil Action Number.
`
`2.
`
`Relevant Deadlines and Dates. All relevant deadlines and dates
`
`established by this Order are set forth in the chart attached as Exhibit A. The
`
`expiration date of any applicable 42-month period imposed pursuant to 21
`
`U.S.C. §§ 255G)(S)(B)(iii), 255G)(S)(F)(ii) is set forth in the first row of the
`
`chart.
`
`3.
`
`Initial Disclosures. Unless otherwise agreed to by the parties, the
`
`parties shall make their initial disclosures required by Federal Rule of Civil
`
`Procedure 26(a)(l) and their initial disclosures required by Paragraph 3 of the
`
`District of Delaware Default Standard on or before 14 days after entry of the
`
`Scheduling Order.
`
`4.
`
`Production of the ANDAs. As required by the Standing Order
`
`Regarding Hatch-Waxman Cases in Which Infringement is Alleged, each of
`
`the five Defendant Groups listed below confirm that they produced to Novo
`
`Nordisk Inc. and Novo Nordisk A/S (collectively, "Plaintiffs"), on the date
`
`3
`
`MPI EXHIBIT 1082 PAGE 3
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`MPI EXHIBIT 1082 PAGE 3
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0003
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 4 of 38 PageID #: 1508
`
`indicated below, the entire Abbreviated New Drug Application ("ANDA")
`
`that is the basis of the Defendant Group's alleged infringement:
`
`(a) Alvogen Inc. ("Alvogen'') confirms that it produced a copy of
`
`the entire ANDA No. 215920 on May 16, 2022;
`
`(b) Dr. Reddy 's Laboratories, Ltd. and Dr. Reddy' s Laboratories,
`
`Inc. (collectively, "DRL") confirm that they produced a copy of
`
`the entire ANDA No. 216417 on May 4, 2022;
`
`(c) Rio Biophannaceuticals fnc. and EMS S/A (collectively, "Rio")
`
`confinn that they produced a copy of the entire ANDA No.
`
`216305 on May 9, 2022;
`
`(d)
`
`Sun Phannaceutical Industries Ltd. and Sun Pharmaceutical
`
`Industries, Inc. (collectively, "Sun") confirm that they produced
`
`a copy of the entire ANDA No. 216478 on June 7, 2022; and
`
`(e)
`
`Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc.,
`
`and Zydus Lifesciences Limited (collectively, "Zydus") confirm
`
`that they produced a copy of the entire ANDA No. 215704 on
`
`May 9, 2022.
`
`Plaintiffs' Position: A number of
`
`e11ed patents relate to the device used
`
`mtiffs therefore requested early production of
`
`4
`
`MPI EXHIBIT 1082 PAGE 4
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`MPI EXHIBIT 1082 PAGE 4
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0004
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 5 of 38 PageID #: 1509
`
`Computer-Aided Design (CAD) files, the Design History File, and samples of
`
`the device described in each Defendant Group 's ANDA to facilitate Plaintiffs'
`
`ment and selection of claims to assert. Th parties were
`
`unable
`
`to
`
`reach a eement on early production o
`
`requested
`
`materials. Production
`
`these materials
`
`is nee ssary
`
`to Plaintiffs'
`
`identification of claims asse ed in the Prelimina Disclosure of Asserted
`
`Claims and preparation of Infrin ement Conte
`
`ions. Defendants' failure to
`
`timely produce these materials in r sponse o any Requests for Production
`
`served by Plaintiffs will constitute
`
`0d cause for amending Plaintiffs'
`
`Plaintiffs will rely on to show inti
`
`this Hatch-Waxman litigation
`
`are
`
`not
`
`publicly
`
`and
`
`are
`
`uniquely m Defendants'
`
`possession. Moreover, t
`
`materials relied on\ by Plaintiffs to show
`
`infringement may very well
`
`be different from the ~ terials produced by
`
`Defendants'
`
`m
`
`support
`
`of
`
`Defendants'
`
`Q_[l-infringement
`
`positions.
`
`gly, Plaintiffs ' dispute any suggestion that their need for
`
`discovery ofDe endants' devices would somehow be satisfied by Defendants'
`
`production obligations under Paragraph 6.
`
`5
`
`MPI EXHIBIT 1082 PAGE 5
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`MPI EXHIBIT 1082 PAGE 5
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0005
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 6 of 38 PageID #: 1510
`
`Defendants' Position: So that there is no ambiguity, there is no dispute
`
`concerning paragraph 4 because plaintiffs are not requesting that any
`
`her than those required by paragraph 4 C .e., defendants'
`
`respective AND.A: be produced prior to submission of P.
`
`intiffs' Preliminary
`
`already produced their re ective ANDAs.
`
`efendants take issue with
`
`plaintiffs' assertion that pos complaint
`
`iscovery from defendants is
`
`cause plaintiffs were required to have
`Defendant Group's ANDA" at least
`a good faith bas is for asserting in fr. { em . n t of its device patents prior to filing
`
`its complaints pw·suant to Ru) · 11 of the ederal Rules of Civil Procedure.
`
`Neve1theless, to the extent
`
`laintiffs seek disc \
`
`ry from defendants beyond
`
`the AND As, they are fre . to submit document req{rests pursuant to Rule 34 of
`
`the Federal Rules of vii Procedure. And to the exten ny defendant intends
`
`to rely on any mat
`
`ials to support any non-infringement po • • on (e.g., CAD
`
`files, to the ext nt they exist), defendants acknowledge that such materials
`
`would need
`
`be produced with non-infringement contentions pursuant to
`
`paragraph 6.
`
`6
`
`MPI EXHIBIT 1082 PAGE 6
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`MPI EXHIBIT 1082 PAGE 6
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0006
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 7 of 38 PageID #: 1511
`
`5.
`
`Preliminary Disclosure of Asserted Claims. No later than
`
`August 26, 2022, Plaintiffs shall serve each Defendant with a "Preliminary
`
`Disclosure of Asserted Claims" that lists each claim of each patent alleged to
`
`be infringed by that Defendant, including for each claim the applicable
`
`statutory subsections of35 U.S.C. § 271 asserted. Unless otherwise agreed to
`
`by the parties, Plaintiffs may assert no more than ten claims of any one patent
`
`and no more than 32 claims in total against each Defendant Group. Plaintiffs
`
`shall produce with the Preliminary Disclosure of Asserted Claims a copy of
`
`the file history for each asserted patent, all documents evidencing ownership
`
`of the asserted patent rights by Plaintiffs, and all agreements, including
`
`licenses, transferring an interest in any asserted patent.
`
`6.
`
`Noninfringement Contentions. Unless otherwise agreed to by
`
`the parties, no later than October 20, 2022, each Defendant Group shall serve
`
`on Plaintiffs "Noninfringement Contentions" that shall set forth any defense
`
`of noninfringement and include a claim chart that identifies each claim at issue
`
`in the case, each limitation of each claim at issue, and any and all claim
`
`limitations that are literally absent from the Abbreviated New Drug
`
`Application(s) or New Drug Application(s) accused of infringement. Each
`
`Defendant Group shall produce with the Noninfringement Contentions any
`
`7
`
`MPI EXHIBIT 1082 PAGE 7
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`MPI EXHIBIT 1082 PAGE 7
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0007
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 8 of 38 PageID #: 1512
`
`document or thing that the Defendant Group intends to rely upon in defense
`
`of any infringement allegations by Plaintiffs.
`
`7.
`
`Invalidity Contentions and Preliminary Disclosure of Asserted
`
`Prior Art. Unless otherwise agreed to by the parties, no later than October
`
`20, 2022, each Defendant Group shall serve on Plaintiffs "Invalidity
`
`Contentions" that shall contain the following information:
`
`(a)
`
`The identity ofno more than 12 prior art references for any
`
`one patent and no more than 40 prior art references in total that the
`
`Defendant Group alleges anticipates each asserted claim or renders the
`
`claim obvious (the "Preliminary Disclosure of Asserted Prior Art").
`
`Each prior art patent shall be identified by its number, country of origin,
`
`and date of issue. Each prior art publication shall be identified by its
`
`title, date of publication, and, where feasible, author and publisher.
`
`Each alleged sale or public use shall be identified by specifying the item
`
`offered for sale or publicly used or known, the date the offer or use took
`
`place or the information became known, and the identity(ies) of the
`
`person( s) or entity(ies) that made the use or made and received the
`
`offer, or the person(s) or entity(ies) that made the information known
`
`or to whom it was made known. For pre-AIA claims, prior art under 35
`
`8
`
`MPI EXHIBIT 1082 PAGE 8
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`MPI EXHIBIT 1082 PAGE 8
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0008
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 9 of 38 PageID #: 1513
`
`U.S.C. § 102(f) shall be identified by providing the name of the
`
`person( s) from whom and the circumstances under which the invention
`
`or any part of it was derived. For pre-AIA claims, prior art under 35
`
`U.S.C. § 102(g) shall be identified by providing the identity(ies) of the
`
`person(s) or entity(ies) involved in and the circumstances surrounding
`
`the making of the invention before the patent applicant( s );
`
`(b) Whether each item of prior art anticipates each asserted
`
`claim or renders it obvious. If obviousness is alleged, an explanation of
`
`why the prior art renders the asserted claim obvious, including an
`
`identification of any combinations of prior art showing obviousness;
`
`( c) A chart identifying specifically where and how in each
`
`alleged item of prior art each limitation of each asserted claim is found,
`
`including, for each limitation that such party contends is governed by
`
`35 U.S.C. § 112(f), the identity of the structure(s), act(s), or material(s)
`
`in each item of prior art that performs the claimed function; and
`
`(d) Any grounds of invalidity based on 35 U.S.C. § 101,
`
`indefiniteness under 35 U.S.C. § 112(b), or lack of enablement or
`
`insufficient written description under 35 U.S.C. § 112(a) of any of the
`
`asserted claims.
`
`9
`
`MPI EXHIBIT 1082 PAGE 9
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`MPI EXHIBIT 1082 PAGE 9
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0009
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 10 of 38 PageID #: 1514
`
`8.
`
`Document Production Accompanying Invalidity Contentions.
`
`With the "Invalidity Contentions," each Defendant Group shall produce a
`
`copy or sample of the prior art identified pursuant to paragraph 7(a) that does
`
`not appear in the file history of the asserted patent(s). To the extent any such
`
`item is not in English, an English translation of the portion( s) relied upon shall
`
`be produced.
`
`9.
`
`Infringement Contentions. Unless otherwise agreed to by the
`
`parties, no later than December 16, 2022, Plaintiffs shall serve on each
`
`Defendant Group "Infringement Contentions." The Infringement Contentions
`
`shall contain the following information:
`
`(a)
`
`Each claim of each asserted patent that Plaintiffs allege the
`
`Defendant Group infringes, including for each claim the applicable
`
`statutory subsections of 35 U .S.C. § 271 asserted;
`
`(b)
`
`Separately
`
`for each asserted claim, each accused
`
`apparatus, product, device, process, method, act, or other
`
`instrumentality (" Accused Instrumentality") of the Defendant Group of
`
`which Plaintiffs are aware. This identification shall be as specific as
`
`possible. Each product, device, and apparatus shall be identified by
`
`name or model number, if known. Each method or process shall be
`
`10
`
`MPI EXHIBIT 1082 PAGE 10
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`MPI EXHIBIT 1082 PAGE 10
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0010
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 11 of 38 PageID #: 1515
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`identified by name, if known, or by any product, device, or apparatus
`
`that, when used, allegedly results in the practice of the claimed method
`
`or process;
`
`( c) A chart identifying specifically where and how each
`
`limitation of each asserted claim is found within each Accused
`
`Instrumentality, including for each limitation that such party contends
`
`is governed by 35 U.S.C. § l 12(f), the identity of the structure(s), act(s),
`
`or material( s) in the Accused Instrumentality that performs the claimed
`
`function;
`
`( d)
`
`For each claim alleged to have been indirectly infringed,
`
`an identification of any direct infringement and a description of the acts
`
`of the alleged indirect infringer that contribute to or are inducing that
`
`direct infringement. Insofar as alleged direct infringement is based on
`
`joint acts of multiple parties, the role of each such party in the direct
`
`infringement must be described;
`
`( e) Whether each limitation of each asserted claim is alleged
`
`to be present in the Accused Instrumentality literally or under the
`
`doctrine of equivalents;
`
`11
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`MPI EXHIBIT 1082 PAGE 11
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`MPI EXHIBIT 1082 PAGE 11
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0011
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 12 of 38 PageID #: 1516
`
`( f)
`
`For any patent that claims priority to an earlier application,
`
`the priority date to which each asserted claim is alleged to be entitled;
`
`and
`
`(g)
`
`If Plaintiffs wish to preserve the right to rely, for any
`
`purpose, on the assertion that their own or their licensee's apparatus,
`
`product, device, process, method, act, or other instrumentality practices
`
`the claimed invention, Plaintiffs shall identify, separately for each
`
`asserted claim, each such apparatus, product, device, process, method,
`
`act, or other instrumentality that incorporates or reflects that particular
`
`claim ("Embodying Instrumentality").
`
`10. Document
`
`Production
`
`Accompanying
`
`Infringement
`
`Contentions. Plaintiffs shall produce with the Infringement Contentions:
`
`(a) Documents ( e.g., contracts, purchase orders, invoices,
`
`advertisements, marketing materials, offer letters, beta site testing
`
`agreements, and third party or joint development agreements) sufficient
`
`to evidence each discussion with, disclosure to, or other manner of
`
`providing to a third party, or each sale of or offer to sell, or any public
`
`use of, the claimed invention prior to the date of application for the
`
`asserted patents;
`
`12
`
`MPI EXHIBIT 1082 PAGE 12
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`MPI EXHIBIT 1082 PAGE 12
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0012
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 13 of 38 PageID #: 1517
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`(b) All documents evidencing the conception, reduction to
`
`practice, design, and development of each claimed invention, that were
`
`created on or before the date of application for the asserted patents or
`
`the priority date(s) identified pursuant to paragraph 9(f) of this Order,
`
`whichever is earlier; and
`
`( c)
`
`If Plaintiffs
`
`identify
`
`instrumentalities pursuant
`
`to
`
`paragraph 9(g) of this Order, documents sufficient to show the
`
`operation of any aspects or elements of such instrumentalities the patent
`
`claimant relies upon as embodying any asserted claims.
`
`Plaintiffs shall separately identify by production number the documents that
`
`correspond to each category set forth in this paragraph. The production of a
`
`document as required by this paragraph shall not constitute an admission that
`
`such document evidences or is prior art under 35 U.S.C. § 102.
`
`11. Responses to Invalidity Contentions, Addition or Substitution of
`
`Asserted Claims or Prior Art and Amendment of Contentions. Plaintiffs shall
`
`serve responses to Invalidity Contentions no later than December 21, 2022.
`
`Any final amendment of or supplement to the Infringement Contentions,
`
`Invalidity Contentions, Preliminary Disclosure of Asserted Claims, and
`
`Preliminary Disclosure of Asserted Prior Art shall be made no later than
`
`13
`
`MPI EXHIBIT 1082 PAGE 13
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`MPI EXHIBIT 1082 PAGE 13
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0013
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 14 of 38 PageID #: 1518
`
`December 1, 2023 without leave of the Court. Any final amendment of or
`
`supplement to the Noninfringement Contentions shall be made no later than
`
`December 15, 2023 without leave of the Court. Any final amendment of or
`
`supplement to the Responses to Invalidity Contentions shall be made no later
`
`than December 15, 2023 without leave of the Court. The addition or
`
`substitution of asserted claims or prior art and the amendment of the
`
`N oninfringement Contentions,
`
`Invalidity Contentions,
`
`Infringement
`
`Contentions, Responses to Invalidity Contentions, Preliminary Disclosure of
`
`Asserted Claims, and Preliminary Disclosure of Asserted Prior Art after the
`
`deadlines set in this paragraph, may be made only by order of the Court upon
`
`a timely showing of good cause. A request to add an asserted claim will likely
`
`only be granted if Plaintiffs drop a claim or claims previously asserted. A
`
`request to add an asserted prior art reference will likely only be granted if the
`
`Defendant Group drops a prior art reference or references previously asserted.
`
`The duty to supplement discovery responses, and the right to amend or
`
`supplement these disclosures and contentions until the deadlines set in this
`
`paragraph, do not excuse the need to provide fulsome initial disclosures and
`
`contentions no later than the deadlines set out herein.
`
`14
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`MPI EXHIBIT 1082 PAGE 14
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`MPI EXHIBIT 1082 PAGE 14
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0014
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 15 of 38 PageID #: 1519
`
`12.
`
`Joinder of Other Parties and Amendment of Pleadings. All
`
`motions to join other parties, and to amend or supplement the pleadings, shall
`
`be filed on or before August 1, 2023.
`
`13. Discovery.
`
`(a) Coordination by the Defendant Groups. The
`
`Defendant Groups shall endeavor to coordinate their discovery
`
`efforts in this matter.
`
`(b) Discovery Cut Off. All fact discovery in this case
`
`shall be initiated so that it will be completed on or before
`
`October 20, 2023.
`
`( c)
`
`Electronic Discovery. The parties will negotiate an
`
`agreement and order for discovery of electronically-stored
`
`information ("ESI Order"), which shall govern this action unless
`
`modified by order of the Court or by agreement of the parties.
`
`The parties will submit a proposed ESI Order to the Court on or
`
`before 21 days after entry of the Scheduling Order.
`
`(d) Document Production. Document production shall
`
`be substantially completed on or before June 2, 2023.
`
`15
`
`MPI EXHIBIT 1082 PAGE 15
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`MPI EXHIBIT 1082 PAGE 15
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0015
`
`
`
`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 16 of 38 PageID #: 1520
`
`( e) Requests for Production. The parties do not believe
`
`that a numeric limitation is required on requests for production
`
`at this time. Defendants agree to serve Plaintiffs with collective
`
`requests for production, to the extent practicable, and to avoid
`
`serving Plaintiffs with duplicative individual requests.
`
`( f)
`
`Requests for Admission. Defendants may serve on
`
`Plaintiffs up to 25 collective requests for admissions. Plaintiffs
`
`may serve on Defendants up to 25 collective requests for
`
`admission. Each Defendant Group may additionally serve up to
`
`15 individualized requests for admission on Plaintiffs. Plaintiffs
`
`may additionally serve up to 15 individualized requests for
`
`admission on each Defendant Group.
`
`Requests
`
`for
`
`authentication or to establish documents as business records shall
`
`not count against a party's requests for admissions limit.
`
`(g)
`
`Interrogatories. Defendants may serve on Plaintiffs
`
`up to 20 collective interrogatories. Plaintiffs may serve on
`
`Defendants up to 20 collective interrogatories. Each Defendant
`
`Group may additionally serve up
`
`to 15
`
`individualized
`
`16
`
`MPI EXHIBIT 1082 PAGE 16
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`MPI EXHIBIT 1082 PAGE 16
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0016
`
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 17 of 38 PageID #: 1521
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`interrogatories on Plaintiffs. Plaintiffs may additionally serve up
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`to 15 individualized interrogatories on each Defendant Group.
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`(h) Depositions.
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`1.
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`Limitations on Deposition Discovery. The
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`parties are limited as follows relating to fact witnesses,
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`with testimony provided under FED. R. CIV. P. 30(b)(6)
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`counting as a single deposition per notice and no single
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`deposition lasting more than 7 hours on the record, except
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`that any deposition of a witness testifying in a foreign
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`language may last no more than 12 hours on the record.
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`The time limits in this section apply regardless of whether
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`the witness is being deposed in a personal capacity, as a
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`3 O(b )( 6) designee, or both. Each fact witness may be
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`deposed only once absent a showing of good cause. The
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`deposition of a single person in both the person's personal
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`capacity and as a 30(b )( 6) designee shall count as a single
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`deposition. Plaintiffs shall be permitted 5 fact depositions
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`upon oral examination of each Defendant Group,
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`excluding depositions of non-parties.
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`Defendants,
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`17
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`MPI EXHIBIT 1082 PAGE 17
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`MPI EXHIBIT 1082 PAGE 17
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0017
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 18 of 38 PageID #: 1522
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`collectively, shall be permitted 18 fact depositions upon
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`oral examination of Plaintiffs, excluding depositions of
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`non-parties. Plaintiffs shall identify which inventors on
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`the patents-in-suit are employed or otherwise represented
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`by Plaintiffs no later than January 19, 2023.
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`2.
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`Location of Depositions. Any party or
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`representative ( officer, director, or managing agent) of a
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`party filing a civil action in this District Court must
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`ordinarily be required, upon request, to submit to a
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`deposition at a place designated within this District, unless
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`the parties mutually agree upon a location for the
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`deposition outside of this District. A Defendant who
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`becomes a counterclaimant, cross-claimant, or third-party
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`plaintiff shall be considered as having filed an action in
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`this Court for the purpose of this provision. Exceptions to
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`these general rules may be made by order of the Court or
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`by agreement of the parties.
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`The parties agree that, by June 5, 2023, they will
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`meet and confer
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`to reach agreement on whether
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`18
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`MPI EXHIBIT 1082 PAGE 18
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`MPI EXHIBIT 1082 PAGE 18
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0018
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 19 of 38 PageID #: 1523
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`depositions will be conducted in-person or be conducted
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`remotely, in view of the ongoing COVID-19 pandemic.
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`During the meet and confer, the parties will reach
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`agreement on how to handle exhibits at any depositions
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`that are conducted remotely. Should the parties agree to
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`conduct depositions remotely, Zoom or other similar
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`methods will be used, and the parties will work together to
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`set a reasonable time for the deposition in view of the
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`normal business hours of the deponent.
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`3.
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`Any witness who refuses to appear for a
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`deposition shall not be allowed to
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`testify at any
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`proceeding, hearing or trial.
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`4.
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`Parties must make all witnesses who are
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`identified to testify at any proceeding, hearing or trial,
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`available for a deposition sufficiently in advance of the
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`scheduled testimony.
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`5.
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`If a witness will testify in a foreign language
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`for any deposition, the party producing said witness shall
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`inform the party taking the deposition of that fact at least
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`19
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`MPI EXHIBIT 1082 PAGE 19
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`MPI EXHIBIT 1082 PAGE 19
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0019
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 20 of 38 PageID #: 1524
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`two weeks prior to the date of the deposition, or at the time
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`the deposition is scheduled if it is less than two weeks in
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`advance.
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`14.
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`Pinpoint Citations. Pinpoint citations are required in all briefing,
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`letters, and concise statements of facts. The Court will ignore any assertions
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`of controverted facts and controverted legal principles not supported by a
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`pinpoint citation to, as applicable: the record, an attachment or exhibit, and/or
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`case law or appropriate legal authority. See United States v. Dunkel, 921 F.2d
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`955, 956 (7th Cir. 1991) ("Judges are not like pigs, hunting for truffles buried
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`in briefs.").
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`15. Application to Court for Protective Order. Counsel believe it will
`
`be necessary to apply to the Court for a protective order specifying terms and
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`conditions for the disclosure of confidential information. Counsel will confer
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`and attempt to reach an agreement on a proposed form of order and submit it
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`to the Court on or before 21 days after entry of the Scheduling Order.
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`Any proposed protective order must include the following paragraph:
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`Other Proceedings. By entering this Order
`and limiting the disclosure of information in
`this case, the Court does not intend to
`preclude another court from finding that the
`information may be relevant and subject to
`disclosure in another case. Any person or
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`20
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`MPI EXHIBIT 1082 PAGE 20
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`MPI EXHIBIT 1082 PAGE 20
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0020
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`
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 21 of 38 PageID #: 1525
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`party subject to this Order who becomes
`subject to a motion to disclose another party's
`information designated
`as
`confidential
`pursuant to this Order shall promptly notify
`that party of the motion so that the party may
`have an opportunity to appear and be heard
`on whether that
`information should be
`disclosed.
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`16. Disputes Relating to Discovery Matters and Protective Orders.
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`Should counsel find that they are unable to resolve a dispute relating to a
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`discovery matter or protective order, the parties shall contact the Court's Case
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`Manager to schedule an in-person conference/argument.
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`(a) Unless otherwise ordered, by no later than 72 hours
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`prior to the conference/argument, the party seeking relief shall
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`file with the Court a letter, not to exceed three pages, outlining
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`the issues in dispute and the party's position on those issues. The
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`party shall submit as attachments to its letter ( 1) an averment of
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`counsel that the parties made a reasonable effort to resolve the
`
`dispute and that such effort included oral communication that
`
`involved Delaware counsel for the parties, and (2) a draft order
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`for the Court's signature that identifies with specificity the relief
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`sought by the party. The party shall file concurrently with its
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`21
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`MPI EXHIBIT 1082 PAGE 21
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`MPI EXHIBIT 1082 PAGE 21
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0021
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 22 of 38 PageID #: 1526
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`letter a motion that in no more than one paragraph sets forth the
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`relief sought.
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`(b) By no
`
`later
`
`than 48 hours prior
`
`to
`
`the
`
`conference/argument, any party opposing the application for
`
`relief may file a letter, not to exceed three pages, outlining that
`
`party's reasons for its opposition.
`
`(c)
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`Two hard copies of the parties'
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`letters and
`
`attachments must be provided to the Court within one hour of e(cid:173)
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`filing the document(s). The hard copies shall comply with
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`paragraphs 14 and 18 of this Order.
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`(d)
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`If a motion concerning a discovery matter or
`
`protective order is filed without leave of the Court and does not
`
`comport with the procedures set forth in this paragraph, the
`
`motion will be denied without prejudice to the moving party's
`
`right to bring the dispute to the Court through the procedures set
`
`forth in this paragraph.
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`17.
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`Papers Filed Under Seal. When filing papers under seal, counsel
`
`shall deliver to the Clerk an original and two copies of the papers. A redacted
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`22
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`MPI EXHIBIT 1082 PAGE 22
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`MPI EXHIBIT 1082 PAGE 22
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0022
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`
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 23 of 38 PageID #: 1527
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`version of any sealed document shall be filed electronically within seven days
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`of the filing of the sealed document.
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`18. Hard Copies. The parties shall provide to the Court two hard
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`copies of all letters filed pursuant to paragraph 16 of this Order, all briefs, and
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`any other documents filed in support of any such letters and briefs. This
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`provision also applies to papers filed under seal.
`
`a.
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`Exhibits and Attachments. Each exhibit and attachment
`
`to a letter, brief, or pretrial order shall be separated by a tab.
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`(Accordingly, each brief filed in connection with a motion in limine in
`
`a pretrial order must be separated by a tab.) Each exhibit and attachment
`
`shall have page numbers of some sort such that a particular page of an
`
`exhibit or attachment can be identified by a page number. The parties
`
`shall take all practical measures to avoid filing multiple copies of the
`
`same exhibit or attachment. The parties should highlight the text of
`
`exhibits and attachments they wish the Court to read. The parties are
`
`encouraged to include in an exhibit or attachment only the pages of the
`
`document in question that ( 1) identify the document ( e.g., the first page
`
`of a deposition transcript or the cover page of a request for discovery)
`
`and (2) are relevant to the issue(s) before the Court.
`
`23
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`MPI EXHIBIT 1082 PAGE 23
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`MPI EXHIBIT 1082 PAGE 23
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1082-0023
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`
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`Case 1:22-cv-00294-CFC Document 22 Filed 06/30/22 Page 24 of 38 PageID #: 1528
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`b.
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`Colors of Front Covers. The covers of briefs filed in
`
`connection with all motions except for motions in limine included in a
`
`pretrial order shall be as follows:
`
`11.
`
`11.
`
`Opening brief-Blue
`
`Answering brief - Red
`
`111.
`
`Reply brief - Gray
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`19. Claim Construction Issue Identification. On or before January
`
`5, 2023, the parties shall exchange a list of those claim term( s )/phrase( s) that
`
`they believe need construction. On or before January 19, 2023, the parties
`
`shall exchange lists of their proposed claim construction( s) of those
`
`term(s)/phrase(s), and any supporting intrinsic evidence. These documents
`
`will not be filed with the Court. On or before January 26, 2023, the parties
`
`will meet and confer to prepare a Joint Claim Construction Chart to be filed
`
`no later than February 1, 2023. The Joint Claim Construction Chart, in Word
`
`format,
`
`shall
`
`be
`
`e-mailed
`
`simultaneously with
`
`filing
`
`to
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`cfc