throbber
Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 1 of 38 PagelD #: 1571
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 1 of 38 PageID #: 1571
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`NOVO NORDISKINC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`V.
`
`RIO BIOPHARMACEUTICALS INC.
`and EMSS/A,
`
`Defendants.
`NOVO NORDISKINC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`SUN PHARMACEUTICAL
`INDUSTRIES LTD. and SUN
`PHARMACEUTICAL INDUSTRIES,
`INC.,
`
`Defendants.
`NOVO NORDISKINC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`V.
`
`ZYDUS WORLDWIDE DMCC, ZYDUS
`PHARMACEUTICALS(USA)INC. and
`ZYDUS LIFESCIENCES LIMITED,
`
`Defendants.
`
`
`
`
`
`
`
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`
`
`
`
`
`
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`Ne?Nome”Neue”Neue”Nee”“eee”“eee”“tee”Stee”“Nmgee”mee”Seee”reee”Stmee”Sengee”“ge”SNe”see”“tee”ee”“Nene”gee”“tee”“Neg”Stee”“tee”NeeeeNee”“Nene“mee”“See”NeSee”“nee”eee”
`
`C.A. No. 22-294 (CFC)
`
`C.A. No. 22-296 (CFC)
`
`C.A. No. 22-297 (CFC)
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 2 of 38 PagelD #: 1572
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 2 of 38 PageID #: 1572
`
`NOVO NORDISKINC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`V.
`
`DR. REDDY’S LABORATORIES, LTD.
`and DR. REDDY’S LABORATORIES,
`INC.,
`
`Defendants.
`
`NOVO NORDISK INC. and
`NOVO NORDISKA/S,
`
`Plaintiffs,
`
`V.
`
`ALVOGEN, INC.,
`
`Defendant.
`
`Neeeeeaaaae
`
`C.A. No. 22-298 (CFC)
`
`C.A. No. 22-299 (CFC)
`
`maornseilsc|SCHEDULING ORDER
`This2¢'Pig of
`“bie
`, 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 resolvedat this juncture
`
`by settlement, voluntary mediation, or binding arbitration, and have prepared
`
`this proposed scheduling order;
`
`IT IS ORDEREDthat:
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00002
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 3 of 38 PagelD #: 1573
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 3 of 38 PageID #: 1573
`
`1.
`
`Case Consoldiation and Caption Modification. These actions are
`
`consolidated for all purposes, andall 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 Orderare 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)(5)(B)(Gili), 255G)(5)(F)Gi) is set forth in the first row of the
`
`chart.
`
`3.
`
`Initial Disclosures. Unless otherwise agreed to by the parties, the
`
`parties shall maketheir initial disclosures required by Federal Rule of Civil
`
`Procedure 26(a)(1) andtheirinitial disclosures required by Paragraph 3 ofthe
`
`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 WhichInfringement is Alleged, each of
`
`the five Defendant Groupslisted below confirm that they produced to Novo
`
`Nordisk Inc. and Novo Nordisk A/S (collectively, “Plaintiffs”), on the date
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00003
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 4 of 38 PagelD #: 1574
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 4 of 38 PageID #: 1574
`
`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 May4, 2022;
`
`(c)
`
`Rio Biopharmaceuticals Inc. and EMS S/A(collectively, “Rio”’)
`
`confirm that they produced a copy of the entire ANDA No.
`
`216305 on May 9, 2022;
`
`(d)
`
`Sun Pharmaceutical 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 numberof
`
`asserted patents relate to the device used
`
`to adrhinistér Ozempic®
`
`intiffs therefore requested early production of
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00004
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 5 of 38 PagelD #: 1575
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 5 of 38 PageID #: 1575
`
`Computer-Aided Design (CAD)files, the Design History File, and samples of
`
`the device described in each Defendant Group’s ANDAtofacilitate Plaintiffs’
`
`infringement assessment and selection of claims to assert. The’parties were
`
`unable
`
`to
`
`reach agreement on
`
`early production of
`
`the
`
`requested
`
`materials.
`
`Production
`
`
`
`these materials
`
`is neceSsary to Plaintiffs’
`
`identification of claims assetted in the Preliminary Disclosure of Asserted
`
`Claims and preparation of Infringement Contentions. Defendants’ failure to
`
`
`
`served by Plaintiffs will constitute
`
`timely produce these materials in response Ao any Requests for Production
`
`
`d cause for amending Plaintiffs’
`ring ment Contentions. The materials
`Disclosure of Asserted Claims and I
`
`
`
`Plaintiffs will rely on to show infpingementin this Hatch-Waxmanlitigation
`
`available
`are
`not
`publicly
`and
`are
`daiquely
`in Defendants’
`
`materials relied on\by Plaintiffs to show
`the
`possession. Moreover,
`
`
`infringement may very/well be different from the materials produced by
`
`Defendants’
`
`in
`
`support
`
`of
`
`Defendants’
`
`on-infringement
`
`positions. Accordjngly, Plaintiffs’ dispute any suggestion that their need for
`
`discovery of Defendants’ devices would somehowbesatisfied by Defendants’
`
`production obligations under Paragraph 6.
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00005
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 6 of 38 PagelD #: 1576
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 6 of 38 PageID #: 1576
`
`Defendants’ Position: So that there is no ambiguity, there is no dispute
`
`concerning paragraph 4 because plaintiffs are not
`
`requesting that any
`
`documents
`
`
`
`‘ether
`
`than those required by paragraph 4 (ie., defendants’
`
`respective ANDAS)
`
`be producedprior to submission ofpJéintiffs’ Preliminary
`
`Disclosure of Asserted‘Claims. And as addressed hefein, all defendants have
`
`already produced their reSpective ANDAs.
`
`efendants take issue with
`
`plaintiffs’ assertion that postcomplaint
`
`discovery from defendants
`
`is
`
`“necessary to Plaintiffs’ infringement analysis of the device described in each
`
`Defendant Group’s ANDA”at least
`
`because plaintiffs were required to have
`
`a goodfaith basis for asserting infrmmgementof its device patentspriortofiling
`
`
`
`
`
`
`
`its complaints pursuant to Rulé
`
`11 of the Kederal Rules of Civil Procedure.
`
`plaintiffs seek discovery from defendants beyond
`
`
`
`to submitdocumentespursuantto Rule 34of
`
`Nevertheless, to the extent
`
`theANDAs,they are fre¢
`
`
`Civil Procedure. And to the extentany defendant intends
`
`
`to rely on any materials to support any non-infringementposition (e.g., CAD
`
`the Federal Rules of
`
`
`
`files, to the ext¢nt they exist), defendants acknowledge that such materials
`
`would needtObe produced with non-infringement contentions pursuant to
`
`
`
`paragraph6.
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00006
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 7 of 38 PagelD #: 1577
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 7 of 38 PageID #: 1577
`
`5.
`
`Preliminary Disclosure of Asserted Claims.
`
`Nolater 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 of 35 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 claimsin 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 Groupshall serve
`
`on Plaintiffs “Noninfringement Contentions” that shall set forth any defense
`
`ofnoninfringement 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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00007
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 8 of 38 PagelD #: 1578
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 8 of 38 PageID #: 1578
`
`documentor thing that the Defendant Group intends to rely upon in defense
`
`of any infringementallegations 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 Groupalleges anticipates each asserted claim or renders the
`
`claim obvious (the “Preliminary Disclosure of Asserted Prior Art”).
`
`Eachprior art patent shall be identified by its number, country oforigin,
`
`and date of issue. Each prior art publication shall be identified by its
`
`title, date of publication, and, where feasible, author and publisher.
`
`Eachalleged 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 andreceived the
`
`offer, or the person(s) or entity(ies) that made the information known
`
`or to whom it was made known.Forpre-AJAclaims, prior art under 35
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00008
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 9 of 38 PagelD #: 1579
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 9 of 38 PageID #: 1579
`
`U.S.C. § 102(f) shall be identified by providing the name of the
`
`person(s) from whom andthe circumstances under whichthe 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 rendersit obvious. If obviousnessis alleged, an explanation of
`
`why the prior art renders the asserted claim obvious, including an
`
`identification of any combinationsofprior art showing obviousness;
`
`(c)
`
`A chart identifying specifically where and how in each
`
`alleged item ofprior 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 ofprior art that performs the claimed function; and
`
`(d) Any grounds ofinvalidity 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.
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00009
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 10 of 38 PagelD #: 1580
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 10 of 38 PageID #: 1580
`
`8.
`
`Document Production Accompanying Invalidity Contentions.
`
`With the “Invalidity Contentions,” each Defendant Group shall produce a
`
`copy or sampleof 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 ofthe 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”) ofthe 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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00010
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 11 of 38 PagelD #: 1581
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 11 of 38 PageID #: 1581
`
`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. § 112(f), the identity ofthe structure(s), act(s),
`
`or material(s) in the Accused Instrumentality that performsthe claimed
`
`function;
`
`(d)
`
`For each claim alleged to have been indirectly infringed,
`
`an identification of any direct infringement and a description ofthe 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;
`
`1]
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00011
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 12 of 38 PagelD #: 1582
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 12 of 38 PageID #: 1582
`
`(f)|For anypatentthat claimspriority 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 ortheir 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 orjoint 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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00012
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 13 of 38 PagelD #: 1583
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 13 of 38 PageID #: 1583
`
`(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,
`
`whicheveris earlier; and
`
`(c)
`
`If Plaintiffs
`
`identify
`
`instrumentalities pursuant
`
`to
`
`paragraph 9(g) of this Order, documents sufficient
`
`to show the
`
`operation ofany 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
`
`documentas required by this paragraph shall not constitute an admission that
`
`such document evidencesoris prior art under 35 U.S.C. § 102.
`
`11.
`
`Responsesto Invalidity Contentions, Addition or Substitution of
`
`Asserted Claims or Prior Art and Amendmentof Contentions. Plaintiffs shall
`
`serve responses to Invalidity Contentions no later than December21, 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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00013
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 14 of 38 PagelD #: 1584
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 14 of 38 PageID #: 1584
`
`December 1, 2023 without leave of the Court. Any final amendment of or
`
`supplement to the Noninfringement Contentions shall be made nolater than
`
`December 15, 2023 without leave of the Court. Any final amendmentofor
`
`supplement to the Responses to Invalidity Contentions shall be made nolater
`
`than December 15, 2023 without leave of the Court. The addition or
`
`substitution of asserted claims or prior art and the amendment of the
`
`Noninfringement Contentions,
`
`Invalidity Contentions,
`
`Infringement
`
`Contentions, Responsesto 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 ofgood cause. A request to add an asserted claim willlikely
`
`only be granted if Plaintiffs drop a claim or claims previously asserted. A
`
`request to add an assertedprior art reference will likely only be granted if the
`
`Defendant Group dropsaprior 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 fulsomeinitial disclosures and
`
`contentions no later than the deadlines set out herein.
`
`14
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00014
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 15 of 38 PagelD #: 1585
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 15 of 38 PageID #: 1585
`
`12.
`
`Joinder_of Other Parties and Amendment of Pleadings. All
`
`motionsto join other parties, and to amend or supplementthe 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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00015
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 16 of 38 PagelD #: 1586
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 16 of 38 PageID #: 1586
`
`(e)
`
`Requests for Production. The parties do not believe
`
`that a numeric limitation is required on requests for production
`
`at this time. Defendants agreeto 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 documentsas business recordsshall
`
`not count against a party’s requests for admissionslimit.
`
`(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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00016
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 17 of 38 PagelD #: 1587
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 17 of 38 PageID #: 1587
`
`interrogatories on Plaintiffs. Plaintiffs may additionally serve up
`
`to 15 individualized interrogatories on each Defendant Group.
`
`(h)
`
`Depositions.
`
`1.
`
`Limitations on Deposition Discovery. The
`
`parties are limited as follows relating to fact witnesses,
`
`with testimony provided under FED. R. CIv. P. 30(b)(6)
`
`counting as a single deposition per notice and no single
`
`deposition lasting more than 7 hours on the record, except
`
`that any deposition of a witness testifying in a foreign
`
`language may last no more than 12 hours on the record.
`
`The time limits in this section apply regardless of whether
`
`the witness is being deposed in a personal capacity, as a
`
`30(b)(6) designee, or both. Each fact witness may be
`
`deposed only once absent a showing of good cause. The
`
`deposition of a single person in both the person’s personal
`
`capacity and as a 30(b)(6) designee shall countas a single
`
`deposition. Plaintiffs shall be permitted 5 fact depositions
`
`upon oral
`
`examination of each Defendant Group,
`
`excluding depositions of non-parties.|Defendants,
`
`17
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00017
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 18 of 38 PagelD #: 1588
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 18 of 38 PageID #: 1588
`
`collectively, shall be permitted 18 fact depositions upon
`
`oral examination of Plaintiffs, excluding depositions of
`
`non-parties. Plaintiffs shall identify which inventors on
`
`the patents-in-suit are employed or otherwise represented
`
`by Plaintiffs no later than January 19, 2023.
`
`2.
`
`Location of Depositions. Any party or
`
`representative (officer, director, or managing agent) of a
`
`party filing a civil action in this District Court must
`
`ordinarily be required, upon request,
`
`to submit
`
`to a
`
`deposition at a place designated within this District, unless
`
`the parties mutually agree upon a location for
`
`the
`
`deposition outside of this District. A Defendant who
`
`becomes a counterclaimant, cross-claimant, or third-party
`
`plaintiff shall be considered as having filed an action in
`
`this Court for the purpose of this provision. Exceptionsto
`
`these general rules may be made by order of the Court or
`
`by agreementofthe parties.
`
`The parties agree that, by June 5, 2023, they will
`
`meet and confer
`
`to reach agreement on whether
`
`18
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00018
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 19 of 38 PagelD #: 1589
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 19 of 38 PageID #: 1589
`
`depositions will be conducted in-person or be conducted
`
`remotely, in view of the ongoing COVID-19 pandemic.
`
`During the meet and confer,
`
`the parties will
`
`reach
`
`agreement on how to handle exhibits at any depositions
`
`that are conducted remotely. Should the parties agree to
`
`conduct depositions remotely, Zoom or other similar
`
`methodswill be used, and the parties will work together to
`
`set a reasonable time for the deposition in view of the
`
`normal business hours of the deponent.
`
`3.
`
`Any witness who refuses to appear for a
`
`deposition shall not be allowed to testify at any
`
`proceeding,hearingortrial.
`
`4.
`
`Parties must make all witnesses who are
`
`identified to testify at any proceeding, hearing ortrial,
`
`available for a deposition sufficiently in advance of the
`
`scheduled testimony.
`
`5.
`
`If a witness will testify in a foreign language
`
`for any deposition, the party producing said witness shall
`
`inform the party taking the deposition of that fact at least
`
`19
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00019
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 20 of 38 PagelD #: 1590
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 20 of 38 PageID #: 1590
`
`two weeksprior to the date ofthe deposition,orat the time
`
`the deposition is scheduledif it is less than two weeks in
`
`advance.
`
`14.
`
`Pinpoint Citations. Pinpointcitations are requiredin all briefing,
`
`letters, and concise statements of facts. The Court will ignore any assertions
`
`of controverted facts and controverted legal principles not supported by a
`
`pinpoint citation to, as applicable: the record, an attachmentor exhibit, and/or
`
`case law or appropriate legal authority. See United States v. Dunkel, 927 F.2d
`
`955, 956 (7th Cir. 1991) (“Judges are notlike pigs, hunting for truffles buried
`
`in briefs.”).
`
`15. Application to Court for Protective Order. Counselbelieve it will
`
`be necessary to apply to the Court for a protective order specifying terms and
`
`conditions for the disclosure of confidential information. Counsel will confer
`
`and attempt to reach an agreement on a proposed form oforder and submitit
`
`to the Court on or before 21 days after entry of the Scheduling Order.
`
`Any proposedprotective order must include the following paragraph:
`
`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
`
`20
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00020
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 21 of 38 PagelD #: 1591
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 21 of 38 PageID #: 1591
`
`party subject to this Order who becomes
`subject to a motionto disclose anotherparty’s
`information
`designated
`as
`confidential
`pursuant to this Order shall promptly notify
`that party of the motionsothat the party may
`have an opportunity to appear and be heard
`on whether
`that
`information should be
`disclosed.
`
`16. Disputes Relating to Discovery Matters and Protective Orders.
`
`Should counsel find that they are unable to resolve a dispute relating to a
`
`discovery matter or protective order, the parties shall contact the Court’s Case
`
`Managerto schedule an in-person conference/argument.
`
`(a)
`
`Unless otherwise ordered, by no later than 72 hours
`
`prior to the conference/argument, the party seeking relief shall
`
`file with the Court a letter, not to exceed three pages, outlining
`
`the issues in dispute and the party’s position on those issues. The
`
`party shall submit as attachmentsto its letter (1) an averment of
`
`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
`
`for the Court’s signature that identifies with specificity the relief
`
`sought by the party. The party shall file concurrently with its
`
`21
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00021
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 22 of 38 PagelD #: 1592
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 22 of 38 PageID #: 1592
`
`letter a motion that in no more than one paragraphsets forth the
`
`relief sought.
`
`(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 reasonsfor its opposition.
`
`(c)
`
`Two hard copies of the parties’
`
`letters and
`
`attachments must be provided to the Court within one hourofe-
`
`filing the document(s). The hard copies shall comply with
`
`paragraphs 14 and 18 of this Order.
`
`(d)
`
`If a motion concerning a discovery matter or
`
`protective orderis 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 proceduresset
`
`forth in this paragraph.
`
`17.
`
`Papers Filed Under Seal. Whenfiling papers under seal, counsel
`
`shall deliver to the Clerk an original and two copies of the papers. A redacted
`
`22
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00022
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 23 of 38 PagelD #: 1593
`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 23 of 38 PageID #: 1593
`
`version of any sealed documentshall befiled electronically within seven days
`
`of the filing of the sealed document.
`
`18. Hard Copies. The parties shall provide to the Court two hard
`
`copies ofall letters filed pursuant to paragraph 16 ofthis Order,all briefs, and
`
`any other documents filed in support of any such letters and briefs. This
`
`provision also applies to papers filed underseal.
`
`a.
`
`Exhibits and Attachments. Each exhibit and attachment
`
`to a letter, brief, or pretrial order shall be separated by a tab.
`
`(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 somesort such that a particular page of an
`
`exhibit or attachment can be identified by a page number. Theparties
`
`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
`
`encouragedto include in an exhibit or attachment only the pagesofthe
`
`documentin 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
`
`Novo Nordisk Exhibit 2006
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00023
`
`

`

`Case 1:22-cv-00299-CFC Document 22 Filed 06/30/22 Page 24 of 38 PagelD

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