Case 1:23-cv-00013-TSK Document 38 Filed 06/28/23 Page 1 of 11 PageID #: 426
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`Plaintiffs,
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`v.
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`VIATRIS INC. and
`MYLAN PHARMACEUTICALS INC.,
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`)
`)
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`) C.A. No. 23-cv-13
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`JOINT REPORT OF INITIAL PLANNING MEETING
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`Defendants.
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`Pursuant to the Federal Rules of Civil Procedure 16 and 26(f), Local Rules of Civil
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`Procedure 16.01(b) and (c), and the Court’s First Order and Notice Regarding Discovery and
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`Scheduling dated April 3, 2023 (Dkt. No. 27) as amended by the Order Extending Deadlines dated
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`May 18, 2023 (Dkt. No. 32), Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S (collectively,
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`“Novo Nordisk” or “Plaintiffs”) and Defendants Viatris Inc. (“Viatris”) and Mylan
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`Pharmaceuticals Inc. (“MPI”) (collectively, “Defendants”) submit this Joint Report of Initial
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`Planning Meeting.1 The parties represent as follows:
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`1 Plaintiffs’ Position: Due to the overlap between this case and the Wegovy® Delaware Action as
`well as the various Ozempic® matters in Delaware (see Section 2.c below), and in order to
`conserve both judicial and party resources and to avoid multiple trials on the same patents, the
`parties are discussing a stipulation relating to streamlining litigation and ultimately having a single
`trial of the patents-in-suit to be tried in the District of Delaware instead of this District. As Plaintiffs
`have made clear to Defendants, Plaintiffs will dismiss this action after there is finalized agreement.
`Plaintiffs expect the parties are close and will reach resolution shortly, after which Plaintiffs expect
`to dismiss this action.
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`Defendants’ Position: Defendants have answered the complaint filed by Plaintiffs in the Delaware
`Wegovy Action asserting the identical patents against identical products. Plaintiffs have requested
`that the litigation proceed in Delaware, and Defendants have repeatedly represented to Plaintiffs
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`1
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`

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`Case 1:23-cv-00013-TSK Document 38 Filed 06/28/23 Page 2 of 11 PageID #: 427
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`1. Initial Planning Meeting
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`The parties’ counsel met and conferred by telephone on June 12, 2023. The parties
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`discussed matters required by Federal Rules of Civil Procedure 16 and 26(f) and Local Civil Rule
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`16.01(b). The participants were:
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`i.
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`James Companion of Schrader Companion Duff & Law, PLLC, and Jenny C. Wu
`of Groombridge, Wu, Baughman & Stone LLP, representing Novo Nordisk; and
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`ii.
`Brandon White of Perkins Coie LLP, representing Defendants.
`2. Fed. R. Civ. P. 26(f) Discovery Plan
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`a. Initial Disclosures
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`The parties served their initial disclosures pursuant to Federal Rule of Civil Procedure
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`26(a)(1) on June 5, 2023.
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`b. Subjects on Which Discovery May Be Needed
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`This is an action for patent infringement brought under the patent laws of the United States
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`and the Hatch-Waxman Act. Defendant Mylan Pharmaceuticals Inc. (“MPI”) filed Abbreviated
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`New Drug Application No. 217705 (“MPI’s ANDA”) with the United States Food and Drug
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`Administration (“FDA”) seeking approval to market semaglutide injection, 0.25 mg/0.5 mL, 0.5
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`mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL and 2.4 mg/0.75 mL, which is a generic version of
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`Plaintiffs’ Wegovy® drug product (“MPI’s Product”), prior to the expiration of United States
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`Patent Nos. 8,129,343 (the “’343 patent”), 8,536,122 (the “’122 patent”), 9,764,003 (the “’003
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`that Defendants will proceed in Delaware. To that end, Defendants appeared before the Delaware
`court at a scheduling conference on June 6, 2023. A scheduling order issued on June 21, 2023,
`ordering the parties to trial in Delaware in December 2024. Novo Nordisk Inc. and Novo Nordisk
`A/S v. Viatris Inc. and Mylan Pharmaceuticals Inc., 1:23-cv-00101-CFC (D. Del.), ECF. No. 27.
`Because Defendants are proceeding in Delaware, this duplicative case should be dismissed. Yet,
`despite Defendants’ repeated requests, Plaintiffs have refused to dismiss this action for reasons
`unknown to Defendants, and Plaintiffs’ insistence on maintaining this action is unnecessarily
`wasting the Court’s and parties’ resources.
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`2
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`

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`Case 1:23-cv-00013-TSK Document 38 Filed 06/28/23 Page 3 of 11 PageID #: 428
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`patent”), 10,888,605 (the “’605 patent”), and 11,318,191 (the “’191 patent”) (collectively, the
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`“patents-in-suit”).
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`Discovery is needed on at least the following matters:
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`i.
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`ii.
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`Defendants’ infringement or non-infringement of the patents-in-suit; and
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`Validity or invalidity of the patents-in-suit.
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`c. Co-Pending Litigations Involving Certain Patents-in-Suit
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`All the patents-in-suit are currently the subject of ongoing litigation between Plaintiffs and
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`Defendants in the District of Delaware with respect to MPI’s ANDA and MPI’s Product (the
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`“Wegovy® Delaware Action”).2 Plaintiffs filed the Wegovy® Delaware Action on January 27,
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`2023, and Defendants answered and counterclaimed on March 31, 2023. The court in the Wegovy®
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`Delaware Action entered a full schedule on June 21, 2023. Novo Nordisk Inc. and Novo Nordisk
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`A/S v. Viatris Inc. and Mylan Pharmaceuticals Inc., 1:23-cv-00101-CFC (D. Del.), ECF. No. 27.
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`The ’343 and ’122 patents (collectively, the “Compound Patents”) are both the subject of
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`this litigation and a separate litigation between Plaintiffs and MPI with respect to Plaintiffs’
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`Ozempic® drug product (the “MPI Ozempic® Action”). The MPI Ozempic® Action was originally
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`filed in this District and has been transferred to the District of Delaware as part of a Multidistrict
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`Litigation (the “Ozempic® MDL”) captioned In re: Ozempic (Semaglutide) Patent Litigation,
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`MDL No. 22-md-3038 (CFC) (D. Del.).3 Plaintiffs filed the MPI Ozempic® Action on March 18,
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`2022, and MPI answered and counterclaimed on April 8, 2022.
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`2 The case is captioned Novo Nordisk Inc. and Novo Nordisk A/S v. Viatris Inc. and Mylan
`Pharmaceuticals Inc., 1:23-cv-00101-CFC (D. Del.).
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`3 The case as filed in this District is captioned Novo Nordisk Inc. and Novo Nordisk A/S v. Mylan
`Pharmaceuticals Inc., 1:22-cv-00023-JPB (N.D.W. Va.), and upon transfer to the District of
`Delaware was renumbered as 1:22-cv-01040-CFC (D. Del.).
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`3
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`Case 1:23-cv-00013-TSK Document 38 Filed 06/28/23 Page 4 of 11 PageID #: 429
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`The Compound Patents are also the subject of five separate litigations between Plaintiffs
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`and five other ANDA filers in the District of Delaware with respect to Plaintiffs’ Ozempic® drug
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`product (collectively, “Ozempic® Delaware Actions”),4 which have been consolidated with the
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`transferred MPI Ozempic® Action as part of the Ozempic® MDL. Plaintiffs filed the Ozempic®
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`Delaware Actions on March 4, 2022, and all defendants in those actions responded to the
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`complaints on or before May 9, 2022.
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`d. Proposed Case Schedules
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`While Defendants are proceeding in Delaware, and Defendants’ position is that there
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`should be no need for Plaintiffs to maintain this action, should the case proceed in this District, the
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`parties propose the following schedules for discovery, pretrial disclosures, and trial.
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`Event
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`Novo Nordisk’s Proposed
`Deadline
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`Defendants’
`Proposed
`Deadline
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`June 5, 2023
`March 1, 2023
`21 days after entry of a full Scheduling Order
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`Rule 26(a)(1) Initial Disclosures
`MPI’s production of MPI’s ANDA5
`Motion for Joint Protective Order
`Defendants’ disclosure of
`noninfringement contention,
`invalidity contentions, and
`preliminary disclosure of asserted
`prior art and accompanying
`production (see section 2(h) infra)
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`4 The cases pending in the District of Delaware include: Novo Nordisk Inc. and Novo Nordisk A/S
`v. Rio Biopharmaceuticals, Inc. and EMS S/A, 1:22-cv-00294-CFC (D. Del.); Novo Nordisk Inc.
`and Novo Nordisk A/S v. Sun Pharmaceutical Industries Ltd. and Sun Pharmaceuticals Industries,
`Inc., 1:22-cv-00296-CFC (D. Del.); Novo Nordisk Inc. and Novo Nordisk A/S v. Zydus Worldwide
`DMCC, Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd., 1:22-cv-00297-CFC (D.
`Del.); Novo Nordisk Inc. and Novo Nordisk A/S v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`Laboratories, Inc., 1:22-cv-00298-CFC (D. Del.); and Novo Nordisk Inc. and Novo Nordisk A/S v.
`Alvogen, Inc., 1:22-cv-00299-CFC (D. Del.).
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`June 22, 2023
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`5 MPI produced MPI’s ANDA to Plaintiffs in the context of the Wegovy® Delaware Action.
`Pending entry of a protective order or other agreement between the Parties, any discovery materials
`produced in this case, including MPI’s ANDA, will be produced on an Outside Counsel’s Eyes
`Only basis.
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`4
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`Event
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`Novo Nordisk’s Proposed
`Deadline
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`Defendants’
`Proposed
`Deadline
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`August 4, 2023
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`November 10, 2023
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`November 17, 2023
`March 1, 2024
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`March 8, 2024
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`July 11, 2023
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`July 21, 2023
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`July 31, 2023
`August 24, 2023
`September 21, 2023
`October 12, 2023
`November 2, 2023
`TBD at the Court’s convenience
`Expert Discovery
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`Plaintiffs’ disclosure of infringement
`contentions, responses to invalidity
`contentions, and accompanying
`production (see section 2(h) infra)
`Substantial completion of document
`production
`Last day to move to join parties or
`amend the pleadings
`Close of fact discovery
`Final deadline to supplement
`infringement and invalidity
`contentions
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`Parties exchange proposed terms for
`claim construction
`Parties exchange preliminary
`proposed constructions for disputed
`terms and identify intrinsic evidence
`support
`Parties file a joint claim construction
`statement
`Plaintiffs’ Opening Markman Brief
`Defendants’ Response Markman
`Brief
`Plaintiffs’ Reply Markman Brief
`Defendants’ Surreply Markman Brief
`Markman Hearing
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`Claim Construction
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`Opening expert reports on issues for
`which the party bears the burden of
`proof
`Responsive/rebuttal expert reports
`Reply expert reports
`Close of expert discovery
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`Dispositive Motions under Fed. R.
`Civ. P. 56
`Responses to Dispositive Motions
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`April 19, 2024
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`May 31, 2024
`June 21, 2024
`August 9, 2024
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`Dispositive Motions
`Novo Nordisk proposes that
`dispositive motions under Rule 56
`are unnecessary in this bench trial
`and the parties should seek leave
`of the Court before filing
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`No later than
`August 30, 2024
`3 weeks after the
`filing of any
`dispositive
`motion
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`5
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`Event
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`Novo Nordisk’s Proposed
`Deadline
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`Replies to Dispositive Motions
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`Defendants’
`Proposed
`Deadline
`2 weeks after the
`filing of any
`dispositive
`motion
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`Pretrial and Trial
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`Motions in limine and Daubert
`Motions
`Responses to Motions in limine and
`Daubert Motions
`Replies to Motions in limine and
`Daubert Motions
`Pretrial Disclosures, Fed. R. Civ. P.
`26(a)(3)
`Objections to Fed. R. Civ. P. 26(a)(3)
`Disclosures
`Biographical Sketches
`Joint Proposed Pretrial Order and
`Stipulation of Facts
`Final Pretrial/Settlement Conference
`Trial
`Deadline for Proposed Findings of
`Fact and Conclusions of Law,
`including Opening and Responsive
`Post-Trial Briefing
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`August 16, 2024
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`August 30, 2024
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`September 6, 2024
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`October 9, 2024
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`October 30, 2024
`October 30, 2024
`No later than 10 days before the pretrial conference
`TBD at the Court’s convenience
`5 days in January 2025 or at the Court’s convenience
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`Miscellaneous Dates
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`TBD
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`N/A
`June 17, 2025
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`Mediation
`Regulatory Stay Deadline
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`e. Phasing
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`Except as described above, with a discrete fact discovery period occurring and closing
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`before beginning a discrete expert discovery period, the parties agree that discovery does not need
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`to be conducted in any other phases.
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`f. Issues Regarding Disclosure, Discovery, or Preservation of Electronically Stored
`Information
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`The parties agree that entry of a protective order is necessary to protect the confidentiality
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`of sensitive business information that may be exchanged during discovery. The parties intend to
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`6
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`meet and confer on the provisions of a proposed protective order and will submit the order to the
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`Court for consideration within 21 days of the entry of a full Scheduling Order.
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`g. Limitations on Discovery
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`Except as expressly set forth below, the parties agree that no deviation from the Federal
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`Rules of Civil Procedure is required with respect to interrogatories, requests for admission,
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`requests for production, or depositions.
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`Unless extended by agreement of the parties or by order of the Court, each individual
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`deposition for witnesses testifying in English shall be limited to a maximum of 7 hours on the
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`record and the parties shall confer on the length of any deposition of a witness testifying in a
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`foreign language. Plaintiffs shall be permitted 5 fact depositions upon oral examination of
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`Defendants, excluding depositions of non-parties. Defendants shall be permitted 14 fact
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`depositions upon oral examination of Plaintiffs, excluding depositions of non-parties. Expert
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`depositions do not count against these limits on fact depositions. A Rule 30(b)(6) notice shall count
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`as a single deposition regardless of how many designees the party receiving the notice provides in
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`response to such notice.
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`Any witness who refuses to appear for a deposition shall not be allowed to testify at any
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`proceeding, hearing, or trial. Parties must make all witnesses who are identified to testify at any
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`proceeding, hearing, or trial, available for a deposition sufficiently in advance of the scheduled
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`testimony.
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`If a witness will testify in a foreign language for any deposition, the party producing said
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`witness shall inform the party taking the deposition of that fact at least two weeks prior to the date
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`of the deposition, or at the time the deposition is scheduled if it is less than two weeks in advance.
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`7
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`h. Discovery Accompanying Contentions
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`i. Discovery Accompanying Infringement Contentions: Plaintiffs shall produce a
`copy of the file history for each asserted patent; all documents evidencing
`ownership of the asserted patent rights by Plaintiffs; all agreements, including
`licenses, transferring an interest in any asserted patent; all documents (e.g.,
`contracts, purchase orders, invoices, advertisements, marketing materials, offer
`letters, beta site testing agreements, licenses, 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, each claimed invention prior to the date of application for each asserted
`patent; and 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 claimed priority date(s), whichever is
`earlier; and documents sufficient to show that Plaintiffs’ own product practices the
`claimed invention, to the extent Plaintiffs wish to rely on such assertion.
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`ii. Discovery Accompanying Invalidity Contentions: Defendant shall produce a copy
`or sample of each asserted prior art reference that does not appear in the file history
`of the asserted patents. To the extent any such item is not in English, an English
`translation of the portion(s) relied upon shall be produced; and
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`3. Topics Discussed Pursuant to Local Rule 16.01(b)
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`a. Complex Case Monitoring
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`The parties do not believe this case should be designated as complex, and do not consider
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`it necessary for the Court to schedule periodic telephonic status conferences. However, the parties
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`are available for such status conferences should the Court find them helpful.
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`b. Disputed Facts
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`Other than the admissions contained in Defendants’ Answer to Plaintiffs’ Complaint and
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`in Plaintiffs’ Answer to Defendants’ Counterclaims, the parties are unable to agree upon disputed
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`facts that have been alleged with particularity in the pleadings.
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`c. Magistrate Judge
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`The parties do not consent to trial by magistrate judge.
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`d. Alternative Dispute Resolution
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`The parties have considered alternative dispute resolution and do not believe it will be
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`beneficial at this time. The parties do not wish the Court to schedule the matter for early mediation.
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`The parties agree to revisit the issue later as appropriate.
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`e. Electronic Discovery
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`The parties intend to meet and confer on the provisions of a stipulated order regarding the
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`discovery of electronically stored information and will submit the order to the Court for
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`consideration within 21 days of the entry of a full Scheduling Order.
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`f. Agenda for Scheduling Conference
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`The parties propose discussing the proposed schedules set forth in this report at the
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`scheduling conference.
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`4. Other Items
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`a. Service of Documents
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`The parties agree that service of documents may occur via email and all service and filing
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`deadlines will be 5:00 p.m. Eastern time unless otherwise stated or specifically agreed by the
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`parties.
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`b. Attendance of Local Attorney at Depositions
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`Pursuant to Local Rule 83.02(b), the parties request that West Virginia counsel be
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`permitted to attend depositions by telephone or videoconference.
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`9
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`Case 1:23-cv-00013-TSK Document 38 Filed 06/28/23 Page 10 of 11 PageID #: 435
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`Dated: June 28, 2023
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`Respectfully submitted,
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`SCHRADER COMPANION DUFF & LAW, PLLC
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`/s/ James F. Companion
`James F. Companion (#790)
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
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`Attorneys for Novo Nordisk Inc.
`and Novo Nordisk A/S
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`OF COUNSEL:
`Nicholas Groombridge
`Josephine Young
`Peter Sandel
`Jenny Wu
`Daniel Klein
`Naz E. Wehrli
`Joshua Reich
`Scott Miller
`GROOMBRIDGE, WU, BAUGHMAN
`& STONE LLP
`565 Fifth Ave, Suite 2900
`New York, NY 10017
`(332) 269-0030
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`Attorneys for Novo Nordisk Inc.
`and Novo Nordisk A/S
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`PERKINS COIE LLP
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`/s/ Brandon M. White
`Brandon M. White (WV Bar #14021)
`700 13th Street NW, Suite 800
`Washington, DC 20005
`Phone: (202) 654-6200
`BMWhite@PerkinsCoie.com
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`Attorneys for Defendants Viatris Inc. and
`Mylan Pharmaceuticals Inc.
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`10
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`Case 1:23-cv-00013-TSK Document 38 Filed 06/28/23 Page 11 of 11 PageID #: 436
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`CERTIFICATE OF SERVICE
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`I hereby certify that on June 28, 2023, I electronically filed the foregoing “JOINT
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`REPORT OF INITIAL PLANNING MEETING” with the Clerk of the Court using the
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`CM/ECF system, which will send notice of same to counsel of record.
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`/s/ Brandon M. White
`Brandon M. White (WV Bar #14021)
`700 13th Street NW, Suite 800
`Washington, DC 20005
`Phone: (202) 654-6200
`BMWhite@PerkinsCoie.com
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`Attorney for Defendants Viatris Inc. and Mylan
`Pharmaceuticals Inc.
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`11
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