Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 1 of 22 PageID #: 3006
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`Defendant.
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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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`MYLAN PHARMACEUTICALS INC.,
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`) C.A. No. 22-cv-23-JPB
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`JOINT REPORT OF INITIAL PLANNING MEETING
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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 March 28, 2022 (Dkt. No. 8), Plaintiffs Novo Nordisk Inc. and Novo Nordisk
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`A/S (collectively, “Novo Nordisk” or “Plaintiffs”) and Defendant Mylan Pharmaceuticals Inc.
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`(“MPI” or “Defendant”) submit this Joint Report of Initial Planning Meeting. The parties represent
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`as follows:
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`1. Initial Planning Meeting
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`The parties’ counsel met and conferred by telephone on April 25, 2022. 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 Jeffrey J.
`Oelke and Laura T. Moran of Fenwick & West LLP, representing Novo Nordisk;
`and
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`ii.
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`Brandon White of Perkins Coie LLP, representing MPI.
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`1
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 2 of 22 PageID #: 3007
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`2. Fed. R. Civ. P. 26(f) Discovery Plan
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`a. Initial Disclosures
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`The parties will complete initial disclosures pursuant to Federal Rule of Civil Procedure
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`26(a)(1) by May 23, 2022.
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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. MPI filed Abbreviated New Drug Application No. 216991 (“MPI’s
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`ANDA”) with the United States Food and Drug Administration (“FDA”) seeking approval to
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`market semaglutide injection (2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml)), which is a
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`generic version of Plaintiffs’ Ozempic® drug product (“MPI’s Product”), prior to the expiration of
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`United States Patent Nos. 8,114,833 (the “’833 patent”), 8,129,343 (the “’343 patent”), 8,536,122
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`(the “’122 patent”), 8,684,969 (the “’969 patent”), 8,920,383 (the “’383 patent”), 9,108,002 (the
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`“’002 patent”), 9,132,239 (the “’239 patent”), 9,457,154 (the “’154 patent”), 9,616,180 (the “’180
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`patent”), 9,687,611 (the “’611 patent”), 9,775,953 (the “’953 patent”), 9,861,757 (the “’757
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`patent”), 10,220,155 (the “’155 patent”), 10,335,462 (the “’462 patent”), 10,357,616 (the “’616
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`patent”), 10,376,652 (the “’652 patent”), 11,097,063 (the “’063 patent”), and RE46,363 (the “’363
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`patent”) (collectively, the “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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`iii.
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`MPI’s infringement or non-infringement of the patents-in-suit;
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`Validity or invalidity of the patents-in-suit; and
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`The listing of certain patents-in-suit in the FDA publication, “Approved Drug
`Products with Therapeutic Equivalence Evaluations” (the “Orange Book”).
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`2
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 3 of 22 PageID #: 3008
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`c. Co-pending Litigations Involving Certain Patents-in-Suit
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`MPI is one of six ANDA-filers currently challenging at least some of the patents that are
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`listed in the Orange Book with respect to Plaintiffs’ Ozempic® drug product. The other five
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`ANDA-filers are defendants in cases pending in the District of Delaware (collectively, the
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`“Ozempic® Delaware Actions”), each of which involves some of the patents that are asserted
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`against MPI in this case1. Plaintiffs filed the Ozempic® Delaware Actions on March 4, 2022, and
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`all defendants in those actions responded to the complaints on or before May 9, 2022.
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`Additionally, fifteen of the patents-in-suit are the subject of a lawsuit in the District of
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`Delaware involving Plaintiffs’ Saxenda® drug product, which contains a different active ingredient
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`(liraglutide) than Ozempic®, but uses the same device as Ozempic® (FlexTouch®) for the branded
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`product. See Novo Nordisk Inc. et al. v. Teva Pharmaceuticals, Inc. et al., 21-cv-01782-CFC (D.
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`Del.) (the “Saxenda® Action”). A scheduling conference is scheduled in the Saxenda® Action on
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`May 12, 2022.
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`Finally, one of the patents-in-suit, the ’833 patent, is the subject of a lawsuit in the District
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`of Delaware involving Plaintiffs’ Victoza® drug product, which also contains the active ingredient
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`liraglutide. See Novo Nordisk Inc. et al. v. Hikma Pharmaceuticals USA Inc., 21-cv-01783-CFC
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`1 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.). Judge Connolly has requested Novo Nordisk’s
`position on whether consolidation, at least for discovery and Markman proceedings, is needed.
`See, e.g., C.A. No. 1:22-cv-00294, Dkt. No. 15 (D. Del. May 11, 2022). Novo Nordisk will submit
`that consolidation is needed. None of the Delaware generic defendants have indicated to the
`contrary, and Novo Nordisk anticipates that the Ozempic® Delaware Actions will be consolidated.
`Details of the patents asserted in each case are provided in tables below.
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`3
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 4 of 22 PageID #: 3009
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`(D. Del.) (the “Victoza® Action”). A schedule was entered in the Victoza® Action on May 5, 2022.
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`Several previous matters regarding the Plaintiffs’ Victoza® drug product and the ’833 patent have
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`been settled.
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`d. Proposed Case Schedules
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`Novo Nordisk’s Position: Novo Nordisk seeks to consolidate this case and the Ozempic®
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`Delaware Actions for coordinated and consolidated pretrial proceedings before the United States
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`Judicial Panel on Multidistrict Litigation (“MDL Panel”) because this case shares numerous
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`questions of fact with the Ozempic® Delaware Actions. See Dkt. No. 22 (“Plaintiffs’ MDL
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`Motion”). All six actions concern a common issue: whether the generic Defendants’ ANDA
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`Products infringe valid and enforceable claims of patents listed in the Orange Book for Ozempic®.
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`In addition, claim construction of terms in the asserted patents and listability in the Orange Book
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`of certain asserted patents will be common across actions. Accordingly, consolidation would serve
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`the convenience of the parties and witness and promote the just and efficient conduct of the actions.
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`While MPI will stress that eight patents at-issue here are not presently at-issue in the
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`Delaware Actions, this does not undermine the efficiency, consistency, and convenience benefits
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`of transfer and consolidation.2 Half of the patents asserted here, but not in the Ozempic® Delaware
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`Actions, belong to patent families that are already at-issue in the Ozempic® Delaware Actions. A
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`patent family is a group of patents that trace their lineage back to the same “priority application.”
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`Such patents concern related inventions and have very similar, if not identical, specifications and
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`closely related claims. Accordingly, patents within the same family present highly similar
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`litigation issues (e.g., discovery, claim construction, infringement, and validity defenses).
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`2 Novo Nordisk notes that it was MPI, and not Novo Nordisk, who decided which Orange Book
`listed patents for Ozempic® MPI would challenge, and therefore which patents would be asserted
`in this litigation.
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`4
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 5 of 22 PageID #: 3010
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`Moreover, the four patents-at-issue in this case whose family members are not already at-issue in
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`the Ozempic® Delaware Actions are already before the District of Delaware’s Chief Judge
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`Connolly in the Saxenda® Action (which involves 15 of the 18 patents-in-suit here). In other words,
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`all of the patent families at-issue here are already before the District of Delaware, by virtue of the
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`Ozempic® Delaware Actions and the Saxenda® Action. The below chart illustrates the overlap in
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`patent families between this case, the Ozempic® Delaware Actions, and the Saxenda® Action.
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`While the patents at-issue in each action are not identical, the overlap in patent families is
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`complete, and therefore this case will present questions of fact that are common with actions
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`pending in Delaware.
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`Mylan incorrectly argues that “Plaintiffs have made this case primarily about injection
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`devices.” To the contrary, this case is very much about semaglutide, which is the novel chemical
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`compound that is the active ingredient in Ozempic®. Semaglutide is protected by the ’343 patent,
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`which does not expire until 2031. The ’343 patent will therefore be a critical part of all cases in
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`which the generic defendant seeks to enter the market with its product prior to 2031 by challenging
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`5
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 6 of 22 PageID #: 3011
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`the validity and/or infringement of the ’343 patent. Mylan chose to challenge eight patents not
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`challenged by any other defendant. Those eight patents are the earliest-expiring of the challenged
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`patents, and include one formulation patent expiring by August 2025, six device patents expiring
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`by January 2026, and one compound patent expiring by March 2026. Mylan’s choice has no
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`bearing on the key role that the chemical compound semaglutide and the ’343 patent will play in
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`this case and in the Ozempic® Delaware Actions, despite Mylan’s efforts to highlight the earlier-
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`expiring patents as a point of differentiation.
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`Because the MDL Panel regularly grants requests for consolidation of Hatch-Waxman
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`litigations like this one,3 including at least six Hatch-Waxman cases since 2019 that were filed
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`against MPI in West Virginia and consolidated with Delaware cases, it would be premature and
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`inefficient to set a complete schedule for this case before the MDL Panel rules on Plaintiffs’ request
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`for transfer and consolidation. Plaintiffs propose that the parties begin to exchange initial
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`disclosures, contentions, and accompanying productions (the deadlines for which the parties agree)
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`while awaiting a decision on Plaintiffs’ MDL Motion. If the MDL Panel denies Plaintiffs’ request
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`3 The Panel has repeatedly acknowledged that transfer and consolidation of Hatch-Waxman cases
`promotes their “just and efficient” conduct as “actions involving the validity of complex
`pharmaceutical patents and the entry of generic versions of the patent holder’s drugs are
`particularly well-suited for transfer under Section 1407.” In re Nebivolol (’040) Patent Litig., 867
`F. Supp. 2d 1354, 1355 (J.P.M.L. 2012) (quoting In re Alfuozosin Hydrochloride Patent Litig.,
`560 F. Supp. 2d 1372, 1372 (J.P.M.L. 2008)). MPI cites In re Sumatriptan Succinate Pat. Litig.,
`381 F. Supp. 2d 1378 (J.P.M.L. 2005) to argue that centralization of Hatch-Waxman litigations is
`not “automatic.” In re Sumatriptan is readily distinguishable as the actions sought to be
`consolidated were at very different stages. Id.at 1378-79 (“the consolidated New York action has
`been pending for almost two years”) (emphasis added). Here the cases sought to be consolidated
`are at the same stage, having been filed only two weeks apart. In re JumpSport, Inc., (’845 &
`’207) Pat. Litig., 338 F. Supp. 3d 1356 (J.P.M.L. 2018), which MPI also cites, is similarly
`distinguishable. See id. at 1357 (“While there are circumstances where centralization of advanced
`patent infringement actions with newer actions will result in significant efficiencies, they are not
`present in this litigation.”) (emphasis added). Neither case suggests that consolidation is unlikely
`here or contradicts the many cases indicating that consolidation is appropriate under circumstances
`like these.
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`6
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 7 of 22 PageID #: 3012
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`for transfer and consolidation, the parties can request that the Court set a schedule for the remainder
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`of the case at that time.
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`Should the Court prefer to enter a full schedule prior to the MDL Panel’s decision, Plaintiffs
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`have proposed the below schedule for the Court’s consideration. Plaintiffs’ schedule allows the
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`time necessary for discovery on complex issues of pharmaceutical patent infringement and validity
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`by fully utilizing the time allotted under the Hatch-Waxman Act per the length of regulatory stay,
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`which in this case runs until June 5, 2025. In particular, this case involves distinct patented
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`inventions, including chemical compounds, formulations, injection devices, and methods of
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`treatment. Discovery in a case of this scope, involving varied subject matter, foreign witnesses,
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`and documents to be collected and produced from Denmark, will necessarily take time. Plaintiffs’
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`proposed schedule for fact discovery—calling for a substantial completion of production by June
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`2023 and a close of fact discovery in September 2023—will allow the necessary time for both
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`sides to collect, review, and produce documents from numerous sources concerning the products
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`and the inventions at-issue in this case. Plaintiffs’ proposed discovery deadlines will also allow
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`the time needed to review incoming productions and depose witnesses. Plaintiffs’ proposed
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`December 2024 trial date is well in advance of the anticipated expiration of the regulatory stay of
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`FDA approval of MPI’s generic product on June 5, 2025, allowing six months for the Court to
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`prepare and issue a decision before expiration of the regulatory stay.4 MPI’s proposed schedule,
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`4 MPI notes that the regulatory stay can expire prior to June 5, 2025 if the court reaches a decision
`on the merits of the patents prior to that date. 21 U.S.C. § 355(j)(5)(B)(iii). However, in order for
`the Court to dissolve the regulatory stay prior to June 5, 2025, the Court would have to find in
`Mylan’s favor on all claims of all asserted patents. Accelerating the schedule for such a complex
`case based on this remote possibility would needlessly burden the Court and the parties. It would
`also run counter to the very purpose of the regulatory stay: to provide the parties to complex cases
`such as this one sufficient time to resolve their dispute before the launch of a generic version of
`the drug-at-issue substantially harms the market for the branded drug and exposes the generic to
`potentially enormous money damages.
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`7
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 8 of 22 PageID #: 3013
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`meanwhile, is unnaturally accelerated in view of the complexity of the case, which is evidenced
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`by its trial date nearly a full year before the FDA regulatory stay will expire. Mylan directs the
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`Court to the schedule entered in Biogen Int’l GmbH v. Mylan Pharm. Inc., Case No. 1:17-cv-116,
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`Dkt. No. 56 (N.D. W. Va.) to consider as a guide to “prior practice in Hatch-Waxman cases in the
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`Northern District of West Virginia.” The schedule in Biogen only highlights the accelerated
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`timeline that MPI proposes here, in a case involving three times as many patents as in Biogen.
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`MPI’s Proposal
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`Timelines (measured in months from complaint filing)
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`Substantial
`Completion of
`Production
`8.5 months
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`Close of Fact
`Discovery
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`13 months
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`Prior Hatch-Waxman
`Schedule (Biogen v. Mylan)
`Novo Nordisk’s Proposal
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`13 months
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`14.5 months
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`15 months
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`18 months
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`Trial
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`28 months
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`31 months
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`33 months
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`If the Court is inclined to enter a full schedule at this time, Novo Nordisk anticipates that
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`its proposed schedule will be closer to the schedule that is entered in the Ozempic® Delaware
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`Actions.5 Thus, adopting Plaintiffs’ schedule will allow for easier informal coordination with the
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`Ozempic® Delaware Actions, even if the MDL Panel were to deny Plaintiffs’ MDL Motion,
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`5 MPI suggests below that its proposed schedule is consistent with what can be expected from
`Judge Connolly in the Ozempic® Delaware Actions based on schedules entered in prior cases
`before him involving liraglutide. But Novo Nordisk notes that the ANDAs at issue in the liraglutide
`actions were subject to only 30-month stays of FDA approval, rather than the 42-month stay to
`which the semaglutide ANDAs are subject. The Hatch-Waxman Act imposes a longer regulatory
`stay here because Mylan and the Delaware generics were permitted to submit ANDAs during the
`last year of Novo Nordisk’s 5-years of exclusivity, which were granted for developing and bringing
`to market an entirely new chemical entity (i.e., semaglutide). Trial dates in the liraglutide actions
`were set for 6-8 months prior to expiration of the 30-month regulatory stay at issue in those cases.
`Plaintiffs propose comparable timing from trial to stay expiration here.
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`8
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 9 of 22 PageID #: 3014
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`contrary to its prior handling of requests involving Mylan in West Virginia and similarly-situated
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`generic defendants in Delaware.
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`MPI’s Position: The Court should enter a complete schedule in this action, and this case
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`should proceed in the normal course. MPI’s proposal provides the parties and the court 28 months
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`to prepare for trial, which is more than ample time for sophisticated parties and counsel. While
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`Novo Nordisk suggests that MPI’s trial schedule is too quick, it is consistent (as shown in the table
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`below) with what can be expected in the Ozempic® Delaware Actions based on Judge Connolly’s
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`prior practice in the actions involving liraglutide while still accommodating the complexity of the
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`present case.
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`The Victoza® Action
`Novo Nordisk v. Mylan Institutional,
`C.A. No. 1:19-cv-01551 (D. Del.)
`(related to Victoza® (liraglutide))
`Novo Nordisk v. Sandoz, C.A. No. 20-
`cv-747 (D. Del.) (related to Victoza®
`(liraglutide))
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`Complaint Filed
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`12/12/2021
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`8/20/2019
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`6/3/2020
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`Trial
`12/4/2023
`(ECF No. 17)
`6/7/2021
`(ECF No. 16)
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`4/4/2022
`(ECF No. 24)
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`Time to Trial
`(from Complaint)
`24 months
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`22 months
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`22 months
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`While Novo Nordisk relies on the FDA regulatory stay as a basis to advocate for a later
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`trial, that stay expires when the asserted patents are found invalid and/or not infringed. 21 U.S.C.
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`§ 355(j)(5)(B)(iii). The FDA regulatory has no impact on trial preparation time. Indeed, the stay
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`prevents generic competitors from providing patients with access to affordable medications, just
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`one reason why the stay is no basis to delay a trial. Moreover, MPI’s schedule also provides the
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`Court sufficient time to prepare a decision after post-trial briefing is concluded and before the
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`expiration of the stay. On the other hand, Novo Nordisk’s proposed trial date unnecessarily leaves
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`the Court just a few months to prepare a decision after post-trial briefing is concluded.
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`9
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 10 of 22 PageID #: 3015
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`Plaintiffs assert eighteen patents in this case against MPI. As shown in the table below,
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`eight of these patents are not asserted against any other party in the Ozempic® Delaware Actions.
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`Only two of the 18 patents asserted against MPI are asserted in the Sun and Zydus actions in
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`Delaware, and only five of the 18 patents asserted against MPI are asserted in the Rio action in
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`Delaware. While there are certain family relationships between the asserted patents, each patent
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`remains a separate patent with unique claims that Novo Nordisk must independently prove is
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`infringed. Accordingly, this is not like the situation in the In re Nebivolol case cited by Plaintiffs,
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`which involved just a single patent. Because eight patents are asserted here that are not asserted
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`against any entity in the Ozempic® Delaware Actions, this case involves numerous unique legal
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`and factual issues absent from the Ozempic® Delaware Actions, making this case inappropriate for
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`MDL consolidation.6 To the extent Novo Nordisk suggests that the Saxenda® Action supports
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`consolidation in Delaware, Mylan notes that Novo Nordisk is not seeking to consolidate this case
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`with the Saxenda® Action or to consolidate the Saxenda® Action with the Ozempic® Delaware
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`Actions. Indeed, those Actions are already proceeding on a different schedule. Moreover, the
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`Saxenda® Action has been set for trial on December 4, 2023. See Saxenda® Action, Dkt No. 17
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`(Scheduling Order). To the extent the Saxenda® Action informs the entry of a schedule here, it
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`counsels in favor of a faster schedule here to allow the parties to potentially achieve efficacies
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`through informal coordination. In any event, the Saxenda® Action still involves fewer patents than
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`at issue here, involves different ANDAs, different active ingredients, and likely different injection
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`devices. In addition, coordination with the Saxenda® Action would include yet another ANDA
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`filer that is not a party to the Ozempic® Delaware Actions, unnecessarily adding to the burden and
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`expense to the ANDA filers in all of the actions. Finally, regardless of the outcome of the Saxenda®
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`6 MPI’s response to Novo Nordisk’s JPMDL motion to transfer is due on May 31, 2022.
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`10
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 11 of 22 PageID #: 3016
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`Action or the Ozempic® Delaware Actions, there will be patents asserted in this case that must be
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`addressed by this Court - neither of those actions resolve all issues pending in this Action.
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`Parties seeking centralization have the burden of demonstrating the existence of common
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`questions of fact such that centralization will serve the convenience of the parties and witnesses
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`and promote the just and efficient conduct of the litigation.” In re: Select Retrieval, LLC, (’617)
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`Pat. Litig., 883 F. Supp. 2d 1353, 1354 (J.P.M.L. 2012). “[W]here only a minimal number of
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`actions are involved, the proponents of centralization bear a heavier burden to demonstrate that
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`centralization is appropriate.” In re JumpSport, Inc., (’845 & ’207) Pat. Litig., 338 F. Supp. 3d
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`1356, 1357 (J.P.M.L. 2018) (denying motion to centralize six patent cases in two districts). This
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`holds true for Hatch-Waxman cases—centralization of these cases is not automatic. See In re
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`Sumatriptan Succinate Pat. Litig., 381 F. Supp. 2d 1378, 1379 (J.P.M.L. 2005). The Panel has
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`denied motion to centralizes Hatch-Waxman cases when multiple actions in one district had
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`already been consolidated and a lone case was pending in a different district. See id. That motion
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`“essentially involve[d] only two actions pending in two districts” and centralization was
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`inappropriate. Id.; see also JumpSport, 338 F. Supp. 3d at 1357 (“Thus, there effectively are only
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`two actions pending here in only two districts.”).
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`Additionally, the District of Delaware’s docket is congested, has a disproportionate number
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`of patent litigations, and is burdened by an unfilled vacancy. Allen Med. Sys., Inc. v. Muzuho
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`Orthopedic Sys., Inc., Mem. Op., Dkt. Nos. 26-27, No. 21-1739-CFC (D. Del. April 7, 2022)
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`(Chief Judge Connolly transferring a patent litigation from the District of Delaware to the Northern
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`District of California based on inter alia the court’s caseload, docket congestion, relative number
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`of patent litigations pending in each court and judicial vacancies).7 The District of Delaware is
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`7 https://www.ded.uscourts.gov/sites/ded/files/opinions/20-1652_0.pdf
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`11
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 12 of 22 PageID #: 3017
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`transferring cases out of that District to alleviate the court’s docket. Id. Thus, in view of the District
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`of Delaware’s continued judicial vacancies, docket congestion, and disproportionately large
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`number of patent litigations, transfer of this case to the District of Delaware, and more specifically,
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`transferring a case with 18 asserted patents to Judge Connolly’s docket, irrespective of alleged
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`overlap, fails to serve the convenience of the parties and witnesses and promote the just and
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`efficient conduct of the litigation.
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`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
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`
`U.S. Patent No.
`8,114,833
`8,684,969
`9,108,002
`9,616,180
`9,861,757
`10,357,616
`8,536,122
`10,376,652
`8,920,383
`9,775,953
`10,220,155
`11,097,063
`RE46,363
`9,687,611
`9,457,154
`8,129,343
`9,132,239
`10,335,462
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`MPI
`N.D. W.Va.
`
`
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`Moreover, while Plaintiffs assert “the MDL Panel regularly grants requests for
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`consolidation of Hatch-Waxman litigations like this one,” this is not a typical Hatch-Waxman
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`litigation. Indeed, Plaintiffs have made this case primarily about injection devices by asserting 14
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`patents claiming devices (i.e., patents claiming a mechanical device used to inject a drug, rather
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`than claiming a drug product or its use). Because there are myriad types of injection devices, and
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`12
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`

`

`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 13 of 22 PageID #: 3018
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`each ANDA filer likely uses a structurally different device from those of other ANDA filers, there
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`will surely be unique, defendant-specific device-related details at issue in each of the six separate
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`litigations. Accordingly, even where certain limited patents are shared between this action and the
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`Ozempic® Delaware Actions, or even the Saxenda® Action, the underlying non-infringement
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`issues will differ on a defendant-by-defendant basis because the underlying accused products
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`(injection devices) are different.
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`These facts demonstrate consolidation of this case with the Ozempic® Delaware Actions
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`would not increase any efficiencies at least because each separate ANDA filer will have unique
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`discovery and because there is minimal legal and factual overlap where at least eight patents
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`asserted against MPI here will not even be at issue in the Ozempic® Delaware Actions. MDL
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`consolidation would burden the District of Delaware and the parties to the Ozempic® Delaware
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`Actions with issues of law and fact now absent in those cases. This would further burden all other
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`parties in coordinating patent litigations having very different issues in dispute (or not having the
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`issues at all in the case of many other ANDA filers’ cases), let alone coordinating with the
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`Saxenda® Action—a case involving a different drug product, likely different injection devices, and
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`parties and counsel that are not involved in the Ozempic® Delaware Actions—which Novo Nordisk
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`seems to suggest supports consolidation in Delaware. For example, consolidation would introduce
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`considerable logistical difficulties in handling highly confidential information that often cannot be
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`shared with, between, or among defendants and would create difficulty in coordinating discovery
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`with ANDA filers facing different legal issues. MDL consolidation makes each of the six separate
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`cases more burdensome and complex for the parties and the Delaware Court. The Plaintiffs chose
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`to assert in a different venue nearly double the number of patents against MPI as they asserted
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`against any other ANDA filer. This, however, does not make consolidation an equitable and
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`13
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 14 of 22 PageID #: 3019
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`efficient outcome for the parties or the Courts. MPI opposes Novo Nordisk’s motion for MDL
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`consolidation with the Ozempic® Delaware Actions, and will respond in due course. Unless and
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`until the MDL Panel rules on any motion, this case should proceed apace for at least these reasons.
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`Last, notwithstanding the above reasons why consolidation is inappropriate, if the MDL
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`Panel seems inclined to agree with Novo Nordisk’s proposal, MPI may also request the MDL
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`Panel to assign the consolidated proceedings to this Court rather than the District of Delaware.
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`Eighteen patents will ultimately need to be heard and tried here, and all other Ozempic® Delaware
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`Actions involve only much smaller subsets of those patents, making this Court the more logical
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`forum to decide these matters.
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`Regardless of the outcome of Novo Nordisk’s motions before the MDL Panel, a trial will
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`occur in this Court, making the Court’s entry of a schedule and trial date necessary.
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`*
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`*
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`*
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`The parties propose the following schedules for discovery, pretrial disclosures, and trial.
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`Event
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`Rule 26(a)(1) Initial Disclosures
`Defendant’s production of MPI’s ANDA89
`Motion for Joint Protective Order
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`Novo Nordisk’s
`Proposed Deadline
`May 23, 2022
`June 1, 2022
`June 15, 2022
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`MPI’s
`Proposed Deadline
`May 23, 2022
`June 1, 2022
`June 15, 2022
`
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`8 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.
`9 Plaintiffs submit that to fully assess infringement, Plaintiffs may require, in addition to MPI’s
`ANDA, Computer Aided Design (“CAD”) Drawings of MPI’s Device, the Design History File
`(“DHF”) of MPI’s Device, and 10 samples of MPI’s Device. MPI has refused to produce these
`materials at this stage of the case, and Plaintiffs reserve all rights to seek them during discovery
`and to amend their infringement contentions following receipt. MPI notes that to date it has not
`received any document requests from Novo Nordisk. MPI will respond to any discovery requests
`received from Novo Nordisk upon receipt of such requests. MPI does not believe a scheduling
`order is the appropriate mechanism to address the scope and context of the production of
`documents and things.
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`14
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`Case 1:22-cv-00023-JPB Document 27 Filed 05/16/22 Page 15 of 22 PageID #: 3020
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`Event
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`Plaintiffs’ disclosure of infringement
`contentions and accompanying production (see
`section 2(h) infra)
`Defendant’s disclosure of invalidity
`contentions and preliminary disclosure of
`asserted prior art 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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`Novo Nordisk’s
`Proposed Deadline
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`MPI’s
`Proposed Deadline
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`August 5, 2022
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`August 5, 2022
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`October 7, 2022
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`October 7, 2022
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`June 2, 2023
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`December 2, 2022
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`September 1, 2023
`September 22, 2023
`December 1, 2023
`Claim Construction
`Parties exchange proposed terms for claim
`December 2, 2022
`construction
`Parties exchange preliminary proposed
`constructions for disputed terms and identify
`intrinsic evidence support
`Parties file a joint claim construction statement
`Opening Markman Briefs
`Response Markman Briefs
`Reply Markman Briefs
`Markman Hearing
`
`December 21, 2022
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`January 20, 2023
`February 17, 2023
`March 17, 2023
`April 14, 2023
`June 2023
`Expert Discovery
`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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`January 19, 2024
`March 1, 2024
`April 5, 2024
`June 28, 2024
`Dispositive Motions
`Dispositive Motions under Fed. R. Civ. P. 56
`Novo Nordisk
`proposes that
`dispositive motions
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`Responses to Dispositive Motions
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`December 9, 2022
`April 14, 2023
`December 1, 2023
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`October 14, 2022
`
`October 21, 2022
`
`November 2, 2022
`December 9, 2022
`January 10, 2023
`January 24, 2023
`February 2023
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`June 16, 2023
`August 18, 2023
`September 22, 2023
`November 17, 2023
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`No later than
`December 8, 202310
`Per Local Rules
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`10 MPI believes summary judgment may be helpful to resolve at least the issue of infringement of
`the ass