Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 1 of 21 PageID #: 619
`
`BEFORE THE UNITED STATES
`JUDICIAL PANEL ON MULTIDISTRICT LITIGATION
`
`In re Ozempic® (Semaglutide) Patent
`Litigation
`
`)
`)
`)
`)
`)
`)
`)
`
`MDL No. ________________
`
`MEMORANDUM IN SUPPORT OF PLAINTIFFS’ MOTION FOR TRANSFER OF
`ACTION TO THE DISTRICT OF DELAWARE PURSUANT TO 28 U.S.C. § 1407 FOR
`COORDINATED AND CONSOLIDATED PRETRIAL PROCEEDINGS
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`
`James F. Companion (W. Va. Bar No. 790)
`Sandra K. Law (W. Va. Bar No. 6071)
`SCHRADER COMPANION DUFF & LAW, PLLC
`401 Main Street Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
`skl@schraderlaw.com
`
`Attorney for Novo Nordisk Inc. and
`Novo Nordisk A/S
`
`OF COUNSEL:
`
`Jeffrey J. Oelke
`Ryan P. Johnson
`Robert E. Counihan
`Laura T. Moran
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010-6035
`(212) 430-2600
`
`May 6, 2022
`
`

`

`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 2 of 21 PageID #: 620
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`BACKGROUND .................................................................................................................1
`
`ARGUMENT .......................................................................................................................4
`
`A.
`
`The Panel Should Transfer the West Virginia Action and Consolidate the Ozempic®
`Patent Litigations .....................................................................................................4
`
`1.
`
`2.
`
`3.
`
`4.
`
`The West Virginia Action Shares Common Questions of Fact with the
`Delaware Actions .........................................................................................6
`
`Transfer and Consolidation Will Serve the Convenience of the Parties
`and Witnesses...............................................................................................9
`
`Transfer and Consolidation Will Promote the Just and Efficient Conduct
`of the Actions .............................................................................................10
`
`The Additional Patents-In-Suit in the West Virginia Action Do Not
`Diminish the Benefits of Transfer..............................................................11
`
`B.
`
`The Panel Should Select the District of Delaware for Consolidated Pretrial
`Proceedings in the Ozempic® Patent Litigations ...................................................14
`
`III.
`
`CONCLUSION ..................................................................................................................16
`
`i
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`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 3 of 21 PageID #: 621
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`In re Alfuzosin Hydrochloride Patent Litig.,
`560 F. Supp. 2d 1372 (J.P.M.L. 2008) .................................................................................5, 10
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003)..................................................................................................7
`
`In re Armodafinil Patent Litig.,
`755 F. Supp. 2d 1359 (J.P.M.L. 2010) .....................................................................................11
`
`In re Auryxia (Ferric Citrate) Patent Litig.,
`412 F. Supp. 3d 1347 (J.P.M.L. 2019) .................................................................................5, 14
`
`Ben Venue Labs., Inc. v. Novartis Pharm. Corp.,
`146 F. Supp. 2d 572 (D.N.J. 2001) ............................................................................................2
`
`Boehringer Ingelheim Pharm. Inc. et al. v. Mankind Pharma Ltd. et al.,
`Case No. 18-cv-1689-CFC-SRF (D. Del.) ...............................................................................14
`
`In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig.,
`999 F. Supp. 2d 1377 (J.P.M.L. 2014) .....................................................................................12
`
`In re Brimonidine Patent Litig.,
`507 F. Supp. 2d 1381 (J.P.M.L. 2007) .....................................................................................11
`
`Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd.,
`533 F.3d 1353 (Fed. Cir. 2008)..................................................................................................8
`
`In re Entresto (Sacubitril/Valsartan) Patent Litig.,
`437 F. Supp. 3d 1372 (J.P.M.L. 2020) .............................................................................5, 6, 14
`
`In re Fenofibrate Patent Litig.,
`787 F. Supp. 2d 1352 (J.P.M.L. 2011) .......................................................................................9
`
`Genzyme Corp. et al. v. Apotex Corp. et al.,
`Case No. 18-cv-1795-CFC (D. Del.) .......................................................................................14
`
`In re Kerydin (Tavaborole) Topical Sol. 5% Patent Litig.,
`366 F. Supp. 3d 1370 (J.P.M.L. 2019) .....................................................................5, 10, 11, 14
`
`In re Metoprolol Succinate Patent Litig.,
`329 F. Supp. 2d 1368 (J.P.M.L. 2004) .....................................................................................11
`
`ii
`
`

`

`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 4 of 21 PageID #: 622
`
`In re Nebivolol (’040) Patent Litig.,
`867 F. Supp. 2d 1354 (J.P.M.L. 2012) ............................................................................. passim
`
`Novo Nordisk Inc. et al. v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`Laboratories, Inc.,
`Case No. 22-cv-298-CFC (D. Del.) .......................................................................................2, 8
`
`Novo Nordisk Inc. et al. v. Hikma Pharmaceuticals USA Inc.,
`Case No. 21-cv-01783 (D. Del.) ..............................................................................................15
`
`Novo Nordisk Inc. et al. v. Mylan Institutional LLC,
`Case No. 19-cv-1551 (D. Del.) ................................................................................................15
`
`Novo Nordisk Inc. et al. v. Mylan Pharmaceuticals Inc.,
`Case No. 22-cv-00023-JPB (N.D. W. Va.) ................................................................................3
`
`Novo Nordisk Inc. et al. v. Sandoz Inc.,
`Case No. 20-cv-00747 (D. Del.) ..............................................................................................15
`
`Novo Nordisk Inc. et al. v. Teva Pharmaceuticals, Inc. et al.,
`Case No. 21-cv-01782-CFC (D. Del.) .....................................................................................12
`
`In re Palbociclib Patent Litig.,
`396 F. Supp. 3d 1360 (J.P.M.L. 2019) .................................................................................5, 14
`
`In re Pharmastem Therapeutics, Inc., Patent Litig.,
`360 F. Supp. 2d 1362 (J.P.M.L. 2005) ...................................................................................6, 9
`
`In re RAH Color Techs. LLC Patent Litig.,
`347 F. Supp. 3d 1359 (J.P.M.L. 2018) .......................................................................................6
`
`In re Sitagliptin Phosphate (’708 & ’921) Patent Litig.,
`402 F. Supp. 3d 1366 (J.P.M.L. 2019) .................................................................................5, 14
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc.,
`574 U.S. 318 (2015) ...................................................................................................................6
`
`UCB, Inc. et al. v. Annora Pharma Private Ltd. et al.,
`Case No. 20-cv-00987-CFC-JLH (D. Del.) .............................................................................14
`
`In re Xarelto (Rivaroxaban) (’310) Patent Litig.,
`2021 WL 5872990 (J.P.M.L. 2021) .....................................................................................5, 14
`
`iii
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`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 5 of 21 PageID #: 623
`
`Rules and Statutes
`
`21 U.S.C. §§ 355(j)(5)(B)(iii) ..........................................................................................................2
`
`21 U.S.C. § 355(j)(5)(F)(ii)..............................................................................................................2
`
`28 U.S.C. § 1407 .................................................................................................................... passim
`
`35 U.S.C. § 103 ................................................................................................................................8
`
`35 U.S.C. § 271(e)(2) .......................................................................................................................2
`
`iv
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`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 6 of 21 PageID #: 624
`
`Pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Judicial Panel
`
`on Multidistrict Litigation, Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S (collectively
`
`“Novo Nordisk”) hereby move to transfer Novo Nordisk Inc. and Novo Nordisk A/S v. Mylan
`
`Pharmaceuticals Inc., Case No. 1:22-cv-00023-JPB, which is pending before Judge John Preston
`
`Bailey in the United States District Court for the Northern District of West Virginia, to Chief Judge
`
`Colm Connolly in the United States District Court for the District of Delaware, for coordinated
`
`and consolidated pretrial proceedings with five related actions already pending before Judge Colm
`
`Connolly in the District of Delaware. Defendant Mylan Pharmaceuticals Inc. has stated that it will
`
`oppose Novo Nordisk’s motion.
`
`I.
`
`BACKGROUND
`
`Ozempic® (semaglutide) is Novo Nordisk’s highly successful type 2 diabetes medicine. In
`
`December 2021, the U.S. Food and Drug Administration (“FDA”) first began accepting
`
`abbreviated new drug applications (“ANDAs”) seeking approval for generic versions of
`
`Ozempic®. Since then, six generic pharmaceutical companies1 have notified Novo Nordisk that
`
`they have submitted ANDAs for Ozempic®. The generics’ notice letters stated that their ANDAs
`
`contain “Paragraph IV certifications” against certain patents listed as covering Ozempic® (or
`
`methods of using it) in the FDA publication, Approved Drug Products with Therapeutic
`
`Equivalence Evaluations, commonly known as the “Orange Book.” A Paragraph IV certification
`
`is a statement of the ANDA-filer’s belief that the patent-in-question is invalid, unenforceable,
`
`1 Four of these six generic companies are actually groups of affiliated companies. This includes:
`(1) Rio Biopharmaceuticals Inc. and EMS S/A (collectively, “Rio”); (2) Sun Pharmaceutical
`Industries Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, “Sun”); (3) Zydus Worldwide
`DMCC, Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. (collectively, “Zydus”);
`and (4) Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively,
`“Dr. Reddy’s”). The fifth and sixth generic companies are: (5) Alvogen, Inc. (“Alvogen”); and
`(6) Mylan Pharmaceuticals Inc. (“Mylan”).
`
`1
`
`

`

`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 7 of 21 PageID #: 625
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`and/or will not be infringed by the ANDA-filer’s generic product. By making Paragraph IV
`
`certifications, the six Ozempic® generics are each seeking FDA approval to market their generic
`
`versions of Ozempic® (collectively, “Defendants’ ANDA Products”) before the patents-in-
`
`question expire.
`
`The Hatch-Waxman Act makes the submission of an ANDA containing a Paragraph IV
`
`certification an act of patent infringement. See 35 U.S.C. § 271(e)(2). If the patent owner sues
`
`the ANDA-filer for patent infringement within 45 days of receiving notice of the Paragraph IV
`
`ANDA filing, the Act prohibits the FDA from granting final approval of the ANDA for a defined
`
`period of time, which in this case is 7.5 years from the approval of the Ozempic® NDA (i.e., until
`
`June 5, 2025). See 21 U.S.C. §§ 355(j)(5)(B)(iii); 355(j)(5)(F)(ii). This regulatory stay of FDA
`
`approval of ANDAs is intended to “create an adequate window of time during which to litigate the
`
`question of whether a generic will infringe the patented product, without actually having to
`
`introduce the generic product to the market.” Ben Venue Labs., Inc. v. Novartis Pharm. Corp.,
`
`146 F. Supp. 2d 572, 579 (D.N.J. 2001) (citing the Hatch-Waxman Act’s legislative history).
`
`In this case, Novo Nordisk sued each of the six generic companies for patent infringement
`
`within the 45-day period. Novo Nordisk sued five of the six—Rio, Sun, Zydus, Dr. Reddy’s, and
`
`Alvogen—in the District of Delaware on March 4, 2022 (collectively, the “Delaware Actions”).
`
`All five Delaware Actions are before Chief Judge Connolly. Novo Nordisk expects that the
`
`Delaware Actions will be consolidated for all purposes, including discovery, claim construction
`
`proceedings, and trial. Dr. Reddy’s filed its Answer, Defenses, and Counterclaims on May 3,
`
`2022. Novo Nordisk Inc. et al. v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
`
`Inc., Case No. 22-cv-298-CFC, ECF No. 10 (D. Del. May 3, 2022). All remaining Defendants in
`
`the Delaware Actions are due to respond to Novo Nordisk’s complaints by May 9, 2022.
`
`2
`
`

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`Novo Nordisk asked Mylan whether it would consent to venue in Delaware, but Mylan
`
`refused. Accordingly, Novo Nordisk filed the sixth action, against Mylan, in the Northern District
`
`of West Virginia, where Mylan is located and incorporated, on March 18, 2022 (the “West Virginia
`
`Action”). The West Virginia Action is pending before Judge John Preston Bailey in the Northern
`
`District of West Virginia. Mylan filed its Answer, Separate Defenses, and Counterclaims in the
`
`West Virginia Action on April 8, 2022. Mylan did not contest personal jurisdiction or venue in
`
`the West Virginia Action. Novo Nordisk Inc. et al. v. Mylan Pharmaceuticals Inc., Case No. 22-
`
`cv-00023-JPB, ECF No. 19, ¶¶ 5-8 (N.D. W. Va. Apr. 8, 2022).
`
`All six actions concern a common issue: whether the generic Defendants’ ANDA Products
`
`infringe valid and enforceable claims of patents listed in the Orange Book for Ozempic®. The
`
`patents asserted in each action vary somewhat depending on which patents each generic Defendant
`
`challenged in its notice letter. But there is considerable overlap, which will lead to a high level of
`
`commonality of claims, defenses, and other issues. U.S. Patent Nos. 9,132,239 and 10,335,462
`
`are common to all six actions, and the Delaware Actions against Dr. Reddy’s and Alvogen share
`
`ten patents in common with the West Virginia Action against Mylan. For any patent commonly
`
`asserted, Novo Nordisk’s claims in the West Virginia Action are substantively identical to Novo
`
`Nordisk’s claims in the Delaware Actions.
`
`Moreover, there is almost complete overlap in “patent families” between the Delaware
`
`Actions and the West Virginia Action. A patent family is a group of patents that trace their lineage
`
`back to the same “priority application.” Such patents concern related inventions and have very
`
`similar, if not identical, specifications and closely related claims. Accordingly, patents within the
`
`same family present highly similar litigation issues (e.g., discovery, claim construction,
`
`infringement, and validity defenses). In this case, eight of the ten patent families that are at-issue
`
`3
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`

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`in the West Virginia Action are also at-issue in the Delaware Actions. The other two families are
`
`at-issue in another case before Chief Judge Connolly concerning a different GLP-1 drug product,
`
`Saxenda®. See infra Section II.A.4 (detailing the overlap in patent families). Thus, all of the
`
`patent families at-issue in the West Virginia Action are before Chief Judge Connolly in the District
`
`of Delaware, by virtue of the Delaware Actions and the separate Saxenda® Litigation.
`
`All six Ozempic® Patent Litigations are at a very early stage. As of the date of filing of
`
`this motion, neither Court has held a conference, neither Court has issued a substantive order, and
`
`the parties have not served any discovery requests.
`
`In light of the foregoing, and as explained further below, Novo Nordisk respectfully
`
`requests transfer of the West Virginia Action and consolidation with the Delaware Actions at this
`
`early stage, to ensure efficient and consistent conduct of all actions; to lessen the burden on the
`
`courts, the parties, and the witnesses; and to guard against the risk of inconsistent decisions on
`
`highly similar (if not identical) legal and factual issues resulting from parallel proceedings in
`
`different courts.
`
`II.
`
`ARGUMENT
`
`A.
`
`The Panel Should Transfer the West Virginia Action and Consolidate the
`Ozempic® Patent Litigations
`
`The Panel may transfer actions for coordinated and consolidated pretrial proceedings
`
`pursuant to 28 U.S.C. § 1407 if the movant establishes: (1) that there are “common questions of
`
`fact” between or among the actions; (2) that transfer and consolidation will “be for the convenience
`
`of [the] parties and witnesses;” and (3) that transfer and consolidation “will promote the just and
`
`efficient conduct of [the] actions.”
`
`Each of these criteria is satisfied here. Hatch-Waxman actions like this one, “involving the
`
`validity of complex pharmaceutical patents and the entry of generic versions of the patent holder’s
`
`4
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`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 10 of 21 PageID #: 628
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`drugs[,] are particularly well-suited” for consolidation. In re Kerydin (Tavaborole) Topical Sol.
`
`5% Patent Litig., 366 F. Supp. 3d 1370, at 1370, 1371 (J.P.M.L. 2019) (MDL No. 2884) (quoting
`
`In re Alfuzosin Hydrochloride Patent Litig., 560 F. Supp. 2d 1372, 1372 (J.P.M.L. 2008) (MDL
`
`No. 1941)). The Panel has held that the “complexity of . . . the regulatory framework governing
`
`Hatch-Waxman cases,” and “the need for swift progress in litigation involving the potential entry
`
`of generic drugs into the market,” support transfer and consolidation of such actions. In re
`
`Kerydin, 366 F. Supp. 3d at 1371.
`
`The Panel has, under highly similar circumstances, transferred and consolidated numerous
`
`Hatch-Waxman litigations filed against this same Defendant (Mylan) from the Northern District
`
`of West Virginia to the District of Delaware. See id. (transferring and consolidating a Mylan West
`
`Virginia action to Delaware); In re Entresto (Sacubitril/Valsartan) Patent Litig., 437 F. Supp. 3d
`
`1372, 1373-74 (J.P.M.L. 2020) (MDL No. 2930) (same); In re Auryxia (Ferric Citrate) Patent
`
`Litig., 412 F. Supp. 3d 1347, 1349-50 (J.P.M.L. 2019) (MDL No. 2896) (same); In re Palbociclib
`
`Patent Litig., 396 F. Supp. 3d 1360, 1361-62 (J.P.M.L. 2019) (MDL No. 2912) (same); In re
`
`Sitagliptin Phosphate (’708 & ’921) Patent Litig., 402 F. Supp. 3d 1366, 1367 (J.P.M.L. 2019)
`
`(MDL No. 2902) (same); In re Xarelto (Rivaroxaban) (’310) Patent Litig., 2021 WL 5872990, at
`
`*2 (J.P.M.L. 2021) (MDL No. 3017) (same). Not only does the Panel “frequently centralize[]”
`
`Hatch-Waxman litigations, In re Nebivolol (’040) Patent Litig., 867 F. Supp. 2d 1354, 1355
`
`(J.P.M.L. 2012) (MDL No. 2364), it has repeatedly granted the exact relief sought here—transfer
`
`of a Hatch-Waxman case involving Mylan from West Virginia to Delaware.
`
`As discussed below, due to numerous common questions of fact, “[c]entralization is
`
`warranted to eliminate duplicative discovery, prevent inconsistent rulings (particularly with
`
`5
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`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 11 of 21 PageID #: 629
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`respect to claim construction and issues of patent validity), and conserve the resources of the
`
`parties, their counsel and the judiciary.” In re Entresto, 437 F. Supp. 3d at 1373.
`
`1.
`
`The West Virginia Action Shares Common Questions of Fact with the
`Delaware Actions
`
`The six actions-at-issue involve parallel efforts by six generic companies to obtain FDA
`
`approval of generic versions of Ozempic® prior to the expiration of Novo Nordisk’s patents. They
`
`will inevitably raise common questions of fact. As the Panel has recognized on numerous
`
`occasions, where, as here, the same patents are asserted in separate, parallel actions, “[a]ll actions
`
`can . . . be expected to share factual and legal questions concerning such matters as the technology
`
`underlying the patents, prior art, claim construction and issues of infringement involving the
`
`patents.” In re Pharmastem Therapeutics, Inc., Patent Litig., 360 F. Supp. 2d 1362, 1363 (J.P.M.L.
`
`2005) (MDL No. 1660). Common questions of fact exist regarding claim construction of terms in
`
`the asserted patents, infringement by Defendants’ ANDA Products, validity of the asserted patents,
`
`and listability in the Orange Book of certain asserted patents.
`
`First, resolution of any claim construction disputes is a necessary prerequisite to deciding
`
`questions of patent validity and infringement. Claim construction is a question of law, often
`
`requiring “subsidiary factfinding,” by the judge presiding over the Hatch-Waxman litigation. See
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 326-327 (2015). The Panel has repeatedly
`
`observed that centralization is necessary to prevent inconsistent pretrial rulings “particularly on
`
`claim construction issues.” See, e.g., In re RAH Color Techs. LLC Patent Litig., 347 F. Supp. 3d
`
`1359, 1360 (J.P.M.L. 2018) (MDL No. 2874); In re Nebivolol, 867 F. Supp. 2d at 1355.
`
`Specifically, a consolidated approach to claim construction is necessary to avoid inconsistent
`
`constructions, which could in turn produce conflicting outcomes on validity and infringement,
`
`even if based on the same facts or legal arguments.
`
`6
`
`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 12 of 21 PageID #: 630
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`Second, there are common questions of fact concerning infringement of the asserted
`
`patents. Defendants’ ANDA Products, if approved, would be generic copies of Ozempic®. While
`
`each Defendant may attempt to raise unique non-infringement arguments, the first step in assessing
`
`patent infringement—i.e., construing the scope and meaning of the patent claims, see Amgen Inc.
`
`v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1324 (Fed. Cir. 2003)—is common to all
`
`Defendants. The second step in the infringement analysis is to compare the “properly construed
`
`claims” to the “accused product or process to determine whether each of the claim limitations is
`
`met, either literally or equivalently.” Amgen Inc., 314 F.3d at 1324. This step will also involve
`
`common questions of fact. See, e.g., In re Nebivolol, 867 F. Supp. 2d at 1355 (“While there may
`
`be some variances in the proposed formulations of defendants’ respective drugs, this does not
`
`weigh strongly against centralization because all defendants are anticipated to raise similar
`
`arguments concerning non-infringement defenses . . . .”). For example, the ’462 patent, which is
`
`asserted in all six actions, claims a method of treatment of type 2 diabetes. The language of the
`
`Defendants’ proposed generic product labels (which will be highly similar to the language of the
`
`Ozempic® label, and to each other) will be central to induced infringement of the ’462 patent.
`
`Third, Defendants are expected to pursue similar invalidity arguments against commonly
`
`challenged patents. While the patents asserted in each action vary according to the actual patents
`
`challenged by the individual Defendant, some patents are common to all actions and each patent
`
`family overlaps between the West Virginia Action and at least one Delaware Action. Specifically,
`
`U.S. Patent Nos. 9,132,239 and 10,335,462 are common to all six actions, and the Delaware
`
`Actions against Dr. Reddy’s and Alvogen share ten patents in common with the West Virginia
`
`Action against Mylan, which will result in many overlapping invalidity theories, leading to
`
`common questions of fact. See infra § II.A.4.
`
`7
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`

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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 13 of 21 PageID #: 631
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`For example, all Defendants are expected to allege, as Mylan has in its Answer, that
`
`inventions claimed by challenged patents would have been obvious under 35 U.S.C. § 103.
`
`Evaluating obviousness requires factual inquiry into the scope and content of the prior art, the level
`
`of ordinary skill in the art, the differences between the claimed invention and the prior art, whether
`
`the person of ordinary skill would have been motivated to combine prior art references, whether
`
`the person of ordinary skill would have had a reasonable expectation of success in achieving the
`
`claimed invention, and evidence of objective indicia of non-obviousness. See Eisai Co. Ltd. v. Dr.
`
`Reddy’s Labs., Ltd., 533 F.3d 1353, 1356 (Fed. Cir. 2008). These factual inquires will be common
`
`across all cases in which a patent is challenged as obvious. Specifically, Novo Nordisk expects
`
`that at least allegations of obviousness of U.S. Patent Nos. 10,335,462 and 9,132,239 will be
`
`common to all six actions. The Delaware Actions against Dr. Reddy’s and Alvogen are likely to
`
`share many more obviousness inquires with the West Virginia Action, given the overlap of ten
`
`common patents.
`
`Finally, in response to Novo Nordisk’s complaint, Mylan filed de-listing counterclaims,
`
`arguing that certain asserted patents are not properly listed in the Orange Book in connection with
`
`the Ozempic® NDA and should therefore be de-listed. Similarly, Dr. Reddy’s, the only Delaware
`
`defendant to have answered its complaint to date, has also asserted de-listing counterclaims based
`
`on substantively identical allegations, serving as yet another example of the overlap in issues
`
`between the West Virginia and Delaware Actions. See Novo Nordisk Inc. et al. v. Dr. Reddy’s
`
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc., Case No. 22-cv-298-CFC, ECF No. 10, ¶¶
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`45-51, 58-64, 71-77, 84-90, 97-103, 110-116, 129-135, 142-148 (D. Del. May 3, 2022).
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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 14 of 21 PageID #: 632
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`2.
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`Transfer and Consolidation Will Serve the Convenience of the Parties
`and Witnesses
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`Transfer of the West Virginia Action and consolidation of the six actions before Chief
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`Judge Connolly in the District of Delaware will serve the convenience of the parties and witnesses
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`by ensuring a common pretrial schedule, common fact and expert discovery, and a “streamlined”
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`and consistent approach to scheduling, motions practice, and claim construction. In re Fenofibrate
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`Patent Litig., 787 F. Supp. 2d 1352, 1354 (J.P.M.L. 2011) (MDL No. 2241).
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`Transfer and consolidation will streamline fact discovery. Specifically, it will eliminate
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`the need to make multiple, costly document productions, on different schedules, and pursuant to
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`different search and review parameters, and it will allow for joint resolution of discovery disputes,
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`sparing the parties the burden of conflicting discovery obligations, and sparing the courts the
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`burden of deciding multiple such disputes. Consolidation will also eliminate the need for fact
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`witnesses to appear and participate in depositions in more than one proceeding. See In re
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`Pharmastem, 360 F. Supp. 2d at 1364 (“[T]ransfer under Section 1407 has the benefit of placing
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`all actions . . . before a single judge who can structure pretrial proceedings to consider all parties’
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`legitimate discovery needs while ensuring that common parties and witnesses are not subjected to
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`discovery demands which duplicate activity that has already occurred or is occurring in other
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`actions.”). This factor is especially important here because several of the parties are foreign
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`entities,2 and all of the inventors of the asserted patents—who will likely be noticed for
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`deposition—live in Europe. See In re Nebivolol, 867 F. Supp. 2d at 1355 (noting the value of
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`eliminating “duplicative discovery” that “will likely be international in scope”).
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`2 The following parties are foreign entities: Novo Nordisk A/S (based in Denmark); EMS S/A
`(based in Brazil); Sun Pharmaceutical Industries Ltd. (based in India); Zydus Worldwide DMCC
`(based in United Arab Emirates); Cadila Healthcare Ltd. (based in India); Dr. Reddy’s
`Laboratories, Ltd. (based in India).
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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 15 of 21 PageID #: 633
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`Transfer and consolidation will also promote efficiency in expert discovery, resulting in
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`greater convenience to the parties and to the expert witnesses. For example, consolidation will
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`eliminate the need for the same experts to submit multiple reports on different schedules in
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`multiple jurisdictions, expressing largely the same opinions. Transfer and consolidation will
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`further eliminate the need for experts to sit for multiple depositions, conserving party and witness
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`resources.
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`3.
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`Transfer and Consolidation Will Promote the Just and Efficient
`Conduct of the Actions
`
`Transferring the West Virginia Action to the District of Delaware and consolidating the
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`Ozempic® Patent Litigations will promote justice and efficiency, including by eliminating
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`duplicative discovery, preventing inconsistent pretrial rulings, and conserving resources of the
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`judiciary and the parties.
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`Notably, the drafters of the Hatch-Waxman Act appreciated the benefits of consolidation
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`of Hatch-Waxman litigations, such as this:
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`In the event of multiple ANDA’s certifying patent invalidity or non-
`infringement, the courts should employ the existing rules for
`multi-district litigation, when appropriate, to avoid hardship on the
`parties and witnesses and to promote the just and efficient conduct
`of the patent infringement actions.
`
`See H.R. Rep. No. 98-857, pt. 1, at 28 & n.14 (1984) (emphasis added). Similarly, the Panel has
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`recognized on numerous occasions that transfer and consolidation of Hatch-Waxman cases
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`promotes their “just and efficient” conduct as “actions involving the validity of complex
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`pharmaceutical patents and the entry of generic versions of the patent holder’s drugs are
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`particularly well-suited for transfer under Section 1407.” In re Nebivolol (’040) Patent Litig.,
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`867 F. Supp. 2d at 1355 (quoting In re Alfuzosin Hydrochloride Patent Litig., 560 F. Supp. 2d
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`1372, 1372 (J.P.M.L. 2008) (MDL No. 1941)). See also In re Kerydin Patent Litig., 366 F. Supp.
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`Case 1:22-cv-00023-JPB Document 22-1 Filed 05/06/22 Page 16 of 21 PageID #: 634
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`3d at 1371 (“Given the complexity of the allegations and regulatory framework . . . as well as the
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`need for swift progress in litigation involving the potential entry of generic drugs into the market,
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`placing all actions before a single judge should foster the efficient resolution of all of the actions.”).
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`The need for consolidation is especially strong here where there are as many as six actions
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`involving Novo Nordisk’s patents on Ozempic®. In fact, due to the benefits it affords, the Panel
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`has “frequently centralized litigation comprised of only two Hatch-Waxman Act cases.” In re
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`Nebivolol, 867 F. Supp. 2d at 1355 & n.4 (emphasis added) (citing In re Armodafinil Patent Litig.,
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`755 F. Supp. 2d 1359 (J.P.M.L. 2010); In re Brimonidine Patent Litig., 507 F. Supp. 2d 1381
`
`(J.P.M.L. 2007); In re Metoprolol Succinate Patent Litig., 329 F. Supp. 2d 1368 (J.P.M.L. 2004)).
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`The Panel has further noted the benefits of transfer and consolidation, explaining that
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`“transfer under Section 1407,” will allow for “assigning the present actions and any future tag-
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`along actions to a single judge who can formulate a pretrial program that ensures that pretrial
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`proceedings will be conducted in a manner leading to the just and expeditious resolution of all
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`actions to the overall benefit of the parties and the courts.” In re Metoprolol Succinate Patent
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`Litig., 329 F. Supp. 2d 1368, 1370 (J.P.M.L. 2004).
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`Any argument by Mylan that informal coordination is an adequate alternative to formal
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`transfer and consolidation should be rejected as it was in In re Kerydin. Id., 366 F. Supp. 3d at
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`1371. A single decisionmaker overseeing the case, under a common schedule, is necessarily more
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`efficient than burdening two courts with ongoing coordination.
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`4.
`
`The Additional Patents-In-S