Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 1 of 20 PageID #: 1188
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`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`
`SANOFI-AVENTIS U.S. LLC,
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`and SANOFI WINTHROP INDUSTRIE,
`
`
`
`Civil Action No. 1:17-CV-181-IMK
`
`Plaintiffs,
`
`v.
`
`
`
`MYLAN N.V., MYLAN GMBH, MYLAN INC.,
`and MYLAN PHARMACEUTICALS INC.,
`
`Defendants.
`
`DEFENDANTS’ OPPOSITION TO PLAINTIFFS’ MOTION TO STAY
`
`
`
`Sanofi Exhibit 2019.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 2 of 20 PageID #: 1189
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`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`FACTUAL BACKGROUND ............................................................................................. 2
`
`A.
`
`B.
`
`C.
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`The District of New Jersey Action.......................................................................... 2
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`This Action.............................................................................................................. 3
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`BPCIA ..................................................................................................................... 4
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`III.
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`ARGUMENT ...................................................................................................................... 4
`
`A.
`
`The First-to-File Rule Does Not Apply .................................................................. 5
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`1.
`
`2.
`
`3.
`
`4.
`
`Forum Shopping Precludes Application of the First-To-File Rule ............. 6
`
`Venue is Unsettled and Sharply Contested in the New Jersey
`Action .......................................................................................................... 8
`
`This Litigation Is Further Progressed Than the New Jersey Action ......... 10
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`The Prerequisites for the First-to-File Rule Are Not Met ......................... 11
`
`B.
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`The Court Should Decline Plaintiffs’ Invitation to Delay Resolution of this
`Dispute .................................................................................................................. 12
`
`1.
`
`2.
`
`3.
`
`The Interest of Judicial Economy Favors Proceeding With This
`Action ........................................................................................................ 12
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`Plaintiffs Will Not Suffer Hardship If This Action Is Not Stayed ............ 13
`
`Mylan GmbH Will Be Severely Prejudiced If This Action Is
`Stayed ........................................................................................................ 14
`
`IV.
`
`CONCLUSION ................................................................................................................. 15
`
`
`
`
`i
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`Sanofi Exhibit 2019.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 3 of 20 PageID #: 1190
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`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Abbott Labs. v. Mylan Pharm., Inc., No. 05-cv-6561,
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`2006 WL 850916 (N.D. Ill. Mar. 28, 2006) .........................................................................7
`
`Affinity Memory & Micro, Inc. v. K & Q Enters., Inc.,
`
`20 F. Supp. 2d 948 (E.D.Va.1998) ......................................................................................5
`
`Aventis Pharma Deutschland GmbH v. Lupin Ltd.,
`
`403 F. Supp. 2d 484 (E.D. Va. 2005) ..................................................................................5
`
`Celgene Corp. v. Abrika Pharm., Inc., No. 06-cv-5818,
`
`2007 WL 1456156 (D.N.J. May 17, 2007) ..........................................................................7
`
`EEOC v. Univ. of Pa.,
`
`850 F.2d 969 (3d Cir. 1988).............................................................................................5, 6
`
`Ellicott Mach. Corp. v. Modern Welding Co.,
`
`502 F.2d 178 (4th Cir. 1974) ...........................................................................................5, 6
`
`Genentech, Inc. v. Eli Lilly & Co.,
`
`998 F.2d 931 (Fed. Cir. 1993)..........................................................................................5, 8
`
`In re Cray,
`
`871 F.3d 1355 (Fed. Cir. 2017)..................................................................................1, 2, 10
`
`Intersearch Worldwide, Ltd. v. Intersearch Grp., Inc.,
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`544 F. Supp. 2d 949 (N.D. Cal. 2008) ...............................................................................11
`
`Landis v. North Am. Co.,
`
`299 U.S. 248 (1936) ...........................................................................................................12
`
`Orthmann v. Apple River Campground, Inc.,
`
`765 F.2d 119 (8th Cir. 1985) ...............................................................................................8
`
`Pfizer Inc. v. Apotex Inc.,
`
`640 F. Supp. 2d 1006 (N.D. Ill. 2009) .................................................................................7
`
`Pfizer, Inc. v. Mylan, Inc., No. 09-cv-0079,
`
`2009 WL 10270101 (N.D. W. Va. Nov. 20, 2009) ......................................................5, 6, 7
`
`Queensberry v. Volvo Grp. N. Am., Inc., No. 1:09-cv-00022,
`
`2009 WL 648658 (W.D. Va. Mar. 10, 2009) .......................................................................5
`
`
`
`
`
`ii
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`Sanofi Exhibit 2019.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 4 of 20 PageID #: 1191
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`Symbology Innovations, LLC v. Lego Sys., Inc., No. 2:17-CV-86,
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`2017 WL 4324841 (E.D. Va. Sept. 28, 2017)......................................................................9
`
`TC Heartland LLC v. Kraft Foods Grp. Brands LLC,
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`137 S. Ct. 1514 (2017) ...................................................................................................1, 10
`
`Tolley v. Monsanto Co.,
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`591 F. Supp. 2d 837 (S.D. W.Va. 2008) ............................................................................12
`
`Touchstone Research Lab, Ltd. v. Anchor Equip. Sales, Inc.,
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`294 F. Supp. 2d 823 (N.D.W. Va. 2003) .............................................................................6
`
`W. Va. Highlands Conservancy v. Monongahela Power Co., No. 1:11-cv-71,
`
`2012 U.S. Dist. LEXIS 744 (N.D.W. Va. 2012)..........................................................12, 14
`
`Wenzel v. Knight, No. 3:14-cv-00432,
`
`2015 WL 222179 (E.D. Va. Jan. 14, 2015) ...................................................................5, 10
`
`Williford v. Armstrong World Indus., Inc.,
`
`715 F.2d 124 (4th Cir. 1983) ...............................................................................................4
`
`STATUTES
`21 U.S.C. § 355(c)(3)(C) ...............................................................................................................13
`
`RULES
`Fed. R. Civ. P. 12(b)(1)....................................................................................................................3
`
`Fed. R. Civ. P. 12(b)(3)....................................................................................................................3
`
`Fed. R. Civ. P. 12(b)(6)....................................................................................................................3
`
`MISCELLANEOUS
`
`Federal Court Management Statistics, June 2017 – District Courts, United States Courts (June
`30, 2017) ..........................................................................................................10, 11, 14, 15
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`
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`iii
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`Sanofi Exhibit 2019.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 5 of 20 PageID #: 1192
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`Defendants Mylan N.V., Mylan GmbH, Mylan Inc., and Mylan Pharmaceuticals Inc.
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`(collectively, “Defendants”) respectfully oppose Plaintiffs Sanofi-Aventis U.S. LLC, Sanofi-
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`Aventis Deutschland GmbH, and Sanofi Winthrop Industrie’s (collectively, “Plaintiffs”) Motion
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`to Stay (the “Motion”).
`
`I.
`
`INTRODUCTION
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`This case involves unique timing issues that make it unlike any other Hatch-Waxman
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`action before this Court and make a stay in this case unfairly prejudicial to Mylan GmbH. The
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`insulin products at issue here are currently subject to approval under the Hatch-Waxman Act.
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`However, as of March 23, 2020, these products will immediately transition to being subject to
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`approval under a separate regulatory process known as the Biologics Price Competition and
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`Innovation Act (“BPCIA”). According to the U.S. Food and Drug Administration (“FDA”), this
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`means that if any application for insulin products—such as Mylan GmbH’s application—is
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`pending as of the March 23, 2020 transition date, FDA will never approve it. Accordingly, the
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`transition date makes the timeline in this case more urgent than in a typical Hatch-Waxman case
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`and warrants denial of Plaintiffs’ Motion.
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`Plaintiffs filed both this action and a related action in the District of New Jersey, despite
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`knowing that a venue challenge in New Jersey was “likely.” See Dkt. No. 42 at 1, 3. Both
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`actions involve identical parties, patents, and infringement allegations. In the New Jersey action,
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`venue is heavily disputed and unresolved, no discovery has occurred, and there is no case
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`schedule. Moreover, Plaintiffs intend to delay resolution of the venue challenge by requesting
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`suspension of briefing on Defendants’ motion to pursue unnecessary and irrelevant discovery
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`purportedly relating to venue. The Supreme Court and Federal Circuit recently clarified the
`
`permissible venues for patent litigation pursuant to 28 U.S.C. § 1400(b). See TC Heartland LLC
`
`v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514, 1519 (2017); In re Cray, 871 F.3d 1355, 1360
`
`1
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`Sanofi Exhibit 2019.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 6 of 20 PageID #: 1193
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`(Fed. Cir. 2017). Pursuant to § 1400(b), New Jersey is not a proper venue for this patent dispute.
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`Under these legal and factual circumstances, the Court should deny Plaintiffs’ Motion.
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`Plaintiffs also lack a sufficient basis to request a stay pursuant to the Court’s
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`discretionary powers because they will suffer no prejudice in the absence of a stay. Plaintiffs
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`chose to file this action in this District. The complaint affirmatively alleges that this Court has
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`competent jurisdiction to preside over this matter. Mylan GmbH should not be forced to run out
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`the clock on its pending application because of Plaintiffs’ decision to forum shop and tie up the
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`Court’s docket as a “backup plan” in the likely event they are unable to litigate in New Jersey.1
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`Defendants stand ready to efficiently litigate this suit in this forum. Despite Plaintiffs’ self-
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`serving, hopeful speculation regarding the outcome of Defendants’ venue challenge in the New
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`Jersey action, there is no just cause to delay this action, especially in light of the grave prejudice
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`Mylan GmbH may suffer. Accordingly, Plaintiffs’ Motion should be denied.
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`II.
`
`FACTUAL BACKGROUND
`
`A.
`
`The District of New Jersey Action
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`On October 24, 2017, Plaintiffs filed a complaint against Defendants in the United States
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`District Court for the District of New Jersey, based on Mylan GmbH’s filing of New Drug
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`Application (“NDA”) No. 210605 for insulin glargine products.2 Ex. 1 (New Jersey complaint).
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`Mylan GmbH is the sole NDA applicant, and Mylan GmbH—not any other party—sent the
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`notice letter to Plaintiffs. Notwithstanding, Plaintiffs’ complaint improperly names as
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`1 As further evidence of Plaintiffs’ forum shopping, Plaintiffs are currently litigating similar
`infringement allegations involving eleven of the patents-in-suit against Merck in an action filed
`in the District of Delaware. See Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A.
`No. 16-cv-812,-RGA (“Merck Delaware Action”).
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`2 The reference listed drugs for Mylan’s NDA products are Lantus® and Lantus® SoloSTAR®.
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`2
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`Sanofi Exhibit 2019.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 7 of 20 PageID #: 1194
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`defendants irrelevant parties Mylan N.V., Mylan Inc., and Mylan Pharmaceuticals Inc. The
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`complaint alleges infringement of 18 U.S. patents: Nos. 7,476,652, 7,713,930, 7,918,833,
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`8,512,297, 8,556,864, 8,603,044, 8,679,069, 8,992,486, 9,011,391, 9,233,211, 9,408,979,
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`9,526,844, 9,533,105, 9,561,331, 9,604,008, 9,604,009, 9,610,409, and 9,623,189 (collectively,
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`“the patents-in-suit”). Id. ¶¶ 101-172.3
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`Defendants moved to dismiss the complaint for improper venue, lack of subject matter
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`jurisdiction, and failure to state a claim pursuant to Federal Rules of Civil Procedure 12(b)(3),
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`12(b)(1), and 12(b)(6), respectively. Plaintiffs have yet to respond, and the court has not ruled
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`on the motion. Indeed, Plaintiffs intend to request a suspension of briefing on Defendants’
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`motion to accommodate irrelevant discovery allegedly relating to venue. Ex. 2. Defendants
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`have not filed an answer or otherwise participated in the New Jersey action for any purpose other
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`than the motion to dismiss. The New Jersey court recently set a date for an initial scheduling
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`conference but no scheduling order has been discussed by the parties or entered.
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`B.
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`This Action
`
`On October 26, 2017, Plaintiffs filed a complaint in this Court, alleging infringement of
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`the patents-in-suit based on the filing of Mylan GmbH’s NDA. Dkt. No. 1. Defendants
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`answered on October 31, 2017 (Dkt. No. 8) and filed an amended answer on November 21,
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`2017, in which Mylan GmbH asserted counterclaims. Dkt. No. 43. A scheduling conference is
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`presently set for January 23, 2018 (Dkt. No. 21), but Defendants are seeking an earlier
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`conference for the reasons set forth herein and in Defendants’ Motion Requesting an Expedited
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`3 Plaintiffs also improperly seek declaratory judgments of infringement of the patents-in-suit
`pursuant to § 271(a)-(c). Id. ¶¶ 173-298.
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`3
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`Sanofi Exhibit 2019.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 8 of 20 PageID #: 1195
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`Scheduling Conference, concurrently filed. Defendants stand prepared to serve written
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`discovery at the earliest opportunity.
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`C.
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`BPCIA
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`Biological products have historically been subject to approval pursuant to § 505 of the
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`Hatch-Waxman Act. However, starting March 23, 2020, these products will transition to a
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`separate regulatory approval process under the BPCIA. FDA has interpreted the transition
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`provision to require submission and final approval by March 23, 2020, meaning that any NDA
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`for a biological product submitted pursuant to § 505—including Mylan GmbH’s insulin glargine
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`products—that has not received final approval by March 23, 2020 will not be able to be
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`approved. See Ex. 3 at 5. Specifically, FDA’s Draft Guidance states:
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`FDA interprets this provision to mean that the Agency will not approve any application
`under section 505 of the FD&C Act for a biological product subject to the transition
`provisions that is pending or tentatively approved “on” March 23, 2020, even though
`section 7002(e)(2) of the BPCI Act expressly permits submission of an application under
`section 505 of the FD&C Act “not later than” March 23, 2020, if certain criteria are met.
`
`Id. (emphasis added) (footnote omitted).
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`III. ARGUMENT
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`Plaintiffs’ request for a stay should be denied at least because Plaintiffs’ arguments in
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`favor of a stay are strained and unconvincing. Any attempt to draw out this litigation past the
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`expiry of the BPCIA’s transition period may place approval of Mylan GmbH’s pending NDA at
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`risk. Given the substantial harm a stay would cause Mylan GmbH, Plaintiffs have fallen well
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`short of their burden. See Williford v. Armstrong World Indus., Inc., 715 F.2d 124, 127 (4th Cir.
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`1983) (plaintiffs bear the burden to “justify [a stay] by clear and convincing circumstances
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`outweighing potential harm to the [non-moving] party” and “make out a clear case of hardship
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`or inequity in being required to go forward”) (internal quotations omitted) (emphasis added).
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`4
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`Sanofi Exhibit 2019.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 9 of 20 PageID #: 1196
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`The first-to-file rule does not apply under these circumstances, and there is no hardship or
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`prejudice to Plaintiffs that would warrant a stay.
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`A.
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`The First-to-File Rule Does Not Apply
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`The first-to-file rule does not apply here for several reasons. First, Courts have
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`consistently and routinely recognized that forum shoppers are not allowed to invoke the first-to-
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`file rule. See, e.g., Novartis Pharms. Corp. v. Mylan Pharms. Inc., No. 1:14-CV-00106, D.I. 47
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`at 9 (N.D. W. Va. Jan. 27, 2015) (“Novartis I”) (citing EEOC v. Univ. of Pa., 850 F.2d 969, 976
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`(3d Cir. 1988); Pfizer, Inc. v. Mylan, Inc., No. 09-cv-0079, 2009 WL 10270101, at *2 n.2 (N.D.
`
`W. Va. Nov. 20, 2009); Ellicott Mach. Corp. v. Modern Welding Co., 502 F.2d 178, 181 (4th
`
`Cir. 1974)); see also Aventis Pharma Deutschland GmbH v. Lupin Ltd., 403 F. Supp. 2d 484,
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`489-90 (E.D. Va. 2005). Second, the first-to-file rule does not apply where, as here, the issue of
`
`venue in the parallel litigation is unsettled and vigorously disputed. See, e.g., Novartis I Dkt. No.
`
`47 at 12; Genentech, Inc. v. Eli Lilly & Co., 998 F.2d 931, 938 (Fed. Cir. 1993). Third, this
`
`action is more advanced than the New Jersey action, not behind it. Wenzel v. Knight, No. 3:14-
`
`cv-00432, 2015 WL 222179, at *6 (E.D. Va. Jan. 14, 2015) (“[C]ourts have declined to defer to
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`the first-filed action when little if anything has been done to advance that action to trial.”)
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`(quoting Affinity Memory & Micro, Inc. v. K & Q Enters., Inc., 20 F. Supp. 2d 948, 954
`
`(E.D.Va.1998)); Queensberry v. Volvo Grp. N. Am., Inc., No. 1:09-cv-00022, 2009 WL 648658,
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`at *3-4 (W.D. Va. Mar. 10, 2009).
`
`5
`
`Sanofi Exhibit 2019.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 10 of 20 PageID #: 1197
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`1.
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`Forum Shopping Precludes Application of the First-To-File Rule
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`Even if this Court were to determine that the first-to-file rule applies, it should still deny
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`Plaintiffs’ Motion because this case is subject to at least one or more exceptions to the rule.4
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`“The first-to-file rule is subject to various exceptions, including consideration of whether the
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`balance of convenience weighs in favor of the second-filed court’s continued exercise of
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`jurisdiction over the suit, whether the suit is filed in bad faith, or whether the suit is filed for the
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`purpose of forum shopping.” Novartis I, Dkt. No. 47 at 9 (citing EEOC, 850 F.2d at 976; Ellicott
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`Mach. Corp., 502 F.2d at 181-82).
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`First, although the first-filed court typically determines whether convenience favors the
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`second-filed court’s continued exercise of jurisdiction over the suit (id. (citing Touchstone
`
`Research Lab, Ltd. v. Anchor Equip. Sales, Inc., 294 F. Supp. 2d 823, 828 (N.D.W. Va. 2003))),
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`here there is no parallel motion to stay in New Jersey. Nonetheless, the convenience factor
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`strongly favors the continued progression of this action. This action is underway, whereas the
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`parties have not completed briefing on Defendants’ motion to dismiss the New Jersey action, and
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`Plaintiffs seek to delay it further. Plaintiffs recently stated their intent to request a suspension of
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`briefing to pursue irrelevant discovery allegedly related to Defendants’ motion. Thus, the parties
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`should continue to pursue this action to prevent needless and prejudicial delay of resolution of
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`the underlying dispute.
`
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`4 Plaintiffs cite dicta in Pfizer, Inc. v. Mylan, Inc. to argue that it is not within the province of the
`second-filed court to determine whether an exception to the first-to-file rule applies. See Dkt.
`No. 42 at 8 (citing No. 09-cv-0079-IMK, 2009 WL 10270101, at *2 (N.D. W. Va. Nov. 20,
`2009)). Pfizer, when properly characterized, supports Defendants’ argument, because the
`second-filed court in Pfizer explicitly determined whether an exception to the first-to-file rule
`applies – just as the Court should do here. See Pfizer, 2009 WL 10270101, at *2-3.
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`6
`
`Sanofi Exhibit 2019.010
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 11 of 20 PageID #: 1198
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`Second, Plaintiffs’ attempt at forum shopping creates a further exception to the first-to-
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`file rule. Despite the fact that New Jersey is not a proper venue for litigation as to any
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`Defendant, Plaintiffs selected the District of New Jersey as their forum of choice. Plaintiffs even
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`acknowledged that a venue challenge was likely in New Jersey. See Dkt. No. 42 at 1, 3. Thus, it
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`is Plaintiffs that are seeking to litigate in a forum they hope will be advantageous—not
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`Defendants, which seek only to litigate in a forum where their constitutional due process rights
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`will not be violated by the exercise of venue over them.
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`Plaintiffs seek to justify their forum shopping by referring to this case as a so-called
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`protective measure. Id. at 4-6. However, nothing in the Hatch-Waxman Act requires or
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`condones the filing of duplicative suits. Plaintiffs rely on Pfizer and several decisions from
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`outside of this Circuit to argue that staying second-filed “protective suits” is common practice in
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`Hatch-Waxman litigations. Id. The facts of Pfizer and the other cases cited by Plaintiffs,
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`however, are inapposite. Pfizer was not decided in the context of a venue or jurisdictional
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`dispute. See Pfizer, 2009 WL 10270101, at *1. Both Celgene and Abbott Labs involved motions
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`to transfer where the court had already reached a resolution on the jurisdictional dispute in the
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`first-filed case. See Celgene Corp. v. Abrika Pharm., Inc., No. 06-cv-5818, 2007 WL 1456156,
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`at *4 (D.N.J. May 17, 2007); Abbott Labs. v. Mylan Pharm., Inc., No. 05-cv-6561, 2006 WL
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`850916, at *8 (N.D. Ill. Mar. 28, 2006). Defendants’ venue dispute in the first-filed case is
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`pending. In Apotex, where Apotex Inc. and Apotex Corp. were defendants, only Apotex Inc.
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`challenged jurisdiction. Pfizer Inc. v. Apotex Inc., 640 F. Supp. 2d 1006 (N.D. Ill. 2009). Here,
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`in contrast, all Defendants contest venue in New Jersey.
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`Plaintiffs do not⎯and cannot⎯deny that they intentionally initiated both this action and
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`a related action in the District of New Jersey. Plaintiffs’ attempt at forum shopping provides an
`
`7
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`Sanofi Exhibit 2019.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 12 of 20 PageID #: 1199
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`exception to the first-to-file rule. Thus, the Court should not apply the rule and should deny
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`Plaintiffs’ Motion.
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`2.
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`Venue is Unsettled and Sharply Contested in the New Jersey Action
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`Setting aside Plaintiffs’ forum shopping, the request for a stay should also be denied
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`because the first-to-file rule does not apply where, as here, the ability of the first-filed court to
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`hear the case is unsettled and vigorously disputed. See Novartis I, Dkt. No. 47 at 12; Genentech,
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`Inc., 998 F.2d at 938-39; Orthmann v. Apple River Campground, Inc., 765 F.2d 119, 121 (8th
`
`Cir. 1985).
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`This Court has decided this issue, on similar facts, several times before in favor of the
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`party opposing a stay. See, e.g., Novartis I, Dkt. No. 47; Novartis Pharms. Corp. v. Mylan Inc.,
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`No. 1:14-cv-111, Dkt. No. 38 (N.D. W. Va. Jan. 29, 2015) (“Novartis II”); Boehringer Ingelheim
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`Pharma GmbH & Co. KG v. Mylan Pharms., Inc., No. 1:15-cv-10, Dkt. No. 37 (N.D. W. Va.
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`March 27, 2015). In all of these cases, as in the present case, the ability of the first-filed matter
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`to proceed was vigorously disputed, and thus the Court denied a stay of the second-filed case.
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`The holdings in Novartis I, Novartis II, and Boehringer are directly applicable to the
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`present facts. Specifically, in Novartis I and Novartis II, this Court denied the plaintiffs’ motion
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`to stay, where the Court presiding over the first-filed case had not yet decided a jurisdictional
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`challenge, and thus the defendant could have been “faced with the possibility of both a stay in
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`this case and a long wait in the District of Delaware.” Novartis I, D.I. 47 at 14; Novartis II, D.I.
`
`38 at 14. Although the dispute in the parallel proceeding is over venue rather than personal
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`jurisdiction, the same risk of a protracted delay exists in the present case.5
`
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`5 Notably, in Novartis I and Boehringer the Court denied a motion to stay despite the parties
`having begun discovery in the first-filed action. Novartis I, Dkt. No. 47 at 5, n. 10; Boehringer,
`(continued...)
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`8
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`Sanofi Exhibit 2019.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 13 of 20 PageID #: 1200
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`Indeed, denial of Plaintiffs’ Motion is even more apt given that Defendants are
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`challenging venue rather than personal jurisdiction in New Jersey. Plaintiffs cite a laundry list of
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`cases where second-filed cases were stayed in favor of a first-filed suit, but these cases all
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`involve a co-pending jurisdictional dispute rather than a venue dispute.6 See Dkt. No. 42 at 4-5
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`n.2. Both the Supreme Court and Federal Circuit have recently indicated their intention to limit
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`the exercise of venue over out-of-state defendants with no physical presence in the forum. See
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`Symbology Innovations, LLC v. Lego Sys., Inc., No. 2:17-CV-86, 2017 WL 4324841, at *1 (E.D.
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`Va. Sept. 28, 2017) (“Two recent decisions . . . have clarified that the permissible venues for
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`patent litigation are narrower than has been allowed in recent practice.”).
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`While a plaintiff is generally entitled to select its forum, that rationale is, of course,
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`meaningless when the forum of choice does not have venue over the defendant. None of the
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`Defendants are incorporated in or have a principal place of business in New Jersey. See Ex. 1,
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`¶¶ 5, 7, 9, 11. The alleged act of infringement, Mylan GmbH’s filing of its NDA, did not occur
`
`
`(...continued from previous page)
`D.I. 37 at 8. Here, no discovery has occurred, and thus denial of a stay is even more appropriate
`than it was in these prior decisions.
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`6 Most of the laundry list of string cites in Plaintiffs’ brief (Dkt. No. 42 at 4-5 n.2) are also not
`applicable to the instant action because the cases involve a situation where either (1) the
`defendants did not object to the stay; or (2) the jurisdictional dispute in the first-filed case was
`already settled. Purdue Pharma L.P. v. Mylan Pharm. Inc., et., No. 15-cv-00232-IMK, Dkt. No.
`11 at 1 (N.D. W. Va. Apr. 6, 2016) (parties submitted a joint motion in favor of stay); Pfizer Inc.
`v. Mylan Inc., No. 15-cv-00188-IMK, Dkt. No. 37 (N.D. W. Va. May 2, 2016) (defendants did
`not object to the stay); Noven Pharm., Inc. v. Mylan Techs., Inc., No. 15-cv-00194-IMK, Dkt.
`No. 95 (N.D. W. Va. Apr. 15, 2016) (same); Janssen Biotech, Inc. v. Mylan Pharm., Inc., No.
`15-cv-00130-IMK, Dkt. No. 31 at 1 (N.D. W. Va. Feb. 11, 2016) (same); AstraZeneca AB v.
`Mylan Pharm., Inc., No. 14-cv-00094-IMK, Dkt. No. 34 at 1 (N.D. W. Va. Dec. 12, 2014) (the
`jurisdictional challenge in the first-filed suit was already resolved); Acorda Therapeutics Inc. v.
`Mylan Pharm. Inc., No. 1:14-cv-139-IMK, Dkt. No. 59 at 9-10 (N.D.W. Va. Feb. 11, 2015)
`(same); Pfizer Inc. v. Mylan Pharm. Inc., No. 15-cv-00013-IMK, Dkt. No. 68 at 4 (N.D. W. Va.
`July 31, 2015) (same).
`
`9
`
`Sanofi Exhibit 2019.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 14 of 20 PageID #: 1201
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`in New Jersey. See id., ¶ 1 (identifying filing of NDA as act of infringement). Nor does any
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`Defendant have a regular and established place of business in New Jersey.
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`These facts present exactly the type of circumstances that the Supreme Court and Federal
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`Circuit have recently determined to constitute improper venue. See TC Heartland, 137 S. Ct. at
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`1519; In re Cray, 871 F.3d at 1360. Granting a stay would therefore only cause needless delay
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`in this Court for a New Jersey action that is likely to be dismissed.
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`While the venue dispute in New Jersey drags on, the clock continues to run on Mylan
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`GmbH’s pending NDA. Thus, due to the unresolved venue dispute and lack of progression in
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`the New Jersey action, the Court should deny Plaintiffs’ Motion.
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`3.
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`This Litigation Is Further Progressed Than the New Jersey Action
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`Plaintiffs’ invocation of the first-to-file rule is also improper in view of the fact that the
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`present case is further along than the New Jersey case. Wenzel, 2015 WL 222179, at *6. Here,
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`pleadings are complete, whereas in New Jersey, briefing is ongoing in connection with
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`Defendants’ motion to dismiss. Moreover, given that the issue of venue in the New Jersey action
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`is unsettled and vigorously disputed, there is no reason to believe that the New Jersey case is
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`likely to move forward much beyond the pleading stage any time soon. Plaintiffs have already
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`made clear that they intend to request irrelevant discovery rather than respond to Defendants’
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`motion. Ex. 2.
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`Time is of the essence for resolution of this dispute. Not only is the litigation in this
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`Court already further progressed than the New Jersey action, but it is likely to remain that way.
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`New Jersey has a longer median time from filing to trial—over 12 months longer—than in this
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`Court. See Federal Court Management Statistics, June 2017 – District Courts, United States
`
`10
`
`Sanofi Exhibit 2019.014
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 15 of 20 PageID #: 1202
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`Courts (June 30, 2017),7 (31.4 months in New Jersey compared to 19.1 months in this Court per
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`the most recently available statistics for each court). Plaintiffs may argue that the New Jersey
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`court has ordered an earlier scheduling conference date than this Court, but the New Jersey court
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`is nevertheless unlikely to reach trial before the end of the BPCIA’s transition period while this
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`Court is likely to do so. Also, because New Jersey courts do not typically set trial dates in
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`advance, trial in the New Jersey action is an uncertain and moving target.
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`A key fact underlying several of the cases cited by Plaintiffs (Dkt. No. 42 at 4-5 n.2) is
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`the significant progress made by the courts in the first-filed suit; progress that is not present in
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`the first-filed suit here. See Pfizer, Inc. v. Mylan, Inc., No. 1:15-cv-00004-IMK, Dkt. No. 41 at
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`10 (N.D.W. Va. Apr. 24, 2015) (finding significant that the judge had issued a scheduling order);
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`Salix Pharm. Ltd. v. Mylan Pharm. Inc., No. 1:14-cv-152-IMK, Dkt. No. 47 at 10 (N.D.W. Va.
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`Feb. 18, 2015) (same). In contrast to the above decisions, the New Jersey action is virtually
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`stagnant and likely to continue to lag behind this Court.
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`4.
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`The Prerequisites for the First-to-File Rule Are Not Met
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`Moreover, the first-to-file rule does not support staying this action because the
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`prerequisites for the rule’s applicability are not met in this case. Courts typically consider three
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`factors in determining whether the first-to-file rule applies: (1) chronology; (2) identity of
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`parties; and (3) similarity of issues. See, e.g., Novartis II, D.I. 38 at 7-8 (citing Intersearch
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`Worldwide, Ltd. v. Intersearch Grp., Inc., 544 F. Supp. 2d 949, 957 (N.D. Cal. 2008)). Here, the
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`New Jersey action was filed before this action, but this action is more advanced. In this action,
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`the pleadings are settled and a Rule 16 conference is scheduled. In New Jersey, the pleadings are
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`not settled and the Court has not yet resolved the dispute regarding venue.
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`7 http://www.uscourts.gov/sites/default/files/data_tables/fcms_na_distprofile0331.2017.pdf
`
`11
`
`Sanofi Exhibit 2019.015
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:17-cv-00181-IMK Document 44 Filed 11/22/17 Page 16 of 20 PageID #: 1203
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`B.
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`The Court Should Decline Plaintiffs’ Invitation to Delay Resolution of this
`Dispute
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`Courts have broad discretion regarding whether to stay proceedings to control their
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`dockets. See Landis v. North Am. Co., 299 U.S. 248, 254-255 (19