Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 1 of 70 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`SANOFI-AVENTIS U.S. LLC,
`SANOFI-AVENTIS DEUTSCHLAND
`GMBH, and SANOFI WINTHROP
`INDUSTRIE,
`
`Plaintiffs,
`
`v.
`
`MYLAN N.V., MYLAN GMBH, MYLAN
`INC., and MYLAN PHARMACEUTICALS
`INC.,
`
`Defendants.
`
`Civil Action No. ___________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`Electronically Filed
`
`
`
`Plaintiffs Sanofi-Aventis U.S. LLC (“Sanofi U.S.”), Sanofi-Aventis Deutschland GmbH
`
`(“Sanofi GmbH”), and Sanofi Winthrop Industrie (“SWIND”) (collectively, “Plaintiffs” or
`
`“Sanofi”), by and through their attorneys, for their Complaint against Mylan N.V., Mylan
`
`GmbH, Mylan Inc., and Mylan Pharmaceuticals Inc. (“Mylan Pharma”) (collectively, “Mylan”
`
`or “Defendants”), hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C. § 100, et seq. arising from Mylan’s filing of New Drug Application (“NDA”)
`
`No. 210605 with the United States Food and Drug Administration (“FDA”), seeking approval to
`
`commercially market Mylan’s proposed copies of Sanofi’s Lantus® and Lantus® SoloSTAR®
`
`drug products (“Proposed Products”) prior to the expiration of United States Patent Nos.
`
`7,476,652 (“the ’652 patent”), 7,713,930 (“the ’930 patent”), 7,918,833 (“the ’833 patent”),
`
`8,512,297 (“the ’297 patent”), 8,556,864 (“the ’864 patent”), 8,603,044 (“the ’044 patent”),
`
`8,679,069 (“the ’069 patent”), 8,992,486 (“the ’486 patent”), 9,011,391 (“the ’391 patent”),
`
`Sanofi Exhibit 2007.001
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 2 of 70 PageID: 2
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`9,233,211 (“the ’211 patent”), 9,408,979 (“the ’979 patent”), 9,526,844 (“the ’844 patent”),
`
`9,533,105 (“the ’105 patent”), 9,561,331 (“the ’331 patent”), 9,604,008 (“the ’008 patent”),
`
`9,604,009 (“the ’009 patent”), 9,610,409 (“the ’409 patent”), and 9,623,189 (“the ’189 patent”),
`
`(collectively, “the patents-in-suit”), which cover Lantus® and/or Lantus® SoloSTAR®.
`
`THE PARTIES
`
`2.
`
`Plaintiff Sanofi U.S. is a Delaware limited liability corporation with its principal
`
`place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
`
`3.
`
`Plaintiff Sanofi GmbH is a German corporation with its principal place of
`
`business located at Industriepark Hoechst, Frankfurt Am Main, Germany D-65926.
`
`4.
`
`Plaintiff SWIND is a French corporation with its principal place of business
`
`located at 20 Avenue Raymond Aron, 92160 Antony, France.
`
`5.
`
`On information and belief, Defendant Mylan N.V. is a company organized and
`
`existing under the laws of the Netherlands, with its global headquarters and principal offices
`
`located at Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL,
`
`England. On information and belief, Mylan N.V. is in the business of, among other things,
`
`marketing and selling follow-on versions of branded pharmaceutical products for the United
`
`States market, alone and/or through its subsidiaries, agents, and affiliates. On information and
`
`belief, Mylan N.V. is the ultimate corporate parent of Mylan GmbH, Mylan Inc., and Mylan
`
`Pharma.
`
`6.
`
`On information and belief, Mylan N.V. conducts business operations, directly or
`
`through its subsidiaries, agents and/or affiliates, in the State of New Jersey.
`
`7.
`
`On information and belief, Defendant Mylan GmbH is a company organized and
`
`existing under the laws of Switzerland, with a principal place of business at Thurgauerstrasse 40,
`
`CH-8050 Zurich, Switzerland. On information and belief, Mylan GmbH is in the business of,
`
`
`
`2
`
`Sanofi Exhibit 2007.002
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 3 of 70 PageID: 3
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`among other things, marketing and selling follow-on versions of branded pharmaceutical
`
`products for the United States market, alone and/or through its subsidiaries, agents, and affiliates.
`
`On information and belief, Mylan GmbH is a wholly-owned subsidiary of Mylan N.V., is
`
`controlled by Mylan N.V., and is an agent and/or affiliate of Mylan Pharma and Mylan Inc.
`
`8.
`
`On information and belief, Mylan GmbH conducts business operations, directly or
`
`through its subsidiaries, agents and/or affiliates, in the State of New Jersey.
`
`9.
`
`On information and belief, Defendant Mylan Inc. is a company organized and
`
`existing under the laws of the Commonwealth of Pennsylvania with its principal place of
`
`business at 1000 Mylan Boulevard, Canonsburg, Pennsylvania 15317. On information and
`
`belief, Mylan Inc. is in the business of, among other things, marketing and selling follow-on
`
`versions of branded pharmaceutical products for the United States market, alone and/or through
`
`its subsidiaries, agents, and affiliates. Mylan Inc. is a wholly-owned subsidiary of Mylan N.V.,
`
`is controlled by Mylan N.V., and is an agent and/or affiliate of Mylan GmbH and Mylan Pharma.
`
`10.
`
`On information and belief, Mylan Inc. conducts business operations, directly or
`
`through its subsidiaries, agents and/or affiliates, in the State of New Jersey.
`
`11.
`
`On information and belief, Defendant Mylan Pharma is a company organized and
`
`existing under the laws of the State of West Virginia, having a principal place of business at 781
`
`Chestnut Ridge Road, Morgantown, West Virginia 26505-4310. On information and belief,
`
`Mylan Pharma is in the business of manufacturing and selling follow-on versions of branded
`
`pharmaceutical products for the United States market alone and/or through its subsidiaries,
`
`agents, and affiliates. On information and belief, Mylan Pharma is wholly-owned subsidiary of
`
`Mylan Inc., is controlled by Mylan Inc., and is an agent and/or affiliate of Mylan GmbH.
`
`
`
`3
`
`Sanofi Exhibit 2007.003
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 4 of 70 PageID: 4
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`12.
`
`On information and belief, Mylan Pharma conducts business operations, directly
`
`or through its subsidiaries, agents and/or affiliates, in the State of New Jersey.
`
`13.
`
`On information and belief, Mylan N.V. and Mylan GmbH operate in the United
`
`States and in the State of New Jersey through Mylan Inc. and Mylan Pharma. On information
`
`and belief, Mylan Inc. and Mylan Pharma are United States agents for Mylan GmbH and Mylan
`
`N.V. for purposes including, but not limited to, corresponding with the Food and Drug
`
`Administration (“FDA”).
`
`14.
`
`For example, on information and belief, at least Mylan Inc. and Mylan GmbH
`
`worked in concert to prepare and file NDA No. 210605 by conducting a “Non-inferiority Study
`
`to Compare the Efficacy and Safety of Mylan’s Insulin Glargine With Lantus® in Type 2
`
`Diabetes Mellitus Patients” and a “Non-inferiority Study to Compare the Efficacy and Safety of
`
`Mylan’s Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients.” See Exhibits S
`
`and T. Mylan Inc. is listed as the Sponsor and Responsible Party on these studies and Mylan
`
`GmbH is listed as Collaborator. Id.
`
`15.
`
`On June 5, 2017, Mylan Pharma filed petitions for Inter Partes Review of the
`
`’652 and ’930 patents. Mylan Pharms. Inc. v. Sanofi-Aventis Deutschland GmbH, IPR2017-
`
`01526, Paper 2 (P.T.A.B. June 5, 2017); Mylan Pharms. Inc. v. Sanofi-Aventis Deutschland
`
`GmbH, IPR2017-01528, Paper 2 (P.T.A.B. June 5, 2017). In accordance with 37 C.F.R. §
`
`42.8(b)(1), Mylan identified Mylan Pharma, Mylan Inc., Mylan GmbH, and Mylan N.V., among
`
`others, as real parties-in-interest. Id. at 2.
`
`16.
`
`That Mylan Pharma, Mylan Inc., Mylan GmbH, and Mylan N.V. are real parties-
`
`in-interest to the petitions filed in IPR2017-01526 and IPR2017-01528 indicates that all four
`
`Mylan entities stand to benefit from approval of NDA No. 210605.
`
`
`
`4
`
`Sanofi Exhibit 2007.004
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 5 of 70 PageID: 5
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`17.
`
`On information and belief, the acts of Mylan GmbH complained of herein were
`
`done at the direction and/or, with the authorization of, and/or with the cooperation, participation,
`
`and assistance of Mylan N.V., Mylan Inc., and Mylan Pharma.
`
`18.
`
`On information and belief, Mylan Inc. is the registrant organization for the
`
`website mylan.com. See Exhibit U. Mylan Inc. has used Mylan Pharma’s address as the
`
`registrant address for the website mylan.com, further indicating that Defendants operate as one
`
`entity. See id.
`
`19.
`
`On information and belief, Mylan holds itself out as having contacts with the
`
`State of New Jersey by stating on its website that it aims to provide a “Better Health for a Better
`
`New Jersey.” See Exhibit V. Specifically, the website reports that in “[i]n 2016, Mylan generics
`
`saved New Jersey $700 million.” Id. Further, it states that “Mylan is the leader in the fight
`
`against many of New Jersey’s most prevalent diseases.” Id.
`
`20.
`
`On information and belief, Mylan holds itself out as having contacts with the
`
`State of New Jersey by stating in its website that:
`
`Mylan’s commitment to expanding access to medicine extends beyond just
`offering products. Take potentially life-threatening allergic reactions, or
`anaphylaxis. These reactions can occur quickly and without warning. Of the
`nearly 8.9 million people in New Jersey, approximately 178,000 may be at risk.
`
`Exhibit W.
`
`21.
`
`On information and belief, Mylan holds itself out as having contacts with the
`
`State of New Jersey by stating in its website that:
`
`Over the past five years, 54,424 free epinephrine auto-injectors have been
`provided to 3,577 schools in New Jersey, approximately 81% of the state’s
`schools. Since the program began in 2012, epinephrine auto-injectors provided
`through the EpiPen4Schools program have been used 109 times in New Jersey to
`treat an anaphylactic reaction in the school setting.
`
`Id. at 2.
`
`
`
`5
`
`Sanofi Exhibit 2007.005
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 6 of 70 PageID: 6
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`22.
`
`On information and belief, Mylan GmbH, Mylan N.V., Mylan Inc., and Mylan
`
`Pharma hold themselves out as a unitary entity and represent to the public that their activities are
`
`directed, controlled, and carried out as a single entity.
`
`JURISDICTION AND VENUE
`
`23.
`
`24.
`
`Plaintiffs repeat and re-allege paragraphs 1-22 above as if fully set forth herein.
`
`This is an action for patent infringement and arises under the patent laws of the
`
`United States, Title 35, United States Code. This Court has jurisdiction over the subject matter
`
`of this action pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`25.
`
`On information and belief, Mylan GmbH, with the assistance and/or direction of
`
`Mylan N.V., Mylan Inc., and/or Mylan Pharma, develops, formulates, manufactures, imports,
`
`offers for sale, sells, commercializes, markets, and/or distributes follow-on versions of branded
`
`pharmaceutical products in/into the United States, including in/into the State of New Jersey.
`
`26.
`
`As part of the foregoing act of infringement, Defendant Mylan GmbH transmitted
`
`a Notice of Certification (“Notice Letter”) pursuant to 21 U.S.C. § 355(b)(3) and 21 C.F.R. §
`
`314.52 regarding NDA No. 210605 to, inter alia, Sanofi U.S. located in New Jersey.
`
`27.
`
`On information and belief, Mylan, N.V., Mylan Inc., and Mylan Pharma acted in
`
`concert with Mylan GmbH to develop Mylan GmbH’s copies of Sanofi’s Lantus® and Lantus®
`
`SoloSTAR® drug products (“Proposed Products”).
`
`28.
`
`On information and belief, Mylan GmbH, acting in concert with Mylan N.V.,
`
`Mylan Inc., and Mylan Pharma, prepared and filed NDA No. 210605, seeking approval from the
`
`FDA to sell its Proposed Products throughout the United States, including within the State of
`
`New Jersey.
`
`29.
`
` On information and belief, Mylan, N.V., Mylan Inc., and Mylan Pharma, acting
`
`in concert with Mylan GmbH, participated in the preparation and/or filing of NDA No. 210605,
`
`
`
`6
`
`Sanofi Exhibit 2007.006
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 7 of 70 PageID: 7
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`seeking approval from the FDA to sell the Proposed Products throughout the United States,
`
`including within the State of New Jersey.
`
`30. Mylan N.V., Mylan GmbH, Mylan Inc., and Mylan Pharma therefore committed
`
`an act of infringement in New Jersey, by participating in the preparation, filing, and submission
`
`of New Drug Application (“NDA”) No. 210605 pursuant to § 505(b)(2) of the FFDCA to FDA,
`
`accompanied by a Paragraph IV Certification.
`
`31.
`
`This Court has personal jurisdiction over Defendants because, inter alia, they
`
`have committed an act of patent infringement under 35 U.S.C. § 271(e)(2), and intend a future
`
`course of conduct that includes acts of patent infringement in New Jersey. These acts have led
`
`and will lead to foreseeable harm and injury to Plaintiffs in New Jersey. For example, on
`
`information and belief, following approval of NDA No. 210605, Defendants intend to and will
`
`work in concert to make, use, import, sell, and/or offer for sale the Proposed Products that are the
`
`subject of NDA No. 210605 in/into the United States, including in/into the State of New Jersey,
`
`prior to the expiration of the patents-in-suit.
`
`32.
`
`This Court has personal jurisdiction over Defendants because Defendants
`
`maintain continuous and systematic contacts with this judicial district. Either directly, or
`
`through their subsidiaries, agents, and/or affiliates, Defendants have conducted and continue to
`
`conduct business in this judicial district, including, upon information and belief, by
`
`manufacturing, marketing, and selling drug products throughout the United States and in the
`
`State of New Jersey.
`
`33.
`
`This Court has personal jurisdiction over Mylan N.V. because, inter alia, Mylan
`
`N.V., on information and belief, directly or through its subsidiaries, agents and/or affiliates: (1)
`
`maintains substantial, systemic, and continuous contacts with the State of New Jersey; (2)
`
`
`
`7
`
`Sanofi Exhibit 2007.007
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 8 of 70 PageID: 8
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`regularly transacts and/or solicits business in the State of New Jersey; (3) continuously and
`
`systematically places its products into the stream of commerce for distribution and consumption
`
`in the State of New Jersey and throughout the United States; (4) engages in the regular conduct
`
`of business within this judicial district; (5) derives substantial revenue and income from sales of
`
`its follow-on versions of branded pharmaceutical products throughout the United States,
`
`including in the State of New Jersey; (6) maintains a broad distributorship network within this
`
`State; and (7) intends to manufacture for distribution, market, sell, or distribute the Proposed
`
`Products to residents of this State, which is confirmed by the filing of NDA No. 210605. See
`
`Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755, 759-63 (Fed. Cir. 2016), petition
`
`for cert. denied, Mylan Pharms. Inc. v. Acorda Therapeutics, Inc., No. 16-360 (U.S. Jan. 9,
`
`2017).
`
`34.
`
`This Court has personal jurisdiction over Mylan GmbH because, inter alia, Mylan
`
`GmbH, on information and belief, directly or through its subsidiaries, agents and/or affiliates:
`
`(1) maintains substantial, systemic, and continuous contacts with the State of New Jersey; (2)
`
`regularly transacts and/or solicits business in the State of New Jersey; (3) continuously and
`
`systematically places its products into the stream of commerce for distribution and consumption
`
`in the State of New Jersey and throughout the United States; (4) engages in the regular conduct
`
`of business within this judicial district; (5) derives substantial revenue and income from sales of
`
`its follow-on versions of branded pharmaceutical products throughout the United States,
`
`including in the State of New Jersey; (6) maintains a broad distributorship network within this
`
`State; and (7) intends to manufacture for distribution, market, sell, or distribute the Proposed
`
`Products to residents of this State, which is confirmed by the filing of NDA No. 210605. See
`
`Acorda, 817 F.3d at 759-63.
`
`
`
`8
`
`Sanofi Exhibit 2007.008
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 9 of 70 PageID: 9
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`35.
`
`This Court has personal jurisdiction over Mylan Inc. because, inter alia, Mylan
`
`Inc., on information and belief, directly or through its subsidiaries, agents and/or affiliates: (1) is
`
`registered to do business in New Jersey under entity ID No. 0100971292 and has appointed
`
`Corporation Service Company, Princeton South Corporate Ctr., Suite 160, 100 Charles Ewing
`
`Blvd., Ewing, NJ 08628, as its registered agent for receipt of process; (2) maintains substantial,
`
`systemic, and continuous contacts with the State of New Jersey; (3) regularly transacts and/or
`
`solicits business in the State of New Jersey; (4) continuously and systematically places its
`
`products into the stream of commerce for distribution and consumption in the State of New
`
`Jersey and throughout the United States; (5) engages in the regular conduct of business within
`
`this judicial district; (6) derives substantial revenue and income from sales of its follow-on
`
`versions of branded pharmaceutical products throughout the United States, including in the State
`
`of New Jersey; (7) maintains a broad distributorship network within this State; and (8) intends to
`
`manufacture for distribution, market, sell, or distribute the Proposed Products to residents of this
`
`State, which is confirmed by the filing of NDA No. 210605. See Acorda, 817 F.3d at 759-63.
`
`36.
`
`Additionally, personal jurisdiction over Mylan Inc. is also proper because Mylan
`
`Inc. has previously availed itself of the benefits and protections afforded by the Court by
`
`asserting counterclaims against plaintiffs in this judicial district. See, e.g., Horizon Pharma, Inc.
`
`et al. v. Mylan Pharms. Inc. & Mylan Inc., Civil Action No. 3-15-cv-03327-MLC-DEA (D.N.J.
`
`May 13, 2015); AstraZeneca Pharms. LP et al. v. Mylan Pharms. Inc. & Mylan Inc., Civil Action
`
`No. 1-15-cv-07009-RMB-KMW (D.N.J. Sept. 21, 2015).
`
`37.
`
`This Court has personal jurisdiction over Mylan Pharma because, on information
`
`and belief, directly or through its subsidiaries, agents and/or affiliates, inter alia, Mylan Pharma
`
`(1) is registered to do business in New Jersey under entity ID No. 0100214277; (2) is registered
`
`
`
`9
`
`Sanofi Exhibit 2007.009
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 10 of 70 PageID: 10
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`as a drug manufacturer and wholesale drug distributer under registration number 5003762; (3)
`
`has appointed Corporation Service Company, Princeton South Corporate Ctr., Suite 160, 100
`
`Charles Ewing Blvd., Ewing, NJ 08628, as its registered agent for receipt of process; (4)
`
`maintains substantial, systemic, and continuous contacts with the State of New Jersey; (5)
`
`regularly transacts and/or solicits business in the State of New Jersey; (6) continuously and
`
`systematically places its products into the stream of commerce for distribution and consumption
`
`in the State of New Jersey and throughout the United States; (7) engages in the regular conduct
`
`of business within this judicial district; (8) derives substantial revenue and income from sales of
`
`its follow-on versions of branded pharmaceutical products throughout the United States,
`
`including in the State of New Jersey; (9) maintains a broad distributorship network within this
`
`State; and (10) intends to manufacture for distribution, market, sell, or distribute the Proposed
`
`Products to residents of this State, which is confirmed by the filing of NDA No. 210605. See
`
`Acorda, 817 F.3d at 759-63.
`
`38.
`
`Additionally, personal jurisdiction over Mylan Pharma is also proper because
`
`Mylan Pharma has previously availed itself of the benefits and protections afforded by the Court
`
`by asserting counterclaims against plaintiffs in this judicial district. See, e.g., Horizon Pharma,
`
`Inc. et al. v. Mylan Pharms. Inc. & Mylan Inc., Civil Action No. 3-15-cv-03327-MLC-DEA
`
`(D.N.J. May 13, 2015); AstraZeneca Pharms. LP et al. v. Mylan Pharms. Inc. & Mylan Inc.,
`
`Civil Action No. 1-15-cv-07009-RMB-KMW (D.N.J. Sept. 21, 2015).
`
`39.
`
`40.
`
`This Court therefore has personal jurisdiction over all Defendants.
`
`Venue is proper in this judicial district as to all Defendants pursuant to 28 U.S.C.
`
`§§ 1391 and 1400(b).
`
`41.
`
`Venue is proper as to alien defendant Mylan N.V. under § 1391(c)(3).
`
`
`
`10
`
`Sanofi Exhibit 2007.010
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 11 of 70 PageID: 11
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`42.
`
`43.
`
`Venue is proper as to alien defendant Mylan GmbH under § 1391(c)(3).
`
`Venue is proper as to Mylan Inc. because Mylan Inc. has committed acts of
`
`infringement within the district and has a regular and established place of business located in the
`
`State of New Jersey through at least its subsidiary, Mylan Specialty, located at 110 Allen Road,
`
`4th Floor, Basking Ridge, NJ 07920 (“Basking Ridge Location”). See Exhibits X and Y; see
`
`also Exhibits Z, AA, and BB (each addressing Mylan’s acquisition of Meda, another New
`
`Jersey-based Mylan entity).
`
`44.
`
`On information and belief, Mylan Inc. committed acts of infringement in New
`
`Jersey, and throughout the United States, because it intends to manufacture for distribution,
`
`market, sell, or distribute the Proposed Products to residents in the State of New Jersey, which is
`
`confirmed by the filing of NDA No. 210605. See Acorda, 817 F.3d at 759-63; Bristol-Myers
`
`Squibb Co. v. Mylan Pharm. Inc., No. CV 17-379-LPS, 2017 WL 3980155, at *8-14 (D. Del.
`
`Sept. 11, 2017).
`
`45.
`
`On information and belief, Mylan Inc. has regular and established places of
`
`business located in the State of New Jersey. For example, the Mylan Specialty Basking Ridge
`
`Location is both “regular” and “established” as a place business because it maintains a
`
`permanent and orderly presence within the State of New Jersey. On information and belief, the
`
`Basking Ridge Location functions as Mylan Specialty’s corporate offices, see Exhibit CC, and
`
`Mylan Specialty is registered with the New Jersey Department of Health, and holds a
`
`manufacturer and wholesale license issued by the State of New Jersey. See Exhibit DD.
`
`46.
`
`The Basking Ridge Location is further both “regular” and “established” as a place
`
`of business because Mylan regularly markets its prescription drug products from the Basking
`
`Ridge facility. For example, HOOVERS reports:
`
`
`
`11
`
`Sanofi Exhibit 2007.011
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 12 of 70 PageID: 12
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`When a peanut or a bee threatens your very existence, Mylan Specialty (formerly
`Dey Pharma) is ready to save the day. Its specialty prescription drugs treat severe
`allergic reactions, respiratory diseases, and psychiatric disorders. It markets
`EpiPen autoinjectors used by patients to self-administer epinephrine in case of
`allergic emergencies (anaphylaxis). Its premeasured unit-dose inhalation products
`include bronchodialators use to treat asthma and chronic obstructive pulmonary
`disease (COPD). Brands include the EasiVent and Perforomist breathing devices.
`A subsidiary of generic giant Mylan, Mylan Specialty also offers non-branded
`generic nebulizer treatment and the Emsam transdermal antidepressant patch.
`
`Exhibit X at 2 (emphasis added).
`
`47. Mylan Specialty’s sales activity further demonstrates Mylan’s permanent and
`
`orderly presence within the State of New Jersey. For example, HOOVERS reports:
`
`Operations: The EpiPen is Mylan Specialty's top-selling product, accounting for
`more than half of sales and is the most prescribed treatment for severe allergic
`reactions in the US. The epinephrine auto-injector is a matter of life and death for
`some, and commands more than 95% of the US market share. Meridian Medical
`Technologies manufactures the EpiPen for the company. Mylan Specialty's
`facilities manufacture nebulized products including Perforomist, DuoNeb,
`AccuNeb, and generic albuterol. Perforomist, used in the treatment of COPD,
`chronic bronchitis, and emphysema is another top seller for the company. Mylan
`Specialty uses existing respiratory treatments to develop its patented products
`using its drug delivery technologies.
`
`Id. at 3.
`
`48.
`
`On information and belief, the Basking Ridge Location is a regular and
`
`established place of business for Defendant Mylan Inc. and can be attributed to Defendant Mylan
`
`Inc. because Mylan Inc. holds itself out as “ONE Mylan” with Mylan Specialty and other Mylan
`
`entities. That is, Mylan Inc. describes itself as “ONE Mylan,” with a “horizontally and vertically
`
`integrated platform with global scale.” Exhibit Z at 4.
`
`49.
`
`The Basking Ridge Location can also be attributed to Mylan Inc. because Mylan
`
`Inc. owns Mylan Specialty and exercises attributes of possession or control over the Basking
`
`Ridge Location. For example, on information and belief, Mylan Inc. pays the salaries and
`
`benefits of individuals employed out of the Basking Ridge Location. See Exhibit EE.
`
`
`
`12
`
`Sanofi Exhibit 2007.012
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 13 of 70 PageID: 13
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`50. Mylan Inc. and the other Mylan Defendants have a regular and established place
`
`of business in this District because they operate as “ONE Mylan” with Mylan Specialty and
`
`other Mylan subsidiaries in New Jersey. On information and belief, Mylan Specialty was
`
`formerly known as Dey Pharma until 2012 when Mylan changed the name “as part of its efforts
`
`to align operations under the Mylan brand.” Exhibit X at 3. Specifically, Defendants’ CEO,
`
`Heather Bresch stated in a press release that:
`
`The name change to Mylan Specialty is an important milestone and a natural step
`in our company's evolution. Bringing Dey under the Mylan brand will align our
`specialty business even more directly with everything Mylan stands for –
`innovating to satisfy unmet needs, making reliability and service a habit, doing
`what's right, not what's easy, and impacting the future through passionate
`leadership. Further, operating under one brand will allow us to speak with a
`more unified and powerful voice as we pursue our mission of providing the
`world's 7 billion people access to high quality medicine.
`
`Exhibit CC (emphases added). On information and belief, “ONE Mylan” uses one newsroom for
`
`press releases such as this, and for press releases involving products from various subsidiaries,
`
`including Mylan Specialty. See Exhibits FF, GG, HH and II.
`
`51. Mylan Inc. and the other Mylan Defendants have a regular and established place
`
`of business in this District because they operate as “ONE Mylan” with Mylan Specialty and
`
`other Mylan subsidiaries in the State of New Jersey, as evidenced by shared revenue reporting.
`
`On information and belief, Mylan Specialty’s revenue is reported with Mylan Inc.’s revenue in
`
`the North American segment. In its presentation to investors in 2017, Mylan stated that it has
`
`changed its “segment reporting to reflect ONE Mylan.” Exhibit JJ at 18. Thus, instead of
`
`reporting profitability for two segments—Generic and Specialty—it now reports profitability
`
`based on three regional segments—North America, Europe, and the rest of the world. See id.
`
`52. Mylan Inc., Mylan Pharma, and the other Mylan Defendants have a regular and
`
`established place of business in this District because they operate as “ONE Mylan” with Mylan
`
`
`
`13
`
`Sanofi Exhibit 2007.013
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 14 of 70 PageID: 14
`
`Specialty and other Mylan subsidiaries in New Jersey, demonstrated by the Mylan entities’
`
`request that they be treated as one cohesive business. For example, in a March 3, 2017 comment
`
`in response to an FDA notice and request for information to assess Generic Drug User Fee
`
`Amendments (“GDUFA”) program fees for fiscal year 2018, Mylan Pharma requested that the
`
`“‘affiliated’ corporate entities listed below be consolidated under ‘Mylan Inc.’ for the purposes
`
`of assessing a single GDUFA II program fee[.]” Exhibit KK. The corporate entities listed
`
`included both Mylan Pharma and Mylan Specialty. See id.
`
`53. Mylan Inc., Mylan Pharma, and the other Mylan Defendants have a regular and
`
`established place of business in this District because they operate as “ONE Mylan” with Mylan
`
`Specialty in the State of New Jersey, in part because the Mylan Defendants post job openings for
`
`the Basking Ridge Location on its website. See Exhibit LL.
`
`54.
`
`The Mylan Defendants have a regular and established place of business in this
`
`District because they operate as “ONE Mylan,” and several Mylan entities, including Mylan Inc.,
`
`regularly run clinical trials in locations throughout the State of New Jersey, including at brick
`
`and mortar locations in, for example, Lawrenceville and Plainsboro. See Exhibit MM. At least
`
`one Mylan clinical trial uses a Somerset-based hotline. See Exhibit NN.
`
`55.
`
`Venue is proper as to Mylan Pharma because Mylan Pharma has committed acts
`
`of infringement within the district and has a regular and established place of business located in
`
`the State of New Jersey through at least its affiliate, Mylan Specialty, located at the Basking
`
`Ridge Location.
`
`56.
`
`On information and belief, Mylan Inc. is a corporate parent of both Mylan Pharma
`
`and Mylan Specialty.
`
`
`
`14
`
`Sanofi Exhibit 2007.014
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 15 of 70 PageID: 15
`
`57.
`
`On information and belief, Mylan Pharma has committed acts of infringement in
`
`the State of New Jersey, and throughout the United States, because it intends to manufacture for
`
`distribution, market, sell, or distribute the Proposed Products to residents of this State, which is
`
`confirmed by the filing of NDA No. 210605. See Acorda, 817 F.3d at 759-63; BMS, 2017 WL
`
`3980155, at *8-14.
`
`58.
`
`On information and belief, the Basking Ridge Location is both “regular” and
`
`“established” as a place business for at least the reasons set out in ¶¶ 45-54.
`
`59.
`
`On information and belief, the Basking Ridge Location is a place of business for
`
`Defendant Mylan Pharma because Mylan Inc. and Mylan Pharma operate as one entity, and
`
`exercise possession and/or control over the Basking Ridge location by, including, but not limited
`
`to, holding themselves out as “ONE Mylan” with Mylan Specialty and other Mylan entities. The
`
`Basking Ridge location is part of “ONE Mylan.”
`
`60.
`
`On information and belief, the Basking Ridge Location is a place of business for
`
`Mylan Pharma because Mylan Inc. and Mylan Pharma operate as one entity, and Mylan Inc.
`
`operates through the Basking Ridge Location. Though Mylan Inc. is incorporated in
`
`Pennsylvania, it corresponds with the FDA using Mylan Pharma’s West Virginia address. See
`
`Exhibits OO and PP. For example, the FDA sent a letter to Mylan Inc. regarding its petition
`
`requesting the FDA to stay the approval of a drug, and addressed the letter to “Brian S. Roman,
`
`Vice President and General Counsel, North America, Mylan, Inc., 781 Chestnut Ridge Road,
`
`Morgantown, WV 26505.” Exhibit PP.
`
`61.
`
`On information and belief, the Basking Ridge Location is a place of business for
`
`Mylan Pharma because Mylan Inc. and Mylan Pharma operate as one entity, and the Basking
`
`Ridge Location has been “aligned … under the Mylan brand.” Exhibit X at 3 (“In 2012 Mylan
`
`
`
`15
`
`Sanofi Exhibit 2007.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17 Page 16 of 70 PageID: 16
`
`changed the company’s name from Dey Pharma to Mylan Specialty as part of its efforts to align
`
`operations under the Mylan brand.”). Specifically, Mylan CEO, Heather Bresch stated in a press
`
`release that:
`
`The name change to Mylan Specialty is an important milestone and a natural step
`in our company's evolution. Bringing Dey under the Mylan brand will align our
`specialty business even more directly with everything Mylan stands for –
`innovati