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Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 1 of 12 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`BAYER PHARMA AG, BAYER AG, and
`JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
` ELECTRONICALLY
` FILED
`Jul 22 2021
` U.S. DISTRICT COURT
` Northern District of WV
`
`C.A. No.
`
`1:21-CV-99 (Keeley)
`
`COMPLAINT
`
`Plaintiffs Bayer Pharma AG, Bayer AG (Bayer AG and Bayer Pharma AG are
`
`collectively referred to herein as “Bayer”), and Janssen Pharmaceuticals, Inc. (“Janssen”) (Bayer
`
`and Janssen are collectively referred to herein as “Plaintiffs”), by their attorneys, for their
`
`Complaint, hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of the submission by Mylan Pharmaceuticals
`
`Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug
`
`Administration (“FDA”) seeking approval to engage in the commercial manufacture, use, offer for
`
`sale, sale, and/or importation of a generic version of Plaintiffs’ 2.5 mg XARELTO® product prior
`
`to the expiration of U.S. Patent No. 10,828,310 (“the ’310 patent”).
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 2 of 12 PageID #: 2
`
`THE PARTIES
`
`Plaintiffs
`
`2.
`
`Plaintiff Bayer Pharma AG is a corporation organized and existing under
`
`the laws of the Federal Republic of Germany, with a place of business at Müllerstrasse 178, 13353
`
`Berlin, Germany.
`
`3.
`
`Plaintiff Bayer AG is a corporation organized and existing under the laws
`
`of the Federal Republic of Germany, with a place of business at Kaiser-Wilhelm-Allee 1, 51368
`
`Leverkusen, Germany.
`
`4.
`
`Plaintiff Janssen Pharmaceuticals, Inc. is a corporation organized and
`
`existing under the laws of the Commonwealth of Pennsylvania, with a principal place of business
`
`at 1125 Trenton-Harbourton Road, Titusville, New Jersey.
`
`Defendants
`
`5.
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc. (“MPI”)
`
`is a corporation organized and existing under the laws of the State of West Virginia with its
`
`principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. On
`
`information and belief, MPI is in the business of, among other things, manufacturing and selling
`
`generic versions of branded pharmaceutical products for the U.S. market.
`
`6.
`
`On information and belief, Defendant Mylan Inc. is a corporation organized
`
`and existing under the laws of the State of Pennsylvania with its principal place of business at 1000
`
`Mylan Blvd., Canonsburg, PA 15317. On information and belief, Mylan Inc. is in the business of,
`
`among other things, manufacturing and selling generic versions of branded pharmaceutical drugs
`
`through various operating subsidiaries, including MPI.
`
`2
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 3 of 12 PageID #: 3
`
`7.
`
`On information and belief, MPI is a wholly owned subsidiary of Mylan Inc.
`
`MPI and Mylan Inc. are collectively referred to herein as “Mylan.”
`
`8.
`
`On information and belief, MPI and Mylan Inc. know and intend that upon
`
`approval of Mylan’s ANDA, MPI and Mylan Inc. will manufacture, market, sell, and distribute
`
`Mylan’s ANDA Product (defined below) throughout the United States, including in West Virginia.
`
`On information and belief, MPI and Mylan Inc. are agents of each other and/or operate in concert
`
`as integrated parts of the same business group, including with respect to Mylan’s ANDA Product,
`
`and enter into agreements that are nearer than arm’s length. On information and belief, MPI and
`
`Mylan Inc. participated, assisted, and cooperated in carrying out the acts complained of herein.
`
`9.
`
`On information and belief, MPI and Mylan Inc. acted in concert to prepare
`
`and submit ANDA No. 212220 for Mylan’s 2.5 mg rivaroxaban tablets (“Mylan’s ANDA
`
`Product”), which was done at the direction of, under the control of, and for the direct benefit of
`
`Mylan Inc.
`
`10.
`
`On information and belief, following any FDA approval of ANDA No.
`
`212220, MPI and Mylan Inc. will act in concert to market, distribute, offer for sale, and sell
`
`Mylan’s ANDA Product throughout the United States and within West Virginia.
`
`JURISDICTION
`
`11.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
`
`herein.
`
`12.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`13. MPI is subject to personal jurisdiction in West Virginia because, among
`
`other things, it has purposely availed itself of the benefits and protections of West Virginia’s laws
`
`3
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 4 of 12 PageID #: 4
`
`such that it should reasonably anticipate being haled into court here. MPI is a corporation formed
`
`under the laws of the State of West Virginia, is qualified to do business in the State of West
`
`Virginia, and has appointed a registered agent in West Virginia to accept service of process. MPI
`
`has thus consented to jurisdiction in West Virginia. In addition, on information and belief, MPI
`
`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the
`
`United States, including in the State of West Virginia, and therefore transacts business within the
`
`State of West Virginia related to Plaintiffs’ claims, and/or has engaged in systematic and
`
`continuous business contacts within the State of West Virginia.
`
`14. Mylan Inc. is subject to personal jurisdiction in West Virginia because,
`
`among other things, Mylan Inc., itself and through its wholly owned subsidiary MPI, has
`
`purposefully availed itself of the benefits and protections of West Virginia’s laws such that it
`
`should reasonably anticipate being haled into court here. On information and belief, Mylan Inc.,
`
`itself and through its wholly owned subsidiary MPI, develops, manufactures, imports, markets,
`
`offers to sell, and/or sells generic drugs throughout the United States, including in the State of
`
`West Virginia, and therefore transacts business within the State of West Virginia, and/or has
`
`engaged in systematic and continuous business contacts within the State of West Virginia. In
`
`addition, Mylan Inc. is subject to personal jurisdiction in West Virginia because, on information
`
`and belief, it controls and dominates MPI, and therefore the activities of MPI in this jurisdiction
`
`are attributed to Mylan Inc.
`
`15.
`
`In addition, this Court has personal jurisdiction over MPI and Mylan Inc.
`
`because, among other things, on information and belief: (1) MPI, acting in concert with Mylan
`
`Inc., has filed an ANDA for the purpose of seeking approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Mylan’s ANDA Product in the United
`
`4
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 5 of 12 PageID #: 5
`
`States, including in West Virginia; and (2) MPI and Mylan Inc., acting in concert and/or as agents
`
`of one another, will market, distribute, offer for sale, and/or sell Mylan’s ANDA Product in the
`
`United States, including in West Virginia, upon approval of ANDA No. 212220, and will derive
`
`substantial revenue from the use or consumption of Mylan’s ANDA Product in the State of West
`
`Virginia. On information and belief, if ANDA No. 212220 is approved, the generic Mylan product
`
`charged with infringing the ’310 patent would, among other things, be marketed, distributed,
`
`offered for sale, and/or sold in West Virginia, prescribed by physicians practicing in West Virginia,
`
`and dispensed by pharmacies located within West Virginia, and/or used by patients in West
`
`Virginia, all of which would have a substantial effect on West Virginia.
`
`16.
`
`On information and belief, Mylan derives substantial revenue from generic
`
`pharmaceutical products that are used and/or consumed within West Virginia, and that are
`
`manufactured by Mylan and/or for which MPI and/or Mylan Inc. is/are the named applicant(s) on
`
`approved ANDAs. On information and belief, various products for which MPI and/or Mylan Inc.
`
`is/are the named applicant(s) on approved ANDAs are available at retail pharmacies in West
`
`Virginia.
`
`herein.
`
`VENUE
`
`17.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
`
`18.
`
`Venue is proper in this district as to MPI pursuant to 28 U.S.C. § 1400(b)
`
`because, inter alia, MPI is a corporation organized and existing under the laws of the State of West
`
`Virginia and is subject to personal jurisdiction in this judicial district.
`
`19.
`
`Venue is proper in this district as to Mylan Inc. pursuant to 28 U.S.C.
`
`§ 1400(b) because, inter alia, Mylan Inc. is subject to personal jurisdiction in this judicial district,
`
`5
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 6 of 12 PageID #: 6
`
`has previously consented to venue in this judicial district, see, e.g., C.A. Nos. 1:20-cv-00052-IMK,
`
`18-cv-00202-IMK, 18-cv-00193-IMK, and, on information and belief, is subject to venue in this
`
`judicial district and/or will consent to venue for the purpose of this case. Mylan Inc. is registered
`
`to do business in West Virginia, with Organization ID No. 230499. Furthermore, on information
`
`and belief, substantial preparation of ANDA No. 212220, and/or the direction of the preparation
`
`of ANDA No. 212220, took place in this district.
`
`FACTUAL BACKGROUND
`
`20.
`
`XARELTO® (active ingredient rivaroxaban) is a factor Xa inhibitor. The
`
`2.5 mg tablet strength of XARELTO® is indicated for administration orally twice daily, in
`
`combination with aspirin (75-100 mg) once daily, to reduce the risk of major cardiovascular events
`
`(cardiovascular (CV) death, myocardial infarction (MI), and stroke) in patients with chronic
`
`coronary artery disease (CAD) or peripheral artery disease (PAD).
`
`21.
`
`Janssen is the holder of New Drug Application No. 022406 for
`
`XARELTO®, which has been approved by the FDA.
`
`22.
`
`The ’310 patent, entitled “Reducing the Risk of Cardiovascular Events,”
`
`was duly and legally issued on November 10, 2020. The ’310 patent is attached as Exhibit A.
`
`23.
`
`As set forth in greater detail in the ’310 patent, the claims of the ’310 patent,
`
`incorporated by reference herein, cover certain methods involving rivaroxaban. For example,
`
`independent claim 1 recites, “A method of reducing the risk of myocardial infarction, stroke or
`
`cardiovascular death in a human patient with coronary artery disease and/or peripheral artery
`
`disease, comprising administering to the human patient rivaroxaban and aspirin in amounts that
`
`are clinically proven effective in reducing the risk of myocardial infarction, stroke or
`
`cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial
`
`6
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 7 of 12 PageID #: 7
`
`disease, wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is
`
`administered in an amount of 75-100 mg daily.”
`
`24.
`
`25.
`
`26.
`
`27.
`
`Bayer Pharma AG is the assignee of the ’310 patent.
`
`Bayer AG is an exclusive licensee under the ’310 patent.
`
`Janssen is an exclusive sublicensee under the ’310 patent.
`
`Pursuant to 21 U.S.C. § 355, the ’310 patent is listed in Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in connection with the
`
`2.5 mg strength of XARELTO®.
`
`COUNT I: INFRINGEMENT OF THE ’310 PATENT
`
`28.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
`
`herein.
`
`29.
`
`By letter dated June 1, 2021 (the “Mylan Notice Letter”), Mylan notified
`
`Bayer Pharma AG and Janssen that MPI had submitted to the FDA ANDA No. 212220 for Mylan’s
`
`ANDA Product. This product is a generic version of the 2.5 mg strength of XARELTO®.
`
`30.
`
`In Mylan’s Notice Letter, Mylan indicated that, in connection with its
`
`ANDA No. 212220, MPI had filed a Paragraph IV Certification with respect to the ’310 patent.
`
`31.
`
`In Mylan’s Notice Letter, Mylan stated that Mylan’s ANDA Product
`
`contains rivaroxaban.
`
`32.
`
`On information and belief, the proposed labeling for Mylan’s ANDA
`
`Product directs a method of reducing the risk of major cardiovascular events (cardiovascular (CV)
`
`death, myocardial infarction (MI), and stroke) in patients with chronic coronary artery disease
`
`(CAD) or peripheral artery disease (PAD). On information and belief, the proposed labeling for
`
`Mylan’s ANDA Product further directs the administration of Mylan’s ANDA Product and aspirin
`
`in amounts that are clinically proven effective in reducing the risk of MI, stroke or CV death in a
`
`7
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 8 of 12 PageID #: 8
`
`human patient with CAD and/or PAD, wherein Mylan’s ANDA Product will be administered twice
`
`daily and aspirin is administered in an amount of 75-100 mg daily.
`
`33.
`
`The purpose of ANDA No. 212220 was, inter alia, to obtain approval under
`
`the Federal Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer
`
`for sale, and/or sale of Mylan’s ANDA Product with its proposed labeling prior to the expiration
`
`of the ’310 patent.
`
`34. Mylan intends to engage in the manufacture, use, offer for sale, sale,
`
`marketing, distribution, and/or importation of Mylan’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 212220, i.e., prior to the expiration of
`
`the ’310 patent.
`
`35.
`
`On information and belief, the manufacture, use (including in accordance
`
`with and as directed by Mylan’s proposed labeling for Mylan’s ANDA Product), offer for sale,
`
`sale, marketing, distribution, and/or importation of Mylan’s ANDA Product will infringe at least
`
`claim 1 of the ’310 patent.
`
`36.
`
`In Mylan’s Notice Letter, Mylan did not contest infringement of the ’310
`
`patent on any basis other than that the claims of the ’310 patent were allegedly invalid.
`
`37. Mylan has knowledge of the claims of the ’310 patent. Notwithstanding
`
`this knowledge, Mylan has continued to assert its intent to engage in the manufacture, use, offer
`
`for sale, sale, marketing, distribution, and/or importation of Mylan’s ANDA Product with its
`
`proposed labeling immediately and imminently upon approval of ANDA No. 212220. On
`
`information and belief, by such activities, Mylan specifically intends to infringe the ’310 patent.
`
`8
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 9 of 12 PageID #: 9
`
`38.
`
`On information and belief, Mylan plans and intends to, and will, actively
`
`induce infringement of the ’310 patent when its ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval.
`
`39.
`
`On information and belief, Mylan knows that Mylan’s ANDA Product with
`
`its proposed labeling is especially made or adapted for use in infringing the ’310 patent, and that
`
`Mylan’s ANDA Product with its proposed labeling is not suitable for substantial noninfringing
`
`use. On information and belief, Mylan plans and intends to, and will, contribute to infringement
`
`of the ’310 patent immediately and imminently upon approval of ANDA No. 212220.
`
`40. Mylan’s submission of ANDA No. 212220 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Mylan’s
`
`ANDA Product was an act of infringement of the ’310 patent under 35 U.S.C. § 271(e)(2).
`
`41.
`
`On information and belief, Mylan has made, and will continue to make,
`
`substantial preparation in the United States to manufacture, use, sell, offer to sell, and/or import
`
`Mylan’s ANDA Product with its proposed labeling prior to the expiration of the ’310 patent.
`
`42. Mylan intends to engage in the manufacture, use, offer for sale, sale,
`
`marketing, distribution, and/or importation of Mylan’s ANDA Product with its proposed labeling
`
`prior to the expiration of the ’310 patent.
`
`43.
`
`The foregoing actions by Mylan constitute and/or will constitute
`
`infringement of the ’310 patent, active inducement of infringement of the ’310 patent, and/or
`
`contribution to the infringement by others of the ’310 patent.
`
`44.
`
`Unless Mylan is enjoined from infringing the ’310 patent, actively inducing
`
`infringement of the ’310 patent, and contributing to the infringement by others of the ’310 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`9
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 10 of 12 PageID #: 10
`
`45.
`
`This action is being commenced before the expiration of forty-five days
`
`from the date Bayer and Janssen received Mylan’s Notice Letter.
`
`COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’310
`PATENT
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
`
`46.
`
`herein.
`
`47.
`
`The Court may declare the rights and legal relations of the parties pursuant
`
`to 28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Plaintiffs on
`
`the one hand and Mylan on the other regarding Mylan’s liability for infringement and active
`
`inducement of infringement of the ’310 patent.
`
`48.
`
`An actual case or controversy exists between Plaintiffs and Mylan with
`
`respect to Mylan’s liability for infringement of the ’310 patent.
`
`49.
`
`The Court should declare that the commercial manufacture, use, sale, offer
`
`for sale or importation of Mylan’s ANDA Product will infringe and induce the infringement of the
`
`’310 patent.
`
`*
`
`*
`
`*
`
`WHEREFORE, Plaintiffs request the following relief:
`
`(a)
`
`(b)
`
`A judgment that Mylan has infringed the ’310 patent;
`
`A judgment ordering that the effective date of any FDA approval for Mylan
`
`to make, use, offer for sale, sell, market, distribute, or import Mylan’s ANDA Product, or any
`
`product or compound the use of which infringes the ’310 patent, be no earlier than the expiration
`
`date of the ’310 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining Mylan, and all persons
`
`acting in concert with Mylan, from making, using, selling, offering for sale, marketing,
`
`10
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 11 of 12 PageID #: 11
`
`distributing, or importing Mylan’s ANDA Product, or any product or compound the use of which
`
`infringes the ’310 patent, or the inducement of or the contribution to any of the foregoing, prior to
`
`the expiration date of the ’310 patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity;
`
`(d)
`
`A judgment declaring that the commercial manufacture, use, sale, offer for
`
`sale or importation of Mylan’s ANDA Product prior to the expiration of the ’310 patent will
`
`infringe and induce the infringement of the ’310 patent;
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’ fees
`
`for Plaintiffs pursuant to 35 U.S.C. § 285;
`
`(f)
`
`(g)
`
`An award of Plaintiffs’ costs and expenses in this action; and
`
`Such further and other relief as this Court may deem just and proper.
`
`July 22, 2021
`
`Respectfully submitted:
`
`
`
`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
`Raymond S. Franks II (WVSB No. 6523)
`CAREY, DOUGLAS, KESSLER & Ruby,
`PLLC
`901 Chase Tower, 707 Virginia Street, East
`(25301)
`P.O. Box 913
`Charleston, WV 25323
`Telephone: (304) 345-1234
`Facsimile: (304) 342-1105
`sruby@cdkrlaw.com
`rfranks@cdkrlaw.com
`Attorneys for Plaintiffs Bayer Pharma AG
`and Bayer AG
`
`
`
`
`
`
`/s/ Chad L. Taylor
`Frank E. Simmerman, Jr. (WVSB No. 3403)
`Chad L. Taylor (WVSB No. 10564)
`Frank E. Simmerman, III (WVSB No. 11589)
`SIMMERMAN LAW OFFICE, PLLC
`254 East Main Street
`Clarksburg, West Virginia 26301
`fes@simmermanlaw.com
`clt@simmermanlaw.com
`trey@simmermanlaw.com
`(304) 623-4900 (Telephone)
`(304) 623-4906 (Facsimile)
`Attorneys for Plaintiff Janssen
`Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`11
`
`

`

`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 12 of 12 PageID #: 12
`
`OF COUNSEL:
`Bruce R. Genderson
`Dov P. Grossman
`Alexander S. Zolan
`Kathryn S. Kayali
`Julie L. Tavares
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street NW
`Washington, DC 20005
`(202) 434-5000
`Attorneys for Plaintiffs Bayer Pharma AG
`and Bayer AG
`
`
`
`OF COUNSEL:
`Thomas D. Rein
`SIDLEY AUSTIN LLP
`One South Dearborn
`Chicago, IL 60603
`(312) 853-7000
`Attorneys for Plaintiff Janssen
`Pharmaceuticals, Inc.
`
`
`12
`
`

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