Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 1 of 12 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`BAYER PHARMA AG, BAYER AG, and
`JANSSEN PHARMACEUTICALS, INC.,
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
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`Defendants.
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` 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
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`collectively referred to herein as “Bayer”), and Janssen Pharmaceuticals, Inc. (“Janssen”) (Bayer
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`and Janssen are collectively referred to herein as “Plaintiffs”), by their attorneys, for their
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`Complaint, hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, that arises out of the submission by Mylan Pharmaceuticals
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`Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug
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`Administration (“FDA”) seeking approval to engage in the commercial manufacture, use, offer for
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`sale, sale, and/or importation of a generic version of Plaintiffs’ 2.5 mg XARELTO® product prior
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`to the expiration of U.S. Patent No. 10,828,310 (“the ’310 patent”).
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`THE PARTIES
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`Plaintiffs
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`2.
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`Plaintiff Bayer Pharma AG is a corporation organized and existing under
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`the laws of the Federal Republic of Germany, with a place of business at Müllerstrasse 178, 13353
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`Berlin, Germany.
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`3.
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`Plaintiff Bayer AG is a corporation organized and existing under the laws
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`of the Federal Republic of Germany, with a place of business at Kaiser-Wilhelm-Allee 1, 51368
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`Leverkusen, Germany.
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`4.
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`Plaintiff Janssen Pharmaceuticals, Inc. is a corporation organized and
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`existing under the laws of the Commonwealth of Pennsylvania, with a principal place of business
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`at 1125 Trenton-Harbourton Road, Titusville, New Jersey.
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`Defendants
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`5.
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`On information and belief, Defendant Mylan Pharmaceuticals Inc. (“MPI”)
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`is a corporation organized and existing under the laws of the State of West Virginia with its
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`principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. On
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`information and belief, MPI is in the business of, among other things, manufacturing and selling
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`generic versions of branded pharmaceutical products for the U.S. market.
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`6.
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`On information and belief, Defendant Mylan Inc. is a corporation organized
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`and existing under the laws of the State of Pennsylvania with its principal place of business at 1000
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`Mylan Blvd., Canonsburg, PA 15317. On information and belief, Mylan Inc. is in the business of,
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`among other things, manufacturing and selling generic versions of branded pharmaceutical drugs
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`through various operating subsidiaries, including MPI.
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`2
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`7.
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`On information and belief, MPI is a wholly owned subsidiary of Mylan Inc.
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`MPI and Mylan Inc. are collectively referred to herein as “Mylan.”
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`8.
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`On information and belief, MPI and Mylan Inc. know and intend that upon
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`approval of Mylan’s ANDA, MPI and Mylan Inc. will manufacture, market, sell, and distribute
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`Mylan’s ANDA Product (defined below) throughout the United States, including in West Virginia.
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`On information and belief, MPI and Mylan Inc. are agents of each other and/or operate in concert
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`as integrated parts of the same business group, including with respect to Mylan’s ANDA Product,
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`and enter into agreements that are nearer than arm’s length. On information and belief, MPI and
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`Mylan Inc. participated, assisted, and cooperated in carrying out the acts complained of herein.
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`9.
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`On information and belief, MPI and Mylan Inc. acted in concert to prepare
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`and submit ANDA No. 212220 for Mylan’s 2.5 mg rivaroxaban tablets (“Mylan’s ANDA
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`Product”), which was done at the direction of, under the control of, and for the direct benefit of
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`Mylan Inc.
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`10.
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`On information and belief, following any FDA approval of ANDA No.
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`212220, MPI and Mylan Inc. will act in concert to market, distribute, offer for sale, and sell
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`Mylan’s ANDA Product throughout the United States and within West Virginia.
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`JURISDICTION
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`11.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
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`herein.
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`12.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331,
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`1338(a), 2201, and 2202.
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`13. MPI is subject to personal jurisdiction in West Virginia because, among
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`other things, it has purposely availed itself of the benefits and protections of West Virginia’s laws
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`3
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`such that it should reasonably anticipate being haled into court here. MPI is a corporation formed
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`under the laws of the State of West Virginia, is qualified to do business in the State of West
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`Virginia, and has appointed a registered agent in West Virginia to accept service of process. MPI
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`has thus consented to jurisdiction in West Virginia. In addition, on information and belief, MPI
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`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the
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`United States, including in the State of West Virginia, and therefore transacts business within the
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`State of West Virginia related to Plaintiffs’ claims, and/or has engaged in systematic and
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`continuous business contacts within the State of West Virginia.
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`14. Mylan Inc. is subject to personal jurisdiction in West Virginia because,
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`among other things, Mylan Inc., itself and through its wholly owned subsidiary MPI, has
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`purposefully availed itself of the benefits and protections of West Virginia’s laws such that it
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`should reasonably anticipate being haled into court here. On information and belief, Mylan Inc.,
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`itself and through its wholly owned subsidiary MPI, develops, manufactures, imports, markets,
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`offers to sell, and/or sells generic drugs throughout the United States, including in the State of
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`West Virginia, and therefore transacts business within the State of West Virginia, and/or has
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`engaged in systematic and continuous business contacts within the State of West Virginia. In
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`addition, Mylan Inc. is subject to personal jurisdiction in West Virginia because, on information
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`and belief, it controls and dominates MPI, and therefore the activities of MPI in this jurisdiction
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`are attributed to Mylan Inc.
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`15.
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`In addition, this Court has personal jurisdiction over MPI and Mylan Inc.
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`because, among other things, on information and belief: (1) MPI, acting in concert with Mylan
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`Inc., has filed an ANDA for the purpose of seeking approval to engage in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of Mylan’s ANDA Product in the United
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`4
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`States, including in West Virginia; and (2) MPI and Mylan Inc., acting in concert and/or as agents
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`of one another, will market, distribute, offer for sale, and/or sell Mylan’s ANDA Product in the
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`United States, including in West Virginia, upon approval of ANDA No. 212220, and will derive
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`substantial revenue from the use or consumption of Mylan’s ANDA Product in the State of West
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`Virginia. On information and belief, if ANDA No. 212220 is approved, the generic Mylan product
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`charged with infringing the ’310 patent would, among other things, be marketed, distributed,
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`offered for sale, and/or sold in West Virginia, prescribed by physicians practicing in West Virginia,
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`and dispensed by pharmacies located within West Virginia, and/or used by patients in West
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`Virginia, all of which would have a substantial effect on West Virginia.
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`16.
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`On information and belief, Mylan derives substantial revenue from generic
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`pharmaceutical products that are used and/or consumed within West Virginia, and that are
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`manufactured by Mylan and/or for which MPI and/or Mylan Inc. is/are the named applicant(s) on
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`approved ANDAs. On information and belief, various products for which MPI and/or Mylan Inc.
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`is/are the named applicant(s) on approved ANDAs are available at retail pharmacies in West
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`Virginia.
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`herein.
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`VENUE
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`17.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
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`18.
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`Venue is proper in this district as to MPI pursuant to 28 U.S.C. § 1400(b)
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`because, inter alia, MPI is a corporation organized and existing under the laws of the State of West
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`Virginia and is subject to personal jurisdiction in this judicial district.
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`19.
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`Venue is proper in this district as to Mylan Inc. pursuant to 28 U.S.C.
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`§ 1400(b) because, inter alia, Mylan Inc. is subject to personal jurisdiction in this judicial district,
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`5
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`has previously consented to venue in this judicial district, see, e.g., C.A. Nos. 1:20-cv-00052-IMK,
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`18-cv-00202-IMK, 18-cv-00193-IMK, and, on information and belief, is subject to venue in this
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`judicial district and/or will consent to venue for the purpose of this case. Mylan Inc. is registered
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`to do business in West Virginia, with Organization ID No. 230499. Furthermore, on information
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`and belief, substantial preparation of ANDA No. 212220, and/or the direction of the preparation
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`of ANDA No. 212220, took place in this district.
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`FACTUAL BACKGROUND
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`20.
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`XARELTO® (active ingredient rivaroxaban) is a factor Xa inhibitor. The
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`2.5 mg tablet strength of XARELTO® is indicated for administration orally twice daily, in
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`combination with aspirin (75-100 mg) once daily, to reduce the risk of major cardiovascular events
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`(cardiovascular (CV) death, myocardial infarction (MI), and stroke) in patients with chronic
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`coronary artery disease (CAD) or peripheral artery disease (PAD).
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`21.
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`Janssen is the holder of New Drug Application No. 022406 for
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`XARELTO®, which has been approved by the FDA.
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`22.
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`The ’310 patent, entitled “Reducing the Risk of Cardiovascular Events,”
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`was duly and legally issued on November 10, 2020. The ’310 patent is attached as Exhibit A.
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`23.
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`As set forth in greater detail in the ’310 patent, the claims of the ’310 patent,
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`incorporated by reference herein, cover certain methods involving rivaroxaban. For example,
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`independent claim 1 recites, “A method of reducing the risk of myocardial infarction, stroke or
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`cardiovascular death in a human patient with coronary artery disease and/or peripheral artery
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`disease, comprising administering to the human patient rivaroxaban and aspirin in amounts that
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`are clinically proven effective in reducing the risk of myocardial infarction, stroke or
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`cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial
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`6
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`disease, wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is
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`administered in an amount of 75-100 mg daily.”
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`24.
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`25.
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`26.
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`27.
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`Bayer Pharma AG is the assignee of the ’310 patent.
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`Bayer AG is an exclusive licensee under the ’310 patent.
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`Janssen is an exclusive sublicensee under the ’310 patent.
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`Pursuant to 21 U.S.C. § 355, the ’310 patent is listed in Approved Drug
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`Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in connection with the
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`2.5 mg strength of XARELTO®.
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`COUNT I: INFRINGEMENT OF THE ’310 PATENT
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`28.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
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`herein.
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`29.
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`By letter dated June 1, 2021 (the “Mylan Notice Letter”), Mylan notified
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`Bayer Pharma AG and Janssen that MPI had submitted to the FDA ANDA No. 212220 for Mylan’s
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`ANDA Product. This product is a generic version of the 2.5 mg strength of XARELTO®.
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`30.
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`In Mylan’s Notice Letter, Mylan indicated that, in connection with its
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`ANDA No. 212220, MPI had filed a Paragraph IV Certification with respect to the ’310 patent.
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`31.
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`In Mylan’s Notice Letter, Mylan stated that Mylan’s ANDA Product
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`contains rivaroxaban.
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`32.
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`On information and belief, the proposed labeling for Mylan’s ANDA
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`Product directs a method of reducing the risk of major cardiovascular events (cardiovascular (CV)
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`death, myocardial infarction (MI), and stroke) in patients with chronic coronary artery disease
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`(CAD) or peripheral artery disease (PAD). On information and belief, the proposed labeling for
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`Mylan’s ANDA Product further directs the administration of Mylan’s ANDA Product and aspirin
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`in amounts that are clinically proven effective in reducing the risk of MI, stroke or CV death in a
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`7
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`human patient with CAD and/or PAD, wherein Mylan’s ANDA Product will be administered twice
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`daily and aspirin is administered in an amount of 75-100 mg daily.
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`33.
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`The purpose of ANDA No. 212220 was, inter alia, to obtain approval under
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`the Federal Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer
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`for sale, and/or sale of Mylan’s ANDA Product with its proposed labeling prior to the expiration
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`of the ’310 patent.
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`34. Mylan intends to engage in the manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Mylan’s ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 212220, i.e., prior to the expiration of
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`the ’310 patent.
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`35.
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`On information and belief, the manufacture, use (including in accordance
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`with and as directed by Mylan’s proposed labeling for Mylan’s ANDA Product), offer for sale,
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`sale, marketing, distribution, and/or importation of Mylan’s ANDA Product will infringe at least
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`claim 1 of the ’310 patent.
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`36.
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`In Mylan’s Notice Letter, Mylan did not contest infringement of the ’310
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`patent on any basis other than that the claims of the ’310 patent were allegedly invalid.
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`37. Mylan has knowledge of the claims of the ’310 patent. Notwithstanding
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`this knowledge, Mylan has continued to assert its intent to engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Mylan’s ANDA Product with its
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`proposed labeling immediately and imminently upon approval of ANDA No. 212220. On
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`information and belief, by such activities, Mylan specifically intends to infringe the ’310 patent.
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`8
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`38.
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`On information and belief, Mylan plans and intends to, and will, actively
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`induce infringement of the ’310 patent when its ANDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon approval.
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`39.
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`On information and belief, Mylan knows that Mylan’s ANDA Product with
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`its proposed labeling is especially made or adapted for use in infringing the ’310 patent, and that
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`Mylan’s ANDA Product with its proposed labeling is not suitable for substantial noninfringing
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`use. On information and belief, Mylan plans and intends to, and will, contribute to infringement
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`of the ’310 patent immediately and imminently upon approval of ANDA No. 212220.
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`40. Mylan’s submission of ANDA No. 212220 for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Mylan’s
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`ANDA Product was an act of infringement of the ’310 patent under 35 U.S.C. § 271(e)(2).
`
`41.
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`On information and belief, Mylan has made, and will continue to make,
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`substantial preparation in the United States to manufacture, use, sell, offer to sell, and/or import
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`Mylan’s ANDA Product with its proposed labeling prior to the expiration of the ’310 patent.
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`42. Mylan intends to engage in the manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Mylan’s ANDA Product with its proposed labeling
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`prior to the expiration of the ’310 patent.
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`43.
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`The foregoing actions by Mylan constitute and/or will constitute
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`infringement of the ’310 patent, active inducement of infringement of the ’310 patent, and/or
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`contribution to the infringement by others of the ’310 patent.
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`44.
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`Unless Mylan is enjoined from infringing the ’310 patent, actively inducing
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`infringement of the ’310 patent, and contributing to the infringement by others of the ’310 patent,
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`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
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`9
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`45.
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`This action is being commenced before the expiration of forty-five days
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`from the date Bayer and Janssen received Mylan’s Notice Letter.
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`COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’310
`PATENT
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
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`46.
`
`herein.
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`47.
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`The Court may declare the rights and legal relations of the parties pursuant
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`to 28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Plaintiffs on
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`the one hand and Mylan on the other regarding Mylan’s liability for infringement and active
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`inducement of infringement of the ’310 patent.
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`48.
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`An actual case or controversy exists between Plaintiffs and Mylan with
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`respect to Mylan’s liability for infringement of the ’310 patent.
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`49.
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`The Court should declare that the commercial manufacture, use, sale, offer
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`for sale or importation of Mylan’s ANDA Product will infringe and induce the infringement of the
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`’310 patent.
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`*
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`*
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`*
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`WHEREFORE, Plaintiffs request the following relief:
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`(a)
`
`(b)
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`A judgment that Mylan has infringed the ’310 patent;
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`A judgment ordering that the effective date of any FDA approval for Mylan
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`to make, use, offer for sale, sell, market, distribute, or import Mylan’s ANDA Product, or any
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`product or compound the use of which infringes the ’310 patent, be no earlier than the expiration
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`date of the ’310 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
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`(c)
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`A preliminary and permanent injunction enjoining Mylan, and all persons
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`acting in concert with Mylan, from making, using, selling, offering for sale, marketing,
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`distributing, or importing Mylan’s ANDA Product, or any product or compound the use of which
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`infringes the ’310 patent, or the inducement of or the contribution to any of the foregoing, prior to
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`the expiration date of the ’310 patent, inclusive of any extension(s) and additional period(s) of
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`exclusivity;
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`(d)
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`A judgment declaring that the commercial manufacture, use, sale, offer for
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`sale or importation of Mylan’s ANDA Product prior to the expiration of the ’310 patent will
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`infringe and induce the infringement of the ’310 patent;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’ fees
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`for Plaintiffs pursuant to 35 U.S.C. § 285;
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`(f)
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`(g)
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`An award of Plaintiffs’ costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`July 22, 2021
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`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.
`
`
`
`
`
`
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`11
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`Case 1:21-cv-00099-IMK Document 1 Filed 07/22/21 Page 12 of 12 PageID #: 12
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`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.
`
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`12
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