Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 1 of 10 PageID #: 1
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`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER AG, and JANSSEN
`PHARMACEUTICALS, INC.,
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`MYLAN PHARMACEUTICALS INC.,
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`v.
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`C.A. No.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`COMPLAINT
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`Plaintiffs,
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`Defendant.
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`Plaintiffs Bayer Intellectual Property GmbH (“BIP”), Bayer AG (Bayer AG and
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`BIP are collectively referred to herein as “Bayer”), and Janssen Pharmaceuticals, Inc.
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`(“Janssen”) (Bayer and Janssen are collectively referred to herein as “Plaintiffs”), by their
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`attorneys, for their 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
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`United States, Title 35, United States Code, that arises out of the submission by Mylan
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`Pharmaceuticals, Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and
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`Drug Administration (“FDA”) seeking approval to engage in the commercial manufacture, use,
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`offer for sale, sale, and/or importation of generic versions of Plaintiffs’ XARELTO® products
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`prior to the expiration of U.S. Patent No. 9,539,218.
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`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER AG, and JANSSEN
`PHARMACEUTICALS, INC.,
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
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`
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`C.A. No.
`
`
`
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`COMPLAINT
`
`Plaintiffs,
`
`Defendant.
`
`Plaintiffs Bayer Intellectual Property GmbH (“BIP”), Bayer AG (Bayer AG and
`
`BIP are collectively referred to herein as “Bayer”), and Janssen Pharmaceuticals, Inc.
`
`(“Janssen”) (Bayer and Janssen are collectively referred to herein as “Plaintiffs”), by their
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`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 generic versions of Plaintiffs’ XARELTO® products
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`prior to the expiration of U.S. Patent No. 9,539,218.
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`
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 2 of 10 PageID #: 2
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`
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`THE PARTIES
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`Plaintiffs
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`2.
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`Plaintiff Bayer Intellectual Property GmbH is a corporation organized and
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`existing under the laws of the Federal Republic of Germany, with a place of business at Alfred-
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`Nobel-Strasse 10, 40789 Monheim am Rhein, 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 place of business at 1125
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`Trenton-Harbourton Road, Titusville, New Jersey.
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`Mylan
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`5.
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`On information and belief, Defendant Mylan Pharmaceuticals Inc.
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`(“Mylan”) is a corporation organized and existing under the laws of the state of West Virginia,
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`with a place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia.
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`6.
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`On information and belief, Mylan is in the business of, among other
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`things, manufacturing, marketing, distributing, offering for sale, and selling generic drug
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`products. As a part of this business, on information and belief, Mylan files ANDAs with the
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`FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of generic versions of drug products that are covered by United States patents. On
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`information and belief, as part of these ANDAs, Mylan files certifications of the type described
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`in Section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (“Paragraph IV
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`Certifications”) to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`2
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 3 of 10 PageID #: 3
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`importation of generic drug products prior to the expiration of United States patents that cover
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`such products.
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`7.
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`On information and belief, Mylan prepared and submitted ANDA No.
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`208561 for Mylan’s 10 mg, 15 mg, and 20 mg rivaroxaban tablets (“Mylan’s ANDA Products”).
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`8.
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`On information and belief, following any FDA approval of ANDA No.
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`208561, Mylan will market, distribute, offer for sale, and sell Mylan’s ANDA Products
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`throughout the United States and within Delaware.
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`9.
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`On information and belief, following any FDA approval of ANDA No.
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`208561, Mylan knows and intends that its ANDA Products will be marketed, used, distributed,
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`offered for sale, and sold in the United States and within Delaware.
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`JURISDICTION
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`10.
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`Plaintiffs incorporate each of the preceding paragraphs as if each fully set
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`forth herein.
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`11.
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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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`12.
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`This Court has personal jurisdiction over Mylan because, on information
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`and belief, Mylan has registered to do business in the State of Delaware and has appointed a
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`registered agent in Delaware to accept service of process. Mylan has thus consented to
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`jurisdiction in Delaware.
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`13.
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`In addition, this Court has personal jurisdiction over Mylan because,
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`among other things, on information and belief: (1) Mylan has filed an ANDA for the purpose of
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`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of Mylan’s ANDA Products in the United States, including in Delaware; and (2)
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`3
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 4 of 10 PageID #: 4
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`Mylan will market, distribute, offer for sale, and/or sell Mylan’s ANDA Products in the United
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`States, including in Delaware, upon approval of ANDA No. 208561, and will derive substantial
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`revenue from the use or consumption of Mylan’s ANDA Products in the State of Delaware. On
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`information and belief, if ANDA No. 208561 is approved, the generic Mylan products charged
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`with infringing the ’218 patent would, among other things, be marketed, distributed, offered for
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`sale, and/or sold in Delaware, prescribed by physicians practicing in Delaware, and dispensed by
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`pharmacies located within Delaware, and/or used by patients in Delaware, all of which would
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`have a substantial effect on Delaware.
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`14. Mylan is actively registered with the Delaware Board of Pharmacy,
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`pursuant to Del. C. § 2540, as a licensed “Pharmacy – Wholesale Drug Distributor,” and as a
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`licensed “Distributor/Manufacturer CSR.”
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`15. Mylan has consented to jurisdiction in Delaware in one or more prior
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`cases arising out of the filing of its ANDAs, and it has filed counterclaims in such cases.
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`VENUE
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`16.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`FACTUAL BACKGROUND
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`17.
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`XARELTO® (active ingredient rivaroxaban) is a factor Xa inhibitor
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`indicated: (i) to reduce the risk of stroke and systemic embolism in patients with nonvalvular
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`atrial fibrillation; (ii) for the treatment of deep vein thrombosis (DVT), pulmonary embolism
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`(PE), and for the reduction in the risk of recurrence of DVT and of PE; and (iii) for the
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`prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement
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`surgery. XARELTO® is available as tablets in 10 mg, 15 mg, and 20 mg dosage strengths.
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`4
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 5 of 10 PageID #: 5
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`18.
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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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`19.
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`U.S. Patent No. 9,539,218 (“the ’218 patent”), entitled “Prevention and
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`Treatment of Thromboembolic Disorders,” was duly and legally issued on January 10, 2017.
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`The ’218 patent is attached as Exhibit A.
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`20.
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`As set forth in greater detail in the ’218 patent, the claims of the ’218
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`patent, incorporated by reference herein, cover certain methods involving rivaroxaban. For
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`example, claim 1 recites, “A method of treating a thromboembolic disorder comprising
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`administering a direct factor Xa inhibitor that is 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-
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`morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide no more than once
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`daily for at least five consecutive days in a rapid-release tablet to a patient in need thereof,
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`wherein the thromboembolic disorder is selected from the group consisting of pulmonary
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`embolisms, deep vein thromboses, and stroke.”
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`21.
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`22.
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`23.
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`24.
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`BIP is the assignee of the ’218 patent.
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`Bayer AG is an exclusive licensee under the ’218 patent.
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`Janssen is an exclusive sublicensee under the ’218 patent.
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`Pursuant to 21 U.S.C. § 355, the ’218 patent is listed in the Approved
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`Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in connection
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`with XARELTO®.
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`Infringement by Mylan
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`25.
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`By letter dated April 6, 2017 (the “Mylan Notice Letter”), Mylan notified
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`BIP and Janssen, among others, that Mylan had submitted to the FDA ANDA No. 208561 for
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`Mylan’s ANDA Products. These products are generic versions of XARELTO®.
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`5
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 6 of 10 PageID #: 6
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`26.
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`In the Mylan Notice Letter, Mylan stated that Mylan’s ANDA Products
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`contain rivaroxaban.
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`27.
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`In the Mylan Notice Letter, Mylan stated that the dosage form of Mylan’s
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`ANDA Products is tablets. On information and belief, the dosage form of Mylan’s ANDA
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`Products satisfies the “rapid-release tablet” requirement of claim 1 of the ’218 patent.
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`28.
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`On information and belief, the proposed labeling for Mylan’s ANDA
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`Products directs the use of Mylan’s ANDA Products for one or more of the following
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`indications: (i) to reduce the risk of stroke and systemic embolism in patients with nonvalvular
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`atrial fibrillation; (ii) for the treatment of deep vein thrombosis (DVT), pulmonary embolism
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`(PE), and for the reduction in the risk of recurrence of DVT and of PE; and (iii) for the
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`prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement
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`surgery. On information and belief, the proposed labeling for Mylan’s ANDA Products further
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`directs the use of Mylan’s ANDA Products in a manner that satisfies the “no more than once
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`daily for at least five consecutive days” requirement of claim 1 of the ’218 patent.
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`29.
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`In the Notice Letter, Mylan did not contest infringement of any claim of
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`the ’218 patent.
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`30.
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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 Products), offer for sale,
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`sale, marketing, distribution, and/or importation of Mylan’s ANDA Products will infringe at
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`least claim 1 of the ’218 patent.
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`31.
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`In the Mylan Notice Letter, Mylan indicated that, in connection with its
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`ANDA No. 208561, Mylan had filed Paragraph IV Certifications with respect to the ’218 patent.
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`6
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 7 of 10 PageID #: 7
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`32.
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`The purpose of ANDA No. 208561 was to obtain approval under the
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`Federal Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer for
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`sale, and/or sale of Mylan’s ANDA Products with their proposed labeling prior to the expiration
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`of the ’218 patent.
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`33. 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 Products with their proposed
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`labeling immediately and imminently upon approval of ANDA No. 208561, i.e., prior to the
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`expiration of the ’218 patent.
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`34. Mylan has knowledge of the claims of the ’218 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 Products with their
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`proposed labeling immediately and imminently upon approval of ANDA No. 208561. On
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`information and belief, by such activities, Mylan specifically intends to infringe the ’218 patent.
`
`35.
`
`On information and belief, Mylan plans and intends to, and will, actively
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`induce infringement of the ’218 patent when its ANDA is approved, and plans and intends to,
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`and will, do so immediately and imminently upon approval.
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`36.
`
`On information and belief, Mylan knows that Mylan’s ANDA Products
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`are especially made or adapted for use in infringing the ’218 patent, and that Mylan’s ANDA
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`Products are not suitable for substantial noninfringing use. On information and belief, Mylan
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`plans and intends to, and will, contribute to infringement of the ’218 patent immediately and
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`imminently upon approval of ANDA No. 208561.
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`7
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 8 of 10 PageID #: 8
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`37.
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`The foregoing actions by Mylan constitute and/or will constitute
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`infringement of the ’218 patent, active inducement of infringement of the ’218 patent, and/or
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`contribution to the infringement by others of the ’218 patent.
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`38.
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`An actual case or controversy exists between Plaintiffs and Mylan with
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`respect to infringement of the ’218 patent.
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`39.
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`This action is being commenced before the expiration of forty-five days
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`from the date BIP and Janssen received the Mylan Notice Letter.
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`CLAIM FOR RELIEF
`(Infringement of the ’218 Patent)
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`40.
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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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`41. Mylan’s submission of ANDA No. 208561 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 Products was an act of infringement of the ’218 patent under 35 U.S.C. § 271(e)(2).
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`42.
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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 Products with their proposed labeling prior to the expiration of the ’218 patent.
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`43. 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 Products with their proposed
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`labeling immediately and imminently upon approval of ANDA No. 208561, i.e., prior to the
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`expiration of the ’218 patent.
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`44.
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`The foregoing actions by Mylan constitute and/or will constitute
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`infringement of the ’218 patent, active inducement of infringement of the ’218 patent, and/or
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`contribution to the infringement by others of the ’218 patent.
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`8
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 9 of 10 PageID #: 9
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`45.
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`Unless Mylan is enjoined from infringing the ’218 patent, actively
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`inducing infringement of the ’218 patent, and contributing to the infringement by others of the
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`’218 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
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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 ’218 patent;
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`A judgment ordering that the effective date of any FDA approval for
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`Mylan to make, use, offer for sale, sell, market, distribute, or import Mylan’s ANDA Products,
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`or any product or compound the use of which infringes the ’218 patent, be no earlier than the
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`expiration date of the ’218 patent, inclusive of any extension(s) and additional period(s) of
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`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 Products, or any product or compound the use of
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`which infringes the ’218 patent, or the inducement of or the contribution to any of the foregoing,
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`prior to the expiration date of the ’218 patent, inclusive of any extension(s) and additional
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`period(s) of exclusivity;
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`(d)
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`A declaration that this is an exceptional case and an award of attorneys’
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`fees for Plaintiffs pursuant to 35 U.S.C. § 285;
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`(e)
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`(f)
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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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`9
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`Case 1:17-cv-00584-RGA Document 1 Filed 05/19/17 Page 10 of 10 PageID #: 10
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Rodger D. Smith (#3778)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`rsmith@mnat.com
`dfahnestock@mnat.com
`
`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH, Bayer AG, and Janssen
`Pharmaceuticals, Inc.
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`OF COUNSEL:
`
`Bruce R. Genderson
`Adam L. Perlman
`Dov P. Grossman
`Alexander S. Zolan
`Martha C. Kidd
`Kathryn S. Kayali
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street NW
`Washington, DC 20005
`(202) 434-5000
`
`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH and Bayer AG
`
`David T. Pritikin
`Lisa A. Schneider
`SIDLEY AUSTIN LLP
`One South Dearborn
`Chicago, IL 60603
`(312) 853-7000
`
`Bindu Donovan
`S. Isaac Olson
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 839-5300
`
`Attorneys for Plaintiff Janssen
`Pharmaceuticals, Inc.
`
`May 19, 2017
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`10
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