Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No.
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`COMPLAINT
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`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER AG, and JANSSEN
`PHARMACEUTICALS, INC.,
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`SIGMAPHARM LABORATORIES, LLC,
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`Plaintiffs,
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`v.
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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 Sigmapharm
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`Laboratories, LLC 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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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No.
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`)))))))))))
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`COMPLAINT
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`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER AG, and JANSSEN
`PHARMACEUTICALS, INC.,
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`SIGMAPHARM LABORATORIES, LLC,
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`Plaintiffs,
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`v.
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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 Sigmapharm
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`Laboratories, LLC 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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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 2 of 10 PageID #: 2
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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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`Sigmapharm Laboratories, LLC
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`5.
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`On information and belief, Defendant Sigmapharm Laboratories LLC
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`(“Sigmapharm”) is a limited liability company organized and existing under the laws of the
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`Commonwealth of Pennsylvania, with a place of business at 3375 Progress Drive, Bensalem,
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`Pennsylvania.
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`6.
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`On information and belief, Sigmapharm 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, Sigmapharm files ANDAs with
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`the FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
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`and/or importation of generic versions of drug products that are covered by United States
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`patents. On information and belief, as part of these ANDAs, Sigmapharm files certifications of
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`the type described in Section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
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`2
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 3 of 10 PageID #: 3
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`(“Paragraph IV Certifications”) to engage in the commercial manufacture, use, offer for sale,
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`sale, and/or importation of generic drug products prior to the expiration of United States patents
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`that cover such products.
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`7.
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`On information and belief, Sigmapharm prepared and submitted ANDA
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`No. 208546 for Sigmapharm’s 10 mg, 15 mg, and 20 mg rivaroxaban tablets (“Sigmapharm’s
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`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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`208546, Sigmapharm will market, distribute, offer for sale, and sell Sigmapharm’s ANDA
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`Products 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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`208546, Sigmapharm knows and intends that its ANDA Products will be marketed, used,
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`distributed, 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 Sigmapharm because, among
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`other things, on information and belief: (1) Sigmapharm 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 Sigmapharm’s ANDA Products in the United States, including in Delaware; and
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`(2) Sigmapharm will market, distribute, offer for sale, and/or sell Sigmapharm’s ANDA Products
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`in the United States, including in Delaware, upon approval of ANDA No. 208546, and will
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`3
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 4 of 10 PageID #: 4
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`derive substantial revenue from the use or consumption of Sigmapharm’s ANDA Products in the
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`State of Delaware. On information and belief, if ANDA No. 208546 is approved, the generic
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`Sigmpharm products charged with infringing the ’218 patent would, among other things, be
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`marketed, distributed, offered for sale, and/or sold in Delaware, prescribed by physicians
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`practicing in Delaware, and dispensed by pharmacies located within Delaware, and/or used by
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`patients in Delaware, all of which would have a substantial effect on Delaware.
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`13.
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`Sigmapharm has consented to jurisdiction in Delaware in one or more
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`prior cases arising out of the filing of its ANDAs, including Case No. 15-902 involving the same
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`ANDA at issue here, and it has filed counterclaims in such cases.
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`VENUE
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`14.
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`Sigmapharm, through its counsel, has represented that it consents to venue
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`in the District of Delaware for purposes of this case.
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`FACTUAL BACKGROUND
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`15.
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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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`16.
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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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`4
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 5 of 10 PageID #: 5
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`17.
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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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`18.
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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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`19.
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`20.
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`21.
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`22.
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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 Sigmapharm
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`23.
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`By letter dated April 12, 2017 (the “Sigmapharm Notice Letter”),
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`Sigmapharm notified BIP and Janssen, among others, that Sigmapharm had submitted to the
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`FDA ANDA No. 208546 for Sigmapharm’s ANDA Products. These products are generic
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`versions of XARELTO®.
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`5
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 6 of 10 PageID #: 6
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`24.
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`In the Sigmapharm Notice Letter, Sigmapharm stated that Sigmapharm’s
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`ANDA Products contain rivaroxaban.
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`25.
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`In the Sigmapharm Notice Letter, Sigmapharm stated that the dosage form
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`of Sigmapharm’s ANDA Products is tablets. On information and belief, the dosage form of
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`Sigmapharm’s ANDA Products satisfies the “rapid-release tablet” requirement of claim 1 of the
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`’218 patent.
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`26.
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`On information and belief, the proposed labeling for Sigmapharm’s
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`ANDA Products directs the use of Sigmpharm’s ANDA Products for one or more of the
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`following indications: (i) to reduce the risk of stroke and systemic embolism in patients with
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`nonvalvular atrial fibrillation; (ii) for the treatment of deep vein thrombosis (DVT), pulmonary
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`embolism (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 Sigmapharm’s ANDA Products
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`further directs the use of Sigmapharm’s ANDA Products in a manner that satisfies the “no more
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`than once daily for at least five consecutive days” requirement of claim 1 of the ’218 patent.
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`27.
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`On information and belief, the manufacture, use (including in accordance
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`with and as directed by Sigmapharm’s proposed labeling for Sigmapharm’s ANDA Products),
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`offer for sale, sale, marketing, distribution, and/or importation of Sigmapharm’s ANDA Products
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`will infringe at least claim 1 of the ’218 patent.
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`28.
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`In the Sigmapharm Notice Letter, Sigmapharm indicated that, in
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`connection with its ANDA No. 208546, Sigmapharm had filed Paragraph IV Certifications with
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`respect to the ’218 patent.
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`6
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 7 of 10 PageID #: 7
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`29.
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`The purpose of ANDA No. 208546 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 Sigmapharm’s ANDA Products with their proposed labeling prior to the
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`expiration of the ’218 patent.
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`30.
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`Sigmapharm intends to engage in the manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Sigmapharm’s ANDA Products with their
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`proposed labeling immediately and imminently upon approval of ANDA No. 208546, i.e., prior
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`to the expiration of the ’218 patent.
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`31.
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`Sigmapharm has knowledge of
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`the claims of
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`the ’218 patent.
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`Notwithstanding this knowledge, Sigmapharm has continued to assert its intent to engage in the
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`manufacture, use, offer for sale, sale, marketing, distribution, and/or
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`importation of
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`Sigmapharm’s ANDA Products with their proposed labeling immediately and imminently upon
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`approval of ANDA No. 208546. On information and belief, by such activities, Sigmapharm
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`specifically intends to infringe the ’218 patent.
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`32.
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`On information and belief, Sigmapharm plans and intends to, and will,
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`actively induce infringement of the ’218 patent when its ANDA is approved, and plans and
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`intends to, and will, do so immediately and imminently upon approval.
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`33.
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`On information and belief, Sigmapharm knows that Sigmapharm’s ANDA
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`Products are especially made or adapted for use in infringing the ’218 patent, and that
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`Sigmapharm’s ANDA Products are not suitable for substantial noninfringing use. On
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`information and belief, Sigmapharm plans and intends to, and will, contribute to infringement of
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`the ’218 patent immediately and imminently upon approval of ANDA No. 208546.
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`7
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 8 of 10 PageID #: 8
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`34.
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`The foregoing actions by Sigmapharm 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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`35.
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`An actual case or controversy exists between Plaintiffs and Sigmapharm
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`with respect to infringement of the ’218 patent.
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`36.
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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 Sigmapharm Notice Letter.
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`CLAIM FOR RELIEF
`(Infringement of the ’218 Patent)
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`37.
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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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`38.
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`Sigmapharm’s submission of ANDA No. 208546 for the purpose of
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`obtaining approval to engage in the commercial manufacture, use, offer for sale, and/or sale of
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`Sigmapharm’s ANDA Products was an act of infringement of the ’218 patent under 35 U.S.C.
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`§ 271(e)(2).
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`39.
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`On information and belief, Sigmapharm has made, and will continue to
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`make, substantial preparation in the United States to manufacture, use, sell, offer to sell, and/or
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`import Sigmapharm’s ANDA Products with their proposed labeling prior to the expiration of the
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`’218 patent.
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`40.
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`Sigmapharm intends to engage in the manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Sigmapharm’s ANDA Products with their
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`proposed labeling immediately and imminently upon approval of ANDA No. 208546, i.e., prior
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`to the expiration of the ’218 patent.
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`8
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`Case 1:17-cv-00648-RGA Document 1 Filed 05/26/17 Page 9 of 10 PageID #: 9
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`41.
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`The foregoing actions by Sigmapharm 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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`42.
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`Unless Sigmapharm 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)
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`(b)
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`A judgment that Sigmapharm 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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`Sigmapharm to make, use, offer for sale, sell, market, distribute, or import Sigmapharm’s ANDA
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`Products, or any product or compound the use of which infringes the ’218 patent, be no earlier
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`than the expiration date of the ’218 patent, inclusive of any extension(s) and additional period(s)
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`of exclusivity;
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`(c)
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`A preliminary and permanent injunction enjoining Sigmapharm, and all
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`persons acting in concert with Sigmapharm, from making, using, selling, offering for sale,
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`marketing, distributing, or importing Sigmapharm’s ANDA Products, or any product or
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`compound the use of which infringes the ’218 patent, or the inducement of or the contribution to
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`any of the foregoing, prior to the expiration date of the ’218 patent, inclusive of any extension(s)
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`and additional 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-00648-RGA Document 1 Filed 05/26/17 Page 10 of 10 PageID #: 10
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Derek J. Fahnestock
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`
`
`
`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
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`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH, Bayer AG, and Janssen
`Pharmaceuticals, Inc.
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`OF COUNSEL:
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`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
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`David T. Pritikin
`Lisa A. Schneider
`SIDLEY AUSTIN LLP
`One South Dearborn
`Chicago, IL 60603
`(312) 853-7000
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`Bindu Donovan
`S. Isaac Olson
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 839-5300
`Attorneys for Plaintiff Janssen
`Pharmaceuticals, Inc.
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`May 26, 2017
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`10
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