Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 1 of 11 PageID #: 1
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`BAYER PHARMA AG, BAYER AG and
`JANSSEN PHARMACEUTICALS, INC.,
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`MICRO LABS LTD. and
`MICRO LABS USA INC.,
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`Plaintiffs,
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`v.
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`Defendants.
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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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`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 and amendment by Micro
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`Labs Ltd. and Micro Labs USA Inc. of an Abbreviated New Drug Application (“ANDA”) to the
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`U.S. Food and Drug Administration (“FDA”) seeking approval to engage in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of a generic version of Plaintiffs’ 2.5 mg
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`XARELTO® product prior to the expiration of U.S. Patent No. 10,828,310 (“the ’310 patent”).
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`BAYER PHARMA AG, BAYER AG and
`JANSSEN PHARMACEUTICALS, INC.,
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`
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`MICRO LABS LTD. and
`MICRO LABS USA INC.,
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`
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`Plaintiffs,
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`
`
`v.
`
`
`
`Defendants.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`C.A. No.
`
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`)
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`)
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`COMPLAINT
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`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
`
`and Janssen are collectively referred to herein as “Plaintiffs”), by their attorneys, for their
`
`Complaint, hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of the submission and amendment by Micro
`
`Labs Ltd. and Micro Labs USA Inc. of an Abbreviated New Drug Application (“ANDA”) to the
`
`U.S. Food and Drug Administration (“FDA”) seeking approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of a generic version of Plaintiffs’ 2.5 mg
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`XARELTO® product prior to the expiration of U.S. Patent No. 10,828,310 (“the ’310 patent”).
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 2 of 11 PageID #: 2
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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,
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`51368 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 Micro Labs Ltd. is a corporation
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`organized and existing under the laws of India, with a place of business at 27 Race Course Road,
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`Bangalore 560 001, India.
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`6.
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`On information and belief, Defendant Micro Labs USA Inc. is a corporation
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`organized and existing under the laws of the State of New Jersey, with a place of business at 104
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`Carnegie Ctr., Suite 216, Princeton, New Jersey.
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`7.
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`On information and belief, Defendant Micro Labs USA Inc. is a wholly-
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`owned subsidiary of Micro Labs Ltd., and is controlled and dominated by Micro Labs Ltd.
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`8.
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`On information and belief, Micro Labs Ltd. is in the business of, among
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`other 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, Micro Labs Ltd., acting in concert
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`2
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 3 of 11 PageID #: 3
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`with Micro Labs USA Inc., files ANDAs with the FDA seeking approval to engage in the
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`commercial manufacture, use, offer for sale, sale, and/or importation of generic versions of drug
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`products that are covered by United States patents. On information and belief, as part of these
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`ANDAs, Micro Labs Ltd., acting in concert with Micro Labs USA Inc., files certifications of the
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`type described in Section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
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`(“Paragraph IV Certifications”) to engage in the commercial manufacture, use, offer for sale, sale,
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`and/or importation of generic drug products prior to the expiration of United States patents that
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`cover such products.
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`9.
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`On information and belief, and consistent with their practice with respect to
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`other generic products, Micro Labs Ltd. and Micro Labs USA Inc. acted in concert to prepare,
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`submit, and amend ANDA No. 208334 for Micro Labs Ltd.’s 2.5 mg rivaroxaban tablets (“Micro
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`Labs’ ANDA Product”), which was done at the direction of, under the control of, and for the direct
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`benefit of Micro Labs Ltd.
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`10.
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`On information and belief, Micro Labs Ltd. and Micro Labs USA Inc. are
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`agents of each other, and/or operate in concert as integrated parts of the same business group, and
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`enter into agreements with each other that are nearer than arm’s length, including with respect to
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`the development, regulatory approval, marketing, sale, offer for sale, and distribution of generic
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`pharmaceutical products throughout the United States, including into Delaware, and including with
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`respect to Micro Labs’ ANDA Product at issue.
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`11.
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`On information and belief, following any FDA approval of ANDA No.
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`208334, Micro Labs Ltd. and Micro Labs USA Inc. will act in concert to market, distribute, offer
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`for sale, and sell Micro Labs’ ANDA Product throughout the United States and within Delaware.
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`These two entities are hereafter collectively referred to as “Micro Labs.”
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`3
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 4 of 11 PageID #: 4
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`12.
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`On information and belief, following any FDA approval of ANDA No.
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`208334, Micro Labs will market, distribute, offer for sale, and sell Micro Labs’ ANDA Product
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`throughout the United States and within Delaware.
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`13.
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`On information and belief, following any FDA approval of ANDA No.
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`208334, Micro Labs knows and intends that its ANDA Product 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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`14.
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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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`15.
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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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`16.
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`In addition, this Court has personal jurisdiction over Micro Labs because,
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`among other things, on information and belief: (1) Micro Labs has filed an ANDA for the purpose
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`of seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of Micro Labs’ ANDA Product in the United States, including in Delaware; and
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`(2) Micro Labs will market, distribute, offer for sale, and/or sell Micro Labs’ ANDA Product in
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`the United States, including in Delaware, upon approval of ANDA No. 208334, and will derive
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`substantial revenue from the use or consumption of Micro Labs’ ANDA Product in the State of
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`Delaware. On information and belief, if ANDA No. 208334 is approved, the generic Micro Labs
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`product charged with infringing the ’310 patent would, among other things, be marketed,
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`distributed, offered for sale, and/or sold in Delaware, prescribed by physicians practicing in
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`Delaware, and dispensed by pharmacies located within Delaware, and/or used by patients in
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`Delaware, all of which would have a substantial effect on Delaware.
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`4
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 5 of 11 PageID #: 5
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`17.
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`Alternatively, if Micro Labs Ltd.’s connections with Delaware are found to
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`be insufficient to confer personal jurisdiction, then, upon information and belief, Micro Labs Ltd.
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`is not subject to jurisdiction in any state’s courts of general jurisdiction, and exercising jurisdiction
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`over Micro Labs Ltd. in Delaware is consistent with the United States Constitution and laws. See
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`Fed. R. Civ. P. 4(k)(2).
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`18. Micro Labs has consented to personal jurisdiction in Delaware in one or
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`more prior cases arising out of the filing of its ANDAs, including C.A. Nos. 16-cv-00242 and 17-
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`cv-00560, and it has filed counterclaims in such cases. In addition, upon information and belief,
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`Micro Labs will consent to personal jurisdiction in Delaware for purposes of this action.
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`VENUE
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`19.
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`Venue is proper in this district for Micro Labs Ltd. pursuant to 28 U.S.C.
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`§§ 1391 and 1400(b) because, inter alia, Micro Labs Ltd. is a company organized and existing
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`under the laws of India and is subject to personal jurisdiction in this judicial district.
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`20.
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`Venue is proper in this district for Micro Labs USA pursuant to 28 U.S.C.
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`§§ 1391 and 1400(b) because, inter alia, Micro Labs USA is subject to personal jurisdiction in this
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`judicial district, has previously consented to venue in this judicial district, and will consent to
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`venue in this judicial district for purposes of this action.
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`FACTUAL BACKGROUND
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`21.
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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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`5
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 6 of 11 PageID #: 6
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`22.
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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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`23.
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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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`24.
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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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`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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`25.
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`26.
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`27.
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`28.
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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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`29.
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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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`6
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 7 of 11 PageID #: 7
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`30.
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`By letter dated December 29, 2021 (the “Micro Labs Notice Letter”), Micro
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`Labs notified, inter alia, Bayer Pharma AG and Janssen that Micro Labs had submitted to the FDA
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`ANDA No. 208334 for Micro Labs’ ANDA Product and had submitted an amendment to that
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`ANDA. This product is a generic version of the 2.5 mg strength of XARELTO®.
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`31.
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`In the Micro Labs Notice Letter, Micro Labs indicated that, in connection
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`with its ANDA No. 208334, Micro Labs had filed, inter alia, a Paragraph IV Certification with
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`respect to the ’310 patent.
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`32.
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`In the Micro Labs Notice Letter, Micro Labs stated that Micro Labs’ ANDA
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`Product contains rivaroxaban.
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`33.
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`On information and belief, the proposed labeling for Micro Labs’ 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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`Micro Labs’ ANDA Product further directs the administration of Micro Labs’ ANDA Product and
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`aspirin in amounts that are clinically proven effective in reducing the risk of MI, stroke or CV
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`death in a human patient with CAD and/or PAD, wherein Micro Labs’ ANDA Product will be
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`administered twice daily and aspirin is administered in an amount of 75-100 mg daily.
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`34.
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`The purpose of ANDA No. 208334 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 Micro Labs’ ANDA Product with its proposed labeling prior to the
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`expiration of the ’310 patent.
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`35. Micro Labs intends to engage in the manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Micro Labs’ ANDA Product with its proposed
`
`7
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 8 of 11 PageID #: 8
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`
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`labeling immediately and imminently upon approval of ANDA No. 208334, i.e., prior to the
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`expiration of the ’310 patent.
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`36.
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`On information and belief, the manufacture, use (including in accordance
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`with and as directed by Micro Labs’ proposed labeling for Micro Labs’ ANDA Product), offer for
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`sale, sale, marketing, distribution, and/or importation of Micro Labs’ ANDA Product will infringe
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`at least claim 1 of the ’310 patent.
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`37. Micro Labs has knowledge of
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`the claims of
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`the ’310 patent.
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`Notwithstanding this knowledge, Micro Labs has continued to assert its intent to engage in the
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`manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Micro Labs’
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`ANDA Product with its proposed labeling immediately and imminently upon approval of ANDA
`
`No. 208334. On information and belief, by such activities, Micro Labs specifically intends to
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`infringe the ’310 patent.
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`38.
`
`On information and belief, Micro Labs plans and intends to, and will,
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`actively induce infringement of the ’310 patent when its ANDA is approved, and plans and intends
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`to, and will, do so immediately and imminently upon approval.
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`39.
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`On information and belief, Micro Labs knows that Micro Labs’ ANDA
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`Product with its proposed labeling is especially made or adapted for use in infringing the ’310
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`patent, and that Micro Labs’ ANDA Product with its proposed labeling is not suitable for
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`substantial noninfringing use. On information and belief, Micro Labs plans and intends to, and
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`will, contribute to infringement of the ’310 patent immediately and imminently upon approval of
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`ANDA No. 208334.
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`40. Micro Labs’ submission of ANDA No. 208334 and submission of an
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`amendment to that ANDA for the purpose of obtaining approval to engage in the commercial
`
`8
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 9 of 11 PageID #: 9
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`
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`manufacture, use, offer for sale, and/or sale of Micro Labs’ ANDA Product were acts of
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`infringement of the ’310 patent under 35 U.S.C. § 271(e)(2).
`
`41.
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`On information and belief, Micro Labs 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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`Micro Labs’ ANDA Product with its proposed labeling prior to the expiration of the ’310 patent.
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`42. Micro Labs intends to engage in the manufacture, use, offer for sale, sale,
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`marketing, distribution, and/or importation of Micro Labs’ ANDA Product with its proposed
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`labeling prior to the expiration of the ’310 patent.
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`43.
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`The foregoing actions by Micro Labs 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.
`
`Unless Micro Labs is enjoined from infringing the ’310 patent, actively
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`inducing infringement of the ’310 patent, and contributing to the infringement by others of the
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`’310 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`45.
`
`This action is being commenced before the expiration of forty-five days
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`from the date Bayer and Janssen received the Micro Labs Notice Letter.
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`COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’310 PATENT
`
`46.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth
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`herein.
`
`47.
`
`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 Micro Labs on the other regarding Micro Labs’ liability for infringement and
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`active inducement of infringement of the ’310 patent.
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`9
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 10 of 11 PageID #: 10
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`48.
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`An actual case or controversy exists between Plaintiffs and Micro Labs with
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`respect to Micro Labs’ 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 Micro Labs’ ANDA Product will infringe and induce the infringement
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`of the ’310 patent.
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`* * *
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`WHEREFORE, Plaintiffs request the following relief:
`
`(a)
`
`(b)
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`A judgment that Micro Labs has infringed the ’310 patent;
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`A judgment ordering that the effective date of any FDA approval for Micro
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`Labs to make, use, offer for sale, sell, market, distribute, or import Micro Labs’ ANDA Product,
`
`or any product or compound the use of which infringes the ’310 patent, be no earlier than the
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`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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`(c)
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`A preliminary and permanent injunction enjoining Micro Labs, and all
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`persons acting in concert with Micro Labs, from making, using, selling, offering for sale,
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`marketing, distributing, or importing Micro Labs’ ANDA Product, or any product or compound
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`the use of which infringes the ’310 patent, or the inducement of or the contribution to any of the
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`foregoing, prior to the expiration date of the ’310 patent, inclusive of any extension(s) and
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`additional period(s) of 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 Micro Labs’ 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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`10
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`Case 1:22-cv-00165-UNA Document 1 Filed 02/04/22 Page 11 of 11 PageID #: 11
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`
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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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`
`
`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@morrisnichols.com
`rsmith@morrisnichols.com
`dfahnestock@morrisnichols.com
`
`Attorneys for Plaintiffs Bayer Pharma AG,
`Bayer AG and Janssen Pharmaceuticals, Inc.
`
`
`
`
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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
`
`Thomas D. Rein
`SIDLEY AUSTIN LLP
`One South Dearborn
`Chicago, IL 60603
`(312) 853-7000
`
`Andrew T. Langford
`SIDLEY AUSTIN LLP
`2021 McKinney Avenue, Suite 2000
`Dallas, TX 75201
`(214) 981-3300
`
`Attorneys for Plaintiff Janssen
`Pharmaceuticals, Inc.
`
`February 4, 2022
`
`11
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`
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