Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 1 of 64 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`COMPLAINT
`
`
`
`
`
`Defendants.
`
`
`
`Plaintiffs Bayer Intellectual Property GmbH (“BIP”), Bayer Pharma AG (“Bayer
`
`Pharma”) (Bayer Pharma and BIP are collectively referred to herein as “Bayer”), and Janssen
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`Pharmaceuticals, Inc. (“Janssen”) (Bayer and Janssen are collectively referred to herein as
`
`“Plaintiffs”), by their 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
`
`United States, Title 35, United States Code, that arises out of the filing by various defendants of
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`Abbreviated New Drug Applications (“ANDA”) with the U.S. Food and Drug Administration
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`(“FDA”) seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of generic versions of Plaintiffs’ XARELTO® products prior to the expiration
`
`
`
`C.A. No.
`
`
`
`
`
`
`
`
`
`))))))))))))))))))))
`
`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER PHARMA AG, and JANSSEN
`PHARMACEUTICALS, INC.,
`
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`AUROBINDO PHARMA LIMITED,
`AUROBINDO PHARMA USA, INC.,
`BRECKENRIDGE PHARMACEUTICAL,
`INC., MICRO LABS LTD., MICRO LABS
`USA INC., MYLAN PHARMACEUTICALS
`INC., MYLAN INC., PRINSTON
`PHARMACEUTICAL INC., SIGMAPHARM
`LABORATORIES, LLC, TORRENT
`PHARMACEUTICALS, LIMITED, and
`TORRENT PHARMA INC.
`
`MYLAN - EXHIBIT 1016
`
`

`
`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 2 of 64 PageID #: 2
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`of one or more of U.S. Patent Nos. 7,157,456 (“the ’456 patent”), 7,585,860 (“the ’860 patent”),
`
`and 7,592,339 (“the ’339 patent”).
`
`THE PARTIES
`
`Plaintiffs
`
`2.
`
`Plaintiff Bayer Intellectual Property GmbH is a corporation organized and
`
`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.
`
`3.
`
`Plaintiff Bayer Pharma AG is a corporation organized and existing under
`
`the laws of the Federal Republic of Germany, with a place of business at Müllerstrasse 178,
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`13353 Berlin, Germany.
`
`4.
`
`Plaintiff Janssen Pharmaceuticals, Inc. is a corporation organized and
`
`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.
`
`Aurobindo
`
`5.
`
`On information and belief, Defendant Aurobindo Pharma Limited is a
`
`company organized and existing under the laws of India, with a place of business at Plot #2,
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`Maitri Vihar, Ameerpet, Hyderabad – 500 038, Andhra Pradesh, India.
`
`6.
`
`On information and belief, Defendant Aurobindo Pharma USA, Inc. is a
`
`corporation organized and existing under the laws of the State of Delaware, with a place of
`
`business at 6 Wheeling Road, Dayton, New Jersey.
`
`7.
`
`On information and belief, Aurobindo Pharma USA, Inc. is a wholly-
`
`owned subsidiary of Aurobindo Pharma Limited, and is controlled and dominated by Aurobindo
`
`Pharma Limited.
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`2
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 3 of 64 PageID #: 3
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`8.
`
`On information and belief, Aurobindo Pharma Limited is in the business
`
`of, among other things, manufacturing, marketing, distributing, offering for sale, and selling
`
`generic drug products. As a part of this business, on information and belief, Aurobindo Pharma
`
`Limited, acting in concert with Aurobindo Pharma USA, Inc., files ANDAs with the FDA
`
`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic versions of drug products that are covered by United States patents. On
`
`information and belief, as part of these ANDAs, Aurobindo Pharma Limited, acting in concert
`
`with Aurobindo Pharma USA, Inc., files certifications of the type described in Section
`
`505(j)(2)(A)(vii)(IV) of
`
`the Federal Food, Drug, and Cosmetic Act (“Paragraph IV
`
`Certifications”) to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic drug products prior to the expiration of United States patents that cover
`
`such products.
`
`9.
`
`On information and belief, and consistent with their practice with respect
`
`to other generic products, Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. acted in
`
`concert to prepare and submit ANDA No. 208544 for Aurobindo Pharma Limited’s 10 mg, 15
`
`mg, and 20 mg rivaroxaban tablets (“Aurobindo’s ANDA Products”), which was done at the
`
`direction of, under the control of, and for the direct benefit of Aurobindo Pharma Limited.
`
`10.
`
`On information and belief, Aurobindo Pharma Limited and Aurobindo
`
`Pharma USA, Inc. are agents of each other, and/or operate in concert as integrated parts of the
`
`same business group, and enter into agreements with each other that are nearer than arm’s length,
`
`including with respect to the development, regulatory approval, marketing, sale, offer for sale,
`
`and distribution of generic pharmaceutical products throughout the United States, including into
`
`Delaware, and including with respect to the infringing Aurobindo’s ANDA Products at issue.
`
`3
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 4 of 64 PageID #: 4
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`11.
`
`On information and belief, following any FDA approval of ANDA No.
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`208544, Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. will act in concert to
`
`market, distribute, offer for sale, and sell Aurobindo’s ANDA Products throughout the United
`
`States and within Delaware. These two entities are hereafter collectively referred to as
`
`“Aurobindo.”
`
`12.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208544, Aurobindo knows and intends that its ANDA Products will be marketed, used,
`
`distributed, offered for sale, and sold in the United States and within Delaware.
`
`Breckenridge
`
`13.
`
`On information and belief, Defendant Breckenridge Pharmaceutical, Inc.
`
`(“Breckenridge”) is a corporation organized and existing under the laws of the State of Florida,
`
`with a place of business at 6111 Broken Sound Parkway, NW, Suite 170, Boca Raton, Florida.
`
`14.
`
`On information and belief, Breckenridge is in the business of, among other
`
`things, manufacturing, marketing, distributing, offering for sale, and selling generic drug
`
`products. As a part of this business, on information and belief, Breckenridge files ANDAs with
`
`the FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of generic versions of drug products that are covered by United States
`
`patents. On information and belief, as part of these ANDAs, Breckenridge files Paragraph IV
`
`Certifications to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic drug products prior to the expiration of United States patents that cover
`
`such products.
`
`4
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 5 of 64 PageID #: 5
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`15.
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`On information and belief, Breckenridge prepared and submitted ANDA
`
`No. 208220 for Breckenridge’s 10 mg, 15 mg, and 20 mg rivaroxaban tablets, oral
`
`(“Breckenridge’s ANDA Products”).
`
`16.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208220, Breckenridge will market, distribute, offer for sale, and sell Breckendridge’s ANDA
`
`Products throughout the United States and within Delaware.
`
`17.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208220, Breckenridge knows and intends that its ANDA Products will be marketed, used,
`
`distributed, offered for sale, and sold in the United States and within Delaware.
`
`Micro Labs
`
`18.
`
`On information and belief, Defendant Micro Labs Ltd. is a corporation
`
`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.
`
`19.
`
`On information and belief, Defendant Micro Labs USA Inc. is a
`
`corporation organized and existing under the laws of the State of New Jersey, with a place of
`
`business at 104 Carnegie Ctr., Suite 216, Princeton, New Jersey.
`
`20.
`
`On information and belief, Defendant Micro Labs USA Inc. is a wholly-
`
`owned subsidiary of Micro Labs Ltd., and is controlled and dominated by Micro Labs Ltd.
`
`21.
`
`On information and belief, Micro Labs Ltd. is in the business of, among
`
`other things, manufacturing, marketing, distributing, offering for sale, and selling generic drug
`
`products. As a part of this business, on information and belief, Micro Labs Ltd., acting in
`
`concert with Micro Labs USA Inc., files ANDAs with the FDA seeking approval to engage in
`
`the commercial manufacture, use, offer for sale, sale, and/or importation of generic versions of
`
`5
`
`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 6 of 64 PageID #: 6
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`drug products that are covered by United States patents. On information and belief, as part of
`
`these ANDAs, Micro Labs Ltd., acting in concert with Micro Labs USA Inc., files Paragraph IV
`
`Certifications to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic drug products prior to the expiration of United States patents that cover
`
`such products.
`
`22.
`
`On information and belief, and consistent with their practice with respect
`
`to other generic products, Micro Labs Ltd. and Micro Labs USA Inc. acted in concert to prepare
`
`and submit ANDA No. 208334 for Micro Labs Ltd.’s 10 mg, 15 mg, and 20 mg rivaroxaban
`
`tablets (“Micro Labs’ ANDA Products”), which was done at the direction of, under the control
`
`of, and for the direct benefit of Micro Labs Ltd.
`
`23.
`
`On information and belief, Micro Labs Ltd. and Micro Labs USA Inc. are
`
`agents of each other, and/or operate in concert as integrated parts of the same business group,
`
`and enter into agreements with each other that are nearer than arm’s length, including with
`
`respect to the development, regulatory approval, marketing, sale, offer for sale, and distribution
`
`of generic pharmaceutical products throughout the United States, including into Delaware, and
`
`including with respect to the infringing Micro Labs’ ANDA Products at issue.
`
`24.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208334, Micro Labs Ltd. and Micro Labs USA Inc. will act in concert to market, distribute, offer
`
`for sale, and sell Micro Labs’ ANDA Products throughout the United States and within
`
`Delaware. These two entities are hereafter collectively referred to as “Micro Labs.”
`
`25.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208334, Micro Labs knows and intends that its ANDA Products will be marketed, used,
`
`distributed, offered for sale, and sold in the United States and within Delaware.
`
`6
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 7 of 64 PageID #: 7
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`Mylan
`
`26.
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc. is a
`
`corporation organized and existing under the laws of the State of West Virginia, with a place of
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`business at 781 Chestnut Ridge Road, Morgantown, West Virginia.
`
`27.
`
`On information and belief, Defendant Mylan Inc. is a corporation
`
`organized and existing under the laws of the Commonwealth of Pennsylvania, with a place of
`
`business at 1500 Corporate Drive, Canonsburg, Pennsylvania.
`
`28.
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc. is a
`
`wholly-owned subsidiary of Mylan Inc., and is controlled and dominated by Mylan Inc.
`
`29.
`
`On information and belief, Mylan Inc. is in the business of, among other
`
`things, manufacturing, marketing, distributing, offering for sale, and selling generic drug
`
`products. As a part of this business, on information and belief, Mylan Pharmaceuticals Inc.,
`
`acting in concert with Mylan Inc., files ANDAs with the FDA seeking approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of generic versions of drug
`
`products that are covered by United States patents. On information and belief, as part of these
`
`ANDAs, Mylan Pharmaceuticals Inc., acting in concert with Mylan Inc., files Paragraph IV
`
`Certifications to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic drug products prior to the expiration of United States patents that cover
`
`such products.
`
`30.
`
`On information and belief, and consistent with their practice with respect
`
`to other generic products, Mylan Inc. and Mylan Pharmaceuticals Inc. acted in concert to prepare
`
`and submit ANDA No. 208561 for Mylan Pharmaceutical Inc.’s 10 mg, 15 mg, and 20 mg
`
`7
`
`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 8 of 64 PageID #: 8
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`rivaroxaban tablets (“Mylan’s ANDA Products”), which was done at the direction of, under the
`
`control of, and for the direct benefit of Mylan Inc.
`
`31.
`
`On information and belief, Mylan Pharmaceuticals Inc. and Mylan Inc. are
`
`agents of each other, and/or operate in concert as integrated parts of the same business group,
`
`and enter into agreements with each other that are nearer than arm’s length, including with
`
`respect to the development, regulatory approval, marketing, sale, offer for sale, and distribution
`
`of generic pharmaceutical products throughout the United States, including into Delaware, and
`
`including with respect to the infringing Mylan ANDA Products at issue.
`
`32.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208561, Mylan Pharmaceuticals Inc. and Mylan Inc. will act in concert to market, distribute,
`
`offer for sale, and sell Mylan’s ANDA Products throughout the United States and within
`
`Delaware. These two entities are hereafter collectively referred to as “Mylan.”
`
`33.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208561, Mylan knows and intends that its ANDA Products will be marketed, used, distributed,
`
`offered for sale, and sold in the United States and within Delaware.
`
`Prinston
`
`34.
`
`On information and belief, Defendant Prinston Pharmaceutical Inc.
`
`(“Prinston”) is a corporation organized and existing under the laws of the State of Delaware, with
`
`a place of business at 2002 Eastpark Blvd, Cranbury, New Jersey.
`
`35.
`
`On information and belief, Prinston is in the business of, among other
`
`things, manufacturing, marketing, distributing, offering for sale, and selling generic drug
`
`products. As a part of this business, on information and belief, Prinston files ANDAs with the
`
`FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`8
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 9 of 64 PageID #: 9
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`importation of generic versions of drug products that are covered by United States patents. On
`
`information and belief, as part of these ANDAs, Prinston files Paragraph IV Certifications to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of generic
`
`drug products prior to the expiration of United States patents that cover such products.
`
`36.
`
`On information and belief, Prinston prepared and submitted ANDA No.
`
`208549 for Prinston’s 10 mg, 15 mg, and 20 mg rivaroxaban tablets (“Prinston’s ANDA
`
`Products”).
`
`37.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208549, Prinston will market, distribute, offer for sale, and sell Prinston’s ANDA Products
`
`throughout the United States and within Delaware.
`
`38.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208549, Prinston knows and intends that its ANDA Products will be marketed, used, distributed,
`
`offered for sale, and sold in the United States and within Delaware.
`
`Sigmapharm
`
`39.
`
`On information and belief, Defendant Sigmapharm Laboratories, LLC
`
`(“Sigmapharm”) is a limited liability company organized and existing under the laws of the
`
`Commonwealth of Pennsylvania, with a place of business at 3375 Progress Drive, Bensalem,
`
`Pennsylvania.
`
`40.
`
`On information and belief, Sigmapharm is in the business of, among other
`
`things, manufacturing, marketing, distributing, offering for sale, and selling generic drug
`
`products. As a part of this business, on information and belief, Sigmapharm files ANDAs with
`
`the FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of generic versions of drug products that are covered by United States
`
`9
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 10 of 64 PageID #: 10
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`patents. On information and belief, as part of these ANDAs, Sigmapharm files Paragraph IV
`
`Certifications to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic drug products prior to the expiration of United States patents that cover
`
`such products.
`
`41.
`
`On information and belief, Sigmapharm prepared and submitted ANDA
`
`No. 208546 for Sigmapharm’s 10 mg, 15 mg, and 20 mg rivaroxaban tablets (“Sigmapharm’s
`
`ANDA Products”).
`
`42.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208546, Sigmapharm will market, distribute, offer for sale, and sell Sigmapharm’s ANDA
`
`Products throughout the United States and within Delaware.
`
`43.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208546, Sigmapharm knows and intends that its ANDA Products will be marketed, used,
`
`distributed, offered for sale, and sold in the United States and within Delaware.
`
`Torrent
`
`44.
`
`On information and belief, Defendant Torrent Pharmaceuticals, Limited is
`
`a corporation organized and existing under the laws of India, with a place of business at Torrent
`
`House, Off Ashram Road, Ahmedabad – 380 009, India.
`
`45.
`
`On information and belief, Defendant Torrent Pharma Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware, with a place of business at 150
`
`Allen Road, Suite 102, Basking Ridge, New Jersey.
`
`46.
`
`On information and belief, Defendant Torrent Pharma Inc. is a wholly-
`
`owned subsidiary of Torrent Pharmaceuticals, Limited, and is controlled and dominated by
`
`Torrent Pharmaceuticals, Limited.
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`10
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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 11 of 64 PageID #: 11
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`47.
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`On information and belief, Torrent Pharmaceuticals, Limited is in the
`
`business of, among other things, manufacturing, marketing, distributing, offering for sale, and
`
`selling generic drug products. As a part of this business, on information and belief, Torrent
`
`Pharmaceuticals, Limited, acting in concert with Torrent Pharma Inc., files ANDAs with the
`
`FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of generic versions of drug products that are covered by United States patents. On
`
`information and belief, as part of these ANDAs, Torrent Pharmaceuticals, Limited, acting in
`
`concert with Torrent Pharma Inc., files Paragraph IV Certifications to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of generic drug products prior to the
`
`expiration of United States patents that cover such products.
`
`48.
`
`On information and belief, and consistent with their practice with respect
`
`to other generic products, Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. acted in
`
`concert to prepare and submit ANDA No. 208556 for Torrent Pharmaceuticals, Limited’s 10 mg,
`
`15 mg, and 20 mg rivaroxaban tablets (“Torrent’s ANDA Products”), which was done at the
`
`direction of, under the control of, and for the direct benefit of Torrent Pharmaceuticals, Limited
`
`49.
`
`On information and belief, Torrent Pharmaceuticals, Limited and Torrent
`
`Pharma Inc. are agents of each other, and/or operate in concert as integrated parts of the same
`
`business group, and enter into agreements with each other that are nearer than arm’s length,
`
`including with respect to the development, regulatory approval, marketing, sale, offer for sale,
`
`and distribution of generic pharmaceutical products throughout the United States, including into
`
`Delaware, and including with respect to the infringing Torrent’s ANDA Products at issue.
`
`50.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208556, Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. will act in concert to market,
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`11
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 12 of 64 PageID #: 12
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`distribute, offer for sale, and sell Torrent’s ANDA Products throughout the United States and
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`within Delaware. These two entities are hereafter collectively referred to as “Torrent.”
`
`51.
`
`On information and belief, following any FDA approval of ANDA No.
`
`208556, Torrent knows and intends that its ANDA Products will be marketed, used, distributed,
`
`offered for sale, and sold in the United States and within Delaware.
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`JURISDICTION
`
`52.
`
`Plaintiffs incorporate each of the preceding paragraphs as if each fully set
`
`forth herein.
`
`53.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`54.
`
`Based on the facts and causes alleged herein, and for additional reasons to
`
`be further developed through discovery if necessary, this Court has personal jurisdiction over
`
`each of the defendants.
`
`Aurobindo
`
`55.
`
`This Court has personal jurisdiction over Aurobindo Pharma USA, Inc.
`
`because, among other things, Aurobindo Pharma USA, Inc. is a corporation formed under the
`
`laws of the State of Delaware.
`
`56.
`
`This Court has personal jurisdiction over Aurobindo Pharma Limited and
`
`Aurobindo Pharma USA, Inc. because, among other things, on information and belief: (1)
`
`Aurobindo Pharma Limited, acting in concert with Aurobindo Pharma USA, Inc., has filed an
`
`ANDA for the purpose of seeking approval to engage in the commercial manufacture, use, offer
`
`for sale, sale, and/or importation of Aurobindo’s ANDA Products in the United States, including
`
`in Delaware; and (2) Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc., acting in
`
`12
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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 13 of 64 PageID #: 13
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`concert and/or as agents of one another, will market, distribute, offer for sale, and/or sell
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`Aurobindo’s ANDA Products in the United States, including in Delaware, upon approval of
`
`ANDA No. 208544, and will derive substantial revenue from the use or consumption of
`
`Aurobindo’s ANDA Products in the State of Delaware. On information and belief, if ANDA No.
`
`208544 is approved, the generic Aurobindo products charged with infringing the ’456, ’860, and
`
`’339 patents would, among other things, be marketed, distributed, offered for sale, and/or sold in
`
`Delaware, prescribed by physicians practicing in Delaware, and dispensed by pharmacies located
`
`within Delaware, and/or used by patients in Delaware, all of which would have a substantial
`
`effect on Delaware.
`
`57.
`
`Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. have
`
`consented to jurisdiction in Delaware in one or more prior cases arising out of the filing of their
`
`ANDAs, and they have filed counterclaims in such cases.
`
`58.
`
`Alternatively, if Aurobindo Pharma Limited’s connections with Delaware,
`
`including its connections with Aurobindo Pharma USA, Inc., are found to be insufficient to
`
`confer personal jurisdiction, then, upon information and belief, Aurobindo Pharma Limited is not
`
`subject to jurisdiction in any state’s courts of general jurisdiction, and exercising jurisdiction
`
`over Aurobindo Pharma Limited in Delaware is consistent with the United States Constitution
`
`and laws. See Fed. R. Civ. P. 4(k)(2).
`
`Breckenridge
`
`59.
`
`This Court has personal jurisdiction over Breckenridge because, on
`
`information and belief, Breckenridge has registered to do business in the State of Delaware and
`
`has appointed a registered agent in Delaware to accept service of process. Breckenridge has thus
`
`consented to personal jurisdiction in Delaware.
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`13
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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 14 of 64 PageID #: 14
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`60.
`
`This Court also has personal jurisdiction over Breckenridge because,
`
`among other things, on information and belief: (1) Breckenridge has filed an ANDA for the
`
`purpose of seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of Breckenridge’s ANDA Products in the United States, including in
`
`Delaware; and (2) Breckenridge will market, distribute, offer for sale, and/or sell Breckenridge’s
`
`ANDA Products in the United States, including in Delaware, upon approval of ANDA No.
`
`208220, and will derive substantial revenue from the use or consumption of Breckenridge’s
`
`ANDA Products in the State of Delaware. On information and belief, if ANDA No. 208220 is
`
`approved, the generic Breckenridge products charged with infringing the ’456 and ’860 patents
`
`would, among other things, be marketed, distributed, offered for sale, and/or sold in Delaware,
`
`prescribed by physicians practicing in Delaware, and dispensed by pharmacies located within
`
`Delaware, and/or used by patients in Delaware, all of which would have a substantial effect on
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`Delaware.
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`61.
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`Breckenridge has consented to jurisdiction in Delaware in one or more
`
`prior cases arising out of the filing of its ANDAs, and it has filed counterclaims in such cases.
`
`62.
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`In addition, Breckenridge, through its counsel, has represented that it will
`
`not contest personal jurisdiction in Delaware for purposes of this case.
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`Micro Labs
`
`63.
`
`This Court has personal jurisdiction over Micro Labs Ltd. and Micro Labs
`
`USA Inc. because, among other things, on information and belief: (1) Micro Labs Ltd., acting in
`
`concert with Micro Labs USA Inc., has filed an ANDA for the purpose of seeking approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Micro
`
`Labs’ ANDA Products in the United States, including in Delaware; and (2) Micro Labs Ltd. and
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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 15 of 64 PageID #: 15
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`Micro Labs USA Inc., acting in concert and/or as agents of one another, will market, distribute,
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`offer for sale, and/or sell Micro Labs’ ANDA Products in the United States, including in
`
`Delaware, upon approval of ANDA No. 208334, and will derive substantial revenue from the use
`
`or consumption of Micro Labs’ ANDA Products in the State of Delaware. On information and
`
`belief, if ANDA No. 208334 is approved, the generic Micro Labs products charged with
`
`infringing the ’456 patent would, among other things, be marketed, distributed, offered for sale,
`
`and/or sold in Delaware, prescribed by physicians practicing in Delaware, and dispensed by
`
`pharmacies located within Delaware, and/or used by patients in Delaware, all of which would
`
`have a substantial effect on Delaware.
`
`64. Micro Labs Ltd. and Micro Labs USA Inc. have consented to jurisdiction
`
`in Delaware in one or more prior cases arising out of the filing of their ANDAs, and they have
`
`filed counterclaims in such cases.
`
`65.
`
`Alternatively, if Micro Labs Ltd.’s connections with Delaware are found
`
`to be insufficient to confer personal jurisdiction, then, upon information and belief, Micro Labs
`
`Ltd. is not subject to jurisdiction in any state’s courts of general jurisdiction, and exercising
`
`jurisdiction over Micro Labs Ltd. in Delaware is consistent with the United States Constitution
`
`and laws. See Fed. R. Civ. P. 4(k)(2).
`
`66.
`
`In addition, Micro Labs Ltd. and Micro Labs USA Inc., through their
`
`counsel, have represented that they will not contest personal jurisdiction in Delaware for
`
`purposes of this case.
`
`Mylan
`
`67.
`
`This Court has personal jurisdiction over Mylan Pharmaceuticals Inc.
`
`because, on information and belief, Mylan Pharmaceuticals Inc. has registered to do business in
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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 16 of 64 PageID #: 16
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`the State of Delaware and has appointed a registered agent in Delaware to accept service of
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`process. Mylan Pharmaceuticals Inc. has thus consented to jurisdiction in Delaware.
`
`68.
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`In addition, this Court also has personal jurisdiction over Mylan
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`Pharmaceuticals Inc. and Mylan Inc. because, among other things, on information and belief: (1)
`
`Mylan Pharmaceuticals Inc., acting in concert with Mylan Inc., has filed an ANDA for the
`
`purpose of seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of Mylan’s ANDA Products in the United States, including in Delaware; and
`
`(2) Mylan Pharmaceuticals Inc. and Mylan Inc., acting in concert and/or as agents of one
`
`another, will market, distribute, offer for sale, and/or sell Mylan’s ANDA Products in the United
`
`States, including in Delaware, upon approval of ANDA No. 208561, and will derive substantial
`
`revenue from the use or consumption of Mylan’s ANDA Products in the State of Delaware. On
`
`information and belief, if ANDA No. 208561 is approved, the generic Mylan products charged
`
`with infringing the ’456, ’860, and ’339 patents would, among other things, be marketed,
`
`distributed, offered for sale, and/or sold in Delaware, prescribed by physicians practicing in
`
`Delaware, and dispensed by pharmacies located within Delaware, and/or used by patients in
`
`Delaware, all of which would have a substantial effect on Delaware.
`
`69. Mylan Pharmaceuticals Inc. is actively registered with the Delaware Board
`
`of Pharmacy, pursuant to Del. C. § 2540, as a licensed “Pharmacy – Wholesale Drug
`
`Distributor,” and as a licensed “Distributor/Manufacturer CSR.”
`
`70. Mylan Inc. and Mylan Pharmaceuticals Inc. have consented to jurisdiction
`
`in Delaware in one or more prior cases arising out of the filing of their ANDAs, and they have
`
`filed counterclaims in such cases.
`
`16
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`

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`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 17 of 64 PageID #: 17
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`Prinston
`
`71.
`
`This Court has personal jurisdiction over Prinston because, among other
`
`things, Prinston is a corporation formed under the laws of the State of Delaware.
`
`72.
`
`This Court also has personal jurisdiction over Prinston because, among
`
`other things, on information and belief: (1) Prinston has filed an ANDA for the purpose of
`
`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of Prinston’s ANDA Products in the United States, including in Delaware; and (2)
`
`Prinston will market, distribute, offer for sale, and/or sell Prinston’s ANDA Products in the
`
`United States, including in Delaware, upon approval of ANDA No. 208549, and will derive
`
`substantial revenue from the use or consumption of Prinston’s ANDA Products in the State of
`
`Delaware. On information and belief, if ANDA No. 208549 is approved, the generic Prinston
`
`products charged with infringing the ’456, ’860, and ’339 patents would, among other things, be
`
`marketed, distributed, offered for sale, and/or sold in Delaware, prescribed by physicians
`
`practicing in Delaware, and dispensed by pharmacies located within Delaware, and/or used by
`
`patients in Delaware, all of which would have a substantial effect on Delaware.
`
`73.
`
`Prinston has consented to jurisdiction in Delaware in one or more prior
`
`cases arising out of the filing of its ANDAs, and it has filed counterclaims in such cases.
`
`Sigmapharm
`
`74.
`
`This Court has personal jurisdiction over Sigmapharm because, among
`
`other things, on information and belief: (1) Sigmapharm has filed an ANDA for the purpose of
`
`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of Sigmapharm’s ANDA Products in the United States, including in Delaware; and
`
`(2) Sigmapharm will market, distribute, offer for sale, and/or sell Sigmapharm’s ANDA Products
`
`17
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`

`
`Case 1:15-cv-00902-SLR Document 1 Filed 10/09/15 Page 18 of 64 PageID #: 18
`
`in the United States, including in Delaware, upon approval of ANDA No. 208546, and will
`
`derive substantial revenue from the use or consumption of Sigmapharm’s ANDA Products in the
`
`State of Delaware. On information and belief, if ANDA No. 208546 is approved, the generic
`
`Sigmapharm products charged with infringing the ’456, ’860, and ’339 patents would, among
`
`other things, be marketed, distributed, offered for sale, and/or sold in Delaware, prescribed by
`
`physicians practicing in Delaware, and dispensed by pharmacies located within Delaware, and/or