Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 1 of 132 Page|D #: 1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`CEPHALON, INC.,
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`Plaintiff,
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`V.
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`DR. REDDY’S LABORATORIES, LTD.; DR.
`REDDY’ S LABORATORIES, INC.;
`EMCURE PHARMACEUTICALS LTD.;
`EMCURE PHARMACEUTICALS USA, INC.;
`PHARMASCIENCE, INC.; HO SPIRA INC.;
`BRECKENRIDGE PHARMACEUTICAL,
`INC.; NATCO PHARMA LTD.; HETERO
`LABS LTD.; HETERO USA, INC.; SUN
`PHARMA GLOBAL FZE; SUN
`PHARMACEUTICAL INDUSTRIES LTD.;
`ACTAvIS LLC, f/k/a ACTAvIS INC.;
`SAGENT PHARMACEUTICALS, INC.;
`WOCKHARDT BIO AG; WOCKHARDT
`LTD.; and WOCKHARDT USA, LLC,
`
`Defendcmls.
`
`C.A. No.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Cephalon, Inc. (“Cephalon” or “Plaintiff’) brings this action for patent
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`infringement against Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
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`Inc. (collectively “DRL”); Emcure Pharmaceuticals Ltd. and Emcure Pharmaceuticals USA, Inc.
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`(collectively, “Emcure”); Pharmascience, Inc. (“Pharmascience”); Hospira Inc. (“Hospira”);
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`Breckenridge Pharmaceutical, Inc. (“Breckenridge”) and Natco Pharma Ltd. (“Natco”)
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`(collectively, “Breckenridge/Natco”); Hetero Labs Ltd. (“Hetero Labs”) and Hetero USA, Inc.
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`(“Hetero USA”) (collectively, “Hetero”); Sun Pharma Global FZE (“Sun FZE”) and Sun
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`Pharmaceutical Industries Ltd. (“Sun Ltd”) (collectively, “Sun”); Actavis LLC, f/k/a Actavis
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`FRESENIUS KABI 1003-OOO1
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`€€€€€€€€€€€€€€€€€€€€
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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 2 of 132 Page|D #: 2
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`Inc. (“Actavis”); Sagent Pharmaceuticals, Inc. (“Sagent”); and Wockhardt Bio AG, Wockhardt
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`Ltd., and Wockhardt USA, LLC (collectively, “Wocl<hardt”) (collectively, “Defendants”).
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`1.
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`This is an action by Cephalon against Defendants for infringement of United
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`States Patent No. 8,669,279 (“the ’279 patent”), United States Patent No. 8,883,836 (“the ’836
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`patent”), and United States Patent No. 8,895,756 (“the ’756 patent”). This action arises out of
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`Defendants’ filing of their respective Abbreviated New Drug Applications (“ANDAs”) seeking
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`approval by the United States Food and Drug Administration (“FDA”) to sell generic versions of
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`TREANDA®, Cephalon’s innovative drug for the treatment of patients with chronic lymphocytic
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`leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ’279 patent, the ’836
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`patent, and the ’756 patent.
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`Cephalon, Inc.
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`THE PARTIES
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`2.
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`Plaintiff Cephalon, Inc. is a corporation operating and existing under the laws of
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`Delaware, with its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355.
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`Cephalon is engaged in the business of research, development, manufacture, and sale of
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`innovative pharmaceutical products throughout the world.
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`DEFENDANTS
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`3.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. is a
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`corporation organized and existing under the laws of India, with its principal place of business at
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`7-l-27, Ameerpet, Hyderabad 500 016, Andhra Pradesh, India.
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`4.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Inc. is a
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`corporation organized and existing under the laws of the State of New Jersey, with its principal
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`place of business at 107 College Road East, Princeton, New Jersey, 08540.
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`FRESENIUS KABI 1003-OOO2
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`5.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Inc. is a wholly
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`owned subsidiary of Dr. Reddy’s Laboratories, Ltd., and is controlled by Dr. Reddy’s
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`Laboratories, Ltd.
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`6.
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`On information and belief, both Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
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`Laboratories, Ltd. submitted, collaborated and/or acted in concert in the preparation or
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`submission of ANDA No. 205376.
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`Emcure
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`7.
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`On information and belief, Defendant Emcure Pharmaceuticals Ltd. is a
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`corporation organized and existing under the laws of India, with its principal place of business at
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`Emcure House, T 184, M.I.D.C., Bhosari, Pune, India 411 026.
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`8.
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`On information and belief, Defendant Emcure Pharmaceuticals USA, Inc. is a
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`corporation organized and existing under the laws of the State of New Jersey, with its principal
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`place of business in 21/B Cotters Lane, East Brunswick, New Jersey 08816.
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`9.
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`On information and belief, Defendant Emcure Pharmaceuticals USA, Inc. is a
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`subsidiary of and is controlled by Emcure Pharmaceuticals Ltd.
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`10.
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`On information and belief, both Emcure Pharmaceuticals Ltd. and Emcure
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`Pharmaceuticals USA, Inc. submitted, collaborated and/or acted in concert in the preparation or
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`submission of ANDA No. 205964.
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`Pharmascience
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`11.
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`On information and belief, Pharmascience is a corporation organized and existing
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`under the laws of the Canada, with a principal place of business at 61 ll Royalmount Avenue,
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`Montreal (Quebec), H4P 2T4, Canada.
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`12.
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`On information and belief, Defendant Pharmascience recently acquired Uman
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`Pharma Inc., the filer and original holder of ANDA No. 205757. On information and belief,
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`FRESENIUS KABI 1003-OOO3
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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 4 of 132 Page|D #: 4
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`because of the acquisition of Uman by Pharmascience, Pharmascience now is the sole owner of
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`ANDA No. 205757.
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`Hospira
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`13.
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`On information and belief, Defendant Hospira is a corporation organized under
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`the laws of Delaware, with its principal place of business at 275 North Field Dr., Lake Forest,
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`Illinois 60045.
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`Breckenridge/Natco
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`14.
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`On information and belief, Defendant Breckenridge is a corporation organized
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`and existing under the laws of Florida, having a principal place of business at 6111 Broken
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`Sound Parkway, NW, Suite 170, Boca Raton, FL 33487.
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`15.
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`On information and belief, Defendant Natco is an Indian company having a
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`principal place of business at Natco House, Road No.2, Banjara Hills, Hyderabad-500 033, India.
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`16.
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`On information and belief, Natco has partnered with Breckenridge to market and
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`distribute Natco’s generic drug products complained of herein, including in this District.
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`Hetero
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`17.
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`On information and belief, Defendant Hetero USA is a corporation organized and
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`existing under the laws of the State of Delaware, having a principal place of business at 1035
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`Centennial Avenue, Piscataway, New Jersey 08854, and is registered to do business in Delaware,
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`including its appointment of a registered agent in Delaware (located at W/K Incorporating
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`Services, Inc., 3500 South DuPont Highway, Dover, DE 19901) for the receipt of service of
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`process.
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`18.
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`On information and belief, Defendant Hetero Labs is a corporation organized and
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`existing under the laws of India, with its principal place of business at 7-2-A2, Hetero Corporate
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`Industrial Estates, Sanath Nagar, Hyderabad — 500 018 A.P. India.
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`FRESENIUS KABI 1003-OOO4
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`19.
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`On information and belief, Hetero Labs is a parent company of Hetero USA.
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`20.
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`On information and belief, Hetero USA acts as an agent of Hetero Labs.
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`Sun
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`21.
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`On information and belief, Defendant Sun FZE is a corporation organized and
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`existing under the laws of the United Arab Emirates, with a principal place of business at
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`Executive Suite #43, Block-Y, SAIF Zone, PO Box 122304, Sharj ah, U.A.E.
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`22.
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`On information and belief, Defendant Sun Ltd. is a corporation organized and
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`existing under the laws of India, having its principal place of business at Acme Plaza, Andheri -
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`Kurla Rd., Andheri (E), Mumbai - 400 059, India.
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`23.
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`On information and belief, Sun FZE is a wholly owned subsidiary of Sun Ltd.
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`Actavis
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`24.
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`On information and belief, Defendant Actavis is a company organized and
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`existing under the laws of Delaware, having its principal place of business at 60 Columbia Road,
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`Building B, Morristown, New Jersey 07960.
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`&ge_I1t
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`25.
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`On information and belief, Defendant Sagent is a Delaware corporation having its
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`corporate offices and a principal place of business at 1901 N. Roselle Road, Ste. 700,
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`Schaumburg, IL 60195-3194.
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`Wockhardt
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`26.
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`On information and belief, Defendant Wockhardt Bio AG is a corporation
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`organized and existing under the laws of Switzerland, having its principal place of business at
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`Baarerstrasse 43, 6300 Zug, Switzerland. On information and belief, Wockhardt Bio AG is a
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`subsidiary of Wockhardt Ltd. On information and belief, Defendant Wockhardt Bio AG
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`FRESENIUS KABI 1003-0005
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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 6 of 132 Page|D #: 6
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`manufactures or distributes numerous generic pharmaceutical products for sale and use
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`throughout the United States, including in this Judicial District, through its subsidiary and agent,
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`Defendant Wockhardt USA, LLC.
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`27.
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`On information and belief, Defendant Wockhardt Ltd. is a corporation organized
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`and existing under the laws of India, having its principal place of business at Wockhardt Towers,
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`Bandra Kurla Complex, Bandra (East), Mumbai 400051, Maharashtra, India. On information
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`and belief, Wockhardt Ltd. manufactures or distributes numerous generic pharmaceutical
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`products for sale and use throughout the United States, including in this Judicial District, through
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`its subsidiaries and agents Wockhardt Bio AG and Wockhardt USA, LLC.
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`28.
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`On information and belief, Defendant Wockhardt USA, LLC is a limited liability
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`company organized and existing under the laws of the State of Delaware, having a place of
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`business at 20 Waterview BlVd., Parsippany, New Jersey. On information and belief, Wockhardt
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`USA, LLC is a subsidiary of Wockhardt Bio AG and Wockhardt Ltd. On information and belief,
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`Wockhardt USA LLC develops, manufactures, markets, sells, or offers to sell generic
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`pharmaceutical products throughout the United States, including in this Judicial District, on
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`behalf of Wockhardt Bio AG and/or Wockhardt Ltd. On information and belief, Wockhardt
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`USA, LLC is the authorized U.S. agent for ANDA No. 207149 that is the subject of this action.
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`29.
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`This action for patent infringement arises under 35 U.S.C. § 271.
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`30.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a), and the Declaratory Judgment Act, 28 U.S.C §§ 2201 and 2202.
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`FRESENIUS KABI 1003-0006
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`Personal Jurisdiction, Generally
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`31.
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`On information and belief, this Court has personal jurisdiction over Defendants
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`because they did not challenge this Court’s exercise of personal jurisdiction over them for
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`purposes of litigating allegations of patent infringement involving the ANDAS that are the
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`subj ect matter of this lawsuit. See In re Bendamustine Consolidated Cases, C.A. No. 13-cv-
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`2046-GMS (D. Del); Cephalon, Inc. v. Dr. Reddy ’s Laboratories, Ltd et al., C.A. Nos. 14-1241,
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`14-334-GMS, 13-2082 (D. Del); Cephalon, Inc. v. Emcure Pharms. Ltd et al., C.A. No. 14-335-
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`GMS (D. Del); Cephalon, Inc. v. Uman Pliarma, Inc., C.A. No. 14-568-GMS (D. Del);
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`Cephalon, Inc. v. Hospira Inc., C.A. Nos. 14-1242-GMS, 13-2094-GMS (D. Del); Cephalon,
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`Inc. v. Breckenridge Pliarm. Inc. et al., C.A. No. 14-0671-GMS (D. Del); Cephalon, Inc. v.
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`Hetero Labs. Ltd, et al., C.A. No. 13-2046-GMS (D. Del); Cephalon, Inc. v. Sun Pliarma Global
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`FZE et al, C.A. Nos. 14-1243-GMS, 14-333-GMS, 13-2096-GMS (D. Del); Cephalon, Inc. v.
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`Actavis LLC, C.A. No. 14-122-GMS (D. Del); Cephalon, Inc. v. Sagent Pliarms, Inc., C.A. No.
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`14-1116-GMS (D. Del); Cephalon, Inc. v. Wockliardt Bio AG et al., C.A. No. 14-1332-GMS (D.
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`Del).
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`Personal Jurisdiction Over DRL
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`32.
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`On information and belief, Defendant Dr. Reddy’ s Laboratories, Ltd. (through its
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`wholly-owned subsidiary Defendant Dr. Reddy’s Laboratories, Inc.) markets, distributes and/or
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`sells generic drugs throughout the United States and within the State of Delaware and therefore
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`purposefully avails itself of the privilege of conducting activities within the State of Delaware.
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`Defendant Dr. Reddy’s Laboratories, Ltd. also has committed, or aided, abetted, contributed to
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`and/or participated in the commission of, the tortious action of patent infringement that has led to
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`foreseeable harm and injury to Cephalon, which manufactures TREANDA® for sale and use
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`throughout the United States, including the State of Delaware.
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`FRESENIUS KABI 1003-OOO7
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`33.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Inc. markets,
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`distributes and/or sells generic drugs throughout the United States and within the State of
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`Delaware and therefore purposefully avails itself of the privilege of conducting activities within
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`the State of Delaware. Defendant Dr. Reddy’s Laboratories, Inc. also has committed, or aided,
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`abetted, contributed to and/or participated in the commission of, the tortious action of patent
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`infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`34.
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`On information and belief, this Court also has personal jurisdiction over
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`Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because they
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`previously have been sued in this Judicial District, did not challenge this Court’s assertion of
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`personal jurisdiction over them, and availed themselves of this forum by asserting counterclaims
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`for the purpose of litigating a patent infringement dispute. Cephalon, Inc. v. Dr. Reddy ’s
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`Laboratories, Lta’. et al., C.A. Nos. l4-1241, l4-334-GMS, l3-2082 (D. Del); Genzyme
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`Corporation et al. v. Dr. Reddy ’s Laboratories Lta’. et al., C.A. No. 13-01506 (D. Del);
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`Fresenius Kabi USA, LLC v. Dr. Reddy ’s Laboratories Ltd. et al., C.A. No. 13-00925 (D. Del).
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`Personal Jurisdiction Over Emcure
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`35.
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`On information and belief, this Court has personal jurisdiction over Defendant
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`Emcure Pharmaceuticals Ltd. because Emcure Pharmaceuticals Ltd., through its subsidiaries,
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`affiliates and/or agents, including Defendant Emcure Pharmaceuticals USA, Inc., (1) conducts
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`business in this Judicial District and (2) has engaged in continuous and systematic contacts with
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`the State of Delaware and/or purposefully availed itself of this forum by, among other things,
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`marketing, making, shipping, using, offering to sell or selling, or causing others to use, offer to
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`sell, or sell, Emcure pharmaceutical products in this Judicial District, and deriving substantial
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`FRESENIUS KABI 1003-OOO8
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`revenue from such activities. On information and belief, Defendant Emcure Pharmaceuticals
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`Ltd. also has committed, or aided, abetted, contributed to and/or participated in the commission
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`of, the tortious action of patent infringement that has led to foreseeable harm and injury to
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`Cephalon, which manufactures TREANDA® for sale and use throughout the United States,
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`including the State of Delaware.
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`36.
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`On information and belief, this Court has personal jurisdiction over Defendant
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`Emcure Pharmaceuticals USA, Inc. because Emcure Pharmaceuticals USA, Inc. (1) conducts
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`business in this Judicial District and (2) has engaged in continuous and systematic contacts with
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`the State of Delaware and/or purposefully availed itself of this forum by, among other things,
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`marketing, making, shipping, using, offering to sell or selling, or causing others to use, offer to
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`sell, or sell, Emcure pharmaceutical products in this Judicial District, and deriving substantial
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`revenue from such activities. On information and belief, Defendant Emcure Pharmaceuticals
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`USA, Inc. also has committed, or aided, abetted, contributed to and/or participated in the
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`commission of, the tortious action of patent infringement that has led to foreseeable harm and
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`injury to Cephalon, which manufactures TREANDA® for sale and use throughout the United
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`States, including the State of Delaware.
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`37.
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`On information and belief, this Court also has personal jurisdiction over Emcure
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`because it previously has been sued in this Judicial District, did not challenge this Court’s
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`assertion of personal jurisdiction over it, and availed itself of this forum by asserting
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`counterclaims for the purpose of litigating a patent infringement dispute. See Cephalon, Inc. v.
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`Emcure Pharms. Ltd. er al., C.A. No. l4-335-GMS (D. Del).
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`Personal Jurisdiction Over Pharmascience
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`38.
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`On information and belief, this Court has personal jurisdiction over
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`Pharmascience at least because Pharmascience markets, distributes and/or sells generic drugs
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`FRESENIUS KABI 1003-0009
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`throughout the United States and within the State of Delaware and therefore purposefully avails
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`itself of the privilege of conducting activities within the State of Delaware. Pharmascience has
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`also committed, or aided, abetted, contributed to and/or participated in the commission of, the
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`tortious action of patent infringement that has led to foreseeable harm and injury to Cephalon,
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`which manufactures TREANDA® for sale and use throughout the United States, including the
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`State of Delaware.
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`39.
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`This Court also has personal jurisdiction over Pharmascience under Federal Rule
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`of Civil Procedure 4(k)(2) because this action arises under federal law and, on information and
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`belief, Pharmascience is not subject to the jurisdiction of the courts of general jurisdiction of any
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`state and the exercise of personal jurisdiction over Pharmascience is consistent with the
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`Constitution and the laws of the United States.
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`Personal Jurisdiction Over Hospira
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`40.
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`On information and belief, this Court has personal jurisdiction over Hospira at
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`least because Hospira: (l) is incorporated in Delaware, (2) conducts business in this Judicial
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`District and (3) has engaged in continuous and systematic contacts with the State of Delaware
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`and/or purposefully availed itself of this forum by, among other things, making, shipping, using,
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`offering to sell or selling, or causing others to use, offer to sell, or sell, Hospira pharmaceutical
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`products in this Judicial District, and deriving substantial revenue from such activities. On
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`information and belief, Hospira also has committed, or aided, abetted, contributed to and/or
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`participated in the commission of, the tortious action of patent infringement that has led to
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`foreseeable harm and injury to Cephalon, which manufactures TREANDA® for sale and use
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`throughout the United States, including the State of Delaware. Also, on information and belief,
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`Hospira maintains a Pharmacy Wholesale License in the State of Delaware.
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`10
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`FRESENIUS KABI 1003-0010
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`41.
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`On information and belief, this Court also has personal jurisdiction over Hospira
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`because Hospira previously has availed itself of this forum for the purpose of litigating its patent
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`infringement disputes. See, e.g., Hospira Inc. v. B. Braun Medical Inc., C.A. No. 13- 00819 (D.
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`Del); Hospira Inc. et al. v. Sandoz International GmbH et al, C.A. No. 09-00665 (D. Del).
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`Additionally, Hospira previously has been sued in this Judicial District, did not challenge this
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`Court’s exertion of personal jurisdiction over it, and availed itself of this forum by asserting
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`counterclaims for the purpose of litigating a patent infringement dispute. See Cephalon, Inc. v.
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`Hospira Inc., C.A. Nos. l4-1242-GMS, l3-2094-GMS (D. Del).
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`Personal Jurisdiction Over Breckenridge/Natco
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`42.
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`On information and belief, this Court has personal jurisdiction over Breckenridge
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`because Breckenridge: (l) conducts business in this Judicial District and (2) has engaged in
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`continuous and systematic contacts with the State of Delaware and/or purposefully availed itself
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`of this forum by, among other things, making, marketing, shipping, using, offering to sell or
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`selling, or causing others to use, offer to sell, or sell, Breckenridge pharmaceutical products in
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`this Judicial District, and deriving substantial revenue from such activities. On information and
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`belief, Breckenridge also has committed, or aided, abetted, contributed to and/or participated in
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`the commission of, the tortious action of patent infringement that has led to foreseeable harm and
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`injury to Cephalon, which manufactures TREANDA® for sale and use throughout the United
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`States, including the State of Delaware.
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`43.
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`On information and belief, this Court also has personal jurisdiction over
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`Breckenridge because Breckenridge previously has filed a patent litigation in this Judicial
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`District, see Pamlab LLC, Metabolite Labs, Inc. and Breckenridge Pliarm., Inc. v. Acella
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`Pharms., LLC, 1:12-cv-01403-SLR, and has been sued in this Judicial District and did not
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`ll
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`FRESENIUS KABI 1003-0011
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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 12 of 132 Page|D #: 12
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`challenge this Court’s exertion of personal jurisdiction over it. See Cephalon, Inc. v.
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`Breckenridge Pharm. Inc. et al., C.A. No. 14-0671-GMS (D. Del); UCB Inc. v. Breckenridge
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`Pharm., Inc., 13-l2ll-LPS (D. Del.); Cephalon, Inc. et al. v. Breckenridge Pnarm., Inc., and
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`Natco Pharma Ltd, C.A. No. ll-1070-GMS (D. Del).
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`44.
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`On information and belief, this Court has personal jurisdiction over Natco because
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`Natco has engaged in continuous and systematic contacts with the State of Delaware and/or
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`purposefully availed itself of this forum, including through its wholly owned subsidiary Natco
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`Pharma Inc., a Delaware company, by among other things, making, marketing, shipping, using,
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`offering to sell or selling, or causing others to use, offer to sell, or sell, Natco pharmaceutical
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`products in this Judicial District, and deriving substantial revenue from such activities. On
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`information and belief, Natco also has committed, or aided, abetted, contributed to and/or
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`participated in the commission of, the tortious action of patent infringement that has led to
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`foreseeable harm and injury to Cephalon, which manufactures TREANDA® for sale and use
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`throughout the United States, including the State of Delaware.
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`45.
`
`On information and belief, this Court also has personal jurisdiction over Natco
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`because Natco has been sued in this Judicial District and did not challenge this Court’s exertion
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`of personal jurisdiction over it. See Cephalon, Inc. v. Breckenridge Pnarm. Inc. et al., C.A. No.
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`14-0671-GMS (D. Del); Cephalon, Inc. er al. v. Breckenridge Phcirm., Inc., and Natco Pharma
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`Ltd, C.A. No. ll-1070-GMS (D. Del.).
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`Personal Jurisdiction Over Hetero
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`46.
`
`On information and belief, Hetero USA is a Delaware corporation, is registered to
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`do business in Delaware, and is the U.S. regulatory agent for Hetero Labs Limited Unit VI.
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`12
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`FRESENIUS KABI 1003-0012
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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 13 of 132 Page|D #: 13
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`47.
`
`On information and belief, Hetero Labs Limited Unit V1 is a division or part of
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`Defendant Hetero Labs Ltd. Hetero Labs’s website, located at http://www.heterodrugs.com/mfg-
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`formulation-facilities.shtml, describes Unit VI as a formulation facility of Hetero Labs.
`
`48.
`
`On information and belief, Hetero USA is in the business of marketing and selling
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`generic prescription pharmaceutical drugs that it distributes in the State of Delaware and
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`throughout the United States. On information and belief, Hetero USA, either directly or through
`
`one or more of its subsidiaries, agents, and/or distributors, markets, sells, and/or distributes a
`
`substantial volume of its pharmaceutical products in the State of Delaware. On information and
`
`belief, the acts of Hetero USA complained of herein were done at the direction of, with the
`
`authorization of, and/or with the cooperation, participation, and assistance of Hetero Labs.
`
`49.
`
`On information and belief, this Court has personal jurisdiction over Defendant
`
`Hetero USA because, among other things, Hetero USA (1) is incorporated in the State of
`
`Delaware; (2) conducts business in this Judicial District; and (3) has engaged in continuous and
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`systematic contacts with the State of Delaware and/or purposefully availed itself of this forum
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`by, among other things, marketing, distributing, making, shipping, using, offering to sell or
`
`selling, or causing others to use, offer to sell, or sell Hetero pharmaceutical products in this
`
`Judicial District, and deriving substantial revenue from such activities. On information and
`
`belief, Hetero USA has also committed, or aided, abetted, contributed to and/or participated in
`
`the commission of the tortious act of patent infringement that has led to foreseeable harm and
`
`injury to Cephalon, which manufactures TREANDA® for sale and use throughout the United
`
`States, including the State of Delaware.
`
`50.
`
`On information and belief, Hetero Labs formulates, develops, markets, and sells
`
`active pharmaceutical ingredients (“API”), pharmaceutical formulations, and/or pharmaceutical
`
`l3
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`FRESENIUS KABI 1003-0013
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`

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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 14 of 132 Page|D #: 14
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`products containing such API or pharmaceutical formulations. Hetero Labs, through its U.S.
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`regulatory agent, Hetero USA, routinely files Abbreviated New Drug Applications seeking FDA
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`approval to market its products in the United States.
`
`51.
`
`On information and belief, Hetero Labs, directly or through Hetero USA and/or
`
`through one or more of its wholly owned subsidiaries, affiliates, agents, distributors, or parent
`
`corporation is in the business of formulating, manufacturing, marketing, and selling generic
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`prescription pharmaceutical drugs that it distributes in Delaware and throughout the United
`
`States. On information and belief, Hetero Labs, either directly or through Hetero USA and/or
`
`through one or more of its subsidiaries, agents, and/or distributors, formulates, manufactures,
`
`markets, sells, and/or distributes a substantial volume of its pharmaceutical products in
`
`Delaware.
`
`52.
`
`Hetero USA’s acts and continuous and systematic contacts with the State of
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`Delaware, as an agent of Hetero Labs, are also attributable to Hetero Labs for jurisdictional
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`purposes.
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`53.
`
`On information and belief, this Judicial District is a likely destination of products
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`that will be manufactured and sold as a result of FDA approval of Hetero’s Abbreviated New
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`Drug Application No. 204081, which is the subject of this lawsuit.
`
`54.
`
`On information and belief, this Court has personal jurisdiction over Hetero Labs
`
`because, among other things (1) its presence in Delaware, including through Hetero USA, and
`
`(2) its course of conduct that is designed to cause the perfonnance of tortious acts that will result
`
`in the foreseeable harm in Delaware.
`
`55.
`
`Further, on information and belief, this Court has personal jurisdiction over
`
`Hetero Labs and Hetero USA because both companies previously have been sued in this Judicial
`
`l4
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`FRESENIUS KABI 1003-0014
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`

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`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 15 of 132 Page|D #: 15
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`District, did not challenge this Court’s exertion of personal jurisdiction over it, and have availed
`
`themselves of this forum by asserting counterclaims for the purpose of litigating a patent
`
`infringement dispute. See, e. g., Cephalon, Inc. v. Hetero Labs Ltd., et al.; C.A. No. 13-2046-
`
`GMS (D. Del); AbbWe Inc. v. Hetero USA Inc. et al.; C.A. No. 13-852 (D. Del); Kissei Pharma
`
`Co. Ltd. et al v. Hetero USA Inc., et al.; C.A. No. 13-1091 (D. Del); UCB Inc. et al. v. Hetero
`
`USA Inc. et al.; C.A. No. 13-l2l3-LPS (D. Del.); Forest Labs., Inc. et al. v. Torrent Pnarmas
`
`Ltd., et al.; C.A. No. 12-305 (D. Del.).
`
`Personal Jurisdiction Over Sun
`
`56.
`
`On information and belief; this Court has personal jurisdiction over Sun FZE at
`
`least because Sun FZE; through its subsidiaries; affiliates and/or agents; including Sun Ltd.; (1)
`
`conducts business in this Judicial District and (2) has engaged in continuous and systematic
`
`contacts with the State of Delaware and/or purposefully availed itself of this forum by; among
`
`other things; marketing; making; shipping; using; offering to sell or selling; or causing others to
`
`use; offer to sell; or sell; Sun pharmaceutical products in this Judicial District; and deriving
`
`substantial revenue from such activities. On information and belief; Sun FZE also has
`
`committed; or aided; abetted; contributed to and/or participated in the commission of; the tortious
`
`action of patent infringement that has led to foreseeable harm and injury to Cephalon; which
`
`manufactures TREANDA® for sale and use throughout the United States; including the State of
`
`Delaware.
`
`57.
`
`On information and belief; this Court has personal jurisdiction over Sun Ltd. at
`
`least because Sun Ltd.; through its subsidiaries; affiliates and/or agents; including Sun FZE; (l)
`
`conducts business in this Judicial District and (2) has engaged in continuous and systematic
`
`contacts with the State of Delaware and/or purposefully availed itself of this forum by; among
`
`other things; marketing; making; shipping; using; offering to sell or selling; or causing others to
`
`15
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`FRESENIUS KABI 1003-0015
`
`

`
`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 16 of 132 Page|D #: 16
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`use, offer to sell, or sell, Sun pharmaceutical products in this Judicial District, and deriving
`
`substantial revenue from such activities. On information and belief, Sun Ltd. also has
`
`committed, or aided, abetted, contributed to and/or participated in the commission of, the tortious
`
`action of patent infringement that has led to foreseeable harm and injury to Cephalon, which
`
`manufactures TREANDA® for sale and use throughout the United States, including the State of
`
`Delaware.
`
`58.
`
`On information and belief, this Court also has personal jurisdiction over Sun
`
`because Sun previously has been sued in this Judicial District, did not challenge this Court’s
`
`exertion of personal jurisdiction over it, and has availed itself of this forum by asserting
`
`counterclaims for the purpose of litigating a patent infringement dispute. See, e.g., Cephalon,
`
`Inc. v. Sun Pharma Gl0balFZE er al., C.A. Nos. 14-1243-GMS, 14-333-GMS, 13-2096-GMS
`
`(D. Del); AbbWe Inc. et al. v. Sun Pharm. Indus. Ltd. er al., C.A. No. 10- 00112 (D. Del);
`
`Aventis Pharma S.A. el al. v. Sun Pharm. Indus. Ltd. er al., C.A. No. 09-00630 (D. Del); UCB
`
`Inc. el al. v Sun Pharma Global FZE er al., C.A. No. 13-01218 (D. Del).
`
`Personal Jurisdiction Over Actavis
`
`59.
`
`This Court has personal jurisdiction over Defendant Actavis because, among
`
`other things, (1) it is incorporated in the State of Delaware; (2) it is registered to do business in
`
`Delaware, including its appointment of a registered agent in Delaware (located at The
`
`Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, DE
`
`19801) for the receipt of service of process; (3) it sells a substantial volume of prescription drugs
`
`in Delaware; and (4) it has engaged in continuous and systematic contacts with the State of
`
`Delaware and/or purposefully availed itself of this forum by, among other things, making,
`
`marketing, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or
`
`16
`
`FRESENIUS KABI 1003-0016
`
`

`
`Case 1:15—cv—OO179—GMS Document 1 Filed 02/23/15 Page 17 of 132 Page|D #: 17
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`sell, Actavis pharmaceutical products in this Judicial District, and deriving substantial revenue
`
`from such activities. Actavis has also committed, aided, abetted, contributed to and/or
`
`participated in the commission of, the tortious action of patent infringement that has led to
`
`foreseeable harm and injury to Cephalon, which manufactures TREANDA® for sale and use
`
`throughout the United States, including the State of Delaware.
`
`60.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`Actavis LLC because Actavis LLC previously has availed itself of this forum for the purpose of
`
`litigating its patent infringement disputes. See, e. g., Kissei Pharmaceutical Co. v. Hetero USA
`
`Inc., C.A. No. l:l3-cv-01091 (D. Del). Additionally, this Court has personal jurisdiction over
`
`Actavis LLC because it previously has been sued in this Judicial District, did not challenge this
`
`Court’s exertion of personal jurisdiction over it, and availed itself of this forum by asserting
`
`counterclaims for the purpose of litigating a patent infringement dispute. See Cephalon, Inc. v.
`
`Actavis LLC, C.A. No. l4-122-GMS (D. Del); Novartis Pharmaceuticals et al. v. Actavis Inc.
`
`and Actavis Elizabeth LLC, C.A. No. 12-366-RGA-CJB (D. Del.); Pfizer Inc. et al. v. Actavis
`
`Group HF et al., CA No. l0-675-LPS (D. Del.); Somaxon Pharmaceu