Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 1 of 88 PageID #: 2306
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-1171-GMS
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`(CONSOLIDATED)
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`))))
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`))
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`)))
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`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
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`SECOND AMENDED COMPLAINT
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`Plaintiffs Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., Teva
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`Neuroscience, Inc. and Yeda Research and Development Co., Ltd. (collectively “Plaintiffs” or
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`“Teva”) bring this action for patent infringement and declaratory judgment against Defendants
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`Doctor Reddy’s Laboratories, Ltd. (“DRL Ltd.”) and Doctor Reddy’s Laboratories, Inc. (“DRL
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`Inc.”) (collectively “DRL”); Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively “Mylan”);
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`Sandoz, Inc. and Momenta Pharmaceuticals, Inc. (collectively “Sandoz”); Synthon
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`Pharmaceuticals Inc., Synthon B.V., Synthon s.r.o., and Pfizer Inc. (collectively “Synthon”); and
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`Amneal Pharmaceuticals LLC (“Amneal LLC”) and Amneal Pharmaceuticals Company GmbH
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`(“Amneal GmbH”) (collectively “Amneal”) (collectively “Defendants”).
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`NATURE OF THE ACTION
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`1.
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`This is an action brought by Teva for infringement of United States Patent No.
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`8,969,302 (“the ’302 patent”) and United States Patent No. 9,155,776 (“the ’776 patent”),
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`attached as Exhibits A and B, respectively. This action arises out of Defendants’ filing of their
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`respective Abbreviated New Drug Applications (“ANDAs”) seeking approval from the United
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`
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 14-1171-GMS
`
`(CONSOLIDATED)
`
`))))
`
`))
`
`)))
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`SECOND AMENDED COMPLAINT
`
`Plaintiffs Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., Teva
`
`Neuroscience, Inc. and Yeda Research and Development Co., Ltd. (collectively “Plaintiffs” or
`
`“Teva”) bring this action for patent infringement and declaratory judgment against Defendants
`
`Doctor Reddy’s Laboratories, Ltd. (“DRL Ltd.”) and Doctor Reddy’s Laboratories, Inc. (“DRL
`
`Inc.”) (collectively “DRL”); Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively “Mylan”);
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`Sandoz, Inc. and Momenta Pharmaceuticals, Inc. (collectively “Sandoz”); Synthon
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`Pharmaceuticals Inc., Synthon B.V., Synthon s.r.o., and Pfizer Inc. (collectively “Synthon”); and
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`Amneal Pharmaceuticals LLC (“Amneal LLC”) and Amneal Pharmaceuticals Company GmbH
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`(“Amneal GmbH”) (collectively “Amneal”) (collectively “Defendants”).
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action brought by Teva for infringement of United States Patent No.
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`8,969,302 (“the ’302 patent”) and United States Patent No. 9,155,776 (“the ’776 patent”),
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`attached as Exhibits A and B, respectively. This action arises out of Defendants’ filing of their
`
`respective Abbreviated New Drug Applications (“ANDAs”) seeking approval from the United
`
`
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 2 of 88 PageID #: 2307
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`States Food and Drug Administration (“FDA”) to sell generic versions of COPAXONE® 40
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`mg/mL injection, Teva’s innovative treatment for patients with relapsing-remitting forms of
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`multiple sclerosis, prior to the expiration of the ’302 and ’776 patents.
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`2.
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`Teva incorporates by reference as if fully alleged herein the allegations contained
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`in the Complaints filed in Consolidated C.A. Nos. 14-1171-GMS (D.I. 1), C.A. No. 14-1172-
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`GMS (D.I. 1), C.A. No. 14-cv-1278 (D.I. 1), C.A. No. 14-1419-GMS (D.I. 1), and C.A. No. 15-
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`124-GMS (D.I. 43 filed in C.A. No. 14-1171). Specifically, Teva incorporates its allegations and
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`claims for relief concerning United States Patent Nos. 8,232,250 and 8,399,413, attached hereto
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`as Exhibits C and D, respectively, as alleged therein.1
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`THE PARTIES
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`Teva
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`3.
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`Teva Pharmaceuticals USA, Inc. (“Teva USA”) is a Delaware corporation with its
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`principal place of business at 1090 Horsham Road, North Wales, Pennsylvania 19454-1090.
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`4.
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`Teva Pharmaceutical Industries Ltd. (“Teva Ltd.”) is an Israeli company with its
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`principal place of business at 5 Basel Street, P.O. Box 3190, Petah Tikva, 49131, Israel.
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`5.
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`Teva Neuroscience, Inc. (“Teva Neuroscience”), is a Delaware corporation with
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`its principal place of business at 901 E. 104th Street, Suite 900, Kansas City, Missouri 64131.
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`6.
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`Yeda Research and Development Co. Ltd. (“Yeda”) is an Israeli company with its
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`principal place of business is at P.O. Box 95, Rehovot, 76100, Israel.
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`DRL
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`1 To avoid unduly burdening the parties and the Court with allegations that remain unchanged in
`this amended pleading, Teva has not repeated such allegations here, but instead refers to the
`allegations and claims contained in such Complaints in the above referenced matters and
`incorporates them by reference herein.
`
`2
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`
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`7.
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`Upon information and belief, Doctor Reddy’s Laboratories Ltd. is a corporation
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`organized and existing under the laws of India with its principal place of business at 8-2-337,
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`Road No. 3, Banjara Hills, Hyderabad, Telangana 500 034, India.
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`8.
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`Upon information and belief, Doctor Reddy’s Laboratories Inc. is a corporation
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`organized and existing under the laws of New Jersey with its principal place of business at 107
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`College Road East, Princeton, NJ 08540, and is a wholly-owned subsidiary of Doctor Reddy’s
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`Laboratories Ltd.
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`Mylan
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`9.
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`Upon information and belief, Mylan Pharmaceuticals Inc. is a corporation
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`organized and existing under the laws of West Virginia with its principal place of business at 781
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`Chestnut Ridge Rd., Morgantown, WV 26505.
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`10. Mylan Pharmaceuticals Inc. is a wholly-owned subsidiary of Mylan Inc.
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`11.
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`Upon information and belief, Mylan Inc. is a corporation organized and existing
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`under the laws of Pennsylvania with its principal place of business at 1500 Corporate Drive,
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`Canonsburg, PA 15317.
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`Sandoz
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`12.
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`Upon information and belief, Sandoz, Inc. is a corporation organized and existing
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`under the laws of Colorado with its principal place of business at 506 Carnegie Center, Suite
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`400, Princeton, NJ 08540.
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`13.
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`Upon information and belief, Momenta Pharmaceuticals, Inc. is a corporation
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`organized and existing under the laws of Delaware with its principal place of business at 675
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`West Kendall Street, Cambridge, MA 02142.
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`3
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 4 of 88 PageID #: 2309
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`Synthon
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`14.
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`Upon information and belief, Synthon Pharmaceuticals Inc. is a corporation
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`organized and existing under the laws of North Carolina with its principal place of business at
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`1007 Slater Road, Suite 150, Durham, NC 27703.
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`15.
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`Upon information and belief, Synthon B.V. is a corporation organized and
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`existing under the laws of the Netherlands with its principal place of business at Microweg 22,
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`P.O. Box 7071, 6503 CM Nijmegen, The Netherlands.
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`16.
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`Upon information and belief, Defendant Synthon s.r.o. is a Czech entity having a
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`principal place of business at Brnenska 32/cp.597, 678 17 Blansko, Czech Republic.
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`17.
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`Upon information and belief, Defendants Synthon Pharmaceuticals Inc. and
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`Synthon s.r.o. are sister companies with Synthon Holding B.V. as their ultimate parent company.
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`18.
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`Upon information and belief, Defendant Pfizer Inc. is a corporation organized and
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`existing under the laws of Delaware with its principle place of business at 235 East 42nd Street,
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`New York, NY 10017.
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`Amneal
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`19.
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`Upon information and belief, Amneal Pharmaceuticals LLC is a limited liability
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`company organized and existing under the laws of Delaware with a principal place of business at
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`400 Crossing Blvd., Third Floor, Bridgewater, NJ 08807-2863.
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`20.
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`Upon information and belief, Amneal GmbH is a limited liability company
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`organized and existing under the laws of Switzerland with a principal place of business at
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`Turnstrasse 30, 6312 Steinhausen – Switzerland.
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`4
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 5 of 88 PageID #: 2310
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`21.
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`22.
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`This action for patent infringement arises under 35 U.S.C. § 271.
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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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`Personal Jurisdiction Over DRL
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`23.
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`Upon information and belief, this Court has personal jurisdiction over DRL
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`because DRL 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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`subject matter of this lawsuit. Teva Pharms. USA, Inc. et al. v. Dr. Reddy’s Labs., Ltd. et al.,
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`C.A. No. 14-cv-1172-GMS (D. Del.).
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`24.
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`25.
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`Upon information and belief, this Court has personal jurisdiction over DRL Inc.
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`DRL Inc. has admitted that it is subject to personal jurisdiction in this district.
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`See Genzyme Corporation et al. v. Dr. Reddy’s Laboratories Ltd. et al., C.A. No. 13-1506 (D.
`
`Del.).
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`26.
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`Upon information and belief, Defendant DRL Inc. markets, distributes and/or
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`sells generic drugs within the State of Delaware and throughout the United States.
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`27.
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`Upon information and belief, Defendant DRL Inc. has engaged in and maintained
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`systematic and continuous business contacts within the State of Delaware, and has purposefully
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`availed itself of the benefits and protections of the laws of Delaware rendering it at home in
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`Delaware.
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`28.
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`Upon information and belief, DRL Inc. routinely files ANDAs in the United
`
`States and markets dozens of generic pharmaceutical products in the State of Delaware,
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`5
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 6 of 88 PageID #: 2311
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`including, inter alia, allopurinol, amlodipine besylate-atorvastatin, amoxicillin, amoxicillin-
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`clavulanate potassium, and anastrozole.
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`29.
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`Upon information and belief, DRL Inc. has agreements with pharmaceutical
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`retailers, wholesalers or distributors providing for the distribution of its products in the State of
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`Delaware, including, inter alia, allopurinol, amlodipine besylate-atorvastatin, amoxicillin,
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`amoxicillin-clavulanate potassium, and anastrozole.
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`30.
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`Upon information and belief, Defendant DRL Inc. has also 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 Teva, which manufactures
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`COPAXONE® 40 mg/mL product for sale and use throughout the United States, including
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`within the State of Delaware.
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`31.
`
`32.
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`Teva sells COPAXONE® 40 mg/mL product in the State of Delaware.
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`Upon information and belief, Defendant DRL Inc. has applied for FDA approval
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`to market and sell a generic version of COPAXONE® 40 mg/mL product throughout the United
`
`States, including in Delaware.
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`33.
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`Upon information and belief, DRL Inc. will market, sell, and offer for sale its
`
`proposed generic version of COPAXONE® 40 mg/mL product in the State of Delaware
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`following FDA approval of that product.
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`34.
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`Upon information and belief, as a result of DRL Inc.’s marketing, selling, or
`
`offering for sale of its generic version of COPAXONE® 40 mg/mL product in the State of
`
`Delaware, Teva will lose sales of COPAXONE® 40 mg/mL product and be injured in the State
`
`of Delaware.
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`6
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 7 of 88 PageID #: 2312
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`35.
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`By letter dated August 1, 2014, DRL Inc. sent a letter to Teva Pharmaceuticals
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`USA, Inc., a Delaware corporation, stating that it had filed ANDA No. 206767 seeking approval
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`to market DRL’s Glatiramer Acetate Product (“DRL’s First Notice Letter”).
`
`36.
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`Further, upon information and belief, DRL Inc., affiliates of DRL Inc. and/or
`
`subsidiaries of DRL Inc. are registered with the Delaware Board of Pharmacy as a
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`“Distributor/Manufacturer” and “Pharmacy-Wholesale” of drug products.
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`37.
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`Upon information and belief, this Court has personal jurisdiction over Defendant
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`DRL Inc. for the reasons stated herein, including, inter alia, Defendant DRL Inc.’s activities in
`
`the forum, activities directed at the forum, and significant contacts with the forum, all of which
`
`render Defendant DRL Inc. at home in the forum.
`
`38.
`
`39.
`
`Upon information and belief, this Court has personal jurisdiction over DRL Ltd.
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`DRL Ltd. has admitted that it is subject to personal jurisdiction in this district.
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`See Genzyme Corporation et al. v. Dr. Reddy’s Laboratories Ltd. et al., C.A. No. 13-1506 (D.
`
`Del.).
`
`40.
`
`Upon information and belief, Defendant DRL Ltd. (through its wholly-owned
`
`subsidiary Defendant DRL Inc.) markets, distributes and/or sells generic drugs within the State
`
`of Delaware and throughout the United States.
`
`41.
`
`Upon information and belief, Defendant DRL Inc. has engaged in and maintained
`
`systematic and continuous business contacts within the State of Delaware, and has purposefully
`
`availed itself of the benefits and protections of the laws of Delaware rendering it at home in
`
`Delaware.
`
`42.
`
`Upon information and belief, DRL Ltd. (through its wholly-owned subsidiary
`
`Defendant DRL Inc.) routinely files ANDAs in the United States and markets dozens of generic
`
`7
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 8 of 88 PageID #: 2313
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`pharmaceutical products in the State of Delaware, including, inter alia, ciprofloxacin, allopurinol,
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`amlodipine besylate, atorvastatin calcium, and citalopram.
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`43.
`
`Upon information and belief, DRL Ltd. (through its wholly-owned subsidiary
`
`Defendant DRL Inc.) has agreements with pharmaceutical retailers, wholesalers or distributors
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`providing for the distribution of its products in the State of Delaware, including, inter alia,
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`ciprofloxacin, allopurinol, amlodipine besylate, atorvastatin calcium, and citalopram.
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`44.
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`Upon information and belief, Defendant DRL Ltd. has also 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 Teva, which manufactures
`
`COPAXONE® 40 mg/mL product for sale and use throughout the United States, including the
`
`State of Delaware.
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`45.
`
`46.
`
`Teva sells COPAXONE® 40 mg/mL product in the State of Delaware.
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`Upon information and belief, Defendant DRL Ltd. has applied for FDA approval
`
`to market and sell a generic version of COPAXONE® 40 mg/mL product throughout the United
`
`States, including in Delaware.
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`47.
`
`Upon information and belief, DRL Ltd. (through its wholly-owned subsidiary
`
`Defendant DRL Inc.) will market, sell, and offer for sale its proposed generic version of
`
`COPAXONE® 40 mg/mL product in the State of Delaware following FDA approval of that
`
`product.
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`48.
`
`Upon information and belief, as a result of DRL Ltd.’s marketing, selling, or
`
`offering for sale of its generic version of COPAXONE® 40 mg/mL product in the State of
`
`Delaware, Teva will lose sales of COPAXONE® 40 mg/mL product and be injured in the State
`
`of Delaware.
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`8
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 9 of 88 PageID #: 2314
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`49.
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`By letter dated August 1, 2014, DRL Ltd. (through its wholly-owned subsidiary
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`Defendant DRL Inc.) sent DRL’s First Notice Letter to Teva Pharmaceuticals USA, Inc., a
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`Delaware corporation, stating that it had filed ANDA No. 206767 seeking approval to market
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`DRL’s Glatiramer Acetate Product.
`
`50.
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`Further, upon information and belief, DRL Ltd., affiliates of DRL Ltd. and/or
`
`subsidiaries of DRL Ltd. are registered with the Delaware Board of Pharmacy as a
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`“Distributor/Manufacturer” and “Pharmacy-Wholesale” of drug products.
`
`51.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`DRL Ltd. for the reasons stated herein, including, inter alia, Defendant DRL Ltd.’s activities in
`
`the forum, activities directed at the forum, and significant contacts with the forum, all of which
`
`render Defendant DRL Ltd. at home in the forum.
`
`52.
`
`Upon information and belief, this Court also has personal jurisdiction over DRL
`
`because it previously has been sued in this district, did not challenge this Court’s assertion of
`
`personal jurisdiction over it, and availed itself of this forum by asserting counterclaims for the
`
`purpose of litigating a patent infringement dispute. See, e.g., Genzyme Corporation, et al. v. Dr.
`
`Reddy’s Laboratories Ltd., et al., C.A. No. 13-1506 (D. Del.); Teijin Ltd., et al. v. Dr. Reddy’s
`
`Laboratories Ltd. et al., C.A. No. 13-1780 (D. Del.); Pfizer, et al. v. Dr. Reddy’s Laboratories
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`Ltd., et al., C.A. No. 13-989 (D. Del.); Fresenius Kabi USA LLC v. Dr. Reddy’s Laboratories
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`Ltd., et al., C.A. No. 13-925 (D. Del.); Novartis Pharmaceuticals Corp., et al. v. Dr. Reddy’s
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`Laboratories, Ltd., et al., C.A. No. 14-157 (D. Del.).
`
`53.
`
`Upon information and belief, following any FDA approval of DRL’s ANDA,
`
`Defendants DRL Inc. and DRL Ltd. will work in concert with one another to make, use, offer to
`
`9
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 10 of 88 PageID #: 2315
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`sell, and sell a generic version of COPAXONE® 40 mg/mL product throughout the United
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`States, including in Delaware.
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`54.
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`Upon information and belief, DRL Ltd. will manufacture DRL’s proposed generic
`
`version of COPAXONE® 40 mg/mL product on behalf of DRL Inc. and DRL Inc. will act as the
`
`agent of DRL Ltd. for sale of that product in the United States, including Delaware.
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`Personal Jurisdiction Over Mylan
`
`55.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Pharmaceuticals Inc.
`
`56.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has availed
`
`itself of this forum by bringing a civil action in this forum. See, e.g., Mylan Pharmaceuticals
`
`Inc., et al. v. Eurand Inc., et al., C.A. No. 10-306 (D. Del.); Mylan Pharmaceuticals Inc., et al. v.
`
`Kremers Urban Development Co., C.A. No. 02-1628 (D. Del.); Mylan Pharmaceuticals Inc., et
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`al. v. Galderma Laboratories Inc. et al., C.A. No. 10-892 (D. Del.); DuPont Merck
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`Pharmaceutical Co., et al. v. Bristol-Myers Squibb Co., et al., C.A. No. 95-290 (D. Del.).
`
`57.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. is registered
`
`to conduct business with the State of Delaware and maintains as a registered agent Corporation
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`Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808.
`
`58.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. is registered
`
`pursuant to 24 Del. C. § 2540 to distribute its generic pharmaceutical products in Delaware.
`
`59.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. holds
`
`current and valid “Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses from the
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`Delaware Board of Pharmacy.
`
`10
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 11 of 88 PageID #: 2316
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`60.
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`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. markets,
`
`distributes and/or sells generic drugs throughout the United States and within the State of
`
`Delaware.
`
`61.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has engaged
`
`in and maintained systematic and continuous business contacts within the State of Delaware, and
`
`has purposefully availed itself of the benefits and protections of the laws of Delaware rendering
`
`it at home in Delaware.
`
`62.
`
`Upon information and belief, Mylan Pharmaceuticals Inc. routinely files ANDAs
`
`in the United States and markets dozens of generic pharmaceutical products in the State of
`
`Delaware, including, inter alia, abacavir sulfate, acyclovir, alprazolam, amitriptyline
`
`hydrochloride-chlordiazepoxide, and amlodipine besylate.
`
`63.
`
`Upon information and belief, Mylan Pharmaceuticals Inc. has agreements with
`
`pharmaceutical retailers, wholesalers or distributors providing for the distribution of its products
`
`in the State of Delaware, including, inter alia, abacavir sulfate, acyclovir, alprazolam,
`
`amitriptyline hydrochloride-chlordiazepoxide, and amlodipine besylate.
`
`64.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has also
`
`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 Teva, which
`
`manufactures COPAXONE® 40 mg/mL product, for sale and use throughout the United States,
`
`including the State of Delaware.
`
`65.
`
`Teva sells COPAXONE® 40 mg/mL product in the State of Delaware.
`
`11
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 12 of 88 PageID #: 2317
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`66.
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`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has applied
`
`for FDA approval to market and sell a generic version of COPAXONE® 40 mg/mL product
`
`throughout the United States, including in Delaware.
`
`67.
`
`Upon information and belief, Mylan Pharmaceuticals Inc. will market, sell, and
`
`offer for sale its proposed generic version of COPAXONE® 40 mg/mL product in the State of
`
`Delaware following FDA approval of that product.
`
`68.
`
`Upon information and belief, as a result of Mylan Pharmaceuticals Inc.’s
`
`marketing, selling, or offering for sale of its generic version of COPAXONE® 40 mg/mL
`
`product in the State of Delaware, Teva will lose sales of COPAXONE® 40 mg/mL product and
`
`be injured in the State of Delaware.
`
`69.
`
`By letter dated August 28, 2014, Mylan Pharmaceuticals Inc. sent a letter to Teva
`
`Pharmaceuticals USA, Inc., a Delaware corporation, stating that it had filed ANDA No. 206936
`
`seeking approval to market Mylan’s Glatiramer Acetate Product (“Mylan’s First Notice Letter”).
`
`70.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`Defendant Mylan Pharmaceuticals Inc. because it previously has been sued in this district
`
`without challenging this Court’s assertion of personal jurisdiction over it and availed itself of this
`
`forum by asserting counterclaims for the purpose of litigating a patent infringement dispute. See,
`
`e.g., Alcon Research Ltd. v. Mylan Inc., et al., C.A. No. 13-1332 (D. Del.); UCB Inc., et al. v.
`
`Mylan Inc., et al., C.A. No. 13-1214 (D. Del.); Forest Laboratories Inc., et al v. Mylan Inc., et
`
`al., C.A. No. 13-1605 (D. Del.).
`
`71.
`
`Defendant Mylan Pharmaceuticals Inc. consented to jurisdiction in Delaware by
`
`registering to conduct business with the State of Delaware and maintaining a registered agent in
`
`Delaware.
`
`12
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`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 13 of 88 PageID #: 2318
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`72.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Pharmaceuticals Inc. for the reasons stated herein, including, inter alia, Defendant Mylan
`
`Pharmaceuticals Inc.’s activities in the forum, activities directed at the forum, and significant
`
`contacts with the forum, all of which render Defendant Mylan Pharmaceuticals Inc. at home in
`
`the forum.
`
`73.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Inc.
`
`74.
`
`Upon information and belief, Defendant Mylan Inc. has availed itself of this
`
`forum by bringing a civil action in this forum. See, e.g., Mylan Pharmaceuticals Inc., et al. v.
`
`Eurand Inc., et al., C.A. No. 10-306 (D. Del.); Mylan Pharmaceuticals Inc., et al. v. Kremers
`
`Urban Development Co., C.A. No. 02-1628 (D. Del.); Mylan Pharmaceuticals Inc., et al. v.
`
`Galderma Laboratories Inc., et al., C.A. No. 10-892 (D. Del.); DuPont Merck Pharmaceutical
`
`Co., et al. v. Bristol-Myers Squibb Co., et al., C.A. No. 95-290 (D. Del.).
`
`75.
`
`Upon information and belief, Defendant Mylan Inc. (through its wholly-owned
`
`subsidiary Defendant Mylan Pharmaceuticals Inc.) markets, distributes and/or sells generic drugs
`
`throughout the United States and within the State of Delaware.
`
`76.
`
`Upon information and belief, Defendant Mylan Inc. has engaged in and
`
`maintained systematic and continuous business contacts within the State of Delaware, and has
`
`purposefully availed itself of the benefits and protections of the laws of Delaware rendering it at
`
`home in Delaware.
`
`77.
`
`Upon information and belief, Mylan Inc. (through its wholly-owned subsidiary
`
`Defendant Mylan Pharmaceuticals Inc.) routinely files ANDAs in the United States and markets
`
`dozens of generic pharmaceutical products in the State of Delaware, including, inter alia,
`
`13
`
`
`
`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 14 of 88 PageID #: 2319
`
`albuterol sulfate, alendronate sodium, alprazolam, amitriptyline hydrochloride-perphenazine, and
`
`amlodipine besylate.
`
`78.
`
`Upon information and belief, Mylan Inc. (through its wholly-owned subsidiary
`
`Defendant Mylan Pharmaceuticals Inc.) has agreements with pharmaceutical retailers,
`
`wholesalers or distributors providing for the distribution of its products in the State of Delaware,
`
`including, inter alia, albuterol sulfate, alendronate sodium, alprazolam, amitriptyline
`
`hydrochloride-perphenazine, and amlodipine besylate.
`
`79.
`
`Upon information and belief, Defendant Mylan Inc. has also 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 Teva, which manufactures
`
`COPAXONE® 40 mg/mL product, for sale and use throughout the United States, including the
`
`State of Delaware.
`
`80.
`
`81.
`
`Teva sells COPAXONE® 40 mg/mL product in the State of Delaware.
`
`Upon information and belief, Defendant Mylan Inc. (through its wholly-owned
`
`subsidiary Defendant Mylan Pharmaceuticals Inc.) has applied for FDA approval to market and
`
`sell a generic version of COPAXONE® 40 mg/mL product throughout the United States,
`
`including in Delaware.
`
`82.
`
`Upon information and belief, Mylan Inc. (through its wholly-owned subsidiary
`
`Defendant Mylan Pharmaceuticals Inc.) will market, sell, and offer for sale its proposed generic
`
`version of COPAXONE® 40 mg/mL product in the State of Delaware following FDA approval
`
`of that product.
`
`83.
`
`Upon information and belief, as a result of Mylan Inc.’s (through its wholly-
`
`owned subsidiary Defendant Mylan Pharmaceuticals Inc.) marketing, selling, or offering for sale
`
`14
`
`
`
`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 15 of 88 PageID #: 2320
`
`of its generic version of COPAXONE® 40 mg/mL product in the State of Delaware, Teva will
`
`lose sales of COPAXONE® 40 mg/mL product and be injured in the State of Delaware.
`
`84.
`
`By letter dated August 28, 2014, Mylan Inc. (through its wholly-owned subsidiary
`
`Defendant Mylan Pharmaceuticals Inc.) sent Mylan’s First Notice Letter to Teva
`
`Pharmaceuticals USA, Inc., a Delaware corporation, stating that it had filed ANDA No. 206936
`
`seeking approval to market Mylan’s Glatiramer Acetate Product.
`
`85.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`Defendant Mylan Inc. because it previously has been sued in this district without challenging this
`
`Court’s assertion 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., Alcon
`
`Research Ltd. v. Mylan Inc., et al., C.A. No. 13-1332 (D. Del.); UCB Inc., et al. v. Mylan Inc., et
`
`al., C.A. No. 13-1214 (D. Del.); Forest Laboratories Inc., et al v. Mylan Inc., et al., C.A. No. 13-
`
`1605 (D. Del.).
`
`86.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Inc. for the reasons stated herein, including, inter alia, Defendant Mylan Inc.’s activities
`
`in the forum, activities directed at the forum, and significant contacts with the forum, all of
`
`which render Defendant Mylan Inc. at home in the forum.
`
`87.
`
`Upon information and belief, following any FDA approval of Mylan’s ANDA,
`
`Defendants Mylan Pharmaceuticals Inc. and Mylan Inc. will work in concert with one another to
`
`make, use, offer to sell, and sell a generic version of COPAXONE® 40 mg/mL product
`
`throughout the United States, including in Delaware.
`
`88.
`
`Upon information and belief, Mylan Pharmaceuticals Inc. will manufacture
`
`Mylan’s proposed generic version of COPAXONE® 40 mg/mL product on behalf of Mylan Inc.
`
`15
`
`
`
`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 16 of 88 PageID #: 2321
`
`and Mylan Pharmaceuticals Inc. will act as the agent of Mylan Inc. for sale of that product in the
`
`United States, including Delaware.
`
`Personal Jurisdiction Over Sandoz
`
`89.
`
`Upon information and belief, this Court has personal jurisdiction over Sandoz Inc.
`
`and Momenta Pharmaceuticals, Inc. because they did not challenge this Court’s exercise of
`
`personal jurisdiction over them for purposes of litigating allegations of patent infringement
`
`involving the ANDAs that are the subject matter of this lawsuit. Teva Pharms. USA, Inc. et al. v.
`
`Sandoz, Inc., et al., C.A. No. 14-1171-GMS (D. Del.).
`
`90.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Sandoz, Inc.
`
`91.
`
`Upon information and belief, Defendant Sandoz, Inc. markets, distributes and/or
`
`sells generic drugs within the State of Delaware and throughout the United States.
`
`92.
`
`Upon information and belief, Defendant Sandoz, Inc. has engaged in and
`
`maintained systematic and continuous business contacts within the State of Delaware, and has
`
`purposefully availed itself of the benefits and protections of the laws of Delaware rendering it at
`
`home in Delaware.
`
`93.
`
`Upon information and belief, Sandoz, Inc. routinely files ANDAs in the United
`
`States and markets dozens of generic pharmaceutical products in the State of Delaware,
`
`including, inter alia, amoxicillin-clavulanate potassium, atorvastatin calcium, decitabine,
`
`ceftriaxone sodium, and clindamycin phosphate.
`
`94.
`
`Upon information and belief, Sandoz, Inc. has agreements with pharmaceutical
`
`retailers, wholesalers or distributors providing for the distribution of its products in the State of
`
`16
`
`
`
`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 17 of 88 PageID #: 2322
`
`Delaware, including, inter alia, amoxicillin-clavulanate potassium, atorvastatin calcium,
`
`decitabine, ceftriaxone sodium, and clindamycin phosphate.
`
`95.
`
`Upon information and belief, Defendant Sandoz, Inc. has also 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 Teva, which manufactures
`
`COPAXONE® 40 mg/mL product for sale and use throughout the United States, including the
`
`State of Delaware.
`
`96.
`
`97.
`
`Teva sells COPAXONE® 40 mg/mL product in the State of Delaware.
`
`Upon information and belief, Defendant Sandoz, Inc. has applied for FDA
`
`approval to market and sell a generic version of COPAXONE® 40 mg/mL product throughout
`
`the United States, including in Delaware.
`
`98.
`
`Upon information and belief, Sandoz, Inc. will market, sell, and offer for sale its
`
`proposed generic version of COPAXONE® 40 mg/mL product in the State of Delaware
`
`following FDA approval of that product.
`
`99.
`
`Upon information and belief, as a result of Sandoz, Inc.’s marketing, selling, or
`
`offering for sale of its generic version of COPAXONE® 40 mg/mL product in the State of
`
`Delaware, Teva will lose sales of COPAXONE® 40 mg/mL product and be injured in the State
`
`of Delaware.
`
`100. By letter dated August 27, 2014, Sandoz, Inc. sent a letter to Teva
`
`Pharmaceuticals USA, Inc., a Delaware corporation, stating that it had filed ANDA No. 206921
`
`seeking approval to market Sandoz’s Glatiramer Acetate Product (“Sandoz’s First Notice
`
`Letter”).
`
`17
`
`
`
`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 18 of 88 PageID #: 2323
`
`101.
`
`Further, upon information and belief, Sandoz, Inc., affiliates of Sandoz, Inc.
`
`and/or subsidiaries of Sandoz, Inc. are registered with the Delaware Board of Pharmacy as a
`
`“Distributor/Manufacturer” and “Pharmacy-Wholesale” of drug products.
`
`102. Upon information and belief, this Court also has personal jurisdiction over
`
`Sandoz, Inc. because it previously has been sued in this district, did not challenge this Court’s
`
`assertion of personal jurisdiction over it, and availed itself of this forum by asserting
`
`counterclaims for the purpose of litigating a patent infringement dispute. See e.g. Genzyme
`
`Corporation, et al. v. Sandoz, Inc., C.A. No. 13-1507 (D. Del.); UCB Inc., et al. v. Sandoz, Inc.,
`
`C.A. No. 13-1216 (D. Del.)); Merck Sharp & Dohme Corp. v. Sandoz., C.A. No. 14-916 (D.
`
`Del.).
`
`103. Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Sandoz, Inc. for the reasons stated herein, including, inter alia, Defendant Sandoz, Inc.’s
`
`activities in the forum, activities directed at the forum, and significant contacts with the forum,
`
`all of which render Defendant Sandoz, Inc. at home in the forum.
`
`104. Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Momenta Pharmaceuticals, Inc.
`
`105. Upon information and belief, Defendant Momenta Pharmaceuticals, Inc. is a
`
`company incorporated in the State of Delaware.
`
`106. Upon information and belief, Defendant Momenta Pharmaceuticals, Inc. markets,
`
`distributes and/or sells generic drugs within the State of Delaware and throughout the United
`
`States.
`
`107. Upon information and belief, Defendant Momenta Pharmaceuticals, Inc. has
`
`engaged in and maintained systematic and continuous business contacts within the State of
`
`18
`
`
`
`Case 1:14-cv-01171-CFC Document 115 Filed 11/10/15 Page 19 of 88 PageID #: 2324
`
`Delaware, and has purposefully availed itself of the benefits and protections of the laws of
`
`Delaware rendering it at home in Delaware.
`
`108. Upon information and belief, Momenta Pharmaceuticals, Inc., through its
`
`business partner, Sandoz, Inc., has agreements with pharmaceutical retailers, wholesalers or
`
`distributors providing for the distribution of its products in the State of Delaware, including, inter
`
`alia, enoxaparin sodium.
`
`109. Upon information and belief, Defendant Momenta Pharmaceuticals, Inc. has also
`
`committed, or aided, abetted, contributed to and/or participated in the
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