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Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 1 of 66 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`Plaintiff,
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`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH, CEPHALON,
`INC., and EAGLE PHARMACEUTICALS,
`INC.,
`
`
`
`
`
`
`)
`)
`)
`)
`)
`)
`)
`) C.A. No. ________
`)
`)
`
`)
`)
`)
`)
`
`
`
`
`
`v.
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`
`
`
`DR. REDDY’S LABORATORIES, LTD.,
`and DR. REDDY’S LABORATORIES,
`INC.,
`
`
`
`
`Defendants.
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`
`
`
`COMPLAINT
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`Plaintiffs Teva Pharmaceuticals International GmbH (“Teva Pharmaceuticals”),
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`Cephalon, Inc. (“Cephalon”) (collectively, with Teva Pharmaceuticals, “Teva”), and Eagle
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`Pharmaceuticals, Inc. (“Eagle”) (collectively, “Plaintiffs”), by their attorneys, for their Complaint,
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`allege as follows:
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, 35 U.S.C., and for a declaratory judgment of patent infringement under 28 U.S.C. §§ 2201
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`and 2202 and the patent laws of the United States, 35 U.S.C., which arises out of Dr. Reddy’s
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`Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”) submission of
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`New Drug Application (“NDA”) No. 215668 to the U.S. Food and Drug Administration (“FDA”)
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`seeking approval to commercially manufacture, use, offer for sale, sell, and/or import a generic
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`version of Bendeka® (bendamustine hydrochloride) Injection, 100 mg/4 mL (25 mg/mL), prior to
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`the expiration of U.S. Patent Nos. 8,609,707 (the “’707 patent”); 9,265,831 (the “’831 patent”);
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`
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`1
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`

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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 2 of 66 PageID #: 2
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`
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`9,572,796 (the “’796 patent”); 9,572,797 (the “’797 patent”); 9,034,908 (the “’908 patent”);
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`9,144,568 (the “’568 patent”); 9,572,887 (the “’887 patent”); 9,597,397 (the “’397 patent”);
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`9,597,398 (the “’398 patent”); 9,597,399 (the “’399 patent”); 9,000,021 (the “’021 patent”);
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`9,579,384 (the “’384 patent”), 10,010,533 (the “’533 patent”); and 10,052,385 (the “’385 patent”)
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`(collectively, the “Patents-in-Suit”).
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`PARTIES
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`2.
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`Plaintiff Teva Pharmaceuticals is a limited liability company organized and
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`existing under the laws of Switzerland, having its corporate offices and principal place of business
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`at Schlüsselstrasse 12, Jona (SG) 8645, Switzerland.
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`3.
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`Plaintiff Cephalon is a corporation organized and existing under the laws of
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`Delaware, having its corporate offices and principal place of business at 145 Brandywine Parkway,
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`West Chester, Pennsylvania 19380.
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`4.
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`Plaintiff Eagle is a corporation organized and existing under the laws of
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`Delaware, having its corporate offices and principal place of business at 50 Tice Boulevard, Suite
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`315, Woodcliff Lake, New Jersey 07677.
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`5.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. is a
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`company organized and existing under the laws of the Republic of India having its corporate
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`offices and principal place of business at Door No. 8-2-337, Road No. 3, Banjara Hills, Hyderabad
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`500 034, Telangana, Republic of India. On information and belief, Dr. Reddy’s Laboratories, Ltd.
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`is in the business of, among other things, manufacturing and selling generic versions of branded
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`pharmaceutical drugs through various operating subsidiaries, including Dr. Reddy’s Laboratories,
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`Inc.
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`2
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`

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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 3 of 66 PageID #: 3
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`6.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Inc. is a
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`company organized and existing under the laws of the State of New Jersey having its corporate
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`offices and principal place of business at 107 College Road East, Princeton, New Jersey 08540.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is in the business of, among other things,
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`manufacturing and selling generic versions of pharmaceutical drug products throughout the United
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`States, including Delaware.
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`7.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is a wholly owned
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`subsidiary of Dr. Reddy’s Laboratories, Ltd. and the U.S. agent for Dr. Reddy’s Laboratories, Ltd.
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`8.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. acted in concert to prepare and submit Dr. Reddy’s NDA to FDA.
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`9.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. actively
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`encouraged, recommended, and promoted that Dr. Reddy’s Laboratories, Inc. prepare and submit
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`Dr. Reddy’s NDA to FDA and knew that the filing of Dr. Reddy’s NDA would infringe the
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`Patents-in-Suit, including because Dr. Reddy’s Laboratories, Ltd. knew that Dr. Reddy’s NDA
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`would include a Paragraph IV Certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with
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`respect to the Patents-in-Suit.
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`10.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. know and intend that upon approval of Dr. Reddy’s NDA, Dr. Reddy’s
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`Laboratories, Ltd. will manufacture Dr. Reddy’s NDA Product; and Dr. Reddy’s Laboratories,
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`Ltd. and Dr. Reddy’s Laboratories, Inc. will directly or indirectly market, sell, and distribute Dr.
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`Reddy’s NDA Product throughout the United States, including in Delaware. On information and
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`belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. are agents of each other
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`and/or operate in concert as integrated parts of the same business group, including with respect to
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`3
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 4 of 66 PageID #: 4
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`Dr. Reddy’s NDA Product, and enter into agreements that are nearer than arm’s length. On
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`information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
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`participated, assisted, and cooperated in carrying out the acts complained about herein.
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`11.
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`On information and belief, following any FDA approval of Dr. Reddy’s
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`NDA, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. will act in concert to
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`distribute and sell Dr. Reddy’s NDA Product throughout the United States, including within
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`Delaware.
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`JURISDICTION AND VENUE
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`12.
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`This Court has subject matter jurisdiction over this action pursuant to 28
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`13.
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`Based on the facts and causes alleged herein, and for additional reasons to
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`be further developed through discovery if necessary, this Court has personal jurisdiction over Dr.
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`Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
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`14.
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`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Ltd.
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`because, among other things, Dr. Reddy’s Laboratories, Ltd., itself and through its subsidiary Dr.
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`Reddy’s Laboratories, Inc., has purposefully availed itself of the benefits and protections of
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`Delaware’s laws such that it should reasonably anticipate being haled into court here. On
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`information and belief, Dr. Reddy’s Laboratories, Ltd., itself and through its subsidiary Dr.
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`Reddy’s Laboratories, Inc., develops, manufactures, imports, markets, offers to sell, sells, and/or
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`imports generic drugs throughout the United States, including in Delaware, and therefore transacts
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`business within Delaware, and/or has engaged in systematic and continuous business contacts
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`within Delaware.
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`4
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 5 of 66 PageID #: 5
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`15.
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`In addition, this Court has personal jurisdiction over Dr. Reddy’s
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`Laboratories, Ltd. because, on information and belief, Dr. Reddy’s Laboratories, Ltd. directs and
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`controls Dr. Reddy’s Laboratories, Inc., and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. are alter egos of each other. Therefore, Dr. Reddy’s Laboratories, Inc.’s
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`activities in Delaware are attributable to Dr. Reddy’s Laboratories, Ltd.
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`16.
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`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Inc.
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`because, among other things, it has purposely availed itself of the benefits and protections of
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`Delaware’s laws such that it should reasonably anticipate being haled into court here. On
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`information and belief, Dr. Reddy’s Laboratories, Inc. is registered as a pharmacy wholesaler
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`under license No. A-4-0002524 and as a controlled substances distributor/manufacturer under
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`license No. DM-0013148 with the Delaware Division of Professional Regulation. In addition, on
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`information and belief, Dr. Reddy’s Laboratories, Inc. develops, manufactures, imports, markets,
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`offers to sell, sells, and/or imports generic drugs throughout the United States, including in
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`Delaware, and therefore transacts business within Delaware relating to Plaintiffs’ claims, and/or
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`has engaged in systematic and continuous business contacts within Delaware.
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`17.
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`In addition, this Court has personal jurisdiction over Dr. Reddy’s
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`Laboratories, Inc. because, on information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr.
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`Reddy’s Laboratories, Inc. are alter egos of each other. Therefore, Dr. Reddy’s Laboratories,
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`Ltd.’s activities in Delaware are attributable to Dr. Reddy’s Laboratories, Inc.
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`18.
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`In addition, this Court also has personal jurisdiction over Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because, among other things, on information
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`and belief: (1) Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. filed Dr. Reddy’s
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`NDA for the purpose of seeking approval to engage in the commercial manufacture, use, offer for
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`5
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 6 of 66 PageID #: 6
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`
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`sale, sale, and/or importation of Dr. Reddy’s NDA Product in the United States, including in
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`Delaware; and (2) upon approval of Dr. Reddy’s NDA, Dr. Reddy’s Laboratories, Ltd. and Dr.
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`Reddy’s Laboratories, Inc. will market, distribute, offer for sale, sell, and/or import Dr. Reddy’s
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`NDA Product in the United States, including in Delaware, and will derive substantial revenue from
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`the use or consumption of Dr. Reddy’s NDA Product in Delaware. See Acorda Therapeutics Inc.
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`v. Mylan Pharm. Inc., 817 F.3d 755, 763 (Fed. Cir. 2016). On information and belief, upon
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`approval of Dr. Reddy’s NDA, Dr. Reddy’s NDA Product will, among other things, be marketed,
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`distributed, offered for sale, sold, and/or imported in Delaware; prescribed by physicians practicing
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`in Delaware; dispensed by pharmacies located within Delaware; and/or used by patients in
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`Delaware, all of which would have a substantial effect on Delaware.
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`19.
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`In addition, this Court has personal jurisdiction over Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because they have committed, aided, abetted,
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`induced, contributed to, or participated in the commission of the tortious act of patent infringement
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`that has led and/or will lead to foreseeable harm and injury to Cephalon and Eagle, both Delaware
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`corporations.
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`20.
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`In addition, this Court has personal jurisdiction over Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. because they regularly engage in patent
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`litigation concerning Dr. Reddy’s NDA or Abbreviated New Drug Application (“ANDA”)
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`Products in this District, do not contest personal jurisdiction in this District, and have purposefully
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`availed themselves of the rights and benefits of this Court by asserting claims and/or counterclaims
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`in this District.1
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`1 See, e.g., Bial Portella & CA S.A. et al. v. Dr. Reddy’s Labs., Ltd. & Dr. Reddy’s Labs.,
`Inc., C.A. No. 21-188-CFC (D. Del. Mar. 3, 2021), D.I. 6, at 4-6; Intercept Pharm., Inc. et al. v.
`Dr. Reddy’s Labs., Inc. Dr. Reddy’s Labs., Ltd., C.A. No. 21-35-MN (D. Del. Feb. 5, 2021), D.I.
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`
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`6
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 7 of 66 PageID #: 7
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`21.
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`For the above reasons, it would not be fundamentally unfair or unreasonable
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`for Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. to litigate this action in this
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`District, and the Court has personal jurisdiction over them here.
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`VENUE
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`22.
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`Plaintiffs incorporate each of the proceeding paragraphs 1–21 as if fully set
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`forth herein.
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`23.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b) with
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`respect to Dr. Reddy’s Laboratories, Ltd., at least because, on information and belief, Dr. Reddy’s
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`Laboratories, Ltd. is a foreign corporation that may be sued in any judicial district in which it is
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`subject to the Court’s personal jurisdiction.
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`24.
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`Venue is proper in this District under 28 U.S.C. § 1400(b) with respect to
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`Dr. Reddy’s Laboratories, Inc., at least because, on information and belief, Dr. Reddy’s
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`Laboratories Ltd. is the U.S. agent and alter ego of Dr. Reddy’s Laboratories, Ltd. (which is subject
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`to venue in this District). In addition, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. regularly engage in patent litigation concerning Dr. Reddy’s NDA or ANDA
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`Products in this District and do not contest venue in this District.2
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`10, at 5-9, 39-59; Pfizer, Inc. et al. v. Dr. Reddy’s Labs., Inc. & Dr. Reddy’s Labs., Ltd., C.A.
`No. 20-1530-CFC (D. Del. Jan. 15, 2021), D.I. 10, at 3-4; Novartis Pharm. Corp. v. Dr. Reddy’s
`Labs., Inc.. & Dr. Reddy’s Labs., Ltd. et al., C.A. No. 19-2053-LPS (D. Del. Feb. 6, 2020), D.I.
`34, at 3-8. 29-32, 85-103; Genzyme Corp. et al. v. Dr. Reddy’s Labs., Inc.. & Dr. Reddy’s Labs.,
`Ltd., C.A. No. 18-1839-CFC (D. Del. Jan. 16, 2019), D.I. 13, at 2-3, 9-15; Onyx Therapeutics,
`Inc. v. Dr. Reddy’s Labs., Ltd. & Dr. Reddy’s Labs., Inc., C.A. No. 17-1811-LPS (D. Del. Jan.
`23, 2018), D.I. 11, at 4-7, 43-63; Bristol Myers Squibb Co. et. al. v. Dr. Reddy’s Labs., Ltd. &
`Dr. Reddy’s Labs., Inc., C.A. No. 17-401-LPS (D. Del. July 7, 2017), D.I. 11, at 3, 9-14; Amgen
`Inc. v. Dr. Reddy’s Labs., Ltd. & Dr. Reddy’s Labs., Inc., C.A. No. 16-900-GMS (D. Del. Nov.
`1, 2016), D.I. 8, at 1-2, 7-11.
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`2 See supra n.1.
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`7
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 8 of 66 PageID #: 8
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`BACKGROUND
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`25.
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`Bendeka®, which contains bendamustine hydrochloride, is an alkylating
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`drug that is indicated for the treatment of patients with (1) chronic lymphocytic leukemia and (2)
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`indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of
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`treatment with rituximab or a rituximab-containing regimen.
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`26.
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`Eagle is the holder of NDA No. 208194 for Bendeka®, which has been
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`approved by FDA.
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`27.
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`The ’707 patent, entitled “Formulations of Bendamustine” (Exhibit A), was
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`duly and legally issued on December 17, 2013. Eagle Pharmaceuticals, Inc. is the owner and
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`assignee of the ’707 patent, subject to the exclusive license referenced herein. The ’707 patent has
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`been listed in connection with Bendeka® in the Orange Book.
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`28.
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`The ’831 patent, entitled “Formulations of Bendamustine” (Exhibit B), was
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`duly and legally issued on February 23, 2016. Eagle Pharmaceuticals, Inc. is the owner and
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`assignee of the ’831 patent, subject to the exclusive license referenced herein. The ’831 patent has
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`been listed in connection with Bendeka® in the Orange Book.
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`29.
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`The ’796 patent, entitled “Formulations of Bendamustine” (Exhibit C), was
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`duly and legally issued on February 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and
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`assignee of the ’796 patent, subject to the exclusive license referenced herein. The ’796 patent has
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`been listed in connection with Bendeka® in the Orange Book.
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`30.
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`The ’797 patent, entitled “Formulations of Bendamustine” (Exhibit D), was
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`duly and legally issued on February 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and
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`assignee of the ’797 patent, subject to the exclusive license referenced herein. The ’797 patent has
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`been listed in connection with Bendeka® in the Orange Book.
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`8
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 9 of 66 PageID #: 9
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`31.
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`The ’908 patent, entitled “Formulations of Bendamustine” (Exhibit E), was
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`duly and legally issued on May 19, 2015. Eagle Pharmaceuticals, Inc. is the owner and assignee
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`of the ’908 patent, subject to the exclusive license referenced herein. The ’908 patent has been
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`listed in connection with Bendeka® in the Orange Book.
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`32.
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`The ’568 patent, entitled “Formulations of Bendamustine” (Exhibit F), was
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`duly and legally issued on September 29, 2015. Eagle Pharmaceuticals, Inc. is the owner and
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`assignee of the ’568 patent, subject to the exclusive license referenced herein. The ’568 patent has
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`been listed in connection with Bendeka® in the Orange Book.
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`33.
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`The ’887 patent, entitled “Formulations of Bendamustine” (Exhibit G), was
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`duly and legally issued on February 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and
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`assignee of the ’887 patent, subject to the exclusive license referenced herein. The ’887 patent has
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`been listed in connection with Bendeka® in the Orange Book.
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`34.
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`The ’397 patent, entitled “Formulations of Bendamustine” (Exhibit H), was
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`duly and legally issued on March 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee
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`of the ’397 patent, subject to the exclusive license referenced herein. The ’397 patent has been
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`listed in connection with Bendeka® in the Orange Book.
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`35.
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`The ’398 patent, entitled “Formulations of Bendamustine” (Exhibit I), was
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`duly and legally issued on March 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee
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`of the ’398 patent, subject to the exclusive license referenced herein. The ’398 patent has been
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`listed in connection with Bendeka® in the Orange Book.
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`36.
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`The ’399 patent, entitled “Formulations of Bendamustine” (Exhibit J), was
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`duly and legally issued on March 21, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee
`
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`9
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 10 of 66 PageID #: 10
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`of the ’399 patent, subject to the exclusive license referenced herein. The ’399 patent has been
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`listed in connection with Bendeka® in the Orange Book.
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`37.
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`The ’021 patent, entitled “Method of Treating Bendamustine-Responsive
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`Conditions in Patients Requiring Reduced Volumes for Administration” (Exhibit K), was duly and
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`legally issued on April 7, 2015. Eagle Pharmaceuticals, Inc. is the owner and assignee of the ’021
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`patent, subject to the exclusive license referenced herein. The ’021 patent has been listed in
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`connection with Bendeka® in the Orange Book.
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`38.
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`The ’384 patent, entitled “Method of Treating Bendamustine-Responsive
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`Conditions in Patients Requiring Reduced Volumes for Administration” (Exhibit L), was duly and
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`legally issued on February 28, 2017. Eagle Pharmaceuticals, Inc. is the owner and assignee of the
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`’384 patent, subject to the exclusive license referenced herein. The ’384 patent has been listed in
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`connection with Bendeka® in the Orange Book.
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`39.
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`The ’533 patent, entitled “Formulations of Bendamustine” (Exhibit M), was
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`duly and legally issued on July 3, 2018. Eagle Pharmaceuticals, Inc. is the owner and assignee of
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`the ’533 patent, subject to the exclusive license referenced herein. The ’533 patent has been listed
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`in connection with Bendeka® in the Orange Book.
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`40.
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`The ’385 patent, entitled “Formulations of Bendamustine” (Exhibit N), was
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`duly and legally issued on August 21, 2018. Eagle Pharmaceuticals, Inc. is the owner and assignee
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`of the ’385 patent, subject to the exclusive license referenced herein. The ’385 patent has been
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`listed in connection with Bendeka® in the Orange Book.
`
`41.
`
`On or around February 13, 2015, Cephalon executed an exclusive license
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`(the “Eagle License”) to, among other things, the ’707 patent, U.S. Patent Application No.
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`14/031,879 (which later issued as the ’831 patent); U.S. Patent Application No. 13/838,090 (which
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`10
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 11 of 66 PageID #: 11
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`later issued as the ’908 patent), U.S. Patent Application No. 13/838,267 (which later issued as the
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`’021 patent), and all patent rights claiming priority to those patents or patent applications (which
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`include the ’796, ’797, ’568, ’887, ’397, ’398, ’399, ’384, ’533, and ’385 patents), for the
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`commercialization of Eagle’s bendamustine hydrochloride rapid infusion product, EP-3102, which
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`became Bendeka®. The Eagle License provides Cephalon the right to sue for infringement of the
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`licensed patents in the event of, among other things, the filing of an NDA that makes reference to
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`Bendeka® and seeks approval before expiry of a licensed patent.
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`42.
`
`On or around October 14, 2015, Cephalon assigned its rights in the Eagle
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`License to Teva Pharmaceuticals.
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`INFRINGEMENT BY DR. REDDY’S
`
`43.
`
`By letter dated March 31, 2021 (“Dr. Reddy’s Notice Letter”), Dr. Reddy’s
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`Laboratories, Inc., as U.S. agent for Dr. Reddy’s Laboratories Ltd., notified Teva and Eagle that it
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`had filed a Paragraph IV Certification with respect to the Patents-in-Suit and was seeking approval
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`from FDA to engage in the commercial manufacture, use, offer for sale, sale, and/or importation
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`of Dr. Reddy’s NDA Product prior to the expiration of the Patents-in-Suit. On information and
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`belief, Dr. Reddy’s NDA contains a Paragraph IV Certification asserting that the Patents-in-Suit
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`will not be infringed by the manufacture, use, offer for sale, sale, or importation of Dr. Reddy’s
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`NDA Product, or alternatively, that the Patents-in-Suit are invalid.
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`44.
`
`The purpose of Dr. Reddy’s submission of Dr. Reddy’s NDA was to obtain
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`approval under the Federal Food, Drug and Cosmetic Act to engage in the commercial
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`manufacture, use, offer for sale, sale, and/or importation into the United States of Dr. Reddy’s
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`NDA Product prior to the expiration of the Patents-in-Suit.
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`11
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`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 12 of 66 PageID #: 12
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`45.
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`In Dr. Reddy’s Notice Letter, Dr. Reddy’s stated that the active ingredient
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`of Dr. Reddy’s NDA Product is bendamustine hydrochloride.
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`46.
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`In Dr. Reddy’s Notice Letter, Dr. Reddy’s stated that Dr. Reddy’s NDA
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`Product contains 100 mg/4 mg (25 mg/mL) bendamustine hydrochloride.
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`47.
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`In Dr. Reddy’s Notice Letter, Dr. Reddy’s did not disclose the composition
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`of Dr. Reddy’s NDA product and furnish samples, data, or other information sufficient to confirm
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`independently the exact composition of Dr. Reddy’s NDA product and assess the properties and
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`functions of Dr. Reddy’s NDA Product.
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`48.
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`In Dr. Reddy’s Notice Letter, Dr. Reddy’s did not contest infringement,
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`among other things, of claims 1-3, 8-13, or 16-29 of the ’887 Patent. For example, claim 1 of the
`
`’887 Patent recites: “1. A method of treating chronic lymphocytic leukemia or indolent B cell non-
`
`Hodgkin's lymphoma in a subject comprising: a. providing a non-aqueous liquid composition
`
`comprising from about 10 mg/mL to about 100 mg/mL of bendamustine or a pharmaceutically
`
`acceptable salt thereof, wherein the total impurities are less than about 5% as determined by HPLC
`
`at a wavelength of 223 nm after 15 months at a temperature of from about 5° C. to about 25° C.;
`
`b. diluting said non-aqueous liquid composition with a parenterally acceptable aqueous diluent;
`
`and c. parenterally administering said diluted composition to the subject at a bendamustine dosage
`
`ranging from about 25 mg/m2 to about 120 mg/m2, wherein said administering step is performed
`
`with a total volume of about 100 mL or less of the diluted composition administered over a period
`
`of less than or equal to about 15 minutes.” Claim 2 of the ’887 Patent recites: “2. The method of
`
`claim 1, wherein the non-aqueous liquid composition comprises a pharmaceutically acceptable
`
`fluid comprising polyethylene glycol, propylene glycol, ethanol, benzyl alcohol, glycofurol, or
`
`DMSO, or a mixture thereof.” Claim 3 of the ’887 Patent recites: “3. The method of claim 1,
`
`
`
`12
`
`

`

`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 13 of 66 PageID #: 13
`
`
`
`wherein the non-aqueous liquid composition comprises polyethylene glycol, propylene glycol, or
`
`a mixture thereof.”
`
`49.
`
`On
`
`information and belief, Dr. Reddy’s NDA Product contains
`
`bendamustine, propylene glycol, polyethylene glycol, and monothioglycerol, in the same or
`
`equivalent amounts as Bendeka®.
`
`50.
`
`On
`
`information and belief, Dr. Reddy’s NDA Product contains
`
`bendamustine, propylene glycol, polyethylene glycol, and monothioglycerol, or equivalent
`
`ingredients, in the same or equivalent amounts as Bendeka®.
`
`51.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration to patients with
`
`chronic lymphocytic leukemia.
`
`52.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration of a bendamustine
`
`dose of 100 mg/m2 to patients with chronic lymphocytic leukemia.
`
`53.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration to patients with
`
`indolent B-cell non-Hodgkin lymphoma.
`
`54.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes administration of a bendamustine
`
`dose of 120 mg/m2 to patients with indolent B-cell non-Hodgkin lymphoma.
`
`55.
`
`On information and belief, the proposed labeling for Dr. Reddy’s NDA
`
`Product recommends, encourages, instructs, and/or promotes the administration of Dr. Reddy’s
`
`NDA Product in a volume of about 50 mL or less over a time period of about 10-minutes or less.
`
`
`
`13
`
`

`

`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 14 of 66 PageID #: 14
`
`
`
`56.
`
`In an exchange of correspondence, counsel for Teva and counsel for Dr.
`
`Reddy’s discussed the terms of Dr. Reddy’s Offer for Confidential Access. The parties did not
`
`agree on terms under which Teva could review, among other things, Dr. Reddy’s NDA and certain
`
`portions of the Drug Master File referred to therein, and Dr. Reddy’s refused to produce samples
`
`of Dr. Reddy’s NDA product and other internal documents and materials relevant to infringement.
`
`In addition, Dr. Reddy’s Offer for Confidential Access placed unreasonable restrictions on the
`
`extent to which Teva could access the documents and materials subject to the offer. Without all
`
`of the materials requested by Teva, including samples of Dr. Reddy’s NDA product, which Dr.
`
`Reddy’s refused to produce, Teva could not confirm, and cannot confirm, the exact composition
`
`and properties of Dr. Reddy’s NDA product. Dr. Reddy’s filing of its NDA seeking approval to
`
`market a generic version of Bendeka® before expiry of the patents asserted herein constitutes an
`
`act of infringement.
`
`57.
`
`On May 12, 2021, shortly before forty-five days had elapsed following
`
`Plaintiffs’ receipt of Dr. Reddy’s Notice Letter, counsel for Dr. Reddy’s responded to Teva’s most-
`
`recent correspondence regarding Dr. Reddy’s Offer for Confidential Access, and the parties
`
`recognized that they were at an impasse.
`
`58.
`
`This action is being commenced before the expiration of forty-five days
`
`from the date of the receipt of Dr. Reddy’s Notice Letter.
`
`COUNT I – INFRINGEMENT BY DR. REDDY’S
`OF U.S. PATENT NO. 8,609,707 UNDER 35 U.S.C. § 271(e)(2)
`
`Plaintiffs incorporate each of the preceding paragraphs 1–58 as if fully set
`
`59.
`
`forth herein.
`
`60.
`
`Dr. Reddy’s submission of Dr. Reddy’s NDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`
`
`14
`
`

`

`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 15 of 66 PageID #: 15
`
`
`
`Dr. Reddy’s NDA Product prior to the expiration of the ’707 patent was an act of infringement of
`
`the ’707 patent under 35 U.S.C. § 271(e)(2)(A).
`
`61.
`
`On information and belief, the manufacture, use, offer for sale, sale,
`
`marketing, distribution, and/or importation of Dr. Reddy’s NDA Product would infringe one or
`
`more claims of the ’707 patent, either literally or under the doctrine of equivalents.
`
`62.
`
`On information and belief, Dr. Reddy’s will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Dr. Reddy’s NDA Product
`
`immediately and imminently upon FDA approval of Dr. Reddy’s NDA.
`
`63.
`
`On information and belief, the use of Dr. Reddy’s NDA Product in
`
`accordance with and as directed by Dr. Reddy’s proposed labeling for that product would infringe
`
`one or more claims of the ’707 patent.
`
`64.
`
`On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`actively induce infringement of the ’707 patent when Dr. Reddy’s NDA is approved, and plans
`
`and intends to, and will, do so after approval.
`
`65.
`
`On information and belief, Dr. Reddy’s knows that Dr. Reddy’s NDA
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’707
`
`patent and that Dr. Reddy’s NDA Product and its proposed labeling are not suitable for substantial
`
`non-infringing use. On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`contribute to infringement of the ’707 patent after approval of Dr. Reddy’s NDA.
`
`66.
`
`The foregoing actions by Dr. Reddy’s constitute and/or will constitute
`
`infringement of the ’707 patent, active inducement of infringement of the ’707 patent, and
`
`contribution to the infringement by others of the ’707 patent.
`
`
`
`15
`
`

`

`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 16 of 66 PageID #: 16
`
`
`
`67.
`
`On information and belief, Dr. Reddy’s has acted with full knowledge of
`
`the ’707 patent and without a reasonable basis for believing that it would not be liable for infringing
`
`the ’707 patent, actively inducing infringement of the ’707 patent, and contributing to the
`
`infringement by others of the ’707 patent.
`
`68.
`
`Unless Dr. Reddy’s is enjoined from infringing the ’707 patent, actively
`
`inducing infringement of the ’707 patent, and contributing to the infringement by others of the
`
`’707 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT II – INFRINGEMENT BY DR. REDDY’S
`OF U.S. PATENT NO. 9,265,831 UNDER 35 U.S.C. § 271(e)(2)
`
`Plaintiffs incorporate each of the preceding paragraphs 1–68 as if fully set
`
`69.
`
`forth herein.
`
`70.
`
`Dr. Reddy’s submission of Dr. Reddy’s NDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Dr. Reddy’s NDA Product prior to the expiration of the ’831 patent was an act of infringement of
`
`the ’831 patent under 35 U.S.C. § 271(e)(2)(A).
`
`71.
`
`On information and belief, the manufacture, use, offer for sale, sale,
`
`marketing, distribution, and/or importation of Dr. Reddy’s NDA Product would infringe one or
`
`more claims of the ’831 patent, either literally or under the doctrine of equivalents.
`
`72.
`
`On information and belief, Dr. Reddy’s will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Dr. Reddy’s NDA Product
`
`immediately and imminently upon FDA approval of Dr. Reddy’s NDA.
`
`73.
`
`On information and belief, the use of Dr. Reddy’s NDA Product in
`
`accordance with and as directed by Dr. Reddy’s proposed labeling for that product would infringe
`
`one or more claims of the ’831 patent.
`
`
`
`16
`
`

`

`Case 1:21-cv-00695-UNA Document 1 Filed 05/13/21 Page 17 of 66 PageID #: 17
`
`
`
`74.
`
`On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`actively induce infringement of the ’831 patent when Dr. Reddy’s NDA is approved, and plans
`
`and intends to, and will, do so after approval.
`
`75.
`
`On information and belief, Dr. Reddy’s knows that Dr. Reddy’s NDA
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’831
`
`patent and that Dr. Reddy’s NDA Product and its proposed labeling are not suitable for substantial
`
`non-infringing use. On information and belief, Dr. Reddy’s plans and intends to, and will,
`
`contribute to infringement of the ’831 patent after approval of Dr. Reddy’s NDA.
`
`76.
`
`The foregoing actions by Dr. Reddy’s constitute and/or will constitute
`
`infringement of the ’831 patent, active inducement of infringement of the ’831 patent, and
`
`contribution to the infringement by others of the ’831 patent.
`
`77.
`
`On information and belief, Dr. Reddy’s has acted with full knowledge of
`
`the ’831 patent and without a reasonable basis for believin

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