Case 1:22-cv-00704-UNA Document 1 Filed 05/27/22 Page 1 of 36 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`EAGLE PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
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`ACCORD HEALTHCARE INC., ACCORD
`HEALTHCARE LTD., and INTAS
`PHARMACEUTICALS LTD.,
`
`Defendants.
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`C.A. No. ________________
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`COMPLAINT
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`Plaintiff Eagle Pharmaceuticals, Inc. (“Eagle”), by its attorneys, for its Complaint, alleges
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`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 States,
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`Title 35, United States Code, that arises out of the submission of New Drug Application (“NDA”)
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`No. 216987 (“Accord’s NDA”) by Defendants Accord Healthcare Inc., Accord Healthcare Ltd.,
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`and Intas Pharmaceuticals Ltd. (collectively, “Accord”) to the United States Food and Drug
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`Administration (“FDA”) that includes a certification under 21 U.S.C. § 355(b)(2)(A)(iv)
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`(“Paragraph IV Certification”) that Accord is requesting approval from FDA of its NDA to
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`manufacture and sell its proposed product, which relies on data from bioavailability and/or
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`bioequivalence studies contained in Eagle’s FDA-approved NDA No. 205580 for BELRAPZO®,
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`100 mg/4 mL (25 mg/mL) Bendamustine Hydrochloride Injection product, prior to the expiration
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`of Eagle’s U.S. Patent Nos. 8,609,707 (“the ’707 patent”); 9,265,831 (“the ’831 patent”);
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`9,572,796 (“the ’796 patent”); 9,572,797 (“the ’797 patent”); 10,010,533 (“the ’533 patent”); and
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`11,103,483 (“the ’483 patent”) (collectively, “the Patents-in-Suit”).
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`PARTIES
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`2.
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`Plaintiff Eagle is a corporation organized and existing under the laws of Delaware,
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`with its corporate offices and principal place of business at 50 Tice Boulevard, Suite 315,
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`Woodcliff Lake, New Jersey 07677.
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`3.
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`On information and belief, Defendant Accord Healthcare 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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`1009 Slater Road, Suite 210-B, Durham, North Carolina 27703. On information and belief,
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`Accord Healthcare Inc. is in the business of, among other things, manufacturing and selling generic
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`versions of branded pharmaceutical drugs throughout the United States, including Delaware.
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`4.
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`On information and belief, Defendant Accord Healthcare Ltd. is a corporation
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`organized and existing under the laws of the Republic of India, with a place of business at
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`Corporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380 054,
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`Republic of India. On information and belief, Accord Healthcare Ltd. is in the business of, among
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`other things, manufacturing and selling generic versions of pharmaceutical drug products,
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`including through various affiliates, including Accord Healthcare Inc., throughout the United
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`States, including Delaware.
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`5.
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`On information and belief, Defendant Intas Pharmaceuticals Ltd. is a corporation
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`organized and existing under the laws of the Republic of India, with a place of business at
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`Chinubhai Centre, Off. Nehru Bridge, Ashram Road, Ahmedabad, Gujarat 380 009, Republic of
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`India. On information and belief, Intas Pharmaceuticals Ltd. is in the business of, among other
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`things, manufacturing and selling generic versions of pharmaceutical drug products, including
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`through various operating subsidiaries, including Accord Healthcare Inc. and Accord Healthcare
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`Ltd., throughout the United States, including Delaware.
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`6.
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`On information and belief, Accord Healthcare Inc. is a wholly owned subsidiary of
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`Intas Pharmaceuticals Ltd. and the U.S. agent for Intas Pharmaceuticals Ltd.
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`7.
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`On information and belief, Accord Healthcare Ltd. is a wholly owned subsidiary of
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`Intas Pharmaceuticals Ltd.
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`8.
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`On information and belief, Accord Healthcare Inc., Intas Pharmaceuticals Ltd., and
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`Accord Healthcare Ltd. acted in concert to prepare and submit Accord’s NDA to FDA.
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`9.
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`On information and belief, Intas Pharmaceuticals Ltd. and Accord Healthcare Ltd.
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`actively encouraged, recommended, and promoted that Accord Healthcare Inc. prepare and submit
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`Accord’s NDA to FDA and knew that the filing of Accord’s NDA would infringe the Patents-in-
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`Suit, including because Intas Pharmaceuticals Ltd. and Accord Healthcare Ltd. knew that Accord’s
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`NDA would include a Paragraph IV Certification pursuant to 21 U.S.C. § 355(b)(2)(A)(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, Accord Healthcare Inc., Intas Pharmaceuticals Ltd., and
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`Accord Healthcare Ltd. know and intend that upon approval of Accord’s NDA, Accord Healthcare
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`Inc., Intas Pharmaceuticals Ltd., and Accord Healthcare Ltd. will manufacture a Bendamustine
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`Hydrochloride Injection product, 100 mg/4 mL (25 mg/mL) in a multi-dose vial (“Accord’s NDA
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`Product”); and Accord Healthcare Inc., Intas Pharmaceuticals Ltd., and Accord Healthcare Ltd.
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`will directly or indirectly market, sell, and distribute Accord’s NDA Product throughout the United
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`States, including Delaware. On information and belief, Accord Healthcare Inc., Intas
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`Pharmaceuticals Ltd., and Accord Healthcare Ltd. are agents of each other and/or operate in
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`concert as integrated parts of the same business group, including with respect to Accord’s NDA
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`Product, and enter into agreements that are nearer than arm’s length. On information and belief,
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`Accord Healthcare Inc., Intas Pharmaceuticals Ltd., and Accord Healthcare Ltd. participated,
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`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 Accord’s NDA, Accord
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`Healthcare Inc., Intas Pharmaceuticals Ltd., and Accord Healthcare Ltd. will act in concert to
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`distribute and sell Accord’s NDA Product throughout the United States, including within
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`Delaware.
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`JURISDICTION
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`12.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`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 be further
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`developed through discovery if necessary, this Court has personal jurisdiction over Accord
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`Healthcare Inc., Accord Healthcare Ltd., and Intas Pharmaceuticals Ltd.
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`14.
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`This Court has personal jurisdiction over Accord because, among other things,
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`Accord Healthcare Inc., itself and through its parent Intas Pharmaceuticals Ltd. and affiliate
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`Accord Healthcare Ltd., has purposefully availed itself of the benefits and protections of
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`Delaware’s laws such that they should reasonably anticipate being haled into court here. On
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`information and belief, Accord Healthcare Inc., itself and through its parent Intas Pharmaceuticals
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`Ltd. and affiliate Accord Healthcare Ltd., develops, manufactures, imports, markets, offers to sell,
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`sells, and/or imports generic drugs throughout the United States, including in Delaware, and
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`therefore transacts business within Delaware, and/or has engaged in systematic and continuous
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`business contacts within Delaware.
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`15.
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`In addition, this Court has personal jurisdiction over Accord Healthcare Inc.
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`because, on information and belief, Accord Healthcare Inc., Intas Pharmaceuticals Ltd., and
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`Accord Healthcare Ltd. are alter egos of each other. Therefore, Intas Pharmaceuticals Ltd.’s and
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`Accord Healthcare Ltd.’s activities in Delaware are attributable to Accord Healthcare Inc.
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`16.
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`This Court has personal jurisdiction over Intas Pharmaceuticals Ltd. because,
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`among other things, it has purposely availed itself of the benefits and protections of Delaware’s
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`laws such that it should reasonably anticipate being haled into court here. On information and
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`belief, Intas Pharmaceuticals Ltd., itself and through its subsidiaries Accord Healthcare Inc. and
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`Accord Healthcare Ltd., 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 relating to Plaintiffs’ claims, and/or has engaged in systematic and
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`continuous business contacts within Delaware.
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`17.
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`In addition, this Court has personal jurisdiction over Intas Pharmaceuticals Ltd.
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`because, on information and belief, Intas Pharmaceuticals Ltd. directs and controls Accord
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`Healthcare Inc. and Accord Healthcare Ltd.; and Accord Healthcare Inc., Intas Pharmaceuticals
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`Ltd., Accord Healthcare Ltd., are alter egos of each other. Therefore, Accord Healthcare Inc.’s
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`and Accord Healthcare Ltd.’s activities in Delaware are attributable to Intas Pharmaceuticals Ltd.
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`18.
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`This Court has personal jurisdiction over Accord Healthcare Ltd. because, among
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`other things, it has purposely availed itself of the benefits and protections of Delaware’s laws such
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`that it should reasonably anticipate being haled into court here. On information and belief, Accord
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`Healthcare Ltd., itself and through its affiliate Accord Healthcare Ltd. and parent Intas
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`Pharmaceuticals Inc., develops, manufactures, imports, markets, offers to sell, sells, and/or imports
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`generic drugs throughout the United States, including in Delaware, and therefore transacts business
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`within Delaware relating to Plaintiffs’ claims, and/or has engaged in systematic and continuous
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`business contacts within Delaware.
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`19.
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`In addition, this Court has personal jurisdiction over Accord Healthcare Ltd.
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`because, on information and belief, Accord Healthcare Inc., Intas Pharmaceuticals Ltd., Accord
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`Healthcare Ltd., are alter egos of each other. Therefore, Accord Healthcare Inc.’s and Intas
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`Pharmaceuticals Ltd.’s activities in Delaware are attributable to Accord Healthcare Ltd.
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`20.
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`In addition, this Court also has personal jurisdiction over Accord because, among
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`other things, on information and belief: (1) Accord Healthcare Inc., Intas Pharmaceuticals Ltd.,
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`and Accord Healthcare Ltd. filed Accord’s NDA for the purpose of seeking approval to engage in
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`the commercial manufacture, use, offer for sale, sale, and/or importation of Accord’s NDA Product
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`in the United States, including in Delaware; and (2) upon approval of Accord’s NDA, Accord
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`Healthcare Inc., Intas Pharmaceuticals Ltd., and Accord Healthcare Ltd. will market, distribute,
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`offer for sale, sell, and/or import Accord’s NDA Product in the United States, including in
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`Delaware, and will derive substantial revenue from the use or consumption of Accord’s NDA
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`Product in Delaware. See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 763 (Fed.
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`Cir. 2016). On information and belief, upon approval of Accord’s NDA, Accord’s NDA Product
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`will, among other things, be marketed, distributed, offered for sale, sold, and/or imported in
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`Delaware; prescribed by physicians practicing in Delaware; dispensed by pharmacies located
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`within Delaware; and/or used by patients in Delaware, all of which would have a substantial effect
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`on Delaware.
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`21.
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`In addition, this Court has personal jurisdiction over Accord Healthcare Inc., Intas
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`Pharmaceuticals Ltd., and Accord Healthcare Ltd. 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 Eagle, a Delaware corporation.
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`22.
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`In addition, this Court has personal jurisdiction over Accord Healthcare Inc., Intas
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`Pharmaceuticals Ltd., and Accord Healthcare Ltd. because they regularly engage in patent
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`litigation concerning Accord’s NDA or Abbreviated New Drug Application (“ANDA”) Products
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`in this District, have previously consented to personal jurisdiction in this District, and/or have
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`purposefully availed themselves of the rights and benefits of this Court by asserting claims and/or
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`counterclaims in this District.1
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`23.
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`In addition, this Court has personal jurisdiction over Accord Healthcare Inc., Intas
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`Pharmaceuticals Ltd., and Accord Healthcare Ltd. because, by e-mail dated May 24, 2022 (Exhibit
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`A hereto), Accord confirmed that it will not oppose jurisdiction in the District of Delaware for
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`purposes of this action, and thus has consented to this Court’s exercise of personal jurisdiction for
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`purposes of this action.
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`24.
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`For the above reasons, it would not be fundamentally unfair or unreasonable for
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`Accord Healthcare Inc., Intas Pharmaceuticals Ltd., and Accord Healthcare Ltd. to litigate this
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`action in this District, and the Court has personal jurisdiction over them here.
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`VENUE
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`25.
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`26.
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`Plaintiff incorporates each of the preceding paragraphs as if fully set forth herein.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b) with respect
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`to Accord Healthcare Inc., at least because, on information and belief, Accord is subject to personal
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`1 See, e.g., Teva Pharmaceuticals Int’l GmbH et al. v. Accord Healthcare Inc., C.A. No. 21-952-
`CFC (D. Del. Feb. 10, 2022), D.I. 24; Purdue Pharma LP et al. v. Accord Healthcare Inc. et al.,
`C.A. No. 20-1362-RGA-SRF (D. Del. Mar. 12, 2021), D.I. 14; Merck Sharp & Dohme Corp. v.
`Accord Healthcare Inc. et al., C.A. No. 19-2192-RGA (D. Del. Jan. 24, 2020), D.I. 13; Amgen Inc.
`v. Accord Healthcare, Inc. et al., C.A. No. 18-956-MSG (D. Del. Sept. 18, 2018), D.I. 10; Novartis
`Pharm. Co. v. Accord Healthcare Inc. et al., C.A. No. 18-1043-LPS (D. Del. Aug. 8, 2018), D.I.
`46.
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`jurisdiction in this District and has previously consented to venue in this District in a related
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`litigation on bendamustine.2
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`27.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b) with respect
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`to Accord Healthcare Ltd., at least because, on information and belief, Accord Healthcare Ltd. is
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`a foreign corporation that may be sued in any judicial district in which it is subject to the Court’s
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`personal jurisdiction and has previously consented to venue in this District.3
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`28.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b) with respect
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`to Intas Pharmaceuticals Ltd., at least because, on information and belief, Intas Pharmaceuticals
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`Ltd. is a foreign corporation that may be sued in any judicial district in which it is subject to the
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`Court’s personal jurisdiction and has previously consented to venue in this District.4In addition,
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`venue is proper in this District with respect to Accord Healthcare Inc., Accord Healthcare Ltd.,
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`and Intas Pharmaceuticals Ltd because, by e-mail dated May 24, 2022 (Exhibit A hereto), Accord
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`confirmed that it will not oppose venue in the District of Delaware for purposes of this action, and
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`thus has consented to venue in this District for purposes of this action.
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`BACKGROUND
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`29.
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`BELRAPZO®, which contains bendamustine hydrochloride, is an alkylating drug
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`that is indicated for the treatment of patients with chronic lymphocytic leukemia, as well as for the
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`2 See supra ¶ 9; Teva Pharmaceuticals Int’l GmbH et al. v. Accord Healthcare Inc., C.A. No. 21-
`952-CFC (D. Del. Jun. 29, 2021), D.I. 24.
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`3 See supra ¶ 4; Teva Pharmaceuticals Int’l GmbH et al. v. Accord Healthcare Inc., C.A. No. 21-
`0952-CFC (D. Del. Jun. 29, 2021), D.I. 1.
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`4 See supra ¶ 5; Teva Pharmaceuticals Int’l GmbH et al. v. Accord Healthcare Inc., C.A. No. 21-
`0952-CFC (D. Del. Jun. 29, 2021), D.I. 1.
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`treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or
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`within six months of treatment with rituximab or a rituximab-containing regimen.
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`30.
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`Eagle is the holder of NDA No. 205580 for BELRAPZO®, whose NDA has been
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`approved by the FDA.
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`31.
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`The ’707 patent, entitled “Formulations of Bendamustine” (Exhibit B hereto), was
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`duly and legally issued on December 17, 2013. Eagle is the owner and assignee of the ’707 patent.
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`The ’707 patent is listed in the FDA’s publication Approved Drug Products with Therapeutic
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`Equivalence Evaluations, also known as the “Orange Book,” in connection with BELRAPZO®.
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`32.
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`The ’831 patent, entitled “Formulations of Bendamustine” (Exhibit C hereto), was
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`duly and legally issued on February 23, 2016. Eagle is the owner and assignee of the ’831 patent.
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`The ’831 patent is listed in connection with BELRAPZO® in the Orange Book.
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`33.
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`The ’796 patent, entitled “Formulations of Bendamustine” (Exhibit D hereto), was
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`duly and legally issued on February 21, 2017. Eagle is the owner and assignee of the ’796 patent.
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`The ’796 patent is listed in connection with BELRAPZO® in the Orange Book.
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`34.
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`The ’797 patent, entitled “Formulations of Bendamustine” (Exhibit E hereto), was
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`duly and legally issued on February 21, 2017. Eagle is the owner and assignee of the ’797 patent.
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`The ’797 patent is listed in connection with BELRAPZO® in the Orange Book.
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`35.
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`The ’533 patent, entitled “Formulations of Bendamustine” (Exhibit F hereto), was
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`duly and legally issued on July 3, 2018. Eagle is the owner and assignee of the ’533 patent. The
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`’533 patent is listed in connection with BELRAPZO® in the Orange Book.
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`36.
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`The ’483 patent, entitled “Formulations of Bendamustine” (Exhibit G hereto), was
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`duly and legally issued on August 31, 2021. Eagle is the owner and assignee of the ’483 patent.
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`The ’483 patent is listed in connection with BELRAPZO® in the Orange Book.
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`INFRINGEMENT BY ACCORD
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`37.
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`By letter dated April 18, 2022 (“Accord Notice Letter”), Accord notified Eagle
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`pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”) that Accord had submitted to
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`the FDA NDA No. 216987 under Section 505(b)(2) of the FDCA, seeking approval from the FDA
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`to engage in the commercial manufacture, use, and/or sale of Accord’s NDA Product prior to the
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`expiration of the Patents-in-Suit. The Accord Notice Letter purported to include the information
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`required by statute – to wit, a “detailed statement of the factual and legal basis of the opinion of
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`the applicant that the patent is invalid or will not be infringed.” 21 U.S.C. § 355(b)(3)(D)(ii).
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`38.
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`On information and belief, Accord’s NDA relies on data from bioavailability and/or
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`bioequivalence studies contained in the approved NDA and/or labeling for BELRAPZO®.
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`BELRAPZO® is approved for a 24-month shelf life. The Accord Notice Letter does not identify
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`any difference in stability between Accord’s NDA Product and BELRAPZO® and, on information
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`and belief, Accord’s NDA Product has the same or substantially similar stability as BELRAPZO®
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`and as recited in the claims of the Patents-in-Suit.
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`39.
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`BELRAPZO®
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`is an embodiment of
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`the claims of
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`the Patents-in-Suit.
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`BELRAPZO® is a ready to use liquid bendamustine-containing composition comprising 25
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`mg/mL bendamustine hydrochloride, polyethylene glycol, about 10% propylene glycol, and a
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`stabilizing amount of an antioxidant, monothioglycerol. BELRAPZO® has less than about 5%
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`peak area response of total impurities resulting from the degradation of the bendamustine, as
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`determined by HPLC at a wavelength of 223 nm after at least 15 months at a temperature of from
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`about 5 °C to about 25 °C. BELRAPZO® is a long term storage stable non-aqueous liquid. The
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`bendamustine-containing composition of BELRAPZO® has less than or equal to 0.11% total PG
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`esters at about 1 month of storage at a temperature of about 5 °C, and the ratio of polyethylene
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`glycol to propylene glycol is about 90:10.
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`40.
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`Pursuant to 35 U.S.C. § 271(e)(2), “[i]t shall be an act of infringement to submit—
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`(A) an application under section 505(j) of the Federal Food, Drug,
`and Cosmetic Act or described in section 505(b)(2) of such Act for
`a drug claimed in a patent or the use of which is claimed in a
`patent . . . .”
`
`41.
`
`The Accord Notice Letter represents that Accord submitted NDA No. 216987
`
`listing BELRAPZO® as the Reference Listed Drug and that Accord submitted a Paragraph IV
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`Certification seeking to obtain approval under Section 505(b)(2) of the FDCA to engage in the
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`commercial manufacture, use, offer for sale, sale, and/or importation of Accord’s NDA Product
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`prior to the expiration of the Patents-in-Suit.
`
`42.
`
`In the Accord Notice Letter, Accord stated that the active ingredient of Accord’s
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`NDA Product is bendamustine hydrochloride.
`
`43.
`
`In the Accord Notice Letter, Accord stated that the proposed dosage strength of
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`Accord’s NDA Product is 25 mg/mL, 4 mL.
`
`44.
`
`In the Accord Notice Letter, Accord did not disclose the composition of Accord’s
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`NDA Product and furnish samples, data, or other information sufficient to confirm independently
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`the exact composition of Accord’s NDA Product and assess the properties and functions of
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`Accord’s NDA Product.
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`45.
`
`On information and belief, Accord’s NDA Product contains a pharmaceutically
`
`acceptable fluid comprising an equivalent of propylene glycol.
`
`46.
`
`On information and belief, Accord’s NDA Product contains polyethylene glycol.
`
`The Accord Notice Letter does not dispute that Accord’s NDA Product contains polyethylene
`
`glycol.
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`47.
`
`On information and belief, Accord’s NDA Product contains a stabilizing amount of
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`an antioxidant. On information and belief, Accord’s NDA Product contains an amount of an
`
`antioxidant that decreases the amount of bendamustine degradation. The Accord Notice Letter
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`does not dispute that Accord’s NDA Product contains an antioxidant.
`
`48. With respect to a “stabilizing amount” of an antioxidant, the specification of the
`
`Patents-in-Suit states:
`
`The bendamustine-containing compositions according to several preferred aspects
`of the invention include a stabilizing amount of an antioxidant. For purposes of the
`present invention, “stabilizing amount” shall be understood to include those
`amounts which increase or enhance the stability of the bendamustine in the
`compositions described herein. The presence of one or more antioxidants described
`herein thus contributes, at least in part to the long term stability of the composition.
`Within this guideline, suitable antioxidant concentrations in the compositions can
`range from about 2.5 mg/mL to about 35 mg/mL, and preferably from about 5
`mg/mL to about 20 mg/mL or from about 10 mg/mL to about 15 mg/mL. In some
`other embodiments, the concentration of the antioxidant in the bendamustine-
`containing composition is about 5 mg/mL.
`
`’483 patent at 3:61-4:8. See also ’707 patent at 3:49-3:63; ’831 patent at 3:49-3:63; ’796 patent at
`
`3:55-4:2; ’797 patent at 3:55-4:2; ’533 patent at 3:58-4:5.
`
`49.
`
`The Court previously construed a “stabilizing amount of an antioxidant” in two of
`
`the Patents-in-Suit, the ’831 and ’797 patents, as “any amount of an antioxidant that decreases the
`
`amount of bendamustine degradation after any time period and at any temperature.” Cephalon,
`
`Inc. v. Slayback Pharma LLC, 456 F. Supp. 3d 594, 624-625 (D. Del. Apr. 27, 2020), affirmed,
`
`856 F. App’x 309 (Fed. Cir. 2021). The Court found that the written description of one of the
`
`Patents-in-Suit, the ’831 patent, “defines a ‘stabilizing amount of an antioxidant’ as an amount that
`
`‘increase[s] or enhance[s] the stability of the bendamustine in the compositions described
`
`herein.’… Thus, the ‘objective’ of the antioxidant amount is not ‘unnamed’ but is instead ‘to
`
`increase or enhance the stability of the bendamustine in the compositions’ described in the
`
`specification.” Id. at 622. The Court found that a person of ordinary skill in the art “would
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`Case 1:22-cv-00704-UNA Document 1 Filed 05/27/22 Page 13 of 36 PageID #: 13
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`understand that a stabilizing amount of an antioxidant includes any amount that decreases the
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`amount of bendamustine degradation after any time period and at any temperature.” Id. at 622-
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`623. The Court further found that in “addition to providing exemplary test methods, the
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`specification also lists ‘suitable antioxidant amounts’ and ‘antioxidants,’ and provides examples
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`of ‘stabilizing’ amounts.” Id. at 623.
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`50.
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`On information and belief, Accord’s NDA Product is a ready to use liquid
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`bendamustine-containing composition. The Accord Notice Letter states that Accord’s NDA
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`Product is a “concentration for solution for infusion” and a “liquid composition.” The Accord
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`Notice Letter does not dispute that Accord’s NDA Product is a ready to use liquid bendamustine-
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`containing composition.
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`51.
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`On information and belief, Accord’s NDA Product has less than about 5% peak
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`area response of total impurities resulting from the degradation of the bendamustine, as determined
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`by HPLC at a wavelength of 223 nm after at least 15 months at a temperature of from about 5 °C
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`to about 25 °C. The Accord Notice Letter does not dispute that Accord’s NDA Product has less
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`than about 5% peak area response of total impurities resulting from the degradation of the
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`bendamustine, as determined by HPLC at a wavelength of 223 nm after at least 15 months at a
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`temperature of from about 5 °C to about 25 °C.
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`52.
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`Upon information and belief, the proposed labeling for Accord’s NDA Product
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`encourages, recommends, instructs, and/or promotes administration of a bendamustine-containing
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`composition to patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin
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`lymphoma, which are types of cancer.
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`53.
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`This action is being commenced before the expiration of forty-five days from the
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`date of the receipt of the Notice Letter.
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`Case 1:22-cv-00704-UNA Document 1 Filed 05/27/22 Page 14 of 36 PageID #: 14
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`COUNT I – INFRINGEMENT BY ACCORD OF U.S. PATENT
`NO. 8,609,707 UNDER 35 U.S.C. § 271(e)(2)
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`54.
`
`55.
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`Eagle incorporates each of the preceding paragraphs as if fully set forth herein.
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`Accord’s submission of NDA No. 216987 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Accord’s
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`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).
`
`56.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
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`distribution, and/or importation of Accord’s NDA Product would infringe one or more claims of
`
`the ’707 patent, including but not limited to claims 1, 14, 15, and 16, either literally and/or under
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`the doctrine of equivalents.
`
`57.
`
`On information and belief, Accord will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Accord’s NDA Product with its proposed
`
`labeling upon FDA approval of NDA No. 216987.
`
`58.
`
`On information and belief, the manufacture, use, sale, offer for sale, and/or
`
`importation of Accord’s NDA Product in accordance with and as directed by Accord’s proposed
`
`labeling for that product would infringe one or more claims of the ’707 patent, including but not
`
`limited to claims 1, 14, 15, and 16.
`
`59.
`
`Upon information and belief, Accord plans and intends to, and will, actively induce
`
`infringement of the ’707 patent when NDA No. 216987 is approved, and plans and intends to, and
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`will, do so after approval.
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`60.
`
`On information and belief, Accord knows that its NDA Product and its proposed
`
`labeling are especially made or adapted for use in infringing the ’707 patent, and that its NDA
`
`Product and its proposed labeling are not suitable for substantial non-infringing use. On
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`Case 1:22-cv-00704-UNA Document 1 Filed 05/27/22 Page 15 of 36 PageID #: 15
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`information and belief, Accord plans and intends to, and will, induce and/or contribute to
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`infringement of the ’707 patent if it obtains FDA approval for NDA No. 216987 with its proposed
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`labeling.
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`61.
`
`The foregoing actions by Accord constitute and/or will constitute infringement of
`
`the ’707 patent, active inducement of infringement of the ’707 patent, and contribution to the
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`infringement by others of the ’707 patent.
`
`62.
`
`On information and belief, Accord has acted with full knowledge of the ’707 patent
`
`and/or the application leading to the ’707 patent, Application No. 13/016,473, 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/or contributing to the infringement by others of the
`
`’707 patent.
`
`63.
`
`Unless Accord is enjoined from infringing the ’707 patent, actively inducing
`
`infringement of the ’707 patent, and/or contributing to the infringement by others of the ’707
`
`patent, Eagle will suffer irreparable injury. Eagle has no adequate remedy at law.
`
`COUNT II – INFRINGEMENT BY ACCORD OF U.S. PATENT
`NO. 9,265,831 UNDER 35 U.S.C. § 271(e)(2)
`
`64.
`
`65.
`
`Eagle incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Accord’s submission of NDA No. 216987 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Accord’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).
`
`66.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Accord’s NDA Product would infringe one or more claims of
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`Case 1:22-cv-00704-UNA Document 1 Filed 05/27/22 Page 16 of 36 PageID #: 16
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`the ’831 patent, including but not limited to claim 1, either literally and/or under the doctrine of
`
`equivalents.
`
`67.
`
`On information and belief, Accord will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Accord’s NDA Product with its proposed
`
`labeling upon FDA approval of NDA No. 216987.
`
`68.
`
`On information and belief, the manufacture, use, sale, offer for sale, and/or
`
`importation of Accord’s NDA Product in accordance with and as directed by Accord’s proposed
`
`labeling for that product would infringe one or more claims of the ’831 patent, including but not
`
`limited to claim 1.
`
`69.
`
`Upon information and belief, Accord plans and intends to, and will, actively induce
`
`infringement of the ’831 patent when NDA No. 216987 is approved, and plans and intends to, and
`
`will, do so after approval.
`
`70.
`
`On information and belief, Accord knows that its NDA Product and its proposed
`
`labeling are especially made or adapted for use in infringing the ’831 patent, and that its NDA
`
`Product and its proposed labeling are not suitable for substantial non-infringing use. On
`
`information and belief, Accord plans and intends to, and will, induce and/or contribute to
`
`infringement of the ’831 patent if it obtains FDA approval for NDA No. 216987 with its proposed
`
`labeling.
`
`71.
`
`The foregoing actions by Accord 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.
`
`72.
`
`On information and belief, Accord has acted with full knowledge of the ’831 patent
`
`and/or the application leading to the ’831 patent, Application No. 14/031,879, and without a
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`Case 1:22-cv-00704-UNA Document 1 Filed 05/27/22 Page 17 of 36 PageID #: 17
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`reasonable basis for believing that it would not be liable for infringing the ’831 patent, actively
`
`inducing infringement of the ’831 patent, and/or contributing to the infringement by others of the
`
`’831 patent.
`
`73.
`
`Unless Accord is enjoined from infringing the ’831 patent, actively inducing
`