Case 1:21-cv-01619-UNA Document 1 Filed 11/16/21 Page 1 of 13 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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`C.A. No. _________
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`)))))))))))
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`EAGLE PHARMACEUTICALS, INC., TEVA
`PHARMACEUTICALS INTERNATIONAL
`GMBH, AND CEPHALON, INC.,
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`Plaintiffs,
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`v.
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`HOSPIRA, INC.,
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`Defendant.
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`COMPLAINT
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`Plaintiffs Eagle Pharmaceuticals, Inc. (“Eagle”), Teva Pharmaceuticals International
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`GmbH (“Teva Pharmaceuticals”), and Cephalon, Inc. (“Cephalon,” and collectively with Teva
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`Pharmaceuticals, “Teva”), and (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 States,
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`Title 35, United States Code, and for a declaratory judgment of patent infringement under 28
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`U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title 35, United States Code,
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`that arises out of the submission of New Drug Application (“NDA”) No. 211530 by Hospira, Inc.
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`(“Hospira” or “Defendant”) to the U.S. Food and Drug Administration (“FDA”) seeking approval
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`to manufacture and sell its proposed product which relies on data from bioavailability and/or
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`bioequivalence studies contained in the approved labeling for Plaintiffs’ BENDEKA®
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`(bendamustine hydrochloride) Injection, 100 mg/4 mL (25 mg/mL) (“BENDEKA®”) prior to the
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`expiration of U.S. Patent No. 11,103,483 (“the ’483 patent” or “the Patent-in-Suit”).
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`Case 1:21-cv-01619-UNA Document 1 Filed 11/16/21 Page 2 of 13 PageID #: 2
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`PARTIES
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`2.
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`Plaintiff Eagle Pharmaceuticals, Inc. is a corporation organized and existing under
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`the laws of Delaware, with its corporate offices and principal place of business at 50 Tice
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`Boulevard, Suite 315, Woodcliff Lake, New Jersey 07677.
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`3.
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`Plaintiff Teva Pharmaceuticals International GmbH is a limited liability company
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`organized and existing under the laws of Switzerland, having a principal place of business at
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`Schlüsselstrasse 12, Jona (SG) 8645, Switzerland.
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`4.
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`Plaintiff Cephalon, Inc. is a corporation organized and existing under the laws of
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`Delaware, having a principal place of business at 145 Brandywine Parkway, West Chester,
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`Pennsylvania 19380.
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`5.
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`On information and belief, Defendant Hospira, Inc. is a corporation organized and
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`existing under the laws of Delaware, with its principal place of business at 275 North Field Drive,
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`Lake Forest, Illinois 60045.
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`JURISDICTION AND VENUE
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`6.
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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, based on Hospira’s filing of NDA No. 211530 and Plaintiffs’ pending suit against
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`Hospira based on Hospira’s infringement of other patents based on Hospira’s same NDA filing.
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`See Eagle Pharm., Inc. v. Hospira, Inc., No. 18-01074-CFC (D. Del.).
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`7.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b) at least because
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`Hospira is organized and existing under the laws of Delaware and therefore resides there for
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`purposes of venue.
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`8.
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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 Hospira.
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`9.
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`This Court has personal jurisdiction over Hospira because, upon information and
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`belief, Hospira is a corporation organized and existing under the laws of Delaware and maintains
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`a registered agent for service of process in Delaware. This Court has personal jurisdiction over
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`Hospira for the additional reasons set forth below and for other reasons that will be presented to
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`the Court if such jurisdiction is challenged.
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`10.
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`In addition, this Court has personal jurisdiction over Hospira because, on
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`information and belief, Hospira has engaged in a persistent course of conduct within Delaware by
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`continuously and systematically placing goods into the stream of commerce for distribution
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`throughout the United States, including Delaware.
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`11.
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`Further, this Court also has personal jurisdiction over Hospira because, among other
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`things, on information and belief: (1) Hospira has filed an NDA for the purpose of seeking approval
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`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of the
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`product described in NDA No. 211530 in the United States, including in Delaware; and (2) Hospira
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`will market, distribute, offer for sale, and/or sell the product described in NDA No. 211530 in the
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`United States, including in Delaware, upon approval of NDA No. 211530, and will derive
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`substantial revenue from the use or consumption of the product described in NDA No. 211530 in
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`the State of Delaware. See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 763
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`(Fed. Cir. 2016). On information and belief, if NDA No. 211530 is approved, the product
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`described in NDA No. 211530 would, among other things, be marketed, distributed, offered for
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`sale, and/or sold in Delaware, prescribed by physicians practicing in Delaware, dispensed by
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`pharmacies located within Delaware, and/or used by patients in Delaware, all of which would have
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`a substantial effect on Delaware.
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`12.
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`The Court also has personal jurisdiction over Hospira because it has committed,
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`aided, abetted, induced, contributed to, or participated in the commission of the tortious act of
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`patent infringement that has led and/or will lead to foreseeable harm and injury to Eagle and
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`Cephalon, both Delaware corporations.
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`13.
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`Hospira has previously submitted to the jurisdiction of this Court and has availed
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`itself of the legal protections of the State of Delaware by having filed suit in this jurisdiction. See,
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`e.g., Hospira, Inc. v. Gland Pharma Ltd., C.A. No. 18-00190-RGA, D.I. 1 (D. Del. Feb. 1, 2018);
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`Hospira, Inc. v. Jiangsu Hengrui Med., C.A. No. 18-00191-RGA, D.I. 1 (D. Del. Feb. 1, 2018);
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`Hospira, Inc. v. Par Sterile Prods., LLC, C.A. No. 16-00879-RGA, D.I. 1 (D. Del. Sep. 29, 2016);
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`Hospira, Inc. v. Amneal Pharm. LLC, C.A. No. 15-00697-RGA, D.I. 1 (D. Del. Aug. 11, 2015);
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`Hospira, Inc. v. Ben Venue Labs. Inc., No. 14-01008-GMS, D.I. 1 (D. Del. Aug. 1, 2014); Hospira,
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`Inc. v. Aurobindo Pharma Ltd., No. 14-00486-GMS, D.I. 1 (D. Del. Apr. 18, 2014).
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`14.
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`Hospira has also previously consented to jurisdiction in Delaware in one or more
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`prior cases arising out of the filing of its ANDAs, NDAs, and BLAs, and it has filed counterclaims
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`in such cases, including in Plaintiffs’ pending suit against Hospira based on Hospira’s infringement
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`of other patents based on Hospira’s same filing of NDA No. 211530. See, e.g., Eagle Pharm., Inc.
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`v. Hospira, Inc., No. 18-01074-CFC, D.I. 39 (D. Del. Jan. 2, 2020); Par Pharm., Inc. v. Hospira,
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`Inc., No. 17-00944-JFB-SRF, D.I. 94 (D. Del. Sep. 5, 2018); Belcher Pharm., LLC v. Hospira,
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`Inc., No. 17-00775-LPS, D.I. 54 (D. Del. Dec. 15, 2017); Millennium Pharm., Inc. v. Hospira,
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`Inc., No. 16-00998-GMS, D.I. 9 (D. Del. Dec. 19, 2016); Amgen Inc. v. Hospira, Inc., No. 15-
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`00839-RGA, D.I. 76 (D. Del. Aug. 19, 2016); Helsinn Healthcare S.A. v. Hospira, Inc., No. 15-
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`00264, D.I. 7 (D. Del. Jun. 8, 2015); Cephalon Inc. v. Hospira Inc., No. 14-01242-GMS, D.I. 7
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`(D. Del. Oct. 20, 2014); Merck Sharp & Dohme Corp. v. Hospira, Inc., No. 14-00915-RGA, D.I.
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`4
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`9 (D. Del. Jul. 21, 2014); Aventis Pharma S.A. v. Hospira, Inc., No. 07-00721-GMS, D.I. 7 (D.
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`Del. Dec. 10, 2007).
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`15.
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`For at least the above reasons, it would not be unfair or unreasonable for Hospira
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`to litigate this action in this District, and there is personal jurisdiction over Hospira here.
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`BACKGROUND
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`16.
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`BENDEKA®, 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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`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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`17.
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`Eagle is the holder of New Drug Application No. 208194 for BENDEKA®, which
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`has been approved by the FDA.
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`18.
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`The ’483 patent, entitled “Formulations of Bendamustine” (Exhibit A hereto), was
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`duly and legally issued on August 31, 2021. Eagle Pharmaceuticals, Inc. is the owner and assignee
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`of the ’483 patent, and Cephalon is a licensee thereof. The ’483 patent is listed in the Orange Book
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`in connection with BENDEKA®.
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`19.
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`On or around February 13, 2015, Cephalon executed a license agreement (“the
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`Eagle license”) involving, inter alia, patent rights that include the ’483 patent, for the
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`commercialization of Eagle’s bendamustine hydrochloride rapid infusion product, EP-3102, which
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`became BENDEKA®.
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`20.
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`On or around October 14, 2015, Cephalon assigned its rights in the Eagle license
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`to Teva Pharmaceuticals.
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`5
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`INFRINGEMENT BY HOSPIRA
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`21.
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`By letter dated June 6, 2018 (the “Notice Letter”), Hospira notified Eagle and Teva
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`pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”) that Hospira had submitted to
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`the FDA NDA No. 211530, seeking approval from the FDA to engage in the commercial
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`manufacture, use, and/or sale of a liquid bendamustine hydrochloride drug product (“Hospira’s
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`NDA Product”) prior to the expiration of, inter alia, U.S. Patent Nos. 9,034,908 (“the ’908
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`patent”); 9,144,568 (“the ’568 patent”); 9,572,887 (“the ’887 patent”); 9,597,397 (“the ’397
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`patent”); 9,597,398 (“the ’398 patent”); 9,597,399 (“the ’399 patent”); 9,000,021 (“the ’021
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`patent”); and 9,579,384 (“the ’384 patent”) (“the Notice Letter Patents”), and therefore prior to the
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`expiration of the ’483 patent.
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`22.
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`The Notice Letter Patents are listed in the Orange Book for BENDEKA®. Plaintiffs
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`filed suit against Hospira for infringement of the Notice Letter Patents. That case remains pending
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`in this Court. See Eagle Pharm., Inc. v. Hospira, Inc., No. 18-01074-CFC, D.I. 1 (D. Del. Jul. 19,
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`2018).
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`23.
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`Upon information and belief, Hospira’s NDA Product received tentative approval
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`from the FDA on January 29, 2019.
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` See https://www.accessdata.fda.gov/drugsatfda_
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`docs/appletter/2019/211530Orig1s000TAltr.pdf (last visited November 15, 2021).
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`24.
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`Upon information and belief, Hospira’s NDA Product relies on data from
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`bioavailability and/or bioequivalence studies contained in the approved labeling for BENDEKA®
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`and contains the same or equivalent ingredients in the same or equivalent amounts as BENDEKA®
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`and/or as recited in the claims of the ’483 patent. BENDEKA® is approved for a 24-month shelf
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`life. Hospira’s Notice Letter does not identify any difference in stability between Hospira’s NDA
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`Product and BENDEKA® and, upon information and belief, Hospira’s NDA Product has the same
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`or substantially similar stability as BENDEKA® and/or as recited in the claims of the ’483 patent.
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`25.
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`On information and belief, the purpose of Hospira’s submission of NDA No.
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`211530 was to obtain approval under the FDCA to engage in the commercial manufacture, use,
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`offer for sale, sale, and/or importation of Hospira’s NDA Product prior to the expiration of the
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`’483 patent.
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`26.
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`In the Notice Letter, Hospira stated that the active ingredient of Hospira’s NDA
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`Product is bendamustine hydrochloride. See also Eagle Pharm., Inc. v. Hospira, Inc., No. 18-
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`01074-CFC, D.I. 20 at 6 (D. Del. Sept. 7, 2018).
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`27.
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`In the Notice Letter, Hospira stated that the proposed dosage strength of Hospira’s
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`NDA Product is 25 mg/mL. See also id.
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`28.
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`Upon information and belief, Hospira’s NDA Product contains polyethylene glycol
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`and a stabilizing amount of an antioxidant. See Notice Letter; Eagle Pharm., No. 18-01074-CFC,
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`D.I. 20 at 6 (D. Del. Sept. 7, 2018).
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`29.
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`Upon information and belief, Hospira’s NDA Product is a ready to use liquid
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`bendamustine-containing composition. See Notice Letter; Eagle Pharm., No. 18-01074-CFC, D.I.
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`20 at 6 (D. Del. Sept. 7, 2018).
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`30.
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`Upon information and belief, Hospira’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.
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`31.
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`Upon information and belief, the proposed labeling for Hospira’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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`COUNT I – INFRINGEMENT OF U.S. PATENT
`NO. 11,103,483 UNDER 35 U.S.C. § 271(e)(2)
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`Hospira’s submission of NDA No. 211530 for the purpose of obtaining approval to
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`32.
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`33.
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Hospira’s
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`NDA Product prior to the expiration of the ’483 patent, was an act of infringement of the ’483
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`patent under 35 U.S.C. § 271(e)(2)(A).
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`34.
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`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
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`distribution, and/or importation of Hospira’s NDA Product would infringe one or more claims of
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`the ’483 patent, including but not limited to claims 1 and 8, either literally and/or under the doctrine
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`of equivalents.
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`35.
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`Upon information and belief, Hospira will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of Hospira’s NDA Product with its proposed
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`labeling upon FDA approval of NDA No. 211530.
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`36.
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`Upon information and belief, the use of Hospira’s NDA Product in accordance with
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`and as directed by Hospira’s proposed labeling for that product would infringe one or more claims
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`of the ’483 patent, including but not limited to claims 1 and 8.
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`37.
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`Upon information and belief, Hospira plans and intends to, and will, actively induce
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`infringement of the ’483 patent when NDA No. 211530 is approved, and plans and intends to, and
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`will, do so after approval.
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`38.
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`Upon information and belief, Hospira will instruct, encourage, promote, and/or
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`recommend the administration of the Hospira NDA Product within the scope of one or more claims
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`of the ’483 patent, either literally or under the doctrine of equivalents. On information and belief,
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`Hospira will market its proposed products to hospitals, clinics, physicians, and other medical care
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`providers and will instruct, encourage, promote, and/or recommend the practice of each of the
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`steps of one or more claims of the ’483 patent, either literally or under the doctrine of equivalents.
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`39.
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`Upon information and belief, Hospira knows that its NDA Product and its proposed
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`labeling are especially made or adapted for use in infringing the ’483 patent, and that its NDA
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`Product and its proposed labeling are not suitable for substantial noninfringing use. Upon
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`information and belief, Hospira plans and intends to, and will, contribute to infringement of the
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`’483 patent after approval of NDA No. 211530.
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`40.
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`The foregoing actions by Hospira constitute and/or will constitute infringement of
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`the ’483 patent, active inducement of infringement of the ’483 patent, and contribution to the
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`infringement by others of the ’483 patent.
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`41.
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`Upon information and belief, Hospira has acted with full knowledge of the ’483
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`patent and/or the application leading to the ’483 patent, Application No. 16/509,920, and without
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`a reasonable basis for believing that it would not be liable for infringing the ’483 patent, actively
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`inducing infringement of the ’483 patent, and contributing to the infringement by others of the
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`’483 patent.
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`42.
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`Unless Hospira is enjoined from infringing the ’483 patent, actively inducing
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`infringement of the ’483 patent, and contributing to the infringement by others of the ’483 patent,
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`Eagle will suffer irreparable injury. Eagle has no adequate remedy at law.
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`COUNT II – DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 11,103,483
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`43.
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`44.
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`Upon information and belief, Hospira has knowledge of the ’483 patent and/or the
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`application leading to the ’483 patent, Application No. 16/509,920.
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`45.
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`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
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`distribution, and/or importation of Hospira’s NDA Product would infringe one or more claims of
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`the ’483 patent, including but not limited to claims 1 and 8, either literally or under the doctrine of
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`equivalents.
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`46.
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`Upon information and belief, Hospira will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of Hospira’s NDA Product with its proposed
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`labeling upon FDA approval of NDA No. 211530.
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`47.
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`Upon information and belief, the use of Hospira’s NDA Product in accordance with
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`and as directed by Hospira’s proposed labeling for that product would infringe one or more claims
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`of the ’483 patent, including but not limited to claims 1 and 8.
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`48.
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`Upon information and belief, Hospira plans and intends to, and will, actively induce
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`infringement of the ’483 patent when NDA No. 211530 is approved, and plans and intends to, and
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`will, do so after approval.
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`49.
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`Upon information and belief, Hospira knows that its NDA Product and its proposed
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`labeling are especially made or adapted for use in infringing the ’483 patent, and that its NDA
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`Product and its proposed labeling are not suitable for substantial noninfringing use. Upon
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`information and belief, Hospira plans and intends to, and will, contribute to infringement of the
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`’483 patent after approval of NDA No. 211530.
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`50.
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`The foregoing actions by Hospira constitute and/or will constitute infringement of
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`the ’483 patent, active inducement of infringement of the ’483 patent, and contribution to the
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`infringement by others of the ’483 patent.
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`51.
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`Upon information and belief, Hospira has acted without a reasonable basis for
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`believing that it would not be liable for infringing the ’483 patent, actively inducing infringement
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`of the ’483 patent, and contributing to the infringement by others of the ’483 patent.
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`52.
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`Accordingly, there is a real, substantial, and continuing case or controversy
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`between Plaintiffs and Hospira regarding whether Hospira’s manufacture, use, sale, offer for sale,
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`or importation into the United States of Hospira’s NDA Product with its proposed labeling
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`according to NDA No. 211530 will infringe one or more claims of the ’483 patent.
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`53.
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`Plaintiffs should be granted a declaratory judgment that the making, using, sale,
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`offer for sale, and importation into the United States of Hospira’s NDA Product with its proposed
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`labeling would infringe, actively induce the infringement of, and contribute to the infringement by
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`others of the ’483 patent.
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`54.
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`Hospira should be enjoined from infringing the ’483 patent, actively inducing
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`infringement of the ’483 patent, and contributing to the infringement by others of the ’483 patent;
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`otherwise Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
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`WHEREFORE, Plaintiffs request the following relief:
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`(a)
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`A judgment that Hospira has infringed, will infringe, and will induce and contribute
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`to infringement of the ’483 patent;
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`(b)
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`A judgment pursuant to, inter alia, 35 U.S.C. § 271(e)(4)(A) ordering that the
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`effective date of any FDA approval for Hospira to make, use, offer for sale, sell, market, distribute,
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`or import Hospira’s NDA Product, or any product or compound the making, using, offering for
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`sale, sale, marketing, distribution, or importation of which infringes the ’483 patent, be not earlier
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`than the expiration date of the ’483 patent, inclusive of any extension(s) and additional period(s)
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`of exclusivity;
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`(c)
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`A preliminary and permanent injunction pursuant to, inter alia, 35 U.S.C.
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`§ 271(e)(4)(B) and 35 U.S.C. § 283 enjoining Hospira, its officers, agents, servants, employees
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`and attorneys, and all persons acting in concert with them, from making, using, selling, offering
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`for sale, marketing, distributing, or importing Hospira’s NDA Product, or any product the making,
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`using, offering for sale, sale, marketing, distribution, or importation of which infringes the ’483
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`patent, or the inducement of or the contribution to any of the foregoing, prior to the expiration date
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`of the ’483 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
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`(d)
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`A judgment declaring that making, using, selling, offering for sale, marketing,
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`distributing, or importing Hospira’s NDA Product, or any product or compound the making, using,
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`offering for sale, sale, marketing, distribution, or importation of which infringes the ’483 patent,
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`prior to the expiration date of the ’483 patent, respectively, will infringe, actively induce
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`infringement of, and/or contribute to the infringement by others of the ’483 patent;
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`(e)
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`An award of Plaintiffs’ damages or other monetary relief to compensate Plaintiffs
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`if Hospira engages in the manufacture, use, offer for sale, sale, marketing, distribution, or
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`importation of Hospira’s NDA Product, or any product the making, using, offering for sale, sale,
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`marketing, distribution, or importation of which infringes the ’483 patent, or the inducement of or
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`the contribution to any of the foregoing, prior to the expiration date of the ’483 patent, inclusive
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`of any extension(s) and additional period(s) of exclusivity, in accordance with 35 U.S.C.
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`§ 271(e)(4)(C);
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`(f)
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`A declaration that this case against Hospira is an exceptional case and an award of
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`attorneys’ fees pursuant to 35 U.S.C. § 285;
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`12
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`Case 1:21-cv-01619-UNA Document 1 Filed 11/16/21 Page 13 of 13 PageID #: 13
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`(g)
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`(h)
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`An award of Plaintiffs’ costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`/s/ Karen E. Keller
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`Attorneys for Plaintiffs
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`OF COUNSEL:
`Daniel G. Brown
`LATHAM & WATKINS LLP
`1271 Avenue of the Americas
`New York, NY 10020
`(212) 906-1200
`
`Kenneth G. Schuler
`Marc N. Zubick
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`(312) 876-7700
`Attorneys for Eagle Pharmaceuticals, Inc.
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`David I. Berl
`Adam D. Harber
`Elise M. Baumgarten
`Shaun P. Mahaffy
`Ben Picozzi
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`Attorneys for Teva Pharmaceuticals
`International GmbH and Cephalon, Inc.
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`Dated: November 16, 2021
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`13
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