Case: 1:16-cv-00651 Document #: 72-1 Filed: 12/04/17 Page 1 of 7 PageID #:2394
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`Exhibit 1
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`Exhibit 1
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`Case: 1:17-cv-07903 Document #: 1 Filed: 11/01/17 Page 1 of 6 PageID #:1Case: 1:16-cv-00651 Document #: 72-1 Filed: 12/04/17 Page 2 of 7 PageID #:2395
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`HOSPIRA, INC.,
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`FRESENIUS KABI USA, LLC
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`v.
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`Plaintiff,
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`Defendant.
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`Civil Action No. 17-cv-7903
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`Plaintiff Hospira, Inc. (“Hospira”), for its Complaint against Defendant Fresenius Kabi
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`COMPLAINT
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`USA, LLC (“Defendant”), hereby alleges as follows:
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`PARTIES
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`1.
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`Hospira is a Delaware corporation with its principal place of business at
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`275 North Field Drive, Lake Forest, Illinois 60045.
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`2.
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`On information and belief, Defendant is a Delaware limited liability
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`company with its principal place of business at Three Corporate Drive, Lake Zurich, IL 60047.
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`NATURE OF THE ACTION
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`3.
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`This is a civil action for infringement of U.S. Patent No. 9,616,049 (the
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`“’049 patent”) (Ex. A) (the “Patent-in-suit”).
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`4.
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`This action is based upon the Patent Laws of the United States, 35 U.S.C.
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`§ 1 et seq. and arises out of the Defendant’s filing of Abbreviated New Drug Application
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`(“ANDA”) No. 208129 seeking approval to market dexmedetomidine hydrochloride products
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`(“Proposed Fresenius Dexmedetomidine Products”) prior to the expiration of the Patent-in-suit,
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`Case: 1:17-cv-07903 Document #: 1 Filed: 11/01/17 Page 2 of 6 PageID #:2Case: 1:16-cv-00651 Document #: 72-1 Filed: 12/04/17 Page 3 of 7 PageID #:2396
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`which is assigned to Hospira and listed in the publication entitled Approved Drug Products with
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`Therapeutic Equivalents (the “Orange Book”) as covering PRECEDEXTM.
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`JURISDICTION AND VENUE
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`5.
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`This action arises under the Patent Laws of the United States, 35 U.S.C. §
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`1 et seq.
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`and 1338(a).
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`6.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
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`7.
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`Defendant is subject to personal jurisdiction in this District by virtue of,
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`inter alia, its residence and conduct of business in this District. On information and belief,
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`Defendant’s principal place of business is located in this District at Three Corporate Drive, Lake
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`Zurich, IL 60047. On information and belief, among Defendant’s operations located in this
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`District are its Corporate Headquarters, a Science, Production and Technology Center, a
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`Manufacturing facility, and a Distribution Center. On information and belief, Defendant
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`develops, formulates, manufactures, markets, and sells drug products throughout the United
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`States, including Illinois, and Illinois is a likely destination of Defendant’s products. On
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`information and belief, Defendant has purposely availed itself of the rights and benefits of the
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`laws of the State of Illinois, and has engaged in substantial and continuous contacts with the
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`State of Illinois. Defendant has a registered agent for service in the State of Illinois. Moreover,
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`there is existing litigation between Defendant and Hospira related to patents covering certain
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`dexmedetomidine hydrochloride products in this District.
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`8.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and
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`1400(b).
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`2
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`Case: 1:17-cv-07903 Document #: 1 Filed: 11/01/17 Page 3 of 6 PageID #:3Case: 1:16-cv-00651 Document #: 72-1 Filed: 12/04/17 Page 4 of 7 PageID #:2397
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`THE PATENT-IN-SUIT
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`9.
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`The ’049 patent, entitled “Dexmedetomidine Premix Formulation,” was
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`duly and legally issued by the USPTO on April 11, 2017. Hospira is the assignee and owner of
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`the ’049 patent.
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`10.
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`The Patent-in-suit is duly listed in the Orange Book as covering
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`PRECEDEXTM. The claims of the Patent-in-suit cover various presentations of PRECEDEXTM.
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`11.
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`Hospira is the holder of New Drug Application (“NDA”) No. 21-038 for
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`dexmedetomidine hydrochloride injection, sold in the United States under the trademark
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`PRECEDEXTM. The United States Food and Drug Administration (“FDA”) originally approved
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`NDA No. 21-038 on December 17, 1999. On March 13, 2013 and November 14, 2014, the FDA
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`approved amendments to Hospira’s NDA No. 21-038 for a premix formulation of
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`PRECEDEXTM.
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`ACTS GIVING RISE TO THIS ACTION
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`12.
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`On October 10, 2017, Hospira received a letter dated October 9, 2017,
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`from Defendant (“the Notice Letter”), notifying Hospira that Defendant had previously filed
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`ANDA No. 208129 with the FDA under 21 U.S.C. § 355(j) (i.e., section 505(j) of the Federal
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`Food, Drug, and Cosmetic Act (“FDCA”)), seeking approval to market the Proposed Fresenius
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`Dexmedetomidine Products prior to the expiry of the Patent-in-suit.
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`13.
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`The stated purpose of the Notice Letter was to notify Hospira that ANDA
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`No. 208129 included a certification under 21 U.S.C. § 355(j)(2)(a)(vii)(IV) (“Paragraph IV
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`Certification”) that the claims of the ’049 patent are invalid.
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`14.
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`Included in the Notice Letter was a description of the Proposed Fresenius
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`Dexmedetomidine Products as well as a “detailed statement” of the alleged factual and legal
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`3
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`basis for Defendant’s Paragraph IV Certification. The sole basis set forth in the detailed
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`statement for Defendant’s Paragraph IV Certification is alleged invalidity.
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`15.
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`The Proposed Fresenius Dexmedetomidine Products meet each limitation
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`of at least one claim of the ’049 patent.
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`16.
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`On information and belief, Defendant was aware of Hospira’s patents
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`related to dexmedetomidine products when it filed ANDA No. 208129. Defendant was further
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`aware of the ’049 patent when it submitted its updated Paragraph IV Certification.
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`COUNT I FOR INFRINGEMENT OF PATENT NO. 9,616,049
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`17.
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`18.
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`Paragraphs 1 through 18 are incorporated herein as set forth above.
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`Defendant submitted ANDA No. 208129 with a Paragraph IV
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`Certification to the FDA under section 505(j) of the FDCA to obtain approval to engage in the
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`commercial manufacture, use, sale, offer for sale, and/or importation into the United States of the
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`Proposed Fresenius Dexmedetomidine Products prior to the expiration of the ’049 patent.
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`Defendant committed an act of infringement under 35 U.S.C. § 271(e)(2).
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`19. Moreover, any commercial manufacture, use, sale, offer for sale, and/or
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`importation into the United States of the Proposed Fresenius Dexmedetomidine Products
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`described in ANDA No. 208129 would infringe the ’049 patent under 35 U.S.C. § 271(a), (b),
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`and/or (c). The Notice Letter does not allege non-infringement of any claim of the ’049 patent.
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`The Proposed Fresenius Dexmedetomidine Products, according to the Notice Letter, meet each
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`limitation of at least one claim of the ’049 patent.
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`20.
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`In addition, Defendant’s actions and conduct, including providing
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`information and instructions for use of its products in the proposed package insert to accompany
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`the products, will also encourage direct infringement of the ’049 patent by others.
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`4
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`21.
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`Defendant was aware of the existence of the Hospira patents related to
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`dexmedetomidine products prior to the filing of ANDA No. 208129, and provided Hospira with
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`Defendant’s Paragraph IV Certification knowing it would constitute infringement of the ’049
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`patent.
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`22.
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`Hospira will be irreparably harmed if Defendant is not enjoined from
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`infringing the ’049 patent.
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`WHEREFORE, Plaintiff prays for judgment as follows:
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`PRAYER FOR RELIEF
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`A.
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`An order decreeing that the submission to the FDA of ANDA No. 208129
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`with a Paragraph IV Certification was an act of infringement by Defendant;
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`B.
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`An order decreeing that Defendant’s commercial manufacture, use, sale,
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`offer for sale, and/or importation into the United States of the Proposed Fresenius
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`Dexmedetomidine Products prior to the expiration of the ’049 patent, including any regulatory
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`extensions, will infringe, directly and/or indirectly, the ’049 patent;
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`C.
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`An order pursuant to 35 U.S.C. 271(e)(4) that the effective date of any
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`approval of ANDA No. 208129 shall be no earlier than the expiration date of the Patent-in-suit,
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`including any applicable extensions;
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`D.
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`A preliminary and permanent injunction pursuant to 35 U.S.C. § 271(e)(4)
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`restraining and enjoining Defendant, its officers, agents, attorneys, and employees, and those
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`acting in privity or concert with it, from engaging in the commercial manufacture, use, offer for
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`sale, sale, and/or importation into the United States of the Proposed Fresenius Dexmedetomidine
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`Products described in ANDA No. 208129, or any other ANDA not colorably different from
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`ANDA No. 208129, until the expiration of the Patent-in-suit, including any applicable
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`extensions;
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`5
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`Case: 1:17-cv-07903 Document #: 1 Filed: 11/01/17 Page 6 of 6 PageID #:6Case: 1:16-cv-00651 Document #: 72-1 Filed: 12/04/17 Page 7 of 7 PageID #:2400
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`E.
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`A declaration that this case is exceptional and an award of attorneys’ fees
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`under 35 U.S.C. § 285;
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`F.
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`G.
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`Costs and expenses in this action; and
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`Such other and further relief as the Court may deem just and proper.
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`Dated: November 1, 2017
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`Respectfully Submitted,
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`HOSPIRA, INC.
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`By: /s/ Bradford P. Lyerla_____
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`Bradford P. Lyerla
`Sara T. Horton
`Yusuf Esat
`Chad J Ray
`JENNER & BLOCK LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`Telephone: 312 222-9350
`Facsimile: 312 527-0484
`blyerla@jenner.com
`shorton@jenner.com
`yesat@jenner.com
`cray@jenner.com
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`Attorneys for Plaintiff Hospira, Inc.
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`6
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