Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 1 of 9 PageID #: 1
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 1 of 9 Page|D #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`v.
`
`Civil Action No. _
`
`AMNEAL PHARMACEUTICALS LLC
`
`Defendant.
`
`COMPLAINT
`
`Plaintiff Hospira, Inc. (“Hospira”), for its Complaint against Defendant Amneal
`
`Pharmaceuticals LLC (“Defendant”), hereby alleges as follows:
`
`PARTIES
`
`1.
`
`Hospira is a Delaware corporation with its principal place of business at
`
`275 North Field Drive, Lake Forest, Illinois 60045.
`
`2.
`
`On information and belief, Defendant is a corporation organized and
`
`existing under the laws of the State of Delaware with its principal place of business at 400
`
`Crossing Boulevard, Third Floor, Bridgewater, New Jersey 08807.
`
`NATURE OF THE ACTION
`
`3.
`
`This is a civil action for infringement of U.S. Patent Nos. 8,242,158 (the
`
`“‘158 patent”) (D.I. 1, Ex. A); 8,338,470 (the ‘“470 patent”) (D.I. 1, Ex. B); 8,455,527 (the ‘“527
`
`patent”) (D.I. 1, Ex. C); and 8,648,106 (the “‘ 106 patent”) (D.I. 1, Ex. D) (collectively, the
`
`“Patents—in—suit”).
`
`4.
`
`This action is based upon the Patent Laws of the United States, 35 U.S.C.
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 2 of 9 PageID #: 2
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 2 of 9 Page|D #: 2
`
`(“ANDA”) No. 207551 seeking approval to market a dexmedetomidine hydrochloride product
`
`(“Proposed Amneal Dexmedetomidine Product”) prior to the expiration of the Patents-in-suit,
`
`which are assigned to Hospira and listed in the publication entitled Approved Drug Products with
`
`Therapeutic Equivalents (the “Orange Book”) as covering PRECEDEXTM.
`
`JURISDICTION AND VENUE
`
`5.
`
`This action arises under the Patent Laws of the United States, 35 U.S.C. §
`
`1 et seq.
`
`and 1338(a).
`
`6.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
`
`7.
`
`Defendant is subject to personal jurisdiction in this District by virtue of,
`
`inter alia, its incorporation under the laws of the State of Delaware, and its conduct of business
`
`in this District. On information and belief, Defendant develops, formulates, manufactures,
`
`markets, and sells drug products throughout the United States, including Delaware, and
`
`Delaware is a likely destination of Defendant’s products. On information and belief, Defendant
`
`has purposely availed itself of the rights and benefits of the laws of the State of Delaware, and
`
`has engaged in substantial and continuous contacts with the State of Delaware.
`
`8.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and
`
`l400(b).
`
`THE PATENTS-IN~S [HT
`
`9.
`
`The ‘158 patent, entitled “Dexmedetomidine Premix Formulation,” was
`
`duly and legally issued by the USPTO on August 14, 2012. Hospira is the assignee and owner of
`
`the ‘158 patent.
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 3 of 9 PageID #: 3
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 3 of 9 Page|D #: 3
`
`10.
`
`The ‘470 patent, entitled “Dexmedetomidine Premix Formulation,” was
`
`duly and legally issued by the USPTO on December 25, 2012. Hospira is the assignee and
`
`owner of the ‘470 patent.
`
`11.
`
`The ‘527 patent, entitled “Methods of Treatment using a
`
`Dexmedetomidine Premix Formulation,” was duly and legally issued by the USPTO on June 4,
`
`2013. Hospira is the assignee and owner of the ‘527 patent.
`
`12.
`
`The ‘ 106 patent, entitled “Dexmedetomidine Premix Formulation,” was
`
`duly and legally issued by the USPTO on February 11, 2014. Hospira is the assignee and owner
`
`of the ‘106 patent.
`
`13.
`
`The Patents-in-suit are duly listed in the Orange Book as covering
`
`PRECEDEXTM. The claims of the Patents-in-suit cover various presentations of PRECEDEXTM
`
`and methods of using PRECEDEXTM.
`
`14.
`
`Hospira is the holder of New Drug Application (“NDA”) No. 21-038 for
`
`dexmedetomidine hydrochloride injection, sold in the United States under the trademark
`
`PRECEDEXTM. The United States Food and Drug Administration (“FDA”) originally approved
`
`NDA No. 21-038 on December 17, 1999. On March 13, 2013 and November 14, 2014, the FDA
`
`approved amendments to Hospira’s NDA No. 21-038 for an alternate premix formulation of
`
`PRECEDEXTM.
`
`ACTS GIVING RISE TO THIS ACTION
`
`15.
`
`On information and belief, Defendant reviewed the Patents-in-suit and
`
`certain commercial and economic information regarding Hospira’s PRECEDEXTM and decided
`
`to file an ANDA seeking approval to market the Proposed Amneal Dexmedetomidine Product.
`
`16.
`
`On June 30, 2015, Hospira received a letter dated June 26, 2015, from
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 4 of 9 PageID #: 4
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 4 of 9 Page|D #: 4
`
`21 U.S.C. § 3550) (i.e. section 5050) of the Federal Food, Drug, and Cosmetic Act (“FDCA’°)),
`
`seeking approval to market the Proposed Amneal Dexmedetomidine Product prior to the expiry
`
`of the Patents-in-suit.
`
`17.
`
`The stated purpose of the letter was to notify Hospira that ANDA No.
`
`207551 included a certification under 21 U.S.C. § 355(j)(2)(a)(vii)(IV) (“Paragraph IV
`
`Certification”) that the claims of the ‘158 patent, the ‘470 patent, the ‘527 patent, and the ‘106
`
`patent are invalid and/or will not be infringed by Defendant.
`
`18.
`
`Included in the June 26, 2015 letter was a “detailed statement” of the
`
`factual and legal basis for Defendant’s Paragraph IV Certification.
`
`19.
`
`On information and belief, Defendant was aware of the Patents-in-suit
`
`when it filed ANDA No. 207551 with a Paragraph IV Certification.
`
`20.
`
`Hospira received the June 26, 2015, letter on June 30, 2015. Hospira
`
`commenced this action within 45 days of receipt of the letter.
`
`COUNT I FOR INFRINGEMENT OF PATENT NO. 8,242,158
`
`21.
`
`22.
`
`Paragraphs 1 through 20 are incorporated herein as set forth above.
`
`Defendant submitted ANDA No. 207551 with a Paragraph IV
`
`Certification to the FDA under section 5050) of the FDCA to obtain approval to engage in the
`
`commercial manufacture, use, sale, offer for sale, and/or importation into the United States of the
`
`Proposed Amneal Dexmedetomidine Product prior to the expiration of the ‘158 patent. By
`
`submitting this ANDA, Defendant committed an act of infringement under 35 U.S.C. §
`
`271(e)(2).
`
`23.
`
`Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`
`importation into the United States of the Proposed Amneal Dexmedetomidine Product described
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 5 of 9 PageID #: 5
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 5 of 9 Page|D #: 5
`
`in ANDA No. 207551 by Defendant would infringe the ‘l58 patent under 35 U.S.C. § 27l(a),
`
`(b), and/or (c).
`
`24.
`
`Defendant’s actions and conduct will encourage direct infringement of the
`
`‘ISS patent by others.
`
`25.
`
`Defendant was aware of the existence of the ‘l58 patent prior to the filing
`
`of ANDA No. 207551, and took such action knowing it would constitute infringement of the
`
`‘ 15 8 patent.
`
`26.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from
`
`infringing the ‘158 patent.
`
`COUNT II FOR INFRINGEMENT OF PATENT NO. 8,338,470
`
`27.
`
`Paragraphs 1 through 20 are incorporated herein as set forth above.
`
`28.
`
`Defendant submitted ANDA No. 207551 with a Paragraph IV
`
`Certification to the FDA under section 5050) of the FDCA to obtain approval to engage in the
`
`commercial manufacture, use, sale, offer for sale, and/or importation into the United States of the
`
`Proposed Amneal Dexmedetomidine Product prior to the expiration of the ’470 patent. By
`
`submitting this ANDA, Defendant committed an act of infringement under 35 U.S.C. §
`
`27l(e)(2).
`
`29.
`
`Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`
`importation into the United States of the Proposed Amneal Dexmedetomidine Product described
`
`in ANDA No. 207551 by Defendant would infringe the ‘470 patent under 35 U.S.C. § 27l(a),
`
`(b), and/or (c).
`
`30.
`
`Defendant’s actions and conduct will encourage direct infringement of the
`
`‘470 patent by others.
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 6 of 9 PageID #: 6
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 6 of 9 Page|D #: 6
`
`31.
`
`Defendant was aware of the existence of the ‘470 patent prior to the filing
`
`of ANDA No. 207551, and took such action knowing it would constitute infringement of the
`
`‘470 patent.
`
`32.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from
`
`infringing the ‘470 patent.
`
`COUNT III FOR INFRINGEMENT OF PATENT NO. 8,455,527
`
`33.
`
`Paragraphs 1 through 20 are incorporated herein as set forth above.
`
`34.
`
`Defendant submitted ANDA No. 207551 with a Paragraph IV
`
`Certification to the FDA under section 505(j) of the FDCA to obtain approval to engage in the
`
`commercial manufacture, use, sale, offer for sale, and/or importation into the United States of the
`
`Proposed Amneal Dexmedetomidine Product prior to the expiration of the ‘527 patent. By
`
`submitting this ANDA, Defendant committed an act of infringement under 35 U.S.C. §
`
`27l(e)(2).
`
`35.
`
`Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`
`importation into the United States of the Proposed Amneal Dexmedetomidine Product described
`
`in ANDA No. 207551 by Defendant would infringe the ‘527 patent under 35 U.S.C. § 27l(a),
`
`(b), and/or (c).
`
`36.
`
`Defendant’s actions and conduct will encourage direct infringement of the
`
`‘527 patent by others.
`
`37.
`
`Defendant was aware of the existence of the ‘527 patent prior to the filing
`
`of ANDA No. 207551, and took such action knowing it would constitute infringement of the
`
`‘527 patent.
`
`38.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 7 of 9 PageID #: 7
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 7 of 9 Page|D #: 7
`
`COUNT IV FOR lNl'+‘Rl'NGEMENT OF PATENT NO. 8,648,106
`
`39.
`
`Paragraphs 1 through 20 are incorporated herein as set forth above.
`
`40.
`
`Defendant submitted ANDA No. 207551 with a Paragraph IV
`
`Certification to the FDA under section 5050) of the FDCA to obtain approval to engage in the
`
`commercial manufacture, use, sale, offer for sale, and/or importation into the United States of the
`
`Proposed Amneal Dexmedetomidine Product prior to the expiration of the ‘l06 patent. By
`
`submitting this ANDA, Defendant committed an act of infringement under 35 U.S.C. §
`
`27l(e)(2).
`
`41.
`
`Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`
`importation into the United States of the Proposed Amneal Dexmedetomidine Product described
`
`in ANDA No. 207551 by Defendant would infringe the ‘106 patent under 35 U.S.C. § 27l(a),
`
`(b), and/or (c).
`
`42.
`
`Defendant’s actions and conduct will encourage direct infringement of the
`
`‘l06 patent by others.
`
`43.
`
`Defendant was aware of the existence of the ‘106 patent prior to the filing
`
`of ANDA No. 207551, and took such action knowing it would constitute infringement of the
`
`‘I06 patent.
`
`44.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from
`
`infringing the ‘I06 patent.
`
`WHEREFORE, Plaintiff prays for judgment as follows:
`
`PRAYER FOR RELIEF
`
`A.
`
`An order decreeing that the submission to the FDA of ANDA No. 207551
`
`with a Paragraph IV Certification was an act of infringement by Defendant;
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 8 of 9 PageID #: 8
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 8 of 9 Page|D #: 8
`
`B.
`
`An order decreeing that Defendant’s commercial manufacture, use, sale,
`
`offer for sale, and/or importation into the United States of the Proposed Amneal
`
`Dexmedetomidine Product prior to the expiration of the ‘158 patent, including any regulatory
`
`extensions, will infringe, directly and/or indirectly, the ‘I58 patent;
`
`C.
`
`An order decreeing that Defendant’s commercial manufacture, use, sale,
`
`offer for sale, and/or importation into the United States of the Proposed Amneal
`
`Dexmedetomidine Product prior to the expiration of the ‘470 patent, including any regulatory
`
`extensions, will infringe, directly and/or indirectly, the ‘470 patent;
`
`D.
`
`An order decreeing that Defendant’s commercial manufacture, use, sale,
`
`offer for sale, and/or importation into the United States of the Proposed Amneal
`
`Dexmedetomidine Product prior to the expiration of the ‘527 patent, including any regulatory
`
`extensions, will infringe, directly and/or indirectly, the ‘527 patent;
`
`E.
`
`An order decreeing that Defendant’s commercial manufacture, use, sale,
`
`offer for sale, and/or importation into the United States of the Proposed Amneal
`
`Dexmedetomidine Product prior to the expiration of the ‘I06 patent, including any regulatory
`
`extensions, will infringe, directly and/or indirectly, the ‘106 patent;
`
`F.
`
`An order pursuant to 21 U.S.C. § 355(c)(3)(C) that the effective date of
`
`any approval of ANDA No. 207551 shall be no earlier than thirty months after the date on which
`
`Hospira received the June 26, 2015, letter, and, if the Court rules that the Proposed Amneal
`
`Dexmedetomidine Product infringes any Patent-in-suit, shall be no earlier than the expiration
`
`date of the infringed Patent(s)-in-suit, including any applicable extensions;
`
`G.
`
`A preliminary and permanent injunction pursuant to 35 U.S.C. § 27l(e)(4)
`
`restraining and enjoining Defendant, its officers, agents, attorneys, and employees, and those
`
`

`
`Case 1:15-cv-00697-RGA Document 1 Filed 08/11/15 Page 9 of 9 PageID #: 9
`
`Case 1:15—cv—OO697—RGA Document 1 Filed 08/11/15 Page 9 of 9 Page|D #: 9
`
`acting in privity or concert with it, from engaging in the commercial manufacture, use, offer for
`
`sale, sale, and/or importation into the United States of the generic dexmedetomidine
`
`hydrochloride product described in ANDA No. 207551, or any other ANDA not colorably
`
`different from ANDA No. 207551, until the expiration of the Patents-in-suit, including any
`
`applicable extensions;
`
`H.
`
`A declaration that this case is exceptional and an award of attorneys’ fees
`
`under 35 U.S.C. § 285;
`
`I.
`
`J.
`
`Costs and expenses in this action; and
`
`Such other and further relief as the Court may deem just and proper.
`
`Dated: August 10, 2015
`
`Respectfully Submitted,
`
`HOSPIRA, INC.
`
`By:
`
`/s/ Arthur G. Connolly III
`
`CONNOLLY GALLAGHER LLP
`
`Arthur G. Connolly III (# 2667)
`Ryan P. Newell (# 4744)
`The Brandywine Building
`1000 West Street, Suite 1400
`Wilmington, Delaware 19801
`Telephone: (302) 757-7300
`
`Bradford P. Lyerla
`Sara T. Horton
`
`Yusuf Esat
`
`J ENNER & 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
`
`Attorneys for Plaz'ntzflHospz'ra, Inc.