`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`HOSPIRA, INC.,
`
`
`
`
`
`AMNEAL PHARMACEUTICALS LLC,
`
`
`
`
`
`v.
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`
`
`
`
`
`
`Plaintiff,
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 15-697-RGA
`
`
`JOINT STIPULATION TO DISSOLVE INJUNCTION IF THE MANDATE ISSUES ON
`THE FEDERAL CIRCUIT’S INVALIDATION OF THE ASSERTED CLAIM
`
`
`
`
`1.
`
`For the reasons stated below, the parties Hospira, Inc. (“Hospira”) and Amneal
`
`Pharmaceuticals LLC (“Amneal”), hereby stipulate to dissolution of the Court’s injunction of
`
`February 6, 2018, if the mandate issues in the Federal Circuit invalidating the underlying patent
`
`claim. (See D.I. 121, Feb. 6, 2018).
`
`2.
`
`The Court’s February 6, 2018 Order enjoined Amneal from certain activities based
`
`on the Court’s judgment in favor of Hospira on Amneal’s infringement of claim 6 of U.S. Patent
`
`No. 8,648,106 (“the ’106 patent”). (Id.) The Federal Circuit affirmed that ruling. Hospira Inc. v.
`
`Amneal Pharmaceuticals LLC, No. 18-1552 (Fed. Cir. Jan. 22, 2019).
`
`3.
`
`Specifically, this Court ordered:
`
`That judgment be and is hereby entered in favor of Hospira that Amneal infringes claim 6
`of the '106 patent;
`
`That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval by the U.S.
`Food and Drug Administration ("FDA") of Amneal' s ANDA No. 207551 shall be not
`earlier than the expiration of the '106 patent on July 4, 2032, as extended by pediatric
`exclusivity; and
`
`That, pursuant to 35 U.S.C. §§ 271(e)(4)(B), Amneal and each of its officers, agents, or
`other entities in active concert with Amneal are permanently enjoined until the expiration
`of the '106 patent, as extended by pediatric exclusivity, on July 4, 2032, from engaging in
`
`
`
`
`
`
`Case 1:15-cv-00697-RGA Document 133 Filed 02/04/20 Page 2 of 3 PageID #: 2935
`
`the commercial manufacture, use, offer to sell, or sale within the United States, or
`importation into the United States, of the products that are the subject of ANDA No.
`207551.
`
`(D.I. 121 at 2.)
`
`
`4.
`
`However, the Federal Circuit recently issued an opinion stating that the invalidity
`
`of claim 6 of the ’106 patent, stemming from a later Northern District of Illinois case, should be
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`affirmed. Hospira Inc. v. Fresenius Kabi USA, LLC, Fed. Cir. 2019-1329, 2019-1367, decided
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`Jan. 9, 2020 (“the Fresenius appeal.”) A copy of that opinion is Exhibit A hereto.
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`5.
`
`The mandate for the Fresenius appeal has not yet been issued to the District Court
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`for the Northern District of Illinois, and Hospira has the right to petition the Federal Circuit for
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`panel rehearing or rehearing en banc.
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`6.
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`If the Federal Circuit denies any rehearing petition, or if Hospira decides not to
`
`petition for rehearing, the mandate on that decision is expected to issue in due course, in mid-
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`February 2020.
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`7.
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`If Hospira moves for rehearing and that request is granted, the parties cannot
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`predict when or if a mandate will issue on the invalidity of the claim 6 of the ‘106 patent.
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`8.
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`Amneal seeks from this Court an order that calls for the automatic dissolution of
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`the injunction as of and when such a mandate issues.
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`9.
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` Additionally, Hospira does not oppose dissolution of the injunction if the mandate
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`issues on the Federal Circuit’s January 9, 2020 decision affirming invalidity (attached as Exhibit
`
`A).
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`10.
`
`Therefore, the parties stipulate to and request an order dissolving the above-quoted
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`injunctive provisions of the Court’s Order (D.I. 121 at 2), to take effect upon entry of a formal
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`mandate arising from the Federal Circuit’s affirmance of invalidity of claim 6 of the ‘106 patent.
`
`
`
`2
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`
`
`Case 1:15-cv-00697-RGA Document 133 Filed 02/04/20 Page 3 of 3 PageID #: 2936
`
`
`
`
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`
`
`
`
` /s/ Kelly E. Farnan
`Frederick L. Cottrell, III (#2555)
`Kelly E. Farnan (#4395)
`Christine D. Haynes (#4697)
`Richards, Layton & Finger, P.A.
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`farnan@rlf.com
`haynes@rlf.com
`
`Attorneys for Defendant-Counterclaim
`Plaintiff Amneal Pharmaceuticals LLC
`
`
`OF COUNSEL:
`
`Steven A. Maddox
`Jeremy J. Edwards
`Matthew C. Ruedy
`Kaveh V. Saba
`Maddox Edwards PLLC
`1900 K Street N.W., Suite 725
`Washington, D.C. 20006
`(202) 830-0707
`smaddox@meiplaw.com
`jedwards@meiplaw.com
`mruedy@meiplaw.com
`ksaba@meiplaw.com
`
` A
`
`
`
` proposed order is submitted herewith.
`
`
`
`/s/ Arthur G. Connolly, III
`
`Arthur G. Connolly, III (#2667)
`Ryan P. Newell (#4744)
`Connolly Gallagher LLP
`1201 North Market Street, 20th Floor
`Wilmington, DE 19801
`(302)757-7300
`aconnolly@connollygallagher.com
`rnewell@connollygallagher.com
`
`Attorneys for Plaintiff-Counterclaim
`Defendant Hospira, Inc.
`
`
`
`
`OF COUNSEL:
`
`Sara T. Horton
`Yusuf Esat
`Jenner & Block LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`(312) 222-9350
`shorton@jenner.com
`yesat@jenner.com
`
`
`Dated: February 4, 2020
`
`
`
`3
`
`
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