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Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`COMPLAINT
`
`
`
`
`
`
`
`
`
`
`
`C.A. No.
`
`
`
`Defendant.
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`Plaintiffs Pfizer Inc., Wyeth LLC, Pfizer Pharmaceuticals LLC, PF PRISM
`
`C.V.andPfizer Manufacturing Holdings LLC, (collectively, “Pfizer”), by their attorneys, hereby
`
`allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of the submission by defendant CFT
`
`Pharmaceuticals LLC (hereinafter “CFT”) of an Abbreviated New Drug Application (“ANDA”)
`
`No. 205722 to the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture
`
`and sell a generic version of Pfizer’s TYGACIL® tigecycline injectable IV infusion,
`
`(“TYGACIL®”) prior to the expiration of U.S. Patent No. 7,879,828 (“the ’828 patent”), and
`
`U.S. Patent No. 8,372,995 (“the ’995 patent”).
`
`PFIZER INC., WYETH LLC, PFIZER
`PHARMACEUTICALS LLC, PF PRISM
`C.V. and PFIZER MANUFACTURING
`HOLDINGS LLC,
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`CFT PHARMACEUTICALS LLC,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 2 of 13 PageID #: 2
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`PARTIES
`
`2.
`
`Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of
`
`Delaware and having a place of business at 235 East 42nd Street, New York, New York 10017.
`
`3.
`
`Plaintiff Wyeth LLC is a limited liability company organized and existing under
`
`the laws of Delaware and having a place of business at 235 East 42nd Street, New York, New
`
`York 10017. Wyeth LLC’s sole member is Pfizer Inc.
`
`4.
`
`Plaintiff Pfizer Pharmaceuticals LLC is a limited liability company organized and
`
`existing under the laws of Delaware and having a place of business at Bo. Carmelitas, Road 689,
`
`Km 1.9, Vega Baja, Puerto Rico 00693. Pfizer Pharmaceuticals LLC is a wholly-owned
`
`subsidiary of PF PRISM C.V.
`
`5.
`
`Plaintiff PF PRISM C.V. is a limited partnership (commanditaire vennootschap)
`
`organized under the laws of the Netherlands, having its registered seat in Rotterdam, the
`
`Netherlands, and registered at the Trade Register held by the Chamber of Commerce in
`
`Rotterdam, the Netherlands, under number 51840456 and that for all purposes is represented by
`
`and acting through its general partner Pfizer Manufacturing Holdings LLC, a limited liability
`
`company organized under the laws of the State of Delaware, USA, and having its address at 235
`
`East 42nd Street, New York, New York 10017, registered in the register held by the Secretary of
`
`State of the State of Delaware under number 4869755. PF PRISM C.V. is the holder of New
`
`Drug Application No. 21821, which has been approved by the FDA.
`
`6.
`
`Plaintiff Pfizer Manufacturing Holdings LLC is a limited liability company
`
`organized and existing under the laws of Delaware and having a place of business at 235 East
`
`42nd Street, New York, New York 10017. Pfizer Manufacturing Holdings LLC is a general
`
`partner of PF PRISM C.V.
`
`2
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 3 of 13 PageID #: 3
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`7.
`
`Upon information and belief, defendant CFT Pharmaceuticals LLC is a limited
`
`liability company organized and existing under the laws of Wisconsin, with a place of business at
`
`10 E. Doty St., Suite 600, Madison, Wisconsin 53703.
`
`8.
`
`Pfizer offers for sale and sells a substantial amount of TYGACIL® within this
`
`District on an annualized basis. Upon information and belief, if approved, CFT will engage in
`
`the commercial manufacture, use, or sale of its tigecycline lyophilized product for IV infusion
`
`containing 50 mg tigecycline within the United States, including in Delaware.
`
`JURISDICTION AND VENUE
`
`9.
`
`Jurisdiction and venue are proper in this District pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 1391, 1400(b) and 2201.
`
`10.
`
`Upon information and belief, CFT has, directly or through an agent, filed an
`
`ANDA, and/or been actively involved in the preparation and submission of an ANDA, for the
`
`purpose of seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of the generic product described in ANDA No. 205722 in the United States,
`
`including in Delaware; and, upon receiving FDA approval, it intends to offer to sell and sell the
`
`generic product described in ANDA No. 205722 in the United States, including in Delaware.
`
`BACKGROUND
`
`11.
`
`TYGACIL® is a tetracycline class antibacterial indicated for the treatment of
`
`complicated skin and skin structure infections, complicated intra-abdominal infections, and
`
`community-acquired bacterial pneumonia, in adults. Each TYGACIL® vial contains 50 mg
`
`tigecycline lyophilized powder for reconstitution for intravenous infusion and 100 mg of lactose
`
`monohydrate.
`
`3
`
`

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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 4 of 13 PageID #: 4
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`12.
`
`The ’828 patent, entitled “Tigecycline Compositions and Methods of Preparation”
`
`(Exhibit A hereto), was duly and legally issued on February 1, 2011 to Wyeth LLC, as assignee,
`
`and subject to the exclusive license referenced herein. TYGACIL® and the use thereof are
`
`covered by one or more claims of the ’828 patent, which has been listed in connection with
`
`TYGACIL® in the FDA’s publication Approved Drug Products with Therapeutic Equivalence
`
`Evaluations, also known as the “Orange Book.”
`
`13.
`
`In 2011, PF PRISM C.V. took an exclusive license to the ’828 patent and
`
`application no. 11/440,032 (which later issued as the ’995 patent). Thereafter, PF PRISM C.V.
`
`contributed its rights under the exclusive license to Pfizer Pharmaceuticals LLC.
`
`14.
`
`The ’995 patent, entitled “Crystalline Solid Forms of Tigecycline and Methods of
`
`Preparing Same” (Exhibit B hereto), was duly and legally issued on February 12, 2013 to Wyeth
`
`LLC, as assignee, and subject to the exclusive license referenced herein. TYGACIL® and the
`
`use thereof are covered by one or more claims of the ’995 patent, which has been listed in
`
`connection with TYGACIL® in the FDA’s publication Approved Drug Products with
`
`Therapeutic Equivalence Evaluations, also known as the “Orange Book.”
`
`15.
`
`Pfizer has all right, title, and interest in the ’828 patent and the ’995 patent,
`
`including the right to sue for infringement thereof.
`
`16.
`
`By letter dated May 7, 2014 (the “Notice Letter”), CFT notified Pfizer that CFT
`
`had submitted to the FDA ANDA No. 205722 for tigecycline lyophilized product for IV infusion
`
`containing 50 mg tigecycline (“CFT’s ANDA Product”). CFT’s ANDA Product is a drug
`
`product that is a generic version of TYGACIL®.
`
`17.
`
`The purpose of CFT’s submission of ANDA No. 205722 was to obtain approval
`
`under the FDCA to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`4
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 5 of 13 PageID #: 5
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`importation of CFT’s ANDA Product prior to the expiration of the ’828 patent and the ’995
`
`patent.
`
`18.
`
`In the Notice Letter, CFT also notified Pfizer that, as part of its ANDA No.
`
`205722, CFT had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the
`
`FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’828 patent and the ’995 patent.
`
`Upon information and belief, CFT submitted ANDA No. 205722 to the FDA containing a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’828 patent and the
`
`’995 patent will not be infringed by the manufacture, use, offer for sale, sale, or importation of
`
`CFT’s ANDA Product, or alternatively, that these patents are invalid.
`
`19.
`
`The parties, while reserving all rights, ultimately negotiated terms under which
`
`Pfizer could review the CFT ANDA, but CFT refused to produce other CFT internal documents
`
`and data relevant to infringement.
`
`20.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of the receipt of the Notice Letter.
`
`COUNT I – INFRINGEMENT OF U.S. PATENT
`NO. 7,879,828 UNDER 35 U.S.C. § 271(e)(2)
`
`Pfizer incorporates each of the preceding paragraphs 1–20 as if fully set forth
`
`21.
`
`herein.
`
`22.
`
`CFT’s submission of ANDA No. 205722 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of CFT’s
`
`ANDA Product prior to the expiration of the ’828 patent was an act of infringement of the ’828
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`5
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 6 of 13 PageID #: 6
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`23.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of CFT’s ANDA Product would infringe one or more claims of
`
`the ’828 patent, either literally or under the doctrine of equivalents.
`
`24.
`
`Upon information and belief, CFT will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
`
`labeling upon approval of ANDA No. 205722.
`
`25.
`
`Upon information and belief, the use of CFT’s ANDA Product in accordance with
`
`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
`
`of the ’828 patent.
`
`26.
`
`Upon information and belief, CFT plans and intends to, and will, actively induce
`
`infringement of the ’828 patent when ANDA No. 205722 is approved, and plans and intends to,
`
`and will, do so after approval.
`
`27.
`
`Upon information and belief, CFT knows that CFT’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’828 patent, and that
`
`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
`
`of the ’828 patent after approval of ANDA No. 205722.
`
`28.
`
`Upon information and belief, after approval of ANDA No. 205722, CFT will,
`
`without authority, import into the United States and/or offer to sell, sell, and/or use within the
`
`United States, a product which is made by a process that infringes one or more claims of the ’828
`
`patent prior to the expiration of the patent.
`
`6
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 7 of 13 PageID #: 7
`
`29.
`
`The foregoing actions by CFT constitute and/or will constitute infringement of the
`
`’828 patent, active inducement of infringement of the ’828 patent, and contribution to the
`
`infringement by others of the ’828 patent.
`
`30.
`
`Upon information and belief, CFT has acted with full knowledge of the ’828
`
`patent and without a reasonable basis for believing that it would not be liable for infringing the
`
`’828 patent, actively inducing infringement of the ’828 patent, and contributing to the
`
`infringement by others of the ’828 patent.
`
`31.
`
`Unless CFT is enjoined from infringing the ’828 patent, actively inducing
`
`infringement of the ’828 patent, and contributing to the infringement by others of the ’828
`
`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
`
`COUNT II – INFRINGEMENT OF U.S. PATENT
`NO. 8,372,995 UNDER 35 U.S.C. § 271(e)(2)
`
`Pfizer incorporates each of the preceding paragraphs 1–31 as if fully set forth
`
`32.
`
`herein.
`
`33.
`
`CFT’s submission of ANDA No. 205722 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of CFT’s
`
`ANDA Product prior to the expiration of the ’995 patent was an act of infringement of the ’995
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`34.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of CFT’s ANDA Product would infringe one or more claims of
`
`the ’995 patent, either literally or under the doctrine of equivalents.
`
`35.
`
`Upon information and belief, CFT will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
`
`labeling upon approval of ANDA No. 205722.
`
`7
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 8 of 13 PageID #: 8
`
`36.
`
`Upon information and belief, the use of CFT’s ANDA Product in accordance with
`
`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
`
`of the ’995 patent.
`
`37.
`
`Upon information and belief, CFT plans and intends to, and will, actively induce
`
`infringement of the ’995 patent when ANDA No. 205722 is approved, and plans and intends to,
`
`and will, do so after approval.
`
`38.
`
`Upon information and belief, CFT knows that CFT’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’995 patent, and that
`
`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
`
`of the ’995 patent after approval of ANDA No. 205722.
`
`39.
`
`Upon information and belief, after approval of ANDA No. 205722, CFT will,
`
`without authority, import into the United States and/or offer to sell, sell, and/or use within the
`
`United States, a product which is made by a process that infringes one or more claims of the ’995
`
`patent prior to the expiration of the patent.
`
`40.
`
`The foregoing actions by CFT constitute and/or will constitute infringement of the
`
`’995 patent, active inducement of infringement of the ’995 patent, and contribution to the
`
`infringement by others of the ’995 patent.
`
`41.
`
`Upon information and belief, CFT has acted with full knowledge of the ’995
`
`patent and without a reasonable basis for believing that it would not be liable for infringing the
`
`’995 patent, actively inducing infringement of the ’995 patent, and contributing to the
`
`infringement by others of the ’995 patent.
`
`8
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 9 of 13 PageID #: 9
`
`42.
`
`Unless CFT is enjoined from infringing the ’995 patent, actively inducing
`
`infringement of the ’995 patent, and contributing to the infringement by others of the ’995
`
`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
`
`COUNT III – DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 7,879,828
`
`43.
`
`Pfizer incorporates each of the preceding paragraphs 1–42 as if fully set forth
`
`
`
`herein.
`
`44.
`
`45.
`
`CFT has knowledge of the ’828 patent.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of CFT’s ANDA Product would infringe one or more claims of
`
`the ’828 patent, either literally or under the doctrine of equivalents.
`
`46.
`
`Upon information and belief, CFT will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
`
`labeling after approval of ANDA No. 205722.
`
`47.
`
`Upon information and belief, the use of CFT’s ANDA Product in accordance with
`
`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
`
`of the ’828 patent.
`
`48.
`
`Upon information and belief, CFT plans and intends to, and will, actively induce
`
`infringement of the ’828 patent when ANDA No. 205722 is approved, and plans and intends to,
`
`and will, do so after approval.
`
`49.
`
`Upon information and belief, CFT knows that CFT’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’828 patent, and that
`
`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`9
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 10 of 13 PageID #: 10
`
`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
`
`of the ’828 patent after approval of ANDA No. 205722.
`
`50.
`
`Upon information and belief, after approval of ANDA No. 205722, CFT will,
`
`without authority, import into the United States and/or offer to sell, sell, and/or use within the
`
`United States, a product which is made by a process that infringes one or more claims of the ’828
`
`patent prior to the expiration of the patent.
`
`51.
`
`The foregoing actions by CFT constitute and/or will constitute infringement of the
`
`’828 patent, active inducement of infringement of the ’828 patent, and contribution to the
`
`infringement by others of the ’828 patent.
`
`52.
`
`Upon information and belief, CFT acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’828 patent, actively inducing infringement of the
`
`’828 patent, and contributing to the infringement by others of the ’828 patent.
`
`53.
`
`Unless CFT is enjoined from infringing the ’828 patent, actively inducing
`
`infringement of the ’828 patent, and contributing to the infringement by others of the ’828
`
`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
`
`COUNT IV – DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,372,995
`
`54.
`
`Pfizer incorporates each of the preceding paragraphs 1–53 as if fully set forth
`
`
`
`herein.
`
`55.
`
`56.
`
`CFT has knowledge of the ’995 patent.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of CFT’s ANDA Product would infringe one or more claims of
`
`the ’995 patent, either literally or under the doctrine of equivalents.
`
`10
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 11 of 13 PageID #: 11
`
`57.
`
`Upon information and belief, CFT will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
`
`labeling after approval of ANDA No. 205722.
`
`58.
`
`Upon information and belief, the use of CFT’s ANDA Product in accordance with
`
`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
`
`of the ’995 patent.
`
`59.
`
`Upon information and belief, CFT plans and intends to, and will, actively induce
`
`infringement of the ’995 patent when ANDA No. 205722 is approved, and plans and intends to,
`
`and will, do so after approval.
`
`60.
`
`Upon information and belief, CFT knows that CFT’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’995 patent, and that
`
`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
`
`of the ’995 patent after approval of ANDA No. 205722.
`
`61.
`
`Upon information and belief, after approval of ANDA No. 205722, CFT will,
`
`without authority, import into the United States and/or offer to sell, sell, and/or use within the
`
`United States, a product which is made by a process that infringes one or more claims of the ’995
`
`patent prior to the expiration of the patent.
`
`62.
`
`The foregoing actions by CFT constitute and/or will constitute infringement of the
`
`’995 patent, active inducement of infringement of the ’995 patent, and contribution to the
`
`infringement by others of the ’995 patent.
`
`11
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 12 of 13 PageID #: 12
`
`63.
`
`Upon information and belief, CFT acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’995 patent, actively inducing infringement of the
`
`’995 patent, and contributing to the infringement by others of the ’995 patent.
`
`64.
`
`Unless CFT is enjoined from infringing the ’995 patent, actively inducing
`
`infringement of the ’995 patent, and contributing to the infringement by others of the ’995
`
`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
`
`WHEREFORE, Pfizer requests the following relief:
`
`(a)
`
`(b)
`
`A judgment that CFT has infringed the ’828 patent and the ’995 patent;
`
`A judgment ordering that the effective date of any FDA approval for CFT
`
`to make, use, offer for sale, sell, market, distribute, or import CFT’s ANDA Product, or any
`
`product or compound the making, using, offering for sale, sale, marketing, distributing, or
`
`importation of which infringes the ’828 patent or the ’995 patent be not earlier than the
`
`expiration date of the ’828 patent or the ’995 patent, respectively, inclusive of any extension(s)
`
`and additional period(s) of exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining CFT, and all persons
`
`acting in concert with CFT, from making, using, selling, offering for sale, marketing,
`
`distributing, or importing CFT’s ANDA Product, or any product or compound the making, using,
`
`offering for sale, sale, marketing, distributing, or importation of which infringes the ’828 patent
`
`or the ’995 patent, or the inducement of or the contribution to any of the foregoing, prior to the
`
`expiration date of the ’828 patent or the ’995 patent, respectively, inclusive of any extension(s)
`
`and additional period(s) of exclusivity;
`
`(d)
`
`A judgment declaring that making, using, selling, offering for sale,
`
`marketing, distributing, or importing CFT’s ANDA Product, or any product or compound the
`
`12
`
`

`
`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 13 of 13 PageID #: 13
`
`making, using, offering for sale, sale, marketing, distributing, or importation of which infringes
`
`the ’828 patent or the ’995 patent, prior to the expiration date of the ’828 patent or the ’995
`
`patent, respectively, will infringe, actively induce infringement of, and/or contribute to the
`
`infringement by others of the ’828 patent or the ’995 patent;
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’
`
`fees pursuant to 35 U.S.C. § 285;
`
`(f)
`
`(g)
`
`An award of Pfizer’s costs and expenses in this action; and
`
`Such further and other relief as this Court may deem just and proper.
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`
`
`/s/ Maryellen Noreika
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`13
`
`
`
`OF COUNSEL:
`
`Thomas H. L. Selby
`David I. Berl
`Stanley E. Fisher
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`June 19, 2014
`8323723

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