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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`COMPLAINT
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`C.A. No.
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`Defendant.
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`Plaintiffs Pfizer Inc., Wyeth LLC, Pfizer Pharmaceuticals LLC, PF PRISM
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`C.V.andPfizer Manufacturing Holdings LLC, (collectively, “Pfizer”), by their attorneys, hereby
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`allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, that arises out of the submission by defendant CFT
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`Pharmaceuticals LLC (hereinafter “CFT”) of an Abbreviated New Drug Application (“ANDA”)
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`No. 205722 to the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture
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`and sell a generic version of Pfizer’s TYGACIL® tigecycline injectable IV infusion,
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`(“TYGACIL®”) prior to the expiration of U.S. Patent No. 7,879,828 (“the ’828 patent”), and
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`U.S. Patent No. 8,372,995 (“the ’995 patent”).
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`PFIZER INC., WYETH LLC, PFIZER
`PHARMACEUTICALS LLC, PF PRISM
`C.V. and PFIZER MANUFACTURING
`HOLDINGS LLC,
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`Plaintiffs,
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`v.
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`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
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`2.
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`Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of
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`Delaware and having a place of business at 235 East 42nd Street, New York, New York 10017.
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`3.
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`Plaintiff Wyeth LLC is a limited liability company organized and existing under
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`the laws of Delaware and having a place of business at 235 East 42nd Street, New York, New
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`York 10017. Wyeth LLC’s sole member is Pfizer Inc.
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`4.
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`Plaintiff Pfizer Pharmaceuticals LLC is a limited liability company organized and
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`existing under the laws of Delaware and having a place of business at Bo. Carmelitas, Road 689,
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`Km 1.9, Vega Baja, Puerto Rico 00693. Pfizer Pharmaceuticals LLC is a wholly-owned
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`subsidiary of PF PRISM C.V.
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`5.
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`Plaintiff PF PRISM C.V. is a limited partnership (commanditaire vennootschap)
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`organized under the laws of the Netherlands, having its registered seat in Rotterdam, the
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`Netherlands, and registered at the Trade Register held by the Chamber of Commerce in
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`Rotterdam, the Netherlands, under number 51840456 and that for all purposes is represented by
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`and acting through its general partner Pfizer Manufacturing Holdings LLC, a limited liability
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`company organized under the laws of the State of Delaware, USA, and having its address at 235
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`East 42nd Street, New York, New York 10017, registered in the register held by the Secretary of
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`State of the State of Delaware under number 4869755. PF PRISM C.V. is the holder of New
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`Drug Application No. 21821, which has been approved by the FDA.
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`6.
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`Plaintiff Pfizer Manufacturing Holdings LLC is a limited liability company
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`organized and existing under the laws of Delaware and having a place of business at 235 East
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`42nd Street, New York, New York 10017. Pfizer Manufacturing Holdings LLC is a general
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`partner of PF PRISM C.V.
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`2
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 3 of 13 PageID #: 3
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`7.
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`Upon information and belief, defendant CFT Pharmaceuticals LLC is a limited
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`liability company organized and existing under the laws of Wisconsin, with a place of business at
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`10 E. Doty St., Suite 600, Madison, Wisconsin 53703.
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`8.
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`Pfizer offers for sale and sells a substantial amount of TYGACIL® within this
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`District on an annualized basis. Upon information and belief, if approved, CFT will engage in
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`the commercial manufacture, use, or sale of its tigecycline lyophilized product for IV infusion
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`containing 50 mg tigecycline within the United States, including in Delaware.
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`JURISDICTION AND VENUE
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`9.
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`Jurisdiction and venue are proper in this District pursuant to 28 U.S.C. §§ 1331,
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`1338(a), 1391, 1400(b) and 2201.
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`10.
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`Upon information and belief, CFT has, directly or through an agent, filed an
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`ANDA, and/or been actively involved in the preparation and submission of an ANDA, for the
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`purpose of seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
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`and/or importation of the generic product described in ANDA No. 205722 in the United States,
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`including in Delaware; and, upon receiving FDA approval, it intends to offer to sell and sell the
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`generic product described in ANDA No. 205722 in the United States, including in Delaware.
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`BACKGROUND
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`11.
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`TYGACIL® is a tetracycline class antibacterial indicated for the treatment of
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`complicated skin and skin structure infections, complicated intra-abdominal infections, and
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`community-acquired bacterial pneumonia, in adults. Each TYGACIL® vial contains 50 mg
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`tigecycline lyophilized powder for reconstitution for intravenous infusion and 100 mg of lactose
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`monohydrate.
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`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.
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`The ’828 patent, entitled “Tigecycline Compositions and Methods of Preparation”
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`(Exhibit A hereto), was duly and legally issued on February 1, 2011 to Wyeth LLC, as assignee,
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`and subject to the exclusive license referenced herein. TYGACIL® and the use thereof are
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`covered by one or more claims of the ’828 patent, which has been listed in connection with
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`TYGACIL® in the FDA’s publication Approved Drug Products with Therapeutic Equivalence
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`Evaluations, also known as the “Orange Book.”
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`13.
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`In 2011, PF PRISM C.V. took an exclusive license to the ’828 patent and
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`application no. 11/440,032 (which later issued as the ’995 patent). Thereafter, PF PRISM C.V.
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`contributed its rights under the exclusive license to Pfizer Pharmaceuticals LLC.
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`14.
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`The ’995 patent, entitled “Crystalline Solid Forms of Tigecycline and Methods of
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`Preparing Same” (Exhibit B hereto), was duly and legally issued on February 12, 2013 to Wyeth
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`LLC, as assignee, and subject to the exclusive license referenced herein. TYGACIL® and the
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`use thereof are covered by one or more claims of the ’995 patent, which has been listed in
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`connection with TYGACIL® in the FDA’s publication Approved Drug Products with
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`Therapeutic Equivalence Evaluations, also known as the “Orange Book.”
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`15.
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`Pfizer has all right, title, and interest in the ’828 patent and the ’995 patent,
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`including the right to sue for infringement thereof.
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`16.
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`By letter dated May 7, 2014 (the “Notice Letter”), CFT notified Pfizer that CFT
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`had submitted to the FDA ANDA No. 205722 for tigecycline lyophilized product for IV infusion
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`containing 50 mg tigecycline (“CFT’s ANDA Product”). CFT’s ANDA Product is a drug
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`product that is a generic version of TYGACIL®.
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`17.
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`The purpose of CFT’s submission of ANDA No. 205722 was to obtain approval
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`under the FDCA to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`4
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`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
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`patent.
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`18.
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`In the Notice Letter, CFT also notified Pfizer that, as part of its ANDA No.
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`205722, CFT had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the
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`FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’828 patent and the ’995 patent.
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`Upon information and belief, CFT submitted ANDA No. 205722 to the FDA containing a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’828 patent and the
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`’995 patent will not be infringed by the manufacture, use, offer for sale, sale, or importation of
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`CFT’s ANDA Product, or alternatively, that these patents are invalid.
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`19.
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`The parties, while reserving all rights, ultimately negotiated terms under which
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`Pfizer could review the CFT ANDA, but CFT refused to produce other CFT internal documents
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`and data relevant to infringement.
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`20.
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`This action is being commenced before the expiration of forty-five days from the
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`date of the receipt of the Notice Letter.
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`COUNT I – INFRINGEMENT OF U.S. PATENT
`NO. 7,879,828 UNDER 35 U.S.C. § 271(e)(2)
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`Pfizer incorporates each of the preceding paragraphs 1–20 as if fully set forth
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`21.
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`herein.
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`22.
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`CFT’s submission of ANDA No. 205722 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of CFT’s
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`ANDA Product prior to the expiration of the ’828 patent was an act of infringement of the ’828
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`patent under 35 U.S.C. § 271(e)(2)(A).
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`5
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 6 of 13 PageID #: 6
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`23.
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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 CFT’s ANDA Product would infringe one or more claims of
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`the ’828 patent, either literally or under the doctrine of equivalents.
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`24.
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`Upon information and belief, CFT will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
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`labeling upon approval of ANDA No. 205722.
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`25.
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`Upon information and belief, the use of CFT’s ANDA Product in accordance with
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`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
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`of the ’828 patent.
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`26.
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`Upon information and belief, CFT plans and intends to, and will, actively induce
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`infringement of the ’828 patent when ANDA No. 205722 is approved, and plans and intends to,
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`and will, do so after approval.
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`27.
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`Upon information and belief, CFT knows that CFT’s ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’828 patent, and that
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`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
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`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
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`of the ’828 patent after approval of ANDA No. 205722.
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`28.
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`Upon information and belief, after approval of ANDA No. 205722, CFT will,
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`without authority, import into the United States and/or offer to sell, sell, and/or use within the
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`United States, a product which is made by a process that infringes one or more claims of the ’828
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`patent prior to the expiration of the patent.
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`6
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 7 of 13 PageID #: 7
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`29.
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`The foregoing actions by CFT constitute and/or will constitute infringement of the
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`’828 patent, active inducement of infringement of the ’828 patent, and contribution to the
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`infringement by others of the ’828 patent.
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`30.
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`Upon information and belief, CFT has acted with full knowledge of the ’828
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`patent and without a reasonable basis for believing that it would not be liable for infringing the
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`’828 patent, actively inducing infringement of the ’828 patent, and contributing to the
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`infringement by others of the ’828 patent.
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`31.
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`Unless CFT is enjoined from infringing the ’828 patent, actively inducing
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`infringement of the ’828 patent, and contributing to the infringement by others of the ’828
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`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
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`COUNT II – INFRINGEMENT OF U.S. PATENT
`NO. 8,372,995 UNDER 35 U.S.C. § 271(e)(2)
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`Pfizer incorporates each of the preceding paragraphs 1–31 as if fully set forth
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`32.
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`herein.
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`33.
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`CFT’s submission of ANDA No. 205722 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of CFT’s
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`ANDA Product prior to the expiration of the ’995 patent was an act of infringement of the ’995
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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 CFT’s ANDA Product would infringe one or more claims of
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`the ’995 patent, either literally or under the doctrine of equivalents.
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`35.
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`Upon information and belief, CFT will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
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`labeling upon approval of ANDA No. 205722.
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`7
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 8 of 13 PageID #: 8
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`36.
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`Upon information and belief, the use of CFT’s ANDA Product in accordance with
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`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
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`of the ’995 patent.
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`37.
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`Upon information and belief, CFT plans and intends to, and will, actively induce
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`infringement of the ’995 patent when ANDA No. 205722 is approved, and plans and intends to,
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`and will, do so after approval.
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`38.
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`Upon information and belief, CFT knows that CFT’s ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’995 patent, and that
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`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
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`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
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`of the ’995 patent after approval of ANDA No. 205722.
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`39.
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`Upon information and belief, after approval of ANDA No. 205722, CFT will,
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`without authority, import into the United States and/or offer to sell, sell, and/or use within the
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`United States, a product which is made by a process that infringes one or more claims of the ’995
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`patent prior to the expiration of the patent.
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`40.
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`The foregoing actions by CFT constitute and/or will constitute infringement of the
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`’995 patent, active inducement of infringement of the ’995 patent, and contribution to the
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`infringement by others of the ’995 patent.
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`41.
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`Upon information and belief, CFT has acted with full knowledge of the ’995
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`patent and without a reasonable basis for believing that it would not be liable for infringing the
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`’995 patent, actively inducing infringement of the ’995 patent, and contributing to the
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`infringement by others of the ’995 patent.
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`8
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 9 of 13 PageID #: 9
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`42.
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`Unless CFT is enjoined from infringing the ’995 patent, actively inducing
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`infringement of the ’995 patent, and contributing to the infringement by others of the ’995
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`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
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`COUNT III – DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 7,879,828
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`43.
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`Pfizer incorporates each of the preceding paragraphs 1–42 as if fully set forth
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`
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`herein.
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`44.
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`45.
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`CFT has knowledge of the ’828 patent.
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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 CFT’s ANDA Product would infringe one or more claims of
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`the ’828 patent, either literally or under the doctrine of equivalents.
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`46.
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`Upon information and belief, CFT will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
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`labeling after approval of ANDA No. 205722.
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`47.
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`Upon information and belief, the use of CFT’s ANDA Product in accordance with
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`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
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`of the ’828 patent.
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`48.
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`Upon information and belief, CFT plans and intends to, and will, actively induce
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`infringement of the ’828 patent when ANDA No. 205722 is approved, and plans and intends to,
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`and will, do so after approval.
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`49.
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`Upon information and belief, CFT knows that CFT’s ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’828 patent, and that
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`CFT’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
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`9
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 10 of 13 PageID #: 10
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`use. Upon information and belief, CFT plans and intends to, and will, contribute to infringement
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`of the ’828 patent after approval of ANDA No. 205722.
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`50.
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`Upon information and belief, after approval of ANDA No. 205722, CFT will,
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`without authority, import into the United States and/or offer to sell, sell, and/or use within the
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`United States, a product which is made by a process that infringes one or more claims of the ’828
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`patent prior to the expiration of the patent.
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`51.
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`The foregoing actions by CFT constitute and/or will constitute infringement of the
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`’828 patent, active inducement of infringement of the ’828 patent, and contribution to the
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`infringement by others of the ’828 patent.
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`52.
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`Upon information and belief, CFT acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’828 patent, actively inducing infringement of the
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`’828 patent, and contributing to the infringement by others of the ’828 patent.
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`53.
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`Unless CFT is enjoined from infringing the ’828 patent, actively inducing
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`infringement of the ’828 patent, and contributing to the infringement by others of the ’828
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`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
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`COUNT IV – DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,372,995
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`54.
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`Pfizer incorporates each of the preceding paragraphs 1–53 as if fully set forth
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`herein.
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`55.
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`56.
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`CFT has knowledge of the ’995 patent.
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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 CFT’s ANDA Product would infringe one or more claims of
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`the ’995 patent, either literally or under the doctrine of equivalents.
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`10
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 11 of 13 PageID #: 11
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`57.
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`Upon information and belief, CFT will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of CFT’s ANDA Product with its proposed
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`labeling after approval of ANDA No. 205722.
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`58.
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`Upon information and belief, the use of CFT’s ANDA Product in accordance with
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`and as directed by CFT’s proposed labeling for that product would infringe one or more claims
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`of the ’995 patent.
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`59.
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`Upon information and belief, CFT plans and intends to, and will, actively induce
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`infringement of the ’995 patent when ANDA No. 205722 is approved, and plans and intends to,
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`and will, do so after approval.
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`60.
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`Upon information and belief, CFT knows that CFT’s ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’995 patent, and that
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`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
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`of the ’995 patent after approval of ANDA No. 205722.
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`61.
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`Upon information and belief, after approval of ANDA No. 205722, CFT will,
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`without authority, import into the United States and/or offer to sell, sell, and/or use within the
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`United States, a product which is made by a process that infringes one or more claims of the ’995
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`patent prior to the expiration of the patent.
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`62.
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`The foregoing actions by CFT constitute and/or will constitute infringement of the
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`’995 patent, active inducement of infringement of the ’995 patent, and contribution to the
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`infringement by others of the ’995 patent.
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`11
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 12 of 13 PageID #: 12
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`63.
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`Upon information and belief, CFT acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’995 patent, actively inducing infringement of the
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`’995 patent, and contributing to the infringement by others of the ’995 patent.
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`64.
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`Unless CFT is enjoined from infringing the ’995 patent, actively inducing
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`infringement of the ’995 patent, and contributing to the infringement by others of the ’995
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`patent, Pfizer will suffer irreparable injury. Pfizer has no adequate remedy at law.
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`WHEREFORE, Pfizer requests the following relief:
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`(a)
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`(b)
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`A judgment that CFT has infringed the ’828 patent and the ’995 patent;
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`A judgment ordering that the effective date of any FDA approval for CFT
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`to make, use, offer for sale, sell, market, distribute, or import CFT’s ANDA Product, or any
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`product or compound the making, using, offering for sale, sale, marketing, distributing, or
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`importation of which infringes the ’828 patent or the ’995 patent be not earlier than the
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`expiration date of the ’828 patent or the ’995 patent, respectively, inclusive of any extension(s)
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`and additional period(s) of exclusivity;
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`(c)
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`A preliminary and permanent injunction enjoining CFT, and all persons
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`acting in concert with CFT, from making, using, selling, offering for sale, marketing,
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`distributing, or importing CFT’s ANDA Product, or any product or compound the making, using,
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`offering for sale, sale, marketing, distributing, or importation of which infringes the ’828 patent
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`or the ’995 patent, or the inducement of or the contribution to any of the foregoing, prior to the
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`expiration date of the ’828 patent or the ’995 patent, respectively, inclusive of any extension(s)
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`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,
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`marketing, distributing, or importing CFT’s ANDA Product, or any product or compound the
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`12
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`Case 1:14-cv-00781-SLR Document 1 Filed 06/19/14 Page 13 of 13 PageID #: 13
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`making, using, offering for sale, sale, marketing, distributing, or importation of which infringes
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`the ’828 patent or the ’995 patent, prior to the expiration date of the ’828 patent or the ’995
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`patent, respectively, will infringe, actively induce infringement of, and/or contribute to the
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`infringement by others of the ’828 patent or the ’995 patent;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’
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`fees pursuant to 35 U.S.C. § 285;
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`(f)
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`(g)
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`An award of Pfizer’s 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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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`
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`/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
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`Attorneys for Plaintiffs
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`13
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`OF COUNSEL:
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`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