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`Case 1:15-cv-OO697-RGA Document 9 Filed 09/01/15 Page 1 of 24 PagelD #: 91
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
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`HOSPIRA, INC.,
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`Plaintiff,
`
`V.
`
`AMNEAL PHARMACEUTICALS LLC
`
`Defendant.
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`vvvvvvvvv
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`CA. No. 15-697-RGA
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`ANSWER AND COUNTERCLAIMS
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`Defendant Amneal Pharmaceuticals LLC (“Amneal”), by and through its undersigned
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`attorneys, answers the averments made in the numbered paragraphs of the Complaint filed by
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`Plaintiff Hospira, Inc. (“Hospira”) as follows:
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`PARTIES
`
`1.
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`On information and belief, Amneal admits the allegations in Paragraph 1 of the
`
`Complaint.
`
`2.
`
`Amneal admits the allegations in Paragraph 2 of the Complaint.
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`NATURE OF THE ACTION
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`3.
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`Paragraph 3 of the Plaintiffs Complaint contains conclusions of law to which no
`
`response is required. To the extent that a response is required, Amneal admits that Plaintiff
`
`purports to state a cause of action for infringement of US. Patent Nos. 8,242,158 (“the ’158
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`patent”); 8,338,470 (“the ’470 patent”); 8,455,527 (“the ’527 patent”); and 8,648,106 (“the ’106
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`patent”)
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`(collectively “the patents-in-suit”). Amneal denies any remaining allegations in
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`Paragraph 3 of the Complaint.
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`4.
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`Paragraph 4 of the Plaintiffs Complaint contains conclusions of law to which no
`
`response is required. To the extent that a response is required, Amneal admits that Plaintiff
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`purports to state a cause of action that arises under the United States Patent Laws, Title 35,
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`U.S.C. § 1 et seq. Amneal admits that Amneal filed Abbreviated New Drug Application No.
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`207551 (referred to herein as “Amneal’s ANDA” and “ANDA No. 2075 5 l”) seeking approval to
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`market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 4 mcg/mL, 50 mL
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`and 100 mL single dose vials (“Amneal’s Proposed ANDA Products”) prior to the expiration of
`
`the patents-in-suit. Amneal admits that the patents-in-suit are listed in the publication entitled
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`Approved Drug Products with Therapeutic Equivalents (“the Orange Book”) for PRECEDEXTM.
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`Amneal is without knowledge or sufficient information to form a belief as to the current assignee
`
`of the patents-in-suit, and therefore denies this allegation. Amneal denies the remaining
`
`allegations in Paragraph 4 of the Complaint.
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`JURISDICTION AND VENUE
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`5.
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`Paragraph 5 of the Plaintiffs Complaint contains conclusions of law to which no
`
`response is required. To the extent a response is required, Amneal admits that Plaintiff purports
`
`to state a cause of action arising under the Patent Laws of the United States, 35 U.S.C. § 1 et seq.
`
`Amneal denies any remaining allegations in Paragraph 5 of the Complaint.
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`6.
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`Paragraph 6 of the Plaintiffs Complaint contains conclusions of law to which no
`
`response is required. For the purposes of this action only, Amneal does not contest subject
`
`matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a), 2201, 2202. Amneal denies any
`
`remaining allegations in Paragraph 6 0f the Complaint.
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`7.
`
`Paragraph 7 of the Plaintiffs Complaint contains conclusions of law to which no
`
`response is required. To the extent a response is required, Amneal admits that this Court has
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`personal jurisdiction over Amneal solely for the purposes of this action. Amneal admits that it
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`develops, manufactures, and distributes pharmaceutical products in the United States, including
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`Delaware. Amneal admits that it is qualified to do business in Delaware and has appointed a
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`RLF] 12913961V.l
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`registered agent for service of process in Delaware. Amneal denies any remaining allegations in
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`Paragraph 7 of the Complaint.
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`8.
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`Paragraph 8 of the Plaintiffs Complaint contains conclusions of law to which no
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`response is required. To the extent a response is required, Amneal will not contest venue in this
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`District under 28 U.S.C. §§ 1391 and 1400(b) for the purposes of this action only. Amneal
`
`denies any remaining allegations in Paragraph 8 of the Complaint.
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`THE PATENTS-IN-SUIT
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`9.
`
`Amneal admits that what purports to be a copy of US. Patent No. 8,242,158 (“the
`
`’158 patent”) is attached to the Complaint as Exhibit A. Amneal further admits that, as indicated
`
`on its face, the ’158 patent issued on August 14, 2012, and is entitled “Dexmedetomidine Premix
`
`Formulation.” Amneal is without knowledge or sufficient information to form a belief as to the
`
`current assignee of the ’158 patent, and therefore denies this allegation. Amneal denies any
`
`remaining allegations in Paragraph 9 of the Complaint.
`
`10.
`
`Amneal admits that what purports to be a copy of US. Patent No. 8,338,470 (“the
`
`’470 patent”) is attached to the Complaint as Exhibit B. Amneal further admits that, as indicated
`
`on its face, the ’470 patent issued on December 25, 2012 and is entitled “Dexmedetomidine
`
`Premix Formulation.” Amneal is without knowledge or sufficient information to form a belief as
`
`to the current assignee of the ’470 patent, and therefore denies this allegation. Amneal denies any
`
`remaining allegations in Paragraph 10 of the Complaint.
`
`11.
`
`Amneal admits that what purports to be a copy of US. Patent No. 8,455,527 (“the
`
`’527 patent”) is attached to the Complaint as Exhibit C. Amneal further admits that, as indicated
`
`on its face, the ’527 patent issued on June 4, 2013 and is entitled “Methods of Treatment Using a
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`Dexmedetomidine Premix Formulation.”
`
`Amneal
`
`is without knowledge or
`
`sufficient
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`RLF] 12913961V.l
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`information to form a belief as to the current assignee of the ’527 patent, and therefore denies
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`this allegation. Amneal denies any remaining allegations in Paragraph 11 of the Complaint.
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`12.
`
`Amneal admits that what purports to be a copy of U.S. Patent No. 8,648,106 (“the
`
`’106 patent”) is attached to the Complaint as Exhibit D. Amneal further admits that, as indicated
`
`on its face, the ’ 106 patent issued on February 11, 2014 and is entitled “Dexmedetomidine
`
`PremiX Formulation.” Amneal is without knowledge or sufficient information to form a belief as
`
`to the current assignee of the ’ 106 patent, and therefore denies this allegation. Amneal denies any
`
`remaining allegations in Paragraph 12 of the Complaint.
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`13.
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`Paragraph 13 of the Complaint contains legal conclusions to which no response is
`
`required. To the extent a response is required, Amneal admits that the patents-in-suit are listed in
`
`the Orange Book for PRECEDEXTM. Amneal denies any remaining allegations in Paragraph 13
`
`of the Complaint.
`
`14.
`
`Amneal admits that the Orange Book identifies “Hospira” as the purported holder
`
`of New Drug Application No. 21038 for PRECEDEXTM (“Hospira’s NDA”), that the Orange
`
`Book indicates the United States Food and Drug Administration (“FDA”) originally approved on
`
`December 17th, 1999, and that the Orange Book indicates that the FDA approved amendments
`
`Hospira’s NDA on March 13th, 2013 and November 14th, 2014. Amneal denies any remaining
`
`allegations in Paragraph 14 of the Complaint.
`
`ACTS GIVING RISE TO THIS ACTION
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`15.
`
`Amneal admits that upon completion of its normal and customary due diligence
`
`practices, which includes evaluation of relevant factual and patent information, it filed ANDA
`
`No. 207551 with the FDA under 21 U.S.C. § 3550) seeking approval to market Amneal’s
`
`Proposed ANDA Products. Amneal denies the remaining allegations in Paragraph 15 of the
`
`Complaint.
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`16.
`
`Amneal admits that it sent Plaintiff a letter dated June 26, 2015
`
`(“Amneal’s
`
`Notice Letter”) notifying Plaintiff that Amneal had filed ANDA No. 2075 5 1 with the FDA under
`
`21 U.S.C. § 3550) seeking approval to market Amneal’s Proposed ANDA Products prior to the
`
`expiry of the patents-in-suit. Amneal denies the remaining allegations in Paragraph 16 of the
`
`Complaint.
`
`17.
`
`Amneal admits that Amneal’s Notice Letter contains a certification under 21
`
`U.S.C. §§ 3550)(2)(B)(ii)(l) and (j)(2)(B)(iv) (“Amneal’s PIV 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. Amneal denies the remaining allegations in Paragraph 17 of the Complaint.
`
`18.
`
`Amneal admits the allegations in Paragraph 18 of the Complaint.
`
`19.
`
`Amneal admits the allegations in Paragraph 19 of the Complaint.
`
`20.
`
`Amneal is without knowledge or sufficient information to form a belief as to the
`
`allegations in Paragraph 20 of the Complaint, and therefore denies the same.
`
`COUNT I FOR INFRINGEMENT OF PATENT NO. 8,242,158
`
`21.
`
`Paragraph 21 of the Complaint contains no allegations of fact to which a response
`
`is required. To the extent a response is required, Amneal repeats and incorporates by reference
`
`paragraphs 1-20 of its Answer as if fully set forth herein.
`
`22.
`
`Paragraph 22 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it filed ANDA No. 207551
`
`ANDA with the FDA under 21 U.S.C. § 3550) seeking approval to engage in the commercial
`
`manufacture, use, sale, offer for sale, marketing, and/or importation into the United States of
`
`Amneal’s Proposed ANDA Products prior to the expiration of the ’ 158 patent. Amneal further
`
`admits that it submitted a Patent Information and Certification Statement to the FDA under 21
`
`U.S.C. § 35 5(j)(2)(A)(vii) with respect to Amneal’s ANDA, which contains a certification under
`
`RLF] 12913961v.l
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`21 U.S.C. §§ 355(j)(2)(A)(Vii)(IV). Amneal denies the remaining allegations in Paragraph 22 of
`
`the Complaint.
`
`23.
`
`Paragraph 23 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 23
`
`of the Complaint.
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`24.
`
`Paragraph 24 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 24
`
`of the Complaint.
`
`25.
`
`Paragraph 25 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it was aware of the ’158
`
`patent prior to filing Amneal’s ANDA. Amneal denies the remaining allegations in Paragraph
`
`25 of the Complaint.
`
`26.
`
`Amneal denies the allegations in Paragraph 26 of the Complaint.
`
`COUNT 11 FOR INFRINGEMENT OF PATENT NO. 8,338,470
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`27.
`
`Paragraph 27 of the Complaint contains no allegations of fact to which a response
`
`is required. To the extent a response is required, Amneal repeats and incorporates by reference
`
`paragraphs 1-20 of its Answer as if fully set forth herein.
`
`28.
`
`Paragraph 28 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it filed Amneal’s ANDA
`
`with the FDA under 21 U.S.C.
`
`§ 3550) seeking approval
`
`to engage in the commercial
`
`manufacture, use, sale, offer for sale, marketing, and/or importation into the United States of
`
`Amneal’s Proposed ANDA Products prior to the expiration of the ’470 patent. Amneal further
`
`admits that it submitted a Patent Information and Certification Statement to the FDA under 21
`
`U.S.C. § 35 5(j)(2)(A)(Vii) with respect to Amneal’s ANDA, which contains a certification under
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`RLFl 12913961V.l
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`21 U.S.C. §§ 355(j)(2)(A)(Vii)(IV). Amneal denies the remaining allegations in Paragraph 28 of
`
`the Complaint.
`
`29.
`
`Paragraph 29 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 29
`
`of the Complaint.
`
`30.
`
`Paragraph 30 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 30
`
`of the Complaint.
`
`31.
`
`Paragraph 31 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it was aware of the ’470
`
`patent prior to filing Amneal’s ANDA. Amneal denies the remaining allegations in Paragraph
`
`31 of the Complaint.
`
`32.
`
`Amneal denies the allegations in Paragraph 32 of the Complaint.
`
`COUNT 111 FOR INFRINGEMENT OF PATENT NO. 8,455,527
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`33.
`
`Paragraph 33 of the Complaint contains no allegations of fact to which a response
`
`is required. To the extent a response is required, Amneal repeats and incorporates by reference
`
`paragraphs 1-20 of its Answer as if fully set forth herein.
`
`34.
`
`Paragraph 34 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it filed Amneal’s ANDA
`
`with the FDA under 21 U.S.C.
`
`§ 3550) seeking approval
`
`to engage in the commercial
`
`manufacture, use, sale, offer for sale, marketing, and/or importation into the United States of
`
`Amneal’s Proposed ANDA Products prior to the expiration of the ’527 patent. Amneal further
`
`admits that it submitted a Patent Information and Certification Statement to the FDA under 21
`
`U.S.C. § 35 50)(2)(A)(Vii) with respect to Amneal’s ANDA, which contains a certification under
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`RLFl 12913961V.l
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`21 U.S.C. §§ 355(j)(2)(A)(Vii)(IV). Amneal denies the remaining allegations in Paragraph 34 of
`
`the Complaint.
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`35.
`
`Paragraph 35 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 35
`
`of the Complaint.
`
`36.
`
`Paragraph 36 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 36
`
`of the Complaint.
`
`37.
`
`Paragraph 37 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it was aware of the ’527
`
`patent prior to filing Amneal’s ANDA. Amneal denies the remaining allegations in Paragraph
`
`37 of the Complaint.
`
`38.
`
`Amneal denies the allegations in Paragraph 38 of the Complaint.
`
`COUNT IV FOR INFRINGEMENT OF PATENT NO. 8,648,106
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`39.
`
`Paragraph 39 of the Complaint contains no allegations of fact to which a response
`
`is required. To the extent a response is required, Amneal repeats and incorporates by reference
`
`paragraphs 1-20 of its Answer as if fully set forth herein.
`
`40.
`
`Paragraph 40 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it filed Amneal’s ANDA
`
`with the FDA under 21 U.S.C.
`
`§ 3550) seeking approval
`
`to engage in the commercial
`
`manufacture, use, sale, offer for sale, marketing, and/or importation into the United States of
`
`Amneal’s Proposed ANDA Products prior to the expiration of the ’ 106 patent. Amneal further
`
`admits that it submitted a Patent Information and Certification Statement to the FDA under 21
`
`U.S.C. § 35 5(j)(2)(A)(Vii) with respect to Amneal’s ANDA, which contains a certification under
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`RLFl 12913961V.l
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`-8-
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`21 U.S.C. §§ 3550)(2)(A)(Vii)(lV). Amneal denies all remaining allegations in Paragraph 40 of
`
`the Complaint.
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`41.
`
`Paragraph 41 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 41
`
`of the Complaint.
`
`42.
`
`Paragraph 42 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal denies the allegations in Paragraph 42
`
`of the Complaint.
`
`43.
`
`Paragraph 43 of the Complaint contains conclusions of law to which no response
`
`is required. To the extent a response is required, Amneal admits that it was aware of the ’106
`
`patent prior to filing Amneal’s ANDA. Amneal denies the remaining allegations in Paragraph
`
`43 of the Complaint.
`
`44.
`
`Amneal denies the allegations in Paragraph 44 of the Complaint.
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`PRAYER FOR RELIEF
`
`Amneal denies all remaining allegations not specifically admitted herein. Amneal denies
`
`that Plaintiff is entitled to any judgment or relief against Amneal and, therefore, specifically
`
`denies paragraphs A through J of Plaintiffs Prayer for Relief. This is an exceptional case under
`
`35 U.S.C. § 285 and Amneal seeks recovery of its attorneys’ fees and costs.
`
`DEFENSES
`
`Without prejudice to the denials set forth in this Answer, without admitting any
`
`allegations of the Complaint not otherwise admitted, and without undertaking any of the burdens
`
`imposed by law on the Plaintiff, Amneal incorporates the above denials, and alleges and asserts
`
`the following defenses to the Complaint:
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`FIRST DEFENSE
`
`Amneal’s Proposed ANDA Products do not infringe, and would not infringe any valid
`
`claim of the ’158 patent if made, used, sold, offered for sale, or marketed in the United States, or
`
`imported into the United States. Plaintiff cannot prove either literal infringement or infringement
`
`under the doctrine of equivalents. Amneal’s actions have not and would not induce anyone else
`
`to commit an act of infringement, nor would Amneal’s activities or Proposed ANDA Products
`
`constitute contributory infringement, of any valid claim of the ’ 158 patent.
`
`SECOND DEFENSE
`
`The ’ 158 patent and all of its claims are invalid under 35 U.S.C. §101 et seq, including,
`
`but not limited to, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`THIRD DEFENSE
`
`The ’158 patent and each of its claims are invalid for failing to meet judicially-created
`
`requirements for patentability.
`
`FOURTH DEFENSE
`
`Plaintiff is estopped from asserting any scope for any one of the claims of the ’ 158 patent
`
`to cover and include Amneal’s Proposed ANDA Products because of amendments,
`
`representations,
`
`assertions, disclaimers,
`
`and/or admissions made during the
`
`course of
`
`proceedings in the United States Patent and Trademark Office (“USPTO”) during prosecution of
`
`the application(s) leading to the issuance of the ’ 158 patent.
`
`FIFTH DEFENSE
`
`To the extent not encompassed by Defendant’s Fourth Defense, Plaintiff is estopped from
`
`construing the claims of the ’ 158 patent to cover and include Amneal’s ANDA Product.
`
`SIXTH DEFENSE
`
`Any additional defenses or counterclaims that discovery may reveal, including enforceability.
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`RLF] 12913961V.l
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`SEVENTH DEFENSE
`
`Amneal’s Proposed ANDA Products do not infringe, and would not infringe any valid
`
`claim of the ’470 patent if made, used, sold, offered for sale, or marketed in the United States, or
`
`imported into the United States. Plaintiff cannot prove either literal infringement or infringement
`
`under the doctrine of equivalents. Amneal’s actions have not and would not induce anyone else
`
`to commit an act of infringement, nor would Amneal’s activities or Proposed ANDA Products
`
`constitute contributory infringement, of any valid claim of the ’470 patent.
`
`EIGHTH DEFENSE
`
`The ’470 patent and all of its claims are invalid under 35 U.S.C. §101 et seq, including,
`
`but not limited to, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`NINTH DEFENSE
`
`The ’470 patent and each of its claims are invalid for failing to meet judicially-created
`
`requirements for patentability.
`
`TENTH DEFENSE
`
`Plaintiff is estopped from asserting any scope for any one of the claims of the ’470 patent
`
`to cover and include Amneal’s Proposed ANDA Products because of amendments,
`
`representations,
`
`assertions, disclaimers,
`
`and/or admissions made during the
`
`course of
`
`proceedings in the United States Patent and Trademark Office (“USPTO”) during prosecution of
`
`the application(s) leading to the issuance of the ’470 patent.
`
`ELEVENTH DEFENSE
`
`To the extent not encompassed by Defendant’s Tenth Defense, Plaintiff is estopped from
`
`construing the claims of the ’470 patent to cover and include Amneal’s ANDA Products.
`
`TWELFTH DEFENSE
`
`Any additional defenses or counterclaims that discovery may reveal, including enforceability.
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`RLF] 12913961V.l
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`THIRTEENTH DEFENSE
`
`Amneal’s Proposed ANDA Products do not infringe, and would not infringe any valid
`
`claim of the ’527 patent if made, used, sold, offered for sale, or marketed in the United States, or
`
`imported into the United States. Plaintiff cannot prove either literal infringement or infringement
`
`under the doctrine of equivalents. Amneal’s actions have not and would not induce anyone else
`
`to commit an act of infringement, nor would Amneal’s activities or Proposed ANDA Products
`
`constitute contributory infringement, of any valid claim of the ’527 patent.
`
`FOURTEENTH DEFENSE
`
`The ’527 patent and all of its claims are invalid under 35 U.S.C. §101 et seq, including,
`
`but not limited to, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`FIFTEENTH DEFENSE
`
`The ’527 patent and each of its claims are invalid for failing to meet judicially-created
`
`requirements for patentability.
`
`SIXTEENTH DEFENSE
`
`Plaintiff is estopped from asserting any scope for any one of the claims of the ’527 patent
`
`to cover and include Amneal’s Proposed ANDA Products because of amendments,
`
`representations,
`
`assertions, disclaimers,
`
`and/or admissions made during the
`
`course of
`
`proceedings in the United States Patent and Trademark Office (“USPTO”) during prosecution of
`
`the application(s) leading to the issuance of the ’527 patent.
`
`SEVENTEENTH DEFENSE
`
`To the extent not encompassed by Defendant’s Sixteenth Defense, Plaintiff is estopped
`
`from construing the claims of the ’527 patent to cover and include Amneal’s ANDA Product.
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`RLF] 12913961V.l
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`_
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`_
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`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 13 of 24 PageID #: 103
`Case 1:15-cv-OO697-RGA Document 9 Filed 09/01/15 Page 13 of 24 PagelD #: 103
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`EIGHTEENTH DEFENSE
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`Any additional defenses or counterclaims that discovery may reveal, including enforceability.
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`NINETEENTH DEFENSE
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`Amneal’s Proposed ANDA Products do not infringe, and would not infringe any valid
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`claim of the ’ 106 patent if made, used, sold, offered for sale, or marketed in the United States, or
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`imported into the United States. Plaintiff cannot prove either literal infringement or infringement
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`under the doctrine of equivalents. Amneal’s actions have not and would not induce anyone else
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`to commit an act of infringement, nor would Amneal’s activities or Proposed ANDA Products
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`constitute contributory infringement, of any valid claim of the ’ 106 patent.
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`TWENTIETH DEFENSE
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`The ’106 patent and all of its claims are invalid under 35 U.S.C. §101 et seq, including,
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`but not limited to, 35 U.S.C. §§ 101, 102, 103, and/or 112.
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`TWENTY-FIRST DEFENSE
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`The ’106 patent and each of its claims are invalid for failing to meet judicially-created
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`requirements for patentability.
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`TWENTY-SECOND DEFENSE
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`Plaintiff is estopped from asserting any scope for any one of the claims of the ’106 patent
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`to cover and include Amneal’s Proposed ANDA Products because of amendments,
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`representations,
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`assertions, disclaimers,
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`and/or admissions made during the
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`course of
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`proceedings in the United States Patent and Trademark Office (“USPTO”) during prosecution of
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`the application(s) leading to the issuance of the ’ 106 patent.
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`RLF] 129l3961v.l
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`-13-
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`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 14 of 24 PageID #: 104
`Case 1:15-cv-OO697-RGA Document 9 Filed 09/01/15 Page 14 of 24 PagelD #: 104
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`TWENTY-THIRD DEFENSE
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`To the extent not encompassed by Defendant’s Twenty-Second Defense, Plaintiff is
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`estopped from construing the claims of the ’106 patent to cover and include Amneal’s ANDA
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`Product.
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`TWENTY-FOURTH DEFENSE
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`Any additional defenses or counterclaims that discovery may reveal, including enforceability.
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`RESERVATION OF RIGHTS
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`Amneal reserves the right to assert such other defenses that may appear as discovery
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`proceeds in this case.
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`COUNTERCLAIMS
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`Counterclaim Plaintiff Amneal Pharmaceuticals LLC (“Amneal”) brings the following
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`counterclaims against Hospira, Inc. (“Hospira”).
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`THE PARTIES
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`l.
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`Amneal is a limited liability company organized and existing under the laws of
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`Delaware, having a principal place of business at 400 Crossing Boulevard, Third Floor,
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`Bridgewater, New Jersey, 08807.
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`2.
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`On information and belief, Hospira is a Delaware corporation with its principal
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`place of business at 275 North Field Drive, Lake Forest, Illinois 60045.
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`JURISDICTION AND VENUE
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`3.
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`These counterclaims concerning US. Patent Nos. 8,242,158 (“the ’158 patent”);
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`8,338,470 (“the ’470 patent”); 8,455,527 (“the ’527 patent”); and 8,648,106 (“the ’106 patent”)
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`(collectively “the patents-in-suit”) arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201
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`and 2202 and under the United States Patent Laws, 35 U.S.C. § 101 et seq.
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`RLF] 129l3961v.l
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`_ 14 _
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`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 15 of 24 PageID #: 105
`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 15 of 24 PagelD #: 105
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`4.
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`This Court has subject matter jurisdiction based on 28 U.S.C. §§ 1331, 1337(a),
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`1338(a) and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
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`5.
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`This Court has personal jurisdiction over Hospira because it
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`is a Delaware
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`corporation, has availed itself of the rights and privileges of this forum by bringing this action in
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`this District, and conducts substantial business in, and has regular and systematic contact with,
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`this District.
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`6.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400, and because
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`Hospira filed this suit in this District.
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`THE CONTROVERSY
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`7.
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`Amneal repeats and re-alleges each of the foregoing paragraphs as fully set forth
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`herein.
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`8.
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`This is an action based on an actual controversy between Counterclaim Plaintiff
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`Amneal and Hospira, concerning the invalidity and/or non-infringement of the patents-in—suit,
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`and Amneal’s right to continue to seek approval of its ANDA No. 207551 (also referred to
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`herein as “Amneal’s ANDA”) for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
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`Injection, 4 mcg/mL, 50 mL and 100 mL single dose vials (“Amneal’s Proposed ANDA
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`Products”), and upon approval by the FDA, to manufacture, use, sell and offer to sell and import
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`into the United States Amneal’s Proposed ANDA Products.
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`9.
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`Amneal has submitted Amneal’s ANDA to the United States Food and Drug
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`Administration (“FDA”) for listing in the FDA’s publication, Approved Drug Products with
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`Therapeutic Equivalence Evaluations (“the Orange Book”), containing a certification under 21
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`C.F.R. § 314.94(a)(l2)(i)(A)(4) and 21 U.S.C. § 355(j)(2)(A)(vii)(lV) (“Paragraph IV”) of the
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`Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) of 1984 to the
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`RLF] 12913961V.l
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`_ 15 _
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`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 16 of 24 PageID #: 106
`Case 1:15-cv-OO697-RGA Document 9 Filed 09/01/15 Page 16 of 24 PagelD #: 106
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`FDA seeking approval to market, manufacture, use, sell, and offer to sell Amneal’s Proposed
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`ANDA Products.
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`10.
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`The ’ 158 patent indicates on its face that it was issued by the USPTO on August
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`14, 2012, is entitled “Dexmedetomidine PremiX Formulation,” and that Priyanka Roychowdhury
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`and Robert A. Cedergren are listed as inventors.
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`11.
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`The ’470 patent
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`indicates on its face that
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`it was issued by the USPTO on
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`December 25, 2012 ,
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`is entitled “Dexmedetomidine PremiX Formulation,” and that Priyanka
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`Roychowdhury and Robert A. Cedergren are listed as inventors.
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`12.
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`The ’527 patent indicates on its face that it was issued by the USPTO on June 4,
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`2013, is entitled “Methods of Treatment Using a Dexmedetomidine Premix Formulation,” and
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`that Priyanka Roychowdhury and Robert A. Cedergren are listed as inventors.
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`13.
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`The ’ 108 patent indicates on its face that it was issued by the USPTO on February
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`11, 2014, is entitled “Dexmedetomidine PremiX Formulation,” and that Priyanka Roychowdhury
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`and Robert A. Cedergren are listed as inventors.
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`14.
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`Hospira has represented that one or more claims of the patents-in-suit relates to its
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`commercially marketed product PRECEDEXTM, which contains
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`the
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`active
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`ingredient
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`dexmedetomidine hydrochloride.
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`15.
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`Hospira alleges that it purportedly owns and has the right to enforce the patents-
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`in-suit.
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`16.
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`Hospira alleges that
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`it
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`is
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`the holder of approved NDA No. 21038 for
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`PRECEDEXTM (“Hospira’s NDA”).
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`RLFl l29l3961v.l
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`-16-
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`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 17 of 24 PageID #: 107
`Case 1:15-cv-OO697-RGA Document 9 Filed 09/01/15 Page 17 of 24 PagelD #: 107
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`17.
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`Hospira has alleged that one or more claims of the patents-in-suit would be
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`infringed by Amneal’s Proposed ANDA Products, and the filing of Amneal’s ANDA constitutes
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`infringement of the patents-in-suit.
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`18.
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`By letter dated June 26, 2015 Amneal notified Hospira that it had submitted to the
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`FDA a Paragraph IV certification stating that the manufacture, use, sale, offer for sale, and/or
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`importation of Amneal’s Proposed ANDA Products would not infringe any valid claim of the
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`patents-in-suit.
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`19.
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`On or about August 11, 2015, Hospira filed a complaint against Amneal in this
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`district alleging infringement of the patents-in-suit under 35 U.S.C. §§ 271(c)(2)(A), 271(a),
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`271(b), and 271(c).
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`20.
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`Amneal has undertaken substantial efforts in developing and seeking approval for
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`Amneal’s Proposed ANDA Products set forth in Amneal’s ANDA.
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`21.
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`In view of the foregoing, an actual justiciable controversy exists by virtue of
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`Amneal’s notification to Hospira of its ANDA filing, and Hospira’s subsequently filing the
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`present suit.
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`COUNT I FOR DECLARATORY JUDGMENT OF NON-
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`INFRINGEMENT OF THE ’158 PATENT
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`22.
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`Counterclaim Plaintiff, Amneal hereby incorporates the allegations of the
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`foregoing paragraphs 1-21.
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`23.
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`A justiciable case or controversy exists between Counterclaim Plaintiff Amneal
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`and Hospira, concerning the non-infringement of the ’158 patent, which requires a declaration of
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`rights by this Court.
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`24.
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`Amneal’s Proposed ANDA Products do not infringe any claim of the ’158 patent,
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`either literally or under the doctrine of equivalents. Amneal’s Proposed ANDA Products do not
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`RLF] 12913961V.l
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`_ 17 _
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`Case 1:15-cv-00697-RGA Document 9 Filed 09/01/15 Page 18 of 24 PageID #: 108
`Case 1:15-cv-OO697-RGA Document 9 Filed 09/01/15 Page 18 of 24 PagelD #: 108
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`infringe, and would not infringe any valid claim of the ’158 patent if made, used, sold, offered
`
`for sale, or marketed in the United States, or imported into the United States. Amneal’s actions
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`have not and would not induce anyone else to commit an act of infringement, nor would
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`Amneal’s activities or Proposed ANDA Products constitute contributory infringement, of any
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`claim of the ’ 158 patent.
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`25.
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`Counterclaim Plaintiff, Amneal has no adequate remedy at law and is entitled to a
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`declaratory judgment
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`that
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`the commercial manufacture, use, offer for sale, marketing, or
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`importation of Amneal’s Proposed ANDA Products do not, will not, and would not infringe any
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`valid claim of the ’ 158 patent.
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`COUNT 11 FOR DECLARATORY JUDGMENT OF
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`PATENT INVALIDITY OF THE ’158 PATENT
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`26.
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`Counterclaim Plaintiff Amneal repeats and incorporates the al