Case: 1:16-cv-00651 Document #: 10 Filed: 01/19/16 Page 1 of 24 PageID #:85
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`HOSPIRA, INC.,
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`Plaintiff,
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`FRESENIUS KABI USA, LLC
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`Defendant.
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`____________________________________:
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`C.A. No. 1:16-cv-00651
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`The Hon. Rebecca R. Pallmeyer, U.S.D.J.
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`ANSWER TO COMPLAINT, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS
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`
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`Defendant Fresenius Kabi USA, LLC (“Fresenius Kabi”) by and through its counsel,
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`answers the Complaint of Plaintiff Hospira, Inc., (“Plaintiff”) as follows:
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`PARTIES
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`1.
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`Hospira is a Delaware corporation with its principal place of business at 275
`North Field Drive, Lake Forest, Illinois 60045.
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`ANSWER: On information and belief, Fresenius Kabi admits the allegations in
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`paragraph 1.
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`2.
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`On information and belief, Defendant is a Delaware limited liability company
`with its principal place of business at Three Corporate Drive, Lake Zurich, IL
`60047.
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` ANSWER: Fresenius Kabi admits the allegations in paragraph 2.
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`NATURE OF THE ACTION
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`3.
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`This is a civil action for infringement of U.S. Patent Nos. 8,242,158 (the “’158
`patent,” (Ex. A); 8,338,470 (the “’470 patent”) (Ex. B); 8,455,527 (the “’527
`patent”) (Ex. C); and 8,648,106 (the “’106 patent”) (Ex. D) (collectively, the
`“Patents-in-suit”).
`
`ANSWER: Fresenius Kabi admits that Plaintiff’s Complaint is for patent infringement
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`of United States Patent Nos. 8,242,158 (“the ’158 patent,” a copy of which appears to be
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`attached to the Complaint as Exhibit A); 8,338,470 (“the ’470 patent,” a copy of which appears
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`to be attached to the Complaint as Exhibit B); 8,455,527 (“the ’527 patent,” a copy of which
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`appears to be attached to the Complaint as Exhibit C); and 8,648,106 (“the ’106 patent,” a copy
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`of which appears to be attached to the Complaint as Exhibit D), but denies that Plaintiff is
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`entitled to relief and denies any remaining allegations.
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`4.
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`This action is based upon the Patent Laws of the United States, 35 U.S.C. § 1 et
`seq. and arises out of the Defendant’s filing of Abbreviated New Drug
`Application (“ANDA”) No. 208129 seeking approval to market dexmedetomidine
`hydrochloride products (“Proposed Fresenius Dexmedetomidine Products”) prior
`to the expiration of the Patents-in-suit, which are assigned to Hospira and listed in
`the publication entitled Approved Drug Products with Therapeutic Equivalents
`(the “Orange Book”) as covering PRECEDEXTM.
`
`ANSWER: Fresenius Kabi admits that Plaintiff’s Complaint arises under the Patent
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`Laws of the United States based on Fresenius Kabi’s filing with the United States Food and Drug
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`Administration (“FDA”) of an Abbreviated New Drug Application (“ANDA”) seeking approval
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`to commercially market a generic version of PRECEDEX™, but denies that Plaintiff is entitled
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`to relief and denies any remaining allegations.
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`JURISDICTION AND VENUE
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`5.
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`This action arises under the Patent Laws of the United States, 35 U.S.C. § 1 et
`seq.
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`ANSWER: Paragraph 5 contains conclusions of law for which no response is required.
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`To the extent that a response is required, Fresenius Kabi admits that Plaintiff’s Complaint arises
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`under the Patent Laws of the United States.
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`6.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`1338(a).
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`ANSWER: Paragraph 6 contains conclusions of law for which no response is required.
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`To the extent that a response is required, Fresenius Kabi admits that this court has subject matter
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`jurisdiction for this matter.
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`‐2‐ 
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`7.
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`Defendant is subject to personal jurisdiction in this District by virtue of inter alia,
`its residence and conduct of business in this District. On information and belief,
`Defendant’s principal place of business is located in this District at Three
`Corporate Drive, Lake Zurich, IL 60047. On information and belief, among
`Defendant’s operations located in this District are its Corporate Headquarters, a
`Science, Production and Technology Center, Manufacturing facility, and
`Distribution Center. On information and belief, Defendant develops, formulates,
`manufactures, markets, and sells drug products throughout the United States,
`including Illinois, and Illinois is a likely destination of Defendant’s products. On
`information and belief, Defendant has purposely availed itself of the rights and
`benefits of the laws of the State of Illinois, and has engaged in substantial and
`continuous contacts with the State of Illinois. Defendant has a registered agent
`for service in the State of Illinois. Defendant has also previously filed
`Counterclaims in this District. See, e.g., Mylan Pharma Acquisition Ltd. v.
`Fresenius Kabi USA, LLC, No. 1:15-cv-06700.
`
`ANSWER: Paragraph 7 contains conclusions of law for which no response is required.
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`To the extent that a response is required, Fresenius Kabi does not object to personal jurisdiction
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`for this particular action. Fresenius Kabi admits that it has a principal place of business located
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`at Three Corporate Drive, Lake Zurich, IL 60047. Fresenius Kabi admits that it filed claims or
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`counterclaims in Mylan Pharma Acquisition Ltd. v. Fresenius Kabi USA, LLC, No. 1:15-cv-
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`06700. Fresenius Kabi denies the remaining allegations in paragraph 7.
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`8.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`ANSWER: Paragraph 8 contains conclusions of law for which no response is required.
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`To the extent that a response is required, Fresenius Kabi does not contest venue for this
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`particular action.
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`THE PATENTS-IN-SUIT
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`9.
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`The ’158 patent, entitled “Dexmedetomidine Premix Formulation,” was duly and
`legally issued by the USPTO on August 14, 2012. Hospira is the assignee and
`owner of the ’158 patent.
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`ANSWER: Fresenius Kabi admits that on its face the ’158 patent is titled
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`“Dexmedetomidine Premix Formulation,” and that the issue date of the ’158 patent is shown as
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`August 14, 2012. Fresenius Kabi denies all remaining allegations in paragraph 9.
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`‐3‐ 
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`10.
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`The ’470 patent, entitled “Dexmedetomidine Premix Formulation,” was duly and
`legally issued by the USPTO on December 25, 2012. Hospira is the assignee and
`owner of the ’470 patent.
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`ANSWER: Fresenius Kabi admits that on its face the ’470 patent is titled
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`“Dexmedetomidine Premix Formulation,” and that the issue date of the ’470 patent is shown as
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`December 25, 2012. Fresenius Kabi denies all remaining allegations in paragraph 10.
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`11.
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`The ’527 patent, entitled “Methods of Treatment Using a Dexmedetomidine
`Premix Formulation,” was duly and legally issued by the USPTO on June 4, 2013.
`Hospira is the assignee and owner of the ’527 patent.
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`ANSWER: Fresenius Kabi admits that on its face the ’527 patent is titled “Methods of
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`Treatment Using a Dexmedetomidine Premix Formulation,” and that the issue date of the ’527
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`patent is shown as June 4, 2013. Fresenius Kabi denies all remaining allegations in paragraph
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`11.
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`12.
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`The ’106 patent, entitled “Dexmedetomidine Premix Formulation,” was duly and
`legally issued by the USPTO on February 11, 2014. Hospira is the assignee and
`owner of the ’106 patent.
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`ANSWER: Fresenius Kabi admits that on its face the ’106 patent is titled
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`“Dexmedetomidine Premix Formulation,” and that the issue date of the ’106 patent is shown as
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`February 11, 2014. Fresenius Kabi denies all remaining allegations in paragraph 12.
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`13.
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`the Orange Book as covering
`in
`listed
`The Patents-in-suit are duly
`PRECEDEXTM. The claims of the Patents-in-suit cover various presentation of
`PRECEDEXTM and methods of using PRECEDEXTM.
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`ANSWER: Fresenius Kabi admits that the ’106 patent, the ’527 patent, the ’470
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`patent, and the ’158 patent are listed in the FDA publication, “Approved Drug Products with
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`Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to dexmedetomidine
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`hydrochloride injection. Fresenius Kabi denies all remaining allegations in paragraph 13.
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`14.
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`Hospira is the holder of New Drug Application (“NDA”) No. 21-038 for
`dexmedetomidine hydrochloride injection, sold in the United States under the
`trademark PRECEDEXTM. The United States Food and Drug Administration
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`‐4‐ 
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`(“FDA”) originally approved NDA No. 21-038 on December 17, 1999. On
`March 13, 2013 and November 14, 2014, the FDA approved amendments to
`Hospira’s NDA No. 21-038 for a premix formulation of PRECEDEXTM.
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`ANSWER: Fresenius Kabi admits that, according to the Orange Book, Hospira, Inc. is
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`listed as the applicant for NDA No. 21-038, which was approved December 17, 1999. Fresenius
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`Kabi lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations in paragraph 14, and therefore denies them.
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`ACTS GIVING RISE TO THIS ACTION
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`15.
`
`On information and belief, Defendant reviewed the Patents-in-suit and certain
`commercial and economic information regarding Hospira’s PRECEDEXTM and
`decided to file an ANDA seeking approval to market the Proposed Fresenius
`Dexmedetomidine Products.
`
`ANSWER: Fresenius Kabi admits that it reviewed the ’106 patent, the ’527 patent, the
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`’470 patent, and the ’158 patent and submitted an ANDA to the FDA seeking approval to market
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`a dexmedetomidine hydrochloride injection product. Fresenius Kabi denies the remaining
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`allegations in paragraph 15.
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`16.
`
`On December 17, 2015, Hospira received a letter dated December 4, 2015, from
`Defendant (“the Notice Letter”), notifying Hospira that Defendant had filed
`ANDA No. 208129 with the FDA under 21 U.S.C. § 355(j) (i.e., section 505(j) of
`the Federal Food, Drug, and Cosmetic Act (“FDCA”)), seeking approval to
`market the Proposed Fresenius Dexmedetomidine Products prior to the expiry of
`the Patents-in-suit.
`
`ANSWER: Fresenius Kabi admits that, on December 4, 2015, it sent a letter notifying
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`Plaintiff that Fresenius Kabi submitted ANDA No. 208129 with the FDA, seeking approval to
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`market a dexmedetomidine hydrochloride injection product prior to the expiration of the ’106
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`patent, the ’527 patent, the ’470 patent, and the ’158 patent. Fresenius Kabi denies all remaining
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`allegations in paragraph 16.
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`17.
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`The stated purpose of the Notice Letter was to notify Hospira that ANDA No.
`208129
`included a certification under 21 U.S.C. § 355(j)(2)9a)(vii)(IV)
`(“Paragraph IV Certification”) that the claims of the ’158 patent, the ’470 patent,
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`‐5‐ 
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`the ’527 patent, and the ’106 patent are invalid and/or that certain claims will not
`be infringed by Defendant.
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`ANSWER: Fresenius Kabi admits the allegations in paragraph 17.
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`18.
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`Included in the Notice Letter was a “detailed statement” of the alleged factual and
`legal basis for Defendant’s Paragraph IV Certification. With the exception of
`certain claims of the ’527 patent, the sole basis set forth in the detailed statement
`for Defendant’s Paragraph IV Certification was alleged invalidity.
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`ANSWER: Fresenius Kabi admits that the Notice Letter included a “detailed
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`statement” of the alleged factual and legal basis for Fresenius Kabi’s Paragraph IV Certification.
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`Fresenius Kabi denies all remaining allegations in paragraph 18.
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`19.
`
`As described in the Notice Letter, the Proposed Fresenius Dexmedetomidine
`Products are Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
`Injection, 4mcg/mL, in 20 mL, 50 mL, and 100 mL vials.
`
`ANSWER: Fresenius Kabi admits the allegations in paragraph 19.
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`20.
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`On information and belief, Defendant was aware of the Patents-in-suit when it
`filed ANDA No. 208129 with a Paragraph IV Certification.
`
`ANSWER: Fresenius Kabi admits the allegations in paragraph 20.
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`21.
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`Hospira received the Notice Letter on December 7, 2015. Hospira commenced
`this action within 45 days of receipt of the Notice Letter.
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`ANSWER: On information and belief, Fresenius Kabi admits the allegations in
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`paragraph 21.
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`COUNT I FOR INFRINGEMENT OF PATENT NO. 8,242,158
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`22.
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`Paragraphs 1 through 21 are incorporated herein as set forth above.
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`ANSWER: Fresenius Kabi repeats and incorporates by reference each of its answers
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`to paragraphs 1 through 21 as if fully set forth herein.
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`23.
`
`Defendant submitted ANDA No. 208129 with a Paragraph IV Certification to the
`FDA under section 505(j) of the FDCA to obtain approval to engage in the
`commercial manufacture, use, sale, offer for sale, and/or importation into the
`United States of the Proposed Fresenius Dexmedetomidine Products prior to the
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`‐6‐ 
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`expiration of the ’158 patent. By submitting this ANDA, Defendant committed
`an act of infringement under 36 U.S.C. § 271(e)(2).
`
`ANSWER: Fresenius Kabi admits it submitted ANDA No. 208129 with a Paragraph
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`IV Certification to the FDA seeking approval to engage in the commercial manufacture, use, or
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`sale of a dexmedetomidine hydrochloride injection product prior to the expiration of the ’158
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`patent. Fresenius Kabi denies the remaining allegations in paragraph 23.
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`24. Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`importation into the United States of the Proposed Dexmedetomidine Products
`described in ANDA No. 208129 would infringe the ’158 patent under 35 U.S.C. §
`271(a), (b), and/or (c). The Proposed Fresenius Dexmedetomidine hydrochloride
`and 0.9% sodium chloride in 20 mL, 50 mL, and 100 mL vials-meet each
`limitation of at least one claim of the ’158 patent. The Notice Letter does not
`allege non-infringement of any claim of the ’158 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 24.
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`25.
`
`In addition, Defendant’s actions and conduct, including providing information
`and instructions for use of its products in the proposed package insert to
`accompany the products, will also encourage direct infringement of the ’158
`patent by others.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 25.
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`26.
`
`On information and belief, Defendant was aware of the existence of the ’158
`patent prior to the filing of ANDA No. 208129, and took such action knowing it
`would constitute infringement of the ’158 patent.
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`ANSWER: Fresenius Kabi denies the allegations in paragraph 26.
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`27.
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`Hospira will be irreparably harmed if Defendant is not enjoined from infringing
`the ’158 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 27.
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`COUNT II FOR INFRINGEMENT OF PATENT NO. 8,338,470
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`28.
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`Paragraphs 1 through 21 are incorporated as set forth above.
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`ANSWER: Fresenius Kabi repeats and incorporates by reference each of its answers
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`to paragraphs 1 through 21 as if fully set forth herein.
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`‐7‐ 
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`29.
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`Defendant submitted ANDA No. 208129 with a Paragraph IV Certification to the
`FDA under section 505(j) of the FDCA to obtain approval to engage in the
`commercial manufacture, use, sale, offer for sale, and/or importation into the
`United States of the Proposed Fresenius Dexmedetomidine Products prior to the
`expiration of the ’470 patent. By submitting this ANDA, Defendant committed
`an act of infringement under 36 U.S.C. § 271(e)(2).
`
`ANSWER: Fresenius Kabi admits it submitted ANDA No. 208129 with a Paragraph
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`IV Certification to the FDA seeking approval to engage in the commercial manufacture, use, or
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`sale of a dexmedetomidine hydrochloride injection product prior to the expiration of the ’470
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`patent. Fresenius Kabi denies the remaining allegations in paragraph 29.
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`30. Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`importation into the United States of the Proposed Dexmedetomidine Products
`described in ANDA No. 208129 would infringe the ’470 patent under 35 U.S.C. §
`271(a), (b), and/or (c). The Proposed Fresenius Dexmedetomidine Products meets
`each limitation of at least one claim of the ’470 patent. The Notice Letter does
`not allege non-infringement of any claim of the ‘470 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 30.
`
`31.
`
`In addition, Defendant’s actions and conduct, including providing information
`and instructions for use of its products in the proposed package insert to
`accompany the products, will also encourage direct infringement of the ’470
`patent by others.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 31.
`
`32.
`
`On information and belief, Defendant was aware of the existence of the ’470
`patent prior to the filing of ANDA No. 208129, and took such action knowing it
`would constitute infringement of the ’470 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 32.
`
`33.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from infringing
`the ’470 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 33.
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`COUNT III FOR INFRINGEMENT OF PATENT NO. 8,455,527
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`34.
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`Paragraphs 1 through 21 are incorporated herein as set forth above.
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`‐8‐ 
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`ANSWER: Fresenius Kabi repeats and incorporates by reference each of its answers
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`to paragraphs 1 through 21 as if fully set forth herein.
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`35.
`
`Defendant submitted ANDA No. 208129 with a Paragraph IV Certification to the
`FDA under section 505(j) of the FDCA to obtain approval to engage in the
`commercial manufacture, use, sale, offer for sale, and/or importation into the
`United States of the Proposed Fresenius Dexmedetomidine Products prior to the
`expiration of the ’527 patent. By submitting this ANDA, Defendant committed
`an act of infringement under 36 U.S.C. § 271(e)(2).
`
`ANSWER: Fresenius Kabi admits it submitted ANDA No. 208129 with a Paragraph
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`IV Certification to the FDA seeking approval to engage in the commercial manufacture, use, or
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`sale of a dexmedetomidine hydrochloride injection product prior to the expiration of the ’527
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`patent. Fresenius Kabi denies the remaining allegations in paragraph 35.
`
`36. Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`importation into the United States of the Proposed Dexmedetomidine Products
`described in ANDA No. 208129 would infringe the ’470 patent under 35 U.S.C. §
`271(a), (b), and/or (c). The Proposed Fresenius Dexmedetomidine Products meets
`each limitation of at least one claim of the ’527 patent. With respect to most
`claims of the ’527 patent, the Notice Letter does not allege non-infringement.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 36.
`
`37.
`
`In addition, Defendant’s actions and conduct, including providing information
`and instructions for use of its products in the proposed package insert to
`accompany the products, will also encourage direct infringement of the ’527
`patent by others.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 37.
`
`38.
`
`On information and belief, Defendant was aware of the existence of the ’527
`patent prior to the filing of ANDA No. 208129, and took such action knowing it
`would constitute infringement of the ’527 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 38.
`
`39.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from infringing
`the ’527 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 39.
`
`
`
`
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`‐9‐ 
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`COUNT IV FOR INFRINGEMENT OF PATENT NO. 8,648,106
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`40.
`
`Paragraphs 1 through 21 are incorporated herein as set forth above.
`
`ANSWER: Fresenius Kabi repeats and incorporates by reference each of its answers
`
`to paragraphs 1 through 21 as if fully set forth herein.
`
`41.
`
`Defendant submitted ANDA No. 208129 with a Paragraph IV Certification to the
`FDA under section 505(j) of the FDCA to obtain approval to engage in the
`commercial manufacture, use, sale, offer for sale, and/or importation into the
`United States of the Proposed Fresenius Dexmedetomidine Products prior to the
`expiration of the ’106 patent. By submitting this ANDA, Defendant committed
`an act of infringement under 36 U.S.C. § 271(e)(2).
`
`ANSWER: Fresenius Kabi admits it submitted ANDA No. 208129 with a Paragraph
`
`IV Certification to the FDA seeking approval to engage in the commercial manufacture, use, or
`
`sale of a dexmedetomidine hydrochloride injection product prior to the expiration of the ’106.
`
`Fresenius Kabi denies the remaining allegations of paragraph 41.
`
`42. Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`importation into the United States of the Proposed Dexmedetomidine Products
`described in ANDA No. 208129 would infringe the ’470 patent under 35 U.S.C. §
`271(a), (b), and/or (c). The Proposed Fresenius Dexmedetomidine Products meets
`each limitation of at least one claim of the ’106 patent. The Notice Letter does
`not allege non-infringement of any claim of the ’106 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 42.
`
`43.
`
`In addition, Defendant’s actions and conduct, including providing information
`and instructions for use of its products in the proposed package insert to
`accompany the products, will also encourage direct infringement of the ’106
`patent by others.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 43.
`
`44.
`
`On information and belief, Defendant was aware of the existence of the ’106
`patent prior to the filing of ANDA No. 208129, and took such action knowing it
`would constitute infringement of the ’106 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 44.
`
`45.
`
`Hospira will be irreparably harmed if Defendant is not enjoined from infringing
`the ’106 patent.
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`‐10‐ 
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`ANSWER: Fresenius Kabi denies the allegations in paragraph 45.
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`PRAYER FOR RELIEF
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`Fresenius Kabi denies that Plaintiff is entitled to any relief.
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`AFFIRMATIVE DEFENSES
`
`First Affirmative Defense
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`The claims of the ’106 patent, the ’527 patent, the ’470 patent, and the ’158 patent are
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`invalid under one or more provisions of 35 U.S.C. §§ 101, 102, 103, and/or 112.
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`Second Affirmative Defense
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`
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`The manufacture, use, or sale of the drug product described in ANDA No. 208129 has
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`not infringed, and would not, if marketed, infringe, directly or indirectly, any valid claim of any
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`asserted patent.
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`Third Affirmative Defense
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`
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`Plaintiff is not entitled to relief because it has not appropriately pled, shown, nor proven
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`adequate standing for the relief sought.
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`Fourth Affirmative Defense
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`Plaintiff is estopped from arguing and has waived arguments that its claims cover
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`Fresenius Kabi’s product by virtue of amendment, positions, and arguments made to the USPTO
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`when obtaining the asserted patents.
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`Fifth Affirmative Defense
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`
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`Plaintiff is barred by 35 U.S.C. §§ 288 from recovering any costs associated with this
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`suit.
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`‐11‐ 
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`Reservation of Additional Defenses
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`Fresenius Kabi reserves the right to assert additional defenses that may be developed
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`through discovery, or otherwise, in this action.
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`COUNTERCLAIMS FOR DECLARATORY JUDGMENT
`
`
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`For its counterclaims against Plaintiff Hospira, Inc., (“Plaintiff” or “Counterclaim
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`Defendant”), Defendant Fresenius Kabi USA, LLC (“Fresenius Kabi”) states as follows:
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`THE PARTIES
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`1.
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`Fresenius Kabi is a limited liability company organized and existing under the
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`laws of Delaware, with a place of business at Three Corporate Drive, Lake Zurich, Illinois
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`60047.
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`2.
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`On information and belief, Plaintiff is a corporation organized and existing under
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`the laws of Delaware and having a place of business at 275 North Field Drive, Lake Forest,
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`Illinois 60045.
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`JURISDICTION AND VENUE
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`3.
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`These counterclaims arise under the Declaratory Judgment Act, 28 U.S.C. §§
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`2201 and 2202, and under the Patent Laws of the United States, Title 35 of the United States
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`Code.
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`4.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331, 1337, 1338(a), 2201 and 2202.
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`5.
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`Plaintiff is subject to personal jurisdiction in this judicial district because it
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`subjected itself to the jurisdiction of this Court by filing its Complaint here. Plaintiff is also
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`subject to personal jurisdiction in this district because it sells products here including the
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`PRECEDEXTM product that is the subject of this case, and because Plaintiff regularly practices
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`business here, and because Plaintiff has purposefully availed itself of the benefits of jurisdiction
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`in this State. Plaintiff is a resident of this judicial district.
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`6.
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`If Plaintiff is able to maintain venue in this action, then these counterclaims are
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`appropriately joined in the pending action.
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`BACKGROUND
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`7.
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`The United States Patent and Trademark Office (“USPTO”) issued U.S. Patent
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`No. 8,242,158 (“the ’158 patent), on August 14, 2012, naming Hospira, Inc. as the assignee on
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`the face of the patent.
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`8.
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`The USPTO issued U.S. Patent No. 8,338,470 (“the ’470 patent), on December
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`25, 2012, naming Hospira, Inc. as the assignee on the face of the patent.
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`9.
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`The USPTO issued U.S. Patent No. 8,455,527 (“the ’527 patent), on June 4, 2013,
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`naming Hospira, Inc. as the assignee on the face of the patent.
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`10.
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`The USPTO issued U.S. Patent No. 8,648,106 (“the ’106 patent), on February 11,
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`2014, naming Hospira, Inc. as the assignee on the face of the patent.
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`11.
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`Upon information and belief, Hospira, Inc., holds approved New Drug
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`Application (“NDA”) No. 21-038 for dexmedetomidine hydrochloride injection, marketed as
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`PRECEDEXTM.
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`12.
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`The Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C. § 301 et seq.,
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`as amended by the Hatch-Waxman Amendments, sets forth the rules that the Food and Drug
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`Administration (“FDA”) follows when considering whether to approve the marketing of both
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`brand-name and generic drugs.
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`13.
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`Under the FFDCA, an applicant seeking to market a new brand-name drug must
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`prepare an NDA for consideration by the FDA. See 21 U.S.C. § 355.
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`14.
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`An NDA may include, among other things, the number of any patent that claims
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`the “drug” or a “method of using [the] drug” for which the NDA was submitted and for which a
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`claim of patent infringement could reasonably be asserted against an authorized party. See 21
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`U.S.C. § 355(b)(I), -(c)(2); 21 C.F.R. § 314.53(b), -(c)(2).
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`15.
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`On request from an NDA holder, the FDA automatically lists the NDA holder’s
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`disclosed patents pursuant to 21 U.S.C. §§ 355(b)(1) and (c)(2) in the publication Approved
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`Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange
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`Book.” The FDA does not evaluate whether the claims of the disclosed patents actually cover
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`the drug or method of using such drug, or whether the patent is valid; its actions are “purely
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`ministerial.” aaiPharma Inc. v. Thompson, 296 F.3d 227, 243 (4th Cir. 2002).
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`16.
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`Plaintiff caused to be listed the ’158 patent, the ’470 patent, the ’527 patent, and
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`the ’106 patent in the Orange Book in connection with NDA No. 21-038.
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`17.
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`Fresenius Kabi filed ANDA No. 208129 seeking FDA approval to market its
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`formulation of dexmedetomidine hydrochloride for injection (“Fresenius Kabi’s ANDA
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`product”), and made reference to NDA No. 21-038. As part of Fresenius Kabi’s ANDA,
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`Fresenius Kabi submitted a certification pursuant to 21 U.S.C. § 355(b)(2)(A)(vii)(IV),
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`commonly called a “paragraph IV certification,” that the ’158 patent, the ’470 patent, the ’527
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`patent, and the ’106 patent are invalid, unenforceable, and/or not infringed by Fresenius Kabi’s
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`ANDA product.
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`18.
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`On December 4, 2015, Fresenius Kabi sent a letter to Plaintiff notifying it that
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`Fresenius Kabi had submitted ANDA No. 208129 for dexmedetomidine hydrochloride injection
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`and that the ANDA contained a paragraph IV certification that the ’158 patent, the ’470 patent,
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`the ’527 patent, and the ’106 patent are invalid, unenforceable, and/or not infringed by Fresenius
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`Kabi’s ANDA product (the “Notice Letter”). The Notice Letter is incorporated by reference,
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`including its detailed description of facts and circumstances sufficient to show that the claims of
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`the ’158 patent, the ’470 patent, the ’527 patent, and the ’106 patent are invalid and/or not
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`infringed.
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`19.
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`The Notice Letter contained an offer of confidential access to relevant portions of
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`ANDA No. 208129 so that Plaintiff could obtain more information if desired to determine
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`whether Fresenius Kabi’s ANDA product would infringe any valid claim of the Orange Book-
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`listed patents, pursuant to 21 U.S.C. § 355(c)(3)(D)(i)(III).
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`20.
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`On information and belief, the Notice Letter was received by Plaintiff on or about
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`December 7, 2015.
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`21.
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`The receipt of the Notice Letter started a statutory 45-day period within which
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`Plaintiff could trigger an automatic thirty-month stay on the approval of Fresenius Kabi’s ANDA
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`No. 208129 by the FDA. 21 U.S.C. § 355(c)(3)(c). The stay is entered by the FDA without
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`consideration of the merits of the litigation claims.
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`22.
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`On January 15, 2016, Plaintiff sued Fresenius Kabi alleging infringement of the
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`’158 patent, the ’470 patent, the ’527 patent, and the ’106 patent. There has been and is now an
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`actual and justiciable controversy between Fresenius Kabi and Plaintiff as to whether the product
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`described in ANDA No. 208129 infringes, induces infringement, or contributes to the
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`infringement of any valid enforceable claim of the ’158 patent, the ’470 patent, the ’527 patent,
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`and the ’106 patent.
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`COUNT I: NON-INFRINGEMENT OF THE ’158 PATENT
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`23.
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`Fresenius Kabi re-alleges and incorporates the allegations of paragraphs 1-22 as if
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`fully set forth herein.
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`24.
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`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C. §
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`1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
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`declaration that no valid claim of the ’158 patent will be infringed by the manufacture, use, sale,
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`offer for sale, or importation into the United States of Fresenius Kabi’s ANDA product described
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`by ANDA No. 208129.
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`25.
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`In the Notice Letter, Fresenius Kabi explained reasons sufficient to show that the
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`ANDA does not infringe the ’158 patent.
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`26.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the manufacture, use, sale, offering for sale, or importation of Fresenius Kabi’s ANDA
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`product described by ANDA No. 208129 will infringe any valid and enforceable claim of the
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`’158 patent.
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`27.
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`Fresenius Kabi is entitled to a judicial declaration that the manufacture, use, sale,
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`offering for sale, or importation of Fresenius Kabi’s ANDA product described by ANDA No.
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`208129 will not infringe, directly or indirectly, any valid claim of the ’158 patent.
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`COUNT II: INVALIDITY OF THE ’158 PATENT
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`28.
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`Fresenius Kabi re-alleges and incorporates the allegations of paragraphs 1-22 as if
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`fully set forth herein.
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`29.
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`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C. §
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`1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
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`declaration that the claims of the ’158 patent are invalid for failure to comply with the statutory
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`prerequisites of Title 35 of the United States Code, including without limitation, one or more of
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`§§ 101, 102, 103, and/or 112, or other judicially-created bases for invalidation and
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`unenforceability.
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`Case: 1:16-cv-00651 Document #: 10 Filed: 01/19/16 P