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`Exhibit 2
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`
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`HOSPIRA, INC.,
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`
`Plaintiff,
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`Defendant.
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`Civil Action No. 17-cv-7903
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`Hon. Thomas M. Durkin
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`
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`v.
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`FRESENIUS KABI USA, LLC
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`
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`FRESENIUS KABI’S ANSWER TO COMPLAINT,
`AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS
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`Defendant Fresenius Kabi USA, LLC, by and through its counsel, answers the Complaint
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`of Plaintiff Hospira, Inc. as follows.
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`PARTIES
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`1. 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
`
`paragraph 1.
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`2. 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: Admitted.
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`NATURE OF THE ACTION
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`3. This is a civil action for infringement of U.S. Patent No. 9,616,049 (the “’049
`patent”) (Ex. A) (the “Patent-in-suit”).
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`ANSWER: Fresenius Kabi admits that Hospira’s Complaint is for patent infringement
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`of U.S. Patent No. 9,616,049 (“the ’049 patent”), a copy of which appears to be attached to the
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`Complaint as Exhibit A, but denies that Hospira is entitled to relief and denies any remaining
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`allegations.
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`4. 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 Patent-
`in-suit, which is assigned to Hospira and listed in the publication entitled Approved Drug
`Products with Therapeutic Equivalents (the “Orange Book”) as covering PRECEDEX™.
`
`ANSWER: Fresenius Kabi admits that Hospira’s Complaint arises under the Patent
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`Laws of the United States based on Fresenius Kabi’s lawful filing within the United States Food
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`and Drug Administration (“FDA”) of an Abbreviated New Drug Application (“ANDA”) seeking
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`approval to commercially market its ANDA product which references the NDA for
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`PRECEDEX™.
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`JURISDICTION AND VENUE
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`5. 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 Hospira’s Complaint arises
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`under the Patent Laws of the United States.
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`6. 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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`7. 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, a Manufacturing facility, and a 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
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`2
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`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. Moreover, there is existing litigation between
`Defendant and Hospira related to patents covering certain dexmedetomidine
`hydrochloride products in this District.
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`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 at
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`Three Corporate Drive, Lake Zurich, IL 60047. Fresenius Kabi admits that there is existing
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`litigation between Fresenius Kabi and Hospira related to patents listed in the Orange Book by
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`Hospira as covering the same product at issue in this litigation. Fresenius Kabi denies the
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`remaining allegations in paragraph 7.
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`8. 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 PATENT-IN-SUIT
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`9. The ’049 patent, entitled “Dexmedetomidine Premix Formulation,” was duly and
`legally issued by the USPTO on April 11, 2017. Hospira is the assignee and owner of the
`’049 patent.
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`ANSWER: Fresenius Kabi admits that on its face, the ’049 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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`April 11, 2017—after Fresenius Kabi submitted its ANDA No. 208129 to the FDA. Fresenius
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`Kabi admits that the assignee on the face of the patent is HOSPIRA, INC. Fresenius Kabi denies
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`all remaining allegations in paragraph 9.
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`10. The Patent-in-suit is duly listed in the Orange Book as covering PRECEDEX™. The
`claims of the Patent-in-suit cover various presentations of PRECEDEX™.
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`3
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`ANSWER: Fresenius Kabi admits that the ’049 patent is listed in the FDA publication,
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`“Approved Drug Products with Therapeutic Equivalence Evaluation” (“the Orange Book”), with
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`respect to dexmedetomidine hydrochloride injection. Fresenius Kabi denies all remaining
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`allegations in paragraph 10.
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`11. Hospira is the holder of New Drug Application (“NDA”) No. 21-038 for
`dexmedetomidine hydrochloride injection, sold in the United States under the trademark
`PRECEDEX™. The United States Food and Drug Administration (“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 PRECEDEX™.
`
`ANSWER: Fresenius Kabi admits that, according to the Orange Book, Hospira, Inc. is
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`listed as the current applicant for NDA No. 21-138, which was approved December 17, 1999.
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`Fresenius Kabi lacks knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations in paragraph 11, and therefore denies them.
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`ACTS GIVING RISE TO THIS ACTION
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`12. On October 10, 2017, Hospira received a letter dated October 9, 2017, from
`Defendant (“the Notice Letter”), notifying Hospira that Defendant had previously 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 Patent-in-suit.
`
`ANSWER: Fresenius Kabi admits that on or about October 9, 2017 it sent a letter
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`notifying Hospira that Fresenius Kabi had previously submitted ANDA No. 208129 with the
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`FDA, seeking approval to market a dexmedetomidine hydrochloride injection product before
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`expiry of the ’049 patent. Fresenius Kabi denies all remaining allegations of paragraph 12.
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`13. 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)(a)(vii)(IV) (“Paragraph IV
`Certification”) that the claims of the ’049 patent are invalid.
`
`ANSWER: Fresenius Kabi admits that the stated purpose of the Notice Letter was to
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`notify that ANDA No. 208129 included a certification under 21 U.S.C. § 355(j)(2)(a)(vii)(IV)
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`4
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`(“Paragraph IV Certification”) that no valid and enforceable claim of the ’049 patent will be
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`infringed by Fresenius Kabi’s ANDA product. Fresenius Kabi denies all remaining allegations
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`of paragraph 13.
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`14. Included in the Notice Letter was a description of the Proposed Fresenius
`Dexmedetomidine Products as well as a “detailed statement” of the alleged factual and
`legal basis for Defendant’s Paragraph IV Certification. The sole basis set forth in the
`detailed statement for Defendant’s Paragraph IV Certification is alleged invalidity.
`
`ANSWER: Fresenius Kabi admits that the Notice Letter contained a “detailed
`
`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 14.
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`15. The Proposed Fresenius Dexmedetomidine Products meet each limitation of at least
`one claim of the ’049 patent.
`
`ANSWER: Fresenius Kabi denies the allegations of paragraph 15.
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`16. On information and belief, Defendant was aware of Hospira’s patents related to
`dexmedetomidine products when it filed ANDA No. 208129. Defendant was further
`aware of the ’049 patent when it submitted its updated Paragraph IV Certification.
`
`ANSWER: Fresenius Kabi admits that it was aware of other patents assigned to Hospira
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`when it filed ANDA No. 208129 in 2015, but that the ’049 patent had not issued at that time.
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`Fresenius Kabi admits it was aware of the ’049 patent when it submitted its updated Paragraph
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`IV Certification. Fresenius Kabi denies all remaining allegations in paragraph 16.
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`COUNT I FOR INFRINGEMENT OF PATENT NO. 9,616,049
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`17. Paragraphs 1 through 18 [sic] are incorporated herein as set forth above.
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`ANSWER: Fresenius Kabi repeats and incorporates by reference each of its answers to
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`paragraphs 1 through 16 as if fully set forth herein.
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`18. 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 ’049 patent.
`Defendant committed an act of infringement under 35 U.S.C. § 271(e)(2).
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`5
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`ANSWER: Fresenius Kabi admits it submitted ANDA No. 208129 to the FDA before
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`the ’049 patent issued. Fresenius Kabi further admits that after the ’049 patent issued it
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`submitted an updated Paragraph IV Certification to the FDA seeking approval to engage in the
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`commercial manufacture, use, or sale of a dexmedetomidine hydrochloride injection product
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`prior to the expiration of the ’049 patent. Fresenius Kabi denies the remaining allegations of
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`paragraph 18.
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`19. Moreover, any commercial manufacture, use, sale, offer for sale, and/or importation
`into the United States of the Proposed Fresenius Dexmedetomidine Products described in
`ANDA No. 208129 would infringe the ’049 patent under 35 U.S.C. § 271(a), (b), and/or
`(c). The Notice Letter does not allege non-infringement of any claim of the ’049 patent.
`The Proposed Fresenius Dexmedetomidine Products, according to the Notice Letter, meet
`each limitation of at least one claim of the ’049 patent.
`
`ANSWER: Fresenius Kabi denies the allegations in paragraph 19.
`
`20. 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 ’049 patent by others.
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`ANSWER: Fresenius Kabi denies the allegations in paragraph 20.
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`21. Defendant was aware of the existence of the Hospira patents related to
`dexmedetomidine products prior to the filing of ANDA No. 208129, and provided
`Hospira with Defendant’s Paragraph IV Certification knowing it would constitute
`infringement of the ’049 patent.
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`ANSWER: Fresenius Kabi denies the allegations in paragraph 21.
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`22. Hospira will be irreparably harmed if Defendant is not enjoined from infringing the
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`’049 patent.
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`ANSWER: Fresenius Kabi denies the allegations in paragraph 22.
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`PRAYER FOR RELIEF
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`Fresenius Kabi denies that Hospira is entitled to any relief.
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`6
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`AFFIRMATIVE DEFENSES
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`First Affirmative Defense
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`The claims of the ’049 patent are invalid under one or more provisions of 35 U.S.C.
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`§§ 101, 102, 103, 112, and/or other judicially-created bases of invalidity.
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`Second Affirmative Defense
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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 directed or indirectly any valid claim of the
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`’049 patent.
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`Third Affirmative Defense
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`Hospira 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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`Hospira 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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`Hospira is barred by 35 U.S.C. § 288 from recovering any costs associated with this suit.
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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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`7
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`COUNTERCLAIMS FOR DECLARATORY JUDGMENT
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`For its counterclaims against Hospira, Inc. (“Hospira” or “Counterclaim Defendant”),
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`Fresenius Kabi USA, LLC 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, Hospira 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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`Hospira 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. Hospira is also
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`subject to personal jurisdiction in this district because it sells products here including the
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`PRECEDEX™ product that is the subject of this case, and because Hospira regularly practices
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`business here, and because Hospira has purposefully availed itself of the benefits of jurisdiction
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`in this State. Hospira is a resident of this judicial district.
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`6.
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`If Hospira 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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`8
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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. 9,616,049 (“the ’049 patent”) on April 11, 2017, naming Hospira, Inc. as the assignee on the
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`face of the patent.
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`8.
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`The USPTO issued U.S. Patent No. 9,320,712 (“the ’712 patent”) on April 26,
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`2016, naming Hospira, Inc. as the assignee on the face of the patent.
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`9.
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`Upon information and belief, Hospira holds approved New Drug Application
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`(“NDA”) No. 21-038 for dexmedetomidine hydrochloride injection, marketed as PRECEDEX™.
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`10.
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`The FDA approved NDA No. 21-038 on December 17, 1999. According to the
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`originally approved label for NDA No. 21-038, PRECEDEX™ was manufactured and
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`distributed by Abbott Laboratories and licensed from Orion Corporation. Upon information and
`
`belief, Abbott Laboratories licensed dexmedetomidine hydrochloride injection from Orion
`
`Corporation in 1994. See, e.g., Press Release, “Abbott Laboratories Receives FDA Approval For
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`Precedex™ (Dexmedetomidine Hydrochloride Injection)” (Dec. 20, 1999), available at:
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`http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=7260. Upon information
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`and belief, as part of the license Orion transferred its Investigational New Drug Application
`
`(“IND”) for dexmedetomidine, NDA No. 21-038, and research and development materials to
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`Abbott Laboratories for valuable consideration. See, e.g., Press Release, “Orion’s
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`Dexmedetomidine Approved in the USA for Sedation of Patients in Intensive Care. Abbott to
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`Launch Early 2000” (Dec. 21, 1999), available at:
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`http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=29987.
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`11.
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`Upon information and belief, Hospira spun off from Abbott Laboratories as a new
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`corporate entity in or around 2004. Upon information and belief, as part of the spin-off
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`transaction, Hospira acquired NDA No. 21-038 from Abbott Laboratories. Upon information
`9
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`and belief, in exchange for, among other things, NDA No. 21-038, related regulatory filings such
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`as IND filed for dexmedetomidine, intellectual property, and data and know-how related to
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`dexmedetomidine Hospira provided equity to shareholders of Abbott Laboratories.
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`12.
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`Upon information and belief, the terms of the spin off between Abbott
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`Laboratories and Hospira were publicly filed with the Securities and Exchange Commission
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`(“SEC”) and made available to the public in regulatory filings. For example, in Hospira’s Form
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`10-Q Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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`for the quarterly period ended March 31, 2004, Hospira reports that:
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`Hospira, Inc. (“Hospira” or the “Company”) was incorporated in Delaware as a
`wholly owned subsidiary of Abbott Laboratories (“Abbott”) on September 16,
`2003, as part of a previously announced plan by Abbott to create a separate
`company relating to the manufacture and sale of hospital products, including
`specialty injectable pharmaceuticals, medication delivery systems and injectable
`pharmaceutical contract manufacturing. Hospira is comprised of most of
`Abbott’s Hospital Products segment and a portion of Abbott’s International
`segment.
`
`On April 30, 2004 (the “distribution date”), Abbott transferred the assets and
`liabilities comprising Hospira to the Company, except as noted below, and
`distributed all of the shares of the Company’s common stock to Abbott
`shareholders in the form of a dividend of one share of the Company’s common
`stock, and the associated preferred stock purchase right, for every ten Abbott
`common shares.
`
`Hospira Form 10-Q (filed May 27, 2004), available at
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`https://www.sec.gov/Archives/edgar/data/1274057/000110465904015693/a04-6330_110q.htm.
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`13.
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`Upon information and belief, some terms of the spin-off between Abbott
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`Laboratories and Hospira were public. For example, attached to Hospira’s May 10, 2004 10-Q
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`filing is Exhibit 2.1, identified as the Separation and Distribution Agreement by and between
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`Abbott Laboratories and Hospira, Inc., dated April 12, 2004 (“Separation Agreement”), available
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`at: https://www.sec.gov/Archives/edgar/data/1274057/000110465904015693/a04-
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`6330_1ex2d1.htm. Upon information and belief, the Separation Agreement included terms
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`10
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`transferring the rights and regulatory filings related to PRECEDEX™ as part of the transfer of
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`Hospira Products and Hospira Business.
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`14.
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`Upon information and belief, Hospira assumed control of NDA No. 21-038 and
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`the IND related to dexmedetomidine in or around 2004 after the spin-off from Abbott
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`Laboratories. Upon information and belief, Hospira assumed the role of Abbott Laboratories in
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`intellectual property licenses, and supply and/or development agreements related to
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`dexmedetomidine in or around 2004 after the spin-off from Abbott. Upon information and
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`belief, as part of the terms of the Separation Agreement, Abbott Laboratories transferred to
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`Hospira physical or digital copies of the papers, reports, and submissions to the FDA, and
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`correspondence to and from the FDA related to dexmedetomidine products, including
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`PRECEDEX™.
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`15.
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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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`16.
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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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`17.
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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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`18.
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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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`11
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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 the
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`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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`19.
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`Hospira caused the ’049 patent and the ’712 patent to be listed in the Orange
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`Book in connection with NDA No. 21-038.
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`20.
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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. At the time Fresenius Kabi filed its ANDA
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`No. 208129, neither the ’049 patent nor the ’712 patent had issued by the USPTO.
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`21.
`
`After the FDA listed the ’712 patent in the Orange Book, Fresenius Kabi sent and
`
`updated certification pursuant to 21 U.S.C. § 355(b)(2)(A)(vii)(IV), commonly called a
`
`“paragraph IV certification,” that the ’712 patent is invalid, unenforceable, and/or not infringed
`
`by Fresenius Kabi’s ANDA Product.
`
`22.
`
`Fresenius Kabi sent a letter to Hospira notifying it that Fresenius Kabi had
`
`submitted an updated paragraph IV certification for ANDA No. 208129 that the ’712 patent is
`
`invalid, unenforceable, and/or not infringed by Fresenius Kabi’s ANDA Product (“the First
`
`Updated Notice Letter”). The First Updated Notice Letter is incorporated by reference,
`
`including its detailed description of facts and circumstances sufficient to show that the claims of
`
`the ’712 patent are invalid, and therefore not infringed.
`
`23.
`
`The First Updated Notice Letter contained an offer of confidential access to
`
`relevant portions of ANDA No. 208129 so that Hospira could obtain more information if desired
`
`
`
`12
`
`

`

`
`
`Case: 1:17-cv-07903 Document #: 18 Filed: 12/01/17 Page 13 of 19 PageID #:71Case: 1:16-cv-00651 Document #: 72-2 Filed: 12/04/17 Page 14 of 20 PageID #:2414
`
`to determine whether Fresenius Kabi’s ANDA product would infringe any valid claim of the
`
`Orange Book-listed patents, pursuant to 21 U.S.C. § 355(c)(3)(D)(i)(III).
`
`24.
`
`On information and belief, the First Updated Notice Letter was received by
`
`Hospira.
`
`25.
`
`After the FDA listed the ’049 patent in the Orange Book, Fresenius Kabi sent and
`
`updated certification pursuant to 21 U.S.C. § 355(b)(2)(A)(vii)(IV), commonly called a
`
`“paragraph IV certification,” that the ’049 patent is invalid, unenforceable, and/or not infringed
`
`by Fresenius Kabi’s ANDA Product.
`
`26.
`
`On October 9, 2017, Fresenius Kabi sent a letter to Hospira notifying it that
`
`Fresenius Kabi had submitted an updated paragraph IV certification for ANDA No. 208129 that
`
`the ’049 patent is invalid, unenforceable, and/or not infringed by Fresenius Kabi’s ANDA
`
`Product (“the Second Updated Notice Letter”). The Second Updated Notice Letter is
`
`incorporated by reference, including its detailed description of facts and circumstances sufficient
`
`to show that the claims of the ’049 patent are invalid, and therefore not infringed.
`
`27.
`
`The Second Updated Notice Letter contained an offer of confidential access to
`
`relevant portions of ANDA No. 208129 so that Hospira could obtain more information if desired
`
`to determine whether Fresenius Kabi’s ANDA product would infringe any valid claim of the
`
`Orange Book-listed patents, pursuant to 21 U.S.C. § 355(c)(3)(D)(i)(III).
`
`28.
`
`On information and belief, the Second Updated Notice Letter was received by
`
`Hospira on or about October 10, 2017.
`
`29.
`
`On November 1, 2017, Hospira sued Fresenius Kabi alleging infringement of the
`
`’049 patent. More than 45 days have passed since Hospira received the First Updated Notice
`
`Letter, but Hospira has not alleged infringement of the ’712 patent. The claims of the ’712
`
`
`
`13
`
`

`

`
`
`Case: 1:17-cv-07903 Document #: 18 Filed: 12/01/17 Page 14 of 19 PageID #:72Case: 1:16-cv-00651 Document #: 72-2 Filed: 12/04/17 Page 15 of 20 PageID #:2415
`
`patent closely resemble claims that have been asserted against Fresenius Kabi in the related
`
`litigation, Hospira, Inc. v. Fresenius Kabi USA, LLC, No. 1:16-cv-00651 (N.D. Ill.). There has
`
`been and is now an actual and justiciable controversy between Fresenius Kabi and Hospira as to
`
`whether the product described in ANDA No. 2018129 infringes, induces infringement, or
`
`contributes to the infringement of any valid enforceable claim of the ’049 patent and the ’712
`
`patent.
`
`COUNT I: NON-INFRINGEMENT OF THE ’049 PATENT
`
`30.
`
`Fresenius Kabi re-alleges and incorporates the allegations of paragraphs 1–29 as
`
`if fully set forth herein.
`
`31.
`
`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C.
`
`§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
`
`declaration that no valid claim of the ’049 patent will be infringed by the manufacture, use, sale,
`
`offer for sale, or importation into the United States of Fresenius Kabi’s ANDA product described
`
`by ANDA No. 208129.
`
`32.
`
`In the Second Updated Notice Letter, Fresenius Kabi explained reasons sufficient
`
`to show that the ANDA does not infringe any valid claim of the ’049 patent.
`
`33.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the manufacture, use, sale, offering for sale, or importation of Fresenius Kabi’s ANDA
`
`product described by ANDA No. 208129 will infringe any valid and enforceable claim of the
`
`’049 patent.
`
`34.
`
`Fresenius Kabi is entitled to a judicial declaration that the manufacture, use, sale,
`
`offering for sale, or importation of Fresenius Kabi’s ANDA product described by ANDA No.
`
`208129 will not infringe, directly or indirectly, any valid claim of the ’049 patent.
`
`
`
`14
`
`

`

`
`
`Case: 1:17-cv-07903 Document #: 18 Filed: 12/01/17 Page 15 of 19 PageID #:73Case: 1:16-cv-00651 Document #: 72-2 Filed: 12/04/17 Page 16 of 20 PageID #:2416
`
`COUNT II: INVALIDITY OF THE ’049 PATENT
`
`35.
`
`Fresenius Kabi re-alleges and incorporates the allegations of paragraphs 1-34 as if
`
`fully set forth herein.
`
`36.
`
`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C.
`
`§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
`
`declaration that the claims of the ’049 patent are invalid for failure to comply with the statutory
`
`prerequisites of Title 35 of the United States Code, including without limitation, one or more of
`
`§§ 101, 102, 103, and/or 112, or other judicially-created bases for invalidation and
`
`unenforceability.
`
`37.
`
`In the Second Updated Notice Letter, Fresenius Kabi explained reasons sufficient
`
`to show that the claims of the ’049 patent are invalid, yet Hospira brought this case anyway.
`
`38.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the manufacture, use, sale, offering for sale, or importation of Fresenius Kabi’s ANDA
`
`product described by ANDA No. 208129 will infringe any valid and enforceable claim of the
`
`’049 patent.
`
`39.
`
`Fresenius Kabi is entitled to a judicial declaration that the claims of the ’049
`
`patent are invalid for failure to comply with the statutory prerequisites of Title 35 of the United
`
`States Code, including without limitation, one or more of §§ 101, 102, 103, and/or 112 or other
`
`judicially-created bases for invalidation and unenforceability.
`
`COUNT III: NON-INFRINGEMENT OF THE ’712 PATENT
`
`40.
`
`Fresenius Kabi re-alleges and incorporates the allegations of paragraphs 1–39 as
`
`if fully set forth herein.
`
`41.
`
`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C.
`
`§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
`
`
`
`15
`
`

`

`
`
`Case: 1:17-cv-07903 Document #: 18 Filed: 12/01/17 Page 16 of 19 PageID #:74Case: 1:16-cv-00651 Document #: 72-2 Filed: 12/04/17 Page 17 of 20 PageID #:2417
`
`declaration that no valid claim of the ’712 patent will be infringed by the manufacture, use, sale,
`
`offer for sale, or importation into the United States of Fresenius Kabi’s ANDA product described
`
`by ANDA No. 208129.
`
`42.
`
`In the First Updated Notice Letter, Fresenius Kabi explained reasons sufficient to
`
`show that the ANDA does not infringe any valid claim of the ’712 patent.
`
`43.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the manufacture, use, sale, offering for sale, or importation of Fresenius Kabi’s ANDA
`
`product described by ANDA No. 208129 will infringe any valid and enforceable claim of the
`
`’712 patent.
`
`44.
`
`Fresenius Kabi is entitled to a judicial declaration that the manufacture, use, sale,
`
`offering for sale, or importation of Fresenius Kabi’s ANDA product described by ANDA No.
`
`208129 will not infringe, directly or indirectly, any valid claim of the ’712 patent.
`
`COUNT IV: INVALIDITY OF THE ’712 PATENT
`
`45.
`
`Fresenius Kabi re-alleges and incorporates the allegations of paragraphs 1-44 as if
`
`fully set forth herein.
`
`46.
`
`This counterclaim arises under the Patent Laws of the United States, 35 U.S.C.
`
`§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and seeks a
`
`declaration that the claims of the ’712 patent are invalid for failure to comply with the statutory
`
`prerequisites of Title 35 of the United States Code, including without limitation, one or more of
`
`§§ 101, 1