Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 1 of 9 PageID #: 273
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BAXTER HEALTHCARE CORPORATION,
`
` Plaintiff,
`
`v.
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`HOSPIRA, INC. and ORION CORP.,
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` Defendants.
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`)
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`)
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`C.A. No. 18-303-RGA
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`PLAINTIFF’S ANSWER TO DEFENDANTS’ COUNTERCLAIM
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`OF COUNSEL:
`
`Neal Seth
`Lawrence M. Sung
`Bethany A. Corbin
`WILEY REIN, LLP
`1776 K St. NW
`Washington, DC 20006
`(202) 719-7000
`
`
`
`
`
`Dated: April 10, 2018
`
`Philip A. Rovner (#3215)
`Jonathan A. Choa (#5319)
`Alan R. Silverstein (#5066)
`POTTER ANDERSON & CORROON LLP
`Hercules Plaza
`P.O. Box 951
`Wilmington, DE 19899
`(302) 984-6000
`provner@potteranderson.com
`jchoa@potteranderson.com
`asilverstein@potteranderson.com
`
`Attorneys for Plaintiff
`Baxter Healthcare Corporation
`
`PUBLIC VERSION
`
`Public version dated: April 17, 2018
`
`

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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 2 of 9 PageID #: 274
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`Plaintiff Baxter Healthcare Corporation (“Baxter”), through counsel, hereby answers the
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`March 20, 2018 Counterclaim of Defendants Hospira, Inc. (“Hospira”) and Orion Corp. (“Orion”)
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`(collectively, “Defendants”).
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`Parties, Jurisdiction, and Venue
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`Baxter has filed a Complaint against Defendants seeking, among other things, a
`1.
`judgment that Baxter does not infringe U.S. Patent No. 6,716,867 (“the ‘867 Patent”). An
`immediate and justiciable controversy exists between Baxter and Defendants regarding the
`infringement and validity of the ‘867 patent.
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`RESPONSE: Baxter admits that it filed a Complaint against Defendants seeking a judgment of
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`noninfringement regarding U.S. Patent No. 6,716,867 (“the ’867 Patent”), and that an immediate
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`and justiciable controversy exists between Baxter and Defendants regarding infringement of the
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`’867 Patent. Baxter denies that a controversy exists regarding the validity of the ’867 Patent.
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`This Counterclaim arises under the patent laws of the United States, 35 U.S.C. § 1
`2.
`et seq., and the Federal Food, Drug and Cosmetic Act.
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, Baxter admits that Defendants’ Counterclaim purports to arise
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`under the laws cited in this paragraph.
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`Subject matter jurisdiction in this Court is proper under, among other things, 28
`3.
`U.S.C. §§ 1331 and 1338.
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, admitted.
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`Hospira is a Delaware corporation with its principal place of business at 275 North
`4.
`Field Drive, Lake Forest, Illinois 60045.
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`RESPONSE: Admitted, on information and belief.
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`Orion is a corporation organized under the laws of Finland, with its principal place
`5.
`of business at Orionintie IA, FI-02200 Espoo, Finland.
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`RESPONSE: Admitted, on information and belief.
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`

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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 3 of 9 PageID #: 275
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`On information and belief, Baxter Healthcare Corporation is a corporation
`6.
`incorporated in Delaware with its principal place of business at One Baxter Parkway, Deerfield,
`IL 60015.
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`RESPONSE: Admitted.
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`This Court has personal jurisdiction over Baxter because, among other things,
`7.
`Baxter is incorporated in this District and Baxter has submitted to the jurisdiction of this Court by
`filing its Complaint with this Court.
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, Baxter admits that this Court has personal jurisdiction for
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`purposes of this action only.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400 because, among
`8.
`other things, Baxter is incorporated in this District and selected this venue by filing its Complaint
`with this Court.
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, Baxter admits that venue is proper for purposes of this action
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`only.
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`The ‘867 Patent
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`The ‘867 patent, entitled “Use of Dexmedetomidine for ICU Sedation,” was duly
`9.
`and legally issued by the USPTO on April 6, 2004.
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, Baxter admits that the ’867 Patent is entitled “Use of
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`Dexmedetomidine for ICU Sedation,” and that the ’867 Patent was issued by the U.S. Patent and
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`Trademark Office on April 6, 2004. All other allegations not expressly admitted are denied.
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`10.
`patent.
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`Hospira and Orion are co-assignees of the ‘867 patent and share ownership of the
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`RESPONSE: Baxter admits that, according to the records at the U.S. Patent and Trademark
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`Office, Hospira and Orion are co-assignees of the ’867 Patent. Baxter lacks information sufficient
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`2
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`

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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 4 of 9 PageID #: 276
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`to admit or deny the remaining allegations in this paragraph and, therefore, denies all allegations
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`not expressly admitted.
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`Hospira is the holder of New Drug Application (“NDA”) No. 21-038 for
`11.
`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.
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`RESPONSE: Admitted, upon information and belief.
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`The ‘867 patent is duly listed in the Orange Book as covering PRECEDEX®. The
`12.
`claims of the ‘867 patent cover various methods of using PRECEDEX®.
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`RESPONSE: This paragraph contains conclusions of law and a characterization of the ’867
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`Patent, which speaks for itself, to which no response is required. To the extent a response is
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`required, Baxter admits that the ’867 Patent is listed in the Orange Book by Hospira as covering
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`PRECEDEX® with a current use code only for “intensive care unit sedation, including sedation
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`of non-intubated patients prior to and/or during surgical and other procedures.” Attach. A,
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`Declaration of Jon Clark, M.S. ¶ 44 [hereinafter Clark Decl.]. All other allegations not expressly
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`admitted are denied.
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`Count I: Infringement Of The ‘867 Patent
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`13.
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`Defendants re-allege herein the foregoing paragraphs of their Counterclaim.
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`RESPONSE: Baxter incorporates herein its responses to the foregoing paragraphs of the
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`Counterclaim.
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`On information and belief, Celerity Pharmaceuticals, LLC (“Celerity”) submitted
`14.
`ANDA No. 208532 to the FDA to seek approval to engage in the commercial manufacture, use,
`offer for sale, sale, and/or importation into the United States of its generic dexmedetomidine
`hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL and 400 mcg/100 mL (“Baxter
`ANDA Product”) prior to the expiry of the ‘867 patent.
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`RESPONSE: Admitted. See Attach. B, Declaration of Jonathan M. Edwards ¶ 12 [hereinafter
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`Edwards Decl.].
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`3
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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 5 of 9 PageID #: 277
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`15.
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`Celerity was aware of the ‘867 patent when it submitted its ANDA.
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`RESPONSE: Baxter lacks information sufficient to admit or deny the allegations in this
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`paragraph and, therefore, denies all allegations.
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`On information and belief, Baxter has assumed all rights and responsibilities with
`16.
`respect to ANDA No. 208532.
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`RESPONSE: Admitted.
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`The ‘867 patent covers, among other things, a method of sedating a patient in an
`17.
`intensive care unit comprising administering
`to
`the patient an effective amount of
`dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the patient remains
`arousable and orientated.
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`RESPONSE: This paragraph contains a characterization of the ’867 Patent, which speaks for
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`itself, and to which no response is required. To the extent a response is required, Baxter admits
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`that claim 1 of the ’867 Patent claims “[a] method of sedating a patient in an intensive care unit,
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`which comprises administering to the patient an effective amount of dexmedetomidine or a
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`pharmaceutically acceptable salt thereof, wherein the patient remains arousable and orientated.”
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`All other allegations not expressly admitted are denied.
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`Celerity was not required by the FDA to maintain a Paragraph IV Certification as
`18.
`to the ‘867 patent because its ANDA did not seek approval for the Precedex® indication that
`covers “sedation of initially intubated and mechanically ventilated patients during treatment in an
`intensive care setting.”
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, Baxter admits that Celerity did not provide a Paragraph IV
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`certification to the ’867 Patent. All other allegations not expressly admitted are denied.
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`However, on information and belief, while Baxter’s ANDA omits this indication,
`19.
`Baxter knows that its product will be used for this indication, which keeps ICU patients arousable
`and orientated. Medical professionals use dexmedetomidine drug products for this indication even
`when the drug products are not approved by the FDA for the indication.
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`4
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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 6 of 9 PageID #: 278
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`RESPONSE: Baxter admits that ANDA No. 208532 omits an indication for “[s]edation of
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`initially intubated and mechanically ventilated patients during treatment in an intensive care
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`setting.” See Attach. C, Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
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`Label [hereinafter Full Label]; Attach. D, Dexmedetomidine Hydrochloride in 0.9% Sodium
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`Chloride Injection Label Annotated Comparison with Precedex [hereinafter Annotated Label]. By
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`carving this indication out of its label, Baxter demonstrated its unambiguous intent not to sell or
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`market the Baxter ANDA Product for this use. Attach. B, Edwards Decl. ¶¶ 20, 28-31. Baxter
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`lacks information sufficient to admit or deny the remaining allegations in this paragraph and,
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`therefore, denies all allegations not expressly admitted.
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`20. Moreover, on information and belief, Baxter’s ANDA seeks approval to market the
`Baxter ANDA Product for the Precedex® indication of “sedation of non-intubated patients prior
`to and/or during surgical and other procedures.” Such sedation often occurs in an intensive care
`unit, and allows the patient to remain arousable and orientated.
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`RESPONSE: This paragraph contains a characterization of Baxter’s ANDA, which speaks for
`
`itself, and to which no response is required. To the extent a response is required, Baxter admits
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`that its ANDA seeks approval to market the Baxter ANDA Product for “[s]edation of non-
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`intubated patients prior to and/or during surgical and other procedures.” See Attach. C, Full Label;
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`Attach. D, Annotated Label. For an ANDA to be approved, the label must have at least one
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`indication for use from the reference listed drug. Attach. A, Clark Decl. ¶ 32. Baxter, however,
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`has no intent to market the Baxter ANDA Product for use in an intensive care unit, and views the
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`two Precedex indications as mutually exclusive. Attach. B, Edwards Decl. ¶¶ 22-31. Thus,
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`because Baxter carved out the indication relating to use of Precedex for “[s]edation of initially
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`intubated and mechanically ventilated patients during treatment in an intensive care setting,”
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`(emphasis added), the remaining indication for “[s]edation of non-intubated patients prior to and/or
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`during surgical and other procedures” does not include those procedures that occur in an intensive
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`5
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`

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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 7 of 9 PageID #: 279
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`care setting. See id. ¶¶ 22-28; Attach. A, Clark Decl. ¶ 48. All other allegations not expressly
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`admitted are denied.
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`Therefore, the Baxter ANDA seeks approval to market the Baxter ANDA Product
`21.
`for uses covered by the ‘867 patent.
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`RESPONSE: Denied. Baxter does not seek approval to market the Baxter ANDA Product for use
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`in an intensive care setting. Attach. B, Edwards Decl. ¶¶ 29-31. Therefore, the Baxter ANDA
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`Product is not being marketed for any uses covered by the ’867 Patent.
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`By submitting this ANDA, Baxter committed an act of infringement under 35
`22.
`U.S.C. § 271(e)(2).
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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
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`the extent a response is required, denied as to the ’867 Patent.
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`23. Moreover, any commercial manufacture, use, sale, offer for sale, and/or
`importation into the United States of the Baxter ANDA Product would infringe the ‘867 patent
`under 35 U.S.C. § 271(a), (b), and/or (c).
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`RESPONSE: Baxter denies that any commercial manufacture, use, sale, offer for sale, and/or
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`importation into the United States of the Baxter ANDA Product would infringe the ’867 Patent
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`under 35 U.S.C. § 271(a), (b), and/or (c). A claim for direct infringement under § 271(a) fails
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`because Baxter does not use the Baxter ANDA Product to treat any patients, meaning it cannot be
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`held liable for directly infringing a method-of-use patent. Attach. B, Edwards Decl. ¶ 32.
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`A claim for induced infringement under § 271(b) similarly fails because Baxter has not
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`knowingly induced infringement and possesses no specific intent to encourage another’s
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`infringement. See id. ¶¶ 20-31. The label for the Baxter ANDA Product carves out (i.e., omits) use
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`of the product in an intensive care unit. Id. ¶¶ 20, 28; Attach. C, Full Label; Attach. D, Annotated
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`Label. Specifically, the Baxter ANDA Product omits any indication for “[s]edation of initially
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`intubated and mechanically ventilated patients during treatment in an intensive care setting.”
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`6
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`

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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 8 of 9 PageID #: 280
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`Attach. B, Edwards Decl. ¶¶ 20, 29; Attach. C, Full Label; Attach. D, Annotated Label. The label
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`for the Baxter ANDA Product never references or requires patients to be in an intensive care unit,
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`which is required under the ’867 Patent. See Attach. B, Edwards Decl. ¶¶ 19-21; Attach. C, Full
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`Label; Attach. D, Annotated Label. This carve-out, and the lack of any instructions encouraging
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`physicians to prescribe the Baxter ANDA Product in an intensive care unit negate any reasonable
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`inference of an intent to induce infringement. See Attach. B, Edwards Decl. ¶¶ 20-31.
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`Finally, a claim for contributory infringement under § 271(c) fails at least because Baxter
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`is not selling a component of a product designed for use in a patented invention and substantial
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`non-infringing uses exist for the Baxter ANDA Product.
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`24.
`by others.
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`Baxter’s actions and conduct will encourage direct infringement of the ‘867 patent
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`RESPONSE: Denied.
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`25.
`‘867 patent.
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`Defendants will be irreparably harmed if Baxter is not enjoined from infringing the
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`RESPONSE: Denied.
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`Defendants’ Prayer for Relief
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`RESPONSE: Baxter denies that Defendants are entitled to any of the relief they request with
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`respect to the ’867 Patent.
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`7
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`

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`Case 1:18-cv-00303-RGA Document 15 Filed 04/17/18 Page 9 of 9 PageID #: 281
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`OF COUNSEL:
`
`Neal Seth
`Lawrence M. Sung
`Bethany A. Corbin
`WILEY REIN, LLP
`1776 K St. NW
`Washington, DC 20006
`(202) 719-7000
`
`
`
`
`
`Dated: April 10, 2018
`
`5740289
`
`POTTER ANDERSON & CORROON LLP
`
`By: /s/ Philip A. Rovner
`Philip A. Rovner (#3215)
`Jonathan A. Choa (#5319)
`Alan R. Silverstein (#5066)
`Hercules Plaza
`P.O. Box 951
`Wilmington, DE 19899
`(302) 984-6000
`provner@potteranderson.com
`jchoa@potteranderson.com
`asilverstein@potteranderson.com
`
`Attorneys for Plaintiff
`Baxter Healthcare Corporation
`
`8
`
`Public version dated: April 17, 2018
`
`