Case 1:18-cv-00303-RGA Document 40 Filed 06/21/18 Page 1 of 5 PageID #: 1031
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
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`BAXTER HEALTHCARE CORPORATION,
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`Plaintiff,
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`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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`CONSENT JUDGMENT
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`On February 22, 2018, Plaintiff Baxter Healthcare Corporation ("Baxter") filed its
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`Complaint for Declaratory Judgment against Defendants Hospira, Inc. ("Hospira") and Orion
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`Corp. ("Orion") ( collectively, "Defendants"). The Complaint seeks a declaration of non-
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`infringement of United States Patent Nos. 6,716,867 (the '" 867 Patent"); 8,242,158 (the "' 158
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`Patent"); 8,338,470 (the "'470 Patent"); and 8,455,527 (the "' 527 Patent") (collectively, "the
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`Patents-in-Suit"). Defendants filed their Answer and Counterclaim on March 20, 2018.
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`Baxter and Defendants have agreed to the entry of this Consent Judgment regarding the
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`' 158 Patent, the '470 Patent, and the '527 Patent upon the following findings of fact and
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`conclusions of law. No claim, counterclaim, affirmative defense, or demand related to the ' 867
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`Patent is affected by this Consent Judgment. Each party has waived the right to appeal from this
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`Consent Judgment. Should judicial enforcement of any of the terms of this Consent Judgment
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`become necessary in the future, the prevailing party will be entitled to its attorneys' fees and costs.
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`It is therefore found, adjudged, and decreed as follows:
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`BAXTER HEALTHCARE CORPORATION,
`
`Plaintiff,
`
`V.
`
`HOSPIRA, INC. and ORION CORP.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 18-303-RGA
`
`CONSENT JUDGMENT
`
`On February 22, 2018, Plaintiff Baxter Healthcare Corporation ("Baxter") filed its
`
`Complaint for Declaratory Judgment against Defendants Hospira, Inc. ("Hospira") and Orion
`
`Corp. ("Orion") ( collectively, "Defendants"). The Complaint seeks a declaration of non-
`
`infringement of United States Patent Nos. 6,716,867 (the '" 867 Patent"); 8,242,158 (the "' 158
`
`Patent"); 8,338,470 (the "'470 Patent"); and 8,455,527 (the "' 527 Patent") (collectively, "the
`
`Patents-in-Suit"). Defendants filed their Answer and Counterclaim on March 20, 2018.
`
`Baxter and Defendants have agreed to the entry of this Consent Judgment regarding the
`
`' 158 Patent, the '470 Patent, and the '527 Patent upon the following findings of fact and
`
`conclusions of law. No claim, counterclaim, affirmative defense, or demand related to the ' 867
`
`Patent is affected by this Consent Judgment. Each party has waived the right to appeal from this
`
`Consent Judgment. Should judicial enforcement of any of the terms of this Consent Judgment
`
`become necessary in the future, the prevailing party will be entitled to its attorneys' fees and costs.
`
`It is therefore found, adjudged, and decreed as follows:
`
`
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`Case 1:18-cv-00303-RGA Document 40 Filed 06/21/18 Page 2 of 5 PageID #: 1032
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`FINDINGS OF FACT
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`1.
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`Baxter is a corporation incorporated in Delaware with its principal place of business
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`at One Baxter Parkway, Deerfield, Illinois 60015 .
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`2.
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`Hospira is a Delaware corporation with its principal place of business at 275 North
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`Field Drive, Lake Forest, Illinois 60045.
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`3.
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`Orion is a corporation organized under the laws of Finland with its principal place
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`of business at Orionintie 1, FIN-02200 Espoo, Finland.
`
`4.
`
`On August 14, 2012, the U.S. Patent and Trademark Office issued United States
`
`Patent No. 8,242,158, entitled "Dexmedetomidine Premix Formulation." Hospira is the assignee
`
`of the ' 15 8 Patent.
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`5.
`
`On December 25, 2012, the U.S. Patent and Trademark Office issued United States
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`Patent No. 8,338,470, entitled "Dexmedetomidine Premix Formulation." Hospira is the assignee
`
`of the ' 470 Patent.
`
`6.
`
`On June 4, 2013, the U.S. Patent and Trademark Office issued United States Patent
`
`No. 8,455,527, entitled "Methods of Treatment Using a Dexmedetomidine Premix Formulation."
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`Hospira is the assignee of the ' 527 Patent.
`
`7.
`
`Celerity Pharmaceuticals, LLC ("Celerity") submitted and later transferred to
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`Baxter ANDA No. 208532 ("Baxter ANDA") for a proposed drug product containing
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`dexmedetomidine HCI, 200 mcg base/50 mL and 400 mcg base/100 mL. Baxter' s ANDA seeks
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`approval from the Food and Drug Administration ("FDA") for the commercial manufacture, use,
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`importation, offer for sale and sale of generic dexmedetomidine HCI , 200 mcg base/50 mL and
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`400 mcg base/100 mL in flex ible plastic containers ("Baxter ANDA Product").
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`2
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`
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`Case 1:18-cv-00303-RGA Document 40 Filed 06/21/18 Page 3 of 5 PageID #: 1033
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`8.
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`Hospira received a Notice Letter informing Hospira of Baxter's ANDA seeking
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`approval to engage in the commercial manufacture, use, importation, offer for sale, or sale of
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`Baxter' s ANDA Product before the expiration of three of the patents-in-suit, the ' 158 Patent, the
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`'470 Patent, or the ' 527 Patents, and that the Baxter ANDA contained a section viii statement
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`regarding the ' 867 patent, but Hospira did not file suit in connection with ANDA No. 208532 or
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`otherwise object to ANDA No. 208532 within 45 days of receipt of the Notice Letter.
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`9.
`
`On January 22, 2018, FDA issued a letter tentatively approving Baxter' s ANDA
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`No. 208532.
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`CONCLUSIONS OF LAW
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`10.
`
`This is an action for declaratory judgment arising under the Patent Laws of the
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`United States, 35 U.S.C. § 100 et seq., the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202,
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`and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended by the Drug
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`Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585
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`(1984) (codified as amended at 21 U.S .C. § 355), and the Medicare Prescription Drug,
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`Improvement and Modernization Act of 2003 , Pub. L. No. 108-173, 17 Stat. 2066 (2003).
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`11.
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`This Court has subject matter jurisdiction over this lawsuit pursuant to 28 U .S.C.
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`§§ 1331, 1338(a), and 2201.
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`12.
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`This Court has personal jurisdiction over Baxter and the Defendants for purposes
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`of this action, and venue is proper in this aistrict pursuant to 28 U .S.C. § 1400(b) for purposes of
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`this action.
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`13 .
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`Orion has no ownership interest in the ' 158 Patent, the ' 470 Patent, or the ' 527
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`Patent.
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`3
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`
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`t
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`-
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`•
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`..
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`\
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`Case 1:18-cv-00303-RGA Document 40 Filed 06/21/18 Page 4 of 5 PageID #: 1034
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`14.
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`Baxter does not infringe the ' 158 Patent through the manufacture, marketing, use,
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`offer for sale, sale, and/or importation of the Baxter ANDA Product.
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`15.
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`Baxter does not infringe the '470 Patent through the manufacture, marketing, use,
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`offer for sale, sale, and/or importation of the Baxter ANDA Product.
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`16.
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`Baxter does not infringe the ' 527 Patent through the manufacture, marketing, use,
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`offer for sale, sale, and/or importation of the Baxter ANDA Product.
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`17.
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`Baxter does not contest the validity or enforceability of the ' 158 Patent, the '470
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`Patent, and '527 Patent for purposes of this action.
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`18.
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`This Consent Judgment shall finally conclude and dispose of all claims related to
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`the ' 158 Patent, the ' 470 Patent, and the ' 527 Patent as to Baxter and Defendants with respect to
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`the Baxter ANDA Product. All claims, counterclaims, affirmative defenses, and demands related
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`to these three patents are dismissed with prejudice. All claims, counterclaims, affirmative defenses,
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`and demands related to the ' 867 Patent are not affected by this Consent Judgment and remain
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`active in this litigation.
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`19.
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`This Consent Judgment is a final adjudication on the merits with respect to all
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`claims related to the '158 Patent, the ' 470 Patent, and the ' 527 Patent as to Baxter and Defendants
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`with respect to the Baxter ANDA Product.
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`20.
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`This Consent Judgment constitutes a final , non-appealable judgment that the ' 158
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`Patent, the '470 Patent, and the ' 527 Patent are not infringed as provided in 21 U.S.C §
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`355U)(5)(D)(i)(bb)(AA) and (BB) by Baxter with respect to the Baxter ANDA Product.
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`21.
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`The Court retains jurisdiction to enforce or supervise performance under this
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`Consent Judgment.
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`4
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`4
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`~
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`••
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`'
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`Case 1:18-cv-00303-RGA Document 40 Filed 06/21/18 Page 5 of 5 PageID #: 1035
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`ORDER
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`IT IS HEREBY FOUND, ORDERED, ADJUDGED, AND DECREED THAT:
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`A.
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`Baxter' s request for declaratory judgment is GRANTED with respect to United
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`States Patent Nos. 8,242,158 (the "' 158 Patent"), 8,338,470 (the "'470 Patent"), and 8,455 ,527
`
`(the '"527 Patent"). The Court finds that Baxter' s ANDA Product does not infringe these three
`
`patents.
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`B.
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`This Court retains exclusive jurisdiction of this action for the purpose of (1)
`
`ensuring compliance with this Consent Judgment, and (2) determining whether Baxter' s ANDA
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`Product infringes United States Patent No. 6,716,867.
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`C.
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`D.
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`No appeal shall be taken by any party from this Consent Judgment.
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`This Consent Judgment shall finally conclude and dispose of all claims against
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`Defendants by Baxter related to the' 158 Patent, the '470 Patent, and the '527 Patent with respect
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`to the Baxter ANDA Product.
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`E.
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`This Consent Judgment shall be entered without further notice.
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`IT IS SO ORDERED.
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`Dated:
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`5
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