`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`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:
`
`
`
`Case 1:18-cv-00303-RGA Document 38 Filed 06/15/18 Page 2 of 6 PageID #: 934
`
`FINDINGS OF FACT
`
`1.
`
`Baxter is a corporation incorporated in Delaware with its principal place of business
`
`at One Baxter Parkway, Deerfield, Illinois 60015.
`
`2.
`
`Hospira is a Delaware corporation with its principal place of business at 275 North
`
`Field Drive, Lake Forest, Illinois 60045.
`
`3.
`
`Orion is a corporation organized under the laws of Finland with its principal place
`
`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 ’158 Patent.
`
`5.
`
`On December 25, 2012, the U.S. Patent and Trademark Office issued United States
`
`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.”
`
`Hospira is the assignee of the ’527 Patent.
`
`7.
`
`Celerity Pharmaceuticals, LLC (“Celerity”) submitted and later transferred to
`
`Baxter ANDA No. 208532 (“Baxter ANDA”) for a proposed drug product containing
`
`dexmedetomidine HCl, 200 mcg base/50 mL and 400 mcg base/100 mL. Baxter’s ANDA seeks
`
`approval from the Food and Drug Administration (“FDA”) for the commercial manufacture, use,
`
`importation, offer for sale and sale of generic dexmedetomidine HCl, 200 mcg base/50 mL and
`
`400 mcg base/100 mL in flexible plastic containers (“Baxter ANDA Product”).
`
`2
`
`
`
`Case 1:18-cv-00303-RGA Document 38 Filed 06/15/18 Page 3 of 6 PageID #: 935
`
`8.
`
`Hospira received a Notice Letter informing Hospira of Baxter’s ANDA seeking
`
`approval to engage in the commercial manufacture, use, importation, offer for sale, or sale of
`
`Baxter’s ANDA Product before the expiration of three of the patents-in-suit, the ’158 Patent, the
`
`’470 Patent, or the ’527 Patents, and that the Baxter ANDA contained a section viii statement
`
`regarding the ’867 patent, but Hospira did not file suit in connection with ANDA No. 208532 or
`
`otherwise object to ANDA No. 208532 within 45 days of receipt of the Notice Letter.
`
`9.
`
`On January 22, 2018, FDA issued a letter tentatively approving Baxter’s ANDA
`
`No. 208532.
`
`CONCLUSIONS OF LAW
`
`10.
`
`This is an action for declaratory judgment arising under the Patent Laws of the
`
`United States, 35 U.S.C. § 100 et seq., the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202,
`
`and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended by the Drug
`
`Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585
`
`(1984) (codified as amended at 21 U.S.C. § 355), and the Medicare Prescription Drug,
`
`Improvement and Modernization Act of 2003, Pub. L. No. 108-173, 17 Stat. 2066 (2003).
`
`11.
`
`This Court has subject matter jurisdiction over this lawsuit pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), and 2201.
`
`12.
`
`This Court has personal jurisdiction over Baxter and the Defendants for purposes
`
`of this action, and venue is proper in this district pursuant to 28 U.S.C. § 1400(b) for purposes of
`
`this action.
`
`13.
`
`Orion has no ownership interest in the ’158 Patent, the ’470 Patent, or the ’527
`
`Patent.
`
`3
`
`
`
`Case 1:18-cv-00303-RGA Document 38 Filed 06/15/18 Page 4 of 6 PageID #: 936
`
`14.
`
`Baxter does not infringe the ’158 Patent through the manufacture, marketing, use,
`
`offer for sale, sale, and/or importation of the Baxter ANDA Product.
`
`15.
`
`Baxter does not infringe the ’470 Patent through the manufacture, marketing, use,
`
`offer for sale, sale, and/or importation of the Baxter ANDA Product.
`
`16.
`
`Baxter does not infringe the ’527 Patent through the manufacture, marketing, use,
`
`offer for sale, sale, and/or importation of the Baxter ANDA Product.
`
`17.
`
`Baxter does not contest the validity or enforceability of the ’158 Patent, the ’470
`
`Patent, and ’527 Patent for purposes of this action.
`
`18.
`
`This Consent Judgment shall finally conclude and dispose of all claims related to
`
`the ’158 Patent, the ’470 Patent, and the ’527 Patent as to Baxter and Defendants with respect to
`
`the Baxter ANDA Product. All claims, counterclaims, affirmative defenses, and demands related
`
`to these three patents are dismissed with prejudice. All claims, counterclaims, affirmative defenses,
`
`and demands related to the ’867 Patent are not affected by this Consent Judgment and remain
`
`active in this litigation.
`
`19.
`
`This Consent Judgment is a final adjudication on the merits with respect to all
`
`claims related to the ’158 Patent, the ’470 Patent, and the ’527 Patent as to Baxter and Defendants
`
`with respect to the Baxter ANDA Product.
`
`20.
`
`This Consent Judgment constitutes a final, non-appealable judgment that the ’158
`
`Patent, the ’470 Patent, and the ’527 Patent are not infringed as provided in 21 U.S.C §
`
`355(j)(5)(D)(i)(bb)(AA) and (BB) by Baxter with respect to the Baxter ANDA Product.
`
`21.
`
`The Court retains jurisdiction to enforce or supervise performance under this
`
`Consent Judgment.
`
`4
`
`
`
`Case 1:18-cv-00303-RGA Document 38 Filed 06/15/18 Page 5 of 6 PageID #: 937
`
`ORDER
`
`IT IS HEREBY FOUND, ORDERED, ADJUDGED, AND DECREED THAT:
`
`A.
`
`Baxter’s request for declaratory judgment is GRANTED with respect to United
`
`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.
`
`B.
`
`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
`
`Product infringes United States Patent No. 6,716,867.
`
`C.
`
`D.
`
`No appeal shall be taken by any party from this Consent Judgment.
`
`This Consent Judgment shall finally conclude and dispose of all claims against
`
`Defendants by Baxter related to the ’158 Patent, the ’470 Patent, and the ’527 Patent with respect
`
`to the Baxter ANDA Product.
`
`E.
`
`This Consent Judgment shall be entered without further notice.
`
`IT IS SO ORDERED.
`
`Dated:
`
`_____________________________________________
`
`5
`
`
`
`Case 1:18-cv-00303-RGA Document 38 Filed 06/15/18 Page 6 of 6 PageID #: 938
`
`STIPULATED AND AGREED TO:
`
`Dated: June 15, 2018
`
`POTTER ANDERSON & CORROON LLP
`
`CONNOLLY GALLAGHER 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
`
`By: /s/ Arthur G. Connolly, III
`Arthur G. Connolly, III (#2667)
`Ryan P. Newell (#4744)
`The Brandywine Building
`1000 West Street
`Suite 1400
`Wilmington, DE 19801
`(302) 757-7300
`aconnolly@connollygallagher.com
`rnewell@connollygallagher.com
`
`OF COUNSEL:
`
`Neal Seth
`Lawrence M. Sung
`Bethany A. Corbin
`WILEY REIN LLP
`1776 K St. NW
`Washington, DC 20006
`(202) 719-7000
`
`Attorneys for Plaintiff
`
`OF COUNSEL:
`
`Bradford P. Lyerla
`Sara T. Horton
`Yusuf Esat
`Ren-How Harn
`JENNER & BLOCK LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`(312) 222-9350
`
`Attorneys for Defendants
`
`5844701
`
`6
`
`