Case 1:18-cv-00303-UNA Document 1 Filed 02/22/18 Page 1 of 22 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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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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`C.A. No. 18- ________
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`COMPLAINT FOR DECLARATORY JUDGMENT
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`Plaintiff Baxter Healthcare Corporation (“Baxter”), through counsel, hereby brings its
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`Complaint for Declaratory Judgment against Hospira, Inc. (“Hospira”) and Orion Corp.
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`(“Orion”), and alleges as follows:
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`NATURE OF THE SUIT
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`1.
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`This is a declaratory judgment action seeking a declaration of non-infringement of
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`United States Patent Nos. 6,716,867 (the “’867 Patent”), 8,242,158 (the “’158 Patent”),
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`8,338,470 (the “’470 Patent”), and 8,455,527 (the “’527 Patent”) (collectively, “the Patents-in-
`
`Suit”) to enable Baxter to bring its generic dexmedetomidine hydrochloride in 0.9% sodium
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`chloride injection 200 mcg/50 mL and 400 mcg/100mL (the “Baxter ANDA Product”) to market
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`at the earliest possible date under the applicable statutory and Food and Drug Administration
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`(“FDA”) regulatory provisions, and to allow the public to enjoy the benefits of generic
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`competition for these products.
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`THE PARTIES
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`2.
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`Baxter Healthcare Corporation is a corporation incorporated in Delaware with its
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`principal place of business at One Baxter Parkway, Deerfield, IL 60015.
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`3.
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`Upon information and belief, Hospira, Inc. is a Delaware corporation with its
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`principal place of business at 275 North Field Drive, Lake Forest, Illinois 60045.
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`4.
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`Upon information and belief, Orion Corp. is a corporation organized under the
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`laws of Finland with its principal place of business at Orionintie 1, FIN-02200 Espoo, Finland.
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`JURISDICTION, VENUE AND JOINDER
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`5.
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`This Complaint arises under the Patent Laws of the United States, 35 U.S.C. §
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`100 et seq.; the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202; and the Federal Food,
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`Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended by the Drug Price Competition and
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`Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984 (codified as
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`amended at 21 U.S.C. § 355)) (the “Hatch-Waxman Amendments”), and the Medicare
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`Prescription Drug, Improvement and Modernization Act of 2003, Pub. L. No. 108-173, 17 Stat.
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`2066 (2003) (the “MMA”), based upon an actual controversy between the parties to declare that
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`Baxter is free, upon approval by the FDA, to manufacture, use, market, sell, offer to sell, and/or
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`import its proposed product as described in Abbreviated New Drug Application (“ANDA”) No.
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`208532.
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`6.
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`7.
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`This Court has original jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`Venue is proper in this District pursuant to 28 U.S.C. § 1391 and 1400(b), at least
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`because Hospira resides in this District within the meaning of 28 U.S.C. § 1400(b).
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`8.
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`This Court has personal jurisdiction over Hospira because, among other things,
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`Hospira is a Delaware corporation, that, having availed itself of Delaware’s corporate laws, is
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`subject to personal jurisdiction in Delaware.
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`9.
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`This Court has personal jurisdiction over Orion because, among other things, on
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`information and belief, Orion does business in this District by co-owning a patent covering
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`2
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`Precedex® (i.e., the ’867 Patent), exclusively licensing in the United States its ownership interest
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`in said patent to Hospira—a Delaware corporation—and receiving royalty payments from
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`Hospira for the sale of Precedex®, which is sold in Delaware.
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`10.
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`This Court also has personal jurisdiction over Orion because Orion has regularly
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`and purposefully availed itself of the privileges and benefits of this forum, having brought
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`multiple suits in this District, including suits specifically alleging infringement of the ’867 Patent
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`at issue in this suit: Hospira Inc. and Orion Corp v. Sandoz International GmbH, et al., Civ. No.
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`09-00665 (D. Del.); Hospira, Inc. and Orion Corp. v. Aurobindo Pharma Ltd., at al., Civ. No.
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`14-00486 (D. Del.); Hospira, Inc. and Orion Corp. v. Ben Venue Labs, Inc., Civ. No. 14-00487
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`(D. Del.); Hospira, Inc. and Orion Corp. v. Actavis LLC et. Al., Civ. No. 14-00488 (D. Del.);
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`Hospira, Inc. and Orion Corp. v. Ben Venue Labs., Inc., et al., Civ. No. 14-1008 (D. Del.).
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`11.
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`Upon information and belief, the license agreement between Orion and Hospira
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`imposes an obligation on Orion to participate in the enforcement or defense of the ’867 patent
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`with Hospira, which is engaged in exploiting the patent rights in Delaware through its sale of
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`Precedex®.
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`12.
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`By virtue of its repeated assertion of infringement of the ’867 Patent in this
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`District, Orion has waived any argument that it is not subject to specific personal jurisdiction in
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`this District for actions relating to the infringement thereof.
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`13.
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`Venue is proper in this district for Orion pursuant to 28 U.S.C. §§ 1391 and
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`1400(b) because, inter alia, Orion is a corporation organized and existing under the laws of
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`Finland and is subject to personal jurisdiction in this judicial district.
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`3
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`Case 1:18-cv-00303-UNA Document 1 Filed 02/22/18 Page 4 of 22 PageID #: 4
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`THE PATENTS-IN-SUIT
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`The ’867 Patent
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`14.
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`On its face the ’867 Patent, entitled “Use of Dexmedetomidine for ICU Sedation,”
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`indicates it was issued by the U.S. Patent and Trademark Office on April 6, 2004. A copy of the
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`’867 Patent is attached as Exhibit A.
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`15.
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`According to records at the U.S. Patent and Trademark Office, Hospira and Orion
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`are co-assignees of the ’867 Patent.
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`16.
`
`On information and belief, Hospira is the exclusive licensee in the United States
`
`of Orion’s interest in the ’867 Patent.
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`17.
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`18.
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`19.
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`The ’867 Patent contains twelve claims.
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`The ’867 Patent contains two independent claims.
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`Each independent claim of the ’867 Patent recites “[a] method of sedating a
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`patient in an intensive care unit.”
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`20.
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`The ’867 Patent’s ten dependent claims incorporate the limitations of the claims
`
`from which they depend. Thus, all claims of the ’867 Patent require “[a] method of sedating a
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`patient in an intensive care unit.”
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`The ’158 Patent
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`21.
`
`On its face the ’158 Patent, entitled “Dexmedetomidine Premix Formulation,”
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`indicates it was issued by the U.S. Patent and Trademark Office on August 14, 2012. A copy of
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`the ’158 Patent is attached as Exhibit B.
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`22.
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`The ’158 Patent issued from application number 13/343,672 (the “’672
`
`Application”).
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`23.
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`According to records at the U.S. Patent and Trademark Office, Hospira is the
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`4
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`assignee of the ’158 Patent.
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`24.
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`25.
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`26.
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`The ’158 Patent contains four claims.
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`The ’158 Patent contains one independent claim.
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`The independent claim of the ’158 Patent recites “[a] ready to use liquid
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`pharmaceutical composition . . . disposed within a sealed glass container.”
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`27.
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`The ’158 Patent’s three dependent claims incorporate the limitations of the claims
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`from which they depend. Thus, all claims of the ’158 Patent require “[a] ready to use liquid
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`pharmaceutical composition . . . disposed within a sealed glass container.”
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`28. When the ’672 Application was initially filed, its claims did not require that the
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`sealed container be made of glass.
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`29.
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`On March 13, 2012, in response to an office action rejecting the originally-filed
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`claims of the ’672 Application, Hospira amended the sole pending independent claim to include
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`the present requirement that the sealed container be “a sealed glass container.”
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`30.
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`In its March 13, 2012 filing with the U.S. Patent and Trademark Office, Hospira
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`argued that it discovered that using glass containers resulted in unexpectedly superior stability
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`compared to using plastic containers. Response to Office Action, at 7-8 (Mar. 13, 2012)
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`(arguing it was surprising that “a 4µg/mL premixture formulation stored in glass vials and
`
`ampoules maintained a higher level of potency after a 5 month storage period compared to
`
`storage in plastic, CR3, or PVC containers”).
`
`31.
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`On April 18, 2012, the U.S. Patent and Trademark Office issued a notice of
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`allowance for the ’672 Application. In this notice, the examiner stated that “requiring the
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`composition to be disposed within a sealed glass container[] was effective to overcome the
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`previous rejection under 35 U.S.C[. §] 102(b).” Notice of Allowance, ¶ 3 (Apr. 18, 2012)
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`5
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`32.
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`The specification of the ’158 Patent discloses plastic as an alternative material for
`
`the container:
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`In certain non-limiting embodiments, the container or vessel includes, but
`is not limited to glass vials (for example, but not limited to, flint glass
`vials), ampoules, plastic flexible containers, for example, but not limited
`to, PVC (polyvinyl chloride) containers, VisIV™ plastic containers
`(Hospira, Inc., Lake Forest, Ill.) and CR3 elastomer copolyester ether
`containers (Hospira, Inc., Lake Forest, Ill.), CZ resin containers, poly
`propylene containers and syringes.
`
`’158 Patent at 9:17-24.
`
`33.
`
`No claims of the ’158 Patent cover a ready to use liquid pharmaceutical
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`composition for parenteral administration to a subject, comprising dexmedetomidine or a
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`pharmaceutically acceptable salt thereof at a concentration of about 4 μg/mL disposed within a
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`sealed plastic container.
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`34.
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`On February 6, 2018, the Honorable Richard G. Andrews of the United States
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`District Court for the District of Delaware entered a final judgment in the action Hospira, Inc. v.
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`Amneal Pharmaceuticals LLC, Civ. No. 1:15-cv-00697-RGA (the “Amneal Judgment”),
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`invalidating claims 3 and 4 of the ’158 Patent for obviousness. Because claims 3 and 4 depend
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`from claims 1 and/or 2, a Court would likewise properly find claims 1 and 2 also invalid.
`
`The ’470 Patent
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`35.
`
`On its face the ’470 Patent, entitled “Dexmedetomidine Premix Formulation,”
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`indicates it was issued by the U.S. Patent and Trademark Office on December 25, 2012. A copy
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`of the ’470 Patent is attached as Exhibit C.
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`36.
`
`The ’470 Patent issued from application number 13/541,524 (the “’524
`
`Application”).
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`37.
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`According to records at the U.S. Patent and Trademark Office, Hospira is the
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`assignee of the ’470 Patent.
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`38.
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`39.
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`40.
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`The ’470 Patent contains seven claims.
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`The ’470 Patent contains one independent claim.
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`The independent claim of the ’470 patent recites “[a] ready to use liquid
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`pharmaceutical composition . . . disposed within a sealed glass container.”
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`41.
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`The ’470 Patent’s six dependent claims incorporate the limitations of the claims
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`from which they depend. See 35 U.S.C. § 112(d). Thus, all claims of the ’470 Patent require
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`“[a] ready to use liquid pharmaceutical composition . . . disposed within a sealed glass
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`container.”
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`42.
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`On August 17, 2012, the U.S. Patent and Trademark Office issued an office action
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`rejecting all pending claims of the ’524 Application as obvious.
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`43.
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`On September 17, 2012, Hospira responded to the rejection, arguing that using
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`glass containers resulted in unexpectedly superior stability compared to using plastic containers.
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`Response to Office Action, at 6 (Sept. 17, 2012) (arguing it was surprising that “a 4µg/mL
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`premixture formulation stored in glass vials and ampoules maintained a higher level of potency
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`after a 5 month storage period compared to storage in plastic, CR3, or PVC containers”); Decl.
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`of Huailiang Wu, Ph.D., ¶ 13 (Sept. 17, 2012) (“[S]toring a ready to use formulation of
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`dexmedetomidine at concentrations recited by the claims of the ’524 application in glass
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`containers resulted in an unexpected reduction in potency loss of the composition compared to
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`storage in plastic PVC containers.”).
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`44.
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`On October 22, 2012, the U.S. Patent and Trademark Office issued a notice of
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`allowance for the ’524 Application. In this notice, the examiner credits Hospira’s arguments that
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`dexmedetomidine formulations stored in glass containers exhibit unexpectedly better stability
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`than those stored in plastic. Notice of Allowance, ¶ 3 (Oct. 22, 2012) (crediting Hospira’s
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`7
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`argument that “the Specification demonstrates that a dexmedetomidine 4µg/mL formulation
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`‘stored in glass vials and ampoules maintained a higher level of potency after a 5 month storage
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`period compared to storage in plastic, CR3 or PVC containers,’” as well as “the Declaration of
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`Huailang Wu provided by Applicants [which] provides further evidence of the surprising
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`increase in stability of dexmedetomidine compositions (1, 10, 15 and 50 µg/ml) stored in sealed
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`glass containers compared to storage in PVC bags.”).
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`45.
`
`The specification of the ’470 Patent discloses plastic as an alternative material for
`
`the container:
`
`In certain non-limiting embodiments, the container or vessel includes, but
`is not limited to glass vials (for example, but not limited to, flint glass
`vials), ampoules, plastic flexible containers, for example, but not limited
`to, PVC (polyvinyl chloride) containers, VisIV™ plastic containers
`(Hospira, Inc., Lake Forest, Ill.) and CR3 elastomer copolyester ether
`containers (Hospira, Inc., Lake Forest, Ill.), CZ resin containers, poly
`propylene containers and syringes.
`
`’470 Patent at 9:22-29.
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`46.
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`No claims of the ’470 Patent cover a ready to use liquid pharmaceutical
`
`composition for parenteral administration to a subject, comprising dexmedetomidine or a
`
`pharmaceutically acceptable salt thereof at a concentration of about 4 μg/mL disposed within a
`
`sealed plastic container.
`
`47.
`
`On February 6, 2018, the Honorable Richard G. Andrews of the United States
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`District Court for the District of Delaware entered the Amneal Judgment, invalidating claim 4 of
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`the ’470 Patent for obviousness. Because claim 4 depends from claim 1, a Court would likewise
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`properly find at least claim 1 also invalid.
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`The ’527 Patent
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`48.
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`On its face the ’527 Patent, entitled “Methods of Treatment Using a
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`Dexmedetomidine Premix Formulation,” indicates it was issued by the U.S. Patent and
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`Trademark Office on June 4, 2013. A copy of the ’527 Patent is attached as Exhibit D.
`
`49.
`
`The ’527 Patent issued from application number 13/678,148 (the “’148
`
`Application”).
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`50.
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`According to records at the U.S. Patent and Trademark Office, Hospira is the
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`assignee of the ’527 Patent.
`
`51.
`
`52.
`
`53.
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`The ’527 Patent contains fifteen claims.
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`The ’527 Patent contains one independent claim.
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`The independent claim of the ’527 Patent recites a method of using “a ready to
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`use liquid pharmaceutical composition . . . disposed within a sealed glass container.”
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`54.
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`The ’527 Patent’s fourteen dependent claims incorporate the limitations of the
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`claims from which they depend. Thus, all claims of the ’527 Patent require “a ready to use liquid
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`pharmaceutical composition . . . disposed within a sealed glass container.”
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`55.
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`In the November 15, 2012 Accelerated Examination Support Document, filed
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`concomitantly with the ’148 Application, Hospira argues that using glass containers resulted in
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`unexpectedly superior stability compared to using plastic containers. Accelerated Examination
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`Support Document, at 46 (Nov. 15, 2012) (arguing that it was unexpected that “when stored in
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`glass vials or ampoules, the ready to use liquid pharmaceutical composition maintained over
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`98% potency after 5 months,” but “when stored in plastic or PVC containers, which include
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`plastic syringes and plastic bags, the potency was reduced by as much as 20% after only a two-
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`week storage period.”).
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`56.
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`On January 11, 2013, the U.S. Patent and Trademark Office issued a notice of
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`allowance for the ’148 Application. In this notice, the examiner “concur[red] with [Hospira’s]
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`detailed explanation of patentability as set forth at pages 44-73 of the Examination Support
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`Document filed by [Hospira] on 11/15/2008 [sic, 2012].” Notice of Allowance, supra, ¶ 3.
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`57.
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`The specification of the ’527 Patent discloses plastic as an alternative material for
`
`the container:
`
`In certain non-limiting embodiments, the container or vessel includes, but
`is not limited to glass vials (for example, but not limited to, flint glass
`vials), ampoules, plastic flexible containers, for example, but not limited
`to, PVC (polyvinyl chloride) containers, VisIV™ plastic containers
`(Hospira, Inc., Lake Forest, Ill.) and CR3 elastomer copolyester ether
`containers (Hospira, Inc., Lake Forest, Ill.), CZ resin containers, poly
`propylene containers and syringes.
`
`’527 Patent at 9:22-29.
`
`58.
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`No claims of the ’527 Patent cover methods of using a ready to use liquid
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`pharmaceutical composition
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`for parenteral administration
`
`to a
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`subject, comprising
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`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 4
`
`μg/mL disposed within a sealed plastic container.
`
`59.
`
`On February 6, 2018, the Honorable Richard G. Andrews of the United States
`
`District Court for the District of Delaware entered the Amneal Judgment, invalidating claim 5 of
`
`the ’527 Patent. Because claim 5 depends from claims 1, a Court would likewise properly find at
`
`least claim 1 also invalid.
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`BACKGROUND
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`60.
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`In December 2003, Congress passed the Medicare Modernization Act of 2003
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`(the “MMA”). Title XI of that Act, entitled “Access to Affordable Pharmaceuticals,” included a
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`provision allowing an ANDA applicant to bring a declaratory judgment action for invalidity or
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`non-infringement of a patent listed in FDA’s Approved Drug Products with Therapeutic
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`Equivalence Evaluations (commonly referred to as the Orange Book) if the NDA holder does not
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`sue within 45 days of receiving notice of a Paragraph IV certification. 21 U.S.C. § 355(j)(5)(C).
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`61.
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`The MMA also added provisions for the forfeiture of eligibility for the 180-day
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`exclusivity
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`to which an ANDA “first applicant,” as defined
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`in 21 U.S.C. §
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`355(j)(5)(B)((iv)(II)(bb), might otherwise be entitled pursuant to the Hatch Waxman Act. Id. §
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`355 (j)(5)(D). The forfeiture provision at issue here requires, inter alia, the entry of a judgment
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`of non-infringement, unenforceability or invalidity with respect to the patents to which a first
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`applicant has filed a Paragraph IV certification, regardless of whether those patents are asserted
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`against subsequent ANDA applicants. Id. § 355(j)(5)(D)(i)(I)(bb).
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`62.
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`Upon information and belief, Hospira, Inc. is the current holder of approved New
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`Drug Application (“NDA”) No. 21-038 for Precedex® Injection (dexmedetomidine HCl), 200
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`mcg base/50 mL and 400 mcg base/100 mL.
`
`63.
`
`Hospira identified the Patents-in-Suit to the FDA for listing in the Orange Book,
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`as patents to which “a claim of patent infringement could reasonably be asserted if a person not
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`licensed by the owner engaged in the manufacture, use, or sale of the drug” products containing
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`dexmedetomidine HCl, 200 mcg base/50 mL and 400 mcg base/100 mL (“Dexmedetomidine
`
`Product”).
`
`64.
`
`The Patents-in-Suit remain listed in the Orange Book with respect to NDA No.
`
`21-038 and Hospira maintains and continues to represent to the public that the Patents-in-Suit
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`claim the drug approved in NDA 21-038 or a method of using that drug, and that a claim of
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`patent infringement could reasonably be asserted against any unlicensed ANDA applicant who
`
`attempts to market a generic version of the drug prior to the delisting of the Patents-in-Suit. The
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`FDA Orange Book also lists a six-month pediatric exclusivity for each of the Patents-in-Suit,
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`which upon information and belief will prevent ANDA applicants from obtaining final FDA
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`marketing approval for their generic dexmedetomidine products until six months after the
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`expiration of the Patents-in-Suit.
`
`65.
`
`According to Orange Book listings, Precedex®, or treatments using Precedex®
`
`are claimed in the Patents-in-Suit.
`
`66.
`
`Celerity Pharmaceuticals, LLC (“Celerity”) submitted and later transferred to
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`Baxter ANDA No. 208532 for a proposed drug product containing dexmedetomidine HCl, 200
`
`mcg base/50 mL and 400 mcg base/100 mL. Baxter’s ANDA seeks FDA approval for the
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`commercial manufacture, use, importation, offer for sale and sale of generic dexmedetomidine
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`HCl, 200 mcg base/50 mL and 400 mcg base/100 mL.
`
`67.
`
`In ANDA No. 208532 Baxter/Celerity filed a certification under 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) certifying that the ’158 Patent, the ’470
`
`Patent, and the ’527 Patent (collectively, the “Paragraph IV Patents”) will not be infringed by the
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`manufacture, use, or sale of the Baxter’s ANDA Product.
`
`68.
`
`In ANDA No. 208532 Baxter/Celerity included a statement pursuant to 21 U.S.C.
`
`§ 505(j)(2)(A)(viii) and 21 C.F.R. § 314.94(a)(12)(iii)(A) (“Section viii Carve-out”) that the
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`method of use recited in the ’867 patent does not claim any indication for which Baxter’s ANDA
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`seeks approval. Under 21 U.S.C. § 505(j)(2)(A)(viii), a statement pursuant to that section—in
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`lieu of a certification—is appropriate if the listed method of use patent “does not claim a use for
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`which the [ANDA] applicant is seeking approval. . . .” Id.
`
`69.
`
`In accordance with 35 U.S.C. § 355(j)(2)(B) and 21 C.F.R. § 314.95,
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`Baxter/Celerity, on or about June 6, 2016, served Hospira with a Notice Letter informing
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`Hospira of Baxter’s ANDA seeking approval to engage in the commercial manufacture, use,
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`importation, offer for sale, or sale of Baxter’s ANDA Product before the expiration of the
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`Patents-in-Suit. Celerity’s Notice Letter included a Paragraph IV certification that the Paragraph
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`IV Patents would not be infringed by the manufacture, use, or sale of the product covered by the
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`ANDA because Baxter’s ANDA Product is provided in a plastic container rather than a “sealed
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`glass container,” as claimed in the Paragraph IV Patents.
`
`70.
`
`Celerity’s June 6, 2016 notice letter further informed Hospira that Baxter’s
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`ANDA Product does not infringe the ’867 Patent because of the Section viii Carve-out.
`
`71.
`
`Baxter desires to bring its generic dexmedetomidine HCl, 200 mcg base/50 mL
`
`and 400 mcg base/100 mL to market and to allow the public to enjoy the benefits of generic
`
`competition for these products at the earliest possible date under the applicable statutory and
`
`FDA regulatory provisions.
`
`72.
`
`On January 25, 2018, FDA issued a letter tentatively approving Baxter’s ANDA
`
`No. 208532. As stated in that letter, FDA’s approval of ANDA No. 208532 was tentative rather
`
`than final on the basis of a first applicant’s continued eligibility for 180-day exclusivity. But for
`
`a first applicant’s continued eligibility for 180-day exclusivity, FDA would have finally
`
`approved ANDA No. 208532, thus permitting the immediate marketing of the Baxter ANDA
`
`Product.
`
`73.
`
`On information and belief, the earliest possible date that Baxter can currently
`
`obtain final FDA marketing approval for the Baxter ANDA Product is upon the expiration of the
`
`Paragraph IV Patents and any applicable pediatric exclusivity. Unless a court enters a final
`
`decision from which no appeal (other than a petition to the Supreme Court for a writ of
`
`certiorari) has been or can be taken that the Patents-in-Suit are invalid or not infringed, Baxter
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`may not be able to begin marketing the Baxter ANDA Product until the expiration of the
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`Paragraph IV Patents and any applicable pediatric exclusivity.
`
`74.
`
`Prior to Baxter/Celerity filing ANDA No. 208532, other ANDA applicants filed
`
`ANDAs for dexmedetomidine HCl, 200 mcg base/50 mL and 400 mcg base/100 mL containing
`
`Paragraph IV certifications to the Patents-in-Suit challenging, inter alia, the validity of the
`
`Patents-in-Suit. For example, Hospira filed a patent infringement suit in this District against
`
`Amneal Pharmaceuticals, Inc.—one of the generic manufacturers to have filed Paragraph IV
`
`statements before Baxter/Celerity in this District for patent infringement—alleging that Amneal
`
`infringed the Paragraph IV Patents. Hospira did not assert the ’867 Patent against Amneal in that
`
`lawsuit. Amneal failed in its Paragraph IV challenge to noninfringement of the ’106 Patent.
`
`75.
`
`Because Amneal failed in its attempt to have all claims of the Patents-in-Suit held
`
`invalid or otherwise prevail, Amneal’s Paragraph IV certification with respect to the ’106 patent
`
`should convert to a Paragraph III certification, which requires Amneal to wait until 2032, when
`
`the ’106 patent and any applicable pediatric exclusivity expire, before it can market its generic
`
`dexmedetomidine HCl products.
`
`76.
`
`On the basis of FDA’s tentative approval letter of January 25, 2018, a first
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`applicant retains eligibility for 180-day generic exclusivity for dexmedetomidine HCl, 200 mcg
`
`base/50 mL and 400 mcg base/100 mL by virtue of a first applicant’s Paragraph IV certification
`
`to one or more of the Patents-in-Suit. Presently, unless a first applicant triggers the running of
`
`the 180-day exclusivity period by obtaining approval and initiating marketing, the FDA will be
`
`statutorily prohibited from granting final approval of Baxter’s ANDA Product until the
`
`expiration of the Patents-in-Suit and any applicable pediatric exclusivity in 2032. Such a
`
`scenario can be prevented if a court enters a final decision from which no appeal (other than a
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`Case 1:18-cv-00303-UNA Document 1 Filed 02/22/18 Page 15 of 22 PageID #: 15
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`petition to the Supreme Court for a writ of certiorari) has been or can be taken that the Patents-
`
`in-Suit are invalid or not infringed. 21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(AA).
`
`77.
`
`Unless the Court declares the Patents-in-Suit invalid, unenforceable or not
`
`infringed by Baxter’s ANDA Product, Baxter will be prohibited from selling its product until a
`
`first applicant eventually obtains approval of its ANDA, initiates marketing, and 180 days have
`
`expired thereby injuring Baxter by depriving it of sales revenue for that period of time and
`
`injuring the public by depriving the public of the benefit of the generic competition that would
`
`otherwise be provided by Baxter’s ANDA product. If a first applicant fails to obtain approval of
`
`its ANDA, or for some other reason fails to initiate marketing, Baxter may be forced to wait until
`
`2032 to market its product, thereby greatly prolonging the period of injury to Baxter and the
`
`public.
`
`78.
`
`On information and belief, no court has entered the “final decision” identified in
`
`21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(AA) with respect to the Patents-in-Suit. Upon information and
`
`belief, no court has entered a final decision from which an appeal has been or can be taken that
`
`all claims of the Patents-in-Suit are invalid or not infringed. However, the Amneal Judgment
`
`invalidated claims 3 and 4 of the ’158 Patent, claim 4 of the ’470 Patent, and claim 5 of the ’527
`
`Patent. Because the issues of invalidity of each of those claims are substantially identical to
`
`issues of invalidity of the remaining claims in each of those patents, Hospira is collaterally
`
`estopped from arguing that all claims of the ’158, ’470, and ’527 Patents are not invalid.
`
`79.
`
`On information and belief, no court has signed a “settlement order or consent
`
`decree” identified in 21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(BB) that enters final judgment which
`
`includes a finding that the Patents-in-Suit are invalid or not infringed.
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`COUNT ONE:
`Declaratory Judgment of Noninfringement of the ’867 Patent
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`80.
`
`Baxter repeats and realleges each and every allegation set forth in the foregoing
`
`paragraphs, as though fully set forth herein.
`
`81.
`
`Because every claim of the ’867 Patent requires practicing “[a] method of
`
`sedating a patient in an intensive care unit,” and the tentatively approved label for the Baxter
`
`ANDA Product does not contain an indication for such use, the claims of the ’867 Patent will not
`
`be infringed by Baxter’s manufacture, marketing, use, offer for sale, sale and/or importation of
`
`the Baxter ANDA Product.
`
`82.
`
`There is a substantial and continuing controversy between Baxter on the one hand
`
`and Hospira and Orion on the other, and a declaration of rights is both necessary and appropriate
`
`to establish that Baxter does not infringe any valid or enforceable claim of the ’867 Patent and
`
`allow Baxter to bring the Baxter ANDA Product to market.
`
`83.
`
`But for Hospira’s decision to list the Patents-in-Suit in the Orange Book, FDA
`
`approval of Baxter’s ANDA No. 208352 would not have been delayed by those patents. Baxter
`
`is being injured by Hospira’s actions of requesting the FDA to list the Patents-in-Suit in the
`
`Orange Book and continuing said listing in the Orange Book.
`
`84.
`
`Baxter’s injury can be redressed by the requested relief: declaratory judgment of
`
`non-infringement of the Patents-in-Suit would necessitate a first applicant initiating marketing
`
`within 75 days or risk forfeiting its eligibility for 180-day exclusivity, which currently blocks
`
`final FDA marketing approval of Baxter’s ANDA. Because approval of Baxter’s ANDA No.
`
`208532 is blocked by a first applicant’s eligibility for 180-day exclusivity, Baxter will be
`
`monetarily harmed, as it will lose sales of the Baxter ANDA Product by virtue of not being able
`
`to enter the market at the earliest possible date under the applicable statutory and FDA regulatory
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`provisions, and will be deprived of an economic opportunity to compete in the market for
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`dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL and 400
`
`mcg/100 mL single-dose containers.
`
`COUNT TWO:
`Declaratory Judgment of Noninfringement of the ’158 Patent
`
`85.
`
`Baxter repeats and realleges each and every allegation set forth in the foregoing
`
`paragraphs, as though fully set forth herein.
`
`86.
`
`Because every claim of the ’158 Patent requires “[a] ready to use liquid
`
`pharmaceutical composition . . . disposed within a sealed glass container” and the tentatively
`
`approved Baxter ANDA Product is not disposed within a sealed glass container, the claims of the
`
`’158 Patent will not be infringed by the manufacture, marketing, use, offer for sale, sale and/or
`
`importation of the Baxter ANDA Product.
`
`87.
`
`Because Hospira amended its claims by adding the limitation that the sealed
`
`container be made of glass to overcome a rejection made during the prosecution of the ’158
`
`Patent, the doctrine of prosecution history estoppel prevents Hospira from asserting that the
`
`Baxter ANDA Product infringes the ’158 Patent’s claims under the doctrine of equivalents.
`
`88.
`
`Because Hospira argued during the prosecution of the ’158 Patent that disposing
`
`the composition in a glass container provided surprising and unexpected results over plastic
`
`containers, the doctrine of prosecution history estoppel prevents Hospira from asserting that the
`
`Baxter ANDA Product infringes the ’158 Patent’s claims under the doctrine of equivalents.
`
`89.
`
`Because the ’158 Patent discloses plastic as an alternate material for the container
`
`but only claims glass containers, the Baxter ANDA Product cannot infringe the ’158 Patent’s
`
`claims under the doctrine of equivalents pursuant to the disclosure-dedication rule.
`
`90.
`
`There is a substantial and continuing controversy between Baxter and Hospira and
`
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`Case 1:18-cv-00303-UNA Document 1 Filed 02/22/18 Page 18 of 2