Case 1:18-cv-00303-RGA Document 10 Filed 03/20/18 Page 1 of 29 PageID #: 113
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BAXTER HEALTHCARE
`CORPORATION,
`
`
`
`
`
`HOSPIRA, INC. and ORION CORP.,
`
`
`
`v.
`
`
`
`Plaintiff,
`
`Defendants.
`
`C.A. No. 18-303-RGA
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`DEFENDANTS’ ANSWER AND COUNTERCLAIM
`
`Defendants Hospira, Inc. (“Hospira”) and Orion Corp. (“Orion”) (collectively,
`
`“Defendants”), through counsel, hereby answer the February 22, 2018, Complaint of Plaintiff
`
`Baxter Healthcare Corporation (“Baxter”).
`
`NATURE OF THE SUIT
`
`This is a declaratory judgment action seeking a declaration of non-infringement of
`1.
`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”) to
`enable Baxter to bring its generic dexmedetomidine hydrochloride in 0.9% sodium chloride
`injection 200 mcg/50 mL and 400 mcg/100mL (the “Baxter ANDA Product”) to market at the
`earliest possible date under the applicable statutory and Food and Drug Administration (“FDA”)
`regulatory provisions, and to allow the public to enjoy the benefits of generic competition for these
`products.
`
`RESPONSE: Admitted that Baxter’s suit seeks a declaration of non-infringement of the Patents-
`
`in-Suit. Otherwise denied.
`
`THE PARTIES
`
`Baxter Healthcare Corporation is a corporation incorporated in Delaware with its
`2.
`principal place of business at One Baxter Parkway, Deerfield, IL 60015.
`
`RESPONSE: Admitted, on information and belief.
`
`Upon information and belief, Hospira, Inc. is a Delaware corporation with its
`3.
`principal place of business at 275 North Field Drive, Lake Forest, Illinois 60045.
`
`

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`RESPONSE: Admitted.
`
`Upon information and belief, Orion Corp. is a corporation organized under the laws
`4.
`of Finland with its principal place of business at Orionintie 1, FIN-02200 Espoo, Finland.
`
`RESPONSE: Admitted.
`
`JURISDICTION, VENUE AND JOINDER
`
`This Complaint arises under the Patent Laws of the United States, 35 U.S.C. § 100
`5.
`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)) (the “Hatch-Waxman Amendments”), and the Medicare Prescription Drug,
`Improvement and Modernization Act of 2003, Pub. L. No. 108-173, 17 Stat. 2066 (2003) (the
`“MMA”), based upon an actual controversy between the parties to declare that Baxter is free, upon
`approval by the FDA, to manufacture, use, market, sell, offer to sell, and/or import its proposed
`product as described in Abbreviated New Drug Application (“ANDA”) No. 208532.
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that Baxter’s Complaint purports to arise under the laws
`
`cited in this paragraph. Admitted that there is a controversy as to patent infringement by Baxter’s
`
`ANDA pursuant to the cited statutes. Otherwise denied.
`
`6.
`
`This Court has original jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted.
`
`Venue is proper in this District pursuant to 28 U.S.C. § 1391 and 1400(b), at least
`7.
`because Hospira resides in this District within the meaning of 28 U.S.C. § 1400(b).
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that venue is proper for purposes of this action only.
`
`This Court has personal jurisdiction over Hospira because, among other things,
`8.
`Hospira is a Delaware corporation that, having availed itself of Delaware’s corporate laws, is
`subject to personal jurisdiction in Delaware.
`
`
`
`2
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`

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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that this Court has personal jurisdiction over Hospira
`
`for purposes of this action only.
`
`This Court has personal jurisdiction over Orion because, among other things, on
`9.
`information and belief, Orion does business in this District by co-owning a patent covering
`Precedex® (i.e., the ’867 Patent), exclusively licensing in the United States its ownership interest
`in said patent to Hospira—a Delaware corporation—and receiving royalty payments from Hospira
`for the sale of Precedex®, which is sold in Delaware.
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that this Court has personal jurisdiction over Orion for
`
`purposes of this action only. Otherwise denied.
`
`This Court also has personal jurisdiction over Orion because Orion has regularly
`10.
`and purposefully availed itself of the privileges and benefits of this forum, having brought multiple
`suits in this District, including suits specifically alleging infringement of the ’867 Patent at issue
`in this suit: Hospira Inc. and Orion Corp v. Sandoz International GmbH, et al., Civ. No. 09-00665
`(D. Del.); Hospira, Inc. and Orion Corp. v. Aurobindo Pharma Ltd., at al., Civ. No. 14-00486 (D.
`Del.); Hospira, Inc. and Orion Corp. v. Ben Venue Labs, Inc., Civ. No. 14-00487 (D. Del.);
`Hospira, Inc. and Orion Corp. v. Actavis LLC et. al., Civ. No. 14-00488 (D. Del.); Hospira, Inc.
`and Orion Corp. v. Ben Venue Labs., Inc., et al., Civ. No. 14-1008 (D. Del.).
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that this Court has personal jurisdiction over Orion for
`
`purposes of this action only.
`
`Upon information and belief, the license agreement between Orion and Hospira
`11.
`imposes an obligation on Orion to participate in the enforcement or defense of the ’867 patent with
`Hospira, which is engaged in exploiting the patent rights in Delaware through its sale of
`Precedex®.
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, denied.
`
`By virtue of its repeated assertion of infringement of the ’867 Patent in this District,
`12.
`Orion has waived any argument that it is not subject to specific personal jurisdiction in this District
`for actions relating to the infringement thereof.
`
`
`
`3
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`

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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that this Court has personal jurisdiction over Orion for
`
`purposes of this action only. Otherwise denied.
`
`Venue is proper in this district for Orion pursuant to 28 U.S.C. §§ 1391 and 1400(b)
`13.
`because, inter alia, Orion is a corporation organized and existing under the laws of Finland and is
`subject to personal jurisdiction in this judicial district.
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that venue is proper in this district for purposes of this
`
`action only.
`
`THE PATENTS-IN-SUIT
`
`The ’867 Patent
`
`On its face the ’867 Patent, entitled “Use of Dexmedetomidine for ICU Sedation,”
`14.
`indicates it was issued by the U.S. Patent and Trademark Office on April 6, 2004. A copy of the
`’867 Patent is attached as Exhibit A.
`
`RESPONSE: Admitted.
`
`According to records at the U.S. Patent and Trademark Office, Hospira and Orion
`15.
`are co-assignees of the ’867 Patent.
`
`RESPONSE: Admitted.
`
`On information and belief, Hospira is the exclusive licensee in the United States of
`16.
`Orion’s interest in the ’867 Patent.
`
`RESPONSE: Denied.
`
`17.
`
`The ’867 Patent contains twelve claims.
`
`RESPONSE: Admitted.
`
`18.
`
`The ’867 Patent contains two independent claims.
`
`RESPONSE: Admitted.
`
`Each independent claim of the ’867 Patent recites “[a] method of sedating a patient
`19.
`in an intensive care unit.”
`
`
`
`4
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`

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`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that the independent claims recite, among other things,
`
`“a method of sedating a patient in an intensive care unit.” Otherwise denied.
`
`The ’867 Patent’s ten dependent claims incorporate the limitations of the claims
`20.
`from which they depend. Thus, all claims of the ’867 Patent require “[a] method of sedating a
`patient in an intensive care unit.”
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that Claims 1 and 3 recite, among other things, “a
`
`method of sedating a patient in an intensive care unit.” Further admitted that Claim 2 depends
`
`from Claim 1 and Claims 4-12 depend from Claim 3. Otherwise denied.
`
`The ’158 Patent
`
`On its face the ’158 Patent, entitled “Dexmedetomidine Premix Formulation,”
`21.
`indicates it was issued by the U.S. Patent and Trademark Office on August 14, 2012. A copy of
`the ’158 Patent is attached as Exhibit B.
`
`RESPONSE: Admitted.
`
`22.
`Application”).
`
`The ’158 Patent issued from application number 13/343,672 (the “’672
`
`RESPONSE: Admitted.
`
`According to records at the U.S. Patent and Trademark Office, Hospira is the
`23.
`assignee of the ’158 Patent.
`
`RESPONSE: Admitted.
`
`24.
`
`The ’158 Patent contains four claims.
`
`RESPONSE: Admitted.
`
`25.
`
`The ’158 Patent contains one independent claim.
`
`RESPONSE: Admitted.
`
`The independent claim of the ’158 Patent recites “[a] ready to use liquid
`26.
`pharmaceutical composition . . . disposed within a sealed glass container.”
`
`
`
`5
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`

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`RESPONSE: Admitted that Claim 1 of the ‘158 patent recites “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 glass container.” Otherwise denied.
`
`The ’158 Patent’s three dependent claims incorporate the limitations of the claims
`27.
`from which they depend. Thus, all claims of the ’158 Patent require “[a] ready to use liquid
`pharmaceutical composition . . . disposed within a sealed glass container.”
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that claim 1 of the ‘158 patent recites, among other
`
`things, “a ready to use liquid pharmaceutical composition . . . disposed within a sealed glass
`
`container.” Further admitted that Claims 2-4 depend from Claim 1. Otherwise denied.
`
`28. When the ’672 Application was initially filed, its claims did not require that the
`sealed container be made of glass.
`
`RESPONSE: Admitted.
`
`On March 13, 2012, in response to an office action rejecting the originally-filed
`29.
`claims of the ’672 Application, Hospira amended the sole pending independent claim to include
`the present requirement that the sealed container be “a sealed glass container.”
`
`RESPONSE: Admitted.
`
`In its March 13, 2012 filing with the U.S. Patent and Trademark Office, Hospira
`30.
`argued that it discovered that using glass containers resulted in unexpectedly superior stability
`compared to using plastic containers. Response to Office Action, at 7-8 (Mar. 13, 2012) (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”).
`
`RESPONSE: Admitted that, in the passage cited in this paragraph, the patent applicants stated,
`
`in part, that “Applicants also submit that the claimed ready to use premixture composition provides
`
`for surprising and unexpected advantages over the diluted 4 µg/mL composition described by the
`
`Draft Labeling. . . . As described in Example 1, a 4 µg/mL premixture formulation stored in glass
`
`
`
`6
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`

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`vials and ampoules maintained a higher level of potency after a 5 month storage period compared
`
`to storage in plastic, CR3 or PVC containers.” Otherwise denied.
`
`On April 18, 2012, the U.S. Patent and Trademark Office issued a notice of
`31.
`allowance for the ’672 Application. In this notice, the examiner stated that “requiring the
`composition to be disposed within a sealed glass container[] was effective to overcome the
`previous rejection under 35 U.S.C[. §] 102(b).” Notice of Allowance, ¶ 3 (Apr. 18, 2012)
`
`RESPONSE: Admitted that the PTO issued a notice of allowance for the ‘672 Application on
`
`April 18, 2012. Further admitted that the notice stated, in part, “Applicants’ amendment to Claim
`
`1, requiring the composition to be disposed within a sealed glass container, was effective to
`
`overcome the previous rejection under 35 U.S.C. 102(b).” Otherwise denied.
`
`32.
`the container:
`
`The specification of the ’158 Patent discloses plastic as an alternative material for
`
`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.
`
`RESPONSE: Admitted that the ‘158 patent contains the quoted passage. Otherwise denied.
`
`No claims of the ’158 Patent cover a ready to use liquid pharmaceutical
`33.
`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.
`
`RESPONSE: Admitted that Baxter does not infringe any claim of the ‘158 patent that requires
`
`a “sealed glass container.” Otherwise denied.
`
`On February 6, 2018, the Honorable Richard G. Andrews of the United States
`34.
`District Court for the District of Delaware entered a final judgment in the action Hospira, Inc. v.
`Amneal Pharmaceuticals LLC, Civ. No. 1:15-cv-00697-RGA (the “Amneal Judgment”),
`invalidating claims 3 and 4 of the ’158 Patent for obviousness. Because claims 3 and 4 depend
`from claims 1 and/or 2, a Court would likewise properly find claims 1 and 2 also invalid.
`
`
`
`7
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`

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`RESPONSE: Admitted that the Amneal Judgment held claims 3 and 4 of the ‘158 patent invalid.
`
`However, the Amneal Judgment is pending appeal. Otherwise denied.
`
`The ’470 Patent
`
`On its face the ’470 Patent, entitled “Dexmedetomidine Premix Formulation,”
`35.
`indicates it was issued by the U.S. Patent and Trademark Office on December 25, 2012. A copy
`of the ’470 Patent is attached as Exhibit C.
`
`RESPONSE: Admitted.
`
`36.
`Application”).
`
`The ’470 Patent issued from application number 13/541,524 (the “’524
`
`RESPONSE: Admitted.
`
`According to records at the U.S. Patent and Trademark Office, Hospira is the
`37.
`assignee of the ’470 Patent.
`
`RESPONSE: Admitted.
`
`38.
`
`The ’470 Patent contains seven claims.
`
`RESPONSE: Admitted.
`
`39.
`
`The ’470 Patent contains one independent claim.
`
`RESPONSE: Admitted.
`
`The independent claim of the ’470 patent recites “[a] ready to use liquid
`40.
`pharmaceutical composition . . . disposed within a sealed glass container.”
`
`RESPONSE: Admitted that Claim 1 of the ‘470 patent recites “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 0.005
`
`to about 50 µg/mL disposed within a sealed glass container.” Otherwise denied.
`
`The ’470 Patent’s six dependent claims incorporate the limitations of the claims
`41.
`from which they depend. See 35 U.S.C. § 112(d). Thus, all claims of the ’470 Patent require “[a]
`ready to use liquid pharmaceutical composition . . . disposed within a sealed glass container.”
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that Claim 1 of the ‘470 patent recites, among other
`8
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`
`
`

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`things, “a ready to use liquid pharmaceutical composition . . . disposed within a sealed glass
`
`container.” Further admitted that Claims 2-7 depend from Claim 1. Otherwise denied.
`
`On August 17, 2012, the U.S. Patent and Trademark Office issued an office action
`42.
`rejecting all pending claims of the ’524 Application as obvious.
`
`RESPONSE: Admitted.
`
`On September 17, 2012, Hospira responded to the rejection, arguing that using glass
`43.
`containers resulted in unexpectedly superior stability compared to using plastic containers.
`Response to Office Action, at 6 (Sept. 17, 2012) (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”); Decl. of
`Huailiang Wu, Ph.D., ¶ 13 (Sept. 17, 2012) (“[S]toring a ready to use formulation of
`dexmedetomidine at concentrations recited by the claims of the ’524 application in glass containers
`resulted in an unexpected reduction in potency loss of the composition compared to storage in
`plastic PVC containers.”).
`
`RESPONSE: Admitted that, in the passage referred to in this paragraph, the patent applicants
`
`stated, in part, that “Applicants also submit that the claimed ready to use premixture composition
`
`provides for surprising and unexpected advantages over the diluted 4 µg/mL composition
`
`described by the cited references. . . . As described in Example 1, a 4 µg/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.” Further admitted that the
`
`Wu declaration includes the passage quoted in the allegation. Otherwise denied.
`
`On October 22, 2012, the U.S. Patent and Trademark Office issued a notice of
`44.
`allowance for the ’524 Application. In this notice, the examiner credits Hospira’s arguments that
`dexmedetomidine formulations stored in glass containers exhibit unexpectedly better stability than
`those stored in plastic. Notice of Allowance, ¶ 3 (Oct. 22, 2012) (crediting Hospira’s argument
`that “the Specification demonstrates that a dexmedetomidine 4µg/mL 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,’” as well as “the Declaration of Huailang Wu
`provided by Applicants [which] provides further evidence of the surprising increase in stability of
`dexmedetomidine compositions (1, 10, 15 and 50 µg/ml) stored in sealed glass containers
`compared to storage in PVC bags.”).
`
`
`
`9
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`

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`RESPONSE: Admitted that the PTO issued a notice of allowance for the ‘524 Application on
`
`October 22, 2012. Defendants refer to the Notice of Allowability for its actual content. Otherwise
`
`denied.
`
`45.
`the container:
`
`The specification of the ’470 Patent discloses plastic as an alternative material for
`
`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.
`
`RESPONSE: Admitted that the ‘470 patent contains the quoted passage. Otherwise denied.
`
`No claims of the ’470 Patent cover a ready to use liquid pharmaceutical
`46.
`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.
`
`RESPONSE: Admitted that Baxter does not infringe any claim of the ‘470 patent that requires a
`
`“sealed glass container.” Otherwise denied.
`
`On February 6, 2018, the Honorable Richard G. Andrews of the United States
`47.
`District Court for the District of Delaware entered the Amneal Judgment, invalidating claim 4 of
`the ’470 Patent for obviousness. Because claim 4 depends from claim 1, a Court would likewise
`properly find at least claim 1 also invalid.
`
`RESPONSE: Admitted that the Amneal Judgment held claim 4 of the ‘470 patent invalid.
`
`However, the Amneal Judgment is pending appeal. Otherwise denied.
`
`The ’527 Patent
`
`On its face the ’527 Patent, entitled “Methods of Treatment Using a
`48.
`Dexmedetomidine Premix Formulation,” indicates it was issued by the U.S. Patent and Trademark
`Office on June 4, 2013. A copy of the ’527 Patent is attached as Exhibit D.
`
`RESPONSE: Admitted.
`
`
`
`10
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`49.
`Application”).
`
`The ’527 Patent issued from application number 13/678,148 (the “’148
`
`RESPONSE: Admitted.
`
`According to records at the U.S. Patent and Trademark Office, Hospira is the
`50.
`assignee of the ’527 Patent.
`
`RESPONSE: Admitted.
`
`51.
`
`The ’527 Patent contains fifteen claims.
`
`RESPONSE: Admitted.
`
`52.
`
`The ’527 Patent contains one independent claim.
`
`RESPONSE: Admitted.
`
`The independent claim of the ’527 Patent recites a method of using “a ready to use
`53.
`liquid pharmaceutical composition . . . disposed within a sealed glass container.”
`
`RESPONSE: Admitted that Claim 1 of the ‘527 patent recites “a method of providing sedation
`
`to a patient in need thereof, the method comprising administering to the patient an effective amount
`
`of a composition, wherein the composition comprises dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 0.005 to about 50 µg/mL, wherein the
`
`composition is a ready to use liquid pharmaceutical composition for parenteral administration to
`
`the patient disposed within a sealed glass container.” Otherwise denied.
`
`The ’527 Patent’s fourteen dependent claims incorporate the limitations of the
`54.
`claims from which they depend. Thus, all claims of the ’527 Patent require “a ready to use liquid
`pharmaceutical composition . . . disposed within a sealed glass container.”
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that Claim 1 of the ‘527 patent recites, among other
`
`things, “a ready to use liquid pharmaceutical composition . . . disposed within a sealed glass
`
`container.” Further admitted that Claims 2-15 depend from Claim 1. Otherwise denied.
`
`In the November 15, 2012 Accelerated Examination Support Document, filed
`55.
`concomitantly with the ’148 Application, Hospira argues that using glass containers resulted in
`
`
`
`11
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`unexpectedly superior stability compared to using plastic containers. Accelerated Examination
`Support Document, at 46 (Nov. 15, 2012) (arguing that it was unexpected that “when stored in
`glass vials or ampoules, the ready to use liquid pharmaceutical composition maintained over 98%
`potency after 5 months,” but “when stored in plastic or PVC containers, which include plastic
`syringes and plastic bags, the potency was reduced by as much as 20% after only a two- week
`storage period.”).
`
`RESPONSE: Admitted that, in the passage cited in this paragraph, the patent applicants stated,
`
`in part, that “Applicants submit that the claimed ready to use liquid pharmaceutical composition
`
`provides for advantages over the diluted 4 µg/mL composition described by the Precedex® label.
`
`. . . As described in Example 1, when stored in glass vials or ampoules, the ready to use liquid
`
`pharmaceutical composition maintained over 98% potency after 5 months. However, when stored
`
`in plastic or PVC containers, which include plastic syringes and plastic bags, the potency was
`
`reduced by as much as 20% after only a two-week storage period.” Otherwise denied.
`
`On January 11, 2013, the U.S. Patent and Trademark Office issued a notice of
`56.
`allowance for the ’148 Application. In this notice, the examiner “concur[red] with [Hospira’s]
`detailed explanation of patentability as set forth at pages 44-73 of the Examination Support
`Document filed by [Hospira] on 11/15/2008 [sic, 2012].” Notice of Allowance, supra, ¶ 3.
`
`RESPONSE: Admitted that the PTO issued a notice of allowance for the ‘148 Application on
`
`January 11, 2013. Admitted that the notice states, in part, “Additionally, the Examiner concurs
`
`with Applicants’ detailed explanation of patentability as set forth at pages 44-73 of the
`
`Examination Support Document filed by Applicants.” Otherwise denied.
`
`57.
`the container:
`
`The specification of the ’527 Patent discloses plastic as an alternative material for
`
`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.
`
`
`
`12
`
`

`

`Case 1:18-cv-00303-RGA Document 10 Filed 03/20/18 Page 13 of 29 PageID #: 125
`
`RESPONSE: Admitted that the ‘527 patent contains the quoted passage. Otherwise denied.
`
`No claims of the ’527 Patent cover methods of using a ready to use liquid
`58.
`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.
`
`RESPONSE: Admitted that Baxter does not infringe any claim of the ‘527 patent that requires
`
`a “sealed glass container.” Otherwise denied.
`
`On February 6, 2018, the Honorable Richard G. Andrews of the United States
`59.
`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.
`
`RESPONSE: Admitted that the Amneal Judgment held claim 5 of the ‘527 patent invalid.
`
`However, the Amneal Judgment is pending appeal. Otherwise denied.
`
`BACKGROUND
`
`In December 2003, Congress passed the Medicare Modernization Act of 2003 (the
`60.
`“MMA”). Title XI of that Act, entitled “Access to Affordable Pharmaceuticals,” included a
`provision allowing an ANDA applicant to bring a declaratory judgment action for invalidity or
`non-infringement of a patent listed in FDA’s Approved Drug Products with Therapeutic
`Equivalence Evaluations (commonly referred to as the Orange Book) if the NDA holder does not
`sue within 45 days of receiving notice of a Paragraph IV certification. 21 U.S.C. § 355(j)(5)(C).
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that the cited statutory provision is entitled “Civil action
`
`to obtain patent certainty.” Defendants respectfully refer to the cited statutory provision for its full
`
`contents. Otherwise denied.
`
`The MMA also added provisions for the forfeiture of eligibility for the 180-day
`61.
`to which an ANDA “first applicant,” as defined
`in 21 U.S.C. §
`exclusivity
`355(j)(5)(B)((iv)(II)(bb), might otherwise be entitled pursuant to the Hatch Waxman Act. Id. § 355
`(j)(5)(D). The forfeiture provision at issue here requires, inter alia, the entry of a judgment of non-
`infringement, unenforceability or invalidity with respect to the patents to which a first applicant
`has filed a Paragraph IV certification, regardless of whether those patents are asserted against
`subsequent ANDA applicants. Id. § 355(j)(5)(D)(i)(I)(bb).
`
`
`
`13
`
`

`

`Case 1:18-cv-00303-RGA Document 10 Filed 03/20/18 Page 14 of 29 PageID #: 126
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that the cited 21 U.S.C. § 355(j)(5)(D) provision is
`
`entitled “Forfeiture of 180-day exclusivity period.” Defendants respectfully refer to the cited
`
`statutory provisions for their full contents. Otherwise denied.
`
`Upon information and belief, Hospira, Inc. is the current holder of approved New
`62.
`Drug Application (“NDA”) No. 21-038 for Precedex® Injection (dexmedetomidine HCl), 200 mcg
`base/50 mL and 400 mcg base/100 mL.
`
`RESPONSE: Admitted that Hospira is the holder of NDA No. 21-038, which includes Precedex®
`
`Injection (dexmedetomidine HCl), 200 mcg base/50 mL and 400 mcg base/100 mL.
`
`Hospira identified the Patents-in-Suit to the FDA for listing in the Orange Book, as
`63.
`patents to which “a claim of patent infringement could reasonably be asserted if a person not
`licensed by the owner engaged in the manufacture, use, or sale of the drug” products containing
`dexmedetomidine HCl, 200 mcg base/50 mL and 400 mcg base/100 mL (“Dexmedetomidine
`Product”).
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that Hospira properly identified the Patents-in-Suit to
`
`the FDA for listing in the Orange Book with respect to its dexmedetomidine HCl, 200 mcg base/50
`
`mL and 400 mcg base/100 mL drug products that are part of NDA No. 21-038. Otherwise denied.
`
`The Patents-in-Suit remain listed in the Orange Book with respect to NDA No. 21-
`64.
`038 and Hospira maintains and continues to represent to the public that the Patents-in-Suit claim
`the drug approved in NDA 21-038 or a method of using that drug, and that a claim of 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 FDA
`Orange Book also lists a six-month pediatric exclusivity for each of the Patents-in-Suit, which
`upon information and belief will prevent ANDA applicants from obtaining final FDA marketing
`approval for their generic dexmedetomidine products until six months after the expiration of the
`Patents-in-Suit.
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that the Patents-in-Suit remain properly listed in the
`
`Orange Book with respect to certain of Hospira’s dexmedetomidine products that are the subject
`
`
`
`14
`
`

`

`Case 1:18-cv-00303-RGA Document 10 Filed 03/20/18 Page 15 of 29 PageID #: 127
`
`of NDA No. 21-038. Further admitted that the Orange Book lists a six-month pediatric exclusivity
`
`for each Patent-in-Suit. Otherwise denied.
`
`According to Orange Book listings, Precedex®, or treatments using Precedex® are
`65.
`claimed in the Patents-in-Suit.
`
`RESPONSE: This paragraph contains conclusions of law to which no response is required. To
`
`the extent a response is required, admitted that the Patents-in-Suit claim certain compositions
`
`containing dexmedetomidine or a pharmaceutically acceptabl