Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 1 of 30 PageID #: 1270
`
`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
`
`JOINT CLAIM CONSTRUCTION BRIEF
`
`POTTER ANDERSON & CORROON LLP
`
`CONNOLLY GALLAGHER LLP
`
`Philip A. Rovner (#3215)
`Jonathan A. Choa (#5319)
`Alan R. Silverstein (#5066)
`Hercules-Plaza
`P.O. Box 951
`Wilmington, DE 19899
`Phone: (302) 984-6000
`provner@potteranderson.com
`jchoa@potteranderson.com
`asilverstein@potteranderson.com
`
`OF COUNSEL
`Neal Seth
`Lawrence M. Sung
`Bethany A. Corbin
`WILEY REIN LLP
`1776 K Street NW
`Washington, DC 20006
`Phone: (202) 719-7000
`nseth@wileyrein.com
`lsung@wileyrein.com
`bcorbin@wileyrein.com
`
`Arthur G. Connolly, III (#2667)
`Ryan P. Newell (#4744)
`The Brandywine Building
`1000 West Street
`Wilmington, DE 19801
`Phone: (302) 757-7300
`aconnolly@connollygallagher.com
`rnewell@connollygallagher.com
`
`OF COUNSEL
`Bradford P. Lyerla
`Sara T. Horton
`Yusuf Esat
`Ren-How Harn
`JENNER & BLOCK LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`Phone: (312) 222-9350
`blyerla@jenner.com
`shorton@jenner.com
`yesat@jenner.com
`rharn@jenner.com
`
`Attorneys for Plaintiff Baxter Healthcare
`Corporation
`
`Attorneys for Defendants Hospira, Inc. and
`Orion Corp.
`
`Dated: October 15, 2018
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 2 of 30 PageID #: 1271
`
`TABLE OF CONTENTS
`
`Pages
`
`I.
`
`II.
`
`III.
`
`IV.
`
`DEFENDANTS’ INTRODUCTION ...................................................................................1
`
`BAXTER’S INTRODUCTION ...........................................................................................2
`
`AGREED UPON CONSTRUCTION .................................................................................3
`
`DISPUTED CONSTRUCTION – INTENSIVE CARE UNIT ...........................................3
`
`A. DEFENDANTS’ OPENING POSITION ........................................................................... 3
`
`B. BAXTER’S ANSWERING POSITION ............................................................................. 6
`
`1.
`
`2.
`
`Intrinsic and Extrinsic Evidence Supports Baxter’s Claim Construction ..................... 7
`
`Hospira Itself Has Previously Advocated for Baxter’s Construction ......................... 12
`
`C. DEFENDANTS’ REPLY POSITION .............................................................................. 14
`
`1.
`
`2.
`
`3.
`
`Summary ..................................................................................................................... 14
`
`Baxter’s Non-Infringement Argument is Erroneous and Irrelevant ........................... 15
`
`Baxter’s Construction is Unduly Narrow ................................................................... 15
`
`i
`
`There is no dispute that intensive care patients are “critically ill” ............................. 15
`
`ii Baxter’s construction imports unwarranted requirements .......................................... 16
`
`D. BAXTER’S SUR-REPLY POSITION ............................................................................. 19
`
`1.
`
`2.
`
`Background ................................................................................................................. 19
`
`Argument .................................................................................................................... 19
`
`i Hospira’s Construction Is Circular And Ignores Intrinsic And Extrinsic Evidence. .. 20
`
`ii Hospira’s Construction Reads Out The Word “Unit.” ............................................... 22
`
`iii
`
`“Typically” Adds Ambiguity To An Otherwise Precise Construction. .................. 24
`
`i
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 3 of 30 PageID #: 1272
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Brewington v. State Farm Mut. Auto. Ins. Co.,
`45 F. Supp. 3d 1215 (D. Nev. 2014) ....................................................................................7, 20
`
`Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp.,
`93 F.3d 1572 (Fed. Cir. 1996)..................................................................................................23
`
`Fathauer v. United States,
`566 F.3d 1352 (Fed. Cir. 2009)..................................................................................................3
`
`Fitness Quest Inc. v. Monti,
`No. 5:06-cv-02691, 2011 WL 2530948 (N.D. Ohio June 20, 2011) .......................................11
`
`Genzyme Corp. v. Atrium Med. Corp.,
`212 F. Supp. 2d 292 (D. Del. 2002) .....................................................................................7, 20
`
`Hospira, Inc. v. Amneal Pharm. LLC,
`No. 15-697-RGA, 2016 WL 3021719 (D. Del. May 25, 2016) ...............................................13
`
`Hospira, Inc. v. Fresenius Kabi USA, LLC,
`No. 16 C 651, 2017 WL 5891058 (N.D. Ill. Nov. 27, 2017) ...................................................13
`
`Junio v. Livingston Par. Fire Dist. No. 5,
`717 F.3d 431 (5th Cir. 2013) .....................................................................................................7
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009)..................................................................................................3
`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005)................................................................................................11
`
`Nationwide Mut. Ins. Co. v. Darden,
`503 U.S. 318 (1992) .............................................................................................................7, 20
`
`Nautilus Grp., Inc. v. Icon Health & Fitness, Inc.,
`82 F. App’x 691 (Fed. Cir. 2003) ............................................................................................23
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)..........................................................................................12, 20
`
`Prolifa Software Inc. v. Veeva Sys. Inc.,
`No. C13-03644, 2014 WL 3870016 (N.D. Cal. Aug. 6, 2014)..................................................7
`
`ii
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 4 of 30 PageID #: 1273
`
`Reddy Ice Corp. v. Schur Mktg. & Techs. U.S.A. Inc.,
`No. CV09-1670, 2010 WL 11515495 (D. Ariz. June 9, 2010)................................................11
`
`Tex. Instruments, Inc. v. U.S. Int’l Trade Comm’n,
`988 F.2d 1165 (Fed. Cir. 1993)................................................................................................23
`
`Statutes
`
`21 U.S.C. § 505(j)(2)(A)(viii) ..........................................................................................................2
`
`Other Authorities
`
`U.S. Patent No. 6,716,867...................................................................................................... passim
`
`U.S. Patent No. 8,455,527................................................................................................................4
`
`Extrinisc Evidence
`
`’867 Patent, May 2, 2003, Amendment and Request for Continued Examination ........................10
`
`David Crippen & Sergei Ermakov, Stress Agitation and Brain Failure in Critical
`Care medicine, Critical Care Nursing Q. 52 (Aug. 1992) ...........................................10, 21, 22
`
`Elizabeth Caudwell et al., Nursing Considerations in Intensive Care Unit
`Sedation and Experience with Dexmedetomidine, Int’l Congress &
`Symposium Series No. 221 (Royal Society of Medicine Press Ltd. 1998) .............................11
`
`Hospira Inc. v. Amneal Pharm. LLC, CA 15-697-RGA, Joint Claim Construction
`Brief (D. Del. Apr. 28, 2016) (D.I. 44) ....................................................................................20
`
`Hospira Inc. v. Amneal Pharm. LLC, CA 15-697-RGA, Claim Construction
`Memorandum (D. Del.) (D.I. 57) ..................................................................................... passim
`
`Hospira, Inc. v. Caraco Pharm. Labs., Ltd., No. 2:10-cv-14514 (D. Del. Apr. 13,
`2012) (D.I. 51) ...................................................................................................................12, 13
`
`Hospira, Inc. v. Eurohealth Int’l Sarl, C.A. No. 14-14-1008 (D. Del. Aug. 21,
`2015) (D.I. 53) ...................................................................................................................12, 13
`
`Hospira, Inc. v. Eurohealth Int’l Sarl, C.A. No. 14-487-GMS (D. Del.) (D.I. 89) .........................4
`
`Hospira Inc. v. Fresenius Kabi USA, LLC, CA 16-651 (N.D. Ill.), Claim
`Construction Memorandum (D.I. 69) .................................................................................... passim
`
`Hospira Inc. v. Sandoz, Inc., CA 9-4591 (D.N.J.), Draft Markman Opinion ......................4, 20, 21
`
`Intensive Care Unit, Collins English Dictionary,
`https://www.collinsdictionary.com/us/dictionary/english/intensive-care-unit ....................8, 22
`
`iii
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 5 of 30 PageID #: 1274
`
`Jean Mantz et al., Phase III Study on Dexmedetomidine Used for Postoperative
`sedation of Patients Requiring Mechanical Ventilation for Less than 24
`Hours: The French Experience (2002) ....................................................................................10
`
`Marie T. O’Toole Ed.D., R.N., F.A.A.N., Miller-Keane Encyclopedia and
`Dictionary of Medicine, Nursing, and Allied Health (7th ed. 2003) ...................................8, 22
`
`Michael L. Pepperman, Benzodiazepine Sedation and the Use of Benzodiazepine
`Antagonists in Intensive Care, Intensive Therapy & Clinical Monitoring, 58
`(Feb. 1989) .........................................................................................................................10, 22
`
`Stedman’s Concise Medical Dictionary (4th ed. 2001) .........................................................5, 8, 22
`
`The Merck Manual of Diagnosis and Treatment (19th ed. 2011).......................................... passim
`
`The New American Medical Dictionary and Health Manual (7th ed. 1999) .........................5, 8, 22
`
`Unit, Merriam-Webster Dictionary, https://www.merriam-
`webster.com/dictionary/unit (last updated Aug. 18, 2018) ......................................................11
`
`Vallire D. Hooper & Beverly George-Gay, Sedation in the Critically Ill Patient, 9
`Critical Care Nursing Clinics of N.A. 395 (Sept. 1997) ..........................................................10
`
`iv
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 6 of 30 PageID #: 1275
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`Pursuant to Paragraph 9 of the Court’s Scheduling Order (D.I. 21), Plaintiff Baxter
`
`Healthcare Corporation (“Baxter”) and Defendants Hospira, Inc. and Orion Corp. (“Defendants”)
`
`hereby submit this Joint Claim Construction Brief.
`
`As specified in the Scheduling Order, this Joint Claim Construction Brief is compiled from
`
`Defendants’ Opening Claim Construction Brief (served August 15, 2018), Baxter’s Answering
`
`Claim Construction Brief (served September 4, 2018), Defendants’ Reply Claim Construction
`
`Brief (served September 19, 2018), and Baxter’s Sur-Reply Claim Construction Brief (served
`
`October 4, 2018). The exhibits and declarations originally filed with the briefs are included in a
`
`Joint Appendix.1
`
`I.
`
`DEFENDANTS’ INTRODUCTION
`
`U.S. Patent No. 6,716,867 (“’867 patent” or “patent-in-suit”) covers the use of a
`
`dexmedetomidine formulation in a method of sedating a patient in an intensive care unit (“ICU”)
`
`wherein the patient remains arousable and orientated. (See e.g., ’867 pat. 1:13-15.)2 The
`
`inventors discovered that the active pharmaceutical ingredient, dexmedetomidine, was able to
`
`provide sedation to patients while keeping the patients responsive. This property is particularly
`
`beneficial in the ICU.
`
`The only disputed claim construction term is “intensive care unit.” The term is defined in
`
`the ‘867 patent as follows: “the word intensive care unit includes any setting that provides
`
`intensive care.” (’867 patent 1:17-18; see also 3:49-51; 4:44-45.) Accordingly, Defendants
`
`propose the term be defined as “any setting that provides intensive care.”
`
`1 Citations to “J.A. __” refer to pages in the Joint Appendix.
`2 The patent-in-suit is attached to the parties’ Joint Claim Construction Chart. (D.I. 39, Ex. B.) It
`is also included at J.A. 96-106.
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 7 of 30 PageID #: 1276
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`II.
`
`BAXTER’S INTRODUCTION
`
`This action arises out of submission of Baxter’s Abbreviated New Drug Application
`
`(“ANDA”) No. 208532 seeking approval to market a drug product containing dexmedetomidine
`
`hydrochloride in 0.9% sodium chloride injection 200 mcg/50 mL and 400 mcg/100 mL (“Baxter
`
`ANDA Product”). The Baxter ANDA Product is a generic version of Precedex, which is
`
`manufactured by Hospira, Inc. Precedex is approved for two uses: (1) Sedation of initially
`
`intubated and mechanically ventilated patients during treatment in an intensive care setting
`
`(“ICU Sedation”); and (2) Sedation of non-intubated patients prior to and/or during surgical and
`
`other procedures (“Procedural Sedation”). The label for the Baxter ANDA Product carves out all
`
`references to ICU Sedation. See 21 U.S.C. § 505(j)(2)(A)(viii).
`
`The Food and Drug Administration (“FDA”) tentatively approved ANDA No. 208532 on
`
`January 22, 2018, but withheld final approval at that time because a first applicant remained
`
`eligible for 180-day exclusivity. To trigger the running of the first applicant’s exclusivity period,
`
`Baxter initiated this action to obtain a final, non-appealable judgment of non-infringement of
`
`four patents, of which only U.S. Patent No. 6,716,867 (the “’867 Patent”) remains at issue in this
`
`case. Baxter has avoided infringement of the ’867 Patent by carving out ICU Sedation in its
`
`entirety from the label of the Baxter ANDA Product. Baxter’s label refers only to Procedural
`
`Sedation, which does not include ICU use. Nevertheless, Hospira has counterclaimed for
`
`infringement of the ’867 Patent, arguing that the claims of the ’867 Patent encompass both
`
`Precedex indications.
`
`The ’867 Patent recites “[a] method of sedating a patient in an intensive care unit . . .
`
`wherein the patient remains orientated and arousable.” (emphasis added). The parties dispute a
`
`single claim term: “intensive care unit.”
`
`2
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 8 of 30 PageID #: 1277
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`III.
`
`AGREED UPON CONSTRUCTION
`
`The parties agree to the construction of “dexmedetomidine”:
`
`Term
`
`Agreed Construction
`
`“dexmedetomidine” (’867 patent, claims 1-
`12)
`
`“substantially pure, optically active
`dextrorotary stereoisomer of medetomidine,
`as the free base or pharmaceutically
`acceptable salt”
`
`IV.
`
`DISPUTED CONSTRUCTION – INTENSIVE CARE UNIT
`
`The parties dispute the construction of only one term: “intensive care unit.” The parties’
`
`proposed constructions are set forth below:
`
`Defendants’ Proposed Construction
`
`Baxter’s Proposed Construction
`
`“any setting that provides intensive care”
`
`“any setting that provides care to critically ill
`patients, characterized by high nurse-to-
`patient ratios, continuous medical
`supervision, and intensive monitoring”
`
`A.
`
`DEFENDANTS’ OPENING POSITION
`
`a. Defendants’ Construction: “any setting that provides intensive care”
`
`Defendants propose that the term be construed as explicitly defined in the ’867 patent:
`
`“the word intensive care unit includes any setting that provides intensive care.” (’867 patent
`
`1:17-18; see also 3:49-51; 4:44-45.) The patentee’s lexicography governs. See Martek
`
`Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee
`
`explicitly defines a claim term in the patent specification, the patentee’s definition controls.”).
`
`Furthermore, Defendants’ proposed construction is the same construction previously adopted by
`
`courts (including this Court) with respect to a patent related to the ’867 patent. (J.A. 5 (Hospira
`
`Inc. v. Amneal Pharm. LLC., CA 15-697-RGA, D.I. 57, Claim Construction Memorandum at 5);
`
`3
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 9 of 30 PageID #: 1278
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`J.A. 21-22 (Hospira Inc. v. Fresenius Kabi USA, LLC, CA 16-651 (N.D. Ill.), D.I. 69, Claim
`
`Construction Memorandum at 16-17.)) The patent at issue in Amneal and Fresenius referenced
`
`the specification of the ’867 patent in defining “intensive care unit.” (J.A. 28 (U.S. Patent No.
`
`8,455,527 10:33-35); see also J.A. 21 (Fresenius Opinion at 16).) In both cases, the courts
`
`construed the term to mean either “any setting that provides care to critically ill patients” or “any
`
`setting that provides intensive care.” (Id.) These terms are not materially different from
`
`Defendants’ proposed construction.
`
`b. Baxter’s Construction: “any setting that provides care to critically ill patients,
`characterized by high nurse-to-patient ratios, continuous medical supervision,
`and intensive monitoring”
`
`Plaintiff, Baxter, proposes a much more limited construction that requires “high nurse-to-
`
`patient ratios, continuous medical supervision and intensive monitoring.” There is no support for
`
`this narrowing construction in the intrinsic record. There are many different things that
`
`characterize intensive care settings, but nothing in the specification or prosecution history
`
`indicates that the term should be limited to settings that meet all three requirements set forth in
`
`Baxter’s proposed construction.
`
`In fact, when Defendants have proposed even broader constructions than Baxter’s,
`
`indicating that ICUs “typically” are characterized by these three features, these constructions
`
`have been rejected.3 As discussed above, both Amneal and Fresenius involved a patent that
`
`referenced the ’867 patent to define the term “intensive care unit.” (J.A. 5 (Amneal Opinion at
`
`5); J.A. 21 (Fresenius Opinion at 16).) However, in both cases, the courts rejected limiting
`
`3 The construction was used in two cases, but was not litigated there. In one case, the parties
`stipulated to it. (J.A. 39-46 (Hospira, Inc. v. Eurohealth Int’l Sarl, C.A. No. 14-487-GMS, D.I.
`89).) In another case, the Court created its own definition after the parties stipulated to the
`definition from the ’867 patent that Defendants propose here. (J.A. 47-55 (Hospira Inc. v.
`Sandoz, Inc., CA 9-4591 (D. N.J.), Draft Markman Opinion).)
`
`4
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 10 of 30 PageID #: 1279
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`“intensive care unit” to settings involving high nurse-to-patient ratios, continuous supervision,
`
`and intensive monitoring because those requirements lacked support in the intrinsic record. (Id.)
`
`In Fresenius, for example, the court stated, “There is no evidence in the intrinsic record to
`
`suggest that nurse-to-patient ratios, continuous supervision, and intensive monitoring should be
`
`considered.” (J.A. 21-22 (Fresenius Opinion at 16-17).) And this Court in Amneal rejected that
`
`language stating, “This language finds no support in the intrinsic record.” (J.A. 5 (Amneal
`
`Opinion at 5).) In addition, the Fresenius court pointed out that the requirements of the
`
`additional language introduce “additional confusion,” because of the necessity to determine what
`
`“high” ratios are and what “intensive” monitoring entails. (J.A. 21 (Fresenius Opinion at 16).)
`
`Extrinsic evidence also shows that all three features dictated by Baxter’s proposal—high
`
`nurse-to-patient ratios, continuous supervision, and intensive monitoring—are not always
`
`required by definitions of “intensive care unit.” For example, the environment that defines an
`
`“intensive care unit” has been characterized as:
`
`[A] hospital facility for provision of intensive nursing and medical
`care of critically ill patients, characterized by high quality and
`quantity of continuous nursing and medical supervision and by use
`of sophisticated monitoring and resuscitative equipment.
`
`(J.A. 58 (Stedman’s Concise Medical Dictionary at 505 (4th ed. 2001)).) Another reference
`
`characterizes an ICU as follows:
`
`A separate area in the hospital where extremely sick patients are
`cared for. The ICUs are manned 24 hours a day by physicians and
`specially trained nurses. They are also equipped with life-support
`apparatus.
`
`(J.A. 61 (The New American Medical Dictionary and Health Manual at 179 (7th ed. 1999)).)
`
`And a third reference emphasizes different features:
`
`5
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 11 of 30 PageID #: 1280
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`ICUs have a high nurse:patient ratio to provide the necessary high
`intensity of service, including treatment and monitoring of
`physiologic parameters.
`
`(J.A. 64-65 (The Merck Manual of Diagnosis and Treatment at 2243-44 (19th ed. 2011)).) Thus,
`
`in the extrinsic evidence, as well as the intrinsic evidence, no definition of intensive care unit
`
`requires all three features dictated by Baxter’s proposed construction. Accordingly, Baxter’s
`
`construction should be rejected.
`
`To the extent the Court is inclined to define intensive care using some or all of the
`
`features that Baxter lists in its proposal, Defendants assert that the word “typically” should be
`
`included. To the extent there is any support in the extrinsic evidence for importing these features
`
`into the definition of “intensive care,” the extrinsic evidence fails to support using these features
`
`as limitations. Rather, the extrinsic evidence discloses these criteria as typical features of
`
`intensive care units, not essential requirements. (See J.A. 21-22 (Fresenius Opinion at 16-17)
`
`(“True, most intensive care units are likely to reflect the criteria Hospira recites, but even the
`
`medical dictionaries cited by Hospira identify these as typical features of intensive care units, not
`
`limitations.”).) Nothing in the intrinsic record (or in any extrinsic evidence) requires all three of
`
`(1) a high nurse-to-patient ratio, (1) continuous medical supervision and (3) intensive
`
`monitoring, as required under Baxter’s proposal.
`
`Accordingly, “intensive care unit” should be construed to mean: “any setting that provides
`
`intensive care.”
`
`B.
`
`BAXTER’S ANSWERING POSITION
`
`Baxter proposes that the term “intensive care unit” be construed as “any setting that
`
`provides care to critically ill patients, characterized by high nurse-to-patient ratios, continuous
`
`medical supervision, and intensive monitoring.” Baxter’s construction is consistent not only with
`
`the intrinsic evidence and the understanding of a person of skill in the art, but also with Hospira’s
`
`6
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 12 of 30 PageID #: 1281
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`prior interpretations of “intensive care unit” as used in the ’867 Patent. Hospira’s proposed
`
`construction, “any setting that provides intensive care,” provides no assistance for the Court
`
`because it defines “intensive care unit” circularly and omits two critical elements of an intensive
`
`care unit. First, an intensive care unit provides care to critically ill patients. It is the patients’
`
`critical illness that drives the other features of “intensive care,” which include the high nurse-to-
`
`patient ratio, the continuous medical supervision, and the intensive monitoring. Second, an
`
`intensive care unit is a specific, well-defined, and recognizable place. Hospira’s broad definition
`
`of this term ignores and reads out the word “unit.”
`
`1.
`
`Intrinsic and Extrinsic Evidence Supports Baxter’s Claim
`Construction
`
`Baxter’s construction, like Hospira’s, starts with the ’867 Patent specification, which states
`
`that “the word intensive care unit includes any setting that provides intensive care.” (’867 Patent
`
`col. 1:18-20, 3:49-51; 4:44-45.) This definition, however, is circular in that it defines “intensive
`
`care unit” by using the word “intensive care.” Circular definitions have often been described as
`
`“explain[ing] nothing,” Nationwide Mut. Ins. Co. v. Darden, 503 U.S. 318, 323 (1992), and are
`
`“inherently ambiguous” because they require additional information outside the stated definition
`
`to construe the term, Brewington v. State Farm Mut. Auto. Ins. Co., 45 F. Supp. 3d 1215, 1219 (D.
`
`Nev. 2014). See Genzyme Corp. v. Atrium Med. Corp., 212 F. Supp. 2d 292, 329 n.22 (D. Del.
`
`2002) (explaining that a “circular definition . . . is meaningless”); Prolifiq Software Inc. v. Veeva
`
`Sys. Inc., No. C13-03644, 2014 WL 3870016, at *8 (N.D. Cal. Aug. 6, 2014) (“This circular
`
`definition provides no guidance as to what is actually meant by the claim term.”).
`
`When confronted with a circular definition, courts have consistently sought to give the
`
`pertinent text meaning. See, e.g., Juino v. Livingston Par. Fire Dist. No. 5, 717 F.3d 431, 434 (5th
`
`Cir. 2013). The Federal Circuit has looked to dictionary definitions to supply a term’s ordinary
`
`7
`
`

`

`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 13 of 30 PageID #: 1282
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`meaning. See Fathauer v. United States, 566 F.3d 1352, 1355 (Fed. Cir. 2009). Here, “intensive
`
`care” has a well-understood plain and ordinary meaning to a person of skill in the art, which is
`
`care provided to critically ill patients, characterized by high nurse-to-patient ratios, continuous
`
`medical supervision, and intensive monitoring. As the Merck Manual explains, “ICUs have a high
`
`nurse:patient ratio to provide the necessary high intensity of service, including treatment and
`
`monitoring of physiologic parameters.” (J.A. 64 (The Merck Manual of Diagnosis and Treatment
`
`at 2243)). Hospira itself has recognized this interpretation, see Section B.2., infra, and numerous
`
`dictionary definitions support this construction:
`
`Intensive care unit (ICU) a hospital facility for provision of intensive nursing and
`medical care of critically ill patients, characterized by high quality and quantity of
`continuous nursing and medical supervision and by use of sophisticated monitoring
`and resuscitative equipment.
`
`(J.A. 58 (Stedman’s Concise Medical Dictionary at 505)).
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`Intensive Care Unit (ICU) A separate area in the hospital where extremely sick
`patients are cared for. The ICUs are manned 24 hours a day by physicians and
`specially trained nurses. They are also equipped with life-support apparatus.
`
`(J.A. 61 (The New American Medical Dictionary and Health Manual at 179)).
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`[T]he part of a hospital where extensive and continuous care and treatment are
`provided for an acutely ill patient.
`
`Intensive Care Unit, Collins English Dictionary,
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`https://www.collinsdictionary.com/us/dictionary/english/intensive-care-unit.
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`“[A] hospital unit in which is concentrated special equipment and specially trained
`personnel for the care of seriously ill patients requiring immediate and continuous
`attention.
`
`Marie T. O'Toole Ed.D., R.N., F.A.A.N., Miller-Keane Encyclopedia and Dictionary of Medicine,
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`Nursing, and Allied Health (7th ed. 2003).
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`In addition to these dictionary definitions, Baxter’s construction is fully supported by and
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`demonstrated throughout the intrinsic evidence. The ’867 Patent itself states at least eight times
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`that intensive care unit patients are critically ill:
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`“Patients recovering from an episode of critical illness have reported factors they found
`most distressing during their ICU stay . . . .” (’867 Patent col. 1:31-33);
`
`“At the moment, there is no universally accepted sedative regimen for critically ill
`patients.” (’867 Patent col. 1:42-43);
`
`“The preferred level of sedation for critically ill patients has changed considerably in
`recent years.” (’867 Patent col. 2:15-16);
`
`“According to Tryba et al., clonidine has its limitations in sedating critically ill patients
`mainly because of its unpredictable hemodynamic effects, i.e., bradycardia and
`hypotension, so that it must be titrated for each individual patient.” (’867 Patent col.
`2:40-45);
`
`“Long term treatment of critically ill patients with clonidine has been reported to be
`associated with such rebound effects as tachycardia and hypertension.” (’867 Patent
`col. 2:45-47);
`
`“An ideal sedative agent for a critically ill patient should provide sedation at easily
`determined doses with ready arousability together with hemodynamic stabilizing
`effects.” (’867 Patent col. 2:57-59);
`
`“Lack of respiratory depression should allow dexmedetomidine to be used also for non-
`ventilated, critically ill patients who require sedation, anxiolysis, analgesia, and
`hemodynamic stability yet must remain oriented and easily aroused.” (’867 Patent col.
`4:62-66); and
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`“The cases described above illustrate the benefits of dexmedetomidine sedation in
`critically ill patients.” (’867 Patent col. 13:41-42).
`
`(emphasis added). Moreover, the case studies in Example 3 describe the critically ill state of the
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`patients in the Precedex clinical trials. (See generally ’867 Patent col. 8:53-13:41.)
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`The prosecution history and prior art also support Baxter’s construction. The ’867 Patent
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`applicants consistently explained that the intensive care unit is a place in which care is provided
`
`to critically ill patients. Specifically, the applicants explained to the examiner that “ICU patients
`
`are critically ill, recovering from surgical intervention, trauma, cardiorespiratory disease, severe
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`infection or other serious illness and are often intubated by endotracheal tube for mechanical
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`ventilation. Sedatives used in the ICU should provide an appropriate quality of sedation for patients
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`subjected to these circumstances.” (May 2, 2003, Amendment and Request for Continued
`
`Examination) (emphasis added).
`
`This prosecution history is consistent with references to “intensive care unit” in the prior
`
`art. In David Crippen and Sergei Ermakov’s article, the ICU is described as “hav[ing] the potential
`
`to return critically ill patients to productivity by using technological advances in monitoring and
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`closely titrated care . . . .” (J.A. 70 (David Crippen & Sergei Ermakov, Stress Agitation and Brain
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`Failure in Critical Care Medicine, Critical Care Nursing Q. 52, 53 (Aug. 1992)) (emphasis added).
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`These authors further state that “ICUs accept wider ranges of critically ill patients for longer
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`periods of time,” and that patients in the ICU are “attached to sophisticated monitoring devices.”
`
`(J.A. 82 (Crippen & Ermakov at 65)) (emphasis added). Similarly, Michael L. Pepperman’s article
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`explains that “[t]he accepted role of an intensive care unit (ICU) is the management of patients
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`with life threatening conditions requiring: intensive monitoring; continuous reassessment of
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`therapeutic regimens; [and] the application of special techniques.” (J.A. 93 (Michael L.
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`Pepperman, Benzodiazepine Sedation and the Use of Benzodiazepine Antagonists in Intensive
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`Care, Intensive Therapy & Clinical Monitoring 58, 60 (Feb. 1989)) (emphasis added).
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`Other prior art is similarly focused on sedation of “critically ill” patients. See, e.g., Vallire
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`D. Hooper & Beverly George-Gay, Sedation in the Critically Ill Patient, 9 Critical Care Nursing
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`Clinics of N.A. 395 (Sept. 1997) (HOSPIRA_000000257-271) (including repeated references to
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`“critically ill” patients); Jean Mantz et al., Phase III Study on Dexmedetomidine Used for
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`Postoperative Sedation of Patients Requiring Mechanical Ventilation for Less than 24 Hours: The
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`French Experience, at 598 (2002) (HOSPIRA_000000293) (“Altogether, these data suggest that
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`Case 1:18-cv-00303-RGA Document 58 Filed 10/15/18 Page 16 of 30 PageID #: 1285
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`dexmedetomidine may be a very interesting agent for sedation of critically ill patients.”); Elizabeth
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`Caudwell et al., Nursing Considerations in Intensive Care Unit Sedation and Experience with
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`Dexmedetomidine, Int’l Congress & Symposium Series No. 221, at 73 (Royal Society of Medicine
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`Press Ltd. 1998) (HOSPIRA_000000326) (“Achieving and maintaining appropriate sedation for
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`critically ill patients is a central concern of nurses in the intensive care unit (ICU).”).
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`Moreover, Baxter’s construction is necessary to give meaning to each word in the phrase
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`“intensive care unit.” See Merck & Co. v. Teva Pharms