Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 1 of 108 PageID #: 1300
`
`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
`
`APPENDIX TO 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.
`
`October 15, 2018
`
`

`

`Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 2 of 108 PageID #: 1301
`
`DOCUMENT
`
`TABLE OF CONTENTS
`
`
`STARTING PAGE NUMBER
`
`Hospira, Inc. v. Amneal Pharmaceuticals
`LLC, No. 15-697, Memorandum Order (D.
`Del.) (D.I. 57)
`
`Hospira, Inc. v. Fresenius Kabi USA, LLC,
`No. 16 C 651, Memorandum Opinion and
`Order (N.D. Ill.) (D.I. 69)
`
`United States Patent No. 8,455,527
`
`Hospira, Inc., et al. v. Eurohealth Int’l SARL,
`et al., No. 14-487, Second Amended Joint
`Claim Construction Chart (D. Del.) (D.I. 89)
`
`Hospira, Inc., et al. v. Sandoz, Inc., et al., No.
`09-4591, Draft Markman Opinion (D.N.J.)
`
`Stedman’s Concise Medical Dictionary for
`the Health Professions (John H. Dirckx, ed.,
`2001)
`
`The New American Medical Dictionary and
`Health Manual (Robert E. Rothenberg, ed.
`1999)
`
`The Merck Manual of Diagnosis and Therapy
`(Robert S. Porter & Justin L. Kaplan, eds.
`19th edition, 2011)
`
`David Crippen & Sergei Ermakov, Stress
`Agitation and Brain Failure in Critical Care
`Medicine, Critical Care Nursing Q. 52 (Aug.
`1992)
`
`Michael L. Pepperman, Benzodiazepine
`Sedation and the Use of Benzodiazepine
`Antagonists in Intensive Care, Intensive
`Therapy & Clinical Monitoring 58, 60 (Feb.
`1989)
`
`U.S. Patent No. 6,716,867
`
`J.A. 1
`
`J.A. 6
`
`J.A. 23
`
`J.A. 39
`
`J.A. 47
`
`J.A. 56
`
`J.A. 59
`
`J.A. 62
`
`J.A. 69
`
`J.A. 92
`
`J.A. 96
`
`
`
`

`

`
`
`Case 1:15-cv-00697-RGA Document 57 Filed 05/25/16 Page 1 of 5 PageID #: 889Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 3 of 108 PageID #: 1302
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`· HOSPIRA, INC.,
`
`Plaintiff,.
`
`v.
`
`AMNEAL PHARMACEUTICALS LLC,
`
`Defendant.
`
`Civil Action No. 15-697-RGA
`
`MEMORANDUM ORDER
`
`· Presently before the Court is the issue of claim construction of multiple terms in U.S .
`
`. Patent Nos. 8,242, 158 ("the '158 patent"); 8,338,4 70 ("the '4 70 patent"); 8,455,527 ("the '527
`
`patent"); and 8,648, 106 ("the '106 patent") (collectively "the patents-in-suit"). The Court has
`
`considered the parties' Joint Claim Construction Brief. (D.I. 44).
`
`"It is a bedrock principle of patent law that the claims of a patent define the invention to
`
`which the patentee is entitled the right to exclude." Phillips v. A WH C01p., 415 F.3d 1303, 1312
`
`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). '"[T]here is no magic formula or
`
`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
`
`weight to appropriate sources 'in light of the statutes and policies that inform patent law.'"
`
`Soft View LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
`
`415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
`
`claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
`
`Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
`
`sources, "the specification is always highly relevant to the claim construction analysis. Usually,
`
`1
`
`J.A.1
`
`

`

`
`
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`it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d
`
`at 1315 (internal quotation marks and citations omitted).
`
`"[T]he words of a claim are generally given their ordinary and customary meaning ....
`
`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
`
`question at the time of the invention, i.e., as of the effective filing date of the patent application."
`
`Id. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a
`
`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
`
`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
`
`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
`
`construction in such cases involves little more than the application of the widely accepted
`
`meaning of commonly understood words." Id. at 1314 (internal citations omitted).
`
`When a court relies solely upon the intrinsic evidence-the patent claims, the
`
`specification, and the prosecution history-the court's construction is a determination of law.
`
`See TevaPharms. USA, Inc. v. Sandoz, Inc., l-35 S. Ct. 831, 841 (2015). The court may also
`
`make factual findings based upon consideration of extrinsic evidence, which "consists of all
`
`evidence external to the patent and prosecution history, including expert and inventor testimony,
`
`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and
`
`citations omitted). Extrinsic evidence may assist the court in understanding the underlying
`
`technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
`
`Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
`
`and its prosecution history. Id.
`
`"A claim construction is persuasive, not because it follows a certain rule, but because it
`
`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per
`
`2
`
`J.A.2
`
`

`

`
`
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`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would
`
`exclude the inventor's device is rarely the correct interpretation." Osram GmbH v. Int'! Trade
`
`Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks and citation omitted).
`
`The parties agree that the term "effective amount," found in claim 1 of the '527 patent,
`
`should be construed as "amount sufficient to produce the desired effect." (D.I. 44 at p. 4). The
`
`Court adopts this construction.
`
`The parties dispute the construction of four terms: (1) "dexmedetomidine;" (2) "no more
`
`than about 2% decrease in the concentration of dexmedetomidine;" (3) "critically ill;" and ( 4)
`
`"intensive care unit." (Id.). The Court addresses each term separately.
`
`1.
`
`"dexmedetomidine" (all asserted claims)
`
`Plaintiff's proposed construction: "substantially pure; optically active
`a.
`dextrorotary stereoisomer of medetomidine, as the free base or pharmaceutically
`acceptable salt"
`
`b.
`Defendant's proposed construction: "substantially pure, optically active
`dextrorotary stereoisomer ofmedetomidine, as the.free base"
`
`Court's construction: "substantially pure, optically active dextrorotary
`c.
`stereoisomer ofmedetomidine, as the free base or pharmaceutically acceptable
`salt"
`
`The specification of each of the patents-in-suit sets forth an explicit definition for this
`
`term. See, e.g., '158 patent at 3:21-24. That definition aligns with Plaintiff's proposed
`
`construction. "When a patentee explicitly defines a claim term in the patent specification, the
`
`patentee's definition controls." Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363,
`
`1380 (Fed. Cir. 2009). Thus, here, the inventor's lexicography governs. I therefore construe
`
`"dexmedetomidine" to mean "substantially pure, optically active dextrorotary stereoisomer of
`
`medetomidine, as the free base or pharmaceutically acceptable salt."
`
`3
`
`J.A.3
`
`

`

`
`
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`"no more than about 2% decrease in the concentration of dexmedetomidine"
`2.
`(' 106 patent, claim 1)
`
`a.
`
`b.
`
`c.
`
`Plaintiff's proposed construction: Plain meaning
`
`Defendant's proposed construction: Indefinite
`
`Court's construction: Plain meaning
`
`A patent must "inform those skilled in the art about the scope of the invention with
`
`reasonable certainty." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014).
`
`Defendant's first indefiniteness argument depends on its proposed construction of
`
`"dexmedetomidine." Since the Court rejected that construction, this argument is also rejected.
`
`Defendant's second argument focuses on the word "about." "When 'about' is used as part of a
`
`numeric range, ... [that use] avoids a strict numerical boundary to the specified parameter [and]
`
`[i]ts range must be interpreted in its technologic and stylistic context."' Cohesive Techs., Inc. v.
`
`Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (quoting Pall Corp. v. Micron Separations,
`
`Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995)). The '106 patent's specification explains that "'about'
`
`... as used herein means within an acceptable errorrange for the particular value as determined
`
`by one of ordinary skill in the art." '106 patent at 5:31-33. The specification further states that
`
`this "will depend in part on how the value is measured or determined, i.e., the limitations of the
`
`measurement system." Id. at 5:33-35. In context, a PHOSITA would understand the scope of the
`
`"about" limitation with reasonable certainty. Therefore, Defendant's indefiniteness argument is
`
`rejected. The term is afforded its plain and ordinary meaning.
`
`3.
`
`"critically ill" ('527 patent, claim 10)
`
`a.
`
`b.
`
`c.
`
`Plaintiff's proposed construction: Plain meaning
`
`Defendant's proposed construction: Indefinite
`
`Court's construction: Plain meaning
`
`4
`
`J.A.4
`
`

`

`
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`"' [A] patentee need not define his invention with mathematical precision in order to
`
`comply with the definiteness requirement."' Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364,
`
`1370 (Fed. Cir. 2014) (quoting Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed.
`
`Cir. 2005)). The term "critically ill" has a recognizable meaning to those having skill in the art.
`
`Further, the '527 patent provides examples of medical conditions that may satisfy the "critically
`
`ill" limitation. '527 patent at 10:62-11:1. Therefore, Defendant's indefiniteness argument is
`
`rejected. The term is afforded its plain and ordinary meaning.
`
`4.
`
`"intensive care unit" ('527 patent, claim 8)
`
`. Plaintiff's proposed construction: "any setting that provides care to
`a.
`critically ill patients, typically characterized by high nurse-to-patient ratios,
`continuous medical supervision, and intensive monitoring"
`
`Defendant's proposed construction: "any setting that provides intensive
`
`b.
`care"
`
`Court's construction: Either "any setting that provides care to critically ill
`c.
`patients" or "any setting that provides intensive care"
`
`The latter part of Plaintiff's proposed construction-"typically characferized by high
`
`nurse-to-patient ratios, continuous medical supervision, and intensive monitoring"-is rejected.
`
`This language finds no support in the intrinsic record. I cannot discern any material distinction
`
`between "any setting that provides care to critically ill patients" and "any setting that provides
`
`intensive care." I therefore decline to construe the term further at this time. The parties are
`
`permitted to bring up any additional arguments pertaining to this term at the pretrial conference.
`
`Entered this 2Y day of May, 2016.
`
`5
`
`J.A.5
`
`

`

`
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`v.
`
`FRESENIUS KABI USA, LLC,
`
`Defendants.
`
`)
`)
`)
`)
`) No. 16 C 651
`)
`) Judge Rebecca R. Pallmeyer
`)
`)
`
`MEMORANDUM OPINION AND ORDER
`
`Plaintiff Hospira, Inc., a Delaware corporation with its primary place of business in
`
`Illinois, manufactures pharmaceuticals and medical supplies. At issue in this case is a chemical
`
`compound known as dexmedetomidine, which Hospira sells to health care providers under the
`
`brand name Precedex. Between 2012 and 2014, Hospira obtained four patents covering a new
`
`product made from dexmedetomidine: U.S. Patent Nos. 8,242,158 (the “ ‘158 Patent”),
`
`8,338,470 (the “ ‘470 Patent”), 8,455,527 (the “ ‘527 Patent”), and 8,648,106 (the “ ‘106 Patent”).
`
`(Complaint [1] (“Pl.’s Compl.”), 3.)
`
`Defendant Fresenius Kabi USA, LLC, is an American subsidiary of a German
`
`pharmaceutical manufacturer which is also registered in Delaware and headquartered in Illinois.
`
`On December 4, 2015, Fresenius Kabi notified Hospira that it had filed an abbreviated new drug
`
`application (“ANDA”) with
`
`the FDA, seeking approval
`
`to market
`
`its own proposed
`
`dexmedetomidine products prior to the expiry of Hospira’s patents. (Answer to Complaint,
`
`Affirmative Defenses, and Counterclaims [10] (“Def.’s Answer”), ¶ 16.) Hospira filed suit a
`
`month later, alleging patent infringement. (Pl.’s Compl. 8–9.) Fresenius Kabi has denied the
`
`allegations and counterclaimed for a declaration that the four patents at issue are invalid or,
`
`alternatively, that Fresenius Kabi’s actions will not infringe. (Def.’s Answer 22.)
`
`The parties have presented competing interpretations of two terms common to all four
`
`patents-in-suit, and of one term unique to the ‘527 Patent. The court’s construction of those
`
`terms follows.
`
`J.A.6
`
`

`

`
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`The Patented Invention
`
`BACKGROUND
`
`Dexmedetomidine is a chemical compound known as an alpha2-adrenergic agonist.
`
`A.
`
`
`
`(‘158 Patent, JA-2, col. 1 ll. 21–24.) In layman’s terms, this means it stimulates certain
`
`receptors in the central nervous system to produce a desired effect. U.S. National Library of
`
`Medicine, Adrenergic Agonists, Medicinal Subject Headings 2018 (last visited Nov. 27, 2017),
`
`https://meshb-prev.nlm.nih.gov/record/ui?ui=D000322. Dexmedetomidine is used primarily as a
`
`sedative, though it is also used to treat pain, anxiety, and high blood pressure. (‘158 Patent, JA-
`
`2, col. 1 ll. 21–24.) The compound was originally isolated and patented in 1990 by a Finnish
`
`corporation, which later licensed the sales rights to Hospira’s predecessor organization, Abbott
`
`Laboratories. (Fresenius Kabi USA, LLC’s Opening Claim Construction Brief [43] (“Def.’s
`
`Opening Br.”), 2, 4.) Plaintiff Hospira has sold dexmedetomidine-based medications under the
`
`Precedex trade name since 1999. (Hospira’s Responsive Claim Construction Brief [47] (“Pl.’s
`
`Resp. Br.”), 1.)
`
`
`
`The original Precedex product, known as Precedex Concentrate, is sold in 2-mL glass
`
`vials containing a concentration of 100 micrograms per milliliter (µg/mL) of dexmedetomidine.
`
`(Id.) This concentration is too strong to administer directly to patients. Accordingly, hospital
`
`personnel are required to dilute Precedex Concentrate with a 0.9% sodium chloride solution to a
`
`reach a concentration of just 4 µg/mL before injecting patients with the medication. (Id. at 2; JA-
`
`260 (“Precedex Concentrate Label”).) In addition, once diluted, the prepared dexmedetomidine
`
`solution must be used within 24 hours for maximum potency. (Id.)
`
`
`
`As Hospira notes,
`
`this extra dilution step has obvious drawbacks,
`
`including
`
`inconvenience, added cost, and
`
`increased safety concerns
`
`resulting
`
`from possible
`
`contamination or overdose. (Id.) To address these concerns, Hospira developed a new, pre-
`
`diluted dexmedetomidine formulation, which it calls Precedex Premix. (Id. at 3.) It is for this
`
`invention that Hospira filed for and obtained the patents at issue in this case.
`
`J.A.7
`
`

`

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`
`
`Hospira summarized its invention as “premixed pharmaceutical compositions of
`
`dexmedetomidine, or a pharmaceutically acceptable salt thereof, that are formulated for
`
`administration to a patient, without the need to reconstitute or dilute the composition prior to
`
`administration.” (‘158 Patent, JA-2, col. 1 ll. 61–65.) While surmounting the shortcomings of its
`
`original, concentrated formulation, Hospira faced several challenges in developing Precedex
`
`Premix: namely, the need to ensure that the product remained stable and potent over a much
`
`longer shelf-life. (Pl.’s Resp. Br. 2–3.) After conducting trials with modified chemical formulas,
`
`Hospira identified the packaging as the solution to its problems. (Id.) Specifically, Hospira
`
`asserts, it “discovered that glass packaging exhibited superior stability relative to other
`
`packaging materials” such as plastic infusion bags or pre-filled syringes. (Id.; ‘158 Patent, JA-8,
`
`col. 13 ll. 22–67.) Hospira found further that “developing a sealed system” could ensure shelf-
`
`life stability and product sterility. (Pl.’s Resp. Br. 3.) On this front, Hospira “tested several
`
`closure systems for integrity without success before finding a stopper that was compatible with
`
`the glass container[.]” (Id.)
`
`
`
`The ‘158, ‘470, and ‘106 Patents all cover the same basic subject matter—the
`
`medication itself—and share a title: “Dexmedetomidine Premix Formulation.” (See, e.g., ‘158
`
`Patent, JA-1.)
`
` The
`
`final,
`
`‘527 Patent addresses “Methods of Treatment using a
`
`Dexmedetomidine Premix Formulation.” (‘527 Patent, JA-29.) All the patents share a common
`
`specification. The core of the invention, Hospira states, is “a ‘ready to use’ dexmedetomidine
`
`formulation in a ‘sealed glass container.’” (Pl.’s Resp. Br. 3.)
`
`
`
`J.A.8
`
`

`

`
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`
`B.
`
`
`
`The Disputed Claim Terms
`
`The parties contest three claim terms: “ready to use,” “sealed glass container,” and
`
`“intensive care unit.” The first two of these terms are present in every asserted claim throughout
`
`all four patents, while the third relates to just one claim in the ‘527 Patent.
`
`
`
`The ‘158 Patent is representative of the manner in which the terms “ready to use” and
`
`“sealed glass container” are used in all four patents.1 It claims:
`
`1.
`
`2.
`
`3.
`
`4.
`
`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.
`The ready to use liquid pharmaceutical composition of claim 1, further
`comprising sodium chloride at a concentration of between about 0.01 and
`about 2.0 weight percent.
`The ready to use liquid pharmaceutical composition of claim 2, wherein
`the sodium chloride is present at a concentration of about 0.9 weight
`percent.
`The ready to use liquid pharmaceutical composition of claim 1, wherein
`the composition is formulated as a total volume selected from the group
`consisting of 20 mL, 50 mL and 100 mL.
`
`
`(‘158 Patent, JA-14, col. 26 ll. 4–18) (emphasis added).
`
`
`
`The ‘527 Method Patent contains 15 claims covering various concentrations, delivery
`
`methods, and settings
`
`in which
`
`the premixed dexmedetomidine
`
`formulation may be
`
`administered. (‘527 Patent, JA-42, col. 25 l. 24–col. 26 l. 31.) Claim 8 contains the disputed
`
`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.
`
`The method of claim 1, wherein the composition is administered to the
`patient in an intensive care unit.
`
`term:
`
`1.
`
` .
`
` . .
`
`
`8.
`
`1
`The parties agree on this point, and cite to the first-filed ‘158 Patent in the Joint
`
`Appendix when discussing these two terms throughout their briefs. (See Def.’s Opening Br. 4
`n.3.)
`
`J.A.9
`
`

`

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`
`
`(Id. at col. 25 ll. 25–32, col. 26 ll. 16–17) (emphasis added).
`
`C.
`
`
`
`Prosecution History
`
`The inventors filed the four patent applications between January 4, 2012, and April 22,
`
`2013. (‘158 Patent, JA-1; ‘106 Patent, JA-43.) The Patent Office issued the patents between
`
`August 14, 2012, and February 11, 2014, in the order in which they were filed. (Id.) The
`
`prosecution history of the first-filed ‘158 Patent reflects the history of the family of patents as a
`
`whole.
`
`
`
`In the original application, the independent claim of the ‘158 Patent read:
`
`1.
`
`A pharmaceutical composition comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of about 4
`μg/mL, wherein the composition is formulated as a liquid for parenteral
`administration to a subject, and wherein the composition is disposed with
`a sealed container as a premixture.
`
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`(JA-175.) The phrase “ready to use” and word “glass” to describe the sealed container were not
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`yet present. The Patent Office rejected all four claims as anticipated or made obvious by the
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`prior art: in this case, the label that appears on the Precedex Concentrate product. (Id. at 286.)
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`The examiner’s comments explained that the Precedex Concentrate label “teaches that the
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`dexmedetomidine HCL formulation must be diluted in 0.9% sodium chloride solution prior to
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`administration” and “provides instructions for dilution.” (Id.) (emphasis in original). Notably, the
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`label disclosed that Precedex Concentrate was sold in “clear glass vials and . . . ampules.” (Id.
`
`at 261.) The examiner further stated in regards to the claimed “sealed container” that, given the
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`choice between diluting the solution in a sealed versus unsealed container, “[t]he artisan would
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`clearly immediately envisage the mixing of the formulation in a sealed container in order to
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`maintain the sterility of the composition for parenteral administration.” (Id. at 287.)
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`
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`In response, the inventors amended the claim to read “wherein the composition is
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`disposed within a sealed glass container as a ready to use premixture.” (JA-298) (emphasis in
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`original). In support of these amendments, the record states:
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`J.A.10
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`

`

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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 6 of 17 PageID #:2373Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 13 of 108 PageID #: 1312
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`[Hospira] noted that the claims are directed to a composition comprising 4 µg/mL
`dexmedetomidine that is a premixture, which does not require dilution prior to
`administration to a subject. The claimed composition differs from the formulation
`described by the cited reference, which requires dilution to a concentration of 4
`µg/mL dexmedetomidine prior to administration to a patient. As such, [Hospira]
`maintained that unlike the claimed composition, the formulation disclosed by the
`cited reference is not a ready to use premixture.
`
`
`(Id. at 299.) As for the modification of “sealed container” to “sealed glass container,” Hospira
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`successfully argued that the prior art did not meet the legal standard for inherent anticipation
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`because the examiner’s conclusion was based on the “mere probability that the skilled artisan
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`would prepare the dilution in a sealed glass container and not in an unsealed container” made
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`of another substance. (Id. at 301–02.) Anticipation “may not be established by probabilities or
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`possibilities,” (Id. at 301 (citing In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)), and
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`Hospira distinguished Precedex Premix as being “necessarily disposed with a sealed glass
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`container.” (Id. at 302) (emphasis in original).
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`
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`Hospira further argued that a “sealed glass container” was not obvious in the light of the
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`prior art because a skilled artisan would likely prepare a solution for intravenous delivery to a
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`patient in a plastic infusion bag rather than a sealed glass container. (Id. at 303.) While
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`Precedex Concentrate was sold in glass vials, it was not diluted in those same containers.
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`Hospira also presented evidence that distributing Precedex Premix in sealed glass containers
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`exhibited superior potency over a longer shelf life than alternative vessels. (Id.) The PTO
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`accepted these arguments as “effective to overcome the previous rejection” for inherent
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`anticipation and obviousness. (JA-421.)
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`
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`The ‘158 Patent reached its final form on March 30, 2012, through an amendment
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`requested by the examiner and authorized by the inventors. (Id. at 420.) The amendment
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`maintained the inventors’ addition of “ready to use” and “glass” to the claims, but rearranged the
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`sentence for grammar and syntax to read:
`
`1.
`
`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.
`
`J.A.11
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`

`

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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 7 of 17 PageID #:2374Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 14 of 108 PageID #: 1313
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`
`(Id.; ‘158 Patent, JA-14, col. 26 ll. 4–8.) The remaining patents underwent a similar process of
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`rejection and modification before being approved by the PTO. (See, e.g., JA-757–66; JA-843–
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`65) (discussing the term “sealed glass container” in the context of the ‘470 Patent).
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`Legal Standards Governing Claim Construction
`
`DISCUSSION
`
`The claims of a patent define the scope of the invention to which the patentee may
`
`A.
`
`
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`exercise his right of exclusivity. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005).
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`Where a claim’s meaning is disputed, the court must determine its proper construction as a
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`matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 391 (1996). Claim
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`construction is an objective exercise, and courts should generally give claim terms the ordinary
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`and customary meaning they would have “to a person of ordinary skill in the art at the time of
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`the invention.” Phillips, 415 F.3d at 1313. Claim construction often “involves little more than the
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`application of the widely accepted meaning of commonly understood words.” Id. at 1314 (“In
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`such circumstances, general purpose dictionaries may be helpful.”). Importantly, however,
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`judges must always read claims “in the context of the entire patent.” Id. at 1313.
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`
`
`The Federal Circuit instructed in Phillips that if the meaning of a disputed claim term is
`
`not readily apparent, the court should first turn to sources of evidence intrinsic to the patent. 415
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`F.3d at 1314–19. Foremost among these intrinsic sources is the patent’s specification, which
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`must include a “full, clear, concise, and exact” description of the claimed invention as the
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`inventor saw it. Id. at 1316 (quoting 35 U.S.C. § 112). If the specification defines or gives
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`consistent meaning to certain terms, “the inventor’s lexicography governs.” Id. The same rule
`
`applies if an inventor explicitly limits the scope of a term in the specification. Id. If the
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`specification merely provides examples or preferred embodiments of an invention, however,
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`Phillips warns courts not to confine the patent’s claims to those embodiments. Id. at 1323; see
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`also Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, 1136 (Fed. Cir. 2011)
`
`(declining to limit a claim “where the references to a certain limitation as being the ‘invention’ are
`
`J.A.12
`
`

`

`
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 8 of 17 PageID #:2375Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 15 of 108 PageID #: 1314
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`not uniform, or where other portions of the intrinsic evidence do not support applying the
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`limitation to the entire patent.”).
`
`
`
`In addition to the specification, the court may look to the patent’s prosecution history as
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`further evidence of how the inventor and the Patent Office understood the invention. Id. at
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`1317. The court must be mindful, however, that the prosecution history represents an ongoing
`
`discussion, and may be less clear than the specification “and thus less useful for claim
`
`construction purposes.” Id. Finally, while consulting the intrinsic evidence will resolve
`
`ambiguities in most situations, courts must sometimes go beyond the contents of the patent
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`itself and consider extrinsic evidence—such as technical dictionaries, treatises, or expert
`
`testimony—to aid in claim construction. Id. Though the Federal Circuit in Phillips outlined
`
`several reasons why extrinsic evidence is less reliable than intrinsic evidence, it declined to
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`exclude such evidence provided it is not used to contradict claim language made clear by
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`intrinsic evidence. Id. at 1318–19, 1324; see also Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
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`1576, 1582 (Fed. Cir. 1996).
`
`
`
`With these standards of construction in mind, the court turns to the disputed claim
`
`language.
`
`B.
`
`“ready to use” (all asserted claims)
`
`Claim Term
`
`Plaintiff Hospira’s Proposed
`Construction
`
`Defendant Fresenius Kabi’s
`Proposed Construction
`
`“suitable for administration to a
`patient without requiring
`dilution”
`
`“ready to use”
`
`
`“formulated to be suitable for administration
`to a patient upon manufacture without
`dilution or reconstitution”
`
`
`
`
`
`The ‘158 Patent defines the term “ready to use” as an embodiment of the invention
`
`“formulated as ‘ready to use’ compositions which refer to premixed compositions that are
`
`suitable for administration to a patient without dilution.” (‘158 Patent, JA-3, col. 3 ll. 57–59.)
`
`The specification previously defines a “premix” or “premixture” as “a pharmaceutical formulation
`
`that does not require reconstitution or dilution prior to administration to a patient.” (Id. at ll. 48–
`
`J.A.13
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`

`

`
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 9 of 17 PageID #:2376Case 1:18-cv-00303-RGA Document 59 Filed 10/15/18 Page 16 of 108 PageID #: 1315
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`50.) Such compositions, the specification continues, do not require dilution by “a clinician,
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`hospital personnel, caretaker, patient, or any other individual.” (Id. at ll. 53–55.) Here, the
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`inventor has clearly acted as his own lexicographer. See Philips, 415 F.3d at 1316. As such,
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`Hospira’s proposed construction more accurately describes the scope of the term “ready to
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`use.”
`
`
`
`Fresenius Kabi contends that its proposed construction appropriately describes the
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`“distinguishing characteristic” of “ready to use”—namely, “the ability to administer