Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 1 of 52 PageID: 1607
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`HONORABLE JEROME B. SIMANDLE
`
`
`
`
`
`
`
`
`
`
`BAXTER HEALTHCARE CORPORATION,
`BAXTER INTERNATIONAL INC., and
`BAXTER HEALTHCARE S.A.,
`
`
`Plaintiffs,
`v.
`
`
`MYLAN LABORATORIES LTD. and
`MYLAN PHARMACEUTICALS INC.,
`
`
`Defendants.
`
`BAXTER HEALTHCARE CORPORATION,
`BAXTER INTERNATIONAL INC., and
`BAXTER HEALTHCARE S.A.,
`
`
`Plaintiffs,
`v.
`
`
`SAGENT PHARMACEUTICALS INC.,
`
`
`Defendant.
`APPEARANCES:
`Robert D. Rhoad, Esq.
`Brian M. Goldberg, Esq.
`DECHERT LLP
`902 Carnegie Center, Suite 500
`Princeton, NJ 08540
`
`-and-
`Martin J. Black, Esq.
`Kevin M. Flannery, Esq.
`Teri-Lynn A. Evans, Esq.
`DECHERT LLP
`Circa Centre
`2929 Arch Street
`Philadelphia, PA 19104
`
`Counsel to the Baxter Plaintiffs
`
`Amy Luria, Esq.
`CRITCHLEY, KINUM, & DENOIA, LLC
`75 Livingston Avenue
`
`
`
`
`
`Civil Action Nos.
`14-7094 (JBS/JS)
`15-1684 (JBS/JS)
`
`
`
`MARKMAN OPINION
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`HONORABLE JEROME B. SIMANDLE
`
`
`
`
`
`
`
`
`
`
`BAXTER HEALTHCARE CORPORATION,
`BAXTER INTERNATIONAL INC., and
`BAXTER HEALTHCARE S.A.,
`
`
`Plaintiffs,
`v.
`
`
`MYLAN LABORATORIES LTD. and
`MYLAN PHARMACEUTICALS INC.,
`
`
`Defendants.
`
`BAXTER HEALTHCARE CORPORATION,
`BAXTER INTERNATIONAL INC., and
`BAXTER HEALTHCARE S.A.,
`
`
`Plaintiffs,
`v.
`
`
`SAGENT PHARMACEUTICALS INC.,
`
`
`Defendant.
`APPEARANCES:
`Robert D. Rhoad, Esq.
`Brian M. Goldberg, Esq.
`DECHERT LLP
`902 Carnegie Center, Suite 500
`Princeton, NJ 08540
`
`-and-
`Martin J. Black, Esq.
`Kevin M. Flannery, Esq.
`Teri-Lynn A. Evans, Esq.
`DECHERT LLP
`Circa Centre
`2929 Arch Street
`Philadelphia, PA 19104
`
`Counsel to the Baxter Plaintiffs
`
`Amy Luria, Esq.
`CRITCHLEY, KINUM, & DENOIA, LLC
`75 Livingston Avenue
`
`
`
`
`
`Civil Action Nos.
`14-7094 (JBS/JS)
`15-1684 (JBS/JS)
`
`
`
`MARKMAN OPINION
`
`
`
`
`
`
`Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 2 of 52 PageID: 1608
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`Roseland, NJ 07068
`
`-and-
`Tung-On Kong, Esq.
`Sami Sedghani, Esq.
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`One Market Street
`Spear Tower, Suite 3300
`San Francisco, CA 94105
`
`-and-
`Wendy L. Devine, Esq.
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`
`-and-
`Lisa D. Zang, Esq.
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`
`Counsel to the Mylan Defendants
`
`George H. Parsells, III, Esq.
`Michael Rato, Esq.
`Riadh Quadir, Esq.
`MCELROY, DEUTSCH, MULVANEY & CARPENTER, LLP
`1300 Mount Kemble Avenue
`Morristown, NJ 07962
`
`-and-
`Ronald M. Daignault, Esq.
`POLSINELLI PC
`900 Third Avenue, 21st Floor
`New York, NY 10022
`
`-and-
`Richard Juang, Esq.
`POLSINELLI PC
`100 S. Fourth Street, Suite 1000
`St. Louis, MO 63102
`
`Counsel to Defendant Sagent Pharmaceuticals Inc.
`
`SIMANDLE, Chief Judge:
`
`Table of Contents
` INTRODUCTION ............................................... 3
` BACKGROUND ................................................. 8
`A. Factual and Procedural Background ......................... 8
`
`
`
`2
`
`
`
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`1. Background to Esmolol Hydrochloride and Baxter’s
`Innovative Esmolol Research ................................ 8
`2. Baxter’s Innovative Esmolol Hydrochloride Product,
`BREVIBLOC®.................................................. 9
`3. Defendants’ Proposed Generic Esmolol Hydrochloride
`Products and Litigation in this District .................. 12
`STANDARD OF REVIEW....................................... 12
`A. Claim Construction, Generally ............................ 12
`B. Standards for Finding Lexicography and/or Disavowal ...... 14
` DISCUSSION ................................................ 16
`A. Defendants’ No Construction Approach ..................... 16
`B. “Sterile” ................................................ 19
`1. The Patentees Acted as their own Lexicographers ........ 21
`2. Defining “State of Sterility” .......................... 24
`3. The Express Definition Embodied in the ’540 Patent Carries
`to the ’094 Patent ........................................ 28
`C. “Aqueous” pharmaceutical composition ..................... 33
`D. Injectable, aqueous pharmaceutical composition ........... 42
` CONCLUSION ................................................ 52
`
`
`
`
`
`INTRODUCTION
`These related patent infringement actions under the Hatch-
`
`Waxman Act, 35 U.S.C. §§ 271, 282, generally concern the
`assertions of Plaintiffs Baxter Healthcare Corporation, Baxter
`International Inc., and Baxter Healthcare S.A. (collectively,
`“Baxter”) that the proposed generic esmolol hydrochloride
`
`
`
`3
`
`
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`products of Defendants Mylan Laboratories Ltd., Mylan
`Pharmaceuticals Inc. (hereinafter, “Mylan”), and Sagent
`Pharmaceuticals Inc. (hereinafter, “Sagent” and collectively,
`“Defendants”)1 infringe the various patents covering Baxter’s
`esmolol hydrochloride product, U.S. Patent Nos. 6,310,094
`(hereinafter, “’094 Patent”) and 6,528,540 (hereinafter, “’540
`Patent” and collectively, the “patents-in-suit” or “Patents”), a
`“continuation-in-part” of the ’094 Patent.2
`
`Following factual and claims construction discovery, the
`parties now request that the Court construe the following three
`claim terms:3
`“Sterile,” as it appears in asserted claims 4 through
`1.
`9 of the ’094 Patent, and claims 6, and 12 through 16
`of the ’540 Patent;4
`
`1 Although Defendants seek to market generic esmolol products
`under different abbreviated new drug applications (hereinafter,
`“ANDAs”), they jointly briefed the disputed claim terms at issue
`here.
`2 As a result, the patents-in-suit share essentially identical
`specifications and disclosures. (Compare ’094 Patent, with ’540
`Patent.) For that reason, the Court will, in the interests of
`simplicity, primarily cite to the ’094 Patent, unless otherwise
`indicated.
`3 The parties initially sought construction of the claim term
`“osmotic-adjusting agent,” but subsequently stipulated that the
`Court’s construction of “osmotic-adjusting agent” in a related
`case, Baxter Healthcare Corp. v. HQ Specialty Pharma Corp., ___
`F. Supp. 3d ____, No. 13-6228, 2015 WL 5646779, at *6 (D.N.J.
`Sept. 23, 2015) (hereinafter, the “HQ case”), would govern these
`actions. [See Docket Item 82 in 14-7094; Docket Item 58 in 15-
`1684.]
`4 Although Baxter purports to seek construction of only the term
`“sterile,” the definition proposed by Baxter contains two
`discrete components, and ultimately requires (if adopted)
`construction of the terms “sterile” and “state of sterility.”
`4
`
`
`
`
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`2.
`
`3.
`
`
`
`
`“Aqueous,” as it appears in asserted claims 1 through
`9 of the ’094 Patent, and claims 6, and 12 through 16
`of the ’540 Patent;5 and
`“Injectable, aqueous pharmaceutical composition,” as
`it appears in asserted claims 1 through 9 of the ’094
`Patent.
`In seeking construction, Baxter takes the position, on
`
`essentially each disputed claim term, that the intrinsic record
`discloses a specific definition, and/or reflects the patentee’s
`intention that the term be defined by reference to the
`“ordinary” meaning advanced in its extrinsic sources (namely,
`expert testimony and dictionary definitions). (See, e.g.,
`Baxter’s Opening Br. at 8-23; Baxter’s Responsive Br. at 2-20.)
`More specifically, though, Baxter claims (1) that the inventors
`acted as their own lexicographer in reciting the term “sterile,”
`(2) intended to incorporate their view on the “ordinary mean” of
`the term “aqueous,” and (3) limited the scope of the phrase
`“injectable, aqueous pharmaceutical composition” through
`reference, in the specification, to the characteristics that
`form the “heart” of Baxter’s claimed invention (namely, a
`stable, ready-to-use composition, capable of being autoclaved).
`(Baxter’s Opening Br. at 8-23; Baxter’s Responsive Br. at 2-20.)
`
`
`5 Similar to the situation the Court confronts relative to the
`term “sterile,” the parties’ positions on the term “aqueous”
`reflect the need to construe the concept of an “aqueous”
`pharmaceutical composition, as opposed to simply the term
`“aqueous.”
`
`
`
`5
`
`
`
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`Defendants, by contrast, largely eschew the need for formal
`
`claim construction and submit, in each instance, that the claim
`terms involve little more than the application of widely
`accepted meanings to commonly understood words. (See, e.g.,
`Defs’ Opening Br. at 5-7, 11, 15-16; Defs.’ Responsive Br. at 1,
`4, 10, 13.) In other words, Defendants claim that the disputed
`terms have “self-evident” or “readily apparent” meanings, and
`argue that Baxter’s narrow definitions result from a litigation-
`driven effort to avoid relevant prior art. (See, e.g., id.) In
`the event this Court deems construction necessary (as it does),
`Defendants alternatively advance specific constructions
`consonant with their view of the intrinsic record of the
`patents-in-suit. (See, e.g., Defs.’ Opening Br. at 7-10, 12-14,
`16.)
`Despite any nuances in the disclosures of the patents-in-
`
`suit, the claim terms at issue here constitute obviously
`commonplace terms. The primary issue relative to the
`construction of “sterile” and “injectable, aqueous
`pharmaceutical composition” concerns whether the patentees
`ascribed a specific scope to these claim terms, or whether the
`more general ordinary meaning should prevail. Resolution of the
`term “aqueous,” by contrast, turns, more simply, upon how to
`characterize the plain and ordinary meaning.
`
`
`
`6
`
`
`
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`In considering the claim terms,
`
`the Court has benefited
`
`from extensive briefing and attorney argument at a Markman
`
`hearing.5 For the reasons that follow,
`
`the Court construes the
`
`disputed claim terms as follows:7
`
` Court’ 8 Construction
`“sterile” and “state of
`a composition that has been
`sterility"
`brought to a state of sterility
`
`and has not been subsequently
`exposed to microbiological
`contamination (i.e.
`the
`container holding the sterile
`composition has not been
`compromised)
`
`—and—
`
`sterility is freedom from live
`bacteria or other
`
`microorganisms
`an “aqueous” pharmaceutical
`composition is a solution in
`which water is the solvent
`
`“aqueous” pharmaceutical
`composition
`
`“Injectable, aqueous
`pharmaceutical composition"
`
`ready—to—use aqueous
`a stable,
`parenteral solution
`
`5 The Court conducted a Markman hearing on March 31, 2016, at
`which time the Court received a brief technical tutorial, and
`attorney argument on the disputed claim terms.
`7 The relatively brief record amassed by the parties in
`connection with the pending Markman submissions includes the
`parties’ briefing, certain extrinsic authority, and the
`declaration (with exhibits) of Baxter's expert, Steven J.
`Bannister, Ph.D (hereinafter, “Dr. Bannister”).
`
`7
`
`
`
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` BACKGROUND
`A.
`Factual and Procedural Background
`1.
`Background to Esmolol Hydrochloride and Baxter’s
`Innovative Esmolol Research
`Esmolol hydrochloride constitutes one type of “beta-
`
`blocker,” a class of drugs that block the “beta” receptor of
`heart muscles, arteries, and certain other tissue. (’094 Patent
`at 1:13-23.) Within this large class of drugs, however, esmolol
`proves unique because of its “short-acting” nature, making it
`“often desirable in the critical care setting to quickly reduce
`heart work or improve rhythmicity during a cardiac crisis.”
`(Id.)
`
`Baxter, a trailblazer in the esmolol industry, has
`“‘successfully commercialized various esmolol products under its
`BREVIBLOC® trademark’” for over thirty years. Baxter Healthcare
`Corp v. HQ Specialty Pharma Corp., ___ F. Supp. 3d ____, No. 13-
`6228, 2016 WL 344888, at *3 (D.N.J. Jan. 26, 2016) (citations
`omitted). Early esmolol formulations, however, suffered from
`“extreme susceptibility to hydrolytic degradation,” limited (if
`any) resilience to sterilization by autoclaving,8 and dilution
`errors by the ultimate users (often resulting in patients
`
`8 As this Court explained in the HQ case, “[a]utoclaving refers
`to a form of sterilization that subjects a product in its final
`packaging to a combination of heat and steam for a period of
`time sufficient to kill any microorganisms.” HQ Specialty
`Pharma Corp., ___ F. Supp. 3d ____, 2016 WL 344888, at *2 n.7
`(citation omitted).
`
`
`
`8
`
`
`
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`receiving an excess dosage of the formulation). (’540 Patent at
`1:30-40.) In other words, the prior art esmolol compositions
`readily broke down in the presence of water, and proved
`incapable of effective terminal sterilization (requiring that
`the formulations instead be sterilized aseptically in a “clean”
`environment). (’094 Patent at 1:40-49; ’540 Patent at 2:1-41.)
`2.
`Baxter’s Innovative Esmolol Hydrochloride
`Product, BREVIBLOC®
`Through the patents-in-suit, Baxter claims to have solved
`
`these problems, and developed a ready-to-use, stable aqueous
`esmolol formulation capable of sterilization by autoclaving.
`(’094 Patent at 2:1-14; ’540 Patent at 2:1-14.) Indeed, in
`contrast to the prior art, the claimed formulations prove
`“stable against hydrolytic degradation and other adverse
`chemical reactions,” and possess “a pharmaceutically-acceptable
`shelf-life.” (’094 Patent at 2:3-5.)
`
`Taken together, Baxter’s Patents purport to provide a
`stable, ready-to-use parenteral solution containing esmolol
`hydrochloride, a buffering agent, an osmotic-adjusting agent,
`and methods for preparing the solution in a premixed and
`injectable form. More specifically, though, the ’094 Patent,
`titled “READY-TO-USE ESMOLOL SOLUTION,” discloses a ready-to-use
`injectable, aqueous form of Baxter’s esmolol formulation, in a
`flexible plastic container or intravenous bag (generally
`
`
`
`9
`
`
`
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`identified in the ’094 Patent as an IntraVia™ flexible plastic
`container). (’094 Patent at Title Page, 1:4-10, 62-65.) The
`claims of the ’094 Patent, in turn, disclose an esmolol
`composition and a method for preparing that composition. (’094
`Patent at Title Page, 5:1-6:24.) Asserted claim 1, for example,
`speaks in terms of an esmolol composition, and specifically
`claims (with emphasis for the disputed claim terms):
`An injectable, aqueous pharmaceutical composition for
`the treatment of cardiac conditions, having a pH
`between 3.5 and 6.5 and comprising:
`
`a. 0.1-100 mg/ml methyl-3-[4-(2-hydroxy-3-
`isopropylamino) propoxy] phenylpropionate
`hydrochloride (esmolol hydrochloride),
`
`b. 0.1-5.0 mg/ml buffering agent, and
`c. 1-100 mg/ml osmotic-adjusting agent.
`(’094 Patent at 5:9-16 (emphasis added).)9 Asserted claim 4, by
`contrast, recites a method for preparing the composition, and
`specifically provides (again, with emphasis for the disputed
`claim terms):
`A method for preparing a sterile, injectable aqueous
`pharmaceutical composition for the treatment of
`cardiac conditions, comprising forming an aqueous
`composition having a pH between 3.5 and 6.5 comprising
`methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]
`phenylpropionate hydrochloride (esmolol
`hydrochloride), a buffering agent, and an osmotic-
`adjusting agent in a sealed container, and autoclaving
`for a period of time sufficient to render the
`composition sterile.
`
`
`
`
`
`
`9 Claims 2 and 3 depend upon claim 1.
`10
`
`
`
`
`
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`(’094 Patent at 6:1-9 (emphases added).) The ’540 Patent then
`incorporates the disclosures associated with the ’094 Patent,
`and builds upon them, by teaching the ready-to-use bag form of
`the esmolol formulation, as well as a concentrated esmolol
`form.10 Asserted claim 6 of the ’540 Patent, for example,
`teaches an aqueous, sterile pharmaceutical composition comprised
`of:
`a. 0.1-100 mg/ml esmolol hydrochloride;
`
`
`b. 0.01-.5 M buffering agent, and
`
`
`c. 1-100 mg/ml osmotic-adjusting agent.
`
`
`(’540 Patent at 6:45-50.) Claim 13, in turn, provides (with
`emphasis for the disputed claim terms):
`A method for preparing an aqueous, sterile
`pharmaceutical composition suitable for parenteral
`administration for the treatment of cardiac
`conditions, comprising forming an aqueous composition
`having a pH between 3.5 and 6.5 comprising 0.1-500
`mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino)
`propoxy]phenylpropionate hydrochloride (esmolol
`hydrochloride), 0.01-2 M buffering agent, and 1-500
`mg/ml osmotic-adjusting agent in a sealed container
`and autoclaving for a period of time sufficient to
`render the composition sterile.
`(’540 Patent at 7:7-13 (emphases added).)
`
`Following the issuance of these Patents, the United States
`Food and Drug Administration (hereinafter, the “FDA”), approved
`
`
`10 The ’540 Patent issued on March 4, 2003, and identifies itself
`as a “continuation-in-part” of the ’094 Patent, which issued on
`October 30, 2001. (’540 Patent at 1:5-7.)
`11
`
`
`
`
`
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`Baxter’s New Drug Application (hereinafter, “NDA”) No. 19-386/S-
`018 (an supplemental NDA No. 19-386/S-020) for BREVIBLOC®
`Premixed Injection in 2500mg/250ml IntaVia Containers and
`BREVIBLOC® Double Strength Premixed Injection 20 mg/mL in 100 mL
`Containers (together, “the BREVIBLOC® Premixed Injection
`Products”), and listed the patents-in-suit in its listing of
`approved drug products (i.e., the so-called Orange Book). (See
`Baxter’s Mylan Am. Compl. at ¶¶ 23-24, 28.)
`3.
`Defendants’ Proposed Generic Esmolol
`Hydrochloride Products and Litigation in this
`District
`In September 2014 (by Mylan) and then January 2015 (by
`
`Sagent), Defendants requested FDA approval to sell generic
`esmolol products in 10 mg/mL and 20 mg/mL dosage forms, prior to
`the expiration of the patents-in-suit. (See id. at ¶¶ 29-30;
`Baxter’s Sagent Compl. at ¶¶ 30-31.) As a result of these ANDA
`filings, Baxter filed infringement Complaints in this District,
`and the pending Markman submissions followed.
` STANDARD OF REVIEW
`Claim Construction, Generally11
`A.
`When construing asserted claims, claim terms must
`
`ordinarily be given “‘their ordinary and accustomed meaning as
`
`11 The construction of claim terms constitutes a question of law,
`Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.
`Cir. 1995), aff’d, 517 U.S. 370 (1996), and the Court need not
`follow the parties’ proposed constructions. See Marine Polymer
`Techs., Inc. v. HemCon, Inc., 672 F.3d 1350, 1359 n.4 (Fed. Cir.
`12
`
`
`
`
`
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`understood by one of ordinary skill in the art.’” Shire Dev.,
`LLC v. Watson Pharm., Inc., 787 F.3d 1359, 1364 (Fed. Cir. 2015)
`(quoting Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364,
`1372 (Fed. Cir. 2001); citing Phillips v. AWH Corp., 415 F.3d
`1303, 1312–13 (Fed. Cir. 2005) (en banc)). In determining the
`ordinary and customary meaning, the intrinsic evidence, “the
`specification and the prosecution history,”12 Sunovion Pharm.,
`Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir.
`2013) (citations omitted), “‘may shed’” significant “‘contextual
`light.’” Shire Dev., LLC, 787 F.3d at 1364 (Fed. Cir. 2015)
`(quoting Aventis Pharm. Inc. v. Amino Chems. Ltd., 715 F.3d
`1363, 1373 (Fed. Cir. 2013)); see also Golden Bridge Tech., Inc.
`v. Apple Inc., 758 F.3d 1362, 1365 (Fed. Cir. 2014) (citing
`Phillips, 415 F.3d at 1315–17). Indeed, the Federal Circuit has
`
`
`2012) (en banc); see also Otsuka Pharm. Co. v. Torrent Pharm.
`Ltd., Inc., ___ F. Supp. 3d ____, No. 14-1078, 2015 WL 7195222,
`at *6 n.17 (D.N.J. Nov. 16, 2015) (explaining same).
`12 If the intrinsic evidence fails to disclose the meaning of a
`term, extrinsic evidence, such as dictionaries and expert
`testimony, may shed useful light on the appropriate construction
`of a particular term. Phillips, 415 F.3d at 1318. The Federal
`Circuit, however, discourages “heavy reliance” upon extrinsic
`sources because it “risks transforming the meaning of the claim
`term to the artisan into the meaning of the term in the
`abstract,” and divorced from the intrinsic evidence. Id. at
`1321. Indeed, the Federal Circuit directs courts to
`“‘discount’” extrinsic evidence “‘clearly at odds ... with the
`written record of the patent.’” Shire Dev., LLC, 787 F.3d at
`1365 (citations and internal quotation marks omitted). Despite
`these restrictions, however, extrinsic authorities may prove
`useful, even necessary, under certain circumstances, as
`explained below.
`
`
`
`13
`
`
`
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`repeatedly expressed the view that “‘[t]he construction that
`stays true to the claim language and most naturally aligns with
`the patent’s description of the invention will be, in the end,
`the correct construction.’” Shire Dev., LLC, 787 F.3d at 1364
`(quoting Phillips, 415 F.3d at 1316); see also Otsuka Pharm. Co.
`v. Torrent Pharm. Ltd., Inc., ___ F. Supp. 3d ____, 2015 WL
`7195222 (D.N.J. Nov. 16, 2015) (setting forth the same framework
`for claims construction).
`B.
`Standards for Finding Lexicography and/or Disavowal
`As relevant here, though, a patentee may deviate from the
`
`plain and ordinary meaning, when it “sets out a definition and
`acts as his own lexicographer,” or unequivocally “disavows” a
`certain meaning or “the full scope of a claim term” in order to
`obtain the patent. Thorner v. Sony Computer Entm’t Am. LLC, 669
`F.3d 1362, 1365 (Fed. Cir. 2012) (citation omitted); see also
`Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324 (Fed.
`Cir. 2003). Though “no magic words” trigger either exception,
`Hill-Rom Servs. v. Stryker Corp., 755 F.3d 1367, 1373 (Fed. Cir.
`2014), the standards for finding lexicography and disavowal
`prove “‘exacting.’” Pacing Techs., LLC v. Garmin Int’l, Inc.,
`778 F.3d 1021, 1024 (Fed. Cir. 2015) (quoting GE Lighting
`Solutions, LLC v. AgiLight, Inc., Inc., 750 F.3d 1304, 1309
`(Fed. Cir. 2014)).
`
`
`
`14
`
`
`
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`In order to act as a lexicographer, a patentee must
`
`“‘clearly set forth a definition of the disputed claim term’”
`and express a clear intention “‘to redefine the term.’” Luminara
`Worldwide, LLC v. Liown Elecs. Co., ___ F.3d ____, No. 2015-
`1671, 2016 WL 797925, at *7 (Fed. Cir. 2016) (quoting Thorner,
`669 F.3d at 1365 (quoting CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359, 1366 (Fed. Cir. 2002))). In other words, the
`patentee must make plain, through the specification, its
`intention to define the term in specific way, and apart from the
`ordinary meaning. See id. (quoting Helmsderfer v. Bobrick
`Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008);
`citing Kara Tech. Inc. v. Stamps.com, 582 F.3d 1341, 1347–48
`(Fed. Cir. 2009)); see also C.R. Bard, Inc. v. U.S. Surgical
`Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (noting that the
`“inventor’s written description of the invention” may prove
`“relevant and controlling insofar as it provides clear
`lexicography”).
`
`Disavowal, by contrast, requires that the specification or
`prosecution history “‘make[] clear that the invention’” does not
`include “‘a particular feature.’” Pacing, 778 F.3d at 1024
`(quoting SciMed Life, 242 F.3d at 1341). The Federal Circuit
`has found that the patentee deviated from the ordinary meaning
`based upon phrases like, “‘the present invention includes...’ or
`‘the present invention is...’ or ‘all embodiments of the present
`
`
`
`15
`
`
`
`Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 16 of 52 PageID: 1622
`
`invention are....,’” or where the specification “‘requires’” a
`particular step or identifies a specific feature as
`“‘important’” to the overall invention. Id. (citations
`omitted). In those circumstances, the applicant “alerts the
`reader” to a narrowed scope of the invention, id. (citation
`omitted), “‘even though the language of the claims, read without
`reference to the specification,” might otherwise support a
`broader construction. Thorner, 669 F.3d at 1366 (quoting SciMed
`Life, 242 F.3d at 1341).
`
`Absent lexicography or disavowal, courts “do not depart
`from the plain meaning of the claims.” Luminara Worldwide, LLC,
`___ F.3d ____, 2016 WL 797925, at *7 (citation omitted); see
`also Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352,
`1358 (Fed. Cir. 2004) (explaining that the patentee should
`ordinarily receive the benefit of “the full scope of its claim
`language”).
` DISCUSSION
`The parties, as stated above, request construction of the
`following claim terms: (1) “sterile,” (2) “aqueous,” and
`“injectable, aqueous pharmaceutical composition.”
`A.
` Defendants’ No Construction Approach
`Prior to turning to the merits of the parties’ positions,
`
`the Court addresses one introductory deficiency common to each
`of Defendants’ claims construction positions. More
`
`
`
`16
`
`
`
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`
`specifically, the Court rejects, at the outset, the notion that
`the disputed claim terms require no construction, or can be
`construed simply by reference, without explanation, to the
`“plain and ordinary meaning.” (See, e.g., Defs.’ Opening Br. at
`5, 11, & 15; Defs.’ Responsive Br. at 1.) Indeed, “[w]hen the
`parties present a fundamental dispute regarding the scope of a
`claim term,” even an ordinary one, this Court has a “duty to
`resolve it.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech.
`Co., Ltd., 521 F.3d 1351, 1362 (Fed. Cir. 2008).
`
`The claims construction arguments advanced here plainly
`demonstrate the parties’ fundamental disagreement on the
`appropriate meaning of the disputed claim terms. Indeed, the
`parties devoted ample attention in their briefing to the
`appropriate definitions, and the claim terms themselves form, at
`least in part, the fundamental fabric of Baxter’s claimed
`invention. In that way, reliance upon the phrase “plain and
`ordinary meaning,” or a determination that the claim terms
`require “no construction,” would offer little in terms of
`facilitating a resolution of these related actions. Stated
`differently, a blanket resort to the “‘ordinary’” meaning of the
`disputed claim terms would leave unresolved the parties’
`disputes, and would largely negate the importance of the claims
`construction process — a phase of patent litigation specifically
`directed at determining claim scope in view of the patents-in-
`
`
`
`17
`
`
`
`Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 18 of 52 PageID: 1624
`
`suit. See id. (explaining that “[a] determination that a claim
`term ‘needs no construction’ or has the ‘plain and ordinary
`meaning’ may be inadequate when a term has more than one
`‘ordinary’ meaning or when reliance on a term’s ‘ordinary’
`meaning [would] not resolve the parties’ dispute”).
`
`As a result, the Court concludes that the terms at issue
`here, though ordinary, require meaningful construction,
`irrespective of the simplicity of this Court’s ultimate
`constructions.13 See id. (explaining that courts routinely
`construe “‘ordinary’ words,” and remanding the case for
`consideration, in the first instance, of the appropriate
`construction of the term “only if”); compare ActiveVideo
`Networks v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1326 (Fed.
`Cir. 2012) (finding no error in the district court’s decision
`that the disputed terms required no construction, because the
`plaintiff’s “proposed construction erroneously read[]
`limitations into the claims,” and the district court “rejected
`that construction and [therefore] resolved the dispute between
`the parties”).
`
`
`13 For that reason, in the charts that follow, the Court will
`strikethrough this portion of Defendants’ proposed
`constructions.
`
`
`
`18
`
`
`
`Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 19 of 52 PageID: 1625
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`
`With that prefatory determination,
`
`the Court turns to the
`
`parties’ substantive positions relative to each disputed claim
`
`term.
`
`B.
`
`“Sterile” and “State of Sterility"
`
`Baxter's Patents aim, overall,
`
`to provide an “aqueous,
`
`sterile pharmaceutical composition ... for the treatment of
`
`cardiac conditions,” and specifically to disclose the inventors’
`
`discovery of ready—to—use and concentrated esmolol formulations
`
`capable of withstanding terminal sterilization by autoclaving.
`
`(’094 Patent at 2:l—14 (emphasis added), 5:9—10; see also ’540
`
`Patent at 2:l—14.)
`
`In terms of defining “sterile,” the parties advance the
`
`following competing constructions:
`
`Defendants’ Proposed Construction
`
`
`
`P1ain—aad—erdinary—meafiing
`
`having a reduced microbial burden
`(can be achieved through aseptic
`processing, autoclaving, etc.)
`
`
`
`Baxter's Proposed
`Construction
`
`
`
`a composition that has been
`brought to a state of
`sterility and has not been
`subsequently exposed to
`microbiological
`contamination (i.e.
`the
`container holding the
`sterile composition has not
`been compromised)
`
`
`
`—and—
`
`sterility is freedom from
`live bacteria or other
`
`
`
`microorganisms
`
`More specifically, Baxter points to the specification of
`
`the ’540 Patent, and claims that the “express definition” stated
`
`19
`
`
`
`Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 20 of 52 PageID: 1626
`
`in the specification governs the construction of the patents-in-
`suit (including the earlier-filed ’094 Patent), and embodies, in
`any event, “the ordinary meaning of the term ‘sterile’ in the
`context of pharmaceutical compositions.” (Baxter’s Responsive
`Br. at 4-11.) From this “express definition,” though, Baxter
`then asks the Court to determine that the phrase “state of
`sterility” connotes, in the ordinary sense, a composition free
`“of live bacteria or other micoorganisms.” (Id. at 7-9.)
`
`Defendants argue, by contrast, that Baxter’s proposed
`construction finds no footing in the specification of the ’094
`Patent, and that no case law supports the notion that a
`“selective quote” from the later-in-time ’540 Patent can be
`applied to the construction of the earlier-issued ’094 Patent.
`(Defs.’ Responsive Br. at 6-8.) Even more, Defendants argue
`that Baxter’s construction needlessly creates ambiguity by
`interweaving concepts without “basis in the intrinsic record of
`either patent-in-suit.” (Id. at 7-8.) As a result, Defendants
`urge the Court to adopt their narrow construction, which they
`claim better represents the aspects of the specification
`directed at the concept of “sterile.”14 (See id. at 9.)
`
`
`14 During the Markman hearing, counsel for Defendants attempted
`to cast doubt upon Baxter’s current construction, in light of
`its “ever-changing” construction position in this and the
`related HQ matter. Even if Baxter proposed a more narrow
`construction in the Joint Claim Construction Statement in this
`or the related HQ case, this Court has never construed the term
`20
`
`
`
`
`
`Case 1:14-cv-07094-JBS-JS Document 103 Filed 04/05/16 Page 21 of 52 PageID: 1627
`
`1. The Patentees Acted as their own Lexicographers
`The Court begins with the essentially unremarkable
`
`observation that the ’094 Patent provides, standing alone, no
`information from which to divine the meaning of the term
`“sterile.” Indeed, “sterile” appears only in asserted claim 4,
`and the specification sheds no contextual light on the
`patentees’ intention relative to the disputed term. (’094
`Patent at 6:1-9 (describing a “method of preparing a sterile,
`injectable aqueous pharmaceutical composition” that has, among
`other things, been “autoclave[ed] for a period of time
`sufficient to render the composition sterile”).) The asserted
`claims of the ’540 Patent similarly add little to the story, and
`provide no point of reference for the concept of “sterile.”
`(See generally ’540 Patent at 5:55-8:11.)
`
`The specification of the ’540 Patent, though, which Baxter
`built upon the ’094 Patent, explains in unequivocal terms that,
`A “sterile” composition, as used in the context of
`this application, means a composition that has been
`brought to a state of sterility and has not been
`subsequently exposed to microbiological contamination,
`i.e. the container holding the sterile composition has
`not been compromised. Sterile compositions are
`generally prepared by pharmaceutical manufacturers in
`accordance with current Good Manufacturing Practice
`
`
`“sterile,” and can find no fault in the position Baxter advances
`here. Nor, in any event, can the Court find Baxter’s earlier
`positions so inconsistent with the present position that Baxter
`s
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