Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 1 of 15 PageID #:1978
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`HOSPIRA, INC.,
`
`
`
`
`
`
`FRESENIUS KABI USA, LLC,
`
`
`
`
`
`
`
`
`Plaintiff,
`
`Defendant.
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`Civil Action No. 1:16-cv-00651
`
`Hon. Judge Rebecca R. Pallmeyer
`
`
`
`
`
`
`
`
`HOSPIRA’S RESPONSIVE CLAIM CONSTRUCTION BRIEF
`
`The parties dispute the construction of three terms, two of which lie at the center of the
`
`claimed invention: “ready to use” and “sealed glass container.” As discussed below, these
`
`features solved a need in the art for a safer and more convenient dexmedetomidine drug product.
`
`While Hospira’s constructions of the terms accurately define the invention, Fresenius Kabi has
`
`proposed incorrect constructions that are based on an oversimplified view of the claimed subject
`
`matter.
`
`I. The Claimed Invention
`
`The four patents-in-suit1 relate to ready-to-use compositions of the sedative
`
`dexmedetomidine. (E.g., JA-2 at 1:5-10.) Hospira’s predecessor, Abbott Laboratories, began
`
`selling dexmedetomidine under the name PrecedexTM in 1999. (See JA-249-61.) However, the
`
`100 microgram per milliliter (µg/mL) concentration of dexmedetomidine in PrecedexTM was too
`
`
`1 The patents are 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”). They share a common
`specification.
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 2 of 15 PageID #:1979
`
`concentrated to administer to patients. (JA-2 at 1:48-49.) Medical personnel had to dilute
`
`PrecedexTM to 4 µg/mL before administering it to the patient. (Id.; JA-62.) Upon dilution, the
`
`composition would be administered to the patient within twenty-four hours to prevent any loss of
`
`potency. (E.g., JA-373 (FDA Memorandum noting that “[t]he drug product is prepared for use
`
`by diluting it with sterile 0.9% sodium chloride solution for injection after which it is stable for
`
`24 hours”).)
`
`This dilution step presented problems. (E.g., JA-2 at 1:50-53.) The need to have a
`
`medical professional perform dilution at the time of administration was an inconvenience that
`
`entailed added cost. (E.g., id.) It also posed safety concerns, as errors made in preparing the
`
`diluted composition would result in a patient receiving dexmedetomidine at the wrong
`
`concentration. (Id.) There was also a risk of contamination during dilution. (Id.) However,
`
`because it was believed that diluted dexmedetomidine was stable for no more than twenty-four
`
`hours, PrecedexTM continued to be sold only in its concentrated form for well over a decade.
`
`(See, e.g., JA-2 at 1:48-49.)
`
`The inventors set out to solve these problems by creating a ready-to-use formulation that
`
`eliminated the dilution step. (JA-2 – JA-3 at 1:53-65, 2:62-3:3.) They faced a major challenge
`
`due to the diluted composition’s very low dexmedetomidine concentration. Specifically, at 4
`
`µg/mL, even small changes in dexmedetomidine potency would amount to a significant loss in
`
`relative terms. (E.g., JA-12 at 21:59-61.) Thus, the inventors needed to develop a diluted, low
`
`concentration dexmedetomidine formulation that maintained its potency for an extended period.
`
`(JA-2 at 2:62-66.) The inventors experimented with numerous different formulations, trying
`
`various buffers, pH levels, additives, and packaging materials. (See JA-8 – JA-9.) After months
`
`2
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 3 of 15 PageID #:1980
`
`of stability testing, they discovered that glass packaging exhibited superior stability relative to
`
`the other packaging materials tested. (E.g., JA-8 at Example 1.)
`
`The inventors’ work was still not done. They then had to ensure the shelf-life stability
`
`and sterility of the product by developing a sealed system. (See JA-4 at 5:59-65; JA-6 at 9:1-7.)
`
`They tested several closure systems for integrity without success before finding a stopper that
`
`was compatible with the glass container and formed a “sealed glass container.” (See JA-11 – JA-
`
`12 at 20:45-21:16.)
`
`Through their work, the inventors developed the claimed invention—a “ready-to-use”
`
`dexmedetomidine formulation in a “sealed glass container.” Claim 1 of the ‘158 patent is
`
`exemplary:
`
`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.
`
`(JA-14 at Claim 1.) This inventive composition exhibited prolonged stability, allowing it to be
`
`kept on the shelf until needed, as claimed in the ‘106 patent:
`
`A ready to use liquid pharmaceutical composition for parenteral
`administration to a subject, comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof disposed within a sealed
`glass container, wherein the liquid pharmaceutical composition
`when stored in the glass container for at least five months exhibits
`no more than about 2% decrease in the concentration of
`dexmedetomidine.
`
`
`(JA-57 at Claim 1.)
`
`
`The benefits of the claimed invention are manifest. The embodiment of the claimed
`
`subject matter, PrecedexTM Premix, enjoys a majority share of the dexmedetomidine market and
`
`commands a premium price. Indeed, even though Fresenius Kabi currently sells a generic
`
`3
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 4 of 15 PageID #:1981
`
`version of the concentrated version of PrecedexTM, it is now seeking approval to sell the superior
`
`ready-to-use product prior to the expiry of the patents-in-suit.
`
`II.
`
`Proposed Constructions
`
`a. “ready to use” (all asserted claims)
`
`Hospira's Proposed Construction
`
`Fresenius Kabi's Proposed
`Construction
`
`“formulated to be suitable for
`administration to a patient upon
`manufacture without dilution or
`reconstitution”
`
`
`“suitable for administration to a patient
`without requiring dilution”
`
`
`The parties agree on much of the construction of “ready to use”: that it is suitable for
`
`
`
`administration to a patient without dilution. However, Fresenius Kabi’s construction, which
`
`goes no further, is too broad. It includes, for example, syringes containing the old concentrated
`
`version of PrecedexTM that had been diluted by hospital personnel prior to administration. Such
`
`diluted compositions are plainly beyond the scope of the invention here. Only Hospira’s
`
`construction captures that the claimed “ready to use” composition is manufactured for direct
`
`administration to patients without any dilution (or, similarly, reconstitution).
`
`The patents’ specification explains that “ready to use” compositions are “premixed
`
`compositions that are suitable for administration to a patient without dilution.” (JA-3 at 3:56-
`
`59.) In turn, a “premixed composition” is a “pharmaceutical formulation that does not require
`
`reconstitution or dilution prior to administration to a patient” by anyone at any time—“in
`
`contrast to non-premixed formulations of dexmedetomidine, the premixed compositions
`
`provided herein are suitable for administration to a patient without dilution by, for example, a
`
`clinician, hospital personnel, caretaker, patient or any other individual.” (JA-3 at 3:48-55.)
`
`4
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 5 of 15 PageID #:1982
`
`The key feature of the claimed “ready to use” formulation is that there is no user dilution
`
`at any time prior to administration. The specification explains that “[t]he requirement of a
`
`dilution step in the preparation of the dexmedetomidine formulation is associated with additional
`
`costs and inconvenience, as well as the risk of possible contamination or overdose due to human
`
`error.” (JA-2 at 1:50-53.) The claimed “ready to use” composition eliminates this dilution step:
`
`The present invention is based in part on the discovery that
`dexmedetomidine prepared in a premixed formulation that does not
`require reconstitution or dilution prior to administration to a
`patient, remains stable and active after prolonged storage. Such
`premixed formulations therefore avoid the cost, inconvenience,
`and risk of contamination or overdose that can be associated with
`reconstituting or diluting a concentrated dexmedetomidine
`formulation prior to administration to a patient.
`
`
`(JA-2 – JA-3 at 2:62-3:3; see also JA-2 at 1:53-57.) To eliminate the dilution step, the “ready to
`
`use” composition must be “formulated as a premixed composition.” (JA-2 at 1:61-67 (“The
`
`present invention relates to 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. Thus, the
`
`compositions of the present invention are formulated as a premixed composition comprising
`
`dexmedetomidine.”).) To avoid the need for dilution, the inventors developed a composition that
`
`could be manufactured in diluted form and that would maintain long-term stability during
`
`storage. (E.g., JA-1041 (“[U]nlike the claimed ready to use liquid pharmaceutical composition,
`
`which can be stored for prolonged periods of time, the diluted composition described by the
`
`PrecedexTM label is prepared for use within a 24 hour period, and is not a formulation suitable for
`
`prolonged storage. Accordingly, while diluting a 100 µg/mL concentrate to a 4 µg/mL dilution
`
`produces a composition that is stable and useable for a 24 hour period after dilution, the claimed
`
`5
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 6 of 15 PageID #:1983
`
`ready to use liquid pharmaceutical composition can be stored for at least 9 months in a sealed
`
`glass container.”); JA-304-05.)
`
`During prosecution, Hospira explained that its ready to use composition is “formulated”
`
`so that it is ready to use “directly” upon removal from its sealed container, i.e., upon
`
`manufacture. At the very outset of prosecution, Hospira explained that its claims were “directed
`
`to a 4 µg/mL dexmedetomidine composition disposed within a sealed container that is
`
`formulated as a premixture for administration to a subject upon removal from the sealed
`
`container.” (JA-62; see also JA-97; JA-303 (“Accordingly, upon withdrawing the claimed
`
`composition from a sealed glass container, as artisan of ordinary skill can administer the
`
`composition directly to a subject.”); JA-448; JA-851.) Were it otherwise—that a formulation
`
`that was not “ready to use” in its manufactured form could later become “ready to use” once it
`
`was subsequently diluted—the invention would not have solved the need to eliminate the
`
`undesirable dilution step.
`
`Thus, Fresenius Kabi errs when it asserts, without support, that “the focus is not on
`
`whether the composition had ever been diluted, but whether it requires a dilution step before
`
`administration.” (D.I. 43, Opening Br. at 13.) To the contrary, that is precisely the focus of the
`
`inventive “ready to use” composition. See, e.g., Retractable Techs., Inc. v. Becton, Dickinson &
`
`Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011) (explaining that a construction must “strive to capture
`
`the scope of the actual invention” and “tether the claims to what the specifications indicate the
`
`inventor actually invented”). Tellingly, in trying to justify its proposed construction, Fresenius
`
`Kabi glosses over a key portion of the specification definition upon which it purports to rely,
`
`omitting that “ready to use” compositions are “premixed compositions that are suitable for
`
`administration to a patient without dilution.” (See JA-3 at 3:56-59; Opening Br. at 10.) The
`
`6
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 7 of 15 PageID #:1984
`
`specification explains that a premixed composition is a composition that is not diluted or
`
`reconstituted by anyone after it has been manufactured. (JA-3 at 3:48-55.) Similarly, in
`
`referencing a passage in the prosecution history discussing that “ready to use” compositions are
`
`suitable for administration without dilution, Fresenius Kabi ignores that this very passage
`
`explains that the composition must be so suitable as “formulated.” (See Opening Br. at 13.)
`
`Indeed, under Fresenius Kabi’s construction, every composition is a “ready to use”
`
`composition because after any necessary dilution is performed, every composition becomes
`
`suitable for administration to a patient without further dilution. For example, a solution of the
`
`concentrated formulation of PrecedexTM that is diluted by a pharmacist for use later in the day by
`
`an anesthesiologist would become “ready to use” upon its preparation. But such a composition
`
`still entails the cost, inconvenience, and risk of the dilution step. The advantage of the claimed
`
`invention is that it eliminates this step. (JA-2 – JA-3 at 2:62-3:3.) The Court should reject
`
`Fresenius Kabi’s attempt to prop up its invalidity defense by broadening the scope of “ready to
`
`use” to encompass essentially any composition.
`
`In sum, a “ready to use” composition is “formulated to be suitable for administration to a
`
`patient upon manufacture without dilution or reconstitution.” The Court should adopt Hospira’s
`
`proposed construction.
`
`b. “sealed glass container” (all asserted claims)
`
`Hospira's Proposed Construction
`
`Fresenius Kabi's Proposed
`Construction
`
`“glass container closed to maintain
`sterility by having a seal or another
`closure that passes closure integrity
`testing”
`
`
`
`
`“closed tightly to prevent unwanted
`materials entering or exiting the glass
`container”
`
`7
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 8 of 15 PageID #:1985
`
`The “sealed glass container” limitation of the claimed invention dovetails with the “ready
`
`to use” element. The inventors developed a sealed product to ensure that the product remains
`
`sterile during its prolonged storage:
`
`premixed
`the
`embodiments,
`non-limiting
`certain
`In
`dexmedetomidine composition of the present invention is disposed
`in a container or vessel that can maintain the sterility of, or prevent
`the contamination of, a premixed dexmedetomidine composition
`that is purified or substantially free of any contaminants. In certain
`non-limiting embodiments, the container or vessel is a sealed
`container or vessel.
`
`(JA-6 at 9:1-7; see also JA-4 at 5:59-6:4 (“In all cases, the form can be sterile . . . .”).) Indeed,
`
`Fresenius Kabi appears to agree that a “sealed” container maintains the sterility of the
`
`composition. (See Opening Br. at 15-16 (“But the Examiner considered both as examples of
`
`‘sealed containers’ because they can ‘maintain the sterility of the formulation.’”).) A sterile
`
`product is one that remains free of microbial contaminants during its shelf life. (E.g., Ex. 1,
`
`Food and Drug Administration, Guidance for Industry: Container and Closure System Integrity
`
`Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
`
`at 2 (“Products labeled as sterile are expected to be free from viable microbial contamination
`
`throughout the product’s entire shelf life or dating period.”).) The PTO Examiner recognized
`
`this ability to maintain sterility as one of the bases of patentability of the claimed invention. (JA-
`
`954-55 (noting, in reasons for allowance, that “Applicants point to the Specification teaching that
`
`the claimed formulation ‘can be stable under the conditions of manufacture and storage and can
`
`be preserved against the contaminating action of microorganisms such as bacteria and fungi’”)
`
`(internal citation omitted).)
`
`The specification teaches a person of skill in the art how to determine whether a product
`
`is “sealed.” Of course, by its plain terms, a product with an actual seal is “sealed.” But, the
`
`8
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 9 of 15 PageID #:1986
`
`inventors also developed a sealed system using a rubber stopper after experimenting with several
`
`potential stoppers for the product. (JA-11 – JA-14 at 20:45-25:12.) To determine whether a
`
`given stopper sealed the formulation, the inventors performed container closure integrity testing,
`
`which is standard in the art. (JA-12 at 21:6-17 (detailing performance of integrity tests,
`
`including dye ingress testing); Ex. 1, FDA Guidance at 4 (recommending the use of closure
`
`system integrity testing, such as dye ingress tests, to assess sterility).) For example, the inventors
`
`employed a dye ingress test—which assesses whether a closure system prevents the entry of an
`
`external fluid under pressure—to determine whether a stopper provided an appropriate seal. (JA-
`
`12 at 21:6-10.) Thus, a “sealed glass container” is one that is “closed to maintain sterility by
`
`having a seal or another closure that passes closure integrity testing.”
`
`Fresenius Kabi’s proposed construction—“closed tightly to prevent unwanted materials
`
`entering or exiting the glass container”—is unworkable. First, it raises more questions than it
`
`answers—for example, how to determine the closure’s level of tightness; how to determine
`
`whether a closure is sufficiently “tight”; whether a given material is “unwanted”; and how to
`
`determine whether an “unwanted material” has entered the system. Fresenius Kabi points to no
`
`support for its vague construction.
`
`Second, Fresenius Kabi’s proposed construction is inconsistent with the plain meaning of
`
`the term “sealed.” Fresenius Kabi asserts that, under its construction, a composition of
`
`concentrated PrecedexTM that is diluted, placed in a tube, and closed with a cap is “sealed.”
`
`(Opening Br. at 14.) But in plain usage, a water bottle, for example, is not considered “sealed”
`
`when, after a sip, it is “closed tightly to prevent unwanted materials entering or exiting.” Rather,
`
`the bottle’s seal existed at the time of manufacture but was broken upon first use. Similarly, the
`
`9
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 10 of 15 PageID #:1987
`
`claimed “ready to use” composition is sealed at the time of manufacture to maintain sterility and
`
`is kept that way until the seal is broken at the time of administration.
`
`Fresenius Kabi attempts to justify its construction by arguing that Hospira conceded
`
`during prosecution that plastic infusion devices are “sealed.” (Opening Br. at 15-18.) Even if
`
`such devices were “sealed,” it is unclear why that would support Fresenius Kabi’s construction.
`
`In any case, nowhere in any of the statements upon which Fresenius Kabi relies does Hospira
`
`state that infusion devices are sealed. (See id.) To the contrary, Hospira explained that “infusion
`
`devices”—not just plastic infusion devices—are not “sealed glass containers.” (JA-303
`
`(“Because the diluted composition is administered to a subject by an intravenous infusion, an
`
`artisan of ordinary skill would have diluted the dexmedetomidine in a device for infusion, such
`
`as a plastic infusion bag or plastic syringe, and not disposed the 4 µg/mL dilution in a sealed
`
`glass container.” (emphasis added) (internal citation omitted)).)
`
`Acknowledging as much, Fresenius Kabi appears to argue that because Hospira
`
`differentiated plastic infusion devices from “sealed glass containers” on the basis that glass
`
`containers exhibit superior stability, Hospira implicitly agreed that plastic infusion devices are
`
`“sealed containers.” But this negative inference is illogical. Both elements—“sealed” and
`
`“glass”—differentiate the claimed invention from plastic infusion devices. While the inventors
`
`discovered that glass maintained potency of the “ready to use” formulation better than other
`
`more preferred materials (e.g., JA-421), they also developed a sealed product that maintained
`
`sterility (JA-954-55). Diluted dexmedetomidine compositions in the prior art were not “sealed.”
`
`(JA-301; JA-303.) Thus, to the extent Fresenius Kabi’s construction defines plastic infusion
`
`devices (such as syringes) as “sealed,” it is contradicted by the intrinsic record.
`
`10
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 11 of 15 PageID #:1988
`
`Thus, the Court should reject Fresenius Kabi’s vague construction and construe “sealed
`
`glass container” as “glass container closed to maintain sterility by having a seal or another
`
`closure that passes closure integrity testing.”
`
`c. “intensive care unit” (‘527 patent, Claim 8)
`
`Hospira's Proposed Construction
`
`Fresenius Kabi's Proposed
`Construction
`
`“any setting that provides care to
`critically ill patients, typically
`characterized by high nurse-to-patient
`ratios, continuous medical supervision,
`and intensive monitoring”
`
`
`“any setting that provides care to
`critically ill patients,” or
`“any setting that provides intensive
`care”
`
`Claim 8 of the ‘527 patent recites a method of sedation using the inventive ready to use
`
`
`
`dexmedetomidine composition “wherein the composition is administered to the patient in an
`
`intensive care unit.” (JA-42 at Claim 8.) The parties agree that “intensive care unit” is “any
`
`setting that provides care to critically ill patients.” However, only Hospira’s proposed
`
`construction further characterizes that setting to clearly delineate the scope of the term. See, e.g.,
`
`O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360-62 (Fed. Cir. 2008)
`
`(noting that claim construction serves to resolve disputes as to claim scope to assist the fact-
`
`finder).
`
`The specification explains that “intensive care unit” refers to any setting that provides
`
`intensive care, as described, for example, in U.S. Pat. No. 6,716,867.” (JA-34 at 10:30-40.) In
`
`view of the ‘867 patent and the plain meaning of the term, a POSITA would understand that
`
`“intensive care unit” includes certain features. Specifically, treatment of critically ill patients is
`
`characterized by continuous, detailed medical attention—“high nurse-to-patient ratios,
`
`continuous medical supervision, and intensive monitoring.” This environment defines an
`
`intensive care unit:
`
`11
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 12 of 15 PageID #:1989
`
`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.
`
`(Ex. 3, Stedman's Concise Medical Dictionary at 505 (4th ed. 2001).)
`
`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.
`
`(Ex. 4, The New American Medical Dictionary and Health Manual at 179 (7th ed. 1999).)
`
`ICUs have a high nurse:patient ratio to provide the necessary high
`intensity of service, including treatment and monitoring of
`physiologic parameters.
`
`(Ex. 5, The Merck Manual of Diagnosis and Therapy at 2243-44 (19th ed. 2011).)
`
`Tellingly, the District of New Jersey, in a draft Opinion, tentatively construed “intensive
`
`care” in the ‘867 patent in much the same manner as Hospira proposes here: “care provided to
`
`critically ill patients, typically characterized by high nursing-to-patient ratios, continuous
`
`medical supervision, and continuous monitoring.” (Ex. 2, Draft Opinion at 9.)
`
`Fresenius Kabi’s arguments against Hospira’s construction should be rejected. First,
`
`while the District of Delaware construed “intensive care unit” as Fresenius Kabi proposes, the
`
`court there reserved further construction of the term. Hospira regards the Delaware court’s
`
`construction as subject to re-argument at the appropriate time. And, of course, even if it is not
`
`revised before trial, the ruling of the Delaware court is not binding on this Court. E.g., Lexington
`
`Luminance LLC v. Amazon.com Inc., 601 F. App’x 963, 969 (Fed. Cir. 2015); In re Neurografix
`
`(‘360) Patent Litig., --- F. Supp. 3d ----, 2016 WL 4425712, at *8 (D. Mass. Aug. 19, 2016).
`
`Second, contrary to Fresenius Kabi’s suggestion, construing a term with reference to
`
`dictionary definitions does not add “new matter” to the patent. (See Opening Br. at 21.)
`
`12
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 13 of 15 PageID #:1990
`
`Extrinsic evidence is an appropriate claim construction tool that can illuminate the meaning of a
`
`term in appropriate circumstances, particularly where the intrinsic evidence does not fully define
`
`a term. See, e.g., Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015); Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1317-19 (Fed. Cir. 2005).
`
`Third, Fresenius Kabi’s attempt to marginalize the construction of “intensive care” with
`
`respect to the ‘867 patent is also misguided. Fresenius Kabi contends that the meaning of
`
`‘intensive care unit” in the ‘867 patent is irrelevant because that patent is “entirely unrelated.”
`
`(Opening Br. at 21.) But the ‘867 patent is part of the intrinsic record for “intensive care unit”—
`
`the patents specifically reference the ‘867 patent when discussing the term.2 See, e.g., Powell v.
`
`Home Depot U.S.A., Inc., 663 F.3d 1221, 1231 (Fed. Cir. 2011) (“Our cases establish that ‘prior
`
`art cited in a patent or cited in the prosecution history of the patent constitutes intrinsic
`
`evidence.’”); see also Arthur A. Collins Inc. v. N. Telecom Ltd., 216 F.3d 1042, 1044-45 (Fed.
`
`Cir. 2000) (relying on definition of claim term provided by unrelated patents cited in patent-in-
`
`suit because “[w]hen prior art that sheds light on the meaning of a term is cited by the patentee, it
`
`can have particular value as a guide to the proper construction of the term”). Therefore, evidence
`
`relating to the construction of “intensive care unit” in the ‘867 patent is relevant here.
`
`Thus, the Court should clarify that “any setting that provides care to critically ill patients”
`
`is “typically characterized by high nurse-to-patient ratios, continuous medical supervision, and
`
`intensive monitoring.”
`
`III. Conclusion
`
`For the foregoing reasons, Hospira requests that the Court adopt its proposed
`
`constructions of “ready to use,” “sealed glass container,” and “intensive care unit.”
`
`
`2 Moreover, along with the patents-in-suit, the ‘867 patent is listed in the Orange Book for
`PrecedexTM Premix. (Ex. 6, Orange Book listing for PrecedexTM.)
`
`13
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 14 of 15 PageID #:1991
`
`Dated: November 8, 2016
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`HOSPIRA, INC.
`
`By: /s/ Bradford P. Lyerla
`
`Bradford P. Lyerla
`Sara T. Horton
`Yusuf Esat
`Chad J. Ray
`JENNER & BLOCK LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`Telephone: 312 222-9350
`blyerla@jenner.com
`shorton@jenner.com
`yesat@jenner.com
`cray@jenner.com
`
`Attorneys for Plaintiff Hospira, Inc.
`
`14
`
`

`

`Case: 1:16-cv-00651 Document #: 47 Filed: 11/08/16 Page 15 of 15 PageID #:1992
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Yusuf Esat, an attorney at the law firm of Jenner & Block LLP, certify that on
`
`November 8, 2016, the foregoing Hospira’s Responsive Claim Construction Brief was served
`
`on counsel of record via the Court’s ECF system.
`
`
`/s/ Yusuf Esat
` Yusuf Esat
`
`
`
`
`
`
`
`
`
`
`