Case: 1:16-cv-00651 Document #: 56 Filed: 11/22/16 Page 1 of 19 PageID #:2215
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`C.A. No. 1:16-cv-00651
`
`v.
`
`Honorable Rebecca Pallmeyer
`
`FRESENIUS KABI USA, LLC
`
`Defendant.
`
`PUBLIC VERSION
`
`FRESENIUS KABI USA, LLC’S REPLY CLAIM CONSTRUCTION BRIEF
`
`

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`Case: 1:16-cv-00651 Document #: 56 Filed: 11/22/16 Page 2 of 19 PageID #:2216
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`TABLE OF CONTENTS
`
`
`INTRODUCTION .............................................................................................................. 1
`
`ARGUMENT ...................................................................................................................... 1
`
`I.
`
`II.
`
`A.
`
`“ready to use” .......................................................................................................... 1
`
`1.
`
`2.
`
`The Intrinsic Evidence Does Not Support Hospira’s
`Attempt to Impute a Temporal limitation Into the “Ready to
`Use” Construction ....................................................................................... 3
`
`The Specification Specifically Distinguishes the Definition
`of “Premixture” and “Ready to Use” .......................................................... 5
`
`B.
`
`“sealed glass container” .......................................................................................... 6
`
`1.
`
`2.
`
`3.
`
`4.
`
`The Inventor of the Patents-in-Suit and Hospira’s
`Corporate Witness Do Not Understand a “Sealed Glass
`Container” As Relating To Integrity Testing .............................................. 7
`
`The Specification And Hospira’s 30(b)(6) Witness Shows a
`“Sealed Glass Container” Is Not Limited To A “Single Use
`Dosage” ....................................................................................................... 8
`
`The Prosecution History Shows That A Previously Opened
`Container May Be “Sealed” Upon Closing .............................................. 11
`
`The Court Should Not Import A Sterility Limitation to
`“Sealed Glass Container” .......................................................................... 12
`
`C.
`
`“intensive care unit” .............................................................................................. 13
`
`1.
`
`2.
`
`This Court Should Adopt the Delaware District Court’s
`Construction .............................................................................................. 13
`
`Extrinsic Evidence Cannot Overcome The Clear Language
`of The Patent Specification ....................................................................... 14
`
`III.
`
`CONCLUSION ................................................................................................................. 15
`
`
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`
`ii
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`

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`Case: 1:16-cv-00651 Document #: 56 Filed: 11/22/16 Page 3 of 19 PageID #:2217
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`Cases
`
`TABLE OF AUTHORITIES
`
`Abbott Labs. v. Dey, L.P.,
`110 F. Supp. 2d 667 (N.D. Ill. 2000) ........................................................................................ 14
`
`Aventis Pharms. Inc. v. Amino Chems. Ltd.,
`715 F.3d 1363 (Fed. Cir. 2013)................................................................................................... 8
`
`Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
`512 F.3d 1338 (Fed. Cir. 2008)................................................................................................... 2
`
`CollegeNet, Inc. v. ApplyYourself, Inc.,
`418 F.3d 1225 (Fed. Cir. 2005)................................................................................................... 3
`
`Finisar Corp. v. DirecTV Group, Inc.,
`523 F.3d 1323 (Fed. Cir. 2008)................................................................................................. 13
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`481 F.3d 1371 (Fed. Cir. 2007)................................................................................................... 4
`
`Not Dead Yet Mfg., Inc. v. Pride Solution, LLC,
`No. 13-cv-3418, 2015 WL 5829761 (Oct. 5, 2015) (Pallmeyer, J.) ........................................... 3
`
`Nystrom v. TREX Co.,
`424 F.3d 1136 (Fed. Cir. 2005)................................................................................................... 5
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................................................. 8, 14
`
`Tate Access Floors, Inc. v. Interface Architectural Resources, Inc.,
`279 F.3d 1357 (Fed. Cir. 2002)............................................................................................... 1, 4
`
`Vanguard Prods. Corp. v. Parker Hannifin Corp.,
`234 F.3d 1370 (Fed. Cir. 2001)................................................................................................... 2
`
`
`
`
`
`
`
`
`
`iii
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`

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`Case: 1:16-cv-00651 Document #: 56 Filed: 11/22/16 Page 4 of 19 PageID #:2218
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`Pursuant to the Local Patent Rules and Scheduling Order entered in this case Defendant
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`Fresenius Kabi USA, LLC submits this Reply Claim Construction Brief in response to Plaintiff
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`Hospira Inc.’s Responsive Markman Brief dated November 8, 2016 concerning U.S. Patent Nos.
`
`8,242,158; 8,338,470; 8,455,527; and 8,648,106 (“the patents-in-suit”). D.I. 19.
`
`I.
`
`INTRODUCTION
`
`Fresenius Kabi respectfully requests that the Court adopt its proposed constructions of the
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`three terms at issue: “ready to use,” “sealed glass container,” and “intensive care unit.”
`
`Consistent with Federal Circuit authority, Fresenius Kabi relies on the intrinsic evidence
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`including the patent specification and prosecution history. To the extent extrinsic evidence is
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`helpful, the inventor of the patents-in-suit and Hospira’s own corporate representative admitted
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`by deposition that Fresenius Kabi’s proposed constructions are correct. Hospira, nevertheless,
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`seeks to read extraneous limitations into the claims, and for the sole and express purpose of
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`saving them from invalidity. And they do so by contradicting what the patent itself says about
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`the claim terms now at issue. Claim construction is not a results-oriented determination. Rather,
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`the purpose of claim construction is to determine the proper scope of the claims, even if that
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`renders the claims invalid. Tate Access Floors, Inc. v. Interface Architectural Resources, Inc.,
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`279 F.3d 1357, 1372 (Fed. Cir. 2002) (“[W]here claim language is clear we must accord it full
`
`breadth even if the result is a claim that is clearly invalid.”).
`
`II.
`
`ARGUMENT
`
`A.
`
`“ready to use”
`
`Fresenius Kabi’s Proposed
`Construction
`“suitable for administration to a
`patient without requiring dilution”
`
`Hospira’s Proposed Construction
`
`“formulated to be suitable for
`administration to a patient upon
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`

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`
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`manufacture without dilution or
`reconstitution”1
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`Each claim of the ’158 patent, ’470 patent, and ’106 patent is directed to a “ready to use
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`liquid composition for parenteral administration to a subject.” JA-14 (’158 claims), JA-28 (’470
`
`claims), JA-57 (’106 claims). The ’527 patent is directed to a “method of providing sedation to a
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`patient in need thereof . . . wherein the composition is a ready to use liquid pharmaceutical
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`composition for parenteral administration. . . .” JA-42 (’527 claims). The dispute about this
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`term is what in particular the claim covers, as between how a composition is made versus what
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`the composition is. Fresenius Kabi submits that the claim covers the latter, which is the
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`composition itself, and what a composition was before the time of analysis is irrelevant.
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`Hospira, on the other hand, seeks to convert its composition claims into product-by-
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`process claims or method claims. That violates black-letter patent law that “[a] novel product
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`that meets the criteria of patentability is not limited to the process by which it was made.”
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`Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2001); see also
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`Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1344 (Fed. Cir. 2008) (“Court must
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`generally take care to avoid reading process limitations into an apparatus claim….”). The claims
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`at issue were drafted as compositions, regardless of how they were made; if Hospira wanted to
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`draft their claims as method claims, they could have done so. It is too late now and claim
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`construction cannot be used to rewrite the claims.
`
`
`1 Hospira chose not to disclose its proposed constructions until after Fresenius Kabi set forth its
`position in its Opening Brief, and relied instead on “plain and ordinary meaning.” Thus, by
`waiting to spring its proposed construction for the first time in its Responsive Brief, Hospira
`seeks to obtain an unfair advantage and prejudice Fresenius Kabi. Therefore as an initial matter,
`Fresenius Kabi requests the Court reject Hospira’s proposed constructions and arguments in
`support thereof.
`
`2
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`

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`
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`In addition, Hospira’s proposed construction also imports a limitation from the
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`specification that is not in the claims itself. Hospira is asking the Court to read a particular
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`manufacturing process from the specification into the claims. That request, too, runs contrary to
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`the law of claim construction that particular examples and ways of making a claimed
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`composition from the specification cannot be used to limit the claims. CollegeNet, Inc. v.
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`ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005) (“In examining the specification for
`
`proper context, however, this court will not at any time import limitations from the specification
`
`into the claims.”); Not Dead Yet Mfg., Inc. v. Pride Solution, LLC, No. 13-cv-3418, 2015 WL
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`5829761, *7 (Oct. 5, 2015) (Pallmeyer, J.) (declining to import width and thickness limitations
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`from the specification into construction).
`
`1.
`
`The Intrinsic Evidence Does Not Support Hospira’s Attempt to Impute
`a Temporal limitation Into the “Ready to Use” Construction
`
`Fresenius Kabi’s proposed “ready to use” construction should be adopted because it is
`
`consistent with the definition set forth in the specification. Hospira seeks to add a temporal
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`component to the “ready to use” construction, specifically, that the formulation is “ready to use”
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`from the time it is first manufactured at the factory. However, there is no support in the
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`intrinsic record for such a construction. In fact, the definition of “ready to use” provided in the
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`specification is inconsistent with requiring the formulation to be “ready to use” upon
`
`manufacture. The specification makes clear that “‘ready to use’ compositions [ ] refer to
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`premixed compositions that are suitable for administration to a patient without dilution.” JA-2,
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`’158 patent 2:56-62. To the extent the specification permits a temporal component to the “ready
`
`to use” construction, it states that, “the compositions of the present invention are ‘ready to use’
`
`upon removing the compositions from a sealed container or vessel.” JA-3, ’158 patent, 3:60-62
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`(emphasis added). In other words, the specification defines the time at which the fact finder
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`3
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`

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`
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`should evaluate whether a composition is “ready to use” — i.e., suitable for administration
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`without dilution — as the moment it is removed from a sealed glass container. Even if the
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`specification were a guide to limit the claims, as Hospira wrongly suggests, it still does not say
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`that the compositions must be ready at the point of manufacturing, as opposed to the point of
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`administration (which is what the claim itself provides).
`
`Hospira’s proposed construction would require a “ready to use” composition to be
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`suitable for administration without dilution at the specific point of manufacture. That would
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`require any analysis about what the claim covers to look into the history of the alleged infringing
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`product. However, the history of a composition is not relevant to the determination of whether a
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`composition is “ready to use” upon removing it from the sealed container. The composition
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`infringes at the moment the claim elements are met in one product, irrespective of where that
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`product happens to be on the commercial distribution scale from manufacturer to end consumer.
`
`Hospira incorrectly argues that adapting Fresenius Kabi’s proposed construction would
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`somehow render every product a “ready to use” composition. D.I. 47 at 7. In particular, Hospira
`
`states that “a solution of the concentrated formulation of Precedex that is diluted by a pharmacist
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`for use later in the day by an anesthesiologist would become “ready to use” upon its preparation.
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`Id. In that situation the product sold — that is, the product being evaluated for infringement —
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`would not be ready to use. The appropriate question for infringement is whether the accused
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`infringer sells a product that does not require any further dilution. Hospira chose to define
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`“ready to use” broadly in its specification so that its claims cover more products, so it cannot
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`now complain that that same broad definition would include more prior art that may render the
`
`claims invalid. See Tate, 279 F.3d at 1372; Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d
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`1371, 1383 (Fed. Cir. 2007) (finding claims anticipated based on patentee’s broad usage of terms
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`4
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`

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`
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`during prosecution, noting Plaintiff “argued for a broad meaning, and succeeded, but suffers a
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`Pyrrhic victory”).
`
`2.
`
`The Specification Specifically Distinguishes
`“Premixture” and “Ready to Use”
`
`the Definition of
`
`Hospira points to the definition of a different term, “premixture” to support its erroneous
`
`construction. D.I. 47 at 4-5. Hospira’s proposed construction thereby seeks to supplant the
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`definition of “ready to use” with the definition of “premix” or “premixture.” “Premixture,”
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`however, is a separate term and has its own definition distinct from “ready to use.” By using
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`those terms separately, the patent confirms that they are different, further supporting Fresenius
`
`Kabi’s proposal.
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`The specifications of the patents-in-suit provide a definition of “premix” or “premixture”
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`separately from the definition of “ready to use.”
`
`The terms “premix” or “premixture” as used herein refers to a pharmaceutical
`formulation that does not require reconstitution or dilution prior to administration
`to a patient. For example, 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, ’158 patent 3:48-55. Conversely, the specification defines “ready to use” as suitable for
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`administration to a patient without dilution.” JA-2, ’158 patent 2:56-62. These terms have
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`different sections within the “Definitions” section of the specification because they are intended
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`to have different meanings and scopes.
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`“Ready to use” and “premixture” cannot be identical in scope because the applicants
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`consistently used both terms to describe the compositions, showing that they have two different
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`meanings. Even more generally, different terms are presumed to have different meanings and
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`different scopes. Nystrom v. TREX Co., 424 F.3d 1136, 1143 (Fed. Cir. 2005) (“When different
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`words or phrases are used in separate claims, a difference in meaning is presumed.”).
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`5
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`

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`
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`“Premixture” is a different term that is not at issue because it does not appear in any claim of the
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`patents-in-suit. As noted in the Opening Brief, the claims of the ’158 patent originally included
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`the term “premixture,” but that language was removed. D.I. 43 at 11-12. Hospira’s construction
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`is litigation-driven and serves only to obscure rather than clarify the meaning of the “ready to
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`use” term. If it wanted to claim a “premixture,” Hospira could have done so, but chose not to.
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`Moreover, even if the term “premix” composes part of the “ready to use” construction, it
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`still does not say anything about manufacturing. Hospira concludes “that a premixed
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`composition is a composition that is not diluted or reconstituted by anyone after it has been
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`manufactured.” D.I. 47 at 6-7. How Hospira comes to this conclusion, however, is not
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`explained. The separate construction for “premixture” describes the suitability of administration
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`without dilution by various individuals without respect to when a clinician, hospital personnel,
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`etc., would no longer need to dilute the composition. The “premix” definition does not mention
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`anything about manufacturing.
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`B.
`
`“sealed glass container”
`
`Fresenius Kabi’s Proposed
`Construction
`
`“closed tightly to prevent unwanted
`materials entering or exiting the glass
`container”
`
`Hospira’s Proposed Construction
`“glass container closed to maintain
`the sterility by having a seal or
`another closure that passes closure
`integrity testing”
`
`
`Fresenius Kabi’s proposed “sealed glass container” construction should be adopted
`
`because it presents the ordinary meaning of the term as evidenced not only by the specification
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`of the patents-in-suit, but also by an inventor of the patents-in-suit and Hospira’s own corporate
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`representative. Hospira, meanwhile, seeks to introduce numerous extraneous limitations to the
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`term “sealed glass container.” Hospira seeks to restrict the claim to only a product that “passes
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`closure integrity testing;” in other words a product that meets all FDA requirements for closure
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`6
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`

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`
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`integrity. The patent claims, however, have nothing to do with FDA requirements on how tightly
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`a product is closed, and just requires a “sealed” container. Adding all the extra terminology that
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`Hospira asks to add would mean not only collecting material wholesale from third party extrinsic
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`sources, but then also would require another round of claim construction briefing to understand
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`what that new terminology would actually require. There is no basis to accept Hospira’s
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`proposal.
`
`1.
`
`The Inventor of the Patents-in-Suit and Hospira’s Corporate Witness
`Do Not Understand a “Sealed Glass Container” As Relating To
`Integrity Testing
`
`The term “sealed glass container” has a plain and ordinary meaning to artisans in the field
`
`of pharmaceutical formulation and product development. A glass container is “sealed” when it is
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`“closed tightly to prevent unwanted materials entering or exiting the glass container.” This plain
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`meaning of the term was confirmed by both an inventor and Hospira’s own corporate
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`representative. Dr. Robert Cedergren, named inventor of the patents-in-suit, testified
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`
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`Similarly, Hospira’s corporate designee, Dr. Rao Tata-Venkata testified
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` Ex. 1, Cedergren Rough 193:17-194:7 (inventor).
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`
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` Ex. 2, Venkata Dep. 41:6-17 (Hospira’s corporate representative). Thus, neither the
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`inventor of the patents-in-suit nor Hospira’s own corporate witnesses understands a “sealed glass
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`container” as having anything to do with closure integrity testing. That is just a new litigation-
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`induced term that unnecessarily narrows the claim without any basis in the record.
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`Hospira posits that Fresenius Kabi’s construction is vague because it does not explain
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`how to determine the closure’s level of tightness or how to determine whether a closure is
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`7
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`

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`
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`sufficiently tight, and how to determine whether an unwanted material has entered the container.
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`D.I. 47 at 9. Not so. The infringement analysis under Fresenius Kabi’s construction is whether a
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`closure that prevents unwanted materials from entering or exiting the container is present. The
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`degree of tightness is not relevant. Indeed, a closure integrity test may be one way to test
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`whether the integrity of the material inside a vial is maintained but it is not necessarily the only
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`way. Claims are construed from the perspective of a person of ordinary skill in the art. Phillips
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`v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc); Aventis Pharms. Inc. v. Amino
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`Chems. Ltd., 715 F.3d 1363, 1374–75 (Fed. Cir. 2013) (reversing construction that ignores the
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`perspective of a person of ordinary skill in the art). The evidence in the specification and of
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`Hospira’s witnesses show that a person of ordinary skill in the art of the patents-in-suit do not
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`find Fresenius Kabi’s proposed construction vague; in fact, they the term “sealed glass
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`container” has a broad meaning. If anything, it is Hospira’s proposal that is vague and
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`confusing, and does not help construe the claim, as it invites more questions than it answers
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`about what the term means.
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`2.
`
`The Specification And Hospira’s 30(b)(6) Witness Shows a “Sealed
`Glass Container” Is Not Limited To A “Single Use Dosage”
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`Hospira seeks to use the term “sealed glass container” to read in a limitation that would
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`result in claims that only cover a single-use product. Hospira’s position is that “a water bottle,
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`for example, is not considered ‘sealed’ when, after a sip, it is ‘closed tightly to prevent unwanted
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`materials entering or exiting.’” D.I. 47 at 9. Thus, under Hospira’s proposed construction
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`“sealed glass container” may only contain a single use product. Once again, however, the
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`specifications of the patents-in-suit contradict such a construction because they specifically
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`distinguish these two different approaches, and therefore show they are different. The
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`specification discusses single-use products in the “Definitions” section and refers to them as
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`8
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`
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`“single use dosage.” JA-3, 3:63-67. The specification states that “certain embodiments [ ] of the
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`present invention can be formulated as a ‘single use dosage,’ which refers to a premixed
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`composition that is disposed within a sealed container or vessel as a one dose per container or
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`vessel formulation.” Id. And the specification discloses other embodiments of the alleged
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`invention which are not single use dosage products. In fact, the specification states, “[i]n certain
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`non-limiting embodiments, the premixed dexmedetomidine composition of the present invention
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`is disposed in a container or vessel and is formulated as a dosage for multiple use.” JA-6, 9:14-
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`20 (discussing single use and multiple use embodiments of premixed compositions). Further, as
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`made clear by the specification, a vial that has been punctured multiple times by a needle may
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`still be considered “sealed.” Limiting “sealed glass container” to single use dosage products
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`would improperly cut out the full range of potential embodiments of the invention in
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`contradiction to the specification. If Hospira wanted to claim a “single use” container, they
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`could have done so, but once again chose not to do so.
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`Moreover, even Hospira’s 30(b)(6) corporate representative himself testified that a
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`“sealed glass container” includes a container that may be opened and closed multiple times, so
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`long as it is tightly closed each time. As described in Fresenius Kabi’s Opening Brief, the rubber
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`vial stopper tested in the specification was considered a sufficient seal even after it had been
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`punctured multiple times by a needle. D.I. 43 at 14-15; JA-12, ’158 pat., 21:6-16. The stoppers
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`were “self-sealing” because they closed sufficiently after puncture to prevent dye from entering
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`the vial. Id. The needle punctures opened and “unsealed” the glass vials tested in Example 6.
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`Dr. Cedergren
`
`
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`
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`Ex. 1, Cedergren Rough 134:3-135:5 (
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`); id. 190:4-19
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`9
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`. Therefore, a “sealed glass
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`container” cannot be limited to a container that has never previously been opened. In fact,
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`Hospira’s requirement that a “closure integrity test” be used is precisely the kind of test
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`described in Example 6, and that test necessitates accessing and resealing the container.
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`Hospira’s corporate representative also confirmed that “sealed glass container” is not
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`equivalent to a one-use container. Hospira’s Precedex Premix NDA states
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`
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`.2 Ex. 3,
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`Development Rpt at HOSPIRA_0545104.
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`. Ex. 2, Venkata Dep. 163:12-164:14.
`
` Id.
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`?
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`2 The report
`. Ex. 3 at
`HOSPIRA_00545098. As such, it reflects the understanding of that term by persons skilled in the
`art before the filing of the patents-in-suit in January 2012.
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`10
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`

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`Id. Hospira offers a construction of “sealed glass container” that is directly at odds with the plain
`
`and ordinary usage of that term, even by its own scientists.
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`3.
`
`The Prosecution History Shows That A Previously Opened Container
`May Be “Sealed” Upon Closing
`
`Hospira is incorrect that the “sealed” term “differentiate[s] the claimed invention from
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`plastic infusion devices.” D.I. 47 at 10. During prosecution of the ’158 patent, both Hospira and
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`the Examiner considered plastic infusion bags to be “sealed containers.” E.g., JA-288
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`(rejection); JA-303 (response). But a plastic infusion bag is a large sealed container into which
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`the concentrated solution is to be diluted, i.e., another material is added. The Examiner made
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`this understanding clear in his summary of the February 28, 2012 interview discussing the
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`originally filed claims directed to a “sealed container.”
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`That is, the art [Draft Label] teaches dexmedetomidine solution provided at a
`concentration of 100 µg/mL and further teaches the solution must be diluted to a
`concentration of 4 µg/mL prior to use and teaches mixing 2 mL of the concentrate
`with 48 mL of 0.9% sodium chloride solution, resulting in the 4 µg/mL
`concentration (e.g., injecting 2 mL of the concentrate into an intravenous bag
`containing 48 mL isotonic saline). The resulting solution anticipates the claimed
`invention.
`
`JA-295 (Interview Summary). As described by the Examiner, a plastic infusion bag, into which
`
`2 mL of concentrate and 48 mL of sodium chloride solution were added and mixed is a “sealed
`
`container:” “One of ordinary skill in the art at the time of the invention would have found it
`
`obvious to make the dilution in a sealed container (such as a sealed glass vial or an infusion
`
`bag) to maintain the sterility of the formulation, which is administered by intravenous infusion.
`
`JA-288 (emphasis added). The infusion bag was necessarily opened to add the materials
`
`together for mixing. So a “sealed container” was not understood by the Examiner to require that
`
`the container had never previously been opened. Nor did the applicants disturb this
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`
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`understanding. Hospira pointed to this very statement by the Examiner to support its distinction
`
`between plastic and glass containers, not to distinguish the infusion bags as not being sealed.
`
`JA-303.
`
`The only point of differentiation between IV bags and glass containers during prosecution
`
`was the material. Hospira is incorrect when it tells the Court that “[d]iluted dexmedetomidine
`
`compositions in the prior art were not ‘sealed.’” D.I. 47 at 10. During prosecution the Examiner
`
`stated that a “sealed container” included an infusion bag, and Hospira never disturbed or
`
`corrected that finding, upon which the Examiner relied. Hospira cannot now rewrite this history
`
`to adopt an overly narrow construction hoping to obtain a results-oriented construction to help its
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`invalidity case.
`
`4.
`
`The Court Should Not Import A Sterility Limitation to “Sealed Glass
`Container”
`
`The claims do not require an additional sterility step. The specification describes sealed
`
`containers as a separate embodiment from sterile containers. As such, the Court should decline
`
`Hospira’s invitation to read this limitation from the specification into the claims.
`
`The specification describes that a sterile solution may be created by adding the step of
`
`sterilizing a sealed container. JA-4, 6:17–21. Had the applicants sought to claim a sterile
`
`composition, they could have done so by simply using the language from the specification. The
`
`quote Hospira cites supports this distinction. D.I. 47 at 8. The applicants state that “certain non-
`
`limiting embodiments” include “a container or vessel that can maintain sterility of, or maintain
`
`the contamination of, a premixed dexmedetomidine composition that is purified or substantially
`
`free of any contaminants.” JA-6, 9:1-6. The specification makes clear that “a premixed
`
`dexmedetomidine composition” on its own is not sterile unless additional purification steps are
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`added before or during the mixing process. And this “sterile” embodiment is intended to be non-
`
`limiting, i.e., not a requirement of the claims unless specifically claimed.
`
`Moreover, the next sentence identifies the “sealed container” as a different embodiment:
`
`“In certain non-limiting embodiments, the container or vessel is a sealed container or vessel.”
`
`JA-6, 9:6–7. In other words, the “sealed container” embodiment is a different embodiment than
`
`the sterile embodiment. The Court should take the applicants at their word—these are different
`
`embodiments.
`
`C.
`
` “intensive care unit”
`
`Fresenius Kabi’s Proposed
`Construction
`“any setting that provides care to
`critically ill patients,” or
`“any setting that provides intensive
`care”
`
`Hospira’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”
`
`The dispute over “intensive care unit” again asks whether the Court should take the
`
`inventors at their word, or should read in limitations without invitation. The patents-in-suit state
`
`that the products may be used in “any setting that provides intensive care.” JA-34, ’527 patent at
`
`10:26–40. Hospira cannot rely on extrinsic evidence to narrow this meaning.
`
`1.
`
`This Court Should Adopt the Delaware District Court’s Construction
`
`The Court may choose to adopt the construction of the parallel Delaware litigation,
`
`Hospira, Inc. v. Amneal Pharmaceuticals LLC, No. 15-cv-697-RGA (D. Del.), in the interests of
`
`comity and judicial economy. See, e.g., Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323,
`
`1329 (Fed. Cir. 2008) (“[I]n the interest of uniformity and correctness,” the Federal Circuit
`
`“consults the claim analysis of different district courts on identical terms in the context of the
`
`same patent.”). While the law is mixed on the subject, the weight of precedent is that Judge
`
`Andrews’s claim construction may be binding on later courts’ interpretation of the same claim
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`term. Abbott Labs. v. Dey, L.P., 110 F. Supp. 2d 667, 669–74 (N.D. Ill. 2000) (finding issue
`
`preclusion bars re-litigation of claim construction for same terms and, alternatively, that it would
`
`apply the same construction based on the persuasiveness of prior ruling). Even if not binding, it
`
`would be illogical to proceed in parallel litigations involving the same patents and the same
`
`product, but with different interpretations of the same term. If the claim construction ends up
`
`being dispositive on any issue, then it may appeal the claim constructions later. Moving forward
`
`with different constructions for the same patent guarantees, though, that these issues must be
`
`addressed on appeal to resolve the split between the jurisdictions.
`
`2.
`
`Extrinsic Evidence Cannot Overcome The Clear Language of The
`Patent Specification
`
`Hospira attempts to overcome the lack of intrinsic support for its construction by citing