Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 1 of 28 PageID #:1870
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`
`
`HOSPIRA, INC.,
`
`
`Plaintiff,
`
`
`v.
`
`FRESENIUS KABI USA, LLC
`
`
`Defendants.
`
`
`
`
`
`C.A. No. 1:16-cv-00651
`
`Honorable Rebecca Pallmeyer
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FRESENIUS KABI USA, LLC’S OPENING CLAIM CONSTRUCTION BRIEF
`
`
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 2 of 28 PageID #:1871
`
`I.
`
`II.
`
`III.
`
`IV.
`
`TABLE OF CONTENTS
`INTRODUCTION .............................................................................................................. 1
`
`BACKGROUND ................................................................................................................ 2
`
`A.
`
`B.
`
`C.
`
`The Precedex™ Product ......................................................................................... 2
`
`The Patents-in-Suit.................................................................................................. 5
`
`The Claim Construction Issues ............................................................................... 7
`
`LEGAL STANDARD OF CLAIM CONSTRUCTION ..................................................... 8
`
`ARGUMENT ...................................................................................................................... 9
`
`A.
`
`“ready to use” .......................................................................................................... 9
`
`1.
`
`2.
`
`The patentee’s express definition should govern ...................................... 10
`
`Fresenius Kabi’s proposed construction is consistent with
`the use of “ready to use” in the prosecution history ................................. 10
`
`B.
`
`“sealed glass container” ........................................................................................ 13
`
`1.
`
`2.
`
`The specification supports Fresenius Kabi’s construction ........................ 14
`
`Fresenius Kabi’s proposed construction is consistent with
`the prosecution history .............................................................................. 15
`
`C.
`
`“intensive care unit” .............................................................................................. 18
`
`1.
`
`2.
`
`3.
`
`The Court may adopt the previous decision of Judge
`Andrews regarding the construction of the same term ............................. 18
`
`Fresenius Kabi’s proposed construction is supported by the
`intrinsic evidence ...................................................................................... 20
`
`Hospira’s construction relies entirely on unrelated, extrinsic
`evidence .................................................................................................... 20
`
`V.
`
`CONCLUSION ................................................................................................................. 22
`
`
`
`
`
`
`
`ii
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 3 of 28 PageID #:1872
`
`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`Abbott Labs. v. Dey, L.P.,
`110 F. Supp. 2d 667 (N.D. Ill. 2000) ........................................................................................ 19
`
`Atl. Research Mktg. Sys., Inc. v. Troy,
`659 F.3d 1345 (Fed. Cir. 2011)................................................................................................... 8
`
`Chef Am., Inc. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004)................................................................................................. 22
`
`Cybor Corp. v. FAS Techs. Inc.,
`138 F.3d 1448 (Fed. Cir. 1998)................................................................................................. 21
`
`Finisar Corp. v. DirecTV Group, Inc.,
`523 F.3d 1323 (Fed. Cir. 2008)................................................................................................. 19
`
`Hospira, Inc. v. Amneal Pharmaceuticals LLC,
`No. 15-cv-697-RGA (D. Del.) .................................................................................................. 18
`
`Hospira, Inc. v. Eurohealth Int’l SARL,
`No. 14-cv-487-GMS (D. Del.) .................................................................................................... 5
`
`Hospira, Inc. v. Sandoz Int’l GmbH,
`No. 3:09-cv-4591 (D.N.J.) .......................................................................................................... 5
`
`In re Rasmussen,
`650 F.2d 1212 (C.C.P.A. 1981) ................................................................................................ 21
`
`KX Indus., L.P. v. PUR Water Purification Prods., Inc.,
`108 F. Supp. 2d 380, 387 (D. Del. 2000), aff’d, 18 Fed. Appx. 871 (Fed. Cir. 2001) ............. 19
`
`Laitram Corp. v. Cambridge Wire Cloth Co.,
`863 F.2d 855 (Fed. Cir. 1988)................................................................................................... 21
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008)................................................................................................. 22
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ................................................................ 8, 10, 20, 21
`
`Process Control Corp. v. HydReclaim Corp.,
`190 F.3d 1350 (Fed. Cir. 1999)................................................................................................. 22
`
`Tate Access Floors, Inc. v. Interface Architectural Resources, Inc.,
`279 F.3d 1357 (Fed. Cir. 2002)................................................................................................. 14
`iii
`
`
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 4 of 28 PageID #:1873
`
`Texas Instruments, Inc. v. United States Int'l Trade Comm'n,
`805 F.2d 1558 (Fed. Cir. 1986)................................................................................................. 22
`
`Transmatic, Inc. v. Gulton Indus., Inc.,
`53 F.3d 1270 (Fed. Cir. 1995)................................................................................................... 21
`
`V-Formation, Inc. v. Benetton Group SPA,
`401 F.3d 1307 (Fed. Cir. 2005)................................................................................................... 5
`
`Visto Corp. v. Sproqit Techs., Inc.,
`445 F. Supp. 2d 1104 (N.D. Cal. 2006) .................................................................................... 19
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)..................................................................................................... 9
`
`
`
`
`
`
`
`
`
`iv
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 5 of 28 PageID #:1874
`
`Defendant Fresenius Kabi USA, LLC submits this Opening Claim Construction Brief
`
`seeking construction of three terms from U.S. Patent Nos. 8,242,158; 8,338,470; 8,455,527; and
`
`8,648,106 (“the patents-in-suit”) pursuant to the Local Patent Rules and Scheduling Order
`
`entered in this case. (D.I. 19.)
`
`I.
`
`INTRODUCTION
`
`Plaintiff Hospira, Inc. has asserted that Fresenius Kabi’s proposed ANDA products will
`
`infringe claims of four related patents. These four patents are part of the same family, share a
`
`specification, and are generally directed to the same invention: “sealed glass containers”
`
`containing the drug dexmedetomidine at specific concentrations combined with sodium chloride
`
`(saline) solution that are “ready to use” by physicians. One patent, the ’527 patent, is directed to
`
`methods of sedating patients by providing them this same “ready to use” composition, including
`
`one claim to sedating patients in the “intensive care unit.”
`
`Fresenius Kabi has proposed common sense constructions of two key terms — “ready to
`
`use” and “sealed glass container” — that comport with the intrinsic evidence of the patents in
`
`suit. Specifically, a composition is “ready to use” when it does not require any further dilution
`
`before it can be administered to a patient. Fresenius Kabi proposes that a “sealed glass
`
`container” is exactly what it says — a glass container that is closed tightly to prevent unwanted
`
`materials to enter or exit. These common sense constructions are supported by the specification,
`
`claims, and prosecution history of the patents-in-suit.
`
`Hospira disagrees with Fresenius Kabi’s proposed constructions, but has not provided its
`
`own constructions, or even identified exactly why Fresenius Kabi’s constructions differ from the
`
`plain and ordinary meaning of those terms. But Hospira’s contentions in this case, and positions
`
`in the related Delaware litigation indicate that Hospira hopes to introduce extraneous limitations
`
`not supported by the specification or intrinsic record, or to improperly import limitations from
`
`
`
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 6 of 28 PageID #:1875
`
`
`
`the specification. Hospira seeks to add unstated limitations to its claims to save these claims
`
`from prior art that likely renders each invalid, but was not before the Patent Office during
`
`prosecution of the patents-in-suit. Fresenius Kabi requests that the Court follow the principals of
`
`claim construction, and adopt Fresenius Kabi’s constructions of these terms.
`
`Similarly, the third term, “intensive care unit,” has already been construed in the parallel
`
`litigation in Delaware. Hospira is hoping for a second bite at the apple by offering the same
`
`construction and arguments it already lost on before Judge Andrews. Judge Andrews was
`
`correct, and this Court should similarly find that Hospira’s proposed construction lacks support
`
`and is another attempt to read extraneous limitations into claims to avoid prior art.
`
`II. BACKGROUND
`
`A. The Precedex™ Product
`
`The patents-in-suit are not directed to a new compound, a new dosage form, or even a
`
`new formulation. Instead, the patents are directed to the same drug that had already been sold, in
`
`the same formulation, but in a lower concentration. The product is not even considered a new
`
`product by the FDA; it was added as a new strength to the original label. In essence, Hospira
`
`took a product already approved by the FDA and added a strength variation as an improper
`
`attempt to extend its exclusivity. The two central issues in this litigation are: (1) whether
`
`Hospira’s patents addressing this line extension are valid and (2) whether Fresenius Kabi’s
`
`proposed product infringes those patents.
`
`Hospira acquired the Precedex™ drug franchise from others. The active compound,
`
`dexmedetomidine, was created by a Finnish company, Farmos Group, which later became part of
`
`the Orion Corporation. JA-322. Dexmedetomidine is a single enantiomer of medetomidine — a
`
`previously disclosed and marketed drug. JA-2, ’158 patent at 1:21-2 (emphasis added; stating
`
`dexmedetomidine was disclosed in U.S. Patent No. 4,910,214 (“the ‘214 patent)); JA-249
`
`2
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 7 of 28 PageID #:1876
`
`
`
`(Precedex™ Label). In other words, medetomidine is a mixture of two enantiomers: (1) the “d”
`
`or “dex” enantiomer: dex-medetomidine; and (2) the “l” or “levo” enantiomer: levo-
`
`medetomidine. As disclosed in the ’214 patent and discussed in the specifications of the patents-
`
`in-suit, the difference between the two enantiomers is that at one carbon bond, a hydrogen atom
`
`and methyl group (CH3) rotate forward or backwards, as depicted below in the red boxes.1
`
`
`Ex. A, ’214 patent, 1:27-43 (identifying the d- and l- enantiomers medetomidine as Formulae II
`
`and III, respectively) (notations added).2
`
`The dexmedetomidine enantiomer was determined to be responsible for the sedative
`
`effect of medetomidine, and so Orion isolated it, patented it, and sought approval for its use;
`
`
`1 In standard chemistry representations, the solid wedge represents an atom or group that is
`projecting out of the plane of the paper, toward the viewer. Formulae II and III differ because
`the CH3 group and hydrogen atom in the red boxes are rotated around the carbon at the top of the
`figure in different orientations.
`
`2 All exhibits cited are exhibits to the Declaration of Joel M. Wallace in Support of Fresenius
`Kabi USA, LLC’s Opening Claim Construction Brief, filed contemporaneously with this brief.
`
`3
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 8 of 28 PageID #:1877
`
`
`
`Orion also patented the method of using dexmedetomidine for sedation of patients in an intensive
`
`care unit. See JA-2, ’158 patent 1:21-47 (describing prior art dexmedetomidine patents and
`
`disclosed uses).3 Medetomidine was approved by the FDA for use for sedation of animals under
`
`the trade name Domitor® at least as early as August 2007. Ex. B, Domitor® Package Insert.
`
`Orion licensed the rights to sell dexmedetomidine in the United States for human use to
`
`Abbott Laboratories. JA-261 (Label); JA-322 (FDA Review Memo). The FDA approved this
`
`product in 1999 under the trade name Precedex™. JA-249 (Precedex™ 1999 Draft Label); JA-
`
`261. After being spun off, Hospira took over the human medicine franchise from Abbott. Orion
`
`separately licensed the rights to sell a dexmedetomidine product for animal use to Pfizer Animal
`
`Health, which later was spun off and renamed as Zoetis, Inc. The FDA approved veterinary
`
`product is marketed as Dexdomitor®. Ex. I, Dexdomitor Package Insert. The FDA approved
`
`human product was originally marketed by Abbott as Precedex™. JA-261.
`
`The first Precedex™ product, referred to as Precedex™ Concentrate, is still marketed and
`
`sold by Hospira as glass vials containing 100 micrograms (mcg or µg) of dexmedetomidine. The
`
`Precedex™ label, available before the filing of the patents-in-suit, instructs physicians or
`
`pharmacists to dilute the product in 0.9% sodium chloride (saline) solution to achieve a
`
`concentration of 4 mcg/mL prior to administration: “To prepare the infusion, withdraw 2 mL of
`
`Precedex™ and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL.” JA-260
`
`(Precedex™ Label); JA-286–87 (Office Action discussing Precedex™ Label).4
`
`
`3 The patents-in-suit share a specification. Therefore, for terms that are present in multiple
`patents, Fresenius Kabi will provide citations only to the ’158 patent because it was the first filed
`and incorporated by reference into the three later-filed patents.
`
`4 Hospira provided a copy of the Precedex™ label during prosecution of each of the patents-in-
`suit. A copy of the label is included in the prosecution history. E.g., JA-249–261. The same
`label served as the basis of rejections during prosecution. E.g., JA-286. The Precedex™ label is
`therefore part of the intrinsic record. V-Formation, Inc. v. Benetton Group SPA, 401 F.3d 1307,
`
`4
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 9 of 28 PageID #:1878
`
`
`
`After acquiring the Precedex™ franchise, Hospira faced numerous challenges to Orion’s
`
`patents covering (1) the dexmedetomidine compound (U.S. Patent No. 4,910,214) and (2) the
`
`method of using dexmedetomidine to sedate patients (U.S. Patent No. 6,716,867).5 E.g.,
`
`Hospira, Inc. v. Eurohealth Int’l SARL, No. 14-cv-487-GMS (D. Del.); Hospira, Inc. v. Sandoz
`
`Int’l GmbH, No. 3:09-cv-4591 (D.N.J.). Hospira conducted internal meetings regarding its
`
`Precedex™ line extension program, had a market research company conduct focus groups with
`
`physicians and pharmacists, and decided to attempt to extend its line by offering a strength
`
`variation of the original product. Thus, Hospira filed a supplement to the previously approved
`
`Precedex™ NDA seeking to sell vials of dexmedetomidine already diluted to the concentration
`
`specified on the label. This product is now referred to as Precedex™ Premix.
`
`B. The Patents-in-Suit
`
`At the same time Hospira was seeking FDA approval to introduce a strength variation of
`
`its old product, it filed multiple patent applications with the Patent and Trademark Office seeking
`
`to protect the lower concentration product.
`
`The first in the line of the patents-in-suit was filed January 4, 2012. JA-1. This
`
`application ultimately issued as the ’158 patent. Hospira filed a Petition to Make Special to
`
`
`1311 (Fed. Cir. 2005) (“[P]rior art cited in a patent or cited in the prosecution history of the
`patent constitutes intrinsic evidence.”).
`
`5 Importantly, the method of use patent, U.S. Patent No. 6,716,867, is listed in the Orange Book
`as covering the Precedex™ Premix product. This patent was found invalid by Judge Cooper in
`the District of New Jersey. Order & Judgment, Hospira, Inc. v. Sandoz Inc., No. 09-cv-4591, D.I.
`376 (D.N.J. Apr. 30, 2012). But the judgment was vacated after the parties settled while the
`decision was on appeal. Corrected Order & Judgment, Hospira, Inc. v. Sandoz Inc., No. 09-cv-
`4591, D.I. 417 (D.N.J. Mar. 27, 2014) (vacating judgment as to the ’867 patent); Memorandum
`ISO Joint Mtn to Vacate Hospira, Inc. v. Sandoz Inc., No. 09-cv-4591, D.I. 404-1 at 1–2 (D.N.J.
`Dec. 23, 2013) (requesting vacatur because of settlement). Multiple generic versions of
`Precedex™ Concentrate are on the market.
`
`5
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 10 of 28 PageID #:1879
`
`
`
`receive expedited review by the Patent Office. JA-59–60. In exchange, Hospira was required to
`
`conduct a prior art search, identify relevant prior art, and explain why the filed claims were valid
`
`in view of that prior art. See JA-61–132. During prosecution of the ’158 patent, two of the
`
`currently disputed claim terms “ready to use” and “sealed glass container” were added to the
`
`claims in their final form to overcome rejections from the Examiner. JA-298 (amended claims);
`
`JA-300 (discussion of amendments). The Examiner issued a Notice of Allowance for the ’158
`
`patent on April 18, 2012. JA-416–18. The ’158 patent issued on August 14, 2012. JA-1.
`
`Shortly after receiving the Notice of Allowance, Hospira filed its second application on
`
`July 3, 2012. JA-15. The second application was filed as a continuation of the first application,
`
`which had been indicated to be allowable. Hospira again filed a Petition to Make Special. JA-
`
`436–608. The claims submitted as part of the second application incorporated the claim terms
`
`“ready to use” and “sealed glass container” previously determined to distinguish the prior art
`
`during prosecution of the ’158 patent. JA-651. The Examiner rejected these claims as obvious
`
`in view of the prior art. JA-755–68. In response, Hospira did not amend its claims, but
`
`submitted a declaration from Huailiang Wu, Ph.D. offering evidence of secondary
`
`considerations. JA-846–65. The Examiner issued a Notice of Allowance on October 22, 2012.
`
`JA-949–56. The second application issued as the ’470 patent on December 25, 2012.
`
`Again, shortly after receiving the Notice of Allowance for the ’470 patent, Hospira filed
`
`another continuation application, this time directed to methods of using the compositions of the
`
`patents-in-suit for methods of sedation. JA-29. Again, the application included a Petition to
`
`Make Special and incorporated the information from the prosecution of the two previous patents.
`
`JA-985–1076. The Examiner issued a Notice of Allowance on January 11, 2013 without
`
`6
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 11 of 28 PageID #:1880
`
`
`
`additional substantive review of the application. JA-1390–97. The third application issued as
`
`the ’527 patent on June 4, 2013.
`
`The fourth of the patents-in-suit was filed shortly after the Notice of Allowance was
`
`issued for the ’527 patent, on April 22, 2013. Unlike the other applications, the fourth did not
`
`include a Petition to Make Special. Again, the Examiner issued a Notice of Allowance on
`
`October 2, 2013 without further substantive review of the application. JA-1561–64. In fact, the
`
`Examiner explicitly relied on the argument and declaration from the previously issued patents.
`
`JA-1568–69. The fourth application issued as the ’106 patent on February 11, 2014.
`
`Just before the ’106 patent issued, Hospira filed another related patent application on
`
`February 10, 2014. That application issued as U.S. Patent No. 9,320,712 on April 26, 2016.
`
`Ex. C, ’712 pat. Although the ’712 patent shares a specification with and claims the same
`
`products as the four patents-in-suit, Hospira has not listed the patent in the Orange Book and has
`
`not asserted it in litigation. Hospira also has another related patent application, U.S. Application
`
`No. 15/058,602, directed to variations of the claims of the patents-in-suit pending before the
`
`PTO that has been issued a Notice of Allowance, but has not yet issued. Ex. D, ’602 prosecution
`
`excerpts. All claims of the ’712 patent and ’602 application include the disputed terms “ready to
`
`use” and “sealed glass container.” Ex. C at 26:21–49; Ex. D at 14–15 (Listing of the Claims).
`
`C. The Claim Construction Issues
`
`Pursuant to the Local Patent Rules and Scheduling Order entered in this case (D.I. 19),
`
`the parties exchanged proposed constructions on September 6, 2016 and met and conferred on
`
`September 13, 2016 to narrow the issues. During the meet and confer, both parties stated that
`
`they did not intend to provide expert testimony. The parties have agreed to the following
`
`constructions of claim terms from the asserted claims.
`
`7
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 12 of 28 PageID #:1881
`
`
`
`Claim Terms
`“dexmedetomidine”
`
`“subject”
`
`“patient”
`
`Location
`’158 patent: claim 1
`’470 patent: claims 1–4
`’527 patent: claims 1–5
`’106 patent: claims 1–6
`’158 patent: claim 1
`’470 patent: claim 1
`’106 patent: claim 1
`’527 patent: claims 1, 8, 9, 10
`
`“effective amount”
`
`’527 patent: claim 1
`
`Agreed Construction
`“substantially pure, optically active
`dextrorotary stereoisomer of
`medetomidine, as the free base or
`pharmaceutically acceptable salt”
`“a human, a non-human mammal or
`a non-human animal”
`
`“a human, a non-human mammal or
`a non-human animal”
`“amount sufficient to produce the
`desired effect”
`
`The Parties request that the Court adopt the agreed constructions of these terms.
`
`The parties were unable to reach agreement regarding the terms “ready to use,” “sealed
`
`glass container,” and “intensive care unit.” Fresenius Kabi requests that the Court adopt its
`
`proposed constructions of these terms.
`
`III. LEGAL STANDARD OF CLAIM CONSTRUCTION
`
`As the Federal Circuit clarified in Phillips, the court begins its claim construction analysis
`
`with the words of the claims themselves, giving those words their ordinary and customary meaning
`
`“in the context of the entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d
`
`1303, 1312-13 (Fed. Cir. 2005) (en banc). The Federal Circuit has long held that the specification
`
`is usually “dispositive” and the “single best guide” to the meaning of claim terms in dispute. Id.
`
`at 1314-15. Differences in language between different claims in a patent should not be ignored,
`
`particularly where those differences relate to critical features. Atl. Research Mktg. Sys., Inc. v.
`
`Troy, 659 F.3d 1345, 1354-55 (Fed. Cir. 2011). The patent prosecution is also helpful evidence
`
`of how both the inventor and the Patent and Trademark Office understood the patent. Phillips, 415
`
`F.3d at 1317. Extrinsic evidence, like expert declarations or references, are less useful because
`
`they are not contemporaneous and are even “improper” where “analysis of the intrinsic evidence
`
`8
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 13 of 28 PageID #:1882
`
`
`
`alone will resolve any ambiguity in a disputed claim term.” Vitronics Corp. v. Conceptronic, Inc.,
`
`90 F.3d 1576, 1583 (Fed. Cir. 1996).
`
`IV. ARGUMENT
`
`The parties dispute the construction of three terms, “ready to use,” “sealed glass
`
`container,” and “intensive care unit.” Fresenius Kabi respectfully requests that the Court adopt
`
`its constructions of these terms. Fresenius Kabi’s constructions are the plain and ordinary
`
`meanings of the terms as evidenced by the intrinsic record. Each of Hospira’s proposals, to the
`
`extent they can be inferred, seek to improperly add limitations to the claims in an attempt to
`
`avoid prior art. Such efforts are improper as a matter of law.
`
`A. “ready to use”
`
`Term
`
`“ready to use”
`
`Fresenius Kabi’s
`Proposed Construction
`“suitable for administration
`to a patient without
`requiring dilution”
`
`Hospira’s
`Proposed Construction
`No construction necessary.
`
`The term “ready to use” is present in each of the asserted claims. Each asserted claim
`
`either expressly includes this term, or depends from a claim that expressly includes the term.
`
`Resolution of the meaning of this term, therefore, fundamentally affects the disputes between the
`
`parties, especially as it relates to invalidity of the patents-in-suit.6
`
`
`6 Hospira states that it disagrees with Fresenius Kabi’s proposed construction. Although asked, it
`has refused to provide Fresenius Kabi with a proposed construction of its own. Instead, Hospira
`has stated that: “After receiving Fresenius Kabi’s Opening Brief, Hospira can, in its Responsive
`Brief, respond to Fresenius Kabi’s position and explain the terms’ plain meaning, to which
`Fresenius Kabi may then respond in its Reply Brief.” Ex. E, Wallace Email to Esat at 2. The
`parties engaged in further meet and confer on October 3, 3016. Hospira reiterated that it did not
`feel it necessary to provide Fresenius Kabi with its proposed constructions.
`
`9
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 14 of 28 PageID #:1883
`
`
`
`1.
`
`The patentee’s express definition should govern
`
`Fresenius Kabi’s proposed construction of “ready to use” is taken directly from the
`
`specification:
`
`In certain embodiments, the compositions of the present invention can be
`formulated as “ready to use” compositions which refer to premixed compositions
`that are suitable for administration to a patient without dilution. For example, in
`certain embodiments, the compositions of the present invention are “ready to use”
`upon removing the compositions from a sealed container or vessel.
`
`JA-2, ’158 patent 2:56-62 (emphasis added). Fresenius Kabi’s construction is appropriate
`
`because it is expressly found in the section of the specification entitled “Definitions” and the
`
`proposed construction is identical to the expressly recited definition of the claim term. A
`
`patentee is free to be her own lexicographer and define terms so that the world is on notice as to
`
`exactly how the term is used in that patent. Phillips, 415 F.3d at 1316 (“Consistent with that
`
`general principle, our cases recognize that the specification may reveal a special definition given
`
`to a claim term by the patentee that differs from the meaning it would otherwise possess. In such
`
`cases, the inventor’s lexicography governs.”). Here, by including a “Definitions” section and
`
`providing their own constructions, the inventors invoked the right to act as a lexicographer and
`
`not rely on the plain and ordinary meaning of these specific terms in the patent. By invoking that
`
`right, the inventors, and now Hospira as the assignee, are bound by those definitions. See id.
`
`2.
`
`Fresenius Kabi’s proposed construction is consistent with the use of “ready
`to use” in the prosecution history
`
`The term and concept of “ready to use” was discussed during the prosecution history of
`
`the ’158 patent. In each instance, the term “ready to use” is used in a manner consistent with
`
`Fresenius Kabi’s proposal of “suitable for administration to a patient without requiring dilution.”
`
`As described in detail below, the prosecution history is intrinsic evidence to establish the
`
`construction of a claim term. Phillips, 415 F.3d at 1317 (“Nonetheless, the prosecution history
`
`10
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 15 of 28 PageID #:1884
`
`
`
`can often inform the meaning of the claim language by demonstrating how the inventor
`
`understood the invention and whether the inventor limited the invention in the course of
`
`prosecution, making the claim scope narrower than it would otherwise be.”). Notably, the
`
`originally filed claims for the ’158 patent did not include any reference to a “ready to use”
`
`composition. Independent claim 1 of the original application is reproduced below:
`
`1. A pharmaceutical composition comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of about 4 µg/mL,
`wherein the composition is formulated as a liquid for parenteral administration to
`a subject, and wherein the composition is disposed within a sealed container as a
`premixture.
`
`JA-175 (Claims). This claim and the three other dependent claims were rejected by the
`
`Examiner in view of the Precedex™ Concentrate label (referred to by the Examiner as the “Draft
`
`Labeling”). JA-283–89.
`
`In response, Hospira conducted an interview with the Examiner (JA-295), and then
`
`amended the claim to add the “ready to use” language.
`
`1. (Currently amended) A pharmaceutical composition comprising
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration
`of about 4 µg/mL, wherein the composition is formulated as a liquid for
`parenteral administration to a subject, and wherein the composition is disposed
`within a sealed glass container as a ready to use premixture.
`
`JA-298.7
`
`Hospira explained the purpose of its amendment in its Remarks accompanying the
`
`amendment. Hospira specifically attempted to distinguish the Precedex™ Concentrate Draft
`
`Labeling by referring to the “ready to use” claim limitation:
`
`Additionally, Applicants note that a primary difference between the claimed 4
`μg/mL premixture composition and the 4 μg/mL diluted composition described by
`the Draft Labeling, is that the claimed composition is a ready to use premixture
`
`7 The underlining is in the original and indicates additions over the previously submitted claims.
`Deletions to previously submitted claims, when present, are indicated in brackets.
`
`11
`
`

`

`Case: 1:16-cv-00651 Document #: 43 Filed: 10/11/16 Page 16 of 28 PageID #:1885
`
`
`
`that does not require any dilution or reconstitution prior to administration to a
`subject. (See the specification, p. 5, paras. [0024][0025]). Accordingly, upon
`withdrawing the claimed composition from a sealed glass container, an artisan
`of ordinary skill can administer the composition directly to a subject. In contrast,
`the composition described by the Draft Labeling is not suitable for administering
`to a patient upon withdrawing the composition from a sealed container (i.e., a 2
`mL vial or ampoule which the concentrated 100 μg/mL formulation is stored in,
`see the Draft Labeling, p. 13). Rather, after withdrawing the concentrated 100
`μg/mL composition from a sealed container, the composition must be diluted
`prior to administration to a subject.
`
`JA-303 (Remarks at 7 (Mar. 13, 2012)) (emphasis added). According to the applicants, the
`
`critical distinction between the “claimed composition” and the Draft Labeling according to
`
`Hospira during prosecution of the ’156 patent is whether the “claimed composition” requires
`
`further dilution before administration, i.e. “suitable for administration to a patient without
`
`requiring dilution.” No other meaning of “ready to use” is provided in the Remarks.
`
`Notably, the Remarks also include a summary of the interview between the Examiner and
`
`Hospira. Hospira specifically notes again that the distinction between the cited prior art (the
`
`Precedex™ Concentrate Draft Labeling) and the pending claims is the ability to administer the
`
`composition without further dilution.
`
`Although no consensus was reached, Applicants noted that the claims are directed
`to a composition comprising 4 μg/mL dexmedetomidine that is a premixture,
`which does not require dilution prior to administration to a subject. The claimed
`composition differs from the formulation described by the cited reference, which
`requires dilution to a concentration of 4 μg/mL dexmedetomidine prior to
`administration to a patient. As such, Applicants maintained that unlike the
`claimed composition, the formulation