Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 1 of 17 PageID #:2368
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`) No. 16 C 651
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`) Judge Rebecca R. Pallmeyer
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`HOSPIRA, INC.,
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`Plaintiff,
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`v.
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`FRESENIUS KABI USA, LLC,
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`Defendants.
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`MEMORANDUM OPINION AND ORDER
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`Plaintiff Hospira, Inc., a Delaware corporation with its primary place of business in
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`Illinois, manufactures pharmaceuticals and medical supplies. At issue in this case is a chemical
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`compound known as dexmedetomidine, which Hospira sells to health care providers under the
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`brand name Precedex. Between 2012 and 2014, Hospira obtained four patents covering a new
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`product made from dexmedetomidine: U.S. Patent Nos. 8,242,158 (the “ ‘158 Patent”),
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`8,338,470 (the “ ‘470 Patent”), 8,455,527 (the “ ‘527 Patent”), and 8,648,106 (the “ ‘106 Patent”).
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`(Complaint [1] (“Pl.’s Compl.”), 3.)
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`Defendant Fresenius Kabi USA, LLC, is an American subsidiary of a German
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`pharmaceutical manufacturer which is also registered in Delaware and headquartered in Illinois.
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`On December 4, 2015, Fresenius Kabi notified Hospira that it had filed an abbreviated new drug
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`application (“ANDA”) with
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`the FDA, seeking approval
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`to market
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`its own proposed
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`dexmedetomidine products prior to the expiry of Hospira’s patents. (Answer to Complaint,
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`Affirmative Defenses, and Counterclaims [10] (“Def.’s Answer”), ¶ 16.) Hospira filed suit a
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`month later, alleging patent infringement. (Pl.’s Compl. 8–9.) Fresenius Kabi has denied the
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`allegations and counterclaimed for a declaration that the four patents at issue are invalid or,
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`alternatively, that Fresenius Kabi’s actions will not infringe. (Def.’s Answer 22.)
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`The parties have presented competing interpretations of two terms common to all four
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`patents-in-suit, and of one term unique to the ‘527 Patent. The court’s construction of those
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`terms follows.
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 2 of 17 PageID #:2369
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`The Patented Invention
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`BACKGROUND
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`Dexmedetomidine is a chemical compound known as an alpha2-adrenergic agonist.
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`A.
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`(‘158 Patent, JA-2, col. 1 ll. 21–24.) In layman’s terms, this means it stimulates certain
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`receptors in the central nervous system to produce a desired effect. U.S. National Library of
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`Medicine, Adrenergic Agonists, Medicinal Subject Headings 2018 (last visited Nov. 27, 2017),
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`https://meshb-prev.nlm.nih.gov/record/ui?ui=D000322. Dexmedetomidine is used primarily as a
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`sedative, though it is also used to treat pain, anxiety, and high blood pressure. (‘158 Patent, JA-
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`2, col. 1 ll. 21–24.) The compound was originally isolated and patented in 1990 by a Finnish
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`corporation, which later licensed the sales rights to Hospira’s predecessor organization, Abbott
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`Laboratories. (Fresenius Kabi USA, LLC’s Opening Claim Construction Brief [43] (“Def.’s
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`Opening Br.”), 2, 4.) Plaintiff Hospira has sold dexmedetomidine-based medications under the
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`Precedex trade name since 1999. (Hospira’s Responsive Claim Construction Brief [47] (“Pl.’s
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`Resp. Br.”), 1.)
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`The original Precedex product, known as Precedex Concentrate, is sold in 2-mL glass
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`vials containing a concentration of 100 micrograms per milliliter (µg/mL) of dexmedetomidine.
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`(Id.) This concentration is too strong to administer directly to patients. Accordingly, hospital
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`personnel are required to dilute Precedex Concentrate with a 0.9% sodium chloride solution to a
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`reach a concentration of just 4 µg/mL before injecting patients with the medication. (Id. at 2; JA-
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`260 (“Precedex Concentrate Label”).) In addition, once diluted, the prepared dexmedetomidine
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`solution must be used within 24 hours for maximum potency. (Id.)
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`As Hospira notes,
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`this extra dilution step has obvious drawbacks,
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`including
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`inconvenience, added cost, and
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`increased safety concerns
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`resulting
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`from possible
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`contamination or overdose. (Id.) To address these concerns, Hospira developed a new, pre-
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`diluted dexmedetomidine formulation, which it calls Precedex Premix. (Id. at 3.) It is for this
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`invention that Hospira filed for and obtained the patents at issue in this case.
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`2
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 3 of 17 PageID #:2370
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`Hospira summarized its invention as “premixed pharmaceutical compositions of
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`dexmedetomidine, or a pharmaceutically acceptable salt thereof, that are formulated for
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`administration to a patient, without the need to reconstitute or dilute the composition prior to
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`administration.” (‘158 Patent, JA-2, col. 1 ll. 61–65.) While surmounting the shortcomings of its
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`original, concentrated formulation, Hospira faced several challenges in developing Precedex
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`Premix: namely, the need to ensure that the product remained stable and potent over a much
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`longer shelf-life. (Pl.’s Resp. Br. 2–3.) After conducting trials with modified chemical formulas,
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`Hospira identified the packaging as the solution to its problems. (Id.) Specifically, Hospira
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`asserts, it “discovered that glass packaging exhibited superior stability relative to other
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`packaging materials” such as plastic infusion bags or pre-filled syringes. (Id.; ‘158 Patent, JA-8,
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`col. 13 ll. 22–67.) Hospira found further that “developing a sealed system” could ensure shelf-
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`life stability and product sterility. (Pl.’s Resp. Br. 3.) On this front, Hospira “tested several
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`closure systems for integrity without success before finding a stopper that was compatible with
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`the glass container[.]” (Id.)
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`The ‘158, ‘470, and ‘106 Patents all cover the same basic subject matter—the
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`medication itself—and share a title: “Dexmedetomidine Premix Formulation.” (See, e.g., ‘158
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`Patent, JA-1.)
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` The
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`final,
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`‘527 Patent addresses “Methods of Treatment using a
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`Dexmedetomidine Premix Formulation.” (‘527 Patent, JA-29.) All the patents share a common
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`specification. The core of the invention, Hospira states, is “a ‘ready to use’ dexmedetomidine
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`formulation in a ‘sealed glass container.’” (Pl.’s Resp. Br. 3.)
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`3
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 4 of 17 PageID #:2371
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`B.
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`The Disputed Claim Terms
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`The parties contest three claim terms: “ready to use,” “sealed glass container,” and
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`“intensive care unit.” The first two of these terms are present in every asserted claim throughout
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`all four patents, while the third relates to just one claim in the ‘527 Patent.
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`The ‘158 Patent is representative of the manner in which the terms “ready to use” and
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`“sealed glass container” are used in all four patents.1 It claims:
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`1.
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`2.
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`3.
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`4.
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`A ready to use liquid pharmaceutical composition for parenteral
`administration
`to a subject, comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of about 4
`μg/mL disposed within a sealed glass container.
`The ready to use liquid pharmaceutical composition of claim 1, further
`comprising sodium chloride at a concentration of between about 0.01 and
`about 2.0 weight percent.
`The ready to use liquid pharmaceutical composition of claim 2, wherein
`the sodium chloride is present at a concentration of about 0.9 weight
`percent.
`The ready to use liquid pharmaceutical composition of claim 1, wherein
`the composition is formulated as a total volume selected from the group
`consisting of 20 mL, 50 mL and 100 mL.
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`(‘158 Patent, JA-14, col. 26 ll. 4–18) (emphasis added).
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`The ‘527 Method Patent contains 15 claims covering various concentrations, delivery
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`methods, and settings
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`in which
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`the premixed dexmedetomidine
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`formulation may be
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`administered. (‘527 Patent, JA-42, col. 25 l. 24–col. 26 l. 31.) Claim 8 contains the disputed
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`A method of providing sedation to a patient in need thereof, the method
`comprising administering to the patient an effective amount of a
`composition, wherein the composition comprises dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of about
`0.005 to about 50 μg/mL, wherein the composition is a ready to use liquid
`pharmaceutical composition for parenteral administration to the patient
`disposed within a sealed glass container.
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`term:
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`1.
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` . .
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` .
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`8.
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`The method of claim 1, wherein the composition is administered to the
`patient in an intensive care unit.
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`1
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`The parties agree on this point, and cite to the first-filed ‘158 Patent in the Joint
`Appendix when discussing these two terms throughout their briefs. (See Def.’s Opening Br. 4
`n.3.)
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`4
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`(Id. at col. 25 ll. 25–32, col. 26 ll. 16–17) (emphasis added).
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`C.
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`Prosecution History
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`The inventors filed the four patent applications between January 4, 2012, and April 22,
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`2013. (‘158 Patent, JA-1; ‘106 Patent, JA-43.) The Patent Office issued the patents between
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`August 14, 2012, and February 11, 2014, in the order in which they were filed. (Id.) The
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`prosecution history of the first-filed ‘158 Patent reflects the history of the family of patents as a
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`whole.
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`In the original application, the independent claim of the ‘158 Patent read:
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`1.
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`A pharmaceutical composition comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of about 4
`μg/mL, wherein the composition is formulated as a liquid for parenteral
`administration to a subject, and wherein the composition is disposed with
`a sealed container as a premixture.
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`(JA-175.) The phrase “ready to use” and word “glass” to describe the sealed container were not
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`yet present. The Patent Office rejected all four claims as anticipated or made obvious by the
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`prior art: in this case, the label that appears on the Precedex Concentrate product. (Id. at 286.)
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`The examiner’s comments explained that the Precedex Concentrate label “teaches that the
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`dexmedetomidine HCL formulation must be diluted in 0.9% sodium chloride solution prior to
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`administration” and “provides instructions for dilution.” (Id.) (emphasis in original). Notably, the
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`label disclosed that Precedex Concentrate was sold in “clear glass vials and . . . ampules.” (Id.
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`at 261.) The examiner further stated in regards to the claimed “sealed container” that, given the
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`choice between diluting the solution in a sealed versus unsealed container, “[t]he artisan would
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`clearly immediately envisage the mixing of the formulation in a sealed container in order to
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`maintain the sterility of the composition for parenteral administration.” (Id. at 287.)
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`In response, the inventors amended the claim to read “wherein the composition is
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`disposed within a sealed glass container as a ready to use premixture.” (JA-298) (emphasis in
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`original). In support of these amendments, the record states:
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`5
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`[Hospira] noted that the claims are directed to a composition comprising 4 µg/mL
`dexmedetomidine that is a premixture, which does not require dilution prior to
`administration to a subject. The claimed composition differs from the formulation
`described by the cited reference, which requires dilution to a concentration of 4
`µg/mL dexmedetomidine prior to administration to a patient. As such, [Hospira]
`maintained that unlike the claimed composition, the formulation disclosed by the
`cited reference is not a ready to use premixture.
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`(Id. at 299.) As for the modification of “sealed container” to “sealed glass container,” Hospira
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`successfully argued that the prior art did not meet the legal standard for inherent anticipation
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`because the examiner’s conclusion was based on the “mere probability that the skilled artisan
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`would prepare the dilution in a sealed glass container and not in an unsealed container” made
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`of another substance. (Id. at 301–02.) Anticipation “may not be established by probabilities or
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`possibilities,” (Id. at 301 (citing In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)), and
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`Hospira distinguished Precedex Premix as being “necessarily disposed with a sealed glass
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`container.” (Id. at 302) (emphasis in original).
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`Hospira further argued that a “sealed glass container” was not obvious in the light of the
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`prior art because a skilled artisan would likely prepare a solution for intravenous delivery to a
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`patient in a plastic infusion bag rather than a sealed glass container. (Id. at 303.) While
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`Precedex Concentrate was sold in glass vials, it was not diluted in those same containers.
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`Hospira also presented evidence that distributing Precedex Premix in sealed glass containers
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`exhibited superior potency over a longer shelf life than alternative vessels. (Id.) The PTO
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`accepted these arguments as “effective to overcome the previous rejection” for inherent
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`anticipation and obviousness. (JA-421.)
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`The ‘158 Patent reached its final form on March 30, 2012, through an amendment
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`requested by the examiner and authorized by the inventors. (Id. at 420.) The amendment
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`maintained the inventors’ addition of “ready to use” and “glass” to the claims, but rearranged the
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`sentence for grammar and syntax to read:
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`1.
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`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.
`6
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`(Id.; ‘158 Patent, JA-14, col. 26 ll. 4–8.) The remaining patents underwent a similar process of
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`rejection and modification before being approved by the PTO. (See, e.g., JA-757–66; JA-843–
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`65) (discussing the term “sealed glass container” in the context of the ‘470 Patent).
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`Legal Standards Governing Claim Construction
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`DISCUSSION
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`The claims of a patent define the scope of the invention to which the patentee may
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`A.
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`exercise his right of exclusivity. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005).
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`Where a claim’s meaning is disputed, the court must determine its proper construction as a
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`matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 391 (1996). Claim
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`construction is an objective exercise, and courts should generally give claim terms the ordinary
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`and customary meaning they would have “to a person of ordinary skill in the art at the time of
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`the invention.” Phillips, 415 F.3d at 1313. Claim construction often “involves little more than the
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`application of the widely accepted meaning of commonly understood words.” Id. at 1314 (“In
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`such circumstances, general purpose dictionaries may be helpful.”). Importantly, however,
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`judges must always read claims “in the context of the entire patent.” Id. at 1313.
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`The Federal Circuit instructed in Phillips that if the meaning of a disputed claim term is
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`not readily apparent, the court should first turn to sources of evidence intrinsic to the patent. 415
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`F.3d at 1314–19. Foremost among these intrinsic sources is the patent’s specification, which
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`must include a “full, clear, concise, and exact” description of the claimed invention as the
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`inventor saw it. Id. at 1316 (quoting 35 U.S.C. § 112). If the specification defines or gives
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`consistent meaning to certain terms, “the inventor’s lexicography governs.” Id. The same rule
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`applies if an inventor explicitly limits the scope of a term in the specification. Id. If the
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`specification merely provides examples or preferred embodiments of an invention, however,
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`Phillips warns courts not to confine the patent’s claims to those embodiments. Id. at 1323; see
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`also Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, 1136 (Fed. Cir. 2011)
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`(declining to limit a claim “where the references to a certain limitation as being the ‘invention’ are
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`not uniform, or where other portions of the intrinsic evidence do not support applying the
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`limitation to the entire patent.”).
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`In addition to the specification, the court may look to the patent’s prosecution history as
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`further evidence of how the inventor and the Patent Office understood the invention. Id. at
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`1317. The court must be mindful, however, that the prosecution history represents an ongoing
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`discussion, and may be less clear than the specification “and thus less useful for claim
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`construction purposes.” Id. Finally, while consulting the intrinsic evidence will resolve
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`ambiguities in most situations, courts must sometimes go beyond the contents of the patent
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`itself and consider extrinsic evidence—such as technical dictionaries, treatises, or expert
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`testimony—to aid in claim construction. Id. Though the Federal Circuit in Phillips outlined
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`several reasons why extrinsic evidence is less reliable than intrinsic evidence, it declined to
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`exclude such evidence provided it is not used to contradict claim language made clear by
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`intrinsic evidence. Id. at 1318–19, 1324; see also Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
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`1576, 1582 (Fed. Cir. 1996).
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`With these standards of construction in mind, the court turns to the disputed claim
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`language.
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`B.
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`“ready to use” (all asserted claims)
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`Claim Term
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`Plaintiff Hospira’s Proposed
`Construction
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`Defendant Fresenius Kabi’s
`Proposed Construction
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`“suitable for administration to a
`patient without requiring
`dilution”
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`“ready to use”
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`“formulated to be suitable for administration
`to a patient upon manufacture without
`dilution or reconstitution”
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`The ‘158 Patent defines the term “ready to use” as an embodiment of the invention
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`“formulated as ‘ready to use’ compositions which refer to premixed compositions that are
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`suitable for administration to a patient without dilution.” (‘158 Patent, JA-3, col. 3 ll. 57–59.)
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`The specification previously defines a “premix” or “premixture” as “a pharmaceutical formulation
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`that does not require reconstitution or dilution prior to administration to a patient.” (Id. at ll. 48–
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`8
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`50.) Such compositions, the specification continues, do not require dilution by “a clinician,
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`hospital personnel, caretaker, patient, or any other individual.” (Id. at ll. 53–55.) Here, the
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`inventor has clearly acted as his own lexicographer. See Philips, 415 F.3d at 1316. As such,
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`Hospira’s proposed construction more accurately describes the scope of the term “ready to
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`use.”
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`Fresenius Kabi contends that its proposed construction appropriately describes the
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`“distinguishing characteristic” of “ready to use”—namely, “the ability to administer the
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`compositions without further dilution.” (Def.’s Opening Br. 13.) That construction, however,
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`relies on an incomplete quotation of the patent’s definition and cuts out the phrases “formulated
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` and “premixed compositions.” Viewing the term “ready to use” in the light of the patent’s
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`complete definition confirms that the term should be read as “ready to use” in its original formula
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`or design, not merely “ready to use” whenever no further dilution step is required. See also
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`Formula, Formulate, MERRIAM-WEBSTER COLLEGIATE DICTIONARY (10th ed. 1997). Fresenius
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`Kabi contends that relying on the term “premixed” to define “ready to use” is improper; as the
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`terms are not used interchangeably, Fresenius Kabi insists they must mean different things.
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`(Fresenius Kabi USA, LLC’s Reply Claim Construction Brief [60] (“Def.’s Reply Br.”), 5–6) (citing
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`Nystrom v. TREX Co., 424 F.3d 1136, 1143 (Fed. Cir. 2005)). But “ready to use” compositions
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`can fairly be understood to be a subset of “premixed” compositions—which the specification
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`clearly states are “formulations” that do not require dilution by anyone, at any time. (‘158
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`Patent, JA-3, col. 3 ll. 49–55.) A “ready to use” composition must thus also be “premixed” and
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`incorporate any additional meaning the parent term bears.
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`The most straightforward reading of the term necessarily implies that the composition is
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`“ready to use” from the moment it leaves Hospira’s possession. Fresenius Kabi contends this is
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`an improper “attempt to impute a temporal limitation” onto the term. (Def.’s Reply Br. 3.)
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`Assuming such a temporal limitation is appropriate at all, Fresenius Kabi asserts, the temporal
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`limitation on “ready to use” more appropriately dates to the moment the dexmedetomidine is
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`9
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 10 of 17 PageID #:2377
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`removed from the sealed glass container, not to “the specific point of manufacture.” (Id. at 4.)
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`Thus, “the focus is not on whether the composition had ever been diluted, but whether it
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`requires a dilution step before administration.” (Def.’s Opening Br. 13.) The court disagrees.
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`The Defendant’s definition is overbroad, and would cover any dexmedetomidine formulation that
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`had been diluted at any point in the past. (Pl.’s Resp. Br. 7.) The specification does not support
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`such a reading.
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`Fresenius Kabi cites to the prosecution history to bolster its reading, highlighting
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`passages where Hospira distinguished the Precedex Concentrate prior art as “[u]nlike the
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`claimed composition that is formulated at a concentration which is ready for administration to a
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`patient upon removal from the sealed glass container.” (Def.’s Opening Br. 13) (quoting JA-97–
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`98) (emphasis in original). In this passage again, however, Fresenius Kabi’s proposed
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`construction ignores all language stressing that the medication is “formulated” as such.
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`Throughout the patents-in-suit, the inventors stress that the core distinction between Precedex
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`Concentrate and Precedex Premix is that the formulas are different. Any person of ordinary skill
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`in the art (“POSITA”) would have to incorporate that distinction in understanding the patents’
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`scope.
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`Fresenius Kabi also asserts that Hospira is impermissibly trying to “convert its
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`composition claims into product-by-process or method claims.” (Def.’s Reply Br. 2) (citing
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`Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2001)). As
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`Fresenius Kabi reads Hospira’s proposed claim construction, Hospira is attempting to redefine
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`its claims to cover “how a composition is made” rather than “what the composition is.” (Id.)
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`Again, the court disagrees: recognizing the necessary temporal limitations that define the
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`claimed product is not the same as imposing process restrictions on the claims. Fresenius
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`Kabi’s position suggests that any “do-it-yourself” product can be transformed into a “ready to
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`use” product after the customer has put it together on his own. This is an untenable conclusion.
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`If a consumer buys a flat-pack bookcase at IKEA, it will never be a “pre-built” bookcase. Some
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`10
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 11 of 17 PageID #:2378
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`assembly—even if not done by the consumer himself—will always be required. A bookcase,
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`like a premixed dexmedetomidine formulation, is either “ready to use” from the outset, or not at
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`all. Any POSITA handling a product described as “ready to use” would recognize that it requires
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`no further manipulation by anyone. Fresenius Kabi itself recognized as much when it stated
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`“[t]he appropriate question for infringement is whether the accused infringer sells a product that
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`does not require further dilution.” (Def.’s Reply Br. 4.)
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`Hospira is correct that “ready to use” includes a temporal component, but this court
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`nevertheless declines to adopt Hospira’s construction wholesale. The record bears no support
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`for Hospira’s attempt to insert the term “upon manufacture.” The specification’s summary
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`section states that “[t]he present invention relates to premixed pharmaceutical compositions of
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`dexmedetomidine, or a pharmaceutically acceptable salt thereof, that are formulated for
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`administration to a patient, without the need to reconstitute or dilute.” (‘158 Patent, JA-2, col. 1
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`ll. 61–64.) As stated above, the definitions section describes “ready to use” compositions in the
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`same manner: calling them “formulations” and “premixed compositions” may imply that the
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`compositions are ready for use “upon manufacture,” but such a phrase is not part of the claim.
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`(Id. at col. 3 ll. 57–59.)
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`Indeed, the parties’ efforts to draw a line between the moment of manufacture and the
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`moment of dispensing may well be academic: if the glass container is “sealed,” the contents of
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`that container are likely “ready to use” when the seal is placed during manufacturing. The
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`patents-in-suit do not anticipate any additional intermediate steps between making and bottling
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`the premixed dexmedetomidine. In most cases, therefore, the parties’ constructions overlap.
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`To the extent Defendant suggests that the dexmedetomidine composition may be diluted by
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`anyone else at some point before administration, the court rejects that construction. Likewise,
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`pinpointing the precise moment of readiness to be “upon manufacturing” is unnecessary and
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`overly specific. That is simply not what the claims refer to.
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 12 of 17 PageID #:2379
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`Accordingly, this court adopts the following construction: “formulated to be suitable for
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`administration to a patient without dilution or reconstitution.”
`
`C.
`
`“sealed glass container” (all asserted claims)
`
`Claim Term
`
`Plaintiff Hospira’s Proposed
`Construction
`
`“sealed glass
`container”
`
`“glass container closed to maintain the
`sterility by having a seal or another closure
`that passes closure integrity testing”
`
`
`Defendant Fresenius Kabi’s
`Proposed Construction
`
`“closed tightly to prevent
`unwanted materials entering or
`exiting the glass container”
`
`
`
`
`The parties do not dispute the meanings of “glass” or “container.” Instead, they propose
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`different interpretations of what it means for a glass container to be “sealed.” Notably, the
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`specification does not define the term “sealed glass container.” The only detailed reference to
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`the subject matter states:
`
`In certain non-limiting embodiments, the premixed 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.
`
`
`(‘158 Patent, JA-6, col. 9 ll. 1–7.) In addition, the specification details at length the process by
`
`which Hospira developed the “sealed glass container” by experimenting with different container
`
`types and closures.
`
`
`
`Hospira seeks to supplant the common-place meaning of “sealed” with a lengthy set of
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`standards referencing the need to maintain sterility and pass FDA-recommended closure-
`
`integrity tests. (Pl.’s Resp. Br. 8–9.) This level of detail is unnecessary. For one, whether a
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`container is “sterile” is a separate question from whether it is “sealed.” It is just as possible for a
`
`sealed container to be keeping contaminants in rather than out. The specification clarifies that a
`
`sterile container and a sealed container are not used interchangeably. (See ‘158 Patent, JA-6,
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`col. 9 ll. 1–7) (describing a sterile container and a sealed container as separate non-limiting
`
`embodiments of the invention). Furthermore, maintaining sterility is not the only purpose of
`
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 13 of 17 PageID #:2380
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`sealing the container—Example 6 describes additional aims of potency and stability. (‘158
`
`Patent, JA-12, col. 21 ll. 18–44.) The specification does not suggest that one of these goals
`
`must be elevated to define the term “sealed” while the others should not. Finally, inserting the
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`phrase “to maintain the sterility”—or any other language suggesting the purpose of the seal—
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`would be redundant. The act of sealing a container already implies that the contents will remain
`
`untouched until the seal is broken. The additional language Hospira proposes adds nothing to a
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`POSITA’s ability to understand the commonplace word “sealed.”
`
`
`
`The latter half of Hospira’s proposed construction, “by having a seal or another closure
`
`that passes closure integrity testing,” is similarly unsupported by the specification. Hospira
`
`criticizes Fresenius Kabi’s construction as “raising more questions than it answers,” but in
`
`advocating for this court to incorporate the entire body of FDA closure integrity standards by
`
`reference, Hospira is guilty of the same transgression. (Pl.’s Resp. Br. 9.) As noted by
`
`Fresenius Kabi: “[a]dding all the extra terminology that Hospira asks to add would mean not only
`
`collecting material wholesale from third party extrinsic sources, but then would require another
`
`round of claim construction briefing to understand what that new terminology would actually
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`require.” (Def.’s Reply Br. 7.) While Hospira may prefer the incorporation of its preferred
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`embodiment—a glass container sealed using a “Helvoet FM 259/0 OmniflexPlus fluoropolymer
`
`coated stopper”—the specification cannot be read to mean that such a stopper is the only
`
`means of sealing the glass container. (See ‘158 Patent, JA-12, col. 21 ll. 1–2.) Nor was that
`
`the view of the named inventor or of Hospira’s own corporate witness, both of whom confirmed
`
`that “a sealed glass container refers to a container that is closed sufficiently [ ] to maintain the
`
`integrity of the . . . solution inside the glass bottle.” (Dep. of Robert Cedergren, Ex. 1 to Def.’s
`
`Reply Br., 194:3–7; Dep. of Rao Tata-Venkata, Ex. 2 to Def.’s Reply Br., 41:9–12.) Hospira’s
`
`corporate witness, Dr. Rao Tata-Venkata, went further; he pointed out that “‘sealed’ is a very
`
`general term,” and observed that, in his experience, “sealed” means “closed with a closure.”
`
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`Case: 1:16-cv-00651 Document #: 69 Filed: 11/27/17 Page 14 of 17 PageID #:2381
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`(Dep. of Rao Tata-Venkata 41:2–8.) This intrinsic evidence, and the use of the general term
`
`“sealed,” signals that the patents’ claims were intended to sweep broadly.
`
`
`
`Fresenius Kabi’s proposed construction is closer to the mark, but is arguably too
`
`imprecise. This court agrees with Plaintiff Hospira that “sealed” means something beyond
`
`“covered” or “closed,” and even beyond the Defendant’s proposed meaning “closed tightly.”
`
`(Pl.’s Resp. Br. 9) (emphasis added). In common usage, the Defendant’s proposal is not
`
`incorrect, but in the context of a prescription drug patent a POSITA would read the word
`
`“sealed” to suggest something more secure and permanent than just “tightly closed.” Thus, in a
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`patent infringement case from the District of Delaware regarding an anti-tumor medication, the
`
`court addressed the term “sealed container” and concluded that “[t]he ordinary meaning of the
`
`term ‘sealed’ is different from, and encompasses something more than, the ordinary meaning of
`
`the term ‘closed.’” Pharmacia & Upjohn Co. v. Sicor & Sicor Pharm., Inc., 447 F. Supp. 2d 363,
`
`373 (D. Del. 2006)
`
`
`
`A standard dictionary definition of a “seal” is “a tight and perfect closure (as against the
`
`passage of gas or water).” Seal, MERRIAM-WEBSTER COLLEGIATE DICTIONARY (10th ed. 1997).
`
`The verb “to seal” means either “to fasten with or as if with a seal to prevent tampering,” or “to
`
`close or make secure against access, leakage, or passage by a fastening or coating.” Id.
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`Despite Hospira’s assertions that a “sealed” container requires rigorous closure testing, the
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`concept is not a complicated one. The court concludes no construction of this term is required.
`
`That said, the court does not understand the term “sealed” as broad enough to include
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`containers that are merely “closed” as a person might close a desk drawer or a book. If the
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`court were to adopt a construction of the term, it would adopt Fresenius Kabi’s proposal, as it
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`more accurately reflects the broad scope of the chosen claim language.
`
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`14
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`Case: 1:16-cv-00