Case 1:15-cv-00697-RGA Document 57 Filed 05/25/16 Page 1 of 5 PageID #: 889
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`· HOSPIRA, INC.,
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`Plaintiff,.
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`v.
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`AMNEAL PHARMACEUTICALS LLC,
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`Defendant.
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`Civil Action No. 15-697-RGA
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`MEMORANDUM ORDER
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`· Presently before the Court is the issue of claim construction of multiple terms in U.S .
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`. Patent Nos. 8,242, 158 ("the '158 patent"); 8,338,4 70 ("the '4 70 patent"); 8,455,527 ("the '527
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`patent"); and 8,648, 106 ("the '106 patent") (collectively "the patents-in-suit"). The Court has
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`considered the parties' Joint Claim Construction Brief. (D.I. 44).
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`"It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude." Phillips v. A WH C01p., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). '"[T]here is no magic formula or
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`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
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`weight to appropriate sources 'in light of the statutes and policies that inform patent law.'"
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`Soft View LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
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`415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
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`claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
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`Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
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`sources, "the specification is always highly relevant to the claim construction analysis. Usually,
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`Case 1:15-cv-00697-RGA Document 57 Filed 05/25/16 Page 2 of 5 PageID #: 890
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`it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d
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`at 1315 (internal quotation marks and citations omitted).
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`"[T]he words of a claim are generally given their ordinary and customary meaning ....
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`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application."
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`Id. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a
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`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
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`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
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`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
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`construction in such cases involves little more than the application of the widely accepted
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`meaning of commonly understood words." Id. at 1314 (internal citations omitted).
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`When a court relies solely upon the intrinsic evidence-the patent claims, the
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`specification, and the prosecution history-the court's construction is a determination of law.
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`See TevaPharms. USA, Inc. v. Sandoz, Inc., l-35 S. Ct. 831, 841 (2015). The court may also
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`make factual findings based upon consideration of extrinsic evidence, which "consists of all
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`evidence external to the patent and prosecution history, including expert and inventor testimony,
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`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and
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`citations omitted). Extrinsic evidence may assist the court in understanding the underlying
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`technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
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`Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
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`and its prosecution history. Id.
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`"A claim construction is persuasive, not because it follows a certain rule, but because it
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`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per
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`Case 1:15-cv-00697-RGA Document 57 Filed 05/25/16 Page 3 of 5 PageID #: 891
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`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would
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`exclude the inventor's device is rarely the correct interpretation." Osram GmbH v. Int'! Trade
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`Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks and citation omitted).
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`The parties agree that the term "effective amount," found in claim 1 of the '527 patent,
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`should be construed as "amount sufficient to produce the desired effect." (D.I. 44 at p. 4). The
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`Court adopts this construction.
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`The parties dispute the construction of four terms: (1) "dexmedetomidine;" (2) "no more
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`than about 2% decrease in the concentration of dexmedetomidine;" (3) "critically ill;" and ( 4)
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`"intensive care unit." (Id.). The Court addresses each term separately.
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`1.
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`"dexmedetomidine" (all asserted claims)
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`Plaintiff's proposed construction: "substantially pure; optically active
`a.
`dextrorotary stereoisomer of medetomidine, as the free base or pharmaceutically
`acceptable salt"
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`b.
`Defendant's proposed construction: "substantially pure, optically active
`dextrorotary stereoisomer ofmedetomidine, as the.free base"
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`Court's construction: "substantially pure, optically active dextrorotary
`c.
`stereoisomer ofmedetomidine, as the free base or pharmaceutically acceptable
`salt"
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`The specification of each of the patents-in-suit sets forth an explicit definition for this
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`term. See, e.g., '158 patent at 3:21-24. That definition aligns with Plaintiff's proposed
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`construction. "When a patentee explicitly defines a claim term in the patent specification, the
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`patentee's definition controls." Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363,
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`1380 (Fed. Cir. 2009). Thus, here, the inventor's lexicography governs. I therefore construe
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`"dexmedetomidine" to mean "substantially pure, optically active dextrorotary stereoisomer of
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`medetomidine, as the free base or pharmaceutically acceptable salt."
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`Case 1:15-cv-00697-RGA Document 57 Filed 05/25/16 Page 4 of 5 PageID #: 892
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`"no more than about 2% decrease in the concentration of dexmedetomidine"
`2.
`(' 106 patent, claim 1)
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`a.
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`b.
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`c.
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`Plaintiff's proposed construction: Plain meaning
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`Defendant's proposed construction: Indefinite
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`Court's construction: Plain meaning
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`A patent must "inform those skilled in the art about the scope of the invention with
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`reasonable certainty." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014).
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`Defendant's first indefiniteness argument depends on its proposed construction of
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`"dexmedetomidine." Since the Court rejected that construction, this argument is also rejected.
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`Defendant's second argument focuses on the word "about." "When 'about' is used as part of a
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`numeric range, ... [that use] avoids a strict numerical boundary to the specified parameter [and]
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`[i]ts range must be interpreted in its technologic and stylistic context."' Cohesive Techs., Inc. v.
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`Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (quoting Pall Corp. v. Micron Separations,
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`Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995)). The '106 patent's specification explains that "'about'
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`... as used herein means within an acceptable errorrange for the particular value as determined
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`by one of ordinary skill in the art." '106 patent at 5:31-33. The specification further states that
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`this "will depend in part on how the value is measured or determined, i.e., the limitations of the
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`measurement system." Id. at 5:33-35. In context, a PHOSITA would understand the scope of the
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`"about" limitation with reasonable certainty. Therefore, Defendant's indefiniteness argument is
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`rejected. The term is afforded its plain and ordinary meaning.
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`3.
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`"critically ill" ('527 patent, claim 10)
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`a.
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`b.
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`c.
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`Plaintiff's proposed construction: Plain meaning
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`Defendant's proposed construction: Indefinite
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`Court's construction: Plain meaning
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`Case 1:15-cv-00697-RGA Document 57 Filed 05/25/16 Page 5 of 5 PageID #: 893
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`"' [A] patentee need not define his invention with mathematical precision in order to
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`comply with the definiteness requirement."' Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364,
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`1370 (Fed. Cir. 2014) (quoting Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed.
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`Cir. 2005)). The term "critically ill" has a recognizable meaning to those having skill in the art.
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`Further, the '527 patent provides examples of medical conditions that may satisfy the "critically
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`ill" limitation. '527 patent at 10:62-11:1. Therefore, Defendant's indefiniteness argument is
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`rejected. The term is afforded its plain and ordinary meaning.
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`4.
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`"intensive care unit" ('527 patent, claim 8)
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`. Plaintiff's proposed construction: "any setting that provides care to
`a.
`critically ill patients, typically characterized by high nurse-to-patient ratios,
`continuous medical supervision, and intensive monitoring"
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`Defendant's proposed construction: "any setting that provides intensive
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`b.
`care"
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`Court's construction: Either "any setting that provides care to critically ill
`c.
`patients" or "any setting that provides intensive care"
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`The latter part of Plaintiff's proposed construction-"typically characferized by high
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`nurse-to-patient ratios, continuous medical supervision, and intensive monitoring"-is rejected.
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`This language finds no support in the intrinsic record. I cannot discern any material distinction
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`between "any setting that provides care to critically ill patients" and "any setting that provides
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`intensive care." I therefore decline to construe the term further at this time. The parties are
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`permitted to bring up any additional arguments pertaining to this term at the pretrial conference.
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`Entered this 2Y day of May, 2016.
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