Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 1 of 10 PageID #:2003
`Case: 1:16-cv—00651 Document #: 47-2 Filed: 11/08/16 Page 1 of 10 PagelD #:2003
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`EXHIBIT 2
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`EXHIBIT 2
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`Case: 1:16-cv—00651 Document #: 47-2 Filed: 11/08/16 Page 1 of 10 PagelD #:2003
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`EXHIBIT 2
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`EXHIBIT 2
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 2 of 10 PageID #:2004
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`NOT FOR PUBLICATION
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`HOSPIRA, INC., et al.
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`CIVIL ACTION NO. 09-4591
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`(MLC)
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`DRAFT MARKMAN OPINION
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`Plaintiffs,
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`v.
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`SANDOZ,
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`INC., et al.
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`Defendants.
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`COOPER, District Judge
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`The Court's Draft Construction of the Term "Intensive Care"
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`Although the parties used the term "intensive care" in two
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`definitions under United States Patent No. 6,716,867 ("the '867
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`Patent"), they did not define it.
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`(See id. at 4 ("The parties do
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`not dispute the construction of any terms of the Patents-In-
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`Suit.").) Because the Court has determined that it must define
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`this term before resolving the Motions, it will now construe it.
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`The Court begins by noting the "'heavy presumption' "that a
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`claim term carries its ordinary and customary meaning." CCS
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`Fitness Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir.
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`2002). The ordinary and customary meaning of a claim term is the
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`meaning a "person of ordinary skill in the art in question" (a
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`"POSITA") would assign such term on the patent's priority date.
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`Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). A
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`POSITA is deemed to interpret the claim term in the context of
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`
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 3 of 10 PageID #:2005
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`the entire patent, including the specification.
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`Id. Claims
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`terms carry their ordinary and customary meanings unless
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`otherwise indicated in the patent specification or file history.
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`Wolverine Worldwide, Inc. v. Nike, Inc., 38 F.3d 1192, 1196 (Fed.
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`Cir. 1994).
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`"To ascertain the scope and meaning of the asserted claims,
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`we look to the words of the claims themselves, the specification,
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`the prosecution history, and any relevant extrinsic evidence.ff
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`'
`Retractable Techs., Inc. v. Becton, Dicksinon & Co., 653 F.3d
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`1296, 1303 (Fed. Cir. 2011), rehearing and rehearing en bane
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`denied, 659 F.3d 1369. The Court first looks to the intrinsic
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`evidence of record, which includes the patent's claims,
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`specification, and complete prosecution history. Markman, 52
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`F.3d at 979. Such intrinsic evidence is the most significant
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`source of the legally operative meaning of disputed claim
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`language. Vitronic Corp. v. Conceptronic, Inc., 90 F.3d 1576,
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`1583 (Fed. Cir. 1996). The specification is "always highly
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`relevant to the claim construction analysis" and is "the single
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`best guide to the meaning of a disputed term.ff Honeywell Int'l,
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`Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006)
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`(internal quotation marks omitted) . The specification may
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`contain an intentional disclaimer or a disavowal of claim scope
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`by the inventor, whereby the inventor's intention, expressed in
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`the specification, is dispositive. Phillips, 415 F.3d at 1316.
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`2
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 4 of 10 PageID #:2006
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`It is, however, improper to read a limitation from the
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`specification into the claims. Teleflex, Inc. v. Ficosa N. Am.
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`Corp., 299 F.3d 1313, 1326 (Fed. Cir. 2002).
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`In some instances, the ordinary meaning of claim language,
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`as understood by a POSITA, will be readily apparent to the Court
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`after reviewing the intrinsic evidence.
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`In such instances, claim
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`construction will involve simply applying the widely accepted
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`meanings of commonly understood words. Phillips, 415 F.3d at
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`1314.
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`In other circumstances, however, the Court may consider
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`extrinsic evidence, such as "expert and inventor testimony,
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`dictionaries, and learned treatises."
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`Id.
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`In general, such
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`evidence is less reliable than its intrinsic counterparts.
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`Id.
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`at 1318. Notably, "heavy reliance on the dictionary divorced
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`from the intrinsic evidence risks transforming the meaning of the
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`claim term to the artisan into the meaning of the term in the
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`abstract, out of its particular context, which is the
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`specification."
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`Id. at 1321. Further, unsupported assertions by
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`experts as to the definition of a claim term are not useful, and
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`the after-the-fact testimony of the inventor is accorded little
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`if any weight in the claim construction inquiry.
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`Id. at 1318.
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`The term that actually appears in the '867 Patent claims is
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`"intensive care unit." The parties have stipulated that an
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`"intensive care unit" is "any setting that provides intensive
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`care", but failed to define "intensive care".
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`3
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 5 of 10 PageID #:2007
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`The Court begins its claim construction inquiry by examining
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`the intrinsic evidence of record. While the '867 Patent claims
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`and related prosecution history do not help to define "intensive
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`care", the'867 Patent specification provides some guidance.
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`In
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`the specification, Plaintiffs repeatedly refer to sedating
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`patients that suffer from "critical illness" and sedating
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`"critically ill patients".
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`(See, e.g., '867 Patent at col. 1 at
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`32, 43.)
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`In Example 3, the specification details sixteen cases
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`of sedation of "critically ill patients", describing Phase III
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`trials of dexmedetomidine and "the benefits of dexmedetomidine
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`sedation in critically ill patients."
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`(Id. at col. 8 at line 47
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`- col. 13 at line 54.) The specification provides that each of
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`the sixteen "critically ill" patients was admitted to an "ICU",
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`i.e., an intensive care unit, either preoperatively or
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`postoperatively, and underwent some form of surgery.
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`The
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`specification does not, however, disclose whether these patients
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`underwent surgery because they were "critically ill" or whether
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`they were considered"critically ill" because they underwent
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`surgery.
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`It also fails to disclose the type of nursing care
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`provided to these patients or, more generally, the quality of
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`perioperative care provided, except inasmuch as it discloses the
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`administration of dexmedetomidine, analgesics, and other
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`sedatives.
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`(Id.)
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`4
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 6 of 10 PageID #:2008
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`Because examination of the intrinsic evidence does not
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`render a clear definition of "intensive care", the Court next
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`turns to extrinsic evidence. During discovery, the parties
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`solicited deposition regarding the definition of "intensive
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`care". Romeo Bachand, one of the named inventors of the '867
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`Patent, testified that "intensive care is a unit or a place where
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`people get total care, human care, not procedural care."
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`(Dkt.
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`entry no. 229-12, Bachand Dep. at 164.) He explained that
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`"intensive care[,] by its meaning in the [1990s]
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`. had to do
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`with care, and the care was with generally the ratio of patients
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`to nurses taking care of the total patient."
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`(Id. at 162.)
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`Bachand further explained that preoperative and postoperative
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`surgical care are more closely related to the underlying surgical
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`procedure than to intensive care.
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`(Id. at 163.)
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`Plaintiffs' expert witness, Michael Ramsey, M.D., testified
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`that a "setting that provides intensive care" "would be an area
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`where the patient is intensively monitored for a period of time
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`until the condition that had taken the patient to that unit had
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`resolved or the need for intensive care monitoring, intensive
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`monitoring had passed."
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`(Dkt. entry no. 229-7, Ramsay Dep. at
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`64.) Ramsay defined "intensive monitoring" as "[o]ne-on-one or
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`two-to-one nursing care, continual monitoring of vital signs,
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`immediate availability of support systems."
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`(Id. at 65.) He
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`testified that a patient could receive such monitoring in many
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`5
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 7 of 10 PageID #:2009
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`areas of a hospital, including an intensive care unit, an
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`operating room, or a postoperative recovery area.
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`(Id. at 67-68;
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`dkt. entry no. 229-8, Ramsey Dep. II at 209-10.)
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`The Sandoz Companies' expert witness, Jesse B. Hall, M.D.,
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`opined that critical care settings are defined more so "by the
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`nature of the patient than by the label over the geographic
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`location in the hospital."
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`(Dkt. entry no. 228-2, Ex. E, Hall
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`Dep. at 24.) He stated:
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`[I]f a patient is critically ill and is in the
`emergency department but must wait six hours for a bed
`to be available, we don't say they are denied critical
`care management while they're in the emergency room.
`The facility can be turned to that purpose for that
`patient's needs.
`The same thing occurs in the recovery room when
`there isn't an ICU bed or perhaps the ICUs need to be
`decompressed.
`It's common to just change the nursing
`ratios to make the circumstance of adequate critical
`care environment because the physicians can go there as
`needed, and the monitoring equipment exists to ahieve
`the same endpoints.
`It becomes a nursing coverage
`issue more than anything else.
`
`(Id. at 22.) Hall clarified that patients could thus receive
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`intensive care in emergency rooms and postoperative recovery
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`rooms.
`
`(Id. at 23.)
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`The Court also sua sponte reviewed information provided by
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`dictionaries and treatises. The Court, specifically, reviewed
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`information in THE MERCK M.11.NUAL or D.::AGNosrs AND T:~::.:ATMSNT, 19th ed.
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`("The Merck Manual") and STt:DMM1's Mr:1ncA1 01CTlONAtn ("Stedman's").
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`The Merck Manual does not provide an explicit definition of
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`6
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 8 of 10 PageID #:2010
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`"intensive care"; indeed, the index entry for "intensive care"
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`states only "see Critically ill patient".
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`T:-i:!: M;:::r<.c:<: MA:.JJAL or
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`DIAGNOSIS A:w TRE:ATME:NT 364 0 (Robert S. Porter, MD, et al. eds., 19th
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`ed., 2011). The main entry for that section, i.e., "Critical
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`Care Medicine", provides:
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`Critical care medicine specializes in caring for
`the most seriously ill patients. These patients are
`best treated in an ICU staffed by experienced
`personnel.
`ICUs have a high nurse:patient ratio
`to provide the necessary high intensity of service,
`including treatment and monitoring of physiologic
`parameters.
`Supportive care for the ICU patient includes
`provision of adequate nutrition and prevention of
`infection, stress ulcers and gastritis, and pulmonary
`embolism. Because 15 to 25% of patients admitted to
`the ICUs die there, physicians should know how to
`minimize suffering help dying patients maintain
`dignity.
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`Id. at 2243-44. The rest of that section sets forth the methods
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`for procedures used to monitor and treat critically ill patients.
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`See id. at 2243-2302.
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`Stedman's defines "intensive care" as "management and care
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`of critically ill patients".
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`STSDMAN' s MED.::CAL D1CTIONAT£ 315 (28th
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`ed., 2006).
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`It defines "critical" as "[d)enoting a morbid
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`condition in which death is possible."
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`Id. at 462.
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`It also
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`defines an "intensive care unit" as "a hospital facility for
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`provision of intensive nursing and medical care of critically ill
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`patients, characterized by the high quality and quantity of
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`continuous nursing and medical supervision and by use of
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`7
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 9 of 10 PageID #:2011
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`sophisticated monitoring and resuscitative equipment".
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`Id. at
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`2067 (emphasis added).
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`Upon consideration of this evidence, and placing
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`considerable weight on the intrinsic evidence, i.e., on the
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`specification of the '867 Patent, the Court has determined that
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`the term "intensive care" has two important aspects. First,
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`First, "intensive care" involves "critically ill", patients.
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`(See '867 Patent, col. 1 at line 32, 43, col. 8 at line 47 - col.
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`13 at line 54). See also M.sH.cK MA:-1uA1 Or' D1AGNos1s A:m Tt<.±::ATMJ::Nr 2243-
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`44; STED:1JAN'S MEDICAL DICI'lO>JARY 315, 462, 2067. Such "critically
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`ill" patients are typically "the most seriously ill patients" who
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`undergo surgery or other major medical procedures.
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`(See '867
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`Patent, col. 8 at line 47 - col. 13 at line 54). See also
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`STSDMAN'S MEDICAL DICTlONM<Y 315, 462. These patients may die,
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`either as a result of underlying medical conditions or as a
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`result of the treatment for those conditions.
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`(See '867 Patent,
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`col. 8 at line 47 - col. 13 at line 54). See also STEDMAN' s
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`MEDICAL 02:CTIONA!<.Y 315, 462.
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`Second, intensive care is characterized by ongoing medical
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`supervision. MERC:<: MANUAL OF' DIAGNos=s AND TREAT'.'IENT 2243-44. Such
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`supervision typically includes a high nurse-to-patient ratio and
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`continuous nursing care.
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`(Bachand Dep. at 162-64; Hall Dep. at
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`22-23 (noting that intensive care is characterized as "a nursing
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`coverage issue more than anything else.") . ) See also MERC:« MANUAL
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`8
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`Case: 1:16-cv-00651 Document #: 47-2 Filed: 11/08/16 Page 10 of 10 PageID #:2012
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`OF DIAGNOSIS AND T:<.:::ATMENT 2243. This supervision generally includes
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`monitoring.
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`Id.
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`The Court will thus construe the term "intensive care" as
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`follows:
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`care provided to critically ill patients, typically
`characterized by high nursing-to-patient ratios,
`continuous medical supervision, and continuous
`monitoring.
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`[DRAFT - NOT SIGNED]
`
`MARY L. COOPER
`United States District Judge
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`9
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