Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 1 of 61 PageID #: 542
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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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`AMNEAL PHARMACEUTICALS LLC,
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`Civil Action No. 15-697-RGA
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`Plaintiff,
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`v.
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`Defendant.
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`JOINT CLAIM CONSTRUCTION BRIEF
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 2 of 61 PageID #: 543
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`TABLE OF CONTENTS
`
`I. 
`
`Introduction ................................................................................................................................1 
`
`A.  Hospira's Introduction ..........................................................................................................1 
`
`B.  Amneal's Introduction ..........................................................................................................1 
`
`1.  Dexmedetomidine is not a new Drug.............................................................................1 
`
`2.  The Patents-in-Suit.........................................................................................................2 
`
`3.  Legal Principles .............................................................................................................2 
`
`II.  Agreed-Upon Constructions ......................................................................................................4 
`
`III. Disputed Constructions ..............................................................................................................4 
`
`A.  "dexmedetomidine" (all asserted claims) .............................................................................4 
`
`1.  Hospira's Opening Position ............................................................................................4 
`
`2.  Amneal's Answering Position ........................................................................................8 
`
`a.  Intrinsic Evidence makes clear that "dexmedetomidine" refers to the free
`base form ..................................................................................................................8 
`
`b.  Plaintiff's Proposed Construction of "demedetomidine" is Not Supported
`by the Specification or Prosecution History ..........................................................12 
`
`3.  Hospira's Reply Position ..............................................................................................15 
`
`4.  Amneal's Sur-Reply Position .......................................................................................18 
`
`B.  "no more than about 2% decrease in the concentration of dexmedetomidine" ('106
`patent, Claim 1) ..................................................................................................................23 
`
`1.  Hospira's Opening Position ..........................................................................................23 
`
`2.  Amneal's Answering Position ......................................................................................26 
`
`3.  Hospira's Reply Position ..............................................................................................30 
`
`4.  Amneal's Sur-Reply Position .......................................................................................34 
`
`C.  "critically ill" ('527 patent, Claim 10) ................................................................................36 
`
`1.  Hospira's Opening Position ..........................................................................................36 
`
`
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`i
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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 3 of 61 PageID #: 544
`Case 1:15—cv—OO697—RGA Document 44 Filed 04/28/16 Page 3 of 61 Page|D #: 544
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`2.  Amneal's Answering Position ......................................................................................38 
`2. Amneal's Answering Position .................................................................................... ..38
`
`3.  Hospira's Reply Position ..............................................................................................41 
`3. Hospira's Reply Position ............................................................................................ ..4l
`
`4.  Amneal's Sur-Reply Position .......................................................................................43 
`4. Amneal's Sur-Reply Position ..................................................................................... ..43
`
`D.  "intensive care unit" ('527 patent, Claim 8) .......................................................................44 
`D. "intensive care unit" (‘S27 patent, Claim 8) ..................................................................... ..44
`
`1.  Hospira's Opening Position ..........................................................................................45 
`1. Hospira's Opening Position ........................................................................................ ..45
`
`2.  Amneal's Answering Position ......................................................................................47 
`2. Amneal's Answering Position .................................................................................... ..47
`
`3.  Hospira's Reply Position ..............................................................................................50 
`3. Hospira's Reply Position ............................................................................................ ..50
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`4.  Amneal's Sur-Reply Position .......................................................................................52 
`4. Amneal's Sur-Reply Position ..................................................................................... ..52
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`ii
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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 4 of 61 PageID #: 545
`
`
`TABLE OF AUTHORITIES 
`
`Page(s)
`
` 
`
`CASES
`
`01 Communique Lab., Inc. v. Logmein, Inc.,
`687 F.3d 1292 (Fed. Cir. 2012)............................................................................................6, 20
`
`Accentra, Inc. v. Staples, Inc.,
`500 F. App’x 922 (Fed. Cir. 2013) ..........................................................................................24
`
`AIA Eng’g Ltd. v. Magotteaux Int’l S/A,
`657 F.3d 1264 (Fed. Cir. 2011)..........................................................................................16, 19
`
`Amgen, Inc. v. Chugai Pharm. Co., Ltd.,
`927 F.2d 1200 (Fed.Cir.1991)......................................................................................27, 31, 32
`
`Andrulis Pharm. Corp. v. Celgene Corp.,
`No. 13-1644(RGA), 2015 WL 3978578 (D. Del. June 26, 2015) ...........................................44
`
`Arthur A. Collins Inc. v. N. Telecom Ltd.,
`216 F.3d 1042 (Fed. Cir. 2000)................................................................................................51
`
`Bd. of Regents v. BENQ Am. Corp.,
`533 F.3d 1362 (Fed. Cir. 2008)................................................................................................19
`
`Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP,
`616 F.3d 1249 (Fed. Cir. 2010)................................................................................................19
`
`BJ Servs. Co. v. Halliburton Energy Servs., Inc.,
`338 F.3d 1368 (Fed. Cir. 2003)........................................................................................ passim
`
`C.R. Bard, Inc. v. U.S. Surgical Corp.,
`388 F.3d 858 (Fed. Cir. 2004 ).................................................................................................48
`
`Chef Am., Inc. v. Lamb–Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004)................................................................................................52
`
`Cohesive Techs., Inc. v. Waters Corp.,
`543 F.3d 1351 (Fed. Cir. 2008)..........................................................................................24, 25
`
`Cordis Corp. v. Boston Scientific Corp.,
`561 F.3d 1319 (Fed. Cir. 2009)................................................................................................25
`
`Corning Optical Commc’ns Wireless, Ltd. v. SOLiD Inc.,
`2015 WL 5096472 (N.D. Cal. Aug. 19, 2015) ........................................................................37
`
`
`
`iii
`
`

`
`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 5 of 61 PageID #: 546
`
`
`Cybor Corp. v. FAS Techs. Inc.,
`138 F.3d 1448 (Fed. Cir. 1998)................................................................................................48
`
`dunnhumby USA, LLC v. emnos USA Corp.,
`2015 WL 1542365 (N.D. Ill. Apr. 1, 2015) .............................................................................37
`
`Edwards Lifesciences LLC v. Cook Inc.,
`582 F.3d 1322 (Fed. Cir. 2009)............................................................................................7, 20
`
`Exxon Research & Eng’g Co. v. United States,
`265 F.3d 1371 (Fed Cir. 2001).....................................................................................27, 38, 39
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) ...................................................................................................................3
`
`Hospira, Inc. v. Eurohealth Int’l Sarl,
`2015 WL 6697257 (D. Del. Nov. 3, 2015) ...................................................................... passim
`
`In re Imes,
`778 F.3d 1250 (Fed. Cir. 2015)................................................................................................15
`
`In re Rasmussen,
`650 F.2d 1212 (C.C.P.A. 1981) ...............................................................................................48
`
`Interval Licensing LLC v. AOL, Inc.,
`766 F.3d 1364 (Fed. Cir. 2014)....................................................................................36, 40, 42
`
`Kustom Signals, Inc. v. Applied Concepts, Inc.,
`264 F.3d 1326 (Fed. Cir. 2001)............................................................................................8, 19
`
`Linear Tech. Corp. v. Int’l Trade Comm’n,
`566 F.3d 1049 (Fed. Cir. 2009)................................................................................................15
`
`Laitram Corp. v. Cambridge Wire Cloth Co.,
`863 F.2d 855 (Fed. Cir. 1988)..................................................................................................48
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005)..................................................................................................3
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008)..........................................................................................20, 52
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) ...................................................................................................................2
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996) .........................................................3
`
`
`
`iv
`
`

`
`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 6 of 61 PageID #: 547
`
`
`Martek Bioscis. Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009)..................................................................................................4
`
`Medrad, Inc. v. MRI Devices Corp.,
`401 F.3d 1313 (Fed. Cir. 2005)..................................................................................................2
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014), cert. denied, 136 S. Ct. 569 (2015) ........................................... passim
`
`NTP, Inc. v. Research in Motion, Ltd.,
`418 F.3d 1282 (Fed. Cir. 2005)..................................................................................................7
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)................................................................................................50
`
`Oakley, Inc. v. Sunglass Hut Int’l,
`316 F.3d 1331 (Fed. Cir. 2003)..........................................................................................34, 41
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ....................................................................... passim
`
`Pony Pal, LLC v. Claire’s Boutiques, Inc.,
`No. 05-2355 (CSH), 2006 WL 2827642 (S.D.N.Y. Oct. 2, 2006) ..........................................14
`
`Powell v. Home Depot U.S.A., Inc.,
`663 F.3d 1221 (Fed. Cir. 2011)................................................................................................51
`
`Praxair, Inc. v. ATMI, Inc.,
`543 F.3d 1306 (Fed. Cir. 2008)................................................................................................26
`
`Process Control Corp. v. HydReclaim Corp.,
`190 F.3d 1350 (Fed. Cir. 1999)..........................................................................................20, 52
`
`Rambus Inc. v. Infineon Techs. AG,
`318 F.3d 1081 (Fed. Cir. 2003)................................................................................................14
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006)..................................................................................................9
`
`Schoenhaus v. Genesco, Inc.,
`440 F.3d 1354 (Fed. Cir. 2006)................................................................................................19
`
`Seattle Box Co. v. Indus. Crating & Packing, Inc.,
`731 F.2d 818 (Fed. Cir. 1984)............................................................................................27, 38
`
`Source Search Techs., LLC v. LendingTree, LLC,
`588 F.3d 1063 (Fed. Cir. 2009)..............................................................................36, 37, 41, 42
`
`
`
`v
`
`

`
`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 7 of 61 PageID #: 548
`
`
`Southwall Techs., Inc. v. Cardinal IG Co.,
`54 F.3d 1570 (Fed. Cir. 1995)....................................................................................................3
`
`Standard Oil Co. v. American Cyanamid Co.,
`774 F.2d 448 (Fed. Cir. 1985)..................................................................................................27
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`135 S. Ct. 831 (2015) ...............................................................................................................50
`
`Texas Instruments, Inc. v. United States Int’l Trade Comm’n,
`805 F.2d 1558 (Fed. Cir. 1986)................................................................................................48
`
`Transmatic, Inc. v. Gulton Indus., Inc.,
`53 F.3d 1270 (Fed. Cir. 1995)..................................................................................................48
`
`Veracode, Inc. v. Appthority, Inc.,
`2015 WL 5749435 (D. Mass. Sept. 30, 2015) .........................................................................36
`
`ViiV Healthcare UK Ltd. v. Lupin Ltd.,
`6 F. Supp. 3d 461, 475 (D. Del. 2013) .......................................................................7, 9, 11, 20
`
`Voda v. Cordis Corp.,
`536 F.3d 1311 (Fed. Cir. 2008)................................................................................................14
`
`Warner- Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997) .....................................................................................................................2
`
`
`
`STATUTES
`
`35 U.S.C. § 112 ............................................................................................................25, 29, 39, 52
`
`
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 1.57 .............................................................................................................................47
`
`New American Medical Dictionary ...............................................................................................45
`
`
`
`
`
`vi
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 8 of 61 PageID #: 549
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`
`I.
`
`Introduction
`
`A.
`
`Hospira's Introduction
`
`The four patents-in-suit—U.S. Patent Nos. (1) 8,242,158 (" '158 patent"); (2) 8,338,470
`
`(" '470 patent"); (3) 8,455,527 (" '527 patent"); and (4) 8,648,106 (" '106 patent") (collectively,
`
`"the patents" or "the patents-in-suit")—recite "ready to use" formulations of dexmedetomidine,
`
`and methods of use thereof. Whereas prior art dexmedetomidine formulations had to be diluted
`
`prior to administration to patients, the claimed formulations can be administered to patients as
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`manufactured. (E.g., '158 pat. 1:5-10, 1:53-62, 2:60-3:3.) Uses of dexmedetomidine include
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`sedation, pain relief, and the treatment of hypertension and anxiety. ('158 pat. 1:22-37.)1
`
`B.
`
`Amneal's Introduction
`
`1.
`
`Dexmedetomidine is not a new Drug
`
`Dexmedetomidine was prior art drug provided as a concentrate that must be diluted prior
`
`to administration to a patient. See e.g., 8,242,158 at col. 1, ll. 49-50. Dexmedetomidine
`
`formulations for sedation were commercially available in the U.S. as early as December 23,
`
`1999, as a Precedex® injection for intravenous infusion following dilution. The prior art product
`
`label instructed doctors to dilute the concentrate with 0.9% sodium chloride solution to achieve
`
`the required concentration prior to administration.
`
`By adding well-known 0.9% sodium chloride solutions to the prior art dexmedetomidine
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`concentrate formulations in a "ready to use" vial, Plaintiff in this case obtained patents and
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`market exclusivity for the reintroduction of an old drug diluted identically as instructed in the
`
`prior art.
`
`
`1 The patents-in-suit are attached to the parties' Joint Claim Construction Chart (D.I. 39 Exs. 1-4)
`and are included as part of the joint appendix filed herewith (CC-JA-002-62). They share a
`common specification and a priority date of January 4, 2012.
`
`
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 9 of 61 PageID #: 550
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`2.
`
`The Patents-in-Suit
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`U.S. Patent Nos. 8,648,106 ("the '106 Patent"), 8,338,470 ("the '470 Patent"), and
`
`8,242,158 ("the '158 Patent")(collectively, "the Composition Patents") are directed to "ready to
`
`use" liquid pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof. U.S. Patent No. 8,445,527 ("the '527 Patent")(collectively with the
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`composition patents as "Patents-in-suit") is directed to methods of providing sedation to a patient
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`in need thereof, comprising administering to the patient an effective amount of dexmedetomidine
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`in a "ready to use" liquid pharmaceutical composition.
`
`3.
`
`Legal Principles
`
`The claims of a patent define the scope of the invention. Markman v. Westview
`
`Instruments, Inc., 517 U.S. 370, 373 (1996). Claims are to be interpreted in view of the intrinsic
`
`evidence, which includes the claim language, the specification, and the prosecution history. See
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-17 (Fed. Cir. 2005) (en banc).
`
`First, a court should "look to the language of the claims to determine what 'the applicant
`
`regards as his invention.'" Id. at 1312. The words of a claim are generally given their ordinary
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`meaning, which is "the meaning that the term would have to a person of ordinary skill in the art
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`in question at the time of the invention, i.e., as of the effective filing date of the patent
`
`application." Id. at 1312-13. The Supreme Court has emphasized that "[e]ach element contained
`
`in a patent claim is deemed material to defining the scope of the patented invention." Warner-
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`Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997).
`
`The Court "cannot look at the ordinary meaning of the term . . . in a vacuum;" it must
`
`"look at the ordinary meaning in the context of the written description and the prosecution
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`history." Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005). The Federal
`
`Circuit has emphasized that the specification may be dispositive on the term meaning as "it is the
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`2
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 10 of 61 PageID #: 551
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`single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (internal citation
`
`omitted). At the same time, a claim term should not be construed so broadly that it does not find
`
`support in the specification. See LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336,
`
`1344 (Fed. Cir. 2005).
`
`Next, the Federal Circuit has emphasized that the "'undisputed public record' of
`
`proceedings in the Patent and Trademark Office is of primary significance in understanding the
`
`claims." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995), aff'd, 517
`
`U.S. 370 (1996). Statements made by the applicants during the application process are highly
`
`relevant to claim interpretation. Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576
`
`(Fed. Cir. 1995). Thus, the prosecution history constitutes part of the "intrinsic evidence" that
`
`directly reflects how the patentee and the PTO understood the invention. Phillips, 415 F.3d at
`
`1317. In addition, claim amendments made during prosecution also may be significant in
`
`construing claims, since, as the Supreme Court has emphasized, a patentee's decision to "submit
`
`an amended claim is taken as a concession that the invention as patented does not reach as far as
`
`the original claim." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 734
`
`(2002). Finally, the Federal Circuit has made clear that extrinsic evidence used in the
`
`interpretation of the claim has a subservient role to that of the intrinsic evidence, is "less reliable
`
`than the patent and its prosecution history in determining how to read claim terms," and cannot
`
`be used to change the meaning of claims. Phillips v. AWH Corp., 415 F.3d 1303, 1318-19 (Fed.
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`Cir. 2005).
`
`As discussed below, Defendant's claim constructions are based on the claim language and
`
`the intrinsic evidence, including repeated examples from the specifications that confirm the
`
`meaning of the disputed claim terms and the scope of the asserted claims. In contrast, many of
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`3
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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 11 of 61 PageID #: 552
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`Plaintiff's constructions lack any support in the intrinsic evidence, and are based largely on
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`extrinsic evidence.
`
`II.
`
`Agreed-Upon Constructions
`
`The parties agree to the construction of "effective amount":
`
`Term
`
`Agreed Construction
`
`"effective amount" ('527 patent, Claim
`1)
`
`"amount sufficient to produce the
`desired effect"
`
`
`III. Disputed Constructions
`
`The parties dispute the constructions of four terms: (1) "dexmedetomidine"; (2) "no more
`
`than about 2% decrease in the concentration of dexmedetomidine"; (3) "critically ill"; and (4)
`
`"intensive care unit."
`
`A.
`
`"dexmedetomidine" (all asserted claims)
`
`Hospira's Proposed Construction
`
`Amneal's Proposed Construction
`
`"substantially pure, optically active
`dextrorotary stereoisomer of
`medetomidine, as the free base or
`pharmaceutically acceptable salt"
`
`"substantially pure, optically active
`dextrorotary stereoisomer of
`medetomidine, as the free base"
`
`
`
`1.
`
`Hospira's Opening Position
`
`Hospira proposes that the term be construed as explicitly defined in the "Definitions"
`
`section of the specification:
`
`According to the present invention, the term "dexmedetomidine" as used
`herein refers to a substantially pure, optically active dextrorotary
`stereoisomer of medetomidine, as the free base or pharmaceutically
`acceptable salt.
`
`('158 pat. 3:21-24.) This definition governs. See, e.g., Martek Bioscis. Corp. v. Nutrinova, Inc.,
`
`579 F.3d 1363, 1379-82 (Fed. Cir. 2009) (rejecting accused infringer's argument that the
`
`
`
`4
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 12 of 61 PageID #: 553
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`specification definition of "animal" as including humans did not apply because "[w]hen a
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`patentee explicitly defines a claim term in the patent specification, the patentee's definition
`
`controls" and "the patentee has used no words or expressions that manifestly exclude coverage of
`
`humans").
`
`Amneal's proposal improperly excises "or pharmaceutically acceptable salt" from the
`
`specification's definition. Amneal's sole apparent rationale for doing so is that, because most
`
`asserted claims recite "dexmedetomidine or a pharmaceutically acceptable salt thereof," its
`
`construction eliminates redundancy in the claims. This does not justify departure from the
`
`patents' explicit definition. To the contrary, in addition to the explicit definition, the patents
`
`repeatedly make clear that "dexmedetomidine" includes the pharmaceutically acceptable salts
`
`thereof.
`
`First, the patents' discussion of embodiments uses "dexmedetomidine" and "salts thereof"
`
`interchangeably. For example, the specification initially describes embodiments as comprising
`
`"dexmedetomidine, or a pharmaceutically acceptable salt thereof" in certain concentration
`
`ranges:
`
`In certain non-limiting embodiments, the premixed dexmedetomidine
`composition comprises dexmedetomidine, or a pharmaceutically
`acceptable salt thereof, at a concentration of . . . between about 0.5 μg/mL
`and about 10 μg/mL.
`
`('158 pat. 7:55-63 (emphasis added).) Compare that with its subsequent discussion of these same
`
`embodiments:
`
`In certain non-limiting embodiments, the premixed dexmedetomidine
`composition comprises dexmedetomidine at a concentration of about 0.5
`μg/mL, or about 1 μg/mL, or about 1.5 μg/mL, or about 2 μg/mL, . . . or
`about 9 μg/mL, or about 9.5 μg/mL, or about 10 μg/mL . . . .
`
`
`
`5
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 13 of 61 PageID #: 554
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`('158 pat. at 7:63-8:13 (emphasis added).)
`
` It
`
`is apparent
`
`that
`
`the
`
`inventors used
`
`"dexmedetomidine, or a pharmaceutically acceptable salt thereof" and "dexmedetomidine"
`
`interchangeably.
`
`Second, Example 3 makes clear that "dexmedetomidine" includes both the free base and
`
`pharmaceutically acceptable salts by comparing the physical properties of the two "form[s]" of
`
`dexmedetomidine. It notes that "[t]he free base form of dexmedetomidine is more adsorptive"
`
`and that "[a]t lower pH ~4.0, most of the dexmedetomidine is in the ionized [(i.e., salt)] form,
`
`which minimized adsorption." ('158 pat. 15:28-31.) If "dexmedetomidine" included only the
`
`free base form, there would have been no need to discuss the differences between the "free base
`
`form" of dexmedetomidine, and "dexmedetomidine . . . in the ionized form."
`
`Third, other of the patents' Examples and claims interchangeably refer to compositions
`
`comprising dexmedetomidine salts as "dexmedetomidine" compositions. Example 5 refers to a
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`solution of dexmedetomidine hydrochloride—which is a salt—as the "dexmedetomidine
`
`solution." (Id. 17:37-44.) Moreover, Claim 1 of the '106 patent recites a composition
`
`comprising "dexmedetomidine or a pharmaceutically acceptable salt thereof," but then refers to
`
`the composition's concentration as simply "the concentration of dexmedetomidine." ('106 pat.
`
`26:18-24.) The reason is clear—"dexmedetomidine" refers to both the free base and salts
`
`thereof.
`
`Indeed, this District has previously rejected Amneal's 'redundancy' argument. In
`
`construing "dexmedetomidine" in U.S. Patent No. 6,716,867 ("the '867 patent")—a patent
`
`referenced in the patents-in-suit's specification ('158 pat. at 10:25-30)—the court held that the
`
`term includes salts:
`
`The parties dispute whether dexmedetomidine, in the context of the patent,
`includes pharmaceutically acceptable salts. . . . While the court recognizes
`
`
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`6
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 14 of 61 PageID #: 555
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`some level of redundancy created by its construction, the court is not
`convinced that the patentees intended to disclaim pharmaceutically
`acceptable salts . . . . In context, it seems clear that the patentee intended
`to claim not only dexmedetomidine, but also its pharmaceutically
`acceptable salts. Throughout the specification, where the patent refers
`only to "dexmedetomidine," the pharmaceutically acceptable salt is
`implicitly included.
`
`Hospira, Inc. v. Eurohealth Int'l Sarl, 2015 WL 6697257, at *1 n.1 (D. Del. Nov. 3, 2015).
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`Similarly, other courts have consistently declined to construe terms in a manner contrary
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`to its clear meaning simply to avoid perceived redundancy. See 01 Communique Lab., Inc. v.
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`Logmein, Inc., 687 F.3d 1292, 1296 (Fed. Cir. 2012) ("Communique argues that because those
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`functions are set forth expressly in the claim, it would be 'redundant and unnecessary' to
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`incorporate them into the construction of 'location facility.' However, 01 Communique has not
`
`cited, and we have not discovered, any authority for the proposition that construction of a
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`particular claim term may not incorporate claim language circumscribing the meaning of the
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`term."); Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1330 (Fed. Cir. 2009) (adopting
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`the construction "demanded by the specification" regardless of whether the construction
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`"rendered the dependent claim redundant"); ViiV Healthcare UK Ltd. v. Lupin Ltd., 6 F. Supp. 3d
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`461, 475 (D. Del. 2013) ("It would be better to allow for some redundancy than to adopt a
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`construction that is inconsistent with the invention.").
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`Therefore, the Court should construe "dexmedetomidine" to include pharmaceutically
`
`acceptable salts.
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`
`
`7
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 15 of 61 PageID #: 556
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`2.
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`Amneal's Answering Position
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`The term "dexmedetomidine" is found in all asserted claims in the '158 Patent, '470
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`Patent, '106 Patent, and '527 Patent.2 The parties dispute whether the term includes
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`pharmaceutically acceptable salt in its definition.
`
`
`
`a.
`
`Intrinsic Evidence makes clear that "dexmedetomidine" refers to the
`free base form
`
`Amneal's proposed construction is supported by the intrinsic evidence, including the
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`language of the claims, as interpreted by one of ordinary skill in the art in the context of the
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`entire patent, as well as the specification and the prosecution history. Phillips, 415 F.3d at 1313.
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`The specification and claims clearly differentiate between pharmaceutically acceptable salts of
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`dexmedetomidine and dexmedetomidine itself in free base (neutral) form. When the
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`prosecution history is considered, the intrinsic evidence as a whole makes clear that
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`dexmedetomidine is the name of a chemical substance in free base form that does not encompass
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`pharmaceutically acceptable salts forms.
`
`Beginning with the language of the claims, claim 1 of the ʼ106 patent, the only
`
`independent claim, recites:
`
`1. A ready to use liquid pharmaceutical composition for parenteral
`to a subject, comprising dexmedetomidine or a
`administration
`pharmaceutically acceptable salt thereof disposed within a sealed glass
`container, wherein the liquid pharmaceutical composition when stored in
`the glass container for at least five months exhibits no more than about 2%
`decrease in the concentration of dexmedetomidine.
`
`ʼ106 Patent at col. 26, ll. 18-24 (emphasis added).
`
`First, on its face claim 1 literally distinguishes between dexmedetomidine and salts of
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`the common use of
`dexmedetomidine, and
`
`2 When the asserted patents all derive from the same parent application and share many common
`terms, the claims must be interpreted consistently across all asserted patents. See NTP, Inc. v.
`Research in Motion, Ltd., 418 F.3d 1282, 1293 (Fed. Cir. 2005).
`
`that
`
`the disjunctive
`
`term "or" reveals
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`
`
`8
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`

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`Case 1:15-cv-00697-RGA Document 44 Filed 04/28/16 Page 16 of 61 PageID #: 557
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`dexmedetomidine and its salts are claimed as alternatives. Kustom Signals, Inc. v. Applied
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`Concepts, Inc., 264 F.3d 1326, 1331 (Fed. Cir. 2001) (claim term "or" construed as referring to
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`alternative embodiments: "there is no basis whatsoever for believing that Kustom intended its
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`usage of 'or' somehow to embrace 'and.'"). As a result, the free base of dexmedetomidine is
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`understood in the context of the claims to be different from the salt form.
`
`Second, claim 1 recites
`
`that
`
`
`
`the concentration of
`
` dexmedetomidine (not
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof) exhibits no more than about a
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`2% decrease when the liquid pharmaceutical composition is stored in a glass container for at
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`least five months. This language makes clear the patentee