Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 1 of 59 Page|D #: 1530
`
`HV THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`IN RE BENDAl\/IUSTINE CONSOLIDATED
`
`CASES
`
`Q%%%%%%%
`
`C.A. No. 13-2046-GMS (consolidated)
`
`PLAHVTIFF CEPHALON H\IC.’S ANSWERING CLAIM CONSTRUCTION BRIEF
`
`OF COUNSEL:
`
`David M. Hashmall
`
`Calvin E. Wingfield Jr.
`Jonathan A. Auerbach
`
`Timothy J. Rousseau
`Joshua A. Whitehill
`GOODWIN PROCTER LLP
`
`The New York Times Building
`620 8th Avenue
`
`New York, New York 10018
`
`(212) 813-8800
`
`Paul F. Ware
`
`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. 1\/Iitrokostas
`
`GOODWIN PROCTER LLP
`
`Exchange Place
`53 State Street
`
`Boston, Massachusetts 02109
`
`(617) 570-1000
`
`Dated: January 16, 2015
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`SHAW KELLER LLP
`
`300 Delaware Avenue, Suite 1120
`
`Wilmington, Delaware 19801
`(302) 298-0700
`jshaw@shawkeller.com
`
`Stephen B. Brauerman (No. 4952)
`Vanessa R. Tiradentes (No. 5398)
`Sara E. Bussiere (No. 5725)
`BAYARD, P.A.
`
`222 Delaware Avenue, Suite 900
`
`Wilmington, Delaware 19801
`(302) 655-5000
`sbrauerman@bayardlaw.com
`vtiradentes@bayardlaw. com
`sbussiere@bayardlaw. com
`
`Counselfor PIaz'ntzflCephal0n, Inc.
`
`FRESENIUS KABI 1020-OOO1
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 2 of 59 Page|D #: 1531
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`TABLE OF CONTENTS
`
`Table of Authorities ..................................................................................................................... .. iii
`
`Table of Asserted Patents (Updated) ........................................................................................... .. vi
`
`Table of Abbreviations ............................................................................................................... .. vii
`
`Introduction .................................................................................................................................... . . 1
`
`Argument ....................................................................................................................................... ..2
`
`1.
`
`Proposed Constructions for the Disputed Terms of the ‘ 190 Patent ...................... ..2
`
`(a)
`
`(b)
`
`(c)
`
`(d)
`
`“Tertiary-Butyl Alcohol”: The Plain and Ordinary Meaning
`Applies ....................................................................................................... ..2
`
`“Pharmaceutical Composition”: The ‘190 Patent’s Express
`Definition Controls the Construction ......................................................... ..6
`
`“Lyophilized Pharmaceutical Composition” Encompasses
`Pharmaceutical Compositions That Are or Have Been Lyophilized ....... .. 10
`
`“0.5%” Refers to the Amount of Bendamustine Ethylester Relative
`to the Amount of Bendamustine, As Determined, e. g. , by HPLC ........... .. 12
`
`2.
`
`Proposed Constructions for the Disputed Terms of the ‘863 Patent .................... .. 14
`
`(a)
`
`(b)
`
`“Trace Amount of Tertiary-Butyl Alcohol (TBA)” Does Not
`Require That the Amount Be “Detectable” ............................................. .. 14
`
`“Stable Lyophilized Preparation”: The ‘863 Patent’s Express
`Definition Controls the Construction ....................................................... .. 15
`
`3.
`
`Proposed Constructions for the Disputed Terms of the ‘270 Patent .................... .. 18
`
`(a)
`
`(b)
`
`“Area Percent of Bendamustine” Should Be Construed How the
`Inventors Explicitly Defined That Phrase in the Patent
`Specification ............................................................................................ .. 18
`
`“Containing Not More Than About 0.9% [0.5% or 0.4%] (Area
`Percent of Bendamustine) of HP1” Means “Containing Not More
`Than about 0.9% [0.5% or 0.4%] of HP1 Relative to the Amount
`of Bendamustine As Determined, e. g. , by HPLC” .................................. ..20
`
`(c)
`
`“Amount of HP1 Measured at Time Zero after Reconstitution”:
`“Time Zero after Reconstitution” Refers to the First HPLC
`
`Measurement Taken Soon After the Lyophilized Preparation Is
`Dissolved in a Solvent, and Is Not Restricted to an Illusory, Precise
`Point in Time at Which the Lyophilized Preparation Is
`“Reconstituted” ........................................................................................ ..21
`
`“Bendamustine Degradants” Is Not Limited to the Four Degradants
`Identified in Accord and Breckenridge’s Construction ........................... ..24
`
`“Containing Less Than or Equal to 4.0% (Area Percent of
`Bendamustine) of Bendamustine Degradants” Should Be
`
`(d)
`
`(e)
`
`FRESENIUS KABI 1020-OOO2
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 3 of 59 Page|D #: 1532
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`Construed According to How the ‘270 Patent Explicitly Defines
`the Phrase’s Constituent Terms and Not to Require, As
`Innopharma Proposes, That the Claimed Composition Have “an
`Alcohol Added That Materially Alters the Solubility of
`Bendamustine” ......................................................................................... ..27
`
`(f)
`
`(g)
`
`(h)
`
`(i)
`
`“Pharmaceutical Composition”: The ‘270 Patent’s Express
`Definition Controls the Construction ....................................................... ..29
`
`“Pharmaceutical Composition That Has Been Reconstituted”
`Means “Pharmaceutical Composition That Has Been Dissolved in
`a Solvent” ................................................................................................. ..37
`
`“Lyophilized Preparation” and “Lyophilized Composition” Mean
`“Freeze-Dried Preparation” and “Freeze-Dried Composition” ............... ..40
`
`“Not More Than” / “Not More Than about” / “about” Should Be
`Construed According to Their Plain and Ordinary Meanings ................. ..4l
`
`4.
`
`Proposed Constructions for the Disputed Terms of the ‘524 Patent .................... ..42
`
`(a)
`
`(b)
`
`The Construction of “Solid Form of Bendamustine Hydrochloride,
`Designated As Bendamustine Hydrochloride Form 1” Should Not
`Include a Limitation That the Crystal Form “Does Not Contain
`Any Water” .............................................................................................. ..42
`
`The “X-Ray Powder Diffraction Pattern” Claim Terms Do Not
`Require “Peaks That Are Freestanding and Do Not Overlap with the
`Characteristic Peaks of Any of the Other Forms of Bendamustine” ......... ..47
`
`(c)
`
`“Lyophilized Composition” Means “Freeze-Dried Composition” .......... ..49
`
`Conclusion ................................................................................................................................... ..50
`
`ii
`
`FRESENIUS KABI 1020-OOO3
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 4 of 59 Page|D #: 1533
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`Abbott Labs. v. Dey, L.P.,
`287 F.3d 1097 (Fed. Cir. 2002) .............................................................................................. ..36
`
`ActiveVideo Networks, Inc. v. Verizon Commc ’ns, Inc.,
`
`694 F.3d 1312 (Fed. Cir. 2012) .............................................................................................. ..42
`
`Agere Sys., Inc. v. Broadcom Corp.,
`No. 03-3138, 2004 WL 1658530 (E.D. Pa. July 20, 2004) ................................................... ..22
`
`ArcelorMittal France v. AK Steel Corp,
`700 F.3d 1314 (Fed. Cir. 2012) .............................................................................................. ..32
`
`Aventis Pharma S.A. v. Hospira, Inc.,
`743 F. Supp. 2d 305 (D. Del. 2010) ....................................................................... ..3, 18, 28, 41
`
`Blackboard, Inc. v. Desire2Learn, Inc.,
`
`574 F.3d 1371 (Fed. Cir. 2009) .............................................................................................. ..38
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) .............................................................................................. ..32
`
`Cephalon Inc. v. Mylan Pharm. Inc.,
`962 F. Supp. 2d 688 (D. Del. 2013) ....................................................................................... ..22
`
`Comark Commc ’ns, Inc. v. Harris Corp.,
`156 F.3d 1182 (Fed. Cir. 1998) ...................................................................................... .. passim
`
`C VI/Beta Ventures, Inc. v. Tura LP,
`
`112 F.3d 1146 (Fed. Cir. 1997) .............................................................................................. ..32
`
`Epistar Corp. v. Int ’l Trade Comm ’n,
`566 F.3d 1321 (Fed. Cir. 2009) .............................................................................................. ..46
`
`Hill-Rom Servs., Inc. v. Stryker Corp,
`755 F.3d 1367 (Fed. Cir. 2014) ........................................................................................ ..33, 36
`
`Honeywell Int ’l, Inc. v. Universal Avionics Sys. Corp,
`493 F.3d 1358 (Fed. Cir. 2007) .............................................................................................. ..19
`
`In re Johnston,
`
`435 F.3d 1381 (Fed. Cir. 2006) .............................................................................................. ..38
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc.,
`381 F.3d 1111 (Fed. Cir. 2004) .............................................................................................. ..31
`
`iii
`
`FRESENIUS KABI 1020-0004
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 5 of 59 Page|D #: 1534
`
`Intel Corp. v. US. Int'l Trade Comm ’n,
`946 F.2d 821 (Fed. Cir. 1991) ............................................................................................ ..3, 32
`
`Intermec Techs. Corp. v. Palm Inc.,
`811 F. Supp. 2d 973 (D. Del. 2011) ................................................................................... ..4, 38
`
`Invitrogen Corp. v. Clontech Labs, Inc.,
`429 F.3d 1052 (Fed. Cir. 2005) .............................................................................................. ..34
`
`Kara Tech. Inc. v. Stamps. com Inc.,
`582 F.3d 1341 (Fed. Cir. 2009) .............................................................................. ..3, 18, 28, 41
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`
`358 F.3d 898 (Fed. Cir. 2004) ...................................................................................... ..5, 29, 33
`
`02 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008) .............................................................................................. ..24
`
`Paragon Solutions, LLC v. Timex Corp.,
`566 F.3d 1075 (Fed. Cir. 2009) .............................................................................................. ..22
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006) .............................................................................................. ..35
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .................................................................................. ..42, 46, 50
`
`Pragmatus AV, LLC v. Yahoo/ Inc.,
`No. CV 11-902-LPS-CJB, 2014 WL 1961980 (D. Del. May 15, 2014) ............................... ..35
`
`Purdue Pharma L.P. v. Endo Pharms., Inc. ,
`
`438 F.3d 1123 (Fed. Cir. 2006) .................................................................................. ..18, 28, 41
`
`Regents of Univ. ofMinnesota v. AGA Med. Corp.,
`717 F.3d 929 (Fed. Cir. 2013) ................................................................................................ ..32
`
`Renishaw PLC v. Marposs Societa ’ per Azioni,
`158 F.3d 1243 (Fed. Cir. 1998) ........................................................................................ ..22, 24
`
`ResQNet.com, Inc. v. Lansa, Inc.,
`346 F.3d 1374 (Fed. Cir. 2003) .............................................................................................. ..34
`
`SanDisk Corp. v. Memorex Prods., Inc.,
`415 F.3d 1278 (Fed. Cir. 2005) .............................................................................................. ..16
`
`Select Retrieval LLC v. Amerimark Direct LLC,
`
`No. 1:11-CV-00812-RGA, 2013 WL 5657565 (D. Del. Oct. 17, 2013) ........................... ..5, 29
`
`iv
`
`FRESENIUS KABI 1020-0005
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 6 of 59 Page|D #: 1535
`
`Sinorgchem Co., Shandong v. Int ’l Trade Comm ’n,
`511 F.3d 1132 (Fed. Cir. 2007) ...................................................................................... .. passim
`
`Thorner v. Sony Computer Enlm ’tAm. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) ...................................................................................... .. passim
`
`Utica Enterprises, Inc. v. Fed. Brooch &Mach. Co.,
`109 F. App’): 403 (Fed. Cir. 2004) .................................................................................... ..3, 32
`
`V
`
`FRESENIUS KABI 1020-0006
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 7 of 59 Page|D #: 1536
`
`TABLE OF ASSERTED PATENTS UPDATED
`
`The table below identifies the patents Cephalon is asserting against each Defendant:
`
`Defendant(s)
`
`‘524
`
`‘190
`
`‘863
`
`‘270
`
`Patent
`
`-nan
`
`X
`
`ZM
`
`ama
`Mama
`Z-Z
`H--H
`III!
`
`X
`
`--
`
`Accord Healthcare, Inc. and Intas
`Pharmaceuticals Ltd.
`
`Actavis LLC
`
`Agila Specialties Inc. f/k/a Strides, Inc. and
`Onco Therapies Limited
`
`Dr. Reddy’s Laboratories, Ltd. and Dr.
`Reddy’s Laboratories, Inc.
`
`Eagle Pharmaceuticals Ltd. (NDA filer)
`
`Emcure Pharmaceuticals Ltd. and Emcure
`
`Pharmaceuticals USA, Inc.
`
`Glenmark Pharmaceuticals Ltd., Glenmark
`
`Generics Ltd., Glenmark Generics S.A., and
`
`Glenmark Generics Inc., USA
`
`Hetero Labs Ltd. and Hetero USA Inc.
`
`Hospira, Inc.
`
`InnoPharma, Inc.
`
`Sandoz Inc.
`
`l.
`
`2.
`
`3.
`
`4.
`
`5 6
`
`.
`
`.
`
`8.
`
`9.
`
`10.
`
`11.
`
`12.
`
`Sun Pharma Global FZE and Sun
`
`Pharmaceutical Industries Ltd.
`
`Uman Pharma Inc.
`
`Breckenridge Pharmaceutical, Inc. and Natco
`Pharma Ltd.
`
`West-Ward Pharmaceutical Corp. and
`Eurohealth International Sarl
`
`Sagent Pharmaceutical, Inc.
`
`Wockhardt Bio AG, Wockhardt Ltd., and
`
`Wockhardt USA, LLC
`
`Vi
`
`- X
`
`III!
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`FRESENIUS KABI 1020-OOO7
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 8 of 59 Page|D #: 1537
`
`TABLE OF ABBREVIATIONS
`
`Ceph. Br.
`
`Plaintiff Cephalon Inc.’s Opening Claim Construction Brief (D.I. 85)
`
`Def. Br.
`
`Defendants’ Opening Claim Construction Brief (D.I. 89)
`
`Eagle Br.
`
`Defendants Eagle Pharmaceuticals, Inc. ’s Supplemental Opening Claim
`Construction Brief (D.I. 88)
`
`Vii
`
`FRESENIUS KABI 1020-OOO8
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 9 of 59 Page|D #: 1538
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`HVTRODUCTION
`
`Defendants’ varied positions and arguments should be rejected and Plaintiffs’ proposed
`
`constructions of the terms in the ‘ 190, ‘863, ‘270 and ‘524 patents should be adopted. The
`
`patents at issue in this case are directed to different attributes (formulations, impurity levels and
`
`polymorphic crystal forms) of Cephalon’s successful Treanda® treatment for two forms of
`
`cancer, chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma. The
`
`seventeen Defendants in this action have filed with the FDA for approval of generic versions of
`
`Cephalon’s product. While the Defendants have developed varying formulations of
`
`bendamustine (the active ingredient in Treanda®), when the claims are properly construed, each
`
`and every one of those proposed products infringes one or more of the asserted patents.’
`
`In its opening brief, Cephalon explained that for many terms, the inventors acted as their
`
`own lexicographers and the appropriate construction is to adopt the definition set forth in the
`
`specification. When such a construction is not set forth in the specification, the common
`
`meaning to a person of ordinary skill in the art controls. Different Defendants attempt to read
`
`different limitations into the various claims, presumably because they are attempting to generate
`
`non-infringement arguments for their different proposed generic products. But these results-
`
`oriented claim construction arguments from the Defendants should be rejected. The correct
`
`constructions are governed by the Federal Circuit’s canons of claim construction, not the
`
`Defendants’ attempts to create non-infringement positions by improperly narrowing the claims
`
`as they see fit.
`
`Notably, the Defendants cannot even agree on appropriate constructions among
`
`themselves. For example, Eagle Pharmaceuticals (the only Defendant who is not seeking
`
`1 This answering brief includes an updated Table of Asserted Patents that identifies which of the
`four patents-in-suit are currently asserted against each of the Defendants. This updated Table
`replaces the Table previously submitted with Cephalon’s opening brief.
`
`1
`
`FRESENIUS KABI 1020-0009
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 10 of 59 Page|D #: 1539
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`approval for a lyophilized formulation) argues that the ‘270 patent should be construed to cover
`
`only lyophilized products, see Eagle Br. at 1-2; the other Defendants admit that the ‘270 patent
`
`discloses “a ready-made solution” in the specification. Def. Br. at 23. As another example, every
`
`Defendant except Innopharma agrees that the term “tert-butyl alcohol” should be given its plain
`
`and ordinary meaning. Innopharma, on the other hand, proposes a 29-word construction, reading
`
`in a specific amount and function to this otherwise uncomplicated claim term. As explained
`
`below, for these and other terms, the Court should adopt the constructions proposed by Plaintiffs
`
`based on the intrinsic record of the patents-in-suit.
`
`ARGUMENT
`
`1.
`
`Proposed Constructions for the Disputed Terms of the ‘190 Patent
`
`(a)
`
`“Tertiary-Butyl Alcohol”: The Plain and Ordinary Meaning Applies
`
`Claim Term
`
`[applicable claims}
`“tertiary-butyl
`alcohol”
`
`Cephalon’s Proposed
`Construction
`
`Plain and ordinary
`meaning.
`
`[claims 1-3, 5, 6]
`
`Defendants’ Proposed Constructions
`
`Construction A (Innopharma only): “a
`pharmaceutically relevant amount of TBA that
`materially alters the solubility of bendamustine
`in water, wherein the amount of TBA is not
`
`less than 10% v/v and is separately added”
`
`Construction B: Plain and ordinary meaning.
`
`The claim term “tertiary-butyl alcohol” has a plain and ordinary meaning, and nearly
`
`every defendant agrees with Cephalon on that point. Innopharma appears to be the only
`
`defendant who disagrees and, in its 29-word construction for the three-word term “tertiary-butyl
`
`alcohol,” seeks to import limitations that are directly contradicted by the claim language and
`
`nowhere found in the specification. As explained below, the Court should reject Innopharma’s
`
`efforts to unduly narrow the plain and ordinary meaning of “tertiary-butyl alcohol.”
`
`Despite acknowledging that TBA is a well-known solvent with a well-understood
`
`meaning, see Def. Br. at 19, Innopharma seeks to import a complicated, multi-pronged “amount”
`
`2
`
`FRESENIUS KABI 1020-0010
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 11 of 59 Page|D #: 1540
`
`limitation into this straightforward term. The law of claim construction is clear, however, that
`
`“[a]bsent a clear disavowal in the specification or the prosecution history, the patentee is entitled
`
`to the full scope of its claim language.” See Ihorner v. Sony Computer Entm ’tAm. LLC, 669
`
`F.3d 1362, 1366 (Fed. Cir. 2012) (citation omitted). Innopharma fails to point to anything in the
`
`‘190 patent or its prosecution history that even suggests redefining “tertiary-butyl alcohol” to
`
`have the complicated meaning Innopharma proposes. Nor does Innopharma identify any
`
`intrinsic evidence of clear and unmistakable disavowal of the full scope of this claim term.
`
`Instead, Innopharma’s argument rests only on the disclosure of preferred and exemplary
`
`embodiments in the specification. But this Court has repeatedly recognized that preferred
`
`embodiments and examples should not be read as limitations into the claims. See, e. g., Kara
`
`Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341, 1347-48 (Fed. Cir. 2009) (specification
`
`embodiments do not limit the claims); Comark Commc ’ns, Inc. v. Harris Corp., 156 F.3d 1182,
`
`1187 (Fed. Cir. 1998) (same); Aventis Pharma S.A. v. Hospira, Inc., 743 F. Supp. 2d 305, 334
`
`n.10 (D. Del. 2010) (Sleet, J.) (“It is axiomatic, however, that courts should not import
`
`limitations into the claims from the specification”).
`
`Innopharma relies heavily on the inventors’ purported “purpose behind these patents[-in-
`
`suit]” “to make a more stable form of the well-known bendamustine drug,” and suggests that this
`
`goal requires the Court to construe “tertiary-butyl alcohol” to contain an “amount” limitation.
`
`Def. Br. at 19-21. Innopharma is wrong. The inventors’ stated purpose for the claimed
`
`invention, while sometimes informative, is not read into the claims. See Intel Corp. v. US. Int’l
`
`Trade Comm ’n, 946 F.2d 821, 836 (Fed. Cir. 1991) (“Although the specification
`
`stated that
`
`the goal of the invention was an UPROM cell that could withstand 300 hours of ultraviolet light
`
`exposure, this limitation is not contained in the claims”); Utica Enterprises, Inc. v. Fed. Brooch
`
`FRESENIUS KABI 1020-0011
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 12 of 59 Page|D #: 1541
`
`& Mach. C0,, 109 F. App’x 403, 408 (Fed. Cir. 2004) (construing term broader than goal stated
`
`in specification).
`
`Innopharma also relies heavily on Example 2 of the ‘ 190 patent and, in particular, the
`
`following statement: “The 20% (v/v) TBA may likely be the lower limit required for efficient
`
`and robust pharmaceutical manufacturing due to the stability and solubility of bendamustine.”
`
`‘190 patent at 29:41-43 (JA24) (emphasis added). But, as all the other Defendants who have
`
`similarly rejected Innopharma’s construction appear to acknowledge, this passage, using the
`
`phrase “may likely be” is merely permissive and, at most, reflects a preference to use
`
`concentrations of TBA of at least 20% v/v for purposes of “efficient and robust pharmaceutical
`
`manufacturing.” See, e.g., Intermec Techs. Corp. v. Palm Inc., 811 F. Supp. 2d 973, 988 (D. Del.
`
`2011) (refusing to limit claims when they had no express limitations, and the language in the
`
`specification that allegedly limited the claims through “inherency” contained permissive language
`
`such as “may”). Innopharma further relies on the Figures in the patents. But those describe
`
`varying amounts of tertiary-butyl alcohol, and Figure 4, for example, indicates that using 5% v/v
`
`TBA was also associated with reduced impurities. Nowhere does the patent state that 10% v/v is
`
`the minimum amount of TBA that can be used according to the invention. To the contrary, even
`
`Innopharma acknowledges that the patent states that “an organic solvent (0. 5-99. 9% v/v), such as
`
`TBA,” can be used. Def. Br. at 20 (emphasis added) (quoting ‘ 190 patent at 17:28-34 (JA18)).
`
`The claims of the ‘ 190 patent directly refute Innopharma’s suggestion that “tertiary-butyl
`
`alcohol,” without further qualification, is limited to a particular amount. Where the inventors
`
`wanted to limit the claims to specified amounts of tertiary-butyl alcohol, they did so explicitly.
`
`See ‘190 patent, claim 2 (JA26) (“said tertiary-butyl alcohol is present at a concentration of about
`
`10-50% (v/v)”), claim 3 (“said tertiary-butyl alcohol is present at a concentration of about 30%
`
`FRESENIUS KABI 1020-0012
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 13 of 59 Page|D #: 1542
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`(v/v)”), claim 4 (“said tertiary-butyl alcohol is present at a concentration of about 10-50%
`
`(v/v)”), and claim 6 (“said tertiary-butyl alcohol is present at a concentration of about 30%
`
`(v/v).” See Ceph. Br. at 7. There simply is no support in the intrinsic record for importing an
`
`“amount of TBA is not less than 10% v/v” limitation into the construction of this claim term.2
`
`Innopharma’s proposed construction is further marred by the fact that it seeks to add
`
`extraneous process limitations into the claims. Innopharma argues that the commonly
`
`understood term “tertiary-butyl alcohol” should be construed to require that the “tertiary-butyl
`
`alcohol” be “separately added” into the claimed formulation by relying on a statement in the
`
`specification that describes an exemplary process for formulating bendamustine compositions
`
`that happens to use the word “adding”: “pre-lyophilization solution or dispersion normally is
`
`first formulated in a pharmaceutically acceptable container by. .
`
`. adding an organic solvent (0.5-
`
`99.9% v/v), such as TBA to the aqueous solution with mixing at about 20°-35 °C.” Def. Br. at
`
`20 (quoting ‘190 patent at 17:28-34 (JA18)) (emphases added).
`
`In further support of its strained construction, Innopharma asserts that “[n]otably, there is
`
`not a single example [in the ‘ 190 patent specification] where TBA can be present without being
`
`separately added.” Def. Br. at 21. Even setting aside the ambiguity in the phrase “separately
`
`added,” nothing about the patent’s examples transforms “separately added” into a required claim
`
`element. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 905 (Fed. Cir. 2004) (refusing
`
`to read into the claims an element that was included in every example in the specification as a
`
`limitation absent a clear disavowal of embodiments lacking that element); Select Retrieval LLC
`
`v. AmerimarkDirect LLC, No. 1:11-CV-00812-RGA, 2013 WL 5657565, at *3 (D. Del. Oct. 17,
`
`2 This proposed “not less than 10% v/v” limitation also violates the doctrine of claim
`differentiation and improperly construes claim 1 to be narrower than dependent claims 2 and 5.
`See Ceph. Br. 6-7.
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`FRESENIUS KABI 1020-0013
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`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 14 of 59 Page|D #: 1543
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`2013) (same); see also Thorner, 669 F.3d at 1366 (Fed. Cir. 2012) (“It is likewise not enough
`
`that the only embodiments, or all of the embodiments, contain a particular limitation. We do not
`
`read limitations from the specification into claims[.]”). Innopharma’s proposed construction
`
`runs afoul of canons of claim construction, and the Court should reject it.
`
`For the foregoing reasons and those set forth in Cephalon’s opening brief, the Court
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`should reject Innopharma’s proposed construction for “tertiary-butyl alcohol (TBA)” and give
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`“tertiary-butyl alcohol” its plain and ordinary meaning, as Cephalon and all the remaining
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`defendants have proposed.
`
`(b)
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`“Pharmaceutical Composition”: The ‘190 Patent’s Express Definition
`Controls the Construction
`
`Claim Term
`
`[applicable
`claims]
`“pharmaceutical
`composition”
`
`[claims 1-9]
`
`Cephalorfs Proposed Construction Defendants’ Prnposed
`
`Constructinns
`
`“composition that is made under
`conditions such that it is suitable for
`
`Construction A: “a composition
`that is made under conditions such
`
`administration to humans, and
`
`includes, but is not limited to, a pre-
`lyophilization solution or dispersion as
`well as a liquid form ready for injection
`or infusion after reconstitution of a
`
`lyophilized preparation”
`
`that it is suitable for administration
`
`to humans”
`
`Construction B (Accord and
`Breckenridge only): “A pre-
`lyophilization solution, dispersion or
`liquid.”
`
`The ‘ 190 patent specification expressly defines the term “pharmaceutical composition,”
`
`and Cephalon’s proposed construction is the entirety of that definition:
`
`The term “pharmaceutical composition” as used herein shall mean a
`composition that
`is made under conditions such that
`it
`is suitable for
`administration to humans[.]
`As used herein pharmaceutical composition
`includes but is not limited to a pre-lyophilization solution or dispersion as well
`as a liquid form ready for injection or infusion after reconstitution of a
`lyophilized preparation.
`
`‘190 patent at 10:53-62 (JA14). When, as here, the inventors clearly chose to act as their own
`
`lexicographers and set forth an explicit definition for a claim term in the patent specification, the
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`FRESENIUS KABI 1020-0014
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`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 15 of 59 Page|D #: 1544
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`specification’s definition controls the term’s construction. See Sinorgchem C0., Shcmdong v.
`
`Im"l Trade Comm ’n, 511 F.3d 1132, 1136 (Fed. Cir. 2007). As explained below, the Court
`
`should reject Defendants’ alternative proposed constructions, which either disregard part of the
`
`express definition in the specification for the term “pharmaceutical composition,” or seek to
`
`completely rewrite that definition.
`
`Defendants’ Construction A: Twelve of the Defendants assert that a “pharmaceutical
`
`composition” is “a composition that is made under conditions such that it is suitable for
`
`administration to humans”—which is identical to the first half of Cephalon’s construction—but
`
`then proceed to delete the remainder of the express definition in the specification. These
`
`Defendants argue, however, that the second half of the definition (“and includes, but is not limited
`
`to, a pre-lyophilization solution or dispersion as well as a liquid form ready for injection or
`
`infusion after reconstitution of a lyophilized preparation”) is superfluous and unnecessary
`
`because “this very same language is found in the claims themselves.” Def. Br. at 23.
`
`Defendants point to nothing, however, that supports their argument.
`
`Defendants first focus on the fact that dependent claim 4 expressly requires a
`
`“lyophilized pharmaceutical composition.” Id. at 24. Defendants proceed to argue that, because
`
`the definition of pharmaceutical composition includes pre-lyophilized solutions, claim 4 is
`
`“nonsensical and contradictory.” Id. Defendants’ argument is flawed, however, because
`
`dependent claim 4 is a narrower claim, which further limits the pharmaceutical compositions in
`
`claim 1 to “lyophilized pharmaceutical compositions.” There is nothing nonsensical or
`
`contradictory about that. Indeed, it is completely logical that the patentee intended the term
`
`“pharmaceutical composition” in independent claim 1 to be broader than the “lyophilized
`
`pharmaceutical composition” in claim 4. See Ceph. Br. at 10-1 1. Moreover, and contrary to
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`FRESENIUS KABI 1020-0015
`
`

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`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 16 of 59 Page|D #: 1545
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`Defendants’ contention, Cephalon’s proposed construction for “lyophilized pharmaceutical
`
`composition” is entirely consistent because it does not cover a pre-lyophilized solution since it is
`
`limited to, among other things, “a pre-lyophilization solution or dispersion that has been freeze-
`
`dried,” i.e., lyophilized. See Ceph. Br. at ll; infra, § l(c).
`
`Similarly, notwithstanding Defendants’ contention to the contrary, claim 1 of the ‘270
`
`patent (which has a nearly identical specification as the ‘ 190 patent) is consistent with
`
`Cephalon’s proposed construction and the express definition in the specification. Claim 1 of the
`
`‘270 patent limits the claimed pharmaceutical compositions to those that have “been
`
`reconstituted from a lyophilized preparation.” (JA83). Claim 7 recites only a “pharmaceutical
`
`composition,” without specifying whether the composition is reconstituted, lyophilized, pre-
`
`lyophilized, or not lyophilized at all.
`
`(Id.) Thus, the additional language in independent claim 1
`
`modifies “pharmaceutical composition” so that the claim covers a narrower subset of
`
`compositions than those recited in independent claim 7. Cephalon’s construction, which is the
`
`express definition in the specification, does not render any claim elements in the ‘270 patent
`
`superfluous.
`
`Defendants’ Construction B: Two defendants, Accord and Breckenridge, argue that
`
`“pharmaceutical composition” must be limited to a pre-lyophilization solution, dispersion or
`
`liquid. That construction ignores the definition in the specification, which makes clear that the
`
`term is not limited in that way. The patent explicitly states that a “pharmaceutical composition”
`
`“is not limited to a pre-lyophilization solution or dispersion” and that it “includes,” among other
`
`things, “a liquid form ready for injection or infusion after reconstitution of a lyophilized
`
`preparation.” ‘ 190 patent at 10:53-62 (JAl4). Other parts of the specification likewise indicate
`
`that a “pharmaceutical composition” is not limited to “a pre-lyophilization solution, dispersion or
`
`FRESENIUS KABI 1020-0016
`
`

`
`Case 1:13—cv—O2046—GMS Document 138 Filed 01/16/15 Page 17 of 59 Page|D #: 1546
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`liquid.” See, e. g., id. at 3:4-22 (JA11) (“An embodiment of the invention is a pharmaceutical
`
`composition of bendamustine containing not more than about 0.5% to about 0.9% (area percent of
`
`bendamustine) HP1
`
`at time zero after reconstitution of a lyophilized pharmaceutical
`
`composition of bendamustine as described herein”) (emphases added); 4:27-50 (JA11) (similar);
`
`7:25-37 (JA13) (“Included in the inventions are methods of treating a medical condition in a
`
`patient that involve administering a therapeutically effective amount of a pharmaceutical
`
`composition of the invention where the condition is amenable to treatment with said
`
`pharmaceutical composition”) (emphasis adde