Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 1 of 58 PageiD #: 945
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`IN RE BENDAMUSTINE CONSOLIDATED )
`CASES
`)
`)
`)
`_____________________________ )
`
`C.A No. 13-2046-GMS (consolidated)
`
`PLAINTIFF CEPHALON, INC.'S OPENING 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 A venue
`New York, New York 10018
`(212) 813-8800
`
`Paul F. Ware
`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`GoODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, Massachusetts 02109
`(617) 570-1000
`
`Dated: December 19, 2014
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, Delaware 19801
`(302) 298-0700
`j shaw@shawkeller. com
`kkell er@shawkell er. com
`
`Stephen B. Brauerman (No. 4952)
`Vanessa R. Tiradentes (No. 5398)
`Sara E. Bussiere (No. 5725fs)
`BAYARD, P.A.
`222 Delaware Avenue, Suite 900
`Wilmington, Delaware 19801
`(302) 655-5000
`sbrauerman@bayardlaw. com
`vitradentes@bayardlaw.com
`sbussiere@bayardlaw.com
`
`Counsel for Plaintif.!Cephalon, Inc.
`
`FRESENIUS KABI1015-0001
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 2 of 58 PageiD #: 946
`
`TABLE OF CONTENTS
`
`Table of Authorities ....................................................................................................................... iii
`
`Table of Asserted Patents ............................................................................................................... vi
`
`Introduction ...................................................................................................................................... !
`
`Background ..................................................................................................................................... .2
`
`Argument ......................................................................................................................................... 4
`
`1.
`
`Proposed Constructions for the Disputed Terms of the' 190 Patent ....................... .4
`
`(a)
`
`(b)
`
`(c)
`
`"Tertiary-Butyl Alcohol" Should Be Construed According to Its
`Plain and Ordinary Meaning ........................................................................ 4
`
`"Pharmaceutical Composition" Means "Composition That Is Made
`under Conditions Such That It Is Suitable for 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" ................................................................................................. 8
`
`"Lyophilized Pharmaceutical Composition" Means "Freeze-Dried
`Composition That Is Made under Conditions Such That It Is
`Suitable for Administration to Humans, and Includes, but Is Not
`Limited to, a Pre-Lyophilization Solution or Dispersion That Has
`Been Freeze-Dried As Well As a Liquid Form Ready for Injection
`or Infusion after Reconstitution of a Lyophilized Preparation" ................. 11
`
`(d)
`
`"0.5%" Means "0.5 Area Percent Relative to the Amount of
`Bendamustine As Determined, e.g., by HPLC" ......................................... 12
`
`2.
`
`Proposed Constructions for the Disputed Terms of the '863 Patent ...................... 15
`
`(a)
`
`(b)
`
`"Trace Amount of Tertiary-Butyl Alcohol (TBA)" Means
`"Amount of Tertiary-Butyl Alcohol That Is Equal to or Below
`Recommended Levels for Pharmaceutical Products" ................................ 15
`
`"Stable Lyophilized Preparation" Means "Solid Material Obtained
`by Freeze-Drying Having Sufficient Stability to Have Utility As a
`Pharmaceutical Product" ............................................................................ 17
`
`3.
`
`Proposed Constructions for the Disputed Terms of the '270 Patent ..................... .20
`
`(a)
`
`(b)
`
`"Area Percent ofBendamustine" Means "Amount of a Specified
`Degradant Relative to the Amount ofBendamustine As
`Determined, e.g., by HPLC" ..................................................................... .20
`
`"Containing Not More Than About 0.9% [0.5% or 0.4%] (Area
`Percent ofBendamustine) ofHPl" Means "Containing Not More
`Than about 0.9% [0.5% or 0.4%] ofHPl Relative to the Amount
`of Bendamustine As Determined, e.g., by HPLC" ................................... .21
`
`FRESENIUS KABI1015-0002
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 3 of 58 PageiD #: 947
`
`(c)
`
`(d)
`
`(e)
`
`(f)
`
`(g)
`
`(h)
`
`(i)
`
`"Amount ofHPl Measured at Time Zero after Reconstitution"
`Means "Amount ofHPl Measured Soon after Dissolution in a
`Solvent" ..................................................................................................... .23
`
`"Bendamustine Degradants" Means "Chemical Compounds
`Resulting from a Change in Chemical Structure of Bendamustine" ........ .24
`
`"Containing Less Than or Equal to 4.0% (Area Percent of
`Bendamustine) of Bendamustine Degradants" Means "Containing
`Less Than or Equal to 4% of Total Chemical Compounds
`Resulting from a Change in Chemical Structure OfBendamustine
`Relative to the Amount ofBendamustine As Determined, e.g., by
`HPLC" ....................................................................................................... .27
`
`"Pharmaceutical Composition" Means "Composition That Is Made
`under Conditions Such That It Is Suitable for 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" ............................................................................................... 32
`
`"Pharmaceutical Composition That Has Been Reconstituted"
`Means "Pharmaceutical Composition That Has Been Dissolved in
`a Solvent" ................................................................................................... 37
`"Lyophilized Preparation" I "Lyophilized Composition" Means
`"Freeze-Dried Preparation" I "Freeze-Dried Composition" ...................... 38
`"Not More Than" I "Not More Than about" I "about" Should Be
`Construed According to Their Plain and Ordinary Meanings ................... 39
`
`4.
`
`Proposed Constructions for the Disputed Terms of the '524 Patent ..................... .40
`
`(a)
`
`(b)
`
`"Solid Form ofBendamustine Hydrochloride, Designated As
`Bendamustine Hydrochloride Form 1" Should Be Construed As
`"Crystal Form ofBendamustine Hydrochloride That Can Be
`Distinguished from Other Forms by Its X-Ray Powder Diffraction
`Pattern" ...................................................................................................... 40
`
`The "X-Ray Powder Diffraction Pattern" Claim Terms Should Be
`Construed According to Their Plain Meanings, as Cephal on
`Proposes, and Not to Require, As Defendants Assert, "Peaks That
`Are Freestanding and Do Not Overlap with the Characteristic Peaks
`of Any of the Other Forms ofBendamustine" ........................................... .43
`
`(c)
`
`"Lyophilized Composition" Means "Freeze-Dried Composition" ........... .49
`
`Conclusion ..................................................................................................................................... 50
`
`11
`
`FRESENIUS KABI1015-0003
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 4 of 58 PageiD #: 948
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`
`Abbott Labs. v. Dey, L.P.,
`287 F.3d 1097 (Fed. Cir. 2002) ................................................................................................ 36
`
`Active Video Networks, Inc. v. Verizon Commc 'ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) ............................................................................................... .40
`
`AFG Indus., Inc. v. Cardinal IG Co,
`375 F.3d 1367 (Fed. Cir. 2004) .................................................................................................. 7
`
`Alcon Research, Ltd v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012) .................................................................................................. 6
`
`Aventis Pharma S.A. v. Hospira, Inc.,
`743 F. Supp. 2d 305 (D. Del. 2010) .................................................................................. .20, 31
`
`Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
`512 F.3d 1338 (Fed. Cir. 2008) .................................................................................................. 7
`
`Beachcombers v. Wilde Wood Creative Products, Inc.,
`31 F.3d 1154 (Fed. Cir. 1994) ................................................................................................. .46
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ................................................................................................ 31
`
`Cardiac Sci., Inc. v. Koninklijke Philips Elecs. NV,
`No. 03-1064, 2006 WL 1050629 (D. Minn. Apr. 20, 2006) .................................................... 35
`
`Comark Commc 'ns, Inc. v. Harris Corp.,
`156 F.3d 1182 (Fed. Cir. 1998) .............................................................................. 19, 31, 39, 46
`
`Dealertrack, Inc. v. Huber,
`674 F.3d 1315 (Fed. Cir. 2012) .......................................................................................... 10, 26
`
`Epistar Corp. v. Int 'l Trade Comm 'n,
`566 F.3d 1321 (Fed. Cir. 2009) ............................................................................................... .47
`
`Ferring B. V v. Watson Labs., Inc.-Fla.,
`764 F.3d 1382 (Fed. Cir. 2014) ............................................................................................... .22
`
`Gillette Co. v. Energizer Holdings, Inc.,
`405 F.3d 1367 (Fed. Cir. 2005) ............................................................................................... .44
`
`Honeywell Int 'l, Inc. v. Universal Avionics Sys. Corp.,
`493 F.3d 1358 (Fed. Cir. 2007) .................................................................................................. 9
`
`111
`
`FRESENIUS KABI1015-0004
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 5 of 58 PageiD #: 949
`
`Intamin Ltd v. Magnetar Techs., Corp.,
`483 F.3d 1328 (Fed. Cir. 2007) .................................................................................................. 6
`
`InterDigital Commc'ns, LLC v. Int'l Trade Comm 'n,
`690 F.3d 1318 (Fed. Cir. 2012) ................................................................................................ 34
`
`Intervet Inc. v. Merial Ltd,
`617 F.3d 1282 (Fed. Cir. 2010) ............................................................................................... .20
`
`Invensas Corp. v. Renesas Elecs. Corp.,
`No. 11-448-GMS, 2013 WL 3753621 (D. Del. July 15, 2013) ............................................... 16
`
`Johnson Worldwide Assocs., Inc. v. Zebco Corp.,
`175 F.3d 985 (Fed. Cir. 1999) .................................................................................................. 30
`
`Kara Tech. Inc. v. Stamps. com Inc.,
`582 F.3d 1341 (Fed. Cir. 2009) .......................................................................................... 19, 31
`
`L'Oreal S.A. v. Johnson & Johnson Consumer Cos.,
`No. 12-98-GMS, 2013 WL 3788803 (D. Del. July 19, 2013) ................................................. 16
`
`Linear Tech. Corp. v. Int 'l Trade Comm 'n,
`566 F.3d 1049 (Fed. Cir. 2009) ................................................................................ 9, 18, 21, 33
`
`Merck & Co. v. Teva Pharm. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) ............................................................................................ 6, 22
`
`Mobil Oil Corp. v. Amoco Chems. Corp.,
`779 F. Supp. 1429 (D. Del. 1991) ............................................................................................ 16
`
`Nippon Steel & Sumitomo Metal Corp v. FOSCO,
`No. 12-2429, 2014 WL 2534929 (D.N.J. June 4, 2014) ......................................................... .49
`
`0 2 Micro Int 'l Ltd v. Beyond Innovation Tech. Co.,
`521 F. 3d 1351 (Fed. Cir. 2008) .............................................................................................. .23
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd,
`457 F.3d 1284 (Fed. Cir. 2006) ................................................................................................ 36
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en bane) ........................................................................ passim
`
`Prism Techs. LLC v. Verisign, Inc.,
`512 F. Supp. 2d 174 (D. Del. 2007) ......................................................................................... 16
`
`ResQNet.com, Inc. v. Lansa, Inc.,
`346 F.3d 1374 (Fed. Cir. 2003) ................................................................................................ 36
`
`IV
`
`FRESENIUS KABI1015-0005
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 6 of 58 PageiD #: 950
`
`Scriptgen Pharm., Inc. v. 3-Dimensional Pharm., Inc.,
`79 F. Supp. 2d 409 (D. Del. 1999) ........................................................................................... 34
`
`Sinorgchem Co., Shandong v. Int 'l Trade Comm 'n,
`511 F.3d 1132 (Fed. Cir. 2007) ........................................................................................ passim
`
`Teva Pharm. Indus. v. Dr. Reddy's Labs., Ltd,
`No. 07-2894, 2008 WL 2557510 (D.N.J. June 23, 2008) ........................................................ 36
`
`Thorner v. Sony Computer Entm 'tAm. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) ........................................................................................ passim
`
`Virnetx, Inc. v. Cisco Sys., Inc.,
`767 F.3d 1308 (Fed. Cir. 2014) ................................................................................................ 34
`
`Vitro nics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) .................................................................................................... 9
`
`Water Techs. Corp. v. Calco, Ltd,
`850 F.2d 660 (Fed. Cir. 1988) .................................................................................................. 36
`
`Woods v. DeAngelo Marine Exhaust, Inc.,
`692 F.3d 1272 (Fed. Cir. 2012) ............................................................................................... .20
`
`v
`
`FRESENIUS KABI1015-0006
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 7 of 58 PageiD #: 951
`
`TABLE OF ASSERTED PATENTS
`
`The table below identifies the patents Cephalon is asserting against each Defendant:
`
`Defendant(s)
`
`'524
`
`'190
`
`'863
`
`'270
`
`Patent
`
`1.
`
`2.
`
`3.
`
`Accord Healthcare, Inc. and Intas
`Pharmaceuticals Ltd.
`
`Actavis LLC
`
`Agila Specialties Inc. f/kla Strides, Inc. and
`Onco Therapies Limited
`
`4. Dr. Reddy's Laboratories, Ltd. and Dr.
`Reddy's Laboratories, Inc.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`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.
`
`10.
`
`InnoPharma, Inc.
`
`11. Sandoz Inc.
`
`12. Sun Pharma Global FZE and Sun
`Pharmaceutical Industries Ltd.
`
`13. Uman Pharma Inc.
`
`14. Breckenridge Pharmaceutical, Inc. and Natco
`Pharma Ltd.
`
`15. West-Ward Pharmaceutical Corp. and
`Eurohealth International Sarl
`
`16. Sagent Pharmaceutical, Inc.
`
`17. Wockhardt Bio AG, Wockhardt Ltd., and
`W ockhardt USA, LLC
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`Vl
`
`FRESENIUS KABI1015-0007
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 8 of 58 PageiD #: 952
`
`INTRODUCTION
`
`The parties dispute constructions of approximately twenty claim terms in the four
`
`patents-in-suit. Plaintiff Cephal on, Inc. ("Cephal on") requests that the Court construe each term
`
`according to the patent's express definition of the term, when one is provided. Where no express
`
`definition is provided in the specification, Cephalon seeks a construction that is consistent with
`
`the term's plain and ordinary meaning in light of the intrinsic record. Cephalon's approach is
`
`consistent with binding precedent, which requires that a claim term carry its plain and ordinary
`
`meaning unless the inventors expressly defined the term in the patent or "clearly and
`
`unmistakably" disavowed the full scope of the term in the specification or during prosecution.
`
`In contrast, the varying constructions offered by Defendants 1
`'
`
`2 violate basic principles of
`
`claim construction and conflict with the intrinsic record. For example, Defendants improperly
`
`disregard the patents' explicit definitions of terms, proffering instead conflicting constructions
`
`that ignore the fact that the inventors unequivocally acted as their own lexicographers. Even
`
`where Defendants rely on definitions in the specifications, their proposed constructions
`
`selectively or arbitrarily read out words and phrases from the patent's definitions. Elsewhere,
`
`Defendants improperly seek to read examples or preferred embodiments in the specification as
`
`limitations into the claims, try to import limitations that are found nowhere in the patents, or
`
`portray the prosecution history as effectuating a disavowal of claim scope where there was none.
`
`For the reasons set forth below, the Court should adopt Cephalon's proposed construction for
`
`each claim term in dispute, and reject Defendants' proposed constructions, which are nothing
`
`more than transparent attempts to manufacture defenses to infringement where none exists.
`
`1 The 17 Defendants in this consolidated action are unable to reach agreement, even among
`themselves, as to the proper construction of some terms. In those situations, the Defendants have
`proposed multiple constructions (denominated "Construction A," "Construction B" etc.).
`2 Eagle requested and was granted leave to file a supplemental opening brief to address the two
`claim terms it disputes. Cephal on addresses Eagle's proposed constructions in this brief
`
`1
`
`FRESENIUS KABI1015-0008
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 9 of 58 PageiD #: 953
`
`BACKGROUND
`
`Cephalon brought these consolidated actions against Defendants for infringing U.S.
`
`Patent Nos. 8,436,190 ("the' 190 patent"), 8,609,863 ("the '863 patent"), 8,791,270 ("the '270
`
`patent"), and 8,445,524 ("the '524 patent") (collectively, "the patents-in-suit") because
`
`Defendants seek FDA approval to market generic versions ofCephalon's Treanda® injectable
`
`products before those patents expire? Treanda® contains bendamustine hydrochloride as its
`
`active ingredient and is widely prescribed in the United States for the treatment of at least two
`
`types of cancer: chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma.
`
`The FDA has awarded Treanda ® orphan-drug exclusivity in recognition of Treanda ®, s success in
`
`addressing the unmet medical needs of patients suffering from these relatively rare forms of
`
`cancer. As originally marketed, Treanda® was sold as a lyophilized (i.e., freeze-dried) powder4
`
`in single-use vials of either 25 mg or 100 mg ofbendamustine hydrochloride. The powder itself,
`
`however, is not injected into patients. Before Treanda® is injected, the powder is dissolved or
`
`reconstituted in a small amount of water and then further diluted in an IV infusion bag.
`
`Bendamustine hydrochloride was originally developed in the 1960s in East Germany,
`
`where, beginning in the 1970s, it was sold as a lyophilized injectable anti-cancer drug under the
`
`name Cytostasan and later Ribomustin. Bendamustine hydrochloride, however, was known to be
`
`highly unstable, especially in water. It was understood that, when dissolved in or crystallized
`
`with solvents such as water, bendamustine hydrochloride quickly degraded and formed inactive
`
`degradant products, resulting in a loss of potency and threatening the therapeutic effect of the
`
`product. Moreover, the solubility of the prior Ribomustin and Cytostasan formulations was such
`
`that dissolution of those formulations in water, which was necessary prior to injection, required a
`
`3 The Table of Asserted Patents, supra, identifies the patents asserted against each Defendant.
`4 Cephal on recently launched a liquid formulation of Treanda®.
`
`2
`
`FRESENIUS KABI1015-0009
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 10 of 58 PageiD #: 954
`
`relatively long period of time. The instability ofbendamustine hydrochloride in water thus also
`
`created technical difficulties in preparing and administering bendamustine hydrochloride
`
`formulations that limited its usefulness as a pharmaceutical product. It was not until decades
`
`after bendamustine hydrochloride was first developed that scientists from Cephalon finally
`
`invented improved formulations and crystalline forms ofbendamustine hydrochloride that were
`
`stable and significantly reduced the tendency ofbendamustine hydrochloride to degrade. Those
`
`inventions, embodied and claimed in the patents Cephalon is asserting against Defendants in this
`
`case, provided the pathway for Cephalon to develop and launch Treanda® in the United States,
`
`which FDA approved in 2008. Treanda® is an undeniable commercial success, generating sales
`
`of approximately $3 billion in the United States alone since the product's approval.
`
`The '190, '863, and '270 Patents: The '190, '863, and '270 patents share a common
`
`specification and arise from the discovery ofvarious formulations ofbendamustine
`
`hydrochloride having improved stability and lower degradant profiles than the prior art
`
`formulations. The claims of the' 190 patent recite various pharmaceutical compositions
`
`generally comprising bendamustine hydrochloride, mannitol, tertiary-butyl alcohol ("TBA"), and
`
`water. The claims of the '863 patent recite various stable lyophilized preparations generally
`
`comprising bendamustine hydrochloride, mannitol, and a trace amount of TBA. The claims of
`
`the '270 patent recite various pharmaceutical compositions ofbendamustine hydrochloride
`
`having reduced levels of degradants, such as HP1, bendamustine ethylester, BM1 dimer, and
`
`BM1DCE, and methods of using those formulations to treat certain types of cancers.
`
`The '524 Patent: The '524 patent is directed to a novel crystalline form ofbendamustine
`
`hydrochloride, referred to in short-hand as "Form 1," that the patent's inventors found to be
`
`generally more stable than prior art crystalline forms ofbendamustine hydrochloride. As
`
`3
`
`FRESENIUS KABI1015-0010
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 11 of 58 PageiD #: 955
`
`described in the '524 patent, Form 1 is distinguishable from other crystalline forms of
`
`bendamustine hydrochloride (e.g., Form 2, Form 3, and Form 4) by the specific pattern of peaks
`
`that are generated when tested by a technique known as X-ray Powder Diffraction, or "XRPD."
`
`The claims of the '524 patent recite Form 1, compositions comprising Form 1, methods of
`
`preparing such compositions, and methods of treating cancer using those compositions.
`
`ARGUMENT
`
`Phillips v. AWH Corp. sets forth a guide for claim construction. 415 F.3d 1303, 1312-19
`
`(Fed. Cir. 2005) (en bane). A claim term is examined to determine whether it has an ordinary
`
`meaning to a person of skill in the technical field of the patent. !d. at 1312-13. Where a term has
`
`an ordinary meaning, it should be given that meaning unless the intrinsic evidence, the patent
`
`specification and prosecution history, point to an alternative meaning. Id.
`
`1.
`
`Proposed Constructions for the Disputed Terms of the '190 Patent
`
`(a)
`
`"Tertiary-Butyl Alcohol" Should Be Construed According to Its Plain and
`Ordinary Meaning
`
`Claim Term
`[applicable claims]
`"tertiary-butyl
`alcohol"
`
`Cephalon's Proposed
`Construction
`Plain and ordinary
`meamng.
`
`[claims 1-3, 5, 6]
`
`Defendants' Proposed Constructions
`
`Construction A: "a pharmaceutically relevant
`amount ofTBA that materially alters the
`solubility ofbendamustine in water, wherein
`the amount of TBA is not less than 10% v/v
`and is separately added"
`
`Construction B: Plain and ordinary meaning.
`
`As some of the Defendants agree, 5 tertiary-butyl alcohol (TBA) is an organic solvent with
`
`a well-understood, plain and ordinary meaning in the art. And neither the' 190 patent
`
`specification nor its prosecution history deviates from that well-understood meaning. See, e.g.,
`
`5 Although Defendants propose multiple constructions for several disputed claim terms,
`Cephalon does not know which Defendants propose which constructions. Cephalon asked
`Defendants to identify who proposes which constructions, but Defendants (other than Eagle)
`have refused to provide that information.
`
`4
`
`FRESENIUS KABI 1015-0011
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 12 of 58 PageiD #: 956
`
`'190 patent at 5:16-18 (JA12)6 ("A more preferred organic solvent is tertiary butanol, also known
`
`as TBA, t-butanol, tert-butyl alcohol or tertiary butyl alcohol"). Cephal on and some Defendants,
`
`therefore, propose that "tertiary-butyl alcohol" be given its plain and ordinary meaning. See
`
`Thorner v. Sony Computer Entm 'tAm. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) ("The words
`
`of a claim are generally given their ordinary and customary meaning as understood by a person
`
`of ordinary skill in the art when read in the context of the specification and prosecution history.
`
`There are only two exceptions to this general rule: 1) when a patentee sets out a definition and
`
`acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term
`
`either in the specification or during prosecution.") (citations omitted).
`
`Other Defendants, however, propose a construction of "tertiary-butyl alcohol" requiring
`
`that the "amount" ofTBA present in the claimed compositions (1) be "pharmaceutically
`
`relevant," (2) "materially alter[] the solubility ofbendamustine in water," (3) be "not less than
`
`10% v/v," and (4) be "separately added." See Defendants' Construction A Defendants'
`
`unnecessarily complicated, multi -pronged construction of "tertiary-butyl alcohol" is unsupported
`
`by the plain claim language or the intrinsic evidence and, thus, the Court should reject it.
`
`First, inserting an "amount" limitation into the construction of "tertiary-butyl alcohol"
`
`does not make sense. Claim 1 of the '190 patent recites a composition comprising bendamustine
`
`hydrochloride, mannitol, TBA, and water, but does not contain any "amount" limitations for any
`
`of the claimed components. See '190 patent, claim 1 (JA26). There is no contextual reason to
`
`import an "amount" limitation into claim 1 for only one of the four recited components.
`
`Furthermore, construing "tertiary-butyl alcohol" to require that TBA be present in the
`
`claimed compositions in an amount "not less than 10% v/v" would violate the principle of claim
`
`6 Citations to "JA_" refer to corresponding pages of the Joint Appendix oflntrinsic Evidence.
`
`5
`
`FRESENIUS KABI1015-0012
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 13 of 58 PageiD #: 957
`
`differentiation by making claim 1 directly conflict with or be redundant of the language of other
`
`claims in the same patent. See Phillips, 415 F.3d at 1324-25 ("The inclusion of such a specific
`
`limitation on the term 'baffles' in claim 2 makes it likely that the patentee did not contemplate
`
`that the term 'baffles' [as recited in claim 1] already contained that limitation."). For example,
`
`whereas claim 1 does not recite any "amount" for TBA, claims 2 and 5- both of which depend
`
`from claim 1- recite compositions comprising, inter alia, TBA concentrations of"about 10-50%
`
`(v/v)." See '190 patent, claims 1, 2 and 5 (JA26). The inclusion of such a specific amount
`
`limitation on the term "tertiary-butyl alcohol" in claims 2 and 5 means the patentee did not
`
`contemplate that the term "tertiary-butyl alcohol" alone, as recited in independent claim 1,
`
`already contained such a limitation. See Phillips, 415 F.3d at 1324-25.
`
`To make matters worse, Defendants propose that "tertiary-butyl alcohol" in claim 1 is
`
`limited to "not less than 10% v/v," but claims 2 and 5 depend from claim 1 and specifically
`
`recite a broader concentration of"about 10-50% (v/v)." The Court should reject Defendants'
`
`proposed construction because it would make independent claim 1 narrower than the explicit
`
`limitations of dependent claims 2 and 5. See Alcon Research, Ltd v. Apotex Inc., 687 F.3d 1362,
`
`1367 (Fed. Cir. 2012) ("It is axiomatic that a dependent claim cannot be broader than the claim
`
`from which it depends."); Intamin Ltd v. Magnetar Techs., Corp., 483 F.3d 1328, 1335 (Fed.
`
`Cir. 2007) ("An independent claim impliedly embraces more subject matter than its narrower
`
`dependent claim."). Moreover, Defendants' proposal of limiting "tertiary-butyl alcohol" to an
`
`amount "not less than 10% v/v" improperly reads the term "about" out of claims 2 and 5, and
`
`makes no sense. See Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1369-72 (Fed. Cir.
`
`2005) (refusing to construe "about" to mean "exactly" and holding that "about" has a plain and
`
`ordinary meaning of "approximately").
`
`6
`
`FRESENIUS KABI1015-0013
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 14 of 58 PageiD #: 958
`
`Second, Defendants' proposal to include limitations about a "pharmaceutically relevant"
`
`amount of TBA or an amount that "materially alters the solubility ofbendamustine in water"
`
`lacks any support in the intrinsic evidence. The' 190 patent specification never uses either
`
`phrase or comes close to stating that either criterion is necessary for the claimed inventions. The
`
`same is true as to the "separately added" limitation that some of the Defendants propose.
`
`Moreover, the Court should reject Defendants' proposed "separately added" limitation
`
`because it would import a process limitation into what are plainly product claims. See Baldlvin
`
`Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1344 (Fed. Cir. 2008) ("Courts must generally
`
`take care to avoid reading process limitations into [a product] claim, because the process by
`
`which a product is made is irrelevant to the question of whether that product infringes a pure
`
`[product] claim."); AFG Indus., Inc. v. Cardinal IG Co, 375 F.3d 1367, 1372-73 (Fed. Cir. 2004)
`
`(declining to import a process limitation into a product claim).
`
`Finally, the Court should reject the proposed requirement that TBA be "separately added"
`
`when preparing the composition because it merely adds ambiguity to the scope of the claim. Do
`
`the claims cover compositions comprising TBA that was added in combination with another
`
`ingredient? Do the claims cover compositions comprising TBA that is present in the
`
`composition merely because it was an impurity in another ingredient? Given the uncertainty
`
`about what the phrase "separately added" would mean in the context claims, the Court should
`
`reject Defendants' proposal to add that phrase to the construction here.
`
`Cephalon's plain-meaning construction for "tertiary-butyl alcohol" is consistent with how
`
`the term is used throughout the '190 patent specification, and how a person of ordinary skill in
`
`7
`
`FRESENIUS KABI1015-0014
`
`

`

`Case 1:13-cv-02046-GMS Document 85 Filed 12/19/14 Page 15 of 58 PageiD #: 959
`
`the art7 would understand that term in view of the claim language and the intrinsic evidence. See
`
`Phillips, 415 F.3d at 1315-17. The inventors did not redefine "tertiary-butyl alcohol" to have a
`
`meaning other than its usual meaning, nor did they clearly and unmistakably disavow the full
`
`scope of the term "tertiary-butyl alcohol." See Thorner, 669 F .3d at 1366-67 ("We do not read
`
`limitations from the specification into claims; we do not redefine words. Only the patentee can
`
`do that. To constitute disclaimer, there must be a clear and unmistakable disclaimer.").
`
`(b)
`
`"Pharmaceutical Composition" Means "Composition That Is Made under
`Conditions Such That It Is Suitable for 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 Infu