celg v act - joint markman statement
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Charles M. Lizza
William C. Baton
SAUL EWING LLPOne Riverfront Plaza, Suite 1520
Newark, New Jersey 07102-5426(973) 286-6700
Attorneys for Plaintiff
Celgene Corporation
James S. Richter
WINSTON &STRAWN LLP
The Legal CenterOne Riverfront Plaza, 7
thFloor
Newark, New Jersey 07102(973) 848-7676
Attorneys for Defendants
Natco Pharma Limited,
Arrow International Limited, andWatson Laboratories, Inc.
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
CELGENE CORPORATION,
Plaintiff,
v.
NATCO PHARMA LIMITED,
ARROW INTERNATIONAL LIMITED,
and WATSON LABORATORIES, INC.,
Defendants.
Civil Action No. 10-5197 (SDW) (MCA)
Hon. Susan D. Wigenton, U.S.D.J.
Hon. Madeline C. Arleo, U.S.M.J.
(Filed Electronically)
CORRECTED JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
Plaintiff Celgene Corporation (Celgene) and Defendants Natco Pharma Limited, Arrow
International Limited, and Watson Laboratories, Inc. (collectively, Natco) hereby submit their
Corrected Joint Claim Construction and Prehearing Statement in accordance with Local Patent
Rule 4.3.
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other things, that Natcos submission of ANDA No. 201452 to the FDA constitutes infringement
of certain claims of United States Patent Nos. 5,635,517 (the 517 patent), 6,045,501 (the
501 patent), 6,281,230 (the 230 patent), 6,315,720 (the 720 patent), 6,555,554 (the
554 patent), 6,561,976 (the 976 patent), 6,561,977 (the 977 patent), 6,755,784 (the
784 patent), 7,119,106 (the 106 patent), 7,189,740 (the 740 patent), 7,465,800 (the
800 patent), 7,968,569 (the 569 patent), 7,977,357 (the 357 patent), 8,193,219 (the
219 patent), 8,288,415 (the 415 patent), 8,315,886 (the 886 patent), 8,404,717 (the
717 patent), and 8,431,598 (the 598 patent) owned by Celgene (collectively, the patents-in-
suit) under 35 U.S.C. 271(e)(2). Natco alleges, among other things, that the asserted claims
are invalid, unenforceable, and/or not infringed.
Pursuant to Local Patent Rules 4.2(a)-(b), on August 5, 2013, the parties exchanged
preliminary claim constructions and identified intrinsic as well as extrinsic evidence in support
of their proposed Preliminary Constructions. Pursuant to Local Patent Rule 4.2(c), on August
19, 2013, the parties identified all intrinsic and extrinsic evidence that each party intends to rely
upon to oppose any other partys proposed construction. Pursuant to Local Patent Rule 4.2(d),
on August 21, 2013, counsel for the parties met and conferred for the purposes of narrowing the
issues and preparation of the Joint Claim Construction and Prehearing Statement.
II. CONSTRUCTION OF PATENT TERMSA. Agreed Upon Claim ConstructionsPursuant to Local Patent Rule 4.3(a), the parties identify the following terms and phrases
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UNITED STATES PATENT NO. 5,635,517
Term Definition
Undesirable levels of
TNFin a mammal
non-optimal levels of TNFin a
mammal
UNITED STATES PATENT NO. 6,281,230
Term Definition
Inflammation a local response to cellular injurycharacterized by pain, redness,
swelling and/or loss of function
Inflammatory disease a disease caused or characterized
by inflammation
Autoimmune disease a disease caused by an immune
reaction against the bodys owncells and/or tissues
An oncogenic orcancerous condition
a condition tending to cause orgive rise to tumors
UNITED STATES PATENT NO. 6,555,554
Term Definition
Reducing the level ofTNF
lowering levels of TNF
Improving an
oncogenic orcancerous condition
making better a condition
tending to cause or give rise totumors
Reducinginflammation
diminishing inflammation
Improving making better an autoimmune
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UNITED STATES PATENT NO. 6,045,501
Term Definition
Teratogenic drug a drug that may disturb the
normal growth and development
of an embryo or fetus
UNITED STATES PATENT NO. 6,315,720
Term Definition
Consulted accessed and considered
Teratogenic effect any effect that disturbs the
normal growth and development
of an embryo or fetus
Adverse side effect any unfavorable abnormality,
defect, mutation, lesion,degeneration or injury which may
be caused by taking the drug
UNITED STATES PATENT NO. 6,561,976
Term Definition
Teratogenic risks risks of disturbing the normal
growth and development of an
embryo or fetus
UNITED STATES PATENT NO. 6,561,977
Term Definition
Contraindicated Any condition in a patient which
renders a particular line of
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UNITED STATES PATENT NO. 8,315,886
Term Definition
Non-teratogenic side
effects
Any abnormality, defect,
mutation, lesion, degeneration or
injury which may be caused bytaking the drug, but excluding any
effect that disturbs the normal
growth and development of an
embryo or fetus
UNITED STATES PATENT NO. 7,465,800
Term Definition
Crystalline made up of crystals
UNITED STATES PATENT NO. 7,977,357
Term Definition
Endotherm the position of a peak on a DSC
thermogram representing anendothermic event such as a
melting point, rather than theonset or the endset of the peak
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B. Disputed Claim TermsPursuant to Local Patent Rule 4.3(b), attached hereto as Exhibit A is a series of claim
charts identifying the claim terms and phrases in dispute, the parties proposed constructions, and
the evidence (both intrinsic and extrinsic) that each party intends to rely on in support of its
proposed constructions. To the extent that claim terms are used repeatedly throughout a patent
or family of patents, any constructions of such terms carry the same meaning throughout a patent
or family of patents.
C. Claim Terms Whose Construction Will Be Most SignificantPursuant to Local Patent Rule 4.3(c), the parties were unable to agree that there are any
terms whose construction will be most significant to the resolution of the case. Likewise, the
parties were unable to agree that there are any terms whose construction will be case or claim
dispositive or substantially conducive to promoting settlement.
D. Anticipated Length of Time Necessary for the Claim Construction HearingPursuant to Local Patent Rule 4.3(d), the parties anticipate that the Court will be able to
conduct a hearing on the meaning of the disputed terms in less than one day.
E. Identification of Witnesses For The Claim Construction HearingPursuant to Local Patent Rule 4.3(e), Celgene has identified Dr. Jerry Atwood, Ph.D., Dr.
Stephen R. Byrn, Ph.D., and Dr. Ross L. Levine, M.D., as potential experts for the claim
construction hearing. Pursuant to Local Patent Rule 4.3(e), Natco has identified Dr. Robert
Boeckman, Ph.D., Dr. Mark Hollingsworth, Ph.D., and Dr. Frederick Luzzio, Ph.D., as potential
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October 18, 2013
By: s/ Charles M. LizzaCharles M. Lizza
William C. Baton
SAUL EWING LLP
One Riverfront Plaza, Suite 1520Newark, New Jersey 07102-5426
(973) [email protected]
OF COUNSEL:
F. Dominic Cerrito
Eric C. Stops
Andrew S. Chalson
QUINN EMANUEL URQUHART &SULLIVAN LLP
51 Madison Avenue
New York, New York 10010(212) 849-7000
Anthony M. InsognaJONES DAY
12265 El Camino RealSuite 200
San Diego, California 92130-4096
(858) 314-1200
Richard G. Greco
RICHARD G.GRECO PC
90 State Street, Suite 700Albany, New York 12207
(212) 203-7625
Attorneys for Plaintiff
Celgene Corporation
Respectfully submitted,
By: s/ Melissa Steedle BogadJames S. Richter
Melissa Steedle Bogad
WINSTON &STRAWN LLP
The Legal CenterOne Riverfront Plaza, Suite 730
Newark, New Jersey 07102gs. 1 [email protected]
OF COUNSEL:
George C. Lombardi
Michael K. NutterMaureen L. Rurka
Kevin E. Warner
Laura B. GreenspanWINSTON &STRAWN LLP
35 West Wacker Drive
Chicago, Illinois 60601-9703(312) 558-5600
Attorneys for Defendants
Natco Pharma Limited,
Arrow International Limited, and
Watson Laboratories, Inc.
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EXHIBIT A
DISPUTED CLAIM TERMS & EVIDENCE
United States Patent No. 6,281,230
Term Celgenes Proposal & Evidence Defendants Proposal
Said compound has
the R-configuration
Said compound has the R-isomer
Evidence:
230 patent generally, including, but not limited to,
8:1-17
230 patent file history generally, including, but not
limited to, Paper No. 7 (2/15/01 Response to Office
Action)
Celgene may rely on the deposition transcript of
Defendants expert Dr. Robert Boeckman.
the stereochemical configuratio
all or substantially all the R-iso
compound that is a racemic mixt
Evidence:
See below for 554 patent, incor
Intrinsic Evidence:
Specification of the 230 patent,limited to 8:1-17 and 17:28-18:6
File history of the 230 patent
Extrinsic Evidence:
Websters Online Dictionary, Exenantiomer, http://www.webster
dictionary.org/definitions/enanti
0939450753529744%3Av0qd01tdlq&cof=FORID%3A9&ie=UT8&q=enantiomer&sa=Search#92
Defendants may rely on the expeRobert Boeckman. Dr. Boeckma
about the understanding of this clanguage R-configuration and
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United States Patent No. 6,281,230
Term Celgenes Proposal & Evidence Defendants Proposala person of skill in the art; backg
concerning isomers and enantiobetween enantiomers and racemi
chirality. Dr. Boeckman may opi
proposed claim construction is c
teachings of the specification an230 patent, and contrary to the
term to a person of ordinary skill
Boeckman may also offer an opiproposed construction is consiste
intrinsic evidence and the meani
to a person of ordinary skill in th
Said compound has
the S-configuration
Said compound has the S-isomer
Evidence:
230 patent at 8:1-17
230 patent file history generally, including, but not
limited to, Paper No. 7 (2/15/01 Response to Office
Action)
Celgene may rely on the deposition transcript of
Defendants expert Dr. Robert Boeckman.
the stereochemical configuratio
all or substantially all the S-isom
compound that is a racemic mixt
Evidence:
See below for 554 patent, incor
Intrinsic Evidence:
Specification of the 230 patent,
limited to 8:1-17 and 17:28-18:6
File history of the 230 patent
Extrinsic Evidence:
Websters Online Dictionary, Ex
enantiomer, http://www.webster
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04841.62499/5478002.4 - 3 -
United States Patent No. 6,281,230
Term Celgenes Proposal & Evidence Defendants Proposaldictionary.org/definitions/enanti
0939450753529744%3Av0qd01tdlq&cof=FORID%3A9&ie=UT
8&q=enantiomer&sa=Search#92
Defendants may rely on the expeRobert Boeckman. Dr. Boeckma
about the understanding of this c
language R-configuration anda person of skill in the art; backg
concerning isomers and enantio
between enantiomers and racemichirality. Dr. Boeckman may opi
proposed claim construction is c
teachings of the specification an230 patent, and contrary to theterm to a person of ordinary skill
Boeckman may also offer an opi
proposed construction is consisteintrinsic evidence and the meani
to a person of ordinary skill in th
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United States Patent No. 6,555,554
Term Celgenes Proposal & Evidence Defendants ProposalSaid compound has
the R-configuration
Same as 230 patent Same as 230 patent
Evidence:
See above for 230 patent, incor
Intrinsic Evidence:
Specification of the 554 patent,
limited to 7:38-54 and 17:9-18:4
File history of the 554 Patent, i
limited to February 12, 2001 am
Extrinsic Evidence:
Websters Online Dictionary, Exenantiomer, http://www.websterdictionary.org/definitions/enanti
0939450753529744%3Av0qd01
tdlq&cof=FORID%3A9&ie=UT8&q=enantiomer&sa=Search#92
Defendants may rely on the expe
Robert Boeckman. Dr. Boeckmaabout the understanding of this c
language R-configuration anda person of skill in the art; backg
concerning isomers and enantiobetween enantiomers and racemi
chirality. Dr. Boeckman may opi
proposed claim construction is c
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United States Patent No. 6,555,554
Term Celgenes Proposal & Evidence Defendants Proposalteachings of the specification an
554 patent, and contrary to theterm to a person of ordinary skill
Boeckman may also offer an opi
proposed construction is consiste
intrinsic evidence and the meanito a person of ordinary skill in th
Said compound hasthe S-configuration
Same as 230 patent Same as 230 patent
Evidence:
See above for 230 patent, incor
Intrinsic Evidence:
Specification of the 554 patent,limited to 7:38-54 and 17:9-18:4
File history of the 554 Patent, ilimited to February 12, 2001 am
Extrinsic Evidence:
Websters Online Dictionary, Ex
enantiomer, http://www.webster
dictionary.org/definitions/enanti0939450753529744%3Av0qd01
tdlq&cof=FORID%3A9&ie=UT
8&q=enantiomer&sa=Search#92
Defendants may rely on the expe
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C 2 0 0 9 S C 2 8 il d 0/ 8/ 3 3 f 0
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United States Patent No. 6,555,554
Term Celgenes Proposal & Evidence Defendants ProposalRobert Boeckman. Dr. Boeckma
about the understanding of this clanguage R-configuration and
a person of skill in the art; backg
concerning isomers and enantio
between enantiomers and racemichirality. Dr. Boeckman may opi
proposed claim construction is c
teachings of the specification an554 patent, and contrary to the
term to a person of ordinary skill
Boeckman may also offer an opiproposed construction is consiste
intrinsic evidence and the meani
to a person of ordinary skill in th
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C 2 10 05197 SDW MCA D t 248 Fil d 10/18/13 P 14 f 40 P I
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04841.62499/5478002.4 - 7 -
United States Patent No. 8,228,415
Term Celgenes Proposal & Evidence Defendants ProposalUnit dosage form Physically discrete units suitable as a unitary dosage
Evidence:
415 patent generally
415 patent file history generally
Physically discrete units suitabl
containing a predetermined quancalculated to produce the desired
Evidence:
Intrinsic Evidence:
Specification of the 415 patent,
limited to 9:18-25 and Claims 1-
File history of the 415 patent
Extrinsic Evidence:
Defendants may rely on the expe
Frederick Luzzio. Dr. Luzzio maabout the understanding of the cldosage form as it pertains to a p
skill in the art. Dr. Luzzio may o
construction of unit dosage forteachings of the specification, cl
of the 415 patent, and contrary t
claim term to a person of ordinar
Luzzio may also offer an opinioproposed construction is consiste
intrinsic evidence and the meaniunit dosage form to a person o
art.
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United States Patent No. 7,465,800
Term Celgenes Proposal & Evidence Defendants Proposal3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione
No construction required
Evidence:
800 patent generally
800 patent file history generally
Celgene may rely on the expert opinion of Dr.Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about the
understanding of this term to ordinarily skilledartisans at the time the 800 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this term has
its plain and ordinary meaning and does not require
any process limitations. Dr. Byrn and Dr. Atwoodmay also opine regarding the level of ordinary skill
in the art and/or the qualifications of one of ordinary
skill in the art.
lenalidomide, prepared accordi
described in U.S. Patent Nos. 6,25,635,517
Evidence:
Intrinsic Evidence:
Specification of the 800 patent,limited to 4:52 5:1.
File history of the 800 patent.
Hemihydrate A hydrate containing approximatelyhalf a mole of
water to one mole of the compound forming thehydrate
Evidence:
800 patent generally, including, but not limited to,
5:36-40, 6:53-7:35, 12:31-36, 22:40-43
Merriam Websters Collegiate Dictionary (10th
ed.)
a solid crystalline form of lenali
one water molecule for every twamino-1-oxo-1,3 dihydro-isoind
2,6-dione, formally associated wthe unit cell in the solid crystalliwhich crystal form is specificall
800 patent as the Form B polym
demonstrated in TGA, Karl FiscX-ray diffraction patterns, IR spe
analysis, as distinguishable from
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United States Patent No. 7,465,800
Term Celgenes Proposal & Evidence Defendants Proposal
at 540
Merriam Websters Collegiate Dictionary (11th
ed.)
at 579
Celgene may rely on the deposition transcript ofDefendants expert Dr. Mark Hollingsworth.
Celgene may rely on the expert opinion of Dr.Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about the
understanding of this term to ordinarily skilledartisans at the time the 800 patent was filed. Dr.
Byrn and Dr. Atwood may opine that the term
requires approximately half a mole of water to one
mole of the compound forming the hydrate, and thatthe term does not require any of the additional
limitations proposed by Defendants. Dr. Byrn and
Dr. Atwood may also opine regarding the level ofordinary skill in the art and/or the qualifications of
one of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
opinions of Defendants expert Dr. MarkHollingsworth.
such as the anhydrous form
Evidence:
Intrinsic Evidence:
Specification of the 800 patent,limited to 3:53-55; 5:36-40; 6:67
40; 12:31-36; 6:56 7:35; 12:445; 15:56-57; and Figs. 37-39.
File history of the 800 Patent, i
limited to Original Application a2007 Office Action at 2-3; July 2
at 9-10 (citing Original Applicati
10, 2007 Office Action at 2-3; Ja
Amendment at 2-3, 5; Apr. 30, 2Allowability at 2; and Nov. 3, 20
Allowability at 2.
Extrinsic Evidence:
Websters New Collegiate Dictio
at 313 (defining crystal and c
(defining hemihydrates);
Remington: The Science And Pr(20th ed. 2000), at 175 (discussi
702, 717 (discussing hemihydrat
Defendants may rely on the expe
Mark Hollingsworth. Dr. Holling
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United States Patent No. 7,465,800
Term Celgenes Proposal & Evidence Defendants Proposal
opinions about the understandin
hemihydrate to a person of skilstructures in general; the water c
structures; means and methods f
water content of crystal structure
of certain crystal structures depecontent. Dr. Hollingsworth may
proposed claim construction of contrary to the teachings of the shistory of the 800 patent, and co
of this claim term to a person of
art, in particular with respect to themihydrate is a term of approxi
Hollingsworth may also offer an
Defendants proposed constructi
all relevant intrinsic evidence anclaim term to a person of ordinar
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United States Patent No. 7,977,357
Term Celgenes Proposal & Evidence Defendants Proposal
Form A A polymorphic form of 3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione that canbe distinguished from other forms
Evidence:
357 patent generally
357 patent file history generally
Celgene may rely on the expert opinion of Dr.
Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrnand Dr. Atwood may offer opinions about the
understanding of this term to ordinarily skilled
artisans at the time the 357 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this term refersto a polymorphic crystal form of lenalidomide that
can be distinguished from other forms of
lenalidomide, and that the term does not require thehost of unrecited limitations that Defendants seek to
read into the claims. Dr. Byrn and Dr. Atwood may
also offer an opinion that Defendants proposed
construction is illogical in the context of the claims.Dr. Byrn and Dr. Atwood may also opine that
Defendants proposed construction is inconsistentwith the intrinsic evidence. Dr. Byrn and Dr.
Atwood may also opine regarding the level ofordinary skill in the art and/or the qualifications of
one of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
The lenalidomide crystal form
specification as Form A, havingcharacteristics assigned to Form
specification
Evidence:
Intrinsic Evidence:The 357 patent in its entirety, inlimited to 6:17 6:54; 9:5061;
114; and Figs. 154.
Prosecution history of the 357 p
including but not limited to June
Action at 4; March 7, 2011 Inter
March 10, 2011 Amendment.
Extrinsic Evidence:
Defendants may rely on the expeMark Hollingsworth. Dr. Holling
opinions about the understandin
Form A to a person of ordinar
including but not limited to the cwith naming crystals and the ana
unique to each specific crystallinmethods of characterizing these
including with DSC, TGA, IR, Rsorption/desorption data. Dr. Hol
offer an opinion that Celgenes p
of Form A is contrary to the te
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United States Patent No. 7,977,357
Term Celgenes Proposal & Evidence Defendants Proposal
opinions of Defendants expert Dr. Mark
Hollingsworth.
specification and file history of t
contrary to the meaning of this clof ordinary skill in the art. Dr. H
also offer an opinion that Defen
construction is consistent with al
evidence and the meaning of theto a person of ordinary skill in th
3-(4-amino-l-oxo-l,3dihydro-isoindol-2-yl)-
piperidine-2,6-dione
Same as 800 patent Same as 800 patent
Evidence:
Intrinsic Evidence:
The 357 patent in its entirety, in
limited to 4:54 5:3.
Prosecution history of the 357 p
unsolvated crystalline
Form A of 3-( 4-
amino-1-oxo-1,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione,
which has adifferential scanningcalorimetry
thermogram having an
endotherm atapproximately 270 C
No construction required
Evidence:
357 patent generally
357 patent file history generally
Celgene may rely on the expert opinion of Dr.
Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrnand Dr. Atwood may offer opinions about the
understanding of this phrase to ordinarily skilled
artisans at the time the 357 patent was filed. Dr.
The lenalidomide crystal form
specification as Form A, having
characteristics assigned to Form
specification
Evidence:
The 357 patent in its entirety, in
limited to 6:17 6:54; 9:5061;
114; and Figs. 154.
Prosecution history of the 357 p
including but not limited to June
g g
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United States Patent No. 7,977,357
Term Celgenes Proposal & Evidence Defendants Proposal
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Byrn and Dr. Atwoodmay opine that Defendants definition of this phrase
is confusing, redundant, illogical, and contrary to the
understanding of ordinarily skilled artisans to the
extent that Defendants seek to assign a meaning forthis phrase that is identical to its proposed meaning
for the claim term Form A, which is includedwithin this phrase. Dr. Byrn and Dr. Atwood mayalso offer an opinion that Defendants proposed
construction is illogical in the context of the claims.
Dr. Byrn and Dr. Atwood may also opine thatDefendants proposed construction is inconsistent
with the intrinsic evidence. Dr. Byrn and Dr.
Atwood may also opine regarding the level of
ordinary skill in the art and/or the qualifications ofone of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
opinions of Defendants expert Dr. MarkHollingsworth.
Action at 4; March 7, 2011 Inter
March 10, 2011 Amendment.
Extrinsic Evidence:
Defendants may rely on the expe
Mark Hollingsworth. Dr. Hollingopinions about the understandin
unsolvated crystalline Form A1,3 dihydro-isoindol-2-yl)-piperiwhich as a differential scanning
thermogram having an endother
270 C to a person of ordinary sincluding, but not limited to, the
associated with naming crystals
attributes unique to each specific
and methods of characterizing thincluding with DSC, TGA, IR, R
sorption/desorption data. Dr. Hol
offer an opinion that Celgenes pof unsolvated crystalline Form
oxo-1,3 dihydro-isoindol-2-yl)-p
which as a differential scanning
thermogram having an endother270 C is contrary to the teachi
specification and file history of tcontrary to the meaning of this cl
of ordinary skill in the art. Dr. Halso offer an opinion that Defen
construction is consistent with al
evidence and the meaning of the
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United States Patent No. 7,977,357
Term Celgenes Proposal & Evidence Defendants Proposal
unsolvated crystalline Form A
1,3 dihydro-isoindol-2-yl)-piperiwhich as a differential scanning
thermogram having an endother
270 C to a person of ordinary s
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United States Patent No. 8,193,219
Term Celgenes Proposal & Evidence Defendants Proposal
3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione
Same as 800 patent Same as 800 patent
Evidence:
Intrinsic Evidence:
The 219 patent in its entirety, inlimited to 4:65 5:12
Prosecution history of the 219 p
unsolvated crystalline
3-(4-amino-1-oxo-1,3dihydro-isoindol-2-yl)-
piperidine-2,6-dione
having an X-ray
powder diffractionpattern comprising
peaks at approximately
8, 14.5, 16, 17 .5, 20.5,24, and 26 degrees 2
No construction required
Evidence:
219 patent generally
219 patent file history generally
Celgene may rely on the expert opinion of Dr.Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about the
understanding of this phrase to ordinarily skilledartisans at the time the 219 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this phrase isnot a claim limitation. Dr. Atwood may opine thatDefendants definition of this phrase is confusing,
redundant, illogical, and contrary to the
understanding of ordinarily skilled artisans to theextent that Defendants seek to assign a meaning for
this phrase that is identical to its proposed meaning
The lenalidomide crystal form
specification as Form A, havingcharacteristics assigned to Form
specification
Evidence:
Intrinsic Evidence:
The 219 patent in its entirety, inlimited to 6:27 6:64; 9:60 10:
Prosecution history of the 219 pincluding but not limited to Dece
Action at 24; December 12, 2014; March 12, 2012 Amendment
Extrinsic Evidence:
Defendants may rely on the expeMark Hollingsworth. Dr. Holling
opinions about the understandin
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United States Patent No. 8,193,219
Term Celgenes Proposal & Evidence Defendants Proposal
for the claim term Form A from the 357 patent,
even though Form A is not recited in any claims ofthe 219 patent. Dr. Byrn and Dr. Atwood may also
offer an opinion that Defendants proposed
construction is illogical in the context of the claims.
Dr. Byrn and Dr. Atwood may also opine thatDefendants proposed construction is inconsistent
with the intrinsic evidence. Dr. Byrn and Dr.Atwood may also opine regarding the level ofordinary skill in the art and/or the qualifications of
one of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut theopinions of Defendants expert Dr. Mark
Hollingsworth.
unsolvated crystalline 3-(4-ami
isoindol-2-yl)-piperidine-2,6-diopowder diffraction pattern comp
approximately 8, 14.5, 16, 17.5,
degrees 2 to a person of ordin
polymorphic forms of crystal strand the definition of certain crys
Hollingsworth may opine that Cclaim construction of unsolvateamino-1-oxo-1,3 dihydro-isoind
2,6-dione having an X-ray powd
comprising peaks at approximate20.5, 24, and 26 degrees 2 is c
teachings of the specification an
219 patent, and contrary to the
term to a person of ordinary skillHollingsworth may also offer an
Defendants proposed constructi
all relevant intrinsic evidence anclaim term unsolvated crystalli
1,3 dihydro-isoindol-2-yl)-piperi
having an X-ray powder diffracti
comprising peaks at approximate20.5, 24, and 26 degrees 2 to a
skill in the art.
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United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione
Same as 800 patent Same as 800 patent
Evidence:
Intrinsic Evidence:
598 patent in its entirety, includ4:65 5:12; Claims 1-8, 10-13, 1
Prosecution history of the 219 p
Form A Same as 357 patent
Evidence:
Same as 357 patent, in addition to:
598 patent generally
598 patent file history generally
Same as 357 patent
Evidence:
Intrinsic Evidence:
598 Patent in its entirety, includ
6:276:64; 9:6010:4; 10:616;
154.
Prosecution History of the 598
including but not limited to MarAction; May 15, 2012 Response
Requirement; June 14, 2012 OffiDecember 12, 2012 Amendment
Extrinsic Evidence:
Defendants may rely on the expeMark Hollingsworth. Dr. Holling
opinions about the understandin
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United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
Form A to a person of ordinar
including but not limited to the cwith naming crystals, the analyti
to each specific crystalline struct
characterizing these unique attrib
DSC, TGA, IR, Raman, and moisorption/desorption data. Dr. Ho
offer an opinion that Celgenes pof Form A is contrary to the tespecification and file history of t
contrary to the meaning of this cl
of ordinary skill in the art. Dr.also offer an opinion that Defen
construction is consistent with al
evidence and the meaning of the
to a person of ordinary skill in th
unsolvated crystalline
Form A of 3-(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione
No construction required
Evidence:
598 patent generally
598 patent file history generally
Celgene may rely on the expert opinion of Dr.
Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about theunderstanding of this phrase to ordinarily skilled
artisans at the time the 598 patent was filed. Dr.
The lenalidomide crystal form
specification as Form A, havingcharacteristics assigned to Form
specification
Evidence:
Intrinsic Evidence:
Specification of the 598 patent,
limited to 6:27-6:64; 9:60-10:4;Figs. 1-54.
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04841.62499/5478002.4 - 19 -
United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Byrn and Dr. Atwoodmay opine that Defendants definition of this phrase
is confusing, redundant, illogical, and contrary to the
understanding of ordinarily skilled artisans to the
extent that Defendants seek to assign a meaning forthis phrase that is identical to its proposed meaning
for the claim term Form A, which is includedwithin this phrase. Dr. Byrn and Dr. Atwood mayalso offer an opinion that Defendants proposed
construction is illogical in the context of the claims.
Dr. Byrn and Dr. Atwood may also opine thatDefendants proposed construction is inconsistent
with the intrinsic evidence. Dr. Byrn and Dr.
Atwood may also opine regarding the level of
ordinary skill in the art and/or the qualifications ofone of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
opinions of Defendants expert Dr. MarkHollingsworth.
File history of the 598 patent, in
limited to March 15, 2012 Office2012 Response to Restriction Re
2012 Office Action; December 1
and Response
Extrinsic Evidence:
Defendants may rely on the expeMark Hollingsworth. Dr. Holling
opinions about the understandin
unsolvated crystalline Form A1,3 dihydro-isoindol-2-yl)-piperi
person of ordinary skill in the art
limited to the convention associa
crystals, the analytical attributesspecific crystalline structure, and
characterizing these unique attrib
DSC, TGA, IR, Raman, and moisorption/desorption data. Dr. Hol
offer an opinion that Celgenes p
of unsolvated crystalline Formoxo-1,3 dihydro-isoindol-2-yl)-p
is contrary to the teachings of th
file history of the 598 patent, anmeaning of this claim term to a p
skill in the art. Dr. Hollingswortopinion that Defendants propos
consistent with all relevant intrin
meaning of the claim term unso
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United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
Form A of 3-(4-amino-1-oxo-1,3
yl)-piperidine-2,6-dione to a pein the art.
an unsolvatedcrystalline Form A of
3-(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-piperidine-2,6-dionehaving a differential
scanning calorimetry
thermogramendotherm at
approximately 270 C
No construction required
Evidence:
598 patent generally
598 patent file history generally
Celgene may rely on the expert opinion of Dr.
Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about the
understanding of this phrase to ordinarily skilledartisans at the time the 598 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Byrn and Dr. Atwoodmay opine that Defendants definition of this phrase
is confusing, redundant, illogical, and contrary to the
understanding of ordinarily skilled artisans to theextent that Defendants seek to assign a meaning for
this phrase that is identical to its proposed meaningfor the claim term Form A, which is includedwithin this phrase. Dr. Byrn and Dr. Atwood may
also offer an opinion that Defendants proposed
construction is illogical in the context of the claims.Dr. Byrn and Dr. Atwood may also opine that
Defendants proposed construction is inconsistent
The lenalidomide crystal formspecification as Form A, having
characteristics assigned to Form
specification
Intrinsic Evidence:
Specification of the 598 patent,limited to 6:27-6:64; 9:60-10:4;
Figs. 1-54.
File history of the 598 patent, inlimited to March 15, 2012 Office
2012 Response to Restriction Re
2012 Office Action; December 1and Response
Extrinsic Evidence:
Defendants may rely on the expeMark Hollingsworth. Dr. Hollingopinions about the understandin
an unsolvated crystalline Form
oxo-1,3 dihydro-isoindol-2-yl)-phaving a differential scanning ca
thermogram endotherm at appro
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04841.62499/5478002.4 - 21 -
United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
with the intrinsic evidence. Dr. Byrn and Dr.
Atwood may also opine regarding the level ofordinary skill in the art and/or the qualifications of
one of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
opinions of Defendants expert Dr. MarkHollingsworth.
person of ordinary skill in the art
limited to the convention associacrystals, the analytical attributes
specific crystalline structure, and
characterizing these unique attrib
DSC, TGA, IR, Raman, and moisorption/desorption data. Dr. Hol
offer an opinion that Celgenes pof an unsolvated crystalline Foroxo-1,3 dihydro-isoindol-2-yl)-p
having a differential scanning ca
thermogram endotherm at approcontrary to the teachings of the s
history of the 598 patent, and co
of this claim term to a person of
art. Dr. Hollingsworth may alsoDefendants proposed constructi
all relevant intrinsic evidence an
claim term an unsolvated crystaamino-1-oxo-1,3 dihydro-isoind
2,6-dione having a differential sc
thermogram endotherm at approperson of ordinary skill in the art
an unsolvatedcrystalline form of 3-
(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione
having a differential
No construction required
Evidence:
598 patent generally
The lenalidomide crystal formspecification as Form A, having
characteristics assigned to Form
specification
Intrinsic Evidence:
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04841.62499/5478002.4 - 23 -
United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
offer an opinion that Celgenes p
of an unsolvated crystalline foroxo-1,3 dihydro-isoindol-2-yl)-p
having a differential scanning ca
thermogram endotherm at appro
an X-ray powder diffraction pattat approximately 8, 14.5, and 16
thermogravimetric analysis curvunsolvated material is contraryspecification and file history of t
contrary to the meaning of this cl
of ordinary skill in the art. Dr. Halso offer an opinion that Defen
construction is consistent with al
evidence and the meaning of the
unsolvated crystalline form of 3-dihydro isoindol-2-yl)-piperidine
differential scanning calorimetry
endotherm at approximately 270powder diffraction pattern comp
approximately 8, 14.5, and 16 de
thermogravimetric analysis curvunsolvated material to a person
the art.
an unsolvated
crystalline form of 3-
(4-amino-1-oxo-1,3dihydro-isoindol-2-yl)-
piperidine-2,6-dione
No construction required
Evidence:
598 patent generally
The lenalidomide crystal form
specification as Form A, having
characteristics assigned to Formspecification
-
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United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
(4-amino-1-oxo-1,3 dihydro-isoi
2,6-dione having an X-ray powdcomprising peaks at approximate
20.5, 24, and 26 degrees 2 is c
teachings of the specification an
598 patent, and contrary to theterm to a person of ordinary skill
Hollingsworth may also offer anDefendants proposed constructiall relevant intrinsic evidence an
claim term an unsolvated crysta
amino-1-oxo-1,3 dihydro isoind2,6-dione having an X-ray powd
comprising peaks at approximate
20.5, 24, and 26 degrees 2 to a
skill in the art.
an unsolvated
crystalline form of 3-(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dionehaving a differential
scanning calorimetrythermogramendotherm at
approximately 270 C
No construction required
Evidence:
598 patent generally
598 patent file history generally
Celgene may rely on the expert opinion of Dr.
Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about theunderstanding of this phrase to ordinarily skilled
artisans at the time the 598 patent was filed. Dr.
Intrinsic Evidence:
Specification of the 598 patent,
limited to 6:27-6:64; 9:60-10:4;
and Figs. 1-54.
File history of the 598 patent, inlimited to March 15, 2012 Office2012 Response to Restriction Re
2012 Office Action; December 1
and Response
Extrinsic Evidence:
-
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04841.62499/5478002.4 - 27 -
United States Patent No. 8,431,598
Term Celgenes Proposal & Evidence Defendants Proposal
person of ordinary skill in the art
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United States Patent No. 7,159,740
Term Celgenes Proposal & Evidence Defendants Proposal
opinions to rebut the opinions of Defendants expert.
administered in a cycle No construction required
Evidence:
740 patent generally, including, but not limited to,
1:13-21, 5:64-8:3, 15:29-18:35, 19:4-21, 29:56-59,
claims 18-22, 29-30.
Tabers Cyclopedic Medical Dictionary (19th ed.) at
518, 520; Stedmans Medical Dictionary (27th ed.)at 442-444.
Celgene may rely on the expert opinion of Ross L.
Levine, MD. Dr. Levine may offer opinions aboutthe understanding of this term to ordinarily skilled
artisans at the time the 740 patent was filed. Dr.
Levine may also offer an opinion that the term doesnot require a pre-determined dosing regimen that
includes administering lenalidomide for an initial
period, followed by a pre-determined treatment-freeinterval. Dr. Levine may also opine that
Defendants proposed construction of this term isinconsistent with the intrinsic evidence. Dr. Levinemay also opine that this term is composed of words
that would have had clear meanings to ordinarily
skilled artisans at the time the 740 patent was filed,and therefore needs no construction. Dr. Levine
may also opine regarding the level of ordinary skill
Administered according to a pr
regimen that includes administer
an initial period, followed by a ptreatment-free interval, and repe
administration
Evidence:
Intrinsic Evidence:
The 740 patent in its entirety, inlimited to 19:421; 26:48 29:6
and 30.
Extrinsic Evidence:Defendants may rely on the expe
Frederick Luzzio. Dr. Luzzio ma
about the understanding of the cladministered in a cycle as it pe
pharmaceutical drug dosing regi
understood by a person of ordinaLuzzio may opine that Celgenes
administered in a cycle is contof the specification and file histoand contrary to the meaning of t
person of ordinary skill in the art
offer an opinion that Defendantsconstruction is consistent with al
evidence and the meaning of the
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04841.62499/5478002.4 - 30 -
United States Patent No. 7,159,740
Term Celgenes Proposal & Evidence Defendants Proposal
in the art and/or the qualifications of one of ordinary
skill in the art.
administered in a cycle to a pe
in the art.
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United States Patent No. 7,968,569
Term Celgenes Proposal & Evidence Defendants Proposal
cyclicallyadministering
No construction required
Evidence:
569 patent generally, including, but not limited to,1:13-23, 3:38-4:10, 4:29-5:18, 11:64-12:14, 16:23-
23:11, 24:19-25:9, 32:59-33:15, 38:39-55, claims 1-15.
Tabers Cyclopedic Medical Dictionary (19th ed.) at
518, 520; Stedmans Medical Dictionary (27th ed.)at 442-444.
Celgene may rely on the expert opinion of Ross L.
Levine, MD. Dr. Levine may offer opinions aboutthe understanding of this term to ordinarily skilled
artisans at the time the 569 patent was filed. Dr.
Levine may also offer an opinion that the term doesnot require administering lenalidomide and
dexamethasone in combination for 21 consecutive
days. Dr. Levine may also offer an opinion thatDefendants proposed construction is illogical in the
context of the claims. Dr. Levine may also opinethat Defendants proposed construction of this termis inconsistent with the intrinsic evidence. Dr.
Levine may also opine that this term is composed ofwords that would have had clear meanings to
ordinarily skilled artisans at the time the 569 patent
was filed, and therefore needs no construction. Dr.
Administering lenalidomide ancombination for 21 consecutive
Evidence:
Intrinsic Evidence:
The 569 patent in its entirety, inlimited to 24:55 25:9; 38:395
Prosecution history of the 569 p
including but not limited to OctoResponse at 7 (see, e.g., claim 7
Amendment and Response at 4 (
70); March 9, 2010 Amendment,
Request for Continued Examinatclaim 69); and December 12, 20
Statement of Interview Summar
24).
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United States Patent No. 7,968,569
Term Celgenes Proposal & Evidence Defendants Proposal
Levine may also opine regarding the level of
ordinary skill in the art and/or the qualifications ofone of ordinary skill in the art.
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CERTIFICATION OF SERVICE
I hereby certify that on October 18, 2013, copies of the foregoing Corrected Joint Claim Constr
Statement was electronically filed and served by electronic mail upon all counsel of record.
I certify that the foregoing statements made by me are true. I am aware that if any of the foregoing state
false, I am subject to punishment.
s/ Melissa Steedle BogadMelissa Steedle Bogad
Dated: October 18, 2013