CELG v ACT - Joint Markman Statement

5/26/2018 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

[email protected]

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

[email protected]

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.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 1 of 40 PageID: 6728


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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





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


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


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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Term Definition

Teratogenic drug a drug that may disturb the

normal growth and development

of an embryo or fetus


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


Term Definition

Teratogenic risks risks of disturbing the normal

growth and development of an

embryo or fetus


Term Definition

Contraindicated Any condition in a patient which

renders a particular line of



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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


Term Definition

Crystalline made up of crystals


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]

[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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04841.62499/5478002.4 - 1 -

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

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 8 of 40 PageID


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04841.62499/5478002.4 - 2 -


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


Extrinsic Evidence:

Websters Online Dictionary, Ex

enantiomer, http://www.webster

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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


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


Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 10 of 40 PageI


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04841.62499/5478002.4 - 4 -


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:


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




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04841.62499/5478002.4 - 5 -


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


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



C 2 0 0 9 S C 2 8 il d 0/ 8/ 3 3 f 0


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04841.62499/5478002.4 - 6 -


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


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



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 -


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:


limited to 9:18-25 and Claims 1-


Extrinsic Evidence:


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.


Case 2:10 cv 05197 SDW MCA Document 248 Filed 10/18/13 Page 15 of 40 PageI


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04841.62499/5478002.4 - 8 -


Term Celgenes Proposal & Evidence Defendants Proposal3-(4-amino-l-oxo-l,3

dihydro-isoindol-2-yl)-piperidine-2,6-dione

No construction required

Evidence:



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:


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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04841.62499/5478002.4 - 9 -



at 540

Merriam Websters Collegiate Dictionary (11th

ed.)

at 579

Celgene may rely on the deposition transcript ofDefendants expert Dr. Mark Hollingsworth.



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


Mark Hollingsworth. Dr. Holling




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04841.62499/5478002.4 - 10 -



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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04841.62499/5478002.4 - 11 -



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:



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



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


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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04841.62499/5478002.4 - 12 -



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


Evidence:

Intrinsic Evidence:

The 357 patent in its entirety, in

limited to 4:54 5:3.


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


Evidence:




Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrnand Dr. Atwood may offer opinions about the

understanding of this phrase to ordinarily skilled



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.


including but not limited to June

g g



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04841.62499/5478002.4 - 13 -



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.



Action at 4; March 7, 2011 Inter

March 10, 2011 Amendment.

Extrinsic Evidence:


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


evidence and the meaning of the



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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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04841.62499/5478002.4 - 15 -



3-(4-amino-l-oxo-l,3



Evidence:

Intrinsic Evidence:

The 219 patent in its entirety, inlimited to 4:65 5:12



3-(4-amino-1-oxo-1,3dihydro-isoindol-2-yl)-


having an X-ray

powder diffractionpattern comprising

peaks at approximately

8, 14.5, 16, 17 .5, 20.5,24, and 26 degrees 2


Evidence:





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



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:





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04841.62499/5478002.4 - 16 -



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



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


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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3-(4-amino-l-oxo-l,3



Evidence:

Intrinsic Evidence:

598 patent in its entirety, includ4:65 5:12; Claims 1-8, 10-13, 1


Form A Same as 357 patent

Evidence:

Same as 357 patent, in addition to:



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:





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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





Form A of 3-(4-amino-1-oxo-1,3

dihydro-isoindol-2-yl)-



Evidence:




Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn

and Dr. Atwood may offer opinions about theunderstanding of this phrase to ordinarily skilled




specification

Evidence:

Intrinsic Evidence:


limited to 6:27-6:64; 9:60-10:4;Figs. 1-54.



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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




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.



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:



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


DSC, TGA, IR, Raman, and moisorption/desorption data. Dr. Hol


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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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


Evidence:






understanding of this phrase to ordinarily skilledartisans at the time the 598 patent was filed. Dr.




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


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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Atwood may also opine regarding the level ofordinary skill in the art and/or the qualifications of





limited to the convention associacrystals, the analytical attributes

specific crystalline structure, and


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


having a differential


Evidence:


The lenalidomide crystal formspecification as Form A, having


specification

Intrinsic Evidence:


29/40



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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



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)-



Evidence:



specification as Form A, having

characteristics assigned to Formspecification


31/40Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 32 of 40 PageI


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(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


Evidence:





and Dr. Atwood may offer opinions about theunderstanding of this phrase to ordinarily skilled


Intrinsic Evidence:


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 - 29 -



opinions to rebut the opinions of Defendants expert.

administered in a cycle No construction required

Evidence:


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


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


offer an opinion that Defendantsconstruction is consistent with al




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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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04841.62499/5478002.4 - 31 -



cyclicallyadministering


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


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


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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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

[email protected]

Dated: October 18, 2013

CELG v ACT - Joint Markman Statement

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Transcript of CELG v ACT - Joint Markman Statement