Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 1 of 25 PageID: 1468
`
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`
`James S. Richter
`WINSTON & STRAWN LLP
`The Legal Center
`One Riverfront Plaza, 7th Floor
`Newark, New Jersey 07102
`(973) 848-7676
`jrichter@winston.com
`
`Attorneys for Defendants
`Natco Pharma Limited,
`Arrow International Limited, and
`Watson Laboratories, Inc.
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`CELGENE CORPORATION,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`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)
`
`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
`
`Plaintiff Celgene Corporation and Defendants Natco Pharma Limited, Arrow
`
`International Limited, and Watson Laboratories, Inc. (collectively, (cid:147)Natco(cid:148)) hereby submit their
`
`Joint Claim Construction and Prehearing Statement in accordance with Local Patent Rule 4.3.
`
`I.
`
`BACKGROUND
`
`This case arises out of Natco(cid:146)s filing of ANDA No. 201452 with the U.S. Food and Drug
`
`Administration ((cid:147)FDA(cid:148)), which seeks approval to market a generic version of Celgene(cid:146)s
`
`Revlimidfi product. The active ingredient in Revlimidfi is lenalidomide. Plaintiffs allege, among
`
`other things, that Natco(cid:146)s submission of ANDA No. 201452 to the FDA constitutes infringement
`
`
`
`- 1 -
`
`CFAD VI 1030-0001
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 2 of 25 PageID: 1469
`
`
`of certain claims of United States Patent Nos. 5,635,517 (the (cid:147)(cid:146)517 patent(cid:148)), 6,045,501 (the
`
`(cid:147)(cid:146)501 patent(cid:148)), 6,281,230 (the (cid:147)(cid:146)230 patent(cid:148)), 6,315,720 (the (cid:147)(cid:146)720 patent(cid:148)), 6,555,554 (the
`
`(cid:147)(cid:146)554 patent(cid:148)), 6,561,976 (the (cid:147)(cid:146)976 patent(cid:148)), 6,561,977 (the (cid:147)(cid:146)977 patent(cid:148)), 6,755,784 (the
`
`(cid:147)(cid:146)784 patent(cid:148)), 7,119,106 (the (cid:147)(cid:146)106 patent(cid:148)), and 7,465,800 (the (cid:147)(cid:146)800 patent(cid:148)) owned by
`
`Celgene (collectively, (cid:147)the patents-in-suit(cid:148)) under 35 U.S.C. §271(e)(2). Natco alleges, among
`
`other things, that certain of the asserted claims are invalid, unenforceable, and/or not infringed.
`
`Pursuant to Local Patent Rules 4.2(a)-(b), on June 7, 2011, 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 June 24,
`
`2011, the parties identified all intrinsic and extrinsic evidence that each party intends to rely
`
`upon to oppose any other party(cid:146)s proposed construction. Pursuant to Local Patent Rule 4.2(d),
`
`on July 8, 2011, 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 TERMS
`
`A.
`
`Agreed Upon Claim Constructions
`
`Pursuant to Local Patent Rule 4.3(a), the parties identify the following terms and phrases
`
`on which the parties agree
`
`UNITED STATES PATENT NO. 6,045,501
`
`Term
`Teratogenic drug
`
`Definition
`(cid:147)a drug that may disturb the
`normal growth and development
`of an embryo or fetus(cid:148)
`
`
`
`
`
`- 2 -
`
`CFAD VI 1030-0002
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 3 of 25 PageID: 1470
`
`
`UNITED STATES PATENT NO. 6,315,720
`
`Term
`Consulted
`Teratogenic effect
`
`Definition
`(cid:147)accessed and considered(cid:148)
`(cid:147)any effect that disturbs the
`normal growth and development
`of an embryo or fetus(cid:148)
`
`UNITED STATES PATENT NO. 6,561,976
`
`Term
`Teratogenic risks
`
`Definition
`(cid:147)risks of disturbing the normal
`growth and development of an
`embryo or fetus(cid:148)
`
`UNITED STATES PATENT NO. 7,465,800
`
`Term
`Crystalline
`
`Definition
`(cid:147)made up of crystals(cid:148)
`
`
`
`
`
`
`
`B.
`
`Disputed Claim Terms
`
`Pursuant 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 and the parties(cid:146) proposed constructions.
`
`Additionally, attached hereto as Exhibit B is a series of claim charts providing the evidence,
`
`including intrinsic and extrinsic evidence, that each party intends to rely on in support of its
`
`proposed constructions.
`
`C.
`
`Claim Terms Whose Construction Will Be Most Significant
`
`Pursuant to Local Patent Rule 4.3(c), the parties were unable to agree that there are any
`
`terms (cid:147)whose construction will be most significant to the resolution of the case.(cid:148) Likewise, the
`
`parties were unable to agree that there are any terms (cid:147)whose construction will be case or claim
`
`dispositive or substantially conducive to promoting settlement.(cid:148)
`
`
`
`- 3 -
`
`CFAD VI 1030-0003
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 4 of 25 PageID: 1471
`
`
`D.
`
`Anticipated Length of Time Necessary for the Claim Construction Hearing
`
`Pursuant 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 Hearing
`
`Pursuant to Local Patent Rule 4.3(e), Celgene has identified Dr. Jerry Atwood, Ph.D. and
`
`Dr. Stephen R. Byrn, Ph.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. and Dr. Mark
`
`Hollingsworth, Ph.D., as potential experts for the claim construction hearing. A summary of
`
`each expert(cid:146)s testimony is included in Exhibit B where appropriate.
`
`
`
`
`
`Respectfully submitted,
`
`July 18, 2011
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`OF COUNSEL:
`
`F. Dominic Cerrito
`Eric C. Stops
`JONES DAY
`222 East 41st Street
`New York, New York 10017-6702
`(212) 326-3939
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`(212) 203-7625
`
`
`
`
`
`
`
`
`
`
`By: s/ James S. Richter
`James S. Richter
`WINSTON & STRAWN LLP
`The Legal Center
`One Riverfront Plaza, 7th Floor
`Newark, New Jersey 07102
`(973) 848-7676
`jrichter@winston.com
`
`OF COUNSEL:
`
`George C. Lombardi
`Michael K. Nutter
`Maureen L. Rurka
`Kevin E. Warner
`WINSTON & 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.
`
`
`
`- 4 -
`
`CFAD VI 1030-0004
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 5 of 25 PageID: 1472
`
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`
`- 5 -
`
`
`
`
`
`CFAD VI 1030-0005
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 6 of 25 PageID: 1473
`
`
`Exhibit A
`
`Disputed Claim Terms
`
`
`UNITED STATES PATENT NO. 6,045,501
`
`Celgene(cid:146)s Proposal
`Enrolling
`Fitted (as by training or experience)
`for a given purpose
`Getting or obtaining
`
`Defendants(cid:146) Proposal
`Plain and ordinary meaning
`Plain and ordinary meaning
`
`Plain and ordinary meaning
`
`UNITED STATES PATENT NO. 6,315,720
`
`Defendants(cid:146) Proposal
`Plain and ordinary meaning
`
`Plain and ordinary meaning
`Same as (cid:146)501 patent
`Plain and ordinary meaning; or,
`alternatively, (cid:147)groups defined based
`on the level of risk that a particular
`outcome(s) will occur(cid:148)
`Plain and ordinary meaning; or,
`alternatively, (cid:147)references or values
`that influence or are suspected to
`influence the likelihood that a
`particular outcome(s) will occur(cid:148)
`Plain and ordinary meaning; or,
`alternatively, (cid:147)indication of approval
`by any means to take a particular
`action(s)(cid:148)
`
`Term
`Registering
`Qualified
`
`Retrieving
`
`
`Term
`Adverse side effect
`
`Registered
`Qualified
`Risk groups
`
`Celgene(cid:146)s Proposal
`Any unfavorable abnormality,
`defect, mutation, lesion,
`degeneration or injury which may be
`caused by taking the drug
`Enrolled
`Same as (cid:146)501 patent
`Classifications based upon the
`chance that an adverse side effect
`may occur
`
`Risk parameters
`
`Factors that influence the chance that
`an adverse side effect may occur
`
`Approval code
`
`Symbol(s) representing consent to
`fill a prescription
`
`
`
`
`
`- 1 -
`
`CFAD VI 1030-0006
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 7 of 25 PageID: 1474
`
`
`Term
`Registering
`
`
`Term
`Contraindicated
`
`Retrieved
`Registering
`Registered
`Adverse side effect
`
`
`Term
`Contraindicated
`Retrieved
`Registering
`Registered
`Adverse side effect
`
`
`UNITED STATES PATENT NO. 6,561,976
`
`Celgene(cid:146)s Proposal
`Same as (cid:146)501 patent
`
`Defendants(cid:146) Proposal
`Same as (cid:146)501 patent
`
`UNITED STATES PATENT NO. 6,561,977
`
`Celgene(cid:146)s Proposal
`Any condition in a patient which
`renders a particular line of treatment,
`including the administration of one
`or more drugs, undesirable or
`improper
`Got or obtained
`Same as (cid:146)501 patent
`Same as (cid:146)720 patent
`Same as (cid:146)720 patent
`
`Defendants(cid:146) Proposal
`Plain and ordinary meaning; or,
`alternatively, (cid:147)inadvisable for use as
`a medical treatment or use as
`indicated(cid:148)
`
`Plain and ordinary meaning
`Same as (cid:146)501 patent
`Same as (cid:146)720 patent
`Same as (cid:146)720 patent
`
`UNITED STATES PATENT NO. 6,755,784
`
`Celgene(cid:146)s Proposal
`Same as (cid:146)977 patent
`Same as (cid:146)977 patent
`Same as (cid:146)501 patent
`Same as (cid:146)720 patent
`Same as (cid:146)720 patent
`
`Defendants(cid:146) Proposal
`Same as (cid:146)977 patent
`Same as (cid:146)977 patent
`Same as (cid:146)501 patent
`Same as (cid:146)720 patent
`Same as (cid:146)720 patent
`
`UNITED STATES PATENT NO. 5,635,517
`
`Term
`Undesirable levels of
`TNF
` in a mammal
`
`Celgene(cid:146)s Proposal
`Non-optimal levels of TNF
` in a
`mammal
`
`Effective amount
`
`An amount sufficient to produce a
`desired therapeutic effect
`
`Defendants(cid:146) Proposal
`Suboptimal levels of TNF
` in a
`mammal, excluding levels related to
`myelodysplastic syndrome
`Plain and ordinary meaning
`
`
`
`
`
`- 2 -
`
`CFAD VI 1030-0007
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 8 of 25 PageID: 1475
`
`
`UNITED STATES PATENT NO. 6,281,230
`
`Defendants(cid:146) Proposal
`A local response to cellular injury
`characterized by pain, redness,
`swelling and/or loss of function,
`excluding myelodysplastic
`syndrome
`A disease caused or characterized by
`inflammation, excluding
`myelodysplastic syndrome
`A disease caused by an immune
`reaction against the body(cid:146)s own cells
`and/or tissues, excluding
`myelodysplastic syndrome
`Same as (cid:146)517 patent
`Plain and ordinary meaning; or,
`alternatively, (cid:147)an agent having a
`therapeutic effect(cid:148)
`the stereochemical configuration of
`the compound is all or substantially
`all the R-isomer, thus excluding a
`compound that is a racemic mixture
`the stereochemical configuration of
`the compound is all of substantially
`all the S-isomer, thus excluding a
`compound that is a racemic mixture
`Plain and ordinary meaning; or,
`alternatively, (cid:147)dosage regimen
`during which the second dose is
`either given after the first dose has
`been eliminated (single dosage
`regimen) or prior to the complete
`elimination of the first dose
`(multiple dosage regimen)(cid:148)
`Plain and ordinary meaning
`
`Term
`Inflammation
`
`Celgene(cid:146)s Proposal
`A local response to cellular injury
`characterized 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 body(cid:146)s own
`cells and/or tissues
`
`Effective amount
`A therapeutic agent
`
`Same as (cid:146)517 patent
`A substance associated with the
`treatment of disease or disorders
`
`Said compound has
`the R-configuration
`
`Said compound has the R-isomer
`
`Said compound has
`the S-configuration
`
`Said compound has the S-isomer
`
`A single or multiple
`dose regimen
`
`One or more doses per day over
`multiple days
`
`Pharmaceutical
`composition
`
`One or more active ingredients with
`one or more inert or inactive
`ingredients
`
`
`
`- 3 -
`
`CFAD VI 1030-0008
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 9 of 25 PageID: 1476
`
`
`Term
`An oncogenic or
`cancerous condition
`
`Celgene(cid:146)s Proposal
`A condition tending to cause or give
`rise to tumors
`
`Defendants(cid:146) Proposal
`A condition tending to cause or give
`rise to tumors, excluding
`myelodysplastic syndrome
`
`UNITED STATES PATENT NO. 6,555,554
`
`
`
`Term
`In combination with a
`pharmaceutically and
`physiologically
`suitable carrier
`
`Pharmaceutical
`composition
`Reducing the level of
`TNF
`
`
`Improving an
`oncogenic or
`cancerous condition
`
`Reducing
`inflammation
`
`Celgene(cid:146)s Proposal
`With one or more inert or inactive
`ingredients appropriate for
`administration to a human
`
`Same as (cid:146)230 patent
`
`Lowering levels of TNF
`
`
`
`Making better a condition tending to
`cause or give rise to tumors
`
`Diminishing inflammation
`
`Improving
`autoimmune disease
`
`Making better an autoimmune
`disease
`
`Defendants(cid:146) Proposal
`Plain and ordinary meaning; or,
`alternatively, (cid:147)together with a
`carrier that is acceptable to be in a
`medicine for functioning in a
`physiological environment(cid:148)
`Same as (cid:146)230 patent
`
` in a
`Lowering levels of TNF
`mammal, excluding in association
`with myelodysplastic syndrome
`Making better a condition tending to
`cause or give rise to tumors,
`excluding myelodysplastic
`syndrome
`Diminishing inflammation,
`excluding that associated with
`myelodysplastic syndrome; see
`proposed construction for
`(cid:147)inflammation(cid:148) in connection with
`the (cid:146)230 patent.
`Making better an autoimmune
`disease, excluding myelodysplastic
`syndrome; see proposed
`construction for (cid:147)autoimmune
`disease(cid:148) in connection with the (cid:146)230
`patent.
`Same as (cid:146)230 patent
`
`Said compound has
`the R-configuration
`Said compound has
`the S-configuration
`Effective amount
`
`Same as (cid:146)230 patent
`
`Same as (cid:146)230 patent
`
`Same as (cid:146)230 patent
`
`Same as (cid:146)517 patent
`
`Same as (cid:146)517 patent
`
`
`
`- 4 -
`
`CFAD VI 1030-0009
`
`
`
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 10 of 25 PageID: 1477
`
`
`Term
`Undesirable levels of
`TNF
` in a mammal
`
`
`Term
`Pharmaceutical
`composition
`Effective amount
`
`
`Term
`3-(4-amino-l-oxo-l,3
`dihydro-isoindol-2-yl)-
`piperidine-2,6-dione
`Hemihydrate
`
`Celgene(cid:146)s Proposal
`Same as (cid:146)517 patent
`
`Defendants(cid:146) Proposal
`Same as (cid:146)517 patent
`
`UNITED STATES PATENT NO. 7,119,106
`
`Celgene(cid:146)s Proposal
`Same as (cid:146)230 patent
`
`Defendants(cid:146) Proposal
`Same as (cid:146)230 patent
`
`Same as (cid:146)517 patent
`
`Same as (cid:146)517 patent
`
`UNITED STATES PATENT NO. 7,465,800
`
`Celgene(cid:146)s Proposal
`No construction required
`
`A hydrate containing approximately
`half a mole of water to one mole of
`the compound forming the hydrate
`
`Defendants(cid:146) Proposal
`lenalidomide, prepared according to
`the methods described in U.S. Patent
`Nos. 6,281,230 and 5,635,517
`a solid crystalline form of
`lenalidomide containing one water
`molecule for every two molecules of
`3-(4-amino-1-oxo-1,3 dihydro-
`isoindol-2-yl)- piperidine-2,6-dione,
`formally associated with one another
`within the unit cell in the solid
`crystalline structure, and which
`crystal form is specifically identified
`in the (cid:145)800 patent as the Form B
`polymorphic form, and
`demonstrated in TGA, Karl Fischer
`analysis, powder X-ray diffraction
`patterns, IR spectra, and/or DSC
`analysis, as distinguishable from
`other polymorphs, such as the
`anhydrous form
`
`
`
`- 5 -
`
`
`
`CFAD VI 1030-0010
`
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 11 of 25 PageID: 1478
`
`
`Exhibit B
`
`Evidence In Support Of the Parties’ Proposed Construction for Disputed Terms1
`
`UNITED STATES PATENT NO. 6,045,501
`
`Term
`Registering
`
`Qualified
`
`Natco(cid:146)s Evidence
`(cid:146)501 patent at 4:39-44.
`
`(cid:146)501 patent file history.
`
`(cid:146)501 patent specification and file
`history.
`
`Webster(cid:146)s College Dictionary (3rd
`ed.) at 1099.
`
`Celgene(cid:146)s Evidence
`(cid:146)501 patent at Abstract; 4:10-49;
`4:60-5:53.
`
`(cid:146)501 patent file history, Paper No. 6
`(11/12/99 Response to Office
`Action).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 984-85.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 1048.
`(cid:146)501 patent at 4:10-13.
`
`(cid:146)501 patent file history, Paper No. 6
`(11/12/99 Response to Office
`Action).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 955.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 1017.
`
`
`1 Each party objects to any other party(cid:146)s listing of evidence in this chart to the extent it was not
`properly disclosed in compliance with L. Pat. R. 4.2. Additionally, each party incorporates by
`reference its disclosures pursuant to L. Pat. R. 4.2 as if recited herein.
`
`
`
`- 1 -
`
`CFAD VI 1030-0011
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 12 of 25 PageID: 1479
`
`
`Term
`Retrieving
`
`
`
`Term
`Adverse side effect
`
`Registered
`
`Qualified
`
`Natco(cid:146)s Evidence
`(cid:146)501 patent specification and file
`history.
`
`Webster(cid:146)s Unabridged Dictionary
`(2nd Ed.) at 1644-1645.
`
`Celgene(cid:146)s Evidence
`(cid:146)501 patent at 8:26-39; 9:53-62;
`9:65-10:2.
`
`(cid:146)501 patent file history, Paper No. 6
`(11/12/99 Response to Office
`Action).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 1001.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 1065.
`
`UNITED STATES PATENT NO. 6,315,720
`
`Celgene(cid:146)s Evidence
`(cid:146)720 patent at Abstract; 1:19-45;
`2:50-60; 4:14-18.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 17.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 19.
`See evidence for (cid:147)registering(cid:148) in
`(cid:146)501 patent.
`
`(cid:146)720 patent at Abstract; 4:43-5:16;
`5:27-6:10.
`
`(cid:146)720 patent file history, Paper No. 4
`(3/28/01 Response to Office Action).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 984-85.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 1048.
`Same as (cid:146)501 patent
`
`Natco(cid:146)s Evidence
`(cid:146)720 patent at 3:38-44.
`
`(cid:146)720 patent file history.
`
`(cid:146)720 patent at 4:54-5:16; 5:21-24.
`
`(cid:146)720 patent file history.
`
`See above for (cid:146)501 patent,
`incorporated by reference.
`
`
`
`- 2 -
`
`CFAD VI 1030-0012
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 13 of 25 PageID: 1480
`
`
`Term
`Risk groups
`
`Risk parameters
`
`Approval code
`
`Natco(cid:146)s Evidence
`(cid:146)720 patent at Abstract.
`
`(cid:146)720 patent file history.
`
`(cid:146)720 patent at 6:30-53.
`
`(cid:146)720 patent file history.
`
`(cid:146)720 patent at 13:42-45.
`
`(cid:146)720 patent file history.
`
`Celgene(cid:146)s Evidence
`(cid:146)720 patent at Abstract; 6:30-39;
`6:45-65; 7:4-19; 7:24-36; 7:46-53;
`8:23-27.
`
`(cid:146)720 patent file history, Paper No. 6
`(6/28/01 Response to Office Action).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 515, 1011.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 552, 1076.
`(cid:146)720 patent at 6:30-39; 6:45-7:3.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 843, 1011.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 899, 1076.
`(cid:146)720 patent at 13:42-61; 14:67-15:6.
`
`(cid:146)720 patent file history, Paper No. 4
`(3/28/01 Response to Office Action);
`Paper No. 6 (6/28/01 Response to
`Office Action).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 57, 221.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 61, 239.
`
`
`
`UNITED STATES PATENT NO. 6,561,976
`
`Term
`Registering
`
`Celgene(cid:146)s Evidence
`Same as (cid:146)501 patent
`
`
`
`
`
`- 3 -
`
`Natco(cid:146)s Evidence
`See above for (cid:146)501 patent,
`incorporated by reference.
`
`(cid:146)976 patent specification and file
`history.
`
`CFAD VI 1030-0013
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 14 of 25 PageID: 1481
`
`
`UNITED STATES PATENT NO. 6,561,977
`
`Term
`Contraindicated
`
`Celgene(cid:146)s Evidence
`(cid:146)977 patent at 4:8-22.
`
`Retrieved
`
`Registering
`
`(cid:146)977 patent at 13:45-67; 15:3-9;
`16:20-27.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 1001.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 1065.
`Same as (cid:146)501 patent
`
`Registered
`
`Same as (cid:146)720 patent
`
`Adverse side effect
`
`Same as (cid:146)720 patent
`
`Natco(cid:146)s Evidence
`(cid:146)977 patent at 4:8-22.
`
`(cid:146)977 patent file history.
`(cid:146)977 patent specification.
`
`(cid:146)977 patent file history.
`
`Webster(cid:146)s Unabridged Dictionary
`(2nd Ed.) at 1644-1645.
`
`See above for (cid:146)501 patent,
`incorporated by reference.
`
`(cid:146)977 patent specification and file
`history.
`See above for (cid:146)720 patent,
`incorporated by reference.
`
`(cid:146)977 patent specification and file
`history.
`See above for (cid:146)720 patent,
`incorporated by reference.
`
`(cid:146)977 patent at 3:42-48.
`
`(cid:146)977 patent file history.
`
`
`
`UNITED STATES PATENT NO. 6,755,784
`
`Term
`Contraindicated
`
`Celgene(cid:146)s Evidence
`Same as (cid:146)977 patent
`
`Natco(cid:146)s Evidence
`See above for (cid:146)977 patent,
`incorporated by reference.
`
`(cid:146)784 patent at 4:14-28.
`
`(cid:146)784 patent file history.
`
`
`
`- 4 -
`
`CFAD VI 1030-0014
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 15 of 25 PageID: 1482
`
`
`Term
`Retrieved
`
`Celgene(cid:146)s Evidence
`Same as (cid:146)977 patent
`
`Registering
`
`Same as (cid:146)501 patent
`
`Registered
`
`Same as (cid:146)720 patent
`
`Adverse side effect
`
`Same as (cid:146)720 patent
`
`Natco(cid:146)s Evidence
`See above for (cid:146)977 patent,
`incorporated by reference.
`
`(cid:146)784 patent specification and file
`history.
`See above for (cid:146)501 patent,
`incorporated by reference.
`
`(cid:146)784 patent specification and file
`history.
`See above for (cid:146)720 patent,
`incorporated by reference.
`
`(cid:146)784 patent specification and file
`history.
`See above for (cid:146)720 patent,
`incorporated by reference.
`
`(cid:146)784 patent at 3:48-54.
`
`(cid:146)784 patent file history.
`
`
`
`UNITED STATES PATENT NO. 5,635,517
`
`Term
`Undesirable levels of
`TNF
` in a mammal
`
`Celgene(cid:146)s Proposal
`(cid:146)517 patent at Abstract, 1:6-11; 1:21-
`29; 1:46-57; 2:58-3:3; 3:45-62; 4:15-
`17; 4:34-57.
`
`Effective amount
`
`(cid:146)517 patent at 4:34-40; 5:62-6:3;
`Examples 3 through 8.
`
`
`
`
`
`- 5 -
`
`Defendants(cid:146) Proposal
`(cid:146)517 patent at 1:21-22; 1:46-53;
`3:59-62.
`
`(cid:146)517 patent file history.
`
`Celgene(cid:146)s Objections and Responses
`to Defendants(cid:146) First Set of
`Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`(cid:146)517 patent specification.
`
`(cid:146)517 patent file history.
`
`Webster(cid:146)s College Dictionary (3rd
`ed.) at 432 ((cid:147)effective(cid:148)).
`
`CFAD VI 1030-0015
`
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 16 of 25 PageID: 1483
`
`
`UNITED STATES PATENT NO. 6,281,230
`
`Term
`Inflammation
`
`Celgene(cid:146)s Evidence
`(cid:146)230 patent at Abstract; 1:25-32;
`2:1-9; 3:45-50; 4:8-31.
`
`Inflammatory disease
`
`(cid:146)230 patent at Abstract; 1:25-32;
`2:1-9; 2:12-44; 3:45-50; 4:8-31.
`
`Autoimmune disease
`
`(cid:146)230 patent at Abstract; 1:24-31;
`4:17-34.
`
`Effective amount
`
`Same as (cid:146)517 patent
`
`Natco(cid:146)s Evidence
`(cid:146)230 patent at 1:25-31.
`
`(cid:146)230 patent file history.
`
`Celgene(cid:146)s Objections and Responses
`to Defendants(cid:146) First Set of
`Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`(cid:146)230 patent at 2:12-13; 2:26-29.
`
`(cid:146)230 patent file history.
`
`Celgene(cid:146)s Objections and Responses
`to Defendants(cid:146) First Set of
`Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`Webster(cid:146)s College Dictionary (3rd
`ed.) at 93 ((cid:147)autoimmune(cid:148)).
`
`(cid:146)230 patent specification.
`
`(cid:146)230 patent file history.
`
`Celgene(cid:146)s Objections and Responses
`to Defendants(cid:146) First Set of
`Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`See above for (cid:146)517 patent,
`incorporated by reference.
`
`(cid:146)230 patent specification and file
`history.
`
`
`
`- 6 -
`
`CFAD VI 1030-0016
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 17 of 25 PageID: 1484
`
`
`Term
`A therapeutic agent
`
`Natco(cid:146)s Evidence
`(cid:146)230 patent at 5:25-28.
`
`(cid:146)230 patent file history.
`
`Celgene(cid:146)s Evidence
`(cid:146)230 patent at 4:31-35; 5:23-28;
`28:53-54.
`
`(cid:146)230 patent file history, Paper No. 2
`(Preliminary Amendment).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 22, 1223.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 24, 1296.
`
`
`
`- 7 -
`
`CFAD VI 1030-0017
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 18 of 25 PageID: 1485
`
`
`Term
`Said compound has
`the R-configuration
`
`Celgene(cid:146)s Evidence
`(cid:146)230 patent at 8:1-17.
`
`(cid:146)230 patent file history, Paper No. 7
`(2/15/01 Response to Office
`Action).
`
`Expert opinion and/or testimony of
`Dr. Stephen R. Byrn and/or Dr.
`Jerry Atwood: The term requires
`nothing more than the presence of
`the R-isomer, and does not require
`the absence of the S-isomer or any
`excess of the R-isomer. The term
`does not exclude the racemic
`mixture. Dr. Byrn and Dr. Atwood
`may also opine regarding the level
`of ordinary skill in the art and/or the
`qualifications of one of ordinary
`skill in the art.
`
`Natco(cid:146)s Evidence
`(cid:146)230 patent at 8:1-17; 17:28-18:61
`(Example 16).
`
`(cid:146)230 patent file history.
`
`Webster(cid:146)s Online Dictionary,
`Extended Definition: Enantiomer,
`http://www.websters-online-
`dictionary.org/definitions/
`enantiomer?cx=partner-pub-
`0939450753529744%3Av0qd01-
`tdlq&cof =FORID%3A9&ie=UTF-
`8&q=enantiomer&sa=Search#922.
`
`Natco may rely on the expert
`opinion of Dr. Robert Boeckman.
`Dr. Boeckman may offer opinions
`about the understanding of this
`claim term and the language (cid:147)R-
`configuration(cid:148) and (cid:147)S-
`configuration(cid:148) to a person of skill in
`the art; background technology
`concerning isomers and
`enantiomers; differences between
`enantiomers and racemic
`compounds; chirality. Dr.
`Boeckman may opine that Celgene(cid:146)s
`proposed claim construction is
`contrary to the teachings of the
`specification and file history of the
`(cid:146)230 patent, and contrary to the
`meaning of this claim term to a
`person of ordinary skill in the art.
`Dr. Boeckman may also offer an
`opinion that Natco(cid:146)s proposed
`construction is consistent with all
`relevant intrinsic evidence and the
`meaning of this claim term to a
`person of ordinary skill in the art.
`
`
`
`- 8 -
`
`CFAD VI 1030-0018
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 19 of 25 PageID: 1486
`
`
`Term
`Said compound has
`the S-configuration
`
`Celgene(cid:146)s Evidence
`(cid:146)230 patent at 8:1-17.
`
`(cid:146)230 patent file history, Paper No. 7
`(2/15/01 Response to Office
`Action).
`
`Expert opinion and/or testimony of
`Dr. Stephen R. Byrn and/or Dr.
`Jerry Atwood: The term requires
`nothing more than the presence of
`the S-isomer, and does not require
`the absence of the R-isomer or any
`excess of the S-isomer. The term
`does not exclude the racemic
`mixture. Dr. Byrn and Dr. Atwood
`may also opine regarding the level
`of ordinary skill in the art and/or the
`qualifications of one of ordinary
`skill in the art.
`
`Natco(cid:146)s Evidence
`(cid:146)230 patent at 8:1-17; 17:28-18:61
`(Example 16).
`
`(cid:146)230 patent file history.
`
`Webster(cid:146)s Online Dictionary,
`Extended Definition: Enantiomer,
`http://www.websters-online-
`dictionary.org/definitions/
`enantiomer?cx=partner-pub-
`0939450753529744%3Av0qd01-
`tdlq&cof =FORID%3A9&ie=UTF-
`8&q=enantiomer&sa=Search#922.
`
`Natco may rely on the expert
`opinion of Dr. Robert Boeckman.
`Dr. Boeckman may offer opinions
`about the understanding of this
`claim term and the language (cid:147)R-
`configuration(cid:148) and (cid:147)S-
`configuration(cid:148) to a person of skill in
`the art; background technology
`concerning isomers and
`enantiomers; differences between
`enantiomers and racemic
`compounds; chirality. Dr.
`Boeckman may opine that Celgene(cid:146)s
`proposed claim construction is
`contrary to the teachings of the
`specification and file history of the
`(cid:146)230 patent, and contrary to the
`meaning of this claim term to a
`person of ordinary skill in the art.
`Dr. Boeckman may also offer an
`opinion that Natco(cid:146)s proposed
`construction is consistent with all
`relevant intrinsic evidence and the
`meaning of this claim term to a
`person of ordinary skill in the art.
`
`
`
`- 9 -
`
`CFAD VI 1030-0019
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 20 of 25 PageID: 1487
`
`
`Term
`A single or multiple
`dose regimen
`
`Pharmaceutical
`composition
`
`Celgene(cid:146)s Evidence
`(cid:146)230 patent at 8:27-35.
`
`(cid:146)230 patent file history, Paper No. 1
`(Application).
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (10th ed.) at 346, 764,
`984, 1095.
`
`Merriam Webster(cid:146)s Collegiate
`Dictionary (11th ed.) at 373, 816,
`1048, 1163.
`(cid:146)230 patent at 1:16-21; 8:27-57;
`Examples 1 through 36.
`
`(cid:146)230 patent file history, Paper No. 2
`(Preliminary Amendment).
`
`An oncogenic or
`cancerous condition
`
`(cid:146)230 patent at Abstract; 2:1-11;
`4:17-35.
`
`
`
`Natco(cid:146)s Evidence
`(cid:146)230 patent specification.
`
`(cid:146)230 patent file history.
`
`Applied Biopharmaceutics &
`Pharmacokinetics, 5e, Chapter 8.
`Multiple-Dosage Regimens (Leon
`Shargel et al., The McGraw-Hill
`Companies, Inc. 1980).
`
`(cid:146)230 patent specification.
`
`(cid:146)230 patent file history.
`
`Webster(cid:146)s Online Dictionary,
`Definition: Pharmaceutical,
`http://www.websters- online-
`dictionary.org/definitions/
`pharmaceutical?cx=partner-pub-
`0939450753529744 %3Av0qd01-
`tdlq&cof=FORID%3A9&ie=UTF-
`8&q=pharmaceutical&sa
`=Search#922.
`(cid:146)230 patent at 2:7-11.
`
`(cid:146)230 patent file history.
`
`Celgene(cid:146)s Objections and Responses
`to Defendants(cid:146) First Set of
`Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`
`
`
`- 10 -
`
`CFAD VI 1030-0020
`
`

`

`Case 2:10-cv-05197-SDW-SCM Document 81 Filed 07/18/11 Page 21 of 25 PageID: 1488
`
`
`UNITED STATES PATENT NO. 6,555,554
`
`Celgene(cid:146)s Evidence
`(cid:146)554 patent at 8:14-38; Examples 18
`through 36.
`
`Natco(cid:146)s Evidence
`(cid:146)554 patent at 8:17-25.
`
`(cid:146)554 patent file history.
`
`Same as (cid:146)230 patent
`
`See above for (cid:146)230 patent,
`incorporated by reference.
`
`(cid:146)554 patent specification and file
`history.
`(cid:146)554 patent specification.
`
`(cid:146)554 patent file history.
`
`Celgene(cid:146)s Objections and
`Responses to Defendants(cid:146) First Set
`of Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`
`Webster(cid:146)s College Dictionary (3rd
`ed.) at 1126 ((cid:147)reduce(cid:148)).
`(cid:146)554 patent at 2:5-9.
`
`(cid:146)554 patent file history.
`
`Celgene(cid:146)s Objections and
`Responses to Defendants(cid:146) First Set
`of Interrogatories (Nos. 1-14), at
`Response to Interrogatory No. 9.
`
`Webster(cid:146)s College Dictionary (3rd
`ed.) at 679 ((cid