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CELG v ACT - Joint Markman Statement

CELG v ACT - Joint Markman Statement

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04841.62499/5478002.

4 - 1 -
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, 7
th
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,
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.
I. BACKGROUND
This case arises out of Natco’s filing of ANDA No. 201452 with the U.S. Food and Drug
Administration (“FDA”), which seeks approval to market a generic version of Celgene’s
Revlimid
®
product. The active ingredient in Revlimid
®
is lenalidomide. Plaintiffs allege, among
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 1 of 40 PageID: 6728

04841.62499/5478002.4 - 2 -
other things, that Natco’s 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 party’s 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 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. 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 unless otherwise specified.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 2 of 40 PageID: 6729

04841.62499/5478002.4 - 3 -
UNITED STATES PATENT NO. 5,635,517
Term Definition
Undesirable levels of
TNFα in a mammal
“non-optimal levels of TNFα in a
mammal”

UNITED STATES PATENT NO. 6,281,230
Term Definition
Inflammation “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’s own
cells and/or tissues”
An oncogenic or
cancerous condition
“a condition tending to cause or
give rise to tumors”

UNITED STATES PATENT NO. 6,555,554
Term Definition
Reducing the level of
TNFα
“lowering levels of TNFα”
Improving an
oncogenic or
cancerous condition
“making better a condition
tending to cause or give rise to
tumors”
Reducing
inflammation
“diminishing inflammation”
Improving
autoimmune disease
“making better an autoimmune
disease”

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 3 of 40 PageID: 6730

04841.62499/5478002.4 - 4 -
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
treatment, including the
administration of one or more
drugs, undesirable or improper”

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 4 of 40 PageID: 6731

04841.62499/5478002.4 - 5 -
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 by
taking 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 an
endothermic event such as a
melting point, rather than the
onset or the endset of the peak”

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 5 of 40 PageID: 6732

04841.62499/5478002.4 - 6 -
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, 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 Significant
Pursuant 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 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., 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
experts for the claim construction hearing. A summary of each expert’s testimony is included in
Exhibit A where appropriate.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 6 of 40 PageID: 6733

04841.62499/5478002.4 - 7 -


October 18, 2013

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
Andrew S. Chalson
QUINN EMANUEL URQUHART &
SULLIVAN LLP
51 Madison Avenue
New York, New York 10010
(212) 849-7000

Anthony M. Insogna
JONES DAY
12265 El Camino Real
Suite 200
San Diego, California 92130-4096
(858) 314-1200

Richard G. Greco
RICHARD G. GRECO PC
90 State Street, Suite 700
Albany, New York 12207
(212) 203-7625

Attorneys for Plaintiff
Celgene Corporation
Respectfully submitted,



By: s/ Melissa Steedle Bogad
James S. Richter
Melissa Steedle Bogad
WINSTON & STRAWN LLP
The Legal Center
One Riverfront Plaza, Suite 730
Newark, New Jersey 07102
gs. 1 848-7676
jrichter@winston.com
mbogad@winston.com

OF COUNSEL:

George C. Lombardi
Michael K. Nutter
Maureen L. Rurka
Kevin E. Warner
Laura B. Greenspan
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.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 7 of 40 PageID: 6734

04841.62499/5478002.4 - 1 -
EXHIBIT A
DISPUTED CLAIM TERMS & EVIDENCE
United States Patent No. 6,281,230
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
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 configuration of the compound is
all or substantially all the R-isomer, thus excluding a
compound that is a racemic mixture”

Evidence:

See below for ‘554 patent, incorporated by reference.

Intrinsic Evidence:
Specification of the ’230 patent, including but not
limited to 8:1-17 and 17:28-18:61.

File history of the ’230 patent

Extrinsic Evidence:
Webster’s Online Dictionary, Extended Definition:
enantiomer, http://www.websters-online-
dictionary.org/definitions/enantiomer?cx=partnerpub-
0939450753529744%3Av0qd01-
tdlq&cof=FORID%3A9&ie=UTF-
8&q=enantiomer&sa=Search#922.

Defendants 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 “R-configuration” and “S-configuration” to
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 8 of 40 PageID: 6735

04841.62499/5478002.4 - 2 -
United States Patent No. 6,281,230
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
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’s
proposed claim construction is contrary to the
teachings of the specification and file history of the
’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 Defendants’
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.
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 configuration of the compound is
all or substantially all the S-isomer, thus excluding a
compound that is a racemic mixture”

Evidence:

See below for ‘554 patent, incorporated by reference.

Intrinsic Evidence:
Specification of the ’230 patent, including but not
limited to 8:1-17 and 17:28-18:61.

File history of the ’230 patent

Extrinsic Evidence:
Webster’s Online Dictionary, Extended Definition:
enantiomer, http://www.websters-online-
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 9 of 40 PageID: 6736

04841.62499/5478002.4 - 3 -
United States Patent No. 6,281,230
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
dictionary.org/definitions/enantiomer?cx=partnerpub-
0939450753529744%3Av0qd01-
tdlq&cof=FORID%3A9&ie=UTF-
8&q=enantiomer&sa=Search#922.

Defendants 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 “R-configuration” and “S-configuration” 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’s
proposed claim construction is contrary to the
teachings of the specification and file history of the
’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 Defendants’
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.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 10 of 40 PageID: 6737

04841.62499/5478002.4 - 4 -
United States Patent No. 6,555,554
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Said compound has
the R-configuration
Same as ’230 patent Same as ’230 patent

Evidence:

See above for ’230 patent, incorporated by reference.

Intrinsic Evidence:
Specification of the ’554 patent, including but not
limited to 7:38-54 and 17:9-18:43.

File history of the ’554 Patent, including but not
limited to February 12, 2001 amendment at p. 5.

Extrinsic Evidence:
Webster’s Online Dictionary, Extended Definition:
enantiomer, http://www.websters-online-
dictionary.org/definitions/enantiomer?cx=partnerpub-
0939450753529744%3Av0qd01-
tdlq&cof=FORID%3A9&ie=UTF-
8&q=enantiomer&sa=Search#922.

Defendants 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 “R-configuration” and “S-configuration” 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’s
proposed claim construction is contrary to the
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 11 of 40 PageID: 6738

04841.62499/5478002.4 - 5 -
United States Patent No. 6,555,554
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
teachings of the specification and file history of the
’554 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 Defendants’
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.
Said compound has
the S-configuration
Same as ’230 patent Same as ’230 patent

Evidence:

See above for ’230 patent, incorporated by reference.

Intrinsic Evidence:
Specification of the ’554 patent, including but not
limited to 7:38-54 and 17:9-18:43.

File history of the ’554 Patent, including but not
limited to February 12, 2001 amendment at p. 5.

Extrinsic Evidence:
Webster’s Online Dictionary, Extended Definition:
enantiomer, http://www.websters-online-
dictionary.org/definitions/enantiomer?cx=partnerpub-
0939450753529744%3Av0qd01-
tdlq&cof=FORID%3A9&ie=UTF-
8&q=enantiomer&sa=Search#922.

Defendants may rely on the expert opinion of Dr.
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04841.62499/5478002.4 - 6 -
United States Patent No. 6,555,554
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Robert Boeckman. Dr. Boeckman may offer opinions
about the understanding of this claim term and the
language “R-configuration” and “S-configuration” 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’s
proposed claim construction is contrary to the
teachings of the specification and file history of the
’554 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 Defendants’
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.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 13 of 40 PageID: 6740

04841.62499/5478002.4 - 7 -
United States Patent No. 8,228,415
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Unit dosage form Physically discrete units suitable as a unitary dosage

Evidence:

’415 patent generally

’415 patent file history generally
“Physically discrete units suitable as a unitary dosage
containing a predetermined quantity of active material
calculated to produce the desired therapeutic effect”

Evidence:

Intrinsic Evidence:
Specification of the ’415 patent, including but not
limited to 9:18-25 and Claims 1-5.

File history of the ’415 patent

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Frederick Luzzio. Dr. Luzzio may offer opinions
about the understanding of the claim term “unit
dosage form” as it pertains to a person of ordinary
skill in the art. Dr. Luzzio may opine that Celgene’s
construction of “unit dosage form” is contrary to the
teachings of the specification, claims and file history
of the ’415 patent, and contrary to the meaning of this
claim term to a person of ordinary skill in the art. Dr.
Luzzio may also offer an opinion that Defendants’
proposed construction is consistent with all relevant
intrinsic evidence and the meaning of the claim term
“unit dosage form” to a person of ordinary skill in the
art.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 14 of 40 PageID: 6741

04841.62499/5478002.4 - 8 -
United States Patent No. 7,465,800
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
3-(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 skilled
artisans 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. 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.
“lenalidomide, prepared according to the methods
described in U.S. Patent Nos. 6,281,230 and
5,635,517”

Evidence:

Intrinsic Evidence:
Specification of the ’800 patent, including but not
limited to 4:52 – 5:1.

File history of the ’800 patent.
Hemihydrate A hydrate containing approximately half a mole of
water to one mole of the compound forming the
hydrate

Evidence:

’800 patent generally, including, but not limited to,
5:36-40, 6:53-7:35, 12:31-36, 22:40-43

Merriam Webster’s Collegiate Dictionary (10
th
ed.)
“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
‘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,
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04841.62499/5478002.4 - 9 -
United States Patent No. 7,465,800
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
at 540

Merriam Webster’s Collegiate Dictionary (11
th
ed.)
at 579

Celgene may rely on the deposition transcript of
Defendants’ 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 skilled
artisans 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 that
the term does not require any of the additional
limitations proposed by Defendants. 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. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
opinions of Defendants’ expert Dr. Mark
Hollingsworth.
such as the anhydrous form”

Evidence:

Intrinsic Evidence:
Specification of the ’800 patent, including but not
limited to 3:53-55; 5:36-40; 6:67-7:6; 7:31-33; 17:37-
40; 12:31-36; 6:56 – 7:35; 12:44-46; 13:36-37; Table
5; 15:56-57; and Figs. 37-39.

File history of the ’800 Patent, including but not
limited to Original Application at 32-35; June 22,
2007 Office Action at 2-3; July 23, 2007 Amendment
at 9-10 (citing Original Application at 5-19); October
10, 2007 Office Action at 2-3; Jan. 9, 2008
Amendment at 2-3, 5; Apr. 30, 2008 Notice of
Allowability at 2; and Nov. 3, 2008 Notice of
Allowability at 2.

Extrinsic Evidence:
Webster’s New Collegiate Dictionary (9th ed. 1991),
at 313 (defining “crystal” and “crystalline”); id. at 564
(defining “hemihydrates”);

Remington: The Science And Practice of Pharmacy
(20th ed. 2000), at 175 (discussing solvates); id. at
702, 717 (discussing hemihydrates).

Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
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04841.62499/5478002.4 - 10 -
United States Patent No. 7,465,800
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
opinions about the understanding of the claim term
“hemihydrate” to a person of skill in the art; crystal
structures in general; the water content of crystal
structures; means and methods for measuring the
water content of crystal structures; and the definition
of certain crystal structures depending on their water
content. Dr. Hollingsworth may opine that Celgene’s
proposed claim construction of “hemihydrates” is
contrary to the teachings of the specification and file
history of the ’800 patent, and contrary to the meaning
of this claim term to a person of ordinary skill in the
art, in particular with respect to the suggestion that
hemihydrate is a term of approximation. Dr.
Hollingsworth may also offer an opinion that
Defendants’ 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.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 17 of 40 PageID: 6744

04841.62499/5478002.4 - 11 -
United States Patent No. 7,977,357
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Form A A polymorphic form of 3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione that can
be 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. Byrn
and 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 refers
to a polymorphic crystal form of lenalidomide that
can be distinguished from other forms of
lenalidomide, and that the term does not require the
host 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 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 of
one of ordinary skill in the art. Dr. Byrn and Dr.
Atwood may also provide opinions to rebut the
“The lenalidomide crystal form described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Evidence:

Intrinsic Evidence:
The ’357 patent in its entirety, including but not
limited to 6:17 – 6:54; 9:50–61; 9:63 – 10:6; Claims
1–14; and Figs. 1–54.

Prosecution history of the ’357 patent in its entirety,
including but not limited to June 18, 2010 Office
Action at 4; March 7, 2011 Interview Summary;
March 10, 2011 Amendment.

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“Form A” to a person of ordinary skill in the art,
including but not limited to the convention associated
with naming crystals and the analytical attributes
unique to each specific crystalline structure and
methods of characterizing these unique attributes
including with DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
offer an opinion that Celgene’s proposed construction
of “Form A” is contrary to the teachings of the
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 18 of 40 PageID: 6745

04841.62499/5478002.4 - 12 -
United States Patent No. 7,977,357
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
opinions of Defendants’ expert Dr. Mark
Hollingsworth.
specification and file history of the ’357 patent, and
contrary to the meaning of this claim term to a person
of ordinary skill in the art. Dr. Hollingsworth may
also offer an opinion that Defendants’ proposed
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term “Form A”
to a person of ordinary skill in the art.
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 ’357 patent in its entirety, including but not
limited to 4:54 – 5:3.

Prosecution history of the ’357 patent in its entirety
unsolvated crystalline
Form A of 3-( 4-
amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione,
which has a
differential scanning
calorimetry
thermogram having an
endotherm at
approximately 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. Byrn
and 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 described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Evidence:

The ’357 patent in its entirety, including but not
limited to 6:17 – 6:54; 9:50–61; 9:63 – 10:6; Claims
1–14; and Figs. 1–54.

Prosecution history of the ’357 patent in its entirety,
including but not limited to June 18, 2010 Office
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 19 of 40 PageID: 6746

04841.62499/5478002.4 - 13 -
United States Patent No. 7,977,357
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Byrn and Dr. Atwood
may 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 for
this phrase that is identical to its proposed meaning
for the claim term “Form A,” which is included
within 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
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 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. Mark
Hollingsworth.
Action at 4; March 7, 2011 Interview Summary;
March 10, 2011 Amendment.

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“unsolvated crystalline Form A of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,
which as a differential scanning calorimetry
thermogram having an endotherm at approximately
270° C” to a person of ordinary skill in the art,
including, but not limited to, the convention
associated with naming crystals and the analytical
attributes unique to each specific crystalline structure
and methods of characterizing these unique attributes
including with DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
offer an opinion that Celgene’s proposed construction
of “unsolvated crystalline Form A of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,
which as a differential scanning calorimetry
thermogram having an endotherm at approximately
270° C” is contrary to the teachings of the
specification and file history of the ’357 patent, and
contrary to the meaning of this claim term to a person
of ordinary skill in the art. Dr. Hollingsworth may
also offer an opinion that Defendants’ proposed
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 20 of 40 PageID: 6747

04841.62499/5478002.4 - 14 -
United States Patent No. 7,977,357
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
“unsolvated crystalline Form A of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,
which as a differential scanning calorimetry
thermogram having an endotherm at approximately
270° C” to a person of ordinary skill in the art.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 21 of 40 PageID: 6748

04841.62499/5478002.4 - 15 -
United States Patent No. 8,193,219
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
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, including but not
limited to 4:65 – 5:12

Prosecution history of the ’219 patent in its entirety
unsolvated crystalline
3-(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione
having an X-ray
powder diffraction
pattern comprising
peaks at approximately
8, 14.5, 16, 17 .5, 20.5,
24, and 26 degrees 2θ
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 skilled
artisans at the time the ’219 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Atwood may 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 for
this phrase that is identical to its proposed meaning
“The lenalidomide crystal form described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Evidence:

Intrinsic Evidence:
The ’219 patent in its entirety, including but not
limited to 6:27 – 6:64; 9:60 – 10:4; 10:6–16.

Prosecution history of the ’219 patent in its entirety,
including but not limited to December 5, 2011 Office
Action at 2–4; December 12, 2011 Office Action at 3–
4; March 12, 2012 Amendment at 2–8.

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 22 of 40 PageID: 6749

04841.62499/5478002.4 - 16 -
United States Patent No. 8,193,219
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
for the claim term “Form A” from the ’357 patent,
even though “Form A” is not recited in any claims of
the ’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 that
Defendants’ 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 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. Mark
Hollingsworth.
“unsolvated crystalline 3-(4-amino-1-oxo-1,3 dihydro-
isoindol-2-yl)-piperidine-2,6-dione having an X-ray
powder diffraction pattern comprising peaks at
approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26
degrees 2θ” to a person of ordinary skill in the art;
polymorphic forms of crystal structures in general;
and the definition of certain crystal structures. Dr.
Hollingsworth may opine that Celgene’s prposed
claim construction of “unsolvated crystalline 3-(4-
amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-
2,6-dione having an X-ray powder diffraction pattern
comprising peaks at approximately 8, 14.5, 16, 17.5,
20.5, 24, and 26 degrees 2θ” is contrary to the
teachings of the specification and file history of the
’219 patent, and contrary to the meaning of this claim
term to a person of ordinary skill in the art. Dr.
Hollingsworth may also offer an opinion that
Defendants’ proposed construction is consistent with
all relevant intrinsic evidence and the meaning of the
claim term “unsolvated crystalline 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having an X-ray powder diffraction pattern
comprising peaks at approximately 8, 14.5, 16, 17.5,
20.5, 24, and 26 degrees 2θ” to a person of ordinary
skill in the art.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 23 of 40 PageID: 6750

04841.62499/5478002.4 - 17 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
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, including but not limited to
4:65 – 5:12; Claims 1-8, 10-13, 17-23

Prosecution history of the ’219 patent in its entirety
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, including but not limited to
6:27–6:64; 9:60–10:4; 10:6–16; Claims 1–4; and Figs.
1–54.

Prosecution History of the ’598 Patent in its entirety,
including but not limited to March 15, 2012 Office
Action; May 15, 2012 Response to Restriction
Requirement; June 14, 2012 Office Action; and
December 12, 2012 Amendment and Response.

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 24 of 40 PageID: 6751

04841.62499/5478002.4 - 18 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
“Form A” to a person of ordinary skill in the art,
including but not limited to the convention associated
with naming crystals, the analytical attributes unique
to each specific crystalline structure, and methods of
characterizing these unique attributes including with
DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
offer an opinion that Celgene’s proposed construction
of “Form A” is contrary to the teachings of the
specification and file history of the ’598 patent, and
contrary to the meaning of this claim term to a person
of ordinary skill in the art. Dr. Hollingsworth may
also offer an opinion that Defendants’ proposed
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term “Form A”
to a person of ordinary skill in the art.
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 the
understanding of this phrase to ordinarily skilled
artisans at the time the ’598 patent was filed. Dr.
“The lenalidomide crystal form described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Evidence:

Intrinsic Evidence:

Specification of the ’598 patent, including but not
limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 1; and
Figs. 1-54.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 25 of 40 PageID: 6752

04841.62499/5478002.4 - 19 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Byrn and Dr. Atwood
may 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 for
this phrase that is identical to its proposed meaning
for the claim term “Form A,” which is included
within 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
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 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. Mark
Hollingsworth.
File history of the ’598 patent, including but not
limited to March 15, 2012 Office Action; May 15,
2012 Response to Restriction Requirement; June 14,
2012 Office Action; December 12, 2012 Amendment
and Response

Extrinsic Evidence:

Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“unsolvated crystalline Form A of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione” to a
person of ordinary skill in the art, including but not
limited to the convention associated with naming
crystals, the analytical attributes unique to each
specific crystalline structure, and methods of
characterizing these unique attributes including with
DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
offer an opinion that Celgene’s proposed construction
of “unsolvated crystalline Form A of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione”
is contrary to the teachings of the specification and
file history of the ’598 patent, and contrary to the
meaning of this claim term to a person of ordinary
skill in the art. Dr. Hollingsworth may also offer an
opinion that Defendants’ proposed construction is
consistent with all relevant intrinsic evidence and the
meaning of the claim term “unsolvated crystalline
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 26 of 40 PageID: 6753

04841.62499/5478002.4 - 20 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Form A of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-
yl)-piperidine-2,6-dione” to a person of ordinary skill
in the art.
an unsolvated
crystalline Form A of
3-(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione
having a differential
scanning calorimetry
thermogram
endotherm at
approximately 270º 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 skilled
artisans 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. Atwood
may 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 for
this phrase that is identical to its proposed meaning
for the claim term “Form A,” which is included
within 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 form described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Intrinsic Evidence:

Specification of the ’598 patent, including but not
limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 1;
Figs. 1-54.

File history of the ’598 patent, including but not
limited to March 15, 2012 Office Action; May 15,
2012 Response to Restriction Requirement; June 14,
2012 Office Action; December 12, 2012 Amendment
and Response

Extrinsic Evidence:

Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“an unsolvated crystalline Form A of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C” to a
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 27 of 40 PageID: 6754

04841.62499/5478002.4 - 21 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
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 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. Mark
Hollingsworth.
person of ordinary skill in the art, including but not
limited to the convention associated with naming
crystals, the analytical attributes unique to each
specific crystalline structure, and methods of
characterizing these unique attributes including with
DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
offer an opinion that Celgene’s proposed construction
of “an unsolvated crystalline Form A of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C” is
contrary to the teachings of the specification and file
history of the ’598 patent, and contrary to the meaning
of this claim term to a person of ordinary skill in the
art. Dr. Hollingsworth may also offer an opinion that
Defendants’ proposed construction is consistent with
all relevant intrinsic evidence and the meaning of the
claim term “an unsolvated crystalline Form A of 3-(4-
amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-
2,6-dione having a differential scanning calorimetry
thermogram endotherm at approximately 270 C” to a
person of ordinary skill in the art.
an unsolvated
crystalline 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 form described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Intrinsic Evidence:
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 28 of 40 PageID: 6755

04841.62499/5478002.4 - 22 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
scanning calorimetry
thermogram
endotherm at
approximately 270º C
and an X-ray powder
diffraction pattern
comprising peaks at
approximately 8, 14.5,
and 16 degrees 2θ and
a thermogravimetric
analysis curve
indicative of an
unsolvated material
’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 skilled
artisans at the time the ’598 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Atwood may 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 for
this phrase that is identical to its proposed meaning
for the claim term “Form A” from the ’357 patent,
even though “Form A” is not recited in this claim.
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 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 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. Mark
Hollingsworth.

Specification of the ’598 patent, including but not
limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 5; and
Figs. 1-54.

File history of the ’598 patent, including but not
limited to March 15, 2012 Office Action; May 15,
2012 Response to Restriction Requirement; June 14,
2012 Office Action; December 12, 2012 Amendment
and Response

Extrinsic Evidence:

Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“an unsolvated crystalline form of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)- piperidine-2,6-dione
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C and
an X-ray powder diffraction pattern comprising peaks
at approximately 8, 14.5, and 16 degrees 2θ and a
thermogravimetric analysis curve indicative of an
unsolvated material” to a person of ordinary skill in
the art, including but not limited to the convention
associated with naming crystals, the analytical
attributes unique to each specific crystalline structure,
and methods of characterizing these unique attributes
including with DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 29 of 40 PageID: 6756

04841.62499/5478002.4 - 23 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
offer an opinion that Celgene’s proposed construction
of “an unsolvated crystalline form of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C and
an X-ray powder diffraction pattern comprising peaks
at approximately 8, 14.5, and 16 degrees 2θ and a
thermogravimetric analysis curve indicative of an
unsolvated material” is contrary to the teachings of the
specification and file history of the ’598 patent, and
contrary to the meaning of this claim term to a person
of ordinary skill in the art. Dr. Hollingsworth may
also offer an opinion that Defendants’ proposed
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term “an
unsolvated crystalline form of 3-(4-amino-1-oxo-1,3
dihydro isoindol-2-yl)-piperidine-2,6-dione having a
differential scanning calorimetry thermogram
endotherm at approximately 270 C and an X-ray
powder diffraction pattern comprising peaks at
approximately 8, 14.5, and 16 degrees 2θ and a
thermogravimetric analysis curve indicative of an
unsolvated material” to a person of ordinary skill in
the art.
an unsolvated
crystalline form of 3-
(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione
No construction required

Evidence:

’598 patent generally
“The lenalidomide crystal form described in the
specification as Form A, having all of the
characteristics assigned to Form A in the
specification”

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 30 of 40 PageID: 6757

04841.62499/5478002.4 - 24 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
having an X-ray
powder diffraction
pattern comprising
peaks at approximately
8, 14.5, 16, 17.5, 20.5,
24, and 26 degrees 2θ

’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 skilled
artisans at the time the ’598 patent was filed. Dr.
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Atwood may 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 for
this phrase that is identical to its proposed meaning
for the claim term “Form A” from the ’357 patent,
even though “Form A” is not recited in this claim.
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 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 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. Mark
Hollingsworth.
Intrinsic Evidence:

Specification of the ’598 patent, including but not
limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 10;
and Figs. 1-54.

File history of the ’598 patent, including but not
limited to March 15, 2012 Office Action; May 15,
2012 Response to Restriction Requirement; June 14,
2012 Office Action; December 12, 2012 Amendment
and Response

Extrinsic Evidence:

Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“an unsolvated crystalline form of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having an X-ray powder diffraction pattern
comprising peaks at approximately 8, 14.5, 16, 17.5,
20.5, 24, and 26 degrees 2θ” to a person of ordinary
skill in the art, including but not limited to the
convention associated with naming crystals, the
analytical attributes unique to each specific crystalline
structure, and methods of characterizing these unique
attributes including with DSC, TGA, IR, Raman, and
moisture sorption/desorption data. Dr. Hollingsworth
may also offer an opinion that Celgene’s proposed
construction of “an unsolvated crystalline form of 3-
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 31 of 40 PageID: 6758

04841.62499/5478002.4 - 25 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-
2,6-dione having an X-ray powder diffraction pattern
comprising peaks at approximately 8, 14.5, 16, 17.5,
20.5, 24, and 26 degrees 2θ” is contrary to the
teachings of the specification and file history of the
’598 patent, and contrary to the meaning of this claim
term to a person of ordinary skill in the art. Dr.
Hollingsworth may also offer an opinion that
Defendants’ proposed construction is consistent with
all relevant intrinsic evidence and the meaning of the
claim term “an unsolvated crystalline form of 3-(4-
amino-1-oxo-1,3 dihydro isoindol-2-yl)-piperidine-
2,6-dione having an X-ray powder diffraction pattern
comprising peaks at approximately 8, 14.5, 16, 17.5,
20.5, 24, and 26 degrees 2θ” to a person of ordinary
skill in the art.
an unsolvated
crystalline form of 3-
(4-amino-1-oxo-1,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione
having a differential
scanning calorimetry
thermogram
endotherm at
approximately 270º 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 skilled
artisans at the time the ’598 patent was filed. Dr.
Intrinsic Evidence:

Specification of the ’598 patent, including but not
limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 17;
and Figs. 1-54.

File history of the ’598 patent, including but not
limited to March 15, 2012 Office Action; May 15,
2012 Response to Restriction Requirement; June 14,
2012 Office Action; December 12, 2012 Amendment
and Response

Extrinsic Evidence:
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 32 of 40 PageID: 6759

04841.62499/5478002.4 - 26 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Byrn and Dr. Atwood may opine that this phrase is
not a claim limitation. Dr. Atwood may 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 for
this phrase that is identical to its proposed meaning
for the claim term “Form A” from the ’357 patent,
even though “Form A” is not recited in this claim.
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 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 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. Mark
Hollingsworth.

Defendants may rely on the expert opinion of Dr.
Mark Hollingsworth. Dr. Hollingsworth may offer
opinions about the understanding of the claim term
“an unsolvated crystalline form of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C” to a
person of ordinary skill in the art, including but not
limited to the convention associated with naming
crystals, the analytical attributes unique to each
specific crystalline structure, and methods of
characterizing these unique attributes including with
DSC, TGA, IR, Raman, and moisture
sorption/desorption data. Dr. Hollingsworth may also
offer an opinion that Celgene’s proposed construction
of “an unsolvated crystalline form of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C” is
contrary to the teachings of the specification and file
history of the ’598 patent, and contrary to the meaning
of this claim term to a person of ordinary skill in the
art. Dr. Hollingsworth may also offer an opinion that
Defendants’ proposed construction is consistent with
all relevant intrinsic evidence and the meaning of the
claim term “an unsolvated crystalline form of 3-(4-
amino-1-oxo-1,3 dihydro isoindol-2-yl)-piperidine-
2,6-dione having a differential scanning calorimetry
thermogram endotherm at approximately 270 C” to a
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 33 of 40 PageID: 6760

04841.62499/5478002.4 - 27 -
United States Patent No. 8,431,598
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
person of ordinary skill in the art.

Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 34 of 40 PageID: 6761

04841.62499/5478002.4 - 28 -
United States Patent No. 7,159,740
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
administered
cyclically
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.

Taber’s Cyclopedic Medical Dictionary (19th ed.) at
518, 520; Stedman’s Medical Dictionary (27th ed.)
at 442-444.

Celgene may rely on the expert opinion of Ross L.
Levine, MD. Dr. Levine may offer opinions about
the 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 does
not require “a pre-determined dosing regimen that
includes administering lenalidomide for an initial
period, followed by a pre-determined treatment-free
interval.” Dr. Levine may also opine that
Defendants’ proposed construction of this term is
inconsistent with the intrinsic evidence. Dr. Levine
may 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
in the art and/or the qualifications of one of ordinary
skill in the art. Dr. Levine may also provide
“Administered according to a pre-determined dosing
regimen that includes administering lenalidomide for
an initial period, followed by a pre-determined
treatment-free interval, and repeating this sequential
administration”

Evidence:

Intrinsic Evidence:
The ’740 patent in its entirety, including but not
limited to 19:4–21; 26:48 – 29:60; Claims 18–22, 29
and 30.

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Frederick Luzzio. Dr. Luzzio may offer opinions
about the understanding of the claim term
“administered cyclically” as it pertains to
pharmaceutical drug dosing regimens and as would be
understood by a person of ordinary skill in the art. Dr.
Luzzio may opine that Celgene’s construction of
“administered cyclically” is contrary to the teachings
of the specification and file history of the ’740 patent,
and contrary to the meaning of this claim term to a
person of ordinary skill in the art. Dr. Luzzio may also
offer an opinion that Defendants’ proposed
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term
“administered cyclically” to a person of ordinary skill
in the art.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 35 of 40 PageID: 6762

04841.62499/5478002.4 - 29 -
United States Patent No. 7,159,740
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
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.

Taber’s Cyclopedic Medical Dictionary (19th ed.) at
518, 520; Stedman’s Medical Dictionary (27th ed.)
at 442-444.

Celgene may rely on the expert opinion of Ross L.
Levine, MD. Dr. Levine may offer opinions about
the 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 does
not require “a pre-determined dosing regimen that
includes administering lenalidomide for an initial
period, followed by a pre-determined treatment-free
interval.” Dr. Levine may also opine that
Defendants’ proposed construction of this term is
inconsistent with the intrinsic evidence. Dr. Levine
may 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 pre-determined dosing
regimen that includes administering lenalidomide for
an initial period, followed by a pre-determined
treatment-free interval, and repeating this sequential
administration”

Evidence:

Intrinsic Evidence:
The ’740 patent in its entirety, including but not
limited to 19:4–21; 26:48 – 29:60; Claims 18–22, 29
and 30.

Extrinsic Evidence:
Defendants may rely on the expert opinion of Dr.
Frederick Luzzio. Dr. Luzzio may offer opinions
about the understanding of the claim term
“administered in a cycle” as it pertains to
pharmaceutical drug dosing regimens and as would be
understood by a person of ordinary skill in the art. Dr.
Luzzio may opine that Celgene’s construction of
“administered in a cycle” is contrary to the teachings
of the specification and file history of the ’740 patent,
and contrary to the meaning of this claim term to a
person of ordinary skill in the art. Dr. Luzzio may also
offer an opinion that Defendants’ proposed
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 36 of 40 PageID: 6763

04841.62499/5478002.4 - 30 -
United States Patent No. 7,159,740
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
in the art and/or the qualifications of one of ordinary
skill in the art.
“administered in a cycle” to a person of ordinary skill
in the art.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 37 of 40 PageID: 6764

04841.62499/5478002.4 - 31 -

United States Patent No. 7,968,569
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
cyclically
administering
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.

Taber’s Cyclopedic Medical Dictionary (19th ed.) at
518, 520; Stedman’s Medical Dictionary (27th ed.)
at 442-444.

Celgene may rely on the expert opinion of Ross L.
Levine, MD. Dr. Levine may offer opinions about
the 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 does
not require “administering lenalidomide and
dexamethasone in combination for 21 consecutive
days.” Dr. Levine may also offer an opinion that
Defendants’ proposed construction is illogical in the
context of the claims. Dr. Levine may also opine
that Defendants’ proposed construction of this term
is inconsistent with the intrinsic evidence. Dr.
Levine may also opine that this term is composed of
words 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 and dexamethasone in
combination for 21 consecutive days”

Evidence:

Intrinsic Evidence:
The ’569 patent in its entirety, including but not
limited to 24:55 – 25:9; 38:39–55; Claims 1–13.

Prosecution history of the ’569 patent in its entirety,
including but not limited to October 28, 2005,
Response at 7 (see, e.g., claim 70); February 26, 2007
Amendment and Response at 4 (see, e.g., claims 69–
70); March 9, 2010 Amendment, Response and
Request for Continued Examination at 3 (see, e.g.,
claim 69); and December 12, 2010 Response and
Statement of Interview Summary at 2 (see, e.g., claim
24).
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 38 of 40 PageID: 6765

04841.62499/5478002.4 - 32 -
United States Patent No. 7,968,569
Term Celgene’s Proposal & Evidence Defendants’ Proposal & Evidence
Levine may also opine regarding the level of
ordinary skill in the art and/or the qualifications of
one of ordinary skill in the art.


Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 39 of 40 PageID: 6766

04841.62499/5478002.4 - 33 -
CERTIFICATION OF SERVICE

I hereby certify that on October 18, 2013, copies of the foregoing Corrected Joint Claim Construction and Prehearing
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 statements are willfully
false, I am subject to punishment.
s/ Melissa Steedle Bogad
Melissa Steedle Bogad
mbogad@winston.com

Dated: October 18, 2013
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 40 of 40 PageID: 6767

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