CELG V ACT - Joint Markman Statement

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 Natcos filing of ANDA No. 201452 with the U.S. Food and Drug
Administration (FDA), which seeks approval to market a generic version of Celgenes
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 Natcos submission of ANDA No. 201452 to the FDA constitutes infringement
of certain claims of United States Patent Nos. 5,635,517 (the 517 patent), 6,045,501 (the
501 patent), 6,281,230 (the 230 patent), 6,315,720 (the 720 patent), 6,555,554 (the
717 patent), and 8,431,598 (the 598 patent) owned by Celgene (collectively, the patents-in-
suit) under 35 U.S.C. 271(e)(2). Natco alleges, among other things, that the asserted claims
are invalid, unenforceable, and/or not infringed.
Pursuant to Local Patent Rules 4.2(a)-(b), on August 5, 2013, the parties exchanged
preliminary claim constructions and identified intrinsic as well as extrinsic evidence in support
of their proposed Preliminary Constructions. Pursuant to Local Patent Rule 4.2(c), on August
19, 2013, the parties identified all intrinsic and extrinsic evidence that each party intends to rely
upon to oppose any other partys proposed construction. Pursuant to Local Patent Rule 4.2(d),
on August 21, 2013, counsel for the parties met and conferred for the purposes of narrowing the
issues and preparation of the Joint Claim Construction and Prehearing Statement.
II. CONSTRUCTION OF PATENT 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.

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

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 bodys own
cells and/or tissues
An oncogenic or
cancerous condition
a condition tending to cause or
give rise to tumors

Term Definition
Reducing the level of
TNF
lowering levels of TNF
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


04841.62499/5478002.4 - 4 -
Term Definition
Teratogenic drug a drug that may disturb the
normal growth and development
of an embryo or fetus

Term Definition
Consulted accessed and considered
Teratogenic effect any effect that disturbs the
normal growth and development
of an embryo or fetus
Adverse side effect any unfavorable abnormality,
defect, mutation, lesion,
degeneration or injury which may
be caused by taking the drug

Term Definition
Teratogenic risks risks of disturbing the normal
growth and development of an
embryo or fetus

Term Definition
Contraindicated Any condition in a patient which
renders a particular line of
treatment, including the
administration of one or more
drugs, undesirable or improper


04841.62499/5478002.4 - 5 -
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

Term Definition
Crystalline made up of crystals

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


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 experts testimony is included in
Exhibit A where appropriate.

04841.62499/5478002.4 - 7 -

October 18, 2013

By: s/ Charles M. Lizza
Charles M. Lizza
William C. Baton
SAUL EWING LLP
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
The Legal Center
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
35 West Wacker Drive
Chicago, Illinois 60601-9703
(312) 558-5600

Attorneys for Defendants
Natco Pharma Limited,
Arrow International Limited, and
Watson Laboratories, Inc.


04841.62499/5478002.4 - 1 -
EXHIBIT A
DISPUTED CLAIM TERMS & EVIDENCE
United States Patent No. 6,281,230
Term Celgenes 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:
Websters 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

04841.62499/5478002.4 - 2 -
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 Celgenes
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)

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:
limited to 8:1-17 and 17:28-18:61.


Extrinsic Evidence:

04841.62499/5478002.4 - 3 -
0939450753529744%3Av0qd01-



04841.62499/5478002.4 - 4 -
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:
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:
0939450753529744%3Av0qd01-


04841.62499/5478002.4 - 5 -
Said compound has
the S-configuration

Evidence:

See above for 230 patent, incorporated by reference.

Intrinsic Evidence:
limited to 7:38-54 and 17:9-18:43.

limited to February 12, 2001 amendment at p. 5.

Extrinsic Evidence:
0939450753529744%3Av0qd01-


04841.62499/5478002.4 - 6 -


04841.62499/5478002.4 - 7 -
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:
limited to 9:18-25 and Claims 1-5.


Extrinsic Evidence:
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 Celgenes
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
intrinsic evidence and the meaning of the claim term
unit dosage form to a person of ordinary skill in the
art.


04841.62499/5478002.4 - 8 -
3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-
piperidine-2,6-dione
No construction required

Evidence:



Celgene may rely on the expert opinion of Dr.
Stephen R. Byrn and/or Dr. Jerry Atwood. Dr. Byrn
and Dr. Atwood may offer opinions about the
understanding of this term to ordinarily 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:
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:

5:36-40, 6:53-7:35, 12:31-36, 22:40-43

Merriam Websters 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,

04841.62499/5478002.4 - 9 -
at 540

Merriam Websters Collegiate Dictionary (11
th
ed.)
at 579

Defendants expert Dr. Mark Hollingsworth.

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:
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.

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:
Websters 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).

Mark Hollingsworth. Dr. Hollingsworth may offer

04841.62499/5478002.4 - 10 -
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 Celgenes
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.

04841.62499/5478002.4 - 11 -
Form A A polymorphic form of 3-(4-amino-l-oxo-l,3
dihydro-isoindol-2-yl)-piperidine-2,6-dione that can
be distinguished from other forms

Evidence:



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
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; 9:5061; 9:63 10:6; Claims
114; and Figs. 154.

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:
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 Celgenes proposed construction
of Form A is contrary to the teachings of the

04841.62499/5478002.4 - 12 -
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
construction is consistent with all relevant intrinsic
evidence and the meaning of the claim term Form A

Evidence:

Intrinsic Evidence:
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
piperidine-2,6-dione,
which has a
differential scanning
calorimetry
thermogram having an
endotherm at
approximately 270 C

Evidence:



understanding of this phrase to ordinarily skilled
specification

Evidence:

limited to 6:17 6:54; 9:5061; 9:63 10:6; Claims
114; and Figs. 154.

including but not limited to June 18, 2010 Office

04841.62499/5478002.4 - 13 -
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
Hollingsworth.
Action at 4; March 7, 2011 Interview Summary;
March 10, 2011 Amendment.

Extrinsic 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,
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
of unsolvated crystalline Form A of 3-(4-amino-1-
oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,
270 C is contrary to the teachings of the
evidence and the meaning of the claim term

04841.62499/5478002.4 - 14 -
1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,
270 C to a person of ordinary skill in the art.


04841.62499/5478002.4 - 15 -

Evidence:

Intrinsic Evidence:
limited to 4:65 5:12

3-(4-amino-1-oxo-1,3
having an X-ray
powder diffraction
pattern comprising
peaks at approximately
8, 14.5, 16, 17 .5, 20.5,
24, and 26 degrees 2

Evidence:



not a claim limitation. Dr. Atwood may opine that
Defendants definition of this phrase is confusing,
redundant, illogical, and contrary to the
specification

Evidence:

Intrinsic Evidence:
limited to 6:27 6:64; 9:60 10:4; 10:616.

including but not limited to December 5, 2011 Office
Action at 24; December 12, 2011 Office Action at 3
4; March 12, 2012 Amendment at 28.

Extrinsic Evidence:

04841.62499/5478002.4 - 16 -
for the claim term Form A from the 357 patent,
even though Form A is not recited in any claims of
the 219 patent. Dr. Byrn and Dr. Atwood may also
offer an opinion that Defendants proposed
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 2 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 Celgenes 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 2 is contrary to the
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
20.5, 24, and 26 degrees 2 to a person of ordinary
skill in the art.

04841.62499/5478002.4 - 17 -

Evidence:

Intrinsic Evidence:
598 patent in its entirety, including but not limited to
4:65 5:12; Claims 1-8, 10-13, 17-23

Form A Same as 357 patent

Evidence:

Same as 357 patent, in addition to:


Same as 357 patent

Evidence:

Intrinsic Evidence:

598 Patent in its entirety, including but not limited to
6:276:64; 9:6010:4; 10:616; Claims 14; and Figs.
154.

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:

04841.62499/5478002.4 - 18 -
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
of Form A is contrary to the teachings of the
evidence and the meaning of the claim term Form A
Form A of 3-(4-
amino-1-oxo-1,3

Evidence:



specification

Evidence:

Intrinsic Evidence:

limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 1; and
Figs. 1-54.


04841.62499/5478002.4 - 19 -
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:

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
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

04841.62499/5478002.4 - 20 -
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
having a differential
scanning calorimetry
thermogram
endotherm at
approximately 270 C

Evidence:



specification

Intrinsic Evidence:

limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 1;
Figs. 1-54.

and Response

Extrinsic Evidence:

an unsolvated crystalline Form A of 3-(4-amino-1-
having a differential scanning calorimetry
thermogram endotherm at approximately 270 C to a

04841.62499/5478002.4 - 21 -
Hollingsworth.
of an unsolvated crystalline Form A of 3-(4-amino-1-
thermogram endotherm at approximately 270 C is
art. Dr. Hollingsworth may also offer an opinion that
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
person of ordinary skill in the art.
an unsolvated
crystalline form of 3-
(4-amino-1-oxo-1,3

Evidence:


specification

Intrinsic Evidence:

04841.62499/5478002.4 - 22 -
thermogram
endotherm at
approximately 270 C
and an X-ray powder
diffraction pattern
comprising peaks at
approximately 8, 14.5,
and 16 degrees 2 and
a thermogravimetric
analysis curve
indicative of an
unsolvated material

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.

limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 5; and
Figs. 1-54.

and Response

Extrinsic Evidence:

an unsolvated crystalline form of 3-(4-amino-1-oxo-
1,3 dihydro-isoindol-2-yl)- piperidine-2,6-dione
thermogram endotherm at approximately 270 C and
an X-ray powder diffraction pattern comprising peaks
at approximately 8, 14.5, and 16 degrees 2 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

04841.62499/5478002.4 - 23 -
of an unsolvated crystalline form of 3-(4-amino-1-
thermogram endotherm at approximately 270 C and
an X-ray powder diffraction pattern comprising peaks
at approximately 8, 14.5, and 16 degrees 2 and a
unsolvated material is contrary to the teachings of the
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 2 and a
unsolvated material to a person of ordinary skill in
the art.
an unsolvated
(4-amino-1-oxo-1,3

Evidence:

specification


04841.62499/5478002.4 - 24 -
having an X-ray
powder diffraction
pattern comprising
peaks at approximately
8, 14.5, 16, 17.5, 20.5,
24, and 26 degrees 2


Hollingsworth.
Intrinsic Evidence:

limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 10;
and Figs. 1-54.

and Response

Extrinsic Evidence:

having an X-ray powder diffraction pattern
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 Celgenes proposed
construction of an unsolvated crystalline form of 3-

04841.62499/5478002.4 - 25 -
(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-
20.5, 24, and 26 degrees 2 is contrary to the
claim term an unsolvated crystalline form of 3-(4-
amino-1-oxo-1,3 dihydro isoindol-2-yl)-piperidine-
skill in the art.
an unsolvated
(4-amino-1-oxo-1,3
thermogram
endotherm at
approximately 270 C

Evidence:



Intrinsic Evidence:

limited to 6:27-6:64; 9:60-10:4; 10:6-16; Claim 17;
and Figs. 1-54.

and Response

Extrinsic Evidence:

04841.62499/5478002.4 - 26 -
Hollingsworth.

of an unsolvated crystalline form of 3-(4-amino-1-
thermogram endotherm at approximately 270 C is
art. Dr. Hollingsworth may also offer an opinion that
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

04841.62499/5478002.4 - 27 -
person of ordinary skill in the art.


04841.62499/5478002.4 - 28 -
administered
cyclically

Evidence:

1:13-21, 5:64-8:3, 15:29-18:35, 19:4-21, 29:56-59,
claims 18-22, 29-30.

Tabers Cyclopedic Medical Dictionary (19th ed.) at
518, 520; Stedmans Medical Dictionary (27th ed.)
at 442-444.

Celgene may rely on the expert opinion of Ross L.
Levine, MD. Dr. Levine may offer opinions about
the understanding of this term to ordinarily skilled
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
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:
limited to 19:421; 26:48 29:60; Claims 1822, 29
and 30.

Extrinsic Evidence:
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 Celgenes 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
administered cyclically to a person of ordinary skill
in the art.

04841.62499/5478002.4 - 29 -
opinions to rebut the opinions of Defendants expert.
administered in a cycle No construction required

Evidence:

1:13-21, 5:64-8:3, 15:29-18:35, 19:4-21, 29:56-59,
claims 18-22, 29-30.

at 442-444.

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
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:
limited to 19:421; 26:48 29:60; Claims 1822, 29
and 30.

Extrinsic Evidence:
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 Celgenes 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

04841.62499/5478002.4 - 30 -
skill in the art.
administered in a cycle to a person of ordinary skill
in the art.

04841.62499/5478002.4 - 31 -

cyclically
administering

Evidence:

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.

at 442-444.

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:
limited to 24:55 25:9; 38:3955; Claims 113.

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).

04841.62499/5478002.4 - 32 -
Levine may also opine regarding the level of
one of ordinary skill in the art.


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

CELG V ACT - Joint Markman Statement

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04841.62499/5478002.

product. The active ingredient in Revlimid

is lenalidomide. Plaintiffs allege, among

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