CELG V ACT - ACT Response Markman Brief

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

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CELGENE CORPORATION,

Plaintiff,
v.

NATCO PHARMA LIMITED,
ARROW INTERNATIONAL LIMITED,
and WATSON LABORATORIES, INC.

Defendants.
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Honorable Susan D. Wigenton, U.S.D.J.

Civil Action No. 10 CV 5197 (SDW) (MCA)

Electronically Filed
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NATCO PHARMA LIMITED,
ARROW INTERNATIONAL LIMITED,
and WATSON LABORATORIES, INC.

Counterclaim Plaintiffs,

v.

CELGENE CORPORATION,

Counterclaim Defendant.

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DEFENDANTS RESPONSIVE CLAIM CONSTRUCTION BRIEF

OF COUNSEL
George C. Lombardi
Michael K. Nutter
Maureen L. Rurka
Kevin E. Warner
WINSTON & STRAWN LLP
35 West Wacker Drive
Chicago, Illinois 60601
(312) 558-5600
The Legal Center
One Riverfront Plaza, Suite 730
Newark, NJ 07102
(973) 848-7676
James S. Richter
Melissa Steedle Bogad

Attorneys for Defendants Natco Pharma Ltd.,
Arrow International Ltd.
and Watson Laboratories, Inc.
Case 2:10-cv-05197-SDW-MCA Document 290 Filed 04/08/14 Page 1 of 40 PageID: 8867

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TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES ......................................................................................................... iii
I. INTRODUCTION .............................................................................................................. 1
II. DISPUTED TERMS OF THE POLYMORPH PATENTS ................................................ 2
a. Form A and Form A Terms ..............................................................................2
i. Form A .....................................................................................................3
1. Celgenes Construction Is Internally Inconsistent And
Violates Established Canons Of Claim Construction ......................5
2. The BMS Case Does Not Support Celgenes Construction .............7
3. Celgenes Construction Improperly Seeks Coverage of
More Than The Subject Matter Disclosed .....................................10
4. Celgenes Construction Also Renders Claim Terms
Duplicative And/Or Superfluous ...................................................12
ii. Remaining Form A Terms ......................................................................13
b. Unsolvated Crystalline [Lenalidomide] Terms ..................................................15
c. Hemihydrate .......................................................................................................17
i. Hemihydrate Is Not A Term Of Approximation ....................................17
1. The 800 Patent Does Not Redefine Hemihydrate And
The Plain Meaning Should Control ...............................................17
2. Dr. Byrns Prior Works Are Consistent With Natcos
Construction And Directly Contradict His Declaration .................19
3. Celgenes Construction Is Unsupported By The Intrinsic
Record ............................................................................................20
ii. Hemihydrate Refers To The Form B Polymorph ...................................21
d. 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ..................22
III. DISPUTED TERMS OF THE PHARMACEUTICAL PATENTS.................................. 24

ii

a. Said Compound has the R-Configuration and Said Compound has the
S-Configuration ....................................................................................................24
i. Natcos Constructions Are Consistent With The Intrinsic Record ............25
ii. Celgenes Constructions Violate Established Principles Of Claim
Construction ...............................................................................................26
iii. Celgenes Constructions Are Inconsistent With The Understanding
Of A Person Of Ordinary Skill In The Art ................................................28
b. Unit Dosage Form ..............................................................................................29
IV. THE REMAINING DISPUTED TERMS ........................................................................ 30
a. Administered in a Cycle/ Administered Cyclically ........................................30
b. Cyclically Administering ...................................................................................32
V. CONCLUSION ................................................................................................................. 34

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TABLE OF AUTHORITIES
Page(s)
CASES
AstraZeneca AB v. Mutual Pharma Co. Inc.,
384 F.3d 1333 (Fed. Cir. 2004)....................................................................................13, 16, 23
Baran v. Med. Device Techs., Inc.,
616 F.3d 1309 (Fed. Cir. 2010)................................................................................................25
Bristol-Myers Squibb Co. v. Mylan Pharms., Inc.,
No. 09-651-LPS, 2012 WL 1753670 (D. Del. May 16, 2012) ..............................................7, 8
Dow Chem. Co. v. United States,
226 F.3d 1334 (Fed. Cir. 2000)................................................................................................27
Gen. Am. Transp. Corp. v. Cryo-Trans, Inc.,
93 F.3d 766 (Fed. Cir. 1996)....................................................................................................22
Glaxo Group Ltd. v. Ranbaxy Pharm. Inc.,
262 F.3d 1333 (Fed. Cir. 2001)................................................................................................25
Markman v. Westview Instruments, Inc.,
52 F.3d 967 (Fed. Cir. 1995) (en banc), affd, 517 U.S. 370 (1996) .......................................30
Modine Mfg. Co. v. U.S. Intl Trade Commn,
75 F.3d 1545 (Fed. Cir. 1996)..................................................................................................16
Multiform Desiccants, Inc. v. Medzam, Ltd.,
133 F.3d 1473 (Fed. Cir. 1998)....................................................................................29, 31, 32
Novozymes A/S v. DuPont Nutrition BioSciences APS,
723 F.3d 1336 (Fed. Cir. 2013)................................................................................................12
O2 Micro Intl Ltd. v. Beyond Innovation Tech. Co.,
521 F.3d 1351 (Fed. Cir. 2008)................................................................................................31
Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005)....................................................................................17, 30, 32
Rhine v. Casio, Inc.,
183 F.3d 1342 (Fed.Cir. 1999).................................................................................................12
Telcordia Techs., Inc. v. Cisco Sys. Inc.,
612 F.3d 1365 (Fed. Cir. 2010)................................................................................................22
Teleflex, Inc. v. Ficosa N. Am. Corp.,
299 F.3d 1313 (Fed. Cir. 2002)..........................................................................................18, 22

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Toro Co. v. White Consol. Indus., Inc.,
199 F.3d 1295 (Fed. Cir. 1999)................................................................................................22
Vitronics Corp. v. Conceptronic, Inc.,
90 F.3d 1576 (Fed. Cir. 1996)................................................................................17, 18, 28, 30
STATUTES
35 U.S.C. 112 ..................................................................................................................11, 25, 27
OTHER AUTHORITIES
A Dictionary of Chemistry 275 (4th ed. 2000) .............................................................................18
McGraw-Hill Dictionary of Scientific and Technical Terms 977 (6th ed. 2003) .........................18
The Penguin Dictionary of Science 200 (7th ed. 1993) ................................................................18

I. INTRODUCTION
Celgenes approach to claim construction for each of the four patent families at issue is at
odds with established Federal Circuit precedent and contravenes long-accepted scientific
principles.
For the Polymorph Patents,
1
Natco proposes constructions for Form A, hemihydrate,
and terms directed to unsolvated crystalline [lenalidomide] that are consistent with how these
terms are defined in the specification and understood by a person of skill in the art. By contrast,
Celgene offers broad, litigation-driven constructions that ignore the undisputed scientific
definitions of hemihydrate and Form A, as well as the inventors unambiguous
characterization of these terms in the intrinsic record. In doing so, Celgene seeks to improperly
broaden the claim scope to cover more than the subject matter that is disclosed and properly
supported by the specification. For example, the testimony of Celgenes own expert, Dr. Jerry
Atwood, clearly shows that its proposed constructions are internally inconsistent, read out
express claim limitations, and lead to absurd resultsincluding the proposition that a claim
expressly limited to the Form A crystal also includes the undisputedly distinct Form F
crystal. There is no authority supporting that type of proposal.
Natcos proposed constructions for the Pharmaceutical Patents
2
likewise consistently
adhere to established scientific principles and to the intrinsic evidence. By contrast, Celgenes
constructions are contrary to general scientific concepts and violate established concepts of claim
construction, including the doctrine of claim differentiation. For example, under Celgenes

1
As defined in Defendants Opening Markman Brief (D.I. 250), Natco refers to U.S. Pat. Nos.
7,465,800 (the 800 patent), 7,977,357 (the 357 patent), 8,193,219 (the 219 patent), and
8,431,598 (the 598 patent) collectively as the Polymorph Patents.

2
As defined in Defendants Opening Markman Brief, Natco refers to U.S. Pat. Nos. 6,281,230
(the 230 patent), 6,555,554 (the 554 patent), and 8,228,415 (the 415 patent) collectively
as the Pharmaceutical Patents.

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construction, all claims cover all disclosed embodiments and additional limitations in certain
dependent claims are given no independent meaning. For at least these reasons, Celgenes
proposed constructions of the disputed terms of the Pharmaceutical Patents are incorrect.
The third and fourth patent families each cover one patent (the Multiple Myeloma
Patent
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and the MDS Patent
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) and relate to methods of treating multiple myeloma and
myelodysplastic syndrome, respectively. The disputed terms in both patents relate to dosing
lenalidomide pursuant to a cyclical dosing regimen, which has established technical meanings
in the pharmaceutical art. Consistent with Federal Circuit mandate that construction of disputed
technical terms is required, Natcos proposed construction aligns with statements in the
specification and the file history, as well as scientific understanding. Celgene, by contrast,
proposes no construction at all, despite the fact that these disputed technical terms do not have a
plain and ordinary meaning. For at least this reason, Natcos proposals should be adopted over
Celgenes non-construction.
II. DISPUTED TERMS OF THE POLYMORPH PATENTS
a. Form A and Form A Terms
The first dispute concerning the Polymorph Patents relates to certain terms in the 357
and 598 patents that expressly require the distinct crystal form of lenalidomide that the
specification describes and characterizes as Form A. The disputed terms and the parties
constructions are set forth below.

3
As defined in Defendants Opening Markman Brief, Natco refers to U.S. Pat. No. 7,968,569 as
the Multiple Myeloma Patent or the MM Patent.

4
As defined in Defendants Opening Markman Brief, Natco refers to U.S. Pat. No. 7,189,740 as
the Myelodysplastic Syndrome Patent or the MDS Patent.

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chemical characteristics. (Ex. A,
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357 patent, 6:13-54, 2:16-25, 3:37-42, Figs. 1-5, 51, and 53-
54.) For example, the specification defines Form A in the following way:
One embodiment of the invention encompasses Form A of 3-( 4-
amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione.
Form A is an unsolvated, crystalline material that can be obtained
from non-aqueous solvent systems. . . .

5.2.1 Form A

The data described herein for Form A, as well as for Forms
B-H, were obtained using the experimental methods described in
Examples 6.3-6.7, provided below.

Form A can be obtained from various solvents, including,
but not limited to 1-butanol, butyl acetate, ethanol, ethyl acetate,
methanol, methyl ethyl ketone, and THF. FIG. 1 shows a
representative XRPD pattern of Form A. The pattern is
characterized by peaks, preferably significant peaks, at
approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26 degrees 2.
Representative IR and Raman spectra data are provided in FIGS. 2
and 3.

Representative thermal characteristics of Form A are shown
in FIG. 4. TGA data show a small weight increase up to about 150
C., indicating an unsolvated material. Weight loss above 150 C. is
attributed to decomposition. The DSC curve of Form A exhibits an
endotherm at about 270 C.

Representative moisture sorption and desorption data are
plotted in FIG. 5. Form A does not exhibit a significant weight gain
from 5 to 95% relative humidity. Equilibrium can be obtained at
each relative humidity step. As the form dries from 95% back down
to 5% relative humidity, it tends to maintain its weight such that at
5% relative humidity it has typically lost only about 0.003% by
weight from start to finish. Form A is capable of remaining a
crystalline solid for about 11 days when stored at about 22, 45, 58,
and 84% relative humidity.

Interconversion studies show that Form A can convert to
Form B in aqueous solvent systems and can convert to Form C in
acetone solvent systems. Form A tends to be stable in anhydrous

5
All references herein to Ex. __ refer to exhibits attached to the accompanying Declaration of
Melissa Steedle Bogad (Bogad Declaration), submitted herewith.

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solvent systems. In water systems and in the presence of Form E,
Form A tends to convert to Form E.

When stored for a period of about 85 days under two
different temperature/relative humidity stress conditions (room
temperature/0% relative humidity (RH) and 40 C./93% RH), Form
A typically does not convert to a different form.

In sum, Form A is a crystalline, unsolvated solid that melts
at approximately 270 C. Form A is weakly or not hygroscopic and
appears to be the most thermodynamically stable anhydrous
polymorph of 3-(4amino-1-oxo-1,3 dihydroisoindol-2-yl)-
piperidine-2,6-dione discovered thus far.

(Ex. A, 5:35-38; 6:13-54.) In short, the patent uses Form A as a label that refers to a particular
polymorph called Form A that has all the analytical characteristics by which it is described in the
specification, in order to distinguish it from the other crystalline Forms B-H. Because Celgenes
construction attempts to read out the term Form A from the claim, it is incorrect.
1. Celgenes Construction Is Internally Inconsistent And Violates
Established Canons Of Claim Construction
Celgenes proposed construction is internally inconsistent and violates established
principles of claim construction at least because it renders the term Form A superfluous and
violates the plain meaning of this term. For example, Celgenes proposed construction of Form
A requires only that it can be distinguished from other forms. (Celgenes Opening Markman
Brief at 23.) Celgene then argues that the term Form A is a term of reference that means
any crystal form of lenalidomide that has the particular characteristic value specified in the
claim. (Id. at 28.) But Celgenes own expert, Dr. Jerry Atwood, admits that a single analytical
characteristic such as DSC or XRPD as recited in claims 1 and 2, respectively, is not always
sufficient, when taken in isolation, to distinguish one polymorphic form of a compound from
another. (Ex. B, Deposition of Dr. Jerry L. Atwood, Ph.D., Jan. 17, 2014 (Atwood Dep. Tr.),
35:16-36:11; 41:21-43:12.) For lenalidomide specifically, multiple techniques would be required

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to differentiate Forms A-H in instances where the XRPD pattern is not, by itself, sufficient. (Id.
at 44:3-45:7; 46:7-47:11.) By Dr. Atwoods own admission, therefore, the claimed characteristic
of XRPD or DSC included in the claims is not sufficient to distinguish one crystal form from
other forms, as Celgene now argues is required by its construction.
Dr. Atwoods testimony also reveals a plethora of additional inconsistencies in Celgenes
proposed construction that illustrate why it does not make sense and violates established canons
of claim construction. First, Dr. Atwoods interpretation of the 357 patent claims allows for
things that are not Form A, such as Form F lenalidomide, to be covered by certain claims of the
357 patent, notwithstanding that all of the asserted claims specifically require Form A. (Id. at
72:6-15; 73:8-74:6; 74:9-19; 75:4-14; 103:2-13.) Dr. Atwood readily admits that Form A and
Form F as disclosed by the 357 patent are not the same crystal form, and can be differentiated
from each other on the basis of their properties. (Id. at 123:8-124:12.) But he still says a claim
that says Form A can cover Form F. That construction is inconsistent with the plain
meaning of Form A, which does not include or equate to Form F, an entirely different
crystalline form having distinct physical and chemical properties.
Second, Dr. Atwood testified that unsolvated crystalline lenalidomide that has none of
the XRPD associated with Form A can still fall within the scope of Form A in claim 1 of the
357 patent. (Id. at 70:15-22; 69:2-12.) This is also inconsistent with the express disclosure in
the specification requiring that Form A alone is characterized by certain XRPD peaks that are
expressly linked to Form A. (Ex. A, 6:22.)
Third, Dr. Atwood admits that Celgenes construction, which effectively ignores the term
Form A and focuses solely on the additional analytical limitation in the claims, entirely reads
out the claim requirement for Form A. (Ex. B, 88:13-16 (Whether the A is there or not, if

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form is construed as I have construed Form A, then the claim has the same scope in my
opinion.); id. at 72:22-74:6; 89:15-20; 91:2-18; 92:11-23; 93:12-25.) In other words, Dr.
Atwood testified that Form A lenalidomide has the same construction as Form B, Form C,
or Form D. (Id. at 77:7-12; 78:20-79:17, 80:16-81:8.) This proposed constructionwhich
entirely reads out the express claim limitation requiring Form Acannot be correct.
Finally, Celgenes proposed construction leads to absurd results. Under Celgenes
construction, a hypothetical product can infringe claim 1 directed to the Form A crystal if it
meets the subsequent DSC limitation in the claim, while not infringing claim 2 that is also
directed to Form A, if it does not meet the particular XRPD limitation in that claim. For
example, Dr. Atwood admits that an unsolvated crystalline form of lenalidomide that has none of
the characteristic XRPD peaks attributed to Form A in the specification and in Figure 1 would
not be considered Form A for purposes of claim 2, but would be considered Form A for
purposes of claim 1, if it met the DSC limitations recited in claim 1. (Id. at 103:2-13.) This
result makes no sense because the patentee invented only one crystalline Form A and described
this crystalline Form A, not by its individual analytical characteristics such as DSC in isolation,
but by a combination of its analytical characteristics exactly as described in the specification.
2. The BMS Case Does Not Support Celgenes Construction
Celgenes reliance on Bristol-Myers Squibb Co. v. Mylan Pharms., Inc. (BMS), which
is not controlling authority, is entirely misplaced. No. 09-651-LPS, 2012 WL 1753670 (D. Del.
May 16, 2012). The patents involved in that case were directed to various polymorphs of a drug
called efavirenz, which were described and claimed using numerical designations (e.g., Form I,
Form II, etc.). Id. at *1. The parties disputed whether the Form terms incorporated the XRPD
and DSC patterns in the Figures (defendants proposal), or whether the terms were intended only

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as shorthand references for the defining characteristics recited in the remainder of the claim
(plaintiffs proposal). Id. at *3.
In adopting plaintiffs construction, the BMS decision hinged on particular aspects of the
patent specification that have no counterpart to the specification at issue here. Specifically, the
BMS court found that the inventors description of these embodiments with varying levels of
detail demonstrates a clear intent to claim crystal forms of efavirenz that required less than the
full [XRPD] diffractograms and [DSC] thermograms as depicted in the Figures. Id. at *4
(emphasis added). For example, the specification stated:
In a first embodiment, the present invention provides Form
1 of crystalline Efavirenz.

In a preferred embodiment, Form 1 crystalline Efavirenz is
in substantially crystalline form.

In another preferred embodiment, the Form 1 crystalline
Efavirenz is characterized by an x-ray powder diffraction pattern
comprising four or more 2 values selected from the group
consisting of 6.0 0.2, 6.3 0.2, 10.3 0.2, 10.8 0.2, 14.1 0.2,
16.8 0.2, 20.0 0.2, 20.5 0.2, 21.1 0.2, and 24.8 0.2.

Efavirenz is characterized by an x-ray powder diffraction pattern
substantially in accordance with that shown in in FIG. 1.

Efavirenz is characterized by a differential scanning calorimetry
thermogram having a peak at about 138 C to about 140 C

(Ex. C, U.S. Pat. No. 6,673,372 at 3:13-30 (emphasis added).) In other words, the patent
specifications described the claimed crystalline form of efavirenz in several separate
embodiments, with each embodiment reciting a different analytical characteristic of the crystal
form such as XPRD or DSC characteristics. On this basis, the court concluded that there was no

9

basis to strictly limit[ing] the various Form terms to the complete XRPD and/or DSC patterns
illustrated in the Figures. 2012 WL 1753670 at *4.
That is not the case here because the Polymorph Patent specifications do not repeatedly
describe different Form embodiments using less than the full set of [analytical] data shown in the
Figures. Id. Here, each polymorph is disclosed in a single embodiment that describes and
characterizes the polymorph in terms of several analytical characteristics including XRPD, DSC,
IR, Raman, and TGA, among others. For example, the intrinsic record does not even suggest
that the inventors intended to claim crystalline Form A lenalidomide having less than the full set
of analytical attributes expressly associated with Form A. Celgene does not, and cannot, argue
otherwise. Instead, the specification here explicitly states, and Celgene acknowledges, that just
[o]ne embodiment of the invention encompasses Form A. (Atwood Decl. 23; Celgene
Opening Markman Brief at 28; Ex. A, 357 patent, 5:35 (emphasis added).) This single
embodiment describes Form A exactly as Natco proposes, i.e., by describing all its attributes,
including by reference to each figure that describes the Form A crystal. Unlike the patents
involved in the BMS case, other disclosed embodiments in the 357 patent specification are
directed not to Form A having a subset of its characteristics, but instead to Forms B-H, which are
entirely different crystal forms. (Ex. A, 5:38-67.)
The facts in the BMS case are also distinguishable on the basis of differences in the
prosecution history. In that case, the Examiner rejected pending claims reciting Form terms as
not enabled. The patentee amended the claims to recite additional XRPD and/or DSC
characteristics in response to the enablement rejection. The court agree[d] with Plaintiffs that
such changes would have been unnecessary if the meaning of the various Form terms were
properly understood already to incorporate the Figures. 2012 WL 1753670 at *4.

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In the present case, the facts are exactly the opposite. As explained in Natcos opening
brief, the then-pending 357 patent claims were initially directed generally to unsolvated
crystalline lenalidomide having specific XRPD characteristics and did not recite any Form
terms. (Defendants Opening Markman Brief at 16-17.) The examiner rejected these claims,
stating that the specification, while being enabling for [lenalidomide] Form A with a[sic] X-ray
diffraction pattern of fig. 1; does not reasonably provide enablement for the claimed scope of
unsolvated [lenalidomide] with the claimed XRPD peaks. In response, Celgene narrowed
these claims by adding the Form A limitation, and the objection was withdrawn. (Defendants
Opening Markman Brief at 16-17.) Based on this file history, it is clear that the patentee
intended Form A to have a clearly defined meaning as described in the specification, as
opposed to being a shorthand reference to a particular crystalline form having the characteristics
set forth in the remainder of the claim.
3. Celgenes Construction Improperly Seeks Coverage of More
Than The Subject Matter Disclosed
Celgene argues that Natcos construction improperly reads limitations into the claims and
therefore cannot be correct. Contrary to what Celgene suggests, Natcos proposed construction
simply gives meaning to the otherwise meaningless Form A term (Atwood Decl., 26) by
clarifying the inherent characteristics of the claimed Form A crystal that are necessarily and
inevitably present in the crystal form recited in the 357 patent claims. Under Celgenes
construction, however, Form A is required to have only the characteristic recited in the
particular claim, and does not require the additional characteristics that define Form A in the
specification.
As discussed above, Celgene does not, and cannot, argue that the Polymorph Patent
specification discloses a version of Form A crystal having the DSC characteristics recited in

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claim 1, but not also having the XRPD, IR, Raman, TGA, and other analytical characteristics that
the specification associates with the Form A crystal. Similarly, Celgene does not, and cannot,
argue that the specification discloses a version of the Form A crystal having the XRPD
characteristics recited in claim 2, but not also having all the other analytical characteristics
recited in the other claims, and attributed by the specification to the Form A crystal. (See
Atwood Decl. 23.) Indeed, Celgene conveniently ignores that Form A is described in the
specification in a single embodiment, as having all the analytical characteristics disclosed.
Thus, Natcos proposed construction does not narrow the scope of the claims to cover less than
what is disclosed and claimed as Form A in the 357 patent.
To the contrary, Celgenes litigation-driven construction seeks coverage of more than
what is supported by the specification (i.e. Form A having one or some but not all the
characteristics attributed to it by the specification). Dr. Atwoods testimony on this issue is
particularly telling. For instance, Dr. Atwood testified that under Celgenes construction,
undiscovered forms [] would similarly be covered by claim 1 of the 357 patent. (Ex. B,
139:22-140:14 (emphasis added).) A proposed construction that results in the claim covering
more than what the specification teaches a person of ordinary skill how to make lacks
enablement as required by 35 U.S.C. 112. See ALZA Corp. v. Andrx Pharma, LLC, 603 F.3d
935, 940 (Fed. Cir. 2010) (To be enabling, the specification of a patent must teach those skilled
in the art how to make and use the full scope of the claimed invention without undue
experimentation.) (internal citations omitted). By Dr. Atwoods own admission, that is
precisely the case here because the specification does not teach how to make and use any Form
A crystal that does not have all the characteristics attributed to Form A by the specification.

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Celgenes construction that covers undiscovered forms also makes the claim invalid for
lack of a supporting written description. To satisfy the written description requirement [of
112], the applicant must convey with reasonable clarity to those skilled in the art that, as of the
filing date sought, he or she was in possession of the invention, and demonstrate that by
disclosure in the specification of the patent. Novozymes A/S v. DuPont Nutrition BioSciences
APS, 723 F.3d 1336, 1344 (Fed. Cir. 2013) (internal citations omitted). And the patent
specification here does not disclose any undiscovered crystal forms that fall within the claim
scope of Form A, let alone convey with reasonable clarity that the inventors were in
possession of these undiscovered crystal forms.
The Federal Circuit has previously explained that claims should be so construed, if
possible, as to sustain their validity. Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999).
That maxim requires rejecting Celgenes constructions, which render the claims invalid as
lacking written description and/or enablement.
4. Celgenes Construction Also Renders Claim Terms Duplicative
And/Or Superfluous
To the extent Celgene argues that Natcos proposed construction is incorrect because it
renders limitations to specific analytical characteristics in claims 1-14 of the 357 patent
duplicative and/or superfluous, the argument has no merit in view of Celgenes own proposed
construction that suffers from the same alleged deficiencies. As Dr. Atwood admits, Celgenes
construction of Form A includes the chemical name of lenalidomide and therefore renders
duplicative and superfluous the express recitation of the chemical name of lenalidomide
elsewhere in the claim. (Ex. B, 101:13-22.) The fact is that it is poor claim drafting that results
in alleged redundancies, not Natcos proposed construction.

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For at least the foregoing reasons, Celgenes construction of Form A lacks merit and
the Court should adopt Natcos proposed construction of this term.
ii. Remaining Form A Terms
Natco proposes that the other three disputed terms that recite Form A as part of a larger
phrase be given the same construction as Form A, because the additional characteristics recited
in these terms whose meanings are not in dispute simply describe characteristics that the
specification attributes to the Form A crystal. Celgene agrees that Form A requires
construction when taken alone, but incredibly asserts that larger phrases containing the term
Form A do not require construction. In support, Celgene argues that there is no lexicography
in the specification, for these longer phrases containing Form A, and therefore that the plain
and ordinary meaning should apply. (Celgenes Opening Markman Brief at 30.)
This makes little sense. The specification clearly describes Form A as a crystal having
certain identified characteristics. It is thus illogical to say that the specification provides
lexicography for the phrase Form A, but then drops that lexicography when Form A is used
followed by certain of those associated characteristics. Additionally, the Federal Circuit long
ago rejected the rigid formalism requiring lexicography to take the form of a statement that I
define ___ to mean ___. AstraZeneca AB v. Mutual Pharm. Co., Inc., 384 F.3d 1333, 1339
(Fed. Cir. 2004). Celgene has already agreed that the phrase Form A does not have a plain and
ordinary meaning, but rather that it requires construction. Therefore, larger terms containing this
phrase necessarily also require construction. For this reason alone, the Court should adopt
Natcos proposed construction of these terms. (See also Defendants Opening Markman Brief at
14-20.)
Celgene also contends that Natcos proposal is incorrect because (1) it allegedly reads out
the agreed-upon definitions of the claim terms crystalline and endotherm; and (2) it results in

16

that has characteristics assigned to Form A in the specification, and the characteristics assigned
to Form A in the specification equal the crystal form called Form A.
Not only is this construction entirely consistent with the specification and file history, it
avoids the enablement and written description issues that result from adopting Celgenes
construction. See Modine Mfg. Co. v. U.S. Intl Trade Commn, 75 F.3d 1545, 1557 (Fed. Cir.
1996) (When claims are amenable to more than one construction, they should when reasonably
possible be interpreted so as to preserve their validity.) (internal citations omitted), abrogated
on other grounds by Festo Corp. v. Shoketsu Kizoku Kogyo Kabushiki Co., Ltd., 234 F.3d 558
(Fed. Cir. 2000).
Celgene, on the other hand, argues that these terms do not require construction. It
suggests that there is no lexicography in the specification for these terms and therefore that the
plain and ordinary meaning should apply. (Celgenes Opening Markman Brief at 33.) This
makes no sense because Celgenes bald assertion that there is no lexicography for these terms
begs the question of whether a person of ordinary skill would understand these phrases to have a
special meaning based on the specification disclosure. Additionally, the Federal Circuit long ago
rejected the rigid formalism requiring lexicography to take the form of a statement that I define
___ to mean ___. AstraZeneca AB, 384 F.3d at 1339. The specification clearly defines Form A
as the crystal form having the characteristics assigned to Form A. For this reason alone, the
Court should adopt Natcos proposed construction of these claims for the reasons discussed in
Natcos opening brief. (Defendants Opening Markman Brief at 20-25.)
Celgene also contends that Natcos proposal is incorrect because it reads out the agreed-
upon definitions of crystalline and endotherm, terms that are nested within these larger

18

by numerous extrinsic sources, and that should end the inquiry. (See, e.g., Ex. D, McGraw-Hill
Dictionary of Scientific and Technical Terms 977 (6th ed. 2003) (defining hemihydrate as [a]
hydrate with a 2:1 molecular ratio of anhydrous compound to water); Ex. E, A Dictionary of
Chemistry 275 (4th ed. 2000) (defining hemihydrate as [a] crystalline hydrate containing two
molecules of compound per molecule of water); Ex. F, The Penguin Dictionary of Science 200
(7th ed. 1993) (defining hemihydrate as [a] compound that has one molecule of water of
crystallization for every two molecules of the compound). See also D.I. 251, Attachment #2,
Second Declaration of Mark D. Hollingsworth, Ph.D., (Hollingsworth Decl.) 21-22.) The
intrinsic evidence changes nothing about this understanding. Accordingly, the term should be
construed as it is used in the art, as reflected by every dictionary definition in evidence, and not
solely by reference to the patent disclosure. This is what Natco proposes when recognizing the
heavy presumption in favor of the terms ordinary meaning. Teleflex, Inc. v. Ficosa N. Am.
Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002).
Yet, despite the unanimity of dictionary definitions and the fact that the patentees
expressly chose not to redefine hemihydrate, Celgene attempts to rely on the intrinsic record to
justify redefining the term in a manner that is inconsistent with how it is used in the art and that
was clearly not intended by the patentees. (See Celgenes Opening Markman Brief at 20-23; see
Such
reliance on the intrinsic record is improper and inconsistent with Celgenes own prior statements
that hemihydrate is not redefined in the patent, but rather is used in its ordinary capacity.

20

3. Celgenes Construction Is Unsupported By The Intrinsic
Record
Celgene also improperly relies on data reported in the specification that it incorrectly
contends redefines hemihydrate as a term of approximation. For instance, Celgene argues that
data concerning the Form B polymorph suggests it is a hemihydrate that can have differing water
contents ranging from approximately 0.46 moles to approximately 0.59 moles of water per mole
of lenalidomide. (Celgenes Opening Markman Brief at 21 (citing Ex. 4 (800 patent), 6:67 7:5
& Figs. 9, 37-39).) Not only is this inconsistent with Celgenes prior statements that the patent
does not redefine hemihydrate (Celgenes Opening Markman Brief at 20-21), but such
language is fully consistent with Natcos proposed construction of hemihydrate.
The reality is that specification data showing a range of water contents in the tested
samples reflects the practical limitations inherent in measuring water contents associated with
samples of hemihydrate. As Celgene admits, the patent does not redefine hemihydrate, but
rather reports the water content of measured samples of the claimed hemihydrate. A person of
ordinary skill in the art (POSA) would not read this disclosure as redefining the claimed
hemihydrate, but rather as reporting the measured water content of the claimed hemihydrate.

Simply

21

because the method of measuring the hemihydrate sample does not provide a water content in an
exact 1:2 ratio does not mean that the sample itself is not in reality a hemihydrate. Thus, the
specification language that Celgene points to as allegedly supporting its construction is, in fact,
fully consistent with Natcos proposed construction.
ii. Hemihydrate Refers To The Form B Polymorph
Based on the unambiguous disclosure in the intrinsic record and the patentees clear
disavowal of claim scope directed to polymorphs other than Form B, hemihydrate must also be
limited in this instance to the Form B polymorph.
As Natco pointed out in its opening brief, the 800 patent specification is littered with
numerous references to the Form B polymorph being the hemihydrate, and to the lenalidomide
hemihydrate being in the form of polymorph Form B. (See Defendants Opening Markman Brief
at 9-10); Ex. I, 800 patent, 17:37-40, 5:35-51, 7:31, 6:677:6, 12:31-32).) There is no
disclosure in the specification or file history of the hemihydrate being any polymorph other than
Form B, and conversely, there is no disclosure of the Form B polymorph having, or being
capable of having, any hydration state other than as the hemihydrate. Additionally, the
patentees conduct during prosecution clearly identifies the claimed hemihydrate as referring
to the Form B polymorph and disavows claim scope directed to any other disclosed polymorph
or mixtures, or unidentified hemihydrates. (See Defendants Opening Markman Brief at 11-13.)
Celgenes argument that Natcos construction improperly limits the claim scope to a
specific embodiment is unavailing and misleading for at least two reasons. First, and as
explained above, the 800 patent specification discloses only one embodiment, the Form B
polymorph, in connection with the hemihydrate. Thus, Natcos construction does not randomly
select one of several disclosed embodiments in limiting the claims scope, but rather construes
hemihydrate in the context of the intrinsic record, which repeatedly refers to hemihydrate as

23

the methods described in U.S. Pat. Nos. 6,281,230 and 5,635,517, the entireties of which are
incorporated herein by reference. (Ex. I, 800 patent at 4:665:1.) The specification then
proceeds to detail how, from the lenalidomide prepared by the processes denoted in the 230 and
517 patents, various forms of lenalidomide may be obtained, as disclosed in the 800 patent.
(Id. at 5:13-32.) The specification, file history, and extrinsic evidence in the record provide no
further information about how to synthesize the claimed compounds. Consistent with this
disclosure, Natco proposes that lenalidomide is made by the methods described in the 517 and
230 patents. A broader construction would lead to a compound that a person of ordinary skill in
the art did not know how to make at the time of the invention, and which would therefore be
invalid for reasons discussed above.
Celgene suggests this construction is incorrect because it changes the standard meaning
of the phrase, and further that lexicography requires a statement in the form I define ___ to
mean ___. But the Federal Circuit has repeatedly held that such rigid formalism is not
required for an inventor to change the otherwise ordinary meaning of a term. AstraZeneca AB,
384 F.3d at 1339 (Fed. Cir. 2004). Rather, a claim may be clearly redefined without an explicit
statement of redefinition . . . [T]he specification may define claim terms by implication such
that the meaning may be found in or ascertained by a reading of the patent documents. Id. at
1339-40 (internal citation omitted).) That is what the inventors did here. Nowhere does the
specification or the file history disclose or suggest alternate methods of making lenalidomide that
is used to produce the claimed crystalline polymorphs.
Moreover, all lenalidomide used to make the crystal forms disclosed in the specification
and used in the working examples presumably was made by the processes of the 517 and 230
patents, further suggesting implicit disavowal of other processes. AstraZeneca AB, 384 F.3d at

25

specification that it argues compel a conclusion that all claims cover racemates and therefore that
Natcos construction is an attempt to read out preferred embodiments absent a disavowal of
claim scope. (Id. at 7.) This is clearly inconsistent and violates established Federal Circuit
precedent that not all claims need cover all embodiments disclosed in a patent. Baran v. Med.
Device Techs., Inc., 616 F.3d 1309, 1316 (Fed. Cir. 2010). In reality, this portion of the
specification fully supports Natcos construction, which recognizes that certain claims cover
racemates and isomers, and certain narrowed, dependent claims cover only isomers.
i. Natcos Constructions Are Consistent With The Intrinsic Record
Claims 1 and 18 of the 230 patent, and claims 1 and 10 of the 554 patentthe broadest,
independent claimssay nothing about R-configuration or S-configuration, and Natco makes no
attempt here to limit the scope of those claims in that respect. (See Defendants Opening
Markman Brief 25-26; Ex. J, 230 patent; Ex. K, 554 patent.) By stark contrast, dependent
claims 15, 16, 24, and 25 of the 230 patent, and claims 2, 3, 14, and 15 of the 554 patent,
contain additional, narrowing limitations expressly limiting those claims to the R-configuration
or the S-configuration, not the racemate. (See Defendants Opening Markman Brief at 25-26,
Ex. J, 230 patent at 28:1518; 28:5861; Ex. K, 554 patent at 27:6228:2, 28:5054); see also
35 U.S.C. 112 ([A] claim in dependent form shall contain a reference to a claim previously set
forth and then specify a further limitation of the subject matter claimed.); Glaxo Group Ltd. v.
Ranbaxy Pharm. Inc., 262 F.3d 1333, 1336 (Fed. Cir. 2001) (Dependent claims are generally
narrower in scope than the claims from which they depend.). Accordingly, Natcos
constructions of ha[ving] the R-configuration and ha[ving] the S-configuration are entirely
consistent with certain embodiments of the invention as disclosed in the specification, and limit
the scope of only of those dependent claims.

26

Celgene recognizes the patents express statement that [t]he racemates can be used as
such or can be separated into their individual isomers for use in the claimed invention.
(Celgenes Opening Markman Brief at 6-7, citing Ex. 1 (230 patent), 8:6-7 (emphasis added).)
In fact, the patents describe two distinct methods to obtain either or both [isomer] substantially
free of the other; i.e., in a form having an optical purity of >95%:
The racemates can be used [on their own] or can be separated into
their individual isomers mechanically as by chromatography using
a chiral adsorbent. Alternatively, the individual isomers can be
prepared in chiral form or separated chemically from a mixture by
forming salts with a chiral acid, such as the individual enantiomers
of 10-camphorsulphonic acid, camphoric acid, -bromocamphoric
acid, methoxyacetic acid, tartaric acid, diacetyltartaric acid, malic
acid, pyrrolidone-5-carboxylic acid, and the like, and then freeing
one or both of the resolved bases, optionally repeating the process,
so as to obtain either or both substantially free of the other; i.e., in
a form having an optical purity of >95%.

(Defendants Opening Markman Brief, citing 230 patent at 8:6-17 (emphasis added); accord id.,
citing 554 patent at 7:43-54 (emphasis added).) The specification therefore clearly teaches that
certain embodiments can use only the individual R- or S-isomer. The dependent claims
containing this restrictive language should be construed consistently with that understanding.
ii. Celgenes Constructions Violate Established Principles Of Claim
Construction
Claim 2 of the 230 patent recites a method of treating certain conditions through the use
of a chemical compound. (See Defendants Opening Markman Brief at 28-29; Ex. J, 27:44-45.)
It contains no language about racemic forms of the compound, or that compound containing
the R-isomer or S-isomer in any amounts. Claims 15 and 16, on the other hand, depend from
claim 2 and contain the additional limitation that the compound have the R-configuration or the
S-configuration, respectively. (See Ex. J, 28:15-18.) This narrowing language is consistent with
the specification disclosure that the lenalidomide can be used as the racemate or as an individual

27

isomer. (Id. at 8:6-17 (emphasis added); Ex. K, 554 patent, 7:43-54 (emphasis added).) Where
the specification expressly discloses embodiments that are narrower than others, and these
embodiments are recited as additional limitations in certain dependent claims, these limitations
must have some narrowing effect. See 35 U.S.C. 112 ([A] claim in dependent form shall
contain a reference to a claim previously set forth and then specify a further limitation of the
subject matter claimed.) (emphasis added). Under Celgenes construction, however, claims 15
and 16 would cover racemic mixtures. The R-isomer and the S-isomer and would add no
further limitation over claim 2.
Celgenes construction is also inconsistent with the specification that clearly
contemplates the use of lenalidomide as a racemic mixture and also, alternatively, as an isomer
in the R-configuration or in the S-configuration. In other words, the Pharmaceutical Patent
disclosure does disclose different embodiments that are directed to use of the racemic mixture or
to use of the individual isomers. But the fact that there is no difference between these claims
under Celgenes construction, even though the specification unequivocally discloses narrower
embodiments directed to the individual isomers, is the clearest evidence that Celgenes
construction is incorrect. See Dow Chem. Co. v. United States, 226 F.3d 1334, 1341-42 (Fed.
Cir. 2000) (applying the doctrine of claim differentiation and concluding that an independent
claim should be given broader scope than a dependent claim to avoid rendering the dependent
claim redundant).
7
Essentially, Celgenes proposal ignores the additional claim limitations
completely and cannot be what the patentees intended or what Federal Circuit precedent permits.

7
In the Polymorph Patent specification, Form A is never disclosed as having less than the full
set of characteristics described and attributed to the Form A crystal. See supra Section II.a.i.3.

28

iii. Celgenes Constructions Are Inconsistent With The Understanding Of
A Person Of Ordinary Skill In The Art
Celgenes proposed constructions are also at odds with the meaning of the claim terms as
would be understood by a person having ordinary skill in the art. Celgene admits that the 230
and 554 specifications do not redefine the meaning of the disputed claim terms. (Celgenes
Opening Markman Brief at 6.) Their meaning to a person of skill in the art thus controls the
inquiry. See Vitronics, 90 F.3d at 1582.
Expressly denoting the compounds stereochemical R- or S-configuration as the patentees
chose to do in the dependent claims at issue indicates to the skilled artisan that the compound is
present as the single enantiomer having that particular stereochemical configuration, and not as
the racemic mixture. (D.I. 251, Second Decl. of Robert K. Boeckman, Jr., Ph.D., (Boeckman
Decl.) 20; Defendants Opening Markman Brief at 27.)
8
As Natcos expert explained, the
racemic mixture would never be described as having the R-configuration or as having the S-
configuration. (Boeckman Decl., 18, 20.) By contrast, omitting any express reference to
either the R- or S-isomer, as the patentees chose to do in claim 2 indicates to the skilled artisan
that the racemic mixture is covered by that claim. (Id. 18, 20.) Celgenes proposal is thus
inconsistent with the manner in which the skilled artisan would understand the claim terms. One
cannot have at the same time a compound that is both the racemate and also exists in the R-
configuration or the S-configuration. Celgenes proposal is therefore incorrect.

8
Dr. Boeckmans own prior work reflects the common understanding in the art that a reference
to either the R- or S-isomer implies a degree of optical purity that excludes the racemic mixture.
Specifically, in a patent claiming a different novel enantiomeric compound, Dr. Boeckman
defines the level of purity for that compound as above 95% or, alternatively, as above 98%.
Accordingly, the racemic mixture (50/50) is clearly excluded, and any presence of the other
enantiomer is due only to an impurity. See Ex. L, U.S. Patent No. 7,781,418, 3:60-65 (defining
substantially enantiomerically pure in the context a different enantiomeric compound as
having a purity of at least 95% of a referenced enantiomer and at most 5% of the other
enantiomer, and in other embodiments, defining it as a purity of at least 98% of a reference
enantiomer and at most 2% of the other enantiomer).

31

Westview Instruments, Inc., 52 F.3d 967, 973 (Fed. Cir. 1995) (en banc) (interpreting inventory
as used in the patent claim to mean articles of clothing rather than cash or inventory receipts),
affd, 517 U.S. 370 (1996). This case is no different. Cyclical administration has an established
technical meaning in the pharmaceutical field and is distinguishable from other types of dosing
regimens, for example, continuous administration. The patent specification further evidences the
technical nature of the cyclic dosing concept by devoting an entire section, titled Cycling
Therapy, to defining and explaining this dosing regimen, as well as describing specific
embodiments contemplated under the cyclical administration regimen. (Ex. N, 740 patent, 19:4-
21.) If these were ordinary English words whose meanings were apparent, there would have
been no need for specific discussion of the concept in the specification.
When the meaning of a technical term is in dispute, the Federal Circuit has made clear
that it must be construed. Multiform Dessicants, 133 F.3d at 1476; O2 Micro Intl Ltd. v. Beyond
Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008) (holding that failure to construe the
term only if was error where parties engaged in technical dispute over its scope). In
compliance with this mandate, Natco has provided constructions for these claim terms that are
faithful to the intrinsic record. Celgene has offered no construction at all. For this reason alone,
Natcos proposed construction should be adopted.
Additionally, because Celgenes underlying premise that the disputed terms have well-
understood meanings is incorrect, its reliance on general-purpose dictionaries is also misplaced.
As Celgene points out, the Federal Circuit explained that the ordinary meaning of claim
language as understood by a person of skill in the art may be readily apparent even to lay judges,
and claim construction in such cases involves little more than application of the widely accepted
meaning of commonly understood words. . . .In such circumstances, general purpose dictionaries

32

may be helpful. Phillips, 415 F.3d at 1314 (emphasis added). As explained above, however,
this is not such a circumstance because the disputed terms are technical in nature and do not have
a readily apparent meaning. For such technical terms, the proper construction results, not from
examining general-purpose dictionaries, but the intrinsic record which reveals how those closest
to the patenting process. . .viewed the subject matter. Multiform Dessicants, Inc., 133 F.3d at
1478. Indeed, the Federal Circuit has cautioned that [c]ourts must exercise caution lest
dictionary definitions, usually the least controversial source of extrinsic evidence, be converted
into technical terms of art having legal, not linguistic, significance. The best source for
understanding a technical term is the specification from which it arose, informed, as needed, by
the prosecution history. Id. Based on the correct analytical framework, Natcos construction of
these terms is consistent with the intrinsic record and in keeping with established scientific
principles.
9
(Defendants Opening Markman Brief, p. 32-35.)
For at least the foregoing reasons, the Court should reject Celgenes non-construction of
these disputed terms and adopt Natcos construction instead.
b. Cyclically Administering
Certain asserted claims of the 569 patent require cyclically administering lenalidomide
and dexamethasone in treating multiple myeloma. (Ex. O, 569 patent.) The parties
construction of these terms is as follows.

9
To the extent extrinsic evidence is relevant it is not both dictionaries that Celgene cites are
entirely consistent with Natcos proffered construction in that they both require repeated,
sequential administration at regular intervals. (Defendants Opening Markman Brief, p. 35.)
Likewise, Natcos construction also requires repeated, sequential administration over a pre-
determined period. (Id.)

34

V. CONCLUSION
For all of the reasons set forth above, Natco requests that the Court to adopt its proposals
for the disputed claims terms of the patents-in-suit.
Attorneys for Natco Pharma Ltd.,
Arrow International Ltd., and
Watson Laboratories, Inc.

By: s/ Melissa Steedle Bogad
James S. Richer
jrichter@winston.com
mbogad@winston.com
Dated: April 8, 2014
OF COUNSEL:
George C. Lombardi
Michael K. Nutter
Maureen L. Rurka
Kevin E. Warner
Chicago, Illinois 60601-9703
(312) 558-5600

35

CERTIFICATION OF SERVICE
I hereby certify that on April 8, 2014, copies of the foregoing Defendants
Responsive Claim Construction Brief and supporting documents were electronically filed and
served by electronic mail upon the following:
Charles M. Lizza
William C. Baton
SAUL EWING
One Riverfront Plaza, Suite 1520
Newark, New Jersey 07102-5426

F. Dominic Cerrito
Eric Stops
Andrew Chalson
QUINN EMANUEL URQUHART & SULLIVAN, LLP
51 Madison Avenue, 22nd Floor
New York, New York 10010

Anthony M. Insogna
JONES DAY
12265 El Camino Real
Suite 200
San Diego, California 92130-4096

Jason G. Winchester
JONES DAY
Chicago, Illinois 60601-1692

Richard G. Greco
RICHARD G. GRECO PC
90 State Street, Suite 700
Albany, New York 12207

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

Dated: April 8, 2014


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UNITED STATES DISTRICT COURT

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