Biotechnology/Pharmaceutical/Chemical Business ... - Elance

ahemhootBiotechnology

Dec 5, 2012 (4 years and 6 months ago)

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1


Technology
/Devices
/IT
/ Biotechnology/Pharmaceutical/Chemical

Business Development
/
Due Diligence/Product Team
s
/Patents/Litigation

Experience

Summary Highlights
: 2000
-
2010

G. Kevin Townsend

Business Development

and IP
Attorney

11750 Carmel Drive,
Lakewood, CO 80215

g.kevin.townsend@gmail.com
;
cell:
609
-
240
-
7589



Contents:


1. Executive Summary.


2. Business Development:
Major Agreements involving biopharmaceutical,
medical device and


pharmaceutical licensing
,
cross
-
licensing
, VC funding, and
acquisitions

(including
discovery, feasibility, R&D,
manufacturing, IP
, services,
IIS,
asset

purchase
, clinical, manufacturing, IT,
co
-
promotion,
and
marketing

agreements).






3
.
Major Due Diligences, Freedom to Operate, Regulatory, Management


Counseling and Related Work.




4. Product/Project Team Participation.



5. Issued Patents and Prepared and Filed Patent Applications.


6
.
Dispute Resolution and Litigation Experience



7.
Bibliography
/Presentations
.









Novem
ber

2
9
, 2010




2

1
.

Summary of Experience
:



I have
>
2
2

years

worldwide transactional, IP, litigation, regulatory, and business aspects of technology,
chemical, pharmaceutical, biotechnology, device, computer, and related technologies, including
>10
years in house

at
Johnson

& Johnson

and
Eli Lilly
, and
>10 years at law firms
, including
Hogan Lovells
,
and
Foley and Lardner
, &
Sterne
,
Kessler, Goldstein and Fox
.



Scope of Experience:
continuous and substantive transactional and licensing,
IP acquisition,
freedom to operate and defensive and offensive dispute resolution and litigation, and related
regulatory and business aspects, in support of small, medium & global high technology companies
in the United States, Europe & Asia.



Management:

I have continuously managed transactional, agreement, licensing, IP, litigation and
prosecution attorneys, patent agents, paralegals, technical specialists, and IT and administrative
support.



Business Development/Transactional/Licensing:
Conducted and man
aged attorneys on
>1000
contracts
, acquisitions, and agreements: due diligence, negotiations and drafting
, including:

o

>100 major product/company (>US$100M)
transactional and IP due diligences,
negotiations and agreements;

o

Relating to
all types of transa
ctions

involving: patents, know how, trade secrets,
copyrights, trademarks, products, services, and asset sales and licensing; for research,
development, collaborations; IIS studies; pre
-
clinical, clinical, master research and clinical,
and phase IV; CRO,
institution, academic and commercial licensing and technology transfer,
manufacturing, CMOs, and co
-
manufacturing, marketing and co
-
marketing, profit sharing,
commercialization, and in
-

and out
-
licensing; government, military, physician, and
consortium: r
esearch, consulting, collaboration, services, and master agreements; IT
support, systems and software.



IP Experience
: US, EU, Japan and Asia patentability, freedom to operate, opinions, drafting,
prosecution, interferences, reexaminations, oppositions, ap
peals, and dispute resolution, relating
to utility, design and plant patents and trademarks, including managing in house and outside
counsel patent attorneys, patent agents, and paralegals.

o

Drafted >500

original applications including utility
-
, design
-
,
and plant
-

patents,
trademarks, and copyrights;

o

Prosecuted >
20
00

US patent, trademark and copyright applications;

o

Issued >1000 US and >2000 International Patents;


o

Managed prosecution of >500 patent families

in > 60 countries for worldwide prosecution,
o
ppositions, and appeals, including > 25 oppositions and appeals;

o

>15 US patent interferences
, including District Court & Federal Circuit appeals (such as the
Fiers v. Sugano biotechnology Federal Circuit appeal); and

o

>50 appeals

to the Board of Patent Ap
peals & Interferences and the Federal Circuit, 15
reexaminations, & 10 reissues.



Litigation/Dispute Resolution:


o

>
50 major US, EU, and Japan/Asia multi
-
jurisdictional opinions, arbitrations, litigations, IP
and license dispute litigations, preliminary injunctions, and nullity actions;

o

>15 EU EPO and Japanese JPO oppositions and appeals
; and

o

Greatest Accomplishment
:
Solely drafted, directly managed prosecution and initially
managed the litigation of US patent 7,070,775, asserted by Centocor against Abbott that
resulted in a
record US$1.67 billion infringement jury verdict

against Abbott in the
Eastern District of Texa
s (
2:07
-
CV
-
00139
-
TJW, E.D. Texas (Marshall) 2009; WL 3734119;
Lexis 102427)
.



3




Product Portfolio Management:

o

Solely managed IP acquisition, defense and enforcement, due diligence, licensing and related
agreements and legal aspects, for
>50 major product
portfolios

(>$100M market)

in all
stages of development

o

Multi
-
billion dollar products
, such as J&J’s Stelara™ (ustekinumab), Simponi™ (golimumab)
and, e.g.,
Remicade™

(infliximab,
>$4B annual sales
), including, e.g.,
>100 major related
agreements

for pat
ents, clinical, licensing, cross
-
licensing, manufacturing, co
-
marketing
and commercialization;
>40 issued US and >100 issued worldwide patents, international
arbitrations, and US and international patent litigation.





Presentations:
Presented, managed & d
eveloped
>50 in house & public presentations

relating to
various aspects of US & international transactional, patent, regulatory, & related IP issues.




Scientific Experience:
studied
physics, chemistry, biochemistry, and molecular biology

in
undergraduate

and graduate school and then
worked 5 years post
-
graduate as a molecular
biologist at the NIH

studying DNA repair & cytochrome p450 expression, characterization,
enzymology & monoclonal antibody inhibition in recombinant vaccinia, retrovirus & baculovirus

expression systems, including analysis using spectroscopy, protein expression and purification,
enzyme kinetics, and nucleic acid analysis.


2
.

Business Development:



Major Agreements involving biopharmaceutical, medical device and pharmaceutical
licensing,
cross
-
licensing, VC funding, and acquisitions (including discovery, feasibility, R&D, manufacturing,
IP, services, IIS, asset purchase, clinical, manufacturing, IT, co
-
promotion, and marketing
agreements

, involving chemical, medical device,
pha
rmaceutical, biotechnology, computer, IT, and
manufacturing companies, universities, medical centers, non
-
profit institutions, and government
and military agencies and laboratories
.




Companies

for which I have

substantial personal experience in due diligence, negotiations and
agreement, licensing and acquisition drafting
,

with or for
, include, but are not limited to
: DuPont, Dow
Corning,
Schering Plough,

Merck,

BMS,

Pfizer,

Johnson &

Johnson, Centocor, Ortho Biotech, Eli Lilly,

Abbott Labs, Tanabe,
Ortho Clinical Diagnostics, Monsanto, Dow
, Dow

Agro,

Epicyte,

Morphosys,
Diosynth, DSM,
Pantheon
,
Lonza,

Invitrogen, Chromos, GlycoFi,
Santa Cruz Biotech,
Rinat, Gala
Biotech,

Biovation,

Xoma,


Elan Pharmaceuticals, Belarus Health (Neurochem), Biosite, Medarex,

Abgenix,

Biogen
-
Idec, Ablynx, Arizeke,

Diagnostics,
Apex, Theranos, Cambridge Antibody
Technologies, Crucell, Apex,

Delphion, Thompson IP Management Services, First to File, Co
llaborative
Technologies, CPA Software Solutions, Aurigen, MicroPatent,

Mayo Clinic,
New York University Medical
Center,
U Toronto,
U Michigan, Wake Forest U, Duke U,
U Pennsylvania, th
e National Institutes of
Health, Department of the Army,

and the like.


Subject matter including
:
phage display,
human, humanized, chimeric, rodent and mammalian
monoclonal antibodies, therapeutic
and diagnostic
proteins, DNA
, RNA, fusion proteins, PEGylated
proteins, antibody fusion proteins,

more than25 different

interleukins, cytokines and antibodies
thereto, bacterial, plant, algae, yeast, and mammalian cell expression of proteins for therapy and
diagnostics, injector, nasal, oral, and inhalation devices,


Counseling, due diligence, negotiations, drafting and ag
reements, including licensing and cross
-
licensing, for:

(2006
-
2008)

(1)
monoclonal antibody

phage display patent
licenses and cross
-
licenses
.


4

(2) use of transgenic mice for
monoclonal antibody

discovery and development

and
licenses and
cross
-
licenses
.

(3) Alzheimer’s
monoclonal antibody

development and
licenses and cross
-
licenses
.

(4) inhalation IL
-
4 mutein for asthma

development and
licenses and cross
-
licenses
.


(5)
contra
ct
manufacturing

agreements for manufacturing of
monoclonal antibody

drug products
including potential capital investment in manufacturing facilities under construction.

(6)

s
elf injector device being developed for use with
monoclonal antibody

drug products
,

and

potential licensing of this technology to for its distribution of
monoclonal antibody

drug products

outside the US under
existing Distribution Agreement.

(7)
monoclonal antibody


drug products
marketing agreement
.

(
8
)
monoclonal antibody

bacterial displa
y technology agreement.

(
9
) Feasibility and Option agreement for potential commercial manufacturing cell lines for
monoclonal antibody


drug products
.


(1
0
) CD
-
20
monoclonal antibodies

and know how;

(1
1
) autoinjector

training device with and third party suppliers;

(1
2
)
monoclonal antibody

clinical assay development and web based automated clinical data
collection and analysis system platform.

(1
3
) extension of agreement for use and development of
monoclonal antibod
y

phage display
technology to develop new therapeutic
monoclonal antibodies
.

(1
4
) research license for use of
monoclonal antibodies

in research programs.

(1
5
) Feas
i
bility and Option agreement for potential commercial manufacturing cell lines for
monoclona
l antibody

drug products
.


(2005
-
2006)


(1)
Amended License Agreement for Japan distribution and marketing of
monoclonal antibody

drug products
.

(2)

contract manufacturing agreements for manufacturing of
monoclonal antibody

drug products

including potential capital investment in manufacturing facilities under construction.

(3)

self injector device being developed for use with
monoclonal antibody

drug products
,
evaluation and counseling
for

management regarding the potential licensing of
this technology to
for its distribution of
monoclonal antibody

drug products

outside the US under existing
Distribution Agreement.

(4)

research, collaboration, co
-
promote option and license agreement

for pharmaceutical for
amyloidosis
;

(5)

Monoclonal antibody
M&A
;

(6)

research, collaboration and license agreement for IL
-
13
monoclonal antibody
.

(7)

O
ut
-
licensing
agreement for Alzheimer’s diagnostic
monoclonal antibodies


with therapeutic
rights retained by Centocor
.

(8)

B
acterial display te
chnology agreement.

(9)

license agreements for different aspects

of Alzheimer’s transgenic mice.

(10)

Feasability and Option agreement for potential commercial manufacturing cell lines for
monoclonal antibody

drug products
.

(11)

S
ingle domain
monoclonal

antibody

platform
.


(2004
-
2005)

(1)

S
mall molecule CCR2 antagonist collaboration for treating va
rious immune and other
diseases.

(2)

phage display of
monoclonal antibodies

for therapeutic and researc
h uses.

(3)

license agreement
for Alzheimer’s transge
nic mice.

(4)

Feasibility and Option Agreement completed for
monoclonal antibody

expression in artificial
chromosomes
for potential manufacturing use.


5

(
5
)

collaboration and license agr
eement regarding GLP
-
2 agonists.

(
6
)

C
ollaboration and co
-
promotion agreement for co
-
development, co
-
promote, supply and
license agreement regarding secondary amyloidosis small molecule therapeutic
.

(
7
)

Y
east expression technology for commercial production of therapeutic
monoclonal
antibodies
.

(
8
)

Feasi
bility and Option agreement for potential commercial manufacturing cell lines for
monoclonal antibody

drug products
.

(
9
)

monoclonal antibody

research, collaboration, co
-
promote option and license agreement
.

(12)
B
acterial display technology ag
reement.

(14)

P
erformed initial IP due diligence on single domain
monoclonal antibody

platform.

(15)

R
esearch, collaboration and license agreement for IL
-
13
monoclonal antibody
.


(2003
-
2004)


(1) N
eedleless injection devices for
therapeutic
monoclonal
antibody

therapeutics.

(2)

P
lanning agreement and commercial supply agreement
for the
manufacture

of

monoclonal
antibody


drug products
.

(3)

P
rocess, formulat
ion

and packag
ing of

monoclonal antibody

drug products
.

(4)

R
esearch and license agreements for evaluating and developing engineered
monoclonal
antibodies

using
proprietary

technology
, development
,

licenses and cross
-
licenses
.

(5)


A
greement to in license patent rights for use of
Cre
-
Lox cloning an
d expression syst
ems
.

(6)

R
esearch agreement for using HIV
monoclonal antibody

fusion

in animal models of HIV
infection.

(7)

C
onsulting agreement for developing assays and animal models for the development of
therapeutics for prion or TSE related diseases.

(8)


C
linical agreements for clinical study for use of chimeric HIV

monoclonal antibody

in clinical
studies for treatment of HIV.

(9)

F
easibility study for
monoclonal antibody


expression in artificial chromosomes for potential
manufacturing use.

(10)

F
easibility study for
monoclonal antibody


expression in yeast for potential manufacturing
use.


(2002
-
2003):


(1)
Amendments to Research Agreement for to provide contractor/collaborator services for
therapeutic and research
monoclonal antibody

generation using phage display for
development
,

and
licenses and cross
-
licenses
.


(2)

I
nstallation, set up and training for use of
monoclonal antibody

phage display libraries,
panning systems and technology for in house use by Centocor, PRI and Janssen.

(2
)


T
ransfer agreement for transgenic corn clinical production and seed stocks expressing
therapeutic
monoclonal antibodies

developed under prior feasibility agreement.

(3)


A
greement to in license patent rights for
monoclonal
antibodies to

MCP
-
1 and MCP
-
1
as
target.

(4)

A
greement to in license patent rights for
monoclonal
antibodies to

interleukin
-
12 and use of
IL
-
12 target in development.

(5)

P
lanning agreement and commercial s
upply agreement to have manufacturing company

prepare and set up to
manufacture

monoclonal antibody


drug products
for Centocor

(6)

A
greement

to process, formulate and package
monoclonal antibody


drug products
for

development

and commercialization,

and
licenses and cross
-
licenses
.

(7)

F
easibi
lity agreement to evaluate

technology to formulate
monoclonal antibody


drug
products

with higher concentrations.

(8)

Am
endment to add
Party
to
other party’s

license agreement to in license patent rights and
cell lines for use of
Hep
G2

cell lines
in

development and
licenses and cr
oss
-
licenses
.


6

(9)

R
esearch and license agreements for evaluating and developing engineered
monoclonal
antibodies


using Biovation technology.

(10)


A
greement to in license patent rights for use of Cre
-
Lox cloning and expression systems at
Centocor.

(11)

Re
search agreement for using HIV
monoclonal antibody


fusion

in animal models of HIV
infection.

(12)

C
onsulting agreement for developing assays and animal models for the development of
therapeutics for prion or TSE related diseases.

(13)

C
linical agreeme
nt for clinical study for use of
monoclonal antibody


drug products
in early
RA relating to changes in synovial fluid.

(14)

C
linical agreement for clinical study for use of
monoclonal antibody


drug products
in RA
with switch from
competitor drug
.

(15)

C
linical agreement for clinical study for use of
monoclonal antibody

drug products
in
hepatitis C.

(16)

R
esearch agreement for testing, assay and animal model development and use for
development of HIV
antibody fusion proteins
.

(17)

R
esearch agreement for testing and animal studies of IL
-
13
monoclonal antibodies

in
asthma.

(18)

C
ounseling, due diligence, negotiations, and drafting/revisions to clinical agreements for
clinical study for use of chimeric HIV
monoclonal antibody


in clini
cal studies for treatment of HIV.

(19)

C
ounseling, due diligence, negotiations, and drafting/revisions to clinical agreement for
toxicity studies in animal models of cancer for gencitabine for use in clinical studies of treatment
of cancer treatment relat
ed cachexia by infliximab.


(2001
-
2002)

(1)


C
ounseling, due diligence, negotiations and drafting for non
-
exclusive
out licensing

agreement relating to CD95/APO
-
1
monoclonal antibodies

for use in diagnostics.

(2)

C
ounseling, due diligence, negotiations
and drafting for research agreement for the role of
lung collections in asthma and regulation by cytokines.

(3)


C
ounseling, due diligence, negotiations and drafting for research agreement for the function
of IL
-
13 in smooth airway muscle cells including
the identification of new targets for treating
asthma.

(4)


C
ounseling, due diligence, negotiations and drafting for a manufacturing supply agreement
for the supply of
m
onoclonal antibody


clinical trial material.

(5)


C
ounseling, due diligence, negotiations and drafting for a research, evaluation and option
agreement for the use of GS vectors and CHO cells for the commercial expression
and
manufacture

of
monoclonal antibodies
.

(6)


C
ounseling, due diligence, negotiation
s and drafting for a collaboration agreement to develop
a human form of a chimeric
monoclonal antibody

as a therapeutic.

(7)


C
ounseling, investigation, due diligence, negotiations and drafting of agreement for out

licensing

of know how and patents for c
ommercialization of rabies
monoclonal antibodies

and
diagnostic kits.

(8)


C
ounseling, due diligence, negotiations, and revisions to agreement to in license patent rights
for the treatment of inflammatory bowel disease using
monoclonal antibodies

to
interleukin
-
12

.

(9)


C
ounseling, due diligence, negotiations, and drafting of agreement to in license patent rights
for the monocyte activating protein
-
1 (MCP
-
1) protein,
monoclonal antibodies
.

(10)


C
ounseling, due diligence, negotiations, and drafting

of agreement to in license patent
rights for
monoclonal antibodies

to interleukin
-
12.



(2000
-
2001)

(1)

C
ounseling, due diligence, negotiations and drafting for two agreements including:


7


(a)

Research Agreement for to provide contractor/collaborato
r services for therapeutic and
research
monoclonal antibody


generation using phage display for Centocor, PRI and Janssen; and


(b)


Subscription Agreement for to provide installation, set up and training for use of phage
display libraries, panning systems and technology for in house use by Centocor, PRI and Janssen.

(2)

C
ounseling, due diligence, negotiations and drafting for agreeme
nt for supply and use of
transgenic mice to discover and develop human therapeutic
monoclonal antibodies
.


(3)

c
ounseling, due diligence, negotiations and drafting for
feasibility

agreement to evaluate
transgenic corn commercial production
and
manufacture

of therapeutic
monoclonal antibodies

for Centocor.

(4)

C
ounseling, due diligence, negotiations and drafting for
feasibility

agreement to evaluate
transgenic corn commercial production
and
manufacture

of therapeutic
monoclonal antibodies

for Centocor.

(5)

C
ounseling, due diligence, litigation analysis and preparation, negotiations and drafting for
patent license agreement for tumor necrosis factor
monoclonal antibody

patents
, and
licenses
and cross
-
licenses
.

(6)

C
ounseling, investigation, due diligence,
negotiations and drafting of agreement for out
-
licensing

of know how and patents for commercialization of rabies
monoclonal antibodies

and
diagnostic kits.

(7)

C
ounseling, due diligence, negotiations and drafting of agreement to license Bluestone’s
inter
ests in CD3
monoclonal antibody

patents under development by Centocor.

(8)

c
ounseling, due diligence, negotiations, and revisions to agreement to in license patent rights
for the treatment of inflammatory bowel disease using
monoclonal antibodies

to inter
leukin
-
12.

(9)

Counseling, d
ue diligence, ne
gotiations and drafting of feasi
bility agreement for to evaluate
oral delivery of therapeutic
monoclonal antibody


using Arizeke technology.

(10)


C
ounseling, due diligence, negotiations, and revisions to
evaluation and option license to
patent and company document search, analysis and warehousing software and database system.

(11)


C
ounseling, due diligence, negotiations and drafting of new agreement to conduct research
and clinical studies.


3
. Major Freedom to Operate,
Regulatory,
Management Counseling
,

and
Related Work


Freedom
-
to
-
Operate evaluations

(2007
-
2008)

1.

EPO
monoclonal antibody

fusion

variants
, compositions, methods and devices.

2.

EPO
mimetic
monoclonal antibody


fusion
and potential
indications, compositions, methods
and devices.

3.

IL
-
17A target variants and
monoclonal antibodies

, inclu
ding new product in development
,
compositions, methods and devices.

4.

Adiponectin target,
monoclonal antibodies


and indications
, compositions, methods
and
devices.

5.

Phage Display methodologies using bacteriophage pVII/pIX for de novo fab library display
,
compositions, methods and devices.

6.

Phage Display methodologies using bacteriophage pVII/pIX for peptide library display
,
compositions, methods and device
s.

7.

Phage Display methodologies using bacteriophage pVII/pIX for fab maturation
, compositions,
methods and devices.

8.

Phage Display methodologies using bacteriophage pVII/pIX for hybridoma fab library display
and maturation
, compositions, methods and devices.

9.

IL
-
13 target,
monoclonal antibodies

, indications and generation, inclu
ding new product in
development
, compositions, methods and devices.


8

10.

IL
-
14 target,
monoclonal antibodies

, indications and generation , compositions, methods and
devices.

11.

IL
-
27 target,
monoclonal antibodies


and
indication , compositions, methods and devices.

12.

GLP1 target
, mimetibodies and indications, compositions, methods and devices.

13.

Beta
-
amyloid target,
monoclonal antibodies


and indications, compositions, methods and
devices.

14.

Beta
-
am
yloid transgenic mice, compositions, methods and devices.

15.

MCP
-
1/CCR
-
2 target,
monoclonal antibodies


implicated in immune and cancer related
diseases;
and


TNF alpha
monoclonal antibodies


implicated in immune related diseases, including new
product
in

de
velopment
, compositions, methods and devices.

16.

Use of fluorescent proteins for research use
, compositions, methods and devices.


(2006
-
2007)

1.

EPO
monoclonal antibody


fusion variants
, compositions, methods and devices.

2.

EPO mimetic
monoclonal antibody


fusion pro
tein and potential indications
, compositions,
methods and devices.

3.

IL
-
17A target variants and
monoclonal antibodies
, compositions, methods and devices.

4.

Adiponectin target,
monoclonal antibodies


and indications
, compositions, methods and
devices
.

5.

Phage Display methodologies using bacteriophage pVII/pIX for de novo fab library display
,
compositions, methods and devices.

6.

Phage Display methodologies using bacteriophage pVII/pIX for peptide library display
,
compositions, methods and devices.

7.

Phage Di
splay methodologies using bacteriophage pVII/pIX for fab maturation
, compositions,
methods and devices.

8.

Phage Display methodologies using bacteriophage pVII/pIX for hybridoma fab library display
and maturation
, compositions, methods and devices.

9.

IL
-
13 targ
et,
monoclonal antibodies

, indications and generation
, compositions, methods and
devices.

10.

IL
-
14 target,
monoclonal antibodies

, indications and generation
, compositions, methods and
devices.

11.

IL
-
21 target,
monoclonal antibodies


and indications
, compositio
ns, methods and devices.

12.

IL
-
27 target,
monoclonal antibodies


and indi
cations
, compositions, methods and devices.

13.

GLP1 target
, mimetibodies and indications
, compositions, methods and devices.

14.

Beta
-
amyloid target,
monoclonal antibodies


and indications
, com
positions, methods and
devices.

15.

Beta
-
amyloid transgenic mice
, compositions, methods and devices.

16.

MCP
-
1/CCR
-
2 target,
monoclonal antibodies


implicated in immune and cancer related
diseases
, compositions, methods and devices.

17.

TNF alpha
monoclonal antibodies


implicated in immune related diseases
, compositions,
methods and devices.

18.

Use of fluorescent proteins for research use
, compositions, methods and devices.


(2005
-
2006)

1.

EPO
monoclonal antibody


fusion variants
, compositions, methods and devices.

2.

EPO mimetic
monoclonal antibody


fusion protein and potential indications
, compositions,
methods and devices.


3.

-
IL
-
17A target variants and
monoclonal antibodies
, compositions, methods and devices.


9

4.

adiponectin target,
monoclonal antibodies


and indications
,

compositions, methods and
devices.

5.

Phage Display methodologies using bacteriophage pVII/pIX for de novo fab library display
,
compositions, methods and devices.

6.

Phage Display methodologies using bacteriophage pVII/pIX for peptide library display
,
compositi
ons, methods and devices.

7.

Phage Display methodologies using bacteriophage pVII/pIX for fab maturation
, compositions,
methods and devices.

8.

Phage Display methodologies using bacteriophage pVII/pIX for hybridoma fab library display
and maturation
, composition
s, methods and devices.

9.

IL
-
13 target,
monoclonal antibodies

, indications

and generation
, compositions, methods and
devices.

10.

IL
-
14 target,
monoclonal antibodies

, indications and generation
, compositions, methods and
devices.

11.

IL
-
21 target,
monoclonal
antibodies


and indications
, compositions, methods and devices.

12.

IL
-
27 target,
monoclonal antibodies


and indications
, compositions, methods and devices.

13.

GLP1 target
, mimetibodies and indications
, compositions, methods and devices.

14.

Beta
-
amyloid target,
mono
clonal antibodies


and indications
, compositions, methods and
devices.

15.

Beta
-
amyloid transgenic mice
, compositions, methods and devices.

16.

MCP
-
1/CCR
-
2 target,
monoclonal antibodies


implicated in immune and cancer related
diseases
, compositions, methods and d
evices.

17.

TNF alpha
monoclonal antibodies


implicated in immune related diseases
, compositions,
methods and devices.

18.


Use of green fluorescent protein for research us
e
, compositions, methods and devices.


(2004
-
2005)

1.

Expression and manufacturing of therapeutic
monoclonal antibody


products in transgenic
plants
, compositions, methods and devices.

2.

EPO
monoclonal antibody


fusion variants
, compositions, methods and devices.

3.

Monoclonal antibody


fusions and potential indic
ati
ons
, compositions, methods and devices.

4.

EPO mimetic
monoclonal antibody


fusion pro
tein and potential indications
, compositions,
methods and devices.

5.

IL
-
17 target variants and
monoclonal antibodies
, compositions, methods and devices.

6.

GLP
-
2 receptors
,
compositions, methods and devices.

7.

adiponectin target,
monoclonal antibodies


and indications
, compositions, methods and
devices.

8.

Phage Display methodologies using bacteriophage pVII/pIX
, compositions, methods and
devices.

9.

IL
-
13 target,
monoclonal antibodi
es

, indications and generation
, compositions, methods and
devices.

10.

IL
-
14 target,
monoclonal antibodies

, indications and generation
, compositions, methods and
devices.

11.

IL
-
18 muteins discovered for use in generating therapeutic IL
-
18
monoclonal antibodies
,

compositions, methods and devices.

12.

IL
-
21 target,
monoclonal antibodies


and indications
, compositions, methods and devices.

13.

IL
-
27 target,
monoclonal antibodies


and indications
, compositions, methods and devices.

14.

GLP1/GLP2 target
, mimetibodies and indicat
ions
, compositions, methods and devices.

15.

Beta
-
amyloid target,
monoclonal antibodies


and indications
, compositions, methods and
devices.

16.

Beta
-
amyloid transgenic mice
, compositions, methods and devices.


10

17.

EPO mimetic
monoclonal antibody


f
usion and potential
indications
, compositions, methods
and devices.

18.

MCP
-
1/CCR
-
2 target,
monoclonal antibodies


implicated in immune and cancer related
diseases
, compositions, methods and devices.

19.

TNF alpha
monoclonal antibodies


implicated in immune related diseases
, composit
ions,
methods and devices.


(2003
-
2004)

Freedom
-
to
-
Operate evaluations

relating to:

1)

Expression and manufacturing of therapeutic
monoclonal antibody


products in transgenic
plants
, compositions, methods and devices.

2)

Review of patents relating to
monoclonal
antibodies to

IL
-
12 and IL
-
23 as a target for a
research program, including counseling on patent coverage for
monoclonal antibodies

and
target
, compositions, methods and devices.

3)

Review of patents relating to
monoclonal
antibodies to

RSV
, compos
itions, methods and
devices.

Review

of patents relating to EPO mimetics
, compositions, methods and devices.

4)

Review of patents relating to
monoclonal
antibodies to

MCP
-
1
, compositions, methods and
devices.

5)

Review of patents relating to
monoclonal
antibodies

to

TNF
, compositions, methods and
devices.

Review

of patents relating to
monoclonal
antibodies to

IL
-
13
, compositions, methods
and
devices.

Review

of patents relating to
monoclonal
antibodies to

MMP
-
3
, compositions,
methods and devices.

6)

Review of patents relating to
monoclonal
antibodies to

HIV gp41
, compositions, methods and
devices.

7)

Review of patents relating to
monoclonal
antibodies to

IL
-
27
, compositions, methods and
devices.

8)

Review of patents relating to
monoclonal
antibodies to

GLP
-
1
, compositions, methods and
devices.

9)

Review of patents relating to
monoclonal
antibodies to

GLP
-
2
, compositions, methods and
devices.

10)

Review of patents relating to
monoclonal
antibodies to

beta amyloid
, compositions, methods
and devices.

11)

Review of pa
tents relating to
monoclonal
antibodies to

CCR
-
3
, compositions, methods and
devices.

12)

Review of patents relating to
monoclonal
antibodies to

IL
-
18
, compositions, methods and
devices.

13)

Review of patents relating to
monoclonal
antibodies to

MC4 receptor
, compo
sitions, methods
and devices.

14)

Review of patents relating to
monoclonal
antibodies to

adiponectin
, compositions, methods
and devices.

15)

Review of patents relating to
monoclonal
antibodies to

TLR
-
3
, compositions, methods and
devices.

16)

Review of patents relating

to
monoclonal
antibodies to

alpha
-
MSH
, compositions, methods
and devices.

17)

Phage Display methodologies using bacteriophage pVII and pIX. This included a review of
potential royalty obligations and
licenses and cross
-
licenses

that would be required for
commercialization.


(2002
-
2003)


(1)

Expression and manufacturing of therapeutic
monoclonal antibody


products in transgenic
plants
, compositions, methods and devices.


11

(2)

Review of patents relating to DNA vaccine products in developmen
t includi
ng MUC
-
1, PSA,
KLK
-
3, and IL
-
18, compositions, methods and devices.

(3)

Review of patents relating to
monoclonal
antibodies to

IL
-
12 and IL
-
23 as a target for a
research program, including counseling on patent coverage for
monoclonal
antibodies and
ta
rget, compositions, methods and devices.

(4)

Review of patents relating to
monoclonal
antibodies to

RSV
, compositions, methods and
devices.

(5)

Review of patents relating to EPO mimetics
, compositions, methods and devices.

(6)

Review of patents relating to
monoclonal
antibodies to

MCP
-
1
, compositions, methods and
devices.

(7)

Review of patents relating to
monoclonal
antibodies to

TNF
, compositions, methods and
devices.

(8)

Review of patents relating to
monoclonal
antibodies to

IL
-
13
, compositions, methods and
devices.

(9)

Review o
f patents relating to
monoclonal
antibodies to

MMP
-
3
, compositions, methods and
devices.

(10)

Review of patents relating to
monoclonal
antibodies to

HIV gp41
, compositions, methods and
devices.

(11)

Review of patents relating to
monoclonal
antibodies to

IL
-
27
, compo
sitions, methods and
devices.

(12)

Review of patents relating to
monoclonal
antibodies to

GLP
-
1
, compositions, methods and
devices.

(13)

Review of patents relating to
monoclonal
antibodies to

GLP
-
2
, compositions, methods and
devices.

(14)

Review of patents relating to
monoclonal
antibodies to

beta amyloid
, compositions, methods
and devices.

(15)

Review of patents relating to
monoclonal
antibodies to

CCR
-
3
, compositions, methods and
devices.

(16)

Review of patents relating to
monoclonal
antibodies to

IL
-
18 BP
, compositions, method
s and
devices.

(17)

Review of patents relating to
monoclonal
antibodies to

MC4 receptor
, compositions,
methods and devices.

(18)

Review of patents relating to
monoclonal
antibodies to

adiponectin
, compositions, methods
and devices.

(19)

Review of patents relating to
mono
clonal
antibodies to

TLR
-
3
, compositions, methods and
devices.

(20)

Review of patents relating to
monoclonal
antibodies to

alpha
-
MSH
, compositions, methods
and devices.

(21)

Conducted a review of the DNA vaccine program against targets for oncology, MUC
-
1 and
PSA
, c
ompositions, methods and devices.


(2001
-
2002)


(1)

Review of patents relating to
monoclonal
antibodies to

EPO mimetic
monoclonal antibody


fusion
, compositions, methods and devices.

(2)

Review of patents relating to IL
-
18 mutants discovered by Centocor, including counseling on
patent coverage for
monoclonal
antibodies and target, compositions, methods and devices.

(3)

Review of patents relating to IL
-
13 mutants discovered by Centocor, includi
ng counseling on
patent coverage for
monoclonal
antibodies and target, compositions, methods and devices.

(4)

Review of patents relating to
monoclonal
antibodies to

IL
-
21 as a target for a research
program, including counseling on patent coverage for
monoclona
l
antibodies and target,
compositions, methods and devices.


12

(5)

Review of patents relating to
monoclonal
antibodies to

Toll
-
Like Receptor 3 (TLR3), as a target
for a research program, including counseling on patent coverage for
monoclonal
antibodies
and target
, compositions, methods and devices.

(6)

Review of patents relating to use of protein free media in manufacturing
, compositions,
methods and devices.

(7)

Review of patents relating to Lonza glutamine synthetase expression system.

(8)

Review of patents and companies re
lating to expression and manufacturing of therapeutic
monoclonal antibody


products in transgenic plants;

(9)

Review of patents relating to DNA vaccine products in development including MUC
-
1, PSA,
KLK
-
3, and IL
-
18
.

(10)

Review of patents relating to
monoclonal
ant
ibodies to

IL
-
12 and IL
-
23 as a target for a
research program, including counseling on patent coverage for
monoclonal
antibodies and
target, compositions, methods and devices.

(11)

Review of patents relating to
monoclonal
antibodies to

RSV
, compositions, method
s
and devices.

(12)

Review of patents relating to EPO mimetics
, compositions, methods and devices.

(13)

Review of patents relating to
monoclonal
antibodies to

CD
-
3 and CD
-
4
, compositions,
methods and devices.

(14)

Review of patents relating to
monoclonal
antibodies to

MC
P
-
1 and Eta
-
1
, compositions,
methods and devices.

(15)

Review of patents relating to
monoclonal
antibodies to

TNF
, compositions, methods
and devices.

(16)

Review of patents relating to
monoclonal
antibodies to

integrins
, compositions,
methods and devices.

(17)

Review of patents relating to
monoclonal
antibodies to

IL
-
1
, compositions, methods
and devices.

(18)

Review of patents relating to
monoclonal
antibodies to

IL
-
13
, compositions, methods
and devices.

(19)

Review of patents relating to
monoclonal
antibodies to

IL
-
18
, c
ompositions, methods
and devices.

(20)

Conducted a review of the DNA vaccine program against targets for oncology, MUC
-
1
and PSA. This included a review of potential royalty obligations and
licenses and cross
-
licenses

that would be required for commercializatio
n.


(2000
-
2001)


1)

Expression and manufacturing of therapeutic
monoclonal antibody


products in transgenic
plants;

2)

Review of patents relating to DNA vaccine products in development including MUC
-
1, PSA,
KLK
-
3, and IL
-
18.

3)

Review of patents relating to
monoclo
nal
antibodies to

IL
-
12 and IL
-
23 as a target for a
research program, including counseling on patent coverage for
monoclonal
antibodies and
target, compositions, methods and devices.

4)

Review of patents relating to
monoclonal
antibodies to

RSV
, compositions,

methods and
devices.

5)

Review of patents relating to EPO mimetics
, compositions, methods and devices.

6)

Review of patents relating to
monoclonal
antibodies to

CD
-
3 and CD
-
4
, compositions, methods
and devices.

7)

Review of patents relating to
monoclonal
antibodie
s to

MCP
-
1 and Eta
-
1
, compositions,
methods and devices.

8)

Review of patents relating to
monoclonal
antibodies to

TNF
, compositions, methods and
devices.


13

9)

Review of patents relating to
monoclonal
antibodies to

GPIIb/IIIa
, compositions, methods and
devices.

10)

Re
view of patents relating to
monoclonal
antibodies to

integrins
, compositions, methods and
devices.

11)

Review of patents relating to
monoclonal
antibodies to

IL
-
1
, compositions, methods and
devices.

12)

Review of patents relating to
monoclonal
antibodies to

IL
-
6
,
compositions, methods and
devices.

13)

Review of patents relating to
monoclonal
antibodies to

IL
-
13
, compositions, methods and
devices.

14)

Review of patents relating to
monoclonal
antibodies to

IL
-
18
, compositions, methods and
devices.

15)

Conducted a review of paten
ts relating to
monoclonal
antibodies to

Tissue Factor as a target
for a research program in the cardiovascular area utilizing the humanized form of the anti
-
tissue factor
monoclonal antibody


obtained from Scripps Research Institute. This included
advice concerning the present patent coverage on the
monoclonal antibody


as well as patent
position concerning competing products in development.

16)

Conducted a review of the DNA vaccine program agains
t targets for oncology, MUC
-
1 and PSA.
This included a review of potential royalty obligations and
licenses and cross
-
licenses

that
would be required for commercialization
.

17)

Conducted
validity
evaluation of a US patent issued to the Kennedy Institute of Rhe
umatology
relating to co
-
administering anti
-
TNF
monoclonal antibodies


and methotrexate, which is
licensed to Centocor
.


Regulatory Support:

(2007
-
2008)


(1)


Remicade
™:

existing

and new label indication product regulatory, data exclusivity and related
IP issues

(2)


TNF
monoclonal antibody

:

new product regulatory, data exclusivity and related IP issues;

(3)


EPO mimetic

monoclonal antibody


fusion:

Regulatory, data exclusivit
y and related IP issues
for
out licensing

(4)


MCP
-
1/CCL2
monoclonal antibody

:

Regulatory, data exclusivity and related IP issues

(5)


GLP
-
1
monoclonal antibody


fusion
:

Regulatory, data exclusivity and related IP issues

(6)


IL
-
13
monoclonal antibo
dy

:

Regulatory, data exclusivity and related IP issues

(7)


IL
-
17A
monoclonal antibody

:

Regulatory, data exclusivity and related IP issues

(8)


IL
-
27
monoclonal antibody

:

Regulatory, data exclusivity and related IP issues

(9)


Eta
-
1
monoclonal
antibody

:

Regulatory, data exclusivity and related IP issues

(10)



beta amyloid
monoclonal antibody

:

Regulatory, data exclusivity and related IP issues

(11)



beta amyloid assay/animal model
:

Regulatory, data exclusivity and related IP issues

(12)



adi
ponectin
monoclonal antibody

:

Regulatory, data exclusivity and related IP issues

(13)



alpha
-
MSH
monoclonal antibody

:

Regulatory, data exclusivity and related IP issues

(14)


P
hage display teams for peptide, protein and
monoclonal antibody


display and engineering
:
Regulatory, data exclusivity and related IP issues


(2005
-
2007)


(1)

Remicade™:

new label indication product regulatory, data exclusivity and related IP
issues


(2)

TNF
monoclonal antibody


new product regulatory, data exclusivity and related IP issues;


14

(3)

EPO
monoclonal antibody


fusion Regulatory, data exclusivity and related IP issues for
out
licensing


(4)

MCP
-
1/CCL2
monoclonal antibody


Regulatory, data exclusivity and related IP issue
s

(5)

GLP
-
1
monoclonal antibody


fusion Regulatory, data exclusivity and related IP issues

(6)

IL
-
13
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(7)

IL
-
21
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(
8)

IL
-
27
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(9)

Eta
-
1
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(10)


beta amyloid
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(
11)
beta amyloid assay/animal model Centocor/PRD team

(12)


adiponectin
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(13)


alpha
-
MSH
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(14)


IL
-
17A
monoclonal

antibody


Regulatory, data exclusivity and related IP issues

(15)


P
hage display Regulatory, data exclusivity and related IP issues


(2003
-
2005)


(1)

Monoclonal antibody


drug products new label indication product regulatory, data exclusivity
and related
IP
issues


(2)

TNF
monoclonal antibody


new product regulatory, data exclusivity and related IP issues;

(3)

IL
-
12
monoclonal antibody


new product regulatory, data exclusivity and related IP issues

(4)

EPO
monoclonal antibody


fusion Regulatory, data exclu
sivity and related IP issues

(5)

MCP
-
1/CCL2
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(6)

GLP
-
1
monoclonal antibody


fusion Regulatory, data exclusivity and related IP issues

(7)

IL
-
13
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(8)

IL
-
18
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(9)


IL
-
21
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(10)


MCP
-
1
monoclonal antibody


Regula
tory, data exclusivity and related IP issues

(11)


Eta
-
1
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(12)


beta amyloid
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(13)


beta amyloid assay/animal m
odel Centocor/PRD team

(14)


adiponectin
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(15)

alpha
-
MSH
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(16)

HIV gp41
monoclonal antibody


fusion Regulatory, data exclusivity and related IP issues



(2000
-
2003):

(1)

TNF
monoclonal antibody


new product regulatory, data exclusivity and related IP issues;

(2)

IL
-
12
monoclonal antibody


new product regulatory, data exclusivity and related IP i
ssues

(3)

EPO
monoclonal antibody


fusion Regulatory, data exclusivity and related IP issues

(4)

GLP
-
1
monoclonal antibody


fusion Regulatory, data exclusivity and related IP issues

(5)

HIV gp41
monoclonal antibody


fusion Regulatory, data exclusivity and

related IP issues

(6)

IL
-
23
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(7)

IL
-
13
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(8)

IL
-
18
monoclonal antibody


Regulatory, data exclusivity and related I
P issues

(9)


IL
-
21
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(10)

MCP
-
1
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(11)

Eta
-
1
monoclonal antibody


Regulatory, data exclusivity and related IP iss
ues

(12)


adiponectin
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(13)


alpha
-
MSH
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(14)

MUC
-
1 DNA vaccine Regulatory, data exclusivity and related IP issues

(15)

PSA DNA vaccine Regulatory, data exclusivity and related IP issues


15

(16)

CD
-
3
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(17)

IL
-
21
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(18)

TLR3
monoclo
nal antibody


Regulatory, data exclusivity and related IP issues

(19)


IgE
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(20)

MCP
-
1/Eta
-
1 DNA vaccine team

(21)


Beta amyloid
monoclonal antibody


Regulatory, data exclusivity and related IP issues

(22)


Epitope mapping Regulatory, data exclusivity and related IP issues

(23)


Monoclonal antibody


and Protein Modification Regulatory, data exclusivity and related
IP issues



Management Guidance, Suppo
rt and Strategy:


(2007
-
2008)

(1)


Opposition Appeals of 2 EP patents relating to T
umor
N
ecrosis
F
actor


(2)


TEC team to evaluate technologies for potential licensing

(3)


Bayh
-
Dole issues related to the research and clinical agreements.

(4)


IP iss
ues relating to investigator brochure di
sclosures for Remicade, follow on

(5)


IP issues relating to Japanese infliximab and
follow on

regulatory filings

(6)


IP issues relating to

Chinese infliximab and follow on

regulatory filings

(7)


IP issues relating to South Korea infliximab regulatory filings

(8)


IP issues relating to publications of TNF
monoclonal antibody


(9)


IP issues rela
ting to development of
TNF
monoclonal antibody


(10)


IP issues relating to development and
out
licensing

of EPO mimeti
c
monoclonal antibody


fusion

(11)


IP issues relating to research agreements and MTAs

(12)


IP issues relating to clinical study agreements in the US

(13)


IP issues relating to clinical study agreements in the EU


Interferences:

M
ember of Interference Committee for providing Patent Department education and resource for
interferences. Analyzed and advised on potential
interferences relating to TNF
monoclonal antibody


patents relating to neurodegenerative diseases and IL
-
12
monoclonal antibody


patent applications.

Managed interference between two patent applications of relating to TNF
monoclonal antibodies

and
two issued patents and two pending patent

applications
relating to neurodegenerative disorder
treatment with

TNF
mo
noclonal antibodies

using direct injection into the CNS. Were able to negotiate
settlement agreement that did not limit Centocor’s patent rights relating to these applications.


Litigation Support:
managed

outside counsel in litigation filed against Abbot
t Labs for infringement of
Humira


of
human TNF
monoclonal antibody

patent

of Centocor’s
.


Stage gate

II, III and IV reviews:

(i) Supported the IL
-
17A product development team for
Stage gate

II
review ; (ii) the
MCP
-
1
monoclonal antibody


Product Team for
Stage gate

III review for Phase I studies
in Oncology indi
cations, and (iii) the TNF
monoclonal antibody


Product Team for
Stage gate

V/VI
review for immunology indications, the Patent Department completed and updated Stage Gate Patent
Reviews of Centocor’
s patent portfolio and the third party patent situation concerning these products.


European Oppositions: (3 total)

worked with outside counsel and legal counsel on
support
oppositions to appeals filed by third party patent owners from the EPO Oppositio
n Division’s decisions
revoking of two European patents related to TNF technology. Also, we continued work on an
opposition to a granted EPO patent relating to
monoclonal
antibodies to

IL
-
17A, including preparing
and filing of opposition briefs.
Worked on

monitoring additional pending EPO patent applications that

16

may be opposed by Centocor. We conducted two hearings related to one of the TNF oppositions
appeals relating to substantive and procedural issues.


Out licensing
:
s
upported business development i
n several
out licensing

initiatives involving EPO
mimetic
monoclonal antibody


fusion

including negotiations and due diligence with two prospective
partners.


Molecular discovery platform support
: significant efforts continued reviewing the patents and
pro
secution histories of various families of issued U.S. patents relating to phage display technology for
use in
monoclonal antibody

, peptide and protein optimization research and development.


(2006
-
2007)


Guidance, support and strategy was provided
concerning:

(1)

Expression of
monoclonal antibodies


in plants, including final eval
uation and termination of
milk weed expression feasibility

agreement

(2)

EPO Opposition Appeals of 2 EU

patents relating to TNF

(3)

TEC team to evaluate technologies for potential
licensing

(4)

De
fense of opposition appeal of EU

patent relating to Remicade

(5)

Bayh
-
Dole issues related to the research and clinical agreements.

(6)

IP issues relating to investigator brochure disclosures for Remicade,
GOLIMUMAB

(7)

IP issues relating to Japanese inf
liximab and
GOLIMUMAB

regulatory filings

(8)

IP issues relating to Chinese infliximab and
GOLIMUMAB

regulatory filings

(9)

IP issues relating to South Korea infliximab regulatory filings

(10)

IP issues relating to publications of TNF
monoclonal antibody


(11)

IP issues rela
ting to development of TNF
monoclonal antibody


(12)

IP issues relating to development and
out licensing

of EPO mimetic
monoclonal antibody


fusion protein

(13)

IP issues relating to research agreements and MTAs

(14)

IP issues relating to clinical study agreements in the

US

(15)

IP issues relating to clinical study agreements in the EU


Interferences:

Manager of
Interference Committee for providing Patent Department education and resource for
interferences. Analyzed and advised on potential
interferences relating to
TNF
mono
clonal antibody


patents
and IL
-
12
monoclonal antibody


patent applications.


Litigation Support:
managed outside counsel

in litigation filed against Abbott Labs for infringement of
Humira


of
human TNF monoclonal antibody


patent

of Centocor’s
.


Stage
gate

IV review:

Supported New Multibillion
Monoclonal antibody


Clinical Development Team in
the respective Full Development Decisions (entry into Phase III trials) by the New Product
Development Committee (NPDC) and Centocor’s Research and Development Man
agement Committee
(RDMC). In connection with the projects entering full development, the Patent Department completed
and updated Stage Gate IV Patent Reviews of Centocor’s patent portfolio and the third party patent
situation concerning the products.


Euro
pean Oppositions: (3 total)

worked with outside counsel and legal counsel on
support
oppositions to appeals filed by third party patent owners from the EPO Opposition Division’s decisions
revoking of two European patents related to TNF technology and, in

the REMICADE patent family, the
European patent was upheld in Opposition and issued, which will maintain European patent coverage

17

for REMICADE with SPC protection until 2014. Also, we filed an opposition to a granted EPO patent
relating to
monoclonal
ant
ibodies to

IL
-
17A.
Worked on monitoring additional pending EPO patent
applications that may be opposed by Centocor.


Out licensing
:
s
upported business development in several
out licensing

initiatives involving EPO
mimetic
monoclonal antibody


fusion protein.


Molecular discovery platform support
: significant efforts continued reviewing the patents and
prosecution histories of various families of issued U.S. patents relating to phage display technology for
use in
monoclonal antibody

, peptide a
nd protein optimization research and development.


(2005
-
2006)


Guidance, support and strategy was provided concerning:

(1)

expression of
monoclonal antibodies


in plants, including milkweed expression

agreement

(2)

opposition of 1 EP patent relating to TNF

(3)

TEC

team to evaluate technologies for potential licensing

(4)

Defense of opposition appeal of EP patent relating to Remicade

(5)

Bayh
-
Dole issues related to the research and clinical agreements.

(6)

IP issues relating to investigator brochure disclosures for Remicade,

GOLIMUMAB

(7)

IP issues relating to Japanese infliximab and
GOLIMUMAB

regulatory filings

(8)

IP issues relating to Chinese infliximab and
GOLIMUMAB

regulatory filings

(9)

IP issues relating to South Korea infliximab regulatory filings

(10)


IP issues relating to publicati
ons of TNF
monoclonal antibody


(11)


IP issues relating to development of TNF
monoclonal antibody


(12)


IP issues relating to development of EPO mimetic
monoclonal antibody


fusion protein

(13)


IP issues relating to research agreements and MTAs

(14)


IP issues relating to
clinical study agreements in the US

(15)


IP issues relating to clinical study agreements in the EU


Interferences:

Member of Interference Committee for providing Patent Department education and resource for
interferences. Analyzed and advised on potential
interferences relating to TNF
monoclonal antibody


patents relating to neurodegenerative diseases and IL
-
12
monoclonal antibody


patent applications.


Litigation Support:
managed outside counsel

in litigation filed against Abbott Labs for infringement of
Humira


of
human TNF monoclonal antibody


patent

of Centocor’s
.


Stage gate

IV review:

Supported New multibillion
monoclonal antibody


Clinical Development Team in
the respective Full Development Decisions (entry into Phase III trials) by the New Product
D
evelopment Committee (NPDC) and Centocor’s Research and Development Management Committee
(RDMC). In connection with the projects entering full development, the Patent Department completed
Stage Gate IV Patent Reviews of Centocor’s patent portfolio and the
third party patent situation
concerning the products.


European Oppositions: (2 total)

worked with outside counsel and legal counsel on two European
oppositions and appeals potentially related to Remicade or follow up
GOLIMUMAB

product
commercialization. Worked on monitoring additional pending EPO patent applications that may be
opposed by Centocor.



18

Molecular discovery platform support
: significant efforts continued reviewing the patents and
prosecution histories of various
families of issued U.S. patents relating to phage display technology for
use in
monoclonal antibody

, peptide and protein optimization research and development.


(2004
-
2005)


Guidance, support and strategy was provided concerning:

(1)

expression of
monoclona
l antibodies


in plants, including
milkweed expression

agreement

(2)

opposition of 4 EP patents relating to TNF and IL
-
18,

(3)

Defense of opposition of EP patent relating to Remicade

(4)

Bayh
-
Dole issues related to the research and clinical agreements.

(5)

IP issues r
elating to investigator brochure disclosures for
3 existing and new multibillion
monoclonal antibody

s

(6)

IP issues relating to Japanese infliximab regulatory filings

(7)

IP issues relating to Chinese infliximab regulatory filings

(8)

IP issues relating to South Korea infliximab regulatory filings

(9)

IP issues relat
ing to publications of new
monoclonal antibody


IL
-
12
monoclonal antibody


(10)


IP issues relating to publications of
TNF
monoclonal antibody


(11)


IP issues relating to development of
TNF
monoclonal antibody


(12)


IP is
sues relating to development of
EPO
mimetic
monoclonal antibody


fusion

(13)


IP issues relating to research MTAs

(14)


IP issues relating to clinical study agreements in the US

(15)


IP issues relating to clinical study agreements in the E
U


Interferences:

M
onitored and analyzed two interferences that were initiated by the US Patent and Trademark Office
relating to patents and patent applications relating to HIV proteins, DNA and methods.


Stage IV review:

Supported New multibillion
monoclonal antibody


Clinical Development Team in the
respective Full Development Decisions (entry into Phase III trials) by the New Product Development
Committee (NPDC) and Centocor’s Research and Development Management Committee (RDMC). In
connection wit
h the projects entering full development, the Patent Department completed Stage Gate
IV Patent Reviews of Centocor’s patent portfolio and the third party patent situation concerning the
products.


European Oppositions: (4 total)

worked with outside couns
el and legal counsel on three European
oppositions and appeals that might be asserted by third party patentees to relate to Remicade or
follow up
GOLIMUMAB

product commercialization. Worked on 1 additional EU opposition relating to
targets that are being

researched by Centocor. Worked on monitoring additional pending EPO patent
applications that may be opposed by Centocor.


Molecular discovery platform support
: significant efforts continued reviewing the prosecution
histories of various families of issue
d U.S. patents relating to phage display technology for use in
monoclonal antibody

, peptide and protein optimization research and development.


(2003
-
2004)

Guidance, support and strategy was provided concerning:

(1)

expression of
monoclonal antibodies


in plants,

(2)

opposition of 4 EP patents relating to TNF and IL
-
18,

(3)

Defense of opposition of EP patent relating to Remicade

(4)

Bayh
-
Dole issues related to the research and clinical agreements.


19

(5)

IP issues relating to investigator brochure disclosures for Remicade,
GOLIMUMAB
, CNTO 1275

(6)

IP issues relating to Japanese infliximab regulatory filings

(7)

IP issues relating to Chinese infliximab regulatory filings

(8)

IP issues relating to South Korea infliximab

regulatory filings

(9)

IP issues relating to publications of CNTO 1275 IL
-
12
monoclonal antibody


(10)


IP issues relating to publications of
TNF
monoclonal antibody


(11)


IP issues relating to development of CNTO 1275 IL
-
12
monoclonal antibody


(12)


IP issues relating to

development of
TNF
monoclonal antibody


(13)


IP issues relating to development of EPO
monoclonal antibody


fusion

(14)


IP issues relating to research MTAs

(15)


IP issues relating to clinical study agreements in the US

(16)

IP issues relating to clinical study agreements i
n the EU



(2002
-
2003)

Guidance, support and strategy was provided concerning:

(1)

expression of
monoclonal antibodies


in plants,

(2)

opposition of various EP patents relating to TNF, IL
-
12 and IL
-
18, and

(3)

Bayh
-
Dole issues related to the research and clinical agreements.

(4)

IP issues relating to investigator brochure disclosures

(5)

IP issues relating to Japanese infliximab regulatory filings

(6)

IP issues relating to Chinese infliximab regulatory filings

(7)

IP issues relating to publications of CNTO 1275 IL
-
12
monoclonal antibody


(8)

IP issues relating to publications of
TNF
monoclonal antibody


(9)

IP issues relating to development of CNTO 1275 IL
-
12
monoclonal antibody


(10)


IP issues relating to development of
TNF
mo
noclonal antibody


(11)


IP issues relating to development of EPO
monoclonal antibody


fusion

(12)


IP issues relating to research MTAs

(13)


IP issues relating to clinical study agreements in the US

(14)


IP issues relating to clinical study agreements in the EU


(2001
-
2002
)

Guidance, support and strategy was provided concerning:

(1)

current and potential manufacturing components and methods,

(2)

expression of
monoclonal antibodies


in plants,

(3)

opposition of various EP patents relating to TNF, IL
-
12 and IL
-
18
monoclonal antibodies

,

(4)

opposition of Remicade EP patent by competitors; and

(5)

Bayh
-
Dole issues related to the research and clinical agreements.


(2000
-
2001)

Guidance, support and strategy was provided concerning:

(1)

current and potential manufacturing components and methods,

(2)

expression of
monoclonal antibodies


in plants,

(3)

opposition of various EP patents relating to TNF, IL
-
12 and IL
-
18, and

(4)

Bayh
-
Dole issues related to the research and clinical agreements.







20

5. Product/Project Team Participation:

Each of the following
established Project/Product Teams were provided with comprehensive counseling,
agreement, regulatory, and IP support relating to
compositions, methods and devices
:

(2000
-
2008)

(1)

Remicade Manufacturing Team

(2)

Therapeutic Antibody Manufacturing Team

(3)

Remicade
existing

and new label indication product teams

(4)

TNF monoclonal antibody


new product team;

(5)

EPO mimetic monoclonal antibody


fusion monoclonal antibody


fusion R&D team for
out
licensing

(6)

MCP
-
1/CCL2 monoclonal antibody


R&D team

(7)

GLP
-
1 monoclonal antibody


f
usion R&D team

(8)

IL
-
13 monoclonal antibody


R&D team

(9)

IL
-
17A monoclonal antibody


R&D team

(10)

IL
-
27 monoclonal antibody


R&D team

(11)

Eta
-
1 monoclonal antibody


R&D team

(12)


beta amyloid monoclonal antibody


R&D team

(13)


beta amyloid assay/animal model Centocor/PRD team

(14)


adiponectin monoclonal antibody


R&D team

(15)


alpha
-
MSH monoclonal antibody


R&D team

(16)


phage display teams for peptide, protein and monoclonal antibody


display and engineering


(2005
-
2007)

(1)

Monoclonal an
tibody


drug products new label indication product teams

(2)

TNF monoclonal antibody


new product team;

(3)

EPO monoclonal antibody


fusion R&D team for
out licensing


(4)

MCP
-
1/CCL2 monoclonal antibody


R&D team

(5)

GLP
-
1 monoclonal antibody


fusion R&D
team

(6)

IL
-
13 monoclonal antibody


R&D team

(7)

IL
-
21 monoclonal antibody


R&D team

(8)

IL
-
27 monoclonal antibody


R&D team

(9)

Eta
-
1 monoclonal antibody


R&D team

(10)


beta amyloid monoclonal antibody


R&D team

(11)


beta amyloid assay/animal model Centocor/PRD team

(12)


adiponectin monoclonal antibody


R&D team

(13)


alpha
-
MSH monoclonal antibody


R&D team

(14)


IL
-
17A monoclonal antibody


R&D team

(15)


Joint Centocor/
outside company

phage display team


(2003
-
2005)

(1)

Monoclonal antibody


drug products new label indication product teams

(2)

TNF monoclonal antibody


new product team;

(3)

IL
-
12 monoclonal antibody


new product team

(4)

EPO monoclonal antibody


fusion R&D team

(5)

MCP
-
1/CCL2 monoclonal ant
ibody


R&D team

(6)

GLP
-
1 monoclonal antibody


fusion R&D team

(7)

IL
-
13 monoclonal antibody


R&D team

(8)

IL
-
18 monoclonal antibody


R&D team

(9)


IL
-
21 monoclonal antibody


R&D team

(10)


MCP
-
1 monoclonal antibody


R&D team


21

(11)


Eta
-
1 monoclonal antib
ody


R&D team

(12)


beta amyloid monoclonal antibody


R&D team

(13)


beta amyloid assay/animal model Centocor/PRD team

(14)


adiponectin monoclonal antibody


R&D team

(15)

alpha
-
MSH monoclonal antibody


R&D team

(16)

HIV gp41 monoclonal antibody


fusi
on R&D team


(2000
-
2003):

(1)

TNF monoclonal antibody


new product team;

(2)

IL
-
12 monoclonal antibody


new product team

(3)

EPO monoclonal antibody


fusion R&D team

(4)

GLP
-
1 monoclonal antibody


fusion R&D team

(5)

HIV gp
41 monoclonal antibody


fusion R&D team

(6)

IL
-
23 monoclonal antibody


R&D team

(7)

IL
-
13 monoclonal antibody


R&D team

(8)

IL
-
18 monoclonal antibody


R&D team

(9)


IL
-
21 monoclonal antibody


R&D team

(10)


MCP
-
1 monoclonal antibody


R&D team

(11)

Eta
-
1 monoclonal antibody


R
&D team

(12)


adiponectin monoclonal antibody


R&D team

(13)


alpha
-
MSH monoclonal antibody


R&D team

(14)

MUC
-
1 DNA vaccine R&D team

(15)

PSA DNA vaccine R&D team

(16)

CD
-
3 monoclonal antibody


R&D team

(17)

IL
-
21 monoclonal antibody


R&D team

(18)


TLR3 monoclonal antibody


R&D team

(19)


IgE monoclonal antibody


R&D team

(20)

MCP
-
1/Eta
-
1 DNA vaccine team

(21)


Beta amyloid monoclonal antibody


R&D team

(22)


Epitope mapping R&D team

(23)


Monoclonal antibody


and Protein Modification R&D team




22

6.
Issued Patents and Prepared and Filed Patent Applications


Issued Patents


Exemplary Patents
:

Representative Patented Subject Matter: Organic Chemistry
-
Polymers/Medical
Devices/Pharmaceuticals/ Biotechnology
:

1.

US 5654008, 5650173:

A process for preparing biodegradable microparticles comprising a
biodegradable polymeric binder and a biologically active agent. A first phase, comprising the
active agent and the polymer, and a second phase are pumped through a static mixer into a
quench

liquid to form microparticles containing the active agent.

2.

US6117425, 7229959: Supplemented tissue sealants with at least one cytotoxin or cell
proliferation inhibiting composition further supplemented with polymers.

3.

US7196054: Unsupplemented tissue seal
ants supplemented with at least one antimicrobial
composition further supplemented with polymers.

4.

US5866619; A colonic delivery system for delivering a drug to the colon is provided. The system
comprises a drug in combination with a matrix, wherein the mat
rix comprises a saccharide
-
containing polymer.

5.

US6559119: Methods for the preparation of a tissue sealant
-
treated biomaterial comprising at
least one composition comprising polymers.

6.

US5438076: Methods for the treatment of gingivitis, oral plaque and funga
l infections by the
administration of a liquid methacrylic acid copolymer composition that contains a release
adjusting agent and a pharmacological agent.

7.

US5688801: A pharmaceutical composition comprising a biodegradable and biocompatible
composition comp
rising a 1,2 benzazole within a polymeric matrix.

8.

US6284727: Prolonged administration of GLP
-
1, and related peptides, may also be achieved by
formulation as a solution in various water
-
soluble polymers. These polymers

are generally low
molecular weight (<
15 kDa) polymers. Non
-
limiting examples of such low molecular weight
polymers

include polyethylene glycol, polyvinylpyrrolidone, polyvinylalcohol and
polyoxyethylene
-
polyoxypropylene copolymers.

9.

US 5211666: Hip Joint Femoral Component Endoprosthesis With A

Lateral Load
-
Transferring
Support Surface.

10.

US 5635404: Applications of Electrospray Ionization Mass Spectrometry to Neutral Organic
Molecules Including Fullerenes.

11.

US 5298509: Octahydronaphthoquinolizines, & Methods of Making & Using Thereof:
Compounds
, Compositions, Devices, & Methods Of Treating Receptor Mediated Pathologies.

12.

US 5446203: Synthesis of Haloenones & Aryl or Alkyl Substituted Enones or Alkenes.

13.

US 5376652: Administration of a 27
-
Hydroxycholesterol or Related Compound or Sterol
-
27
-
Hydroxy
lase Stimulation to Prevent Restenosis Following Vascular Endothelial Injury,
composition, and devices.

14.

US 5624847. Method for Optically Measuring
An
al
ytes

using LED Lasers, Devices and Medical
Applications.

15.

US 6900056: Chemically Defined Medium For Cultur
ed Mammalian Cells, Devices.

16.

US 7166284: Methods of Treating Joint Inflammation with Anti
-
TNF Monoclonal Antibodies,
Compositions, Devices, and Methods

.

17.

US 7166285: Anti
-
IL
-
12 Monoclonal Antibodies,
Compositions, Methods
, and Devices.

18.

US 7169386: Methods
of Treating Inflammation Associated with Viral Infection with Anti
-
TNF
Monoclonal Antibodies, Compositions, Methods and Devices

.

19.

US 7169388: Methods of Inhibiting TNF
-
Alpha in Patients with Cancer, Compositions, Methods
and Devices.


23

20.

US 7179893: Recombinan
t Anti
-
TNF


Monoclonal Antibodies, Compositions, Methods and
Devices.



Issued Patents: 2000
-
2010



(2010)

1.

US7777018: CDR
-
grafted anti
-
tissue factor antibodies and methods of use thereof, composition,
methods and devices.

2.

US7754207: Methods of trea
ting pulmonary fibrosis, composition, methods and devices.

3.

US7744885:Methods of treating vascular inflammatory pathology using anti
-
TNF antibodies and
fragments thereof, compositions, methods and devices.

4.


US 7,736,650: Anti
-
IL
-
12 antibody based vect
ors, host cells, and methods of production and
uses, c
ompositions, methods and devices.


5.

US 7,666,993: Cynomolgus prostate specific antigen, c
ompositions, methods and devices.


(2009)

1.

US 7,560,247: Nucleic acids encoding anti
-
IL
-
12 antibodies, and
methods of production,
c
ompositions, methods and devices.



2.

US 7,744,885: Methods of treating vascular inflammatory pathology using anti
-
TNF antibodies
and fragments thereof, c
ompositions, methods and devices.

3.

US 7,691,378: Anti
-
TNF antibodies, c
omp
ositions, methods and devices.


4.

US 7521206 Anti
-
TNF Monoclonal Antibodies

, Compositions, Methods And Devices .

5.

US 7550142 Anti
-
Integrin Monoclonal Antibodies

, Compositions, Methods And Devices.

6.

US 7560247 Nucleic Acids Encoding Anti
-
IL
-
12 Mon
oclonal Antibodies, And Methods Of
Production, Compositions, Methods and Devices.

7.

US 7598083 Chemically Defined Media Compositions, Methods and Devices.


(2008)

1.

US 7326687 CNGH0010 Specific Polynucleotides, Polypeptides, Monoclonal Antibodies

,
Compositions, Methods And Devices.

2.

US 7335358 Methods of Treating Psoriasis With Anti
-
TNF Monoclonal Antibodies

,
Compositions,
Methods and Devices.

3.

US 7342107 Cynomolgus Prostate Specific Antigen, Compositions, Methods and Devices.

4.

US 7364742 RSV Proteins
, Monoclonal Antibodies

, Compositions, Methods And Devices

5.

US 7371825 Anti
-
MCP
-
1 Monoclonal Antibodies, Compositions, Methods And Devices.

6.

US 7374761 Recombinant A2
-
Specific TNFα
-
Specific Monoclonal Antibodies,
Compositions,
Methods and Devices.


7.

US 7393662 Human EPO Mimetic Hinge Core Mimetibodies, Compositions, Methods And
Devices.

8.

US 7404955 Methods of Inhibiting Or Neutralizing TNFα

In Patients With Tissue Injury,
Compositions, Methods and Devices.

9.

US 7416729 Methods of Treating Rheumatoid Arth
ritis With Anti
-
TNF Monoclonal Antibodies
,
Compositions, Methods and Devices.

10.

US 7425330 Methods of Inhibiting TNFα

Activity In The Blood Of A Patient,
Compositions,
Methods and Devices.

11.

US 7479479 CNGH0010 Specific Polynucleotides, Polypeptides, Monoclon
al Antibodies

,
Compositions, Methods And Devices.


24



(2006
-
2007)

1.

US 7160542; Method of Treating Psoriasis Using Human Anti
-
TNF Monoclonal Antibodies


and
Fragments ,
Compositions, Methods and Devices.

2.

US 7160543, Methods of Inhibiting TNF
-


in Patients With Crohn’s Disease,
Compositions,
Methods and Devices.

3.

US 7160995
,
DNA Encoding Anti
-
TNF Monoclonal Antibodies


and Peptides,
Compositions,
Methods and Devices.

4.

US 7166284; Methods of Treating Joint Inflammation with Anti
-
TNF Monoclonal Anti
bodies
,
Compositions, Methods and Devices.

5.

US 7169386: Methods of Treating Inflammation Associated with Viral Infection with Anti
-
TNF
Monoclonal Antibodies,
Compositions, Methods and Devices.


6.

US 7169388; Methods of Inhibiting TNF
-
Alpha in Patients with Ca
ncer,
Compositions, Methods
and Devices.

7.

US 7179893; Recombinant Anti
-
TNF


Monoclonal Antibodies
,
Compositions, Methods and
Devices.

8.

US 7179466; Methods of Treating Rheumatoid Arthritis by Multiple Administration of Anti
-
TNF
Monoclonal Antibodies
,
Compositions, Methods and Devices.

9.

US 7192584; Methods of Treating Psoriasis with Anti
-
TNF Monoclonal Antibodies
,
Compositions, Methods and Devices.

10.

US 7204985; Methods of Treating Disseminated Intravascular Coagulation by Multiple
Administration of Anti
-
T
NF Monoclonal Antibodies
,
Compositions, Methods and Devices.

11.

US 7214376; Methods of Inhibiting TNF
-
Alpha in Patients with Neoplastic Disease,
Compositions, Methods and Devices.

12.

US 7223396; Methods of Treatment of Fistulas in Crohn’s Disease with Anti
-
TNF M
onoclonal
Antibodies
,
Compositions, Methods and Devices.

13.

US7227003; Anti
-
TNF Monoclonal Antibody


Fragments,
Compositions, Methods and Devices.

14.

US 7226593; Methods of Treating Cachexia with Chimeric Anti
-
TNF Monoclonal Antibodies
,
Compositions, Methods and

Devices.

15.

US 7241733; Mammalian EPO Mimetic CH1 Deleted Mimetibodies, Compositions, Methods
and Devices.

16.

US 7250165; Anti
-
TNF Monoclonal Antibodies

, Compositions, Methods and Devices.

17.

US 7252823; Recombinant A2
-
Specific TNF
-
alpha
-
Specific Monoclonal Antib
odies

,
Compositions, Methods and Devices.

18.

US7276239: Recombinant A2
-
Specific TNF
-
alpha
-
Specific Monoclonal Antibodies
,
Compositions, Methods and Devices.

19.

US7288390 Anti
-
Dual Integrin Monoclonal Antibodies

, Compositions, Methods And Devices.



(2005
-
2006)

1.

US6964199, Methods and Compositions for Enhanced Protein Expression and/or Growth of
Cultured Transcription of a BLC2 Encoding Nucleic Acid,
Compositions, Methods and Devices.

2.

US6991791; Anti
-
TNF Monoclonal Antibodies

, Fragments And Regions
Specific For Human
Tumor Necrosis Factor
-


(TNF

),
Compositions, Methods and Devices.

3.

US7070786; RSV Proteins, Monoclonal Antibodies

, Compositions, Methods and Devices.


25

4.

US7063964; Nucleic Acids Encoding IL
-
12 Monoclonal Antibody

,
Compositions, Me
thods and
Devices.

5.

US7070775: Recombinant A2
-
Specific TNF


Specific Monoclonal Antibodies
,
Compositions,
Methods and Devices.

6.

US7074755; Erythropoietin Conjugate Compounds with Extended Half
-
Lives,
Compositions,
Methods and Devices.

7.

US7101674;
Anti
-
Idiotypic Anti
-
TNF Monoclonal Antibodies


and Related Immunoassay
Methods,
Compositions, Methods and Devices.


(2004
-
2005)

1.

US 6835823 Anti
-
TNF Monoclonal Antibodies


and Peptides to Tumor Necrosis Factor,
Compositions, Methods and Devices.

2.

US 6900056 Chemically Defined Medium for Cultured Mammalian Cells,
Compositions, Methods
and Devices.

3.

US 6902734 Anti
-
IL
-
12 Monoclonal Antibodies


And Compositions Thereof,
Compositions,
Methods and Devices.


(2003
-
2004)

1.

US 6652863 Method of Reducing T
he Immunogenicity Of Compounds,
Compositions, Methods
and Devices.

2.

US 6790444 Anti
-
TNF Monoclonal Antibodies


And Peptides Of Human Necrosis Factor,
Compositions, Methods and Devices.


(2002
-
2003):

1.

US 6528487 Peptide Inhibitors Of Inflammation Mediated By Selectins,
Compositions, Methods
and Devices.

2.

US 6610476 Detection of HIV
-
1 DNA ,
Compositions, Methods and Devices.



(2001
-
2002):

1.


US 6444207 Immunotherapy Of Tumor With Monoclonal Antibody


Ag
ainst The IL
-
17
-
1A
Antigen,
Compositions, Methods and Devices.


(2000
-
2001):

1.

US 6277969 Anti
-
TNF Monoclonal Antibodies


And Peptides Of Human Tumor Necrosis Factor,
Compositions, Methods and Devices.

2.

US 6284471 Anti
-
TNFa Monoclonal Antibodies


And Assays
Employing Anti
-
TNFa Monoclonal
Antibodies

,
Compositions, Methods and Devices.

3.

US 6111065 Peptide Inhibitors Of Inflammation Mediated By Selectins,
Compositions, Methods
and Devices.





26

Published Patent Applications: Drafting, Filing, and Prosecution:
2000
-
2010


(2009
-
2010)

1.

12/665,033: PCT/US08/67056: Methods and Systems For Check or Electronic Bill Payment
Using Portional Crediting from Additional Available Cash Balances

2.

12/631,216: US 2010
-
0145782 A1: Cards and Related Services Provided by Credi
t Card Entities
That Use Non
-
Metallic Symbolic Colors

3.

12/596,444: US 2010
-
0114763 A1: Methods and Systems for Providing Cash Using Alternative
Debiting and Accounting Functions From Associated Cash and Credit, or Crebit, Accounts

4.

11/857,440: US 200
8
-
0006690 A1: Credit Cards and Related Services Provided by Credit Card
Service Entities that Provide Health Reminders Unrelated to Credit Card or Financial Account
Information

5.

11/612,467: US 2007
-
0168265 A1: Method, Transaction Card Or Identification S
ystem For
Transaction Network Comprising Proprietary Card Network, EFT, ACH, Or ATM, And Global
Account For End User Automatic Or Manual Presetting Or Adjustment Of Multiple Account Balance
Payoff, Billing Cycles, Budget Control And Overdraft Or Fraud Prot
ection For At Least One
Transaction Debit Using At Least Two Related Financial Accounts To Maximize Both End User
Control And Global Account Issuer Fees From End Users And Merchants, Including Account,
Transaction And Interchange Fees

6.

10/865,188: US 200
8
-
0010189 A1: Multiple Account Multiple Parameter Debit Method,
Apparatus And Systems For Transaction Processor


(2007
-
2008)

1.

61/074437; PCT/US09/46073: CEN5225: Methods Of Diagnosing Neurological Disorders,
Compositions, Methods and Devices.

2.

61/022385; PC
T/US09/31433: CEN5213PSP: Methods Of Predicting Monoclonal Antibody


Solubility,
Compositions, Methods and Devices.

3.

61/019367; PCT/US08/84497: CEN5212: Method Of Treating EPO Hyporesponsive Anemias,
Compositions, Methods and Devices.

4.

61/014778; PCT/US08/87
696: CEN5209PSP: Alternative Scaffold Protein Fusions Phase Display
Via Fusion to pIX f M13 Phage,
Compositions, Methods and Devices.

5.

61/014777; PCT/US08/84317: CEN5208PSP: Engineered Phage Vectors for the Design and the
Generation of a Human Non
-
Monoclona
l antibody


Peptide or Protein Phase Library Via Fusion
to pIX of M13 Phage,
Compositions, Methods and Devices.

6.

61/014773; PCT/US08/84281: CEN5207PSP: Engineered Hybrid Phage Vectors for the Design
and the Generation of a Human Non
-
Monoclonal antibody


Pep
tide or Protein Phase Library
Via Fusion to pIX of M13 Phage,
Compositions, Methods and Devices.

7.

12/251518; 60/979954: CEN5198 PSP:
Human Anti
-
Amyloid Monoclonal Antibodies

,
Compositions, Methods and Devices.,
Compositions, Methods and Devices.

8.

12/670179;

60/955414: CEN5190: Methods And Compositions For Treating Fibrosis Related
Disorders Using IL
-
17 Antagonists,
Compositions, Methods and Devices.

9.

60/949270; PCT/US08/69915: CEN5189:
Cynomolgus IL
-
17 Proteins, Monoclonal Antibodies

,
Compositions, Methods A
nd Devices.

10.

12/602164; 60/946998: CEN5188:
Anti
-
MCP
-
1 Monoclonal Antibodies

, Compositions,
Methods And Devices.

11.

60/946193; PCT/US08/68334: CEN5185: IL
-
17 Mutein Proteins, Monoclonal Antibodies

,
Compositions, Methods And Devices.

12.

12/595979; 60/915724 (5/07); PCT/US08/62621: Matrix Marker Model And Methods For
Assessing And Treating Arthritis And Related Disorders,
Compositions, Methods and Devices.


27

13.

60/909097; PCT/US08/58561: CEN5177:
An Improved Way To Obtain High Expression Clone
s
Of Mammalian Cells Using A Methylcellulose With Fluorescent Protein A or G And Fluorescent
Screening Method,
Compositions, Methods and Devices.

14.

12/514466: CEN5167:
Methods And Compositions For Treating IL
-
4 And IL
-
13 Related Fibrosis
Related Pathologies,

Compositions, Methods and Devices.

15.

12/443503: CEN5163:
Cynomolgus IL
-
13 Mutein Proteins, Monoclonal Antibodies

,
Compositions, Methods and Devices.
,
Compositions, Methods and Devices.


(2006
-
2007)

1.

12/443492: CEN5162:
Enhancement Of Hybridoma

Fusion Efficiencies Through Cell
Synchronization,
Compositions, Methods and Devices.

2.

12/376485: CEN5154:
Prostaglandin E2 (Pge2) As An Adjuvant In Monoclonal Antibody


Generation,
Compositions, Methods and Devices.

3.

12/442723: CEN5148:
Human EPO Receptor
Agonists, Compositions, Methods and Devices. For
Preventing Or Treating Glucose Intolerance Related Conditions

,
Compositions, Methods and
Devices.

4.

12/303269: CEN5143:
Anti
-
Amyloid Monoclonal Antibodies

, Compositions, Methods And
Devices.

5.

12/302427 : CEN
5141:
CCR2 Antagonists For Chronic Organ Transplantation Rejection,
Compositions, Methods and Devices.

6.

12/ ; CEN5140:
Anti
-

MCP
-
1 Monoclonal Antibodies


Expressed In Lemna, Compositions,
Methods And
Devices.

7.

12/299171; CEN5135:
Inflammatory Condition Prog
ression, Diagnosis And Treatment
Monitoring Methods, Systems, Apparatus, And Devices.

8.

12/295334: CEN5133: Binding Partners With Immunoglobulin Domains Modified To Have
Extended Half
-
Life,
Compositions, Methods and Devices.

9.

12/295318: CEN5132:
Human EPO Mim
etic Hinge Core Mimetibodies, Compositions, Methods
and Devices. For Preventing Or Treating Glucose Intolerance Related Conditions On Renal
Disease Associated Anemia,
Compositions, Methods and Devices.

10.

60/752826; PCT/US06/62223: CEN5129: Human GLP
-
1 Mimeti
bodies And Compositions For
Treating Obesity And Related Disorders, Methods And Devices.

11.

11/962214: CEN5170:
Use Of Long
-
Acting GLP
-
1 Receptor Agonists To Improve Insulin
Sensitivity And Lipid Profiles,
Compositions, Methods and Devices.

12.

11/942216: CEN509
8:
Anti
-
MCP
-
1 Monoclonal Antibodies

, Compositions, Methods And Devices.


(2005
-
2006)

1.

11/779316: CEN5144:
HUMAN GLP
-
1 Mimetibodies, Compositions, Methods And Devices.

2.

60/812188; PCT/US07/70833: CEN5140:

Anti
-
MCP
-
1 Monoclonal Antibodies


Expressed In
Lemna,

Compositions, Methods And Devices.


3.

11/536704: CEN5112:
Compositions And Methods For IL
-
13 Biomarkers,
Compositions, Methods
and Devices.

4.

11/512911: CEN5109:
Anti
-
TNF

Monoclonal Antibodies

, Compositions, Methods And Devices.

5.

11/437890: CEN5099: Anti
-
Biot
in
-
Pegylated
-
MCP
-
1 Mutein Monoclonal Antibodies

,
Compositions, Methods And Devices.

6.

11/431794: CEN5097:
Compositions, Methods and Devices For IL
-
13 Biomarkers

7.

11/394608: CEN5093:
Methods And Compositions For Treating IL
-
21 Related Pathologies,
Composition
s, Methods and Devices.


(2004
-
2005)

1.

11/315725: CEN5090:
Human GLP
-
1 Agonists In Diabetes, Compositions, Methods And Devices.


28

2.

11/241269: CEN5078:
Methods and Compositions for Treating Renal Cell Carcinoma Related
Pathologies,
Compositions, Methods and
Devices.

3.

11/240275: CEN5077:
Treating Renal Cell Carcinoma With An Anti
-
TNF Human Monoclonal
Antibody


Or Fragment,
Compositions, Methods and Devices.

4.

11/236889: CEN5074:
Anti
-
Amyloid Monoclonal Antibodies

, Compositions, Methods And
Devices.

5.

11/170453: CE
N5068:
Anti
-
MCP
-
1 Monoclonal Antibodies

, Compositions, Methods and
Devices.

6.

11/170311: CEN0184::

Detection Or Measurement Of Monoclonal Antibodies To Antigenic
Proteins In Monoclonal Antibody

Al Tissues Or Samples, Compositions, Methods and Devices.

7.

11/0
91234: CEN5052:
Method And Apparatus For Analyzing And Generating Human
Monoclonal Antibody


Amino Acid And Nucleic Acid Sequences, Compositions, Methods and
Devices.

8.

11/091181: CEN5050:
Human GLP
-
1 Mimetibodies, Compositions, Methods and Devices.

9.

11/06182
1: CEN5048:
Methods And Compositions For Treating IL
-
13 Related Pathologies
,
Compositions, Methods and Devices.


(2003
-
2004)


1.

10/999866: CEN5042: Anti
-
Human Lymphotoxin Alpha Monoclonal Antibodies

, Compositions,
Methods and Devices.

2.

10/981936: CEN5041:
Methods And Compositions For Treating MCP
-
1 Related Pathologies
,
Compositions, Methods and Devices.

3.

10/935005; 12/031840; 12/031849: CEN5039: Human EPO Mimetic Hinge Core Mimetibodies

4.

10/953613: CEN5038: Hinge Core Mimetibodies, Compositions, Methods and D
evices.

5.

10/928815: CEN5034: A Rapid Way To Obtain High Expression Clones Of Mammalian Cells
Using A Methylcellulose And Immunoprecipitation Screening Method
, Compositions, and
Devices.

6.

10/872932: CEN5031:
Engineered Anti
-
Target Immunoglobulin Derived Prote
ins, Compositions,
Methods and Devices.

7.

10/867992: CEN5029:
Interleukin
-
21 Analogs, Compositions, Methods and Devices.

8.

10/810881: CEN5021: Anti
-
Amyloid Monoclonal Antibodies

, Compositions, Methods and
Devices.


(2002
-
2003):

1.

10/666490: CEN312: Method Of Inducing Maturation Of Dendritic Cells And Uses Therefor

2.

10/609783: CEN311: Mammalian EPO Mimetic Ch1 Deleted Mimetibodies, Compositions,
Methods and Devices.

3.

10/404466: CEN309: Method For Generating Monoclonal Antibodies
, Comp
ositions, Methods
and Devices.


4.

10/608395: CEN302: Mammalian Ch1 Deleted Mimetibodies, Compositions, Methods and
Devices.

5.

10/603313: CEN301:
Cngh0005 Polypeptides, Monoclonal Antibodies

, Compositions, Methods
and Devices.

6.

10/603283: CEN300:
Cngh0004
Polypeptides, Monoclonal Antibodies

, Compositions, Methods
and Devices.

7.

10/452642: CEN296: Anti
-
RELP

Fusion Monoclonal Antibodies

, Compositions, Methods and
Devices.

8.

10/408694: CEN291: Asthma
-
Related Immunoglobulin Derived Proteins Compositions, Methods
and Devices.


29

9.

10/398130: CEN288: Multiple Sclerosis
-
Related Immunoglobulin Derived Proteins,
Compositions, Methods and Devices.

10.

10/397786: CEN287: Diabetes Disease Derived Proteins, Compositions, Methods and Devices.

11.

10/393926: CEN243:
Epitope Mapping Using

Nuclear Magnetic Resonance, Compositions,
Methods and Devices.


12.

10/393804: CEN290: MCP
-
1 Mutant Proteins, Monoclonal Antibodies

, Compositions, Methods
and Devices.

13.

10/393,685: CEN191: Mammalian Cdr Mimetibodies, Compositions, Methods and Devices.


(2001
-
2002):

1.

10/322680: CEN5009: A Novel Screening Method for Molecular Antagonist Using flow
-
Cytometry
,
Compositions, Methods and Devices.

2.

10/316311: CEN5007:
Clonal myeloma cell lines useful for manufacturing proteins in
chemically defined media
, Compositions
, Methods and Devices.

3.

10/309722: CEN 5006: Pseudo
-
Monoclonal Antibody


Constructs
, Compositions, Methods and
Devices.

4.

10/305347: CEN5005: Anti
-
TNF Monoclonal Antibodies

, Compositions, Methods and Devices.

5.

10/281365: CEN 324: RSV Proteins, Monoclonal
Antibodies

, Compositions, Methods and Devices.

6.

10/280609: CEN321: Mutein Cytokine Targets And Monoclonal Antibodies


Thereto, Including
Human IL
-
18
, Compositions, Methods and Devices.

7.

10/280645: CEN320; Mutein Cytokine Targets And Monoclonal Antibodies


Thereto, Including
Human IL
-
13
, Compositions, Methods and Devices.

8.

10/280671: CEN319: Mutein Cytokine Targets And Monoclonal Antibodies


Thereto, Including
Human IL
-
4
, Compositions, Methods and Devices.

9.

10/247203: CEN310: Nucleic Acid Vaccines Using Tumor
Antigen Encoding Nucleic Acids With
Cytokine Adjuvant Encoding Nucleic Acid, Compositions, Methods and Devices.

10.

10/128616: CEN295: Methods And Compositions For Enhanced Protein Expression And/Or
Growth Of Cultured Cells Using Co
-
Transcription Of A Bcl2 Enc
oding Nucleic Acid
, Compositions,
Methods and Devices.

11.

10/099791: CEN285:

REG
-
Like Proteins, Monoclonal Antibodies

, Compositions, Methods and
Devices.




(2000
-
2001):

1.

10/099007: CEN286:
Chronic Obstructive Pulmonary Disease
-
Related

Immunoglobulin

Derived
Proteins, Compositions, Methods and Devices.

2.

10/003632: CEN269: Methods and
Compositions

for Enhanced Protein Expression and/or
Growth of Cultured Cells Using Co
-
Transcription of A BC12 Encoding
Nucleic

Acid
, Compositions,
Methods and Devices.

3.

09/
920262: CEN248:
Anti
-
IL
-
12 Monoclonal Antibodies

, Compositions, Methods and Devices.

4.

09/920267: CEN249: Anti
-
Dual Integrin Monoclonal Antibodies

, Compositions, Methods and
Devices.

5.

09/920137: CEN250: Anti
-
TNF Alpha Monoclonal Antibodies

, Compositions, M
ethods and
Devices.





30

Published PCT Applications: 2002
-
2009



01

WO/2009/094331A1

Methods Of Predicting Monoclonal Antibody

Solubility
, Compositions,
Methods and Devices.



02

WO/2009/088572A2

Method Of Treating Erythropoietin Hyporesponsive Anemias
,
Compositions, Methods and Devices.



03

WO/2009/086116A2

Alternative Scaffold Protein Fusions Phage Display Via Fusion Of M13
Phage
, Compositions, Methods and Devices.


04

WO/2009/085468A2

Engineered Phage Vectors For The Design And The Generation
Of A
Human Non
-
Monoclonal Antibody


Peptide Or Protein Phage Library Via Fusion To Pix Of M13 Phage
,
Compositions, Methods and Devices.



05

WO/2009/085464A2

Engineered
Hybrid

Phage Vectors For The Design And The Generation Of
A Human Non
-
Monoclonal Ant
ibody


Peptide Or Protein Phage Library Via Fusion To Pix Of M13
Phage
, Compositions, Methods and Devices.



06

WO/2009/085462A1

Design And Generation Of Human De Novo Pix Phage Display Libraries
Via Fusion To
pIX

Or
pVII
, Vectors, Monoclonal Antibodies


And Methods
, Compositions, Methods and
Devices.



07

WO/2009/015063A2

Methods And Compositions For Treating Fibrosis Related Disorders Using
IL
-
17 Antagonists
, Compositions, Methods and Devices.



08

WO/2009/009782A2

Cynomolgus IL
-
17 Proteins, Monoc
lonal Antibodies

, Compositions,
Methods and Devices
, Compositions, Methods and Devices.


09

WO/2009/006359A2

Anti
-

MCP
-
1 Monoclonal Antibodies

, Compositions, Methods and
Devices.


10

WO/2009/003096A2

IL
-
17 Mutein Proteins, Monoclonal Antibodies

, Compositions, Methods
and Devices.


11

WO/2008/147869A2

Markers And Methods For Assessing And Treating Crohn's Disease And
Related Disorders
, Compositions, Methods and Devices.



12

WO/2008/137828A1

Matrix Marker Model And Methods For Assessing An
d Treating Arthritis
And Related Disorders
, Compositions, Methods and Devices.


13

WO/2008/137383A2

Markers And Methods For Assessing And Treating Ulcerative Colitis And
Related Disorders Using A 19 Gene Panel
, Compositions, Methods and Devices.


14

WO/
2008/121940A1

Cxcl13 Antagonists And Their Use For The Treatment Of Inflammatory
Diseases
, Compositions, Methods and Devices.



15

WO/2008/121757A1

High Expression Clones Of Mammalian Cells With Fluorescent Protein A
Or G
, Compositions, Methods and Dev
ices.



16

WO/2008/094871A2

Selection Of High
-
Producing Cell Lines
, Compositions, Methods and
Devices.



17

WO/2008/080042A2

Use Of Long
-
Acting GLP
-
1 Receptor Agonists To Improve Insulin
Sensitivity And Lipid Profiles
, Compositions, Methods and Devic
es.



18

WO/2008/076784A2

Methods, Compositions and Devices For Treating IL
-
4 Or IL
-
13 Related
Fibrosis Related Pathologies


19

WO/2008/060783A2

Ccr2 Antagonists For Treatment Of Fibrosis
, Compositions, Methods and
Devices.



20

WO/2008/048871A2

Cynomolgus IL
-
13 Mutein Proteins, Monoclonal Antibodies

,
Compositions, Methods and Devices.


31

21

WO/2008/042800A2

Human EPO Receptor Agonists, Compositions, Methods and Devices. For
Preventing Or Treating Glucose Intolerance Related Conditions
, Compos
itions, Methods and Devices.



22

WO/2008/040009A1

Prostaglandin E2 (Pge2) As An Adjuvant In Monoclonal Antibody


Generation
, Compositions, Methods and Devices.



23

WO/2008/028117A2

GLP
-
2 Mimetibodies, Polypeptides, Compositions, Methods and Devices
.


24

WO/2008/011446A2

Human GLP
-
1 Mimetibodies, Compositions, Methods and Devices.


25

WO/2008/002893A2

Anti
-
Amyloid Monoclonal Antibodies

, Compositions, Methods and
Devices.


26

WO/2007/147026A2

Ccr2 Antagonists For Chronic Organ Transplant
ation Rejection
,
Compositions, Methods and Devices.



27

WO/2007/146857A2

Anti
-

MCP
-
1 Monoclonal Antibodies


Expressed In Lemna, Compositions,
Methods and Devices.


28

WO/2007/131078A2

Inflammatory Condition Progression, Diagnosis And Treatment
Monitoring Methods, Systems, Apparatus, And Uses


29

WO/2007/115150A2

Binding Partners With Immunoglobulin Domains Modified To Have
Extended Half
-
Life
, Compositions, Methods and Devices.



30


WO/2007/115148A2

Human EPO Mimetic Hinge Core Mimetibodies, Compositions, Methods
and Devices for Preventing Or Treating Glucose Intolerance Related Conditions Or Renal Disease
Associated Anemia


31

WO/2007/081302A2

Human GLP
-
1 Mimetibodies, Composi
tions, Methods and Devices.


32

WO/2007/076523A2

Markers And Methods For Assessing And Treating Psoriasis And Related
Disorders
, Compositions, Methods and Devices.



33

WO/2007/076319A2

Human GLP
-
1 Mimetibodies And Compositions For Treating Obesity
And
Related Disorders, Methods and Devices.


34

WO/2007/046834A2

GLP
-
1 Agonists, Compositions, Methods and Devices.


35

WO/2007/041219A2

Compositions And Methods For Il13 Biomarkers
, Compositions, Methods
and Devices.



36

WO/2007/027805A2

Metho
d For Generating Anti
-
Variable Region Monoclonal Antibodies
,
Compositions, Methods and Devices.




37

WO/2007/019064A2

Anti
-
TNF Monoclonal Antibodies
, Compositions, Methods and Devices.



38

WO/2006/125202A2

Anti
-

MCP
-
1 Monoclonal Antibodies

, Compositions, Methods and
Devices.


39

WO/2006/125201A2

Anti
-
Biotin
-
Pegylated
-
MCP
-
1 Mutein Monoclonal Antibodies

,
Compositions, Methods and Devices.


40

WO/2006/124451A2

Anti
-
IL
-
13 Monoclonal Antibodies

, Compositions, Methods and Devices.


41


WO/2006/105538A2

Methods And Compositions For Treating IL
-
21 Related Pathologies
,
Compositions, Methods and Devices.



42

WO/2006/085961A2

Anti
-
MCP
-
1 Monoclonal Antibodies

, Compositions, Methods and
Devices.


43

WO/2006/065975A2

Methods Of Treat
ing Ankylosing Spondylitis Using Anti
-
TNF Monoclonal
Antibodies


And Peptides Of Human Tumor Necrosis Factor
, Compositions, Methods and Devices.



44

WO/2006/050050A2

Chemically Defined Media
, Compositions, Methods and Devices.



45

WO/2006/039638A2

Treating Renal Cell Carcinoma With An Anti
-
TNF Human Monoclonal
Antibody


or Fragment
, Compositions, Methods and Devices.



32


46

WO/2006/039631A2

Methods And Compositions For Treating Renal Cell Carcinoma Related
Pathologies
, Compositions, Methods and De
vices.



47

WO/2006/039470A2

Anti
-

Amyloid Monoclonal Antibodies

, Compositions, Methods and
Devices.


48

WO/2006/004958A2

Detection Or Measurement Of Monoclonal Antibodies To Antigenic
Proteins In Monoclonal Antibody

Tissues Or Samples
, Composition
s, Methods and Devices.



49

WO/2005/097175A2

Human GLP
-
1 Mimetibodies, Compositions, Methods and Devices.


50

WO/2005/091856A2

Asthma
-
Related Anti
-
IL
-
13 Immunoglobulin Derived Proteins,
Compositions, Methods and Devices.


51

WO/2005/091853A2

M
ethods And Compositions For Treating IL
-
13 Related Pathologies
,
Compositions, Methods and Devices.



52

WO/2005/081873A2

IL
-
13 Mutein Proteins, Monoclonal Antibodies

, Compositions, Methods
and Devices.


53

WO/2005/081687A2

Human Hinge Core Mimetibo
dies, Compositions, Methods and Devices.


54

WO/2005/067477A2

Anti
-
Human Lymphotoxin Alpha Monoclonal Antibodies

, Compositions,
Methods and Devices.


55

WO/2005/044200A2

Methods And Compositions For Treating MCP
-
1 Related Pathologies
,
Compositions
, Methods and Devices.



56

WO/2005/042768A2

Method For Maintaining Low Shear In A Bioprocessing System
,
Compositions, Methods and Devices.



57

WO/2005/032460A2

Human EPO Mimetic Hinge Core Mimetibodies, Compositions, Methods
and Devices.


58

WO/
2005/028511A2

Anti
-
Amyloid Monoclonal Antibodies

, Compositions, Methods and
Devices.


59

WO/2005/020927A2

Method Of Promoting Graft Survival With Anti
-
Tissue Factor Monoclonal
Antibodies
, Compositions, Methods and Devices.




60

WO/2005/020924A2

A

Rapid Way To Obtain High Expression Clones Of Mammalian Cells
Using A Methylcellulose And Immunoprecipitation Screening Method
, Compositions, and Devices.



61

WO/2005/005604A2

Engineered Anti
-
Target Immunoglobulin Derived Proteins, Compositions,
Metho
ds and Devices.


62

WO/2004/112703A2

Interleukin
-
21 Analogs
, Compositions, Methods and Devices.



63

WO/2004/110363A2

Method Of Inhibiting Tumor Growth With Anti
-
Tissue Factor Monoclonal
Antibodies
, Compositions, Methods and Devices.




64

WO/2004
/098502A2

Cngh0010 Specific Polynucleotides, Polypeptides, Monoclonal Antibodies

, Compositions, Methods and Devices.


65

WO/2004/053080A2

Clonal Myeloma Cell Lines Useful For Manufacturing Proteins In
Chemically Defined Media
, Compositions, Methods a
nd Devices.



66

WO/2004/031276A2

Method Of Inducing Maturation Of Dendritic Cells And Uses Therefor
,
Compositions, Methods and Devices.



67

WO/2004/003149A2

Cngh0005 Polypeptides, Monoclonal Antibodies

, Compositions,
Methods and Devices.


68

WO/2004/003147A2

Cngh0004 Polypeptides, Monoclonal Antibodies

, Compositions,
Methods and Devices.


69

WO/2004/002424A2

Mammalian EPO Mimetic Ch1 Deleted Mimetibodies, Compositions,
Methods and Devices.


33


70

WO/2004/002417A2

Mammalian Ch1 Deleted Mim
etibodies, Compositions, Methods and
Devices.


71

WO/2004/001035A1

Method For Generating Monoclonal Antibodies
, Compositions, Methods
and Devices.




72

WO/2003/105898A1

Modified 'S' Monoclonal Antibodies
, Compositions, Methods and
Devices.




74

W
O/2003/102017A2

Anti
-
RELP

Fusion Monoclonal Antibodies

, Compositions, Methods and
Devices.


75

WO/2003/091700A2

Epitope Mapping Using Nuclear Magnetic Resonance
, Compositions,
Methods and Devices.



76

WO/2003/086451A1

Asthma
-
Related Anti
-
IL
-
13 Immunoglobulin Derived Proteins,
Compositions, Methods and Devices.


77

WO/2003/084477A2

Mammalian Cdr Mimetibodies, Compositions, Methods and Devices.


78

WO/2003/083071A2

Diabetes
-
Related Immunoglobulin Derived Proteins,

Compositions,
Methods and Devices.


79

WO/2003/083061A2

Anti
-
TNF Monoclonal Antibodies

, Compositions, Methods and Devices.


80

WO/2003/083059A2

MCP
-
1 Mutant Proteins, Monoclonal Antibodies

, Compositions,
Methods and Devices.


81

WO/2003/08220
6A2

Multiple Sclerosis
-
Related Immunoglobulin Derived Proteins,
Compositions, Methods and Devices.


82

WO/2003/063767A2

RSV

Proteins, Monoclonal Antibodies

, Compositions, Methods and
Devices.


83

WO/2003/057821A2

Mut
-
IL
-
18 Or Mut
-
IL
-
18r Proteins,

Monoclonal Antibodies

,
Compositions, Methods and Devices.


84

WO/2003/056301A2

A Novel Screening Method For Molecular Antagonist Using Flow
-
Cytometry
, Compositions, Methods and Devices.



85

WO/2003/052064A2

Clonal Myeloma Cell Lines Useful For Ma
nufacturing Proteins In
Chemically Defined Media
, Compositions, Methods and Devices.



86

WO/2003/049684A2

Pseudo
-
Monoclonal Antibody


Constructs
, Compositions, Methods and
Devices.



87

WO/2003/047510A2

Anti
-
TNF Monoclonal Antibodies, Compositions,
Methods and Devices.


88

WO/2003/041637A2

Lyophilized Monoclonal Antibody
, Compositions, Methods and Devices.



89

WO/2003/040374A1

Methods And Compositions For Enhanced Protein Expression And/Or
Growth Of Cultured Cells Using Co
-
Transcription Of A B
cl2 Encoding Nucleic Acid
, Compositions,
Methods and Devices.



90

WO/2003/038041A2

IL
-
4 Mutein Proteins, Monoclonal Antibodies

, Compositions, Methods
and Devices.


91

WO/2003/035847A2

IL
-
13 Mutein Proteins, Monoclonal Antibodies

, Compositions, Me
thods
and Devices.


92

WO/2003/031569A2

Nucleic Acid Vaccines Using Tumor Antigen Encoding Nucleic Acids With
Cytokine Adjuvant Encoding Nucleic Acid
, Compositions, Methods and Devices.



93

WO/2002/097048A2

Anti
-
P40 Immunoglobulin Derived Proteins,

Compositions, Methods and
Devices.


94

WO/2002/074916A2

REG
-
Like Protein Immunoglobulin Derived Proteins, Compositions,
Methods and Devices.


34


95

WO/2002/072788A2

Chronic Obstructive Pulmonary Disease
-
Related
Immunoglobulin

Derived
Proteins, Compositions, Methods and Devices.


96

WO/2002/066603A2

Chemically Defined Medium For Cultured Mammalian Cells
,
Compositions, Methods and Devices.



97

WO/2002/012502A2

Anti
-
TNF Monoclonal Antibodies

, Compositions, Methods and De
vices.


98

WO/2002/012501A2

Anti
-
Dual Integrin Monoclonal Antibodies

, Compositions, Methods and
Devices.


99

WO/2002/012500A2

Anti
-
IL
-
12 Monoclonal Antibodies

, Compositions, Methods and Devices.


100

WO/2001/037874A2

Treatment Of Psoriasis By

Using An Monoclonal Antibody


To TNF Alpha
,
Compositions, Methods and Devices.




6. Dispute Resolution and Litigation Experience:




Greatest Accomplishment
: Solely drafted, directly managed prosecution and initially managed the
litigation of US patent 7,070,775, asserted against Abbott that resulted in a
record US$1.67 billion
infringement jury verdict

against Abbott in the Eastern District of Texas (
2:
07
-
CV
-
00139
-
TJW, E.D.
Texas (Marshall) 2009; WL 3734119; Lexis 102427)
.



>50 major US, EU, and Japan/Asia multi
-
jurisdictional opinions, arbitrations, litigations, IP and
license dispute litigations, preliminary injunctions, and nullity actions;



>15 EU EPO and

Japanese JPO oppositions and appeals; and


Examples:

-

Developing, managing, and implementing patent infringement action against competitor based on
prosecution management resulting in 35 new patents based companies patent family relating to its
own mult
ibillion dollar biotechnology product, of which 10 were assertable against competitor
s
, and
are currently being asserted, including validity, enforceability and infringement analysis and strategy,
technical analysis supporting infringement case, and develo
pment of expert testing of asserted
infringing product, witnesses, and testimony.

-

Managing US
, EU, Japan, and other country

arbitrations and patent litig
ation defense preparation
for hundred million to
multibillion dollar biotechnology
and pharmaceutica
l
product
s

for large global
pharmaceutical company, including litigation analyses, patent invalidity and non
-
infringement analysis
and strategies, technical analysis supporting non
-
infringement case, and development of expert
testing, witnesses, and testim
ony, resulting in settlement
s

and significant reduction in royalties to less
than potential litigation costs.

-

Developing, managing, and implementing patent pre
-
infringement, non
-
litigation procedures against
competitor to support non
-
infringement, inval
idity and potential cross
-
licensing of patent families,
involving competing products in development, including interferences, reexams, and litigation
preparation, including validity, enforceability and infringement analysis and strategy, technical analysis

supporting infringement case, and development of expert testing of asserted infringing product,
witnesses, and testimony.





35

7. Bibliography
/Presentations
:


Lecturing/Teaching/Committees
:



Townsend Technology IP Consulting
: “Biotechnology and Pharmaceutical IP Due Diligence:
Evolving Roles, Increasing Complexity and the Increasing Need for Experienced Counsel at Reasonable
Cost.” Licensing Executives Society Annual Meeting, San Francisco, CA, October 18
-
21, 2009;



Hogan
L
ovells, LLP:
"Navigating the

Genomics Business IP Landscape for Success: Considerations
for Successful

Genomics
-
Based Discovery, Development, Clinical Monitoring and Therapy", Business of
Genomics, June 8, 2009, San Francisco, CA, Cambridge Healthcare Ins
titute;



Johnson & Johnson
: "In
-
House Perspective on Managing IP Arbitrations" at Seminar "International
Patent Arbitration and Dispute Resolution", Lovells LLP, NY, NY, May 8, 2008; Various legal & patent
department committees, organizer, coordinator, &

presenter. IP presentations & seminars to
Centocor
Ortho Biotech
management, R&D, manufacturing, Product Teams, Pre
-
Clinical, Clinical,
Medical Affairs, & Marketing, 2000
-
2008;



Eli Lilly
: Various legal & patent department committees, organizer, coord
inator, & presenter for
monthly patent topic meetings, 1998
-
2000;



Sterne, Kessler et al.
: Organized & presented training seminars for all attorneys & agents, 1994
-
1997, including current US, EU and Japanese patent law and licensing topics; Automation
Committee
(office computer systems evaluation & implementation), 1996
-
1998;



Sughrue et al.
: Organized & presented weekly training seminars for all attorneys & agents, 1990
-
1992;
AIPLA/USPTO
: "Patent Bar Perspectives on Considerations for Application Fi
ling, Prosecution,
Interferences & Litigation as a Result of the Implementation of the Biotechnology Sequence Listing
Rules, 37

C.F.R. § 1.812
-
1.825"; San Francisco, California, January, 1991; Monthly Lectures for
U.S.P.T.O. in Washington, D.C., February
-
J
uly, 1991.



Scientific
Bibliography
:


1. Faletto, M.B., Koser, P.L., Maccubbin, A.E., Battula, N.,
Townsend, G.K.
, Gelboin, H.V., Gurtoo,
H.L.;
“Cytochrome P3
-
450 cDNA encodes aflatoxin B
1
-
4
-
Hydroxylase
,”
Journal of Biological Chemistry

263
:12187
-
89
(1988).


2. Battula, N., Shut, H.A.J., Snyderwine, E.G.,
Townsend, G.K.
, and Thorgeirsson, S.S.,

Introduction of Cytochrome P
-
450 Genes into Mammalian Cells by Recombinant Viruses and Analysis
of the Expressed P
-
450's,”

In
Biochemistry and Biophysics of
Cytochromes P
-
450, 6th International
Congress
, ed. J. Schuster (1988).


3. Kraemer, K.H., Herlyn, M., Yuspa, S., Clark, W.H.,
Townsend,

G.K.
, Neises, G., Hearing, V.;
“Reduced DNA Repair in Cultured Melanocytes and Nevus cells from a patient with Xeroder
ma
Pigmentosum,”
Archives of Dermatology

125
:263
-
268 (1989).


4. Battula, N.,
Townsend, G.K.
, Shut, H.A.J., Snyderwine, E.G., and Thorgeirsson, S.S., “
Role of
Recombinant Cytochrome P
-
450IA1 and P
-
450IA2 in the Metabolism and Genotoxicity of Food Derived

Mutagens
,”
Progress in Clinical and Biological Research
, 340E
:127
-
37 (1990).


5. Battula, N.,
Townsend, G.K.
, Shut, H.A.J., Snyderwine, E.G., and Thorgeirsson, S.S., “
Preferred
Activation and Genotoxicity of Food Derived Heterocyclic Amino Mutagens by R
ecombinant
Cytochrome P
-
450IA2
,”
Progress in Clinical and Biological Research

347
:55
-
69 (1990).