Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 320

MEMORANDUM in Support re #319 MOTION to Compel Deposition Testimony under Rule 30(b)(6) filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D#5 Exhibit E#6 Exhibit F#7 Exhibit G)(Huston, Julia)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 320 Att. 1

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 1 of 19

EXHIBIT A

Dockets.Justia.com

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 2 of 19

UNTED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS
AMGEN INC.,
Plaintiff,
vs.
)

) )
) ) )

CIVIL ACTION No.: 05-cv-12237WGY

F. HOFFMA-LA ROCHE LTD, ROCHE DIAGNOSTICS GmbH, AN HOFFMANNLA ROCHE INC.,
Defendants.

) ) ) )

DEFENDANTS' FIRST NOTICE OF DEPOSITION TO AMGEN PURSUANT TO RULE 30(b)(6)

PLEASE TAK NOTICE that, pursuant to Rule 30(b)(6) of

the Federal Rules of

Civil

Procedure, Defendants F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, and HoffmannLa Roche Inc. (collectively "Roche" or "Defendants"), wil take the deposition of

Plaintiff
the following
Ave, New York, New York 10022 or

Amgen Inc. ("Amgen" or "Plaintiff'), by a person or persons with knowledge of

subject areas, at the offices ofKaye Scholer LLP, 425 Park

such other place as mutually agreed between the partes, commencing at 9:00 a.m. on February 27, 2007. This deposition shall be taken before a notary public or another official authorized by
law to administer oaths, and will continue from day to day thereafter until completed, excluding

weekdays and holidays. The deposition wil be recorded by videotape and/or audiotape, or other
similar means in addition to recording this testimony by the stenographic method.
PLEASE TAK FURTHER NOTICE that, pursuant to Rule 30(b)(6) of

the Federal

Rules of Civil Procedure and the Local Rules of the issuing Court, Amgen is required to

designate one or more of its offcers, directors, parters, managing agents, employees or other
representatives as are most qualified, knowledgeable, and competent to testify on behalf of

30(b)( 6).DOC

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 3 of 19

Amgen as to all matters known or reasonably available to it to testifY accurately and completely
with respect to each of

the following subjects set forth in Schedule A attached hereto. For each

person designated, Amgen is to set forth all matters on which the person will testify on behalf of

Amgen in a written response to be served on or before February 20,2007.
DATED:

February 9, 2007
F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC.
By its attorneys,

Isl Patrcia A. Carson Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard Suh (pro hac vice) Peter Fratangelo (BBO# 639775)
KA YE SCHOLER LLP 425 Park Avenue

New York, NY 10022 Tel: [phone]

and
Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110
TeL. [phone]

30(b)(6).DOC

2

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 4 of 19

SCHEDULE A

DEFINITIONS AN INSTRUCTIONS
I. The term "Amgen" includes plaintiff Amgen, Inc., any predecessor company or
companies, present and past divisions, subsidiaries, joint ventures, parent companies or other

legal entities which are or wholly or partally owned or controlled by Amgen, Inc., and each of
their respective present or former directors, officers, Employees, agents, consultants, experts, representatives, and attorneys, as well as all other individuals or business entities in the employ
of or otherwise acting or purportng to act on behalf of Amgen, Inc.

2. The term "Roche" includes defendants F. Hoffmann-La Roche Ltd, Roche

Diagnostics GmbH, and Hoffmann-La Roche Inc., any predecessor company or companies,

present and past divisions, subsidiaries, joint ventures, parent companies or other legal entities
which are wholly or partially owned or controlled by F. Hoffmann-La Roche Ltd, Roche
Diagnostics GmbH, or Hoffmann-La Roche Inc., and each of

their respective present or former

directors, offcers, Employees, agents, consultants, experts, representatives, and attorneys, as
well as all other individuals or business entities in the employ of or otherwise acting or

purportng to act on behalf ofF. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, or
Hoffmann-La Roche Inc.

3. The term "Affliate" means a person or Entity that, directly or indirectly, though one
or more intermediates, controls, is controlled by, or is under common control with the person or
Entity specified.

4. The term "Entity" means any individual and any other cognizable entity, Including

corporations, proprietorships, parterships, joint ventures, businesses, consortums, clubs,
associations, foundations, governmental agencies or instrmentalities, societies, and orders.

30(b)( 6).DOC

3

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 5 of 19

5. The term "Amgen's EPO Patents" means the following patents and any foreign
counterparts of any of them, considered individually, in groups of

two or more, and collectively:

a. United States Patent No. 4,703,008 issued October 27, 1987, to Fu-Kuen Lin

entitled "DNA Sequences Encoding Eryhropoietin" ("the '008 patent"), the
application from which it issued United States Patent Application No. 06/675,298,

and all related United States Patent Applications Including United States Patent
Application Nos. 06/655,841; 06/582,185; and 06/561,024;
b. United States Patent No. 5,441,868 issued August 15, 1995, to Fu-Kuen Lin

entitled "Production of Recombinant Eryhropoietin" ("the '868 patent"), the
application from which it issued United States Patent Application No. 07/113,179,

and all related United States Patent Applications Including United States Patent
Application Nos. 06/675,298; 06/655,841; 06/582,185;

and 06/561,024;

c. United States Patent No. 5,547,933 issued August 20, 1996, to Fu-Kuen Lin

entitled "Production of

Eryopoietin" ("the '933 patent"), the application from

which it issued United States Patent Application No. 08/487,774, and all related
United States Patent Applications Including United States Patent Application Nos.
07/202,874; 07/113,179; 06/675,298; 061655,841; 06/582,185; and 06/561,024;

d. United States Patent No. 5,618,698 issued April 8, 1997, to Fu-Kuen Lin entitled

"Production of

Eryhropoietin" ("the '698 patent"), the application from which it

issued United States Patent Application No. 08/468,381, and all related United
States Patent Applications Including United States Patent Application Nos.

07/113,179; 06/675,298; 06/655,841; 06/582,185; and 06/561,024;

30(b)(6).DOC

4

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 6 of 19

e. United States Patent No. 5,621,080 issued April 15, 1997, to Fu-Kuen Lin entitled

"Production of Eryropoietin" ("the '080 patent"), the application from which it
issued United States Patent Application No. 08/468,556, and all related United
States Patent Applications Including United States Patent Application Nos.
07/202,874; 07/113,179; 061675,298; 06/655,841; 06/582,185; and 06/561,024;

f. United States Patent No. 5,756,349 issued May 26, 1998, to Fu-Kuen Lin entitled

"Production of

Eryropoietin" ("the '349 patent"), the application from which it

issued United States Patent Application No. 08/468,369, and all related United
States Patent Applications Including United States Patent Application Nos.

07/113,179; 06/675,298; 06/655,841; 06/582,185; and 06/561,024; and
g. United States Patent No. 5,955,422 issued September 21, 1999, to Fu-Kuen Lin

entitled "Production of

Eryhropoietin" ("the '422 patent"), the application from

which it issued United States Patent Application No. 08/100,197, and all related
United States Patent Applications Including United States Patent Application Nos.
07/957,073; 07/609,744; 07/113,179; 06/675,298; 061655,841; 06/582,185; and

06/561,024.
6. The term "Patent Application" means all parent, continuation application,

continuation-in-part application, divisional application, fie-wrapper contiuation, reexamination

proceeding, reissue application, provisional application or abandoned application and other
applications, including applications from which an issued patent claims priority in whole or in
part, regardless of

whether the patent application issued as a patent, was abandoned, or is
whether the patent application was filed in the United States

currently pending, and regardless of

Patent and Trademark Office or any foreign patent offce or both..

30(b)(6).DOC

5

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 7 of 19

7. The term "Communication" is used in its broadest sense, and means any transmission
of information from one person or Entity to another, by any means, Including oral conversations,

telephone calls, written correspondence, memoranda or notes, email, facsimile transmissions,

meetings, video conferences, or document transmittls.
8. The term "Including" means "including but not limited to."

9. The term "Thing" means each item, sample, specimen, concrete or tangible object.
10. The term "Person" shall include but is not limited to, any natural person, alive or

deceased, business or corporation (whether for-profit or not-for-profit), firm, partership, sole
proprietorship, or other non-corporate business organization, or Employee, agent or
representative of the foregoing.
11. The term "Employee" means any director, trstee, offcer, employee, parter,
corporate parent, subsidiary, affliate or servant of

the designated Entity, whether active or

retired, full-time or part-time, current or former, and compensated or not.

12. The term "Concerning" or "Concern" means relating to, referrng to, describing,
evidencing, constituting, or mentioning in any way.

13. The term "Eryhropoiesis Stimulating Agent" or "ESA" means any substance, drug or
pharmaceutical composition that is capable of stimulating the production of red blood cells by

bone marrow Including human eryhropoietin or eryhropoietin from any mammalian species,
epoetin alfa, epoetin beta, darbepoetin alfa, and any fragment, mimetic or variant thereof, sold
under any brand name, Including Epogen(j, Procrit(j, Eprex(j, NeoRecormon(j and Aranesp(j.

14. The term "Pegylated Compounds" means any substance, drug or pharmaceutical

incorporating into its chemical strcture one or more polyethylene glycol polymers of any
weight, size, shape, means of attachment, or degree of

branching, and shall include without

30(b)( 6).DOC

6

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 8 of 19

limitation human erythopoietin or eryhropoietin from any mammalian species, epoetin alfa,
epoetin beta, darbepoetin alfa, and any fragment, mimetic or variant thereof chemically modified
by pegylation.

15. As used herein MIRCERATM refers to the formulated product for which Biologic
License Application (BLA) STN 125164/0 was submitted to the United States Food and Drug
Administration on April 18, 2006 by Roche.

16. As used herein, "characterization" and "comparison" shall include a description of
any experimental method used, identification of the persons involved, description of assumptions
made and conclusions made.

17. The term "Health Care Provider" means any person or Entity involved in providing health services to the public, Including Large Dialysis Organizations (e.g., Fresenius Medical
Care or Da Vita Inc.), small or medium chain dialysis centers, non-profit dialysis centers,

independent dialysis centers, hospitals, distrbutors, purchasing groups, doctors or clinics,
Including their affiliated Entities, parents, subsidiaries (for example, DaVita Clinical Research),

related companies, and companies merged or acquired (for example, Renal Care Group, Inc. and
Gambro Healthcare).

18. As used herein, the words "and" and "or" shall be constred either conjunctively and
disjunctively as necessary to bring within the scope of the topic all responses that might
otherwise be constred as being outside of its scope; the singular shall be deemed to refer to the

plural and vice-versa; and any reference to the male gender shall include the female gender.

30(b)(6).DOC

7

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 9 of 19

TOPICS
1. All efforts by Amgen though 1987, either planned and/or carred out, to characterize
any human eryropoietin, but also including all efforts after 1987 where Amgen relied on,

discussed, or referred to such characterization in connection with the prosecution of any of
Amgen's EPO patents, opposition proceedings in Europe to Genetics Institute's European

patents EP 411 678 ("the '678 patent") and EP 209539 ("the '539 patent"), opposition
proceedings in Europe involving Amgen's European patent EP 148605 ("the '605 patent"),
including:
a. characterization of any human eryhropoietin purified, isolated or otherwise

derived from any mammalian cell or cell culture;
b. characterization of any eryopoietin purified, isolated or otherwise derived from

human urine, plasma or blood, including any obtained through any collaboration
with Eugene Goldwasser, or from any source material provided by Eugene
Goldwasser;
c. characterization of any recombinant human eryhropoietin purified, isolated or

otherwise derived from any mammalian host cell;
d. characterization of any physical, chemical or biological propert including
strcture, conformation, amino acid composition, carbohydrate composition,

glycosylation, sialic acid content, number, and disposition, actual or apparent
molecular weight, biological activity, interaction with the human eryhropoietin

receptor (including the equilibrium constant, disassociation constant, association rate constant, change in free energy), pharmacodynamics, internalization and
recycling by cells, immunogenicity and/or antigenicity, manner of clearance;

30(b)(6).DOC

8

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 10 of 19

e. any comparison of a recombinant human eryhropoietin product produced through

mammalian cell expression with any erythropoietin isolated from, or present in

any human source, including plasma or urine, including any comparison or
analysis of data from separate studies or experiments;
f. all personnel involved in planning, conducting or supervising such efforts,

including their titles, roles and activities;
g. the experimental techniques, approaches and methods considered or used by

Amgen in connection with such efforts;
h. all memoranda, reports, summaries and/or other documentation of such efforts

including any published artcles and abstracts;
1. any communication, at any time, of such efforts to any individual involved in

prosecution of Amgen's EPO Patents.
2. The role of any Amgen Employee or Agent having any involvement in the
prosecution of Amgen's EPO Patents in the United States, in (1) the prosecution of

any of

Amgen's EPO Patents in Europe or the United Kingdom (including but not limited to Amgen's EP 0 148,605) or (2) in connection with any opposition proceeding or litigation in Europe or the United Kingdom involving any of Amgen's EPO Patents (including but not limited to Amgen's EP 0 148,605), or (3) in connection with any opposition proceeding or litigation involving

Genetics Institute's EP 0 411 678 and EP 0 209539, including:
a. the identity of any such Employee or Agent;

b. the periods of

time during which such Employee or Agent was involved in

prosecution of Amgen' s EPO Patents in the United States, and the matters for

which that Employee or Agent was responsible;

30(b)(6).DOC

9

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 11 of 19

c. the periods of

time during which such Employee or Agent was involved in the

prosecution of, or in connection with any opposition proceeding or litigation in
Europe or the United Kingdom involving any of Amgen's EPO Patents; and the
matters for which that Employee or Agent was responsible;
d. any representations, contentions or other statements by that Employee or Agent

regarding the characterization of any recombinant human erythropoietin produced
through mammalian cell expression, including any comparison of such a

recombinant human eryhropoietin with any eryopoietin isolated from, or
present in any human source, including plasma or urine, including any
comparison or analysis of data from different studies or experiments.
3. All efforts by Amgen, either planed and/or carred out, concerning any attempts to

identify, and/or conduct any analysis of, any cell or tissue expressing, secreting and/or otherwise

producing eryhropoietin, (apart from any such characterization of cells used to make the active

drg product in Epogen(l) or of any eryhropoietin purified, isolated or otherwise derived from
human urine, plasma, blood or other body fluid, including (a) any characteriation of
eryhropoietin produced by any such cell or tissue, (b) the source of any such cell, tissue or

eryhropoietin, (c) any comparison between any human eryopoietin purified, isolated or
otherwise derived from any non-recombinant source (cell, tissue or body fluid) with any

recombinant human eryopoietin produced though mammalian cell expression and (d) any
communications by Amgen with any third part concerning such efforts.

4. All efforts by Amgen prior to 1985, either planned and/or carred out, to express any
biologically active glycosylated protein or polypeptide in any mammalian cell, including:
a.

all personnel involved in planning, conducting or supervising such efforts;

30(b)(6).DOC

10

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 12 of 19

b. all experimental techniques, approaches and methods considered or used by

Amgen in connection with such efforts;
c. the identity of each cell or cell line considered and/or used in connection with

such efforts;
d. all memoranda, reports, summaries and/or other documentation of such efforts;
e. all communication, at any time, of such efforts to any individual involved in

prosecution of Amgen' s EPO Patents.

5. Research, development and evaluation ofPegylated Compounds by Amgen,
including attempts by Amgen to modifY EPO proteins or any ESA, including attempts successful

or otherwise to create Pegylated Compounds using EPO or any ESA such that any chemical,
physical, pharmacological and/or pharmacokinetic propertes of

the chemically modified

compound differs from the EPO or

ESA, and including attempts by Amgen to chemically modify

the EPO protein such that its pharmacologic and/or pharmacokinetic profile is different from the
active drug product in Epogen(j, including increased half

life and different eryopoiesis

activity.

6. The contrbution of any Amgen Employee or other Person of which Amgen is aware,
including Dr. Fu-Kuen Lin, (a) to cloning of

the human eryopoietin gene, (b) to developing

any method for expressing DNA encoding human EPO in mammalian host cells, including
without limitation identifYing and developing any vectors, host cells, and/or protocols or

procedures for transforming host cells, culturing host cells, glycosylating the EPO protein so expressed and/or isolating the resulting EPO protein to make a product having biological activity
in vivo, (c) to developing the subject matter disclosed in the specification of Amgen's EPO

Patents and (d) to the claimed subject matter of Amgen's EPO Patents, including without

30(b)(6).DOC

11

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 13 of 19

limitation the date of any contrbution, including the conception and/or reduction to practice of
(a)-(d), and including the conception and reduction to practice of each claim element of

the

asserted claims of Amgen's EPO Patents.

7. The earliest effective filing date for each ofthe asserted claims of Amgen's EPO
Patents including all facts and circumstances known to Amgen supportng such contention.
8. The relationship between Eugene Goldwasser and Amgen, including

Communications between Dr. Goldwasser and Amgen, further including the transfer, exchange,
provision or supply of

information, know-how, or Things to Dr. Goldwasser from Amgen (or

from Amgen to Dr. Goldwasser) concerning eryhropoietin, crude or purified human urinary
eryhropoietin, eryopoietin radioimmunoassays, iodinated eryhroietin, eryhropoietin

purification methods, and antibodies to eryopoietin.
9. Characterizations of the active drug product in Epogen(j and of

the active drg

product in Aranesp (j, including:
a.

strcture
composition

b.
c.

conformation glycosylation
carbohydrate strcture

d.

e.
f.

sialic acid content, number, and disposition actual or apparent molecular weight

g.

h.
1.

positional isomers
biological activity

30(b)(6).DOC

12

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 14 of 19

J. interaction with the human erythropoietin receptor (including the

equilibrium constant, disassociation constant, association rate constant,
change in free energy)
k. pharmacodynamics
L. pharmacokinetics

m. immunogenicity and/or antigenicity
n. internalization and recycling by cells

o. manner of clearance
10. Any comparisons, either experimental or otherwise (such as though the analysis of

different studies) pedormed by Amgen, at the direction of, or for the benefit of Amgen of the

active drug product in Aranesp(j to recombinant human eryhropoietin, including but not limited
to comparisons to the active drg product in Epogen(j, Procrit(j, Eprex(j, NeoRecormon(j or any

other ESA, including MIRCERATM, including comparisons regarding:
a.

strcture
composition
conformation glycosylation
carbohydrate strcture

b.
c.

d.
e.
f.

sialic acid content, number, and disposition

g.

actual or apparent molecular weight
positional isomers
biological activity

h.
1.

30(b)( 6).DOC

13

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 15 of 19

J. interaction with the human eryhropoietin receptor (including the

equilibrium constant, disassociation constant, association rate constant,
change in free energy)
k. pharmacodynamics
1. pharmacokinetics

m. immunogenicity and/or antigenicity
n. internalization and recycling by cells

o. manner of clearance

11. All facts and circumstances known to Amgen concerning the contention by Amgen
that Aranesp(j or the active drg product in Aranesp(j is covered or falls within any claim of any

of the patents in suit.
12. All facts and circumstances known to Arigenc.supporting any contention by Amgen

that there has been any act of infrngement of the patents in suit by Roche.
13. All facts and circumstances known to Amgen supporting any contention that Amgen

is entitled to seek injunctive relief of any tye against Roche in this action, and including that
Amgen would be entitled to a permanent injunction should it succeed on the merits of the
underlying action, based on the factors and relevant analysis under the decision of eBay v.

MercExchange LLC, 126 S. Ct. 1837 (2006), or other applicable authorities, including all facts

and circumstances known to Amgen supportng it position as to (1) any alleged irreparable harm
it may suffer; (2) the alleged inadequacy of remedies at law including money damages; (3) how
the balance of

the hardships allegedly tip in its favor; and (4) how the public interest is affected.

14. All facts and circumstances known to Amgen supporting any contention that Amgen

is or may be entitled to damages in this action, including all facts, circumstances and data which

30(b)(6).DOC

14

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 16 of 19

Amgen has or knows supporting any claim for lost profits or reasonable royalty, or price erosion
or any other form of damages.
15. The strcture, parameters, and characteristics of any market(s) or submarket(s) in the

United States for ESA products, including Amgen's share of

total sales in such market(s) and

submarket(s), and the extent of competition, if any, to Amgen's ESA products in such market(s)
and submarket(s), the barrers to entr of

new ESA products into such market(s) and

submarket( s), and the terms and operation of the agreement between Amgen and Orto
Pharmaceuticals Corporation, dated September 30, 1985, and the effect of

that agreement on

such market(s) and submarket(s).

16. Actual or potential substitutes for ESA products for the treatment of anemia in

patients with end-stage renal disease on dialysis ("ESRD") and jn patients with chronic kidney
disease not on dialysis ("CKD") in the United States.
17. The factors used by Amgen to determine the prices it charges for ESA products in

the United States.
18. Governent and private insurance reimbursement for ESA products in the United

States, the effect of such reimbursement on Amgen's sales and marketing strategies for ESA

products, and the potential consequences of entr of new ESA products on reimbursement.
19. Amgen' s business plans, marketing plans, or sales strategies for ESA products in the
United States, including Amgen's plans, strategies, or actions concerning, the entr of

non-

Amgen ESA products (including MIRCERATM), and Amgen's plans, strategies, or actions to

compete against Procrit(j in any market(s) or submarket(s) in the United States for ESA products.
20. Amgen's analyses of projected sales, market share, or other consequence of

the entr

ofMIRCERATM into any market(s) for ESA products in the United States.

30(b)(6).DOC

15

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 17 of 19

21. The strcture, parameters, or characteristics of any market( s) or submarket( s) in the
United States in which Neulasta(j or Neupogen(j is sold, including Amgen's share of

total sales

in such market(s) and submarket(s), the extent of competition, if any, to Neulasta(j or Neupogen(j
in such market(s) and submarket(s), and the barrers to entr of

new products into such market(s)

and submarket(s).

22. Amgen's plans, strategies, or actions for contracting with Health Care Providers in

any market(s) or submarket(s) in the United States for ESA products, including communications

with Health Care Providers concerning the actual or potential purchase of MIRCERA TM or any
other potential entrant into such market(s).

23. Any actual or contemplated linkage in a contract or agreement by Amgen of
discounts on a non-ESA Amgen product to a customer's purchase of an ESA product, including
the reasons or justifications for any such linkage.

24. Amgen's basis for instituting and maintaining legal proceedings against Roche before
the International Trade Commission in In re: Certain Products and Pharmaceutical

Compositions Containing Recombinant Human Erythropoietin, filed April 11,2006 (the "ITC
Investigation") .

25. Any communications with any attorney or other Person on which Amgen relies to

show that Amgen's intent in instituting and maintaining the ITC Investigation against Roche was

not an attempt to interfere directly with Roche's business through the proceedings themselves as
a competitive weapon against Roche.

26. Amgen's basis for assertng against Roche claims in the '080 Patent related to the

mature eryopoietin amino acid sequence of figure 6 of the patent specification.
27. Amgen's basis for asserting against Roche claims in the '933 Patent.

30(b)(6).DO

16

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 18 of 19

28. Amgen's gross revenue and variable or incremental costs associated with the sale in

the United States of any Amgen ESA product, and the amount of and manner in which Amgen
calculates its profit on the sale of any Amgen ESA product, including itemization of costs
subtracted from the gross revenue of that Amgen ESA product in determining the profit.

29. Any wrtten or oral communications with any attorney or other Person on which
Amgen relies to show that it did not intend to mislead the United States Patent and Trademark Office in the prosecution or defense any of the EPO Patents during any prosecution or
interference proceeding.

30(b)(6).DOC

17

Case 1:05-cv-12237-WGY

Document 320-2

Filed 03/15/2007

Page 19 of 19

CERTIFICATE OF SERVICE
I hereby certifY that a copy of DEFENDANTS' FIRST NOTICE OF DEPOSITION TO

AMGEN PURSUANT TO RULE 30(b)(6) was served upon the attorneys of record for the
plaintiff (as listed below) by facsimile on February 9, 2007.

Lloyd R. Day, Jr. (pro hac vice) David A. Madrid (pro hac vice) Linda A. Sasaki-Baxley (pro hac vice)
Deborah Fishman (pro hac vice)

D. Dennis Allegretti (BBO#545511) Michael R. Gottfred (BBO#542156)
Patrcia R. Rich (BBO# 640578)

DAY CASEBEER MARID &
BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertno, CA 95014 Telephone: [phone] Facsimile: [phone]

DUANE MORRS LLP 470 Atlantic Avenue, Suite 500 Boston, MA 02210 Telephone: [phone] Facsimile: [phone]

Wiliam G. Gaede II (pro hac vice) Michele E. Moreland (pro hac vice) McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: [phone] Facsimile: [phone]

Kevin M. Flowers (pro hac vice)
Thomas I. Ross (pro hac vice)

Mark Izraelewicz (pro hac vice)

MAHAL, GERSTEIN & BORUN LLP
233 South Wacker Drive 6300 Sears Tower Chicago IL 60606
Telephone: [phone]

Facsimile: [phone]

Is/Denise LOtlez

Denise Lopez

30(b)( 6).DOC

18