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

Filing 379

DECLARATION re #377 MOTION to Preclude Further Interference with Third-Party Discovery and Compel Production of Documents And Deposition Testimony, or in the Alternative, Motion to Strike Defendants? Defense Under 35 U.S.C. Section 271(e)(1), #378 Memorandum in Support of Motion, OF MARIO MOORE by Amgen Inc.. (Attachments: #1 Confidential Exhibit Coversheet#2 Exhibit 1#3 Exhibit 2#4 Exhibit 3# 5 Exhibit 5# 6 Exhibit 6# 7 Exhibit 7# 8 Exhibit 8# 9 Exhibit 9, Part 1 of 2# 10 Exhibit 9, Part 2 of 2# 11 Exhibit 10# 12 Exhibit 11# 13 Exhibit 12# 14 Exhibit 15# 15 Exhibit 16# 16 Exhibit 17# 17 Exhibit 18#18 Exhibit 19#19 Exhibit 20#20 Exhibit 21#21 Exhibit 22#22 Exhibit 25#23 Exhibit 26#24 Exhibit 27# 25 Exhibit 28# 26 Exhibit 29#27 Exhibit 30)(Gottfried, Michael) Additional attachment(s) added on 4/16/2007 (Paine, Matthew). Additional attachment(s) added on 4/16/2007 (Paine, Matthew).

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

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EXHIBIT 3

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SCHEDULE A DEFINITIONS 1. 2. As used herein, "all" means "any and all"; "any" means "any and all." As used herein, "and" and "or" encompass both "and" and "or," and references

shall be construed either as singular or plural, as necessary to bring within the scope of these requests any information or documents and things that might otherwise be construed to be outside their scope. 3. As used herein, "communication" means the transmittal of information (in the

form of facts, ideas, inquiries, or otherwise). 4. constituting. 5. As used herein, "FRESENIUS" "you" and "your" means Fresenius Medical Care As used herein, "concerning" means referring to, describing, evidencing, or

AG & Co. KGaA and Fresenius Medical Care North America, their directors, officers, employees, attorneys, accountants, consultants, representatives, agents, divisions, parents, subsidiaries, or affiliates (including any related non-US entities), past or present, any partnership or joint ventures to which they are a party, any entity for which you provide management or purchasing services, and all others acting on your behalf. References herein to activities conducted by, for, and/or on your behalf, and/or any entity that directly, or indirectly controls at least fifty percent (50%) of the stock normally entitled to vote for election of directors of FRESENIUS, any entity owned or directly controlled by FRESENIUS through ownership of at least fifty percent (50%) of the stock normally entitled to vote for election of directors, and any entity under common control with FRESENIUS; provided, however, that in the circumstance where the country of incorporation of such owned or controlled corporation requires the

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maximum ownership by a foreign entity be less than fifty percent (50%), the percentage of ownership required to make such an entity an affiliate, shall be equal to the maximum percentage of ownership permitted by such country, and/or any contract research organization or consultant retained by you. 6. As used herein, "document" shall have the same meaning as specified in Fed. R.

Civ. P. 34(a), including any written, printed, typed, recorded, digital, magnetic, punched, copied, graphic or other tangible thing in, through, or from which information may be embodied, translated, conveyed, stored or obtained (including electronic mail, personal productivity software, databases, spreadsheets, group or collaboration servers and software, websites, electronic bulletin boards, electronic discussion boards, video recordings, audio recordings, digital recordings, computer tapes, computer disks, microfilm, microfiche and all other media from which information can be obtained. Pursuant to Local Rule 26.5(c)(2), drafts or nonidentical copies are considered separate documents within the meaning of this term. 7. As used herein, "EPO" means any human erythropoietin or human erythropoietin

analog produced from vertebrate cells. 8. Aranesp®. 9. 10. As used herein, "including" means "including but not limited to." As used herein, "peg-EPO" means any erythropoietin having one or more As used herein, "currently-marketed ESP" means Epogen®, Procrit®, or

molecules of polyethylene glycol attached or linked thereto, including but not limited to any form of the chemical entity/entities referred to as "CERA," "Continuous Erythropoiesis Receptor Activator," "MIRCERA," "pegserepoetin alfa," "pegzerepoetin," "pegepoetin," "pegzyrepoetin," "Ro 50-3821," "R-744," "MIX," "Methoxy Polyethylene Glycol-Epoetin Beta," "pegylated

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epoetin beta," "peg-EPO," "PEG-epoetin beta," "pegylated erythropoietin," or "pegylated EPO," "peg-epoetin," "pegylated recombinant human erythropoietin," "polyethylene glycol conjugated recombinant human epoetin beta," and any EPO having at least one attached moiety comprising polyethylene glycol 11. As used herein, "relating to" shall mean relating to, referring to, concerning,

mentioning, reflecting, pertaining to, evidencing, involving, describing, depicting, discussing, commenting on, embodying, responding to, supporting, contradicting, or constituting (in whole or part), as necessary to bring within the scope of the discovery request all responses that might otherwise be construed to be outside of its scope. 12. As used herein, "ROCHE" means Defendant(s) Hoffmann-La Roche Inc., F.

Hoffman-La Roche Ltd., or Roche Diagnostics GmbH, their directors, officers, employees, attorneys, accountants, consultants, representatives, agents, divisions, parents, subsidiaries, or affiliates, past or present, any partnership or joint ventures to which they are a party and all others acting on behalf of the named Defendants. References herein to activities conducted by, for, and/or on behalf of ROCHE includes, without limitation, activities conducted by, for, or on behalf of Chugai Pharmaceuticals Co., Ltd., Boehringer Mannheim GmbH, and/or any entity that directly, or indirectly controls at least fifty percent (50%) of the stock normally entitled to vote for election of directors of the named Defendants, any entity owned or directly controlled by the named Defendants through ownership of at least fifty percent (50%) of the stock normally entitled to vote for election of directors, and any entity under common control with the named Defendants; provided, however, that in the circumstance where the country of incorporation of such owned or controlled corporation requires the maximum ownership by a foreign entity be less than fifty percent (50%), the percentage of ownership required to make such an entity an affiliate,

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shall be equal to the maximum percentage of ownership permitted by such country, and/or any contract research organization or consultant retained by ROCHE. 13. As used herein, 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 partially 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 purporting to act on behalf of Amgen, Inc.

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DEPOSITION TOPICS 1. Communications between FRESENIUS and ROCHE relating to peg-EPO,

including the ongoing and planned uses (other than for clinical studies or trials for registration for FDA approval), offers for sale, sale, supply, storage, pricing, dosing, and reimbursement of pegEPO since January 1, 2003. 2. Any plan or consideration by FRESENIUS to purchase peg-EPO if and when peg-

EPO is commercially available in the United States in place of, or in addition to, the purchase and administration of Epogen®, Procrit®, and/or Aranesp®, including but not limited to any analyses of the financial effect or impact of switching, in whole or in part, to peg-EPO. 3. FRESENIUS's understanding or belief regarding any clinical or economic benefit

or harm that would result from its purchase or use of peg-EPO as compared to other ESPs currently-marketed in the United States. 4. FRESENIUS's communications with third parties since January 1, 2003 regarding

the comparative economic advantages or disadvantages of peg-EPO with respect to pricing, cost of acquisition, discounts or rebates, dosing, or net cost recovery as compared to other ESPs currently-marketed in the United States. 5. FRESENIUS's knowledge or understanding of any efforts or actions by AMGEN

to interfere with the conduct of any ROCHE clinical study to determine the safety, efficacy, or pharmacodynamic or pharmacokinetic properties of peg-EPO. 6. FRESENIUS's actual or planned participation in any trial, research, or other study

sponsored or conducted by or on behalf of ROCHE, scheduled to commence after April 18, 2006. 7. Benefits or services provided to FRESENIUS by AMGEN, including benefits such

as increasing efficiency, reducing costs, education, and improving patient care and outcomes.

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8.

All communications between FRESENIUS and AMGEN since January 1, 2006

regarding any contract or agreement to purchase ESPs for use in the US, including (without limitation) the October 13, 2006 Sourcing & Supply Agreement between FRESENIUS and AMGEN 9. The motivation and objectives of FRESENIUS in negotiating or executing the

October 13, 2006 Sourcing & Supply Agreement with AMGEN. 10. The effect of FRESENIUS's October 13, 2006 Sourcing & Supply Agreement

with AMGEN on FRESENIUS, AMGEN or any other person or entity.

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