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

Filing 277

DECLARATION re #275 MOTION to Determine the Sufficiency of Roche's Responses to Amgen's Requests for Admission of Krista M. Carter by Amgen Inc.. (Attachments: #1 Confidential Exhibits Coversheet#2 Exhibit 1#3 Exhibit 3#4 Exhibit 4#5 Exhibit 5#6 Exhibit 6#7 Exhibit 7#8 Exhibit 8#9 Exhibit 12)(Gottfried, Michael)

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EXHIBIT 1 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) Plaintiff, ) ) v. ) ) ) F. HOFFMANN-LAROCHE ) LTD., a Swiss Company, ROCHE ) DIAGNOSTICS GmbH, a German ) Company and HOFFMANN LAROCHE ) INC., a New Jersey Corporation, ) ) Defendants. ) __________________________________________) AMGEN INC., Civil Action No.: 05-12237 WGY AMGEN INC.'S FIRST SET OF REQUESTS FOR ADMISSION (NOS. 1-22) Amgen Inc. ("Amgen"), pursuant to Rule 36 of the Federal Rules of Civil Procedure and the Local Rules of this Court, requests within thirty (30) days of service hereof that each of Defendants F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffmann-La Roche Inc. individually admit or deny each of the following statements. If any objection is made to any part of any Request, the responding Defendants shall specify the part of the Request to which an objection is made and respond to the remaining part or parts. DEFINITIONS 1. 2. As used herein, "all" means "any and all"; "any" means "any and all." As used herein, "Amgen's related patents and patent applications" means one or more of any United States or foreign patent which claims priority benefit in whole or in part based on the filing date(s) recited on the first page(s) of the patents-in-suit. 3. As used herein, "and" and "or" encompass both "and" and "or," and references 383167_1 1 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. 4. As used herein, "communication" means the transmittal of information (in the form of facts, ideas, inquiries, or otherwise). 5. 6. constituting. 7. As used herein, "document" shall have the same meaning as specified in Fed. R. As used herein, "comprises" means includes, but not necessarily limited to. As used herein, "concerning" means referring to, describing, evidencing, or 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. 8. As used herein, "EPO" means recombinant human erythropoietin, as that term is used in ROCHE's April 2006 Biologics License Application (see e.g., ITC-R-BLA-00004029 and ITC-R-00004178). 9. As used herein, "DN2-33" means the host cell system described in the Chemistry, Manufacturing, and Control section of ROCHE's April 2006 Biologics License Application that is used to produce the EPO used to make RO-0503821 (see e.g., ITC-R-BLA00004667). 383167_1 2 10. 11. As used herein, "including" means "including but not limited to." As used herein, "patents-in-suit" means U.S. Patent No. 5,547,933; U.S. Patent No. 5,618,698; U.S. Patent No. 5,621,080; U.S. Patent No. 5,441,868; U.S. Patent No. 5,955,422; or U.S. Patent No. 5,756,349. 12. 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. 13. As used herein, "RO-0503821" means the product for which you are seeking approval from the Food and Drug Administration to market and sell in the United States, as described in ROCHE's April 2006 Biologics License Application (see e.g., ITC-R-BLA00004027). 14. As used herein, "ROCHE," "you" and "your" mean 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 383167_1 3 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, shall be equal to the maximum percentage of ownership permitted by such country, and/or any contract research organization or consultant retained by ROCHE. INSTRUCTIONS 1. With respect to any claim of privilege by ROCHE relating to any response by ROCHE to these requests for admissions, ROCHE is hereby requested to identify each such communication, information, or document withheld on grounds of an alleged privilege, and specifically set forth the following: (a) (b) (c) (d) (e) (f) the nature and basis of the privilege claimed; the author(s); the addressee(s), including the recipients of copies; the date of the communication, document or information; the subject matter of the communication, document or information; if the privilege claimed is the attorney-client privilege, an indication of which author(s) or addressee(s) is/are attorneys; and (g) 2. any other information necessary to support the claim of privilege. If ROCHE contends that any of the following requests for admission is objectionable in whole or in part, ROCHE shall state with particularity each objection, the basis for it, and the categories of information to which the objection applies, and shall respond to the request insofar as it is not deemed objectionable. 383167_1 4 3. If ROCHE believes that the meaning of any term in these requests for admissions is unclear, ROCHE shall assume a reasonable meaning, state the assumed meaning and respond to the request according to the assumed meaning. 4. The following requests are continuing and ROCHE is reminded of its obligation for timely supplementation pursuant to Rule 26(e) of the Federal Rules of Civil Procedure. REQUESTS FOR ADMISSION REQUEST FOR ADMISSION NO. 1 MIRCERA comprises RO-0503821. REQUEST FOR ADMISSION NO. 2 RO-0503821 is therapeutically effective in treating humans with anemia associated with chronic renal failure, when administered in appropriate amounts. REQUEST FOR ADMISSION NO. 3 RO-0503821 comprises EPO. REQUEST FOR ADMISSION NO. 4 Epoetin-beta comprises EPO. REQUEST FOR ADMISSION NO. 5 ROCHE uses EPO to make RO-0503821. REQUEST FOR ADMISSION NO. 6 The EPO used to make RO-0503821 comprises the 165 amino acid sequence identified as amino acids 1-165 in Figure 6 of the Amgen patents-in-suit. REQUEST FOR ADMISSION NO. 7 RO-0503821 comprises a glycosylated polypeptide. 383167_1 5 REQUEST FOR ADMISSION NO. 8 RO-0503821 comprises a glycosylated polypeptide having three N-linked oligosaccharides. REQUEST FOR ADMISSION NO. 9 RO-0503821 and the EPO used to make RO-0503821 have the identical amino acid sequence and carbohydrate composition. REQUEST FOR ADMISSION NO. 10 RO-0503821 is capable of causing bone marrow cells to increase production of reticulocytes and red blood cells in vivo. REQUEST FOR ADMISSION NO. 11 RO-0503821 does not occur in nature. REQUEST FOR ADMISSION NO. 12 RO-0503821 is made by linking methoxy-polyethylene glycol to EPO. REQUEST FOR ADMISSION NO. 13 The EPO used to make RO-0503821 is produced by mammalian host cells grown in culture. REQUEST FOR ADMISSION NO. 14 The EPO used to make RO-0503821 is produced by culturing vertebrate cells under suitable nutrient conditions. REQUEST FOR ADMISSION NO. 15 The EPO used to make RO-0503821 is produced by the recombinant Chinese Hamster Ovary (CHO) cell line known as "DN2-33." 383167_1 6 REQUEST FOR ADMISSION NO. 16 The DN2-33 cell line was originally created by and supplied to ROCHE by Genetics Institute, Inc. REQUEST FOR ADMISSION NO. 17 The EPO used to make RO-0503821 is produced by growing DN2-33 cells under suitable nutrient conditions and isolating purified EPO. REQUEST FOR ADMISSION NO. 18 DN2-33 cells comprise an exogenous DNA sequence encoding EPO. REQUEST FOR ADMISSION NO. 19 DN2-33 cells comprise amplified DNA encoding EPO. REQUEST FOR ADMISSION NO. 20 DN2-33 cells comprise transcription control DNA sequences, other than human transcription control sequences, which control transcription of DNA encoding EPO. REQUEST FOR ADMISSION NO. 21 DN2-33 cells are capable upon growth in culture of producing EPO in the medium of their growth in excess of 100U of erythropoietin per 106 cells in 48 hours as determined by radioimmunoassay. /// /// /// /// 383167_1 7 REOUEST FOR ADMISSION NO .22 RO-0503821 contains a pharmaceutically acceptable diluent, adjuvant or carrier. Respectfully Submitted, AMGEN INC., By its attorneys, Of Counsel: STUART L . WATT WENDY A. WHITEFORD MONIQUE L . CORDRAY DARRELL G . DOTSON MARYSUSAN HOWARD KIMBERLIN L . MORLEY AMGEN INC. One Amgen Center Drive Thousand Oaks, CA 91320-1789 (805) 447-5000 A , R. AVID M . MADRID LINDA A . SASAKI-BAXLE DAY CASEBEER MADRID & BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone : (408) 873-0110 Facsimile : (408) 873-0220 D . DENNIS ALLEGRETTI (BBO#545511) MICHAEL R .GOTTFRIED (BBO#542156) DUANE MORRIS LLP 470 Atlantic Avenue, Suite 500 Boston, MA 02210 Telephone : (617) 289-9200 Facsimile : (617) 289-9201 WILLIAM GAEDE III McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone : (650) 813-5000 Facsimile : (650) 813-5100 MICHAEL F . BORUN KEVIN M. FLOWERS MARSHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower Chicago IL 60606 Telephone : (312) 474-6300 Facsimile : (312) 474-0448 November 17, 2006 383167_1 8 CERTIFICATE OF SERVICE I hereby certify that a copy of this document was served upon the attorneys of record for the plaintiff (as listed below) via federal express overnight delivery and electronic mail on November 17, 2006. Leora Ben-Ami, Esd. Patricia A . Carson, Esq. Thomas F . Fleming, Esq. Howard Suh, Esq. Peter Fratangelo, Esq. KAYE SCHOLER LLP 425 Park Avenue New York, NY 10022 Tel : (212) 836-8000 Emails : lbenami@kayescholer .com pcarson@kayescholer .com tfleming@kayescholer .com hsuh@kayescholer .com pfratangelo@kayescholer .com and Lee Carl Bromberg, Esq. Julia Huston, Esq. Keith E . Toms, Esq. BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel . (617) 443-9292 Emails : lbromberg@bromsun .com jhuston@bromsun .com ktoms@bromsun .com 383167_1 9

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