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

Filing 726

DECLARATION re #724 MOTION Defendants' Motion to Preclude Testimony from Amgen's Belatedly Disclosed Fact Witnesses (of Aldred H. Heckel) 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)(Toms, Keith)

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

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., Plaintiff, v. F. HOFFMANN-LAROCHE LTD., a Swiss Company, ROCHE DIAGNOSTICS GMBH, a German Company, and HOFFMANN LAROCHE INC., a New Jersey Corporation Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) )

EXHIBIT C

C.A. No.: 05-12237 WGY

PLAINTIFF AMGEN INC.'S SECOND SUPPLEMENTAL DISCLOSURES PURSUANT TO FED. R. CIV. P. 26(A)(1) Pursuant to Fed. R. Civ. P. 26(a) and the local rules of the District of Massachusetts, Amgen hereby provides the following disclosures that supplement and incorporate the disclosures previously provided by Amgen in its original Rule 26(a)(1) initial disclosure as well as Amgen's written discovery responses provided to Roche to date. These disclosures are based on information reasonably available to Amgen as of the date of this disclosure and are without the benefit of forthright and fulsome discovery responses from Defendants' on issues such as invalidity and inequitable conduct on which they bear the burden of proof. Amgen's effort to identify potentially relevant witnesses, documents, and things pertinent to those defenses has been prejudiced and delayed by Roche's refusal to provide fair and complete responses to the written discovery requests concerning its putative invalidity and unenforceability defenses. Amgen reserves the right to amend or supplement these disclosures consistent with its obligations under Fed. R. Civ. R. 26(e) as additional information becomes known to it and if and when Roche provides fulsome discovery responses. 1

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I.

INDIVIDUALS LIKELY TO HAVE DISCOVERABLE INFORMATION THAT AMGEN MAY USE TO SUPPORT ITS CLAIMS OR DEFENSES: As can be determined from information reasonably available to Amgen and based on its

present understanding of such disputed facts as can be discerned from the allegations of the parties' respective pleadings and the written discovery to date, Amgen believes that following individuals may have discoverable information that Amgen may use to support its claims or defenses. Amgen reserves the right to amend this list as necessary or as further information becomes available to it. A. Research and development leading to the inventions described and claimed in Amgen's patents-in-suit

Arnold J. Berk, M.D. 1632 Pandora Avenue Los Angeles, CA 90024 Jeffrey K. Browne c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Joan Egrie c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Steven Elliot c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Jeri Lane c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]

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Fu-Kuen Lin c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] George Rathmann 525 Byron Street Palo Alto, CA 94301 [phone] Ralph Smalling 341 Scarborough Street Thousand Oaks, CA 91361 Thomas W. Strickland c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Daniel Vapnek 414 Plaza Rubio Santa Barbara, CA B. Amgen's Efforts to Express Erythropoietin, Characterize Erythropoietin, or Produce peg-EPO

Tom Boone c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Joan Egrie c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Steven Elliot c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]

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Eugene Goldwasser University of Chicago 920 E. 58th Street Chicago, Illinois 60637 [phone] Fu-Kuen Lin c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Gary Rogers c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Thomas W. Strickland c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] C. Urinary erythropoietin

Tsutomu Arakawa Kenneth Aoki c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Joseph Baron The University of Chicago Hematology/Oncology, Dept. Medicine 5801 South Ellis Avenue Chicago, IL 60637 Joan Egrie c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]

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Joseph Eschbach, M.D. 101 101st Ave SE #301A Bellevue, WA 98004 Eugene Goldwasser University of Chicago 920 E. 58th Street Chicago, Illinois 60637 [phone] Charles K. H. Kung Jeri Lane c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Gary Rogers c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Thomas W. Strickland c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] D. The State of the Erythropoietin Art as of the Date of Lin's Inventions

Joseph Baron The University of Chicago Hematology/Oncology, Dept. Medicine 5801 South Ellis Avenue Chicago, IL 60637 Arnold J. Berk, M.D. 1632 Pandora Avenue Los Angeles, CA 90024 Jeffrey K. Browne c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]

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Joan Egrie c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Joseph Eschbach, M.D. 101 101st Ave SE #301A Bellevue, WA 98004 Eugene Goldwasser University of Chicago 920 E. 58th Street Chicago, Illinois 60637 [phone] Charles K. H. Kung Fu-Kuen Lin c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Stuart H. Orkin Howard Hughes Medical Institute Children's Hospital 300 Longwood Avenue Boston, MA 02115 George Rathmann 525 Byron Street Palo Alto, CA 94301 [phone] Axel Ullrich Max Planck Institute of Biochemistry Dept. of Molecular Biology Am Klopferspitz 18 82152 Martinsried Germany E. Clinical Profile of ESPs in Anemic Patients

Robert Brenner c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]
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Mahesh Krishnan c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] F. Preparation and prosecution of Amgen's patents-in-suit (without waiver of privilege or work product)

Michael F. Borun Marshall, Gerstein & Borun LLP 6300 Sears Tower 233 South Wacker Drive Chicago, Illinois 60606-6357 [phone] Steven M. Odre c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Stuart L. Watt c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] G. Facts regarding Defendants' peg-EPO activities and their impact on Amgen and facts regarding Defendants' counterclaims

Serena Anderson c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Paul Audhya c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]

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Bob Azelby c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Robert Brenner c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Jeff Brown c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Pete Feldman c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Mahesh Krishnan c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Fred Manak c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Phil Marinelli c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Leslie Mirani c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] 8

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Josh Ofman c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Jeff Parkhurst c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Helen Torley c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Jeff Weisinger c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Ren Yuthok c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Jeff Zavitz c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] H. Amgen's Product License Agreement with Ortho.

James Daly c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone]

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Stu Mackey c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] Scott Foraker c/o Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 [phone] In addition, a witness knowledgeable about the impact of Roche's potential market entry on Amgen's research and development efforts will be identified. I. Fact Witnesses in the Prior Litigations

In addition to the above individuals, some 30 witnesses, including Amgen employees, gave testimony related to the patents-at-issue in Amgen Inc. v. Genetics Institute, Inc. and Chugai Pharmaceutical Co. Ltd., C.A. 87-2617-Y (D. Mass.) and some 24 witnesses, including Amgen employees, gave testimony relating to the patents-at-issue in Amgen Inc. v. Hoechst Marion Roussel, Inc. and Transkaryotic Therapies, Inc., C.A. 97-10814-WGY (D. Mass.), Likewise, Amgen believes that some of the witnesses, including Amgen witnesses, who gave testimony in the following proceedings may have knowledge relevant to the claims and defenses in this case: Amgen v. Integrated Genetics, C.A. 86-2616-Y (D. Mass.), In the Matter of Certain Recombinant Erythropoetin, 337-TA-281, and Fritsch v. Lin Interference Nos. 102,096; 102,097; and 102,334. J. Individuals Affiliated with Roche

It is apparent that individuals employed by, acting for, funded by, or affiliated with Roche are likely to have discoverable information relevant to disputed facts alleged with particularity in the pleadings regarding erythropoietin and peg-EPO research, development, patent applications, opinions, regulatory matters, and commercialization. These individuals, as

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presently known, are: George Abercrombie Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110 George R. Aranoff 615 South Preston Street, Louisville, Kentucky Pascal Sebastian Bailon 21 Woodbine Road Florham Park, NJ 07932

Anatole Besarab Division of Nephrology and Hypertension Henry Ford Hospital, CFP-511 2799 West Grand Boulevard Detroit, Michigan 48202 Ute Dugan F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland

Ulrich Beyer Pharma Development F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland Lars Birgerson F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland Michael Brandt Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany

George Esgro Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110 Steven Fishbane Winthrop-University Hospital Department of Medicine 200 Old Country Rd. Suite 135 Mineola, NY 11501 Anton Haselbeck Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany Bernd Hilger Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany Dick Hinson 11

Josef Burg Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany William M. Burns Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110

Bernard Canaud
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Hopital Lapayronie Montpellier, France

Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110 Eduard Holdener Head Global Pharma Development F. Hoffmann-LaRoche, Ltd. Grenzacherstrasse 124, CH-4070 Basel, Switzerland Chrys Kokino Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110 Francesco Locatelli A Manzoni Hospital Department of Nephrology and Dialysis Via dell'Eremo 9/11 23900 Lecco Italy Iain MacDougall Department of Renal Medicine King's College Hospital Denmark Hill London, SE5 9RS, United Kingdom Minoru Machida Pre-clinical Research Department I Chugai Pharmaceutical Co. Ltd. 1-135 Komakado 412-8513 Gotemba Shizoka, Japan Guido Magni Head of Global Medical Science F. Hoffmann-LaRoche, Ltd. Grenzacherstrasse 124, CH-4070 Basel, Switzerland

Frank C. Dougherty Pharma Development F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland Franz B. Humer F. Hoffmann-La Roche, Ltd. Basel, Switzerland

Michael Jarsch Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany

Hans-Peter Josel Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany Hiromitsu Kawata Chugai Pharmaceutical Co. Ltd. 1-1 Nihonbashi-Muromachi 2-Chome Chuo-Ku Tokyo 103-8324 Japan John Keefe Marketing Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110

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Iris Kingma-Johnson Roche Laboratories Inc. 340 Kingsland Street Nutley, New Jersey 07110

Ken Miller Marketing Group Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110 Severin Schwan Chief Executive Officer Roche Diagnostics GmbH Sandhofer Strasse 116, D-68305 Mannheim, Germany Yasuo Sekimori Chugai Pharmaceutical Co. Ltd. 1-1 Nihonbashi-Muromachi 2-Chome Chuo-Ku Tokyo 103-8324 Japan

Hajime Miyamoto Unit of Anatomy and Cell Biology Department of Animal Sciences Kyoto University Kyoto 806-8502 Japan Teruo Nakamura Department of Medical Technology Hirosaki University School of Health Sciences Hirosaki University Hirosaki Aomori 036-8562 Japan Allen Nissenson David Geffen School of Medicine 200 Medical Plaza, Suite 565 University of California, Los Angeles Los Angeles, CA 90095 [phone] Wulf Pahlke Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany

Barbara Senich Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110

Nadine Tare Drug Discovery Roche Research Center F. Hoffmann-La Roche, Inc. 340 Kingsland Street Nutley, New Jersey 07110 Hanns-Christian Tillmann Medical Research Center University of Heidelberg Klinikum Mannheim, Germany

Anne Pannier Pharma Development F. Hoffman-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland

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Apollon Papadimitriou Roche Diagnostics GmbH Pharma Research Penzberg Nonnenwaldstrasse 2 82372 Penzberg, Germany

Motoo Ueno Representative Director, Deputy President Chugai Pharmaceutical Co. Ltd. 1-1 Nihonbashi-Muromachi 2-Chome Chuo-Ku Tokyo103-8324 Japan Phillipe Van der Auwera F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland

Robert Provenzano St. John Hospital and Medical Center Department of Nephrology and Hypertension 22101 Moross Road Detroit, Michigan 48236

Bruno Reigner Pharma Development F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland

II.

DOCUMENTS The categories of documents listed below may be relevant to disputed facts and are

within the possession, custody or control of Amgen. Subject to any Protective Order entered in this or other cases or any objection, such as attorney-client privilege or work-product immunity, the following categories of documents will be made available for inspection by counsel for Roche: Document category Documents containing information related to the infringement of Amgen's patents-in-suit by the Roche defendants Documents containing information related to the preparation and prosecution of Amgen's patents-in-suit Documents containing information related to erythropoietin research and development at Amgen leading to the Lin inventions Documents containing information related to
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Location Amgen Inc. One Amgen Center Drive Thousand Oaks, California Amgen Inc. One Amgen Center Drive Thousand Oaks, California Amgen Inc. One Amgen Center Drive Thousand Oaks, California Amgen Inc. 14

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pegylated erythropoietin Documents containing information related to the effect of Roche's potential market entry with peg-EPO Pleadings, submissions, exhibits, and decisions from prior litigation involving one or more of Amgen's patents-in-suit

One Amgen Center Drive Thousand Oaks, California Amgen Inc. One Amgen Center Drive Thousand Oaks, California Amgen Inc. One Amgen Center Drive Thousand Oaks, California

III.

COMPUTATION OF DAMAGES Amgen is currently not seeking damages in this equitable action for declaratory relief.

Amgen may seek costs and expenses of suit and any further relief the Court deems proper in this equitable action. These costs, expenses, and further relief cannot be computed until the conclusion of this suit. IV. INSURANCE Amgen is presently unaware of any insurance agreement under which any insurer may be liable to satisfy all or part of any judgment that might be entered in this action or to indemnify or reimburse for payments made to satisfy the judgment. Dated: May 7, 2007

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