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

Filing 744

DECLARATION re #743 Memorandum in Opposition to Motion, #741 MOTION to Strike , In the Alternative, Untimely Expert Testimony of Ralph A. Bradshaw Regarding Amgen's Motion for Summary Judgment of No Obviousness-Type Double Patenting (by Timothy M. Murphy) 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#8 Exhibit H)(Toms, Keith)

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

Doc. 744 Att. 3

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EXHIBIT C

Dockets.Justia.com

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) Plaintiff, ) ) v. ) ) F. HOFFMAN-LA ROCHE, LTD., ) ROCHE DIAGNOSTICS, GmbH, and ) HOFFMAN-LA ROCHE, INC. ) ) Defendants. ) _______________________________________) AMGEN INC.,

Civil Action No. 05-CV-12237 WGY

REBUTTAL REPORT OF RALPH A. BRADSHAW, PH.D. TO NEW NON-INFRINGEMENT ARGUMENTS RAISED IN THE REBUTTAL REPORTS OF DEFENDANTS' EXPERTS Contains Amgen Confidential and Roche Restricted Access Confidential Information BLA/IND Material Subject To Protective Order

REDACTED

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1.

I have been retained as an expert in this case by counsel on behalf of Amgen Inc.

("Amgen"). If called to testify at trial, I expect to provide testimony regarding the matters set forth in this Report. Qualifications and Compensation 2. I am the same Ralph A. Bradshaw who submitted a Rebuttal Expert Report on

May 11, 2007 in response to Defendants' April 6, 2007 Reports. My qualifications and the compensation I am receiving as an expert in this matter are set forth in my May 11, 2007 Report and are incorporated herein by reference. Information Considered 3. In addition to this information identified in my May 11 Report, I have also

considered the following things: The May 11, 2007 Non-Infringement Expert Report of Richard A. Flavell, Ph.D. and the references and information cited in ¶¶ 76-85 of that Report; The May 11, 2007 Rebuttal Expert Report of Professor Alexander M. Klibanov and references and information cited in ¶¶ 112-122 and 132-133 of that Report; The May 11, 2007 Expert Report of Gregory D. Longmore, M.D. and references and information cited in ¶¶ 103-107 of that Report; The April 17, 2007 Markman Hearing Transcript, pp. 81-97; and The publications, references, and other information cited in this Report. In forming my opinions, I additionally have relied upon the knowledge, training, and experience that I have acquired during my over 40 years as a protein chemist.

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Summary of My Opinions 4. I have reviewed the May 11, 2007 Expert Reports of Drs. Richard Flavell,

Alexander Klibanov, and Gregory Longmore. In those reports, Drs. Flavell, Klibanov, and Longmore offer the opinion that the EPO used to make peg-EPO is materially changed from the isolated EPO preparation obtained using the processes claimed by Dr. Lin. I have been asked to consider this opinion. 5. Based on my review of the above-referenced documents, it is my opinion that: The human erythropoietin used to make peg-EPO is not materially changed from the human erythropoietin isolated according to the processes claimed in Dr. Lin's `868 and `698 patents. The human erythropoietin used to make peg-EPO is not materially changed from the human erythropoietin claimed in Dr. Lin's `933 and `422 patents. Opinions Opinion 1: The human erythropoietin used to make peg-EPO is not materially changed from the human erythropoietin isolated according to the processes claimed in Dr. Lin's `868 and `698 patents. and Opinion 2: The human erythropoietin used to make peg-EPO is not materially changed from the human erythropoietin isolated according to the EPO claimed in Dr. Lin's `933 and `422 patents. 6. Drs. Flavell, Klibanov, and Longmore's Reports contain the opinion that the

Opinion 1:

Opinion 2:

purified EPO used to make peg-EPO is materially changed from the "crude EPO isolate" obtained using the processes claimed in U.S. Patent Nos. 5,441,868 and 5,618,698 (the `868 and `698 patents, respectively) and claimed in U.S. Patent Nos. 5,547,933 and 5,955,422 (the `933 and `422 patents, respectively). This opinion is based in part on the premise that one of ordinary skill in the art, following the teaching in Dr. Lin's specification on how to isolate EPO from cell

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