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

Filing 1424

DECLARATION re 1420 MOTION in Limine Regarding Flavell No. 6: To Preclude Richard Flavell from Offering Opinions Based on a Claim Construction that is Inconsistent with the Court's Construction of '868 Claim Term "Isolated DNA Sequence Encoding Human Er, 1415 MOTION in Limine Regarding Flavell No. 1: To Preclude Richard A. Flavell From Testifying During the Infringement Stage on Issues Pertaining to Invalidity, 1423 MOTION in Limine Regarding Flavell No. 9: To Preclude Richard Flavell from Offering Opinions Regarding "Isolated DNA Sequence Encoding Human Erythropoietin" Based on His Refusal to Provide the Basis for Those Opinions at Deposition, 1421 MOTION in Limine Regarding Flavell No. 7: To Preclude Richard Flavell From Offering Opinions Based on a Claim Construction that Requires That the Term "Obligate" Glycoprotein Be Read into the Asserted '933 Claim, 1419 MOTION in Limine Regarding Flavell No. 5: To Preclude Richard Flavell from Offering Opinions Based on an Infringement Analysis that is Inconsistent with Federal Circuit Precedent and with the Court's Claim Construction Ruling that Amgen's, 1416 MOTION in Limine Regarding Flavell No. 2: To Preclude Richard A. Flavell from Offering Opinions Based on a Claim Construction that is Inconsistent with the Claim Terms "Isolating" and "Comprising," as set forth in the Asserted &, 1417 MOTION in Limine Regarding Flavell No. 3: to Preclude Richard Flavell from Offering Opinions Based on a Claim Construction that is Inconsistent with the Court's Claim Construction of the '933 Patent Claim Term "Non-Naturally Occurrin, 1418 MOTION in Limine Regarding Flavell No. 4: To Preclude Richard Flavell from Offering Opinions Regarding the Asserted '933 Claims that are Based on a Construction that is Inconsistent with the Court's Claim Construction of the Claim Term &q of Linda Sasaki-Baxley by Amgen Inc.. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3)(Gottfried, Michael)

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

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EXHIBIT 1

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Amgen v. Roche Unsigned Page 1

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

----------------------------) AMGEN INC. Plaintiff(s), ) ) Civil Action No. ) 05-12237 WGY F.HOFFMANN-LA ROCHE, LTD. ) (This transcript contains Confidential a Swiss Company, a German Company and a New Jersey Corporation Defendant(s). ----------------------------) ) ) ) BLA/IND information. Please treat the ) entire transcript in accordance with the ) ) Amended Protective Order in this matter) ROCHE DIAGNOSTICS GmbH, HOFFMANN-LA ROCHE INC., )

DEPOSITION Of: RICHARD A. FLAVELL, Ph.D DATE: HELD AT: June 26, 2007 Omni Hotel Goffe Room New Haven, Connecticut

Reporter: JENNY C. EBNER, RPR, LSR 00030. BRANDON SMITH REPORTING SERVICES, LLC 44 Capitol Avenue Hartford, CT. 06106 [phone]

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and so that is cumulative in what my opinion is. Q How does Roche insert the DNA sequencing coding human EPO into itself? MR. FLEMING: Objection; mischaracterizes his opinions, ambiguous as to term insert human EPO DNA, misstates the opinions in this report. THE WITNESS: So, as I said, I described this completely in this report here. If you would like to refer to a particular paragraph. BY MS. BAXLEY: Q No, well, you just referred to a number of paragraphs -A Uh-huh. Q -- as to explain your opinion, and I am trying to understand from these paragraphs whether you can tell me what is the basis for your opinion that Roche does not transform or transvect with isolated DNA sequence in coding human EPO itself? A I am sorry, you'll have to repeat that. Q I am trying to understand the basis for your opinion that Roche does not transform or transvect with an isolated DNA in coding human

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THE WITNESS: I am not sure I understand the question. BY MS. BAXLEY: Q I am asking you which of the four methods that you -- would you -- you would agree with me, wouldn't you, that Roche's cells have EPO DNA inserted into it; is that correct? MR. FLEMING: Objection; vague as to EPO DNA, mischaracterizes the testimony, calls for a legal conclusion. THE WITNESS: Yes, I don't want -- I am not quite sure what you mean by EPO DNA. Do you want -BY MS. BAXLEY: Q Do you have any understanding as to whether Roche uses CHO cells, Chinese hamster ovary cells, to manufacture the epoetin beta starting material used to make CERA? MR. FLEMING: Objection; vague, mischaracterizes the record, mischaracterizes his opinions. THE WITNESS: If we go to the right part of the report I think we will find the statement I make on that. If you would like to go to that.

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cell; is that correct? MR. FLEMING: Objection; mischaracterizes his testimony, his opinion is what it is, vague as to the term. THE WITNESS: Well, what I just read was the DNA contents of the bacterial protoplasts are incorporated into the host cell. In the event that it is akin to a somatic cell hybridization the bacterial chromosome, and I think this is the relevant part for you, is transferred into the host cells and therefore there is a real possibility that some bacterial DNA sequences are incorporated into the transformed cells. BY MS. BAXLEY: Q Do you know whether Roche used bacterial protoplast fusion to introduce genetic material into their host cells? MR. FLEMING: Objection; vague, beyond the scope of his expert report. THE WITNESS: I don't think that's -- I actually asked that question, but as I sit here now, I don't

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recall exactly. It's beyond the scope of the report. BY MS. BAXLEY: Q So you have no opinion as to how Roche introduces its genetic material into its host cells? MR. FLEMING: Objection; mischaracterizes his testimony. He says he doesn't recall, vague. THE WITNESS: I don't recall. What I do recall is what they do not do which is what I described. I described several times now. BY MS. BAXLEY: Q In bacterial protoplast fusion is that -- let me represent to you that Roche actually uses bacterial protoplast fusion to introduce the EPO DNA in coding epoetin beta into its host cell. How does that EPO -- when it does that, does any human DNA, other than the DNA in coding the epoetin beta, get introduced into the host cell? MR. FLEMING: Objection; assumes facts not in evidence, mischaracterizes the record.

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Q So, using the protoplast, bacterial protoplast fusion technique that you describe in paragraph 65, other than epoetin beta DNA, the DNA in coding epoetin beta, is any other human DNA introduced into Roche's host cells? MR. FLEMING: Objection; assumes facts not in evidence, mischaracterizes the record because he doesn't, he never opined in paragraph 65 as Roche's process. He's never opined in paragraph 65 as Roche's process. That is what you tried to interject into the question, and it's been asked and answered. MS. BAXLEY: But Dr. Flavell, doesn't have a recollection as to how the DNA in coding epoetin beta is introduced in cells. I will represent to you that it is introduced by bacterial protoplast fusion. MR. FLEMING: He doesn't have to accept your representations. BY MS. BAXLEY: Q So if -- assuming that that is how it is done, is any human DNA, other than the DNA in coding epoetin beta, introduced into the host

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cells? A What I am -MR. FLEMING: Objection; incomplete hypothetical, mischaracterizes the record, assumes facts not in evidence, beyond the scope of his report. THE WITNESS: So the problem is you, I would be extremely surprised if you know Roche's production processes. We do not have the information here. I certainly haven't got that information in front of me. And I am not going to respond to a speculative question. I just don't know what the answer is. BY MS. BAXLEY: Q Okay. So then when you refer to Amgen's process for introducing genetic material into the host cell as described in Amgen's patent specification. You describe that at paragraph 67 of your report. Is it your opinion that only EPO DNA is introduced or described to be introduced in the host cells by Dr. Lin? MR. FLEMING: Objection. THE WITNESS: What I am saying is that --

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Q Dr. Flavell, paragraph 73 of your report, Flavell Exhibit 3, again you say -A My third report. Q Third report, Flavell Exhibit 3, paragraph 73. You say that Roche has not infringed claims one or two of the 868 patent because the cells Roche uses to create epoetin beta reagent are not, quote, transformed or transvected with an isolated DNA sequence in coding human epoetin, closed quote. So Roche's cells, what type of DNA was used to transform or transvect Roche's cells? MR. FLEMING: Objection. Mischaracterizes the testimony; mischaracterizes his report; asked and answered. THE WITNESS: I think you asked this question before lunch. BY MS. BAXLEY: Q And you said you didn't know how Roche transformed or transvected its cells; is that correct? MR. FLEMING: Objection. Mischaracterizes his testimony. He said he doesn't recall.

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And to that end what I am asking is: How does Roche introduce DNA sequence in coding human epoetin into their cells? MR. FLEMING: Objection. Mischaracterizes his testimony; ambiguous as to introducing human epoetin; lacks foundation, if that is even done, and asked and answered. BY MS. BAXLEY: Q If you know. A So, I don't know what they do. I don't remember -- I don't recall, as I sit here now. The basic reason for this is that I have a vast volume of paperwork here. I don't have any material in front of me now that tells me or refreshes my memory of what they do. Q Okay. So can I have you turn to Flavell Exhibit 2, which is your second report? Specifically, if you can go to paragraph 10 of that report -- sorry -- make sure I have the right one. MR. FLEMING: Do you want Exhibit 2? Exhibit 2 is the May 8 -MS. BAXLEY: I think the one -- I am sorry. It is actually Flavell Exhibit

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