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

Filing 737

DECLARATION re #735 Opposition to Motion by Kimberly J. Seluga by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit 1#2 Exhibit 2)(Huston, Julia)

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

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EXHIBIT 1

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Cords, Dr. Sven-Michael CONFIDENTIAL

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS Civil Action No. 05-12237 WGY AMGEN, INC., ) DEPOSITION OF: )DR. SVEN-MICHAEL CORDS ) Plaintiff, ) ) vs. ) **CONFIDENTIAL** ) ) F. HOFFMANN-LA ROCHE LTD., a ) Swiss Company, ROCHE ) DIAGNOSTICS GmbH, a German ) Company, and HOFFMANN-LA ) ROCHE, INC., A New Jersey ) Corporation, ) ) Defendants. )

TRANSCRIPT of the stenographic notes of the proceedings in the above-entitled matter, as taken by and before LISA FORLANO, RMR, CRR, CSR, CLNR, Notary Public, held at the offices of Duane, Morris, 1540 Broadway, New York, New York, on Wednesday, May 30, 2007, commencing at 9:03 a.m. (This transcript has been designated CONFIDENTIAL as per Section 5(c) of the Amended Protective Order. Please treat the entire transcript in accordance with the Protective Order.)

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rephrase the question? BY MR. NIELSEN: Q A Q A Q A Q You had a protocol that you followed in Yes. And that protocol didn't include a step No, the whole calculation was not part The calculation of normalization? That's correct. You normalized the data simply for performing your bioassay, correct?

of normalizing data, did it? of the protocol.

purposes of generating Figure 3 to appear in your expert report, is that right? A Q ago -A Q A Q A Q Yeah. -- that normalizing the data was not Correct. Okay. But you did normalize the data I'm sorry, can you repeat? Well, you explained just a moment

part of your protocol, right?

for purposes of generating Figure 3, right? That's correct. And was the purpose of normalizing the

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A Q A Q A Q

Yes, it was my understanding. You did not write Paragraph 10 of your As I said, it was prepared by the The entire report? Yes. Dr. Cords, if you will, please provide

report, correct? attorneys of Roche.

us today with the tutorial that you think you might give at trial in this case on the general aspects of the Normomouse bioassay. A Yes. The general aspect of this protocol or the general aspect when you normally test erythropoietic stimulating agents for quality control purposes, for example? Q Well, I want both out of you. I want to hear from you today everything that you think you might possibly tell the Court later on in this case as part of a tutorial. A general. detail. Q A Fair enough. The normocythaemic assay is a part of Yes. So let's start first with the protocol in this case. Maybe I start a little bit more It might be easier and then go into the

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the European Pharmacopoeia, so it's a validated test to test the activity of erythropoietic stimulating agents. standard. In this test, you compare one or two The difference to the protocol of this samples of one distinct substance against its own study is that instead of using one dosage, you use three dosages and instead of sampling four samples over a time period, you sample after four days after injection of the mice. The activity is calculated by comparison, the reticulocyte response of the samples in comparison to the standard and it is analyzed by the so-called parallel line assay which compares parallelity and linearity and dosage effectiveness. Instead of this in this protocol, we measured over different time points the samples using one dosage and comparing different substances and no deeper statistical analytical measurement was made. Q Is there anything else that you think MR. LEEMAN: BY MR. NIELSEN: Q Let me ask you a better question. In addition to what you just explained Objection. will be part of your tutorial in this case?

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to me, do you believe there are any other aspects or parts of a tutorial which you might explain later on at trial in this case? MR. LEEMAN: THE WITNESS: Objection. It's possible to go in

very detail how the samples were diluted, for example, and then applicated to the mice, how the receiving of the blood of each animal was performed and then the calculation by flow cytometry of the reticulocytes. BY MR. NIELSEN: Q Do you think you may go into such MR. LEEMAN: THE WITNESS: Objection. I can do this. Of course detail at trial?

this is in some -- to some extent privileged information, just keeping the way we are performing our assay in-house. BY MR. NIELSEN: Q A Q A Q How is it privileged? It's just a question of know how. The know how of Bioassay GmbH? Yes, that's right. And I assume that you don't plan on

discussing the know how or the confidential know how

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BY MR. NIELSEN: Q I believe earlier, Dr. Cords, you said something to the effect, and please correct me if I'm wrong, I'm trying to be accurate here, that the difference between the protocol, the typical protocol for a Normomouse bioassay and the study you performed was that instead of one dosage, there were three dosages and instead of four samples -A Q A Q Four times. Okay. Instead of testing at four

times, there's only a test at one time? One time after four days, yes. Okay. Which goes with the

Normomouse -- strike that. Which goes with the standard Normomouse bioassay and which goes with the version that you performed in this case? A The standard Normomouse assay, we use three different dosages at one time point measurement after four days after injection. Q A Q And in the modified Normomouse bioassay You had four times measurements with You never performed this modified that you performed in this case? only one dosage.

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mono-PEG-EPO were samples that were assayed in a Normomouse assay that generated the data shown in this document. A Q Okay? Let's also assume that all other I just recognize it, yes. Okay.

parameters of the Normomouse bioassay that was performed that yielded these results were done in a manner consistent with the bioassay which you performed in this case, okay? A consistent? Q Not that the results are consistent, but I'm asking you to assume for purposes of looking at Cords Deposition Exhibit 3 that the other parameters of the Normomouse bioassay that was applied to yield these results were the same or comparable to the parameters of your bioassay. A Yes. Apart from the parameter of the time collection, it seems that the four groups have the same parameters. Q A Q A Your assay didn't measure reticulocyte Correct. Why not? Sorry? formation at 144 hours, correct? You assume that these both results are

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Q A Q

Why not? Simply because we were not asked. Roche asked you -- strike that. The attorneys for Roche asked you to

conduct a bioassay that measured reticulocyte formation through an ending at 120 hours, is that correct? A Q A Q in this case? A Q A Q A Q A Q Roche? A He's located in Frankfurt. The protocol was sent by the attorneys. When did they send it to you? It was at the end of March. Do you remember who sent it? I'm not absolute sure. It could be Yes. The end point was 120 hours. And that's what the attorneys for Roche Yes. It was included in the protocol.

instructed you to do, right? Did the attorneys for Roche or Roche

itself send you a written protocol for the bioassay

Mr. Jungermann. I'm sorry, what was the first name? The first name is Sebastian. Is Mr. Jungermann an attorney for

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Q A Kaye Scholer. Q A Q A Q

Does he work for Roche? I don't know, but he's an attorney for Do you recall roughly how many pages The protocol, I'm not absolute sure, Two pages? Two pages, yes. Do you know if that protocol has been MR. LEEMAN: THE WITNESS: Objection. Can you specify or

the protocol was that was sent to you? but two sides I would suggest.

produced to Amgen in this case?

rephrase the question? BY MR. NIELSEN: Q Do you know if the protocol which you just referred to or a copy of it was produced or given to Amgen or Amgen attorneys in this case? MR. LEEMAN: THE WITNESS: it, no. BY MR. NIELSEN: Q case, do you? You don't have any knowledge of whether any particular documents were given to Amgen in this Objection. I have no -- I don't know

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in no other respect and, therefore, and maybe without the hand writing, so this document arguably has more information because of the handwriting than the -- any non-identical equivalent that might be out there without the handwriting, so I expect that there won't be need for additional questioning, if there is such an equivalent out there. MR. NIELSEN: MR. LEEMAN: MR. NIELSEN: deposition. MR. LEEMAN: position, Matt. BY MR. NIELSEN: Q Dr. Cords, counsel for Roche just provided an explanation of what he believes to be the, you know, facts and circumstances surrounding the non-identical version of this document which you referred to, but I haven't heard from you yet as to what you think about what he said. I'm a little surprised, I have to admit, that now it seems like things have changed, so do you now recognize the I understand your And you haven't seen this I'm unaware of the other Okay. Well, we can't additional document, have you? document or its where abouts. agree to waive any rights we have to resume the

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document bearing Bates numbers 8890792 through 93? A Yes. The emphasis was that I've never seen this particular document with the Roche emblem and the handwriting and -- except from the head of this first page, the protocol was identical of which was sent to us. Q And when you say the head of the page, can you please make it clear for the record, beginning where and ending where you're referring to? A From my remembering the protocol starts with the sentence protocol of sample preparation for the comparison study for epoetin beta and MIRCERA. Q What was it that jogged your memory, if you will, as to as to you having seen that remaining portion of this document before? MR. LEEMAN: THE WITNESS: BY MR. NIELSEN: Q Why is it that you're coming back now after having been off the record for a substantial amount of time, I believe with counsel for Roche, and telling me that now there are parts of this document which look familiar to you? A Yes, but the first question you rise is Objection. I didn't understand it.

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role? A Q that. What other individuals at Bioassay GmbH had a role in the bioassay that was performed in this case other than yourself? A Q A Q A Q A Q A Q A technician. Q A What was that technician's name, the I know that Mrs. Hach, H-A-C-H, was first technician? I have my predecessor who is also my And his name is? Professor Sponer. Can you spell that, please? S-P-O-N-E-R. Were there any other individuals who The lab head as already mentioned, I'm sorry, what was the name? Pahlke. Okay. Anyone else? And a technician and a second backup and he's also our scientific advisor. No, that's all. What other people -- pardon me, strike

had a role in the bioassay performed in this case? Eckart Pahlke.

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involved and a second, I cannot remember. look at the protocols. Q

I have to

Did you observe each of the procedures

or measurements that were a part of the bioassay that your company performed? A Q No, I did not see the experiment. If I could direct your attention to Are there any publications which

Exhibit 2 to your expert report, Doctor, your publication list. erythropoietin? A Q No, I'm not. Any publications which you're an author you're an author or co-author of regarding work with

or co-author of involving experiments with any erythropoietic stimulating agent? A Q No. Are there any publications which you're

listed as an author or co-author on which involve experiments with the Normomouse bioassay? A Q A Q No. And I take it the answer would be the That's correct. If I could direct your attention to

same for a modified Normomouse bioassay?

Paragraph 4 of your expert report.

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Do you see the last sentence which says: "I have tested approximately 1,000 samples, measuring the biological activity of erythropoietin samples in the parallel line assay according to the European Pharmacopoeia."? A Q A Yeah, that's correct. What biological activity of It's a standard protocol, as I already

erythropoietin have you measured prior to this case? mentioned, as part of the quality control of these agents to confirm the biological activity. Q A Q A Q Have those tests been efforts to Yes, correct, it's a potency assay. Than was that done by measuring That's correct, yes. Is there any other biological activity determine the potency of a sample?

reticulocytes?

that -- of erythropoietin that that sentence is referring to or is that it, what you just said? A Q A That's what we do in our lab. Your lab measures the potency of That's correct, just by the

erythropoietin samples? normocythaemic mouse assay.

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Q

If I could direct your attention to Please take as much time as you'd like

Paragraph 15, Dr. Cords. to look at that paragraph, but my question to you is are the assays that you refer to in Paragraph 15 the potency assays that you were referring to a moment ago? A Q A Q A Q You asked me whether these assay that I Yes. Yes, that's correct. And just so the record is clear, here Yes. Forgive me if we've covered this mentioned here are referring to the potency assay?

is Paragraph 15 of your report, correct?

earlier, but is it correct that prior to your work in this case, you had not previously had experience with a modified version of the Normomouse bioassay? A Q That's correct, yes. And is it also correct that prior to

your work in this case, your company, Bioassay GmbH, had not previously had experience with a modified Normomouse bioassay? MR. LEEMAN: THE WITNESS: Objection. That's hard for me to

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protein content. Q A Q That wasn't something that was No. If you could move on to pages three and I believe counsel earlier performed by you or your company?

four of Cords Exhibit 11.

characterized those two pages as essentially identical or virtually identical to documents that we've already looked at today. Do you agree with that? A Q Yes, I do. Counsel for Roche also referred to

there potentially being something additionally in this document regarding modifications that were made to the standard Normomouse protocol, is that correct? MR. LEEMAN: THE WITNESS: don't think so. BY MR. NIELSEN: Q Is it your testimony that Cords Exhibit Is it your testimony that pages three and four of Cords Exhibit 11 don't provide any additional comment about any modifications to the 11 doesn't -- strike that. Objection. I don't think so. No, I

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standard Normomouse protocol? A Yes, as already stated -MR. LEEMAN: THE WITNESS: Objection. -- this is true. Apart

from number one on the third page, examples to be included in the study you can see or you can conclude that it is not the standard protocol. BY MR. NIELSEN: Q There are no other comments on pages three and four of this document regarding any modifications to be made to the standard Normomouse protocol? MR. LEEMAN: THE WITNESS: Objection. They're reflecting all So it's hardly to

kinds we are not responsible for.

say that we can make any commands on it if this is the same procedure as is done in the standard protocol or not. BY MR. NIELSEN: Q Is there anything else in Cords Exhibit 11, other than what we've talked about already, that relates to any actual or potential modifications for a standard Normomouse bioassay? A Yes, it's on the page two, the last sentence, reticulocyte counting after two, three,

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four and five days, five mice per group each. Q Is there anything else in this document about any potential or actual modifications to the standard assay? A Q Analytics. No. If you take a look at Page 4 under 2.4, See where it says: "Normomouse bioassay, Do you see that, Dr. Cords? A Q Yes, I see it. Was there a memo from Wolf Pahlke

(see memo from Wolf Pahlke, P-A-H-L-K-E)"

regarding the Normomouse bioassay that was ever considered by you in this case? A Q A Q No. As already stated, we did not receive any memo. What is this referring to, then? That's -- I can't judge about it. Is it your testimony, Dr. Cords, that

Cords Exhibit 11 is the protocol that was sent to you by Kaye Scholer which you were to follow in performing the assay that was conducted in this case? A Q Yes, that's correct. Maybe I'm missing something, but it

just doesn't seem to me that there is much in here

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about the conditions to perform the Normomouse bioassay, so how did you know the parameters of the assay? A What we need for the dilution is the It's given. What we need to All we And protein concentration.

know how much we have to inject is given on the second page, this 100-milligram per mouse. the rest is I think quite clear. Q A Q have to evaluate then is the dilution protocol.

We have to count

reticulocytes after two, three, four and five days. Did you follow the protocol that is Yes, we did. In following the protocol, you ignored MR. LEEMAN: THE WITNESS: Objection. This memo was for us provided in Cords Exhibit 11?

the reference on Page 4 to a memo from Wolf Pahlke?

absolutely not relevant because we had all the information on the first two pages. BY MR. NIELSEN: Q A Q But you don't know -- well, do you know No, I don't. Cords Exhibit 14 -- strike that. Cords Exhibit 11 does not say anything what the subject of that memo is about?

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analyzes on the samples. Q So you don't know, Dr. Cords, whether the samples were still in the same condition when you began to assay them as they were when you received them, is that correct? A this. It's out of my scope to judge about I just can tell you the way -- the way we Analytical parts we cannot

handled the samples. conclude. Q

If you can go to Page 4 of Cords

Exhibit 11 and go to the second to the last bullet point -- I'm sorry, third to the last under risks/issues. Do you see where it says: "The experiment has not been performed since 1999, there is no possibility for training and test experiments (only one shot!)." Do you see that, Dr. Cords? A Q Yes, I see this. You didn't receive any training for

performing the modified Normomouse bioassay that you performed in this case, is that correct? A We did not received any training because all our staff members are well trained with Normomouse, the standard of Normomouse assay, and especially the handling is exactly the same.

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Q

No one had received -- strike that. No one at your company received any

special training for the -- strike that again. No one at your company received any special training for the modified Normomouse bioassay that was actually performed in this case, though, is that correct? A That's correct. MR. NIELSEN: at this time. Subject to my comments

earlier on the record, we have no further questions That said, we do reserve our rights to resume the deposition and continue it and we consider it to still be an open deposition, but at this time, considering the circumstances that we're in, we have no further questions. MR. LEEMAN: disagree on that. questions myself. BY MR. LEEMAN: Q A Q Did you receive a draft of your expert Yes. Did you have a chance to make some report before you signed it? Okay, Matt, we obviously We consider the deposition to be

at an end or soon to be, but let me ask a few

edits for purposes of accuracy?

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JURAT I, DR. SVEN-MICHAEL CORDS, the witness herein, the foregoing testimony of the pages of this deposition, do hereby certify it to be a true and correct transcript, subject to the corrections, if any, shown on the attached page. ______________________________ DR.SVEN-MICHAEL CORDS

Subscribed and Sworn to before me this _______ day of Notary Public 2007. _____________________________________

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CERTIFICATION I, LISA FORLANO, a Certified Realtime Reporter, Certified Court Reporter and Notary Public, do hereby certify that I reported the deposition in the above-captioned matter, that the said witness was duly sworn by me; that the foregoing is a true and correct transcript of the stenographic notes of testimony taken by me in the above-captioned matters. I further certify that I am not an attorney or counsel for any of the parties, not a relative or employee of any attorney or counsel connected with the action, nor financially interested in the action. _______________________________ LISA FORLANO, CRR, CCR #XI01143 DATED: May 31, 2007

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