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

Filing 323

Response by Amgen Inc. to #311 Brief (Defendants' Claim Construction Brief). (Attachments: #1 Exhibit 1-Declaration of Harvey Lodish in Support of Defendants' Claim Construction Brief#2 Exhibit A-to Lodish Declaration#3 Exhibit B-Part 1 of 2 to Lodish Declaration#4 Exhibit B-Part 2 of 2 to Lodish Declaration#5 Exhibit C-to Lodish Declaration#6 Exhibit D- to Lodish Declaration#7 Exhibit E - Part 1 of 2 - to Lodish Declaration#8 Exhibit E-Part 2 of 2 - to Lodish Declaration#9 Exhibit 2 - Declaration of Vladimir Torchilin, Ph.D, D.Sc.#10 Exhibit A-to Torchilin Declaration#11 Exhibit B-Part 1 of 5 - to Torchilin Declaration#12 Exhibit B- Part 2 of 5 to Torchilin Declaration#13 Exhibit B-Part 3 of 5 to Torchilin Declaration#14 Exhibit B-Part 4 of 5 to Torchilin Declaration#15 Exhibit B-Part 5 of 5 to Torchilin Declaration#16 Exhibit C- Part 1 of 2 to Torchilin Declaration#17 Exhibit C-Part 2 of 2 to Torchilin Declaration#18 Exhibit D-Part 1 of 2 to Torchilin Declaration#19 Exhibit D-Part 2 of 2 to Torchilin Declaration#20 Exhibit E - Part 1 of 3 to Torchilin Declaration#21 Exhibit E-Part 2 of 3 to Torchilin Declaration#22 Exhibit E - Part 3 of 3 to Torchilin Declaration#23 Exhibit F to Torchilin Declaration#24 Exhibit 3)(Gottfried, Michael)

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

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EXHIBIT 3

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110303F.TXT 637

1 2 3 4 5 6 7 8 9 10 11 12 13 APPEARANCES: 14 15 16 17 18 19 20 21 22 23 24 25

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS Civil Action No. 97-10814-WGY ***************** * AMGEN, INC., * * Plaintiff, * * DAILY TRANSCRIPT OF v. * PROCEEDINGS ON REMAND * (Volume 6) HOECHST MARION ROUSSEL, INC. * and * TRANSKARYOTIC THERAPIES, INC., * * Defendants. * * ***************** BEFORE: The Honorable William G. Young, District Judge

DAY CASEBEER MADRID & BATCHELDER, LLP (By Lloyd R. Day, Jr., Esq., David M. Madrid, Esq., Jonathan Loeb, Esq., and Robert M. Galvin, Esq.) 20400 Stevens Creek Blvd., Suite 750, Cupertino, California 95014 - and HOWREY, SIMON, ARNOLD & WHITE, LLP (By Edward M. O'Toole, Esq.), 321 North Clark Street, Chicago, Illinois 60610-4714 - and DUANE MORRIS, LLP (By D. Dennis Allegretti, Esq.), 470 Atlantic Avenue, Suite 500, Boston, Massachusetts 02210 - and STUART L. WATT, ESQ. and MONIQUE L. CORDRAY, ESQ., Amgen, Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799, on behalf of the Plaintiff 1 Courthouse Way Boston, Massachusetts November 3, 2003 638

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A P P E A R A N C E S (Cont'd) CHOATE, HALL & STEWART (By Eric J. Marandett, Page 1

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110303F.TXT Esq.), Exchange Place, 53 State Street, Boston, Massachusetts 02109 - and FISH & NEAVE (By Herbert F. Schwartz, Esq., Douglas J. Gilbert, Esq., Gerald J. Flattmann, Jr., Esq., Kenneth B. Herman, Esq. James F. Haley, Esq., Barbara A. Ruskin, Esq. and Katherine A. Helm, Esq.), 1251 Avenue of the Americas, New York, New York 10020, on behalf of the Defendants

639

1 2 3 4 5 6 JOSEPH W. ESCHBACH By Mr. Madrid 644

INDEX ___________________________________________________________ WITNESS: DIRECT CROSS REDIRECT RECROSS ___________________________________________________________

757,

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110303F.TXT 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 640 By Mr. Flattmann 707 785 783

1 2 3 4 5 6 7 8 9 10 HMR/TKT.

THE CLERK: be seated.

All rise.

Court is in session, please

Calling Civil Action No. 97-10814, Amgen v.

THE COURT: COUNSEL: THE COURT:

Well, good morning, counsel. Good morning. I have two motions before me, both of I've read them carefully. I'm

which I'm going to decide.

going to decide them without hearing. First, I have Amgen's motion for judgment. Page 3 That

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110303F.TXT 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 plasma corrected the anemia of the sheep model that we created that had renal failure, and then we subsequently tried to do the same study in one patient with erythropoietin rich human plasma and it was unsuccessful in the sense that we could not treat that but, we did not have enough erythropoietin rich plasma to succeed, but we did show that it was effective in a sense in terms of a biological response. It wasn't until we had recombinant

human erythropoietin that we've had the most experience in treating this anemia. Q. In the context of your investigations have you measured

reticulocytes? A. Q. A. Yes. For what purpose? Reticulocytes were used to, primarily as an early

indicator of a biological response to erythropoietin therapy. It wasn't clear as I mentioned whether uremic

inhibitors would interfere with the action of 648

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erythropoietin.

And so we needed to have some clue as to

whether this would, whether we were overcoming that uremic factor, and reticulocytes were one of those measures that we used. Q. A. Q. A. Q. Did you measure ferrokinetic effects? Yes. For what purpose? For the same reason. Now, have you interacted with the Food and Drug

Administration concerning any clinical studies? A. Yes, several. Page 10

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110303F.TXT 12 13 14 15 16 17 18 19 20 21 22 23 24 25 problem. 649 Q. A. Can you list what those are? With recombinant human erythropoietin and also with

intravenous iron gluconate. Q. How did you first become involved in the study of the

anemia chronic renal failure? A. Over 40 years ago when I decided to become a

nephrologist I was a research fellow with Dr. Belding Scribner at the University of Washington. He had just

started doing, or keeping patients alive with chronic dialysis, and as a result of this a lot of complications were revealed, one of which was the significance of anemia chronic renal failure. When I arrived he said, Joe, solve the anemia

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Q.

Now, have you had any exposure to the field of

hematology? A. Yes. Very fortunately the hematology division at the I was

University of Washington was just down the hallway.

very fortunate to work with Dr. Clem Finch, head of the division of hematology, a world-renown hematologist. MR. FLATTMANN: I object, your Honor. I don't

believe any of this is in the report about hematological experience. THE COURT: It seems to be somewhat background. Let's get to this case,

What he's testified to will stand. Mr. Madrid. MR. MADRID: Q.

Yes, your Honor.

One final question with respect to background, Doctor. Since the year 2000 have you become involved in Page 11

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110303F.TXT 16 17 18 19 20 21 22 23 24 25 any professional organizations? A. Q. A. Yes. Please describe your involvement? The organization was called National Anemia Action

Council, and it's a group of subspecialists from various specialties that are interested in anemia and anemia in general and our aim is to educate not only the public but the profession at large about the significance of anemia and how important its treatment is. Q. Doctor, I'm going to ask you some questions today with 650

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respect to the Court's claim construction. understand? A. Q. Yes, I do.

Do you

Before I do that, I would like to ask a few brief

background questions with respect to that subject. Doctor, by or before November 1984 did you try to help or cure -- did you try to help to heal or cure any patients suffering from anemia? A. Q. Oh, yes. Approximately how many anemia patients did you try to

help to heal or cure? A. Q. Several hundred. Were you successful in helping to heal or cure their

anemia? A. Q. A. No. Why not? We had no effective therapy at that time. The two

therapies that we had available were androgens and red cell transfusions, both of which had their own problems. Page 12

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110303F.TXT 20 21 22 23 24 25 Androgens resulted in a minimal increase in hematocrit and did not work in everybody, and complications were not very good for, particularly for female patients. Red cell

transfusions was a temporary treatment, never resolving the anemia, and in the long run causing further complications that patients continue to have trouble with today. 651

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Q.

With the advent of recombinant human erythropoietin did

you try to help to heal or cure any anemia patients? A. Q. A. Q. Yes. How many? Well over 500. Were you successful in helping to heal or cure their

anemia? A. Q. A. Yes. How did you know you were successful? Well, by two criteria. One, we were able to increase

the hematocrit from 20's up to a target range of 35 to 40, which is near normal or normal levels, and because of their clinical response. Patients improved dramatically in their

clinical overall well-being. Q. Now, Doctor, if you could, please, I would like to

direct your attention to Demonstrative Exhibit BTA.1. That's Tab 2 in the notebook. Now, this is a reproduction of the Court's September 18, 2003 working construction. Are you familiar

with the Court's September 18, 2003 working construction to determine therapeutically effective amount? A. Q. Yes, I am. I would like to direct your attention to the first Page 13

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110303F.TXT 24 25 sentence of the Exhibit BTA.1, Tab 2, which reads: therapeutically effective amount is a quantity that 652 A

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produces a result that in and of itself helps to heal or cure. Do you see that? A. Q. Yes, I do. Do you have an opinion regarding whether the ordinary

skilled artisan in 1984 would have understood there to be a plain meaning for the term therapeutically effective amount? A. Q. A. Yes. What's that opinion? That opinion in terms of the anemia of chronic renal

failure would be that we would need to show not only an increase in the hematocrit in normal or near normal levels but to achieve a clinical improvement in the patient as demonstrated with quality of life and other measures. Q. A. Q. A. Now, why do you hold that opinion? I'm sorry, why? Why do you hold that opinion? What are the bases?

Because that's the definition of being therapeutically

effective. Q. Doctor, do you have an opinion as to whether or not the

ordinary skilled artisan would have understood that a sustainable increase in hematocrit was necessary in order to help heal or cure? A. Yes. 653 Page 14

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110303F.TXT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Q. A. What is that opinion? A temporary improvement in raising hematocrit is only You need to have a sustained response in order

temporary.

to achieve the therapeutically effectiveness that we're talking about. Q. A. What is anemia? Anemia is basically a reduction in the amount of

circulating red cells in the body as determined by a hematocrit or hemoglobin concentration. Q. Why do doctors use hematocrit or hemoglobin

concentration to determine whether a patient has anemia? A. Q. A. Q. They're standard techniques. How would -Accepted, accepted by the profession. I'm sorry. How would the ordinary skilled physician in 1984 have determined whether a treatment was helping to heal or cure the anemia of a patient? A. We would be following the hematocrit or hemoglobin

level. Q. Do you have an opinion as to whether or not the

ordinary skilled artisan would have considered a biologic effect in and of itself to be sufficient to heal or cure? A. Q. Yes. What is that opinion? 654

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A.

Biological effect in and of itself is not sufficient to

determine whether there's healing or curing of a problem. Q. Why is that? Page 15

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A.

110303F.TXT Well, biological effect by definition is more or less a

chemical, or something happening on the cellular level that shows you're getting a response to some therapeutic agent, in this case let's say erythropoietin. And so, this is

usually an acute response and doesn't guarantee that you'll have a sustained, sustained response, nor that you'll have a sufficient amount to get to your target level. Q. I would like to direct your attention now back to

Exhibit BTA.1 in Tab 2, and specifically to the second sentence of the Court's working construction. read that for the record: And I'll

A therapeutically effective

amount is one that elicits in vivo biological activity of natural EPO such as those listed in the specification, column 33, lines 24 through 28. And then the listing:

Stimulation of reticulocyte response, development of ferrokinetic effects, and erythrocyte mass changes, and one that increases the level of hematocrit. Now, Doctor, I would like to also direct your attention to the Lin patent. your notebook. This would be at Tab 3 of And in particular, if

This is Exhibit 1.

you would turn to column 33 of the Lin patent. Now, do you have an opinion as to how the ordinary 655

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skilled physician would have understood column 33 of Dr. Lin's specification? A. Q. A. Q. A. Yes. What is that opinion? May I read through this? Yes, please. Your Honor, I'm particularly focusing on the third Page 16

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110303F.TXT paragraph, column 33, and it starts off by talking about the in vitro biological activity of EPO isolates from natural sources that the patent shares with, and consequently are projected to have utility as substitutes for EPO isolates in culture media. This is all in vitro effects of erythropoietin. Q. A. Doctor, can you speak into the microphone, please. Oh, I'm sorry. The first part of the paragraph refers

to the in vitro effects, the biological activity of EPO isolates, affecting EPO isolates in culture media employed for growth of erythropoietin cells in culture. Then it goes on and says: Similarly, to the

extent the polypeptide products of the invention share the in vivo activity of natural EPO isolates they are conspicuously suitable to use in erythropoietin therapy procedures practiced in mammals, including humans, to develop any or all of the effects herefore attributed to in vivo EPO. 656

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The here -- the, what it says, herefore, at this time in 1984 we knew what the biological effects were, but there was not anything available for therapy. So, the fact

that we start with the in vitro effects of EPO, which were well-known, and move on to the in vivo biological activity, it then mentions stimulation of reticulocyte response, development of ferrokinetic effect, such as plasma iron turnover effects and marrow transit time effects, erythrocyte mass changes, stimulation of hemoglobin C synthesis, see Eschbach, et al., and as indicated increasing hematocrit levels in mammals. Page 17

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110303F.TXT So my review of this is that the specific effects that are listed here are clearly biological effects following the mention of the in vitro biological effects listed earlier. And I amplify that further because the specific statement about stimulation of hemoglobin C synthesis, which I'm very acutely aware of having spent twelve years working with sheep, this is a phenomena seen only in certain sheeps and goats in which hemoglobin, a phenotype of hemoglobin A is shifted to hemoglobin C and can be, and is an indicator that erythropoietin has been acting. However, it has no, absolutely no effect upon hematocrit or therapy. THE COURT: And the language you're just 657

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explaining is the reference to stimulation of hemoglobin C synthesis? THE WITNESS: THE COURT: citing there -THE WITNESS: THE COURT: Yes. -- that's something that you found Synthesis, correct. That's something that you, and you're

with respect to sheep? THE WITNESS: THE COURT: respect to sheep? THE WITNESS: look at goats, sir. THE COURT: THE WITNESS: No, it's in goats. But I didn't Correct. But have not found other than with

But it's not in humans. Sheep and goats. Yes.

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16 17 18 19 20 21 22 23 24 25 Q. A. Q.

110303F.TXT THE COURT: And you're saying that was known then? THE WITNESS: THE COURT: Yes. Go ahead, Mr. Madrid.

Doctor, have you finished with your answer? Well, I could amplify more with ferrokinetics, too. Go ahead. MR. FLATTMANN: I object, your Honor; form. Have

a question and answer. THE COURT:

I don't know what was answered.

No, I'm satisfied with the form, in

the same form as we just had. 658

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 tool.

What about ferrokinetic effect? THE WITNESS: Ferrokinetics is an investigational

It does not tell you what the hematocrit or tell you It clearly helps to

anything about therapeutic response.

determine how the bone marrow was functioning and particularly about iron metabolism. It helps to quantitate

red cell production, but does not give you any indication as to what's happened to the hematocrit. Q. Do you have an opinion with respect to the mention of

erythrocyte mass changes in column 33? A. Q. A. Yes. What is that opinion? Erythrocyte mass changes likewise are both, both

biologic and if there's significant mass changes can be related to therapy. Q. And column 33 makes reference to increasing hematocrit Do you have an opinion with respect to

levels in mammals.

the significance of that sentence? A. Yes. Well, to continue on with my analysis of the Page 19

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110303F.TXT patent in column 33, we go from the in vitro effects to the in vivo biologic effects and then increasing hematocrit levels, both the biologic and eventually a therapeutic effect. And then it moves beyond that to the next sentence

which talks about the various medical conditions that might be impacted and improved by such therapy. 659

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So I think it shows an evolution of the use of erythropoietin from, in the laboratory to biological effects to, finally to potential therapy. THE COURT: And roughly speaking, you think that

the Court's construction, the second sentence -- well, put the Court's construction to one side. You're saying the

second sentence talks about biologic effects and the third sentence is directed toward therapeutic effects? THE WITNESS: Well, I would like to amplify that

further, if I may, your Honor. THE COURT: MR. MADRID: THE WITNESS: You may. Tab 2 is the -The thing I liked about your second

sentence is that it provides a very natural transition, as does the patent, the first part of your second sentence in which you list simulation of reticulocyte response, development of ferrokinetic effects, and erythrocyte mass changes are biological responses. Then you say, and one

that increases the level of hematocrit, which is moving on to showing that this is then going to become a therapeutic response, which then ties into your first sentence very nicely. So I think your second sentence and the first Page 20

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110303F.TXT sentence are very much related. THE COURT: But I did hear you say that 660

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erythrocyte mass changes, if in sufficient quantity, have a therapeutic effect, correct? THE WITNESS: Well, let me explain that. Yes.

Erythrocyte mass changes really basically shows the hematocrit is increased. THE COURT: THE WITNESS: THE COURT: THE WITNESS: THE COURT: It's another way -It's another --- of getting at that? Yes, exactly. I take it that the key to you as a

physician here, the key to treating humans who have anemia which causes other bad things to happen, is to get that hematocrit up? THE WITNESS: THE COURT: THE WITNESS: THE COURT: THE WITNESS: That's correct. Have I got that right? Absolutely correct. Go ahead, Mr. Madrid. I'm talking about adult humans now.

I've been talking mainly about the anemia chronic renal failure, but that's true of many other anemias as well. THE COURT: Q. Yes.

Now, Doctor, do you understand HMR/TKT to contend that

an increase in reticulocyte count or ferrokinetic effects is a result that helps to heal or cure anemia? A. I understand that question. 661 Page 21

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110303F.TXT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Q. A. Q. A. Do you agree? No. Why not? Well, as I mentioned, the reticulocyte response and

ferrokinetic responses are biological effects, they're acute effects, and they do not have, they do not guarantee that you will have a sustained effect to result in helping to heal or cure the parent. THE COURT: Let's just get at this, your concern

about a sustained effect. THE WITNESS: THE COURT: Uh-huh. First of all, I heard you say that --

and you'll forgive me if my questions are foolish. THE WITNESS: THE COURT: No. I'm groping here.

You want to get, as a physician you want to get that hematocrit level out of the 20's as you mentioned -THE WITNESS: THE COURT: THE WITNESS: THE COURT: THE WITNESS: is still anemia. THE COURT: But you're better off -- well, I Now, since we're talking about 662 Uh-huh. -- up into the 30's. Correct. 30's is what, low normal? Right. It's still anemia. Low 30's

shouldn't assume anything.

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a therapeutic effect, your concept of therapeutic effect falls to a sustained response. THE WITNESS: THE COURT: Yes.

In other words, if you can get the Page 22

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110303F.TXT 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 me? MR. MADRID: Yes. 663 patient. down -THE WITNESS: THE COURT: Correct? THE WITNESS: THE COURT: Quantity sustained? THE WITNESS: THE COURT: THE WITNESS: Could I use an analogy to -Sure. -- try to illustrate this with you? When we take a bath we Let's think of The hematocrit Correct. What do you mean by sustained then? Right. -- it wouldn't be much good to the hematocrit to spike up that would certainly be interesting. THE WITNESS: THE COURT: Yes. But if it immediately went back

And this is a bathtub.

like to have the tub up, water up so high. that in terms of our body and red cells. being a measure of that level. illustration purposes.

Let's say 40 just for

The patient that has renal failure -- can you hear

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THE WITNESS:

The patient that has renal failure It may be lower, it may

has a hematocrit, let's say of 20. be a little higher.

So it's half full.

Now, our hematocrit is determined by two things. One is the amount of red cells being produced, and two, by the number of red cells being destroyed. And the But in

destruction -- our red cells last up to 120 days. general there's a balance. Page 23

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110303F.TXT 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Now, in the patient with renal failure that balance may not be stable. Many times the hematocrit drops

because red cell destruction exceeds the rate at which it's being produced. Now, let's then, let me use the analogy that what's coming out of the spigot are reticulocytes. are early red cells. Those

We have a drain that is analogous for And there's a balance here,

red cell destruction, or loss. there's a rule.

Well, when we start erythropoietin stimulation we're actually turning the knob and increasing the amount of water or red cells coming out of the spigot, increase reticulocytes. Now, initially there's very little change in that level of water, or blood, in the blood. start to fill. Eventually it will

But there's no guarantee for that because a And we've seen 664

number of intervening effects can happen.

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this repeatedly, clinically.

Number one, we can have iron

deficiency which then results in basically turning that knob down. A more important one is an infection or

inflammation which really blunts the action of EPO so you don't get much coming out. You have blood loss, the drain

is going to be increased so you've got more blood coming out and you can't possibly overcome the amount losing with the amount coming in. And the red cells themselves can be

destroyed quicker if there's more infection. So, there's these intervening things that can affect then what's coming in. So just measuring the retics

doesn't tell you whether you're going to get up here. Page 24

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110303F.TXT 13 14 15 16 17 18 19 20 21 22 23 24 25 THE COURT: But -- well, I appreciate that answer

and I think I understand it. THE WITNESS: THE COURT: had a sure source -THE WITNESS: THE COURT: Uh-huh. -- of reticulocytes, which I take it Uh-huh. But if I, if I were a physician and I

this invention claims to give you -THE WITNESS: THE COURT: Right. -- while it would be true that in

certain patients I would not get that sustained response -THE WITNESS: THE COURT: Uh-huh. -- I could then go looking for these 665

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other causes, iron deficiency, too quick destruction of the red blood cells, infection, the things you've mentioned. THE WITNESS: THE COURT: Yes. And if I could stop them or take care

of them then, since your analogy is to physics, if I've got a sure source of reticulocytes that hematocrit is going to come up, correct? THE WITNESS: But you're assuming then that you

have to measure both, the retics and the hematocrit. Measuring just the retics alone is not going to give you that answer. THE COURT: That's fine. I think I understand.

But my point as I grapple with the legal aspects -THE WITNESS: THE COURT: Uh-huh. -- of this is, you've introduced the,

not introduced, but you've pointed out that in order to be Page 25

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110303F.TXT 17 18 19 20 21 22 23 24 25 therapeutically effective you've got to have sort of a sustained effect. THE WITNESS: THE COURT: Correct. And then when I asked you about that

you pointed out how complex the matter was because a number of things are going to, other things are going to -THE WITNESS: THE COURT: Right. -- be at play here.

How would you measure a sustained supply of, as 666

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you call them, retics? THE WITNESS:

Would you? We know clinically that if the

hematocrit is staying stable with erythropoietin therapy there has to be new retics coming out. THE COURT: by sustained. THE WITNESS: Well, a sustained level of But I'm trying to get at what you mean

hematocrits have to be -THE COURT: what period of time? THE WITNESS: that therapeutic agent. THE COURT: And is that how it works? In other As long as you're treating, using Isn't it a temporal concept? Over

words, have you discovered that if you're using this therapeutic agent you can get those hematocrit levels up and you can hold them up, save for these other things? THE WITNESS: years. THE COURT: therapy? Page 26 So for you sustained is a successful Oh, yes. Been doing this for 18

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110303F.TXT 21 22 23 24 25 THE WITNESS: THE COURT: Exactly. You're saying this, this works unless

I've got some other problem. THE WITNESS: THE COURT: Exactly right. Infection. 667

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Q.

THE WITNESS: THE COURT: THE WITNESS: THE COURT: THE WITNESS: THE COURT: problems -THE WITNESS: THE COURT: THE WITNESS: THE COURT: MR. MADRID:

Yes. Too quick destruction. Right. Iron deficiency. Yes. -- there's others. But an array of And I'm sure --

Yes. -- that physicians know. Exactly. Thank you. Go ahead, Mr. Madrid.

Thank you, your Honor.

Doctor, do you have an opinion as to whether or not in

the context of your bathtub analogy the erythropoietin preparation that you administer can have an effect with respect to accomplishing sustained increase? A. Yes. MR. FLATTMANN: the reports. THE COURT: Yes. The analogy wasn't in the reports This is I object, your Honor. It's not in

MR. FLATTMANN:

but it was in response to your Honor's question. clearly not -THE COURT: There we are. Page 27

I'll sustain it.

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110303F.TXT 25 MR. MADRID: Your Honor, if I may? 668

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 23 -report. report. it is.

THE COURT: MR. MADRID:

Yes. The reports address the Goldwasser

study, in fact, address this very point as to whether or not -THE COURT: Well, where is it? Just show me where

MR. MADRID:

Sure.

If we look at the 10-03

And if one looks at Paragraph 32. THE COURT: MR. MADRID: Just a moment. Wait a minute. Sorry. Paragraph 33

of the 10-03 report. THE COURT:

And Paragraph 23. Yes. But my problem is, my ruling as

to the untimely report was I would allow you to make reference to specific citations. report is it? MR. MADRID: misunderstanding here. filed and served timely. Your Honor, I believe there may be a The 10-03 -- 10-3-03 report is That's not contested. The Where in some earlier

earlier report, the 9-16 report, was filed timely but in the 9-16 report we did not specify specific pages that Dr. Eschbach was relying upon. THE COURT: So, it's the correction of the 9-16 All right, go ahead. In the 10-3-03, Paragraph

I'm following. MR. MADRID:

Okay.

669

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