Free Transcript - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT IN AND FOR THE DISTRICT OF DELAWARE ELAN PHARMA INTERNATIONAL LIMITED, Plaintiff, : : : : : : : : : : Civil Action

6 v. 7 ABRAXIS BIOSCIENCE INC., 8 Defendant. 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 BEFORE:

No. 06-438-GMS

- - Wilmington, Delaware Thursday, May 29, 2008 11:30 a.m. Telephone Conference - - HONORABLE GREGORY M. SLEET, Chief Judge

APPEARANCES: JOHN G. DAY, ESQ. Ashby & Geddes -andPAUL FEHLNER, ESQ., STEPHEN SCHEVE, ESQ. (Houston, Texas), and JEFFREY SULLIVAN, ESQ. Baker Botts LLP (New York, New York) -andGREGORY BOKAR, ESQ. Counsel - Elan Drug Delivery Counsel for Plaintiff

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APPEARANCES CONTINUED: MICHELLE BUDICAK, ESQ. Young Conaway Stargatt & Taylor, LLP -andMICHAEL A. JACOBS, ESQ., and EMILY EVANS, ESQ. Morrison & Foerster (San Francisco, California) Counsel for Defendant

THE COURT:

Good morning, counsel.

Counsel, who

is on the line for Elan this morning? MR. SCHEVE: Good morning, Your Honor. From

Elan this morning you have John Day at Ashby & Geddes locally, Steve Scheve, Jeff Sullivan, and Paul Fehlner from Baker & Botts, and also Greg Bokar, Elan's vice president for intellectual property and litigation. THE COURT: MS. BUDICAK: Good morning. For Abraxis.

Good morning, Your Honor.

Michelle Budicak at Young Conaway, Delaware counsel for Abraxis. With me on the line is Michael Jacobs of Morrison

& Foerster, as well as Emily Evans from Morrison & Foerster. THE COURT: Good morning. Counsel, is it the

case that both sides asked for the call or one or the other? MR. JACOBS: THE COURT: MR. JACOBS: This is our initiation, Your Honor. Mr. Jacobs, go ahead. Your Honor, I am on a speaker. We I

will try and make sure we don't over-speak the Court.

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are set up over here.

The trial site isn't perfect yet.

The Court may have seen the filings that have been coming in, the notice of service. We have gotten six

additional expert reports from Elan since the pretrial conference. It's rather extraordinary. They range from a

damages report to a new theory of infringement to an expert report by an expert, Berkland, on critiquing x-ray powder diffraction. The Court's order on our Motions in Limine 1

and 4 ordered that only Brittain could critique our x-ray powder diffraction. We think that the standard for supplemental or additional expert reports in the week before trial should be really, really, really good cause. meet that standard. We would ask that the Court strike these expert reports. THE COURT: MR. JACOBS: Go ahead. If the Court would like, I could And Elan can't possibly

detail a little bit more our concerns with these reports. THE COURT: Let's get a general reaction. I

will take that as a general opening comment. we can short-circuit this. Mr. Scheve. MR. SCHEVE:

Let's see if

Maybe we won't be able to.

I will do my best, Judge.

Thank

you for taking time from what I know is a very busy

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schedule. Judge, I need to give you a little background. You will recall at the pretrial conference an issue arose about a witness named Katherine Melody, who is with a company called Micron Laboratories. Since the

initial Rule 26 conference in this case, Abraxis has taken the position, both with Elan and with the Court, that the product is amorphous. It was not until February 1, 2008,

five and a half months after the close of discovery, and without ever identifying Ms. Melody in responses to discovery, that Abraxis listed her as a witness for them in the case and produced four discrete, edited or cropped pages from some lab notebooks which purport to support their x-ray powder diffraction evidence in this case. We moved to exclude her, Your Honor. Your Honor

said that she would be allowed to testify, but you said that she must be produced for deposition. Her deposition was taken last Wednesday, May the 21st. It was a bombshell, and undercuts everything that

Abraxis has been telling Your Honor and the world since the start of this case. She testified that Micron Labs routinely advises its clients that in order to have interpretable data one needs to have two things: limits of detection. particle size standards and

She says that they are advised of that

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because these are spelled out in the United States Pharmacopeia. Abraxis did not do the control testing to allow anyone to determine crystallinity in Abraxane. particle size standards. detection. They did no

They did not establish limits of

All Abraxis did was to provide them powder and

ask that x-ray powder diffraction be performed. Ms. Melody then testified, and she used the word surprised, she would be advised to hear that her testing would be the basis for claiming amorphousness, because in order to make such a conclusion one would need to test to determine the limits of detection, which was never done. She further testified that when dealing with nanoparticles, x-ray powder diffraction is less conclusive, and as a result it's important to have a control, for a control, a nano-sized standard, which was not done. She said, I still don't know if it's amorphous or crystalline. Importantly, we learned at the deposition that Abraxis had submitted samples for further testing in 2007, after this lawsuit was filed, none of which had ever been produced to my client. It was produced the evening before

the deposition that Your Honor ordered and which took place last Tuesday. What they produced were various lab notebooks

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and various reports.

But we learned during the course of

the deposition that there was a whole wealth of other laboratory notebook information that had never been produced. And it was only produced to us yesterday. Against that backdrop, Your Honor, we received from Your Honor last week the clarification order. the Court is extremely busy and overloaded due to circumstances that the Senate of the United States has not deemed appropriate to deal with, which creates a tremendous amount of work for Your Honor. We further assumed that if Your Honor took the time to issue a clarification order, it was important that we submit it to our experts. What we did is this. After the deposition of Katherine Melody, we submitted that information to Dr. Berkland and said, please consider this. In addition, after Your Honor's We know

clarification order of last week, we submitted that to two of our experts, Dr. Byrn and Dr. Munson. state of the art expert. Dr. Byrn is our

Dr. Munson is the one who has

performed solid state nuclear magnetic resonance testing to determine crystallinity within Abraxane. We asked him three questions. this change your opinion? second question. If so, how so? Number one: That is the Does

Number three:

If your opinions are not

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changed, are you able to supplement your reports to track the language of the Court's clarification order? Knowing,

Your Honor, that it is important that they be in tune with how Your Honor has construed the terms, and that if they don't articulate their opinions in a manner which is consistent with Your Honor's construction, all we will hear from Abraxis is, the opinions shouldn't be offered. should be excluded. What has become very, very clear here, Your Honor, is this is part of an overall plan to tie Elan's hands, not identify the people who did this Micron testing, not tell us that they had done x-ray powder diffraction testing, until last Tuesday, the day before Ms. Melody's deposition, that there was testing in 2007. They still produce documents to us just yesterday. And now they want to exclude these supplemental They

reports that were brought about by Melody's deposition and by Your Honor's clarification order, so that they can, number one, prevent those reports from being amended or supplemented, and then stand up before Your Honor on Monday and say, Your Honor, they shouldn't be allowed to offer this testimony. The other thing, Your Honor, relates to our damages expert. This is Mr. Jarosz. There is an

interrogatory that asked them to supplement or to provide

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information about sales of Abraxane going straight to damages. The Federal Rules, of course, require that they They didn't do that

supplement their discovery seasonally. for us.

So Mr. Jarosz, when he got access to quarterly

sales information for the first quarter of 2008, in order to come up with a number against which to multiply a royalty rate, supplemented his report to reflect that new information. Secondly, there was a document called the Korean Green Cross Agreement, where Abraxis licensed its product Abraxane to a company in Korea. We asked for a copy of it It was not

at the deposition of their economist. forthcoming.

And it wasn't until sometime in the last six

weeks that we had to write Abraxis back and say, please produce it. That information was recently produced. My

notes suggest it was produced on April 7th of '08. And Mr. Jarosz, the economist, is addressing the updated financial information that we never got from Abraxis. We had to go out and search for it, once the first

quarter data was submitted. And secondly, the Korean agreement, which wasn't provided to us until April the 7th. forward it on until April the 8th. But, Your Honor, I will shut up. effort to do nothing but hand-tie our case. This is an These were very Of course, we couldn't

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discrete supplements.

The suggestion that we put in some We

new infringement theory is absolutely without basis. went to Dr. Munson and said, look at Your Honor's clarification order. Look at the language.

It appears to

us, there was a "Whereas" clause, Your Honor, that we said you need to look at this. It says, whereas something would

reject an argument that a purely amorphous product could infringe the '363. We said look at that and then look at

the later language about the medicament within the particles. report. He says his opinion doesn't change. He says, in And he addressed only those in his supplemental

a manner that is absolutely consistent with his prior report, that there are particles wherein the crystalline medicament is entirely crystalline, utilizing that word "entirely," which, Your Honor, had not appeared back in your August of 2007 Markman order. That is what we did. These reports are, I think

the longest is ten pages, but most of them are in the fiveto six-page-in-length area, with, of course, the caption taking up the entire first page. We have attempted to follow the rules. understand the importance of the Court's language. understand the Court's role in construing terms. We We We went

back to our experts immediately and said, please look at

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this order.

Do your reports need to be supplemented in

light thereof? That is what we did. THE COURT: Okay. Bear with me just a second

before you respond, Mr. Jacobs. (Pause.) THE COURT: MR. JACOBS: for a minute. Mr. Jacobs, I am sorry. Your Honor, let's set Melody aside

We can come back to that, because Mr. Scheve

has vastly overstated what happened at her deposition. Setting Melody aside, marching through them, let's start with Munson, who has turned into their lead infringement expert. In Munson's original report, he had one fragmentary reference to the possibility that individual particles might be more crystalline than Abraxane as a whole. The sentence was this: Samples that are on average

from 3.5 percent to 12 percent crystalline such as those discussed above include individual particles that are mostly crystalline. That was the entirety of the expert report last fall. Munson was asked about that sentence at his expert deposition. question. He really did not want to answer the He had

He asked how long was on the videotape.

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to be instructed twice by Mr. Sullivan that he needed to answer the question. Then he went on, went on a lengthy

exegesis on really an unrelated topic, and gave no foreshadowing of what he was about to say in the supplemental report we received yesterday. In that report, he notes his original sentence, individual particles that are mostly crystalline, and then he attempts to quantify the number of particles in Abraxane that are entirely crystalline. And he says, well, there are

two trillion -- there are probably two trillion particles in which there is a portion of the paclitaxel that is crystalline. Of these two trillion particles, it is my

opinion that most of them contain paclitaxel that is entirely crystalline. So we have gone from individual particles that are mostly crystalline, a half-expressed thought, to a quantification of particles that are entirely crystalline. That, in turn, is based on an entirely new theory that we haven't had advanced before to us. It is called the theory

of nucleation, the nucleation theory of crystallization, which is, as stated by Munson here, when one crystallizes a substance, it usually becomes completely or essentially completely crystalline. I think I can prove the newness of this in several different ways. One is just by way of the

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comparison with the earlier report and the early sentence -and the fragmentary sentence about mostly crystalline particles there. But as the Court will recall, as recently as a week ago, Elan submitted a motion for reconsideration in which all of the evidence advanced in that motion was that particles are not entirely crystalline or entirely amorphous. They are within some sort of gradient or

variable quantities. There are two paragraphs in which that is elaborated at great length as a way of saying that the Court's clarification of the claim construction is wrong. Now we have a supplemental report for Munson which goes the other direction, and says, no, no, no. They

are entirely crystalline and I can tell you how many of them there are. By the way, the quantifications are not detailed. He doesn't explain how he gets to two trillion. But it's not explained. Of course, all of

We can guess.

the work we had done in analyzing Munson's 50-percent error rate to get above ten percent, the doubling from four percent to get to eight percent, all of that is now out the window because it appears he is not relying on that argument at all. Munson nowhere mentioning Melody. So Melody has

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nothing to do with this theory.

This was a theory that There

Munson and Elan could have articulated along the way.

should be no surprise, based on the Court's original claim construction, that the particles' medicament had to be entirely crystalline. whatsoever. Of course, he had this half-fragment that individual particles could be mostly crystalline. If we had this report back in September, our approach to challenging Munson's expert testimony would have gone off on a very different path. We now would have been There should be no surprise

looking for not particles that are in some sense sort of, this whole crystalline phase issue that they were articulating, we would have been attacking a report that says, I know that there are some billions or trillions of particles in Abraxane that are entirely crystalline. If we had the nucleation theory in September, we would have gone off and embarked on attacking the nucleation theory. So that's Munson. Munson, you don't need to

hear about from Melody, because Munson doesn't mention Melody. Let me turn to Berkland. Berkland is directly Yes, Berkland

in violation of the Court's order on 1 and 4. references Melody.

But much of his report is not based on

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Melody's testimony at all.

It is based on things that have

long been available to them, including all the reports from a year ago that had Melody's name on them and Micron's name on them, and had the USP referenced. So the newness argument for Berkland is very powerful as well. But the killer here is that Your Honor issued an order that said Brittain is the only one who is going to criticize Abraxis's x-ray powder diffraction -- I'm sorry, that Brittain is the only one. Now they are submitting an

additional report from Berkland. Maybe if we focus on those two, we can make some focused progress, Your Honor. THE COURT: Mr. Scheve, let's do that. Let's

focus our attention for now on Munson and Berkland. MR. SCHEVE: All right. I will start with

Berkland, because I think that's the shortest, Your Honor. As Your Honor knows, a motion in limine doesn't preserve anything for appeal. So in order for me to

preserve for appellate review Your Honor's decision that I am limited, in other words, I am not free to pick between Dr. Berkland and Dr. Brittain, we felt it necessary to supplement his report. We expected to go before Your Honor outside the presence of the jury, offer that testimony. I frankly, Your

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Honor, expected that Your Honor would again, at the time of trial, rule in the way consistent with your in limine notion. But the suggestion that I have done something

wrong -- and Mr. Jacobs knows it, the only way I can preserve this issue for appeal is to supplement his report, because I understand Your Honor has said if it is not in the report it can't be offered, and then make an offer of proof, if Your Honor said it can't be heard by the jury. That is why I did what I did, to protect my rights. And the notion that it should be stricken, when Mr. Jacobs knows I have to do that in order to preserve rights, is simply again another desperate position to try to make sure that the truth -- and I think that is what this process is about, is to get the truth to come out. And Dr.

Berkland attended the deposition of Melody, Ms. Melody last week. And that's the first time that he had heard anything

about how they had customarily told their customers, including Abraxis, you have to do these standards, you have to do the particle size standards, you have to create the appropriate standards against USP, and that Abraxis chose not to do it. That's the first time that any of that came

out and the first time that he had heard testimony that to this day she doesn't know if it is either crystalline or amorphous based on that x-ray powder diffraction because

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those standards were not done. THE COURT: Before you go on to Munson, I do

have a question, Mr. Scheve. Why not supplement Brittain's report instead? Why did you make that election? Was it because of your

assessment of how one goes about preserving the appellate rights? MR. SCHEVE: purpose. Yes, sir. That was my primary

And Dr. Brittain has already expressed all of his

criticisms in depositions about the x-ray powder diffraction that was done. THE COURT: MR. SCHEVE: Why don't you go on to Munson then. Yes, sir.

Here is what is happening, Your Honor, and what Mr. Jacobs -- as they say, here is the rest of the story. The particles that are contained -- let me back up. Abraxane is nine parts amorphous albumin and one part paclitaxel. In their documents, which we will

demonstrate at trial, they did some separation of this free albumin, meaning this unbound albumin, and did some calculations of how much paclitaxel and how much albumin is in the particles. And their own conclusion is that 95

percent of that albumin is free. We have got these particles, which according to

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their own documents submitted to the FDA are 88-percent paclitaxel and 12-percent amorphous albumin. What Dr. Munson testified to in light of what Your Honor's claim construction was -- I said testified. What he put in his report, which tracked again Your Honor's claim construction of August of 2007, which construed the phrase consisting essentially of crystalline medicament, surface modifier and other ingredients that do not affect the basic and novel properties of the invention, by definition, those particles, 18 percent of them are amorphous, of the particles. When Your Honor issued the clarification, and that's why he said in his report that, of his opinion in August of last year, that there are particles contained in that product that are mostly crystalline, because by definition, if we are talking about it as a particle, it is going to be 82-percent paclitaxel and 18-percent amorphous albumin. When Your Honor clarified last week, and there is the "Whereas" clause, and I actually looked up the word whereas, and the phrase has the meaning, it is taken as fact, whereas it is taken as fact that an amorphous product, a largely amorphous product could not infringe the '363, we asked him, what would your opinion be if that is the Court's construction. And his report says --

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THE COURT: construction.

That is not the Court's

I fear that I have created controversy where

I was making an effort to give the parties clarity, which, with the benefit of hindsight, I had given in the issuance of the first order and the infamous footnote in question. reject that notion, Mr. Scheve. MR. SCHEVE: But go ahead. I

But if I can just explain, Your

I asked him first, I said, if this were the And his report

construction, what would your opinion be.

says, if that's the construction, then it doesn't infringe. Then I said, assume that what we are talking about here is that the word product meant medicament, that we are talking about the medicament within the particles. your opinion? And he said no. Does that change

And I said, in what way?

And he said, well, it would serve to reduce the number of infringing particles. But, you know, we are talking 60

trillion particles within Abraxane, and if you take the most conservative number, my three and a half percent, and multiply it by 60 trillion, he said there are around two trillion particles that contain crystallinity. Then he did further calculations and said, conservatively, the most conservative assumption I have is that the number of infringing particles is in the billions. And I said, can you articulate that then in a way that's consistent with the Court's construction.

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And so all he did was to say, there are particles wherein the medicament is entirely crystalline and those numbers would be in the billions. All I have tried to do, Your Honor, is give him your clarification order and say it's important that we track the Court's construction language. offer an opinion that meets this? Can you still

Because, Your Honor, if

he had said, no, I can't, then I as an officer of the Court would be faced with the issue of can we proceed or not. THE COURT: I think he should have been able to

do that based on the original order. Go ahead, Mr. Jacobs. MR. JACOBS: Let's hear a response. You know, there

First on Berkland.

is a way to make an offer of proof or to say I am making an offer of proof. not what we got. You say this is an offer of proof. That's

We got a supplemental expert report.

So if what he is saying is he doesn't plan to offer that testimony at trial, it's just an offer of proof, fine, he can make whatever offers of proof he wishes. On Munson, I think Your Honor has it exactly The point of the clarification of the claim

construction was this was always in the claim construction. Footnote 4 rejected "a portion of." We are seeing another We are seeing a

variation on the "a portion of" theory.

variation on the "a portion of" theory that not only should

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and could have been forecast from the original claim construction, but really represents kind of the just before trial version of hiding the ball. It's really quite extraordinary that when the issue has always been whether there is crystallinity in Abraxane from the very first case management conference, now we are getting a quantification of the supposed number of crystalline particles in Abraxane. To say that Munson did calculations, where are the calculations? Are we once again going to hear more at

trial that we haven't had a chance to develop pretrial? There are no calculations set forth here. So I think this is all, this really is, as I started to get worked up to say, Your Honor, this is hiding the ball at its most extreme, in its most extreme form. THE COURT: MR. SCHEVE: THE COURT: Okay. May I respond, Your Honor? Well, I think I have made -- you had Please

already anticipated the Court's ruling, Mr. Scheve. respond briefly. MR. SCHEVE:

Your Honor, the position we are in

is, if it was so clear, why was the Court issuing a clarification? And we took that very seriously. And I think I have already addressed If that is the

THE COURT: that issue.

Perhaps I muddied the waters.

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case, and it does appear to be, indeed, the case, my apologies to both sides. It seems, with the benefit of

hindsight and listening to this argument, that I should have left stand the original order and let the parties have at it based upon my original claim construction order. And you correctly anticipate my ruling as to Berkland and Munson, Mr. Scheve. I am going to reject the offers of proof, and order that the supplemental reports be removed or struck from the record. Let's talk about, I guess Melody is a discrete issue. Is Melody a separate issue? MR. JACOBS: Your Honor, I think Melody was -So as we look at the

the Berkland report was about Melody.

other reports, frankly, Your Honor, I think on the other reports we are okay dealing with them closer in -- well, Manning. Emily Evans is here with me, Your Honor. just talk briefly about Manning. MR. SCHEVE: Your Honor, can I get some Let's

clarification on Dr. Munson? THE COURT: Scheve. Go ahead. MR. SCHEVE: Your Honor, I have a witness who I am afraid to clarify anything, Mr.

put in his report that those particles were mostly

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crystalline because he was focusing at that time on the August order. Do I understand, Your Honor, that I would not

be allowed to ask him at trial do you have an opinion whether it contains particles that infringe under the Court's construction order? THE COURT: construction order? Under the Court's original Right? He has

He has opined on that.

opined with the Court's original order in mind, in other words. MR. SCHEVE: THE COURT: Yes, sir. Well, I see no reason that you can't

have him discuss that with the jury. MR. SCHEVE: THE COURT: that? MR. JACOBS: Your Honor, I think what Mr. Scheve Okay. Mr. Jacobs, any difficulties with

is indirectly exposing is a slightly different variation on a theme. Recall that what Munson says in his original

report is individual particles that are mostly crystalline. Then Elan reads the Court's clarification and writes to the Court, we don't have an infringement theory anymore. agree with that. And we

We agree, we thought they didn't have an But they kept the case

infringement theory last August. alive.

But they told, they wrote to the Court and said

three times in the request for clarification, we don't have

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an infringement theory anymore. Now they have told the Court that they gave the Court's order to Munson and said, can you come up with an infringement theory? And Munson is saying, yes, I can. But

that report has now been stricken. can they have it both ways?

So the question is, how

How can they represent to the

Court that they don't have an infringement theory, have Munson's report be stricken, and still have an infringement theory? THE COURT: MR. SCHEVE: Mr. Scheve. Your Honor, the statements made in

our motions in limine last week went to the "Whereas" clause, whereas, again, taken from Webster's Dictionary says -THE COURT: Counsel, given the fact that,

indeed, I do have limited time, I am going to stick by what I said originally, in my original ruling. Should we need to Okay?

address this further in realtime, I will do that.

But as to your request for clarification, I think I have been as clear as I possibly can be at this point. But I will not get exorcised if you want to, feel it

appropriate to, I will say renew, for lack of a better word, at least your request for clarification. MR. SCHEVE: THE COURT: Thank you, Your Honor. So we were talking about Melody.

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MR. JACOBS:

Your Honor, there are no -- to my There

knowledge, there are no other Melody-related issues. were some other supplemental reports. deal with them in realtime.

But I think we could

The one I would flag for everybody, especially, But as I say, I think we can deal with that in

THE COURT:

All right, then.

So of those

witnesses teed up initially, we still have Byrn and I guess Jarosz to talk about? MR. JACOBS: Jarosz is the damages theory. What Byrn

Again, I think we can deal with that in realtime. did was re-do his obviousness analysis.

It's a mix of re-do

based on the Court's claim construction and things he should have done earlier. realtime. THE COURT: MR. SCHEVE: Do you agree with that, Mr. Scheve? Certainly, it can be dealt with in Again, I think we can deal with that in

But I don't believe -- as you know my position,

Your Honor, there is no issues to be dealt with. THE COURT: Okay. me ask it this way. I understand your position, yes. Have you filed -- let

An issue of mine.

Have you been able to agree on a set of

preliminary instructions? MR. JACOBS: Your Honor, we have been trying to

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get some responses from Elan on this. e-mail.

I am just checking my

It looks like something may have finally -MR. SCHEVE: It was filed a few minutes ago,

Your Honor. THE COURT: Is it an agreed-upon set? Your Honor, it is an

MR. SULLIVAN: almost-agreed-upon set. THE COURT:

All right. But it is a set that complies

MR. SULLIVAN:

with the Court's instructions to provide clean language with objections set forth elsewhere. THE COURT: Okay. In other words, what you have

filed is in an effort to preserve appellate issues. MR. SULLIVAN: THE COURT: MR. JACOBS: Honor. Exactly.

Would you please file -It is not just appellate, Your

I think there are some other things that we would

like the Court to take a look at. THE COURT: That is what I am interested in

knowing, whether there are things that we need to attend. So can you just tell me -- I haven't pulled that yet, because it was just filed -- if you have a set in front of you, what pages, or at least what instructions are at issue, if not the pages? MR. SULLIVAN: Your Honor, I think the

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submission sets it forth pretty clearly. THE COURT: Here is the thing, Mr. Sullivan. I

am just wanting to know that I will know when, and Ms. Walker has just gone to try to retrieve this, the distinction between issues that I need to address for Munson and those that I don't, because they are merely highlighted in the interests of the preservation of appellate rights. MR. JACOBS: Your Honor, I think it's really There is a word must and a

actually a pretty small issue. word shall.

And we don't need to give you a lot of You just need to call this one.

argumentation on all this.

It is highlighted in the comments. The other objections, they are serious objections. But I understand that the Court might not want

to -- I understand the Court's position on whether to decide those in advance. MR. SULLIVAN: I will differ with that only to

the extent, sir, that Elan has objected on two grounds, Abraxis has objected on five grounds. in a cover sheet. Those are set forth

Elan objects to issues of

unenforceability being submitted to the jury and the use of the mandatory language must versus the word should. objects to -THE COURT: Did I not already rule on the issue Abraxis

of enforceability being submitted to the jury?

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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 take a look. will.

MR. SULLIVAN: THE COURT:

Yeah.

And I think, sir -You mean yes?

"Yeah"?

MR. SULLIVAN:

Sir, I think, yes, that's true.

And I think that potentially the word must versus the word shall or should will be up to the Court's sound discretion. THE COURT: Here is the thing. If they are

issues I have already ruled upon, and it sounds like this is at least one, they have been ruled on. MR. SULLIVAN: Your Honor, we have tried very

assiduously, and certainly Elan has removed all of its objections to instructions on the '025, because the Court has made it clear that the '025 will be in issue, so we have tried to facilitate things for the Court and the jury. THE COURT: Here is what we will do. I will

If I need to get you back on the phone, I

What's next, if anything? MR. JACOBS: the call, Your Honor. That is all that really prompted

I hope we don't get any more

supplemental reports, because we are trying to get ready for trial. It would be helpful to know if this is the last one. MR. SULLIVAN: I will only note on Elan's

behalf, just for the record, that Dr. Berkland's report was largely or entirely prompted by the very recent testimony of Ms. Melody, which took place last week.

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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 Sorry. need 1.7? agreement.

THE COURT:

Mr. Scheve made that amply clear.

I

really don't have time for a rehash, counsel. MR. SULLIVAN: THE COURT: in front of me. I apologize, Your Honor.

I have the preliminary instructions

Let me just page through them while I have

you all here to see if we can benefit from the fact that we are all on the line. You said there is a cover sheet. MR. JACOBS: objections are laid out. THE COURT: I see. There is a comment, is where the

Did we agree or not that the video was going to be used in this case? MR. JACOBS: THE COURT: Right? MR. SCHEVE: THE COURT: You are correct, Your Honor. Do, then, counsel, believe that we We did, Your Honor. Mr. Scheve, we did have that

MR. JACOBS:

Let me jump ahead, Your Honor.

No, Your Honor, I do not think that we need -- I think a summary of the patent issues is technically in 1.7. Yes, it is. THE COURT: Yes, it is. I think you can modify

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this a little more, because the video covers at least the first part, up to the heading Summary of Patent Issues. Doesn't it? MR. JACOBS: more, Your Honor. THE COURT: So the comments say, in part, that Why don't we work on that some

the parties maintain several outstanding objections to the instructions. We have Elan's objection to enforceability, That's been dealt with. We

reference to unenforceability.

have this "must" issue, I will look at that, in the fifth sentence of the first paragraph of Instruction 1.6. Then these Abraxis objections, these have been previously raised? There are five in number? They have been raised in the sense And our

MR. JACOBS:

that they surfaced in the actual jury instructions.

argument, if you will, on these issues is in the submission to the Court of the actual jury instructions. THE COURT: instructions? instructions? MR. JACOBS: They are extant in the sense that But they are not in the preliminary

They are not issues extant in the preliminary

there are references, for example, to willful infringement or the presumption of validity in the preliminary instructions; hence, the objection here. MR. SULLIVAN: Sir, just to clarify. In the

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pretrial order, all of the objections of both parties should be stated. THE COURT: Okay. I will take a look, and then

we will issue probably another oral order. But what I expect at this point is for 1.7 to be edited in accordance with our earlier discussion and now just recent discussion. I will take a look at the balance. Okay? All right, counsel. Thank you. But I

MR. SCHEVE:

Your Honor, I apologize.

have to raise this with you. You recall at the pretrial conference, we dealt with the so-called Atwood exception. THE COURT: MR. SCHEVE: The Atwood exception, okay. Dr. Atwood two and a half months You allowed And the

after his deposition supplemented his report. it and didn't allow us to take his deposition.

question was raised about rebuttal and what's in the reports. And Your Honor said on repeated occasions, and I

can find the quotes and the pages in the transcript for you if necessary, but you said, well, we may have to have an Atwood exception. Among the things that Dr. Munson did was

to supplement to deal with the supplemental material provided by Dr. Atwood. Do I understand that that portion

of his supplemental report is going to be stricken, too?

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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 Reporter: you. Mr. Scheve?

MR. JACOBS:

Your Honor, that is the first That is something

supplemental report we got for Munson.

again that I think we can deal with on the fly. THE COURT: All right. Do you agree with that,

MR. SCHEVE: THE COURT:

We certainly can. Okay. All right, counsel. Thank

(Conference concluded at 12:15 p.m.) Kevin Maurer -