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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 BEFORE:

No. 06-438-GMS

- - Wilmington, Delaware Thursday, May 15, 2008 9:30 a.m. Conference - - HONORABLE GREGORY M. SLEET, Chief Judge

APPEARANCES: JOHN G. DAY, ESQ. Ashby & Geddes -andSTEPHEN SCHEVE, ESQ., LINDA M. GLOVER, ESQ., LISA A. CHIARINI, ESQ., and ROBERT RIDDLE, Ph.D., ESQ. Baker Botts LLP (Houston, TX) -andGREGORY BOKAR, ESQ. Counsel - Elan Drug Delivery Counsel for Plaintiff

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APPEARANCES CONTINUED: ELENA C. NORMAN, ESQ., and MICHELLE SHERETTA BUDICAK, ESQ. Young Conaway Stargatt & Taylor, LLP -andMICHAEL A. JACOBS, ESQ., EMILY A. EVANS, ESQ., and ERIC S. WALTERS, ESQ. Morrison & Foerster (San Francisco, CA) Counsel for Defendant THE COURT: seats. Please, take your

Good morning.

It's an office conference.

As counsel know, during

my office conference process, you are free to stand or sit, however you are comfortable. Why don't we start with, for the record, a round of introductions. MR. DAY: comfortable standing. On behalf of Elan, John Day from Ashby & Geddes, local counsel. At counsel table from Baker & Botts, Good morning, Your Honor. I feel more

starting at Your Honor's right, Steve Scheve, Linda Glover, Robert Riddle, and Lisa Chiarini. In our back row, Your

Honor, Greg Bokar, whom you have already been introduced to, vice president of intellectual property and litigation for Elan. With him, Richard Collier, Elan's executive vice

president and general counsel. THE COURT: Good morning.

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Counsel. MS. NORMAN: Good morning, Your Honor. On With me

behalf of Abraxis, Elena Norman from Young Conaway.

at counsel table, Michael Jacobs, Morrison & Foerster, Emily Evans, Morrison & Foerster, Eric Walters, Morrison & Foerster, in-house counsel for Abraxis Rick Marone (phonetic), in the second row Michelle Budicak at Young Conaway. THE COURT: Okay. The way I generally approach We will start out with the

these things is rather randomly.

motions in limine, then go through the tabs that I have marked in Volume I of the proposed pretrial order. necessarily in this order, we will talk about the preliminary jury instructions. there. There are some disputes Not

Actually, there are a number of disputes all over

the place in this case, which causes me to say to you that time is going to be somewhat at a premium. I can spend the time necessary, hopefully, to resolve those issues, and those that I have to take back to chambers with me I will, those that need further thought. But I do want you to keep the thought in mind that there are a lot of issues between the parties. you would keep your arguments in check, keeping those thoughts in mind, I would appreciate it. will. If you don't, I So if

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I am going to start out -- we will talk about the preliminary instructions. I don't think we are going to I don't think we are

get to the final instructions today. going to have enough time.

We will talk about your proposed voir dire. will talk about general nudges and nits that I have and

We

requirements that I have for your conduct before me and the jury. Then I will entertain whatever agenda items you might

want to raise with me. I am going to start out with what may be perhaps an unhappy note for Elan, because I think you have not paid close attention to one of my requirements. That is that the Depending

motions in limine be kept down in number to five.

upon how you count, it seems to me there are anywhere between, I will give you a range, eight and ten separate motions that have been filed, depending upon how you count. I am going to give you a chance to look at your list, whoever is pulling the laboring oar on this, and decide what you want to do. For instance, let me give you a for-instance, I think Abraxis appropriately and correctly points out, in the second motion, it's really three motions in one. Motion No. 1 to be two motions in one. is my count. I count That

Again, No. 3.

You may count differently, but I guess since

it's my count that counts, if you will, that is the count

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you are going to have to use. You have got at least, probably, ten. So you

need to think about which of these motions is really important to you, which of those you want to pursue. you on the spot a little. I put

If you need a few moments, I can

retire back to chambers and come back, if you want some time to think about it. If you want to talk to Mr. Jacobs and

talk to his team about it, I am willing to have you do that. But I am going to have to insist on process being adhered to. MR. SCHEVE: Honor? THE COURT: Sure, no problem. Could we have five minutes, Your

(Recess taken.) THE COURT: MR. SCHEVE: Okay. What is your pleasure? In light of the

Thank you, Judge.

Court's request, we first would like to address the generic Abraxane issue that was raised. THE COURT: In other words --

Do you have a docket item or some Is that No. 2?

way that you have identified that? MR. SCHEVE:

It's what we have in our Tab A as I am not sure I have got it.

our first motion in limine. THE COURT:

Is that styled plaintiff farms

motion in limine to exclude products marketed by -UNIDENTIFIED SPEAKER: That's the motion.

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THE COURT:

Do you want to do that one or no,

MR. SCHEVE:

Actually, it is just one of the It

issues that is raised in that motion, Your Honor.

relates to the issue about admissibility of testimony or evidence about the fact that my client spent a total of $80,000 evaluating whether or not it should look into devoting a development program -THE COURT: You are talking about the marketing The

of the product that is embodied by the '363 patent? first part of the motion?

The reason I characterize it as

two, counsel, is that what I call the second part was your motion to preclude references to patents covering Abraxane. MR. SCHEVE: It is on Page 3 of our first motion

in limine, where we advise the Court that we expect that Abraxis would proffer evidence that Elan considered making a generic Abraxane. We believe that that particular evidence It is on Page 3 of

should not be coming into this lawsuit. our Motion in Limine No. 1. THE COURT:

Does it start at Argument III,

Paragraph A, Evidence that Elan has not manufactured any products embodying the '363 patent should be excluded regarding the '202 and the '403? MR. SCHEVE: It is in that section, the top of

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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 Your Honor. 1.

THE COURT: MR. SCHEVE:

The pages are different, apparently. It is the second paragraph, which

says, Similarly, Elan expects that Abraxis... THE COURT: So it's that subheading under III,

Subheading A that you want to discuss. MR. SCHEVE: THE COURT: MR. SCHEVE: Yes, Your Honor. What's next? The next would be our Motion in

Limine No. 2, relating to efforts by Abraxis's expert, Dr. Amiji, to usurp the Court's authority on claim construction. THE COURT: That's one that I counted as 3 and

You have, I think, a motion to bifurcate in there? MR. SCHEVE: We are not going to pursue that,

It is only the usurpation of the Court's

construction issue. It starts at Subpart A on Page 1. With regard, then, to Dr. Amiji, Your Honor, there are two bits of evidence that we have requested in a separate motion. If Your Honor used that as being two

separate motions, then it's taking up those two pieces of evidence relied upon by Dr. Amiji on the crosslinking issue. THE COURT: note Dr. Amiji. We can discuss that together. One is an I did

This is denominated No. 3.

effort to preclude Atwood and Mansoor Amiji. MR. SCHEVE: That one, Your Honor, which is No.

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3, goes to qualifications. Atwood as our fifth motion.

We are only going address Dr.

There is two particular pieces of evidence on the issue of crosslinking. qualification. It doesn't go to his

There are two pieces of evidence that under

any sort of Daubert standard wouldn't be deemed reliable or admissible. That is in our motion denominated No. 4. THE COURT: I know that's your position. Let me

make sure I have the right one. This has to do with the unreliable data concerning human albumin, the crosslinking? MR. SCHEVE: THE COURT: The crosslinking, yes. You are going to withdraw stealth Okay.

Motion for Summary Judgment No. 5.

With that in mind, let's go ahead and start with your first motion. MR. SCHEVE: The first motion we would like to

address, Your Honor, goes to what we anticipate to be evidence that will be presented by Abraxis about a so-called generic Abraxane program, as characterized by Abraxis. By way of background, Your Honor, Abraxis and some of its representatives starting making presentations at various scientific meetings about their product, claiming that it was both amorphous in terms of the nanoparticles that are in the drug -- and that is really what this case is

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about.

Our client's invention are nanoparticles.

They sell

a product that contains a bunch of free albumin, and albumin is a protein. Your body has albumin gushing through it. Their product has a Then there

Mine has albumin gushing through it.

bunch of free, meaning it's unbound, protein. are these particles.

Our claim, Your Honor, is that those particles, which have some albumin bound to the exterior, that those particles infringe our product. In other words, contained

within the 65 trillion particles in every vial, that there are two or more particles that infringe upon my client's patent, '363. After Abraxis started touting its product as being amorphous, and folks within my client were present at some of this and heard about it, the thought process was, wow, if they have really done this, from a business perspective, should we evaluate as part of our business model whether or not we ought to look at trying to make a generic version of that? My client spent I believe it's

$80,000 evaluating it, determining eventually that this product, Abraxane, actually infringes my client's product because it contains more than ten percent by weight of particles that are crystalline, or contains crystalline medicament, as Your Honor has construed it in the Markman hearing.

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So the business decision within the company was that it was going to protect its intellectual property. And

it brought this lawsuit, rather than spending money to go out and develop the generic Abraxane. Our position, Your Honor, is the fact that my company spent a total of $80,000, which in development of pharmaceuticals is a drop, and decided from a business perspective not to move forward is, number one, irrelevant to any claim in this lawsuit. There is no countersuit

claiming that by virtue of doing that we somehow infringed Abraxis's patents. In fact, as Your Honor knows, the Patent

Code specifically excepts research for development of products from infringement claims. It, number one, has no relevance under Rules 401 More importantly, Your Honor, under Rule 403, it

would do nothing but confuse and create problems in terms of misleading the jury. In a sense, it is going to create a

lot of frolic and side issue at trial. I point this out in that Abraxis has two arms in its business. products. One is that it markets over 75 generic On March the

Their business is making generics.

25th, they announced, in a press release, if I may read it, this arm called APP, they have recently reorganized and Abraxis Pharmaceutical Partners, APP, characterized as the leading manufacturer of multi-source and branded injectable

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pharmaceutical products, today announced that it launched celaphine hydrochloride for injection, the generic equivalent of Maxopene marketed by Elan. They are out marketing, introducing generics of our products. And it just gives further evidence that what

this will create is a bunch of evidence to come in on an absolute side issue that has no relevance toward the question of whether or not they infringe upon the '363 patent and any of the other issues relating to invalidity. This is a sideshow to try to create some appearance that, as I understand it, frankly -- I am sure Mr. Jacobs will correct me -- but during the course of discovery, the accusations that have been made are that my client only wanted access to documents in discovery so that it could use it to create a generic form and that we were going to misappropriate it, we were going to misuse it, et cetera. My clients made the decision before this lawsuit

ever started, witnesses have sworn to that, multiple witnesses have been questioned, that this business decision not to pursue a generic version of Abraxane was made before the decision to move forward with this litigation was ever made. So we would ask that evidence about the fact my client for a limited period of time considered, evaluated whether or not it ought to spend money and put in place a

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development program for a generic Abraxane, based upon their public statements that, in fact, their product was amorphous -- we are going to prove in this lawsuit that, in fact, it contains crystallinity. And the business decision As Your Honor So this

was made, we are going to protect our IP.

knows, we have an obligation to protect our IP. lawsuit was the course that my client took.

So it is not relevant, and if it is even tangentially relevant, 403 should require its exclusion, Your Honor, because as Your Honor has told us, our time is cramped, the Court's time is cramped, and valuable. And this is nothing but a sideshow, a circus, and we will end up in a frolic with the admissibility about who is a bigger problem: When they filed and started

marketing a generic of one of my company's drugs, or when my company considered and spent a total of $80,000 and then decided not to go forward with the generic of Abraxane? We would ask for exclusion of that topic during the course of trial. THE COURT: this? MR. JACOBS: I am a little puzzled, Your Honor. Mr. Jacobs, who is going to handle

The motion was a motion in general to exclude evidence, commercial embodiments. We responded to that. There is a

fragmentary -- there is a reference to the generic Abraxane

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issue.

But it isn't fully developed in their brief.

It's

being kind of explicated here for the first time. If the Court were to exclude evidence of the generic Abraxane program, I put "evidence" in quotes, it would be excluding evidence that goes to the similarity or differences between crystalline and amorphous forms. In Elan's generic Abraxane documents, they talk about, well, gee, can we get a crystalline version of this approved? How will the crystalline version compare with an

amorphous version? The question of equivalence is raised by their affirmative case, their own documents, we will adduce, to show that Elan itself considered the crystalline and amorphous forms to be very different. The documents will,

in fact, go to not just this particular effort to develop a paclitaxel-based anticancer drug using the crystalline grinding technology that is described in the '363. This is

an effort that has gone on for over, for about 15 years. This was just another episode in that effort. And there is

documents that talk about the long-term failure of Elan to develop a paclitaxel-based program. All of that evidence is relevant to enablement. So those are just two of the reasons why excluding evidence of generic Abraxane would be highly -- it would be damaging to our ability to put on our case, Your

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Honor. THE COURT: I should also say as an aside that

enablement, I will permit argument to the jury on that. There is going to be, I think, competing evidence on that issue. So agreed that it is a matter of law, ultimately. I

It seems to me that is an issue that should come in.

think that that is an issue that is raised somewhere in the papers that I have read. You are going to have to be prepared, and I think the whole issue of enablement, both parties should be able to discuss that with the jury at the appropriate time. Do you want to respond, Mr. Scheve? MR. SCHEVE: Only, Your Honor, by suggesting

that, again, their brief does not address this, even though it was clearly raised in our briefing. My client's business model, Your Honor, is -and I don't want to be accused by BASF of stealing their line -- my client doesn't make the drugs, it makes the drugs you make better by providing delivery forms. In other

words, if you have a product and you want to extend it out, you see these controlled-release ads for drugs, Ambien CR, controlled release, there are dozens of those products out there. My client is the CR. It's the company that's My

involved in giving you different ways to deliver drugs.

client's business model is, it takes that technology, for

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which it has around the world over 1200 patents and applications protecting its drug delivery business. So when they started making public announcements that they had come up with an amorphous product which no one had been able to do for 30 years, then my client started saying, well, should we evaluate whether or not from a drug delivery perspective we ought to spend some time and money doing that? it. And what the evidence is, it becomes a sideshow on this whole generics concept because then I am going to be sitting there cross-examining them about the 75 drugs that they have gone out and done investigation on, because you can't file an Abbreviated New Drug Application -THE COURT: MR. JACOBS: What about that, Mr. Jacobs? Maybe this will help, Your Honor. They spent 80,000, and decided not to pursue

There is a certain element of reciprocity on this issue. Elan is going to argue that Abraxis got a copy of their patent in 1996, and studied that patent and, quote, copied from it. That's going to be part of their case-in-chief. We are going to be saying, look, Elan, when you were trying to create a generic Abraxane, you studied Abraxis patents. It is typical in the pharmaceutical That

industry for companies to study each other's patents. is not something that is in itself actionable. To the

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contrary, we all know the patent policies. If Mr. Scheve will argue that there is nothing improper about -- if Mr. Scheve will not advance an argument about impropriety going in our direction, we will not advance an argument about the impropriety per se of Elan trying to develop a generic Abraxane. It isn't our plan,

because everybody knows, the jury knows, that there are generics out there. So maybe that's helpful. I do not plan to argue

that per se their effort to create a generic Abraxane was in some way improper. I do plan to rely on the documents

arising out of that program to prove basic elements of our case. THE COURT: MR. SCHEVE: Mr. Scheve. Well, Your Honor, what was the word A "stealth"

you used to describe our Motion in Limine 4? motion for summary judgment? THE COURT: MR. SCHEVE:

A very interesting proposal.

5, actually. Excuse me. They

We filed a patent infringement case. didn't.

They didn't claim, not before this Court is any

claim anywhere that our activity somehow infringed their patent. We will show that they got a packet in 1996 that is just covered with handwritten notes, including copy --

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it's there to show that they willfully infringed upon our patent. So, hearing his offer, I certainly will decline that, Your Honor, because this issue about who engages -you can't file or seek approval to market a generic unless the product, the marketed or branded product reaches what is called Abbreviated New Drug Application status. Either the

patent expires, the patent is declared invalid, or there are some other enumerated things. this case. So we would be going through a bunch of mini-trials about the fact that that is all they do is study drugs, because over 75 of the products that they sell in order to be marketed have to be studied before you can file an ANDA. It's the way business is done. We will end up None of that is an issue in

with a bunch of side trials on prejudicial grounds about, is there anything inappropriate about trying to evaluate and then deciding not to proceed with trying to develop a product because we came to the conclusion they are infringing on our technology, we are going pursue our rights through the courts? THE COURT: additional thought. MR. JACOBS: Honor. I am trying to refine it, Your Your colleague may have an

But if it doesn't go anywhere, I have taken my best

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shot. Neither side should argue that it is improper per se to attempt to development generic pharmaceuticals. We know for all sorts of reasons the statutes favor that. Neither side should argue that it is per se improper to study another party's patents in the course of drug development. And if that is an agreement, yes, we can avoid

having to do some kind of basic, fundamental stuff at trial that may be a bit of a sideshow. such a stipulation. I would actually favor

That doesn't negate his ability to

argue -- I don't know how he is going to argue it, because their patent says crystalline and in handwritten notation on the patent is amorphous or they are crystalline or we are amorphous or something like that. It is the issue of the claims of the patent that goes to willfulness, not the disclosure. That is my proposal for trying to keep this down to a minimum. I would add, under time limits, we don't have time for mini-trials. Scheve is arguing. I don't see the real risk that Mr.

But I offer that proposal because I

think it would make for a better trial. THE COURT: MR. SCHEVE: to, Your Honor. Mr. Scheve. I am not sure what I am responding

What I did hear him say is he didn't want

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any sideshows.

We are in agreement there.

I am asserting

they went to our patents and they lifted stuff, it all goes to willfulness, I will be able to prove that. They haven't a claim -- there is no claim before the Court that what we did violated their patents, infringed their patents. With no claim being present, why would we

have any evidence in the case that in any way reflects upon the fact that my client considered for a very discrete period of time: Should we spend resources and money to try

to develop something which they claim was different than our product? THE COURT: statement. MR. JACOBS: There were two. Mr. Jacobs, your reaction to that

On the first, again, all I am saying is, there is nothing improper per se in studying another company's patents. THE COURT: MR. SCHEVE: MR. JACOBS: Conceded by both parties, I think. Correct. There is nothing improper per se

about attempting to develop generic pharmaceutical products. MR. SCHEVE: MR. JACOBS: Agree. Then I think that resolves what the

primary argument for trying to keep out the generic Abraxane program of Elan is, because if I am not going to argue, And,

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ladies and gentlemen of the jury, they tried to develop a generic and that was wrong, then the evidence about the generic Abraxane comes in for the purposes that I anticipate using it for. There is another piece of this, just in terms of reviewing the actual briefing we did on this particular topic. For example, there is a notebook from their chief --

one of their inventors on their patent in this generic Abraxane program about the unsuitability of human serum albumin. We just heard about human serum albumin. We use

human serum albumin.

Once again, they are saying their

patent says their patent covers something that we, Elan, with 15 years of experience with the '363 under our belts, we can't use hsa, it's unsuitable, even though Abraxis has launched a blockbuster drug based on this hsa. So to exclude that evidence would harm our ability to prove our nonenablement case. MR. SCHEVE: What my motion goes to, Judge, is

we have heard ad nauseam, I wish I brought the e-mails -THE COURT: MR. SCHEVE: of stealing. I am glad you didn't, counsel. -- accusing my team and my client

Their CEO, we took his deposition, and he

accused us of stealing and this full lawsuit is motivated by our desire to steal their technology to create a generic. THE COURT: I don't understand that to be what

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underlies this current issue. MR. SCHEVE: the lawsuit, Your Honor. THE COURT: I think counsel has agreed with you That's what we want to keep out of

on that, other than for purposes that I think he has argued, a relevant use. MR. SCHEVE: If the only thing he is arguing is

relevant is enablement, Your Honor, whatever we did to consider creating, mimicking their product, somehow goes to enablement of our invention, which they claim is different than their product, that is nonsensical. THE COURT: relevant. It may be nonsensical, but it is

You are free to argue that point to the jury, But I don't know

that there is no logic to this assertion.

that that drags us down into the mud of the sideshow issue that you are talking about. MR. SCHEVE: Honor. That is the sense of it, Your

But it is Your Honor's duty as gatekeeper and to

apply Rule 403, that if this gets into a recitation about how we tried to mimic their product, et cetera, this generic version, we do -THE COURT: The reason we are having this

discussion and that I take the time that I do to have discussions like this, rather than me get up on the Bench in a robe and have it done in a very formalistic kind of way,

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is so we can talk about it.

I think in talking about it, we

massage the issue to the point where there is appropriate agreement. I think I have identified an appropriate use of

the evidence. I am well-aware of my gatekeeping functions. You better believe I am well-aware. And lawyers who have

been in here -- I don't know who has been in here, Mr. Jacobs has, of course he has -- will tell you that I am pretty -- I don't like to get in your case, just as a general matter, the parties are well-represented here, experienced, smart lawyers. arbiter of the rules. I am going to do my job as the Okay?

Please, I will. Thank you.

MR. SCHEVE: THE COURT:

I guess that is to say, I will deny

the motion based upon the discussion we have just had and given the parameters that we all agreed on just now and that I have indicated are the parameters. MR. SCHEVE: our second motion. THE COURT: MR. SCHEVE: Yes. This is the motion that focuses on Your Honor, if we may proceed to

what we believe is an effort by Abraxis to gain a second bite of the apple on the Court's construction of terms. This is embodied through their witness, Dr. Amiji. It is

our motion that seeks to prevent the usurpation of Your

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Honor's role as the person to construe the terms. Dr. Amiji, Your Honor, has, in his testimony, in his deposition and in his report, attempted, and what Abraxis has done, in fact, in its briefing and is clearly trying to do, is to get their witness to take issue with Your Honor's claim construction that was memorialized in the Markman hearing on three specific terms, every single one of which were construed by Your Honor, were part of Your Honor's decision. They are going to try to pursue an indefiniteness claim in this lawsuit, and do it by having Dr. Amiji stand up and talk about these terms and open up these terms and try to have a witness give meaning to terms that Your Honor has already -THE COURT: me. Let me interrupt. Mr. Jacobs knows

He knows that is not going to be permitted. Mr. Jacobs, do you want to react to this? MR. JACOBS: Sure. I think there are two Let's take

motions.

There is the indefiniteness issue.

that first. Your Honor, if I may, I think I do know the Court's practices pretty well. You have told me in cases in

which I have been before you, you have told other litigants, we do claim construction. That doesn't speak to the The Court does its best job on

question of indefiniteness.

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claim construction that it can, based largely on the intrinsic evidence. If that leads to an indefiniteness We deal with

issue, that leads to an indefiniteness issue. that later. Can I spend a minute on that? THE COURT: MR. JACOBS: Go ahead.

The way this issue tees up, and it

is an issue of law for the Court, on the question of average particle size, the specification defines average particle size about as specifically as it can do. The Court in its And then

claim construction order adopts that definition. we take our expert depositions.

And their experts are all

over the map in applying the definition provided in the specification that the Court provided in its claim construction. So the indefiniteness issue that was maybe lurking there has become very tangible, and we intend to argue it to Your Honor. We win, we lose. But we don't

think you precluded us from doing that with your claim construction ruling. There are about three issues lurking on the question of the real issue here, which is how are we going to manage between now and trial and in trial debate about what the claim scope is in light of the claim construction. Issue No. 1, which is really what Amiji's

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testimony goes to, is that if one concludes as Elan is arguing, that you could have infringement with, say, ten percent crystallinity and .1 percent noncrosslinked surface modifier, then that is not supported in the specification, and there is a written description problem. Again, in doing claim construction, we didn't argue to you, and the Court doesn't generally entertain, here are the validity issues that will follow from the claim construction. The Court does the claim construction based So there is a written

on the intrinsic evidence.

description issue that falls out from the Court's claim construction. The second issue, we actually thought we won from the Court's claim construction on the question of a portion of the medicament being crystalline. let me back up a second. And, indeed --

We also won on another key claim

construction issue that we identified for Your Honor. THE COURT: that assertion. MR. JACOBS: Exactly. Let me stay with that. Footnote 4 supports that contention,

The point I was making is after claim construction they dropped the '025 patent but they continued to pursue the '363. And they are pursuing the '363 based on a theory that

consisting essentially of A and B can mean consisting essentially of small amounts of A, large amounts of not A,

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and moderate amounts of B and moderate amounts of not B. That is their theory, taking Munson at his best. The Court's claim construction took a straight-up approach to construing what "consisting essentially of" means and adopted the sort of verbal formulation, if you will, that the Federal Circuit gives us. That leaves open, in our view, legal issues. It

leaves open the legal question, what are the basic and novel properties? And we submit, Your Honor, that in deciding the

portion of the question, although it is not explicit, that one can infer from everything the Court read and included in the footnote that based on the specification and the file history, a basic and novel property of this invention is crystallinity and not crystallinity, i.e., amorphous, by definition, affects the basic and novel properties. Now, let me just acknowledge a move I am making in this argument to you. You could call that a claim construction issue, and we could have an argument about whether we should have argued that to you earlier, and I can explain that we didn't have their infringement contentions until we got their expert reports. issue. And I could show you how we did argue the

But I don't think we need -- I would suggest that's The right way to

not the right way to think about this.

think about this is this is an issue of claim scope after

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claim construction. I want to alert Your Honor to a case that I provided to Elan last night, the 02 Micro case. copies of it here. I have My

It is a really interesting case.

colleagues happened to be on the losing side of it, Your Honor (handing document to Court). If you go to Page 15 of this decision, Your Honor, what was going on at trial was the Court had decided that the words "only if," "only if" -- and I can see exactly what happened. Right? The Court thinks, "Only if," why do

I have to construe 'only if'"? But the litigants start debating at trial what "only if" means. Does it really mean "only only only if" or It is

does it mean "only if some of the times not only if"? one of those things we get into in patent cases. court decided, you know what? to construe any further.

The trial

That is an issue I don't need

And the Federal Circuit reversed.

It said, look, at trial, an issue of claim scope arose that is an issue of law for the Court. decide that issue. We remand. The trial court needed to

So in the motion in preliminary briefing, in our pretrial briefing, we have teed up to Your Honor the claim scope issues that we think are outstanding. The question of basic and novel properties -and then there is a Federal Circuit case that says that,

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that we cited in our papers, that says consisting essentially of A and B means, at most, consisting essentially of A and B and small amounts of C. that, too, is an issue of law. should be decided by the Court. So we don't think we are in any way acting inconsistently with the Court's claim construction. We We think

And we think that, too,

think that because of the positions Elan has taken, the Court's claim construction leaves us with disputes about claim scope that are issues of law for the Court to decide. Thank you. THE COURT: MR. SCHEVE: Honor. Mr. Jacobs talked about average particle size and went on for about five minutes when the actually term is average effective particle size. To get to the heart of it, Mr. Scheve. I don't know where to start, Your

the case he just cited was vacated by the United States Supreme Court as well, not the one he handed you, but the other one. Our motion goes to three terms you have already construed, Judge. The notion about basic and novel

properties, I will agree, they didn't ask you to construe it at the Markman hearing. because that's your job. I will argue they should have, It's not for Dr. Amiji to preach

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to the jury or tell the jury what those terms mean.

But the

three terms that Dr. Amiji purports now to give meaning to are, quote, "particles consisting essentially of," one of which Mr. Jacobs just told you about. Your Honor, you addressed it. You defined it.

We have your Markman order telling us what that term means. And to now suggest that "consisting essentially of" ought to have a different meaning and that Dr. Amiji ought to be able to opine about that meaning is the kind of testimony we seek to exclude. They are also asserting, if you read their brief, that the word maintain, "sufficient to maintain," is indefinite because it doesn't say, well, maintain for six hours, maintain for a day. construe. Your Honor was asked to It

Your Honor did construe that term and phrase. And it's not for Dr.

has been construed by Your Honor.

Amiji to read into it or to now sort of rehash and try to get a second bite at what the term "sufficient to maintain" means. And then again with regard to the phrase "average effective particle size," we have quoted to you in our brief how Dr. Amiji would define it. He wants to define

it as being the average size of each individual particle. By definition, I don't have an average weight. weight. I have my We have

Your Honor doesn't have an average weight.

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Your Honor's weight.

There is no such thing as the average

of an individual particle. So he has attempted to read limitations into terms that Your Honor has already construed. And with regard to this "consisting essentially of," I understand fully why Mr. Jacobs wants to do this, because it goes to, you know, he wants to cut out my ability to argue. Your Honor construed "consisting essentially of"

as containing a crystalline medicament with a surface modifier and other ingredients that don't affect the basic and novel properties of the invention. They want to read

words into that, de minimis other ingredients, almost none other ingredients. In fact, Dr. Amiji has testified that it

has to equal 100 percent. Our point is, you have told us what the definition is. Our experts have prepared their testimony, Those are the

we have prepared our case in light of that.

three examples, Your Honor, where we are asking that they not go out to put on Dr. Amiji to confuse this jury by offering that kind of testimony, which is nothing but a naked effort to end-run what Your Honor has already done on those three specific claim terms. THE COURT: MR. JACOBS: maintain. Anything further you want to add? To clarify what is going on with

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We didn't spot this one until expert The question is, do the particles have to

exist -- remember, you may recall from Elan's tutorial that the '363 is about keeping these particles separate so they don't agglomerate. particle size. It says maintain average effective

We thought, maintain means maintain for some

pharmaceutically useful purpose because Claim 11 is about using these particles to improve the treatment of cancer. Then we take their expert deposition. looking at the prior art. They are saying, well, And They are

maintaining it for 15 minutes is good enough.

maintaining them separate for 15 minutes on visual inspection, on visual inspection, is good enough. So all of a sudden, what seemed to us to be pretty clear, actually, from the Court's construction, turned out to be unstable. there. Dr. Amiji, I think counsel for Elan is reading into Dr. Amiji's proposed testimony quarrels with the Court's claim construction. That is just not there. He is That is the indefiniteness issue

not going to quarrel with the Court's claim construction. THE COURT: take a break. Okay. At some point we are going to If

I want to think about this a little more.

I feel after the break I am still not ready to rule, I will issue some written order. I think I have a view I am fairly

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comfortable with.

I will announce it shortly.

Okay, Mr. Scheve. MR. SCHEVE: The next motion, Your Honor, and I

interpreted Your Honor to say that you would treat it as two motions, it is the motion to exclude the unreliable test evidence that Dr. Amiji relies upon on the issue of crosslinking of the albumin. It should be denominated as Motion in Limine No. 4. I apologize for not having the document number. THE COURT: MR. SCHEVE: It's 473. Okay.

By way just of a little bit of

background, Your Honor, again, my client's invention are these particles. There are medicines or there are compounds

that are called water-insoluble or poorly-water-soluble. And those compounds, when you put them in water, since they don't like water, they migrate to one another. And that

migration is called aggregation or the clumping of these particles together. What Dr. Gary Liversidge and his team did when it patented the '363 invention was to recognize a number of things. Number one, if you could reduce these particles

down to very small size so that you increase their dissolution rate, you could increase the bioavailability, in other words, how much of this can actually get into the body, be absorbed by the body, get to the tumor. But the

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question then became, how do you engineer this in such a way that you prevent these highly water-insoluble drugs from getting in the body and clumping together and all of a sudden the body treats them as big molecules again, and big molecules create problems because they can't get through the very small vasculature, the capillaries and other things. What Dr. Liversidge and others invented was a way to reduce the particle size, in other words, they invented particles with a specific nanometer limit on them. There are three different claims. than a thousand nanometers. Claim No. 1 is smaller

To give you an idea of how

small that is, Your Honor, their vial of Abraxane is about half this size (indicating). In terms of particles, it

contains 65 trillion, that's how small nanoparticulate size was. That was the nature of Dr. Liversidge's invention. Then he described these surface modifiers that would be adsorbed -- my secretary, God love her, if I have had to correct the spelling of adsorb once I have had to correct it 50 times, because we are all used to the word absorb, to suck up. Adsorb describes a physical connection

but not a chemical connection, so that the surface modifiers are on the exterior but they are not chemically bonded to it. He described this. He patented it in the '363.

One of the claim elements -- as Ms. Evans told

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you during discovery, there are really only two issues in this case. That is, does their product -- they have Their drug

conceded virtually every other claim limitation. contains particles. for particle size.

They come within the claim limitation They have a surface modifier. They

concede that it's adsorbed onto the surface.

We really get

down to, then, do these particles, which are drug and the protein adsorbed on the surface, do they meet the claim limitation of particles that are greater than 10 percent by weight of crystalline medicament. this crosslinking. And secondly, it goes to

As to these proteins that are on the

exterior of the drug, Dr. Liversidge referenced in his patent that these are essentially noncrosslinked. Your

Honor was specifically asked during the Markman hearing to define that term. We have now Your Honor's construction.

So the issue, one of the two issues that this case will be about is, Abraxis seeks to avoid the patent and avoid infringement by claiming that these surface modifiers that are adsorbed onto the surface aren't crosslinked. contention is that they are essentially crosslinked, whatever the magic language is. specific word. So they brought in this fellow from Northeastern University, I think it's Dr. Monsoor Amiji, is his first name, I will just refer to him as Dr. Amiji, who is their I may have misstated that Our

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person who is going to talk about the crosslinking issue. And crosslinking will get down to a bunch of discussion at trial about things called monomers, which are, mono meaning single chemical unit, dimers, which means two units that somehow form together, trimers, oligomers, polymers, et cetera. But you will hear a lot of discussion about what's

the chemical -- I should say the characteristics of that protein. Are they monomers, which by definition, if it is a

single unit, they can't be crosslinked to other monomers or dimers or trimers or whatever. So we have got Dr. Amiji who will testify on that issue. The two pieces of evidence, Your Honor, it's Defendant's Exhibit 50 and Defendant's Exhibit 76, it's DX-050 and DX-076. I will take them, if I may, Your Honor,

if you would like, we can show you copies of what they are. THE COURT: MR. SCHEVE: Honor. THE COURT: appended to? easier. THE COURT: If I may. Which declaration would they be Aren't they part of your appendices? They certainly should be, yes, Your

If you have an extra copy, that's probably

(Counsel confer.) THE COURT: Would this be in the replacement and

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supplemental exhibits? MS. EVANS: This document, which has a lot to

it, is not part of the exhibits that were filed with Elan's motion. MR. SCHEVE: Your Honor, this is the first of

the two issues, these two exhibits that relate to one particular test that Dr. Amiji relies upon. The second test that he relies upon is reflected in Defendant's Exhibit 563. This is the second test.

So what we have, Your Honor, again, looking at 050 and 076, we have a circumstance where Abraxis back in 2000 and 2001 performed a test called size exclusion chromatography -- I call it SEC because I grew up in a small town and I can't say big words very well. as SEC. So I refer to it

This data was never submitted to the Food & Drug

Administration as part of their filing, never published, never went anywhere. It was just this raw data.

Then what happened was after this lawsuit was filed in July of 2006, somebody internally instructed a woman by the name of Sherry C., we have got to deal with these allegations, start digging. And what she did was she

sent an e-mail to their primary scientist, Dr. Desai, purporting to reanalyze after July of 2006 this data that was created back in 2000 or 2001 from this SEC study. Someone at Abraxis created that data back there.

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Again, it was never reduced to any sort of report or anything of that sort, never peer-reviewed, never submitted to the agency. Dr. Amiji then gets this Sherry C. e-mail

with the so-called analysis, and he relies upon it, after admitting that he never looked at the raw data. So I have got an internal document that purports to identify or analyze data that had never been submitted to the Food & Drug Administration. And, of course, there is And I Every

data that was submitted to the FDA to gain approval. am sure Your Honor recognizes and appreciates this. company that seeks to market a drug, one of the FDA's

primary concerns, aside from the question of efficacy or, as they say in London, "ef-ic'-a-see" and safety, is the question of can you show us that your product can be consistently produced? In other words, show us that you Those manufacturing

have valid manufacturing methods.

methods and information about the characteristics of your product have to be sent to the FDA under what's called a CMC portion of a New Drug Application. CMC is another acronym You have to

for chemistry, manufacturing, and controls. submit it to get approved.

So they submitted their data that describes what that protein looks like, monomer content. And now we have

got this data that supposedly -- we don't know who did it, we don't know who created it. Supposedly, it exists back in

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2000, 2001. Desai.

We have got an e-mail from Sherry C. to Dr.

And this e-mail sort of reanalysis, done only after And

the lawsuit was filed, is what Dr. Amiji relies upon.

Dr. Amiji admitted in his deposition, no, I have never gone back and looked at any of the raw data, asking Your Honor to apply a Daubert standard to the admissibility and reliance on this particular document. It simply has no indicia of trustworthiness, never been submitted to the agency to look at. If it were

sufficiently reliable, and by FDA regs Abraxis was required to submit any information that it felt changed the character, quality, safety, or efficacy of its product -character, quality, safety or efficacy -- they never submitted it. to peer review. Never been published. Never been subjected

We don't know who did it.

All we know is Sherry C., who is one of their R&D people, research and development people, finds this data, does an analysis, and that analysis is what Dr. Amiji relies upon. How do I cross-examine Dr. Amiji when he We

hasn't looked at the raw data to form his opinions? don't know who created the raw data.

What is the significance of that, Your Honor? We don't know how the data was generated. We don't have any

of that scientific sort of background to discern what test, how was the test run, who was involved with it, et cetera.

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So we ask Your Honor that, first, those two documents that relate to that specific test relied upon by Dr. Amiji does not have any of the indicia of reliability that should go with it. We are not talking about somebody

pulling out a published article that meets the 803(18) learned treatise exception or some published research that's been subjected out there. indicia of reliability. This does not have any of the Frankly, it was, oh, my gosh, we

don't have anything, let's create something. It sat around for six years before Sherry C. decided, I better create this and send an e-mail to Dr. Desai. And now their expert is relying upon it. We would ask for the exclusion of those two particular exhibits. MR. JACOBS: May I introduce our response to

this, Your Honor, then turn it over to Ms. Evans on the specifics of those documents? THE COURT: MR. JACOBS: Sure. Number one, I am in violent

agreement with Mr. Scheve on one point, which is we endorse the Court's role as gatekeeper under Daubert. get to that in our motions. And we will

Number two, I think we are

beginning to see a different sort of sideshow develop, which is accusations about Abraxis's compliance with FDA rules, how what Abraxis did vis-a-vis the FDA relates to the

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question of infringement in this case.

We may get to that But I think we

later on in our motions in limine as well.

can start to see the volume ramp up about the FDA when this is a patent infringement lawsuit. The question is whether Amiji's testimony passes Daubert standards. I don't think we apply Daubert to That strikes me as a little odd

individual documents. application of it.

But I will now turn it over to Ms. Evans to explain some of the things that Mr. Scheve has pointed out. THE COURT: MS. EVANS: Your Honor. So, a few misimpressions that I think may have been created by Mr. Scheve that I would like to clear up. First of all, as Mr. Scheve said, this work was done in 2000 and 2001. Mr. Scheve attaches an e-mail from Ms. Evans. Thank you, Mr. Jacobs. Thank you,

Sherry C. to Neil Desai, who she reports to, attaching a copy of the report in 2006. That doesn't mean the report We will present testimony

was created in 2006, Your Honor.

at trial that, in fact, it was created at or about the time that the experiments were done, which was 2000 and 2001. The other thing I wanted to say, Your Honor, is that Elan knows who was involved in doing some of these experiments involved in the report. Leslie Liu, they took

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her deposition, talked to her about those experiments.

They

also knew that Sherry C. was involved, and, in fact, had noticed her for deposition, but canceled inexplicably at the last moment, a week before her deposition or less than a week before her deposition, and chose not to take it. So they have had a full opportunity to explore the experiments that are the basis for the disulfide bond report, as Elan has called it in its motion. The next thing I wanted to address was the accusation that Dr. Amiji had not reviewed the underlying data. And that is not correct, Your Honor. Dr. Amiji did

review the underlying data and did a very thorough analysis of it in his report, which is attached as an exhibit. So I don't know, if you looked at the testimony of Dr. Amiji that Elan cites, it doesn't say that he didn't review the underlying data. testimony says, Your Honor. The other point I wanted to raise was, Mr. Scheve referred to two different documents. The first one So that's not what the

was this exhibit which he handed up to Your Honor. THE COURT: MS. EVANS: motion. DX-050? Yes. That is not attached to the

So this is a brand-new -- what Elan had sought to

exclude previously was not that whole document. I haven't even had an opportunity to review

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everything that is in there, Your Honor.

What Elan had

sought to exclude was just the portion of Dr. Amiji's report about the disulfide bond report, and there is a lot more in that exhibit, in that disulfide bond report. underlying experimental data there. So this is brand-new. And I feel a little bit There is the

kind of sandbagged, Your Honor, because I haven't had an opportunity to review all that. subject of the motion. THE COURT: MS. EVANS: You are talking about DX-076. That's correct, Your Honor. A small But that was not the

part of it was, you won't find that anywhere in the exhibits. I think what you will find is Dr. Amiji's very And Elan in

thorough analysis of the disulfide bond report. its papers says that the report is not reliable.

I think that experiments have different values depending on the experiment. And Dr. Amiji didn't find the

disulfide bond report to be conclusive, the be-all-end-all proof. He said it was supportive. And he considered all

the issues with respect to that experiment and discussed it in detail in his report. I should also point out that of the three Elan experts who would testify on the crosslinking issue, they rely -- they don't do any experiments of their own. They

rely on the disulfide bond report, not just criticize it,

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rely on the numbers in it as the basis for their own opinion. So this motion is a little bit odd to me, Your Honor. The other thing that Mr. Scheve handed up to you was a, I believe, since I got a very quick look, Your Honor, what it says at the top, Purpose to separate and identify the protein IN interest. THE COURT: MS. EVANS: DX-563? Well, the DX document isn't in the

exhibit, so I am not a hundred-percent sure it is the same thing I am thinking of. THE COURT: see this? MS. EVANS: Yes, I absolutely would, Your Honor, Did you want another opportunity to

to make certain we are talking about the same thing. MR. SCHEVE: background. THE COURT: MS. EVANS: this is. Hold on. I have the background. I know what Your Honor, for a little

I will be able to address it, Your Honor. MR. SCHEVE: It's an SOP that they first

produced to us in this litigation, first time ever. THE COURT: MR. SCHEVE: 4/4/08? Yes, on April 4th.

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THE COURT: MR. SCHEVE:

It's written on top. That's the first time we have seen

it in this litigation, first time produced to the defendant in this litigation. THE COURT: MS. EVANS: Okay. Go ahead. So the second motion in

Yes, sir.

limine that is part of Motion in Limine 4 has to do with what's called the Vong Trieu experiment. MR. SCHEVE: Which I haven't addressed yet, Your

THE COURT:

He didn't talk about that.

I think

in selecting -- did you select that out? MR. SCHEVE: No, Your Honor. The first was

relating to this SEC test, and the next one is what's called an SDS page test, which I won't even attempt to tell you what the big words are. THE COURT: I don't think he talked about that

MS. EVANS: exclude two documents. he handed up to you.

Your Honor, he said he was moving to I assume that was the two documents

The second document is the one I just That goes to Vong Trieu. That has

looked at, Your Honor. nothing to do with SEC. confused. THE COURT:

That is why I was a little

The one you just looked at.

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MS. EVANS:

Yes, sir.

I can not address that

now if he is not seeking to exclude that based on the first motion. I can wait for that. THE COURT: MR. SCHEVE: THE COURT: MR. SCHEVE: THE COURT: MR. SCHEVE: Okay. May I reply, Your Honor? Yes. First off -You want to talk about the 050. Yes, sir, about the first two

patents which relate to the SEC test, the size exclusion chromatography. If Your Honor would like to see cases where courts have routinely applied Daubert to individual pieces of evidence, I am very familiar, because I argue it all the time in pharmaceutical cases, about whether or not experts can rely on what are called anecdotal reports of medical events, whether or not data submitted to the FDA's spontaneous reporting system is reliable. There are a number of published opinions that show that experts can't be giving testimony when the materials they rely upon aren't deemed relevant. It goes to

the question of whether or not their methodology, i.e., relying on faulty information, is acceptable. routinely find that. Let me, if I may, Your Honor, here is what Dr. Courts

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Amiji says.

Would you like me to get you some opinions,

Your Honor, on that? THE COURT: MR. SCHEVE: I will let you know. Dr. Amiji's report, Paragraph 152.

He said, "I am informed and it appears that the original chromatograms of these experiments are reported at," then he gives an ABRX number, which is their Bates number. There is

nothing in this record that this gentleman went down and looked at this information. THE COURT: Let me ask you this, though, Mr. Ms. Evans just asserts

Scheve, and I will let you continue:

that these documents that we are talking about right now -I think it's DX-050 and DX-076? MR. SCHEVE: THE COURT: basis for his opinion. 050. This document did not form the only Did I understand that to be an Or just 050?

assertion that you are making? MS. EVANS: Amiji opines on. It is part of the documents that Dr.

I think, I believe his testimony in his But it is

report was that it was supportive of his opinion.

not, it is not the primary document on which Dr. Amiji relies. He did evaluate that report, along with all the other experimental evidence on crosslinks. a body of evidence. This is part of

It is not the primary evidence on which

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Dr. Amiji relies. THE COURT: Did you also say that the

plaintiff's expert relied on this document? MS. EVANS: THE COURT: MS. EVANS: THE COURT: Scheve. MR. SCHEVE: Yes, Your Honor. What our experts Three plaintiff's experts. Relied on this document. Yes. It's in their report.

You can talk about that, too, Mr.

did was -- let's assume Your Honor overrules our motion. Let's assume this becomes an issue, even though we clearly think that it is not reliable. They have to comment to the But then

jury on why this study has so many flaws in it.

they went further and said, even if it comes in and even if you accept the numbers and even if it was valid, here is why it still comes within the claim, because there are some mathematical calculations that are outlined in the claims. But that doesn't solve the problem that you have got a bunch of people testifying about something that there is no scientifically reliable basis for it coming into this case. I would be the first to sit down if she told me he wasn't going to rely on this document. is. But she says he

Obviously, if it doesn't come into the case, my experts But I have got to have them

aren't going to talk about it.

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prepared to talk about it since their people dealt with it. But it gets to the basic evidentiary gatekeeping issue. THE COURT: Is this going to form part of the

opinion upon which Dr. Amiji relies? MS. EVANS: I do not anticipate that Dr. Amiji

will rely on the disulfide bond report at trial, Your Honor. THE COURT: There you go.

Do you want to go on to the next? MR. SCHEVE: one. THE COURT: MR. SCHEVE: I think this is the 076 and the 563. Yes. I have two problems. Finding Yes, please, Your Honor. The next

my notes and reading my notes. THE COURT: MR. SCHEVE: I know how you feel. The second test, Your Honor, is I do not

this report done by Mr. Vong Trieu, T-r-i-e-u.

mean to demean him because I don't know what his title is, if it is Dr. Trieu or... THE COURT: That would be what has been

denominated DX-736, for whatever purpose that number was assigned. It is not a part of anything that I have. MS. EVANS: That is my understanding. The

laboratory notebook excerpt that is the Vong Trieu data that the motion sought to exclude is Exhibit 10 to Elan's motion, Your Honor.

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THE COURT:

Okay.

Let me find that.

Go ahead, Mr. Scheve. MR. SCHEVE: DX-076 is Exhib