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IN THE UNITED STATES DISTRICT COURT

IN AND FOR THE DISTRICT OF DELAWARE

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CUBIST PHARMACEUTICALS, INC.,

Plaintiff,

v.

HOSPIRA, INC.,

Defendant.

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MR. PHILLIPS: Good m orning, Your Honor.

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THE COURT: Good m orning.

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Hospira. With me in the courtroom Jim Hurst and Gail J.

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Standish from W inston & Strawn. Also in the courtroom is

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Anne Christopher from Hospira, all the way from Australia.

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THE COURT: Oh, my goodness. Good morning.

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MR. LEE: I asked him not to come today.

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(Laughter.)

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If Your Honor has no preference, what I will do is go

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straight through the two terms and make our presentation.

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Mr. Hurst will follow. If I can have four or five m inutes

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at the end just to offer any rebuttal?

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THE COURT: Sure:

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MR. LEE: May I?

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THE COURT: Yes, please.

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MR. LEE: This is our PowerPoint presentation,

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Civil Action

No. 12-367-GMS

- - Wilmington, Delaware
Wednesday, April 10, 2013
9:30 a.m.
Markman Hearing
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BEFORE:

HONORABLE GREGORY M. SLEET, Chief Judge

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APPEARANCES:
JACK B. BLUMENFELD, ESQ.
Morris, Nichols, Arsht & Tunnell LLP
-andWILLIAM F. LEE, ESQ.,
LISA J. PIROZZOLO, ESQ.,
TIMOTHY A. COOK, ESQ., and
SEAN K. THOMPSON, ESQ.
Wilmer Cutler Pickering Hale and Dorr LLP
(Boston, MA)
Counsel for Plaintiff

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JOHN C. PHILLIPS, JR., ESQ.

Phillips, Goldman & Spence, P.A.
-andJAMES F. HURST, ESQ.
Winston & Strawn LLP
(Chicago IL)
-andGAIL STANDISH, ESQ.
Winston & Strawn LLP
(Los Angeles, CA)
Counsel for Defendant

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MR. PHILLIPS: Jack Phillips on behalf of

It seems we can't keep Messrs. Lee and Hurst out

of this courtroom . I have tried my best.

THE COURT: Nice to have two excellent lawyers

in the courtroom.
Mr. Lee, are you in agreement?
MR. LEE: Your Honor, Mr. Hurst and I talked.

Your Honor.
THE COURT: Do I understand that, Mr. Hurst,

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Blumenfeld for the plaintiff Cubist, along with Bill Lee

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that Hospira does make an attack on the validity of the

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certificate of correction?

(Counsel respond "Good m orning.")

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THE COURT: Counsel, let's start out with a

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case it turns entirely on a claim construction issue.

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THE COURT: Gentlemen, therefore, do I

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understand that the law provides that that in essence is an

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attack on the validity of the patent?

and, Lisa Pirozzolo, of WilmerHale, and two other people

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from Wilm erHale, Sean Thompson and Tim Cook sitting behind

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them.

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patent, no. The certificate of correction goes away, and

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the patent still exists in its earlier form , which is why we

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think it's a threshold claim construction issue.

Your Honor, we have discussed with the other

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side the order. There is only the two terms to be argued.

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W e are happy to do it either term by term or to do both

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terms and have the defendant respond. I think their

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before the correction and it still exists, so it is not an

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preference is to have us just go through both term s then

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attack on validity.

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they will respond, we will rebut. W e leave it to Your Honor

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which way you would want to do it. W e are happy to do it

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certificate of correction stands and Hospira m aintains its

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either w ay.

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position, it's an attack.

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MR. LEE: It's an attack on the validity of the

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you think is orderly and will best help me do what I have to

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patent. I think what Mr. Hurst, the logical conclusion, I

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do, I am com fortable.

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think he would agree, is that if the certificate of

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correction were invalid and the claim reverted to what they

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claim is the claim construction, that there would be no

THE COURT: Good morning. Please, take your

seats.

round of introductions. Mr. Blumenfeld.

MR. BLUMENFELD: Thank you, Your Honor. Jack

In first row in the back from Cubist, Tom

DesRosier, Tim Dorouos and Bill DeVaul.

THE COURT: If counsel have discussed a way that

Mr. Phillips, would you like to m ake

introductions?

1 of 29 sheets

Page 1 to 4 of 70

MR. HURST: We do, Your Honor, because in this

MR. HURST: If the certificate of correction is

not accepted, it is not an attack on the validity of the

THE COURT: When you say the certificate of

correction goes away, what do you m ean?
MR. HURST: The patent reverts to how it was

THE COURT: Mr. Lee, you would say if the

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disagree, respectfully, with each other. We say it is not

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the specification says, daptomycin is a natural product that

THE COURT: Which we are not going to do today.

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occurs in nature in small, small amounts. Eli Lilly, not

MR. LEE: This is just a place where we

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here today, first isolated that antibiotic from a bacterium,

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which I am probably going to butcher the pronunciation,

just a question of claim construction. And the question of

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Streptomycin roseosporus, in the late 1970s to 1980s. And

validity, of certificate of correction, implicates facts

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that is described in the specification and the file history.

that are not here today and should get resolved on summary

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Since then, daptomycin has been obtained for

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judgment. In fact, Your Honor, all the decisions that

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pharmaceutical use by a process called fermentation and

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Hospira and we cite to you are summary judgment decisions.

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filtering. But it is the natural product that results from

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THE COURT: So then this may be one of those few

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times that Sleet finally lets summary judgment go forth in a

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patent case.

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scientists continued to study it. And as they studied it,

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they discovered new impurities in the fermentation process

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to that point, Your Honor, I think we will be able to

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to make it, and developed ways of reducing them.

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demonstrate to Your Honor that there are actually facts here

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as part of the trial, issues to be decided. I don't think

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we are there today.

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MR. HURST: We respectfully disagree with that.

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the inventors of the reissue patent were able to discover

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THE COURT: Why am I not surprised, Mr. Hurst.

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how to minimize the impurities and separate them from

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Mr. Lee.

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daptomycin to make a pure form of daptomycin, which has

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MR. LEE: Thank you, Your Honor.

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obvious clinical benefits.

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If I could go to Slide 2, I am going to briefly

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describe three groups of patents in issue, then go to the

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dosing patents. They came later. They deal with the safe

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disputed claim construction issues, Your Honor. All of the

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and effective methods of administering daptomycin. Again,

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background that I am going to provide is drawn directly from

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directly from the specification, Lilly conducted clinical

infringement. It's basically a summary judgment decision.

MR. LEE: We actually would suggest when we get

this process.
In 1987, after discovering the compound, Lilly

The impurities as described in the specification

were called Anhydro LY146032 and Isomer LY146032.
By identifying how those impurities were formed,

If I go to Slide 4, Your Honor, these are the

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the patents or directly from the file history. So it is all

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trials for daptomycin after their discovery in the 1980s and

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in the intrinsic record.

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early 1990s. But Lilly scientists had a problem. They were

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struggling to find a way to administer a clinically

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on Slide 2. The patents all relate to the purification of

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effective dose. And really what happened, Your Honor, as

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or dosing regimes for an antibiotic called daptomycin, which

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the specification and the file history describes, they came

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has been before the Court once before a couple years ago.

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to a point where they had a really serious side effect,

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which was skeletal muscle toxicity. It is described in the

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very serious infections. And some of those are described in

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specification. It is a bad thing. It was bad enough that

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the specification. It is the active ingredient in a product

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Lilly simply decided to stop its development.

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called Cubicin, which Cubist makes.

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There are, as Your Honor knows, two claim

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1997, Cubist then licensed daptomycin with the intention of

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construction disputes. The parties dispute the proper

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developing a topical drug rather than an intravenously taken

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construction of "compound of Formula 3" or "Formula 3

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drug to avoid the muscle toxicity problem. In the course of

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compound" from one of the patents, from the reissue patent.

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working with daptomycin and developing this topical

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And they also dispute the meaning of the term "daptomycin"

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treatment, they made a discovery that was, as described in

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from the four remaining patents.

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the specification, surprising and counterintuitive. That

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was that the skeletal muscle toxicity issue was not tied so

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as we move through these things, the first patent, the

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much to the dose, the amount you were getting, but it was

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reissue patent, which has been before Your Honor before, is

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tied to the interval between doses. They conducted studies

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one patent which does claim stereochemistry in the claim.

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that are described in the specification where daptomycin

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The other four don't claim stereochemistry at all in the

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administered in one large dose rather than smaller doses

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claim. That will be a dispute that I come back to.

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with an interval between them successfully treated

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infections without patients experiencing muscle toxicity,

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patent is the oldest of the asserted patents. And it's

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skeletal muscle toxicity. So that invention resulted in the

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directed to obtaining daptomycin with fewer impurities. As

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claims of these two patents.

There are five asserted patents, as summarized

Daptomycin is used to treat serious infections,

One thing I would say at the outset, Your Honor,

If I go to Slide No. 3, Your Honor, the reissue

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Page 5 to 8 of 70

At that point in time, or a little bit later, in

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Cubist. It allowed Cubist to get Cubisic approved about

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'689 patent focus on methods of dosing daptomycin once every

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48 hours. It's administered to patients with renal

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daptomycin and how it's produced by fermentation, filtering,

impairment at expanded dosing intervals.

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a natural product. They are throughout all five of the

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patents. There are examples of daptomycin being used, an

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effective antibiotic in in vivo testing and then clinically

2003. It has been used to treat literally hundreds of

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administered to human beings.

thousands of patients.

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For today's purposes, on claim interpretation,

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our claim interpretation of the two terms covers all of the

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disclosed embodiments that describe how the compound is

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made. Our claim interpretation covers all of the disclosed

something Mr. Hurst and I will work out. These two patents

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embodiments that describe how it was administered

were not before the Court the last time. There are a lot of

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successfully to patients.

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asserted claims at this moment in time. That's because the

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question of infringement is dependent upon their

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of them. Their claim interpretation would cover none of the

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manufacturing process, processes. That's something that we

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examples that show how their product is made because we

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will get worked out during the course of discovery.

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agree -- and this has been less contentious than some other

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cases -- we agree that there is no evidence that the L

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intend to go to trial on all of these. This is just a

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version can be produced naturally by fermentation. We also

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question of, unlike the first patent, the first three, where

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agree that the L version is ten times less potent, that's

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there has been a lot of discovery in the prior case which

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described in the Miao paper. It is part of the intrinsic

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they have available to them, it is easier for us to focus on

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record.

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the asserted claims. This is something that will become

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clear during the course of discovery, and, most importantly,

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set of facts, it is going to be this: The claim

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the number of asserted claims doesn't implicate what we put

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interpretation that they propose will not cover the

If we go to Slide 5, the asserted claims of the

This new dosing interval was developed by

The last set, Slide No. 6, the last set of

patents is the most recent, is the high-purity patents.
Let me say one thing. I am sure this is

So I don't want the Court to think that we

divergence between Mr. Hurst and me.

There are examples, as the Court knows, of

Hospira's two claim interpretations cover none

I think if we focus on one key fact or one key

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disclosed embodiments, period. The claim interpretation, as

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These patents result from work done by Cubist in

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we disclose, will cover all of them.

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1999 and 2000. Their work, Your Honor, was to get ready to

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have a clinical product that could be approved by the FDA.

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of Formula 3 or Formula 3 compound, what I have put on the

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They are trying to purify the daptomycin so it is as pure as

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screen now, Your Honor, is just the competing claim

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possible.

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interpretations, the term, ours, and Hospira's.

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that daptomycin actually, under certain conditions, acidic

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capture the dispute. Setting aside the question of the

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conditions, as described in the specification, formed

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attack on the certificate of correction, which I will come

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aggregates or micelles is the word in the patent, and those

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to in a few minutes, the question is should these Formula 3

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collections, those aggregations, affected the purity of the

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claim limitations be construed with the express definition

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daptomycin. Those scientists discovered, as described in

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of Formula 3 that is set forth in the claims as corrected,

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the specification, that under non-acidic conditions, those

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or should they be construed, as Hospira does, as they read

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clusters break out.

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before the certificate of correction.

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That is the dispute.

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scientists developed new processes used to remove those

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So now if I go to Slide 12, Your Honor, on the

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impurities to prevent that aggregation or those micelles.

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left-hand side of Slide 12 is Column 21, Line 41 to Column

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That allowed for purification of larger batches and

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22, Line 39, Slide 12 of the reissued patent. So on the

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commercial scale production.

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left-hand side, we have Claim 26. On the right-hand side,

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we have our proposed construction. We have highlighted the

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a composition of high-purity daptomycin. And on Slide 7,

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D-Asparagine, which is the source of the dispute. But as

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the '342 patent is the process of obtaining that highly pure

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corrected, this is how the claim reads. And our claim

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composition of daptomycin.

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interpretation has exactly that structure.

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before Your Honor.

Another group of Cubist scientists discovered

Based upon that discovery, Your Honor, Cubist's

The '238 patent, which is on the screen, covers

If I go to Slide 8, Your Honor, this may be, at

least for me, the most important point, and the point of

3 of 29 sheets

Page 9 to 12 of 70

So if I go to Slide No. 10, and I go to compound

If I go to Slide 11, I think we correctly

The dispute between us, Your Honor, if I go to

Slide 13 now, arises from this concept called

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stereochemistry. There is no real dispute between us.

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Office at the time that they decided to issue the

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There are two stereochemical forms. We have depicted on the

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certificate of correction.

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right-hand side showing the two as mirror images. The

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If I could go to Slide 17.

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Hospira brief has two hands showing them as mirror images.

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The reissue prosecution includes the Miao

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We agree upon what stereochemistry is.

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publication, as I said, the Miao publication reporting the

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scientific experiments that confirm the D-Asparagine. And

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it was described as the L-Asparagine. In the mid-1980's,

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it also demonstrates, Your Honor, that the Miao paper relied

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when Lilly scientists first determined the chemical

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upon more modern methods, for lack of a better descriptor,

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structure -- and I think it's important, Your Honor, when

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to characterize what had been characterized before

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you look at the specification, the specification describes

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the process by which it's obtained. And we all agree that

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what is obtained from it is the D version. It describes the

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both you and Mr. Hurst. Is this one of those occasions

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method which is used successfully. We all agree that is the

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where it might make sense for the Judge to deviate from his

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D version.

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or her prior practice? What I have in mind specifically is,

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But using the technology that was available at

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I am wondering, as I listen, whether engaging Judge

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the time, it was described as having the L rather than the

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Robinson's practice of handling constructions and summary

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D.

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judgment at the same time might benefit the parties in this

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case. I don't know. I am just throwing that out.

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to the small part of the extrinsic evidence we both offered

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Your Honor. We have offered a declaration that says if you

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go back to this point in time more than two decades ago, the

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manner in which you could characterize these isomers was not

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a look at the New Mexico decision that we cite, I think at

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as robust as it is today. And they did the best they could.

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Page 9 of our brief, what you will see is 255, which governs

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But they got it wrong. And there was actually D rather than

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the certificate of correction, specifically ties the test to

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L. And what happened is, when it was discovered, it was

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new matter. The New Mexico case, which is written by Judge

As the record demonstrates, when first claimed,

Now, be careful, because I am going to move now

incorrectly.
THE COURT: Mr. Lee, let me ask a question of

MR. LEE: Your Honor, I think not. Let me give

you the reason why. The Court may agree or disagree.
I think, Your Honor, if we ask the Court to take

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Lourie, actually is a new matter case. It is not a 255

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If I go to Slide 14, this is from the

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case. But it is discussing the specific concept that's

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specification of the patent as corrected. On the left-hand

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described in Section 255.

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side is Column 7, Lines 1 to 26. On the right-hand side,

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What happens at that point -- it's actually

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most importantly, is the certificate of correction which

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quite a lengthy discussion. What it says is this, and I

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makes the correction changing the L to the D.

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think it's -- to give you the bottom line, Your Honor, I

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think there will be evidence to be taken on how one of

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the reissue file history that is shown on the right, which

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ordinary skill in the art reviews the record as a whole. If

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says J.A. 365. It is specifically the correction.

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Your Honor wanted to take that before trial, it's possible.

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I think it would be better in the context of the whole

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the intrinsic record before you, is in 2007, well before the

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trial. But I think you can only make that determination on

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dispute between Hospira and Cubist was joined, Cubist

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the basis of that record.

09:48:31

13

submitted a request for a certificate of correction to the

09:51:41

13

09:48:34

14

PTO to change the stereochemistry from that which was cited

09:51:43

14

09:48:39

15

in the patent to the D configuration. On January 29, 2008,

09:51:44

15

09:48:44

16

the Patent Office issued the certificates before you now,

09:51:47

16

New Mexico decision, Your Honor, was a case where the

09:48:48

17

changing all instances of the L to the D.

09:51:49

17

chemical structure in the specification was incorrect. And

09:48:56

18

09:51:53

18

they went to correct the specification. And the other side

09:49:00

19

intrinsic record. I think we may disagree on this. But the

09:51:57

19

said, no, no. It's new matter, the same words referred to

09:49:04

20

intrinsic record on the reissue includes the Miao paper,

09:52:01

20

in Section 255. Judge Lourie said, No, look: The chemical

09:49:13

21

which we both referred you to. The Miao paper, which is

09:52:06

21

structure is just words to describe the compound. The

09:49:16

22

much later, describes the discovery of using more robust

09:52:10

22

depiction is just depictions that describe the compound.

09:49:19

23

technologies to characterize that say, no, no, no. It's not

09:52:15

23

The invention is the compound.

09:49:24

24

L. It's D.

09:52:16

24

09:49:25

25

09:52:19

25

corrected.

On Slide 15, Your Honor, is also a portion of

What happened, Your Honor, as demonstrated by

On Slide 16, Your Honor, this is part of the

So that paper was actually before the Patent

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Page 13 to 16 of 70

Let me make two points about the New Mexico

decision.
One is what the New Mexico decision says. The

Here, Your Honor, the invention is the

daptomycin. There are different ways to describe it. And

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19

09:52:23

the description back in the reissue patent with L-Asparagine

09:55:18

the time -- I don't think it is going take a huge amount of

09:52:28

was incorrect, but it doesn't change what the compound is.

09:55:22

the trial time. But to put it in context, the Court will be

09:52:31

That is the key dispute between us.

09:55:26

in a better decision to decide if they are correct or we are

09:52:34

That's important for two reasons. The analogy,

09:55:30

correct.

09:52:37

Your Honor, that I thought about as a non-scientist is this.

09:55:30

09:52:40

It is as if, you know, I invented a genetically engineered

09:55:33

09:52:45

dog, and I came up with a genetically engineered dog, and I

09:55:34

09:52:49

am going to claim the dog. What I do is try to take a

09:55:37

09:52:52

picture of it as it is flying around the lab. The best I

09:55:39

09:52:57

10

can do with the technology is I capture it, you can see it,

09:55:43

10

don't think we can cite you a Federal Circuit case dealing

09:53:00

11

it's got a head and a tail, but you can only see three legs.

09:55:46

11

with it on claim construction. I am not sure we can cite a

09:53:04

12

09:55:50

12

case for you that deals with this Compound A versus Compound

09:53:07

13

dog and I can capture the four legs, the length of the tail

09:55:54

13

B.

09:53:10

14

and the head, but it's still the dog. And that is what

09:55:54

14

09:53:13

15

Judge Lourie is saying. Judge Lourie is saying that when

09:55:58

15

255. We have cited New Mexico. We would ask the Court to

09:53:17

16

you have a new compound -- Your Honor, one thing that is

09:56:02

16

take a look at that case. I think, really, Judge Lourie's

09:53:20

17

important here is, for 20 years back, until we got to your

09:56:06

17

articulation of this issue, I think, is illuminating and it

09:53:25

18

courtroom today, no one has claimed any confusion about what

09:56:12

18

really -- it may be counterintuitive to the layperson like

09:53:28

19

daptomycin is. They knew it was a natural product that

09:56:17

19

me who looks and sees, that's what's described. He said,

09:53:31

20

resulted from fermentation and has been used to treat

09:56:21

20

no, no, no. What you have invented is the compound just

09:53:35

21

millions of patients. There has been no confusion.

09:56:24

21

using the existing technology. You happened to have gotten

09:53:37

22

09:56:28

22

the description wrong.

09:53:39

23

Mexico case -- and I think if we get to briefing it Your

09:56:29

23

09:53:43

24

Honor will see there is a whole body of law built around

09:56:31

24

which is, like this case, what happened was someone took the

09:53:45

25

this concept of new matter -- the question then becomes,

09:56:34

25

process that was described in the New Mexico patent and

Years later, I can get a better picture of the

That means, Your Honor, if you read the New

THE COURT: Mr. Hurst, I will give a chance to

react in your time.
MR. LEE: I think Mr. Hurst will agree with me.
This question of correction of a minor
character, the law is not particularly well developed. I

They cited cases by analogy to other portions of

The interesting thing in New Mexico, Your Honor,

18

20

09:53:48

take a person of ordinary skill in the art. And I actually

09:56:37

later performed the process and got to the right chemical

09:53:51

think there may be a disagreement on that which will become

09:56:41

description. So what we have here is a situation where

09:53:54

a factual matter. Then that person of ordinary skill in the

09:56:46

later daptomycin was produced naturally by fermentation,

09:53:57

art has to look at this specification and all that comes

09:56:52

someone in the Miao paper described it using new technology,

09:54:00

with it. And that only applies to this one claim of

09:56:58

or later developed technology to characterize it, and that's

09:54:05

stereochemistry. And say, okay, would one of ordinary skill

09:57:02

what led to the characterization.

09:54:08

in the art have concluded, have understood that what was

09:57:04

So there is a real parallel here.

09:54:13

claimed was daptomycin, the natural product from

09:57:06

THE COURT: Thank you.

09:54:17

fermentation used to treat patients successfully, or would

09:57:07

MR. LEE: I know we disagree.

09:54:22

10

they understand it to be the L-Asparagine version that was

09:57:10

10

09:54:26

11

never made naturally, never by fermentation? I think you

09:57:15

11

today's purposes, the law in 255 says you have to take the

09:54:28

12

are going to see a lot of facts to resolve that.

09:57:21

12

patent with the certificate of correction and you treat it

09:54:33

13

09:57:24

13

as if it was part of the original patent.

09:54:35

14

candid if I didn't say there are cases that resolve the

09:57:28

14

09:54:40

15

certificate of correction issue on summary judgment. I

09:57:30

15

Hospira's first argument, which is that one of ordinary

09:54:42

16

think you will see that those cases cited by Hospira are

09:57:33

16

skill in the art just wouldn't believe the certificate of

09:54:44

17

cases where the claim is broader, where you go from, for

09:57:36

17

correction. I don't think honestly the Court can do that on

09:54:50

18

instance, the requirement of multiple rear walls to one or

09:57:39

18

claim construction. I don't think you would be able to do

09:54:58

19

more. So it is clearly covering the same plus more.

09:57:42

19

it on summary judgment, the idea that the Patent Office has

09:55:02

20

09:57:47

20

actually applied the 255 standard and made a correction, the

09:55:04

21

our way, we can't find a case where the fight is between not

09:57:51

21

mere fact of disbelief is not supported and I don't think

09:55:10

22

broadening the claim but just saying tell us something will

09:57:57

22

ultimately relevant.

09:55:12

23

be different.

09:57:59

23

I think what is relevant is how the person of

09:55:12

24

09:58:02

24

ordinary skill in the art, how they define this, review the

09:55:14

25

09:58:06

25

whole record and whether they would think it was a

For sure, Your Honor, I would be less than

We can't find a case, I would love to have one

I think we would argue that the Court will have

more facts before it and be able to consider the issue if at

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Page 17 to 20 of 70

If I go to Slide 18, Your Honor, I think, for

Now, I want to deal with one argument, which is

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09:58:09

09:58:12

09:58:16

09:58:19

09:58:22

09:58:25

09:58:28

09:58:33

09:58:35

of law, to be more precise in my answer to Your Honor's

09:58:40

10

09:58:43

11

09:58:45

12

09:58:47

13

09:58:50

14

09:58:54
09:58:57

23
10:00:59

for us to go back to the Patent Office and correct one but

10:01:02

not correct the other four. What happened is these other

10:01:05

four don't claim the stereochemistry.

10:01:10

effort to invalidate the certificate of correction is a

10:01:13

that daptomycin should have the same meaning among the four

summary judgment issue. All the cases Hospira cites, as I

10:01:16

different patents. The specifications differ some. But we

said, are summary judgment cases on a more developed record.

10:01:21

have each proposed a definition that is for daptomycin.

10:01:25

10:01:29

question, it's one of those questions of law that is going

10:01:31

10

If I could approach the screen, Your Honor?

to be dependent, in our view, upon facts that Your Honor is

10:01:33

11

THE COURT: Certainly.

going to have to decide.

10:01:34

12

10:01:39

13

diagram, which is in our claim construction, this is Figure

something closer to obviousness, where Your Honor makes the

10:01:44

14

1 in the high-purity patents. That's right in front of the

15

ultimate determination. But there are facts from the

10:01:50

15

Court, that we agree it should have the same meaning. This

16

perspective of one of ordinary skill in the art that Your

10:01:53

16

is right out of the patents. This Your Honor has seen

09:59:01

17

Honor has to consider. And some of them, I think Your Honor

10:01:55

17

before from the reissue. It is in an article cited in the

09:59:05

18

can see the dispute between us, you can resolve on the

10:01:58

18

patents, but it is not explicitly in the patents themselves,

09:59:07

19

intrinsic record. Some of them you are going to have to

10:02:01

19

but there are articles for sure which I will come to.

09:59:10

20

resolve on the extrinsic record. That's why I think that

10:02:05

20

09:59:14

21

having people in the box being cross-examined is going to

10:02:07

21

There is a lot of briefing about the purporting of ours that

09:59:16

22

educate that process.

10:02:10

22

says it's the cyclic lipopeptide antibiotic derived from...

09:59:19

23

10:02:17

23

09:59:24

24

Superior Fireplace case. That is the case where you went

10:02:19

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Honor put in the words that the cyclic lipopeptide

09:59:27

25

from rear walls, multiple rear walls to a rear wall or more.

10:02:24

25

antibiotic that can be derived from rather than saying it

correction of minor character given this claim.

So if I go to Slide 19, this -- Your Honor, I
will do this briefly. If Your Honor wants to hear more...
As we said in our brief, we think that this

While the question may ultimately be a question

It's not a question exactly like Markman. It's

This is really different, as I said, from the

The second thing, Your Honor, is we both agree

So Cubist's proposal is on the left, and

Hospira's is on the right.

MR. LEE: If I focus, Your Honor, on this

The third thing I would say is this, Your Honor:

It would be also correct, we think, if Your

22
09:59:33

09:59:36

09:59:38

09:59:42

09:59:45

24
10:02:26

has to be. What we are trying to capture there is the

10:02:29

following. That diagram in the middle, which is from Figure

Technologies case, also is a case where the effect was to

10:02:37

1, is something which is only naturally created. And the

expand the range. There is nothing like this case where, as

10:02:43

diagram on the right-hand side, Your Honor, which is their

they claim, we have claimed the wrong drug. We say we

10:02:48

interpretation, that diagram is, as far as the record shows,

09:59:49

claimed the right drug.

10:02:54

I think both of us have done the best we can to figure out

09:59:51

Again, I come back, Your Honor, the type of

10:02:57

what is accurate, it's only synthetically clear. You are

09:59:54

factual question that Your Honor will have to resolve is,

10:03:02

never going to have a fermentation process in filtering that

09:59:57

how would one of ordinary skill in the art who read these

10:03:05

gets you that.

10:00:00

10

patents, would they in fact have read it to cover a compound

10:03:06

10

10:00:04

11

that wouldn't cover any other disclosed embodiments? That

10:03:09

11

our being two ships passing in the night. We are not

10:00:08

12

will be the cross-examination for their folks. Is that a

10:03:13

12

suggesting that it has to be produced by this precise

10:00:11

13

reasonable reading of the claim?

10:03:16

13

process. We trying to capture the idea that this is a

10:00:17

14

10:03:21

14

lipopeptide antibiotic that can be derived this way because

10:00:20

15

10:03:28

15

that then excludes those that can't be disclosed with what

10:00:22

16

10:03:33

16

the specification would teach you.

10:00:26

17

four other patents. Let me say three things by way of

10:03:34

17

10:00:30

18

introduction, Your Honor.

10:03:39

18

It describes the product that resulted from the

10:00:32

19

10:03:42

19

specification. It describes the product that was

10:00:35

20

stereochemistry in the claims. So the reissue patent for

10:03:46

20

administered to patients. It describes the product that was

10:00:38

21

sure has the diagram which we have corrected. The other

10:03:48

21

used to come up with the invention for patenting. The

10:00:43

22

four never claim the stereochemistry in the claims.

10:03:53

22

right-hand panel describes a compound that was not used,

10:00:48

23

In fact, Your Honor, maybe the best indication

10:03:56

23

that did not result from any of the disclosed embodiments,

10:00:51

24

of that is, if we had claimed it, as they are now suggesting

10:03:59

24

was not used in any of the disclosed testing with the

10:00:55

25

we had, it really would have not been very commonsensical

10:04:03

25

patients.

So you have expanded the claim.

The other case that they cite, the Advanced

Your Honor, I am not going to address the merits

of the certificate of correction.
If I could go to Slide 20, this now goes to the

The four other patents do not claim

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Page 21 to 24 of 70

So I think this just may have been a source of

The middle panel, Your Honor, describes Cubisin.

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10:04:04

10:04:08

10:04:14
10:04:20

27
10:07:32

Streptomyces roseosporus. It says what it's composed of.

really, the dispute: For these four patents, for claims

10:07:37

And it does refer to Figure 1A of the Baltz paper, which I

that don't reference stereochemistry, is Cubist's, is our

10:07:41

am going to come back to.

interpretation which goes to Figure 1 from the high-purity

10:07:43

10:04:24

patents correct, or is reference to a diagram related to a

10:07:50

10:04:28

stereochemistry in an article that is cited to incorporate

10:07:55

If I go to the next slide, the examples in the

10:04:32

the right interpretation?

10:08:00

dosing patents -- I apologize. I have gone through the

10:04:33

So I go to Slide 22, Your Honor. What I will

10:08:03

claims of the dosing and the claims of the high purity. I

10:04:37

try to do for the dosing and high-purity patents is very

10:08:06

am now going to do the specification dosing, the

10:04:41

10

quickly move through the claims, the specifications, the

10:08:09

10

specification of the high purity, but only because the claim

10:04:43

11

file history, to show, I hope, or at least argue that what's

10:08:12

11

term is going to have just one meaning.

10:04:49

12

in the claims, the specification, and the file history all

10:08:14

12

10:04:52

13

cover embodiments that would not be covered by their

10:08:19

13

administration of daptomycin to adults with what's called

10:04:59

14

interpretation. It would be covered by ours.

10:08:24

14

serious gram-positive bacteremia. This is one of the

10:05:02

15

10:08:29

15

reasons that the product has been an enormous success.

10:05:05

16

screen, Your Honor. Two important points. The claims say

10:08:33

16

10:05:09

17

nothing about stereochemistry. If you compare this to the

10:08:35

17

the dose amount and dosing intervals that would be safe and

10:05:13

18

reissue patent, it has the diagram where you see the L- or

10:08:38

18

effective for the patient.

10:05:17

19

D-Asparagine. There is nothing in the claim about it.

10:08:40

19

10:05:19

20

Instead, it talks about administering something to a patient

10:08:44

20

product that's described in Example 4. Their claim

10:05:26

21

that is therapeutically effective. So the claims are

10:08:47

21

interpretation would not cover the product that's described

10:05:28

22

referring to a clinical product. And that clinical product

10:08:50

22

in Figure 4.

10:05:32

23

has to be therapeutically effective for a human being.

10:08:53

23

10:05:39

24

10:08:57

24

dosing patents, it's the same issue. The dosing patents

10:05:41

25

10:09:01

25

really are how do you give this to a human being and avoid

So I go to Slide 21. Your Honor, this is,

So for the dosing patents, I put Claim 1 on the

The compound that's described in our claim

interpretation would be therapeutically effective, can be

But again, our claim interpretation would cover

daptomycin produced by fermentation. Theirs would not.

The dosing patents specifically describe the

The example then goes on to report, Your Honor,

Again, our claim interpretation would cover the

If I could go to Slide 26, still within the

26

28

10:05:46

administered to the human being, it can solve the problem

10:09:04

10:05:50

that daptomycin is intended to solve.

10:09:06

10:05:54

10:09:12

demonstrate that the purpose is to give this compound,

10:05:57

10:09:14

daptomycin, to a patient. And again, the same issue: Our

10:05:59

10:09:18

construction covers this disclosed example. Theirs does

10:06:04

patent, Your Honor. So I am going to the other two patents

10:09:22

not.

10:06:06

and to the claims themselves. What's on the screen at Claim

10:09:23

10:06:12

23 is Claim 66. Two points again. Again, there is no

10:09:25

next slide, because I think a fundamental dispute between us

10:06:20

reference to stereochemistry in the claims. Second, Your

10:09:28

is, is one of ordinary skill in the art going to read the

10:06:25

10

Honor, this dependent claim specifically refers to the

10:09:31

10

specification as a whole and have in mind what is the

10:06:30

11

production of daptomycin by the fermentation process

10:09:35

11

compound, as Judge Lourie would put it, or are they just

10:06:34

12

involving Streptomyces roseosporus.

10:09:38

12

going to look at one diagram and say, well, that diagram,

10:06:37

13

And it goes on with a series of steps.

10:09:41

13

even though it conflicts with everything else that is

10:06:40

14

So the dispute before Your Honor is on this

10:09:43

14

described, am I going to rely upon that?

10:06:43

15

claim. We have a claim interpretation that would have this

10:09:46

15

10:06:48

16

claim make sense, if you follow this series of steps, you

10:09:49

16

whole, and you read references that are incorporated by

10:06:52

17

get daptomycin as we have described it, if you follow this

10:09:52

17

reference as a whole, which brings me to Slide 27.

10:06:55

18

series of steps, you would not get what Hospira describes as

10:10:00

18

10:07:02

19

daptomycin. So the claims themselves support the

10:10:03

19

based upon two articles written by Baltz and Tally. The

10:07:05

20

proposition that our claim interpretation is correct.

10:10:08

20

argument is that because these articles -- one is a book and

10:07:10

21

10:10:15

21

one is a review article -- because they contain the

10:07:15

22

specification also support our claim interpretation. On the

10:10:18

22

erroneous stereochemistry, that is the way the claim terms

10:07:20

23

left-hand side is our claim interpretation. On the

10:10:21

23

should be highlighted.

10:07:23

24

right-hand side is a portion of the specification that

10:10:23

24

10:07:27

25

refers to daptomycin being derived from the fermentation of

10:10:25

25

Their claim interpretation, the L-Asparagine,

wouldn't do this.
If I go to Slide 23, this is the high-purity

If I go to Slide 24, Your Honor, the

7 of 29 sheets

Page 25 to 28 of 70

skeletal muscle toxicity?

These embodiments, again, are embodiments that

Let me pause, Your Honor, before I move to the

We believe that you read the specification as a

A substantial portion of Hospira's argument is

Again, Your Honor, the person of ordinary skill

in the art who is going to read the specification as a

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31

10:10:29

whole, they are also going to read Baltz and Tally as a

10:13:27

10:10:32

whole. What they are going to realize if they read Baltz

10:13:30

Honor, it's the same thing. Tally, in addition to what Mr.

10:10:37

and Tally as a whole is both of them have the type of

10:13:35

Hurst has cited, Tally specifically talks about two things.

10:10:40

information you have in the specification, how was the

10:13:40

It talks about how daptomycin is derived. Again, this

10:10:42

product discovered, how was it produced, it's naturally

10:13:45

description, Your Honor, can only result in that which we

10:10:46

occurring, it comes from fermentation, it's been used to

10:13:48

have described to you.

10:10:48

treat patients.

10:13:50

10:10:49

10:10:53

10:10:57
10:11:02
10:11:07

12

10:11:11

13

intrinsic evidence because they are cited in the

10:11:13

14

10:11:17
10:11:21

If I go to Slide 30, this is from Tally, Your

The Tally article also describes the clinical

10:13:53

efficacy in human beings. Again, it's the only thing that

the Baltz publication. It is actually a book chapter. What

10:14:00

nobody could do that before we described how, not what they

10

it is is it is reviewing research on daptomycin. On the

10:14:02

10

11

right is the Tally publication. It's a review paper.

10:14:03

11

10:14:10

12

to the specifications of the high-purity patents. This is a

10:14:13

13

side-by-side comparison of the claim construction we propose

specification. We don't disagree. They are part of the

10:14:16

14

and the portion of the specification of the high-purity

15

record. The question is: How would one of ordinary skill

10:14:20

15

patents.

16

in the art read them? Would they read them by focusing on

10:14:21

16

You will see that our focus on the left-hand

10:11:24

17

the one figure they focus on, or would they also read all of

10:14:24

17

side is Figure 1 -- I am sorry, is the chemical structure

10:11:29

18

the portions of the specification that describe producing it

10:14:30

18

depicted in two dimensions, and on the right-hand side that

10:11:34

19

by fermentation, filtering it, using it to treat,

10:14:37

19

identical structure is Figure 1 of the patent.

10:11:39

20

successfully treat patients. We suggest it is the latter.

10:14:40

20

10:11:43

21

10:14:42

21

three things. The diagram is right out of the patents.

10:11:48

22

from the Baltz publication. This is what we believe one of

10:14:47

22

There has been no correction to it. That's the diagram.

10:11:54

23

ordinary skill in the art would have also -- we are not

10:14:50

23

The second thing is, that diagram would be a compound that

10:11:57

24

saying they wouldn't have considered what they say. We are

10:14:54

24

could be used for all of the examples of how the product was

10:11:59

25

saying there is more to it when read in its entirety. And

10:14:58

25

made. And it is the compound that could be used to treat

So I go to Slide 28, Your Honor. On the left is

Now, Hospira emphasizes that these articles are

If I go to Slide 29, Your Honor, this is a quote

described.
If I go to Slide 31, Your Honor, I am now moving

So our claim construction has the benefit of

30

32

10:12:03

Baltz reported that it was highly active against

10:15:01

effectively humans as described in the specification.

10:12:08

gram-positive bacteria. That is pretty important.

10:15:07

If I go to Slide 32, this is the high-purity

10:12:11

10:15:12

patents, Your Honor. And they specifically describe Figure

10:12:15

with the D-Asparagine, is highly active against

10:15:16

1 as the product which is an antibiotic that can be

10:12:18

gram-positive bacteria. The erroneously described

10:15:22

pharmaceutically acceptable.

10:12:22

L-Asparagine is not.

10:15:26

10:12:25

10:15:31

again, example after example of how they are produced. Our

10:12:27

this part of the intrinsic record incorporated, the very

10:15:37

claim interpretation would cover a compound that's produced

10:12:30

example, it's called daptomycin biosynthesis, would be

10:15:41

in this way. None of the examples would produce a compound

10:12:34

10

covered by our claim interpretation but not by theirs.

10:15:47

10

10:12:38

11

10:15:50

11

10:12:40

12

talks about it being well tolerated in human beings. That

10:15:55

12

same. It's describing the production of fermentation, the

10:12:44

13

wasn't the L version. That was the D version. And if the

10:15:59

13

same issue, whose claim interpretation covers the disclosed

10:12:50

14

Court considers the entire article, I think that what you

10:16:02

14

examples.

10:12:53

15

will see is that the report that's being made here is, there

10:16:05

15

Then, Your Honor, if I go to Slide 35, this is

10:12:57

16

is the invention of this compound, and the way you

10:16:09

16

from the file history of the dosing patents. I have now

10:13:00

17

administer it to patients and it's a big deal. It has

10:16:12

17

skipped back to the dosing patents. And Your Honor will

10:13:03

18

allowed us to come up with a treatment of bacteria that

10:16:15

18

find there a declaration from Dr. Tally, who is one of the

10:13:06

19

simply didn't exist before that can be taken intravenously.

10:16:18

19

two lead inventors on the discovery that has made this

10:13:10

20

That is the significant portion of what one of ordinary

10:16:25

20

available. Dr. Tally has passed away, so the only thing we

10:13:13

21

skill in the art would get.

10:16:27

21

have is his declaration. He actually describes how they

10:13:14

22

10:16:32

22

discovered the key to unlocking the problem that had caused

10:13:16

23

of ordinary skill in the art is the person who is doing the

10:16:38

23

things to come to a stop, and that is the skeletal muscle

10:13:19

24

dosing. So it is probably somewhat closer to someone with

10:16:41

24

toxicity problem.

10:13:23

25

experience in administering to patients.

10:16:42

25

Your Honor, daptomycin, as we have described it,

So even if you take their argument, which is,

So, too, in Baltz for clinical studies. It

For the dosing patents, Your Honor, the person

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Page 29 to 32 of 70

If I go to Slide 33, in the high-purity patents,

that's produced the way Hospira describes.

If I could go to Slide 34, it's more of the

Your Honor will see that in that description

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35

10:16:44

there is not a word about stereochemistry. It's all talking

10:20:01

and the Patent Office never suggested that caused a problem

10:16:47

about this fermentation product. It's all talking about

10:20:04

with the claims.

10:16:51

this fermentation product being administered to patients

10:20:04

10:16:55

having a problem, discovering that dosing and dosing the

10:20:09

least for me, this sort of captures the dispute between us.

10:17:01

amounts in intervals and resulting in the administration of

10:20:13

We talked about this claim a little earlier, Claim 66. If

10:17:05

a compound daptomycin that was safe and effective for

10:20:19

you take Hospira's argument, the claim is inoperative,

10:17:11

patients.

10:20:23

because the L version could be daptomycin in the second Line

10:17:13

10:20:27

of Claim 66, but it can't be made this way. So the claim

10:17:17

Your Honor, the Patent Office actually had before it the

10:20:31

just wouldn't work.

10:17:24

10

Miao paper, the paper that said, the characterization of

10:20:33

10

10:17:29

11

stereochemistry, the opposite was incorrect. Here is the

10:20:38

11

daptomycin can be made by the six steps described there. In

10:17:34

12

correct stereochemistry. The examiner had the Miao paper,

10:20:42

12

fact, Your Honor, those six steps are what is described in

10:17:37

13

the examiner reviewed the Miao paper. If the claims had

10:20:45

13

the specification. So you are given one claim

10:17:42

14

something in there about stereochemistry, which they don't,

10:20:47

14

interpretation that would render a claim inoperative. You

10:17:47

15

and the examiner thought there was something in the Miao

10:20:52

15

are given another which would kind of make complete common

10:17:50

16

paper that implicated the claims, you would have read

10:20:55

16

sense and be completely consistent with the specification.

10:17:53

17

something about it. But there is nothing.

10:20:58

17

Thank you, Your Honor.

10:17:55

18

10:20:59

18

THE COURT: Thank you, Mr. Lee.

10:17:59

19

daptomycin, which is produced as the fermentation product

10:21:01

19

Mr. Hurst.

10:18:02

20

and can be used to successfully treat patients.

10:21:02

20

MR. HURST: Your Honor, Thank you.

10:18:07

21

10:21:34

21

Jim Hurst, Your Honor, for Hospira.

10:18:10

22

10:18:13

23

10:18:17
10:18:19

If I go to Slide 36, in the high-purity patents,

Instead, what the examiner focused upon was

Now, just a couple of other points, and then I

Lastly, Your Honor, our last slide, Slide 39, at

If you take our definition, which is Figure 1,

10:21:37

22

If I can go to Slide 37.

10:21:38

23

going start with the first one, "daptomycin." Just to put

24

First, and I said this at the outset, we are not

10:21:45

24

side by side the two claim constructions, I want to focus on

25

trying to import a process limitation in. We are trying to

10:21:50

25

one oddity that I think helps to clarify the issue before

will yield the floor to Mr. Hurst.

There is two claim terms, Your Honor. I am

34

36

10:18:22

draw this distinction, Your Honor. The record before the

10:21:53

Your Honor. We really only have one core dispute, whether

10:18:25

Court, and I think the facts as both Hospira and we know

10:21:58

daptomycin should be construed as having L-Asn or D-Asn.

10:18:28

them, is the L-Asparagine version is not a naturally

10:22:04

10:18:32

occurring product that can be produced by the fermentation

10:22:06

quote from the spec. It says the compound described in the

10:18:35

process. That is why the source becomes important. In some

10:22:09

Baltz article, that Figure 1, the spec says daptomycin is

10:18:42

sense, if Your Honor uses the figure, Figure 1, to describe

10:22:13

the compound described in the Baltz article and it refers to

10:18:46

it, in our claim construction, that's the key, because as

10:22:16

Figure 1. That is Figure 1, with L-Asn.

10:18:51

the record is before the Court, that can only result from

10:22:21

10:18:56

the fermentation process. But we are not saying that it is

10:22:24

10:18:58

10

required. I think this is a place where we may have been

10:22:29

10

claim construction: the antibiotic derived from the

10:19:01

11

just ships passing in the night. It can be, which is

10:22:33

11

fermentation of Streptomyces roseosporus. That is a

10:19:03

12

critical, because theirs, Your Honor, the L version, it

10:22:39

12

process. So we have this oddity where we are defining a

10:19:06

13

cannot be. It cannot be.

10:22:42

13

compound based on its process. Why? Obviously, the

10:19:09

14

10:22:49

14

argument is that that will enable them to get to where they

10:19:14

15

the patents, Your Honor, are methods that result in our

10:22:53

15

want to be, which is the D-Asn, not the L-Asn, because they

10:19:19

16

compound but not theirs.

10:22:58

16

argue that that fermentation process can only produce D-Asn.

10:19:20

17

10:23:02

17

I am not sure if that is true. It may very well be true.

10:19:29

18

makes the point that the focus is the figure. We are trying

10:23:06

18

10:19:35

19

to draw the distinction between a product that can be made

10:23:09

19

compound with a process? Because they are looking for a

10:19:38

20

by fermentation. We are not trying to import the

10:23:13

20

correction. They are looking for Your Honor, through a

10:19:45

21

L-Asparagine structure into the claim. We are not asking

10:23:16

21

Markman hearing, to correct a scientific mistake that

10:19:48

22

Your Honor to correct the claim. We know we have to go back

10:23:19

22

persisted since 2005. But the law doesn't allow for that,

10:19:51

23

to the Patent Office as we did at one time for that to

10:23:25

23

not through a Markman hearing.

10:19:54

24

happen. And, critically important is this Miao paper, which

10:23:27

24

10:19:56

25

is a big focus for them now, was before the Patent Office

10:23:29

25

And all of the disclosed methods in all four of

So if I go to Slide No. 38, I think this just

9 of 29 sheets

Page 33 to 36 of 70

Our claim construction, that is virtually a

So Cubist, Mr. Lee, they add something to this.

It's a little bit of an oddity. They have a process in the

So the question is, why are we defining a

This is from the Supreme Court in 1876:

"Nothing can be more just and fair, both to the patentee and

04/15/2013 04:59:57 AM

37

39

10:23:32

the public, than the former should understand, and correctly

10:26:09

are construed to have the meaning that the term would have

10:23:35

describe, just what he has invented."

10:26:12

had to a person of ordinary skill in the art in question at

10:23:38

10:26:15

the time of the invention, as of the effective filing date

10:23:40

here. This is the Federal Circuit, 2008. "Courts may not

10:26:18

of the patent application.

10:23:44

redraft claims to cure a drafting error made by the patentee

10:26:20

10:23:47

whether to make them operable," which is the last argument

10:26:22

10:23:49

you heard from Mr. Lee, "to define the claim our way to make

10:26:26

10:23:54

this claim operable." The Federal Circuit said, that is not

10:26:30

it, but this is such a critical issue in this case, we think

10:23:58

a proper way to do that, whether to make them operable or to

10:26:34

it resolves it fully. If you read cover to cover Cubist's

10:24:02

10

sustain their validity.

10:26:37

10

opening brief, you will not see a reference to the important

10:24:03

11

10:26:41

11

point that you have to construe claims as of the effective

10:24:06

12

10:26:43

12

filing date.

10:24:08

13

10:26:44

13

10:24:13

14

They are converting the claim through their proposed Markman

10:26:47

14

cover, you will not see that point addressed in their

10:24:18

15

ruling into a product-by-process claim. I am sure you have

10:26:50

15

answering brief. I listened to Mr. Lee. He did not focus

10:24:21

16

dealt with those. But a product-by-process claim is a

10:26:53

16

on that point. It drives everything. He said to you at the

10:24:23

17

product claim, except that the product is defined as the

10:26:57

17

beginning of his presentation, Your Honor, he said, look at

10:24:26

18

result of the underlying process. "It's often useful where

10:27:02

18

the examples in the patent, the antibiotic produced from

10:24:30

19

a product-to-structure is either not fully known or is too

10:27:06

19

fermentation, the potent antibiotic. He said to you, Our

10:24:37

20

complex to analyze -- "

10:27:10

20

interpretation would cover all of these examples. Our

10:24:38

21

Cubist could have, but did not, seek

10:27:13

21

interpretation would focus on an antibiotic that is included

10:24:42

22

product-by-process claims, where they say, for instance --

10:27:17

22

in all those examples. Hospira's does not. Think about

10:24:47

23

let's take a look at the next page. They could have said

10:27:20

23

that for a second.

10:24:49

24

this. They could have said, "An antibiotic derived from the

10:27:21

24

10:24:52

25

fermentation of Streptomyces roseoporus." They could have

10:27:24

25

There is case after case. There is a couple

A claim is construed as written, as written, not

as the patentee wished it had written it.
I think we have exactly that case, Your Honor.

You can't have different meanings over different

times.
Your Honor, I hate to put such a fine point on

If you read their answering brief cover to

The answer to that question depends on when the

question is asked. As of the effective filing date, someone

38

40

10:24:56

said that. That would have resolved the issue that they

10:27:29

reading the intrinsic evidence would believe that our

10:24:58

had.

10:27:31

antibiotic, L-Asn, was the one covered by all the examples.

10:24:58

10:27:36

And Mr. Lee's antibiotic, the D-Asn, was outside of all of

10:25:01

doing this and trying to characterize the compound the

10:27:40

the examples as of the effective filing date 2000.

10:25:03

technology wasn't so robust to make sure you could get each

10:27:43

10:25:07

of the stereoisomers accurate, that was the argument. I

10:27:46

reading those examples would now know that it's really D-Asn

10:25:10

don't know if that is factually accurate or true, but just

10:27:50

that's produced by the fermentation examples, that's

10:25:12

accepting it is true, if that was true, there was a solution

10:27:52

something people know today, in 2013. They didn't know it

10:25:15

available to Cubist in the Patent Office, which is a

10:27:56

as of the effective filing date of 2000.

10:25:18

10

product-by-process claim. That is what these are for.

10:27:59

10

10:25:21

11

If you are worried about the structure, if you

10:28:01

11

would have believed that our interpretation, our antibiotic,

10:25:24

12

are worried about not being quite accurate, you can do a

10:28:04

12

the L-Asn, was the one that was being produced in all the

10:25:29

13

product-by-process claim. You can say that what I am

10:28:08

13

examples, not D-Asn. That is later-acquired extrinsic

10:25:31

14

claiming is an antibiotic derived from the fermentation of

10:28:11

14

evidence.

10:25:33

15

Streptomyces roseoporus. They didn't do that. Now, in

10:28:15

15

10:25:39

16

2013, it's too late to try to do it through the Markman

10:28:19

16

effective filing dates of all the patents. '87, '99, 2000.

10:25:41

17

hearing.

10:28:25

17

This is Slide 12. Each of those patents discuss and cite

10:25:45

18

10:28:28

18

prior art describing daptomycin with L-Asn. So anybody

10:25:47

19

the way I want to organize myself. Their proposed

10:28:32

19

reading these patents, including every single example, would

10:25:50

20

construction, Your Honor, it literally violates four bedrock

10:28:35

20

have believed that L-Asn daptomycin is what was being

10:25:54

21

principles of claim construction.

10:28:39

21

described.

10:25:57

22

10:28:40

22

10:26:00

23

10:28:44

23

It's a Cubist publication. They called it an unexpected

10:26:02

24

10:28:48

24

discovery, because everybody accepted L-Asn before 2005. So

10:26:05

25

10:28:52

25

it was an unexpected discovery in 2005.

When Mr. Lee said, hey, back when they were

Now, we said this in our reply brief. That's

Number one: Claims are construed as of the

effective filing date.
Slide 10. You know the law. This is from
Phillips. You have got to pick a time period. The claims

04/15/2013 04:59:57 AM

Page 37 to 40 of 70

What he says now, today, in 2013, that someone

In 2000, anyone reading the intrinsic record

Just look at the timeline here. These are the

Then this Miao publication comes out in 2005.

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10:28:57

10:29:00

10:29:03
10:29:08

43
10:32:10

say to the reader, hey, what is daptomycin, they refer the

matters? The effective filing dates of 2000? This is all

10:32:13

reader to Baltz. And Baltz adopts our construction of that

of the art cited in Cubist's patents. And each and every

10:32:17

chemical compound. All four.

one of the these references defined daptomycin in the way we

10:32:22

10:29:13

define it, not the way Mr. Lee defines it.

10:32:26

lot of prior art literature. Every single time, every

10:29:17

10:32:30

single time in the literature that daptomycin is defined,

10:29:20

10:32:34

it's defined with L-Asn, not D-Asn.

10:29:23

10:29:27

10:29:32
10:29:36

But what about before 2005, the time period that

At the time period that matters, all of the art

and the specifications defined it as we define it.

It's more than just Baltz. These patents cite a

10:32:37

compound was defined by Lilly, dzptomycin there at the

10:32:41

10

bottom, Eli Lilly, just as we propose Your Honor define it.

10:32:45

10

say you should define it. In yellow, these are the

11

So before 2005, our definition was accepted. After 2005, I

10:32:48

11

treatment patents. The purity patents actually cite the

10:29:41

12

agree that Mr. Lee's definition would be accepted. But what

10:32:52

12

predecessor to this '071 patent, the one where the

10:29:44

13

matters is, the key point, what time period are we looking

10:32:56

13

certificate of correction is at issue. Here is what they

10:29:49

14

at? What time period drives the analysis? It's 2000, at

10:32:59

14

say. That is the predecessor. '071 is a reissue. So when

10:29:53

15

which time our definition controlled.

10:33:02

15

the daptomycin patent, patents, these four patents, refer to

10:29:59

16

Here is another thing to focus on. Everybody

10:33:06

16

'226, they are actually referring to '071. And they

10:30:02

17

agrees that daptomycin has the same meaning in all four

10:33:10

17

literally refer to it, and '071, as Mr. Lee concedes, as

10:30:04

18

patents. So look at the method patents, for instance. This

10:33:15

18

Cubist concedes, defines daptomycin exactly as we suggest it

10:30:11

19

Miao publication, it didn't exist on the 1999 filing date.

10:33:19

19

be defined with L-Asn.

10:30:16

20

It didn't exist at any time during the prosecution. It was

10:33:22

20

10:30:19

21

never before the examiner. The patents actually issued

10:33:24

21

extrinsic evidence. Granted, they are pointing you to parts

10:30:24

22

before the Miao publication came out.

10:33:28

22

of the specification. Here is the two arguments from the

10:30:26

23

10:33:31

23

briefs.

10:30:29

24

that daptomycin was L-Asn. So Miao can't possibly be

10:33:32

24

Mr. Lee made the arguments. The specification

10:30:33

25

relevant to the proper interpretation of daptomycin for the

10:33:35

25

refers to this compound as being a highly potent antibiotic.

So here is the situation we are facing. This

So these patents issued when everybody believed

These are the purity patents, in green, those

are all the references that define the compound just as we

Here is what I mean when I say Cubist relies on

42

44

10:30:36

method patents, and therefore, since Cubist agrees that all

10:33:39

And it refers to this compound being a product of this

10:30:41

of the patents have the same meaning for daptomycin, Miao

10:33:42

fermentation process. No question about that, that's what

10:30:46

has to be literally irrelevant to your claim construction,

10:33:46

the specification says.

10:30:50

Your Honor.

10:33:47

10:30:55

10:33:50

you put yourself back in the time period where you are

10:31:00

extrinsic evidence in an effort to trump the intrinsic

10:33:52

supposed to put yourself, back in 2000, what would you think

10:31:02

evidence.

10:33:57

was being described there? Daptomycin with L-Asn, because

10:31:08

10:31:10

10:31:14
10:31:19

Bedrock principle No. 2: Cubist is relying on

If you look at only the intrinsic evidence, and

10:34:02

the product of that fermentation process, in the specs -- I

be very brief. But clearly, extrinsic evidence cannot trump

10:34:08

am sorry, in the articles cited in the spec, they tell you

10

intrinsic evidence. This is Phillips, Kara, a bunch of

10:34:11

10

in the prior art that it's L-Asn, that's what they tell you.

11

Federal Circuit cases, they all say the same thing:

10:34:16

11

So a person who is back in the time period we are supposed

10:31:22

12

intrinsic evidence is what controls, not extrinsic evidence.

10:34:19

12

to be looking at, in 2000, reading the specification and the

10:31:27

13

10:34:22

13

examples that Mr. Lee pointed out, would come to the

10:31:29

14

this, the Baltz reference and the Tally reference which are

10:34:25

14

conclusion they are talking about L-Asn. And that's the

10:31:33

15

described in the patents, they are not just cited, they are

10:34:28

15

only thing that matters.

10:31:36

16

discussed. They are part of the prior art, and actually

10:34:32

16

10:31:39

17

they can be of particular value in construing a claim term.

10:34:35

17

to what somebody would think now today, based on extrinsic

10:31:44

18

I think we agree on that.

10:34:37

18

evidence, the Miao article, what they would think today.

10:31:46

19

10:34:40

19

Today, yes, when somebody reads the fermentation experiment

10:31:50

20

claim construction. Daptomycin is described in Baltz. That

10:34:42

20

in the patent, they would know, you know what's that's?

10:31:54

21

is exactly what we said. You see the reference to Figure 1

10:34:44

21

That's probably D-Asn they are coming up with, not L-Asn.

10:31:57

22

there. That's what we put in our claim construction. So we

10:34:48

22

What we think today doesn't matter, though. It's what

10:32:00

23

are lifting the definition from the specification for our

10:34:51

23

people would have thought in 2000. In 2000, I don't think

10:32:02

24

claim construction. That's what we are doing.

10:34:54

24

there is any reasonable disagreement, when people read those

10:32:07

25

10:34:58

25

fermentation examples in the specification, they would have

I know that you know this quite well, so I will

Particularly the prior art, I guess we agree on

This is the actual specification. It echoes our

11 of 29 sheets

All four patents say the same thing. When they

Page 41 to 44 of 70

How does Mr. Lee get to D-Asn? He is referring

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10:35:01

10:35:06

10:35:11

10:35:15

10:35:18
10:35:21

47
10:37:56

10:37:59

of claim construction. The first is you got to focus on the

10:38:04

that Mr. Lee pointed out is that their chemical structure

right date. The second is you can't rely on extrinsic

10:38:07

there is taken from the patent. I concede, that's true.

evidence like the Miao article and post-2005 development.

10:38:10

But if you took out the improper process limitation, and you

And, No. 3, you cannot import a process limitations into a

10:38:14

just left the rest of their claim construction, you would

10:35:23

product claim. You can't do it. And that's what they are

10:38:18

literally get a claim that covers thousands of different

10:35:25

doing. Just a reminder, they are trying to import the

10:38:22

compounds, including both L-Asn and D-Asn. Why is that?

10:35:29

phrase "derived from the fermentation process."

10:38:27

Because if you don't include stereochemistry, which any

10:35:32

10

10:38:32

10

chemist will tell you you have to do in order to

10:35:34

11

made earlier, which is, the time to do this, to define the

10:38:34

11

differentiate between compounds, if you don't include in

10:35:38

12

compound by a process, was when they filed their patent

10:38:37

12

your Markman ruling stereochemistry, this is a class of

10:35:41

13

application, not during a Markman hearing. They could have,

10:38:40

13

compounds. It would include the L and D version of every

10:35:45

14

but did not, seek to define the claim as a product created

10:38:44

14

single one of those 13 amino acids, and if you do the math,

10:35:50

15

from a process. They didn't do that.

10:38:48

15

that is literally thousands of different compounds. So you

10:35:52

16

10:38:52

16

cannot interpret daptomycin without including

10:35:56

17

if there is not a limitation referring to a process in the

10:38:57

17

stereochemistry. If you don't do it, you get a large class.

10:35:59

18

claim, you can't import it. Even when the spec says there

10:39:01

18

10:36:03

19

are certain advantages -- this is a quote from Vanguard --

10:39:05

19

10:36:06

20

"The method of manufacture, even when cited as advantageous,

10:39:12

20

10:36:10

21

does not of itself convert product claims into claims

10:39:16

21

daptomycin, the term data daptomycin is a class of

10:36:13

22

limited to a particular process."

10:39:19

22

compounds. They are not arguing that.

10:36:16

23

10:39:21

23

10:36:19

24

circumstances, where you basically say, my product can be

10:39:24

24

avoiding including stereochemistry in your claim

10:36:24

25

made only by this process and no other process. You got to

10:39:27

25

construction, Your Honor, would leave with you with a large

believed you were getting daptomycin with L-Asn, not D-Asn.

I said they violated the four bedrock principals

And I just want to make the same point that I

When can you do that? As a general proposition,

So when can you do that? Only in very limited

the construction of daptomycin.

Now, say you eliminated it. One of the things

It's nonsensical if you do not define the

compound with the stereochemistry.
Critically, nobody in this case is arguing that

So eliminating the process limitation and

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48

10:36:28

have what the Federal Circuit calls words or expressions of

10:39:32

file, because nobody in the room is saying you should

10:36:32

manifest exclusion or restriction. I am covering only this

10:39:33

construe that term to be a large class. We are giving you a

10:36:38

product and no other product. A product made by only this

10:39:36

choice. It has to be either D-Asn or L-Asn. It is only a

10:36:40

process and no others. And clearly, we don't have that

10:39:39

single compound.

10:36:42

situation here, because when you read the specification on

10:39:41

10:36:47

the right, all it says is daptomycin is a compound that can

10:39:43

and I heard a little bit of it from Mr. Lee, is that, you

10:36:52

be derived from the fermentation process. There is other

10:39:46

know, stereochemistry doesn't matter. It's not something

10:36:54

ways to make it. You can make it synthetically as well.

10:39:48

that people focus on. It's not important when you are

10:36:58

10:39:52

defining a compound to include its stereochemistry. And I

10:37:04

10

inserting a process limitation into these claims, because

10:39:57

10

have to say, Your Honor, I mean, you have had cases, I am

10:37:06

11

the patent doesn't say you can only make it one way and no

10:40:01

11

quite sure, about stereochemistry with enantiomers. It can

10:37:09

12

other way. So just legally, you can't do it. And their

10:40:05

12

make all the difference in the world. When there is more

10:37:13

13

expert actually admits that you can make the compound

10:40:10

13

than one possible stereoisomer, chemists include

10:37:17

14

synthetically.

10:40:14

14

stereochemistry. You have to, to differentiate between one

10:37:18

15

10:40:18

15

and the other.

10:37:20

16

doctrine of claim differentiation. It's just kind of a

10:40:20

16

10:37:25

17

common-sense notion that if you include phrases in one claim

10:40:22

17

doesn't matter, it really flies into the face of what

10:37:29

18

but not another, you assume that phrase is not included in

10:40:26

18

chemistry 101 students will know.

10:37:34

19

the original claim. That's what we have here.

10:40:29

19

10:37:37

20

10:40:32

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ignore stereochemistry, including for method patents even,

10:37:40

21

daptomycin. The unasserted claims actually refer to -- some

10:40:35

21

you would fail to distinguish between infringing and

10:37:45

22

unasserted claims actually refer to the fermentation

10:40:37

22

non-infringing compounds.

10:37:48

23

process.

10:40:38

23

10:37:48

24

10:40:40

24

Federal Circuit 2004. "Regardless of whether a compound is

10:37:52

25

10:40:44

25

claimed per se or a method is claimed that entails the use

So there is no even arguable grounds for

Another way to get to the same place is the

The asserted claims just say daptomycin,

So the doctrine of claim differentiation, that

also tells us that you cannot import this process claim into

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Now, one of the things that their experts say,

So when their experts say stereochemistry

Also, this is the point I made before, if you

This is the University of Rochester from the

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of the compound, the inventor cannot lay claim to that

10:43:27

undisputed that stereochemistry can have an impact not only

10:40:52

subject matter unless he can provide a description of the

10:43:30

on biological activity but also on a compound's properties

10:40:55

compound sufficient to distinguish infringing compounds from

10:43:34

as well.

10:40:58

non-infringing compounds."

10:43:37

10:40:59

The point there, Your Honor, is if you literally

10:43:41

daptomycin. And you know that Cubist agrees because

10:41:02

ignore stereochemistry, you are not picking an individual

10:43:45

otherwise they wouldn't be putting that process limitation

10:41:04

compound. You are picking a class. It's really unavoidable

10:43:48

in their claim. They are putting the process limitation in

10:41:07

that you have to choose between L-Asn and D-Asn.

10:43:50

the claim to try to narrow their claim construction to one

10:41:13

10:43:53

particular stereoisomer, the D-Asn. So they agree that

10:41:15

10

10:43:58

10

stereochemistry matters. But they just go about it in a

10:41:21

11

10:44:01

11

different way with this process limitation, which we think

10:41:23

12

prior art that is actually cited in the specification. This

10:44:03

12

is not proper.

10:41:26

13

is Slide 41. These are some of the articles that we

10:44:06

13

10:41:28

14

cited -- I am just going back to that other slide to point

10:44:09

14

defined by their structure, not by their function. This

10:41:32

15

out that the treatment references, these are purple now,

10:44:12

15

really relates to the following. One of the things you

10:41:35

16

these are all articles or patents discussing treatment with

10:44:14

16

heard from Cubist in their papers and from Mr. Lee is, hey,

10:41:39

17

daptomycin, and every single one defines the term by its

10:44:17

17

the specification calls this a potent antibiotic. We now

10:41:43

18

stereochemistry with L-Asn.

10:44:21

18

know that D-Asn is more potent than L-Asn. So that really

10:41:45

19

10:44:25

19

should be helpful in defining the chemical compound.

10:41:48

20

matters in real life when people are writing even about

10:44:27

20

10:41:51

21

methods of treatment. When they talk about the compound

10:44:29

21

compounds are not defined by their function. They are

10:41:53

22

they are giving to human beings, they define it precisely

10:44:32

22

defined by their structure. This is settled law. Amgen,

10:41:56

23

with stereochemistry. You have to. Otherwise, you don't

10:44:36

23

for instance, tells you you identify a compound by its

10:41:59

24

know what compound you are giving the human being.

10:44:38

24

structure, not by what it does or how it functions.

10:42:02

25

10:44:43

25

And the fact is, the intrinsic evidence shows

that stereochemistry was important to skilled scientists.
Your Honor, you have to go no further than the

The point is, stereochemistry matters. And it

The purity patents, these are purity references

So stereochemistry is critical to defining

The last bedrock principle: Compounds must be

But the fact of the matter is, chemical

The fact of the matter is, Your Honor, all we

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52

10:42:05

in green, same thing. These are articles and patents about

10:44:46

know right now is that L-Asn is tenfold less potent in vitro

10:42:09

purification, purifying daptomycin. And in every single

10:44:50

than D-Asn. It could very well be a great antibiotic, maybe

10:42:13

article, they define daptomycin very precisely with its

10:44:55

a little bit of a higher dose. Maybe it does better in vivo

10:42:17

stereochemistry, because it's important to folks. And that

10:44:59

than in vitro. Nobody knows whether L-Asn is a great

10:42:22

includes Cubist itself. This is one of the inventors in

10:45:02

antibiotic or not. All we know is that in one particular

10:42:28

the '071 patent -- actually, this is a Lilly inventor.

10:45:04

in-vitro test there was a difference in potency. That's all

10:42:31

Cubist bought the Lilly patent. Look what it says. This is

10:45:08

we really know. The only way that Cubist can argue that the

10:42:34

in the Patent Office on the '071 prosecution. "As with most

10:45:11

references to potency point to D-Asn is from extrinsic

10:42:39

peptides, the three-dimensional structure resulting from

10:45:15

evidence that wasn't before the Patent Office and should not

10:42:42

10

intramolecular interactions within the compound is an

10:45:18

10

10:42:45

11

important factor in its biological activity. It is widely

10:45:24

11

10:42:48

12

accepted that relatively minor modifications, including such

10:45:27

12

rejected in this Court, in Delaware, in the Bayer case.

10:42:53

13

subtle changes in stereoisomerism, may result in major

10:45:33

13

There was an enzyme that was mis-described as a

10:42:57

14

changes in pharmacological properties."

10:45:38

14

monooxygenase rather than a dioxygenase in the patent. And

10:42:59

15

10:45:43

15

Bayer argued to try to correct it. So there is the same

10:43:01

16

stereochemistry or otherwise you are not identifying a

10:45:47

16

kind of scientific mistake. There was a scientific mistake

10:43:02

17

particular compound with a particular biological property.

10:45:50

17

that was reported in the patent, and after patent issuance

10:43:05

18

And even a little tiny change like L to D as in this case

10:45:54

18

it was corrected. So it was actually a dioxygenase but in

10:43:09

19

can make a big difference.

10:45:58

19

the patent it was described as a monooxygenase. So like

10:43:11

20

10:46:03

20

Cubist here, Bayer went through various sort of legal

10:43:14

21

tenfold difference. That wasn't something that was

10:46:07

21

gymnastics to try to correct the mistake retroactively. And

10:43:17

22

discovered until 2005, way after the time period that

10:46:11

22

the Court rejected each and every such argument, including

10:43:20

23

matters.

10:46:15

23

an effort to functionally define the enzyme rather than to

10:43:22

24

10:46:18

24

structurally define it, as we are suggesting is appropriate.

10:43:25

25

10:46:26

25

So just to conclude on daptomycin, there really

The point being that you have to include

Here, at least in vitro, it resulted in a

Our experts say the same thing, I am just going

to breeze over them. The fact is, I think it's relatively

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Page 49 to 52 of 70

be part of the consideration for Markman.

This kind of issue and this kind of argument was

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10:46:31

are four bedrock principals of claim construction that we

10:49:35

correction does not involve such changes in the patent as

10:46:34

think Cubist is running into. But if I were to ask Your

10:49:37

would constitute new matter or would require reexamination."

10:46:37

Honor to just focus on one in particular, it's the timing

10:49:48

10:46:41

issue. It's the timing issue.

10:49:50

being a factual issue and he referred you, for instance, to

10:46:43

Nobody would question Hospira's definition in

10:49:53

that New Mexico case that Judge Lourie wrote, those are

10:46:48

the time period that matters. And that's all that matters.

10:49:57

cases about new matter. You don't even get to the new

10:46:54

10:50:00

matter inquiry unless you first pass the first test.

10:46:57

Your Honor. This is the certificate of correction issue.

10:50:03

10:47:00

You asked whether this would be appropriate for a summary

10:50:08

10:47:08

10

judgment ruling on noninfringement. I think it would be. I

10:50:12

10

10:47:11

11

will explain why I think so. But for today, we are

10:50:14

11

10:47:13

12

literally just asking for a claim construction type

10:50:17

12

right to new matter. And when he said to you, there is

10:47:17

13

analysis.

10:50:20

13

going to be a lot of facts, we are going need to hear from

10:47:18

14

10:50:24

14

experts, look at this Judge Lourie case, the New Mexico

10:47:21

15

daptomycin. Formula 3 is daptomycin. This is how it was

10:50:27

15

case, that is the case about new matter. It is not a case

10:47:25

16

defined by Lilly, by the way, by its stereochemistry, just

10:50:30

16

about either one of these issues.

10:47:29

17

as I suggest is appropriate, with L-Asn. And then the L-Asn

10:50:32

17

10:47:32

18

was corrected later in time after 2005 to D-Asn. So the

10:50:34

18

issues in this case? Was there a clerical or

10:47:36

19

question that we raise before Your Honor is, is that

10:50:37

19

typographical -- an error, a mistake of a clerical or

10:47:39

20

certificate of correction proper? That's the question we

10:50:42

20

typographical nature. I concede that can be a factual

10:47:42

21

raise.

10:50:45

21

issue, and if we had that issue in this case I wouldn't be

10:47:44

22

10:50:48

22

arguing in a Markman hearing on it today. But we do not,

10:47:47

23

this issue, because everything I just said, all the learning

10:50:53

23

because Cubist has admitted that we do not. We asked them:

10:47:49

24

you have had today from reading the briefs about this

10:50:56

24

Admit that the alleged mistakes in the '071 patent that were

10:47:52

25

scientific mistake that happened and the L versus the D, it

10:51:00

25

corrected by the certificate of correction were not of a

Now, let me go to this Formula 3 compound issue,

This is how Formula 3 was defined. It's just

We do think it would be wasteful to not resolve

When Mr. Lee talked about the new matter issue

Those are additional requirements. These first

two requirements, you have to pass one of these tests before
a certificate of correction is allowed.
So Mr. Lee bypassed the threshold issue and went

Okay, so, first, do we have one of these two

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would have to be repeated again if we were to litigate the

10:51:02

10:47:58

certificate of correction issue later.

10:51:03

Admitted.

10:48:01

10:51:04

Were not of a typographical nature. Admitted.

10:48:04

in this particular case is a pure question of claim

10:51:08

Of course, I mean, they were being candid. This

10:48:07

construction. And I will tell you why I say that.

10:51:11

wasn't a typo. People literally thought L-Asn was the

10:48:14

10:51:15

correct description of the compound. So it wasn't a typo.

10:48:16

the full statute here to address an argument that Mr. Lee

10:51:18

It was a firmly held belief until 2005. That is why it

10:48:20

made. Can I hand it up to Your Honor?

wasn't clerical and it wasn't typographical.

10:48:23

10:48:38

10

10:48:47

11

certificate of correction is appropriate only for a mistake

10:48:50

12

10:48:53
10:48:56

Moreover, their certificate of correction issue

I think it would be helpful to actually look at

clerical nature.

10:51:23

THE COURT: Sure.

10:51:29

I can skip this one. These are the Texas cases

MR. HURST: So on my slide I show that a

10:51:33

10

saying what I just said, which is the clerical typographical

10:51:36

11

nature, that could be a question of fact. But the second

of one of two different kinds, of a clerical or

10:51:38

12

one, the minor character issue, is a question of law. The

13

typographical nature, or of minor character. The first one,

10:51:41

13

first element is a question of law.

14

the clerical or typographical nature, that can be a possible

10:51:43

14

10:48:59

15

factual issue. We agree, that is a possible factual issue.

10:51:47

15

correction through the second one? Is it of minor

10:49:02

16

It is just not a factual issue in this case. But of a minor

10:51:50

16

character?

10:49:06

17

character, that's purely a legal issue.

10:51:52

17

10:49:08

18

Here is what I wanted you to do, though.

10:51:55

18

turns entirely on claim construction. This is Superior

10:49:11

19

Mr. Lee spent a lot of time talking about new

10:51:59

19

Fireplace, one of the leading certificate of correction

10:49:14

20

matter. Read the statute. "Whenever a mistake of a

10:52:02

20

cases. And it says, 61, "We have interpreted the phrase

10:49:17

21

clerical or typographical nature or of a minor character,

10:52:05

21

mistake of minor character to exclude those mistakes the

10:49:21

22

which is not the fault of the Patent Office, appears in a

10:52:10

22

correction of which would broaden a claim. Since this was

10:49:24

23

patent and a showing has been made that such mistake

10:52:15

23

such a mistake, we conclude as a matter of law that it was

10:49:27

24

occurred in good faith, the director may issue a certificate

10:52:18

24

not" -- not fact, law -- "that it was not correctable by a

10:49:31

25

of correction if," if -- you see the "if" there -- "the

10:52:22

25

certificate of correction."

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So now, go back. Can they get a certificate of

Here is the law. It is a matter of law and it

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59
10:55:08

They de-list the '071 patent from the Orange Book for their

a broader claim. And, Your Honor, that's claim

10:55:13

product.

construction.

10:55:14

10:55:16

unless it covers the drug in question. And so since their

corrected claim is in different scope, it is not correctable

10:55:19

patent covered L-Asn, they took it out of the Orange Book

by a certificate of correction.

10:55:23

because their product was D-Asn.

10:55:25

is what it means to be a broader claim. This is from

10:55:28

correction because the patent no longer covered their drug.

Central Admixture. You can find a lot of cases that say the

10:55:31

It's why we don't infringe.

10

same thing. It's not quite what you would think. When you

10:55:32

10

11

hear broader claim, I thought, somebody had to teach this to

10:55:35

11

patents covers L-Asn, not D-Asn, we don't infringe. And the

10:53:03

12

me, because I said, well, there are old claims and there are

10:55:38

12

patent doesn't cover their product. That's why they took

10:53:06

13

new claims, it is not more square footage. They had the

10:55:41

13

'071 out of the Orange Book.

10:53:10

14

L-Asn before, and then they corrected it to the D-Asn. So

10:55:43

14

10:53:13

15

it's the same kind of square footage. It is not really

10:55:46

15

'07, they get it in '08 and then they re-list it. What that

10:53:15

16

broader, is it?

10:55:50

16

tells you is they are conceding that the old claims cover

10:53:16

17

10:55:53

17

different territory from the new claims. And that

10:53:21

18

as broader if the corrected claim covers territory that the

10:55:56

18

concession is all you need to determine as a matter of law

10:53:24

19

old claim did not, and that's what the case law says.

10:55:59

19

that the certificate of correction was improper.

10:53:27

20

Whether a claim is broadened through a correction requires

10:56:03

20

It covers new territory.

10:53:29

21

interpreting the old and new versions of that claim.

10:56:06

21

I want to address this Knight case for a second,

10:53:31

22

That's why we say this is a claim construction

10:56:11

22

the New Mexico case that Judge Lourie wrote, that Mr. Lee

10:53:34

23

issue, Your Honor. We are asking you to interpret the old

10:56:15

23

asked you to take a look at.

10:53:36

24

L-Asn versus the new D-Asn, pure question of claim

10:56:19

24

10:53:39

25

construction.

10:56:22

25

So the question turns entirely on whether it is

If the uncorrected claim as compared to the

What does it mean to be a broader claim? This

So you take a look at the case law and it counts

You can't list a patent in the Orange Book

So then they requested the certificate of

If you construe the claims as we suggest, that

So they asked for a certificate of correction in

My first point is the one I made before, which

is, this case is about whether or not this scientific

58
10:53:40

10:53:43

10:53:48

10:53:51

couldn't find a case where the corrected claim wasn't

10:53:54

10:53:57
10:54:01

60
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correction of an old compound -- in that particular case,

territory that the old one did not, that's the only inquiry.

10:56:28

under the facts of that case, the question was whether it

Now, one of the things Mr. Lee said is that he

10:56:32

was new matter. That was the question. Remember, the

10:56:34

statute, though, you don't get to the new matter inquiry

broader in square footage. That's what he was saying. He

10:56:37

unless you passed one of the first two tests, minor in

was saying what I said at first. We are just going from the

10:56:39

character, broadening, or typographical error. They can't

one compound, L-Asn, to another compound, D-Asn. And he

10:56:43

pass that first test.

10:54:04

said, you know, that's unsettled in the law as to whether

10:56:45

10:54:06

that counts as broadening. I think that's not correct. I

10:56:47

10:54:10

10

think it is -- they didn't broaden when it reaches something

10:56:50

10

issue, which is not before Your Honor at this point. And it

10:54:15

11

it didn't before reach. So it is broader in that sense.

10:56:52

11

should never be, because they can't pass the first two

10:54:18

12

All you have to do is compare the old to the new. And it's

10:56:55

12

tests.

10:54:21

13

purely a matter of claim construction.

10:56:55

13

10:54:22

14

10:57:00

14

the New Mexico case, it was about prosecution amendment. It

10:54:26

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Cubist's new version covers territory that the old one did

10:57:11

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wasn't about a certificate of correction. So it is not a

10:54:28

16

not.

10:57:14

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certificate of correction case. In the Regents case, this

10:54:29

17

10:57:16

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New Mexico case that Mr. Lee talked about, it was just about

10:54:32

18

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whether you could amend the claims to cover this correction

10:54:38

19

10:57:26

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from the compound. That's all that it was about, and

10:54:41

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what the case law says. If you were to look at any

10:57:29

20

whether that qualified as new matter.

10:54:44

21

underlying facts at all, you might look at what Cubist did

10:57:31

21

10:54:48

22

before the FDA and before the Patent Office.

10:57:34

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claims are permissible. They are permissible if fairly

10:54:55

23

10:57:37

23

disclosed in the specification. For a certificate of

10:55:00

24

in 2005. And it says, hey, you know what? We were wrong.

10:57:41

24

correction, broader claims are not permissible regardless of

10:55:04

25

Everybody was wrong. It's D-Asn. What does Cubist do?

10:57:44

25

what the specification says. These are really apples and

Then determining whether the new version covers

We have that here, of course. Slide 63.

New version, corrected version, covers D-Asn,

the old version covered only L-Asn.
So this is just a pure question of law. That's

If you take a look at Slide 65, Miao comes out

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So when he asked you to focus upon New Mexico,

he is asking you to focus on the subsidiary new matter

But anyway, there is a separate distinction. In

But during prosecution, Your Honor, broader

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63

10:57:46

oranges. And this New Mexico case really offers no guidance

11:00:26

10:57:49

for those two reasons. Number one, it is a new matter case,

11:00:29

start with first. But I am not going to follow his advice

10:57:51

number two, it is not a certificate of correction case.

11:00:32

at this point in time.

10:58:02

11:00:33

10:58:04

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10:58:07

Your Honor, then Cubist does not contest that Formula 3

11:00:38

10:58:11

should be L-Asn. And in that event I think it would be

11:00:41

judgment argument, not the claim construction argument. Let

10:58:14

undisputed that we do not infringe. And so if you just

11:00:43

me give you the best example of why it was the summary

10:58:18

address the purely legal certificate of correction issue,

11:00:47

judgment argument. He had a slide on what we said or didn't

10:58:22

10

which we say turns on a claim construction issue, then I

11:00:51

10

say to the FDA and how that showed, Your Honor, as a matter

10:58:26

11

think that noninfringement will be conceded, and therefore

11:00:54

11

of law the claim was broadened. Well, the letter which was

10:58:28

12

it would be appropriate to address on summary judgment.

11:00:59

12

referred to in an interrogatory, the letter that was sent to

10:58:34

13

So just to wrap up here.

11:01:02

13

the FDA described this difference between L and D as a minor

10:58:37

14

First point is, the daptomycin, it's the

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14

error, just as I have described it to Your Honor.

10:58:41

15

effective date, it's the effective date, it's the effective

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15

If Your Honor would indulge me with my example

10:58:43

16

date. When Mr. Lee stands up, that has to be the first

11:01:13

16

of the engineered dog, what Your Honor is confronted with --

10:58:47

17

thing that he should address, is why would he be looking at

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17

there are other examples -- but what Your Honor is

10:58:51

18

things that happened later, Miao, in 2005? Why would he be

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confronted with there is a patent that describes the

10:58:55

19

looking at the examples in the patent from the perspective

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invention of a genetically engineered dog. It describes the

10:58:58

20

of somebody who now knows about Miao and knows that the

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process, the steps that you would follow, and if you follow

10:59:02

21

fermentation produced D-Asn, when the law tells me I have to

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the steps, you get that dog.

10:59:04

22

take a look at the claims in 2000, when I think there will

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22

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be a concession that Hospira is right, everybody thought it

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describes it with a photograph. And the photograph, because

10:59:09

24

was L-Asn at the time.

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24

the technology that was available may not be as perfect as

10:59:12

25

11:01:42

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the description of how to make it, and they are saying,

So I guess I should just skip to the end here.

If the certificate of correction is invalid,

And on the certificate of correction issue, it

I appreciate Mr. Hurst telling me what I should

I am going to start with the question of the

reissuance of correction, two important points.
What Your Honor just heard is the summary

It describes the dog itself in words, and it

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really is -- and I understand Your Honor does not typically

11:01:46

throw everything out. To go back to the timing issue,

10:59:17

entertain summary judgment motions -- but this really would

11:01:48

that's not claim construction.

10:59:20

be a case where we really have nothing to argue about but

11:01:54

10:59:24

law, at least in our view, so it would be appropriate to

11:01:55

implications of listing and de-listing. There is nothing

10:59:26

address on summary judgment. But again, for today, we are

11:01:58

wrong with a company to be cautious and say we are getting a

10:59:28

just asking you to engage in the claim construction analysis

11:02:02

correction, let's play it safe because if we don't correct

10:59:32

that would lead you to the conclusion that the certificate

11:02:05

it we are going to get an antitrust claim. If we do correct

10:59:35

of correction is inoperable.

11:02:08

it, we might get an antitrust claim. Let's just be same.

10:59:37

11:02:12

That type of intrinsic evidence is not going to drive Your

10:59:41

10

there would be a concession of noninfringement, why wouldn't

11:02:16

10

10:59:42

11

the parties arrive at a stipulation of some type and just

11:02:17

11

10:59:46

12

take that directly to the Federal Circuit?

11:02:20

12

fact that the cases say Your Honor should decide as a matter

10:59:50

13

11:02:25

13

of fact who the person of ordinary skill in the art is.

10:59:52

14

would get that concession. But I think I heard Mr. Lee say

11:02:28

14

Your Honor should decide as a matter of law, with underlying

10:59:55

15

that if the Court rejected the certificate of correction

11:02:33

15

facts, whether that person would think the claims had in

10:59:58

16

that there would not be an issue on infringement. I think I

11:02:36

16

fact been broadened. And the couple cases cited to Your

11:00:02

17

heard that. I am not sure.

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17

Honor all involved broadening, rather than this it's A or B

11:00:04

18

11:02:44

18

or L or D as we have confronted, as we have provided to Your

11:00:06

19

you reject that and adopt their claim construction as a

11:02:48

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Honor today.

11:00:11

20

consequence, then we can talk to them. I think it would be

11:02:48

20

11:00:15

21

less of an issue. I think we know what we joined the issue

11:02:53

21

Honor didn't hear any argument today that for claim

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on.

11:02:55

22

construction purposes, if you accept the claim as corrected,

11:00:22

23

THE COURT: Thank you, Mr. Hurst.

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23

which the law says we should, then the claim, the

24

MR. HURST: Thank you, Your Honor.

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24

stereochemistry in the claim covers the D, because that it

25

MR. LEE: Your Honor, I will brief.

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25

what the claim says. Now, there may be other implications

11:00:24

THE COURT: As you suggest, my ruling of whether

MR. HURST: I think we might. I wasn't sure we

MR. LEE: I think the answer is, Your Honor, if

04/15/2013 04:59:57 AM

Page 61 to 64 of 70

Your Honor knows about the antitrust

Honor to a conclusion.
The second thing is, Mr. Hurst did not rebut the

The last point on the reissue patent is, Your

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every scientist would know what happened at the Patent

11:06:17

Office.

11:06:19

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article sitting right in front of them with the correction

described as having engaged in legal gymnastics, I don't

11:06:24

in stereochemistry, did the patent examiner say you better

think that's right. If anything, I think it's the other

11:06:28

go back and amend the claims in these four patents or I am

way. Let me show Your Honor why.

11:06:32

not going allow these claims unless you put in

11:06:34

stereochemistry? And nothing, there is nothing in these

11:06:37

claims about stereochemistry.

If I can have our Slide 31.

11:06:38

10

Your Honor, when I said that we were two ships

11:06:42

11

rebuttal to the timing question. If a person of ordinary

11:06:45

12

skill in the art followed the fermentation process described

11:06:49

13

in the specification, you get the compound daptomycin. You

Hurst did, and take out the words "derived from the

11:06:52

14

get the D version.

15

fermentation of Streptomyces roseosporus, that's fine with

11:06:55

15

If a person of ordinary skill in the art

16

us. We were trying to distinguish the circumstance that

11:06:57

16

administered the product that's described in the

11:04:08

17

what we were claiming was if you use that process described

11:07:00

17

specification, you have the D version. It's not what they

11:04:12

18

in the claim you get what was in Figure 1. You would not

11:07:03

18

thought. Everybody agrees that the technology to take the

11:04:15

19

get what they claim.

11:07:09

19

photograph of my dog has developed well over 20 years. If

11:04:16

20

11:07:14

20

I, as of the effective date, if a person of ordinary skill

11:04:19

21

import a process limitation, if the claim reads, the

11:07:18

21

in the art followed the specification, you get daptomycin.

11:04:25

22

construction reads, The cyclic lipopeptide antibiotic

11:07:24

22

It happens that if you characterize it today, it's D. But

11:04:34

23

comprised of, and it goes on, words right on the spec, that

11:07:28

23

it's daptomycin. That's what is produced. That is what

11:04:39

24

is equally agreeable to Cubist.

11:07:32

24

results. That was what was administered to patients.

11:04:41

25

11:07:36

25

and that will be resolved later. But it's not for today.
And I am not going to argue all of the summary
judgment points if that is all right with Your Honor.
Let me go to daptomycin. Respectfully, we were

First let me see if I can narrow the dispute for

us.

passing in the night, I think we are.

If you take our claim interpretation, as Mr.

So all of the arguments made about our trying to

Now, let me go back to this timing issue,

In the high-purity patents, with the Miao

And here is what I think is the definitive

So if you focus on the timing issue, there is no

66

68

11:04:44

because, Your Honor, you have been given a false premise.

11:07:40

evidence, Your Honor, that anybody followed those steps and

11:04:49

Here is why. It is not what people thought according to

11:07:44

got the L. There is no evidence that anybody thought you

11:04:53

Hospira. In fact, Your Honor, you have now got competing

11:07:46

could follow those steps and get the L. There is no

11:04:57

declarations where one set of experts says here's what they

11:07:49

evidence that the L was administered to patients

11:05:00

would have recognized. The other says the contrary.

11:07:54

therapeutically.

11:05:03

11:07:56

11:05:07

specification, which is the application, with some

11:08:01

at the specification as a whole. This is a circumstance

11:05:11

amendments, as Your Honor knows, is the following. If you

11:08:03

where if you look at the five patents, the patentees

11:05:13

take the specification from the four patents and the claims,

11:08:07

describe -- I think the Court will agree, from all the other

11:05:19

10

you know these three important things. The first is, the

11:08:10

10

cases, there is a lot more in this spec about how the

11:05:23

11

claims say nothing about stereochemistry at all.

11:08:12

11

inventions came to be, what the problems were, what the

11:05:28

12

11:08:15

12

precise steps were and how each of the three of them moved

11:05:30

13

limitations. It's Hospira that is trying to import a

11:08:18

13

from purification to dosing to really high purity.

11:05:33

14

limitation. And they say, Your Honor, everybody would know

11:08:23

14

11:05:36

15

that that is the only way you define it. That is precisely

11:08:29

15

date, it is daptomycin as we have described it, not what

11:05:39

16

what the experts say is not true. They disagree about that.

11:08:33

16

they describe.

11:05:44

17

11:08:35

17

11:05:46

18

dispute between them. We have to recognize there is a

11:08:38

18

then the patent examiner missed it once, twice, three times,

11:05:49

19

dispute, because, if he is right, if the stereochemistry was

11:08:41

19

four times. And the last time we were here on this patent,

11:05:56

20

essential to defining the claim, think about what they are

11:08:45

20

so did Teva. They missed it, too. That's really unlikely.

11:05:59

21

saying. He mentioned the reissue patent was part of the

11:08:51

21

11:06:01

22

file history. There is a claim that is describing the claim

11:08:54

22

flashed up in the form of different patents. The

11:06:04

23

according to things. If Hospira is correct that

11:08:58

23

interesting thing is, for all of those charts and all the

11:06:07

24

stereochemistry is the beginning and the end of the world,

11:09:02

24

extrinsic evidence, Hospira never said to Your Honor, yes,

11:06:10

25

it is absolutely essential, I think Mr. Hurst's words were,

11:09:08

25

if you look at the examples that are in the patent, the L

It's what does the specification say. And the

There was an accusation that we were importing

But Your Honor doesn't have to resolve the

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Page 65 to 68 of 70

That's what I meant when I said you have to look

If they are read as a whole, as of the effective

If they are so right that it was so evident,

There is a host of extrinsic evidence that was

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69
11:09:13

version covers those examples. That was my earlier point.

11:09:18

Mr. Hurst is a terrific lawyer. If you could say that, he

11:09:21

would. He didn't for a reason.

11:09:23

Their claim interpretation would never result

11:09:27

from the process description. Their claim interpretation

11:09:30

would never result in the successful administration to

11:09:35

patients.

11:09:36

11:09:39

11:09:43

10

11:09:45

11

Their claim interpretation would never result in

the high-purity daptomycin and the successful administration
as described in the spec.
The last point is this, Your Honor. The New

12

Mexico case is not something that is off in some other

13

place. If Your Honor considers the claim interpretation,

11:10:12

14

321 Fed. 3rd at 1121-23, Judge Lourie is not off on some

11:10:14

15

unrelated inventor lark. The statute refers to new matter.

11:10:17

16

He is making that more fundamental point. At those pages

11:10:22

17

you will see, he is dealing with an erroneous description in

11:10:25

18

the specification of a chemical compound.

11:10:27

19

11:10:32

20

a means of describing a compound. It is not the invention

11:10:36

21

itself."

11:10:38

22

The invention here is daptomycin.

11:10:39

23

Thank you, Your Honor.

11:10:40

24

11:10:43

25

He says, "Indeed, a chemical structure is simply

THE COURT: Thank you, Mr. Lee. Thank you, Mr.

Hurst.

70
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11:10:48

3
4
5

Counsel, I will get an order out within 30 days,

give or take. Thank you for your time.
(Counsel respond "Thank you, Your Honor.")
(Hearing concluded at 11:10 a.m.)
Reporter: Kevin Maurer

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aggregates [1] - 10:10
aggregation [1] 10:17
aggregations [1] 10:11
ago [2] - 6:6, 13:21
agree [17] - 4:23,
11:17, 11:18, 11:20,
13:5, 13:11, 13:13,
15:20, 19:7, 23:4,
23:15, 41:12, 42:13,
42:18, 51:9, 54:15,
68:9
agreeable [1] - 65:24
agreement [1] - 3:14
agrees [4] - 41:17,
42:1, 51:5, 67:18
alleged [1] - 55:24
allow [2] - 36:22, 67:7
allowed [4] - 9:6,
10:18, 30:18, 55:10
amend [2] - 60:18,
67:6
amendment [1] 60:14
amendments [1] 66:8
Amgen [1] - 51:22
amino [1] - 47:14
amount [3] - 8:18,
19:1, 27:17
amounts [2] - 7:2,
33:5
analogy [2] - 17:4,
19:14
analysis [3] - 41:14,
53:13, 62:6
analyze [1] - 37:20

AND [1] - 1:2

Angeles [1] - 1:24
anhydro [1] - 7:16
Anne [1] - 3:6
answer [3] - 21:9,
39:24, 62:18
answering [2] - 39:13,
39:15
antibiotic [21] - 6:5,
7:3, 11:6, 23:22,
23:25, 24:14, 32:4,
36:10, 37:24, 38:14,
39:18, 39:19, 39:21,
40:2, 40:3, 40:11,
43:25, 51:17, 52:2,
52:5, 65:22
antitrust [3] - 64:3,
64:7, 64:8
anyway [1] - 60:13
apologize [1] - 27:7
APPEARANCES [1] 1:13
apples [1] - 60:25
application [3] - 39:4,
45:13, 66:7
applied [1] - 20:20
applies [1] - 18:5
appreciate [1] - 63:1
approach [1] - 23:10
appropriate [6] 52:24, 53:9, 53:17,
54:11, 61:12, 62:4
approved [2] - 9:6,
10:4
April [1] - 1:10
arguable [1] - 46:9
argue [6] - 18:24,
25:11, 36:16, 52:7,
62:3, 65:2
argued [2] - 2:14,
52:15
arguing [3] - 47:20,
47:22, 55:22
argument [16] - 20:14,
20:15, 28:18, 28:20,
30:7, 35:6, 36:14,
37:6, 38:6, 52:11,
52:22, 54:7, 63:7,
63:9, 64:21
arguments [3] - 43:22,
43:24, 65:20
arises [1] - 12:25
arrive [1] - 62:11
Arsht [1] - 1:15
art [27] - 16:8, 18:1,
18:4, 18:7, 20:16,
20:24, 21:16, 22:9,
28:9, 28:25, 29:16,
29:23, 30:21, 30:23,
39:2, 40:18, 41:3,
04/15/2013 04:59:57 AM

41:6, 42:13, 42:16,

43:5, 44:10, 49:12,
64:13, 67:12, 67:15,
67:21
article [11] - 23:17,
25:6, 28:21, 30:14,
31:7, 36:5, 36:6,
44:18, 45:5, 50:3,
67:4
articles [8] - 23:19,
28:19, 28:20, 29:12,
44:9, 49:13, 49:16,
50:1
articulation [1] - 19:17
aside [1] - 12:8
Asn [60] - 36:2, 36:7,
36:15, 36:16, 40:2,
40:3, 40:6, 40:12,
40:13, 40:18, 40:20,
40:24, 41:24, 43:7,
43:19, 44:7, 44:10,
44:14, 44:16, 44:21,
45:1, 47:8, 48:3,
49:8, 49:18, 51:9,
51:18, 52:1, 52:2,
52:4, 52:8, 53:17,
53:18, 56:5, 57:14,
57:24, 58:7, 58:17,
58:18, 58:25, 59:5,
59:6, 59:11, 61:7,
61:21, 61:24
Asparagine [11] 12:21, 13:7, 15:6,
17:1, 18:10, 25:19,
26:3, 30:4, 30:6,
34:3, 34:21
asserted [7] - 6:3,
6:24, 9:1, 9:14, 9:23,
9:25, 46:20
assume [1] - 46:18
attack [7] - 4:1, 4:7,
4:9, 4:17, 4:20, 4:21,
12:9
Australia [1] - 3:6
available [5] - 9:22,
13:15, 32:20, 38:9,
63:24
avoid [2] - 8:13, 27:25
avoiding [1] - 47:24

B
background [1] - 5:25
bacteremia [1] - 27:14
bacteria [3] - 30:2,
30:5, 30:18
bacterium [1] - 7:3
bad [2] - 8:8
Baltz [15] - 27:2,
04/15/2013 04:59:57 AM

28:19, 29:1, 29:2,

29:9, 29:22, 30:1,
30:11, 36:5, 36:6,
42:14, 42:20, 43:2,
43:4
based [4] - 10:15,
28:19, 36:13, 44:17
basis [1] - 16:12
batches [1] - 10:18
Bayer [3] - 52:12,
52:15, 52:20
become [2] - 9:23,
18:2
becomes [2] - 17:25,
34:5
bedrock [5] - 38:20,
42:5, 45:2, 51:13,
53:1
BEFORE [1] - 1:12
beginning [2] - 39:17,
66:24
behalf [1] - 3:3
behind [1] - 2:9
beings [4] - 11:7,
30:12, 31:8, 49:22
belief [1] - 56:7
benefit [2] - 15:17,
31:20
benefits [1] - 7:21
best [7] - 2:22, 3:9,
13:23, 17:9, 22:23,
24:6, 63:8
better [6] - 15:8,
16:10, 17:12, 19:3,
52:3, 67:5
between [18] - 8:19,
8:22, 11:1, 12:24,
13:1, 14:12, 17:3,
18:21, 21:18, 28:8,
34:19, 35:4, 47:11,
48:14, 48:21, 49:8,
63:13, 66:18
big [3] - 30:17, 34:25,
50:19
Bill [1] - 2:7
bill [1] - 2:12
biological [3] - 50:11,
50:17, 51:2
biosynthesis [1] 30:9
bit [4] - 8:10, 36:9,
48:6, 52:3
BLUMENFELD [2] 1:14, 2:6
Blumenfeld [2] - 2:5,
2:7
body [1] - 17:24
book [2] - 28:20, 29:9
Book [4] - 59:1, 59:3,
59:5, 59:13

Boston [1] - 1:18

bottom [2] - 16:6,
41:10
bought [1] - 50:7
box [1] - 21:21
break [1] - 10:14
breeze [1] - 50:25
brief [9] - 13:4, 15:23,
21:4, 38:18, 39:10,
39:13, 39:15, 42:9,
62:25
briefing [2] - 17:23,
23:21
briefly [2] - 5:22, 21:3
briefs [2] - 43:23,
53:24
brings [1] - 28:17
broaden [2] - 56:22,
58:10
broadened [3] - 57:20,
63:11, 64:16
broadening [4] 18:22, 58:9, 60:6,
64:17
broader [11] - 18:17,
57:2, 57:7, 57:8,
57:11, 57:16, 57:18,
58:5, 58:11, 60:21,
60:24
built [1] - 17:24
bunch [1] - 42:10
butcher [1] - 7:4
bypassed [1] - 55:11

C
CA [1] - 1:24
candid [2] - 18:14,
56:4
cannot [7] - 34:13,
42:9, 45:6, 46:25,
47:16, 49:1
capture [5] - 12:8,
17:10, 17:13, 24:1,
24:13
captures [1] - 35:4
careful [1] - 13:18
case [55] - 4:4, 5:12,
9:21, 15:18, 15:25,
16:1, 16:2, 16:16,
17:23, 18:20, 18:21,
19:10, 19:12, 19:16,
19:24, 21:24, 22:2,
22:3, 22:4, 37:3,
37:13, 39:8, 47:20,
50:18, 52:12, 54:4,
54:16, 55:5, 55:14,
55:15, 55:18, 55:21,
57:17, 57:19, 58:4,
Page 2 to 2 of 11

58:20, 59:21, 59:22,

59:25, 60:1, 60:2,
60:14, 60:16, 60:17,
61:1, 61:2, 61:3,
62:3, 69:12
cases [16] - 11:18,
18:14, 18:16, 18:17,
19:14, 21:6, 21:7,
42:11, 48:10, 55:6,
56:9, 56:20, 57:9,
64:12, 64:16, 68:10
caused [2] - 32:22,
35:1
cautious [1] - 64:5
central [1] - 57:9
certain [2] - 10:8,
45:19
certainly [1] - 23:11
certificate [43] - 4:2,
4:8, 4:10, 4:13, 4:19,
4:23, 5:6, 12:9,
12:14, 14:5, 14:13,
15:2, 15:24, 18:15,
20:12, 20:16, 21:5,
22:15, 43:13, 53:8,
53:20, 54:2, 54:3,
54:11, 54:24, 55:10,
55:25, 56:14, 56:19,
56:25, 57:6, 59:7,
59:14, 59:19, 60:15,
60:16, 60:23, 61:3,
61:5, 61:9, 61:25,
62:7, 62:15
certificates [1] - 14:16
chance [1] - 19:5
change [3] - 14:14,
17:2, 50:18
changes [3] - 50:13,
50:14, 55:1
changing [2] - 14:6,
14:17
chapter [1] - 29:9
character [9] - 19:9,
21:1, 54:13, 54:17,
54:21, 56:12, 56:16,
56:21, 60:6
characterization [2] 20:6, 33:10
characterize [6] 13:22, 14:23, 15:9,
20:5, 38:4, 67:22
characterized [1] 15:9
charts [1] - 68:23
chemical [11] - 13:8,
16:17, 16:20, 20:1,
31:17, 43:3, 47:3,
51:19, 51:20, 69:18,
69:19
chemist [1] - 47:10

chemistry [1] - 48:18

chemists [1] - 48:13
Chicago [1] - 1:22
Chief [1] - 1:12
choice [1] - 48:3
choose [1] - 49:8
Christopher [1] - 3:6
Circuit [7] - 19:10,
37:4, 37:8, 42:11,
46:1, 48:24, 62:12
circumstance [2] 65:16, 68:7
circumstances [1] 45:24
cite [8] - 5:9, 15:22,
19:10, 19:11, 22:2,
40:17, 43:4, 43:11
cited [15] - 14:14,
18:16, 19:14, 19:15,
23:17, 25:6, 29:13,
31:3, 41:3, 42:15,
44:9, 45:20, 49:12,
49:14, 64:16
cites [1] - 21:6
Civil [1] - 1:4
claim [144] - 4:4, 4:12,
4:24, 4:25, 5:5, 5:24,
6:11, 6:20, 6:21,
6:22, 11:8, 11:9,
11:11, 11:14, 11:15,
11:24, 12:1, 12:5,
12:11, 12:22, 17:8,
18:5, 18:17, 18:22,
19:11, 20:18, 21:1,
22:1, 22:5, 22:13,
22:19, 22:22, 23:3,
23:13, 25:19, 25:24,
26:3, 26:10, 26:15,
26:16, 26:20, 26:22,
26:23, 27:4, 27:10,
27:19, 27:20, 28:22,
30:10, 31:13, 31:20,
32:8, 32:13, 34:7,
34:21, 34:22, 35:5,
35:6, 35:8, 35:13,
35:14, 35:22, 35:24,
36:3, 36:10, 37:7,
37:8, 37:11, 37:14,
37:15, 37:16, 37:17,
38:10, 38:13, 38:21,
42:3, 42:17, 42:20,
42:22, 42:24, 45:3,
45:7, 45:14, 45:18,
46:16, 46:17, 46:19,
46:24, 46:25, 47:6,
47:7, 47:24, 49:1,
51:7, 51:8, 53:1,
53:12, 54:4, 56:18,
56:22, 57:2, 57:4,
57:5, 57:7, 57:8,
20 of 29 sheets

57:11, 57:18, 57:19,

57:20, 57:21, 57:22,
57:24, 58:4, 58:13,
61:10, 62:6, 62:19,
63:7, 63:11, 64:2,
64:7, 64:8, 64:21,
64:22, 64:23, 64:24,
64:25, 65:13, 65:18,
65:19, 65:21, 66:20,
66:22, 69:4, 69:5,
69:8, 69:13
Claim [6] - 12:19,
25:15, 26:7, 26:8,
35:5, 35:8
claimed [8] - 13:6,
17:18, 18:8, 22:5,
22:6, 22:24, 48:25
claiming [2] - 38:14,
65:17
claims [46] - 8:25, 9:1,
9:14, 9:23, 9:25,
12:12, 22:20, 22:22,
25:2, 25:10, 25:12,
25:16, 25:21, 26:7,
26:9, 26:19, 27:8,
33:13, 33:16, 35:2,
37:5, 37:22, 38:25,
39:11, 45:21, 46:10,
46:20, 46:21, 46:22,
57:12, 57:13, 59:10,
59:16, 59:17, 60:18,
60:22, 60:24, 61:22,
64:15, 66:9, 66:11,
67:6, 67:7, 67:9
Claims [1] - 38:22
clarify [1] - 35:25
class [5] - 47:12,
47:17, 47:21, 48:2,
49:7
clear [2] - 9:24, 24:7
clearly [3] - 18:19,
42:9, 46:4
clerical [8] - 54:12,
54:14, 54:21, 55:18,
55:19, 56:1, 56:8,
56:10
clinical [7] - 7:21,
7:25, 10:4, 25:22,
30:11, 31:7
clinically [2] - 8:3,
11:6
closer [2] - 21:14,
30:24
clusters [1] - 10:14
collections [1] - 10:11
Column [3] - 12:17,
14:4
comfortable [1] - 2:23
coming [1] - 44:21
commercial [1] 21 of 29 sheets

10:19
common [2] - 35:15,
46:17
common-sense [1] 46:17
commonsensical [1] 22:25
company [1] - 64:5
compare [2] - 25:17,
58:12
compared [1] - 57:4
comparison [1] 31:13
competing [2] - 12:5,
66:3
complete [1] - 35:15
completely [1] - 35:16
complex [1] - 37:20
composed [1] - 27:1
composition [2] 10:21, 10:23
compound [59] - 6:13,
6:14, 7:11, 11:10,
12:3, 12:4, 16:21,
16:22, 16:23, 17:2,
17:16, 19:20, 22:10,
24:22, 25:24, 28:3,
28:11, 30:16, 31:23,
31:25, 32:8, 32:9,
33:6, 34:16, 36:4,
36:6, 36:13, 36:19,
38:4, 41:9, 43:3,
43:9, 43:25, 44:1,
45:12, 46:6, 46:13,
47:19, 48:4, 48:9,
48:24, 49:1, 49:3,
49:7, 49:21, 49:24,
50:10, 50:17, 51:19,
51:23, 53:7, 56:6,
58:7, 60:1, 60:19,
67:13, 69:18, 69:20
Compound [2] - 19:12
compound's [1] - 51:2
compounds [10] 47:8, 47:11, 47:13,
47:15, 47:22, 48:22,
49:3, 49:4, 51:13,
51:21
comprised [1] - 65:23
concede [2] - 47:4,
55:20
conceded [1] - 61:11
concedes [2] - 43:17,
43:18
conceding [1] - 59:16
concept [3] - 12:25,
16:2, 17:25
concession [4] 59:18, 61:23, 62:10,
62:14

conclude [2] - 52:25,

56:23
concluded [2] - 18:7,
70:4
conclusion [4] - 4:22,
44:14, 62:7, 64:10
conditions [3] - 10:8,
10:9, 10:13
conducted [2] - 7:25,
8:19
configuration [1] 14:15
confirm [1] - 15:6
conflicts [1] - 28:13
confronted [3] 63:16, 63:18, 64:18
confusion [2] - 17:18,
17:21
consequence [1] 62:20
consider [2] - 18:25,
21:17
consideration [1] 52:10
considered [1] - 29:24
considers [2] - 30:14,
69:13
consistent [1] - 35:16
constitute [1] - 55:2
construction [44] 4:4, 4:12, 4:25, 5:5,
5:24, 6:12, 6:13,
12:20, 19:11, 20:18,
23:13, 28:5, 31:13,
31:20, 34:7, 36:3,
36:10, 38:20, 38:21,
42:3, 42:20, 42:22,
42:24, 43:2, 45:3,
47:1, 47:6, 47:25,
51:8, 53:1, 53:12,
54:5, 56:18, 57:3,
57:22, 57:25, 58:13,
61:10, 62:6, 62:19,
63:7, 64:2, 64:22,
65:22
constructions [2] 15:16, 35:24
construe [3] - 39:11,
48:2, 59:10
construed [6] - 12:11,
12:13, 36:2, 37:11,
38:22, 39:1
construing [1] - 42:17
contain [1] - 28:21
contentious [1] 11:17
contest [1] - 61:6
context [2] - 16:10,
19:2
continued [1] - 7:12
Page 3 to 3 of 11

contrary [1] - 66:5

controlled [1] - 41:15
controls [1] - 42:12
convert [1] - 45:21
converting [1] - 37:14
Cook [1] - 2:9
COOK [1] - 1:17
core [1] - 36:1
correct [18] - 16:18,
19:3, 19:4, 23:1,
23:2, 23:23, 25:5,
26:20, 33:12, 34:22,
36:21, 52:15, 52:21,
56:6, 58:9, 64:6,
64:7, 66:23
correctable [2] 56:24, 57:5
corrected [14] - 12:12,
12:22, 14:1, 14:3,
22:21, 52:18, 53:18,
55:25, 57:5, 57:14,
57:18, 58:4, 58:17,
64:22
correction [59] - 4:2,
4:8, 4:10, 4:14, 4:16,
4:19, 4:24, 5:6, 12:9,
12:14, 14:5, 14:6,
14:9, 14:13, 15:2,
15:24, 18:15, 19:8,
20:12, 20:17, 20:20,
21:1, 21:5, 22:15,
31:22, 36:20, 43:13,
53:8, 53:20, 54:2,
54:3, 54:11, 54:25,
55:1, 55:10, 55:25,
56:15, 56:19, 56:22,
56:25, 57:6, 57:20,
59:8, 59:14, 59:19,
60:1, 60:15, 60:16,
60:18, 60:24, 61:3,
61:5, 61:9, 61:25,
62:8, 62:15, 63:5,
64:6, 67:4
correctly [2] - 12:7,
37:1
Counsel [3] - 1:19,
1:25, 70:3
counsel [4] - 2:3, 2:4,
2:21, 70:1
counterintuitive [2] 8:16, 19:18
counts [2] - 57:17,
58:9
couple [4] - 6:6,
33:21, 37:3, 64:16
course [5] - 8:13,
9:17, 9:24, 56:4,
58:14
COURT [25] - 1:1, 2:1,
2:4, 2:21, 3:2, 3:7,

3:12, 3:20, 3:22,

3:25, 4:5, 4:13, 4:18,
5:2, 5:10, 5:19,
15:11, 19:5, 20:8,
23:11, 35:18, 54:9,
62:9, 62:23, 69:24
Court [19] - 6:6, 9:13,
9:18, 11:2, 15:20,
15:21, 18:24, 19:2,
19:15, 20:17, 23:15,
30:14, 34:2, 34:8,
36:24, 52:12, 52:22,
62:15, 68:9
courtroom [5] - 3:4,
3:5, 3:9, 3:13, 17:18
Courts [1] - 37:4
cover [19] - 11:14,
11:15, 11:25, 12:2,
22:10, 22:11, 25:13,
27:4, 27:19, 27:21,
32:8, 39:9, 39:13,
39:14, 39:20, 59:12,
59:16, 60:18
covered [7] - 25:13,
25:14, 30:10, 40:2,
58:18, 59:5, 59:8
covering [2] - 18:19,
46:2
covers [15] - 10:20,
11:9, 11:11, 28:5,
32:13, 47:7, 57:18,
58:1, 58:15, 58:17,
59:4, 59:11, 59:20,
64:24, 69:1
created [2] - 24:3,
45:14
critical [3] - 34:12,
39:8, 51:4
critically [2] - 34:24,
47:20
cross [2] - 21:21,
22:12
cross-examination [1]
- 22:12
cross-examined [1] 21:21
Cubicin [1] - 6:10
Cubisic [1] - 9:6
Cubisin [1] - 24:17
Cubist [30] - 2:7, 2:11,
6:10, 8:11, 9:6, 10:2,
10:7, 14:12, 36:8,
37:21, 38:9, 40:23,
42:1, 42:5, 43:18,
43:20, 50:5, 50:7,
51:5, 51:16, 52:7,
52:20, 53:2, 55:23,
58:21, 58:25, 61:6,
65:24
CUBIST [1] - 1:4
04/15/2013 04:59:57 AM

Cubist's [6] - 10:15,

23:8, 25:3, 39:9,
41:3, 58:15
cure [1] - 37:5
Cutler [1] - 1:18
cyclic [3] - 23:22,
23:24, 65:22

D
D-Asn [26] - 36:2,
36:15, 36:16, 40:3,
40:6, 40:13, 43:7,
44:16, 44:21, 45:1,
47:8, 48:3, 49:8,
51:9, 51:18, 52:2,
52:8, 53:18, 57:14,
57:24, 58:7, 58:17,
58:25, 59:6, 59:11,
61:21
D-Asparagine [4] 12:21, 15:6, 25:19,
30:4
daptomycin [82] - 6:5,
6:7, 6:15, 6:25, 7:1,
7:7, 7:20, 7:24, 8:1,
8:11, 8:14, 8:20, 9:2,
10:5, 10:8, 10:12,
10:21, 10:23, 11:3,
11:5, 16:25, 17:19,
18:8, 20:3, 23:5,
23:7, 26:2, 26:11,
26:17, 26:19, 26:25,
27:5, 27:13, 28:4,
29:10, 30:3, 30:9,
31:4, 33:6, 33:19,
35:7, 35:11, 35:23,
36:2, 36:5, 40:18,
40:20, 41:4, 41:17,
41:24, 41:25, 42:2,
42:20, 43:1, 43:6,
43:15, 43:18, 44:7,
45:1, 46:6, 46:20,
46:21, 47:1, 47:16,
47:21, 49:17, 50:2,
50:3, 51:5, 52:25,
53:15, 61:14, 65:4,
67:13, 67:21, 67:23,
68:15, 69:9, 69:22
data [1] - 47:21
date [13] - 38:23, 39:3,
39:12, 39:25, 40:4,
40:9, 41:19, 45:4,
61:15, 61:16, 67:20,
68:15
dates [2] - 40:16, 41:2
days [1] - 70:1
de [2] - 59:1, 64:4
de-list [1] - 59:1
de-listing [1] - 64:4
04/15/2013 04:59:57 AM

deal [3] - 7:23, 20:14,

30:17
dealing [2] - 19:10,
69:17
deals [1] - 19:12
dealt [1] - 37:16
decades [1] - 13:21
decide [4] - 19:3,
21:12, 64:12, 64:14
decided [3] - 5:16,
8:9, 15:1
decision [6] - 5:1,
15:22, 16:14, 16:15,
16:16, 19:3
decisions [2] - 5:8,
5:9
declaration [3] 13:20, 32:18, 32:21
declarations [1] - 66:4
Defendant [2] - 1:8,
1:25
defendant [1] - 2:16
define [15] - 20:24,
37:7, 41:5, 41:7,
41:10, 43:9, 43:10,
45:11, 45:14, 47:18,
49:22, 50:3, 52:23,
52:24, 66:15
defined [12] - 37:17,
41:4, 41:7, 41:9,
43:6, 43:7, 43:19,
51:14, 51:21, 51:22,
53:14, 53:16
defines [3] - 41:5,
43:18, 49:17
defining [6] - 36:12,
36:18, 48:9, 51:4,
51:19, 66:20
definition [8] - 12:11,
23:7, 35:10, 41:11,
41:12, 41:15, 42:23,
53:5
definitive [1] - 67:10
DELAWARE [1] - 1:2
Delaware [2] - 1:9,
52:12
demonstrate [2] 5:15, 28:3
demonstrated [1] 14:10
demonstrates [2] 13:6, 15:7
dependent [3] - 9:15,
21:11, 26:10
depicted [2] - 13:2,
31:18
depiction [1] - 16:22
depictions [1] - 16:22
derived [11] - 23:22,
23:25, 24:14, 26:25,

31:4, 36:10, 37:24,

38:14, 45:9, 46:7,
65:14
describe [13] - 5:23,
11:10, 11:12, 16:21,
16:22, 16:25, 27:12,
29:18, 32:3, 34:6,
37:2, 68:9, 68:16
described [44] - 6:8,
7:6, 7:15, 8:7, 8:15,
8:20, 10:9, 10:12,
11:21, 13:7, 13:16,
16:3, 19:19, 19:25,
20:4, 25:24, 26:17,
27:20, 27:21, 28:14,
30:3, 30:5, 31:6,
31:9, 31:10, 32:1,
35:11, 35:12, 36:4,
36:6, 40:21, 42:15,
42:20, 44:7, 52:13,
52:19, 63:13, 63:14,
65:5, 65:17, 67:12,
67:16, 68:15, 69:10
describes [17] - 8:5,
13:10, 13:12, 14:22,
24:17, 24:18, 24:19,
24:20, 24:22, 26:18,
31:7, 32:10, 32:21,
63:18, 63:19, 63:22,
63:23
describing [4] - 32:12,
40:18, 66:22, 69:20
description [10] 17:1, 19:22, 20:2,
31:5, 32:25, 49:2,
56:6, 63:25, 69:5,
69:17
descriptor [1] - 15:8
DesRosier [1] - 2:12
determination [2] 16:11, 21:15
determine [1] - 59:18
determined [1] - 13:8
determining [1] - 58:1
DeVaul [1] - 2:12
developed [7] - 7:14,
9:5, 10:16, 19:9,
20:5, 21:7, 67:19
developing [2] - 8:12,
8:14
development [2] - 8:9,
45:5
deviate [1] - 15:13
diagram [12] - 22:21,
23:13, 24:2, 24:4,
24:5, 25:5, 25:18,
28:12, 31:21, 31:22,
31:23
differ [1] - 23:6
difference [5] - 48:12,
Page 4 to 4 of 11

50:19, 50:21, 52:6,

63:13
different [13] - 16:25,
18:23, 21:23, 23:6,
39:5, 47:7, 47:15,
51:11, 54:12, 57:5,
59:17, 68:22
differentiate [2] 47:11, 48:14
differentiation [2] 46:16, 46:24
dimensional [1] - 50:9
dimensions [1] 31:18
dioxygenase [2] 52:14, 52:18
directed [1] - 6:25
directly [4] - 5:25, 6:1,
7:25, 62:12
director [1] - 54:24
disagree [7] - 5:4,
5:18, 14:19, 15:20,
20:9, 29:14, 66:16
disagreement [2] 18:2, 44:24
disbelief [1] - 20:21
disclose [1] - 12:2
disclosed [11] - 11:10,
11:11, 12:1, 22:11,
24:15, 24:23, 24:24,
28:5, 32:13, 34:14,
60:23
discover [1] - 7:18
discovered [7] - 7:13,
10:7, 10:12, 13:25,
29:5, 32:22, 50:22
discovering [2] - 7:11,
33:4
discovery [10] - 8:1,
8:15, 9:17, 9:21,
9:24, 10:15, 14:22,
32:19, 40:24, 40:25
discuss [1] - 40:17
discussed [3] - 2:13,
2:21, 42:16
discussing [2] - 16:2,
49:16
discussion [1] - 16:5
dispute [19] - 6:12,
6:15, 6:22, 12:8,
12:15, 12:21, 12:24,
13:1, 14:12, 17:3,
21:18, 25:2, 26:14,
28:8, 35:4, 36:1,
65:8, 66:18, 66:19
disputed [1] - 5:24
disputes [1] - 6:12
distinction [3] - 34:1,
34:19, 60:13
distinguish [3] -

48:21, 49:3, 65:16

DISTRICT [2] - 1:1, 1:2
divergence [1] - 11:1
doctrine [2] - 46:16,
46:24
dog [10] - 17:7, 17:8,
17:13, 17:14, 63:16,
63:19, 63:21, 63:22,
67:19
done [2] - 10:2, 24:6
Dorouos [1] - 2:12
Dorr [1] - 1:18
dose [5] - 8:4, 8:18,
8:21, 27:17, 52:3
doses [2] - 8:19, 8:21
dosing [21] - 6:5, 7:23,
9:2, 9:4, 9:5, 25:9,
25:15, 27:7, 27:8,
27:9, 27:12, 27:17,
27:24, 30:22, 30:24,
32:16, 32:17, 33:4,
68:13
Dr [2] - 32:18, 32:20
drafting [1] - 37:5
draw [2] - 34:1, 34:19
drawn [1] - 5:25
drive [1] - 64:9
drives [2] - 39:16,
41:14
drug [6] - 8:12, 8:13,
22:5, 22:6, 59:4,
59:8
during [5] - 9:17, 9:24,
41:20, 45:13, 60:21
dzptomycin [1] - 41:9

E
early [1] - 8:2
easier [1] - 9:22
echoes [1] - 42:19
educate [1] - 21:22
effect [2] - 8:6, 22:3
effective [21] - 7:24,
8:4, 11:6, 25:21,
25:23, 25:25, 27:18,
33:6, 38:23, 39:3,
39:11, 39:25, 40:4,
40:9, 40:16, 41:2,
61:15, 67:20, 68:14
effectively [1] - 32:1
efficacy [1] - 31:8
effort [3] - 21:5, 42:6,
52:23
either [5] - 2:15, 2:20,
37:19, 48:3, 55:16
element [1] - 56:13
Eli [2] - 7:2, 41:10
eliminated [1] - 47:2
22 of 29 sheets

eliminating [1] - 47:23

embodiments [8] 11:10, 11:12, 12:1,
22:11, 24:23, 25:13,
28:2
emphasizes [1] 29:12
enable [1] - 36:14
enantiomers [1] 48:11
end [3] - 3:19, 61:4,
66:24
engage [1] - 62:6
engaged [1] - 65:5
engaging [1] - 15:15
engineered [4] - 17:6,
17:7, 63:16, 63:19
enormous [1] - 27:15
entails [1] - 48:25
entertain [1] - 62:2
entire [1] - 30:14
entirely [3] - 4:4,
56:18, 57:1
entirety [1] - 29:25
enzyme [2] - 52:13,
52:23
equally [1] - 65:24
erroneous [2] - 28:22,
69:17
erroneously [1] - 30:5
error [4] - 37:5, 55:19,
60:6, 63:14
ESQ [8] - 1:14, 1:16,
1:16, 1:17, 1:17,
1:20, 1:21, 1:23
essence [1] - 4:6
essential [2] - 66:20,
66:25
event [1] - 61:7
evidence [24] - 11:18,
13:19, 16:7, 29:13,
40:1, 40:14, 42:6,
42:7, 42:9, 42:10,
42:12, 43:21, 44:4,
44:18, 45:5, 49:9,
52:9, 64:9, 68:1,
68:2, 68:4, 68:21,
68:24
evident [1] - 68:17
exactly [5] - 12:23,
21:13, 37:13, 42:21,
43:18
examination [1] 22:12
examined [1] - 21:21
examiner [7] - 33:12,
33:13, 33:15, 33:18,
41:21, 67:5, 68:18
example [8] - 27:16,
28:5, 30:9, 32:7,
23 of 29 sheets

40:19, 63:8, 63:15

Example [1] - 27:20
examples [21] - 11:2,
11:5, 11:16, 27:6,
31:24, 32:9, 32:14,
39:18, 39:20, 39:22,
40:2, 40:4, 40:6,
40:7, 40:13, 44:13,
44:25, 61:19, 63:17,
68:25, 69:1
excellent [1] - 3:12
except [1] - 37:17
exclude [1] - 56:21
excludes [1] - 24:15
exclusion [1] - 46:2
exist [3] - 30:19,
41:19, 41:20
existing [1] - 19:21
exists [2] - 4:11, 4:16
expand [1] - 22:4
expanded [2] - 9:4,
22:1
experience [1] - 30:25
experiencing [1] 8:23
experiment [1] - 44:19
experiments [1] - 15:6
expert [1] - 46:13
experts [6] - 48:5,
48:16, 50:24, 55:14,
66:4, 66:16
explain [1] - 53:11
explicitly [1] - 23:18
express [1] - 12:11
expressions [1] - 46:1
extrinsic [12] - 13:19,
21:20, 40:13, 42:6,
42:9, 42:12, 43:21,
44:17, 45:4, 52:8,
68:21, 68:24

F
face [1] - 48:17
facing [1] - 41:8
fact [16] - 5:8, 11:23,
20:21, 22:10, 22:23,
35:12, 49:9, 50:25,
51:20, 51:25, 56:11,
56:24, 64:12, 64:13,
64:16, 66:3
factor [1] - 50:11
facts [12] - 5:6, 5:15,
11:24, 18:12, 18:25,
21:11, 21:15, 34:2,
55:13, 58:21, 60:2,
64:15
factual [7] - 18:3,
22:8, 54:15, 54:16,

55:4, 55:20
factually [1] - 38:7
fail [1] - 48:21
fair [1] - 36:25
fairly [1] - 60:22
faith [1] - 54:24
false [1] - 66:1
far [1] - 24:5
fault [1] - 54:22
FDA [4] - 10:4, 58:22,
63:10, 63:13
Fed [1] - 69:14
Federal [7] - 19:10,
37:4, 37:8, 42:11,
46:1, 48:24, 62:12
fermentation [37] 7:8, 7:13, 11:3,
11:19, 17:20, 18:9,
18:11, 20:3, 24:8,
26:11, 26:25, 27:5,
29:6, 29:19, 32:12,
33:2, 33:3, 33:19,
34:4, 34:9, 34:20,
36:11, 36:16, 37:25,
38:14, 39:19, 40:7,
44:2, 44:8, 44:19,
44:25, 45:9, 46:7,
46:22, 61:21, 65:15,
67:12
few [2] - 5:10, 12:10
fewer [1] - 6:25
fight [1] - 18:21
Figure [15] - 23:13,
24:2, 25:4, 27:2,
27:22, 31:17, 31:19,
32:3, 34:6, 35:10,
36:5, 36:7, 42:21,
65:18
figure [4] - 24:6,
29:17, 34:6, 34:18
file [9] - 6:1, 7:6, 8:5,
14:8, 25:11, 25:12,
32:16, 48:1, 66:22
filed [1] - 45:12
filing [9] - 38:23, 39:3,
39:12, 39:25, 40:4,
40:9, 40:16, 41:2,
41:19
filtering [4] - 7:9, 11:3,
24:8, 29:19
finally [1] - 5:11
fine [2] - 39:7, 65:15
Fireplace [2] - 21:24,
56:19
firmly [1] - 56:7
first [27] - 2:11, 6:18,
7:3, 9:20, 13:6, 13:8,
20:15, 33:24, 35:23,
45:3, 54:13, 55:7,
55:8, 55:17, 56:13,
Page 5 to 5 of 11

58:6, 59:24, 60:5,

60:7, 60:11, 61:14,
61:16, 63:2, 65:8,
66:10
five [4] - 3:18, 6:3,
11:4, 68:8
flashed [1] - 68:22
flies [1] - 48:17
floor [1] - 33:22
flying [1] - 17:9
focus [18] - 9:2, 9:22,
11:23, 23:12, 29:17,
31:16, 34:18, 34:25,
35:24, 39:15, 39:21,
41:16, 45:3, 48:8,
53:3, 60:8, 60:9,
67:25
focused [1] - 33:18
focusing [1] - 29:16
folks [2] - 22:12, 50:4
follow [7] - 3:18,
26:16, 26:17, 63:2,
63:20, 68:3
followed [3] - 67:12,
67:21, 68:1
following [3] - 24:2,
51:15, 66:8
footage [3] - 57:13,
57:15, 58:5
FOR [1] - 1:2
form [3] - 4:11, 7:20,
68:22
formed [2] - 7:17, 10:9
former [1] - 37:1
forms [1] - 13:2
Formula [10] - 6:13,
12:4, 12:10, 12:12,
53:7, 53:14, 53:15,
61:6
forth [2] - 5:11, 12:12
four [22] - 3:18, 6:16,
6:21, 17:13, 22:17,
22:19, 22:22, 23:2,
23:3, 23:5, 25:2,
34:14, 38:20, 41:17,
42:25, 43:3, 43:15,
45:2, 53:1, 66:9,
67:6, 68:19
from.. [1] - 23:22
front [2] - 23:14, 67:4
full [1] - 54:7
fully [2] - 37:19, 39:9
function [2] - 51:14,
51:21
functionally [1] 52:23
functions [1] - 51:24
fundamental [2] 28:8, 69:16

G
GAIL [1] - 1:23
Gail [1] - 3:4
general [1] - 45:16
genetically [3] - 17:6,
17:7, 63:19
gentlemen [1] - 4:5
given [4] - 21:1, 35:13,
35:15, 66:1
Goldman [1] - 1:20
goodness [1] - 3:7
governs [1] - 15:23
gram [3] - 27:14, 30:2,
30:5
gram-positive [3] 27:14, 30:2, 30:5
granted [1] - 43:21
great [2] - 52:2, 52:4
green [2] - 43:8, 50:1
GREGORY [1] - 1:12
grounds [1] - 46:9
group [1] - 10:7
groups [1] - 5:23
guess [2] - 42:13, 61:4
guidance [1] - 61:1
gymnastics [2] 52:21, 65:5

H
Hale [1] - 1:18
hand [13] - 12:17,
12:19, 13:3, 14:3,
14:4, 24:4, 24:22,
26:23, 26:24, 31:16,
31:18, 54:8
handling [1] - 15:16
hands [1] - 13:4
happy [2] - 2:15, 2:19
hate [1] - 39:7
head [2] - 17:11, 17:14
hear [4] - 21:3, 55:13,
57:11, 64:21
heard [6] - 37:7, 48:6,
51:16, 62:14, 62:17,
63:6
Hearing [2] - 1:11,
70:4
hearing [5] - 36:21,
36:23, 38:17, 45:13,
55:22
held [1] - 56:7
help [1] - 2:22
helpful [2] - 51:19,
54:6
helps [1] - 35:25
high [16] - 9:10, 10:21,
04/15/2013 04:59:57 AM

23:14, 25:4, 25:9,

26:5, 27:8, 27:10,
31:12, 31:14, 32:2,
32:6, 33:8, 67:3,
68:13, 69:9
high-purity [13] - 9:10,
10:21, 23:14, 25:4,
25:9, 26:5, 31:12,
31:14, 32:2, 32:6,
33:8, 67:3, 69:9
higher [1] - 52:3
highlighted [2] 12:20, 28:23
highly [4] - 10:22,
30:1, 30:4, 43:25
history [8] - 6:1, 7:6,
8:5, 14:8, 25:11,
25:12, 32:16, 66:22
honestly [1] - 20:17
Honor [150] - 2:6,
2:13, 2:18, 3:1, 3:15,
3:16, 3:24, 4:3, 5:8,
5:14, 5:15, 5:21,
5:24, 6:11, 6:17,
6:19, 6:23, 7:22, 8:4,
10:1, 10:3, 10:15,
10:24, 12:5, 12:16,
12:24, 13:9, 13:20,
14:7, 14:10, 14:18,
15:7, 15:19, 15:21,
16:6, 16:9, 16:16,
16:24, 17:5, 17:16,
17:22, 17:24, 18:13,
19:23, 20:10, 21:2,
21:3, 21:11, 21:14,
21:17, 22:7, 22:8,
22:14, 22:18, 22:23,
23:4, 23:10, 23:12,
23:16, 23:20, 23:24,
24:4, 24:17, 25:1,
25:8, 25:16, 26:6,
26:10, 26:14, 26:21,
27:16, 28:7, 28:24,
29:8, 29:21, 30:3,
30:22, 31:2, 31:5,
31:11, 32:3, 32:15,
32:17, 32:25, 33:9,
34:1, 34:6, 34:12,
34:15, 34:22, 35:3,
35:12, 35:17, 35:20,
35:21, 35:22, 36:1,
36:20, 37:13, 38:20,
39:7, 39:17, 41:10,
42:4, 47:25, 48:10,
49:5, 49:11, 51:25,
53:3, 53:8, 53:19,
54:8, 57:2, 57:23,
60:10, 60:21, 61:6,
62:1, 62:18, 62:24,
62:25, 63:6, 63:10,
04/15/2013 04:59:57 AM

63:14, 63:15, 63:16,

63:17, 64:3, 64:10,
64:12, 64:14, 64:17,
64:19, 64:21, 65:3,
65:7, 65:11, 66:1,
66:3, 66:8, 66:14,
66:17, 68:1, 68:24,
69:11, 69:13, 69:23,
70:3
Honor's [1] - 21:9
HONORABLE [1] 1:12
hope [1] - 25:11
Hospira [20] - 3:4, 3:6,
4:1, 4:19, 5:9, 12:13,
13:4, 14:12, 18:16,
21:6, 26:18, 29:12,
32:10, 34:2, 35:21,
61:23, 66:3, 66:13,
66:23, 68:24
HOSPIRA [1] - 1:7
Hospira's [8] - 11:14,
12:6, 20:15, 23:9,
28:18, 35:6, 39:22,
53:5
host [1] - 68:21
hours [1] - 9:3
huge [1] - 19:1
human [8] - 11:7,
25:23, 26:1, 27:25,
30:12, 31:8, 49:22,
49:24
humans [1] - 32:1
hundreds [1] - 9:7
HURST [9] - 1:21, 4:3,
4:8, 4:15, 5:18,
35:20, 54:10, 62:13,
62:24
Hurst [22] - 3:4, 3:8,
3:15, 3:18, 3:25,
4:22, 5:19, 9:12,
11:1, 15:12, 19:5,
19:7, 31:3, 33:22,
35:19, 35:21, 62:23,
63:1, 64:11, 65:14,
69:2, 69:25
Hurst's [1] - 66:25

I
idea [2] - 20:19, 24:13
identical [1] - 31:19
identify [1] - 51:23
identifying [2] - 7:17,
50:16
ignore [2] - 48:20,
49:6
IL [1] - 1:22
illuminating [1] -

19:17
images [2] - 13:3, 13:4
impact [1] - 51:1
impairment [1] - 9:4
implicate [1] - 9:25
implicated [1] - 33:16
implicates [1] - 5:6
implications [2] 64:4, 64:25
import [8] - 33:25,
34:20, 45:6, 45:8,
45:18, 46:25, 65:21,
66:13
important [15] - 10:25,
13:9, 17:4, 17:17,
25:16, 30:2, 34:5,
34:24, 39:10, 48:8,
49:10, 50:4, 50:11,
63:5, 66:10
importantly [2] - 9:24,
14:5
importing [1] - 66:12
improper [2] - 47:5,
59:19
impurities [6] - 6:25,
7:13, 7:15, 7:17,
7:19, 10:17
IN [2] - 1:1, 1:2
in-vitro [1] - 52:6
INC [2] - 1:4, 1:7
include [7] - 46:17,
47:9, 47:11, 47:13,
48:9, 48:13, 50:15
included [2] - 39:21,
46:18
includes [3] - 14:20,
15:4, 50:5
including [7] - 40:19,
47:8, 47:16, 47:24,
48:20, 50:12, 52:22
incorporate [1] - 25:6
incorporated [2] 28:16, 30:8
incorrect [3] - 16:17,
17:2, 33:11
incorrectly [1] - 15:10
indeed [1] - 69:19
indication [1] - 22:23
individual [1] - 49:6
indulge [1] - 63:15
infections [3] - 6:7,
6:8, 8:23
information [1] - 29:4
infringe [3] - 59:9,
59:11, 61:8
infringement [3] - 5:1,
9:15, 62:16
infringing [4] - 48:21,
48:22, 49:3, 49:4
ingredient [1] - 6:9
Page 6 to 6 of 11

inoperable [1] - 62:8

inoperative [2] - 35:6,
35:14
inquiry [3] - 55:7,
58:2, 60:4
inserting [1] - 46:10
instance [5] - 18:18,
37:22, 41:18, 51:23,
55:4
instances [1] - 14:17
instead [2] - 25:20,
33:18
intend [1] - 9:19
intended [1] - 26:2
intention [1] - 8:11
interactions [1] 50:10
interesting [2] - 19:23,
68:23
interpret [2] - 47:16,
57:23
interpretation [33] 11:8, 11:9, 11:11,
11:15, 11:25, 12:1,
12:23, 24:5, 25:4,
25:7, 25:14, 25:25,
26:3, 26:15, 26:20,
26:22, 26:23, 27:4,
27:19, 27:21, 30:10,
32:8, 32:13, 35:14,
39:20, 39:21, 40:11,
41:25, 65:13, 69:4,
69:5, 69:8, 69:13
interpretations [2] 11:14, 12:6
interpreted [1] - 56:20
interpreting [1] 57:21
interrogatory [1] 63:12
interval [3] - 8:19,
8:22, 9:5
intervals [3] - 9:4,
27:17, 33:5
intramolecular [1] 50:10
intravenously [2] 8:12, 30:19
intrinsic [16] - 6:2,
11:21, 14:11, 14:19,
14:20, 21:19, 29:13,
30:8, 40:1, 40:10,
42:6, 42:10, 42:12,
44:4, 49:9, 64:9
introduction [1] 22:18
introductions [2] 2:5, 2:25
invalid [2] - 4:24, 61:5
invalidate [1] - 21:5

invented [3] - 17:6,

19:20, 37:2
invention [9] - 8:24,
16:23, 16:24, 24:21,
30:16, 39:3, 63:19,
69:20, 69:22
inventions [1] - 68:11
inventor [3] - 49:1,
50:6, 69:15
inventors [3] - 7:18,
32:19, 50:5
involve [1] - 55:1
involved [1] - 64:17
involving [1] - 26:12
irrelevant [1] - 42:3
isolated [1] - 7:3
isomer [1] - 7:16
isomers [1] - 13:22
issuance [1] - 52:17
issue [46] - 4:4, 4:12,
5:23, 8:17, 15:1,
18:15, 18:25, 19:17,
21:6, 27:24, 28:4,
32:13, 35:25, 38:1,
39:8, 43:13, 52:11,
53:4, 53:7, 53:8,
53:23, 54:2, 54:3,
54:15, 54:16, 54:17,
54:24, 55:3, 55:4,
55:11, 55:21, 56:12,
57:23, 60:10, 61:9,
61:10, 61:25, 62:16,
62:21, 64:1, 65:25,
67:25
issued [3] - 14:16,
41:21, 41:23
issues [4] - 5:16, 5:24,
55:16, 55:18
itself [4] - 45:21, 50:5,
63:22, 69:21

J
J.A [1] - 14:9
JACK [1] - 1:14
Jack [2] - 2:6, 3:3
JAMES [1] - 1:21
January [1] - 14:15
Jim [2] - 3:4, 35:21
JOHN [1] - 1:20
joined [2] - 14:12,
62:21
JR [1] - 1:20
judge [1] - 16:20
Judge [12] - 1:12,
15:13, 15:15, 15:25,
17:15, 19:16, 28:11,
55:5, 55:14, 59:22,
69:14
24 of 29 sheets

judgment [16] - 5:1,

5:8, 5:9, 5:11, 15:17,
18:15, 20:19, 21:6,
21:7, 53:10, 61:12,
62:2, 62:5, 63:7,
63:9, 65:3

K
Kara [1] - 42:10
keep [1] - 3:8
Kevin [1] - 70:5
key [6] - 11:23, 17:3,
32:22, 34:7, 41:13
kind [6] - 35:15, 46:16,
52:11, 52:16, 57:15
kinds [1] - 54:12
Knight [1] - 59:21
known [1] - 37:19
knows [7] - 6:11, 11:2,
52:4, 61:20, 64:3,
66:8

L
L-Asn [34] - 36:2,
36:7, 36:15, 40:2,
40:12, 40:18, 40:20,
40:24, 41:24, 43:7,
43:19, 44:7, 44:10,
44:14, 44:21, 45:1,
47:8, 48:3, 49:8,
49:18, 51:18, 52:1,
52:4, 53:17, 56:5,
57:14, 57:24, 58:7,
58:18, 59:5, 59:11,
61:7, 61:24
L-Asparagine [7] 13:7, 17:1, 18:10,
26:3, 30:6, 34:3,
34:21
lab [1] - 17:9
lack [1] - 15:8
large [4] - 8:21, 47:17,
47:25, 48:2
larger [1] - 10:18
lark [1] - 69:15
last [9] - 9:9, 9:13,
35:3, 37:6, 51:13,
64:20, 68:19, 69:11
lastly [1] - 35:3
late [2] - 7:5, 38:16
later-acquired [1] 40:13
latter [1] - 29:20
Laughter [1] - 3:11
law [26] - 4:6, 17:24,
19:9, 20:11, 21:9,
21:10, 36:22, 38:24,
25 of 29 sheets

51:22, 56:12, 56:13,

56:17, 56:23, 56:24,
57:17, 57:19, 58:8,
58:19, 58:20, 59:18,
61:21, 62:4, 63:11,
64:14, 64:23
lawyer [1] - 69:2
lawyers [1] - 3:12
lay [1] - 49:1
layperson [1] - 19:18
lead [2] - 32:19, 62:7
leading [1] - 56:19
learning [1] - 53:23
least [5] - 10:25,
25:11, 35:4, 50:20,
62:4
leave [2] - 2:18, 47:25
led [1] - 20:6
Lee [29] - 2:7, 3:8,
3:14, 4:18, 5:20,
15:11, 35:18, 36:8,
37:7, 38:3, 39:15,
41:5, 43:17, 43:24,
44:13, 44:16, 47:3,
48:6, 51:16, 54:7,
54:19, 55:3, 55:11,
58:3, 59:22, 60:17,
61:16, 62:14, 69:24
LEE [15] - 1:16, 3:10,
3:15, 3:21, 3:23,
4:21, 5:3, 5:13, 5:21,
15:19, 19:7, 20:9,
23:12, 62:18, 62:25
Lee's [2] - 40:3, 41:12
left [8] - 12:17, 12:19,
14:3, 23:8, 26:23,
29:8, 31:16, 47:6
left-hand [5] - 12:17,
12:19, 14:3, 26:23,
31:16
legal [4] - 52:20,
54:17, 61:9, 65:5
legally [1] - 46:12
legs [2] - 17:11, 17:13
length [1] - 17:13
lengthy [1] - 16:5
less [5] - 11:17, 11:20,
18:13, 52:1, 62:21
letter [2] - 63:11,
63:12
licensed [1] - 8:11
life [1] - 49:20
lifting [1] - 42:23
Lilly [11] - 7:2, 7:11,
7:25, 8:2, 8:9, 13:8,
41:9, 41:10, 50:6,
50:7, 53:16
limitation [10] - 33:25,
45:17, 46:10, 47:5,
47:23, 51:6, 51:7,

51:11, 65:21, 66:14

limitations [3] - 12:11,
45:6, 66:13
limited [2] - 45:22,
45:23
Line [3] - 12:17, 12:18,
35:7
line [1] - 16:6
Lines [1] - 14:4
lipopeptide [4] 23:22, 23:24, 24:14,
65:22
LISA [1] - 1:16
Lisa [1] - 2:8
list [3] - 59:1, 59:3,
59:15
listen [1] - 15:15
listened [1] - 39:15
listing [2] - 64:4
literally [9] - 9:7,
38:20, 42:3, 43:17,
47:7, 47:15, 49:5,
53:12, 56:5
literature [2] - 43:5,
43:6
litigate [1] - 54:1
LLP [4] - 1:15, 1:18,
1:22, 1:24
logical [1] - 4:22
look [23] - 13:10,
15:22, 16:20, 18:4,
19:16, 28:12, 37:23,
39:17, 40:15, 41:18,
44:4, 50:7, 54:6,
55:14, 57:17, 58:20,
58:21, 58:23, 59:23,
61:22, 68:6, 68:8,
68:25
looking [6] - 36:19,
36:20, 41:13, 44:12,
61:17, 61:19
looks [1] - 19:19
Los [1] - 1:24
Lourie [9] - 16:1,
16:20, 17:15, 28:11,
55:5, 55:14, 59:22,
69:14
Lourie's [1] - 19:16
love [1] - 18:20
LY146032 [2] - 7:16

M
MA [1] - 1:18
maintains [1] - 4:19
major [1] - 50:13
manifest [1] - 46:2
manner [1] - 13:22
manufacture [1] Page 7 to 7 of 11

45:20
manufacturing [1] 9:16
Markman [10] - 1:11,
21:13, 36:21, 36:23,
37:14, 38:16, 45:13,
47:12, 52:10, 55:22
math [1] - 47:14
matter [31] - 15:25,
16:1, 16:19, 17:25,
18:3, 44:22, 48:7,
48:17, 49:2, 51:20,
51:25, 54:20, 55:2,
55:3, 55:6, 55:7,
55:12, 55:15, 56:17,
56:23, 58:13, 59:18,
60:3, 60:4, 60:9,
60:20, 61:2, 63:10,
64:12, 64:14, 69:15
matters [10] - 41:2,
41:6, 41:13, 44:15,
49:19, 49:20, 50:23,
51:10, 53:6
Maurer [1] - 70:5
mean [5] - 4:14, 43:20,
48:10, 56:4, 57:7
meaning [7] - 6:15,
23:5, 23:15, 27:11,
39:1, 41:17, 42:2
meanings [1] - 39:5
means [3] - 17:22,
57:8, 69:20
meant [1] - 68:6
mentioned [1] - 66:21
mere [1] - 20:21
merits [1] - 22:14
Messrs [1] - 3:8
method [6] - 13:13,
41:18, 42:1, 45:20,
48:20, 48:25
methods [6] - 7:24,
9:2, 15:8, 34:14,
34:15, 49:21
Mexico [17] - 15:22,
15:25, 16:13, 16:15,
16:16, 17:23, 19:15,
19:23, 19:25, 55:5,
55:14, 59:22, 60:8,
60:14, 60:17, 61:1,
69:12
Miao [23] - 11:21,
14:20, 14:21, 15:4,
15:5, 15:7, 20:4,
33:10, 33:12, 33:13,
33:15, 34:24, 40:22,
41:19, 41:22, 41:24,
42:2, 44:18, 45:5,
58:23, 61:18, 61:20,
67:3
micelles [2] - 10:10,

10:17
mid-1980's [1] - 13:7
middle [2] - 24:2,
24:17
might [5] - 15:13,
15:17, 58:21, 62:13,
64:8
millions [1] - 17:21
mind [2] - 15:14,
28:10
minimize [1] - 7:19
minor [11] - 19:8, 21:1,
50:12, 54:13, 54:16,
54:21, 56:12, 56:15,
56:21, 60:5, 63:13
minutes [2] - 3:18,
12:10
mirror [2] - 13:3, 13:4
mis [1] - 52:13
mis-described [1] 52:13
missed [2] - 68:18,
68:20
mistake [11] - 36:21,
52:16, 52:21, 53:25,
54:11, 54:20, 54:23,
55:19, 56:21, 56:23
mistakes [2] - 55:24,
56:21
modern [1] - 15:8
modifications [1] 50:12
moment [1] - 9:14
monooxygenase [2] 52:14, 52:19
more.. [1] - 21:3
moreover [1] - 54:3
morning [5] - 2:1, 2:3,
3:1, 3:2, 3:7
Morris [1] - 1:15
most [5] - 9:10, 9:24,
10:25, 14:5, 50:8
motions [1] - 62:2
move [4] - 6:18, 13:18,
25:10, 28:7
moved [1] - 68:12
moving [1] - 31:11
MR [25] - 2:6, 3:1, 3:3,
3:10, 3:15, 3:21,
3:23, 4:3, 4:8, 4:15,
4:21, 5:3, 5:13, 5:18,
5:21, 15:19, 19:7,
20:9, 23:12, 35:20,
54:10, 62:13, 62:18,
62:24, 62:25
multiple [2] - 18:18,
21:25
muscle [7] - 8:7, 8:13,
8:17, 8:23, 8:24,
28:1, 32:23
04/15/2013 04:59:57 AM

must [1] - 51:13

N
narrow [2] - 51:8, 65:8
natural [5] - 7:1, 7:9,
11:4, 17:19, 18:8
naturally [6] - 11:19,
18:11, 20:3, 24:3,
29:5, 34:3
nature [8] - 7:2, 54:13,
54:14, 54:21, 55:20,
56:1, 56:3, 56:11
need [2] - 55:13, 59:18
never [11] - 18:11,
22:22, 24:8, 35:1,
41:21, 60:11, 68:24,
69:4, 69:6, 69:8
New [17] - 15:22,
15:25, 16:13, 16:15,
16:16, 17:22, 19:15,
19:23, 19:25, 55:5,
55:14, 59:22, 60:8,
60:14, 60:17, 61:1,
69:11
new [31] - 7:13, 9:5,
10:16, 15:25, 16:1,
16:19, 17:16, 17:25,
20:4, 54:19, 55:2,
55:3, 55:6, 55:12,
55:15, 57:13, 57:21,
57:24, 58:1, 58:12,
58:15, 58:17, 59:17,
59:20, 60:3, 60:4,
60:9, 60:20, 61:2,
69:15
next [3] - 27:6, 28:8,
37:23
Nice [1] - 3:12
Nichols [1] - 1:15
night [3] - 24:11,
34:11, 65:12
nobody [5] - 31:9,
47:20, 48:1, 52:4,
53:5
non [4] - 10:13, 17:5,
48:22, 49:4
non-acidic [1] - 10:13
non-infringing [2] 48:22, 49:4
non-scientist [1] 17:5
none [3] - 11:14,
11:15, 32:9
noninfringement [3] 53:10, 61:11, 62:10
nonsensical [1] 47:18
nothing [10] - 22:4,
04/15/2013 04:59:57 AM

25:17, 25:19, 33:17,

36:25, 62:3, 64:4,
66:11, 67:8
notion [1] - 46:17
number [4] - 9:25,
38:22, 61:2, 61:3

O
obtained [3] - 7:7,
13:11, 13:12
obtaining [2] - 6:25,
10:22
obvious [1] - 7:21
obviously [1] - 36:13
obviousness [1] 21:14
occasions [1] - 15:12
occurred [1] - 54:24
occurring [2] - 29:6,
34:4
occurs [1] - 7:2
oddity [3] - 35:25,
36:9, 36:12
OF [1] - 1:2
offer [1] - 3:19
offered [2] - 13:19,
13:20
offers [1] - 61:1
Office [14] - 14:16,
15:1, 20:19, 23:1,
33:9, 34:23, 34:25,
35:1, 38:9, 50:8,
52:9, 54:22, 58:22,
67:2
often [1] - 37:18
old [10] - 57:12, 57:19,
57:21, 57:23, 58:2,
58:12, 58:15, 58:18,
59:16, 60:1
oldest [1] - 6:24
once [3] - 6:6, 9:2,
68:18
one [74] - 5:10, 6:14,
6:17, 6:20, 8:21,
9:11, 11:23, 15:12,
16:7, 16:15, 17:16,
17:18, 18:5, 18:6,
18:18, 18:20, 20:14,
20:15, 21:10, 21:16,
22:9, 23:1, 27:11,
27:14, 28:9, 28:12,
28:20, 28:21, 29:15,
29:17, 29:22, 30:20,
32:18, 34:23, 35:13,
35:23, 35:25, 36:1,
38:22, 40:2, 40:12,
41:4, 43:12, 46:11,
46:17, 47:2, 47:14,

48:5, 48:13, 48:14,

49:17, 50:5, 51:8,
51:15, 52:5, 53:3,
54:12, 54:13, 55:9,
55:16, 55:17, 56:9,
56:12, 56:15, 56:19,
58:2, 58:3, 58:7,
58:15, 59:24, 60:5,
61:2, 66:4
opening [1] - 39:10
operable [3] - 37:6,
37:8, 37:9
opposite [1] - 33:11
Orange [4] - 59:1,
59:3, 59:5, 59:13
oranges [1] - 61:1
order [3] - 2:14, 47:10,
70:1
orderly [1] - 2:22
ordinary [19] - 16:8,
18:1, 18:3, 18:6,
20:15, 20:24, 21:16,
22:9, 28:9, 28:24,
29:15, 29:23, 30:20,
30:23, 39:2, 64:13,
67:11, 67:15, 67:20
organize [1] - 38:19
original [2] - 20:13,
46:19
otherwise [3] - 49:23,
50:16, 51:6
outset [2] - 6:17,
33:24
outside [1] - 40:3

P
P.A [1] - 1:20
Page [1] - 15:23
page [1] - 37:23
pages [1] - 69:16
panel [2] - 24:17,
24:22
paper [14] - 11:21,
14:20, 14:21, 14:25,
15:7, 20:4, 27:2,
29:11, 33:10, 33:12,
33:13, 33:16, 34:24
papers [1] - 51:16
parallel [1] - 20:7
part [10] - 5:16, 11:21,
13:19, 14:18, 20:13,
29:14, 30:8, 42:16,
52:10, 66:21
particular [9] - 42:17,
45:22, 50:17, 51:9,
52:5, 53:3, 54:4,
60:1
particularly [2] - 19:9,
Page 8 to 8 of 11

42:13
parties [3] - 6:12,
15:17, 62:11
parts [1] - 43:21
pass [4] - 55:7, 55:9,
60:7, 60:11
passed [2] - 32:20,
60:5
passing [3] - 24:11,
34:11, 65:12
Patent [14] - 14:16,
14:25, 20:19, 23:1,
33:9, 34:23, 34:25,
35:1, 38:9, 50:8,
52:9, 54:22, 58:22,
67:1
patent [58] - 4:7, 4:10,
4:11, 4:15, 4:22,
5:12, 6:14, 6:18,
6:19, 6:20, 6:24,
7:18, 9:2, 9:20,
10:10, 10:20, 10:22,
12:18, 14:3, 14:15,
17:1, 19:25, 20:12,
20:13, 22:20, 25:18,
26:6, 31:19, 39:4,
39:18, 43:12, 43:15,
44:20, 45:12, 46:11,
47:4, 50:6, 50:7,
52:14, 52:17, 52:19,
54:23, 55:1, 55:24,
59:1, 59:3, 59:5,
59:8, 59:12, 61:19,
63:18, 64:20, 66:21,
67:5, 68:18, 68:19,
68:25
patentee [3] - 36:25,
37:5, 37:12
patentees [1] - 68:8
patenting [1] - 24:21
patents [69] - 5:23,
6:1, 6:3, 6:4, 6:14,
6:16, 6:24, 7:23,
8:25, 9:10, 9:12,
10:2, 11:5, 22:10,
22:17, 22:19, 23:6,
23:14, 23:16, 23:18,
25:2, 25:5, 25:9,
25:15, 26:6, 27:7,
27:12, 27:24, 30:22,
31:12, 31:15, 31:21,
32:3, 32:6, 32:16,
32:17, 33:8, 34:15,
40:16, 40:17, 40:19,
41:3, 41:18, 41:21,
41:23, 42:1, 42:2,
42:15, 42:25, 43:4,
43:8, 43:11, 43:15,
48:20, 49:16, 49:25,
50:1, 59:11, 66:9,

67:3, 67:6, 68:8,

68:22
patient [3] - 25:20,
27:18, 28:4
patients [18] - 8:23,
9:3, 9:8, 11:13,
17:21, 18:9, 24:20,
24:25, 29:7, 29:20,
30:17, 30:25, 33:3,
33:7, 33:20, 67:24,
68:4, 69:7
pause [1] - 28:7
people [9] - 2:8,
21:21, 40:8, 44:23,
44:24, 48:8, 49:20,
56:5, 66:2
peptides [1] - 50:9
per [1] - 48:25
perfect [1] - 63:24
performed [1] - 20:1
period [10] - 12:1,
38:25, 41:1, 41:6,
41:13, 41:14, 44:5,
44:11, 50:22, 53:6
permissible [3] 60:22, 60:24
persisted [1] - 36:22
person [13] - 18:1,
18:3, 20:23, 28:24,
30:22, 30:23, 39:2,
44:11, 64:13, 64:15,
67:11, 67:15, 67:20
perspective [2] 21:16, 61:19
pharmaceutical [1] 7:8
pharmaceutically [1] 32:5
PHARMACEUTICAL
S [1] - 1:4
pharmacological [1] 50:14
PHILLIPS [3] - 1:20,
3:1, 3:3
Phillips [5] - 1:20,
2:24, 3:3, 38:25,
42:10
photograph [3] 63:23, 67:19
phrase [3] - 45:9,
46:18, 56:20
phrases [1] - 46:17
pick [1] - 38:25
Pickering [1] - 1:18
picking [2] - 49:6,
49:7
picture [2] - 17:9,
17:12
PIROZZOLO [1] - 1:16
Pirozzolo [1] - 2:8
26 of 29 sheets

place [4] - 5:3, 34:10,

46:15, 69:13
plaintiff [1] - 2:7
Plaintiff [2] - 1:5, 1:19
play [1] - 64:6
plus [1] - 18:19
point [28] - 5:14, 8:6,
8:10, 10:25, 13:21,
16:4, 34:18, 39:7,
39:11, 39:14, 39:16,
41:13, 45:10, 48:19,
49:5, 49:14, 49:19,
50:15, 52:8, 59:24,
60:10, 61:14, 63:3,
64:20, 69:1, 69:11,
69:16
pointed [2] - 44:13,
47:3
pointing [1] - 43:21
points [6] - 16:13,
25:16, 26:8, 33:21,
63:5, 65:3
portion [5] - 14:7,
26:24, 28:18, 30:20,
31:14
portions [2] - 19:14,
29:18
position [1] - 4:20
positive [3] - 27:14,
30:2, 30:5
possible [5] - 10:6,
16:9, 48:13, 54:14,
54:15
possibly [1] - 41:24
post-2005 [1] - 45:5
potency [2] - 52:6,
52:8
potent [6] - 11:20,
39:19, 43:25, 51:17,
51:18, 52:1
PowerPoint [1] - 3:23
practice [2] - 15:14,
15:16
precise [3] - 21:9,
24:12, 68:12
precisely [3] - 49:22,
50:3, 66:15
predecessor [2] 43:12, 43:14
preference [2] - 2:17,
3:16
premise [1] - 66:1
presentation [3] 3:17, 3:23, 39:17
pretty [1] - 30:2
prevent [1] - 10:17
principals [2] - 45:2,
53:1
principle [2] - 42:5,
51:13
27 of 29 sheets

principles [1] - 38:21

problem [7] - 8:2,
8:13, 26:1, 32:22,
32:24, 33:4, 35:1
problems [1] - 68:11
process [51] - 7:8,
7:10, 7:13, 9:16,
10:22, 13:11, 19:25,
20:1, 21:22, 24:8,
24:13, 26:11, 33:25,
34:5, 34:9, 36:9,
36:12, 36:13, 36:16,
36:19, 37:15, 37:16,
37:18, 37:22, 38:10,
38:13, 44:2, 44:8,
45:6, 45:9, 45:12,
45:15, 45:17, 45:22,
45:25, 46:4, 46:7,
46:10, 46:23, 46:25,
47:5, 47:23, 51:6,
51:7, 51:11, 63:20,
65:17, 65:21, 67:12,
69:5
processes [2] - 9:16,
10:16
produce [2] - 32:9,
36:16
produced [16] - 11:3,
11:19, 20:3, 24:12,
27:5, 29:5, 32:7,
32:8, 32:10, 33:19,
34:4, 39:18, 40:7,
40:12, 61:21, 67:23
producing [1] - 29:18
product [45] - 6:9, 7:1,
7:9, 10:4, 11:4,
11:16, 17:19, 18:8,
24:18, 24:19, 24:20,
25:22, 27:15, 27:20,
27:21, 29:5, 31:24,
32:4, 33:2, 33:3,
33:19, 34:4, 34:19,
37:15, 37:16, 37:17,
37:19, 37:22, 38:10,
38:13, 44:1, 44:8,
45:7, 45:14, 45:21,
45:24, 46:3, 59:2,
59:6, 59:12, 67:16
product-by-process
[5] - 37:15, 37:16,
37:22, 38:10, 38:13
product-to-structure
[1] - 37:19
production [3] 10:19, 26:11, 32:12
pronunciation [1] 7:4
proper [5] - 6:12, 37:9,
41:25, 51:12, 53:20
properties [2] - 50:14,

51:2
property [1] - 50:17
proposal [1] - 23:8
propose [3] - 11:25,
31:13, 41:10
proposed [4] - 12:20,
23:7, 37:14, 38:19
proposition [2] 26:20, 45:16
prosecution [5] 15:4, 41:20, 50:8,
60:14, 60:21
provide [2] - 5:25,
49:2
provided [1] - 64:18
provides [1] - 4:6
PTO [1] - 14:14
public [1] - 37:1
publication [9] - 15:5,
29:9, 29:11, 29:22,
40:22, 40:23, 41:19,
41:22
pure [6] - 7:20, 10:5,
10:22, 54:4, 57:24,
58:19
purely [3] - 54:17,
58:13, 61:9
purification [4] - 6:4,
10:18, 50:2, 68:13
purify [1] - 10:5
purifying [1] - 50:2
purity [21] - 9:10,
10:11, 10:21, 23:14,
25:4, 25:9, 26:5,
27:8, 27:10, 31:12,
31:14, 32:2, 32:6,
33:8, 43:8, 43:11,
49:25, 67:3, 68:13,
69:9
purple [1] - 49:15
purporting [1] - 23:21
purpose [1] - 28:3
purposes [3] - 11:8,
20:11, 64:22
put [12] - 9:25, 12:4,
19:2, 23:24, 25:15,
28:11, 35:23, 39:7,
42:22, 44:5, 44:6,
67:7
putting [2] - 51:6, 51:7

Q
qualified [1] - 60:20
questions [1] - 21:10
quickly [1] - 25:10
quite [5] - 16:5, 38:12,
42:8, 48:11, 57:10
quote [3] - 29:21,
Page 9 to 9 of 11

36:4, 45:19

R
raise [2] - 53:19, 53:21
range [1] - 22:4
rather [8] - 8:12, 8:21,
13:16, 13:24, 23:25,
52:14, 52:23, 64:17
re [1] - 59:15
re-list [1] - 59:15
reach [1] - 58:11
reaches [1] - 58:10
react [1] - 19:6
read [21] - 12:13,
17:22, 22:9, 22:10,
28:9, 28:15, 28:16,
28:25, 29:1, 29:2,
29:16, 29:17, 29:25,
33:16, 39:9, 39:13,
44:24, 46:5, 54:20,
68:14
reader [2] - 43:1, 43:2
reading [7] - 22:13,
40:1, 40:6, 40:10,
40:19, 44:12, 53:24
reads [4] - 12:22,
44:19, 65:21, 65:22
ready [1] - 10:3
real [3] - 13:1, 20:7,
49:20
realize [1] - 29:2
really [24] - 8:4, 8:6,
19:16, 19:18, 21:23,
22:25, 25:2, 27:25,
36:1, 40:6, 48:17,
49:7, 51:15, 51:18,
52:7, 52:25, 57:15,
60:25, 61:1, 62:1,
62:2, 62:3, 68:13,
68:20
rear [4] - 18:18, 21:25
reason [2] - 15:20,
69:3
reasonable [2] 22:13, 44:24
reasons [3] - 17:4,
27:15, 61:2
rebut [2] - 2:18, 64:11
rebuttal [2] - 3:19,
67:11
recent [1] - 9:10
recognize [1] - 66:18
recognized [1] - 66:5
record [18] - 6:2,
11:22, 13:6, 14:11,
14:19, 14:20, 16:8,
16:12, 20:25, 21:7,
21:19, 21:20, 24:5,

29:15, 30:8, 34:1,

34:8, 40:10
redraft [1] - 37:5
reducing [1] - 7:14
reexamination [1] 55:2
refer [6] - 27:2, 43:1,
43:15, 43:17, 46:21,
46:22
reference [8] - 25:3,
25:5, 26:9, 28:17,
39:10, 42:14, 42:21
references [6] - 28:16,
41:4, 43:9, 49:15,
49:25, 52:8
referred [4] - 14:21,
16:19, 55:4, 63:12
referring [4] - 25:22,
43:16, 44:16, 45:17
refers [6] - 26:10,
26:25, 36:6, 43:25,
44:1, 69:15
regardless [2] - 48:24,
60:24
Regents [1] - 60:16
regimes [1] - 6:5
reissuance [1] - 63:5
reissue [14] - 6:14,
6:19, 6:23, 7:18,
14:8, 14:20, 15:4,
17:1, 22:20, 23:17,
25:18, 43:14, 64:20,
66:21
reissued [1] - 12:18
reject [1] - 62:19
rejected [3] - 52:12,
52:22, 62:15
relate [1] - 6:4
related [1] - 25:5
relates [1] - 51:15
relatively [2] - 50:12,
50:25
relevant [3] - 20:22,
20:23, 41:25
relied [1] - 15:7
relies [1] - 43:20
rely [2] - 28:14, 45:4
relying [1] - 42:5
remaining [1] - 6:16
remember [1] - 60:3
reminder [1] - 45:8
remove [1] - 10:16
renal [1] - 9:3
render [1] - 35:14
repeated [1] - 54:1
reply [1] - 38:18
report [2] - 27:16,
30:15
reported [2] - 30:1,
52:17
04/15/2013 04:59:57 AM

10

Reporter [1] - 70:5

reporting [1] - 15:5
request [1] - 14:13
requested [1] - 59:7
require [1] - 55:2
required [1] - 34:10
requirement [1] 18:18
requirements [2] 55:8, 55:9
requires [1] - 57:20
research [1] - 29:10
resolve [7] - 18:12,
18:14, 21:18, 21:20,
22:8, 53:22, 66:17
resolved [3] - 5:7,
38:1, 65:1
resolves [1] - 39:9
respectfully [3] - 5:4,
5:18, 65:4
respond [4] - 2:3,
2:16, 2:18, 70:3
rest [1] - 47:6
restriction [1] - 46:2
result [10] - 10:2,
24:23, 31:5, 34:8,
34:15, 37:18, 50:13,
69:4, 69:6, 69:8
resulted [4] - 8:24,
17:20, 24:18, 50:20
resulting [2] - 33:5,
50:9
results [2] - 7:9, 67:24
retroactively [1] 52:21
reverted [1] - 4:24
reverts [1] - 4:15
review [3] - 20:24,
28:21, 29:11
reviewed [1] - 33:13
reviewing [1] - 29:10
reviews [1] - 16:8
right-hand [7] - 12:19,
13:3, 14:4, 24:4,
24:22, 26:24, 31:18
Robinson's [1] - 15:16
robust [3] - 13:23,
14:22, 38:5
Rochester [1] - 48:23
room [1] - 48:1
roseoporus [2] 37:25, 38:15
roseosporus [5] - 7:5,
26:12, 27:1, 36:11,
65:15
round [1] - 2:5
row [1] - 2:11
ruling [4] - 37:15,
47:12, 53:10, 62:9
running [1] - 53:2
04/15/2013 04:59:57 AM

S
safe [4] - 7:23, 27:17,
33:6, 64:6
scale [1] - 10:19
scientific [6] - 15:6,
36:21, 52:16, 53:25,
59:25
scientist [2] - 17:5,
67:1
scientists [7] - 7:12,
8:2, 10:7, 10:12,
10:16, 13:8, 49:10
scope [1] - 57:5
screen [5] - 10:20,
12:5, 23:10, 25:16,
26:7
se [1] - 48:25
SEAN [1] - 1:17
Sean [1] - 2:9
seats [1] - 2:2
second [10] - 23:4,
26:9, 31:23, 35:7,
39:23, 45:4, 56:11,
56:15, 59:21, 64:11
Section [2] - 16:3,
16:20
see [17] - 15:23, 17:10,
17:11, 17:24, 18:12,
18:16, 21:18, 25:18,
30:15, 31:16, 32:25,
39:10, 39:14, 42:21,
54:25, 65:8, 69:17
seek [2] - 37:21, 45:14
sees [1] - 19:19
sense [6] - 15:13,
26:16, 34:6, 35:16,
46:17, 58:11
sent [1] - 63:12
separate [2] - 7:19,
60:13
series [3] - 26:13,
26:16, 26:18
serious [4] - 6:7, 6:8,
8:6, 27:14
set [5] - 9:9, 11:24,
12:12, 66:4
setting [1] - 12:8
settled [1] - 51:22
ships [3] - 24:11,
34:11, 65:11
show [4] - 11:16,
25:11, 54:10, 65:7
showed [1] - 63:10
showing [3] - 13:3,
13:4, 54:23
shown [1] - 14:8
shows [2] - 24:5, 49:9
side [18] - 2:14, 8:6,

12:17, 12:19, 13:3,

14:4, 16:18, 24:4,
26:23, 26:24, 31:13,
31:17, 31:18, 35:24
side-by-side [1] 31:13
significant [1] - 30:20
simply [3] - 8:9, 30:19,
69:19
single [7] - 40:19,
43:5, 43:6, 47:14,
48:4, 49:17, 50:2
sitting [2] - 2:9, 67:4
situation [3] - 20:2,
41:8, 46:5
six [2] - 35:11, 35:12
skeletal [5] - 8:7, 8:17,
8:24, 28:1, 32:23
skill [19] - 16:8, 18:1,
18:3, 18:6, 20:16,
20:24, 21:16, 22:9,
28:9, 28:24, 29:15,
29:23, 30:21, 30:23,
39:2, 64:13, 67:12,
67:15, 67:20
skilled [1] - 49:10
skip [2] - 56:9, 61:4
skipped [1] - 32:17
Sleet [1] - 5:11
SLEET [1] - 1:12
slide [6] - 27:6, 28:8,
35:3, 49:14, 54:10,
63:9
Slide [45] - 5:22, 6:4,
6:23, 7:22, 9:1, 9:9,
10:21, 10:24, 12:3,
12:7, 12:16, 12:17,
12:18, 12:25, 14:2,
14:7, 14:18, 15:3,
20:10, 21:2, 22:16,
25:1, 25:8, 26:5,
26:21, 27:23, 28:17,
29:8, 29:21, 31:1,
31:11, 32:2, 32:6,
32:11, 32:15, 33:8,
33:23, 34:17, 35:3,
38:24, 40:17, 49:13,
58:14, 58:23, 65:10
small [3] - 7:2, 13:19
smaller [1] - 8:21
solution [1] - 38:8
solve [2] - 26:1, 26:2
someone [5] - 19:24,
20:4, 30:24, 39:25,
40:5
somewhat [1] - 30:24
sorry [2] - 31:17, 44:9
sort [2] - 35:4, 52:20
source [3] - 12:21,
24:10, 34:5
Page 10 to 10 of 11

spec [7] - 36:4, 36:5,

44:9, 45:18, 65:23,
68:10, 69:10
specific [1] - 16:2
specifically [7] - 14:9,
15:14, 15:24, 26:10,
27:12, 31:3, 32:3
specification [54] 6:9, 7:1, 7:6, 7:15,
7:25, 8:5, 8:8, 8:16,
8:20, 10:9, 10:13,
13:10, 14:3, 16:17,
16:18, 18:4, 24:16,
24:19, 25:12, 26:22,
26:24, 27:9, 27:10,
28:10, 28:15, 28:25,
29:4, 29:14, 29:18,
31:14, 32:1, 35:13,
35:16, 42:19, 42:23,
43:22, 43:24, 44:3,
44:12, 44:25, 46:5,
49:12, 51:17, 60:23,
60:25, 66:6, 66:7,
66:9, 67:13, 67:17,
67:21, 68:7, 69:18
specifications [4] 23:6, 25:10, 31:12,
41:7
specs [1] - 44:8
Spence [1] - 1:20
spent [1] - 54:19
square [3] - 57:13,
57:15, 58:5
standard [1] - 20:20
Standish [1] - 3:5
STANDISH [1] - 1:23
stands [2] - 4:19,
61:16
start [4] - 2:4, 35:23,
63:2, 63:4
STATES [1] - 1:1
statute [4] - 54:7,
54:20, 60:4, 69:15
steps [10] - 26:13,
26:16, 26:18, 35:11,
35:12, 63:20, 63:21,
68:1, 68:3, 68:12
stereochemical [1] 13:2
stereochemistry [47] 6:20, 6:21, 13:1,
13:5, 14:14, 18:6,
22:20, 22:22, 23:3,
25:3, 25:6, 25:17,
26:9, 28:22, 33:1,
33:11, 33:12, 33:14,
47:9, 47:12, 47:17,
47:19, 47:24, 48:7,
48:9, 48:11, 48:14,
48:16, 48:20, 49:6,

49:10, 49:18, 49:19,

49:23, 50:4, 50:16,
51:1, 51:4, 51:10,
53:16, 64:24, 66:11,
66:19, 66:24, 67:5,
67:8, 67:9
stereoisomer [2] 48:13, 51:9
stereoisomerism [1] 50:13
stereoisomers [1] 38:6
still [4] - 4:11, 4:16,
17:14, 27:23
stipulation [1] - 62:11
stop [2] - 8:9, 32:23
straight [1] - 3:17
Strawn [3] - 1:22,
1:24, 3:5
Streptomyces [6] 26:12, 27:1, 36:11,
37:25, 38:15, 65:15
Streptomycin [1] - 7:5
structurally [1] - 52:24
structure [15] - 12:23,
13:9, 16:17, 16:21,
31:17, 31:19, 34:21,
37:19, 38:11, 47:3,
50:9, 51:14, 51:22,
51:24, 69:19
struggling [1] - 8:3
students [1] - 48:18
studied [1] - 7:12
studies [2] - 8:19,
30:11
study [1] - 7:12
subject [1] - 49:2
submitted [1] - 14:13
subsidiary [1] - 60:9
substantial [1] - 28:18
subtle [1] - 50:13
success [1] - 27:15
successful [2] - 69:6,
69:9
successfully [6] 8:22, 11:13, 13:13,
18:9, 29:20, 33:20
sufficient [1] - 49:3
suggest [6] - 5:13,
29:20, 43:18, 53:17,
59:10, 62:9
suggested [1] - 35:1
suggesting [3] 22:24, 24:12, 52:24
summarized [1] - 6:3
summary [16] - 5:1,
5:7, 5:9, 5:11, 15:16,
18:15, 20:19, 21:6,
21:7, 53:9, 61:12,
62:2, 62:5, 63:6,
28 of 29 sheets

11

63:8, 65:2
Superior [2] - 21:24,
56:18
support [2] - 26:19,
26:22
supported [1] - 20:21
supposed [2] - 44:6,
44:11
Supreme [1] - 36:24
surprised [1] - 5:19
surprising [1] - 8:16
sustain [1] - 37:10
synthetically [3] 24:7, 46:8, 46:14

T
tail [2] - 17:11, 17:13
talks [4] - 25:20,
30:12, 31:3, 31:4
Tally [11] - 28:19,
29:1, 29:3, 29:11,
31:1, 31:2, 31:3,
31:7, 32:18, 32:20,
42:14
teach [2] - 24:16,
57:11
technologies [1] 14:23
Technologies [1] 22:3
technology [8] 13:15, 17:10, 19:21,
20:4, 20:5, 38:5,
63:24, 67:18
ten [1] - 11:20
tenfold [2] - 50:21,
52:1
term [10] - 2:15, 6:15,
12:6, 27:11, 39:1,
42:17, 47:21, 48:2,
49:17
terms [7] - 2:14, 2:16,
2:17, 3:17, 11:9,
28:22, 35:22
terrific [1] - 69:2
territory [5] - 57:18,
58:2, 58:15, 59:17,
59:20
test [4] - 15:24, 52:6,
55:7, 60:7
testing [2] - 11:6,
24:24
tests [3] - 55:9, 60:5,
60:12
Teva [1] - 68:20
Texas [1] - 56:9
THE [26] - 1:1, 1:2,
2:1, 2:4, 2:21, 3:2,
29 of 29 sheets

3:7, 3:12, 3:20, 3:22,

3:25, 4:5, 4:13, 4:18,
5:2, 5:10, 5:19,
15:11, 19:5, 20:8,
23:11, 35:18, 54:9,
62:9, 62:23, 69:24
theirs [5] - 27:5, 28:5,
30:10, 34:12, 34:16
themselves [3] 23:18, 26:7, 26:19
therapeutically [4] 25:21, 25:23, 25:25,
68:5
therefore [3] - 4:5,
42:1, 61:11
third [1] - 23:20
THOMPSON [1] - 1:17
Thompson [1] - 2:9
thousands [3] - 9:8,
47:7, 47:15
three [9] - 5:23, 9:20,
17:11, 22:17, 31:21,
50:9, 66:10, 68:12,
68:18
three-dimensional [1]
- 50:9
threshold [2] - 4:12,
55:11
throughout [1] - 11:4
throw [1] - 64:1
throwing [1] - 15:18
tied [2] - 8:17, 8:19
ties [1] - 15:24
Tim [2] - 2:9, 2:12
timeline [1] - 40:15
timing [6] - 53:3, 53:4,
64:1, 65:25, 67:11,
67:25
TIMOTHY [1] - 1:17
tiny [1] - 50:18
today [21] - 3:10, 5:2,
5:7, 5:17, 7:3, 13:23,
17:18, 40:5, 40:8,
44:17, 44:18, 44:19,
44:22, 53:11, 53:24,
55:22, 62:5, 64:19,
64:21, 65:1, 67:22
today's [2] - 11:8,
20:11
tolerated [1] - 30:12
Tom [1] - 2:11
took [4] - 19:24, 47:5,
59:5, 59:12
topical [2] - 8:12, 8:14
toxicity [7] - 8:7, 8:13,
8:17, 8:23, 8:24,
28:1, 32:24
treat [10] - 6:7, 9:7,
17:20, 18:9, 20:12,
29:7, 29:19, 29:20,

31:25, 33:20
treated [1] - 8:22
treatment [6] - 8:15,
30:18, 43:11, 49:15,
49:16, 49:21
trial [5] - 5:16, 9:19,
16:9, 16:11, 19:2
trials [1] - 8:1
tried [1] - 3:9
true [7] - 36:17, 38:7,
38:8, 47:4, 66:16
trump [2] - 42:6, 42:9
try [6] - 17:8, 25:9,
38:16, 51:8, 52:15,
52:21
trying [12] - 10:5, 24:1,
24:13, 33:25, 34:18,
34:20, 38:4, 45:8,
65:16, 65:20, 66:13
Tunnell [1] - 1:15
turns [4] - 4:4, 56:18,
57:1, 61:10
twice [1] - 68:18
two [35] - 2:8, 2:14,
3:12, 3:17, 6:11,
8:25, 9:12, 11:9,
11:14, 13:2, 13:3,
13:4, 13:21, 16:13,
17:4, 24:11, 25:16,
26:6, 26:8, 28:19,
31:3, 31:18, 32:19,
35:22, 35:24, 43:22,
54:12, 55:9, 55:17,
60:5, 60:11, 61:2,
61:3, 63:5, 65:11
type [5] - 22:7, 29:3,
53:12, 62:11, 64:9
typically [1] - 62:1
typo [2] - 56:5, 56:6
typographical [9] 54:13, 54:14, 54:21,
55:19, 55:20, 56:3,
56:8, 56:10, 60:6

U
ultimate [1] - 21:15
ultimately [2] - 20:22,
21:8
unasserted [2] 46:21, 46:22
unavoidable [1] - 49:7
uncorrected [1] - 57:4
under [3] - 10:8,
10:13, 60:2
underlying [3] - 37:18,
58:21, 64:14
understood [1] - 18:7
undisputed [2] - 51:1,
Page 11 to 11 of 11

61:8
unexpected [2] 40:23, 40:25
UNITED [1] - 1:1
university [1] - 48:23
unless [5] - 49:2, 55:7,
59:4, 60:5, 67:7
unlike [1] - 9:20
unlikely [1] - 68:20
unlocking [1] - 32:22
unrelated [1] - 69:15
unsettled [1] - 58:8
up [8] - 17:7, 24:21,
30:18, 44:21, 54:8,
61:13, 61:16, 68:22
useful [1] - 37:18
uses [1] - 34:6

V
validity [7] - 4:1, 4:7,
4:9, 4:17, 4:21, 5:6,
37:10
value [1] - 42:17
Vanguard [1] - 45:19
various [1] - 52:20
version [19] - 11:19,
11:20, 13:12, 13:14,
18:10, 30:13, 34:3,
34:12, 35:7, 47:13,
58:1, 58:15, 58:17,
58:18, 67:14, 67:17,
69:1
versions [1] - 57:21
versus [3] - 19:12,
53:25, 57:24
view [2] - 21:11, 62:4
violated [1] - 45:2
violates [1] - 38:20
virtually [1] - 36:3
vitro [4] - 50:20, 52:1,
52:4, 52:6
vivo [2] - 11:6, 52:3

68:7, 68:14
widely [1] - 50:11
WILLIAM [1] - 1:16
Wilmer [1] - 1:18
WilmerHale [2] - 2:8,
2:9
Wilmington [1] - 1:9
Winston [3] - 1:22,
1:24, 3:5
wished [1] - 37:12
wondering [1] - 15:15
word [2] - 10:10, 33:1
words [8] - 16:19,
16:21, 23:24, 46:1,
63:22, 65:14, 65:23,
66:25
world [2] - 48:12,
66:24
worried [2] - 38:11,
38:12
wrap [1] - 61:13
writing [1] - 49:20
written [5] - 15:25,
28:19, 37:11, 37:12
wrote [2] - 55:5, 59:22

Y
years [4] - 6:6, 17:12,
17:17, 67:19
yellow [1] - 43:10
yield [1] - 33:22
yourself [2] - 44:5,
44:6

W
wall [1] - 21:25
walls [3] - 18:18,
21:25
wants [1] - 21:3
wasteful [1] - 53:22
ways [3] - 7:14, 16:25,
46:8
Wednesday [1] - 1:10
whole [12] - 16:8,
16:10, 17:24, 20:25,
28:10, 28:16, 28:17,
29:1, 29:2, 29:3,
04/15/2013 04:59:57 AM