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IN THE UNITED STATES DISTRICT COURT

IN AND FOR THE DISTRICT OF DELAWARE

- - -

CUBIST PHARMACEUTICALS, INC., ) Civil Action ) Plaintiff, ) ) v. ) )HOSPIRA, INC., ) ) Defendant. ) No. 12-367-GMS

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

BEFORE: HONORABLE GREGORY M. SLEET, Chief Judge

APPEARANCES:

JACK B. BLUMENFELD, ESQ. Morris, Nichols, Arsht & Tunnell LLP -and- WILLIAM 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

JOHN C. PHILLIPS, JR., ESQ. Phillips, Goldman & Spence, P.A. -and- JAMES F. HURST, ESQ. Winston & Strawn LLP (Chicago IL) -and- GAIL STANDISH, ESQ. Winston & Strawn LLP (Los Angeles, CA) Counsel for Defendant

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THE COURT: Good morning. Please, take your 09:30:28 1

seats.09:30:30 2

(Counsel respond "Good morning.") 09:30:31 3

THE COURT: Counsel, let's start out with a 09:30:32 4

round of introductions. Mr. Blumenfeld.09:30:34 5

MR. BLUMENFELD: Thank you, Your Honor. Jack 09:30:36 6

Blumenfeld for the plaintiff Cubist, along with Bill Lee 09:30:41 7

and, Lisa Pirozzolo, of WilmerHale, and two other people 09:30:44 8

from WilmerHale, Sean Thompson and Tim Cook sitting behind 09:30:48 9

them.09:30:52 10

In first row in the back from Cubist, Tom 09:30:52 11

DesRosier, Tim Dorouos and Bill DeVaul.09:30:56 12

Your Honor, we have discussed with the other 09:30:59 13

side the order. There is only the two terms to be argued. 09:31:02 14

We are happy to do it either term by term or to do both 09:31:05 15

terms and have the defendant respond. I think their 09:31:09 16

preference is to have us just go through both terms then 09:31:12 17

they will respond, we will rebut. We leave it to Your Honor 09:31:16 18

which way you would want to do it. We are happy to do it 09:31:18 19

either way. 09:31:21 20

THE COURT: If counsel have discussed a way that 09:31:22 21

you think is orderly and will best help me do what I have to 09:31:24 22

do, I am comfortable.09:31:28 23

Mr. Phillips, would you like to make 09:31:34 24

introductions? 09:31:36 25

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MR. PHILLIPS: Good morning, Your Honor.09:31:36 1

THE COURT: Good morning. 09:31:38 2

MR. PHILLIPS: Jack Phillips on behalf of 09:31:38 3

Hospira. With me in the courtroom Jim Hurst and Gail J. 09:31:40 4

Standish from Winston & Strawn. Also in the courtroom is 09:31:44 5

Anne Christopher from Hospira, all the way from Australia. 09:31:48 6

THE COURT: Oh, my goodness. Good morning.09:31:51 7

It seems we can't keep Messrs. Lee and Hurst out 09:31:54 8

of this courtroom. I have tried my best. 09:31:59 9

MR. LEE: I asked him not to come today. 09:32:01 10

(Laughter.) 09:32:04 11

THE COURT: Nice to have two excellent lawyers 09:32:07 12

in the courtroom.09:32:10 13

Mr. Lee, are you in agreement?09:32:11 14

MR. LEE: Your Honor, Mr. Hurst and I talked. 09:32:13 15

If Your Honor has no preference, what I will do is go 09:32:14 16

straight through the two terms and make our presentation. 09:32:16 17

Mr. Hurst will follow. If I can have four or five minutes 09:32:19 18

at the end just to offer any rebuttal? 09:32:22 19

THE COURT: Sure:09:32:24 20

MR. LEE: May I? 09:32:29 21

THE COURT: Yes, please.09:32:31 22

MR. LEE: This is our PowerPoint presentation, 09:32:32 23

Your Honor. 09:32:34 24

THE COURT: Do I understand that, Mr. Hurst, 09:32:35 25

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that Hospira does make an attack on the validity of the 09:32:38 1

certificate of correction? 09:32:43 2

MR. HURST: We do, Your Honor, because in this 09:32:45 3

case it turns entirely on a claim construction issue.09:32:48 4

THE COURT: Gentlemen, therefore, do I 09:32:51 5

understand that the law provides that that in essence is an 09:32:52 6

attack on the validity of the patent? 09:32:56 7

MR. HURST: If the certificate of correction is 09:32:58 8

not accepted, it is not an attack on the validity of the 09:33:01 9

patent, no. The certificate of correction goes away, and 09:33:05 10

the patent still exists in its earlier form, which is why we 09:33:08 11

think it's a threshold claim construction issue. 09:33:13 12

THE COURT: When you say the certificate of 09:33:16 13

correction goes away, what do you mean? 09:33:17 14

MR. HURST: The patent reverts to how it was 09:33:19 15

before the correction and it still exists, so it is not an 09:33:22 16

attack on validity. 09:33:25 17

THE COURT: Mr. Lee, you would say if the 09:33:26 18

certificate of correction stands and Hospira maintains its 09:33:28 19

position, it's an attack.09:33:31 20

MR. LEE: It's an attack on the validity of the 09:33:33 21

patent. I think what Mr. Hurst, the logical conclusion, I 09:33:36 22

think he would agree, is that if the certificate of 09:33:38 23

correction were invalid and the claim reverted to what they 09:33:41 24

claim is the claim construction, that there would be no 09:33:44 25

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infringement. It's basically a summary judgment decision. 09:33:46 1

THE COURT: Which we are not going to do today. 09:33:50 2

MR. LEE: This is just a place where we 09:33:54 3

disagree, respectfully, with each other. We say it is not 09:33:56 4

just a question of claim construction. And the question of 09:33:58 5

validity, of certificate of correction, implicates facts 09:34:02 6

that are not here today and should get resolved on summary 09:34:06 7

judgment. In fact, Your Honor, all the decisions that 09:34:08 8

Hospira and we cite to you are summary judgment decisions. 09:34:11 9

THE COURT: So then this may be one of those few 09:34:13 10

times that Sleet finally lets summary judgment go forth in a 09:34:16 11

patent case.09:34:20 12

MR. LEE: We actually would suggest when we get 09:34:21 13

to that point, Your Honor, I think we will be able to 09:34:23 14

demonstrate to Your Honor that there are actually facts here 09:34:25 15

as part of the trial, issues to be decided. I don't think 09:34:27 16

we are there today.09:34:31 17

MR. HURST: We respectfully disagree with that. 09:34:33 18

THE COURT: Why am I not surprised, Mr. Hurst.09:34:35 19

Mr. Lee. 09:34:38 20

MR. LEE: Thank you, Your Honor.09:34:38 21

If I could go to Slide 2, I am going to briefly 09:34:40 22

describe three groups of patents in issue, then go to the 09:34:42 23

disputed claim construction issues, Your Honor. All of the 09:34:46 24

background that I am going to provide is drawn directly from 09:34:49 25

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the patents or directly from the file history. So it is all 09:34:52 1

in the intrinsic record.09:34:55 2

There are five asserted patents, as summarized 09:34:57 3

on Slide 2. The patents all relate to the purification of 09:34:59 4

or dosing regimes for an antibiotic called daptomycin, which 09:35:05 5

has been before the Court once before a couple years ago.09:35:10 6

Daptomycin is used to treat serious infections, 09:35:13 7

very serious infections. And some of those are described in 09:35:17 8

the specification. It is the active ingredient in a product 09:35:23 9

called Cubicin, which Cubist makes. 09:35:25 10

There are, as Your Honor knows, two claim 09:35:28 11

construction disputes. The parties dispute the proper 09:35:30 12

construction of "compound of Formula 3" or "Formula 3 09:35:33 13

compound" from one of the patents, from the reissue patent. 09:35:38 14

And they also dispute the meaning of the term "daptomycin" 09:35:41 15

from the four remaining patents.09:35:47 16

One thing I would say at the outset, Your Honor, 09:35:50 17

as we move through these things, the first patent, the 09:35:52 18

reissue patent, which has been before Your Honor before, is 09:35:54 19

one patent which does claim stereochemistry in the claim. 09:35:57 20

The other four don't claim stereochemistry at all in the 09:36:00 21

claim. That will be a dispute that I come back to.09:36:06 22

If I go to Slide No. 3, Your Honor, the reissue 09:36:09 23

patent is the oldest of the asserted patents. And it's 09:36:11 24

directed to obtaining daptomycin with fewer impurities. As 09:36:15 25

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the specification says, daptomycin is a natural product that 09:36:19 1

occurs in nature in small, small amounts. Eli Lilly, not 09:36:22 2

here today, first isolated that antibiotic from a bacterium, 09:36:31 3

which I am probably going to butcher the pronunciation, 09:36:40 4

Streptomycin roseosporus, in the late 1970s to 1980s. And 09:36:40 5

that is described in the specification and the file history.09:36:44 6

Since then, daptomycin has been obtained for 09:36:46 7

pharmaceutical use by a process called fermentation and 09:36:50 8

filtering. But it is the natural product that results from 09:36:54 9

this process.09:36:56 10

In 1987, after discovering the compound, Lilly 09:36:58 11

scientists continued to study it. And as they studied it, 09:37:03 12

they discovered new impurities in the fermentation process 09:37:07 13

to make it, and developed ways of reducing them. 09:37:11 14

The impurities as described in the specification 09:37:14 15

were called Anhydro LY146032 and Isomer LY146032.09:37:17 16

By identifying how those impurities were formed, 09:37:25 17

the inventors of the reissue patent were able to discover 09:37:29 18

how to minimize the impurities and separate them from 09:37:31 19

daptomycin to make a pure form of daptomycin, which has 09:37:34 20

obvious clinical benefits.09:37:37 21

If I go to Slide 4, Your Honor, these are the 09:37:40 22

dosing patents. They came later. They deal with the safe 09:37:43 23

and effective methods of administering daptomycin. Again, 09:37:48 24

directly from the specification, Lilly conducted clinical 09:37:52 25

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trials for daptomycin after their discovery in the 1980s and 09:37:56 1

early 1990s. But Lilly scientists had a problem. They were 09:38:01 2

struggling to find a way to administer a clinically 09:38:06 3

effective dose. And really what happened, Your Honor, as 09:38:09 4

the specification and the file history describes, they came 09:38:12 5

to a point where they had a really serious side effect, 09:38:16 6

which was skeletal muscle toxicity. It is described in the 09:38:20 7

specification. It is a bad thing. It was bad enough that 09:38:23 8

Lilly simply decided to stop its development.09:38:26 9

At that point in time, or a little bit later, in 09:38:29 10

1997, Cubist then licensed daptomycin with the intention of 09:38:32 11

developing a topical drug rather than an intravenously taken 09:38:38 12

drug to avoid the muscle toxicity problem. In the course of 09:38:43 13

working with daptomycin and developing this topical 09:38:48 14

treatment, they made a discovery that was, as described in 09:38:50 15

the specification, surprising and counterintuitive. That 09:38:54 16

was that the skeletal muscle toxicity issue was not tied so 09:38:58 17

much to the dose, the amount you were getting, but it was 09:39:03 18

tied to the interval between doses. They conducted studies 09:39:06 19

that are described in the specification where daptomycin 09:39:10 20

administered in one large dose rather than smaller doses 09:39:12 21

with an interval between them successfully treated 09:39:16 22

infections without patients experiencing muscle toxicity, 09:39:19 23

skeletal muscle toxicity. So that invention resulted in the 09:39:26 24

claims of these two patents.09:39:31 25

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If we go to Slide 5, the asserted claims of the 09:39:35 1

'689 patent focus on methods of dosing daptomycin once every 09:39:39 2

48 hours. It's administered to patients with renal 09:39:44 3

impairment at expanded dosing intervals.09:39:48 4

This new dosing interval was developed by 09:39:51 5

Cubist. It allowed Cubist to get Cubisic approved about 09:39:53 6

2003. It has been used to treat literally hundreds of 09:39:57 7

thousands of patients.09:40:02 8

The last set, Slide No. 6, the last set of 09:40:03 9

patents is the most recent, is the high-purity patents.09:40:08 10

Let me say one thing. I am sure this is 09:40:11 11

something Mr. Hurst and I will work out. These two patents 09:40:13 12

were not before the Court the last time. There are a lot of 09:40:17 13

asserted claims at this moment in time. That's because the 09:40:21 14

question of infringement is dependent upon their 09:40:24 15

manufacturing process, processes. That's something that we 09:40:27 16

will get worked out during the course of discovery. 09:40:31 17

So I don't want the Court to think that we 09:40:34 18

intend to go to trial on all of these. This is just a 09:40:36 19

question of, unlike the first patent, the first three, where 09:40:39 20

there has been a lot of discovery in the prior case which 09:40:42 21

they have available to them, it is easier for us to focus on 09:40:44 22

the asserted claims. This is something that will become 09:40:47 23

clear during the course of discovery, and, most importantly, 09:40:50 24

the number of asserted claims doesn't implicate what we put 09:40:54 25

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before Your Honor.09:40:57 1

These patents result from work done by Cubist in 09:40:58 2

1999 and 2000. Their work, Your Honor, was to get ready to 09:41:02 3

have a clinical product that could be approved by the FDA. 09:41:08 4

They are trying to purify the daptomycin so it is as pure as 09:41:14 5

possible.09:41:17 6

Another group of Cubist scientists discovered 09:41:18 7

that daptomycin actually, under certain conditions, acidic 09:41:20 8

conditions, as described in the specification, formed 09:41:25 9

aggregates or micelles is the word in the patent, and those 09:41:27 10

collections, those aggregations, affected the purity of the 09:41:33 11

daptomycin. Those scientists discovered, as described in 09:41:37 12

the specification, that under non-acidic conditions, those 09:41:41 13

clusters break out.09:41:44 14

Based upon that discovery, Your Honor, Cubist's 09:41:46 15

scientists developed new processes used to remove those 09:41:50 16

impurities to prevent that aggregation or those micelles. 09:41:53 17

That allowed for purification of larger batches and 09:41:56 18

commercial scale production.09:42:02 19

The '238 patent, which is on the screen, covers 09:42:03 20

a composition of high-purity daptomycin. And on Slide 7, 09:42:06 21

the '342 patent is the process of obtaining that highly pure 09:42:11 22

composition of daptomycin.09:42:17 23

If I go to Slide 8, Your Honor, this may be, at 09:42:19 24

least for me, the most important point, and the point of 09:42:23 25

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divergence between Mr. Hurst and me.09:42:28 1

There are examples, as the Court knows, of 09:42:32 2

daptomycin and how it's produced by fermentation, filtering, 09:42:34 3

a natural product. They are throughout all five of the 09:42:39 4

patents. There are examples of daptomycin being used, an 09:42:42 5

effective antibiotic in in vivo testing and then clinically 09:42:47 6

administered to human beings.09:42:52 7

For today's purposes, on claim interpretation, 09:42:55 8

our claim interpretation of the two terms covers all of the 09:42:58 9

disclosed embodiments that describe how the compound is 09:43:03 10

made. Our claim interpretation covers all of the disclosed 09:43:08 11

embodiments that describe how it was administered 09:43:12 12

successfully to patients.09:43:15 13

Hospira's two claim interpretations cover none 09:43:17 14

of them. Their claim interpretation would cover none of the 09:43:20 15

examples that show how their product is made because we 09:43:24 16

agree -- and this has been less contentious than some other 09:43:28 17

cases -- we agree that there is no evidence that the L 09:43:33 18

version can be produced naturally by fermentation. We also 09:43:36 19

agree that the L version is ten times less potent, that's 09:43:41 20

described in the Miao paper. It is part of the intrinsic 09:43:46 21

record. 09:43:50 22

I think if we focus on one key fact or one key 09:43:52 23

set of facts, it is going to be this: The claim 09:43:55 24

interpretation that they propose will not cover the 09:43:58 25

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disclosed embodiments, period. The claim interpretation, as 09:44:01 1

we disclose, will cover all of them.09:44:03 2

So if I go to Slide No. 10, and I go to compound 09:44:06 3

of Formula 3 or Formula 3 compound, what I have put on the 09:44:11 4

screen now, Your Honor, is just the competing claim 09:44:16 5

interpretations, the term, ours, and Hospira's.09:44:19 6

If I go to Slide 11, I think we correctly 09:44:30 7

capture the dispute. Setting aside the question of the 09:44:35 8

attack on the certificate of correction, which I will come 09:44:41 9

to in a few minutes, the question is should these Formula 3 09:44:44 10

claim limitations be construed with the express definition 09:44:47 11

of Formula 3 that is set forth in the claims as corrected, 09:44:51 12

or should they be construed, as Hospira does, as they read 09:44:54 13

before the certificate of correction.09:44:59 14

That is the dispute. 09:45:03 15

So now if I go to Slide 12, Your Honor, on the 09:45:04 16

left-hand side of Slide 12 is Column 21, Line 41 to Column 09:45:09 17

22, Line 39, Slide 12 of the reissued patent. So on the 09:45:16 18

left-hand side, we have Claim 26. On the right-hand side, 09:45:25 19

we have our proposed construction. We have highlighted the 09:45:29 20

D-Asparagine, which is the source of the dispute. But as 09:45:36 21

corrected, this is how the claim reads. And our claim 09:45:42 22

interpretation has exactly that structure.09:45:45 23

The dispute between us, Your Honor, if I go to 09:45:50 24

Slide 13 now, arises from this concept called 09:45:52 25

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stereochemistry. There is no real dispute between us. 09:45:57 1

There are two stereochemical forms. We have depicted on the 09:46:01 2

right-hand side showing the two as mirror images. The 09:46:06 3

Hospira brief has two hands showing them as mirror images. 09:46:11 4

We agree upon what stereochemistry is.09:46:15 5

As the record demonstrates, when first claimed, 09:46:20 6

it was described as the L-Asparagine. In the mid-1980's, 09:46:28 7

when Lilly scientists first determined the chemical 09:46:34 8

structure -- and I think it's important, Your Honor, when 09:46:37 9

you look at the specification, the specification describes 09:46:39 10

the process by which it's obtained. And we all agree that 09:46:42 11

what is obtained from it is the D version. It describes the 09:46:48 12

method which is used successfully. We all agree that is the 09:46:51 13

D version.09:46:54 14

But using the technology that was available at 09:46:55 15

the time, it was described as having the L rather than the 09:46:58 16

D. 09:47:03 17

Now, be careful, because I am going to move now 09:47:04 18

to the small part of the extrinsic evidence we both offered 09:47:07 19

Your Honor. We have offered a declaration that says if you 09:47:10 20

go back to this point in time more than two decades ago, the 09:47:14 21

manner in which you could characterize these isomers was not 09:47:18 22

as robust as it is today. And they did the best they could. 09:47:22 23

But they got it wrong. And there was actually D rather than 09:47:27 24

L. And what happened is, when it was discovered, it was 09:47:33 25

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corrected.09:47:39 1

If I go to Slide 14, this is from the 09:47:40 2

specification of the patent as corrected. On the left-hand 09:47:44 3

side is Column 7, Lines 1 to 26. On the right-hand side, 09:47:51 4

most importantly, is the certificate of correction which 09:47:56 5

makes the correction changing the L to the D.09:47:59 6

On Slide 15, Your Honor, is also a portion of 09:48:05 7

the reissue file history that is shown on the right, which 09:48:10 8

says J.A. 365. It is specifically the correction. 09:48:16 9

What happened, Your Honor, as demonstrated by 09:48:20 10

the intrinsic record before you, is in 2007, well before the 09:48:22 11

dispute between Hospira and Cubist was joined, Cubist 09:48:27 12

submitted a request for a certificate of correction to the 09:48:31 13

PTO to change the stereochemistry from that which was cited 09:48:34 14

in the patent to the D configuration. On January 29, 2008, 09:48:39 15

the Patent Office issued the certificates before you now, 09:48:44 16

changing all instances of the L to the D.09:48:48 17

On Slide 16, Your Honor, this is part of the 09:48:56 18

intrinsic record. I think we may disagree on this. But the 09:49:00 19

intrinsic record on the reissue includes the Miao paper, 09:49:04 20

which we both referred you to. The Miao paper, which is 09:49:13 21

much later, describes the discovery of using more robust 09:49:16 22

technologies to characterize that say, no, no, no. It's not 09:49:19 23

L. It's D. 09:49:24 24

So that paper was actually before the Patent 09:49:25 25

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Office at the time that they decided to issue the 09:49:27 1

certificate of correction.09:49:29 2

If I could go to Slide 17. 09:49:32 3

The reissue prosecution includes the Miao 09:49:37 4

publication, as I said, the Miao publication reporting the 09:49:42 5

scientific experiments that confirm the D-Asparagine. And 09:49:45 6

it also demonstrates, Your Honor, that the Miao paper relied 09:49:50 7

upon more modern methods, for lack of a better descriptor, 09:49:53 8

to characterize what had been characterized before 09:49:59 9

incorrectly. 09:50:03 10

THE COURT: Mr. Lee, let me ask a question of 09:50:04 11

both you and Mr. Hurst. Is this one of those occasions 09:50:06 12

where it might make sense for the Judge to deviate from his 09:50:09 13

or her prior practice? What I have in mind specifically is, 09:50:12 14

I am wondering, as I listen, whether engaging Judge 09:50:18 15

Robinson's practice of handling constructions and summary 09:50:22 16

judgment at the same time might benefit the parties in this 09:50:27 17

case. I don't know. I am just throwing that out.09:50:30 18

MR. LEE: Your Honor, I think not. Let me give 09:50:33 19

you the reason why. The Court may agree or disagree.09:50:38 20

I think, Your Honor, if we ask the Court to take 09:50:40 21

a look at the New Mexico decision that we cite, I think at 09:50:43 22

Page 9 of our brief, what you will see is 255, which governs 09:50:47 23

the certificate of correction, specifically ties the test to 09:50:52 24

new matter. The New Mexico case, which is written by Judge 09:50:56 25

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Lourie, actually is a new matter case. It is not a 255 09:51:01 1

case. But it is discussing the specific concept that's 09:51:04 2

described in Section 255.09:51:07 3

What happens at that point -- it's actually 09:51:12 4

quite a lengthy discussion. What it says is this, and I 09:51:15 5

think it's -- to give you the bottom line, Your Honor, I 09:51:19 6

think there will be evidence to be taken on how one of 09:51:22 7

ordinary skill in the art reviews the record as a whole. If 09:51:24 8

Your Honor wanted to take that before trial, it's possible. 09:51:29 9

I think it would be better in the context of the whole 09:51:34 10

trial. But I think you can only make that determination on 09:51:37 11

the basis of that record. 09:51:40 12

Let me make two points about the New Mexico 09:51:41 13

decision. 09:51:43 14

One is what the New Mexico decision says. The 09:51:44 15

New Mexico decision, Your Honor, was a case where the 09:51:47 16

chemical structure in the specification was incorrect. And 09:51:49 17

they went to correct the specification. And the other side 09:51:53 18

said, no, no. It's new matter, the same words referred to 09:51:57 19

in Section 255. Judge Lourie said, No, look: The chemical 09:52:01 20

structure is just words to describe the compound. The 09:52:06 21

depiction is just depictions that describe the compound. 09:52:10 22

The invention is the compound.09:52:15 23

Here, Your Honor, the invention is the 09:52:16 24

daptomycin. There are different ways to describe it. And 09:52:19 25

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the description back in the reissue patent with L-Asparagine 09:52:23 1

was incorrect, but it doesn't change what the compound is. 09:52:28 2

That is the key dispute between us.09:52:31 3

That's important for two reasons. The analogy, 09:52:34 4

Your Honor, that I thought about as a non-scientist is this. 09:52:37 5

It is as if, you know, I invented a genetically engineered 09:52:40 6

dog, and I came up with a genetically engineered dog, and I 09:52:45 7

am going to claim the dog. What I do is try to take a 09:52:49 8

picture of it as it is flying around the lab. The best I 09:52:52 9

can do with the technology is I capture it, you can see it, 09:52:57 10

it's got a head and a tail, but you can only see three legs. 09:53:00 11

Years later, I can get a better picture of the 09:53:04 12

dog and I can capture the four legs, the length of the tail 09:53:07 13

and the head, but it's still the dog. And that is what 09:53:10 14

Judge Lourie is saying. Judge Lourie is saying that when 09:53:13 15

you have a new compound -- Your Honor, one thing that is 09:53:17 16

important here is, for 20 years back, until we got to your 09:53:20 17

courtroom today, no one has claimed any confusion about what 09:53:25 18

daptomycin is. They knew it was a natural product that 09:53:28 19

resulted from fermentation and has been used to treat 09:53:31 20

millions of patients. There has been no confusion. 09:53:35 21

That means, Your Honor, if you read the New 09:53:37 22

Mexico case -- and I think if we get to briefing it Your 09:53:39 23

Honor will see there is a whole body of law built around 09:53:43 24

this concept of new matter -- the question then becomes, 09:53:45 25

18

take a person of ordinary skill in the art. And I actually 09:53:48 1

think there may be a disagreement on that which will become 09:53:51 2

a factual matter. Then that person of ordinary skill in the 09:53:54 3

art has to look at this specification and all that comes 09:53:57 4

with it. And that only applies to this one claim of 09:54:00 5

stereochemistry. And say, okay, would one of ordinary skill 09:54:05 6

in the art have concluded, have understood that what was 09:54:08 7

claimed was daptomycin, the natural product from 09:54:13 8

fermentation used to treat patients successfully, or would 09:54:17 9

they understand it to be the L-Asparagine version that was 09:54:22 10

never made naturally, never by fermentation? I think you 09:54:26 11

are going to see a lot of facts to resolve that.09:54:28 12

For sure, Your Honor, I would be less than 09:54:33 13

candid if I didn't say there are cases that resolve the 09:54:35 14

certificate of correction issue on summary judgment. I 09:54:40 15

think you will see that those cases cited by Hospira are 09:54:42 16

cases where the claim is broader, where you go from, for 09:54:44 17

instance, the requirement of multiple rear walls to one or 09:54:50 18

more. So it is clearly covering the same plus more.09:54:58 19

We can't find a case, I would love to have one 09:55:02 20

our way, we can't find a case where the fight is between not 09:55:04 21

broadening the claim but just saying tell us something will 09:55:10 22

be different.09:55:12 23

I think we would argue that the Court will have 09:55:12 24

more facts before it and be able to consider the issue if at 09:55:14 25

19

the time -- I don't think it is going take a huge amount of 09:55:18 1

the trial time. But to put it in context, the Court will be 09:55:22 2

in a better decision to decide if they are correct or we are 09:55:26 3

correct. 09:55:30 4

THE COURT: Mr. Hurst, I will give a chance to 09:55:30 5

react in your time.09:55:33 6

MR. LEE: I think Mr. Hurst will agree with me.09:55:34 7

This question of correction of a minor 09:55:37 8

character, the law is not particularly well developed. I 09:55:39 9

don't think we can cite you a Federal Circuit case dealing 09:55:43 10

with it on claim construction. I am not sure we can cite a 09:55:46 11

case for you that deals with this Compound A versus Compound 09:55:50 12

B. 09:55:54 13

They cited cases by analogy to other portions of 09:55:54 14

255. We have cited New Mexico. We would ask the Court to 09:55:58 15

take a look at that case. I think, really, Judge Lourie's 09:56:02 16

articulation of this issue, I think, is illuminating and it 09:56:06 17

really -- it may be counterintuitive to the layperson like 09:56:12 18

me who looks and sees, that's what's described. He said, 09:56:17 19

no, no, no. What you have invented is the compound just 09:56:21 20

using the existing technology. You happened to have gotten 09:56:24 21

the description wrong. 09:56:28 22

The interesting thing in New Mexico, Your Honor, 09:56:29 23

which is, like this case, what happened was someone took the 09:56:31 24

process that was described in the New Mexico patent and 09:56:34 25

20

later performed the process and got to the right chemical 09:56:37 1

description. So what we have here is a situation where 09:56:41 2

later daptomycin was produced naturally by fermentation, 09:56:46 3

someone in the Miao paper described it using new technology, 09:56:52 4

or later developed technology to characterize it, and that's 09:56:58 5

what led to the characterization.09:57:02 6

So there is a real parallel here. 09:57:04 7

THE COURT: Thank you. 09:57:06 8

MR. LEE: I know we disagree. 09:57:07 9

If I go to Slide 18, Your Honor, I think, for 09:57:10 10

today's purposes, the law in 255 says you have to take the 09:57:15 11

patent with the certificate of correction and you treat it 09:57:21 12

as if it was part of the original patent.09:57:24 13

Now, I want to deal with one argument, which is 09:57:28 14

Hospira's first argument, which is that one of ordinary 09:57:30 15

skill in the art just wouldn't believe the certificate of 09:57:33 16

correction. I don't think honestly the Court can do that on 09:57:36 17

claim construction. I don't think you would be able to do 09:57:39 18

it on summary judgment, the idea that the Patent Office has 09:57:42 19

actually applied the 255 standard and made a correction, the 09:57:47 20

mere fact of disbelief is not supported and I don't think 09:57:51 21

ultimately relevant.09:57:57 22

I think what is relevant is how the person of 09:57:59 23

ordinary skill in the art, how they define this, review the 09:58:02 24

whole record and whether they would think it was a 09:58:06 25

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21

correction of minor character given this claim.09:58:09 1

So if I go to Slide 19, this -- Your Honor, I 09:58:12 2

will do this briefly. If Your Honor wants to hear more...09:58:16 3

As we said in our brief, we think that this 09:58:19 4

effort to invalidate the certificate of correction is a 09:58:22 5

summary judgment issue. All the cases Hospira cites, as I 09:58:25 6

said, are summary judgment cases on a more developed record.09:58:28 7

While the question may ultimately be a question 09:58:33 8

of law, to be more precise in my answer to Your Honor's 09:58:35 9

question, it's one of those questions of law that is going 09:58:40 10

to be dependent, in our view, upon facts that Your Honor is 09:58:43 11

going to have to decide.09:58:45 12

It's not a question exactly like Markman. It's 09:58:47 13

something closer to obviousness, where Your Honor makes the 09:58:50 14

ultimate determination. But there are facts from the 09:58:54 15

perspective of one of ordinary skill in the art that Your 09:58:57 16

Honor has to consider. And some of them, I think Your Honor 09:59:01 17

can see the dispute between us, you can resolve on the 09:59:05 18

intrinsic record. Some of them you are going to have to 09:59:07 19

resolve on the extrinsic record. That's why I think that 09:59:10 20

having people in the box being cross-examined is going to 09:59:14 21

educate that process.09:59:16 22

This is really different, as I said, from the 09:59:19 23

Superior Fireplace case. That is the case where you went 09:59:24 24

from rear walls, multiple rear walls to a rear wall or more. 09:59:27 25

22

So you have expanded the claim. 09:59:33 1

The other case that they cite, the Advanced 09:59:36 2

Technologies case, also is a case where the effect was to 09:59:38 3

expand the range. There is nothing like this case where, as 09:59:42 4

they claim, we have claimed the wrong drug. We say we 09:59:45 5

claimed the right drug.09:59:49 6

Again, I come back, Your Honor, the type of 09:59:51 7

factual question that Your Honor will have to resolve is, 09:59:54 8

how would one of ordinary skill in the art who read these 09:59:57 9

patents, would they in fact have read it to cover a compound 10:00:00 10

that wouldn't cover any other disclosed embodiments? That 10:00:04 11

will be the cross-examination for their folks. Is that a 10:00:08 12

reasonable reading of the claim?10:00:11 13

Your Honor, I am not going to address the merits 10:00:17 14

of the certificate of correction. 10:00:20 15

If I could go to Slide 20, this now goes to the 10:00:22 16

four other patents. Let me say three things by way of 10:00:26 17

introduction, Your Honor.10:00:30 18

The four other patents do not claim 10:00:32 19

stereochemistry in the claims. So the reissue patent for 10:00:35 20

sure has the diagram which we have corrected. The other 10:00:38 21

four never claim the stereochemistry in the claims.10:00:43 22

In fact, Your Honor, maybe the best indication 10:00:48 23

of that is, if we had claimed it, as they are now suggesting 10:00:51 24

we had, it really would have not been very commonsensical 10:00:55 25

23

for us to go back to the Patent Office and correct one but 10:00:59 1

not correct the other four. What happened is these other 10:01:02 2

four don't claim the stereochemistry.10:01:05 3

The second thing, Your Honor, is we both agree 10:01:10 4

that daptomycin should have the same meaning among the four 10:01:13 5

different patents. The specifications differ some. But we 10:01:16 6

have each proposed a definition that is for daptomycin.10:01:21 7

So Cubist's proposal is on the left, and 10:01:25 8

Hospira's is on the right.10:01:29 9

If I could approach the screen, Your Honor? 10:01:31 10

THE COURT: Certainly. 10:01:33 11

MR. LEE: If I focus, Your Honor, on this 10:01:34 12

diagram, which is in our claim construction, this is Figure 10:01:39 13

1 in the high-purity patents. That's right in front of the 10:01:44 14

Court, that we agree it should have the same meaning. This 10:01:50 15

is right out of the patents. This Your Honor has seen 10:01:53 16

before from the reissue. It is in an article cited in the 10:01:55 17

patents, but it is not explicitly in the patents themselves, 10:01:58 18

but there are articles for sure which I will come to.10:02:01 19

The third thing I would say is this, Your Honor: 10:02:05 20

There is a lot of briefing about the purporting of ours that 10:02:07 21

says it's the cyclic lipopeptide antibiotic derived from...10:02:10 22

It would be also correct, we think, if Your 10:02:17 23

Honor put in the words that the cyclic lipopeptide 10:02:19 24

antibiotic that can be derived from rather than saying it 10:02:24 25

24

has to be. What we are trying to capture there is the 10:02:26 1

following. That diagram in the middle, which is from Figure 10:02:29 2

1, is something which is only naturally created. And the 10:02:37 3

diagram on the right-hand side, Your Honor, which is their 10:02:43 4

interpretation, that diagram is, as far as the record shows, 10:02:48 5

I think both of us have done the best we can to figure out 10:02:54 6

what is accurate, it's only synthetically clear. You are 10:02:57 7

never going to have a fermentation process in filtering that 10:03:02 8

gets you that.10:03:05 9

So I think this just may have been a source of 10:03:06 10

our being two ships passing in the night. We are not 10:03:09 11

suggesting that it has to be produced by this precise 10:03:13 12

process. We trying to capture the idea that this is a 10:03:16 13

lipopeptide antibiotic that can be derived this way because 10:03:21 14

that then excludes those that can't be disclosed with what 10:03:28 15

the specification would teach you.10:03:33 16

The middle panel, Your Honor, describes Cubisin. 10:03:34 17

It describes the product that resulted from the 10:03:39 18

specification. It describes the product that was 10:03:42 19

administered to patients. It describes the product that was 10:03:46 20

used to come up with the invention for patenting. The 10:03:48 21

right-hand panel describes a compound that was not used, 10:03:53 22

that did not result from any of the disclosed embodiments, 10:03:56 23

was not used in any of the disclosed testing with the 10:03:59 24

patients.10:04:03 25

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25

So I go to Slide 21. Your Honor, this is, 10:04:04 1

really, the dispute: For these four patents, for claims 10:04:08 2

that don't reference stereochemistry, is Cubist's, is our 10:04:14 3

interpretation which goes to Figure 1 from the high-purity 10:04:20 4

patents correct, or is reference to a diagram related to a 10:04:24 5

stereochemistry in an article that is cited to incorporate 10:04:28 6

the right interpretation? 10:04:32 7

So I go to Slide 22, Your Honor. What I will 10:04:33 8

try to do for the dosing and high-purity patents is very 10:04:37 9

quickly move through the claims, the specifications, the 10:04:41 10

file history, to show, I hope, or at least argue that what's 10:04:43 11

in the claims, the specification, and the file history all 10:04:49 12

cover embodiments that would not be covered by their 10:04:52 13

interpretation. It would be covered by ours.10:04:59 14

So for the dosing patents, I put Claim 1 on the 10:05:02 15

screen, Your Honor. Two important points. The claims say 10:05:05 16

nothing about stereochemistry. If you compare this to the 10:05:09 17

reissue patent, it has the diagram where you see the L- or 10:05:13 18

D-Asparagine. There is nothing in the claim about it. 10:05:17 19

Instead, it talks about administering something to a patient 10:05:19 20

that is therapeutically effective. So the claims are 10:05:26 21

referring to a clinical product. And that clinical product 10:05:28 22

has to be therapeutically effective for a human being.10:05:32 23

The compound that's described in our claim 10:05:39 24

interpretation would be therapeutically effective, can be 10:05:41 25

26

administered to the human being, it can solve the problem 10:05:46 1

that daptomycin is intended to solve.10:05:50 2

Their claim interpretation, the L-Asparagine, 10:05:54 3

wouldn't do this. 10:05:57 4

If I go to Slide 23, this is the high-purity 10:05:59 5

patent, Your Honor. So I am going to the other two patents 10:06:04 6

and to the claims themselves. What's on the screen at Claim 10:06:06 7

23 is Claim 66. Two points again. Again, there is no 10:06:12 8

reference to stereochemistry in the claims. Second, Your 10:06:20 9

Honor, this dependent claim specifically refers to the 10:06:25 10

production of daptomycin by the fermentation process 10:06:30 11

involving Streptomyces roseosporus.10:06:34 12

And it goes on with a series of steps.10:06:37 13

So the dispute before Your Honor is on this 10:06:40 14

claim. We have a claim interpretation that would have this 10:06:43 15

claim make sense, if you follow this series of steps, you 10:06:48 16

get daptomycin as we have described it, if you follow this 10:06:52 17

series of steps, you would not get what Hospira describes as 10:06:55 18

daptomycin. So the claims themselves support the 10:07:02 19

proposition that our claim interpretation is correct.10:07:05 20

If I go to Slide 24, Your Honor, the 10:07:10 21

specification also support our claim interpretation. On the 10:07:15 22

left-hand side is our claim interpretation. On the 10:07:20 23

right-hand side is a portion of the specification that 10:07:23 24

refers to daptomycin being derived from the fermentation of 10:07:27 25

27

Streptomyces roseosporus. It says what it's composed of. 10:07:32 1

And it does refer to Figure 1A of the Baltz paper, which I 10:07:37 2

am going to come back to.10:07:41 3

But again, our claim interpretation would cover 10:07:43 4

daptomycin produced by fermentation. Theirs would not.10:07:50 5

If I go to the next slide, the examples in the 10:07:55 6

dosing patents -- I apologize. I have gone through the 10:08:00 7

claims of the dosing and the claims of the high purity. I 10:08:03 8

am now going to do the specification dosing, the 10:08:06 9

specification of the high purity, but only because the claim 10:08:09 10

term is going to have just one meaning.10:08:12 11

The dosing patents specifically describe the 10:08:14 12

administration of daptomycin to adults with what's called 10:08:19 13

serious gram-positive bacteremia. This is one of the 10:08:24 14

reasons that the product has been an enormous success.10:08:29 15

The example then goes on to report, Your Honor, 10:08:33 16

the dose amount and dosing intervals that would be safe and 10:08:35 17

effective for the patient.10:08:38 18

Again, our claim interpretation would cover the 10:08:40 19

product that's described in Example 4. Their claim 10:08:44 20

interpretation would not cover the product that's described 10:08:47 21

in Figure 4.10:08:50 22

If I could go to Slide 26, still within the 10:08:53 23

dosing patents, it's the same issue. The dosing patents 10:08:57 24

really are how do you give this to a human being and avoid 10:09:01 25

28

skeletal muscle toxicity? 10:09:04 1

These embodiments, again, are embodiments that 10:09:06 2

demonstrate that the purpose is to give this compound, 10:09:12 3

daptomycin, to a patient. And again, the same issue: Our 10:09:14 4

construction covers this disclosed example. Theirs does 10:09:18 5

not.10:09:22 6

Let me pause, Your Honor, before I move to the 10:09:23 7

next slide, because I think a fundamental dispute between us 10:09:25 8

is, is one of ordinary skill in the art going to read the 10:09:28 9

specification as a whole and have in mind what is the 10:09:31 10

compound, as Judge Lourie would put it, or are they just 10:09:35 11

going to look at one diagram and say, well, that diagram, 10:09:38 12

even though it conflicts with everything else that is 10:09:41 13

described, am I going to rely upon that?10:09:43 14

We believe that you read the specification as a 10:09:46 15

whole, and you read references that are incorporated by 10:09:49 16

reference as a whole, which brings me to Slide 27.10:09:52 17

A substantial portion of Hospira's argument is 10:10:00 18

based upon two articles written by Baltz and Tally. The 10:10:03 19

argument is that because these articles -- one is a book and 10:10:08 20

one is a review article -- because they contain the 10:10:15 21

erroneous stereochemistry, that is the way the claim terms 10:10:18 22

should be highlighted.10:10:21 23

Again, Your Honor, the person of ordinary skill 10:10:23 24

in the art who is going to read the specification as a 10:10:25 25

04/15/2013 04:59:57 AM Page 29 to 32 of 70 8 of 29 sheets

29

whole, they are also going to read Baltz and Tally as a 10:10:29 1

whole. What they are going to realize if they read Baltz 10:10:32 2

and Tally as a whole is both of them have the type of 10:10:37 3

information you have in the specification, how was the 10:10:40 4

product discovered, how was it produced, it's naturally 10:10:42 5

occurring, it comes from fermentation, it's been used to 10:10:46 6

treat patients.10:10:48 7

So I go to Slide 28, Your Honor. On the left is 10:10:49 8

the Baltz publication. It is actually a book chapter. What 10:10:53 9

it is is it is reviewing research on daptomycin. On the 10:10:57 10

right is the Tally publication. It's a review paper.10:11:02 11

Now, Hospira emphasizes that these articles are 10:11:07 12

intrinsic evidence because they are cited in the 10:11:11 13

specification. We don't disagree. They are part of the 10:11:13 14

record. The question is: How would one of ordinary skill 10:11:17 15

in the art read them? Would they read them by focusing on 10:11:21 16

the one figure they focus on, or would they also read all of 10:11:24 17

the portions of the specification that describe producing it 10:11:29 18

by fermentation, filtering it, using it to treat, 10:11:34 19

successfully treat patients. We suggest it is the latter.10:11:39 20

If I go to Slide 29, Your Honor, this is a quote 10:11:43 21

from the Baltz publication. This is what we believe one of 10:11:48 22

ordinary skill in the art would have also -- we are not 10:11:54 23

saying they wouldn't have considered what they say. We are 10:11:57 24

saying there is more to it when read in its entirety. And 10:11:59 25

30

Baltz reported that it was highly active against 10:12:03 1

gram-positive bacteria. That is pretty important. 10:12:08 2

Your Honor, daptomycin, as we have described it, 10:12:11 3

with the D-Asparagine, is highly active against 10:12:15 4

gram-positive bacteria. The erroneously described 10:12:18 5

L-Asparagine is not.10:12:22 6

So even if you take their argument, which is, 10:12:25 7

this part of the intrinsic record incorporated, the very 10:12:27 8

example, it's called daptomycin biosynthesis, would be 10:12:30 9

covered by our claim interpretation but not by theirs.10:12:34 10

So, too, in Baltz for clinical studies. It 10:12:38 11

talks about it being well tolerated in human beings. That 10:12:40 12

wasn't the L version. That was the D version. And if the 10:12:44 13

Court considers the entire article, I think that what you 10:12:50 14

will see is that the report that's being made here is, there 10:12:53 15

is the invention of this compound, and the way you 10:12:57 16

administer it to patients and it's a big deal. It has 10:13:00 17

allowed us to come up with a treatment of bacteria that 10:13:03 18

simply didn't exist before that can be taken intravenously. 10:13:06 19

That is the significant portion of what one of ordinary 10:13:10 20

skill in the art would get. 10:13:13 21

For the dosing patents, Your Honor, the person 10:13:14 22

of ordinary skill in the art is the person who is doing the 10:13:16 23

dosing. So it is probably somewhat closer to someone with 10:13:19 24

experience in administering to patients.10:13:23 25

31

If I go to Slide 30, this is from Tally, Your 10:13:27 1

Honor, it's the same thing. Tally, in addition to what Mr. 10:13:30 2

Hurst has cited, Tally specifically talks about two things. 10:13:35 3

It talks about how daptomycin is derived. Again, this 10:13:40 4

description, Your Honor, can only result in that which we 10:13:45 5

have described to you.10:13:48 6

The Tally article also describes the clinical 10:13:50 7

efficacy in human beings. Again, it's the only thing that 10:13:53 8

nobody could do that before we described how, not what they 10:14:00 9

described.10:14:02 10

If I go to Slide 31, Your Honor, I am now moving 10:14:03 11

to the specifications of the high-purity patents. This is a 10:14:10 12

side-by-side comparison of the claim construction we propose 10:14:13 13

and the portion of the specification of the high-purity 10:14:16 14

patents.10:14:20 15

You will see that our focus on the left-hand 10:14:21 16

side is Figure 1 -- I am sorry, is the chemical structure 10:14:24 17

depicted in two dimensions, and on the right-hand side that 10:14:30 18

identical structure is Figure 1 of the patent.10:14:37 19

So our claim construction has the benefit of 10:14:40 20

three things. The diagram is right out of the patents. 10:14:42 21

There has been no correction to it. That's the diagram. 10:14:47 22

The second thing is, that diagram would be a compound that 10:14:50 23

could be used for all of the examples of how the product was 10:14:54 24

made. And it is the compound that could be used to treat 10:14:58 25

32

effectively humans as described in the specification.10:15:01 1

If I go to Slide 32, this is the high-purity 10:15:07 2

patents, Your Honor. And they specifically describe Figure 10:15:12 3

1 as the product which is an antibiotic that can be 10:15:16 4

pharmaceutically acceptable.10:15:22 5

If I go to Slide 33, in the high-purity patents, 10:15:26 6

again, example after example of how they are produced. Our 10:15:31 7

claim interpretation would cover a compound that's produced 10:15:37 8

in this way. None of the examples would produce a compound 10:15:41 9

that's produced the way Hospira describes.10:15:47 10

If I could go to Slide 34, it's more of the 10:15:50 11

same. It's describing the production of fermentation, the 10:15:55 12

same issue, whose claim interpretation covers the disclosed 10:15:59 13

examples.10:16:02 14

Then, Your Honor, if I go to Slide 35, this is 10:16:05 15

from the file history of the dosing patents. I have now 10:16:09 16

skipped back to the dosing patents. And Your Honor will 10:16:12 17

find there a declaration from Dr. Tally, who is one of the 10:16:15 18

two lead inventors on the discovery that has made this 10:16:18 19

available. Dr. Tally has passed away, so the only thing we 10:16:25 20

have is his declaration. He actually describes how they 10:16:27 21

discovered the key to unlocking the problem that had caused 10:16:32 22

things to come to a stop, and that is the skeletal muscle 10:16:38 23

toxicity problem.10:16:41 24

Your Honor will see that in that description 10:16:42 25

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33

there is not a word about stereochemistry. It's all talking 10:16:44 1

about this fermentation product. It's all talking about 10:16:47 2

this fermentation product being administered to patients 10:16:51 3

having a problem, discovering that dosing and dosing the 10:16:55 4

amounts in intervals and resulting in the administration of 10:17:01 5

a compound daptomycin that was safe and effective for 10:17:05 6

patients.10:17:11 7

If I go to Slide 36, in the high-purity patents, 10:17:13 8

Your Honor, the Patent Office actually had before it the 10:17:17 9

Miao paper, the paper that said, the characterization of 10:17:24 10

stereochemistry, the opposite was incorrect. Here is the 10:17:29 11

correct stereochemistry. The examiner had the Miao paper, 10:17:34 12

the examiner reviewed the Miao paper. If the claims had 10:17:37 13

something in there about stereochemistry, which they don't, 10:17:42 14

and the examiner thought there was something in the Miao 10:17:47 15

paper that implicated the claims, you would have read 10:17:50 16

something about it. But there is nothing.10:17:53 17

Instead, what the examiner focused upon was 10:17:55 18

daptomycin, which is produced as the fermentation product 10:17:59 19

and can be used to successfully treat patients.10:18:02 20

Now, just a couple of other points, and then I 10:18:07 21

will yield the floor to Mr. Hurst.10:18:10 22

If I can go to Slide 37. 10:18:13 23

First, and I said this at the outset, we are not 10:18:17 24

trying to import a process limitation in. We are trying to 10:18:19 25

34

draw this distinction, Your Honor. The record before the 10:18:22 1

Court, and I think the facts as both Hospira and we know 10:18:25 2

them, is the L-Asparagine version is not a naturally 10:18:28 3

occurring product that can be produced by the fermentation 10:18:32 4

process. That is why the source becomes important. In some 10:18:35 5

sense, if Your Honor uses the figure, Figure 1, to describe 10:18:42 6

it, in our claim construction, that's the key, because as 10:18:46 7

the record is before the Court, that can only result from 10:18:51 8

the fermentation process. But we are not saying that it is 10:18:56 9

required. I think this is a place where we may have been 10:18:58 10

just ships passing in the night. It can be, which is 10:19:01 11

critical, because theirs, Your Honor, the L version, it 10:19:03 12

cannot be. It cannot be.10:19:06 13

And all of the disclosed methods in all four of 10:19:09 14

the patents, Your Honor, are methods that result in our 10:19:14 15

compound but not theirs.10:19:19 16

So if I go to Slide No. 38, I think this just 10:19:20 17

makes the point that the focus is the figure. We are trying 10:19:29 18

to draw the distinction between a product that can be made 10:19:35 19

by fermentation. We are not trying to import the 10:19:38 20

L-Asparagine structure into the claim. We are not asking 10:19:45 21

Your Honor to correct the claim. We know we have to go back 10:19:48 22

to the Patent Office as we did at one time for that to 10:19:51 23

happen. And, critically important is this Miao paper, which 10:19:54 24

is a big focus for them now, was before the Patent Office 10:19:56 25

35

and the Patent Office never suggested that caused a problem 10:20:01 1

with the claims. 10:20:04 2

Lastly, Your Honor, our last slide, Slide 39, at 10:20:04 3

least for me, this sort of captures the dispute between us. 10:20:09 4

We talked about this claim a little earlier, Claim 66. If 10:20:13 5

you take Hospira's argument, the claim is inoperative, 10:20:19 6

because the L version could be daptomycin in the second Line 10:20:23 7

of Claim 66, but it can't be made this way. So the claim 10:20:27 8

just wouldn't work.10:20:31 9

If you take our definition, which is Figure 1, 10:20:33 10

daptomycin can be made by the six steps described there. In 10:20:38 11

fact, Your Honor, those six steps are what is described in 10:20:42 12

the specification. So you are given one claim 10:20:45 13

interpretation that would render a claim inoperative. You 10:20:47 14

are given another which would kind of make complete common 10:20:52 15

sense and be completely consistent with the specification.10:20:55 16

Thank you, Your Honor. 10:20:58 17

THE COURT: Thank you, Mr. Lee.10:20:59 18

Mr. Hurst. 10:21:01 19

MR. HURST: Your Honor, Thank you.10:21:02 20

Jim Hurst, Your Honor, for Hospira. 10:21:34 21

There is two claim terms, Your Honor. I am 10:21:37 22

going start with the first one, "daptomycin." Just to put 10:21:38 23

side by side the two claim constructions, I want to focus on 10:21:45 24

one oddity that I think helps to clarify the issue before 10:21:50 25

36

Your Honor. We really only have one core dispute, whether 10:21:53 1

daptomycin should be construed as having L-Asn or D-Asn. 10:21:58 2

Our claim construction, that is virtually a 10:22:04 3

quote from the spec. It says the compound described in the 10:22:06 4

Baltz article, that Figure 1, the spec says daptomycin is 10:22:09 5

the compound described in the Baltz article and it refers to 10:22:13 6

Figure 1. That is Figure 1, with L-Asn.10:22:16 7

So Cubist, Mr. Lee, they add something to this. 10:22:21 8

It's a little bit of an oddity. They have a process in the 10:22:24 9

claim construction: the antibiotic derived from the 10:22:29 10

fermentation of Streptomyces roseosporus. That is a 10:22:33 11

process. So we have this oddity where we are defining a 10:22:39 12

compound based on its process. Why? Obviously, the 10:22:42 13

argument is that that will enable them to get to where they 10:22:49 14

want to be, which is the D-Asn, not the L-Asn, because they 10:22:53 15

argue that that fermentation process can only produce D-Asn. 10:22:58 16

I am not sure if that is true. It may very well be true. 10:23:02 17

So the question is, why are we defining a 10:23:06 18

compound with a process? Because they are looking for a 10:23:09 19

correction. They are looking for Your Honor, through a 10:23:13 20

Markman hearing, to correct a scientific mistake that 10:23:16 21

persisted since 2005. But the law doesn't allow for that, 10:23:19 22

not through a Markman hearing. 10:23:25 23

This is from the Supreme Court in 1876: 10:23:27 24

"Nothing can be more just and fair, both to the patentee and 10:23:29 25

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37

the public, than the former should understand, and correctly 10:23:32 1

describe, just what he has invented." 10:23:35 2

There is case after case. There is a couple 10:23:38 3

here. This is the Federal Circuit, 2008. "Courts may not 10:23:40 4

redraft claims to cure a drafting error made by the patentee 10:23:44 5

whether to make them operable," which is the last argument 10:23:47 6

you heard from Mr. Lee, "to define the claim our way to make 10:23:49 7

this claim operable." The Federal Circuit said, that is not 10:23:54 8

a proper way to do that, whether to make them operable or to 10:23:58 9

sustain their validity.10:24:02 10

A claim is construed as written, as written, not 10:24:03 11

as the patentee wished it had written it.10:24:06 12

I think we have exactly that case, Your Honor. 10:24:08 13

They are converting the claim through their proposed Markman 10:24:13 14

ruling into a product-by-process claim. I am sure you have 10:24:18 15

dealt with those. But a product-by-process claim is a 10:24:21 16

product claim, except that the product is defined as the 10:24:23 17

result of the underlying process. "It's often useful where 10:24:26 18

a product-to-structure is either not fully known or is too 10:24:30 19

complex to analyze -- " 10:24:37 20

Cubist could have, but did not, seek 10:24:38 21

product-by-process claims, where they say, for instance -- 10:24:42 22

let's take a look at the next page. They could have said 10:24:47 23

this. They could have said, "An antibiotic derived from the 10:24:49 24

fermentation of Streptomyces roseoporus." They could have 10:24:52 25

38

said that. That would have resolved the issue that they 10:24:56 1

had.10:24:58 2

When Mr. Lee said, hey, back when they were 10:24:58 3

doing this and trying to characterize the compound the 10:25:01 4

technology wasn't so robust to make sure you could get each 10:25:03 5

of the stereoisomers accurate, that was the argument. I 10:25:07 6

don't know if that is factually accurate or true, but just 10:25:10 7

accepting it is true, if that was true, there was a solution 10:25:12 8

available to Cubist in the Patent Office, which is a 10:25:15 9

product-by-process claim. That is what these are for. 10:25:18 10

If you are worried about the structure, if you 10:25:21 11

are worried about not being quite accurate, you can do a 10:25:24 12

product-by-process claim. You can say that what I am 10:25:29 13

claiming is an antibiotic derived from the fermentation of 10:25:31 14

Streptomyces roseoporus. They didn't do that. Now, in 10:25:33 15

2013, it's too late to try to do it through the Markman 10:25:39 16

hearing.10:25:41 17

Now, we said this in our reply brief. That's 10:25:45 18

the way I want to organize myself. Their proposed 10:25:47 19

construction, Your Honor, it literally violates four bedrock 10:25:50 20

principles of claim construction. 10:25:54 21

Number one: Claims are construed as of the 10:25:57 22

effective filing date. 10:26:00 23

Slide 10. You know the law. This is from 10:26:02 24

Phillips. You have got to pick a time period. The claims 10:26:05 25

39

are construed to have the meaning that the term would have 10:26:09 1

had to a person of ordinary skill in the art in question at 10:26:12 2

the time of the invention, as of the effective filing date 10:26:15 3

of the patent application.10:26:18 4

You can't have different meanings over different 10:26:20 5

times.10:26:22 6

Your Honor, I hate to put such a fine point on 10:26:26 7

it, but this is such a critical issue in this case, we think 10:26:30 8

it resolves it fully. If you read cover to cover Cubist's 10:26:34 9

opening brief, you will not see a reference to the important 10:26:37 10

point that you have to construe claims as of the effective 10:26:41 11

filing date.10:26:43 12

If you read their answering brief cover to 10:26:44 13

cover, you will not see that point addressed in their 10:26:47 14

answering brief. I listened to Mr. Lee. He did not focus 10:26:50 15

on that point. It drives everything. He said to you at the 10:26:53 16

beginning of his presentation, Your Honor, he said, look at 10:26:57 17

the examples in the patent, the antibiotic produced from 10:27:02 18

fermentation, the potent antibiotic. He said to you, Our 10:27:06 19

interpretation would cover all of these examples. Our 10:27:10 20

interpretation would focus on an antibiotic that is included 10:27:13 21

in all those examples. Hospira's does not. Think about 10:27:17 22

that for a second.10:27:20 23

The answer to that question depends on when the 10:27:21 24

question is asked. As of the effective filing date, someone 10:27:24 25

40

reading the intrinsic evidence would believe that our 10:27:29 1

antibiotic, L-Asn, was the one covered by all the examples. 10:27:31 2

And Mr. Lee's antibiotic, the D-Asn, was outside of all of 10:27:36 3

the examples as of the effective filing date 2000. 10:27:40 4

What he says now, today, in 2013, that someone 10:27:43 5

reading those examples would now know that it's really D-Asn 10:27:46 6

that's produced by the fermentation examples, that's 10:27:50 7

something people know today, in 2013. They didn't know it 10:27:52 8

as of the effective filing date of 2000. 10:27:56 9

In 2000, anyone reading the intrinsic record 10:27:59 10

would have believed that our interpretation, our antibiotic, 10:28:01 11

the L-Asn, was the one that was being produced in all the 10:28:04 12

examples, not D-Asn. That is later-acquired extrinsic 10:28:08 13

evidence.10:28:11 14

Just look at the timeline here. These are the 10:28:15 15

effective filing dates of all the patents. '87, '99, 2000. 10:28:19 16

This is Slide 12. Each of those patents discuss and cite 10:28:25 17

prior art describing daptomycin with L-Asn. So anybody 10:28:28 18

reading these patents, including every single example, would 10:28:32 19

have believed that L-Asn daptomycin is what was being 10:28:35 20

described.10:28:39 21

Then this Miao publication comes out in 2005. 10:28:40 22

It's a Cubist publication. They called it an unexpected 10:28:44 23

discovery, because everybody accepted L-Asn before 2005. So 10:28:48 24

it was an unexpected discovery in 2005.10:28:52 25

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41

But what about before 2005, the time period that 10:28:57 1

matters? The effective filing dates of 2000? This is all 10:29:00 2

of the art cited in Cubist's patents. And each and every 10:29:03 3

one of the these references defined daptomycin in the way we 10:29:08 4

define it, not the way Mr. Lee defines it. 10:29:13 5

At the time period that matters, all of the art 10:29:17 6

and the specifications defined it as we define it.10:29:20 7

So here is the situation we are facing. This 10:29:23 8

compound was defined by Lilly, dzptomycin there at the 10:29:27 9

bottom, Eli Lilly, just as we propose Your Honor define it. 10:29:32 10

So before 2005, our definition was accepted. After 2005, I 10:29:36 11

agree that Mr. Lee's definition would be accepted. But what 10:29:41 12

matters is, the key point, what time period are we looking 10:29:44 13

at? What time period drives the analysis? It's 2000, at 10:29:49 14

which time our definition controlled.10:29:53 15

Here is another thing to focus on. Everybody 10:29:59 16

agrees that daptomycin has the same meaning in all four 10:30:02 17

patents. So look at the method patents, for instance. This 10:30:04 18

Miao publication, it didn't exist on the 1999 filing date. 10:30:11 19

It didn't exist at any time during the prosecution. It was 10:30:16 20

never before the examiner. The patents actually issued 10:30:19 21

before the Miao publication came out. 10:30:24 22

So these patents issued when everybody believed 10:30:26 23

that daptomycin was L-Asn. So Miao can't possibly be 10:30:29 24

relevant to the proper interpretation of daptomycin for the 10:30:33 25

42

method patents, and therefore, since Cubist agrees that all 10:30:36 1

of the patents have the same meaning for daptomycin, Miao 10:30:41 2

has to be literally irrelevant to your claim construction, 10:30:46 3

Your Honor.10:30:50 4

Bedrock principle No. 2: Cubist is relying on 10:30:55 5

extrinsic evidence in an effort to trump the intrinsic 10:31:00 6

evidence.10:31:02 7

I know that you know this quite well, so I will 10:31:08 8

be very brief. But clearly, extrinsic evidence cannot trump 10:31:10 9

intrinsic evidence. This is Phillips, Kara, a bunch of 10:31:14 10

Federal Circuit cases, they all say the same thing: 10:31:19 11

intrinsic evidence is what controls, not extrinsic evidence. 10:31:22 12

Particularly the prior art, I guess we agree on 10:31:27 13

this, the Baltz reference and the Tally reference which are 10:31:29 14

described in the patents, they are not just cited, they are 10:31:33 15

discussed. They are part of the prior art, and actually 10:31:36 16

they can be of particular value in construing a claim term. 10:31:39 17

I think we agree on that.10:31:44 18

This is the actual specification. It echoes our 10:31:46 19

claim construction. Daptomycin is described in Baltz. That 10:31:50 20

is exactly what we said. You see the reference to Figure 1 10:31:54 21

there. That's what we put in our claim construction. So we 10:31:57 22

are lifting the definition from the specification for our 10:32:00 23

claim construction. That's what we are doing.10:32:02 24

All four patents say the same thing. When they 10:32:07 25

43

say to the reader, hey, what is daptomycin, they refer the 10:32:10 1

reader to Baltz. And Baltz adopts our construction of that 10:32:13 2

chemical compound. All four.10:32:17 3

It's more than just Baltz. These patents cite a 10:32:22 4

lot of prior art literature. Every single time, every 10:32:26 5

single time in the literature that daptomycin is defined, 10:32:30 6

it's defined with L-Asn, not D-Asn. 10:32:34 7

These are the purity patents, in green, those 10:32:37 8

are all the references that define the compound just as we 10:32:41 9

say you should define it. In yellow, these are the 10:32:45 10

treatment patents. The purity patents actually cite the 10:32:48 11

predecessor to this '071 patent, the one where the 10:32:52 12

certificate of correction is at issue. Here is what they 10:32:56 13

say. That is the predecessor. '071 is a reissue. So when 10:32:59 14

the daptomycin patent, patents, these four patents, refer to 10:33:02 15

'226, they are actually referring to '071. And they 10:33:06 16

literally refer to it, and '071, as Mr. Lee concedes, as 10:33:10 17

Cubist concedes, defines daptomycin exactly as we suggest it 10:33:15 18

be defined with L-Asn.10:33:19 19

Here is what I mean when I say Cubist relies on 10:33:22 20

extrinsic evidence. Granted, they are pointing you to parts 10:33:24 21

of the specification. Here is the two arguments from the 10:33:28 22

briefs. 10:33:31 23

Mr. Lee made the arguments. The specification 10:33:32 24

refers to this compound as being a highly potent antibiotic. 10:33:35 25

44

And it refers to this compound being a product of this 10:33:39 1

fermentation process. No question about that, that's what 10:33:42 2

the specification says.10:33:46 3

If you look at only the intrinsic evidence, and 10:33:47 4

you put yourself back in the time period where you are 10:33:50 5

supposed to put yourself, back in 2000, what would you think 10:33:52 6

was being described there? Daptomycin with L-Asn, because 10:33:57 7

the product of that fermentation process, in the specs -- I 10:34:02 8

am sorry, in the articles cited in the spec, they tell you 10:34:08 9

in the prior art that it's L-Asn, that's what they tell you. 10:34:11 10

So a person who is back in the time period we are supposed 10:34:16 11

to be looking at, in 2000, reading the specification and the 10:34:19 12

examples that Mr. Lee pointed out, would come to the 10:34:22 13

conclusion they are talking about L-Asn. And that's the 10:34:25 14

only thing that matters.10:34:28 15

How does Mr. Lee get to D-Asn? He is referring 10:34:32 16

to what somebody would think now today, based on extrinsic 10:34:35 17

evidence, the Miao article, what they would think today. 10:34:37 18

Today, yes, when somebody reads the fermentation experiment 10:34:40 19

in the patent, they would know, you know what's that's? 10:34:42 20

That's probably D-Asn they are coming up with, not L-Asn. 10:34:44 21

What we think today doesn't matter, though. It's what 10:34:48 22

people would have thought in 2000. In 2000, I don't think 10:34:51 23

there is any reasonable disagreement, when people read those 10:34:54 24

fermentation examples in the specification, they would have 10:34:58 25

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45

believed you were getting daptomycin with L-Asn, not D-Asn.10:35:01 1

I said they violated the four bedrock principals 10:35:06 2

of claim construction. The first is you got to focus on the 10:35:11 3

right date. The second is you can't rely on extrinsic 10:35:15 4

evidence like the Miao article and post-2005 development. 10:35:18 5

And, No. 3, you cannot import a process limitations into a 10:35:21 6

product claim. You can't do it. And that's what they are 10:35:23 7

doing. Just a reminder, they are trying to import the 10:35:25 8

phrase "derived from the fermentation process."10:35:29 9

And I just want to make the same point that I 10:35:32 10

made earlier, which is, the time to do this, to define the 10:35:34 11

compound by a process, was when they filed their patent 10:35:38 12

application, not during a Markman hearing. They could have, 10:35:41 13

but did not, seek to define the claim as a product created 10:35:45 14

from a process. They didn't do that.10:35:50 15

When can you do that? As a general proposition, 10:35:52 16

if there is not a limitation referring to a process in the 10:35:56 17

claim, you can't import it. Even when the spec says there 10:35:59 18

are certain advantages -- this is a quote from Vanguard -- 10:36:03 19

"The method of manufacture, even when cited as advantageous, 10:36:06 20

does not of itself convert product claims into claims 10:36:10 21

limited to a particular process."10:36:13 22

So when can you do that? Only in very limited 10:36:16 23

circumstances, where you basically say, my product can be 10:36:19 24

made only by this process and no other process. You got to 10:36:24 25

46

have what the Federal Circuit calls words or expressions of 10:36:28 1

manifest exclusion or restriction. I am covering only this 10:36:32 2

product and no other product. A product made by only this 10:36:38 3

process and no others. And clearly, we don't have that 10:36:40 4

situation here, because when you read the specification on 10:36:42 5

the right, all it says is daptomycin is a compound that can 10:36:47 6

be derived from the fermentation process. There is other 10:36:52 7

ways to make it. You can make it synthetically as well.10:36:54 8

So there is no even arguable grounds for 10:36:58 9

inserting a process limitation into these claims, because 10:37:04 10

the patent doesn't say you can only make it one way and no 10:37:06 11

other way. So just legally, you can't do it. And their 10:37:09 12

expert actually admits that you can make the compound 10:37:13 13

synthetically.10:37:17 14

Another way to get to the same place is the 10:37:18 15

doctrine of claim differentiation. It's just kind of a 10:37:20 16

common-sense notion that if you include phrases in one claim 10:37:25 17

but not another, you assume that phrase is not included in 10:37:29 18

the original claim. That's what we have here.10:37:34 19

The asserted claims just say daptomycin, 10:37:37 20

daptomycin. The unasserted claims actually refer to -- some 10:37:40 21

unasserted claims actually refer to the fermentation 10:37:45 22

process.10:37:48 23

So the doctrine of claim differentiation, that 10:37:48 24

also tells us that you cannot import this process claim into 10:37:52 25

47

the construction of daptomycin.10:37:56 1

Now, say you eliminated it. One of the things 10:37:59 2

that Mr. Lee pointed out is that their chemical structure 10:38:04 3

there is taken from the patent. I concede, that's true. 10:38:07 4

But if you took out the improper process limitation, and you 10:38:10 5

just left the rest of their claim construction, you would 10:38:14 6

literally get a claim that covers thousands of different 10:38:18 7

compounds, including both L-Asn and D-Asn. Why is that? 10:38:22 8

Because if you don't include stereochemistry, which any 10:38:27 9

chemist will tell you you have to do in order to 10:38:32 10

differentiate between compounds, if you don't include in 10:38:34 11

your Markman ruling stereochemistry, this is a class of 10:38:37 12

compounds. It would include the L and D version of every 10:38:40 13

single one of those 13 amino acids, and if you do the math, 10:38:44 14

that is literally thousands of different compounds. So you 10:38:48 15

cannot interpret daptomycin without including 10:38:52 16

stereochemistry. If you don't do it, you get a large class.10:38:57 17

It's nonsensical if you do not define the 10:39:01 18

compound with the stereochemistry. 10:39:05 19

Critically, nobody in this case is arguing that 10:39:12 20

daptomycin, the term data daptomycin is a class of 10:39:16 21

compounds. They are not arguing that.10:39:19 22

So eliminating the process limitation and 10:39:21 23

avoiding including stereochemistry in your claim 10:39:24 24

construction, Your Honor, would leave with you with a large 10:39:27 25

48

file, because nobody in the room is saying you should 10:39:32 1

construe that term to be a large class. We are giving you a 10:39:33 2

choice. It has to be either D-Asn or L-Asn. It is only a 10:39:36 3

single compound.10:39:39 4

Now, one of the things that their experts say, 10:39:41 5

and I heard a little bit of it from Mr. Lee, is that, you 10:39:43 6

know, stereochemistry doesn't matter. It's not something 10:39:46 7

that people focus on. It's not important when you are 10:39:48 8

defining a compound to include its stereochemistry. And I 10:39:52 9

have to say, Your Honor, I mean, you have had cases, I am 10:39:57 10

quite sure, about stereochemistry with enantiomers. It can 10:40:01 11

make all the difference in the world. When there is more 10:40:05 12

than one possible stereoisomer, chemists include 10:40:10 13

stereochemistry. You have to, to differentiate between one 10:40:14 14

and the other. 10:40:18 15

So when their experts say stereochemistry 10:40:20 16

doesn't matter, it really flies into the face of what 10:40:22 17

chemistry 101 students will know. 10:40:26 18

Also, this is the point I made before, if you 10:40:29 19

ignore stereochemistry, including for method patents even, 10:40:32 20

you would fail to distinguish between infringing and 10:40:35 21

non-infringing compounds.10:40:37 22

This is the University of Rochester from the 10:40:38 23

Federal Circuit 2004. "Regardless of whether a compound is 10:40:40 24

claimed per se or a method is claimed that entails the use 10:40:44 25

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49

of the compound, the inventor cannot lay claim to that 10:40:49 1

subject matter unless he can provide a description of the 10:40:52 2

compound sufficient to distinguish infringing compounds from 10:40:55 3

non-infringing compounds."10:40:58 4

The point there, Your Honor, is if you literally 10:40:59 5

ignore stereochemistry, you are not picking an individual 10:41:02 6

compound. You are picking a class. It's really unavoidable 10:41:04 7

that you have to choose between L-Asn and D-Asn.10:41:07 8

And the fact is, the intrinsic evidence shows 10:41:13 9

that stereochemistry was important to skilled scientists.10:41:15 10

Your Honor, you have to go no further than the 10:41:21 11

prior art that is actually cited in the specification. This 10:41:23 12

is Slide 41. These are some of the articles that we 10:41:26 13

cited -- I am just going back to that other slide to point 10:41:28 14

out that the treatment references, these are purple now, 10:41:32 15

these are all articles or patents discussing treatment with 10:41:35 16

daptomycin, and every single one defines the term by its 10:41:39 17

stereochemistry with L-Asn. 10:41:43 18

The point is, stereochemistry matters. And it 10:41:45 19

matters in real life when people are writing even about 10:41:48 20

methods of treatment. When they talk about the compound 10:41:51 21

they are giving to human beings, they define it precisely 10:41:53 22

with stereochemistry. You have to. Otherwise, you don't 10:41:56 23

know what compound you are giving the human being.10:41:59 24

The purity patents, these are purity references 10:42:02 25

50

in green, same thing. These are articles and patents about 10:42:05 1

purification, purifying daptomycin. And in every single 10:42:09 2

article, they define daptomycin very precisely with its 10:42:13 3

stereochemistry, because it's important to folks. And that 10:42:17 4

includes Cubist itself. This is one of the inventors in 10:42:22 5

the '071 patent -- actually, this is a Lilly inventor. 10:42:28 6

Cubist bought the Lilly patent. Look what it says. This is 10:42:31 7

in the Patent Office on the '071 prosecution. "As with most 10:42:34 8

peptides, the three-dimensional structure resulting from 10:42:39 9

intramolecular interactions within the compound is an 10:42:42 10

important factor in its biological activity. It is widely 10:42:45 11

accepted that relatively minor modifications, including such 10:42:48 12

subtle changes in stereoisomerism, may result in major 10:42:53 13

changes in pharmacological properties." 10:42:57 14

The point being that you have to include 10:42:59 15

stereochemistry or otherwise you are not identifying a 10:43:01 16

particular compound with a particular biological property. 10:43:02 17

And even a little tiny change like L to D as in this case 10:43:05 18

can make a big difference.10:43:09 19

Here, at least in vitro, it resulted in a 10:43:11 20

tenfold difference. That wasn't something that was 10:43:14 21

discovered until 2005, way after the time period that 10:43:17 22

matters.10:43:20 23

Our experts say the same thing, I am just going 10:43:22 24

to breeze over them. The fact is, I think it's relatively 10:43:25 25

51

undisputed that stereochemistry can have an impact not only 10:43:27 1

on biological activity but also on a compound's properties 10:43:30 2

as well.10:43:34 3

So stereochemistry is critical to defining 10:43:37 4

daptomycin. And you know that Cubist agrees because 10:43:41 5

otherwise they wouldn't be putting that process limitation 10:43:45 6

in their claim. They are putting the process limitation in 10:43:48 7

the claim to try to narrow their claim construction to one 10:43:50 8

particular stereoisomer, the D-Asn. So they agree that 10:43:53 9

stereochemistry matters. But they just go about it in a 10:43:58 10

different way with this process limitation, which we think 10:44:01 11

is not proper.10:44:03 12

The last bedrock principle: Compounds must be 10:44:06 13

defined by their structure, not by their function. This 10:44:09 14

really relates to the following. One of the things you 10:44:12 15

heard from Cubist in their papers and from Mr. Lee is, hey, 10:44:14 16

the specification calls this a potent antibiotic. We now 10:44:17 17

know that D-Asn is more potent than L-Asn. So that really 10:44:21 18

should be helpful in defining the chemical compound. 10:44:25 19

But the fact of the matter is, chemical 10:44:27 20

compounds are not defined by their function. They are 10:44:29 21

defined by their structure. This is settled law. Amgen, 10:44:32 22

for instance, tells you you identify a compound by its 10:44:36 23

structure, not by what it does or how it functions.10:44:38 24

The fact of the matter is, Your Honor, all we 10:44:43 25

52

know right now is that L-Asn is tenfold less potent in vitro 10:44:46 1

than D-Asn. It could very well be a great antibiotic, maybe 10:44:50 2

a little bit of a higher dose. Maybe it does better in vivo 10:44:55 3

than in vitro. Nobody knows whether L-Asn is a great 10:44:59 4

antibiotic or not. All we know is that in one particular 10:45:02 5

in-vitro test there was a difference in potency. That's all 10:45:04 6

we really know. The only way that Cubist can argue that the 10:45:08 7

references to potency point to D-Asn is from extrinsic 10:45:11 8

evidence that wasn't before the Patent Office and should not 10:45:15 9

be part of the consideration for Markman.10:45:18 10

This kind of issue and this kind of argument was 10:45:24 11

rejected in this Court, in Delaware, in the Bayer case. 10:45:27 12

There was an enzyme that was mis-described as a 10:45:33 13

monooxygenase rather than a dioxygenase in the patent. And 10:45:38 14

Bayer argued to try to correct it. So there is the same 10:45:43 15

kind of scientific mistake. There was a scientific mistake 10:45:47 16

that was reported in the patent, and after patent issuance 10:45:50 17

it was corrected. So it was actually a dioxygenase but in 10:45:54 18

the patent it was described as a monooxygenase. So like 10:45:58 19

Cubist here, Bayer went through various sort of legal 10:46:03 20

gymnastics to try to correct the mistake retroactively. And 10:46:07 21

the Court rejected each and every such argument, including 10:46:11 22

an effort to functionally define the enzyme rather than to 10:46:15 23

structurally define it, as we are suggesting is appropriate.10:46:18 24

So just to conclude on daptomycin, there really 10:46:26 25

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53

are four bedrock principals of claim construction that we 10:46:31 1

think Cubist is running into. But if I were to ask Your 10:46:34 2

Honor to just focus on one in particular, it's the timing 10:46:37 3

issue. It's the timing issue.10:46:41 4

Nobody would question Hospira's definition in 10:46:43 5

the time period that matters. And that's all that matters.10:46:48 6

Now, let me go to this Formula 3 compound issue, 10:46:54 7

Your Honor. This is the certificate of correction issue. 10:46:57 8

You asked whether this would be appropriate for a summary 10:47:00 9

judgment ruling on noninfringement. I think it would be. I 10:47:08 10

will explain why I think so. But for today, we are 10:47:11 11

literally just asking for a claim construction type 10:47:13 12

analysis.10:47:17 13

This is how Formula 3 was defined. It's just 10:47:18 14

daptomycin. Formula 3 is daptomycin. This is how it was 10:47:21 15

defined by Lilly, by the way, by its stereochemistry, just 10:47:25 16

as I suggest is appropriate, with L-Asn. And then the L-Asn 10:47:29 17

was corrected later in time after 2005 to D-Asn. So the 10:47:32 18

question that we raise before Your Honor is, is that 10:47:36 19

certificate of correction proper? That's the question we 10:47:39 20

raise.10:47:42 21

We do think it would be wasteful to not resolve 10:47:44 22

this issue, because everything I just said, all the learning 10:47:47 23

you have had today from reading the briefs about this 10:47:49 24

scientific mistake that happened and the L versus the D, it 10:47:52 25

54

would have to be repeated again if we were to litigate the 10:47:55 1

certificate of correction issue later. 10:47:58 2

Moreover, their certificate of correction issue 10:48:01 3

in this particular case is a pure question of claim 10:48:04 4

construction. And I will tell you why I say that.10:48:07 5

I think it would be helpful to actually look at 10:48:14 6

the full statute here to address an argument that Mr. Lee 10:48:16 7

made. Can I hand it up to Your Honor? 10:48:20 8

THE COURT: Sure. 10:48:23 9

MR. HURST: So on my slide I show that a 10:48:38 10

certificate of correction is appropriate only for a mistake 10:48:47 11

of one of two different kinds, of a clerical or 10:48:50 12

typographical nature, or of minor character. The first one, 10:48:53 13

the clerical or typographical nature, that can be a possible 10:48:56 14

factual issue. We agree, that is a possible factual issue. 10:48:59 15

It is just not a factual issue in this case. But of a minor 10:49:02 16

character, that's purely a legal issue. 10:49:06 17

Here is what I wanted you to do, though.10:49:08 18

Mr. Lee spent a lot of time talking about new 10:49:11 19

matter. Read the statute. "Whenever a mistake of a 10:49:14 20

clerical or typographical nature or of a minor character, 10:49:17 21

which is not the fault of the Patent Office, appears in a 10:49:21 22

patent and a showing has been made that such mistake 10:49:24 23

occurred in good faith, the director may issue a certificate 10:49:27 24

of correction if," if -- you see the "if" there -- "the 10:49:31 25

55

correction does not involve such changes in the patent as 10:49:35 1

would constitute new matter or would require reexamination."10:49:37 2

When Mr. Lee talked about the new matter issue 10:49:48 3

being a factual issue and he referred you, for instance, to 10:49:50 4

that New Mexico case that Judge Lourie wrote, those are 10:49:53 5

cases about new matter. You don't even get to the new 10:49:57 6

matter inquiry unless you first pass the first test. 10:50:00 7

Those are additional requirements. These first 10:50:03 8

two requirements, you have to pass one of these tests before 10:50:08 9

a certificate of correction is allowed.10:50:12 10

So Mr. Lee bypassed the threshold issue and went 10:50:14 11

right to new matter. And when he said to you, there is 10:50:17 12

going to be a lot of facts, we are going need to hear from 10:50:20 13

experts, look at this Judge Lourie case, the New Mexico 10:50:24 14

case, that is the case about new matter. It is not a case 10:50:27 15

about either one of these issues.10:50:30 16

Okay, so, first, do we have one of these two 10:50:32 17

issues in this case? Was there a clerical or 10:50:34 18

typographical -- an error, a mistake of a clerical or 10:50:37 19

typographical nature. I concede that can be a factual 10:50:42 20

issue, and if we had that issue in this case I wouldn't be 10:50:45 21

arguing in a Markman hearing on it today. But we do not, 10:50:48 22

because Cubist has admitted that we do not. We asked them: 10:50:53 23

Admit that the alleged mistakes in the '071 patent that were 10:50:56 24

corrected by the certificate of correction were not of a 10:51:00 25

56

clerical nature. 10:51:02 1

Admitted.10:51:03 2

Were not of a typographical nature. Admitted.10:51:04 3

Of course, I mean, they were being candid. This 10:51:08 4

wasn't a typo. People literally thought L-Asn was the 10:51:11 5

correct description of the compound. So it wasn't a typo. 10:51:15 6

It was a firmly held belief until 2005. That is why it 10:51:18 7

wasn't clerical and it wasn't typographical.10:51:23 8

I can skip this one. These are the Texas cases 10:51:29 9

saying what I just said, which is the clerical typographical 10:51:33 10

nature, that could be a question of fact. But the second 10:51:36 11

one, the minor character issue, is a question of law. The 10:51:38 12

first element is a question of law.10:51:41 13

So now, go back. Can they get a certificate of 10:51:43 14

correction through the second one? Is it of minor 10:51:47 15

character?10:51:50 16

Here is the law. It is a matter of law and it 10:51:52 17

turns entirely on claim construction. This is Superior 10:51:55 18

Fireplace, one of the leading certificate of correction 10:51:59 19

cases. And it says, 61, "We have interpreted the phrase 10:52:02 20

mistake of minor character to exclude those mistakes the 10:52:05 21

correction of which would broaden a claim. Since this was 10:52:10 22

such a mistake, we conclude as a matter of law that it was 10:52:15 23

not" -- not fact, law -- "that it was not correctable by a 10:52:18 24

certificate of correction." 10:52:22 25

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57

So the question turns entirely on whether it is 10:52:23 1

a broader claim. And, Your Honor, that's claim 10:52:25 2

construction.10:52:28 3

If the uncorrected claim as compared to the 10:52:30 4

corrected claim is in different scope, it is not correctable 10:52:35 5

by a certificate of correction.10:52:40 6

What does it mean to be a broader claim? This 10:52:41 7

is what it means to be a broader claim. This is from 10:52:50 8

Central Admixture. You can find a lot of cases that say the 10:52:53 9

same thing. It's not quite what you would think. When you 10:52:57 10

hear broader claim, I thought, somebody had to teach this to 10:53:00 11

me, because I said, well, there are old claims and there are 10:53:03 12

new claims, it is not more square footage. They had the 10:53:06 13

L-Asn before, and then they corrected it to the D-Asn. So 10:53:10 14

it's the same kind of square footage. It is not really 10:53:13 15

broader, is it? 10:53:15 16

So you take a look at the case law and it counts 10:53:16 17

as broader if the corrected claim covers territory that the 10:53:21 18

old claim did not, and that's what the case law says. 10:53:24 19

Whether a claim is broadened through a correction requires 10:53:27 20

interpreting the old and new versions of that claim. 10:53:29 21

That's why we say this is a claim construction 10:53:31 22

issue, Your Honor. We are asking you to interpret the old 10:53:34 23

L-Asn versus the new D-Asn, pure question of claim 10:53:36 24

construction.10:53:39 25

58

Then determining whether the new version covers 10:53:40 1

territory that the old one did not, that's the only inquiry. 10:53:43 2

Now, one of the things Mr. Lee said is that he 10:53:48 3

couldn't find a case where the corrected claim wasn't 10:53:51 4

broader in square footage. That's what he was saying. He 10:53:54 5

was saying what I said at first. We are just going from the 10:53:57 6

one compound, L-Asn, to another compound, D-Asn. And he 10:54:01 7

said, you know, that's unsettled in the law as to whether 10:54:04 8

that counts as broadening. I think that's not correct. I 10:54:06 9

think it is -- they didn't broaden when it reaches something 10:54:10 10

it didn't before reach. So it is broader in that sense. 10:54:15 11

All you have to do is compare the old to the new. And it's 10:54:18 12

purely a matter of claim construction.10:54:21 13

We have that here, of course. Slide 63. 10:54:22 14

Cubist's new version covers territory that the old one did 10:54:26 15

not.10:54:28 16

New version, corrected version, covers D-Asn, 10:54:29 17

the old version covered only L-Asn.10:54:32 18

So this is just a pure question of law. That's 10:54:38 19

what the case law says. If you were to look at any 10:54:41 20

underlying facts at all, you might look at what Cubist did 10:54:44 21

before the FDA and before the Patent Office. 10:54:48 22

If you take a look at Slide 65, Miao comes out 10:54:55 23

in 2005. And it says, hey, you know what? We were wrong. 10:55:00 24

Everybody was wrong. It's D-Asn. What does Cubist do? 10:55:04 25

59

They de-list the '071 patent from the Orange Book for their 10:55:08 1

product. 10:55:13 2

You can't list a patent in the Orange Book 10:55:14 3

unless it covers the drug in question. And so since their 10:55:16 4

patent covered L-Asn, they took it out of the Orange Book 10:55:19 5

because their product was D-Asn.10:55:23 6

So then they requested the certificate of 10:55:25 7

correction because the patent no longer covered their drug. 10:55:28 8

It's why we don't infringe. 10:55:31 9

If you construe the claims as we suggest, that 10:55:32 10

patents covers L-Asn, not D-Asn, we don't infringe. And the 10:55:35 11

patent doesn't cover their product. That's why they took 10:55:38 12

'071 out of the Orange Book.10:55:41 13

So they asked for a certificate of correction in 10:55:43 14

'07, they get it in '08 and then they re-list it. What that 10:55:46 15

tells you is they are conceding that the old claims cover 10:55:50 16

different territory from the new claims. And that 10:55:53 17

concession is all you need to determine as a matter of law 10:55:56 18

that the certificate of correction was improper.10:55:59 19

It covers new territory.10:56:03 20

I want to address this Knight case for a second, 10:56:06 21

the New Mexico case that Judge Lourie wrote, that Mr. Lee 10:56:11 22

asked you to take a look at.10:56:15 23

My first point is the one I made before, which 10:56:19 24

is, this case is about whether or not this scientific 10:56:22 25

60

correction of an old compound -- in that particular case, 10:56:25 1

under the facts of that case, the question was whether it 10:56:28 2

was new matter. That was the question. Remember, the 10:56:32 3

statute, though, you don't get to the new matter inquiry 10:56:34 4

unless you passed one of the first two tests, minor in 10:56:37 5

character, broadening, or typographical error. They can't 10:56:39 6

pass that first test.10:56:43 7

So when he asked you to focus upon New Mexico, 10:56:45 8

he is asking you to focus on the subsidiary new matter 10:56:47 9

issue, which is not before Your Honor at this point. And it 10:56:50 10

should never be, because they can't pass the first two 10:56:52 11

tests.10:56:55 12

But anyway, there is a separate distinction. In 10:56:55 13

the New Mexico case, it was about prosecution amendment. It 10:57:00 14

wasn't about a certificate of correction. So it is not a 10:57:11 15

certificate of correction case. In the Regents case, this 10:57:14 16

New Mexico case that Mr. Lee talked about, it was just about 10:57:16 17

whether you could amend the claims to cover this correction 10:57:19 18

from the compound. That's all that it was about, and 10:57:26 19

whether that qualified as new matter.10:57:29 20

But during prosecution, Your Honor, broader 10:57:31 21

claims are permissible. They are permissible if fairly 10:57:34 22

disclosed in the specification. For a certificate of 10:57:37 23

correction, broader claims are not permissible regardless of 10:57:41 24

what the specification says. These are really apples and 10:57:44 25

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61

oranges. And this New Mexico case really offers no guidance 10:57:46 1

for those two reasons. Number one, it is a new matter case, 10:57:49 2

number two, it is not a certificate of correction case.10:57:51 3

So I guess I should just skip to the end here. 10:58:02 4

If the certificate of correction is invalid, 10:58:04 5

Your Honor, then Cubist does not contest that Formula 3 10:58:07 6

should be L-Asn. And in that event I think it would be 10:58:11 7

undisputed that we do not infringe. And so if you just 10:58:14 8

address the purely legal certificate of correction issue, 10:58:18 9

which we say turns on a claim construction issue, then I 10:58:22 10

think that noninfringement will be conceded, and therefore 10:58:26 11

it would be appropriate to address on summary judgment.10:58:28 12

So just to wrap up here. 10:58:34 13

First point is, the daptomycin, it's the 10:58:37 14

effective date, it's the effective date, it's the effective 10:58:41 15

date. When Mr. Lee stands up, that has to be the first 10:58:43 16

thing that he should address, is why would he be looking at 10:58:47 17

things that happened later, Miao, in 2005? Why would he be 10:58:51 18

looking at the examples in the patent from the perspective 10:58:55 19

of somebody who now knows about Miao and knows that the 10:58:58 20

fermentation produced D-Asn, when the law tells me I have to 10:59:02 21

take a look at the claims in 2000, when I think there will 10:59:04 22

be a concession that Hospira is right, everybody thought it 10:59:07 23

was L-Asn at the time.10:59:09 24

And on the certificate of correction issue, it 10:59:12 25

62

really is -- and I understand Your Honor does not typically 10:59:14 1

entertain summary judgment motions -- but this really would 10:59:17 2

be a case where we really have nothing to argue about but 10:59:20 3

law, at least in our view, so it would be appropriate to 10:59:24 4

address on summary judgment. But again, for today, we are 10:59:26 5

just asking you to engage in the claim construction analysis 10:59:28 6

that would lead you to the conclusion that the certificate 10:59:32 7

of correction is inoperable. 10:59:35 8

THE COURT: As you suggest, my ruling of whether 10:59:37 9

there would be a concession of noninfringement, why wouldn't 10:59:41 10

the parties arrive at a stipulation of some type and just 10:59:42 11

take that directly to the Federal Circuit? 10:59:46 12

MR. HURST: I think we might. I wasn't sure we 10:59:50 13

would get that concession. But I think I heard Mr. Lee say 10:59:52 14

that if the Court rejected the certificate of correction 10:59:55 15

that there would not be an issue on infringement. I think I 10:59:58 16

heard that. I am not sure.11:00:02 17

MR. LEE: I think the answer is, Your Honor, if 11:00:04 18

you reject that and adopt their claim construction as a 11:00:06 19

consequence, then we can talk to them. I think it would be 11:00:11 20

less of an issue. I think we know what we joined the issue 11:00:15 21

on.11:00:20 22

THE COURT: Thank you, Mr. Hurst.11:00:22 23

MR. HURST: Thank you, Your Honor. 24

MR. LEE: Your Honor, I will brief.11:00:24 25

63

I appreciate Mr. Hurst telling me what I should 11:00:26 1

start with first. But I am not going to follow his advice 11:00:29 2

at this point in time.11:00:32 3

I am going to start with the question of the 11:00:33 4

reissuance of correction, two important points. 11:00:35 5

What Your Honor just heard is the summary 11:00:38 6

judgment argument, not the claim construction argument. Let 11:00:41 7

me give you the best example of why it was the summary 11:00:43 8

judgment argument. He had a slide on what we said or didn't 11:00:47 9

say to the FDA and how that showed, Your Honor, as a matter 11:00:51 10

of law the claim was broadened. Well, the letter which was 11:00:54 11

referred to in an interrogatory, the letter that was sent to 11:00:59 12

the FDA described this difference between L and D as a minor 11:01:02 13

error, just as I have described it to Your Honor. 11:01:07 14

If Your Honor would indulge me with my example 11:01:11 15

of the engineered dog, what Your Honor is confronted with -- 11:01:13 16

there are other examples -- but what Your Honor is 11:01:19 17

confronted with there is a patent that describes the 11:01:21 18

invention of a genetically engineered dog. It describes the 11:01:24 19

process, the steps that you would follow, and if you follow 11:01:27 20

the steps, you get that dog.11:01:29 21

It describes the dog itself in words, and it 11:01:32 22

describes it with a photograph. And the photograph, because 11:01:35 23

the technology that was available may not be as perfect as 11:01:38 24

the description of how to make it, and they are saying, 11:01:42 25

64

throw everything out. To go back to the timing issue, 11:01:46 1

that's not claim construction. 11:01:48 2

Your Honor knows about the antitrust 11:01:54 3

implications of listing and de-listing. There is nothing 11:01:55 4

wrong with a company to be cautious and say we are getting a 11:01:58 5

correction, let's play it safe because if we don't correct 11:02:02 6

it we are going to get an antitrust claim. If we do correct 11:02:05 7

it, we might get an antitrust claim. Let's just be same. 11:02:08 8

That type of intrinsic evidence is not going to drive Your 11:02:12 9

Honor to a conclusion.11:02:16 10

The second thing is, Mr. Hurst did not rebut the 11:02:17 11

fact that the cases say Your Honor should decide as a matter 11:02:20 12

of fact who the person of ordinary skill in the art is. 11:02:25 13

Your Honor should decide as a matter of law, with underlying 11:02:28 14

facts, whether that person would think the claims had in 11:02:33 15

fact been broadened. And the couple cases cited to Your 11:02:36 16

Honor all involved broadening, rather than this it's A or B 11:02:40 17

or L or D as we have confronted, as we have provided to Your 11:02:44 18

Honor today.11:02:48 19

The last point on the reissue patent is, Your 11:02:48 20

Honor didn't hear any argument today that for claim 11:02:53 21

construction purposes, if you accept the claim as corrected, 11:02:55 22

which the law says we should, then the claim, the 11:02:59 23

stereochemistry in the claim covers the D, because that it 11:03:03 24

what the claim says. Now, there may be other implications 11:03:07 25

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65

and that will be resolved later. But it's not for today. 11:03:10 1

And I am not going to argue all of the summary 11:03:13 2

judgment points if that is all right with Your Honor.11:03:15 3

Let me go to daptomycin. Respectfully, we were 11:03:18 4

described as having engaged in legal gymnastics, I don't 11:03:22 5

think that's right. If anything, I think it's the other 11:03:26 6

way. Let me show Your Honor why.11:03:30 7

First let me see if I can narrow the dispute for 11:03:32 8

us.11:03:35 9

If I can have our Slide 31. 11:03:36 10

Your Honor, when I said that we were two ships 11:03:48 11

passing in the night, I think we are.11:03:51 12

If you take our claim interpretation, as Mr. 11:03:53 13

Hurst did, and take out the words "derived from the 11:03:58 14

fermentation of Streptomyces roseosporus, that's fine with 11:04:00 15

us. We were trying to distinguish the circumstance that 11:04:04 16

what we were claiming was if you use that process described 11:04:08 17

in the claim you get what was in Figure 1. You would not 11:04:12 18

get what they claim.11:04:15 19

So all of the arguments made about our trying to 11:04:16 20

import a process limitation, if the claim reads, the 11:04:19 21

construction reads, The cyclic lipopeptide antibiotic 11:04:25 22

comprised of, and it goes on, words right on the spec, that 11:04:34 23

is equally agreeable to Cubist.11:04:39 24

Now, let me go back to this timing issue, 11:04:41 25

66

because, Your Honor, you have been given a false premise. 11:04:44 1

Here is why. It is not what people thought according to 11:04:49 2

Hospira. In fact, Your Honor, you have now got competing 11:04:53 3

declarations where one set of experts says here's what they 11:04:57 4

would have recognized. The other says the contrary.11:05:00 5

It's what does the specification say. And the 11:05:03 6

specification, which is the application, with some 11:05:07 7

amendments, as Your Honor knows, is the following. If you 11:05:11 8

take the specification from the four patents and the claims, 11:05:13 9

you know these three important things. The first is, the 11:05:19 10

claims say nothing about stereochemistry at all. 11:05:23 11

There was an accusation that we were importing 11:05:28 12

limitations. It's Hospira that is trying to import a 11:05:30 13

limitation. And they say, Your Honor, everybody would know 11:05:33 14

that that is the only way you define it. That is precisely 11:05:36 15

what the experts say is not true. They disagree about that. 11:05:39 16

But Your Honor doesn't have to resolve the 11:05:44 17

dispute between them. We have to recognize there is a 11:05:46 18

dispute, because, if he is right, if the stereochemistry was 11:05:49 19

essential to defining the claim, think about what they are 11:05:56 20

saying. He mentioned the reissue patent was part of the 11:05:59 21

file history. There is a claim that is describing the claim 11:06:01 22

according to things. If Hospira is correct that 11:06:04 23

stereochemistry is the beginning and the end of the world, 11:06:07 24

it is absolutely essential, I think Mr. Hurst's words were, 11:06:10 25

67

every scientist would know what happened at the Patent 11:06:14 1

Office.11:06:17 2

In the high-purity patents, with the Miao 11:06:19 3

article sitting right in front of them with the correction 11:06:22 4

in stereochemistry, did the patent examiner say you better 11:06:24 5

go back and amend the claims in these four patents or I am 11:06:28 6

not going allow these claims unless you put in 11:06:32 7

stereochemistry? And nothing, there is nothing in these 11:06:34 8

claims about stereochemistry.11:06:37 9

And here is what I think is the definitive 11:06:38 10

rebuttal to the timing question. If a person of ordinary 11:06:42 11

skill in the art followed the fermentation process described 11:06:45 12

in the specification, you get the compound daptomycin. You 11:06:49 13

get the D version.11:06:52 14

If a person of ordinary skill in the art 11:06:55 15

administered the product that's described in the 11:06:57 16

specification, you have the D version. It's not what they 11:07:00 17

thought. Everybody agrees that the technology to take the 11:07:03 18

photograph of my dog has developed well over 20 years. If 11:07:09 19

I, as of the effective date, if a person of ordinary skill 11:07:14 20

in the art followed the specification, you get daptomycin. 11:07:18 21

It happens that if you characterize it today, it's D. But 11:07:24 22

it's daptomycin. That's what is produced. That is what 11:07:28 23

results. That was what was administered to patients.11:07:32 24

So if you focus on the timing issue, there is no 11:07:36 25

68

evidence, Your Honor, that anybody followed those steps and 11:07:40 1

got the L. There is no evidence that anybody thought you 11:07:44 2

could follow those steps and get the L. There is no 11:07:46 3

evidence that the L was administered to patients 11:07:49 4

therapeutically.11:07:54 5

That's what I meant when I said you have to look 11:07:56 6

at the specification as a whole. This is a circumstance 11:08:01 7

where if you look at the five patents, the patentees 11:08:03 8

describe -- I think the Court will agree, from all the other 11:08:07 9

cases, there is a lot more in this spec about how the 11:08:10 10

inventions came to be, what the problems were, what the 11:08:12 11

precise steps were and how each of the three of them moved 11:08:15 12

from purification to dosing to really high purity.11:08:18 13

If they are read as a whole, as of the effective 11:08:23 14

date, it is daptomycin as we have described it, not what 11:08:29 15

they describe.11:08:33 16

If they are so right that it was so evident, 11:08:35 17

then the patent examiner missed it once, twice, three times, 11:08:38 18

four times. And the last time we were here on this patent, 11:08:41 19

so did Teva. They missed it, too. That's really unlikely.11:08:45 20

There is a host of extrinsic evidence that was 11:08:51 21

flashed up in the form of different patents. The 11:08:54 22

interesting thing is, for all of those charts and all the 11:08:58 23

extrinsic evidence, Hospira never said to Your Honor, yes, 11:09:02 24

if you look at the examples that are in the patent, the L 11:09:08 25

04/15/2013 04:59:57 AM Page 69 to 70 of 70 18 of 29 sheets

69

version covers those examples. That was my earlier point. 11:09:13 1

Mr. Hurst is a terrific lawyer. If you could say that, he 11:09:18 2

would. He didn't for a reason.11:09:21 3

Their claim interpretation would never result 11:09:23 4

from the process description. Their claim interpretation 11:09:27 5

would never result in the successful administration to 11:09:30 6

patients.11:09:35 7

Their claim interpretation would never result in 11:09:36 8

the high-purity daptomycin and the successful administration 11:09:39 9

as described in the spec.11:09:43 10

The last point is this, Your Honor. The New 11:09:45 11

Mexico case is not something that is off in some other 12

place. If Your Honor considers the claim interpretation, 13

321 Fed. 3rd at 1121-23, Judge Lourie is not off on some 11:10:12 14

unrelated inventor lark. The statute refers to new matter. 11:10:14 15

He is making that more fundamental point. At those pages 11:10:17 16

you will see, he is dealing with an erroneous description in 11:10:22 17

the specification of a chemical compound.11:10:25 18

He says, "Indeed, a chemical structure is simply 11:10:27 19

a means of describing a compound. It is not the invention 11:10:32 20

itself."11:10:36 21

The invention here is daptomycin.11:10:38 22

Thank you, Your Honor. 11:10:39 23

THE COURT: Thank you, Mr. Lee. Thank you, Mr. 11:10:40 24

Hurst.11:10:43 25

70

Counsel, I will get an order out within 30 days, 11:10:43 1

give or take. Thank you for your time.11:10:46 2

(Counsel respond "Thank you, Your Honor.")11:10:48 3

(Hearing concluded at 11:10 a.m.)4

Reporter: Kevin Maurer5

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'07 [1] - 59:15

'071 [9] - 43:12, 43:14,

43:16, 43:17, 50:6,

50:8, 55:24, 59:1,

59:13

'08 [1] - 59:15

'226 [1] - 43:16

'238 [1] - 10:20

'342 [1] - 10:22

'689 [1] - 9:2

'87 [1] - 40:16

'99 [1] - 40:16

1

1 [15] - 14:4, 23:14,

24:3, 25:4, 25:15,

31:17, 31:19, 32:4,

34:6, 35:10, 36:5,

36:7, 42:21, 65:18

10 [3] - 1:10, 12:3,

38:24

101 [1] - 48:18

11 [1] - 12:7

1121-23 [1] - 69:14

11:10 [1] - 70:4

12 [4] - 12:16, 12:17,

12:18, 40:17

12-367-GMS [1] - 1:8

13 [2] - 12:25, 47:14

14 [1] - 14:2

15 [1] - 14:7

16 [1] - 14:18

17 [1] - 15:3

18 [1] - 20:10

1876 [1] - 36:24

19 [1] - 21:2

1970s [1] - 7:5

1980s [2] - 7:5, 8:1

1987 [1] - 7:11

1990s [1] - 8:2

1997 [1] - 8:11

1999 [2] - 10:3, 41:19

1A [1] - 27:2

2

2 [3] - 5:22, 6:4, 42:5

20 [3] - 17:17, 22:16,

67:19

2000 [12] - 10:3, 40:4,

40:9, 40:10, 40:16,

41:2, 41:14, 44:6,

44:12, 44:23, 61:22

2003 [1] - 9:7

2004 [1] - 48:24

2005 [12] - 36:22,

40:22, 40:24, 40:25,

41:1, 41:11, 50:22,

53:18, 56:7, 58:24,

61:18

2007 [1] - 14:11

2008 [2] - 14:15, 37:4

2013 [4] - 1:10, 38:16,

40:5, 40:8

21 [2] - 12:17, 25:1

22 [2] - 12:18, 25:8

23 [2] - 26:5, 26:8

24 [1] - 26:21

255 [7] - 15:23, 16:1,

16:3, 16:20, 19:15,

20:11, 20:20

26 [3] - 12:19, 14:4,

27:23

27 [1] - 28:17

28 [1] - 29:8

29 [2] - 14:15, 29:21

3

3 [12] - 6:13, 6:23,

12:4, 12:10, 12:12,

45:6, 53:7, 53:14,

53:15, 61:6

30 [2] - 31:1, 70:1

31 [2] - 31:11, 65:10

32 [1] - 32:2

321 [1] - 69:14

33 [1] - 32:6

34 [1] - 32:11

35 [1] - 32:15

36 [1] - 33:8

365 [1] - 14:9

37 [1] - 33:23

38 [1] - 34:17

39 [2] - 12:18, 35:3

3rd [1] - 69:14

4

4 [3] - 7:22, 27:20,

27:22

41 [2] - 12:17, 49:13

48 [1] - 9:3

5

5 [1] - 9:1

6

6 [1] - 9:9

61 [1] - 56:20

63 [1] - 58:14

65 [1] - 58:23

66 [3] - 26:8, 35:5,

35:8

7

7 [2] - 10:21, 14:4

8

8 [1] - 10:24

9

9 [1] - 15:23

9:30 [1] - 1:10

A

a.m [2] - 1:10, 70:4

able [4] - 5:14, 7:18,

18:25, 20:18

absolutely [1] - 66:25

accept [1] - 64:22

acceptable [1] - 32:5

accepted [5] - 4:9,

40:24, 41:11, 41:12,

50:12

accepting [1] - 38:8

according [2] - 66:2,

66:23

accurate [4] - 24:7,

38:6, 38:7, 38:12

accusation [1] - 66:12

acidic [2] - 10:8, 10:13

acids [1] - 47:14

acquired [1] - 40:13

Action [1] - 1:4

active [3] - 6:9, 30:1,

30:4

activity [2] - 50:11,

51:2

actual [1] - 42:19

add [1] - 36:8

addition [1] - 31:2

additional [1] - 55:8

address [7] - 22:14,

54:7, 59:21, 61:9,

61:12, 61:17, 62:5

addressed [1] - 39:14

administer [2] - 8:3,

30:17

administered [10] -

8:21, 9:3, 11:7,

11:12, 24:20, 26:1,

33:3, 67:16, 67:24,

68:4

administering [3] -

7:24, 25:20, 30:25

administration [4] -

27:13, 33:5, 69:6,

69:9

admit [1] - 55:24

admits [1] - 46:13

admitted [3] - 55:23,

56:2, 56:3

admixture [1] - 57:9

adopt [1] - 62:19

adopts [1] - 43:2

adults [1] - 27:13

Advanced [1] - 22:2

advantageous [1] -

45:20

advantages [1] -

45:19

advice [1] - 63:2

affected [1] - 10:11

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

1

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 Page 2 to 2 of 11 20 of 29 sheets

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,

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,

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

2

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,

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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] -

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

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

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 Page 4 to 4 of 11 22 of 29 sheets

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

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,

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] -

4

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

23 of 29 sheets Page 5 to 5 of 11 04/15/2013 04:59:57 AM

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,

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,

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

5

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 Page 6 to 6 of 11 24 of 29 sheets

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,

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

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

6

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

25 of 29 sheets Page 7 to 7 of 11 04/15/2013 04:59:57 AM

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,

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] -

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,

7

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 Page 8 to 8 of 11 26 of 29 sheets

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,

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,

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,

8

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

27 of 29 sheets Page 9 to 9 of 11 04/15/2013 04:59:57 AM

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

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,

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,

9

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 Page 10 to 10 of 11 28 of 29 sheets

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

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

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,

10

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,

29 of 29 sheets Page 11 to 11 of 11 04/15/2013 04:59:57 AM

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,

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,

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

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,

11

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