EXHIBIT 32 

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 IN THE UNITED STATES DISTRICT COURT

 FOR THE DISTRICT OF NEW JERSEY

______________________________________________

TAKEDA PHARMACEUTICAL COMPANY LIMITED, TAKEDA )

PHARMACEUTICALS NORTH AMERICA, INC., TAKEDA )

PHARMACEUTICALS LLC, TAKEDA PHARMACEUTICALS )

AMERICA, INC., and ETHYPHARM, S.A. ) Civil Action No.

 Plaintiff, ) 3:11-CV-02506-JAP-DEA

 vs. )

MYLAN PHARMACEUTICALS INC., )

 Defendant. )

______________________________________________)

 DEPOSITION OF DR. STEPHEN R. BYRN

 TRANSCRIPT of the stenographic notes of the

proceedings in the above-entitled matter, as taken

by and before TAB PREWETT, a Registered Professional

Reporter, a Certified LiveNote Reporter, and Notary

Public, held at the Offices of HOGAN LOVELLS US LLP,

875 Third Avenue, New York, New York 10022, on

Friday, June 8, 2012, commencing at 10 a.m. 

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Page 150

1 personal information, what a person skilled in

2 the art knows.

3 Q. But you have presented no

4 documentary proof to support your claim?

5 MS. CHOW: Objection to the form.

6 A. I mean, I don't know. There

7 weren't any -- people just knew this. There

8 weren't any publications. It was just known.

9 Q. And so then the -- also, the USP

10 that you have attached to your declaration --

11 well, we'll get to that in a second -- it's not

12 specific to any particular device, right?

13 A. Correct. That's because of the --

14 one thing that we are missing here is the

15 definitions of what "precision" and "error" is.

16 There are really four levels of precision that

17 one deals with when they do particle size. And

18 you need to know and understand those in order

19 to interpret the claims and the data.

20 Q. Okay. Now, the claim is not

21 limited in terms of how you measure particle

22 size. You can measure it using any other

Page 151

1 technique, including laser diffraction, right?

2 A. Correct.

3 Q. Okay. But your construction is

4 dependent upon the standard deviation of laser

5 diffraction. So how do you reconcile the two, a

6 claim that is not limited to the way you measure

7 it versus construing the term limited to a way

8 it's measured?

9 MS. CHOW: Objection to the form.

10 A. I wanted to do -- be conservative

11 and give a number that was a low number, a

12 conservative number, because of claim

13 construction and because it's a legal issue. So

14 I took a low number. Probably, in reality, it's

15 slightly higher than 10 percent, but that's how

16 I -- that was my approach.

17 Q. So you're correlating -- with all

18 of the other methods of measuring particle size,

19 you are correlating the laser diffraction to all

20 of those other methods?

21 MS. CHOW: Objection to the form.

22 A. No, I am saying that, based on my

Page 152

1 experience of skill in the art, that, when a

2 person skilled in the art reads the number,

3 400 microns they think conservatively plus or

4 minus 10 percent and, you know, there are --

5 Q. I'm sorry --

6 A. -- they think conservatively

7 really. I can just stop there.

8 Q. All right. Let me just give you

9 what is marked as D 27.

10 (Exhibit No. D 27, Excerpt from

11 Physical Pharmacy, is marked by the reporter for

12 identification.)

13 Q. Dr. Byrn, where I am confused is

14 that you are applying a USP -- the portion of

15 the USP describing the standard deviation for

16 laser diffraction. And am I correct you are

17 applying that across the board to every other

18 type of measurement that is being used to

19 determine particle size that is out there? Am I

20 correct about that?

21 MS. CHOW: Objection to the form.

22 A. No. What I am saying -- I am not

Page 153

1 applying that. I am saying a person skilled in

2 the art reading "400" would read "plus or minus

3 10 percent" conservatively.

4 Q. Regardless of what device you used

5 to measure it?

6 MS. CHOW: Objection to the form.

7 Q. Is that your testimony?

8 A. Well, when you read a patent the

9 way I approached it or my analysis, I said a

10 person skilled in the art is going to read this,

11 and they are going to want to figure out how to

12 make the measurement to be -- whether they're

13 within or without the patent.

14 And so they would read this, and

15 they would say it can be measured by laser

16 diffraction; but it could also be measured by

17 other means. And then we have the number,

18 400 microns.

19 So that means to me, in my opinion,

20 a person skilled in the art reading this would

21 say that it's 400 plus or minus 10 percent. And

22 I think that's a conservative number.

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Page 154

1 Q. And that's regardless of the means

2 in which you measure the particle size?

3 MS. CHOW: Objection to the form.

4 A. Well, I didn't ignore the means. I

5 just said, regardless, they would look at all of

6 these options, and they would realize that it's

7 plus or minus 10 percent as a reasonable number

8 and a proper claim construction for that number.

9 And the court -- the court already agreed with

10 me.

11 Q. I understand that. We are going to

12 have -- we'll have a different hearing, and

13 perhaps we have a different approach.

14 A. Okay.

15 Q. But you realize that the only

16 documentation you presented to substantiate the

17 plus or minus 10 percent was a document that was

18 dated after the filing date, and was specific

19 only to laser diffraction, correct?

20 MS. CHOW: Objection to the form.

21 Asked and answered.

22 Q. And there is nothing in that

Page 155

1 document suggesting -- indicating otherwise that

2 that plus or minus 10 percent would apply to any

3 other means of measuring particle size

4 distribution; isn't that correct?

5 MS. CHOW: Objection to the form.

6 Asked and answered.

7 MR. PARKER: It's not asked and

8 answered.

9 A. Although all that's correct, as I

10 explained, I -- my analysis of the claim was

11 based on my experience. And then the plus or

12 minus 10 percent is a conservative number that I

13 put on it that agrees with the USP. But I think

14 it's a conservative number for the time that

15 that was.

16 Another point is there are four

17 types of error we are dealing with it. So the

18 Helos Rodos error is the smallest, by far. The

19 other three are much bigger. And those -- you

20 know, I use those in my analysis.

21 Q. What other types of errors are you

22 talking about?

Page 156

1 A. So if you look in the Snorek paper,

2 it's pretty well-explained there. And it's also

3 explained -- I think it's best explained in the

4 Snorek paper. There is --

5 MS. CHOW: Has that been marked?

6 A. If you can hand me the Snorek

7 paper, I can go through it.

8 Q. I will do that.

9 A. That would be a good way for me to

10 explain it because I think we are getting mixed

11 up on what the error numbers are out there and

12 what the meaning of them are.

13 Q. By the way, I am handing the

14 witness what has been marked as D 28, which is

15 the -- I think we all believe is the Snorek

16 reference.

17 (Exhibit No. D 28, Snorek

18 Reference, is marked by the reporter for

19 identification.)

20 Q. Also, for the sake of completeness,

21 I will hand you what has been marked as D 29,

22 which is the portion of the USP that I believe

Page 157

1 is part of your declaration.

2 Let me find a place to put this.

3 (Exhibit No. D 29, Portion of USP

4 that is part of Dr. Byrn's Declaration, is

5 marked by the reporter for identification.)

6 Q. But just for some foundation, I

7 think this will help.

8 On Exhibit D 27, Dr. Byrn, you will

9 -- it's an excerpt from Physical Pharmacy; and

10 the pages reveal different means of measuring

11 particle size distribution. Do you see that --

12 which includes -- correct me if I'm wrong --

13 optical microscopy, sieving, sedimentation --

14 and, yes, it includes at least those three means

15 that I'm aware of. If I am wrong, you can

16 correct me.

17 A. No, correct.

18 And these methods, these three are

19 wider errors than laser diffraction.

20 Q. Even sieving?

21 A. Yes. Sure. Because consider you

22 have a needle particle, and you have some round

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Page 158

1 particles. The round particles will fall

2 through. The needle won't. And you will get a

3 -- a distortion in the particle size.

4 So sieving is not considered an

5 accurate method, and it wouldn't work for small

6 particles, either like cement, like the -- like

7 this project, you couldn't even sieve. You

8 couldn't come close.

9 Q. You realize in the '994

10 specification that sieving is the method that

11 they -- that they ended up using?

12 MS. CHOW: Objection to the form.

13 A. Well, they just say, for example,

14 Helos Rodos. I think they use some sieving,

15 also. But I think the errors of sieving are

16 larger than 10 percent, in my experience.

17 Q. So, again, I am just trying to be

18 clear now. Your position is 400 microns or less

19 plus or minus 10 percent, as we just talked

20 about, is based on the information, at least in

21 part, what's in the USP as it concerned laser

22 diffraction?

Page 159

1 MS. CHOW: Objection to the form.

2 A. No. In my plus or minus

3 10 percent, my analysis is based on my own

4 experience.

5 Q. So your plus or minus 10 percent --

6 I didn't know this; this is the first time I am

7 hearing this is all encompassing -- it

8 encompasses all the methods of measuring?

9 A. And it's a conservative number.

10 Q. That's your position?

11 A. That's my position.

12 Q. Okay.

13 A. And I would further add that,

14 generally, laser diffraction is the best method,

15 the most precise method. So the numbers that

16 Snorek's talking about, and USP, laser

17 diffraction are the numbers that are most

18 precise. So other methods -- and that's one of

19 the reasons the USP has focused in recent years

20 on the laser diffraction.

21 Q. Are you aware of any published

22 information that would contradict the

Page 160

1 information that is provided in the Helos Rodos

2 materials with respect to standard deviation?

3 I understand your opinions and

4 experience. But are you aware of any published

5 information which actually went out and took on

6 the task of actually seeing how precise this

7 information is or can be?

8 MS. CHOW: Objection to the form.

9 A. Yes. That's the -- well, the --

10 Q. Where can I find that information?

11 A. Okay, it's NIST -- it's a document

12 called capital N-I-S-T-I-R, all capital letters,

13 6883, is one document. And the reason I found

14 that document is that it's on cement. I don't

15 think cement is a proper comparison to drugs.

16 So on the face of this, I don't

17 think it's the right way to do it. But if you

18 look at that document, what they did is they

19 took four or five samples of cement, the

20 National Institute of Standards. They sent them

21 to 25 labs, who ran laser diffraction particle

22 size, not just on a Helos Rodos, but bigger,

Page 161

1 wider still, and measured the average and the

2 standard deviation. And when you look at the

3 data, some of it is as high -- the deviation is

4 as high as 65 percent, not 10 percent, but

5 65 percent.

6 So that's only with cement, and

7 it's only on laser diffraction.

8 You have other data in those things

9 on other measurements. So that alone tells me

10 that this isn't right, and it's not -- it was

11 known that this is not right. This isn't the

12 precision of the method. This is -- and I am

13 going to get to that -- I am going to get to the

14 errors. If you want me to get to the errors, I

15 will explain why it isn't the right way to do

16 it.

17 You want me to keep going, or you

18 want to ask me a question?

19 Q. No, I want to stop there. I am

20 going to get to that.

21 This document -- is this document

22 attached to your declaration?

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Page 162

1 A. No, I found it after I reviewed

2 Dr. Mumper's declaration and was -- saw that he

3 was talking about cement. And I said, "Well,

4 what is out there about cement," because, as I

5 said, I wouldn't have used cement when I wrote

6 my declaration.

7 Q. Now, was this dated prior to 1999?

8 A. I don't remember the date. I think

9 it's more like 2000. It could be '99. It could

10 be -- I don't remember the date. But there's

11 NIST -- there are other NIST measurements going

12 on in that time frame.

13 Q. But isn't the use of cement -- I

14 mean, that's more or less -- it's like a control

15 standard; isn't it?

16 A. Well, it's a lot more precise than

17 drugs. The numbers you get from cement --

18 especially if you sit at the instrument company

19 and measure it a few hundred times, the numbers

20 you get are a lot more precise than you would

21 for a drug.

22 I'm going to explain that if you --

Page 163

1 maybe I should just go ahead so you see what I

2 am talking about.

3 Q. Well, why don't you try -- if you

4 want, try to explain it.

5 A. All right. I can try to do it

6 briefly. If you turn to page 1460 of Snorek --

7 pardon me, 1462, in the bottom right-hand

8 corner, starting there and going over to 1463 in

9 the first column, she lists three -- under

10 "Validation," she lists three ways to figure out

11 error. And in the first one is where the

12 10 percent comes from.

13 The first one, precision

14 repeatability. So that's the repeatability of a

15 measurement. The precision of a set of

16 measurements should be obtained using one

17 analyst conducting the method as written. And

18 then she goes over the method. The measurement

19 should be made in a single lab on a single

20 apparatus. And then the next bullet, from one

21 lot obtain replicant measurements.

22 So you take one lot. You take

Page 164

1 replicant measurements. And you determine the

2 average and the standard deviation. It's

3 10 percent. That's where the 10 percent number

4 is.

5 This measurement that these guys

6 are doing is the instrument error on one sample

7 of one lot submitted many, many times. It's

8 smaller than this number one method.

9 Q. Much smaller.

10 A. Much smaller. Because it should

11 be, because you are just putting the same thing

12 in every time. If the instrument doesn't get

13 the right answer and you just repeatedly put the

14 same thing in, you have got serious problems.

15 So -- but this is not the error, in

16 my opinion, that the patent is talking about.

17 If we go to "Intermediate

18 precision," the next bullet, the measurement

19 should be made in the same lab on different days

20 and on more than one instrument.

21 So now we are doing more than one

22 instrument. And then if you go down to

Page 165

1 reproducibility, it is a precision of the test

2 results made by analysis of same samples under a

3 variety of conditions. So there's levels of

4 error.

5 What this is is the most precise,

6 really low. I actually took the next most

7 precise and used it. But there are two higher

8 than that. I don't think it'S indefinite. I

9 don't think the patent is indefinite. But I

10 think that the 10 percent is conservative based

11 on this. And I don't think this is a reliable

12 thing.

13 Q. And you -- well, you said basically

14 the error in the patent is talking about.

15 A. Well, I don't mean the error in the

16 patent. I mean the error of the plus or minus

17 10 percent that a person skilled in the art. I

18 think that's conservative.

19 Q. So based on what you have described

20 of what was going on prior to when this USP

21 criteria came out, you are saying the standard

22 of error was pretty large, or it was, as you put

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Page 174

1 Snorek is talking about.

2 Q. Forget about Snorek for a second,

3 please. I will go to that in minute.

4 On the USP, we are not talking

5 about -- when it talks about "replicates," we

6 are not talking about instrument precision. We

7 are simply talking about, you get a sample; you

8 want to report that measurement; and in order to

9 show that it's at least accurate under this

10 criteria, you would have to measure that same

11 sample three times. And then you look to see --

12 you take your central value. And then from

13 there, you determine whether you have variation

14 of 10 percent.

15 MS. CHOW: Objection to the form.

16 A. Not the -- not the same sample.

17 Q. Where is it -- okay.

18 A. At least three different

19 representing samples from the same batch.

20 Q. The same batch. I'm sorry. I

21 misspoke.

22 You take the same batch, but you

Page 175

1 are measuring three samples of the same batch?

2 A. You take three different samples

3 out and run them -- and prepare them and run

4 them.

5 Q. I understand that.

6 A. That's a lot different from what

7 Helos Rodos did.

8 Q. Let me back up, though.

9 It's a lot -- what you are saying

10 here, I just want to be clear. We are not

11 talking about instrument precision where it says

12 "replicates." We are talking about the

13 precision of the actual measurement being done.

14 Do you agree with that?

15 MS. CHOW: Objection to the form.

16 A. I agree with that. And I think

17 that's what the patent is talking about. The

18 patent -- it makes little difference to a person

19 skilled in the art what the instrument precision

20 is. They are trying to figure out whether or

21 not a number is within or outside the patent, so

22 they are not worried about the instrument

Page 176

1 precision. They are worried about the

2 repeatability, or even maybe more the higher

3 level error problems like the intermediate

4 precision, which is the next level up.

5 So there, the instrument precision

6 has little to do with what the patent is talking

7 about.

8 Q. So when they come up with 400

9 microns or less -- well, if you look at the

10 values that they have in the '994 patent, in

11 examples 4 through 9, am I -- is one of ordinary

12 skill in the art to assume that is a plus or

13 minus 10 percent value?

14 A. Sure. Absolutely.

15 Q. So -- but you have no idea back

16 then because there was no criteria whether or

17 not it was either the middle value, whether it

18 was -- it was basically from the same batch

19 measured three times; there is no indication

20 that that was done in the patent.

21 MS. CHOW: Objection to the form.

22 A. Well, I am just saying that,

Page 177

1 according to my analysis and the way you would

2 report the data and if I got a paper to review,

3 all that put together, that, when you put a

4 number in there, my whole analysis was plus or

5 minus 10 percent. And that is a conservative

6 number.

7 Q. But you are speculating. You are

8 assuming that, based upon a document that is

9 filed well after the filing that -- published

10 after the filing date, which requires that you

11 take three samples from a single batch and do

12 your analysis to see what the variation is, that

13 that was somehow applied in the context of this

14 patent. And you have no proof of that.

15 MS. CHOW: Objection to the form.

16 A. That's why I use a conservative

17 number. That's why I was 10 percent. I didn't

18 want to speculate closer to what I think the

19 real numbers are. I just used 10 percent

20 because I thought that was a conservative

21 number.

22 Q. So one of ordinary skill in the art

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Page 202

1 (A break is taken.)

2 CONTINUED DIRECT EXAMINATION

3 BY MR. PARKER:

4 Q. Dr. Byrn, a while ago we talked

5 about cushioning. You have already described

6 it, but let me ask a question:

7 How would you test for cushioning?

8 MS. CHOW: Objection to the form.

9 A. I think the way Dr. Shimizu did was

10 fine. You make tablets and then do those

11 experiments he did.

12 Q. You look at the hardness?

13 A. No, acid resistance, and also

14 release. Just -- yeah, I am trying to find

15 exactly --

16 Q. Take your time.

17 A. -- what exhibit it is.

18 MS. CHOW: Are you looking for

19 Dr. Shimizu?

20 THE WITNESS: Yes, what exhibit is

21 that?

22 MR. PARKER: It should be 17.

Page 203

1 THE WITNESS: Here it is, remaining

2 ratio.

3 Q. Okay. How was that -- that was

4 calculated how? How was that calculated?

5 A. The content of the drug -- there

6 are three things he measured: hardness, acid

7 resistance, and remaining ratio. And there it's

8 described that the "remaining ratio" is "a

9 content of the drug in the collected fine

10 granules after the dissolution test for one

11 hour."

12 Q. Okay. So there are three factors:

13 the hardness, acid resistance, and remaining

14 ratio. Then he has a conclusion, "not more than

15 10 percent." Can you just explain what you

16 understood that to mean?

17 A. Sorry, I didn't catch that one,

18 that question.

19 Q. Okay. My question you mean?

20 A. Yes.

21 Q. So in this -- since you have the

22 declaration in front of you, he mentioned in

Page 204

1 conclusions "not more than 10 percent." Do you

2 see that? He has it in quotes.

3 He says:

4 "Acid resistance defined in USP

5 24" -- and it goes on -- "not more than

6 10 percent."

7 Can you just explain what that --

8 what that means to you?

9 A. I would have to check that. I

10 mean, what I was looking at is the -- it's about

11 half -- example B is about half as sensitive to

12 acid as example A. I'm not sure what the "not

13 more than 10 percent" is. I would have to look

14 at that USP test.

15 Q. As far as going back to cushioning,

16 as you stated in your declaration, I mean, a

17 reason to expect when you -- strike that.

18 I just want to turn to now the --

19 go to Claim 1 of the '994 patent, that portion

20 of the claim that refers to orally disintegrable

21 tablets. Then there is a phrase, "wherein said

22 tablet is orally disintegrable."

Page 205

1 Do you recall -- did you take a

2 position on those claim terms in your

3 declaration?

4 A. I don't recall that I did.

5 Q. Do you recall that Dr. Mumper took

6 the position that those phrases, where he

7 referred to "a tablet that is capable of

8 disintegrating either in the mouth with saliva

9 or water and then swallowed."

10 A. Yes.

11 Q. Okay. And do you agree or disagree

12 with that interpretation?

13 A. I disagreed.

14 Q. Okay. And what is the basis of

15 your disagreement?

16 A. Well, one, that it's clearly -- I

17 think it's clearly in the mouth. One is in the

18 abstract. It says "oral cavity" in the '994

19 abstract.

20 Q. So you are looking to the abstract

21 as part of your basis for construing that claim

22 term?

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Page 206

1 A. As part of the basis.

2 Q. Anything else?

3 A. Yes, there are places, if I can --

4 on column 12, line 39, it says that:

5 "Orally disintegrable tablet of the

6 present invention exhibits fast disintegrability

7 or dissolubility in the oral cavity and also an

8 appropriate strength of preparation."

9 Q. Okay. That's column 12, you said,

10 line 37?

11 A. Line 38 or 39. It's 39, sorry.

12 39, 40, and 41.

13 Q. Okay. Anything else at this time?

14 A. The '632 -- are we just confined to

15 the '994?

16 Q. Yes.

17 A. Okay.

18 Q. So if I can just direct your

19 attention to column 17, line --

20 A. There are probably others that I

21 didn't find.

22 Q. Okay. But if I can just direct

Page 207

1 your attention -- and if there's something else,

2 you can just call that out. But if I can just

3 direct your attention to column 17, line 56 --

4 or 57, I'm sorry, all the way down to the end.

5 And, quote:

6 "A solid pharmaceutical preparation

7 comprising the fine granules of the invention as

8 used for an oral disintegrable tablet can be

9 administered without water or together with

10 water."

11 Do you see that?

12 A. I see that.

13 Q. Okay. Now, the "fine granules of

14 the invention," that is -- would you agree it's

15 a reference to the four micrometers or less,

16 microns or less?

17 MS. CHOW: Objection to the form.

18 A. The 400 --

19 Q. Right.

20 A. -- plus or minus 10 percent microns

21 or less.

22 Q. And then it also states that it

Page 208

1 could be administered without water. And that

2 would --

3 A. Well, that would be -- to me,

4 that's just putting it in the mouth.

5 Q. That's right. If it's together

6 with water, that would include with water,

7 correct?

8 A. Well, that's what it says. But it

9 defined "orally disintegrable tablet" as in the

10 oral cavity. So I mean, there, I just look at

11 this -- this isn't defining the tablet. It's

12 just saying that you can also administer without

13 water.

14 Q. Okay.

15 A. But the defined characteristic is

16 dissolubility and disintegrability in the oral

17 cavity.

18 Q. Are you now back on column 12?

19 A. Yes.

20 Q. Again, I know it's tough to -- just

21 the line number, where is that again?

22 A. 39, 40, and 41.

Page 209

1 So this doesn't change my opinion

2 of what that definition means.

3 Q. It says that it "exhibits fast

4 disintegrability or dissolubility in the oral

5 cavity," and it goes on.

6 A. But I mean, it's talking about the

7 mouth.

8 Q. Right.

9 A. No matter what, it's talking about

10 the mouth.

11 Q. Right. Would you agree, though, in

12 column 17 and even down below that, it's talking

13 inside and outside of the mouth?

14 MS. CHOW: Objection to the form.

15 Q. 17, lines 56 down to 67.

16 A. To line, which 67? 6-7?

17 Q. Yes.

18 A. Well, I mean, it's almost what I

19 would call an off-label use. It's not the main

20 use. It's not the defining use. I don't look

21 at this as -- I am not even sure, you know, how

22 to react further other than to me the defining

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