EXHIBIT 31 

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1

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2 IN THE UNITED STATES DISTRICT COURT

3 FOR THE DISTRICT OF NEW JERSEY

4

5 TAKEDA PHARMACEUTICAL )

 COMPANY LIMITED, TAKEDA )

6 PHARMACEUTICALS NORTH )

 AMERICA, INC., TAKEDA ) Civil Action No.

7 PHARMACEUTICALS LLC, TAKEDA ) 3:11-CV-02506-

 PHARMACEUTICALS AMERICA, ) JAP-DEA

8 INC., and ETHYPHARM, S.A., )

 Plaintiffs, )

9 )

 vs. )

10 )

 MYLAN PHARMACEUTICALS, )

11 INC., )

 Defendant. )

12 ___________________________ )

13

14 DEPOSITION OF DR. RUSSELL MUMPER

15 New York, New York

16 June 6, 2012

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18

19

20 Reported By:

21 CATHI IRISH, RPR, CLVS, CCR

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25

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8 June 6, 2012

9 9:30 a.m.

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11 Deposition of DR. RUSSELL MUMPER, held

12 at the offices of Alston & Bird, 90 Park

13 Avenue, New York, New York, before Cathi

14 Irish, a Registered Professional Reporter and

15 Notary Public of the State of New York.

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2 A P P E A R A N C E S:

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4 HOGAN LOVELLS US LLP

5 Attorneys for Plaintiffs

6 875 Third Avenue

7 New York, New York 10022

8 BY: ARLENE L. CHOW, ESQ.

9 TAKASHI OKUDA, ESQ.

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11 ALSTON & BIRD LLP

12 Attorneys for Defendant

13 90 Park Avenue

14 New York, New York 10016

15 BY: DEEPRO R. MUKERJEE, ESQ.

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2 D R. R U S S E L L M U M P E R, called

3 as a witness, having been duly sworn by a

4 Notary Public, was examined and testified

5 as follows:

6 EXAMINATION

7 BY MS. CHOW:

8 Q. Good morning.

9 A. Good morning.

10 Q. How many times have you been deposed?

11 A. One time previously.

12 Q. Was that in the context of a patent

13 litigation?

14 A. It was.

15 Q. How many times have you prepared an

16 expert report?

17 A. I prepared two for the Watson Cephalon

18 trial and so those are expert reports, and I

19 obviously prepared the declaration for this trial.

20 Q. Okay. For the Watson case, did you

21 prepare an expert report in relation to claim

22 construction?

23 A. No.

24 Q. Just generally, was it in relation to

25 infringement, validity?

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1 MUMPER

2 A. It was -- the first one was

3 infringement. Second one was validity.

4 Q. And did that case involve an orally

5 disintegrating tablet?

6 A. It did.

7 Q. Did that case go to trial?

8 A. It did.

9 Q. What was the product at issue?

10 A. This was Cima and Cephalon, two

11 companies. This was their Fentora product, buccal

12 effervescent fentanyl.

13 Q. So that product was a buccal

14 effervescent ODT; is that correct?

15 MR. MUKERJEE: Objection.

16 MS. CHOW: You may answer.

17 MR. MUKERJEE: You may answer.

18 THE WITNESS: Yes.

19 BY MS. CHOW:

20 Q. Where did that ODT disintegrate?

21 A. In the buccal cavity.

22 Q. What do you mean by in the buccal

23 cavity?

24 A. That the Fentora product was meant to

25 be inserted into the mouth, placed against the

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2 cheek, the buccal tissue, and disintegrate at that

3 point.

4 Q. Now, that product was an ODT so that

5 was an orally disintegrating tablet; is that

6 correct?

7 MR. MUKERJEE: Objection.

8 THE WITNESS: That is correct.

9 BY MS. CHOW:

10 Q. Could that product be administered

11 outside of the mouth?

12 A. Can you clarify by what you mean

13 administered outside of the mouth.

14 Q. I understand. Were there different

15 forms of administration for that product?

16 A. The prescribing information had

17 explicit instructions that the tablet was to be

18 placed in the mouth against the buccal tissue at

19 which time it would disintegrate, produce

20 effervescence and the claim was that effervescence

21 would promote absorption of the active fentanyl.

22 Q. Was that product disintegrated outside

23 of the mouth in water prior to administration to

24 the patient?

25 MR. MUKERJEE: Objection, form.

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1 MUMPER

2 THE WITNESS: I don't know if it was.

3 I do know. I recall from the prescribing

4 information that it was very clear that it was

5 to be placed in the mouth. Now, did patients

6 -- or doctors instruct their patients to

7 predissolve it in water? They may have. I

8 have no knowledge of that.

9 BY MS. CHOW:

10 Q. For your infringement report, did you

11 opine on claim construction of the patent?

12 MR. MUKERJEE: Objection, asked and

13 answered.

14 THE WITNESS: No, claim -- there was an

15 agreement before I was to write my expert

16 reports about claim construction, so I didn't

17 write a report specifically about claim

18 construction. There may have been in my

19 noninfringement report my opinions about what

20 certain terms meant.

21 BY MS. CHOW:

22 Q. Okay. Are you saying that there was a

23 claim construction in place prior to your opining

24 on infringement; is that what you're saying?

25 A. As I recall, the judge was deferring

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1 MUMPER

2 claim construction judgment and was including

3 that in the noninfringement and validity

4 contentions to be decided at trial, is my best

5 understanding.

6 Q. What law firm did you work with in that

7 case?

8 A. Frommer Lawrence & Haug.

9 MS. CHOW: I'm going to mark as Mumper

10 Exhibit 1 U.S. patent 6,328,994.

11 (Mumper Exhibit 1, U.S. patent

12 6,328,994, marked for identification.)

13 BY MS. CHOW:

14 Q. Do you recognize this document?

15 A. Yes.

16 Q. Is it the patent-in-suit or one of the

17 patents-in-suit at issue in this case?

18 A. Yes.

19 Q. I'd like to direct your attention to

20 claim 1. It's in column 37.

21 As you can see, claim 1 includes a

22 sustained-release agent. Do you see that?

23 MR. MUKERJEE: Objection.

24 THE WITNESS: I see sustained-release

25 agent listed in claim 1.

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2 BY MS. CHOW:

3 Q. Okay. What is the purpose of the

4 sustained-release agent in claim 1 of the '994

5 patent?

6 MR. MUKERJEE: Objection.

7 THE WITNESS: As I understand the

8 purpose of the sustained-release agent as

9 written in the '994 patent is the traditional

10 meaning of a sustained-release agent as known

11 by people skilled in the art on what a

12 sustained-release agent would do to prolong or

13 sustain drug release based on producing

14 diffusional barrier to control the rate of

15 drug release and defusion through that barrier

16 over time. Ultimately to sustain blood levels

17 over a period of time.

18 BY MS. CHOW:

19 Q. Is it your position that the orally

20 disintegrable tablet described in claim 1 of the

21 '994 patent is a sustained-release product?

22 MR. MUKERJEE: Objection.

23 THE WITNESS: That's not my position.

24 My position is that the tablet described in

25 claim 1 contains a sustained-release agent.

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2 BY MS. CHOW:

3 Q. So is it your position that the tablet

4 contains a sustained-release agent but it does not

5 have sustained-release functionality?

6 MR. MUKERJEE: Objection.

7 THE WITNESS: I have no knowledge on

8 whether the tablet described in claim 1 has

9 sustained-release properties. My position is

10 the tablet in claim 1 contains a

11 sustained-release agent that was well known at

12 the time of filing to provide certain

13 functions and those were described in my

14 declaration.

15 BY MS. CHOW:

16 Q. So it is your understanding that the

17 tablet described in claim 1 of the '994 patent

18 does not necessarily have sustained-release

19 properties?

20 MR. MUKERJEE: Objection,

21 mischaracterizes his testimony.

22 THE WITNESS: My position is that the

23 tablet that's described in claim 1 may not

24 necessarily be a sustained-release tablet but

25 that it contains a sustained-release agent by

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1 MUMPER

2 definition.

3 BY MS. CHOW:

4 Q. So why is a sustained-release agent

5 included in the tablet described by claim 1 of the

6 '994 patent?

7 MR. MUKERJEE: Objection.

8 THE WITNESS: So in my reading of the

9 '994 patent, it is silent as to the purpose of

10 the inclusion of a sustained-release agent in

11 the tablet that's described in claim 1. In

12 the specifications that mention the term

13 sustained-release agent, that has well-known

14 meaning in the field to people of ordinary

15 skill. And so I look at the sustained-release

16 agent, its well-known function to control or

17 sustain drug release, and I would conclude

18 that it was -- I would conclude that it was

19 included in the tablet to impart those types

20 of properties.

21 BY MS. CHOW:

22 Q. So is it your position that you can

23 surmise what the purpose of the sustained-release

24 agent is in the tablet described by claim 1 of the

25 '994 patent based on your understanding of one of

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2 skill in the art but not based on what is taught

3 in the specification?

4 MR. MUKERJEE: Objection.

5 THE WITNESS: Can you repeat that

6 question, please?

7 BY MS. CHOW:

8 Q. So is it your position that you can

9 surmise what the purpose of the sustained-release

10 agent is in the tablet described by claim 1 of the

11 '994 patent based on your understanding of one of

12 skill in the art but not based on what is taught

13 in the specification?

14 MR. MUKERJEE: Same objection.

15 THE WITNESS: So my position is that

16 the '994 patent, the specifications talk about

17 a sustained-release agent but they don't teach

18 explicitly and literally the function of the

19 sustained-release agent. So as I read that, I

20 understand what a sustained-release agent is

21 and what its purpose is and I conclude that

22 that was the purpose of the sustained-release

23 agent in claim 1.

24 I understand in looking at the

25 prosecution history, the Shimizu declaration

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2 and the Byrn declaration, that they are

3 alleging that the sustained-release agent has

4 a different function as I conclude that the

5 sustained-release agent would have after

6 reading the '994 patent.

7 BY MS. CHOW:

8 Q. Let's go to the patent, column 19,

9 lines 9 through 31.

10 Are you there?

11 A. Column 19, lines 9 through 31.

12 Q. Actually it's probably more -- sorry,

13 starting at line 25. So it's more 25 to 31. It's

14 a portion of the specification described as acid

15 resistance, okay? Do you see the acid resistance

16 test?

17 A. I do.

18 Q. What is the purpose of the

19 acid-resistance test in the '994 patent as set

20 forth under column 19?

21 MR. MUKERJEE: Objection. Dr. Mumper

22 can take as much time as he needs.

23 BY MS. CHOW:

24 Q. Dr. Mumper, is this the first time

25 you've considered this question, what is the

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2 purpose of the acid-resistance test in the '994

3 patent?

4 MR. MUKERJEE: Objection.

5 THE WITNESS: No.

6 BY MS. CHOW:

7 Q. So my question --

8 A. Can you repeat the first question?

9 (Record read.)

10 MR. MUKERJEE: Same objection.

11 THE WITNESS: In my opinion, the

12 purpose of the acid-resistance test is to

13 verify the integrity of the enteric coating on

14 the granule and my opinion is consistent with

15 what is taught in the '994 patent. I'm

16 looking for that particular paragraph and I

17 have not been able to identify it on this

18 document.

19 BY MS. CHOW:

20 Q. In the '994 patent, what helps protect

21 the integrity of the enteric coat of the orally

22 disintegrating tablet?

23 MR. MUKERJEE: Objection.

24 THE WITNESS: You said orally

25 disintegrating tablet?

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2 BY MS. CHOW:

3 Q. In the tablet taught by the '994

4 patent, what helps protect the integrity of the

5 enteric coat?

6 MR. MUKERJEE: Objection.

7 THE WITNESS: So the '994 patent

8 teaches an orally disintegrable tablet which

9 in my opinion is different. What protects the

10 integrity of the enteric coating is the fact

11 that the enteric coating agent has specific

12 physical chemical properties and when it is

13 coated on the granules is insoluble and will

14 not dissolve at low pH of the stomach, will

15 dissolve at higher pHs as the acidic moieties

16 become ionized.

17 BY MS. CHOW:

18 Q. Does the sustained-release agent help

19 protect the integrity of the enteric coat in the

20 tablet taught by the '994 patent?

21 A. I have no specific knowledge on whether

22 the sustained-release agent helps protect the

23 integrity of the enteric coating on top of the

24 granules. I know that in the Shimizu declaration,

25 it was claimed and concluded by Shimizu that it

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2 does.

3 Q. In preparing your report, did you

4 investigate the physical properties of known

5 sustained-release agents?

6 MR. MUKERJEE: Objection.

7 THE WITNESS: In preparing my report,

8 and specifically to help develop my opinion on

9 the term sustained-release agent, I did do --

10 I relied on references that are in my

11 declaration as well as my own knowledge of

12 what a sustained-release agent function is in

13 an orally -- in oral tablets.

14 BY MS. CHOW:

15 Q. Do you have any understanding as to

16 whether or not known sustained-release agents can

17 be used to cushion enteric coats?

18 A. Can you repeat the question?

19 Q. Do you have any understanding as to

20 whether or not known sustained-release agents can

21 help protect the integrity of enteric coats on

22 tablets?

23 A. I'd like you to repeat the question

24 because I think you asked two different forms that

25 have two different meanings to me of what a

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2 sustained-release agent would be doing.

3 Q. Do you have any understanding as to

4 whether or not known sustained-release agents can

5 help protect the integrity of the enteric coat?

6 A. I have knowledge of agents that have

7 been included in enteric coatings that are

8 intended to be added during the enteric coating

9 process. These agents may have other functions in

10 the -- in dosage forms such as sustained-release.

11 Q. You're not answering my question. The

12 question was very specifically tailored to

13 protecting the integrity of the enteric coat. I'm

14 using your own words, okay, so do you have any

15 understanding whether or not sustained-release

16 agents can help protect the integrity of the

17 enteric coat?

18 MR. MUKERJEE: Objection, asked and

19 answered.

20 THE WITNESS: I think I am answering

21 the question. Excipients in dosage forms, if

22 you look at the Handbook of Pharmaceutical

23 Excipients, Merck Index, they can have many

24 different functions and what I said was that

25 agents can be -- I'm aware of agents being

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2 Application Publication 2009/0304789, marked

3 for identification.)

4 BY MS. CHOW:

5 Q. I'm just going to direct your attention

6 to paragraphs 84 and 86 which is on page 5.

7 A. Can you tell me again the paragraphs

8 you would like me to look at?

9 Q. Paragraph 84 and then paragraph 86, and

10 just so you know where I'm going, paragraph 86

11 mentions Eudragit L30D-55 so that's --

12 A. I've read paragraphs 84 and 86.

13 Q. Does U.S. 2009/0304789 teach that

14 Eudragit L30D-55 can be used as a

15 sustained-release agent?

16 MR. MUKERJEE: Objection. Again,

17 Dr. Mumper, if you need to read any other

18 portions for context, feel free to do so.

19 THE WITNESS: I would have to read the

20 whole -- this is the first time I've seen this

21 patent application publication, so I would

22 have to read the whole thing to understand

23 what they are teaching.

24 BY MS. CHOW:

25 Q. Based on what you've read so far, is

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2 this patent application associating Eudragit

3 L30D-55 with sustained-release functionality?

4 MR. MUKERJEE: Objection. Again, if

5 you need to read other portions for context,

6 feel free to do so.

7 THE WITNESS: I don't know what it's

8 associating until I read the whole patent.

9 BY MS. CHOW:

10 Q. Is it possible for a specific Eudragit

11 to be used as both a sustained-release agent and

12 an enteric coating agent?

13 A. I think the answer to that question is

14 related to my clarification request before, as in

15 what context? In the context of coating a

16 drug-coated inert core where you have an enteric

17 coating and that enteric coating of a Eudragit

18 must have well-known properties to be an enteric

19 coating, or is it in general, any Eudragit

20 available in any context in any dosage form,

21 whether it be a granule, a tablet, a gel,

22 anything. Can it be used as both? Is that what

23 you're asking, the latter?

24 Q. I'm asking you as one of skill in the

25 art, is it your understanding that a specific

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2 Eudragit can be used as both a sustained-release

3 agent and an enteric coating agent? Is that

4 possible?

5 MR. MUKERJEE: Objection.

6 THE WITNESS: I think that question

7 needs context for me. Again, if it's an oral

8 dosage form and you have a coated tablet or

9 coated granules and you want to impart acid

10 resistance to its context, you need certain

11 properties of that Eudragit.

12 Specifically as it relates to '994, if

13 you wanted to impart an enteric coating to

14 granules to provide acid resistance, that

15 coating of the appropriate enteric coating

16 agent would not be a sustained-release agent.

17 So I think to answer your question in the most

18 general way, I would need to take a specific

19 dosage form understanding what functions you

20 wanted to have of that dosage form to answer

21 that question.

22 BY MS. CHOW:

23 Q. Now, you previously testified that you

24 reviewed the Shimizu declaration that was

25 submitted during the prosecution of the '994

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2 patent in relation to the acid-resistance test; is

3 that right?

4 A. I reviewed the Shimizu declaration.

5 Q. Is it your understanding that

6 Dr. Shimizu represented that the sustained-release

7 agent was used in the '994 to help protect the

8 integrity of the enteric coat?

9 MR. MUKERJEE: Objection.

10 THE WITNESS: As I recall from the

11 declaration of Dr. Shimizu, that he utilized

12 the example 9 in the '994 patent and compared

13 that to a prior art formulation and concluded

14 in the declaration or tested the two

15 formulations, one from example '994 and one

16 from the prior art and looked at

17 acid-resistance, and from that acid-resistance

18 data made the conclusion that the example 9 in

19 the '994 patent provided greater

20 acid-resistance which he attributed to the

21 ability of the sustained-release agent to

22 cushion or provide protection to the enteric

23 coating layer.

24 BY MS. CHOW:

25 Q. So it's your understanding that the

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2 inventor told the PTO during the prosecution of

3 the '994 patent that the sustained-release agent

4 provided protection to the enteric coating layer;

5 is that correct?

6 MR. MUKERJEE: Objection. Maybe,

7 Arlene, you want to put the declaration in

8 front of the witness.

9 THE WITNESS: Can I have the

10 declaration to review?

11 MS. CHOW: Sure. I was just restating

12 your testimony. I was repeating it.

13 Let's mark as Mumper 4 a declaration by

14 Toshihiro Shimizu dated December 18, 2000.

15 (Mumper Exhibit 4, declaration by

16 Toshihiro Shimizu, marked for identification.)

17 THE WITNESS: My recollection as I just

18 stated is consistent with Shimizu's conclusion

19 in the -- in his declaration that the example

20 B from example 9 in '994 had suitable strength

21 and was not damaged through production and had

22 superior acid-resistance, and he concluded

23 that the coating layer of fine granules of the

24 present invention are not damaged after

25 compression or shock and further has superior

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2 acid resistance. His conclusion is

3 consistent with my recollection as I just

4 described.

5 BY MS. CHOW:

6 Q. And he concluded that the

7 sustained-release agent was responsible for the

8 superior acid-resistance, correct?

9 A. He did not explicitly state that in the

10 conclusion. What he explicitly stated was that

11 the coating layer is not damaged and has superior

12 acid-resistance. His conclusion did not

13 explicitly state that it was because of the

14 sustained-release agent.

15 Q. But you derive that from his

16 declaration?

17 MR. MUKERJEE: Objection.

18 THE WITNESS: I'm acknowledging what

19 he's concluding as his conclusion. He didn't

20 conclude specifically and literally that the

21 sustained-release agent was responsible for

22 providing that superior acid-resistance. In

23 comparing example A to example B, those were

24 different formulations with different

25 ingredients and so...

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2 BY MS. CHOW:

3 Q. Is it your position that this Shimizu

4 declaration, which is Mumper 4, has no bearing on

5 the claim construction for, in quotes, "an enteric

6 coating layer comprising a first component which

7 is an enteric coating agent and a second component

8 which is a sustained-release agent"?

9 MR. MUKERJEE: Objection, form.

10 THE WITNESS: You asked if that's my

11 position or -- that's not my position.

12 BY MS. CHOW:

13 Q. So it's your position that Mumper 4,

14 which is the Shimizu declaration, has bearing on

15 the claim construction for, in quotes, "an enteric

16 coating layer comprising a first component which

17 is an enteric coating agent and a second component

18 which is a sustained-release agent"?

19 A. I believe that the Shimizu declaration

20 is very important for -- and I used it and relied

21 upon it to determine claim construction as it

22 relates to the '994 patent.

23 Q. Now, let's look at the patent again.

24 I'm just going to grab an example. Let's just

25 take example 1, okay?

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2 A. I'm sorry, this is the '994?

3 Q. Yes, Mumper 1.

4 A. Okay.

5 Q. Now, example 1 includes Eudragit NE30D

6 and enteric coat. Do you see that? That's in

7 column 20 of the '994 patent.

8 A. In column 20, line 32 or so I see

9 Eudragit NE30D.

10 Q. In example 1, is the Eudragit NE30D

11 used to release the active ingredient at a

12 predetermined rate in order to maintain a constant

13 or prolonged drug concentration for a specific

14 period of time?

15 A. I'm sorry, you said L30D-55.

16 Q. No. Oh, you're reading into my

17 question but no. Example 1. That's funny.

18 Is the Eudragit NE30D used to release

19 the active ingredient at a predetermined rate in

20 order to maintain a constant or prolonged drug

21 concentration for a specific period of time?

22 A. So NE30D and why it's used in example

23 1?

24 Q. Yes, that's correct?

25 A. Or its function in example 1.

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2 My opinion is that Eudragit NE30D in

3 example 1 is used as -- or is a sustained-release

4 agent that's present at a defined ratio relative

5 to the enteric coating agent and is added at the

6 same time as the enteric coating agent to impart

7 the function as a sustained-release agent.

8 MR. MUKERJEE: Arlene, it's 11 o'clock.

9 As I indicated, I need five minutes.

10 MS. CHOW: Why don't we make it a

11 10-minute break.

12 MR. MUKERJEE: That's fine.

13 (Recess taken from 11:00 a.m. to

14 11:13 a.m.)

15 BY MS. CHOW:

16 Q. You didn't answer my question actually

17 before the break so I'm going to ask it again.

18 Example 1 of the '994 patent, is

19 Eudragit NE30D used to release the active

20 ingredient at a predetermined rate in order to

21 maintain a constant or prolonged drug

22 concentration for a specific period of time?

23 A. I don't have any knowledge of how

24 Eudragit NE30D functions in this specific example.

25 I will say that Eudragit NE30D is taught by the

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2 inventors to be a sustained-release agent and as a

3 matter of function, sustained-release agents are

4 known to prolong or control the rate of drug

5 release.

6 Q. Would your answer be the same for

7 example 2, example 3, example 4, example 5,

8 example 6, example 7, example 8, and example 9 of

9 the '994 patent?

10 MR. MUKERJEE: Objection. Dr. Mumper,

11 take as much time as you need to go through

12 each of these examples.

13 THE WITNESS: And you're asking

14 specifically about the Eudragit NE30D?

15 BY MS. CHOW:

16 Q. I'll restate the question. In examples

17 2 -- so this is the question.

18 In examples 1 through 9 of the '994

19 patent, is the Eudragit NE30D being used to

20 release the active ingredient at a predetermined

21 rate in order to maintain a constant or prolonged

22 drug concentration for a specific period of time?

23 THE WITNESS: I would like the reporter

24 to, if you could read back my answer to the

25 previous question. I think that's what you're

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2 asking me.

3 (The following was read by the reporter:

4 "ANSWER: I don't have any knowledge of

5 how Eudragit NE30D functions in this specific

6 example. I will say that Eudragit NE30D is

7 taught by the inventors to be a

8 sustained-release agent and as a matter of

9 function, sustained-release agents are known

10 to prolong or control the rate of drug

11 release.")

12 THE WITNESS: So my answer, my previous

13 answer would be the same as you asked for

14 examples 2 through 9.

15 BY MS. CHOW:

16 Q. So you don't have any knowledge of how

17 Eudragit NE30D is functioning in examples 1

18 through 9 of the '994 patent, yes?

19 MR. MUKERJEE: Objection.

20 THE WITNESS: I don't have knowledge as

21 to how Eudragit NE30D is functioning in the

22 tablets in examples 1 through 9.

23 BY MS. CHOW:

24 Q. Okay. Similar question.

25 In claim 1 of the '994 patent, is the

45

1 MUMPER

2 sustained-release agent used to release the active

3 ingredient at a predetermined rate in order to

4 maintain a constant or prolonged drug

5 concentration for a specific period of time?

6 A. I don't have any knowledge of whether

7 the sustained-release agent listed in claim 1 is

8 causing the drug in the tablets to be released in

9 a prolonged or sustained manner.

10 Q. Is it your understanding that claim 1

11 is not limited to examples 1 through 9 of the '994

12 patent?

13 MR. MUKERJEE: Objection, calls for a

14 legal conclusion.

15 THE WITNESS: Can you restate the

16 question?

17 BY MS. CHOW:

18 Q. Is claim 1 of the '994 patent limited

19 to just the examples 1 through 9?

20 MR. MUKERJEE: Same objection, calls

21 for a legal conclusion.

22 THE WITNESS: Would you like me to

23 answer?

24 BY MS. CHOW:

25 Q. Absolutely.

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1 MUMPER

2 A. My understanding is consistent with the

3 statement in '994 that the examples are

4 illustrative but by no means limit the present

5 invention.

6 Q. Now, I'd like to direct your attention

7 to column 16, lines 37 through -- you know what,

8 it's roughly around line 40. The patent states

9 the coating layer may be constructed by plural

10 layers.

11 Do you see that?

12 A. I see that.

13 Q. Is it your understanding that the

14 enteric coating layer of claim 1 can be

15 constructed by plural layers?

16 MR. MUKERJEE: Objection.

17 THE WITNESS: My understanding from

18 column 16, line 37, is that the enteric

19 coating layer, there may be more than one.

20 There could be two, there could be three, but

21 that each enteric coating layer must contain

22 both an enteric coating agent and a

23 sustained-release agent together in each

24 layer.

25 MS. CHOW: Let me mark as Exhibit

47

1 MUMPER

2 Mumper 5 the joint claim construction

3 statement that was entered into in this case

4 by the parties.

5 (Mumper Exhibit 5, joint claim

6 construction statement, marked for

7 identification.)

8 BY MS. CHOW:

9 Q. And I'll direct your attention to page

10 11 just to cut to the chase. Have you seen that

11 document before?

12 A. I believe I've seen this document

13 before.

14 Q. All right. Now, you see there that

15 plaintiffs have a construction for enteric coating

16 layer on top of page 11; do you see that? I'm

17 going to read it into the record.

18 So plaintiffs' construction for enteric

19 coating layer is the enteric coating layer may be

20 constructed by plural (e.g. 2 or 3) layers.

21 Do you see that?

22 A. I see the enteric coating layer may be

23 constructed by plural (e.g. 2 or 3) layers.

24 Q. Is there anything wrong with that

25 construction?

48

1 MUMPER

2 MR. MUKERJEE: Objection.

3 THE WITNESS: What do you mean by

4 wrong?

5 BY MS. CHOW:

6 Q. Do you disagree with it? Basically I

7 don't know if you agree or disagree with it so I

8 want to know, do you agree or disagree?

9 A. I think that that statement, the

10 enteric coating layer may be constructed by plural

11 (e.g. 2 or 3) layers is verbatim from column 16,

12 line 37 and 38, and so it's consistent with '994.

13 Q. Okay. So you don't disagree with it,

14 correct?

15 Maybe you didn't hear it. Strike that

16 question.

17 A. I was just carefully thinking of my

18 answer.

19 Q. Oh, you are? Because I couldn't tell

20 whether you heard or not.

21 A. You're asking if I disagree or agree

22 with that statement?

23 Q. You're saying it's consistent with the

24 patent?

25 A. It's consistent with the patent.

49

1 MUMPER

2 Q. That's fine.

3 Let's turn to page -- I think it's up

4 one, page 8 of Mumper 5, okay?

5 Now, this is the construction for

6 enteric coating layer comprising a first component

7 which is an enteric coating agent and a second

8 component which is a sustained-release agent.

9 Now, you see plaintiffs' construction

10 right there?

11 A. Yes.

12 Q. It's my understanding that you disagree

13 with plaintiffs' construction for this claim term;

14 is that correct?

15 A. Yes.

16 Q. Is there anything fundamentally wrong

17 with plaintiffs' construction?

18 MR. MUKERJEE: Objection.

19 BY MS. CHOW:

20 Q. So it's one thing if you disagree with

21 it but I'm asking you if there's anything wrong

22 with it.

23 MR. MUKERJEE: Objection.

24 THE WITNESS: I'd like you to clarify

25 the word "wrong" and what do you mean by

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2 any kind?

3 MR. MUKERJEE: Objection.

4 THE WITNESS: When -- when measuring

5 granule size of a powder, you typically have a

6 span of particles and an average and so you

7 would report the data as an average plus a

8 standard deviation with respect to the span or

9 the breadth of that particle size population.

10 That's different than the error that might be

11 associated with measuring the average particle

12 size and the span of that granule population.

13 BY MS. CHOW:

14 Q. Are you familiar with the USP or the

15 U.S. Pharmacopeia?

16 A. I am familiar with the USP.

17 Q. What is it?

18 A. It is a compendium of industry-accepted

19 guidelines on various aspects related to raw

20 materials, drugs and the testing of those.

21 Q. Does the USP set forth the standards

22 for persons of skill in the art of pharmaceutical

23 sciences?

24 MR. MUKERJEE: Objection, form.

25 THE WITNESS: Can you repeat the

59

1 MUMPER

2 question?

3 BY MS. CHOW:

4 Q. Does the USP set forth standards for

5 persons of skill in the pharmaceutical arts?

6 A. In my opinion, the USP sets forth a

7 series of guidelines to guide the industry on

8 acceptable specifications and methods to test raw

9 materials, ingredients and drugs.

10 Q. Does the USP set forth a series of

11 guidelines to guide the pharmaceutical industry on

12 acceptable specifications and methods in relation

13 to average particle size measurements?

14 MR. MUKERJEE: Objection.

15 THE WITNESS: That question is a

16 general question to me because what the USP

17 does is it has guidelines on the testing of

18 powders and particle sizes of those powders

19 based on a specific measure -- method of

20 measurement, so there's not a specification

21 for general measurement because each method

22 that's used to measure particle size is

23 dependent on the method being used, the

24 instrument, and all of the parameters

25 associated with the use of that instrument to

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1 MUMPER

2 measure, in this case, average particle

3 diameter.

4 BY MS. CHOW:

5 Q. Do persons of skill in the art turn to

6 the USP for guidelines in relation to average

7 particle size measurements?

8 A. In my opinion, people of ordinary skill

9 in the art turn to the USP as a potential source

10 of guidelines to understand industry -- kind of

11 basic minimum industry standards of how one might

12 do that but that in my experience, an assay that

13 might be developed to determine average particle

14 size in a laboratory for research or product

15 purposes, those assays might be more rigorous than

16 the guidelines set out in the USP.

17 What the USP intends to do is kind of

18 bring all of the workers in the industry kind of

19 on the same page, per se, as to an accepted

20 practice but it's a minimum standard. It's not a

21 gold standard in my opinion.

22 Q. So the USP sets forth a minimum

23 standard for the pharmaceutical industry but not

24 necessarily the gold standard; is that your

25 testimony?

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1 MUMPER

2 A. My testimony is that in my opinion that

3 the USP sets forward a minimum standard for the

4 testing of various ingredients or products but it

5 doesn't -- it doesn't articulate -- I said gold

6 standard. What I mean is the most rigorous

7 processes that one would employ for the purposes

8 of testing drugs and products for publication or

9 for registration of those products.

10 (Mumper Exhibit 6, U.S. Pharmacopeia

11 Chapter 429, marked for identification.)

12 MS. CHOW: I've marked as Mumper 6

13 U.S. Pharmacopeia Chapter 429 entitled

14 Light Diffraction Measurement of Particle

15 Size.

16 MR. MUKERJEE: Arlene, for the record,

17 it's a copy of the December 1, 2009 to

18 September 30, 2010 USP; is that correct?

19 MS. CHOW: I'll take your

20 representation.

21 MR. MUKERJEE: I'm just reading from

22 the top of the document you've marked as

23 Mumper 6.

24 MS. CHOW: Okay. The document says

25 what it says.

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1 MUMPER

2 particle diameter in '994 could be measured by

3 a number of assays to measure average particle

4 diameter, including laser diffraction, and the

5 HEROS RODOS is just one of the laser

6 diffractometers that could be used in that

7 class.

8 BY MS. CHOW:

9 Q. Do you agree that USP 429 sets forth a

10 standard of error for measurement of average

11 particle size?

12 A. Can you repeat the question or can you

13 read it back to me?

14 (Record read.)

15 THE WITNESS: The question, I just want

16 to be clear, it's general because this

17 specifically is talking about light

18 diffraction. So your question is specifically

19 related to light diffraction and whether or

20 not it sets forth an accepted standard of

21 error using laser diffraction to measure

22 particle size.

23 BY MS. CHOW:

24 Q. Okay.

25 A. Is that your question?

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1 MUMPER

2 Q. My question was: Do you agree that USP

3 429 sets forth a standard of error for measurement

4 of average particle size?

5 A. I am having problems with the question

6 because 429 talks about accepted -- accepted

7 fluxes or deviations around measurements that are

8 specific to why that measurement was done. So

9 replicates, system suitability, and so it lays it

10 out. So your question is -- and I should add

11 accuracy and repeatability.

12 So your question is very general

13 because 429 speaks to accepted fluxes in those

14 data for those different tests of which laser

15 light diffraction will help you to determine.

16 Q. Would one of skill in the art

17 understand that the average particle size

18 measurement required by claim 1 of the '994 patent

19 would include fluxes or deviations around those

20 measurements?

21 A. My opinion of claim 1 is that the

22 inventors claimed exactly what is stated here,

23 that fine granules having an average particle

24 diameter of 400 microns or less means that those

25 fine granules had an average particle diameter of

68

1 MUMPER

2 400 microns or less.

3 Now, there could be a flux around that

4 average based on the true distribution of the

5 particles but that the average particle diameter

6 was precisely 400 microns or less.

7 Q. What do you mean when you say there

8 could be a flux around that average based on the

9 true distribution of the particles? I guess I'm

10 not understanding. I mean it's your position that

11 the average -- there's basically a hard cutoff of

12 400 microns for the average particle diameter; is

13 that your testimony?

14 A. My testimony is that you have a true

15 average particle diameter of granules and so the

16 average is the 50 percent volume median diameter

17 as defined by '994, I accept that, and there will

18 be a true distribution of those particles. They

19 are not all, let's say, 390 or 300. There's a

20 flux of the true distribution of those particles.

21 They could be -- let's say it was 330,

22 they could be a range from 310 to 350 but the

23 average in that example is 330. That's what I

24 mean by the flux around the true average particle

25 diameter. It's a different question then to say

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1 MUMPER

2 what is the error associated with the measurement

3 of those particles.

4 My position then is with respect to

5 claim 1 is that the inventors stated what they

6 literally meant, the average particle diameter of

7 those fine granules is 400 microns or less. The

8 single 50 percent weighted volume parameter is

9 always 400 microns or less.

10 Q. So if I had a tablet that had an

11 average particle diameter of 405 microns, let's

12 say, is it your position it would fall outside

13 claim 1?

14 A. It would literally fall outside of

15 claim 1, in my opinion.

16 Q. If I had a tablet that had an average

17 particle diameter of 401 microns, is it your

18 position it would fall outside claim 1?

19 A. If the average particle diameter was

20 401, it would literally fall out of claim 1 in

21 '994.

22 Q. Is it your understanding that average

23 particle diameter and maximum particle diameter

24 are two distinct concepts?

25 A. My understanding is that average

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1 MUMPER

2 particle diameter and maximum particle diameter

3 are two different concepts, two different things.

4 Q. Now, I want you to look at the patent,

5 '994 patent. I want you to compare claim 1 and

6 claim 7.

7 Do you see that claim 7 captures the

8 concept of a maximum particle diameter of 425

9 microns or less?

10 MR. MUKERJEE: Objection as to form.

11 You can answer.

12 THE WITNESS: I believe that claim 7

13 says -- is referring to the particle diameter

14 of the fine granules as practically 425 or

15 less and that what I believe they are

16 referring to is the maximum particle diameter.

17 BY MS. CHOW:

18 Q. Now, your proposed claim construction

19 for average particle diameter incorporates maximum

20 particle diameter; is that correct? You can look

21 at the joint claim construction chart for

22 reference if you want. It's on page 13.

23 A. Thank you.

24 Yes, that is correct, my proposed claim

25 construction incorporates the maximum particle

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1 MUMPER

2 diameter with the average particle diameter, so

3 wherein the particle diameter of the fine granules

4 is 3- to 400 microns or less with a maximum

5 particle diameter of 425 or less.

6 Q. And there's also --

7 A. There's another one.

8 Q. There's also an earlier -- it's page 2.

9 So your construction for fine granules

10 having an average particle diameter of 400 microns

11 or less incorporates maximum particle diameter; is

12 that right?

13 A. Yes, my proposed claim construction

14 states fine granules having an average particle

15 diameter of 400 microns or less with a maximum

16 particle diameter of 425 microns or less. So both

17 of those are incorporated into the claim

18 construction.

19 Q. So your claim construction for really

20 claim 1 of the patent incorporates a concept

21 that's already set forth in claim 7; is that

22 right?

23 MR. MUKERJEE: Objection.

24 THE WITNESS: I'm not sure I understand

25 the question. Can you restate it?

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1 MUMPER

2 BY MS. CHOW:

3 Q. Claim 7 describes maximum particle

4 diameter; is that right? Okay, yes, no?

5 A. Yes, that's true.

6 Q. When you provided the claim

7 construction for fine granules having an average

8 particle diameter of 400 microns or less for claim

9 1, did you take claim 7 into account?

10 A. I did take claim 7 into account. When

11 I constructed the claims, I looked at the term for

12 average particle diameter and I construed it from

13 the teaching of the '994 patent that the maximum

14 particle diameter was inherent in the teachings of

15 '994 with respect to the average particle diameter

16 of 400 micron or less in claim 1, and then I

17 concluded from that that claim 7 was superfluous.

18 It was not necessary, that inherent in claim 1 was

19 the concept of a maximum particle diameter as

20 taught by '994.

21 Q. Okay. So it's your position that claim

22 7 was superfluous and not necessary in light of

23 claim 1, correct?

24 A. My opinion was claim 7 was not

25 necessary in light of my proposed claim

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1 MUMPER

2 construction for claim 1.

3 Q. Okay.

4 Are you familiar with the Journal for

5 Pharmaceutical Sciences?

6 A. Journal of Pharmaceutical Sciences?

7 I'm familiar --

8 Q. I will defer to you on that.

9 A. I am familiar with the Journal of

10 Pharmaceutical Sciences.

11 Q. Is it peer reviewed?

12 A. Journal of Pharmaceutical Sciences is

13 peer reviewed.

14 Q. Have you published in it?

15 A. I have published in the Journal of

16 Pharmaceutical Sciences.

17 Q. Is it respected?

18 A. What do you mean by respected?

19 Q. Do persons of skill in the art rely

20 on -- strike that.

21 Are you familiar with the PQRI or the

22 Product Quality Research Institute?

23 A. I have heard of the institute and am

24 familiar with the basics of what they do.

25 (Mumper Exhibit 7, article from the

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2 thing, right?

3 A. Non-effervescent excipients and free

4 of organic acids do not mean the same thing to

5 me.

6 Q. Now, you understand that the claim

7 originally included the phrase "free of organic

8 acids" but that was subsequently dropped by the

9 patentee, right?

10 A. My understanding from the prosecution

11 history is that the inventors requested

12 reexamination of the patent based on the discovery

13 of 70 to 72 patents that had not previously been

14 disclosed. And in that analysis, they proposed a

15 reconstruction of their claim that included the

16 term "non-effervescent excipients free of organic

17 acids," and as I recall, the examiner looked at

18 that proposed claim amendment and concluded that

19 there was not sufficient evidence of the term

20 "free of organic acids" in the '632 specifications

21 and struck that.

22 MS. CHOW: I'm going to mark as Mumper

23 12, U.S. patent 5,047,247.

24 (Mumper Exhibit 12, U.S. patent

25 5,047,247, marked for identification.)

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1 MUMPER

2 BY MS. CHOW:

3 Q. Is this familiar to you?

4 A. I recall this in a general way.

5 Q. Is USP 5,047,247 an effervescent

6 tablet?

7 MR. MUKERJEE: Objection. And

8 Dr. Mumper, take as much time as you need to

9 familiarize yourself with the document.

10 BY MS. CHOW:

11 Q. Or while you're skimming it, you can

12 look and see whether or not it teaches the use of

13 organic acids.

14 A. That's a second question because I can

15 answer that one.

16 Q. All right, answer that. Go ahead.

17 A. Column 3, line 29 and 30, preferably

18 citric acid is used as the organic acid.

19 Q. So this is a piece of prior art that

20 the patentee distinguished over during

21 prosecution, okay? So just so we're clear, USP

22 '247 does teach the use of organic acids, right?

23 MR. MUKERJEE: Objection. Again, take

24 as much time as you need.

25 THE WITNESS: '247 does utilize in

100

1 MUMPER

2 examples and in the specifications organic

3 acids like citric acid.

4 BY MS. CHOW:

5 Q. In rendering your opinions, did you

6 study whether or not USP '247 -- strike that.

7 In preparing your expert report, did

8 you assess whether or not the '247 patent

9 disclosed effervescent excipients?

10 A. Can you repeat that? I want to make

11 sure I heard that correctly.

12 (Record read.)

13 THE WITNESS: Yes, in reviewing -- in

14 preparing for my declaration, I considered

15 whether patents in the prosecuting history,

16 including '247, contained effervescent

17 excipients.

18 BY MS. CHOW:

19 Q. And does the '247 patent teach the use

20 of effervescent excipients?

21 MR. MUKERJEE: Objection.

22 THE WITNESS: In my opinion, '247 does

23 teach the use of an effervescent excipient or

24 excipient that is known to be an effervescent

25 excipient in their tablet.

101

1 MUMPER

2 BY MS. CHOW:

3 Q. Does the '247 patent teach the use of

4 an effervescent acid/base couple?

5 A. To the best of my knowledge, the '247

6 does not mention the word effervescent. It does

7 have excipients in the tablet that are known to be

8 effervescent excipients.

9 THE WITNESS: Can I ask to take a

10 five-minute break? Is that okay, just a bio

11 break? I wanted to ask before you ask another

12 question.

13 MS. CHOW: That's okay.

14 (Recess taken from 2:06 p.m. to

15 2:08 p.m.)

16 BY MS. CHOW:

17 Q. Keep the '632 in front of you.

18 A. Okay.

19 Q. That's Mumper 9.

20 What is gastroresistance?

21 A. Are you asking for my interpretation of

22 the '632 patent?

23 Q. No. I'm just asking you what is your

24 understanding of what gastroresistance is.

25 A. My understanding of gastroresistance in

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1 MUMPER

2 a general way is, and as it relates to dosage

3 forms, is the ability of the dosage form to

4 protect to some measurable amount an incorporated

5 drug substance from the enzymes and low pH that

6 would otherwise harm either chemically or

7 physically that drug substance.

8 Q. Does the '632 patent teach

9 gastroresistance?

10 MR. MUKERJEE: Objection as to form.

11 BY MS. CHOW:

12 Q. If you want, I can direct you to some

13 passages.

14 A. I can answer.

15 Q. Okay.

16 A. The '632 patent in column 3, lines 41

17 through 51 is talking about and teaching a tablet

18 according to this invention that permits or

19 impairs, imparts gastroresistance, and they are

20 referring to the drug.

21 Q. Does the patent associate

22 gastroresistance with the coating of -- strike

23 that.

24 Does the patent associate

25 gastroresistance with an enteric coat?

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1 MUMPER

2 MR. MUKERJEE: Objection.

3 THE WITNESS: In my opinion, '632

4 utilizes the well-known principle of enteric

5 coating as to impart gastroresistance or to

6 protect an acid sensitive drug from the

7 gastric or stomach environment.

8 BY MS. CHOW:

9 Q. And when you say the enteric coat

10 imparts gastroresistance or to protect an acid

11 sensitive drug from the gastric or stomach

12 environment, are you referring to the low pH of

13 the stomach?

14 A. As I mentioned earlier,

15 gastroresistance refers to -- the word "gastro"

16 refers to the stomach which is known to have high

17 concentration of enzymes and low pH.

18 Q. So for the '632 patent, the enteric

19 coat helps protect the active ingredient from the

20 low pH of the stomach, correct?

21 A. Yes.

22 Q. Is it fair to say the greater the

23 gastroresistance, the lesser the influence of the

24 low pH of the stomach?

25 A. Can you repeat that question? Or --

104

1 MUMPER

2 okay.

3 Q. Is it fair to say the greater the

4 gastroresistance, the lesser the influence of the

5 low pH of the stomach?

6 A. Can you clarify that question? The

7 lesser the influence of the pH of the stomach on

8 what?

9 Q. Oh, I see. Okay.

10 I'm just trying to get the correlation

11 between gastroresistance and pH. But is it fair

12 to say the greater the gastroresistance, the

13 lesser the influence of the low pH of the stomach

14 on the active ingredient?

15 A. I would say that if you had granules,

16 multiparticulate granules that are coated with an

17 enteric coating and you could measure

18 acid-resistance, let's say by doing an

19 acid-resistance test, that you would expect a

20 granule that had, let's say, more of a coating or

21 a sufficient coating and you showed that it was

22 more resistant, that the drug was more stable in

23 those granules, a drug that was acid sensitive,

24 that that would correlate, or the converse of that

25 is if you had a granule that had an instance

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1 MUMPER

2 sufficient or incomplete coating and you measured

3 more instability due to the low pH of the stomach,

4 so I think that's consistent and I think that's a

5 fair conclusion.

6 Q. Does gastroresistance means that there

7 is reduced pH influence in the digestive track?

8 MR. MUKERJEE: Objection.

9 THE WITNESS: No. I think in the

10 example that I just gave in answer to my last

11 question is that you have a measurable cause

12 and effect. And I think what's missing in

13 your question is being able to measure and

14 correlate the two.

15 BY MS. CHOW:

16 Q. So how would you phrase it, if

17 basically the flaw is in my question?

18 A. I think you're getting at the claim

19 construction and how I concluded that that claim

20 was indefinite, that term was indefinite, and my

21 conclusion is largely based on that you need to be

22 able to measure where you're starting from and

23 where you're going, and so just to have a general

24 statement that they are correlated I think is

25 indefinite.

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2 BY MS. CHOW:

3 Q. Okay. Let's isolate the term. Let's

4 just talk about orally disintegrable so you'll be

5 more comfortable with the question.

6 Let's say I have a tablet that

7 disintegrates only in water but not in the mouth.

8 Is that an orally disintegrable tablet?

9 A. I hear your question and you're asking

10 me a tablet that will only disintegrate in water?

11 Okay. So you have a glass of water. The tablet

12 will only disintegrate in water. That was your

13 words. So that means literally it cannot

14 disintegrate in saliva, only in water, so an

15 orally disintegrable tablet means one that is

16 capable of disintegrating in water or in saliva.

17 So based on the way you asked me that question, I

18 would say no, because you said it only

19 disintegrates in water, which means it's not

20 capable of disintegrating in saliva so it doesn't

21 meet that claim definition.

22 Q. Isn't your definition really that

23 orally disintegrable tablet means a tablet that

24 disintegrates in both water and saliva?

25 MR. MUKERJEE: Objection.

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1 MUMPER

2 BY MS. CHOW:

3 Q. You used the word "or" in our

4 conversation but I'm getting the sense it might be

5 "and" so can you just clarify for me?

6 MR. MUKERJEE: Objection,

7 mischaracterizes the witness's testimony.

8 THE WITNESS: My position about the

9 term disintegrable tablet is consistent in my

10 opinion with what '994 teaches about an orally

11 disintegrable tablet, that it can be

12 disintegrated in the mouth with very little

13 water and in the presence of saliva or it may

14 be administered dissolved or disintegrated

15 with water. My definition of disintegrable

16 tablet is in my opinion completely in

17 agreement with what '994 teaches.

18 BY MS. CHOW:

19 Q. I'm just trying to understand kind of

20 the boundaries of your claim construction, and it

21 seems to me that you're saying, but you can

22 correct me if I'm wrong, that an orally

23 disintegrable tablet does not include a tablet

24 that can only be disintegrated in water, right?

25 THE WITNESS: Can you read the question

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1 MUMPER

2 back to me?

3 (Record read.)

4 THE WITNESS: Maybe the way the

5 question is phrased I'm having problems with.

6 Again, my position in terms of claim

7 construction on what an orally disintegrable

8 tablet is is completely consistent with column

9 17, line '61 through '66, where it says that

10 it may be dissolved or disintegrated with

11 water and with saliva.

12 So in response to your question, this

13 tablet can -- is capable of disintegrating in

14 the oral cavity and per the teaching of '994,

15 the tablet may also be administered, dissolved

16 or disintegrated with water. So '994, again

17 what I am concluding is that they are teaching

18 a tablet that can do either, not one or the

19 other, but either and that's my position and

20 it's consistent with the teaching of '994.

21 BY MS. CHOW:

22 Q. I guess it seems to me there's a

23 distinction between two concepts. One concept is

24 what makes an orally disintegrable tablet an

25 orally disintegrable tablet, and there's a second

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1 MUMPER

2 concept which is how that tablet can be

3 administered. Do you understand what I'm trying

4 to say? I'm trying to understand in terms of your

5 fundamental definition for orally disintegrable

6 tablet. If there's a distinction between what in

7 essence makes an orally disintegrable tablet an

8 orally disintegrable tablet versus the fact that

9 there may or may not be various methods of

10 administering that orally disintegrable tablet.

11 That's what I'm trying to understand.

12 It's hard to ask these questions, hard

13 for you to answer but that's the root of my

14 questioning, okay?

15 A. And I was asked to opine about the

16 definitions of terms in the '994 patent. And one

17 of those terms that I very carefully considered is

18 the term disintegrable and what that means. And

19 again, that is an adjective that means it's

20 capable of disintegrating.

21 And when the '994 patent was applied

22 for, mid to late '90s, ODTs, orally disintegrating

23 tablet, that's a verb, that it must be a

24 disintegrating tablet. The inventors chose a word

25 that has a literal English meaning and that is an

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1 MUMPER

2 adjective meaning that it's capable with, and I,

3 in my opinion, the inventors were very careful in

4 using the word disintegrable instead of

5 disintegrating, and the reason I think in my

6 opinion that they use the word disintegrable

7 meaning capable of is they were explicitly

8 teaching different administration methods and

9 envisioned that their tablet that was capable of

10 disintegrating could be administered either

11 directly in the mouth or added to a tablet for

12 dissolution and disintegration and then that would

13 be swallowed.

14 Q. So if a tablet disintegrates in water

15 outside of the mouth and then is swallowed by the

16 patient, that falls under your construction of

17 orally disintegrable tablet, yes?

18 A. You're asking that question in a very

19 general way. I was asked to opine about '994 and

20 what the term orally disintegrable tablet means.

21 With respect to '994, if that tablet was placed in

22 water and then swallowed, consistent with the

23 teaching of '994 and their claim, I would agree

24 that's an orally disintegrable tablet.

25 Q. So now let me push it a little bit

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1 MUMPER

2 further.

3 If a tablet disintegrates in water

4 outside of the mouth and then is swallowed by the

5 patient but that same tablet cannot disintegrate

6 inside the mouth, okay, does that tablet fall

7 under your construction of orally disintegrable

8 tablet as set forth in the '994?

9 A. That now falls outside as required by

10 the '994 patent that when they talk about the

11 tablet, they mean a specific tablet that has the

12 properties of being able to -- it's capable of

13 dissolving or disintegrating with little water and

14 in the presence of saliva in the cavity, and it

15 says also the tablet. The same tablet may be

16 administered dissolved or disintegrated with

17 water.

18 So my answer when you asked the

19 question so if you have a tablet that is dissolved

20 in water and swallowed but that same tablet cannot

21 disintegrate in the mouth, that falls outside.

22 Q. So do you agree that it is a defining

23 characteristic of an orally disintegrable tablet

24 that it must be able to disintegrate inside the

25 mouth?

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1 MUMPER

2 A. So you're -- just so I understand you,

3 it must disintegrate in the mouth, the claim -- my

4 position is that it must be capable of, that an

5 orally disintegrating tablet could be applied --

6 I'm sorry, an orally disintegrable tablet may be

7 dosed by other routes of administration but it

8 must be capable. You asked the question it has

9 to.

10 Q. So is it a defining characteristic of

11 an orally disintegrable tablet that it must be

12 capable of disintegrating inside the mouth?

13 A. Per '994 teaching, specifically claim

14 1, an orally disintegrable tablet is a tablet

15 capable of disintegrating in the mouth. It

16 doesn't explicitly have to but it has to be

17 capable of.

18 Q. For the '632, does your construction

19 for orally disintegrable as set forth -- sorry,

20 strike that.

21 Does your construction for

22 disintegrable for the '994 patent apply equally to

23 the term disintegratable for the '632 patent?

24 MR. MUKERJEE: Objection, asked and

25 answered.

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1 MUMPER

2 THE WITNESS: In looking at '632, claim

3 1, a rapidly disintegratable tablet, as I have

4 said, that means that it's capable of

5 disintegrating. It's intended for oral

6 administration and it specifies disintegration

7 in the buccal cavity. So it's basically as

8 I -- in my opinion, what claim 1 is doing in

9 the first sentence is saying that you have a

10 rapidly -- you have a tablet that's capable of

11 disintegrating for oral administration, and it

12 specifies it must disintegrate in the buccal

13 cavity.

14 So what's different in '632, and I

15 think this is completely in line with my

16 position, is that it's specifying exactly

17 where the tablet must disintegrate. And it's

18 going a step further than just saying it's

19 capable. Now it's saying it has to

20 disintegrate in the buccal cavity. So where

21 the '994 patent said it's capable of

22 disintegrating in these different places,

23 claim 1 of the '632 is now being literally

24 very specific. A tablet that's capable of

25 disintegrating must be given orally and

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1 MUMPER

2 ordinary skill in the art of the '994 and '632

3 should have more education and more work

4 experience than what was set forth in the

5 omeprazole court decision?

6 MR. MUKERJEE: Objection.

7 THE WITNESS: That's not exactly what

8 I'm saying. I didn't say more education.

9 Just to be clear, I'm saying that the person

10 must have a higher degree. You could have

11 possibly someone with 10 undergraduate

12 degrees. That's a lot of education, perhaps

13 more time than one Ph.D.

14 What I am saying is that Dr. Byrn's

15 definition of someone with ordinary skill I

16 believe is incorrect in my experience and his

17 support for that definition of somebody with

18 ordinary skill is flawed.

19 BY MS. CHOW:

20 Q. Prior to this litigation, were you

21 familiar with Dr. Byrn? Had you heard his name

22 before, see his publications?

23 A. Yes, I know Dr. Byrn.

24 Q. Do you have any understanding as to his

25 reputation?

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1 MUMPER

2 A. Yes, I have my personal -- I have a

3 personal view on his reputation. I don't know how

4 others view his reputation.

5 Q. And what is your personal view?

6 A. Thank you.

7 Q. How could I not follow up on that

8 answer?

9 A. I've known Dr. Byrn for 20, 25 years.

10 Faculty at Purdue. I've listened to his lectures

11 before. He came down to the University of

12 Kentucky and gave a lecture. He was an expert

13 witness on the Watson Cephalon case on the third

14 patent, the one that I was not an expert witness

15 on.

16 My opinion of Dr. Byrn is that he is an

17 expert in -- and I highly regard him in the area

18 of solid state chemistry, crystalline habits of

19 drugs and powders, polymorphism, so aspects

20 related to solid state stability and

21 characterization of those materials, and his CV

22 lists 160 publications. I'm just estimating that

23 90 percent, 95 percent deal with what I just

24 described and so he's highly regarded in that

25 area.

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1 MUMPER

2 I do not know him to be a person with

3 the reputation in ODTs. He -- his curriculum

4 vitae does not document work with ODTs. I

5 understand that he claims to have submitted

6 proposals on ODTs and that in his laboratory or

7 laboratories, he's working on ODTs. That is not

8 indicated, at least to me, on his curriculum

9 vitae.

10 Q. What is your area of expertise?

11 A. My area of expertise is in the area of

12 drug delivery, advanced drug delivery systems. I

13 have pursued various types of delivery systems,

14 almost every route of administration, for 20 or 25

15 years. I teach a course on dosage forms. I

16 taught it for 13 years to pharmacy students and we

17 talked about ODTs and sustained-release oral

18 systems, and as I told you earlier, I was a expert

19 witness representing Watson in the Fentora case,

20 which is an ODT.

21 Q. Does your CV detail any work that you

22 have done on ODTs?

23 A. I do not think that my CV has the term

24 ODT.

25 Q. That doesn't answer my question.

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1 MUMPER

2 Does your CV describe any prior work by

3 you on ODTs?

4 A. I think I did answer the question. It

5 doesn't -- it doesn't mention the term orally

6 disintegrating tablet.

7 MS. CHOW: Okay. Let's take a break.

8 I just want to make sure I don't have any

9 follow-up questions.

10 (Recess taken from 4:00 p.m. to

11 4:14 p.m.)

12 MS. CHOW: I have no further questions

13 for you.

14 MR. MUKERJEE: Mylan has no questions.

15 (Time noted: 4:14 p.m.)

16

17 _________________________________

18 DR. RUSSELL MUMPER

19

20 Subscribed and sworn to before me

21 this _____ day of ____________, 2012.

22

23 _____________________________________

24 Notary Public

25

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