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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` U.S. Patent No. 8,329,216
`
`___________________________________
`
`AMNEAL PHARMACEUTICALS, LLC, ) Case
`
` ) No. Unassigned
`
` Petitioner, )
`
` )
`
` vs. )
`
` )
`
`ENDO PHARMACEUTICALS INC., )
`
` )
`
` Patent Owner, )
`
`___________________________________)
`
` - - -
`
` Wednesday, September 24, 2014
`
` - - -
`
` Deposition of ANTHONY PALMIERI III, PH.D., taken
`
`at the offices of Sterne Kessler Goldstein Fox,
`
`1100 New York Avenue NW, Washington, D.C., beginning
`
`at 9:35 a.m., before Nancy J. Martin, a RMR, CSR.
`
`VERITEXT NATIONAL COURT REPORTING COMPANY
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`ENDO - Ex. 2012
`Amneal v. Endo
`IPR2014-00360
`
`

`

`Page 2
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`Page 4
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`1 DEPOSITION SUPPORT INDEX
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`2 3
`
`DIRECTION TO WITNESS NOT TO ANSWER
`4 Page Line
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`5 6 7 8
`
`REQUEST FOR PRODUCTION OF DOCUMENTS
`9 Page Line
`10
`11
`12
`13 QUESTIONS MARKED:
`14 Page Line
`15
`16
`17
`18
`19
`20
`21
`22
`
`1 A P P E A R A N C E S :
`2
`
` MAYER BROWN LLP
`3 BY: JOSEPH A. MAHONEY, ESQUIRE
` ERICK J. PALMER, ESQUIRE
`4 71 South Wacker Drive
` Chicago, Illinois 60606
`5 (312) 701-8979
` Representing the Patent Owner
`
`678
`
` DECHERT LLP
` BY: ROBERT D. RHOAD, ESQUIRE
`9 902 Carnegie Center
` Princeton, New Jersey 08540
`10 (609) 955-3269
` Representing the Patent Owner
`
`11
`12
`
` STERNE KESSLER GOLDSTEIN FOX
`13 BY: ELDORA L. ELLISON, PH.D.,
` ATTORNEY AT LAW
`14 R. WILSON POWERS III, PH.D., ESQUIRE
` 1100 New York Avenue NW
`15 Washington, D.C. 20005
` (202) 371-2600
`16 Representing the Petitioner
`17
`18
`19
`20
`21
`22
`
`Page 3
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`Page 5
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`1 WASHINGTON, D.C., WEDNESDAY, SEPTEMBER 24, 2014,
`
`2 9:35 A.M.
`
` ANTHONY PALMIERI III, PH.D.,
`
`3 4
`
`5 having been first duly sworn,
`
`6 was examined and testified as follows:
`
` EXAMINATION
`
`7 8
`
`9 BY MR. MAHONEY:
`
`10 Q. Good morning, Dr. Palmieri. Can you state
`
`11 your full name for the record, please.
`
`12 A. Anthony Palmieri, III.
`
`13 Q. And we introduced ourselves before the
`
`14 deposition. I'm Joe Mahoney with the firm Mayer
`
`15 Brown. We represent patent owner Endo Pharmaceuticals
`
`16 in this proceeding, which is IPR 2014-0036. To my
`
`17 left is my colleague from Mayer Brown, Erick Palmer.
`
`18 Also attending is Robert Rhoad from the Dechert firm.
`
`19 And I understand that you've been through
`
`20 depositions before. So you understand the rules
`
`21 generally; is that right?
`
`22 A. That's correct.
`
`1 I N D E X
`2 TESTIMONY OF: ANTHONY PALMIERI III, PH.D.
`3 BY MR. MAHONEY.....................................5
`4 BY DR. ELLISON...................................204
`5 BY MR. MAHONEY...................................210
`
`6 7
`
` - - -
`8 E X H I B I T S
`9 - - -
`10 NUMBER DESCRIPTION PAGE
`11 Exhibit 1003 Declaration of Anthony 33
`12 Palmieri III, Ph.D.,
`13 110 pages
`14 Exhibit 1011 Review Article, Opioid 91
`15 Equianalgesic Calculations,
`16 10 pages
`17 Exhibit 1016 Curriculum Vitae, 14 pages 101
`18
`19
`20
`21
`22
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`Page 6
`
`1 Q. And how many times have you testified by
`2 deposition?
`3 A. As I recall, approximately 10 or so.
`4 Q. Okay. And have you testified at trial?
`5 A. Yes.
`6 Q. How many times?
`7 A. As I recall, 4 or 5.
`8 Q. And your testimony at trial, do you recall
`9 those 4 or 5 cases? In particular, the subject matter
`10 of those 4 or 5 cases?
`11 A. Yes.
`12 Q. And what were they about?
`13 A. They all involved -- excuse me. They all
`14 involved dose forms. As I recall, most of those
`15 involved sustained release, controlled release dosage
`16 forms.
`17 Q. And what were the actives? Active agents in
`18 those sustained release, extended release dosage form?
`19 A. I don't recall, but what I recall today is
`20 one on Tramadol.
`21 Q. And who engaged you on the Tramadol case?
`22 A. Sitting here today, I believe it was Par
`
`Page 8
`1 A. It might have been the last five or six. I'd
`2 have to look at my records. It's probably been five
`3 or six years.
`4 Q. Do you recall the outcome of that trial?
`5 A. As I recall, Par prevailed, but I'm not sure.
`6 Q. Okay. What other active ingredients have you
`7 testified at trial about?
`8 A. There was a trial concerning a sustained
`9 release -- excuse me. There was a trial concerning a
`10 dosage form concerning two actives, Naproxen and
`11 Sumatriptan.
`12 Q. And when was that trial?
`13 A. Within the last five years.
`14 Q. Which court?
`15 A. It was in Tyler, Texas, whatever court that
`16 is.
`17 Q. And who engaged you to provide your
`18 testimony?
`19 A. I don't recall.
`20 Q. Is this information on your CV? We might be
`21 able to save time.
`22 A. It's not on my CV. I believe it to be public
`
`Page 7
`
`Page 9
`
`1 Pharmaceuticals.
`2 REPORTER MARTIN: I'm sorry. Who?
`3 THE WITNESS: Par, P-a-r.
`4 BY MR. MAHONEY:
`5 Q. And where was the trial?
`6 A. The trial was in Delaware.
`7 Q. Do you remember the judge?
`8 A. I believe it was Kent Jordan, but I'm not
`9 exactly sure. I believe that was his name.
`10 Q. Okay. What was the subjects of your
`11 testimony in the Tramadol case?
`12 A. As I recall -- it was a number of years
`13 ago -- it had to do with sustained release
`14 formulations of Tramadol.
`15 Q. And did you provide opinions?
`16 A. Yes.
`17 Q. And what -- were those opinions directed to
`18 validity and infringement of patents?
`19 A. I don't recall if they were both, but it was
`20 certainly one or the other. I don't recall. That was
`21 a number of years ago.
`22 Q. Was it within the last five years?
`
`1 knowledge someplace, but it is not on my CV.
`2 Q. Any particular reason why you don't put it on
`3 your CV?
`4 A. No, other than the fact that it's information
`5 that is, as I understand it, information that parts of
`6 it may be public. Parts of it may not. I've never
`7 had a reason to include it in my CV except for a
`8 general statement that I've been an expert witness in
`9 patent litigations.
`10 Q. Your testimony in Tyler, Texas, did that
`11 relate to the validity and infringement of patents?
`12 A. As I recall, it did.
`13 Q. And by the way, all the trial testimony that
`14 you recall, the four or five trials, are all of those
`15 patent cases?
`16 A. There was an interaction a few years ago in
`17 San Francisco that was an arbitration case which was
`18 not a patent case. It was, in my layman's term, a
`19 violation of trade secret type of case.
`20 Q. And who engaged you in that case?
`21 A. I'd have to look at my records. I don't
`22 recall.
`
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`Page 10
`1 Q. All right. What other drug products have you
`2 testified about at trial?
`3 A. There were a few other trials, but I just
`4 don't recall. I'd have to look at my records.
`5 Q. What about intravenous acetaminophen? Did
`6 you testify at trial in that case?
`7 A. Oh, yes. Yes. Thank you. There was a trial
`8 concerning IV acetaminophen formulations.
`9 Q. In the Tramadol case, and I -- is it correct
`10 for me to assume that your trial testimony was public
`11 in the Tramadol case?
`12 A. I believe so. I'm not certain. I believe it
`13 was public.
`14 Q. In the Tramadol case what do you recall about
`15 the patent claim limitations in that case? In other
`16 words, were there issues about the formulation, about
`17 the pharmacokinetics, about food effect, about
`18 dissolution? Were any of those issues at play in the
`19 Tramadol case?
`20 A. Yes.
`21 Q. Which ones?
`22 A. As I recall, it was -- it certainly was
`
`Page 11
`1 dissolution parameters in the claims. I don't recall
`2 if it was specific excipients or not.
`3 Q. Anything about food effect?
`4 A. I don't recall if there was or not.
`5 Q. And on the Naproxen, Sumatriptan case, what
`6 do you recall about the patent claim limitations in
`7 that trial?
`8 A. As I recall, it was a combination formulation
`9 of two active pharmaceutical ingredients, and it
`10 related to the drug release of the two drugs and the
`11 use of gelling agents or a gel former, which would
`12 delay the release, as I recall.
`13 Q. Your deposition testimony -- and I assume
`14 that you were deposed in the Tramadol and the
`15 Naproxen, Sumatriptan cases; is that correct?
`16 A. Yes.
`17 Q. For the other cases on which you worked, and
`18 in particular on which you provided deposition
`19 testimony, were any of them related to sustained
`20 release or controlled release oral dosage forms?
`21 A. Yes.
`22 Q. And what were the actives in those cases?
`
`Page 12
`
`1 A. I don't recall. I don't recall.
`2 Q. Other than today's deposition, what other
`3 depositions have you been a witness for in the last
`4 five years?
`5 A. I've given deposition testimony in the last
`6 five years probably in about eight or so cases. Most
`7 of them have to do with oral dosage forms and
`8 sustained release. What the specific cases were, I
`9 would have to look at my records.
`10 Q. Do you have your records with you today, for
`11 example, on the computer?
`12 A. No, I don't.
`13 Q. Where are your records?
`14 A. The records are on the hard drive, my
`15 computer in my office.
`16 Q. Do you recall who engaged you to provide
`17 testimony in those cases that you just mentioned?
`18 A. I don't understand the question.
`19 Q. Who were you working for on the cases for
`20 which you've provided deposition testimony?
`21 A. They were a variety of law firms and a
`22 variety of pharmaceutical companies.
`
`Page 13
`
`1 Q. Which pharmaceutical companies?
`2 A. I'll do my best to recollect, but it's -- as
`3 I said, Par, Apotex, Bayer, Excella. Those are the
`4 ones I remember sitting here today. There are others,
`5 but I just don't recall. I believe Mylan may have
`6 been one.
`7 Q. Doctor, in your trial experience, testifying,
`8 do you recall any cases where the judge or the jury
`9 agreed with the opinions that you rendered?
`10 A. There were some cases where the side I
`11 offered opinions for prevailed, and there were some
`12 that they did not.
`13 Q. Which ones did your views prevail?
`14 A. Par and the arbitration hearing in
`15 San Francisco, and there are others, but I don't
`16 recall them.
`17 Q. Which cases did the court or the jury
`18 disagree with your views?
`19 A. The trial in Tyler, the side that I offered
`20 my opinions on did not prevail. I don't know whether
`21 or not the judge agreed with me or not, but I know
`22 that they did not prevail, and I believe it's being
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`Page 14
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`Page 16
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`1 contested still. And in the Excella trial, the
`2 intravenous acetaminophen, that judge -- as I recall,
`3 Excella did not prevail. But, again, whether or not
`4 the judge agreed with my views, I don't know.
`5 Q. Do you know if any of your testimony in these
`6 four or five trials that you mentioned, if any of your
`7 testimony was excluded by the judge?
`8 A. I do not believe any of the testimony was
`9 excluded, but I do not recall.
`10 Q. What did you do to prepare for your
`11 deposition today?
`12 A. I reread my declaration and the references,
`13 and I also spent the last two days interacting with
`14 the attorneys here.
`15 Q. And besides your declaration, what other
`16 documents did you review?
`17 A. I reviewed my -- the exhibits that I cite in
`18 my declaration.
`19 Q. Anything else?
`20 A. Not that I recall.
`21 Q. When were you first contacted about this
`22 case?
`
`1 witness not to reveal the substance of any
`2 communications with counsel.
`3 BY MR. MAHONEY:
`4 Q. Right. So -- yeah. I'm not asking for your
`5 conversations with your lawyers. I just want to
`6 understand your knowledge of the facts around the
`7 district court litigation.
`8 A. All that I know about the district court
`9 litigation is that there is some district court
`10 litigation. That's all I know about that.
`11 Q. Have you prepared a -- an expert report in
`12 that litigation?
`13 A. Do you mean the district court litigation?
`14 Q. Yes.
`15 MS. ELLISON: Counsel, I trust you're not
`16 trying to get to any work product; right? You're only
`17 interested in something that's been filed in the case?
`18 MR. MAHONEY: Correct.
`19 Q. So my question is, just for clarity,
`20 Dr. Palmieri, have you prepared an expert report in
`21 the district court litigation?
`22 A. I have not.
`
`Page 15
`
`Page 17
`
`1 A. I would have to look at my records, but it
`2 was, as I recall, the end of -- sometime in 2013.
`3 Q. And who contacted you?
`4 A. It was an attorney with the firm, but I don't
`5 recall who specifically contacted me.
`6 Q. You mean the Sterne Kessler firm?
`7 A. Yes.
`8 Q. And do you remember approximately when in
`9 2013 you were first contacted?
`10 A. No, I don't.
`11 Q. Okay. You've mentioned the declaration that
`12 you've executed in this proceeding which relates to
`13 the Endo patent, U.S. Patent No. 8,329,216, which, for
`14 convenience, we can just call it "the '216 patent."
`15 Is that correct?
`16 A. Correct.
`17 Q. And there's a district court litigation
`18 related to the '216 patent. Are you aware of that?
`19 A. To a degree, yes.
`20 Q. What do you know about the district court
`21 litigation?
`22 DR. ELLISON: I'm going to instruct the
`
`1 Q. The -- let me back up to the 10 or 15
`2 depositions. Those were all patent cases too?
`3 A. I think 15 is too large of a number. I think
`4 it's about 10 to 12.
`5 Q. Okay. 10 or 12. Were they all patent cases?
`6 A. There was a -- there was a litigation in
`7 San Francisco that was not a patent litigation.
`8 Q. Other than the San Francisco trade secret
`9 arbitration, were the rest patent infringement cases?
`10 A. As I recall, sitting here today, they were
`11 either patent infringement or patent validity
`12 questions or both.
`13 Q. And is it fair for me to conclude that, based
`14 on your answers, your work has primarily been on
`15 behalf of generic drug companies?
`16 A. I have been retained and offered opinions for
`17 both for both generic companies and the patent
`18 holders.
`19 Q. What's the breakout on a percentage basis?
`20 For example, is it 50 percent generic, 50 percent
`21 brand or how does that fall out?
`22 A. As I recall, it's probably 20 to 30 percent
`
`5 (Pages 14 - 17)
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`Page 18
`1 for the patent holders and 80 to 70 percent for the
`2 non-patent holders, as I recall.
`3 Q. And how many years have you been providing
`4 opinions and testimony as an expert in patent
`5 infringement cases?
`6 A. I think about six or seven.
`7 Q. So the depositions in the trial testimony
`8 would all have occurred in the last six or seven
`9 years; is that right?
`10 A. I believe that's correct, yes.
`11 Q. What was the first patent infringement case
`12 you worked on?
`13 A. The first case was the Tramadol case as I
`14 recall.
`15 Q. Shifting to patents generally, are you
`16 familiar with claims construction?
`17 A. I have a layman's understanding of the term.
`18 Q. And what is that understanding?
`19 A. I have an understanding that one needs to
`20 determine the meaning of certain words in the claims
`21 and whether they have their plain meaning or whether
`22 or not the patentee has defined it differently.
`
`Page 19
`1 Q. There's a term that you use in several places
`2 in your declaration. It's the word "inherent" or
`3 "inherency." Are you familiar with that term?
`4 A. I have a non -- essentially, yes.
`5 Q. And what is your understanding?
`6 A. Well, I would prefer to look at any specific
`7 places in my declaration where I used that term so I
`8 could be sure.
`9 Q. Well, for example -- and trust me, we'll get
`10 to your declaration. But you, for example -- well,
`11 strike that.
`12 Let's say hypothetically that there's a
`13 statement that a particular property -- let's say a
`14 food effect -- is inherent. What does that mean?
`15 A. Again, you preface this by saying it was a
`16 hypothetical question.
`17 Q. Correct.
`18 A. I recall discussing this in my declaration.
`19 But in this instance, what it means to me, that it is
`20 a property of the molecule regardless of the dosage
`21 form. And, again, what you asked, you prefaced it by
`22 saying, "hypothetical," and I would want to refer to
`
`Page 20
`
`1 my declaration and specific instances.
`2 Q. Do you have an understanding of what the term
`3 "inherent" means in the context of the patent law?
`4 A. I would need to refer to my declaration to
`5 see if I address that.
`6 Q. But as you sit here today, you do or do not
`7 have an understanding of what "inherent" or
`8 "inherency" means under the patent law?
`9 MS. ELLISON: Objection. Form.
`10 THE WITNESS: I have a form -- I have a
`11 nonlegal understanding of what inherency under the
`12 patent law is. If I address it in my declaration, I
`13 would like you to direct me to that.
`14 BY MR. MAHONEY:
`15 Q. What is your nonlegal understanding of what
`16 "inherency" is under the patent law?
`17 A. Again, I would want to refer to my
`18 declaration as to how I used the term "inherent." I
`19 have a nonlawyer understanding of the word "inherent."
`20 Q. So you're not able to answer my question
`21 unless you consult your declaration. Is that what
`22 you're saying?
`
`Page 21
`
`1 MS. ELLISON: Objection. Form.
`2 THE WITNESS: I don't understand the
`3 question.
`4 MR. MAHONEY: Read it back, please.
`5 (Record read.)
`6 THE WITNESS: I am not a patent lawyer. I
`7 used the term "inherent" or "inherency" in my
`8 declaration, but I'm not a lawyer.
`9 BY MR. MAHONEY:
`10 Q. Let's take it outside of patents. What does
`11 the word "inherent" mean to you as a pharmaceutical
`12 scientist? What does that mean?
`13 A. As a pharmaceutical scientist, the word
`14 "inherent" means to me a property which is a
`15 characteristic of, for example, the active
`16 pharmaceutical ingredient or the excipient. It's
`17 something that it has in and of itself.
`18 Q. And how would you know whether a property is
`19 inherent according to your definition?
`20 A. If I wanted to look at an API, active
`21 pharmaceutical ingredient, to determine if a property
`22 is inherent, I would look in well respected references
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`Page 22
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`Page 24
`
`1 and to determine what the characteristics of that
`2 material is.
`3 Q. So you mentioned you would look in well
`4 respected references. Would you do anything else?
`5 A. If the material -- if the property I was
`6 looking -- I wanted to determine was not in a well
`7 respected reference, I could do routine laboratory
`8 exercises.
`9 Q. Let's say that, for example, you were looking
`10 at whether a pharmacokinetic characteristic was
`11 inherent. What routine laboratory exercises might you
`12 perform?
`13 THE WITNESS: I need the question again,
`14 please.
`15 (Record read.)
`16 THE WITNESS: Again, I don't address that
`17 very broad hypothetical question in my declaration.
`18 What one would do would be to look at the active
`19 pharmaceutical ingredient and its specific
`20 pharmacokinetic properties, and one could change, for
`21 example, the dosage form to see if the pharmacokinetic
`22 properties had changed when compared, for example, to
`
`1 immediate release to a controlled release. Is that an
`2 accurate summary of what you've testified about thus
`3 far?
`4 A. That's one of the things one could do. One
`5 could also give the drug intravenously, for example,
`6 as well as in various dosage forms.
`7 Q. And a pharmacokinetic, of course, Doctor,
`8 talks about drug in the blood; right?
`9 A. Drug in the body.
`10 Q. Yeah, drug in the body. And so it wouldn't
`11 make much sense to do in vitro dissolution tests when
`12 the focus is on whether a particular PK characteristic
`13 is inherent; is that correct?
`14 A. I don't quite understand. I don't understand
`15 the question.
`16 Q. Well, if the focus of your research is to
`17 determine whether a PK characteristic is inherent, one
`18 wouldn't be looking at in vitro tests; right? Because
`19 in vitro tests don't provide information about the
`20 drug in vivo; is that right?
`21 MS. ELLISON: Objection. Form.
`22 THE WITNESS: Again, I'm not -- your question
`
`Page 23
`
`1 the immediate release material.
`2 BY MR. MAHONEY:
`3 Q. Any other routine laboratory exercises that
`4 you would perform to determine if a property were
`5 inherent?
`6 A. Again, you're asking me a hypothetical. One
`7 could -- it would depend on what property one wanted
`8 to know about the ingredient.
`9 Q. Okay. Let's stick with the example being a
`10 pharmacokinetic characteristic. You provided one,
`11 what you call routine laboratory exercise that you
`12 would perform. Would there be any others that you
`13 would perform?
`14 A. Again, you're asking me a hypothetical that I
`15 don't address in my declaration, and I would want to
`16 take some time to think about that in my office or my
`17 laboratory.
`18 Q. If the question that's presented and that I
`19 presented to you and that is how do you establish
`20 whether a particular pharmacokinetic characteristic is
`21 inherent, you've responded with you do a comparison, a
`22 pharmacokinetic comparison to say, for example,
`
`Page 25
`1 appears to me to be very broad, and I want to do -- I
`2 want to make sure I understand the question before I
`3 answer it.
`4 BY MR. MAHONEY:
`5 Q. Well, fair enough. I'm not asking you about
`6 the '216 patent. I'm not asking you about your
`7 declaration. This goes back to where we started where
`8 I asked you what's your understanding of "inherency"
`9 and "inherent," and you testified what your
`10 understanding is. I then asked you how do you
`11 establish that. You said you would look in well
`12 respected textbooks. I then asked you the
`13 hypothetical about how do you establish the inherency
`14 of a PK characteristic, and you said that you would do
`15 a PK study, IR versus controlled release.
`16 I've now just asked you about the use of an
`17 in vitro test. An in vitro test doesn't tell you in
`18 vivo -- it doesn't provide in vivo results; is that
`19 right?
`20 A. What you've done, I think, in my opinion, is
`21 you've brought in a question. We look at in vitro
`22 results to predict in vivo results.
`
`7 (Pages 22 - 25)
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`Page 26
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`1 Q. How do you do that?
`2 A. I don't understand that very broad question.
`3 How do I do what?
`4 Q. You said -- you said, "We look at in vitro
`5 results to predict inch vivo results." My question is
`6 how did you look at in vitro results to predict in
`7 vivo results?
`8 A. For example, we can look at comparative in
`9 vitro to solution profiles. It's been well
`10 established that if two formulations have the same
`11 similar in vitro dissolution results, they'll have the
`12 same in vivo dissolution results. Excuse me. They'll
`13 have the same in vivo profiles. But, again, you're
`14 asking me a hypothetical question that is speculation
`15 on my part, and I would want to have time to think
`16 about the specific question that you present.
`17 Q. Let's go back to what is an inherent
`18 property. Does an inherent property sometimes exist
`19 or must it always exist?
`20 A. I don't understand the question.
`21 Q. What don't you understand about the question?
`22 A. You asked a very broad question.
`
`Page 28
`1 scientist, and, again, I use the word "inherent" in my
`2 declaration, very specific context. A property is
`3 inherent if it is a characteristic of that molecule
`4 and will be there if the surrounding conditions, if
`5 you will, remain the same.
`6 Q. Always or sometimes?
`7 A. I've been speculating or theorizing, if you
`8 will, the answers to your hypothetical questions for a
`9 while now, and I don't want to speculate on that
`10 question any further unless I have a specific
`11 question.
`12 Q. Well, you've qualified your answer about the
`13 property is in the environment. I mean you've talked
`14 about a property being in surrounding conditions and
`15 that those surrounding conditions remain the same.
`16 And so I understand that. Okay. That's how you've
`17 described the property at issue as a pharmaceutical
`18 scientist; that there are surrounding conditions to
`19 the property, and you've said that the surrounding
`20 conditions remain the same.
`21 But my question is in that construct, must
`22 the property be always present or sometimes present
`
`Page 27
`1 THE WITNESS: Could I have the question back,
`2 please.
`3 (Record read.)
`4 THE WITNESS: A property is inherent when it
`5 is a characteristic of that material.
`6 BY MR. MAHONEY:
`7 Q. Always a characteristic or sometimes?
`8 A. Again, you're asking a hypothetical question.
`9 Q. You can finish. Go ahead.
`10 A. As I understand it, you're asking a
`11 hypothetical question about anything.
`12 Q. No, I'm not. I'm asking you, as a
`13 pharmaceutical scientist what is meant when one says
`14 that a property is inherent? It's not a hypothetical.
`15 A. If we were to limit it to the pharmaceutical
`16 sciences, a property is inherent if it is a
`17 characteristic of the material we're discussing in the
`18 environment, in the same environment.
`19 Q. Okay. And, then, so that that property is
`20 present in that environment always or sometimes or
`21 sporadically?
`22 A. Again, you're asking me as a pharmaceutical
`
`Page 29
`
`1 for you to conclude, as a pharmaceutical scientist,
`2 that that property is inherent?
`3 THE WITNESS: I'm sorry. I need it read
`4 back. I need it back to me.
`5 (Record read.)
`6 THE WITNESS: As I heard your question and as
`7 I heard the reporter read it back, I believe that
`8 you mis- -- you did not correctly state what I had
`9 stated.
`10 BY MR. MAHONEY:
`11 Q. Okay. Fair enough. What did I get wrong?
`12 A. Well, you talked about property and the
`13 property in an environment, as I recall. What I
`14 stated was that a property is inherent if that
`15 property is a characteristic of the material -- we'll
`16 use an API, for example -- in the same environmental
`17 conditions. For example, plasma. For example,
`18 stomach. And sitting here today, again, giving you a
`19 theoretical answer to your hypothetical question,
`20 there may be -- I'm not willing to hypothesize any
`21 further on that theoretical question without thinking
`22 about it.
`
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`8 (Pages 26 - 29)
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`Page 30
`
`1 Q. Okay. My question is your definition of
`2 what's inherent as a pharmaceutical scientist. My
`3 question is must that property be always present or
`4 sometimes present for you to consider it to be
`5 inherent?
`6 A. Again, you've asked a theoretical question,
`7 and without having time to think about every example
`8 or every situation, I'm not willing to theorize about
`9 your hypothetical question. I'd be glad to answer
`10 questions about my use of the term "inherent" in my
`11 declaration. And --
`12 Q. Well -- excuse me. You can finish. I
`13 apologize. I didn't mean to interrupt.
`14 A. I'll be glad to answer any questions about my
`15 use of the word "inherent property" in my declaration
`16 in this specific instance, but it would be unfair if I
`17 continue to hypothesize in this environment about your
`18 theoretical question.
`19 Q. Well, in all due respect, it's not a
`20 theoretical question. I'm asking you how do you
`21 define "inherent." Okay? I'm asking you whether
`22 that's always, that the property must be always
`
`Page 31
`1 present or sometimes present, and you won't answer my
`2 question. Is that right? You're not going to answer
`3 that question?
`4 MS. ELLISON: Objection to the form.
`5 THE WITNESS: I believe that I have answered
`6 your question, your theoretical question, your
`7 hypothetical question, and I believe I've done
`8 that. I'd be glad to talk about my use of the word
`9 "inherent" in my declaration.
`10 BY MR. MAHONEY:
`11 Q. Well, maybe I've missed it in your answer,
`12 but must the property be always present or sometimes
`13 present to be inherent?
`14 A. I believe I've answered that.
`15 Q. Okay. So tell me again. Is it always
`16 present or sometimes present?
`17 A. I believe I've answered the question to the
`18 best of my ability without knowing more details.
`19 "Inherent" to me means that it is a characteristic of
`20 the material.
`21 Q. 100 percent of the time characteristic or
`22 sometimes?
`
`Page 32
`1 A. Again, it would depend on the environment.
`2 Q. Okay. As you used --
`3 A. I need -- I'm sorry.
`4 Q. Go ahead.
`5 A. I need -- as a scientist -- and you've
`6 narrowed it down somewhat to saying in my world of
`7 dosage forms. But, again, you're asking hypothetical
`8 questions, and you're asking me to give theoretical
`9 answers. I'll be glad to talk about it in the context
`10 of my declaration.
`11 Q. Okay. Let's do that. So in the context of
`12 your declaration, when you say something is inherent,
`13 does that something, that characteristic, must it
`14 always be present or sometimes present?
`15 A. If you would indicate which section of my
`16 declaration we're discussing, I would be glad to
`17 answer your question.
`18 Q. But, otherwise, you don't know?
`19 MS. ELLISON: Objection. Form.
`20 THE WITNESS: It's not that I don't know.
`21 It's I want to look at how the term "inherent" is used
`22 in my declaration.
`
`Page 33
`
`1 BY MR. MAHONEY:
`2 Q. Apart from your experience in patent
`3 litigation with controlled release, extended release
`4 dosage forms, what other experience do you have with
`5 controlled release dosage form?
`6 A. The subject of my Ph.D. dissertation was a
`7 controlled release dosage form. I have done a number
`8 of -- I've refereed publications in controlled release
`9 dosage forms. I taught controlled release dosage
`10 forms at the University of Wyoming.
`11 I've contributed chapters in books on
`12 controlled release dosage forms and dissolution. I
`13 have taught, in my time at Wyoming, controlled release
`14 dosage forms, both to Pharm.D students and to graduate
`15 classes.
`16 MR. MAHONEY: Let's mark your CV. I'm
`17 handing you what's been marked Amneal Exhibit 1016.
`18 (Deposition Exhibit 1016 was marked for
`19 identification.)
`20 MR. MAHONEY: Can you identify that, please.
`21 (The witness reviewed Exhibit 1016.)
`22