2/3/2016
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`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
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`Dr. Joseph DiPiro
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` _________________
`
` BEFORE THE PATIENT TRIAL AND APPEAL BOARD
` _________________
`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICALS, INC. and
` WOCKHARDT BIO AG,
`
` Petitioners,
`
` v.
`
` JAZZ PHARMACEUTICALS, INC.,
`
` Patent Owner
` ____________________
` Case IPR2015-00554
` Patent 7,668,730
` ____________________
`
` Oral deposition of DR. JOSEPH DIPIRO, taken at the
`
`offices of Quinn Emanuel Urquhart & Sullivan, LLP, 51
`
`Madison Avenue, 22nd Floor, New York, New York 10010, on
`
`Wednesday, February 3, 2016, at 9:35 a.m., before Anthony
`Armstrong, a Realtime Systems Administrator, Certified
`Realtime Reporter, Certified Court Reporter and Notary
`Public of the State of New York.
`
`---------------------------------------------------
` DIGITAL EVIDENCE GROUP
` 1730 M Street NW, Suite 812
` Washington, DC 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`202-232-0646
`
` PAR1055
`IPR of U.S. Patent No. 7,668,730
` Page 1 of 72
`
`

`
`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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`A P P E A R A N C E S:
`
`MADDOX EDWARDS, PLLC
`1900 K Street NW, Suite 725
`Washington, DC 20006
`BY: MATTHEW C. RUEDY, ESQ.,
`(202)830-0779
`mruedy@meiplaw.com
`Attorneys for Amneal Pharmaceuticals
`
`ARENT FOX, LLP
`1717 K Street, NW
`Washington, DC 20038
`BY: RICHARD J. BERMAN, ESQ.,
`(202)857-6000
`richard.berman@arentfox.com
`Attorneys for Par Pharmaceuticals
`
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`BY: ERIC STOPS, ESQ.,
`(212)849-7561
`ericstops@quinnemanuel.com
`BY: EVANGELINE SHIH, ESQ.,
`(212)849-7000
`evangelineshih@quinnemanuel.com
`Attorneys for Jazz Pharmaceuticals
`
`Page 2
`
` INDEX
`
`WITNESS PAGE
`
`DR. JOSEPH DIPIRO
` By Mr. Ruedy 4
`
` E X H I B I T S
`NUMBER DESCRIPTION PAGE
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` (There were no exhibits marked)
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
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`J O S E P H D I P I R O, Pharma.D., a witness, having
` first been duly sworn, testified as follows:
` MR. RUEDY: For the record, we're
` here today for a deposition in a series of
` enter parties' review IPR Nos. 2015-00545,
` 546, 547, 548, 551, 554, and the related
` joined cases. Good morning.
` MR. STOPS: Shall we do
` introductions?
` MR. RUEDY: Sure.
` MR. STOPS: This is Eric Stops from
` Quinn Emanuel for the patent owner Jazz
` Pharmaceuticals and the witness. With me is
` Evangeline Shih, also from Quinn Emanuel.
` MR. RUEDY: Matthew Ruedy from Maddox
` Edwards representing Amneal Pharmaceuticals.
` MR. BERMAN: Rich Berman from Arent
` Fox representing Par Pharmaceutical.
`
` (Testimony continued on next
` page.)
`
`Page 4
`
`DIRECT EXAMINATION
`BY MR. RUEDY:
` Q. Good morning.
` A. Good morning.
` Q. Could you please state your name and
` address for the record.
` A. Joseph T. DiPiro. And my residence
` is at 3991 Reads Landing Circle, Richmond,
` Virginia.
` Q. I just want to go over a few ground
` rules before we get started with the deposition.
` I'm going to ask you a series of
` questions. When you answer, please do so verbally
` for the record, as our court reporter here will be
` transcribing your verbal answers. So no head
` nods, no yes, no shaking of the head, if that
` works.
` A. I may slip from time to time, but I
` will do my best. I would not mind a reminder.
` Q. Sure. If you don't understand one of
` my questions, please ask for clarification. If
` you do answer, that means that you understood the
`Page 5
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` PAR1055
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`

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`2/3/2016
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`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` question. Okay?
` A. Yes.
` Q. And if you need a break at any time,
` just please let me know. All I ask is if there
` is a question pending, that the question be
` answered prior to us taking a break.
` A. Sure.
` Q. Is there any reason that you cannot
` give full and complete answers today?
` A. No.
` Q. Have you ever been deposed before?
` A. Yes.
` Q. How many times?
` A. Twice.
` Q. What did each of those cases involve?
` A. The most recent was about three years
` ago, and was a personal property dispute related
` to my family.
` Q. And the second?
` A. Was a -- approximately 10 years ago,
` with some followup in a year or two after, a
` patent case that I was working with Jones Day
`Page 6
`
` from.
` Q. And do you remember the name of that
` case?
` A. I remember some points about it, the
` particular drug involved in the patent, and I
` probably couldn't recall all the parties involved
` in the litigation.
` Q. But from your general recollection,
` what was the drug involved?
` A. Skelaxin.
` Q. How many patent cases have you been
` involved with?
` A. I know -- so prior to that I was
` involved in another report without deposition
` with Jones Day. It may have been a couple of
` years earlier. And between that experience and
` the first one that I related to, I'm not clear
` how many patents were involved there. To my way
` of thinking, there were two cases that I don't
` recall that they were related.
` Q. Okay. And in that second case with
` Jones Day, do you recall what the drug at issue
`Page 7
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` was?
` A. The one that I referred to first
` occurred about 10 years ago was Skelaxin.
` Q. And then the other one?
` A. I don't recall.
` Q. Was either one of those cases Elan v.
` Corepharma?
` A. That could be. That sounds right.
` Q. And was that the Skelaxin case?
` A. I believe so. Again, it's -- I have
` not refreshed my memory on this, so it's going
` back 10 years.
` Q. And then the second case, was that
` King Pharma versus Eon?
` A. That sounds right, yes, to the best
` of my memory.
` Q. And Quinn Emanuel was your counsel
` for that case, correct?
` MR. STOPS: Objection. Foundation.
` A. I was working with lawyers at Jones
` Day.
` Q. Okay. How many cases have you worked
`Page 8
`
` on -- how many patent cases have you worked with
` Jones Day on?
` A. So the only ones that I was involved
` with -- so 10 years ago one involved report and
` deposition with Skelaxin. Within the next year
` or two, there were followup reports; no further
` depositions. And then a couple of years prior to
` that, a report with Jones Day. And those are the
` only ones related to patents that I have been
` involved with.
` Q. Have you ever testified in a district
` court case?
` A. I once provided testimony for a
` malpractice case. I'm not sure what the
` jurisdiction was. And this would have been
` almost a decade ago.
` Q. But not a patent case?
` A. Not a patent case.
` Q. Are you represented by counsel today?
` A. I'm working in conjunction with the
` legal counsel for Quinn Emanuel.
` Q. What did you do to prepare for
`
`Page 9
`Pages 6 to 9
`202-232-0646
`
` PAR1055
`IPR of U.S. Patent No. 7,668,730
` Page 3 of 72
`
`

`
`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` today's deposition?
` A. I worked in conjunction with legal
` counsel to review the relevant documents that are
` cited in my statement and prepare the -- my
` statement.
` Q. So as far as preparing for today's
` deposition, did you meet with counsel?
` A. Yes.
` Q. Who did you meet with?
` A. With the counsel that you see here,
` and Frank Calvosa.
` Q. How many days did you meet?
` A. Two days.
` Q. And you mentioned that you reviewed
` documents to prepare for your deposition.
` What did you review specifically?
` A. They're all stated in my -- and
` listed in my statement. It includes the ACA
` materials and the patent documents and the
` declaration of Dr. Valuck among those that I
` reviewed.
` Q. Okay. So referring to your expert
`Page 10
`
` declarations, you submitted six of them for six
` different inter partes reviews -- proceedings,
` correct?
` A. Yes.
` Q. I'm just going to shortcut and say
` IPR, if that's okay with you, for inter partes
` review.
` A. I know we have used that term, but
` remind me what that acronym --
` Q. Inter partes review?
` A. Yes.
` Q. I'm just referring to the general
` type of case that we're here for today, if that's
` okay with your understanding.
` A. Right. I don't have a working
` definition of that term, but I thank you for the
` explanation.
` Q. Okay. It just saves me from having
` to repeat inter partes review.
` A. Sure.
` Q. Each of these IPRs were filed either
` by Par Pharmaceutical or Amneal Pharmaceuticals,
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`
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`
` correct?
` A. I'm not clear which documents you're
` referring to.
` Q. I'm just referring to the
` petitioner's on the IPRs. I'll submit to you
` that each of these IPRs were filed initially by
` Par Pharmaceutical and or Amneal pharmaceuticals
` LLC.
` Just to make things easier, I'm
` referring to the entities that filed the IPRs as
` the petitioners, if that's okay with you.
` A. Well, you know, I don't have an
` opinion about that because I'm not familiar with
` the legal process, who files what.
` If you're asking me is that the way it
` happened --
` Q. I'm just asking you so that we have
` an understanding of what I am referring to when I
` say petitioner. I'm referring to the parties
` that filed the IPRs in front of the patent
` office. That's all.
` A. Okay. Yes.
`
`Page 12
`
` Q. So the six different patents in these
` IPRs are owned by Jazz Pharmaceuticals, right?
` A. That's my understanding.
` Q. And these six patents generally deal
` with restricted drug distribution systems, right?
` A. Yes.
` Q. Are you okay with that general
` description? I'm not going to hold you to it
` necessarily, but I just want something that we
` can agree on that the patents generally cover.
` A. Yes.
` Q. Have you read each of the six
` patents?
` A. Yes.
` Q. Did you read the entirety of each of
` them?
` A. Yes. And I recognize that much of
` that is the same or very similar from one to the
` next.
` Q. When were you first contacted about
` this case?
` A. I don't recall the exact date, but it
`Page 13
`Pages 10 to 13
`202-232-0646
`
` PAR1055
`IPR of U.S. Patent No. 7,668,730
` Page 4 of 72
`
`

`
`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` may have been in October -- in the middle of the
` fall this past year, 2015.
` Q. Who contacted you?
` A. Would have been Angela Chi.
` Q. When you were contacted about this
` case, what were you asked to do?
` MR. STOPS: Objection, to the extent
` the question calls for attorney/client
` communications. Maybe there's a way you can
` ask that question without getting to --
` MR. RUEDY: I'm not looking for
` protected information.
`BY MR. RUEDY:
` Q. I'm just looking in general what were
` you asked to do.
` MR. STOPS: That question still may
` call for attorney/client communications.
` You can answer generally to the extent
` you can without revealing attorney/client
` compilations.
` THE WITNESS: Repeat the question.
` MR. RUEDY: If you can read it back,
`Page 14
`
` please.
` (The record was read.)
` ***********
` A. Well, I was asked if I would be
` willing to provide an opinion about the case and
` the issues at hand.
`BY MR. RUEDY:
` Q. After you were contacted, were you
` asked to do any research for this case?
` A. So it depends on what you mean by
` research. I would say yes, in that I then went
` through the relevant documents in the case to
` gain a better understanding of all the issues.
` Q. Did you do your own independent
` literature search?
` A. I do literature searches for a lot of
` things all the time. So specifically for what
` purpose?
` Q. I'm just asking generally if -- once
` you were contacted about this case whether you
` chose to research the subject matter on your own?
` A. What subject matter?
`
`Page 15
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` Q. The subject matter of the patents,
` the restricted drug distribution system.
` A. Well, I relied on what was supplied
` by counsel in terms of the materials that are
` cited in my report. I did not obtain those
` independently.
` Q. So my question is, did you do any
` other research beyond the materials provided by
` counsel?
` A. Minimal.
` Q. What do you mean by minimal?
` A. I spent a small amount of time
` reading about Xyrem and the manufacturers'
` restricted distribution system, the material that
` was on their website.
` Q. Was all the materials that you
` reviewed on the Xyrem website?
` MR. STOPS: Objection, form.
` A. I'm trying to recall what I looked
` at. I really didn't spend a minimal amount of
` time outside the documents that were provided,
` and so I do recall specifically that I looked up
`Page 16
`
` about Xyrem to become more familiar with it and
` redistricted distribution system. I don't recall
` spending time doing other types of research at
` that point time. You've directed me to this
` initial contact and that time period.
` Q. When you say a minimal amount of
` time, can you quantify that at all?
` A. Probably 30 minutes.
` Q. Prior to being contacted in this
` case, had you heard of Xyrem previously?
` A. I had heard of it, yes.
` Q. In what capacity?
` A. I don't recall from what source the
` information came from. It may have been one of a
` number of news feeds that we routinely receive.
` So I don't recall where it came from, but I was
` aware of the name.
` Q. Do you recall when you first heard of
` Xyrem?
` A. No.
` Q. Prior to being contacted in this
` case, had you heard of GHP?
`
`Page 17
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`202-232-0646
`
` PAR1055
`IPR of U.S. Patent No. 7,668,730
` Page 5 of 72
`
`

`
`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` A. Yes.
` Q. In what capacity?
` A. I was aware that it had been featured
` in the news and referred to as "the date rape
` drug."
` Q. And what time period was this?
` A. I don't recall.
` Q. Dr. DiPiro, prior to this case did
` you have any experience with restricted drug
` distribution systems?
` A. No.
` Q. So you have never worked to develop a
` restricted drug distribution system?
` A. No.
` Q. So you are not an expert in
` restricted drug distribution systems?
` MR. STOPS: Objection, form,
` foundation.
` A. I'm here as a POSA expert, but not a
` an expert in drug distribution systems --
` restricted drug distribution systems.
` Q. Prior to this case, did you have any
`Page 18
`
` experience with restricted evaluation and
` mitigation strategies?
` A. No.
` Q. And when I refer to restricted
` evaluation and mitigation strategies, I'm
` referring to REMS, if we can have that
` understanding.
` A. That's my understanding, yes.
` Q. So you have never worked to develop a
` REMS program, correct?
` A. That's correct.
` Q. And you are not an expert in REMS,
` correct?
` MR. STOPS: Objection, form.
` A. Correct.
`BY MR. RUEDY:
` Q. And prior to this case, did you have
` an experience with risk minimization action plan,
` or RiskMAP?
` A. When you say experience, what --
` Q. In any capacity. In general.
` A. Certainly not in the development of
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` one of those programs.
`BY MR. RUEDY:
` Q. I want to go to your '730
` declaration. Dr. DiPiro, you have been handed a
` copy of Exhibit 2046. This is in patent case
` IPR 2015-0054 regarding Patent No. 7668730; is
` that correct?
` A. Yes.
` Q. Do you recognize this document?
` A. Yes.
` Q. And you submitted this document?
` A. I did, yes.
` Q. Turn to page 45. By 45, I'm
` referring to the stamp on the lower left, not the
` middle.
` A. Yes.
` Q. On this page there is a signature on
` page 45. Is that your signature?
` A. It is.
` Q. I want to turn to page 82 of this
` same document.
` MR. STOPS: We may have put these in
`Page 20
`
` order. He has page 82. But just so you
` know, the intervening pages -- they are not
` in this one.
` MR. RUEDY: I can give him a copy of
` that.
` MR. STOPS: For your clarification.
`BY MR. RUEDY:
` Q. On page 82, this is a list of
` materials considered, correct?
` A. Yes.
` Q. Is this list complete?
` A. Yes.
` Q. I will hand you a copy of the full
` document.
` MR. RUEDY: Is this the same as yours
` with the missing CV?
` MR. STOPS: I have a copy of his CV.
` Yes, mine is the same as his.
` Q. If we can work with that copy. I
` will turn to your CV. It starts on page 47, I
` believe. Is this your CV?
` A. It is.
`
`Page 21
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`202-232-0646
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`IPR of U.S. Patent No. 7,668,730
` Page 6 of 72
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`

`
`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` Q. Is this CV correct?
` A. It's correct up to June of 2015.
` Q. Okay. Any updates since then?
` A. Yes.
` Q. What's been updated?
` A. For example, on the editorial
` experience I have been invited to participate in
` an additional editorial board.
` Q. And what editorial board would that
` be?
` A. For the American Journal of Health
` System Pharmacy. And then -- that's page 74.
` Page 76, middle of the page, American Association
` of Colleges of Pharmacy. An additional
` committee. The Strategic Planning Committee.
` Well, that's what I can recall right
` now. So I haven't gone through to think about the
` other changes. There may be something else.
` Q. Okay. I want to turn back to the
` first page of your CV. Under the heading of
` academic ranks and appointments. The first entry
` there says July 2014 to present, that you are the
`Page 22
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` dean of the School of Pharmacy at Virginia
` Commonwealth University, correct?
` A. Yes.
` Q. What are your main responsibilities
` as the dean at VCU?
` MR. STOPS: Objection, form.
` A. My position, similar to deans in
` other schools, is the chief executive, the chief
` academic officer.
` Q. Do you currently do any research?
` A. My school does research. I'm
` responsible for research in that there are people
` within the school who do research.
` Q. When you say you are responsible for
` research, are you involved in the actual research
` studies or projects, or is it just as a
` supervisory role?
` MR. STOPS: Objection, form.
` A. My approval is necessary for any
` research that goes on in the school.
`BY MR. RUEDY:
` Q. Are you currently teaching?
`
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`Digital Evidence Group C'rt 2016
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` A. Yes.
` Q. And what are you currently teaching?
` A. The practice of pharmacy.
` Q. Is this a formal course in the
` pharmacy school?
` A. It is a course. It is a course
` number, so we don't use the term formal course.
` Q. Just in general terms, what does the
` practice of pharmacy course entail?
` A. Well, I teach aspects of the practice
` of pharmacy within a course.
` Q. Any specific aspects, or just general
` pharmacy?
` A. It's general pharmacy. The course
` that I'm involved with does not have a strict
` syllabus, so it's a discussion course, seminar
` course. It changes from week to week.
` Q. This is -- I'm sorry. Go ahead.
` A. The topics can be far ranging and are
` really determined by the students.
` Q. The students are all in the Pharm.D.
` program, correct?
`
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` A. Yes.
` Q. And what year are they typically?
` A. Typically in their final year.
` Q. So the second entry in your academic
` ranks is June 2014 being Dean Emeritus at MUSC;
` is that correct?
` A. Yes.
` Q. And what were your main roles there?
` A. The same - chief executive, chief
` academic officer.
` Q. And if you go down to the 1994 to
` 1997 entry, it says head of department of
` pharmacy practice at the University of Georgia
` College of Pharmacy?
` A. Yes.
` Q. Again, what were your roles in that
` position?
` MR. STOPS: Objection, form.
` A. The main administrative officer for
` the department.
`BY MR. RUEDY:
` Q. And just in general, what was your
`Page 25
`Pages 22 to 25
`202-232-0646
`
` PAR1055
`IPR of U.S. Patent No. 7,668,730
` Page 7 of 72
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`

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`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` day-to-day in that position?
` A. So there's responsibility for the
` major activities of the department - teaching,
` research, and service activities.
` Q. Did you do any research in that role?
` A. Yes.
` Q. What did that research generally
` involve?
` A. Some of the work was related to
` patients who had had severe traumatic injury,
` studying their immune responses. In this
` population, studying the effects of medications
` that were administered. As one example, there
` are other types of research, but that was the
` primary avenue of research.
` Q. Okay. If you go back to your CV, to
` the entry dated 1981 to 2005, at the very bottom
` of page 47 it says consulting clinical
` pharmacist. Do you see that?
` A. Yes.
` Q. What -- sorry. Strike that.
` Does this consulting work involve any
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` pharmaceutical companies?
` MR. STOPS: Objection, form.
` A. This consulting work did not.
` Flipping over the page, the rest of that is...
` Q. Okay.
` A. So consultant to the Medical College
` of Georgia.
` Q. I see. Okay. So what aspects of
` clinical pharmacy were you consulting about in
` this role?
` MR. STOPS: Objection, form.
` A. Primarily within the scope of the
` general surgery and trauma service. Providing a
` lot of that would be patient consultations,
` consultation to the physicians and nurses.
` Q. And the next entry is 1981 to 2000 as
` researcher and investigator to WOC at the
` Veterans Administration Clinical Center in
` Augusta, Georgia?
` A. Yes.
` Q. What were the general topics of
` research in that role?
`
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` A. Primarily to conduct clinical
` research trials, clinical drug trials within the
` VA system.
` Q. What types of drugs?
` A. So we're going back as far back as 30
` years or so ago. I have not refreshed my memory
` on it recently. I would point out that almost
` all of that there is some record in the detailed
` publications that came from that that would
` specify what type of work was going on. And then
` later on -- so that's -- the other pages in my
` curriculum vitae. And in addition, I do have
` details in here regarding -- a lot of this is
` detailed grants awarded. I could read that for
` you. But this is what I would look at to refresh
` my memory about the types of research that I was
` involved in.
` Q. Okay. No need to do that at this
` time.
` So under the heading of academic and
` ranking appointments, out of all of your academic
` work, you didn't do any work on restrictive drug
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` distribution systems, correct?
` MR. STOPS: Objection, form.
` A. Yes, I did. But I would use that in
` a different sense that we're using it here in the
` discussion in the patent. So an example would be
` a non-approved drug that's under study prior to
` approval, but that is a type of restricted drug
` distribution system, that it would be restricted
` only to the investigators who are conducting the
` trial.
` Q. So by that, you are referring to the
` restriction being the drug is only available to
` the patients as part of the clinical study?
` A. Clinical trial, phase two, phase
` three. And again, examples of that are provided
` in the CV. I'm looking at -- so one example of
` something like this, page 79, about five lines,
` TADA monoclonal antibody for grand negative
` sepsis. I did not consider that that was related
` to ream systems that we're talking about in the
` context of Xyrem or as the manufacturer OF Xyrem
` would consider that.
`
`Page 29
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`202-232-0646
`
` PAR1055
`IPR of U.S. Patent No. 7,668,730
` Page 8 of 72
`
`

`
`2/3/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` Q. Okay.
` A. But it is -- it is a type of
` restricted distribution of a non-approved
` medication.
` Q. Turning to the second page of your
` CV, under the heading license, your CV indicates
` that you have an active pharmacist license in
` Kentucky, correct?
` A. Correct.
` Q. When were you first licensed to
` practice pharmacy?
` A. In 1978.
` Q. Do you currently practice pharmacy?
` A. Teaching is considered part of the
` practice, yes.
` Q. Going back just a second.
` Your Georgia license, that's still
` active, correct?
` A. Yes.
` Q. In your pharmacy practice, have you
` ever dealt with Xyrem in any capacity?
` A. No.
`
`Page 30
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` Q. So you have never dispensed Xyrem?
` A. No.
` Q. And you have never counseled a
` patient on Xyrem?
` A. No.
` Q. Have you ever dispensed a drug that
` is subject to a REMS program?
` A. In -- again, in the way that we're
` referring to it in the context of the Xyrem
` patents in the discussion here today, no. I do
` say, though, that there were other types of
` restricted distribution systems for unapproved
` drugs that I was involved with.
` Q. Okay. I'm referring to drugs that
` would be subject to an FDA approved REMS program.
` Have you ever --
` A. So I assume you are referring to
` approved drugs --
` Q. Yes.
` A. -- that are on the market?
` Q. Exactly.
` A. So in that -- no.
`
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