US Patent and Trademark Office
`_________________________________________
`
`Amneal Pharmaceuticals LLC
`and Par Pharmaceutical, Inc.,
`v.
`Jazz Pharmaceuticals, Inc.,
`
`CONFIDENTIAL
`
`_________________________________________
`
`Deposition of:
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`October 9, 2015
`
`
`Page 1 of 45
`
`JAZZ EXHIBIT 2045
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`
`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 223
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------------------------
`AMNEAL PHARMACEUTICALS LLC
`AND PAR PHARMACEUTICAL, INC.,
`
` Petitioners,
`v.
`JAZZ PHARMACEUTICALS, INC.,
`
` Patent Owner.
`
`Case IPR2015-00546
`Patent 7,765,106
`--------------------------------------------
`
`DEPOSITION OF
`Robert Valuck, Ph.D., R.Ph. - Volume 2
`October 9, 2015
`Greenwood Village, Colorado
`Lead: Eric Stops, Esquire
`Firm: Quinn Emanuel
`
`FINAL COPY - CONFIDENTIAL
`JANE ROSE REPORTING 1-800-825-3341
`
`Page 225
`ATTORNEYS FOR THE PATENT OWNER
` Eric Stops, Esquire
` Frank C. Calvosa, Esquire
` QUINN EMANUEL
` 51 Madison Avenue, 22nd Floor
` New York, New York 10010
` 212-849-7000
` ericstops@quinnemanuel.com
` frankcalvosa@quinnemanuel.com
` - and -
` John V. Biernacki, Esquire
` JONES DAY
` 901 Lakeside Avenue
` Cleveland, Ohio 44114
` 216-586-3939
` jvbiernacki@jonesday.com
`
`ALSO PRESENT
` David Silverstein, Par Pharmaceutical
`
`JANE ROSE REPORTING
` 74 Fifth Avenue
` New York, New York 10011
` 1-800-825-3341
` Margie Dauster, Court Reporter
`
`Page 224
`
`Page 226
`
`APPEARANCES
`
`ATTORNEY FOR PETITIONER AMNEAL
` Matthew C. Ruedy, Esquire
` MADDOX EDWARDS, PLLC
` 1900 K Street, NW - Suite 725
` Washington, DC 20006
` 202-830-0779
` mruedy@meiplaw.com
`
`ATTORNEYS FOR PETITIONER PAR
`PHARMACEUTICAL, INC., AND THE
`WITNESS
` Aziz Burgy, Esquire
` Bradford C. Frese, Esquire
` ARENT FOX LLP
` 1717 K Street, NW
` Washington, DC 20006-5344
` 202-857-6000
` aziz.burgy@arentfox.com
` bradford.frese@arentfox.com
`
` TABLE OF CONTENTS
`
`Witness:
`Robert Valuck, Ph.D., R.Ph. - Volume 2
`
`Examination
`By Mr. Burgy............................Page 227
`By Mr. Stops............................Page 314
`
`Begin Confidential Portion..............Page 232/Line 15
`End Confidential Portion................Page 236/Line 2
`Phone Conference with Board.............Page 300 - 314
`
`Reporter Certificate....................Page 345
`
`Notice to Read and Sign.................Page 347
`
`Index of Exhibits.......................Page 349
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 2 of 45
`
`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 229
`V7, 0 to 16 seconds. There -- and I believe there may
`be other instances -- there may be another one at page
`34 similarly.
` The places I refer to that -- that particular
`instance from the video, I believe it's -- should be
`segment -- Video Segment 8 rather than Video Segment 7
`that I was referring to.
` Q. And how did you come about to learn that that
`was an error in the citation?
` A. In -- in reviewing the -- rewatching the video
`for prep myself the last couple of weeks. I rewatched
`the video and reread this. And the videos submitted to
`the -- as far as the -- backing up the references are in
`little pieces. And reviewing them, looked at Video 7,
`and it wasn't -- wasn't what I expected to be for that
`step. It was really Video Segment 8 that I'm really
`referring to.
` So that's a typo in any instance. And those
`are the two that I see from having -- looking back at
`this yesterday. Those are the two that I noticed. If
`there's other instances where I refer to that entry --
`pharmacy staff receives and enters into a computer --
`referring to Video Segment 7, any instance of that
`should be 8. And I -- and those are the two that I know
`of. But if there's others, it would be the same
`
`Page 230
`
`correction.
` Q. Okay. So just so the record is clear, if
`you're citing PAR1006, V7 from time stamp 0 to 16
`seconds, that citation should be changed to Video 8 for
`all applicable citations for all your declarations?
` A. Yes.
` Q. Okay.
` A. That's the only one that I -- that I noticed as
`a -- as a correction for my declarations.
` Q. Okay. Let's move on, Dr. Valuck.
` Counsel asked you yesterday whether you have
`been paid for your work on the six IPR declarations that
`are the subject of the deposition. Do you recall that?
` A. Yes.
` Q. You testified that you have not been
`compensated for your work. Do you recall that?
` A. Yes.
` Q. And why have you not been compensated for your
`work?
` A. I just haven't submitted invoices yet.
` Q. Are Par Pharmaceutical, Inc., and Amneal aware
`that you have not submitted any invoices for your work
`on the six IPR declarations?
` MR. STOPS: Objection. Form.
` A. I made them aware this week when -- when we met
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`Page 227
`
` * * *
` Greenwood Village, Colorado
` 9:29 a.m.
` * * *
`
`ROBERT VALUCK, Phd, RPh,
` having been previously sworn, was examined
` and testified as follows:
`EXAMINATION
`BY MR. BURGY:
` Q. Good morning, Dr. Valuck.
` A. Good morning.
` Q. Welcome back to day 2 of your deposition.
` As you know, my name is Aziz Burgy. I
`represent Par Pharmaceutical, Inc., in this matter. And
`I'm going to be questioning you on redirect on some of
`the topics that counsel, Mr. Eric Stops, asked you about
`yesterday.
` Do you understand that?
` A. Yes.
` Q. Okay. And you understand that you're still
`under oath today?
` A. Yes.
` Q. Before we get started today, I wanted to ask
`you whether you had any discussions with counsel between
`
`Page 228
`yesterday's cross-examination and today's redirect
`questioning by me about your testimony today.
` A. No.
` Q. And did you do anything to prepare for your
`deposition testimony today?
` A. No.
` Q. Counsel yesterday asked you about your
`declarations that you submitted in the IPR proceedings
`that are related to the Jazz patents. Do you recall
`that?
` A. Yes.
` Q. Okay. Do you have any corrections to make to
`your declarations that you know of? And there are
`several declarations from yesterday, so feel free to
`take a look.
` A. If you don't mind. There's one thing that I
`believe is a typo. As we were looking at the '730
`declaration yesterday, we were talking about --
` Q. Can you tell me what page you're on?
` A. Yes. I'm talking about page 40. There's an
`instance in the claim chart that refers to the -- the
`video and transcript. And I refer in the middle of that
`claim chart the entry "Pharmacy staff receives faxed
`prescription and enters information from it into a
`computer" and make reference to the video at PAR1006,
`
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 3 of 45
`
`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`Page 231
`in -- prior to the deposition I made them aware of that.
` Q. (By Mr. Burgy) And why had you not -- why have
`you not submitted invoices yet?
` A. I just hadn't gotten around to it yet.
` Q. So the client should expect a pretty hefty bill
`from you at some point.
` A. Yeah, I suppose that may -- may cause a little
`bit of angst for accounting maybe. But I just hadn't --
`I just hadn't done it yet and will be doing so.
` (Par Exhibit Numbers 1042, 1043, and 1044 were
`marked.)
` Q. Dr. Valuck, I've handed you three documents
`that have been marked as Exhibits PAR 1042, 1043, and
`1044. Do you see that?
` MR. STOPS: Which one is which?
` MR. BURGY: Sorry. And I was just going to get
`to that.
` MR. STOPS: Sorry.
` Q. (By Mr. Burgy) So Xyrem -- the document that
`has the Bates Number Xyrem IPR 1 through 4 is -- has
`been marked PAR 1042. And Xyrem IPR 5 through 8 has
`been marked PAR 1043. And Xyrem IPR 9 through 11 has
`been marked 1044.
` Can you please confirm that that is correct on
`the documents that you have before you.
`
`Page 232
`
` A. Yes.
` Q. Do you recognize these three documents,
`Dr. Valuck?
` A. Yes, I do.
` Q. And what are these three documents?
` A. These are the retainer agreement letters
`between the law firm or firms and myself related to
`these six IPRs that I prepared in this matter.
` Q. And if we could take the first one, PAR 1042.
`Do you see that?
` A. Yes.
` MR. BURGY: And just for the record, I'd like
`to designate this portion of the transcript as
`confidential under the protective order.
` (The following portion is designated
`confidential.)
` Q. (By Mr. Burgy) Dr. Valuck, do you see in the
`first sentence it says Par Pharmaceutical, Inc., the
`retaining party, has authorized you to retain -- has
`authorized us to retain you to provide consulting and
`expert witness services to Arent Fox on behalf of the
`retaining party? Do you see that?
` A. Yes.
` Q. And so who are you retained by with respect to
`these IPRs?
`
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`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 233
`
` A. By Par Pharmaceutical, Inc.
` Q. Okay. And with respect to PAR 1042, you
`testified that these are the engagement letters that
`encompass your work regarding the IPRs in this case?
` A. Yes.
` Q. And is this document -- this engagement letter
`at PAR 1042 specific to any of the specific Jazz
`patents?
` A. Yes.
` Q. Which? And which patents are those?
` A. This is specific to the '059 patent and the
`'988 patent.
` Q. Okay. Let's move on to the next document,
`which is PAR 1043. Are you there, sir?
` A. Yes.
` Q. And briefly, what is this document?
` A. This, similarly, is another retainer agreement
`letter between law firms and myself related to some of
`the IPR work that I've done here.
` Q. And who are the retaining parties?
` A. Here it's Amneal Pharmaceuticals, LLC, and Par
`Pharmaceutical, Inc. Hang on. There's a typo. This
`one --
` Q. Where is that?
` A. The first line. It says "Amneal
`
`Page 234
`Pharmaceuticals, LLC (Amneal) and Par Pharmaceutical
`(Par)," which should be "Par Pharmaceutical, Inc.
`(Par)" --
` Q. Oh, okay. Thank you.
` A. -- "collectively have authorized" and such.
` Q. Okay. And so Amneal and Par are the retaining
`parties; is that correct?
` A. Yes.
` Q. And this engagement letter pertains to which
`Jazz patent?
` A. This letter specifically pertains to the '730
`patent.
` Q. All right. And this letter encompasses your
`work with respect to the IPR declarations that you've
`submitted with respect to the '730 patent; is that
`correct?
` MR. STOPS: Objection. Form.
` A. Yes.
` Q. (By Mr. Burgy) If we can move on to the last
`document, which is PAR 1044. Do you see that?
` A. Yes.
` Q. And what is this document?
` A. Similarly, this is a retainer agreement letter
`between law firms and myself related to some of the IPR
`declarations that I've prepared for this matter.
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 4 of 45
`
`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 235
`
` Q. And who are the retaining parties?
` A. On this letter, the retaining parties are
`Amneal Pharmaceuticals (Amneal) and Par Pharmaceutical,
`Inc. -- same -- sorry -- same typo --
` Q. Okay.
` A. -- as on the last letter. The first one should
`be Par Pharmaceutical, Inc., in the first line. And
`between Sterne, Kessler, Goldstein & Fox -- Locke Lord
`is a typo as well. Locke Lord is not involved in this
`one.
` Q. Okay.
` A. It's just Sterne, Kessler, Goldstein & Fox and
`Arent Fox.
` Q. And what patents does this engagement letter
`refer to?
` A. And this letter refers to the '182 patent, the
`'106 patent, and the '107 patent.
` Q. And does this engagement letter encompass your
`work with respect to the IPR declarations that you've
`submitted with respect to the '182, '106, and '107
`patents?
` MR. STOPS: Objection. Form.
` A. Yes, it does.
` Q. (By Mr. Burgy) Okay. You can put that aside.
` MR. BURGY: And we can go off the confidential
`
`Page 236
`
`record.
` (End of confidential portion.)
` Q. (By Mr. Burgy) Dr. Valuck, yesterday you --
`strike that.
` Yesterday counsel asked you about a person of
`ordinary skill in the art. Do you recall that?
` A. Yes.
` Q. And specifically counsel asked you about the
`qualifications related to a person of ordinary skill in
`the art?
` A. Yes.
` Q. And specifically you testified that a PharmD
`was the only doctor of pharmacy degree, I believe is
`what you said. Do you recall that?
` A. Yes.
` Q. What educational background do you have in
`pharmacy?
` A. I have a bachelor's degree in pharmacy, a
`master's degree in pharmacy, and a PhD degree in
`pharmacy.
` Q. How is a PhD in pharmacy different from a
`PharmD, if any?
` A. They're -- they're both doctorate degrees, but
`it -- the doctor of pharmacy degree is a very specific
`degree. The PharmD is called doctor of pharmacy. The
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`PhD degree is doctor of philosophy in pharmacy. It's
`also in the field. It's an advanced degree beyond
`the -- what we call the entry-level practice degree.
` And the entry-level practice degrees are either
`a bachelor's degree in pharmacy or a PharmD degree.
`Those two degrees -- one of them is a requirement for
`practice and licensure. Master's and PhD degrees are
`additional training in research and different aspects of
`pharmacy, specific aspects.
` A PharmD degree is advanced training in certain
`aspects, clinical aspects. Each is advanced training
`beyond the entry-level training. It's a very -- it's a
`small thing. But doctor of pharmacy versus doctorate in
`pharmacy, there are slight differences but both of those
`exist. So it can be confusing to someone who doesn't
`know those various degrees exist.
` Q. Do you consider yourself to be a person of
`ordinary skill in the art with respect to this case?
` A. Yes.
` Q. How so?
` A. I have a -- what I believe a POSA would have,
`is one of the entry-level practice degrees in pharmacy
`as -- one version. So I have a bachelor's degree in
`pharmacy. I have three to five years of work
`experience. I have experience in a variety of practice
`
`Page 238
`
`settings. So I consider myself a POSA.
` Q. I'd like to turn to your declaration with
`respect to the '730 patent. You have a pile of exhibits
`that we used yesterday. If you could pull that up.
` A. Yes.
` Q. Do you have that?
` A. Yes.
` Q. Do you recall that Jazz's counsel asked you
`about your expertise in this case yesterday? Do you
`recall that?
` A. Yes.
` Q. And, specifically, if you would turn to page 6
`of your declaration at paragraph 9. Do you see that?
` A. Yes.
` Q. I'm at the second sentence at paragraph 9 where
`you state, "I am an expert in the fields of drug safety,
`drug abuse prevention, and prescription drug
`distribution."
` Do you see that?
` A. Yes.
` Q. If we could take each of these in turn. What
`is the basis of your expertise in drug safety?
` A. Well, it comes from a variety of different
`areas. I have specific education and training. I have
`work experience. I have research experience. I have
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 5 of 45
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`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 239
`consulting experience. And I have what I would call
`professional service or service experience in the field.
` Q. I'm just trying to get those down. Give me one
`second.
` So I believe you mentioned five different
`categories. That your expertise is based on, with
`respect to drug safety -- and I believe you mentioned
`education, work experience, research experience,
`consulting work, and professional services work; is that
`correct?
` A. Yes.
` Q. Okay. Let's take each of those in turn.
` How does your education inform your
`understanding of drug safety?
` A. Beginning back to pharmacy school, we are
`taught about drug safety, both at the level of the drugs
`themselves, the efficacy and safety issues related to
`the pharmaceutical products, and we are educated and
`trained regarding safety matters dealing with
`individuals and populations and how safety is approached
`in a more -- you know, in a systems level, if you will.
`Distribution systems, regulatory systems, laws and regs
`and all, you know, manners approaching drug safety that
`are in place. You know, law courses and -- and drug --
`drug development courses and things of that nature in
`
`Page 240
`
`our training.
` We also have practical experiences in our
`education and training or clerkship experiences that we
`are required to do in various settings to gain
`experience in a variety of ways to, again, inform our
`knowledge and skills related to drug safety.
` Q. Now, with respect to your educational
`experience that informs your understanding of drug
`safety, how many years of education have you had that
`pertains to the drug safety field?
` A. Specifically, my pharmacy training was -- in
`pharmacy school for my first degree was five years of
`training. And then beyond that, my master's and PhD
`provided an additional five years of training. So ten
`years was my education and training portion.
` Q. Moving on to the next basis. How does your
`work experience inform your understanding of drug
`safety?
` A. I had a variety of practice -- work practice
`experiences in pharmacy. And through that gained
`experience through -- through that work of how -- how
`pharmacists and pharmacies and pharmacy systems approach
`and ensure drug safety.
` So everything from practice and processing and
`then dispensing prescriptions and creating and
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`Page 241
`implementing systems to do that, to understanding how
`drugs with safety concerns are and should be handled and
`what the laws and regs and implementations of those
`things are in terms of drug safety. So I gained that in
`that way through practice experience.
` Q. And approximately how many years of work
`experience do you have with respect to drug safety?
` A. Again, my first internships began in the
`mid-'80s. I don't remember the exact date of my first
`internship. It was in pharmacy school. So I would
`approximate that to be about 1985 when I began my
`internships. And those continued through the rest of
`pharmacy school, and then I began practicing as a
`pharmacist and practiced through 1994 in clinical
`practice. So approximately a decade of work experience
`in that way.
` Q. Moving on to your research experience. How
`does your research experience inform your understanding
`of drug safety?
` A. It's a large fraction of my work over the last
`20 years. My academic position has been conducting
`research in the specific field of drug safety. So I
`have written proposals, obtained grant funding,
`conducted studies, published studies, presented studies
`at professional conferences, presented results of my
`
`Page 242
`drug safety research to FDA at advisory committee
`hearing. Through all the usual channels of distribution
`of findings, I presented those findings. So I've,
`again, conducted a lot of research that is considered
`drug safety research.
` Q. And approximately how many years of research
`experience in drug safety do you have?
` A. That began in graduate school with my master's
`and PhD theses. That would start in approximately 1990.
`And my master's thesis was in '92. PhD thesis was in
`1994. And then the intervening 21 years as well. So
`from about 1990 to present.
` Q. So about --
` A. About 25 years.
` Q. About 25 years?
` A. Of research.
` Q. Moving on. How did your consulting work inform
`your understanding of drug safety?
` A. I've done a variety of consulting that's
`related to drug safety. Some of that has been
`consulting with or for pharmaceutical companies to
`advise on matters of drug safety, drug safety research,
`risk management-related research or programs addressing
`regulatory agencies, and those agencies' requests for
`risk-related information or studies or proposals for
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`JANE ROSE REPORTING
`1-800-825-3341
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`National Court-Reporting Coverage
`janerose@janerosereporting.com
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`Page 6 of 45
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`

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`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 243
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`risk management or minimization programs.
` I've also been on advisory boards for
`pharmaceutical companies to offer advice to them on
`similar matters about conducting safety research or
`matters related to risk minimization or program design.
` I've also done legal consulting related to drug
`safety. I served as an expert on various cases related
`to -- primarily would be drug product liability, general
`causation primarily. Also some work in pharmacist
`standard of care issues. And now in this engagement
`related to a patent-related matter. That's been my
`consulting experiences.
` Q. And about how many years of consulting work
`have you done that bears on the issue of drug safety?
` A. That began shortly after my academic career
`started. So I'm approximating 1995 when that started to
`occur. So I would say approximately 20 years.
` Q. And then, lastly, I think you mentioned
`professional services work; is that correct?
` A. Yes.
` Q. How does your professional services work inform
`your understanding of drug safety?
` A. Yes. I have been a member of professional
`societies related to drug safety. Chief among them is
`the International Society for Pharmacoepidemiology.
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`Page 244
`
`That's a very long word. But it's the primary
`professional society in the field for drug safety.
` I'm a member of that organization and have been
`since my last year of graduate school. So that would
`have been 1994. And have been on -- a member of some of
`their special interest groups. Have presented findings
`at the conferences of that organization. Have attended
`that organization's professional meetings over the years
`to remain current in my field, learn new techniques in
`my field, share my research in the field, that sort of
`thing.
` And then I've also served as a peer reviewer
`for drug safety-related journals and publications to
`basically serve as a referee for a peer review process
`for a publication of other researchers' work.
` Q. What types of journals?
` A. Those have been a variety of journals.
`Primarily, again, drug safety-related journals, like
`Pharmacoepidemiology and Drug Safety, the Journal of
`Drug Safety, the Journal of Clinical Epidemiology, the
`American Journal of Psychiatry. Various journals.
`That's probably not all of them.
` Over the years, I've peer-reviewed for
`probably -- I don't know -- 12 or 15 different journals
`over the years as a peer reviewer.
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` Q. And about how many years of professional
`services work would you say you've done that helps guide
`your understanding of drug safety?
` A. Again, starting with that first membership in
`the society as a starting point. So I would say that's
`from '94 to now. So 21 years.
` Q. I wanted to move to the next field which you
`mentioned that you are an expert with respect to this
`case. And I think it was mentioned -- drug abuse
`prevention; is that correct?
` A. Yes.
` Q. Now, the bases that you mentioned for drug
`safety, the five bases that we just went through, do
`those bases also help guide your understanding of drug
`abuse prevention?
` A. Yes.
` Q. Okay. So if we could take those in turn as
`well. How does your education inform your understanding
`of drug abuse prevention?
` A. Similarly, in many respects, our education as a
`pharmacist includes specific course work and training in
`the pharmacology and aspects of the drugs themselves,
`including drugs of potential abuse, controlled
`substances, various drugs with potential abuse.
` We learn about the products themselves. We
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`Page 246
`also learn about the laws, regulations, systems in place
`to address those drugs of abuse and how those are
`addressed from the legal and regulatory perspectives.
` We also learn about various distribution
`systems and processes for controlling the distribution
`of abusable drugs. How -- how they can be handled
`throughout -- again, throughout channels of
`distribution. Everything from manufacturing all the way
`through ultimate consumption by a patient and how those
`things can be done through legitimate channels and,
`unfortunately, sometimes can happen outside legitimate
`channels.
` And then the training continued in that
`respect. Practical, as I mentioned before, clerkships
`where we gain experiences -- required experiences in a
`variety of settings and see those things in practical
`application.
` And then my advanced training, master's and my
`PhD degree in pharmacy. I chose to focus on things that
`were related to largely drug safety and drug abuse
`prevention and things like that in my -- my work in
`graduate school. So I have additional training in
`graduate school about those matters.
` Q. And do you have about the same number of years
`of education with respect to drug abuse prevention that
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 7 of 45
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`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 247
`
`you had with respect to drug safety?
` A. Yes. Yes.
` Q. Moving on to research experience. How does
`your research experience inform your understanding of
`drug abuse prevention?
` A. Yes. I have also conducted -- some of my
`research has been in the drug abuse area, specifically
`prescription drug abuse.
` So I have published experience with that --
`grant-related/publication-related experience with
`prescription drug abuse and have recently been involved
`with more grant activity in this area. And just in the
`last few weeks am part of teams that have received
`additional grant funding notices in this area that
`aren't listed here, as they happened after this was
`submitted.
` So not all of that is reflected in my
`declaration. So I have ongoing funding and will be
`continuing to do this kind of research work as well in
`drug abuse.
` Q. Are you at liberty to disclose what funding
`you've recently received with respect to drug abuse
`prevention?
` A. Yes. I don't know of any prohibition. Yes, so
`I believe I can.
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`Page 248
` Q. And what grants have you received recently with
`respect to drug abuse prevention?
` A. I'm part of a team that submitted grants to the
`Department of Justice-Bureau of Justice Assistance. So
`it's the DOJ-BJA. It's all acronym soup.
` And it's called the Harold Rogers PDMP Grant
`program, which is -- prescription drug monitoring
`program is what a PDMP is. And there's a federal grant
`program through the Department of Justice to fund
`studies to better use these PDMP programs, of which
`Colorado has one, to better understand the scope of
`prescription drug abuse and better create ways to
`address the problem of prescription drug abuse at the
`state level.
` And our team that submitted grants, we received
`two of those to do that work over the next several
`years.
` Q. And now these PDMP programs, I believe you
`said -- is that correct?
` A. Yes.
` Q. Are these with respect to a certain class of
`drugs or particular drugs?
` A. Yes. A PDMP, or prescription drug monitoring
`program, is a state-level database that contains records
`of all of the controlled substance prescriptions
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`Page 249
`dispensed in the state. There's very slight variations
`from state to state about how the programs work. But,
`by and large, they're all similar in that respect.
` That they're a state-level database reflecting
`records from pharmacies that the pharmacies submit to
`the State, and the database is maintained of all the
`controlled substance prescriptions that were dispensed
`by those pharmacies.
` Q. Now, these controlled substances that you
`mentioned that would be the basis of the PDMP program,
`do any of these drugs have risk management programs
`associated with them?
` A. Yes.
` Q. And can you elaborate on what types of risk
`management programs are involved with respect to those
`controlled substances?
` A. Yes. For example, prescriptions for Xyrem,
`being that it's a controlled substance, would be
`included in the database. Prescriptions -- and Xyrem is
`subject to a risk management program. Prescriptions for
`extended-release or long-acting opioids would be
`contained in the database, and they're also subject to
`an ERLA REMS program. So there's various drugs that are
`contained in these PDMPs that are subjected to REMS
`programs.
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`Page 250
` Q. How long has Colorado's PDMP been around?
` A. I don't recall the exact year that it was
`implemented, but I believe it's been approximately a
`dozen years. I don't remember the exact year when it
`started.
` Q. Have these PDMP programs been around before
`Colorado's PDMP program was implemented?
` A. Yes, for a long time. The first PDMPs were
`many years ago. Colorado was one of the later ones,
`actually, to start a PDMP program. Colorado was not one
`of the early adopters. We were later in the spectrum.
` Q. How long have you been aware of PDMP programs?
` A. Since pharmacy school I was aware of them. We
`just at that time did not happen to have one in
`Colorado.
` Q. Have you worked on any other PDMP programs
`besides the Colorado one?
` A. I have worked with people who administer these
`programs from around the country. I've attended
`conferences where PDMP program administrators get
`together and have conferences to share best practices
`and share what they're doing, learn from each other.
`I've attended those conferences and -- and met with
`people and learned about the different states and what
`they're doing and helped originally.
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 8 of 45
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`

`
`CONFIDENTIAL
`Amneal and Par v. Jazz
`
`FINAL - October 9, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 2
`
`Page 251
` When we created our PDMP program in Colorado,
`it was on a very small dollar amount. DOJ-BJA grant
`from the same program, the Harold Rogers program --
`again, this is probably -- it's -- if I can refer to