US Patent and Trademark Office
`_________________________________________
`
`Amneal Pharmaceuticals LLC
`and Par Pharmaceutical, Inc.,
`v.
`Jazz Pharmaceuticals, Inc.,
`
`_________________________________________
`
`Deposition of:
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`October 8, 2015
`
`
`Page 1 of 75
`
`JAZZ EXHIBIT 2007
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 1
`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 1
`October 8, 2015
`Greenwood Village, Colorado
`Lead: Eric Stops, Esquire
`Firm: Quinn Emanuel
`
`FINAL COPY
`JANE ROSE REPORTING 1-800-825-3341
`
`Page 3
`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 2
`
`Page 4
`
`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 1
`
`Examination
`By Mr. Stops.............................Page 6
`
`Reporter Certificate.....................Page 218
`
`Notice to Read and Sign..................Page 220
`
`Index of Exhibits........................Page 222
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 2 of 75
`
`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 7
` Q. Would you please state your full name for the
`record and your home address.
` A. Yes. My name is Robert James Valuck. Last
`name is spelled V-a-l-u-c-k. My home address is
`7059 South Magnolia Circle, Centennial, Colorado 80112.
` Q. And just a few instructions before we get
`started. I need your answers orally. The court
`reporter cannot record nods of your head. Do you
`understand?
` A. Yes.
` Q. If you don't understand a question, I need you
`to ask for clarification before you answer. If you do
`answer, that means you understood the question. Is that
`okay?
` A. Yes.
` Q. And are you represented by counsel today?
` A. Yes, I am.
` Q. Who is representing you?
` A. Both Mr. Burgy, Mr. Frese, and Mr. Ruedy.
` Q. How many times have you been deposed?
` A. I don't know the exact number.
` Q. Approximately.
` A. Approximately half a dozen times.
` Q. Have you been deposed in any patent cases
`before?
`
`Page 8
`
` A. No, I have not.
` Q. Do you have any patents in your name?
` A. No, I do not.
` Q. You've filed a patent application; correct?
` A. I was associated with the filing of a patent
`application.
` Q. What do you mean by "associated"?
` A. It was filed by another -- another individual.
` Q. You were a named vendor on that application,
`though?
` A. I believe so, yes.
` Q. Okay.
` A. I don't recall the -- the paper. I don't have
`that with me.
` Q. Do you know what that patent application was
`for?
` A. I would have to review that -- that
`application.
` Q. You don't remember the subject matter of the
`application?
` A. Only generally. Again, I don't have the
`application with me, so I don't have the --
` Q. What's your general recollection?
` MR. BURGY: Objection. Relevance.
` A. Yeah, I was not asked to opine on it for this
`
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`Page 5
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` * * *
` Greenwood Village, Colorado
` 8:58 a.m.
` * * *
`
` MR. STOPS: So this is Eric Stops for Jazz.
`For the record, I guess, do you guys want to introduce
`yourselves first?
` MR. BURGY: Sure. Sure. My name is Aziz
`Burgy, I'm from the law firm of Arent Fox, and I
`represent Par Pharmaceutical, Inc., in this matter and
`also representing the witness here.
` MR. FRESE: My name is Bradford Frese. I'm
`also from the firm of Arent Fox, and I also represent
`Par Pharmaceutical, Inc., in this matter and the
`witness.
` MR. RUEDY: Matt Ruedy representing Amneal, and
`I also represent the witness in this proceeding.
` MR. SILVERSTEIN: David Silverstein, in-house
`counsel at Par Pharmaceutical, Inc.
` MR. STOPS: And for the record, also, with me
`for Jazz is Frank Calvosa from Quinn Emanuel and John
`Biernacki from Jones Day.
` And for the record, this deposition is being
`taken regarding Dr. Valuck's declarations in several
`
`Page 6
`IPRs. The numbers are IPR-2015-545, -546, -547, -548,
`-551, and -554.
` This deposition also applies to several IPRs
`that are in the process of being joined. Those numbers
`are 2015-1810, -1813, -1814, -1815, -1816, -1817, -1818,
`and -1820.
` And we've discussed these multiple IPRs being
`addressed simultaneously with counsel for Par and
`Amneal, and they have consented.
` MR. BURGY: That's fine. This is Aziz Burgy.
`And we've also discussed the issue of objections for
`this deposition. I will be making the primary
`objections on behalf of both Par and Amneal. Certainly,
`if I miss an objection and my colleague, Mr. Ruedy,
`wants to interject an objection, he's free to do so. I
`assume you guys have no objections to that, Eric.
` MR. STOPS: Correct.
` MR. BURGY: Great. Thank you.
`ROBERT VALUCK, Phd, RPh,
` having been duly sworn, was examined
` and testified as follows:
`EXAMINATION
`BY MR. STOPS:
` Q. Good morning again, Dr. Valuck.
` A. Good morning.
`
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 3 of 75
`
`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 9
`matter, so I don't have any recollection or opinion
`about it at this time.
` Q. (By Mr. Stops) It was not about restricted
`distribution systems --
` MR. BURGY: Same --
` Q. (By Mr. Stops) -- is that correct?
` MR. BURGY: I'm sorry. Same objection.
` A. Again, I don't have any opinion on it at this
`time. No recollection.
` Q. (By Mr. Stops) Okay. Do you know if it's --
`that application is still pending?
` MR. BURGY: Same objection.
` A. I don't know.
` Q. (By Mr. Stops) Okay. But through your
`experience in the application, are you generally
`familiar with what patents are?
` A. General familiarity with what patents are.
` Q. Okay. Have you read -- have you ever read a
`patent?
` A. Yes.
` Q. Have you ever read a patent before this case?
` A. Yes.
` Q. Okay. Now, you understand that this deposition
`concerns declarations that you've submitted in
`connection with six separate IPRs on six patents owned
`
`Page 10
`
`by Jazz; correct?
` A. Yes.
` Q. For the purpose of the -- of this deposition,
`I'm going to refer to the patents by their last three
`numbers. So, for example, for Patent Number 7,668,730,
`I'll refer to that as the '730 patent. Is that okay
`with you?
` A. Yes, that's fine.
` Q. And I'm going to refer to the patents about
`which you've submitted declarations collectively as "the
`Jazz patents." Is that clear?
` A. Yes.
` Q. You're a registered pharmacist; correct?
` A. Yes.
` Q. Is your license still -- still current?
` A. My license is active in Colorado.
` Q. And, actually, let me mark -- or hand you your
`CV that was attached to -- well, I'll hand you your CV
`which is designated as PAR1008 which was attached to the
`IPR for the '988 patent.
` And for the record, this is -- this is your CV;
`correct?
` A. Yes.
` Q. And going back to your previous answer, you
`said your license is still current in Colorado. It's no
`
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`Page 11
`
`longer current in the state of Illinois; is that
`correct?
` A. It is on a -- I don't know the term that is
`used in Illinois, but it is on the -- the equivalent of
`a dormant status, which I could apply for that to become
`active again. But it has not lapsed in the sense that
`there is no license in Illinois.
` Q. You don't currently act in a dispensing
`capacity; is that correct?
` A. That's correct.
` Q. And the last time you did act in a dispensing
`capacity was in 1994; correct?
` A. Yes, that's correct.
` Q. Let's talk about your experience with drugs
`that are subject to restricted distribution systems or
`risk management systems. You've never dispensed Xyrem;
`correct?
` MR. BURGY: Objection. Lack of foundation.
` A. That's correct.
` Q. (By Mr. Stops) You've also never dispensed
`Revlimid; correct?
` A. That's correct.
` Q. You've also never dispensed Thalomid; correct?
` MR. BURGY: Objection. Form.
` A. No, I have not. I don't believe -- I'm not
`
`Page 12
`
`sure that's a product.
` Q. (By Mr. Stops) Okay. You've also never
`dispensed a drug that was the subject of an FDA-approved
`risk evaluation and mitigation strategies, or REMS;
`correct?
` MR. BURGY: Objection. Form.
` A. No. I don't believe so, no.
` Q. (By Mr. Stops) And you've never dispensed a
`drug that was subject to an FDA-approved risk
`minimization action plan, or RiskMAP; correct?
` MR. BURGY: Objection. Form. Foundation.
` A. I don't know.
` Q. (By Mr. Stops) Okay. Now, in your
`declarations, you stated you've dispensed Accutane and
`Clozaril; correct?
` A. I would have to refer to those -- those
`declarations to verify any statements I made in them.
` Q. Sure. To your knowledge, have you previously
`dispensed Accutane and Clozaril?
` A. Again, I would have to refer to my declarations
`where I stated my -- my recollection -- recollections
`clearly.
` Q. Okay. If you had dispensed either of those
`drugs, the last time you would have had the opportunity
`to do so would have been in 1994; correct?
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 4 of 75
`
`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 13
`
`Page 15
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` MR. BURGY: Objection. Form.
` A. I couldn't speculate on the last opportunity.
`I'm currently licensed to practice in Colorado.
` Q. (By Mr. Stops) Okay.
` A. So I couldn't speculate on when that would be.
` Q. But you haven't dispensed any drugs since 1994,
`though; correct?
` A. That's correct.
` Q. You don't have any experience designing a risk
`management program; correct?
` A. I have experience --
` MR. BURGY: Sorry. Just slow down just a
`little bit.
` Objection. Foundation.
` A. I have experience with consulting with
`pharmaceutical companies who design and implement risk
`management and risk evaluation and mitigation programs.
`I have familiarity with the FDA and their processes and,
`if justified, at FDA hearings about product risk.
` I have practiced pharmacy in various settings
`to be aware of which products I can dispense and under
`which circumstances, and so I have awareness of the
`RiskMAP and REMS programs that way.
` I've been educated about them in my education
`and training. I have in turn educated future
`
`Page 14
`practitioners about them in their education and training
`in my career as an academic.
` Q. (By Mr. Stops) Okay. But you have not
`designed a risk management program; correct?
` MR. BURGY: Objection. Form.
` A. I believe I just answered.
` Q. (By Mr. Stops) No. You told me a bunch of
`things that you did do. I'm asking, have you actually
`designed a risk management program?
` MR. BURGY: Objection. Form.
` A. I guess I'm not clear on what you mean by
`"design a program."
` Q. (By Mr. Stops) Sure. Is there any risk
`management programs that you had a hand in creating?
` MR. BURGY: Objection. Form.
` A. I'm not quite sure, you know, what you mean by
`"had a hand in creating."
` Q. (By Mr. Stops) Any involvement in creating a
`risk management program?
` MR. BURGY: Same objection.
` A. Again, my -- I had stated my -- my involvement
`with pharmaceutical companies in advising and consulting
`on matters related to risk management, RiskMAP, and REMS
`programs.
` Q. (By Mr. Stops) That's actually what I'm asking
`
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`about.
` For the consulting that you've done with
`pharmaceutical companies, what risk management programs
`have you consulted on?
` MR. BURGY: Objection. Form.
` A. Again, I've provided advice to them on product
`drug, product risk, and possible strategies for risk
`mitigation of the -- of those risks.
` Q. (By Mr. Stops) Was that consulting in
`connection with a particular drug, or was it just
`general consulting?
` MR. BURGY: Objection. Form.
` A. It was with respect to a specific drug.
` Q. (By Mr. Stops) Can you name any specific drugs
`that you have consulted with on the development of a
`risk management program?
` A. Under prior agreement under my -- terms of my
`consulting agreement, I can't disclose the names of the
`products or the companies in that instance.
` Q. Okay. And do you recall what category of
`drugs -- well, let me ask this -- sorry -- a preliminary
`question.
` How many drugs were you involved with in that
`capacity?
` A. I don't recall the exact number. I don't want
`
`Page 16
`
`to misspeak.
` Q. Do you know -- do you recall generally?
` A. I believe it was -- again, I don't want to
`misspeak, but I believe it was two or three. I don't
`have the exact number.
` Q. Do you know what therapeutic category those
`drugs fell in?
` MR. BURGY: Objection. Form.
` A. Yes.
` Q. (By Mr. Stops) Can you disclose that
`information?
` A. No. Under the terms of my consulting
`agreement, I can't disclose the product information.
` Q. Was there a specific category of risk that you
`were trying to minimize in your consulting?
` MR. BURGY: Objection. Foundation.
` A. I don't believe I can disclose that per the
`terms of my consulting agreement. I'd rather not rather
`than risk violating that agreement.
` Q. (By Mr. Stops) Sure. You also mentioned some
`FDA testimony. When was that?
` MR. BURGY: Objection. Form.
` A. I don't recall the exact date. It would have
`been in the fall of 2004. I do not recall the exact
`date, however.
`
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`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 17
` Q. (By Mr. Stops) Do you recall what product it
`was for?
` A. It was -- that was related to a variety of
`products. It was more than one.
` Q. Okay. Do you recall what products they were?
` A. That was related to the class of drugs called
`antidepressants.
` Q. Do you know what kind of antidepressants?
` A. That particular hearing dealt with all
`antidepressants in general.
` Q. Is there a risk management program related to
`antidepressants?
` MR. BURGY: Objection. Form.
` A. I have not been asked to opine on that, and I
`don't know specifically.
` Q. (By Mr. Stops) Was that the only time that you
`consulted or testified before the FDA regarding a risk
`management program?
` A. I'm not sure. That may be a compound question,
`whether I consulted or testified before the FDA.
` Q. Can -- let's start with -- let's start with
`testified.
` Is that the only time you testified before the
`FDA regarding a risk management program?
` A. Yes.
`
`Page 18
` Q. And have you consulted with the FDA regarding
`risk management programs?
` A. Yes.
` Q. What was the -- would you explain what
`consulting you've done for the FDA regarding risk
`management programs?
` MR. BURGY: Objection. Form.
` A. I was contacted by the FDA to present my
`research at the hearing that I mentioned previously in
`the fall of 2004.
` Q. (By Mr. Stops) So the consulting was in
`connection with the hearing on antidepressants; is that
`right?
` A. That's correct.
` Q. Is that the only consulting that you've done
`with the FDA?
` A. Yes.
` Q. Do you have any experience implementing a risk
`management program?
` MR. BURGY: Objection. Form.
` A. The experiences I have I described as
`previously.
` Q. (By Mr. Stops) All right. So the experiences
`you described encompass all of your experience with risk
`management -- with risk management programs; is that
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`correct?
` MR. BURGY: Objection. Form.
` A. It may not include every experience. There's
`also been practice experience that I've had, general
`awareness through practice -- obtained through practice
`in a variety of different settings. Learning what is
`and isn't done in those settings, what is referred out
`to other settings, learning about these programs through
`continuing professional education, scientific
`conferences, the ongoing maintenance of my knowledge and
`experience base over the last 20 years as well, which
`encompasses many activities.
` Q. (By Mr. Stops) Okay. You mentioned what is
`and what is not done in these settings. Just so I'm
`clear, what did you mean by the word "settings"?
` A. In that context, I refer to "settings" as
`pharmacy practice settings.
` Q. And you said what is -- correct me if I
`misquote you. You said what is done in-house and what
`is referred out of those settings.
` What did you mean by the "referred out" of the
`settings?
` MR. BURGY: Objection. Form.
` A. Referring to the usual and customary practices
`within various settings and what is done there and then
`
`Page 20
`
`what is -- if not done in a certain setting, is then
`referred to another setting or system of distribution
`for certain products.
` Q. (By Mr. Stops) Can you give me an example of
`what you meant by that?
` A. For example, if I were working in a retail
`pharmacy, chain pharmacy, for example, like a corner
`drugstore, and was presented with an order for home
`infusion of intravenous antibiotics by a physician or a
`patient, that may not be something that that pharmacy
`setting is equipped to handle. And, therefore, we would
`not receive that order because we were not able to do
`that and would refer their business elsewhere, to the
`appropriate businesses that could.
` Q. I understand. Thank you.
` Do you know approximately how many drugs are
`subject to FDA-approved REMS?
` MR. BURGY: Objection. Form.
` A. No, I do not know.
` Q. (By Mr. Stops) Do you know how many drugs are
`subject to FDA-approved RiskMAPs?
` MR. BURGY: Same objection.
` A. No, I do not know.
` Q. (By Mr. Stops) Do you know how many drugs are
`distributed under restricted distribution systems?
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 6 of 75
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`

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`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 21
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`Page 23
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` MR. BURGY: Same objection.
` A. No, I do not.
` Q. (By Mr. Stops) You don't hold yourself out as
`an FDA regulatory expert; correct?
` MR. BURGY: Objection. Form.
` A. I have expertise in FDA charter, structure,
`process, and activity through the course of my education
`and training, through the course of my practice, through
`the course of my consulting and academic experiences,
`through the course of my continuing professional
`education, through my direct experiences attending and
`testifying at FDA hearing, and the like.
` Q. (By Mr. Stops) That wasn't my question. I
`just asked if you held yourself out as a expert in FDA
`regulatory matters.
` MR. BURGY: Objection. Form.
` A. I believe I have expertise in FDA-related
`matters to the extent that I delineated.
` Q. (By Mr. Stops) I'm going to hand you a
`document that's being marked for identification as
`Exhibit 2042.
` MR. STOPS: I believe that's the next up
`number. If anybody has a different number, just let me
`know.
` (Exhibit Number 2042 was marked.)
`
`Page 22
`
` Q. (By Mr. Stops) Dr. Valuck, this is a
`deposition transcript that you've given in a matter in
`2010; correct?
` A. Yes.
` Q. If you would turn to page 84 of the document.
`The page number is on the bottom right. In your top
`answer you testified, "Again, similarly, I think that's
`a matter for the drug company and the FDA, to figure out
`what the reasonable action is based upon available
`evidence and what is required for labeling or what is
`required for risk management or mitigation strategies
`that might be employed, and I'm not an FDA regulatory
`expert and, therefore, I can't really speak to it."
` Do you see that?
` MR. BURGY: Objection. Foundation. Relevance.
` A. Yes, I see that.
` Q. (By Mr. Stops) You gave that testimony in
`2010; correct?
` A. Yes, that's correct.
` Q. And you agree that because you're not an FDA
`regulatory expert, you can't really speak to what is
`required for risk management or mitigation strategies;
`correct?
` MR. BURGY: Objection. Form, foundation, and
`relevance.
`
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` A. Again, I believe I've stated what I feel
`comfortable and certain that I can speak to with my
`expertise related to the FDA, and I believe it's more --
`more specific than a blanket statement about --
`yes-or-no expertise about FDA matters.
` Q. (By Mr. Stops) Okay. And you went on to
`testify about risk management for mitigation strategies.
`This is now the second answer on page 84.
` "I think it's a possible action that could be
`taken, and that's a contextual thing that then would be
`up to the FDA and the drug company to determine what the
`appropriate thing to do would be. It's outside my
`expertise."
` Do you see that?
` MR. BURGY: Objection. Form, relevance, and
`foundation.
` A. Yes, I see that.
` Q. (By Mr. Stops) And, again, you testified to
`that in 2010; correct?
` MR. BURGY: Same objections.
` A. Yes.
` Q. (By Mr. Stops) You have your CV in front of
`you that is PAR Exhibit 1008. Is this CV up to date?
` MR. BURGY: Objection. Form.
` A. Not completely, no.
`
`Page 24
` Q. (By Mr. Stops) Do you know how out of date the
`CV is? And just from my reading of this, it appears to
`cut off in 2013.
` A. This copy was updated as of September 1st,
`2013.
` Q. How do you know that date?
` A. It's on the last page, page 41. When I update
`the CV, I note the date when I make the most recent
`updates.
` Q. And that's the small text in the parenthetical
`underneath the words "References available upon
`request"?
` A. Yes.
` Q. Okay. Thank you.
` So if you turn to page 2 of the CV, I just have
`a few questions to update some of the material on it.
`You have three current academic appointments as of this
`copy of your CV. Is that still current?
` A. Yes.
` Q. Do you teach any courses -- so -- sorry.
`Strike that.
` The first academic appointment is professor in
`the Department of Epidemiology at the Colorado School of
`Public Health.
` Do you teach any courses as part of that
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 7 of 75
`
`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 25
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`Page 27
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`appointment?
` A. I teach in courses as part of that appointment.
` Q. What do you mean by that?
` A. That I am not the primary course coordinator or
`professor that has full responsibility for the course.
`I may provide certain lectures on certain topics within
`courses.
` Q. I understand.
` Is that the same with respect to your teaching
`in the second appointment at the University of Colorado
`Denver, School of Medicine?
` A. Yes, it is.
` Q. In the third appointment at the University of
`Colorado Denver, School of Pharmacy, you are -- you have
`a certain -- current teaching assignments underneath.
`Are those still current?
` A. No.
` Q. I'm sorry. You said no?
` A. No.
` Q. Can you update that now?
` A. Yes. There have been small changes in the
`subarea labeled "Pharm.D. Curriculum (Entry-level
`program)."
` The first item listed, PHRD6400, has been
`changed slightly in name to a different course
`
`Page 26
`numbering. I don't have the exact number with me. The
`course has been expanded in scope slightly, and,
`therefore, the title of the course has changed from the
`currently listed "Clinical Biostatistics" to a new
`course title of "Evidence-Based Medicine and Literature
`Evaluation." The roles listed in parentheses have not
`changed.
` The additional items there, PHRD4550, the
`numbering has changed only on that item. But, again, I
`don't know right now without referring to current
`numbering what the current number system -- number is
`for that item.
` Q. Okay. Thank you.
` A. And, similarly, for the third item, the
`numbering has changed. I don't know the new number.
`And the sequencing number -- by which I mean
`"Professional Skills Development IV" -- that Roman
`numeral has changed as well, though I don't recall the
`new number of the Professional Skills Development course
`sequencing in which I am a guest lecturer.
` Q. Okay. Are there any new academic appointments
`that should be listed on your CV?
` A. No.
` Q. On the top of page 3, your previous courses
`taught at UCHSC School of Pharmacy, what does the
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`"UCHSC" stand for?
` A. Yes. The "UCHSC" stands for the University of
`Colorado Health Sciences Center School of Pharmacy.
` Q. Is that a different institution than the -- the
`University of Colorado Denver, School of Pharmacy?
` A. No, it is not.
` Q. Okay. In Section C on page 3 of your CV, you
`list your past five years of consulting. Is there any
`additional or new consulting in the last two years since
`your CV was last updated?
` A. I can't answer that for certain without
`referring to my files and my records to be able to
`determine for sure if anything had happened in the last
`two years that could be included under that topic.
` Q. Okay. Under Section D, "Professional," the
`first listing is "Clinical Pharmacist (home health
`care)."
` What is home health care?
` A. Home health care is a -- in the context that I
`use it, home health care is a practice setting for
`pharmacy practice in which drug products and/or services
`are provided to patients in their homes.
` Q. I didn't know that existed. Okay. In the
`fourth entry under "Professional," you have it listed as
`a decentralized pharmacist. Do you see that?
`
`Page 28
`
` A. Yes.
` Q. What's a decentralized pharmacist?
` A. A decentralized pharmacist, as I use the term,
`is a pharmacist who practices primarily outside of a
`centralized pharmacy location but still within a
`hospital setting or system.
` Q. What's a centralized pharmacy?
` A. A centralized pharmacy, in the -- in the way
`that I use the term, is the primary location where drug
`products are stored, where pharmaceutical products in
`the hospital setting may be compounded or created
`specifically for specific patients where most of the
`distributive functions of pharmacy are practiced.
` Q. A corner pharmacy would be considered a
`centralized pharmacy in your use of the term?
` MR. BURGY: Objection. Form.
` A. I would not use the term "centralized" or
`"decentralized" outside of the hospital setting --
` Q. (By Mr. Stops) Oh.
` A. -- the way I use the term. I use it for --
`I -- I'd like to expand on that.
` I would view home health care as a case where
`it's not a typical, you know, corner drugstore. That's
`a more distrib- -- that has a distributed model as well,
`home health care does, where there is a centralized
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 8 of 75
`
`

`
`US Patent and Trademark Office
`Amneal and Par v. Jazz
`
`FINAL - October 8, 2015
`Robert Valuck, Ph.D., R.Ph. - Vol. 1
`
`Page 29
`function of drug product creation, compounding,
`formulation, and initial shipment and distribution. And
`then there are additional distributive functions
`associated with home health care as well.
` But typically the term "centralized/
`decentralized" referring to -- but could be -- again,
`could be applied outside those settings.
` Q. Is home health care an example of a
`decentralized pharmacist function?
` A. As I mentioned, there are components to home
`health care. Some of them are centralized in a specific
`location. Others are distributive -- excuse me --
`others are decentralized and relate to the patient in
`their home.
` Q. Okay. The treatment of the patient in the home
`is a decentralized pharmacist function; is that right?
` MR. BURGY: Objection. Form.
` A. Such a function may be performed by a
`pharmacist either at the centralized location or in the
`home.
` Q. (By Mr. Stops) In the hospital setting is
`the -- when -- strike that.
` In the hospital setting when you were acting as
`a decentralized pharmacist, were you providing
`pharmaceuticals to patients outside of the hospital?
`
`Page 30
`
` A. In that particular case at University Hospital,
`I was not.
` MR. BURGY: I'm sorry. Were you done?
` THE DEPONENT: Yes.
` Q. (By Mr. Stops) You were -- so you were
`providing pharmaceuticals to patients within the
`hospital setting?
` A. Yes.
` Q. Then why was it decentralized, then?
` A. Pharmacists were deployed in our -- during the
`time there -- that I was employed there, the pharmacists
`were deployed in various