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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`_________________________
`HORIZON PHARMA, INC., and
`POZEN INC.,
` Plaintiffs,
` -vs-
`DR. REDDY'S LABORATORIES, INC., and
`DR. REDDY'S LABORATORIES LTD.,
` Defendants.
` CA No.: 3:11-02317 (JAP)(DEA)
`3:13-00091 (JAP)(DEA)
`Caption Continued on Page 2
`_________________________
`
` CONFIDENTIAL
` (ATTORNEY CONFIDENTIAL PORTION INCLUDED)
` PAGES 99-104
` VIDEOTAPED DEPOSITION OF BRIAN AULT, PhD
` PHILADELPHIA, PA
` OCTOBER 25, 2017
`
`Reported by: S. ARIELLE SANTOS, RPR, CSR, CLR
`Job No. 132688
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`_________________________
`HORIZON PHARMA, INC., and
`POZEN INC.,
` Plaintiffs,
` -vs-
`DR. REDDY'S LABORATORIES, INC., and
`DR. REDDY'S LABORATORIES LTD.,
` Defendants.
` CA No.: 3:11-02317 (JAP)(DEA)
`3:13-00091 (JAP)(DEA)
`Caption Continued on Page 2
`_________________________
`
` CONFIDENTIAL
` (ATTORNEY CONFIDENTIAL PORTION INCLUDED)
` PAGES 99-104
` VIDEOTAPED DEPOSITION OF BRIAN AULT, PhD
` PHILADELPHIA, PA
` OCTOBER 25, 2017
`
`Reported by: S. ARIELLE SANTOS, RPR, CSR, CLR
`Job No. 132688
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`_________________________
`HORIZON PHARMA, INC., and
`POZEN INC.,
` Plaintiffs,
` -vs-
`MYLAN PHARMACEUTICALS
`INC., MYLAN LABORATORIES
`LTD., and MYLAN INC.,
` Defendants.
`CA No: 3:13-cv-04022 (JAP)(DEA)
`_________________________
`HORIZON PHARMA, INC., and
`POZEN INC.,
` Plaintiffs,
` -vs-
`ACTAVIS LABORATORIES FL,
`INC., and ACTAVIS PHARMA,
`INC.,
` Defendants.
`CA No. 3:13-cv-03038 (JAP)(DEA)
`_________________________
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`_________________________
`HORIZON PHARMA, INC., and
`POZEN INC.,
` Plaintiffs,
` -vs-
`LUPIN LTD., and LUPIN
`PHARMACEUTICALS INC.,
` Defendants.
`CA No. 3:11-cv-04275 (JAP)(DEA)
`_________________________
`
` OCTOBER 25, 2017
` 10:30 A.M.
`
` Videotaped Deposition of BRIAN AULT, PhD
`held at the offices of Pepper Hamilton, 3000 Two
`Logan Square, Philadelphia, PA, before S. Arielle
`Santos, a Registered Professional Reporter,
`Certified Shorthand Reporter, Certified Livenote
`Reporter and Notary Public.
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` A P P E A R A N C E S
`
`ON BEHALF OF PLAINTIFF HORIZON PHARMA, INC., AND
`THE WITNESS:
`COOLEY
`500 Boylston Street
`Boston, MA 02116
`BY: ELLEN SCORDINO, ESQ.
`
`ON BEHALF OF PLAINTIFF POZEN INC.:
`BAKER BOTTS
`98 San Jacinto Boulevard
`Austin, TX 78701
`BY: JEFF GRITTON, ESQ. (Telephonically)
`
`ON BEHALF OF DEFENDANTS DR. REDDY'S LABORATORIES
`INC., AND DR. REDDY'S LABORATORIES LTD.:
`BUDD LARNER
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`BY: DMITRY SHELHOFF, ESQ.
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` A P P E A R A N C E S (Cont.'d)
`
`ON BEHALF OF DEFENDANTS MYLAN PHARMACEUTICALS
`INC., MYLAN LABORATORIES LTD., AND MYLAN INC.:
`PERKINS COIE
`700 Thirteenth Street N.W.
`Washington, DC 20005
`BY: ROBERT SWANSON, ESQ.
`
`ON BEHALF OF THE WITNESS:
`COVINGTON & BURLING
`One CityCenter
`850 Tenth Street, N.W.
`Washington, DC 20001
`BY: COURTNEY FORREST, ESQ.
`
`ALSO PRESENT:
`GERARD ALFE, Legal Video Specialist
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` INDEX
` BRIAN AULT, PhD 9
` BY MR. SWANSON 9
` BY MR. SHELHOFF 119
`
` DEFENDANT EXHIBITS MARKED - ATTACHED
` Exhibit 9, LinkedIn page 19
` Exhibit 10, scientific publication 46
` Exhibit 11, e-mail sent by Tommy 94
` Andersson on April 7, 2008
` Exhibit 12, spreadsheet 99
` Exhibit 13, Combined Declaration and 144
` Power of Attorney, Bates
` PZC_00013279 to PZC_ 00013299
` Exhibit 14, Summary of Deliverables and 159
` Documentation, Collaboration
` and License Agreement
` Exhibit 15, clinical study protocol for 163
` PN400-104
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` EXHIBITS REFERENCED - PREVIOUSLY MARKED
` Defendant's Exhibit 2 40
` Defendant's Exhibit 6 47
` Defendant's Exhibit 5 63
` Defendant's Exhibit 4 64
`
` ATTORNEY CONFIDENTIAL PORTION
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` BRIAN AULT, PhD - CONFIDENTIAL
` THE VIDEOGRAPHER: This
` deposition is now beginning. The
` date October 25, 2017. The time
` 10:32.
` This is the deposition of
` Brian Ault taken in the matter of
` Horizon Pharma, Inc. and Pozen,
` Inc. v. Dr. Reddy's Laboratories,
` Inc. and Dr. Reddy's Laboratories
` Limited in the United States
` District Court for the District of
` New Jersey, Number 2-15-3324.
` Counsel will now introduce
` themselves.
` MR. SWANSON: Robert Swanson
` from Perkins Coie on behalf of the
` Mylan defendants.
` MR. SHELHOFF: Dmitry Shelhoff
` from Budd Larner on behalf of the
` Dr. Reddy's defendants.
` MS. FORREST: Courtney Forrest
` from Covington & Burling on behalf
` of the witness.
` MS. SCORDINO: Ellen Scordino
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` BRIAN AULT, PhD - CONFIDENTIAL
` from Cooley LLP on behalf of
` Horizon Pharma and the witness.
` MR. GRITTON: And this is Jeff
` Gritton from Baker Botts on behalf
` of Pozen plaintiffs.
` (Whereupon Brian Ault, PhD is
` Sworn In.)
`
` EXAMINATION
`BY MR. SWANSON:
` Q Dr. Ault, could you please state
`and spell your name for the record.
` A Yes. Brian Ault, B-R-I-A-N.
`Last name is A-U-L-T.
` Q And I know you have had your
`deposition taken at least once a few
`years ago in a related matter.
` Have you had your deposition
`taken any other times?
` A No.
` Q Okay.
` And it's been a few years. I
`will remind you of a few things so that
`we are all on the same page.
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` BRIAN AULT, PhD - CONFIDENTIAL
` So I think you know you are
`under oath. Your testimony has the same
`force and effect as it does in a court
`of law. It's being recorded both by the
`court reporter here and by the
`videographer, and if you don't
`understand a question, please feel free
`to stop me, ask me to explain. I will
`be happy to clarify anything for you. I
`want to make sure that you understand
`exactly what I'm asking.
` Your counsel may object from
`time to time to the questions. Unless
`she instructs you not to answer, you
`should feel free to go ahead and answer
`the question, if you can.
` Is that all clear so far?
` A Yes.
` Q And it's also important that we
`try not to talk over each other so that
`the court reporter's job is made easier.
`And similarly, because the court
`reporter is recording the deposition,
`verbal answers are great. So instead of
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` BRIAN AULT, PhD - CONFIDENTIAL
`an "hm-hm" or an "uh-uh" or, you know,
`shaking your head or nodding, just a
`"yes" or "no" would suffice.
` Does that sound good?
` A Yes.
` Q And always, if you want to take
`a break, just let me know and we can
`stop for a few minutes. But I would
`just ask you, if there is a question
`pending at that time, if you could
`answer the question first and then we
`can take a break.
` Okay?
` A Okay.
` Q What did you do to prepare for
`your deposition today?
` A I met with Covington yesterday,
`and I reviewed the transcript and the
`original patent application last week.
` Q And when you refer to the
`"original patent application," which
`patent application are you referring to?
` A I am not sure what the number of
`that application was.
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` BRIAN AULT, PhD - CONFIDENTIAL
` Q Is it the -- is it an
`application in which you're the
`inventor?
` A I was an inventor on it.
` Q Okay.
` Do you understand it to be an
`application that led to a patent that is
`at issue in this proceeding?
` A My understanding that these are
`subsequent patents that came out of the
`original patent.
` Q Okay.
` We will probably look at those
`at some point today, and I will
`probably, you know, ask you then if
`that's the one were you looking at.
`Hopefully, we can remember to do that.
` Did you meet with -- I guess I
`will ask you generally, who did you meet
`with yesterday?
` A I met with Einar Stole and with
`Ellen to review the --
` Q With Ellen Scordino here?
` A Yes.
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` BRIAN AULT, PhD - CONFIDENTIAL
` Q Who do you consider to be your
`attorneys?
` A Today?
` Q In general.
` Who do you consider to be your
`attorneys representing you?
` A I consider Ellen and Courtney to
`be my attorneys.
` Q Do you consider anyone from
`Baker Botts as your attorney?
` A No.
` Q How long in your estimation have
`you been represented by attorneys from
`the Cooley law firm, the law firm that
`Ellen Scordino is with?
` MS. FORREST: Doctor, you can
` answer that, but I will caution you
` not to reveal any communications
` between yourself and any of your
` attorneys.
` THE WITNESS: Okay.
` We signed an agreement
` yesterday.
`BY MR. SWANSON:
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` BRIAN AULT, PhD - CONFIDENTIAL
` Q So it's your understanding that
`since yesterday you have been
`represented by Cooley?
` A Correct.
` Q Have you ever been represented
`by Cooley in the past?
` A No.
` Q Did you ever speak with
`attorneys from Cooley with respect to
`your prior deposition three years ago?
` A I don't believe so.
` Q When was the first time that you
`were contacted by attorneys from Cooley?
` A We spoke for the first time
`yesterday.
` Q And you hadn't had any previous
`contact with them before yesterday?
` A Correct.
` Q How long did you meet with your
`attorneys yesterday?
` A About three and a half hours.
` Q Did you review any documents
`besides your transcript from your prior
`deposition and the patent application we
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` BRIAN AULT, PhD - CONFIDENTIAL
`have already spoken about?
` MS. FORREST: Objection.
` Dr. Ault, you can answer that
` "yes" or "no," but please don't
` discuss which documents, if any,
` you reviewed.
` THE WITNESS: Yes.
`BY MR. SWANSON:
` Q In preparing for your
`deposition, did you speak to anyone
`other than the attorneys you have
`mentioned?
` A No.
` Q As a general matter, how many
`documents did you review in preparation
`for your deposition?
` A I believe it would be four.
` Q Did you review any deposition
`transcripts besides the deposition
`transcript from your prior deposition
`three years ago?
` A I only reviewed the transcript
`of my deposition.
` Q Do you have any consulting
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`agreements currently with AstraZeneca?
` A
`
`
`
` MS. FORREST: Objection to
` form.
`BY MR. SWANSON:
` Q You may answer.
` A
`
`
`
`
`
` Q Have you signed any consulting
`agreements with Cooley?
` A I don't believe that would be
`termed a "consulting agreement."
` Q But you have an agreement in
`which Cooley has agreed to represent
`you?
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` BRIAN AULT, PhD - CONFIDENTIAL
` A Correct.
` Q Do you have any currently
`pending agreements with Pozen?
` MS. FORREST: Object to the
` form.
` THE WITNESS: I don't have any
` agreements currently with Pozen.
`BY MR. SWANSON:
` Q And do you have any agreements
`that are currently enforced with
`Horizon?
` A I don't believe so.
` Q Do you currently in your career
`provide any consulting services besides
`the consulting agreement you have
`already mentioned with Covington?
` A I have not signed any other
`consulting agreements.
` Q Do you provide any consulting
`services, though, outside the scope of
`any agreement?
` I just want to make sure I
`understand your answer.
` A I am not quite sure what the
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` BRIAN AULT, PhD - CONFIDENTIAL
`question is. I discuss business matters
`amongst colleagues.
` Q And that's always informal; you
`are not compensated?
` A Exactly.
` Q Okay.
` Are you being compensated for
`the time that you are spending here
`today?
` A No.
` Q Were you compensated for the
`time that you spent preparing for this
`deposition yesterday?
` A Yes.
` Q And in your personal career, do
`you consider yourself retired at this
`point?
` A Yes.
` Q Do you enjoy retirement?
` A I certainly do.
` Q I guess I have a little ways to
`go. Something to look forward to at
`least.
`
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` Q Have you had any contact with
`Pozen since your last deposition in
`2014?
` A I don't believe so.
` Q And have you had any contact
`with Horizon in the last three years?
` A I don't believe so.
` Q Same question for AstraZeneca.
`Have you had any contact with
`AstraZeneca in the last three years?
` A I have probably traded a few
`personal messages across LinkedIn.
` Q Fair enough. That's actually a
`pretty good segue.
` I am going to grab your LinkedIn
`page -- at least what I think is your
`LinkedIn page and mark it as Exhibit 9.
` (Exhibit 9 is Marked.)
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`BY MR. SWANSON:
` Q And just so you are aware, this
`is a double-sided page, and that will be
`the case with all the exhibits that I
`use today.
` A (Reviewing.)
` Q Does this appear -- the document
`marked as Exhibit 9, does this appear to
`be your LinkedIn page?
` A (Reviewing.)
` It's an unusual printout of a
`LinkedIn page, but it appears to be
`mine.
` Q When you refer to it as
`"unusual," is there anything that is
`incorrect or inaccurate about
`Exhibit 11 -- or I'm sorry, Exhibit 9?
` A (Reviewing.)
` For instance, I would have
`thought that there would have been more
`employment listed.
` Q Maybe that doesn't --
` A I am not sure.
` Q Fair enough. Maybe that doesn't
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`show up because we are not friends,
`unfortunately.
` But does this appear to be --
`you know, aside from not having the full
`scope of information that you perhaps
`may have displayed to your connections,
`does this appear to be an accurate
`rendition of your LinkedIn page?
` A Yes, I would agree with that.
` Q So I would like to go to the
`second page, which is the back side of
`Exhibit 9, and just talk about your
`education for a minute.
` It shows you as having attended
`the University of Bristol and having
`received what appears to be multiple
`degrees culminating in a PhD; is that
`correct?
` A Correct.
` Q And your PhD was in
`pharmacology?
` A Correct.
` Q What is pharmacology?
` A Pharmacology can be summarized
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` BRIAN AULT, PhD - CONFIDENTIAL
`very simply as the effects of drugs on
`the body.
` Q Is pharmacology the same thing
`as pharmacodynamics, or are they
`different?
` A I suppose lots of people would
`have different definitions of those
`words.
` Q To you what is, if anything, the
`difference between pharmacology and
`pharmacodynamics?
` A My personal view is
`pharmacodynamics is part of
`pharmacology. I recall, for instance,
`toxicology as part of pharmacology.
` Q Okay.
` Is pharmacokinetics part of
`pharmacology?
` A Yes.
` Q And so as part of your PhD
`studies, you studied pharmacokinetics?
` A My PhD study was essentially
`research into glutamate and GABA systems
`and their effect on the central nervous
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` BRIAN AULT, PhD - CONFIDENTIAL
`system.
` Q Did you teach any classes as
`part of your studies?
` A I did not teach any official
`classes. I may have been a mentor of
`some meetings.
` Q Did you enjoy that role as
`mentor of some meetings?
` A It was a very minor role.
` Q Have you ever taught classes
`outside of your education?
` A No.
` Q Has your career as a whole
`concentrated on pharmacology?
` A Yes.
` Q Are there any positions listed
`on Exhibit 9 that do not relate to
`pharmacology?
` A Well, I would like to make a
`clarification. My official title, for
`instance, in AstraZeneca was senior
`director in project management.
` That was as leader of the
`clinical team to which I would bring my
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` BRIAN AULT, PhD - CONFIDENTIAL
`pharmacological expertise as part of my
`job.
` Q Were there other senior
`directors in project management working
`alongside you on these teams in
`AstraZeneca?
` A Yes.
` Q And did they bring other areas
`of expertise to the team?
` A Certainly.
` Q And so I will go back to the
`question I asked a few questions ago,
`which is, are there any positions listed
`on Exhibit 9 where pharmacology was not
`the primary focus of your work?
` MS. FORREST: Object to the
` form.
` THE WITNESS: If we use the
` job title, then I would say the
` project management positions that I
` had would had been considered the
` primary job.
`BY MR. SWANSON:
` Q And correct me if I am wrong,
`
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` BRIAN AULT, PhD - CONFIDENTIAL
`but we have already established that
`your role in project management in those
`positions was largely related to
`pharmacology?
` A Project management encompassed
`team leadership of people of different
`expertise in clinical development. It
`also encompassed specific project
`management skills, like contracting,
`budgeting, resourcing.
` Q And the scientific expertise
`that you brought to those projects on
`which you worked was largely related to
`pharmacokinetics; is that correct -- I'm
`sorry pharmacodynamics?
` Let me try again. Let me start
`over. Strike that because I am mixing
`up my science words today.
` The scientific expertise that
`you brought to the projects on which you
`worked at AstraZeneca, was that largely
`related to your expertise in
`pharmacology?
` A Pharmacology is my degree,
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`correct.
` Q And that is the expertise that
`you primarily brought to the programs on
`which you worked at AstraZeneca, right?
` A In addition to the project
`management skills.
` Q What is pharmacokinetics?
` A Pharmacokinetics can be
`described as the effect of the body on a
`drug.
` Q And what is the main application
`of pharmacokinetics in drug development?
` MS. FORREST: Objection to the
` form.
` THE WITNESS: Pharmacokinetics
` characterize the exposure and
` metabolism of drugs in a body.
`BY MR. SWANSON:
` Q How do you go about
`characterizing the exposure and
`metabolism of drugs in a body?
` MS. FORREST: Objection.
` Calls for expert testimony.
` THE WITNESS: Could you
`
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` clarify the question.
`BY MR. SWANSON:
` Q What about the question don't
`you understand?
` A That seems an incredibly broad
`question. How is it...
` For instance, blood samples
`might be taken and characterized if that
`is the type of issue you're asking.
` Q Okay.
` I think we are on the same page.
`So you might, for example, take a blood
`sample and run some analysis of that
`blood sample to characterize the
`exposure and metabolism of drugs in a
`body?
` A Yes.
` Q And to do that -- well, let me
`back up.
` Is that something you often do
`in your work?
` A Me personally, I -- in my
`research, I used to mainly work on in
`vitro systems, so we did not perform any
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`pharmacokinetic analyses.
` Q Did you work on in vitro systems
`at AstraZeneca?
` A In AstraZeneca, I was a clinical
`team leader and so not directly.
` Q So at AstraZeneca, were you
`primarily working with drugs that were
`being developed for humans to take?
` MS. FORREST: Object to the
` form.
` THE WITNESS: The goal of the
` team was to develop drugs for
` marketing authorization.
`BY MR. SWANSON:
` Q And in that work, did you or
`others under your direction take blood
`samples and run analysis to characterize
`pharmacokinetics?
` MS. FORREST: Object to the
` form.
` THE WITNESS: I would not
` characterize them as under my
` direction. AstraZeneca is a very
` large organization.
`
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`BY MR. SWANSON:
` Q Was it part of the team's work
`to ensure that you characterize the
`pharmacokinetics of the drugs that you
`were working on?
` MS. FORREST: Objection to the
` form.
` THE WITNESS: The team member
` primarily responsible for that
` would be clinical pharmacology.
`BY MR. SWANSON:
` Q And was that your department on
`the team?
` A No, I was part of project
`management.
` Q So the teams had project
`managers and also clinical pharmacology
`as a separate entity?
` A Correct, along with many other
`entities.
` Q How closely did you personally
`work with the clinical pharmacology
`team?
` A My primary team was the medical
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`science director, the chief statistical
`officer and the study delivery director.
` Q What did the medical science
`director do?
` A Medical science director is
`responsible for all aspects of patient
`assessments.
` Q What do you mean when you say
`"patient assessments"?
` A In other words, in a study, what
`assessments would be carried out on
`patients and how.
` Q So the medical science director
`was part of the planning process and not
`part of the actual carrying out of the
`trials that you designed?
` MS. FORREST: Objection to
` form.
` THE WITNESS: Physical contact
` with a patient would occur at
` investigator sites.
`BY MR. SWANSON:
` Q And what did the study delivery
`director do?
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` A Study delivery director would be
`accountable for operational activities.
` Q Can you give any example of
`operational activities?
` A Yes. Deciding which
`investigator sites we might use would be
`one of the activities.
` Q I was asking you earlier about
`the types of assessments that might be
`performed when you're looking at
`pharmacokinetics. You mentioned taking
`blood samples.
` Do I have that right as one
`example?
` A Yes.
` Q What other examples are there?
` A Some researchers use imaging of
`radiolabeled drugs as an example.
` Q How often are blood samples
`taken as a part of a clinical trial?
` MS. FORREST: Objection to
` form. Calls for expert testimony.
` THE WITNESS: Totally depends
` on the clinical study.
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`BY MR. SWANSON:
` Q Have you personally been
`involved in any way in a trial in which
`pharmacokinetics were measured?
` MS. FORREST: Object to the
` form.
` THE WITNESS: My team has
` worked on the design of studies in
` which pharmacokinetics were
` measured.
`BY MR. SWANSON:
` Q Can you approximate how many
`times your team has worked on the design
`of studies in which pharmacokinetics
`were measured?
` MS. FORREST: Object to the
` form.
` THE WITNESS: I don't think I
` could estimate that.
`BY MR. SWANSON:
` Q More than ten?
` A Could you specify which team?
` Q Maybe we can broaden it to any
`trial in which you have been involved in
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`any way, designing, carrying out, any
`other, you know, involvement you have
`had.
` Have you -- has any trial in
`which you have been involved -- I'm
`sorry, strike that.
` How many different trials in
`which you have been involved have
`measured pharmacokinetics of a
`pharmaceutical?
` MS. FORREST: Object to the
` form. Vague and ambiguous.
` THE WITNESS: It would depend
` on the definition of "involvement."
`BY MR. SWANSON:
` Q Well, let's define involvement
`as -- like I was trying to say,
`something you have touched in any way --
`well let's -- let's just be more
`specific.
` Any clinical trial in which you
`have designed.
` So how many trials which you
`have been -- in which you have worked on
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`the design have measured
`pharmacokinetics of a pharmaceutical?
` A (Reviewing.)
` I would estimate 10 to 20, but
`that would certainly come back to the
`definitions of involvement, design, et
`cetera.
` Q When you have worked on these
`trials, why have you been interested in
`learning pharmacokinetic data of a
`pharmaceutical?
` MS. FORREST: Objection.
` Vague and ambiguous.
` THE WITNESS: It might be to
` establish that the two drugs are
` bioequivalent.
`BY MR. SWANSON:
` Q Any other reasons?
` MS. FORREST: Same objection.
` THE WITNESS: It would be to
` characterize the exposure of
` metabolites of the drug also.
`BY MR. SWANSON:
` Q What is the value of
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`characterizing the exposure of
`metabolites of the drug?
` A Generally, there is a
`relationship between exposure and
`effect.
` Q In other words, if you can
`characterize the exposure of metabolites
`of the drug, it helps you understand
`whether the drug might be effective?
` A Sometimes.
` Q What is bioequivalence?
` MS. FORREST: Objection.
` Calls for expert testimony.
` THE WITNESS: Bioequivalence
`
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