UNITED STATES DISTRICT COURT
`
`DISTRICT OF DELAWARE
`
`CASE NO.
`
`15-00079-GMS
`
`) ) ) ) ) ) ) ) ) ) ) )
`
`PFIZER,
`
`INC., and UCB PHARMA
`
`GMBH,
`
`Plaintiffs,
`
`MYLAN PHARMACEUTICALS,
`
`INC.,
`
`Defendant.
`
`VIDEOTAPE DEPOSITION OF
`
`CULLEY C. CARSON, III, M.D.
`
`Atlanta, Georgia
`
`Thursday, August 25, 2016
`
`Reported by:
`
`Judith Leitz Moran, CCR, RPR, RSA
`
`JOB NO.: 111438
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0001
`
`
`
`DISTRICT OF DELAWARE
`
`CASE NO.
`
`15-00079-GMS
`
`) ) ) ) ) ) ) ) ) ) ) )
`
`PFIZER,
`
`INC., and UCB PHARMA
`
`GMBH,
`
`Plaintiffs,
`
`MYLAN PHARMACEUTICALS,
`
`INC.,
`
`Defendant.
`
`VIDEOTAPE DEPOSITION OF
`
`CULLEY C. CARSON, III, M.D.
`
`Atlanta, Georgia
`
`Thursday, August 25, 2016
`
`Reported by:
`
`Judith Leitz Moran, CCR, RPR, RSA
`
`JOB NO.: 111438
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0001
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`August 25, 2016
`
`9:00 a.m.
`
`Videotape Deposition of CULLEY C.
`
`CARSON, M.D., held at Hunton & Williams, 600
`
`Peachtree Street, N.E., Suite 4100, Atlanta,
`
`Georgia 30308, before Judith L. Leitz Moran,
`
`Registered Professional Reporter, and Certified
`
`Court Reporter for the State of Georgia.
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0002
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`A P P E A R A N C E S:
`
`WHITE & CASE
`
`Attorneys for Plaintiffs
`
`1155 Avenue of the Americas
`
`New York, New York
`
`10036
`
`BY:
`
`JEFFREY OELKE, ESQUIRE
`
`SO YEON CHOE, ESQUIRE
`
`KILPATRICK TOWNSEND & STOCKTON
`
`Attorneys for Defendant and the Witness
`
`l100 Peachtree Street, NE
`
`Atlanta, Georgia
`
`30309
`
`BY:
`
`ALYSON WOOTEN, ESQUIRE
`
`ALSO PRESENT:
`
`MIKE BROWN, VIDEOGRAPHER
`
`(Pursuant
`
`to OCGA 15-14-37 (a) and (b)
`
`a
`
`written disclosure statement was submitted by the
`
`court reporter to all counsel present at
`
`the
`
`proceeding and is attached hereto.)
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0003
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`VIDEO TECHNICIAN: This marks the
`
`beginning of Video No.
`
`l.
`
`Deposition of Culley Carson, M.D.,
`
`in the
`
`matter Pfizer,
`
`Incorporated, et al., versus Mylan
`
`Pharmaceuticals,
`
`Incorporated.
`
`Today's date, August 25th, 2016.
`
`The
`
`time on the video monitor 9:01 a.m.
`
`This video deposition taking place at 600
`
`Peachtree Street.
`
`Videographer, Mike Brown contracted by
`
`TSG Reporting.
`
`Counsel, please state your name for the
`
`record and whom you represent.
`
`MR. OELKE: Yeah,
`
`I'm Jeff Oelke from
`
`White & Case.
`
`I'm appearing on behalf of the
`
`Plaintiffs UCB and Pfizer, and with me is my
`
`colleague So Yeon Choe.
`
`MS. WOOTEN: Alyson Wooten from
`
`Kilpatrick Townsend & Stockton.
`
`I'm here on behalf
`
`of Defendants and the witness.
`
`VIDEO TECHNICIAN:
`
`The court reporter
`
`today, Judi Moran of TSG.
`
`Will
`
`the court reporter please swear in
`
`the witness.
`
`TSG Reporting - Worldwide
`
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0004
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`CULLEY c. CARSON, M.D.,
`
`being first duly sworn, was examined as follows:
`
`THE WITNESS:
`
`I do.
`
`EXAMINATION
`
`BY MR. OELKE:
`
`Q
`
`Q
`
`Good morning, Dr. Carson.
`
`Good morning.
`
`Can you please state your full name for
`
`the record?
`
`Yes, Culley C. Carson, III, M.D.
`
`Yes. And what's your address?
`
`lO387 Holt, Chapel Hill, North Carolina.
`
`Have you been deposed before?
`
`I have.
`
`How many times?
`
`Many.
`
`Okay.
`
`So you understand the procedure,
`
`to ask you a series of questions today?
`
`Yes.
`
`And you're going to answer those
`
`questions subject to your counsel may have
`
`objections. But once she imposes those objections,
`
`you're expected to answer the question I ask,
`
`right?
`
`TSG Reporting - Worldwide
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`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0005
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Yes.
`
`Okay. And it would help if you wait till
`
`A
`
`Q
`
`I finish my question before you start your answer.
`
`That's easier for the court reporter and for the
`
`record.
`
`If you need a break,
`
`let me know,
`
`that's
`
`fine.
`
`I just ask that you answer the question
`
`that's pending before you do so.
`
`A
`
`Q
`
`Yes.
`
`Okay.
`
`The other times you've been
`
`deposed, have you ever been deposed as an expert
`
`witness before?
`
`A
`
`Q
`
`A
`
`Yes.
`
`And how many times?
`
`As
`
`I said, many times.
`
`I've been in
`
`neurology for more than 30 years.
`
`So only once in
`
`a patent case, during the others malpractice cases.
`
`Q
`
`A
`
`Okay. And when was that patent Case?
`
`It was about five years ago,
`
`I believe.
`
`Four or five years ago.
`
`And what did that patent case concern?
`
`It was Sildenafil.
`
`And you gave a deposition?
`
`Yes,
`
`I did.
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Q
`
`A Q
`
`A
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0006
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Did you testify at trial?
`
`Yes,
`
`I did.
`
`And where was the trial?
`
`The trial was in Norfolk, Virginia.
`
`Now,
`
`in that Sildenafil trial, what were
`
`Q A
`
`Q A
`
`Q
`
`your opinions generally?
`
`A
`
`The case was about when the idea of
`
`Sildenafil for erectile dysfunction had originally
`
`begun. And so my opinion was that it was in early
`
`—— earlier than what
`
`the patent stated.
`
`And there were —— there were some
`
`internal —- internal data from or basically
`
`communications in Pfizer that showed that they were
`
`thinking about ED and —— and Sildenafil prior to
`
`the time it was patented for that use.
`
`Q
`
`And what parties did you testify on
`
`behalf of in that case?
`
`A
`
`Q
`
`A
`
`Q
`
`The —— not Pfizer,
`
`the other side.
`
`The generics?
`
`The generic side, yes.
`
`Okay. Did you give any opinions on
`
`obviousness in that case?
`
`A
`
`Q
`
`No.
`
`Okay. Prior to this case, had you ever
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0007
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`given any opinions relating to obviousness?
`
`A
`
`Q
`
`No.
`
`You mentioned in your report that you
`
`also have been involved in the case called In re:
`
`Testosterone replacement
`
`therapy products liability
`
`litigation, right?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Okay. What was your role in that case?
`
`The case hasn't actually come to fruition
`
`as of yet, but there's a —— there's a major class
`
`action suit against testosterone because of cardiac
`
`issues.
`
`And —— and basically they subpoenaed
`
`virtually all of the people that had any research
`
`interest in testosterone clinically and to send all
`
`of their information to the -— to the plaintiffs’
`
`attorneys, which we've just recently complied with.
`
`Q
`
`Okay.
`
`So you're -- you're not an expert
`
`witness in that case?
`
`A
`
`Not yet.
`
`I mean,
`
`I hope -- I may be,
`
`Okay.
`
`—— to date, no.
`
`Okay.
`
`Now, what is your experience level
`
`TSG Reporting - Worldwide
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0008
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`with patents?
`
`A
`
`Very minimal.
`
`Okay.
`
`You ever been an inventor on a
`
`I have two patents of my own.
`
`Okay. What do they concern?
`
`A
`
`One of them is a tourniquet for bleeding
`
`during —— during renal surgery. And another is an
`
`instrument to do partial nephrectomy, neither of
`
`which have done much other than be patented.
`
`Q
`
`Okay. Who's the assignee on those
`
`patents?
`
`A
`
`I'm not sure what that exactly means.
`
`Who's the owner?
`
`Benad Goldwasser.
`
`Who is Benad Goldwasser?
`
`He's a urologist in Israel.
`
`Okay.
`
`Is he an inventor on those patents
`
`He is, yes.
`
`Okay.
`
`So you have some sort of
`
`arrangement with Mr. -- Dr. —— is it Dr. --
`
`A
`
`O
`
`Doctor.
`
`—— Goldwasser?
`
`TSG Reporting - Worldwide
`
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0009
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`It is, yes.
`
`And what is that arrangement?
`
`Well,
`
`I mean,
`
`the patents have never
`
`Q
`
`A
`
`amounted to anything so they just are sort of
`
`there.
`
`The patents were from the early l9 --
`
`l990s,
`
`I think it was 1991, something like that,
`
`and nothing has ever happened with them.
`
`Q
`
`Okay. What was your level of involvement
`
`in the prosecution of those patents?
`
`A
`
`Basically we invented the -— the devices
`
`and then at the time I was a faculty member at Duke
`
`University and they had some patent attorneys on --
`
`on staff. And so we went
`
`to them with the —— the
`
`inventions and they basically wrote the patents and
`
`that was the end of it.
`
`Q
`
`Okay. Were you involved in the
`
`communications with —— back and forth with the
`
`patent office on those patents?
`
`A
`
`We had some meetings, yes,
`
`just to kind
`
`of define what
`
`-— what the -- what
`
`the invention
`
`actually was.
`
`Q
`
`Okay.
`
`Now, you said you testified at the
`
`trial on Sildenafil, right?
`
`A
`
`Yes.
`
`TSG Reporting - Worldwide
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`877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0010
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Q
`
`How many other times have you testified
`
`at trial?
`
`A
`
`Quite a few actually, but none others
`
`have been patents, it's always been malpractice
`
`cases --
`
`Q
`
`A
`
`Q
`
`Okay.
`
`-- as expert witness.
`
`Okay. Have you ever been a fact witness
`
`in —— in any lawsuit?
`
`A
`
`Q
`
`No.
`
`Okay. Dr. Carson, did you meet with
`
`counsel to prepare for this deposition?
`
`A
`
`I did.
`
`When was that?
`
`Yesterday.
`
`How long did you meet?
`
`About six hours.
`
`Okay. And where was the meeting at?
`
`At their firm.
`
`Q
`
`Okay. You're talking about Kilpatrick
`
`Stockton?
`
`A
`
`Kilpatrick Stockton,
`
`just down the
`
`street.
`
`Q
`
`Okay. And prior to that meeting, did you
`
`TSG Reporting - Worldwide
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`877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0011
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`have meetings with the attorneys at Kilpatrick
`
`Stockton?
`
`A
`
`One previous.
`
`When was that meeting?
`
`In June,
`
`I believe.
`
`June of this year?
`
`Yes.
`
`Q
`
`And you were involved in preparing two
`
`expert reports in this case?
`
`A
`
`Q
`
`Yes.
`
`How many hours did you spend on those
`
`expert reports?
`
`A
`
`Probably all together, close to 40 hours,
`
`I would guess.
`
`Q
`
`Okay.
`
`Now, were you provided documents
`
`for those expert reports?
`
`A
`
`I was provided some and then I
`
`found some
`
`OD. my OWD.
`
`Q
`
`A
`
`Okay. Which ones did you find on your
`
`Oh,
`
`just —— I did a Med—Line search and
`
`just found a number of studies on overactive
`
`bladder,
`
`fesoterodine,
`
`tolterodine,
`
`a variety of
`
`things like that, of that nature.
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0012
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Q
`
`Do you remember any specific publications
`
`that you found?
`
`A
`
`The Paul Abrams study from 1998,
`
`I think.
`
`There are a couple of Steve Kaplan studies.
`
`There's studies by —— let me think who else. There
`
`are just,
`
`I don't know, several others, but those
`
`are the —— those are the ones I
`
`remember
`
`the most
`
`vividly.
`
`Q
`
`Okay.
`
`MR. OELKE: Let's mark his CV.
`
`It's in
`
`MS. CHOE: Yeah,
`
`I
`
`think so.
`
`MR. OELKE: Okay.
`
`It's a big exhibit.
`
`I'd like to mark as Carson Exhibit
`
`1
`
`Opening Expert Report of Culley C. Carson, III,
`
`M.D., which has attachments.
`
`(Deposition Exhibit 1 marked.)
`
`BY MR. OELKE:
`
`Q
`
`Can you identify Carson Exhibit 1,
`
`please?
`
`A
`
`Yes, it's an expert report,
`
`the first
`
`opening expert report from June of 2016.
`
`Q
`
`And that's your signature on the front
`
`page?
`
`TSG Reporting - Worldwide
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0013
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Yes, it is.
`
`Okay. When were you first contacted
`
`A
`
`Q
`
`about working in this case?
`
`MS. WOOTEN: Objection,
`
`just caution the
`
`witness.
`
`You may respond to the question, but
`
`don't reveal any attorney/client privileged
`
`information as part of your response.
`
`THE WITNESS: Okay.
`
`BY MR. OELKE:
`
`Q
`
`Well,
`
`just —— just for the record,
`
`I
`
`don't think it's attorney/client, but
`
`I agree I
`
`don't want you --
`
`MS. WOOTEN: Guess.
`
`BY MR. OELKE:
`
`-- to reveal communications with --
`
`Right.
`
`—— Ms. Wooten.
`
`Sometime in the —— in the spring,
`
`like,
`
`April or May of 2016.
`
`Q
`
`Okay. And your CV is attached as Exhibit
`
`1;
`
`is that right?
`
`A
`
`Q
`
`Yes.
`
`Now, you received your undergraduate
`
`degree from Trinity?
`
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0014
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`I did.
`
`What was your undergraduate degree in?
`
`Biology.
`
`Okay.
`
`Then you received your M.D.
`
`in
`
`That's correct.
`
`What did you do after you received your
`
`A
`
`I did two years of general surgery at
`
`Dartmouth in Hanover, New Hampshire. And then
`
`following that,
`
`I spent two years in the —— in the
`
`Air Force as a flight surgeon. And then following
`
`that, did residency at —— at the Mayo Clinic in
`
`Rochester, Minnesota.
`
`Q
`
`Okay. And you were a urology fellow
`
`there?
`
`A
`
`Q
`
`Yes.
`
`Is that when your —— when you first
`
`started specializing in neurology?
`
`A
`
`Q
`
`Yes.
`
`So you've specialized in neurology since
`
`about I975?
`
`A
`
`O
`
`That's correct.
`
`Okay. And at that time in 1975, what was
`
`TSG Reporting - Worldwide
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`
`
`
`CULLEY C. CARSON, III, M.D.
`
`the treatment standards for urinary incontinence?
`
`A
`
`Well, urinary incontinence is a broad
`
`spectrum of things.
`
`It's —— surgery was one of the
`
`things was —— was —- was used in those days for an
`
`overactive bladder and urge or urgency, depending
`
`on what you want —— how you want to term it,
`
`incontinence.
`
`There wasn't much available, although,
`
`oxybutynin and Ditropan came out around the time I
`
`began my urology training.
`
`Q
`
`Okay.
`
`You used the term "overactive
`
`bladder."
`
`Just for the record, what is overactive
`
`bladder?
`
`A
`
`Basically, overactive bladder is
`
`contracting -- is abnormal, uncontrolled
`
`contractions of the bladder when patients or people
`
`don't want
`
`them to contract.
`
`So it produces frequency, produces
`
`urgency, produces urge incontinence, urgency
`
`incontinence, nocturia, and those things are
`
`bothersome to patients.
`
`Q
`
`A
`
`urine.
`
`What is nocturia?
`
`Nocturia is arising at night to pass
`
`TSG Reporting - Worldwide
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0016
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Q
`
`Okay. After you were done at the Mayo
`
`Clinic, what was your next
`
`job?
`
`A
`
`I was hired to be on the faculty at Duke
`
`University, and I was at Duke University for 15
`
`years.
`
`Q
`
`A
`
`Q
`
`Okay. And you focused on urology at that
`
`Yes.
`
`And did you have a subspecialty in
`
`urology at that time?
`
`A
`
`Most of my entire life of urology has
`
`been in men's health areas.
`
`So erectile
`
`dysfunction, male incontinence,
`
`testosterone
`
`deficiency,
`
`those kinds of things.
`
`Q
`
`So when did you -- what was your next
`
`job
`
`after Duke?
`
`A
`
`In —-
`
`in 1992—'93,
`
`I was —-
`
`I was
`
`selected to be the head of urology at the
`
`University of North Carolina,
`
`so I moved down the
`
`street to be the chief of urology at the University
`
`of North Carolina.
`
`Q
`
`Okay. And -- and that's where you're at
`
`TSG Reporting - Worldwide
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`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0017
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Q
`
`Okay. And what are your titles at
`
`University of North Carolina?
`
`A
`
`I stepped down as being the —— the chief
`
`and —— and -- but I'm now the Rhodes Distinguished
`
`Professor of Urology at the University of North
`
`Carolina, Chapel Hill.
`
`Q
`
`Okay. And during your time at North
`
`Carolina, your function —— your subspecialty has
`
`been in men's health?
`
`A
`
`Q
`
`A
`
`Yes.
`
`Okay.
`
`Sexual dysfunction?
`
`Sexual dysfunction,
`
`incontinence,
`
`prostate cancer, prostate diseases.
`
`Q
`
`Okay. But your subspecialty has not been
`
`overactive bladder, correct?
`
`A
`
`Q
`
`Not specifically.
`
`Okay.
`
`There are other urologists,
`
`their
`
`specialty is overactive bladder, correct?
`
`A
`
`Part of their specialty.
`
`I wouldn't say
`
`that's all they do.
`
`Q
`
`A
`
`Okay.
`
`I'm not sure they could make enough money
`
`to keep themselves healthy just doing that.
`
`Q
`
`Okay. But overactive bladder is not part
`
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`CULLEY C. CARSON, III, M.D.
`
`of your specialty?
`
`A
`
`No. Well, it is to an extent because men
`
`with prostate enlargement have overactive bladder
`
`associated with it,
`
`so I certainly —— I certainly
`
`do have —— am involved with that.
`
`Q
`
`To the extent it overlaps with sexual
`
`dysfunction for men, you are interested in
`
`overactive bladder, but your subspecialty is not
`
`overactive bladder, right?
`
`A
`
`Q
`
`Not that —- not specifically.
`
`Okay.
`
`Now, do you consult with any
`
`pharmaceutical companies?
`
`A
`
`Q
`
`A
`
`I do.
`
`And which ones?
`
`At variable periods of time it depends on
`
`the —-
`
`the life cycle of a particular product.
`
`I've —- I've in the past consulted with Pfizer,
`
`with Endo, with Auxilium, with Abbvie used to be
`
`Abbott, with GlaxoSmithKline, with Bayer,
`
`to name a
`
`few. Several other smaller ones as well.
`
`Q
`
`A
`
`Who are you consulting with now?
`
`Predominantly Abbvie and Endo as well as
`
`Boston Scientific, which is not a drug company but
`
`it's an industry.
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`CULLEY C. CARSON, III, M.D.
`
`Q
`
`Of those companies, who have you
`
`consulted with on the -- in the area of overactive
`
`bladder?
`
`A
`
`Pfizer for one.
`
`I —— I spent some time
`
`consulting with the original Ditropan people,
`
`I
`
`can't even remember
`
`the name of the company
`
`anymore,
`
`that made Ditropan originally, but...
`
`Q
`
`The rest of your consulting has been in
`
`men's sexual dysfunction?
`
`A
`
`Men's health.
`
`I mean, it's not just
`
`sexual dysfunction.
`
`Q
`
`Okay. Overactive bladders, as far as
`
`pharmaceutical treatment,
`
`is mostly directed to
`
`women, right?
`
`A
`
`Q
`
`It has in the past, yeah.
`
`Okay. What do you think the percentage
`
`of the market is for overactive bladder
`
`pharmaceutical treatments with respect to male
`
`versus female?
`
`A
`
`Q
`
`A
`
`Q
`
`It's probably 70/30.
`
`Okay.
`
`Do you still see patients?
`
`Yes.
`
`How many patients do you see in a typical
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`CULLEY C. CARSON, III, M.D.
`
`A
`
`Q
`
`Let's see,
`
`in the neighborhood of 250.
`
`And of that number, 250, how many do you
`
`see for OAB?
`
`A
`
`Pure OAB, probably no more than 15 or 20,
`
`something like that. Most of them have other
`
`problems such as an enlarged prostate that goes
`
`along with their OAB that produces their OAB,
`
`associated with their OAB.
`
`Q
`
`A
`
`Q
`
`Okay.
`
`Do you prescribe OAB medicines?
`
`Yes,
`
`I do.
`
`And of those 250 patients a month,
`
`just
`
`as an average, how many do you think you prescribed
`
`OAB medicine for?
`
`A
`
`Probably, again, maybe 10 or 15,
`
`something like that.
`
`Q
`
`Okay. And what OAB medicines do you
`
`prescribe?
`
`A
`
`A whole gamut of things. And it —— it's
`
`dependent upon what their —— what their insurance
`
`company will pay for to be honest.
`
`Generally the insurance companies want
`
`you to start with oxybutynin because it's a generic
`
`drug and it's inexpensive. And then every
`
`insurance company varies as to what they'll do as a
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`CULLEY C. CARSON, III, M.D.
`
`second line.
`
`The one I use most often now is a
`
`drug called Myrbetriq or Mirabegron.
`
`Q
`
`What kind of mechanism of action does
`
`Myrbetriq have?
`
`A
`
`Yeah, it's —— it's basically a Beta—3
`
`relaxant, and it has the advantage of relaxing the
`
`bladder, although, it's not as potent as some of
`
`the anti—muscarinics, but it doesn't have CNS
`
`problems and it has very little dry mouth and very
`
`little constipation associated with it.
`
`So for
`
`aging patients, it tends to be the best choice.
`
`But it's usually not covered by
`
`insurance.
`
`So it's one of those things where you
`
`have to start with something else, patients have to
`
`fail it and then you move on.
`
`So it's kind of --
`
`it's an iterative process.
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`Have you prescribed tolterodine --
`
`Yes.
`
`—— to patients?
`
`I have.
`
`Okay. And are there instances in which
`
`you will prescribe tolterodine today to patients?
`
`A
`
`Q
`
`Yes. Absolutely, yes.
`
`And what are those instances?
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`CULLEY C. CARSON, III, M.D.
`
`A
`
`The instances are when people —— people
`
`have failed one anti-muscarinic. And failed means
`
`it either doesn't work or they've had onerous side
`
`effects that they Can't tolerate. Or third thing
`
`is that the —— that that's the preferred drug for
`
`their particular insurance policy.
`
`Q
`
`And when did you start prescribing
`
`tolterodine?
`
`A
`
`Q
`
`As soon as it was on the market.
`
`Okay. Were you involved in clinical
`
`trials for tolterodine?
`
`A
`
`Q
`
`I was not.
`
`Okay. And do you recall that it was
`
`approved in March of 1998?
`
`A
`
`Q
`
`A
`
`Yes.
`
`When did you start using it?
`
`You know,
`
`I don't really totally
`
`remember, but as an academic urologist,
`
`I
`
`tend to
`
`be an early adopter of these new drugs.
`
`So probably within the first three or
`
`four months of the time it was approved.
`
`I don't
`
`remember when I wrote the first prescription
`
`particularly, but I'm sure it was early in that
`
`period of time.
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`CULLEY C. CARSON, III, M.D.
`
`Q
`
`And before that you had prescribed
`
`oxybutynin?
`
`A
`
`Q
`
`Yes.
`
`Had you described —— had you prescribed
`
`other drugs for overactive bladder?
`
`A
`
`Q
`
`A
`
`Yes.
`
`What other drugs?
`
`Flavoxate I used for a while or used in
`
`some patients that couldn't tolerate —— couldn't
`
`tolerate oxybutynin.
`
`Really that was about the only —— those
`
`are about
`
`the only reasonable things that were on
`
`the market
`
`in those days.
`
`Q
`
`Okay.
`
`Now, at some point trospium became
`
`available in the U.S., right?
`
`A
`
`Q
`
`Q
`
`Yes.
`
`Have you ever prescribed trospium?
`
`Yes,
`
`I have.
`
`In what types of patients do you —— have
`
`you prescribed trospium for?
`
`A
`
`Very similar to the —— to the
`
`fesoterodine patients. And those are ones that --
`
`where their insurance company says that that's what
`
`you need to use.
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`CULLEY C. CARSON, III, M.D.
`
`And, you know,
`
`I
`
`think physicians‘
`
`prescribing practices are based a lot on what their
`
`personal experience is, what the newest thing on
`
`the market is, what
`
`the marketing of that drug is,
`
`but most often what
`
`the insurance companies will
`
`pay for.
`
`Q
`
`Okay.
`
`Now, when did Myrbetrig come on
`
`the market?
`
`A
`
`Q
`
`Oh, probably three,
`
`four years ago.
`
`Okay. Prior to Myrbetriq's availability,
`
`what drugs did you prescribe for elderly patients?
`
`A
`
`Again, any —— anything other than
`
`oxybutynin because the oxybutynin in elderly
`
`patients is really not a very good choice, and the
`
`CNS side effects are onerous.
`
`Q
`
`Did tolterodine have CNS side effects in
`
`—— in instances in which you prescribed it?
`
`A
`
`Not so much.
`
`I mean, it had some.
`
`A
`
`headache and —— and that sort of thing, but the
`
`confusion issue that you get with oxybutynin was a
`
`lot less with —— with tolterodine.
`
`Q
`
`Okay.
`
`There are certain medications that
`
`are on a —— a list that pilots can't use;
`
`is that
`
`right?
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`CULLEY C. CARSON, III, M.D.
`
`Yes.
`
`And oxybutynin is on that list,
`
`isn't it?
`
`It is.
`
`Tolterodine is not on that list,
`
`is it?
`
`Correct, it is not.
`
`The CNS side effects of tolterodine were
`
`never judged to be serious enough to be put on that
`
`list for —— for pilots, right?
`
`A
`
`Part of it's because of the CNS —— CNS
`
`issues, part of it's because of the ocular
`
`accommodation issues.
`
`So those are both
`
`significant problems with oxybutynin.
`
`Q
`
`And they are not problems for
`
`tolterodine?
`
`A
`
`Q
`
`That's correct.
`
`And other than headache, you've never
`
`noticed CNS side effects in patients in which
`
`you've prescribed tolterodine?
`
`A
`
`You know, patients have all kinds of
`
`problems and you never know if it's the medication
`
`or it's —— it's the —— just have the problems. But
`
`I've had patients that tell me that they have
`
`dizziness from any —— from all of the
`
`anti—muscarinics and you wonder if it's the drug or
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`CULLEY C. CARSON, III, M.D.
`
`if they just had dizziness anyway.
`
`So, basically, it's -- it's not something
`
`that you can generalize about,
`
`I guess, but
`
`certainly better than oxybutynin.
`
`Q
`
`Did you —— so —— strike that.
`
`You've —— you've consulted with
`
`pharmaceutical companies,
`
`right?
`
`A
`
`Q
`
`Yes,
`
`I have.
`
`You've been on advisory boards for those
`
`pharmaceutical companies?
`
`A
`
`Q
`
`I have.
`
`And you ever provided advice on the
`
`development of drugs for OAB?
`
`A
`
`Probably, yes.
`
`I don't remember
`
`specifically, but it's one of those things where a
`
`new drug Qomes out,
`
`they present the data and say
`
`what do you think and you say could be better.
`
`Q
`
`A
`
`Q
`
`Do you --
`
`Is better, but could be better.
`
`Okay. Did you ever have any
`
`conversations in which you suggested that
`
`tolterodine would be a good candidate to make
`
`modifications to?
`
`A
`
`Not to my knowledge.
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`CULLEY C. CARSON, III, M.D.
`
`Okay.
`
`Now, you're familiar with 5—HMT?
`
`Yes.
`
`A metabolite?
`
`Yes.
`
`Q
`
`And it's an active metabolite of
`
`tolterodine, right?
`
`A
`
`Q
`
`That's correct.
`
`Okay.
`
`Do you recall ever discussing with
`
`any pharmaceutical company representative that
`
`5—HMT would be a good candidate as a lead compound
`
`for future drug development?
`
`MS. WOOTEN: Objection,
`
`form.
`
`A
`
`I don't remember specifically —— having
`
`those specific conversations as you're stating
`
`them, but I -- but I
`
`remember having conversations
`
`with some of the marketing people for fesoterodine
`
`that -- you know,
`
`that was a —- that 5—HMT was a
`
`good target.
`
`BY MR. OELKE:
`
`Q
`
`Okay.
`
`That was after fesoterodine had
`
`been developed?
`
`A
`
`Yes.
`
`Okay.
`
`I don't recall before. Maybe I did, but
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`CULLEY C. CARSON, III, M.D.
`
`I don't remember.
`
`Q
`
`Okay.
`
`Do you recall any discussions with
`
`other urologists that 5—HMT would be a good
`
`candidate for future development prior —— prior to
`
`the development of fesoterodine?
`
`A
`
`Fesoterodine, yeah.
`
`I don't recall.
`
`I
`
`mean,
`
`that's -- that's been a long time ago,
`
`so I
`
`don't really remember. We have a lot of
`
`conversations about a lot of things at meetings and
`
`so on, but I don't remember specific conversations,
`
`no.
`
`Q
`
`And you're not aware of any publications
`
`prior to the development of fesoterodine that
`
`suggested 5—HMT would be a good candidate for
`
`future development?
`
`A
`
`No.
`
`There are other publications that
`
`suggest or show that that 5—HMT is a good agent for
`
`bladder relaxation for anti—muscarinic targeting,
`
`so, you know. But as far as saying the way that ——
`
`the way you said it, no.
`
`Q
`
`Those publications you're talking about
`
`are describing 5—HMT as a metabolite, right?
`
`A
`
`Q
`
`As
`
`~— as a metabolite, correct.
`
`None of them are discussing 5—HMT as an
`
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`CULLEY C. CARSON, III, M.D.
`
`active ingredient?
`
`A
`
`Well,
`
`they're discussing 5-HMT as an
`
`active agent
`
`in the —— in the blockade of —— of
`
`muscarinic receptors.
`
`Q
`
`But only as a metabolite of tolterodine,
`
`right?
`
`A
`
`Well, as a —— as a particular compound.
`
`I mean, you know, whether it's a metabolite or
`
`whether it's pure, either way it's —— it's what
`
`it's doing to the bladder.
`
`Q
`
`Okay. But can you identify any
`
`publications prior to the development of
`
`fesoterodine that suggested 5—HMT should be
`
`administered as an agent?
`
`MS. WOOTEN: Objection,
`
`form.
`
`A
`
`I can't —— I don't know specifically.
`
`I'd have to look back, but I don't remember any
`
`specific publications that —— that have that tenor.
`
`BY MR. OELKE:
`
`Q
`
`Okay.
`
`Now, you said you consulted for
`
`Pfizer, right --
`
`A
`
`Q
`
`Yes.
`
`—— at some point in time?
`
`When was that?
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`CULLEY C. CARSON, III, M.D.
`
`In the 1990s predominantly.
`
`Okay.
`
`Early —— the early 2000s, but 19903.
`
`And when did your consulting with Pfizer
`
`stop?
`
`A
`
`I don't even remember, but probably in
`
`the mid-2000s,
`
`I would guess.
`
`I spoke for them about fesoterodine in
`
`the —— in like 2007 to 2009 range,
`
`I guess, and
`
`that's probably —— that was probably the end of it.
`
`MR. OELKE:
`
`I would like to mark Carson
`
`Exhibit 2, Consultant Agreement, Healthcare
`
`Professional Consultant Agreement.
`
`(Deposition Exhibit 2 marked.)
`
`BY MR. OELKE:
`
`Q
`
`Just take a moment to look at Carson
`
`Exhibit 2, Dr. Carson.
`
`A
`
`Q
`
`(Witness reviews document.)
`
`Is Carson Exhibit 2 a consultant
`
`agreement between you and Pfizer?
`
`It surely is, yes.
`
`And you executed it in May of 2015?
`
`I did.
`
`Okay.
`
`A
`
`Q A
`
`Q
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`CULLEY C. CARSON, III, M.D.
`
`A
`
`Yeah, basically,
`
`this was a —— I gave a
`
`talk at -- at the European Association of Urology
`
`that was sponsored by Pfizer.
`
`I had forgotten
`
`about this.
`
`Q
`
`Okay.
`
`So there was a consulting
`
`agreement
`
`in place in 2015 between you and Pfizer,
`
`right?
`
`A
`
`Q
`
`Yes,
`
`that's correct.
`
`And you didn't include that in your
`
`materials for your expert report,
`
`right?
`
`A
`
`No,
`
`I did not.
`
`Okay.
`
`Is there a reason you left this
`
`A
`
`I had totally forgotten about it because
`
`it was a meeting that -- that I presented some --
`
`some —- to some Middle Eastern urologists. And it
`
`was arranged by one of my colleagues in London, and
`
`I —— actually,
`
`to be honest,
`
`I had forgotten that
`
`it was sponsored by Pfizer.
`
`Q
`
`Q
`
`A
`
`Okay.
`
`Now, do you know Dr. MacDiarmid?
`
`Yes, very well.
`
`Okay. And how do you know him?
`
`He was a fellow at Duke when I was a
`
`faculty member at Duke. And I tried to hire him to
`
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`CULLEY C. CARSON, III, M.D.
`
`come to the University of North Carolina which
`
`didn't work, and I've known him since that time.
`
`We used to work out together actually.
`
`Q
`
`Okay.
`
`Is Dr. MacDiarmid a specialist --
`
`first of all,
`
`is he a urologist?
`
`He is.
`
`And is a subspecialty of his OAB?
`
`It's female urology.
`
`Okay.
`
`And incontinence. And OAB is a piece of
`
`Q
`
`Okay. And he sees a lot more patients
`
`with respect to OAB than you do, correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`A
`
`I don't -- I don't know the answer to
`
`that.
`
`BY MR. OELKE:
`
`Q
`
`You don't, okay.
`
`You don't know who
`
`he —— how many patients he sees,
`
`for instance?
`
`A
`
`Q
`
`I don't.
`
`Okay. But you would agree that OAB is
`
`certainly more a specialty of Dr. MacDiarmid's than
`
`yours, correct?
`
`MS. WOOTEN: Objection,
`
`form.
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`CULLEY C. CARSON, III, M.D.
`
`A
`
`Yeah,
`
`I mean,
`
`that's something he's been
`
`interested in for most of his life with the female
`
`urology part.
`
`BY MR. OELKE:
`
`Q
`
`Okay.
`
`Do you respect Dr. MacDiarmid's
`
`I do.
`
`Okay.
`
`Is he a respected urologist?
`
`He is.
`
`How many papers have you published on the
`
`opinions?
`
`A
`
`Q A
`
`Q
`
`topic of overactive bladder?
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`Probably not more than two or three.
`
`Okay.
`
`How many papers have you published
`
`More than 300.
`
`Okay. Quite a few, right?
`
`Yeah.
`
`Okay.
`
`How many of those papers relate to
`
`men's sexual dysfunction?
`
`A
`
`Q
`
`I don't even know, but probably a third.
`
`Okay. Are there any other areas that
`
`most of your writing concerns other than men's
`
`sexual dysfunction and OAB?
`
`A
`
`Yeah,
`
`I mean,
`
`incontinence in men ——
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0034
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`Okay.
`
`A
`
`-- with prostate cancer is another one.
`
`Urinary stone disease is another one.
`
`Q
`
`Okay.
`
`Testosterone replacement.
`
`Kidney stones?
`
`Kidney stones.
`
`Yeah.
`
`I mentioned that, yeah.
`
`MR. OELKE:
`
`I'd like to mark as Carson
`
`Exhibit 3 an article entitled The Pharmacological
`
`Treatment of Urinary Incontinence.
`
`The first
`
`author is Karl Eric Andersson.
`
`(Deposition Exhibit 3 marked.)
`
`BY MR. OELKE:
`
`Q
`
`Dr. Carson, have you seen this article
`
`Yes,
`
`I have.
`
`And who is Karl Eric Andersson?
`
`A
`
`Karl Eric Andersson is probably the
`
`expert on overactive bladder in the world.
`
`He is
`
`—— he is Swedish and he is —- has an M.D. degree,
`
`but basically is a pharmacologist.
`
`He spent a lot of time in —— did most of
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0035
`
`
`
`CULLEY C. CARSON, III, M.D.
`
`his work in Sweden actually. But when he had to
`
`retire from Sweden because of age, he actually came
`
`to North Carolina and was —— spent some time at
`
`Wake Forest, which he subsequently left, and I
`
`think he's in Germany right now.
`
`Oh, he's not at Wake Forest, okay.
`
`He's no longer at Wake Forest.
`
`Okay. This article is dated 1999?
`
`Yes.
`
`Q
`
`And you understand —— well,
`
`just as
`
`background, do you understand there's five patents
`
`at issue in this case, right?
`
`A
`
`Q
`
`Yes.
`
`And one of those patents we refer to as
`
`the '65O patent?
`
`A
`
`Right.
`
`MR. OELKE: Maybe we should mark that
`
`rather than just refer to it.
`
`(Deposition Exhibit 4 marked.)
`
`MR. OELKE: Mark this Carson Exhibit
`
`4
`
`U.S. Patent 6,858,650.
`
`THE WITNESS:
`
`Thank you.
`
`BY MR. OELKE:
`
`Q
`
`Do you recognize Carson 4 as one of the
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2026 - 0036
`
`
`
`CULLEY C. CARSON, I
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