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`IN THE UNITED STATES
`PATENT AND TRADEMARK OFFICE
`-------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`-------------------
`TEVA PHARMACEUTICALS USA, INC.
`Petitioner,
`
`V.
`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
`------------------
`PGR2019-00048
`Patent 10,195,214 B2
`------------------
`
` VIRTUAL DEPOSITION OF TY B. CARROLL, M.D.
`May 8, 2020
`
`Reported by:
`ERICA L. RUGGIERI, RPR
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`800-642-1099
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
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`1
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`TEVA1069
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`
`
`
`IN THE UNITED STATES
`PATENT AND TRADEMARK OFFICE
`-------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`-------------------
`TEVA PHARMACEUTICALS USA, INC.
`Petitioner,
`
`V.
`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
`------------------
`PGR2019-00048
`Patent 10,195,214 B2
`------------------
`
` VIRTUAL DEPOSITION OF TY B. CARROLL, M.D.
`May 8, 2020
`
`Reported by:
`ERICA L. RUGGIERI, RPR
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
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`TEVA1069
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
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`Page 2
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` May 8, 2020
` 9:11 a.m.
`
` Deposition of TY CARROLL, M.D.,
` held by Virtual Zoom Conference,
` pursuant to Notice, before Erica L.
` Ruggieri, Registered Professional
` Reporter and Notary Public of the
` State of New York.
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`A P P E A R A N C E S:
`ATTORNEYS FOR TEVA PHARMACEUTICALS USA, INC.:
`STERNE KESSLER GOLDSTEIN & FOX PLLC
` 1100 New York Ave NW, 6th Floor
` Washington DC 20005
` BY: WILLIAM MILLIKEN, ESQ.
` wmilliken@sternekessler.com
` DEBORAH A. STERLING, ESQ., Ph.D.
` dsterling@sternekessler.com
` JOHN C. ROZENDAAL, ESQ.
` jcrozendaal@sternekessler.com
` UMA N. EVERETT, ESQ.
` ueverett@skgf.com
`
`ATTORNEYS FOR CORCEPT THERAPEUTICS, INC.:
`QUINN EMANUEL URQUHART & SULLIVAN LLP f
` 51 Madison Ave, 22nd Floor
` New York, New York 10010
` BY: ERIC STOPS, ESQ.
` ericstops@quinnemanuel.com
` JOHN P. GALANEK, ESQ.
` johnGalanek@quinnemanuel.com
` DANIEL WIESNER, ESQ.
` danielwiesner@quinnemanuel.com
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` TY B. CARROLL, M.D.
` T Y B. C A R R O L L, M.D., called
` as a witness, having been duly
` sworn by a Notary Public, was
` examined and testified as follows:
` EXAMINATION BY
` MR. MILLIKEN:
` MR. MILLIKEN: This is Teva
` Pharmaceuticals USA, Inc. versus
` Corcept Therapeutics, Inc., Case
` PGR 201948 concerning U.S. patent
` number 10,195,214. My name is Will
` Milliken from Sterne Kessler
` Goldstein & Fox representing Teva
` Pharmaceuticals USA. And I'll let
` my colleagues introduce themselves.
` MR. ROZENDAAL: J.C.
` Rozendaal, also from Sterne Kessler
` Goldstein & Fox, on behalf of Teva.
` MS. EVERETT: Uma Everett,
` also from Sterne Kessler on behalf
` of Teva.
` MR. MILLIKEN: All right.
` EXAMINATION BY
` MR. MILLIKEN:
`
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` TY B. CARROLL, M.D.
` Q. Dr. Carroll, thank you very
` much for joining us this morning
` remotely. Would you please state
` your full name for the record.
` A. Ty Brian Carroll.
` Q. What is your address?
` A. 6060 Conservancy Drive, New
` Berlin, Wisconsin 53151.
` Q. Have you ever had your
` deposition taken before?
` A. No, I have not.
` Q. So you've never been
` deposed remotely before either?
` A. No.
` Q. Okay. Well, I'm just going
` to go over a couple of ground rules
` just to try to make this run as
` smoothly as possible. We have a
` court reporter taking down
` everything that you and I are going
` to say today and so it's important
` for you to please give verbal
` answers as opposed to head nods or
` head shakes.
`
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` TY B. CARROLL, M.D.
` And it's also important that
` we don't speak over each other so if
` you'll please let me finish my
` question before you answer, I'll do
` my best to let you finish your
` answers before I ask another
` question. Does that work?
` A. That works well.
` Q. Great. From time to time
` your counsel is going to make
` objections after I ask questions and
` unless he instructs you not to
` answer you are still to answer the
` question after he's had a chance to
` make an objection. Does that work?
` A. Understood.
` Q. And because of the three
` individuals talking, it's generally
` a good idea to, after I ask a
` question to take a beat and give
` Mr. Stops a moment to object and
` then answer and that will help to
` keep the record clean and so we
` don't get the court reporter mixed
`
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` TY B. CARROLL, M.D.
` up. Does that make sense?
` A. (Camera freeze.)
` MR. MILLIKEN: I seem to have
` lost Dr. Carroll's video. Is
` anyone else having that issue?
` MR. STOPS: Dr. Carroll, did
` you hear the last question? It
` looked like you froze momentarily.
` A. I had a clean audio, the
` video froze for a moment. Now you
` are all live.
` Q. I was just saying because
` of the possibility of objections
` it's a good idea to give your
` counsel a moment to object before
` you answer and that way we will keep
` the record clean and make things
` easier on the court reporter. Does
` that work?
` A. Yes.
` Q. We will take breaks
` periodically today, roughly every
` hour; however, if at any time you
` need a break for any reason, just
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` TY B. CARROLL, M.D.
` let me know and we will take one.
` All I ask is that if a question is
` pending, you go ahead and answer the
` question before we take a break.
` Does that work?
` A. Yes.
` Q. You understand that you are
` under oath today?
` A. I do.
` Q. Is there any reason that
` you can't testify truthfully and
` accurately today?
` A. No, there is not.
` Q. And today's deposition is
` being conducted remotely, correct?
` A. It is.
` Q. Are you at your personal
` residence?
` A. Yes, I am.
` Q. Can you briefly describe
` your environment?
` A. I'm in an office space,
` single room.
` Q. And are you alone?
`
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` TY B. CARROLL, M.D.
` A. I am.
` Q. Do you have any materials
` with you?
` MR. STOPS: I'll represent
` that we have provided Dr. Carroll
` with a clean copy of his
` declaration and the exhibits that
` are cited in Exhibit B, I believe
` all of them are there. So to make
` things -- I figured this would make
` things proceed easier. To the
` extent you are citing something
` that's in his declaration or in
` Exhibit B, he has copies that are
` clean.
` MR. MILLIKEN: Okay. That's
` helpful. Thank you.
` Q. Do you have any materials
` with you other than your declaration
` and the materials that are cited in
` Exhibit B to your declaration?
` A. No, I do not.
` Q. And the materials that you
` have, are those clean copies, i.e.
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` TY B. CARROLL, M.D.
` no notes or highlighting or anything
` on them?
` A. They do not have any
` highlighting, no.
` Q. What equipment are you
` using to participate in the remote
` deposition?
` A. My computer and the audio
` and -- well, the audio is through my
` headset.
` Q. Do you have any other
` electronic equipment in the room
` besides what you are you are using
` to participate in the deposition?
` MR. STOPS: Objection, vague.
` A. I have a cell phone in the
` room off to the side.
` Q. Are you communicating with
` any of your counsel by any means
` right now?
` MR. STOPS: Other than this?
` Q. Other than this.
` A. Other than the Zoom
` conference, no.
`
`800-642-1099
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` TY B. CARROLL, M.D.
` Q. Dr. Carroll, what did you
` do to prepare for your deposition
` today?
` MR. STOPS: Objection. This
` impinges on attorney-client
` communication.
` Dr. Carroll, you can answer
` generally with respect to the when
` you met, who you met, but that's as
` far as I'll let you answer.
` A. I prepared this document,
` my declaration, and reviewed it with
` counsel.
` Q. Approximately how long did
` you meet with your counsel in
` preparation for your deposition
` today?
` A. The preceding two days a
` total of perhaps 15 hours.
` Q. In preparing for your
` deposition did you personally look
` for any documents or other
` materials?
` MR. STOPS: Objection. Vague
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` TY B. CARROLL, M.D.
` as to time. Are you limiting it to
` just the two days of preparation
` preceding the deposition here
` today?
` MR. MILLIKEN: Correct. Just
` the preparation immediately
` preceding this deposition.
` A. Could you please repeat
` that question? I had some technical
` difficulties. You cut out for a
` moment.
` Q. Of course. In your
` preparation immediately preceding
` this deposition, did you look for
` any documents or materials?
` MR. STOPS: Objection, vague.
` I'll let you answer that. I'm
` not sure where you are going with
` this. Just so that we are not
` impinging on any type of privilege
` I'll let you answer that yes, no,
` or I don't know. We will see where
` this goes.
` A. No, I guess. I guess I'm
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` TY B. CARROLL, M.D.
` unclear about if I looked for any
` additional documents. No.
` Q. Let me ask it this way,
` maybe this will be a little clearer.
` In preparing for your deposition did
` you review any documents that are
` not listed in Exhibit B to your
` declaration?
` MR. STOPS: I'll let you
` answer that yes, no, or I don't
` know.
` A. No.
` Q. And I know you have it in
` front of you but just to make this
` easy, I will go ahead and introduce
` what's been previously marked as
` Exhibit 2057, which is the
` Declaration of Ty Carroll. And just
` to make sure the technology is
` working properly, Dr. Carroll, are
` you now able to see Exhibit 2057 in
` the marked exhibits folder?
` A. I'm pulling it up right
` now.
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` TY B. CARROLL, M.D.
` Yes, I am.
` Q. Excellent. And you are
` welcome to download that or use the
` copy that you have in front of you,
` whatever makes things easiest for
` you.
` And in Exhibit B to that
` declaration that has the list of the
` materials, that you've considered in
` forming your opinions in this case,
` correct?
` A. Yes, it does.
` Q. Were all of those documents
` provided to you by your counsel?
` MR. STOPS: Objection, vague.
` Do you mean in the copy that he has
` in the binder in front of him?
` MR. MILLIKEN: No.
` Q. When you were forming the
` opinions that are provided in your
` declaration, were all of those
` documents provided to you by your
` counsel?
` A. No.
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` TY B. CARROLL, M.D.
` Q. So you provided some of the
` documents?
` A. Yes, I did.
` Q. Which documents
` specifically did you include in this
` list?
` A. I'm not sure exactly which
` documents I provided and which were
` provided by counsel.
` Q. If you could turn, please,
` to Exhibit A of your declaration,
` which is your CV, and just let me
` know when you are there.
` A. As it turns out, I
` apparently don't have Exhibit A in
` paper in front of me so I will turn
` to it -- I guess I don't have the
` exhibits. One moment. Let me just
` look more closely.
` MR. STOPS: It should be
` directly -- it should be --
` obviously I don't have access to
` the same binder that you do but my
` understanding is that it will
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` TY B. CARROLL, M.D.
` follow directly after your
` declaration.
` A. Now I have it. Yeah, it
` was -- there was an attached for it.
` I have that in front of me.
` Q. Great, thank you. And I'd
` just like to ask you a few general
` questions about your background and
` experience and to the extent you
` need to or would like to refer to
` your CV, please feel free to do so.
` Could you briefly describe
` your educational background, please.
` A. Sure. I received an
` undergraduate degree from the
` University of Wisconsin Medicine and
` then my medical degree from the
` Medical College of Wisconsin and
` then completed medical training in
` internal medicine and endocrinology
` at the Medical College of Wisconsin.
` Q. So you would consider
` yourself an endocrinologist by
` training; is that correct?
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` A. I'm a board certified
` endocrinologist.
` Q. Just ballpark your best
` estimate, what percentage of your
` time would you estimate that you
` spend on clinical practice, i.e.
` treating patients?
` A. Nearly a hundred percent.
` Q. What about teaching?
` A. It's a small percentage of
` the total time.
` Q. What about research or
` scholarship, the more academic side
` of the field?
` A. Again, a small percentage
` that my entire clinical designation,
` my entire designation as a clinical
` endocrinologist.
` Q. I'm sorry, could you repeat
` that last answer? You broke up just
` a moment.
` A. Sure. My full clinical --
` my full designation as a clinical
` endocrinologist so research is a
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` TY B. CARROLL, M.D.
` small portion of my total time.
` Q. I understand. Prior to
` this case have you worked as an
` expert consultant in litigation
` before?
` MR. STOPS: Objection, vague.
` A. No.
` Q. You said you spend a small
` percentage of your time teaching,
` correct?
` A. That's correct.
` Q. What courses or what types
` of courses do you teach generally?
` A. I currently teach a section
` on adrenal physiology and pathology
` for the medical school. At the
` Medical College of Wisconsin.
` Q. And you have some
` publications and some books and
` chapters, et cetera, that you have
` authored that are listed in your
` declaration, correct?
` A. That's correct.
` Q. Generally speaking, what
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` TY B. CARROLL, M.D.
` sorts of topics have you published
` on in your career?
` A. The vast majority of my
` publications and research is on
` Cushing's syndrome.
` Q. Have you ever published on
` CYP3A inhibitors before?
` A. Not directly.
` Q. Have you ever published on
` drug interactions before?
` A. Not directly.
` Q. Doctor, have you ever
` designed a clinical study?
` A. Yes.
` Q. What -- how many, ballpark?
` A. Perhaps four or five.
` Q. To the extent with sort of
` as much specificity as you can
` remember, what was the nature of
` those clinical studies, what were
` they designed to test?
` A. Most of those would have
` been retrospective studies to do
` with the prevalence of Cushing's
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` TY B. CARROLL, M.D.
` syndrome or diagnostic tests related
` to the Cushing's syndrome.
` Q. Doctor, I apologize would
` you mind repeating that answer.
` Your audio cut out for a moment.
` A. Sure. The vast majority of
` those studies would relate to the
` diagnosis or treatment of Cushing's
` syndrome in a retrospective record
` review manner for the most part.
` Q. Were you the principal
` investigator on any of those
` studies?
` MR. STOPS: Objection,
` foundation.
` A. I was.
` Q. Have you ever designed a
` clinical drug-drug interaction
` study?
` A. No, I have not.
` Q. Have you ever served as a
` principal investigator on a clinical
` drug-drug interaction study?
` A. No, I have not.
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` TY B. CARROLL, M.D.
` Q. Have you ever assisted in
` any way with a clinical drug-drug
` interaction study?
` MR. STOPS: Objection, vague.
` A. No, I have not.
` Q. At page 5 of your CV, which
` to the extent it's helpful, it's
` page 51 of Exhibit 2057, the heading
` at the top says Peer Review
` Workshops and Presentations. If you
` could let me know when you're there.
` A. I'm there.
` Q. Under the heading National,
` in the second item there there's a
` reference to the seismic studies.
` Do you see that?
` A. Yes, I do.
` Q. What is or was the seismic
` studies?
` A. It was a Phase III clinical
` trial of mifepristone for the
` treatment of Cushing's syndrome.
` Q. And is that the study that
` led to the FDA approval of
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` TY B. CARROLL, M.D.
` quinolone?
` MR. STOPS: Objection.
` Foundation.
` A. It was the pivotal trial of
` mifepristone for the treatment of
` Cushing's syndrome.
` Q. Were you involved in the
` seismic study?
` A. I was.
` Q. And what was the nature of
` your involvement?
` A. I was a subinvestigator at
` our clinical site.
` Q. You said subinvestigator?
` A. Subinvestigator I believe
` was the term used.
` Q. Could you explain what a
` subinvestigator is, please?
` A. For the purposes of this
` study one of the investigators who
` was not the principal investigator
` but also had a role as an
` investigator in the trial.
` Q. And in your role as
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` TY B. CARROLL, M.D.
` subinvestigator for whom were you
` working?
` A. To the best I can answer
` that, it was -- I believe it was the
` Medical College was a site for the
` trial sponsored by Corcept but I was
` employed by the Medical College.
` Q. In connection with your
` work on the clinical trial, did you
` receive any compensation from
` Corcept?
` A. No, I did not.
` Q. Have you done any
` additional consulting work for
` Corcept besides -- setting aside the
` work on this case and your role in
` the seismic studies, have you done
` any consulting work for Corcept?
` A. Yes, I have.
` Q. Could you describe
` generally the nature of that
` consulting work?
` A. I have been a speaker or --
` (inaudible).
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` TY B. CARROLL, M.D.
` I think my video has frozen.
` Q. Go ahead. I think I have
` you back now. It froze for a
` moment. If you don't mind repeating
` that last answer.
` A. Sure. I have been a
` speaker regarding Cushing's syndrome
` or the treatment of Cushing's
` syndrome as well as consulted on
` Cushing's syndrome.
` Q. And for how many years
` approximately have you been working
` as a consultant to Corcept?
` A. The last 7 to 10 years.
` Q. And have you been
` compensated for that work?
` A. I have.
` Q. Approximately how much per
` year in compensation would you say
` you received for your consulting
` work for Corcept?
` A. Approximately $6,000 a
` year.
` Q. I'd like you to turn,
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` TY B. CARROLL, M.D.
` please, to paragraph 55 of your
` declaration. It's on page 21.
` A. I'm there.
` Q. And this paragraph is
` discussing a September 2006 draft
` guidance document distributed by the
` FDA, correct?
` A. It is.
` Q. And the second sentence in
` that paragraph states, "In my
` opinion, practicing medical doctors
` rarely rely on FDA Guidances."
` Is that correct?
` A. Yes, it is.
` Q. Do physicians who are
` designing clinical trials rely on
` FDA guidances?
` MR. STOPS: Objection, beyond
` the scope.
` A. It would depend on the
` clinical trial that was being
` developed.
` Q. If I were a physician
` developing a clinical trial to
`
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` TY B. CARROLL, M.D.
` investigate a drug-drug interaction,
` might I rely on an FDA guidance
` document concerning drug-drug
` interaction studies?
` MR. STOPS: Objection,
` incomplete hypothetical.
` A. I have not designed a
` clinical trial of that sort so I
` can't offer an opinion.
` Q. If you could go, please, to
` paragraph 26 of your declaration.
` It's at page 9.
` A. I'm there.
` Q. According to this
` paragraph, you've been treating
` individuals with endogenous
` Cushing's syndrome for over
` 11 years, correct?
` A. That's correct.
` Q. And you would estimate that
` you've treated approximately or at
` least 75 individuals with Cushing's
` syndrome, correct?
` A. Yes, that's correct.
`
`800-642-1099
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` TY B. CARROLL, M.D.
` Q. Just one clarifying
` question. If you turn back to
` paragraph 4 of your declaration,
` which is on page 2, the last
` sentence of that paragraph --
` A. I'm there.
` Q. I'm sorry. The last
` sentence of that paragraph states,
` "I have treated patients with
` Cushing's syndrome with mifepristone
` for at least the last four years."
` Did I read that correctly?
` A. You did.
` Q. But that sentence wasn't
` meant to suggest that you've been
` treating patients with Cushing's
` syndrome with mifepristone for only
` four years; is that correct?
` A. That's correct.
` Q. Do you know approximately
` when you first prescribed
` mifepristone to treat Cushing's
` syndrome?
` A. That would have been in the
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` TY B. CARROLL, M.D.
` seismic trial.
` Q. And that was in the 2011,
` 2012 time frame, is that generally
` accurate?
` A. I believe it was a little
` bit before that.
` Q. Okay.
` A. But somewhere around 2010 I
` think is when our involvement began.
` Q. This paragraph 26, the 75
` individuals with Cushing's syndrome,
` does that include the patients who
` were participating in the seismic
` trials?
` A. Yes.
` Q. Of the 75 individuals with
` Cushing's syndrome that you've
` treated, just ballpark estimate,
` approximately how many have you
` prescribed mifepristone?
` A. I think I lost your audio
` right at the end of that question.
` Could you just repeat it to be
` clear.
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` TY B. CARROLL, M.D.
` Q. Sure. Of the 75
` individuals with Cushing's syndrome
` that you estimate you've treated,
` approximately how many would you
` estimate you have treated with
` mifepristone?
` A. Approximately 15.
` Q. And you've also prescribed
` ketoconazole to patients with
` Cushing's syndrome, correct?
` A. That's correct.
` Q. Do you know approximately
` how many Cushing's syndrome patients
` you've prescribed ketoconazole to?
` A. Perhaps six.
` Q. What are some examples of
` other drugs that you've prescribed
` to patients with Cushing's syndrome?
` A. Metyrapone, mitotane,
` etomidate, to name a few.
` Q. If you could turn to the
` next page of your declaration,
` please, paragraph 29.
` A. I'm there.
`
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` TY B. CARROLL, M.D.
` Q. Feel free to review the
` entire paragraph but I'm
` particularly interested in the last
` sentence which reads, "Because drugs
` have the potential to interact with
` one another if taken concomitantly,
` it is the responsibility of any
` prescriber to be knowledgeable about
` both known and potential DDIs and to
` adjust their prescribing practices
` if necessary."
` Do you see that?
` A. I do.
` Q. And so is it fair to say
` that in the course of treating
` patients who may be taking more than
` one medication you educate yourself
` about potential drug-drug
` interactions that might affect that
` patient?
` A. Yes, that's correct.
` Q. And where do you get your
` information regarding known or
` potential drug-drug interactions?
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` TY B. CARROLL, M.D.
` A. Among other resources,
` package inserts of medications and
` the available literature.
` Q. Anything else besides
` package inserts and medical
` literature?
` A. Those would be the primary
` sources.
` Q. And do you stay abreast of
` the medical literature that involves
` potential drug-drug interactions of
` drugs that you might be prescribing?
` A. I certainly try to.
` Q. Does the medical literature
` include reports of the results of
` clinical drug-drug interaction
` studies?
` A. That would depend on the
` drugs and where those studies were
` published.
` Q. Could you elaborate a
` little bit on what you mean by where
` those studies were published?
` A. Could you repeat that. I
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` TY B. CARROLL, M.D.
` had a technical issue again.
` Q. Sure. You said that -- I
` asked if the medical literature
` include reports on results of
` clinical drug-drug interaction
` studies and you said that would
` depend on the drugs and where those
` studies were published. And I was
` trying to understand the impact of
` where the studies were published,
` how that might affect whether you
` were relying on the results?
` A. The studies, if they are
` published in obscure journals or
` journals in foreign language, I
` certainly wouldn't review those
` regularly, but common endocrinology
` journals would be things that I
` would review.
` Q. I see. So if you have a
` drug-drug interaction study that's
` published in a reputable English
` language endocrinology journal,
` you'd be likely to review that in
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` TY B. CARROLL, M.D.
` the course of your self education,
` is that that fair?
` A. I think it would be likely
` that I would review that or I would
` be aware of it.
` Q. Okay. And you would rely
` on that type of information to
` assist you in making prescribing
` decisions, is that fair?
` MR. STOPS: Objection.
` Mischaracterizes.
` A. I would use the literature
` to help make a decision about
` prescribing practices.
` Q. If you could turn, please,
` to paragraph 58 of your declaration.
` And this is on page 23.
` A. I'm there.
` Q. The first sentence in this
` paragraph states, "Prior to March 1,
` 2017, when I treated patients with
` Cushing's syndrome with Korlym I did
` not simultaneously prescribe strong
` CYP3A inhibitors, including
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` TY B. CARROLL, M.D.
` ketoconazole."
` Is that correct?
` A. That is correct.
` Q. And in fact, you didn't
` even consider prescribing cortilone
` in combination with a strong CYP3A
` inhibitor; is that correct?
` MR. STOPS: Objection.
` Mischaracterizes the witness's
` testimony.
` A. No. I considered the
` combination but I -- at that time I
` did not prescribe the combination or
` had not prescribed the combination.
` Q. Could you please read out
` loud the second sentence of
` paragraph 58 starting with "I did
` not," please?
` A. "I did not consider
` prescribing Korlym in combination
` with a strong CYP3A inhibitor
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