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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ------------------------------------x
` AMERIGEN PHARMACEUTICALS LIMITED AND
` ARGENTUM PHARMACEUTICALS, LLC,
`
` Petitioners,
`
` vs.
`
` JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
` Case IPR2016-00286
` Patent No. 8,822,438 B2
` ------------------------------------x
`
` DEPOSITION OF MATTHEW RETTIG, M.D.
`
` New York, New York
`
` Tuesday, November 22, 2016
`
` 9:15 a.m.
`
`
`
`
`
`Reported by:
`
`Jennifer Ocampo-Guzman, CRR, CLR
`
`JOB NO. 17564
`
`Amerigen Exhibit 1189
`Amerigen v. Janssen IPR2016-00286
`
`TransPerfect Legal Solutions
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`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ------------------------------------x
` AMERIGEN PHARMACEUTICALS LIMITED AND
` ARGENTUM PHARMACEUTICALS, LLC,
`
` Petitioners,
`
` vs.
`
` JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
` Case IPR2016-00286
` Patent No. 8,822,438 B2
` ------------------------------------x
`
` DEPOSITION OF MATTHEW RETTIG, M.D.
`
` New York, New York
`
` Tuesday, November 22, 2016
`
` 9:15 a.m.
`
`
`
`
`
`Reported by:
`
`Jennifer Ocampo-Guzman, CRR, CLR
`
`JOB NO. 17564
`
`Amerigen Exhibit 1189
`Amerigen v. Janssen IPR2016-00286
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
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`Page 2
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` November 22, 2016
`
` 9:15 a.m.
`
` Deposition of MATTHEW RETTIG,
`
` M.D., held at the offices of Sidley
`
` Austin LLP, 787 Seventh Avenue, New
`
` York, New York, pursuant to notice,
`
` before Jennifer Ocampo-Guzman, a
`
` Certified Real-Time Shorthand Reporter
`
` and Notary Public of the State of New
`
` York.
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`Page 3
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` A P P E A R A N C E S:
`
` MCNEELY, HARE & WAR LLP
`
` Attorneys for Petitioner
`
` 12 Roszel Road, Suite C104
`
` Princeton, New Jersey 08540
`
` (347) 400-1154
`
` BY: GABRIELA MATERASSI, ESQ.
`
` materassi@miplaw.com
`
` WILLIAM D. HARE, ESQ.
`
` bill@miplaw.com
`
` SIDLEY AUSTIN LLP
`
` Attorneys for Patent Owner
`
` 787 Seventh Avenue
`
` New York, New York 10019
`
` (212) 839-5300
`
` BY: BINDU DONOVAN, ESQ.
`
` bdonovan@sidley.com
`
` AMANDA POTTER (Admission pending)
`
` amanda.potter@sidley.com
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` APPEARANCES (Continued):
`
`Page 4
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` FINNEGAN HENDERSON FARABOW GARRETT &
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` DUNNER LLP
`
` Attorneys for BTG
`
` 901 New York Avenue, NW
`
` Washington, DC 20001
`
` (202) 408-4150
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` BY: JENNIFER H. ROSCETTI, ESQ.
`
` jennifer.roscetti@finnegan.com
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` (AMG Exhibit 1073, Petitioners'
`
` Notice of Deposition of Matthew Rettig,
`
` M.D., marked for identification, this
`
` date.)
`
` M A T T H E W R E T T I G , M D,
`
` called as a witness, having been duly sworn,
`
` was examined and testified as follows:
`
` EXAMINATION BY
`
` MS. MATERASSI:
`
` Q. Good morning, doctor.
`
` A. Good morning.
`
` Q. My name is Gabriela Materassi. I
`
` represent the petitioner, Amerigen, in this
`
` proceeding.
`
` The first question is, do you
`
` understand why you are here today?
`
` A. Yes.
`
` Q. I am going to hand to you what
`
` we've previously marked as AMG-1073.
`
` I am going to ask you to please
`
` take a look at AMG-1073 and confirm for me
`
` that that is your deposition notice for
`
` today's testimony in this proceeding.
`
` A. Yes, I understand this to be the
`
` notice of deposition.
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` Q. And now, I am going to also hand to
`
` you an exhibit that I think you've seen
`
` before. So this is marked Amerigen 1001.
`
` So do you recognize this document?
`
` A. Yes, I do.
`
` Q. So let me just confirm that this is
`
` a copy of U.S. Patent number 8,822,438.
`
` Is that correct, doctor?
`
` A. Yes, yes.
`
` Q. And so this is the patent at issue
`
` in this proceeding, correct?
`
` A. Yes.
`
` Q. Is that your understanding?
`
` I am going to try to refer to this
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` patent by the shorthand the '438 patent. If
`
` I do that during the deposition, will you
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` understand I'm talking about this patent?
`
` A. Yes, I will, yes.
`
` MS. DONOVAN: Gabriela, I would
`
` like to note for the record that Dr.
`
` Rettig also has a copy of his
`
` declaration with him. You are welcome
`
` to look at it, but I just want you to be
`
` clear he did bring it in with him.
`
` Q. Oh, you did bring it in, okay. So
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` we don't need to burden you with another copy
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`Page 7
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` of your declaration.
`
` A. No, thanks.
`
` Q. So I'll just ask you to refer to
`
` it. Thank you.
`
` So Dr. Rettig, I'm going to be
`
` asking you some questions today in connection
`
` with your written testimony, which you have
`
` in front of you, on behalf the patent owner
`
` Janssen in this proceeding.
`
` Do you understand?
`
` A. Yes.
`
` MS. DONOVAN: Objection.
`
` Q. I'm going to first cover some
`
` ground rules, and please ask me, if anything
`
` that I'm going to explain to you right now is
`
` unclear.
`
` Do you understand that when you
`
` answer my questions, your answer must be
`
` full, complete and truthful, because you are
`
` under oath?
`
` A. Yes, I do.
`
` Q. Do you understand that you are to
`
` respond to my questions regardless of your
`
` counsel's stated objection, unless your
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` counsel expressly instructs you not to
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` respond to any of my questions?
`
` A. Yes, I do.
`
` Q. If for any reason you do not
`
` understand a question, do you understand that
`
` you should raise the issue of your lack of
`
` understanding before answering that question?
`
` A. Yes, I do.
`
` Q. Please let me know if you need to
`
` take a break. I would strongly prefer if we
`
` take the break after you answer a question,
`
` if you request taking a break in the middle
`
` of a question.
`
` Anything unclear --
`
` A. No.
`
` Q. -- about what I said? Okay.
`
` Dr. Rettig, can you please state
`
` your full name for the record?
`
` A. My name is Matthew Benjamin Rettig.
`
` Q. And Dr. Rettig, can you state your
`
` full residential address for the record?
`
` A. My full residential address is
`
` 1842, 1842, Edgecliffe Drive, Los Angeles,
`
` California, 90026, United States.
`
` Q. Dr. Rettig, can you tell me if you
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` are on any medication today that might affect
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` your testimony?
`
` A. No, I'm not.
`
` Q. Are you suffering from any malady
`
` that might affect your testimony today?
`
` A. No.
`
` Q. Do you understand that you are not
`
` to confer or consult with your counsel
`
` regarding any questions that I will ask you,
`
` or any of your responses to any questions
`
` that I will ask you, at any time during a
`
` break in this proceeding?
`
` A. Yes, I do.
`
` Q. Am I correct that you are here
`
` today on behalf of Janssen Oncology Inc.,
`
` Johnson & Johnson and BTG International Ltd.?
`
` A. Yes, I do.
`
` Q. Can we use the shorthand Janssen,
`
` in referring to the patent owner in this
`
` proceeding?
`
` A. Yes.
`
` Q. Can you identify for me your
`
` counsel?
`
` A. Bindu Donovan, sitting to my right.
`
` Q. Dr. Rettig, when were you first
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` approached by counsel regarding your
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` representation of Janssen in this matter?
`
` A. Earlier this year, the first part
`
` of 2016.
`
` Q. Do you remember when in the first
`
` part of 2016, doctor?
`
` A. Approximately March or April. I
`
` don't know the exact date.
`
` Q. Dr. Rettig, are you being
`
` compensated for your testimony in this
`
` proceeding?
`
` A. Yes, I am.
`
` Q. Can you describe the terms of your
`
` compensation?
`
` A. Yes --
`
` MS. DONOVAN: If I may just caution
`
` the witness not to disclose any
`
` privileged communications. You may
`
` answer the question generally.
`
` THE WITNESS: Thank you.
`
` A. Yes, I'm being compensated for my
`
` work, and the details are in my declaration.
`
` I'm being compensated at a rate of $900 per
`
` hour, as well as additional fee for travel.
`
` Q. With respect to your deposition
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` here today, Dr. Rettig, how much time,
`
` approximately, did you spend preparing?
`
` A. I don't know the exact number, but
`
` many hours reviewing documents.
`
` Q. Would it be more than 20 hours
`
` reviewing documents?
`
` A. Yes.
`
` Q. Could it be more than 40 hours
`
` reviewing documents?
`
` A. It could be.
`
` Q. Could it be more than 60 hours
`
` reviewing documents?
`
` A. I suspect not.
`
` Q. So is it fair to say that somewhere
`
` between 40 and 60 hours of time was spent by
`
` you reviewing documents in preparation for
`
` this deposition?
`
` MS. DONOVAN: Objection.
`
` A. That would be --
`
` MS. DONOVAN: You may answer.
`
` A. That would be a fair statement.
`
` Q. Now, how much of this time that
`
` you've just described did you spend with
`
` counsel?
`
` A. Could you please clarify that, what
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` you mean by "with counsel."
`
` Q. Between 40 and 60 hours of time
`
` that you spent reviewing documents, how much,
`
` if any, of that time was spent reviewing
`
` documents with counsel?
`
` MS. DONOVAN: Object to form.
`
` A. So again, I'm not clear on the
`
` question.
`
` Are you talking about in person,
`
` when you say "with counsel," or by phone?
`
` Q. By phone, in person?
`
` A. Yeah --
`
` MS. DONOVAN: Before you respond
`
` again, I would like to just caution the
`
` witness not to disclose the substance of
`
` any communications with counsel. You
`
` may just answer the specific question
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` that's asked.
`
` A. I've spent a number of hours with
`
` counsel. I don't know the exact number. It
`
` represents a number of hours. I don't know
`
` the exact number.
`
` Q. A number of hours?
`
` A. Yes.
`
` Q. Would it be more than 10 hours?
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` A. Yes.
`
` Q. Would it be more than 20 hours,
`
` doctor?
`
` A. Possibly, but in that range.
`
` Q. In the range of about 20 hours?
`
` A. Approximately, yeah.
`
` Q. Did you speak with or consult with
`
` anyone at Janssen, in the course of preparing
`
` for your deposition today?
`
` A. No.
`
` Q. Did you speak or consult with
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` anyone at BTG, in the course of preparing for
`
` your deposition today?
`
` A. No.
`
` Q. Did you speak or consult with
`
` anyone at Cougar, in the course of preparing
`
` for your deposition today?
`
` A. No.
`
` Q. So Dr. Rettig, I'm going to ask
`
` you, please, and you already have a copy of
`
` your declaration, but I'm going to ask you to
`
` please turn to your declaration, which has
`
` been marked Janssen Exhibit 2038.
`
` MS. MATERASSI: And counsel, do you
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` have a copy of Dr. Rettig's --
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` MS. DONOVAN: I do not.
`
` MS. MATERASSI: We have one for
`
` you.
`
` MS. DONOVAN: Why don't you give me
`
` the form that you have it in, actually.
`
` Q. So my first question, doctor, is
`
` I'm going to ask you, please -- actually, I
`
` haven't handed it to you, but usually I hand
`
` the exhibit and I confirm that this is your
`
` declaration. So we're just going have to
`
` have you maybe compare with your counsel and
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` confirm that the copy of your declaration
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` that counsel has is the same as the
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` declaration that you prepared in this
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` proceeding.
`
` A. Yes, it seems to be the same.
`
` MS. DONOVAN: I mean, Gabriela, I'm
`
` comfortable, if you would like him to
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` use your version.
`
` MS. MATERASSI: Whatever your
`
` preference is. I just want to confirm
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` for the record that the copy of the
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` declaration that he has is exactly as
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` what's filed under seal. So that's
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` enough. I mean if you're comfortable
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` with your copy, doctor, please go ahead.
`
` Q. Dr. Rettig, how much time did you
`
` spend preparing your declaration which has
`
` been marked Janssen Exhibit 2038?
`
` MS. DONOVAN: Again, I caution the
`
` witness not to disclose privileged
`
` communications.
`
` You may answer the question
`
` generally.
`
` A. Several hours.
`
` Q. Would it be, again, more than
`
` 20 hours?
`
` A. No.
`
` Q. Would it be less than 10 hours?
`
` A. Possibly.
`
` Q. Could it be less than five hours?
`
` A. No.
`
` Q. So is it fair to say that between
`
` five and 10 hours of your time was spent
`
` preparing the exhibit marked JSN-2038?
`
` MS. DONOVAN: Objection to form.
`
` A. No, I'm not sure exactly.
`
` As I stated to your previous
`
` question, it's approximately ten. It could
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` be more or less than that.
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` Q. Okay, fine. Thank you.
`
` Dr. Rettig, did you conduct your
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` own literature -- I'm sorry, literature
`
` search for articles that you cite in your
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` declaration?
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` A. No.
`
` Q. Did you, did counsel provide you
`
` with all of the articles and materials that
`
` you cite in your declaration?
`
` A. Yes.
`
` Q. Can you generally describe what
`
` documents you reviewed before coming to this
`
` deposed?
`
` MS. DONOVAN: I object, and I
`
` instruct the witness not to answer. I
`
` object on the grounds of attorney/client
`
` privilege.
`
` MS. MATERASSI: We can take that up
`
` later.
`
` MS. DONOVAN: And work product.
`
` MS. MATERASSI: We don't agree that
`
` that is an attorney privileged question,
`
` but we can take that up later with the
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` PTAB.
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` MS. DONOVAN: Also work product.
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` MS. MATERASSI: Again, we disagree,
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` but we can take it up with the PTAB at a
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` later time.
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` MS. ROSCETTI: And I will state for
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` the record, to the extent that Ms.
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` Donovan objects, it's also on behalf of
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` BTG, so I don't have to keep saying
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` "Same objection."
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` MS. MATERASSI: So we will have one
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` counsel objecting on behalf of Janssen
`
` and BTG and of course J&J.
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` MS. ROSCETTI: And unless there is
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` an objection that I want to make, but
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` I'm not going to sit here and say "Same
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` objection."
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` MS. DONOVAN: We're trying to make
`
` it easier.
`
` MS. MATERASSI: Thank you so much,
`
` because my throat...
`
` Q. So the good news, Dr. Rettig, is
`
` that I really cannot go on very long today,
`
` because my throat won't last that long today.
`
` A. I'm sorry to hear that.
`
` Q. But we will have you, hopefully
`
` before the holiday crush starts, at the
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` airport.
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` So Dr. Rettig, my next question is:
`
` Did you review testimony from any of the
`
` other witnesses for Janssen, in the course of
`
` preparing for your deposition today?
`
` A. Yes, I did.
`
` Q. Whose testimony did you review?
`
` A. I reviewed testimony from Dr.
`
` Auchus, A-U-C-H-U-S, and Dr. Chodak,
`
` C-H-O-D-A-K.
`
` Q. Did you review testimony from any
`
` of the witnesses for the petitioner?
`
` A. Yes, I did.
`
` Q. Whose testimony did you review,
`
` doctor?
`
` A. Dr. Serels.
`
` Q. It's actually pronounced Serels,
`
` and he's always chiding us for it. I can
`
` almost hear him.
`
` A. I'm sorry, Dr. Serels.
`
` Q. Did you review any of the
`
` references cited by Dr. Serels in his
`
` declaration?
`
` A. I can't recall.
`
` Q. Did you review -- did you review
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` Dr. McDuff's declaration?
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` A. I don't remember a declaration that
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` was specifically linked to McDuff, that I
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` reviewed.
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` Q. Did you review Dr. McDuff's
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` deposition testimony?
`
` A. No.
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` Q. Did you review any of the
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` references cited by Dr. McDuff in his
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` declaration?
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` A. Given that I don't think I reviewed
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` the declaration, I don't think I would have
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` known to review the references.
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` Q. Did you review any of the
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` references you cite in your declaration? And
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` again, that's JSN-2038.
`
` A. Yes.
`
` Q. Did you review any of the
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` references cited by any other of the
`
` witnesses for Janssen?
`
` A. I don't recall. I believe I did,
`
` but I couldn't tell you which ones.
`
` Q. Okay. Do you have any notes with
`
` you today?
`
` A. No.
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` Q. Have you ever been deposed before,
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`Page 20
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` Dr. Rettig?
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` A. No.
`
` Q. Congratulations.
`
` A. Thank you.
`
` Q. Have you ever testified at trial
`
` before, Dr. Rettig?
`
` A. No.
`
` Q. Have you ever been involved in a
`
` case, outside of this one, that involved an
`
` opinion pertaining to the validity of a
`
` patent claim?
`
` A. No.
`
` Q. Can you go over your educational
`
` background, Dr. Rettig?
`
` A. Where would you like me to start?
`
` Q. Maybe with your medical educational
`
` background.
`
` A. Sure.
`
` I went to medical school at Duke
`
` University in Durham, North Carolina.
`
` Subsequent to that I did an internal medicine
`
` training, first year at USC and the latter
`
` two years -- USC is University of Southern
`
` California, Los Angeles, and the second two
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` years was at the University of Washington in
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` Seattle, Washington.
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` That was followed by a fellowship
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` in hematology and oncology, medical oncology
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` at UCLA and that was completed in 1996. So I
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` was a fellow, as you recall, from 1993 to
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` 1996.
`
` Q. At UCLA?
`
` A. Correct.
`
` Q. Dr. Rettig, how long have you
`
` treated patients with prostate cancer?
`
` A. If one goes back to internship and
`
` residency, we're talking about over 25 years.
`
` Q. How long have you treated patients
`
` with metastatic castration-resistant prostate
`
` cancer?
`
` A. A similar amount of time.
`
` Q. Do you know any of the -- and
`
` actually let me refer you back to AMG or
`
` Amerigen 1001, which you've confirmed is the
`
` '438 patent. I'm going to ask you to take a
`
` look at the face of that patent.
`
` Do you know either of the named
`
` inventors of the '438 patent?
`
` A. Yes.
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` Q. Whom do you know?
`
` A. Arie Belldegrum.
`
` Q. How do you know Dr. Belldegrum?
`
` A. He's a urologist at UCLA.
`
` Q. Have you ever collaborated with Dr.
`
` Belldegrum on any research?
`
` A. No.
`
` Q. Have you ever coauthored any
`
` publications with Dr. Belldegrum?
`
` A. No, not that I'm aware of.
`
` Q. Have you ever participated as an
`
` investigator in any clinical trials that Dr.
`
` Belldegrum also was an investigator for?
`
` MS. DONOVAN: Object to form.
`
` A. I do not recall. To my
`
` recollection, I did not.
`
` Q. What about Dr. Auerbach, do you
`
` know him?
`
` A. No.
`
` Q. Dr. Rettig, have you ever
`
` prescribed abiraterone to a patient with
`
` prostate cancer?
`
` MS. DONOVAN: Object to form.
`
` A. I have -- I have prescribed the
`
` combination of abiraterone acetate and
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` prednisone to patients with prostate cancer.
`
` Q. So you've never prescribed
`
` abiraterone alone to a patient with prostate
`
` cancer?
`
` A. Let me just clarify.
`
` When we're talking about
`
` abiraterone, are you talking about its
`
` acetate form or are you talking about
`
` abiraterone --
`
` Q. The acetate. So just to make the
`
` record clear, we will be -- if it's okay with
`
` you, I will be using the shorthand
`
` abiraterone to describe abiraterone acetate,
`
` which is the active ingredient in the drug
`
` product ZYTIGA, correct?
`
` A. No, that's not correct.
`
` Q. Oh, that's not correct.
`
` What is the active ingredient?
`
` A. It's abiraterone.
`
` Q. Just abiraterone?
`
` A. But the drug is abiraterone
`
` acetate.
`
` Q. Okay.
`
` What is the difference, what
`
` accounts for the difference?
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` A. The abiraterone acetate is in
`
` acetylated form of abiraterone and -- there's
`
` a difference. It's sort of a prodrug,
`
` meaning that abiraterone acetate is converted
`
` into abiraterone, the active drug.
`
` Q. So the abiraterone acetate is
`
` converted into abiraterone when or after
`
` administration to a patient?
`
` A. Correct.
`
` Q. So when the abiraterone is
`
` prepared, right, is marketed, it's in the
`
` form of abiraterone acetate, correct?
`
` A. That is correct.
`
` Q. And so once the abiraterone acetate
`
` is administered to a patient, the drug is
`
` metabolized to abiraterone, correct?
`
` A. That's correct.
`
` Q. So I guess I will be referring to,
`
` I will try actually to, to use abiraterone
`
` acetate throughout the deposition to make it
`
` clear that it's primarily abiraterone acetate
`
` that I will be asking you questions about.
`
` A. Okay.
`
` Q. Now you indicated that you have
`
` never prescribed abiraterone without also
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` prescribing prednisone, correct.
`
` A. Again, are you talking about the
`
` abiraterone or abiraterone acetate?
`
` Q. Abiraterone -- Well, it would be in
`
` the form of abiraterone acetate in the tablet
`
` form, right?
`
` A. Yes. As I stated previously, I've
`
` never prescribed abiraterone acetate as a
`
` monotherapy.
`
` Q. Have you ever prescribed docetaxel
`
` to a patient with prostate cancer, doctor?
`
` A. I have never prescribed -- yes, I
`
` have prescribed docetaxel.
`
` Q. Have you ever prescribed docetaxel
`
` to a patient with prostate cancer, without
`
` also prescribing prednisone to that patient?
`
` A. Yes.
`
` Q. How often, if you recall, have you
`
` prescribed docetaxel to a patient with
`
` prostate cancer, when you have also not or
`
` when you have not prescribed prednisone to
`
` that patient?
`
` A. I don't use docetaxel too
`
` frequently anymore.
`
` I don't recall the exact frequency
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` with which I have prescribed docetaxel
`
` without prednisone, but it is being done by
`
` me with increasing frequency.
`
` Q. I'm sorry, what is being done --
`
` A. Prescribing docetaxel by itself,
`
` without prednisone.
`
` Q. And why are you doing that?
`
` A. There is a trend amongst medical
`
` oncologists who specialize in GU oncology
`
` that the prednisone is not needed. And in
`
` fact, as an example of that, phase 3 clinical
`
` trials leave the usage of prednisone in
`
` addition to the docetaxel as an option left
`
` up to the investigator.
`
` Q. Do you know what the intended
`
` purpose of the coadministration of prednisone
`
` with docetaxel is?
`
` MS. DONOVAN: Object to form.
`
` You may answer.
`
` A. It would be my speculation. I do
`
` not see any, and have never seen any clear
`
` explanation as to why prednisone has been
`
` added to docetaxel.
`
` Q. Do you know that docetaxel was
`
` approved in combination with prednisone to
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` treat metastatic castrate-resistant prostate
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`Page 27
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` cancer?
`
` A. Yes, I do.
`
` Q. Could the fact that docetaxel was
`
` approved in combination with prednisone
`
` account for the use of docetaxel with
`
` prednisone --
`
` MS. DONOVAN: Object to form.
`
` Q. -- to treat patients with prostate
`
` cancer?
`
` MS. DONOVAN: Object to form.
`
` A. I'm sorry, could you repeat the
`
` question?
`
` Q. Yes. So we've established that
`
` docetaxel was approved by FDA in combination
`
` with prednisone to treat metastatic
`
` castrate-resistant prostate cancer, correct?
`
` A. Uh-huh.
`
` Q. So my question is: Could the fact
`
` that approval for the indication to treat
`
` metastatic castrate-resistant patients of
`
` docetaxel, could the fact that that approval
`
` was in combination with prednisone, could
`
` that account for the use of prednisone in
`
` combination with docetaxel?
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` A. I can't speculate as to why
`
` someone, in general, would use the
`
` combination.
`
` Q. But in your practice, you are more
`
` frequently prescribing docetaxel without also
`
` prescribing prednisone to treat a patient
`
` with prostate cancer?
`
` A. Yes, yes.
`
` Q. Why are you doing that?
`
` A. As I said, the general feeling in
`
` the realm of GU oncology, so specialists of
`
` prostate cancer, is that --
`
` Q. I'm sorry, you mentioned GU?
`
` A. I'm sorry, genitourinary.
`
` Q. Okay, thank you.
`
` A. -- genitourinary oncologists is
`
` that it's, it's not necessary to coadminister
`
` prednisone with docetaxel.
`
` MS. DONOVAN: Before you continue,
`
` Gabriela, I would just like to object to
`
` this line of questioning as outside the
`
` scope of the direct testimony that Dr.
`
` Rettig has provided.
`
` MS. MATERASSI: That's fine. We
`
` disagree. We think it is well within
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` the scope.
`
` MS. DONOVAN: And I have a running
`
` objection to all of these questions
`
` related to docetaxel --
`
` MS. MATERASSI: Related to
`
` docetaxel.
`
` MS. DONOVAN: -- administration,
`
` yes.
`
` Q. But you do reference docetaxel in
`
` your declaration, correct?
`
` A. Yes, I do.
`
` Q. So we will get to those portions,
`
` and we think that it is well within the scope
`
` of what you described in your declaration
`
` regarding the use of docetaxel. But again,
`
` this is just between lawyers, and we'll take
`
` it up with the PTAB. There's a lot to take
`
` up with the PTAB.
`
` Dr. Rettig, have you ever
`
` prescribed mitoxantrone to a patient with
`
` prostate cancer?
`
` A. Yes.
`
` Q. Do you recall how often you have
`
` prescribed mitoxantrone to patients with
`
` prostate cancer?
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` A. I have not prescribed that drug in
`
` approximately 10 years.
`
` Q. When you did prescribe mitoxantrone
`
` to treat a patient with prostate cancer, did
`
` you prescribe the mitoxantrone in combination
`
` with prednisone?
`
` A. Yes, I did.
`
` Q. And again, you indicated that you
`
` have not prescribed mitoxantrone in
`
` approximately 10 years, correct?
`
` A. Correct.
`
` Q. Why is that the case, doctor?
`
` A. Mitoxantrone has not been shown to
`
` improve survival, whereas other therapies
`
` since mitoxantrone's approval have been shown
`
` to improve survival.
`
` Q. Have you ever prescribed
`
` cabazitaxel to a patient with prostate
`
` cancer?
`
` A. Yes.
`
` Q. How often, if you recall, have you
`
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