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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` CASE IPR2016-00712
` PATENT 8,927,592
`***************************************************
`MYLAN LABORATORIES
`LIMITED.
`
` Petitioner,
`
`VS.
`
`AVENTIS PHARMA S.A.,
`
` Patent Owner.
`***************************************************
`
` DEPOSITION OF ALTON OLIVER SARTOR, M.D.
` VOLUME II
` (Pages 328 through 558)
` New Orleans, Louisiana
` Monday, May 8, 2017
`
`REPORTED BY:
`DIXIE B. VAUGHAN, CCR, RPR
`JOB NO.: 123317
`
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`MYLAN- EXHIBIT 1098
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` CASE IPR2016-00712
` PATENT 8,927,592
`***************************************************
`MYLAN LABORATORIES
`LIMITED.
`
` Petitioner,
`
`VS.
`
`AVENTIS PHARMA S.A.,
`
` Patent Owner.
`***************************************************
`
` DEPOSITION OF ALTON OLIVER SARTOR, M.D.
` VOLUME II
` (Pages 328 through 558)
` New Orleans, Louisiana
` Monday, May 8, 2017
`
`REPORTED BY:
`DIXIE B. VAUGHAN, CCR, RPR
`JOB NO.: 123317
`
`TSG Reporting - Worldwide 877-702-9580
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`MYLAN- EXHIBIT 1098
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
`
`
`
`Page 329
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` MAY 8, 2017
` 9:02 A.M.
`
` The Deposition of ALTON OLIVER SARTOR,
`M.D., held at Hilton, 333 St. Charles Avenue, New
`Orleans, Louisiana, before Dixie B. Vaughan, a
`Certified Court Reporter (#28009), for the State of
`Louisiana, Registered Professional Reporter, and
`Certified Livenote Reporter.
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` I N D E X
` PAGE
`APPEARANCES 331
`EXAMINATION
` BY MR. REED 332
` BY MR. MINION 533
`RE-EXAMINATION
` BY MR. REED 550
`REPORTER'S CERTIFICATE 557
`ERRATA 558
`
` INDEX OF EXHIBITS
`
` PAGE
`
`EXHIBIT A Appendix 1 344
`EXHIBIT B Handwritten Timeline 550
` PREVIOUSLY MARKED EXHIBITS REFERENCED:
`
`EXHIBIT 1001 365
`EXHIBIT 1008 456
`EXHIBIT 1010 499
`EXHIBIT 1012 489
`EXHIBIT 1021 489
`EXHIBIT 1024 484
`EXHIBIT 1046 497
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`EXHIBIT 1048 469
`EXHIBIT 2093 459
`EXHIBIT 2147 536
`EXHIBIT 2182 529
`EXHIBIT 2224 534
`EXHIBIT 2259 332
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`APPEARANCES:
`
`REPRESENTING THE PETITIONER:
` MATTHEW REED, ESQ.
` STEVE PARMELEE, ESQ.
` (via telephone)
` PATRICK MEDLEY, ESQ.
` (via telephone)
`
` WILSON SONSINI GOODRICH & ROSATI
` 650 Page Mill Road
` Palo Alto, California 94304
`
`REPRESENTING THE PATENT OWNER:
` DANIEL MINION, ESQ.
` WHITNEY MEIER, ESQ.
`
` FITZPATRICK CELLA HARPER & SCINTO
` 1290 Avenue of the Americas
` New York, New York 10104
`
` * * *
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` ALTON OLIVER SARTOR, M.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. REED:
` Q. Good morning, Dr. Sartor.
` A. Good morning.
` Q. My name is Matt Reed, and I represent
`Mylan. Do you understand that?
` A. Yes. Thank you.
` Q. I notice a copy of what I think is
`Exhibit 2259 on the table. It was kind of in
`front of you. Now it's not. Let me give you a
`copy of Exhibit 2259.
` A. Right. Thank you.
` Q. What is Exhibit 2259?
` A. This is my response to Dr. Seth.
` Q. What was your role in preparing or
`creating Exhibit 2259?
` A. It's the document that I have prepared
`and signed off on.
` Q. How did the preparation or creation of
`this document proceed?
` MR. MINION:
` We went through this before. Let's be
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` careful here. What is it you're asking?
` MR. REED:
` The question was: How did the
` preparation or creation of this document
` proceed?
` MR. MINION:
` I'm a little uncomfortable because
` that's going to involve communications
` between us, so...
` A. Yeah. I understand that they're
`privileged communications, and I understand that
`this is a document that I've signed-off on. And
`what I think would be appropriate to say, is that
`after carefully reviewing Dr. Seth's declaration,
`and -- I have gone through and helped to prepare a
`response to that, very specifically on a couple of
`issues.
`BY MR. REED:
` Q. If you'll turn to page 23.
` A. (Complies.)
` Yes. I'm there.
` Q. Is that your signature?
` A. Yes, it is.
` MR. REED:
` Let's go off the record just for a
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` minute.
` (Discussion off the record.)
`BY MR. REED:
` Q. Prior to signing Exhibit 2259, did you
`review it carefully to ensure that it was
`accurate?
` A. Yes.
` Q. Are you aware of any inaccuracies in
`Exhibit 2259?
` A. No.
` Q. Any corrections that you'd like to make
`to Exhibit 2259 today?
` A. No.
` Q. You can refer to Exhibit 2259 at any
`point during the deposition as I'm asking you
`questions.
` A. Okay. Thank you.
` Q. At some points, I might refer you to
`your reply declaration. And if I do refer you to
`your reply declaration, I'm referring to
`Exhibit 2259.
` Do you understand that?
` A. Yes.
` Q. Do you -- when you're talking about
`prostate cancer, is there a difference between the
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`meaning of the phrase "life expectancy" and the
`phrase "overall survival"?
` A. Yes. There -- there is. And it's --
`it's a little bit in the context of the use. So
`overall survival is a way of looking at data. And
`life expectancy has a little bit of a different
`connotation. So even though they're analogous in
`the sense that they are referring to life
`expectancy, the connotation and use of the terms
`can have a distinction in the way that doctors
`speak. For instance, I would talk about your life
`expectancy if I were talking to you now, but if
`you were a patient in my office and I were
`evaluating data, I might talk about overall
`survival. Seemingly, they -- they're both
`referring to how long you might live. The context
`of the use of the terms is somewhat distinct.
` Q. What connotation does "life expectancy"
`have that "overall survival" doesn't?
` A. I think when we use the term -- you
`know, I'm a pretty experienced physician. And
`life expectancy is something that applies to
`individuals whether or not they have cancer or
`not. But if you do have cancer, it's sort of an
`interesting change in terms. We talk about
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`survival because we can divide overall -- overall
`survival implies different forms of survival. For
`instance, survival that might be related to the
`cancer or survival related to other factors. Life
`expectancy is agnostic with regard to those
`different types in general.
` In other words, if a prostate cancer
`patient comes to me, then we do talk about life
`expectancy with those patients, but it's not the
`usual way that we talk to one another. So it's a
`little bit of a subtle distinction.
` Q. When you say "the usual way that we talk
`to one another," who is the "we" that you are
`referring to?
` A. Yeah. The "we" is the clinicians.
` Q. Okay.
` A. Yeah. And --
` Q. It's the doctors amongst themselves?
` A. The doctors among themselves. You know,
`we -- if we're looking at clinical trial result,
`we very explicitly refer to overall survival. If
`you look at protocols, they're very explicitly
`written for overall survival. Now, implicit in
`that is life expectancy, but it has a little bit
`of a different connotation when we're speaking
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`about clinical trials, doctors to one another.
`And we actually don't use the -- either of those
`terms very often in patient communication. We
`don't talk about their overall survival. We might
`talk about their life expectancy, but, you know,
`how long -- they're usually asking about, "What's
`my prognosis, Doc? How long do I have?" And then
`I help explain to them, you know, where their
`disease state is and what our interventions are in
`hopes that we can provide an accurate answer to
`that question.
` Q. So specifically in the context of a
`patient with prostate cancer, do you believe that
`others in the fields have in mind a difference
`between the meanings of the phrases "life
`expectancy" and "overall survival"?
` A. I don't actually think it translates
`into a different meaning. It's just they're used
`in different contexts typically. Even though
`their meaning is basically the same: How long are
`you going to live. You know, we can phrase that
`in multiple different ways.
` Within the phraseology of our
`profession, we use certain terms in certain ways.
`And the way we use "overall survival" is a little
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`bit distinct from the way that we use the term
`"life expectancy." Yeah, it both refers to how
`long are people going to live, which is just
`another way of saying it. I guess it sort of is
`the difference between a vernacular and a, I'll
`say, slang term, but it's a -- "overall survival"
`is a clinical trial term. We don't look at the --
`we don't talk about life expectancy as a clinical
`trial end point if they were both referring to how
`long you expect people to live. I don't know.
`Maybe it's too subtle a distinction. There's not
`a big distinction between the two.
` Q. At the beginning of your answer, you
`made a reference to data --
` A. Correct.
` Q. -- when you were talking about overall
`survival.
` A. Right.
` Q. Can you explain what relevance data has
`to overall survival?
` A. Oh. Well, when -- when we report big
`trials, we typically have overall survival as an
`end point. The data surrounding that end point
`are, you know, often one of the critical figures
`in a manuscript. It's also critical for the
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`interpreting physician. You know, we look at
`overall survival, which is supported by data. I
`mean, you can't talk about overall survival
`without data. I suppose you could, but it
`wouldn't have any credence in the field.
` If you come to me and tell me you have a
`way of increasing overall survival, I'd just say,
`"Well, oh, terrific, show me your data. Let me
`see what you have. What's the hazard ratio? What
`are the confidence intervals? What's the P value?
`What's the power of the trial? What's the patient
`population?" So overall survival is evaluated in
`the context of data.
` Q. I'm interested in following up on a
`portion of your last answer.
` A. Yeah.
` Q. And you said that you can't talk about
`overall survival without data.
` A. Well --
` Q. What did you mean by that?
` A. I mean, if we're going to have a -- if
`you tell me that you have a way of increasing
`survival, I have to look at your data in order to
`know if you speak the truth or not. I can't --
`you know, overall survival is a discussion item
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`among our profession that entails interpretation
`of data.
` Q. Does increasing survival necessarily
`mean that there's a comparison going on between
`two different sets of conditions or sets of
`treatments?
` A. In the --
` MR. MINION:
` Object to form.
` A. In -- in a clinical trial, there is
`always some form of comparison. Now, it's
`possible for that comparison to be a historical
`comparison. But, more typically, in a Phase III,
`it's going to be comparison to a control group.
`BY MR. REED:
` Q. Is the phrase "overall survival" one
`that's used not in the context of making
`comparisons or looking at whether there's been an
`increase in overall survival or not?
` MR. MINION:
` Objection to form.
` A. One could use the term "overall
`survival" in other ways, but it would not be the
`typical way. Typically when we're talking about
`overall survival in our profession, in our field,
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`we're referring to data, we're referring to the
`context of, you know, who -- who are you trying to
`increase overall survival for? Is it the world as
`a whole? The population of New Orleans? Men over
`the age of 98? You know, what is it confined to?
`What does it mean?
` And if you're talking about overall
`survival, typically, it's some form of
`intervention that is being evaluated. Was it
`clean water? Is it fluoride in the water? Is it
`bacterial counts in the water? You know, what --
`what is -- what is it that you're measuring? What
`is it that you're trying to do? So -- I mean, so
`much of this is context-dependent; I guess that's
`the easy way to say it.
`BY MR. REED:
` Q. Can you listen to this statement and
`when I'm finished reading it, tell me if you agree
`with it?
` A. Uh-huh.
` Q. "Once a study shows a statistically
`significant increase in overall survival as
`compared to no therapy or palliative therapy, a
`person of ordinary skill in the art can treat the
`patient with the study regimen with the intent to
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`increase the survival of that patient."
` A. Yes.
` Q. What do you understand from the phrase
`"the intent to increase" to mean?
` A. Well, you know, "intent" is a word I
`suppose that could have different interpretations
`to different people. And when I intend to prolong
`survival, it means that I have some knowledge base
`that I can apply to that particular individual.
` And this is getting back to what I
`talked about before, are we talking about, you
`know, somebody comes to me from Botswana and do I
`intend to increase their survival. As they walk
`into my office, I might not know quite how I would
`intend to do that unless I understood their
`circumstances and what I was intending to do to
`them. So one could intend to prolong survival
`when there's data to support that, but it's
`incredibly difficult to intend to do it if you
`don't have the data.
` Q. I had intended to provide you with this
`at the beginning of the deposition, and I've
`forgotten until just now.
` MR. REED:
` And, Dan and Whitney, maybe you can help
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` me understand how best to identify this
` document. What I've done is I've taken the
` appendix off of Patent Owner's Contingent
` Motion to Amend, which displays the
` substitute claims that are the subject of the
` Motion to Amend, and it's pages 27 and 28 of
` that.
` MR. MINION:
` Mark them any way you want. I don't
` care.
` MR. REED:
` Should we mark them with an exhibit
` number?
` MR. MINION:
` Sure.
` MR. REED:
` Okay. And with a document like that
` that doesn't bear an exhibit number from
` the -- our proceedings, what's the convention
` in terms of the exhibit numbers to use?
` MR. MINION:
` You can use Exhibit Q if you want, I
` guess. Right? You're just marking it for
` identification.
` MR. REED:
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`Page 344
` Okay. Let's mark as Exhibit A, Appendix
` 1, which consists of pages 27 and 28 of
` Patent Owner's Contingent Motion to Amend.
` (Document marked as Exhibit 1 for
` identification.)
` A. Thank you.
`BY MR. REED:
` Q. Dr. Sartor, you understand that the
`patent owner in this IPR proceeding has requested
`that if certain claims of the 592 patent are found
`unpatentable, that they be replaced by the four
`claims that are set forth in Exhibit A; is that
`right?
` A. That is correct.
` Q. Have you seen these four claims set out
`as they are in Exhibit A with what I'll call red
`lines showing deletions and additions?
` A. Oh, gosh, I can't -- I can't remember if
`it was red-lined or not. I've seen the claims,
`but I can't recall if it was a red-lined document.
` Q. Okay. You understand how the red lines
`work in this document, correct?
` A. No, I don't.
` Q. Okay. So on the first line of the first
`page where it says "31," at the end of that line,
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`the word "the" is in brackets and it's crossed
`out.
` Do you see that?
` A. I do.
` Q. I'll represent that that means that's a
`word that was in Claim 27 and that if the motion
`to amend is granted, it would be stricken, it
`would be removed.
` A. Ah. Okay.
` Q. So too on the next line where "of a
`patient" is in brackets and stricken, that
`language would be removed from Claim 27 to create
`Claim 31.
` Do you understand that?
` A. I do now. Thank you.
` Q. Okay. On that same line begins a series
`of words five or six or seven lines long that are
`underlined. And I'll represent that the
`underlining signifies new words that are being
`inserted into what used to be Claim 27 to create
`Claim 31.
` A. Thank you for the clarity.
` Q. Okay. So Exhibit A sets forth the
`Claim 27 language as it's proposed to be changed
`by patent owner if Claim 27 is found unpatentable
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`and if the Motion to Amend is granted.
` Do you understand that?
` A. I do.
` Q. Okay. I know in one of your
`declarations, not the one that we've marked here
`as Exhibit 2259, but a prior declaration of yours,
`you set forth the language of the new claims, the
`proposed new claims, 31 to 34. But I wanted to
`make sure that you had available here both that
`language and the original language of the
`corresponding claims.
` Do you understand that?
` A. I believe that I do.
` Q. Okay. I would like you to focus on
`Claim 31 for a minute.
` A. Okay.
` Q. And tell me if you believe that the
`changes that are made from Claim 27 to Claim -- to
`convert it into Claim 31 here change the meaning
`of this claim with respect to the intent to
`increase the survival of a patient with
`castration-resistant or hormone refractory
`metastatic prostate cancer that has progressed
`during or after treatment with docetaxel?
` MR. MINION:
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` Objection to form. Calls for a legal
` conclusion.
` A. I was actually about to say the question
`was so long that I kind of lost the question. I
`wonder if you might be able to restate it a little
`more succinctly for me.
`BY MR. REED:
` Q. Sure. You've talked in your declaration
`that we do have here, Exhibit 2259 --
` A. Right.
` Q. -- about intending to increase the
`survival of a patient.
` A. Uh-huh. Correct.
` Q. And the patient that we're talking about
`here is one with metastatic castration-resistant
`prostate cancer that's progressed during and after
`docetaxel, right?
` A. Correct.
` Q. Okay. So my question is whether the
`changes from Claim 27 to Claim 31, in your mind,
`make any change with respect to that intent to
`increase the survival of the patient?
` MR. MINION:
` Same objections.
` A. I think I understand. And the change is
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`in noticing several differences in the language.
` You know, first of all, there's the
`addition of the antihistamine corticoid H2
`antagonist and it very clearly specifies a patient
`in need thereof. And so it, to me, what it does,
`is it clarifies a little bit exactly who this
`individual is. It's a patient in need thereof.
`It adds in the premedications administered prior
`to said dose.
` So when I look at the older claim, the
`distinctions include the patient in need thereof,
`which I think is specifying that individual in
`more detail. It's adding in the various
`premedications, which I don't need to repeat. But
`the -- when you increase the survival, here we
`have the patient in need thereof, which I think is
`slightly distinct from just increasing survival.
` Now it gets down to more of the patient
`level as opposed to the -- a little more broader
`claim. So this seems to me like a narrower claim,
`to me. And --
`BY MR. REED:
` Q. What is it that gets down to the patient
`level?
` A. Well, "Administering to a patient in
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`need thereof." It refers very specifically to a
`patient who needs to have their survival
`prolonged.
` Q. So do I understand correctly that you
`believe the changes made from Claim 27 to Claim 31
`make the claim narrower because there's a
`reference to "a patient in need thereof," meaning
`a patient in need of increasing survival?
` A. I think that that's fair. What we have
`defined, we went from increasing survival of a
`patient to specifying what type of patient it is,
`the patient who would have a need thereof of
`prolonging survival. Furthermore, as is obvious,
`the premedications are included, whereas in the
`past, they were excluded.
` Q. So is a patient in need thereof a
`patient in need of the premedications? Is that
`what that "thereof" is referring to, in need of
`premedications?
` A. Well, I believe that the -- this does
`refer to the premedication very precisely.
` Q. So you understand the new claim, 31,
`when it says, "administering to a patient in need
`thereof," to be referring to administering to a
`patient in need of the premedications and the
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`cabazitaxel; is that right?
` A. Well, perhaps in a little more --
`administered prior to said dose of the
`cabazitaxel. And, obviously, it's specifying the
`dose of 25, where -- I'm sorry -- the 20 to 25,
`which I think is obvious.
` Q. So you understand that in Claim 31, the
`phrase, "administering to a patient in need
`thereof," refers to administering to a patient in
`need of the premedications and cabazitaxel where
`the premedications are administered before the
`cabazitaxel?
` MR. MINION:
` Objection to form.
` A. So, basically, they're now being
`administered this particular regimen, whereas in
`the past, it just referred to the cabazitaxel or a
`hydrate or solvate thereof.
` Now this adds this particular regimen to
`have the premedications. I think I'm being clear,
`but I'm not -- I feel like you're fishing for
`something, but I don't know what you're fishing
`for.
`BY MR. REED:
` Q. I think you have been clear. And I
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`appreciate that.
` A. Okay.
` Q. I appreciate your explanation. And I
`don't intend to be redundant or ask the same
`question again, so...
` If we're talking about increasing
`survival, are we talking about any potential cause
`of death?
` A. You know, an interesting question.
`Because, as it turns out, that overall survival is
`improved by this regimen. So that would include
`all causes of death when that is specified.
` Now, obviously, we're treating prostate
`cancer, but in the context -- and this is a point
`that I was perhaps alluding to but not making
`clear earlier. If I'm treating all the men in
`Botswana intending to prolong their survival, it
`becomes a challenge because I don't know what the
`threat to their immediate health might be. But
`under these circumstances where I have individuals
`who have castrate-resistant or hormone refractory
`metastatic prostate cancer progress during or
`after treatment with docetaxel, I've now really
`defined that population. And with this
`combination, I believe that we can prolong overall
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`survival. Perhaps you might even say "life
`expectancy," although I wouldn't typically use
`that term here.
` So prolonging overall survival is a
`critical, critical element in evaluating the
`safety and efficacy of drugs.
` Q. In the context of Claim 31, do I
`understand correctly that increasing survival
`means increasing the period of time that somebody
`will live regardless of their ultimate cause of
`death?
` A. It means -- I'm sorry. I think I heard
`it right, and I don't mean to ask you to repeat it
`unnecessarily. But I'm sorry. Would you say it
`one more time, because I just want to make sure I
`heard it right.
` Q. In the context of Claim 31 --
` A. Right.
` Q. Do I understand correctly that
`increasing survival means increasing the period of
`time that somebody will live regardless of their
`ultimate cause of death?
` A. Yes, that is correct.
` Q. Whether they're in a car crash --
` A. (Nods head.)
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` Q. -- or if they succumb to prostate
`cancer?
` A. That is correct. It's a high bar, isn't
`it?
` I guess you don't have to answer my
`questions, but it's a high bar when you increase
`overall survival.
` Q. In 2007 and 2008, you were enrolling
`patients in the TROPIC study; is that right?
` A. Correct.
` Q. How many patients did you enroll?
` A. You know, I was asked that before and I
`had trouble remembering. And I must admit, I
`still have trouble remembering. You know, there
`were -- I was practicing in two different
`locations and the -- you know, I was in Boston and
`then I was in New Orleans, and I just -- I just
`don't quite remember. So I apologize for not
`being able to remember the answer to that
`precisely.
` Q. I know from my experience in sitting
`through depositions with you, that you do like to
`be very precise. And I appreciate that. And I'm
`trying to be as precise as possible as well.
` A. Sure.
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` Q. In asking you how many patients you
`enrolled in TROPIC, I'm asking about you
`specifically, right --
` A. Right. Me.
` Q. -- you or your center with your
`patients?
` A. Yeah. With me in my leadership,
`correct. Yes, I understand that.
` Q. And while I understand you can't
`remember exactly how many patients that is, out of
`the 700-and-some-odd patients that were enrolled
`in TROPIC, what is your best estimate to the
`nearest ten of the number of patients that you
`enrolled?
` A. Yeah. I think it was -- I think it was
`probably less than ten, but I -- I mean, it was
`probably -- and I actually remember that I was
`asked this previously and I couldn't, you know --
`I'm trying to remember what I said the answer is.
`But since you're asking me something that I don't
`remember, it's hard for me to be more precise. I
`mean, it wasn't one or two, but I don't think it
`was more than ten.
` Q. Okay.
` A. And, you know, again, I could make up a
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`Page 355
`number to make you happy. Would you be happy if I
`told you seven? I don't know. I'm not sure that
`I would be because I can't remember, and that's
`not my style to tell you things that I can't
`remember very well.
` Q. Given everything else that you've said,
`if you gave me the answer seven, I would not be
`happy.
` A. I'm sorry. I was trying to make you
`happy.
` Q. Because we would all know that you
`weren't telling me what you remembered.
` A. Yeah. Because I really -- I wish I
`could remember. I really don't remember exactly.
` Q. Fewer than ten, more than one or two?
` A. Yes.
` Q. And in enrolling those patients, did you
`have an intent to increase their overall survival?
` A. Well, I really couldn't at that time.
`You know, I had a hope. It's a matter of what the
`word "intent" means. And, you know, I, you know,
`always enroll in a trial with the hopes of having
`a positive effect. But, of course, until you have
`the results, you know, that's sort of conjecture.
`So if I were to be more precise in my language, I
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`didn't intend to prolong survival, I conjectured
`to prolong survival, I hoped to prolong survival,
`and I wished for survival to be prolonged. But my
`wishes and hopes could not be really construed as
`intentions because I didn't have adequate
`knowledge at that time to be able to say that I
`intended to do so.
` Q. Do you recall out of the patients that
`you enrolled in TROPIC, whether they received the
`mitoxantrone arm or the cabazitaxel arm?
` A. They had both.
` Q. Roughly even numbers of each?
` A. Yeah. I don't, you know, remember, you
`know -- I want to say it's hard to remember the
`numbers, so...
` But, yeah, I mean, both. I was very
`comfortable with mitoxantrone and, you know, I'd
`used mitoxantrone since the '90s. I kind of knew
`what to expect of it.
` Q. Based only on the results that you saw
`in your own patients, did you come to an
`understanding of whether cabazitaxel offered
`benefit to patients?
` A. I could not determine that based on my
`limited patient sample. That would have been
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`conjecture.
` Q. Did you try? Do you do anything to try
`and evaluate the results of those patients that
`you personally enrolled?
` A. Well, I think we always try, but we
`always fail in a limited number. You know, you
`can't evaluate truly the risks and benefits of a
`therapy in the context of just a few patients. I
`think that's a mistake your expert has made
`repeatedly, by the way. But that's apparently his
`naive approach. I'm pretty experienced.
` Q. Did you come to an understanding of
`whether cabazitaxel offered any benefit other than
`increasing overall survival based on your
`TROPIC-enrolled patients?
` A. I don't feel that I could do that. And,
`you know, the -- to me, patient benefit is
`construed in the risk as well as benefits of a
`patient. And when we -- when we're evaluating
`individual patients, it's very difficult to assess
`the risks and benefits of a drug. You know, we
`have limited observations, particularly in the
`context of a clinical trial. Now, after the
`clinical trial, we know so much more.
` Q. That additional knowledge that you gain
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`as a result of the clinical trial means that today
`if you treat a metastatic castration-resistant
`prostate cancer patient who's progressed during or
`after treatment with docetaxel, you intend to
`increase the overall survival of that
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