4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`Page 1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`-----------------------------x
`WOCKHARDT BIO AG, :
` :
` Petitioner, :
` : Case No.
` vs. :
` : IPR2016-01582
`JANSSEN ONCOLOGY, INC., :
` :
` Patent Owner. :
`-----------------------------x
`
` Washington, D.C.
` Friday, April 21, 2017
`VIDEOTAPED Deposition of:
` ROBERT D. STONER, Ph.D.,
`the witness, was called for examination by counsel
`for the Patent Owner, pursuant to notice,
`commencing at 10:01 a.m., at the law offices of
`Sterne, Kessler, Goldstein & Fox P.L.L.C., before
`Dawn A. Jaques, CSR, CLR, and Notary Public in and
`for the District of Columbia.
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`202-232-0646
`
`JANSSEN EXHIBIT 2187
`Wockhardt v. Janssen IPR2016-01582
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`APPEARANCES:
`On behalf of the Petitioner:
` DENNIES VARUGHESE, ESQ.
` KRISHAN THAKKER, ESQ.
` Sterne, Kessler, Goldstein & Fox P.L.L.C.
` 1100 New York Avenue, N.W.
` Washington, D.C. 20005
` PHONE: (202) 772-8805 (Varughese)
` (202) 772-8643 (Thakker)
` EMAIL: dvarughe@skgf.com
` kthakker@skgf.com
`
`On behalf of the Patent Owner:
` PAUL J. ZEGGER, ESQ.
` Sidley Austin LLP
` 1501 K Street, N.W.
` Washington, D.C. 20005
` PHONE: (202) 736-8060
` FAX: (202) 736-8711
` EMAIL: pzegger@sidley.com
`
`VIDEOGRAPHER: Larry Newman
`
` I-N-D-E-X
`WITNESS: PAGE:
`ROBERT D. STONER, Ph.D.
` Examination by Mr. Zegger ........ 5
`
` E-X-H-I-B-I-T-S
` (No new exhibits marked)
`
`Page 2
`
` PREVIOUSLY MARKED EXHIBITS REFERRED TO
` JANSSEN EXHIBIT NUMBER PAGE
` 2155 ......... 85
`
` WOCKHARDT EXHIBIT NUMBER PAGE
` 1031 ......... 64
` 1077 ......... 8
` 1103 ......... 7
` 1114 ......... 51
`
`Page 3
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`
`5 6 7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` P R O C E E D I N G S
` THE VIDEOGRAPHER: We are now on the
`record. My name is Larry Newman. I am a
`videographer for Golkow Technologies.
` Today's date is Friday, April 21st,
`2017, and the time is 10:01 a.m. This video
`deposition is being held in Washington, D.C., in
`the matter of Wockhardt Bio AG versus Janssen
`Oncology Incorporated, and this is in the
`U.S. Patent and Trademark Office, Patent and
`Trademark -- Patent Trademark and Appeal Board,
`Cause No. IPR2016-01582. Our deponent today is
`Robert D. Stoner, Ph.D.
` And, Counsel, would you please
`identify yourselves and state whom you represent?
` MR. ZEGGER: My name is Paul Zegger.
`I'm with the law firm of Sidley Austin, and I'm
`representing the Patent Owner.
` MR. VARUGHESE: Dennis Varughese from
`the law firm of Sterne, Kessler, Goldstein & Fox,
`on behalf of Petitioner Wockhardt, and with me
`today is Krishan Thakker, also Sterne Kessler.
`Page 4
`
` THE VIDEOGRAPHER: Would our -- our
`court reporter is Dawn Jaques, and will now swear
`in the witness.
` THE REPORTER: Raise your right hand,
`sir.
` (The witness was sworn in by the reporter.)
` MR. VARUGHESE: Just one second. My
`realtime's not working.
` THE REPORTER: Can we go off?
` THE VIDEOGRAPHER: The time is 10:02.
`We'll go off the video record.
` (Pause in the proceedings.)
` THE VIDEOGRAPHER: The time is
`10:04 a.m. Back on the video record.
`Whereupon,
` ROBERT D. STONER, Ph.D.,
` was called as a witness, after having been
` first duly sworn by the Notary Public,
` was examined and testified as follows:
` EXAMINATION BY COUNSEL FOR THE PATENT OWNER
` BY MR. ZEGGER:
` Q Good morning, sir.
`
`Page 5
`Pages 2 to 5
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` A Good morning.
` Q Sir, do you dispute that Zytiga® has
`had over $4 billion in sales since it was
`launched?
` MR. VARUGHESE: Objection, lacks
`foundation.
` THE WITNESS: From the materials I've
`seen, I don't dispute that.
` BY MR. ZEGGER:
` Q Do you think that Janssen regrets
`bringing Zytiga to market?
` MR. VARUGHESE: Objection, vague and
`ambiguous, lacks foundation.
` THE WITNESS: I have no idea how to
`answer that question. I don't -- I haven't seen
`any evidence on the profitability of Zytiga®.
` I've seen evidence on sales and market
`share, but that doesn't tell me necessarily that
`the product has been overall profitable for
`Janssen.
` BY MR. ZEGGER:
` Q Do you seriously think that Janssen
`Page 6
`
`regrets bringing Zytiga® to market?
` MR. VARUGHESE: Objection,
`argumentative, vague and ambiguous.
` THE WITNESS: As I said, I can't
`answer that question.
` BY MR. ZEGGER:
` Q Let me hand you what has been marked
`as Wockhardt Exhibit 3 -- I'm sorry, Wockhardt
`Exhibit 1103. Is this your reply declaration in
`this proceeding?
` A It appears to be, yes.
` Q That's your signature on the last
`page?
` A It is.
` Q You signed on April 18th, 2017?
` A Yes, I did.
` Q And do pages 2 through 5 contain a
`complete list of the materials you considered?
` A Yes, with the caveat in footnote 1
`there that the table includes materials considered
`in my initial declaration only if they are
`specifically cited in my reply.
`
`Page 7
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
` So, you know, this is a continuation
`of the work I did in the initial declaration.
` Q Okay. You mentioned your initial
`declaration. Let me put before you what has been
`marked as Wockhardt Exhibit 1077, and can you
`confirm whether this is your initial declaration
`in connection with this IPR?
` A Yes, it is.
` Q Now, is it correct that you were
`deposed back on February 10th of this year in
`connection with your initial declarations?
` A Correct.
` Q How much work have you done in
`connection with this case since that time?
` A I've done considerable work.
` Q Can you give me an estimate in terms
`of hours?
` A Certainly more than 50 hours.
`Somewhere between 50 and 100 hours.
` Q Has somebody assisted you with your
`reply declaration?
` A There was editing suggestions from the
`Page 8
`
`lawyers. There is citations that were offered by
`the lawyers. There was a back-and-forth after I
`produced the first draft of the report.
` Q Did you undertake any analysis of your
`own?
` A Certainly.
` Q Could you look at your reply
`declaration, paragraph 6. Are you there?
` A I am.
` Q Does that set forth some of the legal
`standards that you were provided in connection
`with this matter?
` A That's correct.
` Q The last sentence of paragraph 6
`states that you understand that to establish a
`proper nexus between a claimed invention and the
`commercial success of a product, quote, "a
`Patent Owner must offer proof that the sales were
`a direct result of the unique characteristics of
`the claimed invention, and not a result of
`economic and commercial factors unrelated to the
`quality of the patented subject matter," close
`Page 9
`Pages 6 to 9
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`quote. Did I read that correctly?
` A Correct.
` Q Is that your understanding of the
`legal standard?
` A That is.
` Q And was that provided to you by
`Wockhardt's lawyers?
` MR. VARUGHESE: Objection. In
`answering this question, I caution the witness not
`to divulge any confidential communications with
`counsel, but you can answer that yes or no.
` THE WITNESS: I've worked on a number
`of these commercial success cases before, and I
`generally know this to be the standard. That
`precise wording, presumably a function of my
`initial wording and any editing that was done by
`the lawyers.
` BY MR. ZEGGER:
` Q Okay. Is that generally referring to
`the nexus requirement?
` A Yes.
` Q Is it your understanding that there
`Page 10
`
`can ever be a presumption of nexus in the context
`of the obviousness inquiry here?
` MR. VARUGHESE: Objection, calls for
`speculation, calls for legal conclusion.
` THE WITNESS: That's a legal aspect
`that I'm probably not in a good position to
`respond to.
` BY MR. ZEGGER:
` Q All right. Well, in paragraph 6, you
`are setting forth your understanding of the legal
`requirements for commercial success, correct?
` A Correct.
` Q And you're discussing specifically the
`requirement for nexus, right?
` A Yes.
` Q So my question is whether you have an
`understanding as to whether there can ever be a
`presumption of nexus in this context?
` MR. VARUGHESE: Objection, calls for a
`legal conclusion, calls for speculation.
` THE WITNESS: I believe I've heard
`that there are situations where there can be a
`Page 11
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`presumption, but I have no idea whether those --
`whether that has any import in the present matter.
` MR. ZEGGER: All right. And, Counsel,
`the coaching objections have to stop. You can
`object to the form, but no coaching, no speaking
`objections, and you understand that.
` MR. VARUGHESE: So, Mr. Zegger, I
`disagree with your characterization of my
`objections. I'm stating my objections and the
`grounds for them. They were no different than the
`objections that Sidley has lodged in other
`depositions in this proceeding. You can look at
`the transcripts.
` MR. ZEGGER: I don't know when it has
`happened in other depositions. I'm just saying
`that your objections here are improper.
` MR. VARUGHESE: I disagree.
` BY MR. ZEGGER:
` Q Sir, did you assume that there was a
`presumption of nexus here in this case?
` A I made no presumption in that regard
`one way or another.
`
`Page 12
`
` Q Well, is it correct that you, in your
`reply declaration, criticized the analysis of
`Dr. Vellturo in this case?
` A That's correct.
` Q Okay. Did you undertake your own
`independent analysis of nexus?
` A In the course of my criticism of
`Dr. Vellturo's analysis of nexus, I made quite
`clear what my conclusions were with respect to
`nexus.
` Q Well, did you do an independent study
`to undertake how much of the sales of Zytiga® were
`due to the patented invention here?
` A I myself did not do a study that
`apportions the success -- purported success of
`Zytiga® to the various aspects of -- that were
`important in its success, but I concluded that one
`could not attribute that success to the patented
`invention.
` Q Well, did you yourself attempt to
`apportion the degree of Zytiga® demand that was
`attributable to the patented invention compared to
`Page 13
`Pages 10 to 13
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`unclaimed features?
` A Yes, in the sense that I believe that
`the success -- I concluded that the success of --
`any commercial success of Zytiga® was a function
`of the independent anticancer effect of
`abiraterone, the independent anticancer effect of
`prednisone, the ability of prednisone to fight the
`side effects of the administration of abiraterone,
`the tablet form of Zytiga®, and potentially other
`unclaimed features as well with no indication that
`there is any nexus to the claimed invention.
` So that's apportionment, 100 percent
`to zero.
` Q I don't understand your last comment,
`apportionment 100 percent to zero.
` A To the claimed versus the unclaimed.
`100 percent to the unclaimed, and zero percent to
`the claimed.
` Q Where does that study appear in your
`reply declaration?
` A In my statements that there's no
`evidence that there's any -- in the statements and
`Page 14
`
`evidence that I presented or that I relied on
`indicating that there's no nexus between the
`success, purported success of Zytiga®, and the
`'438 patent, so that says no means zero.
` And my discussion of all the other
`unclaimed reasons that there was commercial
`success, they are apportioned 100 percent.
` Q Okay. Are you saying that it's your
`opinion in this matter that zero percent of
`Zytiga®'s sales, success, is due to the
`combination of abiraterone acetate and prednisone?
` A That's not what I said. I said it was
`due to the synergistic effect of those two -- of
`the combination of those two.
` None of it is due to the synergistic
`effect or the added effect of adding prednisone
`specifically to abiraterone to -- to develop an
`effect that goes beyond the individual effects of
`prednisone and abiraterone.
` Q Other than criticizing Dr. Vellturo's
`work, what study did you conduct in order to reach
`that conclusion?
`
`Page 15
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
` A I'm perfectly happy to discuss -- I
`mean, I have a 40-page report. There's a lot of
`evidence to discuss there if you want to.
` Q Okay. I see where you've criticized
`Dr. Vellturo in your reply report. I'm asking if
`you can show me in your reply declaration a study,
`an independent study that you undertook, to
`apportion the percentage of commercial success of
`Zytiga® that's due to the patented invention?
` MR. VARUGHESE: Objection, lacks
`foundation.
` THE WITNESS: I present a lot of
`evidence here in the discussions of the various
`parties that were bringing the invention -- that
`were bringing abiraterone forward towards
`commercialization that indicate that there was --
`that there was no belief that there was a synergy
`that was responsible for the commercial success.
` For example, I discuss the label of
`abiraterone, which is the best indicator of the
`belief of the FDA and what makes the drug -- and
`how the drug should be administered and what makes
`Page 16
`
`the drug work, and there's no mention in that of
`an additive effect of prednisone that -- sorry, a
`synergistic effect of prednisone that goes beyond
`the ability of prednisone to offset side effects.
`That's what the -- that's what the label talks
`about.
` BY MR. ZEGGER:
` Q You understand that the label for
`Zytiga® is a combination therapy of abiraterone
`acetate and prednisone?
` A Correct.
` Q Okay. And the '438 patent claims a
`combination therapy of abiraterone acetate and
`prednisone, correct?
` A That's correct.
` Q Could you look at paragraph 10 of your
`reply declaration?
` A Did I look at it or --
` Q Could you.
` A Oh, sure, yes.
` Q Okay. And there you mention that
`commercial success analysis requires an analysis
`Page 17
`Pages 14 to 17
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`of sales and profitability; is that right?
` A Yes. My opinion is that sales and
`market share is not always indicative of
`commercial success, and that -- the success, the
`marketing success of the product. And that one --
`an economist should go beyond looking at sales and
`market share when looking at profitability in
`order to determine whether a third party, at the
`time of the invention or before the invention,
`might well have had an incentive to adopt the
`innovation.
` Q Your view is that a profitability
`analysis is required?
` A Are you asking for a legal opinion, or
`for an economic opinion?
` Q Let's talk about an economic opinion.
` Your economic opinion is that an
`analysis of profitability is required in the
`present context?
` A Well, "required" is a -- puts it in a
`legal context, so I would not use the word
`"required."
`
`Page 18
`
` I'd use the word it's advisable for
`economists to look at whether the product who was
`profitable over its life span, given the R&D costs
`and development costs, and the time span over
`which those occur, to see whether the product had
`a rate of return commensurate with an investment
`that would have made sense at the time that that
`third party might have been in a position to -- to
`pursue that invention.
` Q Okay. So from an economic point of
`view, it would be advisable, but not required, to
`look at profitability?
` A There are probably situations where
`sales and market share and growth and market share
`would be -- would be good indicators of what
`profitability would be, and in those situations,
`particularly if -- well, in those situations, I
`would say potentially one wouldn't need to undergo
`a profitability analysis.
` But in situations such as this, where
`the development time was -- abiraterone was
`discovered in the early '90s; it wasn't
`
`Page 19
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`commercialized until 2011. There was a long
`gestation period, many -- you know, tremendous
`expense over a long period of time, and so I think
`in this situation, a profitability analysis is
`necessary to determine, from an economic
`standpoint as opposed to a legal standpoint,
`whether this was a worthwhile investment from the
`standpoint of somebody that would have been
`looking at the product -- at abiraterone
`development at the time of the invention in
`question.
` Q Is the analysis of profitability from
`an economic point of view context dependent?
` A I didn't quite say it that way,
`because what I was trying to say was that it's
`always necessary. But in some situations, sales
`and market share would be good indicators of
`profitability, and that in those situations,
`because they are a prox- -- they could be a proxy
`in certain situations, it would be acceptable,
`presumably, not to do a full profitability
`analysis.
`
`Page 20
`
` But -- and this is a matter of
`economic expertise -- when it appears that sales
`and market share may not be such a good proxy, and
`those situations -- that situation I believe
`exists here, one would want to look beyond that in
`order to -- in order to make a firm conclusion
`that the product was commercially successful in
`the sense that's important in a commercial
`success, obviousness context.
` Q Well, let's turn now to the legal
`requirement.
` Are you aware of any legal requirement
`that profitability has to be analyzed in the
`context of the commercial success inquiry?
` A I'm not aware of a legal requirement.
`I know it's discussed in some of the cases, but I
`can't -- I can't opine on whether or not there's a
`legal requirement.
` Q Have you ever been shown or seen a
`legal case saying that the analysis of
`profitability is a requirement in the commercial
`success analysis?
`
`Page 21
`Pages 18 to 21
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` MR. VARUGHESE: Objection, lacks
`foundation, calls for legal conclusion.
` THE WITNESS: I don't know that I've
`seen a case where that was in black and white, but
`I haven't read all the cases carefully to
`determine that.
` BY MR. ZEGGER:
` Q Well, certainly in the context of the
`present matter, no one has shown you a case that
`says that profitability is a requirement of the
`analysis, correct?
` A That -- that calls for a legal
`conclusion. I'm not really -- I'm not really in a
`position to say whether any of the cases -- I have
`been shown cases, but I'm not sure that I can say
`whether they -- you know, I'm an economist, and
`I'm just making judgments as to what an economist
`would want to know or show in order to be able to
`make the conclusions that Dr. Vellturo appears to
`draw.
` Q No, I'm certainly not asking you to
`make any legal conclusions. I'm just asking you
`Page 22
`
`if you have been made aware in the present case
`whether there's a legal requirement to analyze
`profitability?
` A I have not.
` Q I have the same question with respect
`to rate of return on investment.
` Is that a legal requirement, based on
`your understanding, for the commercial success
`inquiry?
` A Well, I'm using profitability, rate of
`return on investment, as somewhat synonymous.
` Q Same ball of wax, so to speak?
` A Yeah. One would have to look at the
`development costs and up front costs and see
`whether they are covered when you take into
`account uncertainty and cost of capital and such.
` So I would say that my responses with
`respect to rate of return on investment would be
`similar to what I responded with respect to
`profitability.
` Q Similarly, any analysis comparing the
`sales with upfront costs associated with bringing
`Page 23
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Zytiga® to market, that too would relate to your
`profitability inquiry here?
` A That's correct.
` Q So that factor as well would -- you're
`not sure whether that is a legal requirement in
`the context of the commercial success inquiry?
` A As I said, I'm not a lawyer. It would
`take a lawyer to determine whether that's a legal
`requirement or not.
` Q Okay. In paragraph 11 of your
`declaration, do you find fault with Dr. Vellturo
`for not providing an analysis of Zytiga®'s
`projected lifetime sales?
` A I simply noted that he didn't do so,
`and that typically one of the issues in trying to
`determine profitability, and even in being able to
`look at sales and determine whether those sales
`and market share are going to yield a profitable
`product, one wants to look over the horizon and
`see what's projected.
` And if, for example, some of the loss
`of market share that Zytiga® has had with respect
`Page 24
`
`to Xtandi®, if that were to cause a big decrease
`in sales going off into the future, one would want
`to know that.
` And if there were forecasts that
`Janssen had of Zytiga® sales in the future, and
`those could be part of the analysis, then that
`would improve the ability to forecast whether
`Zytiga® was, in fact, a commercial success.
` Q Well, can we agree that the Zytiga®
`lifetime sales will exceed $4 billion? We know
`that much?
` A That seems to be a reasonable
`conclusion.
` Q What market does Zytiga® compete in?
` A I haven't made a definitive conclusion
`as to what the proper product market in an
`antitrust sense would be for Zytiga®.
` Generally, Zytiga® competes in the
`prostate cancer space. More specifically, it
`competes for -- in the space that's sometimes
`called metastatic castrate-resistant prostate
`cancer.
`
`Page 25
`Pages 22 to 25
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Q That's the mCRPC for short?
` A Yes.
` Q Do you know whether Zytiga® competes
`against all drugs in the prostate cancer market?
` A That's a difficult question to answer
`because the record shows that, in prostate cancer,
`there's a progression of drugs that are used over
`time as the disease progresses, and they can be
`used in different order. And, in fact, a drug
`that was used at one earlier time can come back
`and be used at a later time.
` So it's hard to say precisely what the
`proper product market is because -- or to define
`the market very narrowly because -- because of
`the -- of the progression of the disease and the
`panoply of choices that an oncologist or
`a urol- -- or a, you know, a physician would have
`in making a diagnosis and prescribing a drug.
` Q Do you know what market Zytiga® is FDA
`approved for?
` A I believe it would be the metastatic
`castrate-resistant prostate cancer segment, but I
`Page 26
`
`don't -- I'm not sure about that.
` Q Is it your understanding that Zytiga®
`is generally used for mCRPC patients?
` A That's correct, although there is a
`distinction between post-chemo and pre-chemo
`patients, and at one point, Zytiga® was only
`approved for post-chemo mCRPC patients, and now
`it's approved for both pre and post.
` Q Is it your understanding that the
`pre-chemo and post-chemo markets that you
`mentioned are subparts of the mCRPC market?
` A That's my understanding.
` Q Okay. Is it appropriate to look at
`Zytiga®'s market shares then within the mCRPC
`universe of drugs?
` A It's appropriate to look at it within
`that universe, but it's also appropriate to look
`at it within other universes.
` Q Well, do you think it's arbitrary to
`look at Zytiga®'s market shares based on the mCRPC
`universe?
` A That's a reasonable starting place for
`Page 27
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`the analysis, but I would not end there.
` Q All right. Do you think that it's
`arbitrary to look at the Zytiga® market share
`within the mCRPC universe?
` A I think it's arbitrary without any
`further analysis to present the market shares in
`that particular space and not -- unless one has
`done the analysis to show that that's the relevant
`market, to not present the market shares in other
`spaces that could also be relevant.
` Q Was it wrong to look at Zytiga®'s
`market share in the mCRPC universe?
` A As I said, it wasn't wrong if that was
`part of a wider analysis that included
`profitability and included looking at other
`potential market definitions, that's a reasonable
`one to look at in addition, but not alone.
` Q Well, if we shouldn't be looking at
`the mCRPC market shares, what -- what is the
`relevant market that we should be evaluating
`Zytiga® in?
` A As I said, I haven't made the
`
`Page 28
`
`determination of what the relevant market is. I'm
`simply saying that Dr. Vellturo hasn't proven his
`case. And, you know, most notably, I'd say he
`hasn't proven his case because he doesn't analyze
`whether Zytiga® has been profitable.
` I also say that he has given a limited
`analysis of his -- of market share in particular
`because he only looks at the mPRPC [sic].
` Q Yeah, I'm not talking about
`profitability. I'm just talking about defining
`what the relevant market is for Zytiga®.
` Do you understand?
` A Yes.
` Q Okay. What's the relevant market we
`should be looking at if it's not the mCRPC market?
` A For example, in Dr. Vellturo's initial
`declaration, I can't remember if it's also in his
`reply, you know, he talked about market shares of
`something like 70 percent in the -- in the
`post-chemo segment of that mPRPC [sic] market, and
`that was misleading in the sense that the
`pre-chemo part of that market is much larger, and
`Page 29
`Pages 26 to 29
`202-232-0646
`
`

`

`4/21/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Robert Stoner
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Zytiga® has a much smaller share in that market.
` And so it was misleading to present
`the market shares in the post-chemo part of the
`market without discussing the fact that the market
`shares in the pre-chemo market were much smaller.
` Q So what's the best market definition
`that we should be looking at?
` A As I say, a reasonable starting place
`is the mPRPC [sic] market, but that doesn't mean
`that it's also -- as I discussed about the
`progression of the disease and the different
`choices, and the fact that as, you know, doctors
`say that a prostate cancer patient, in the course
`of the disease over time, will probably go through
`all the relevant drugs for prostate cancer.
` In that sense, it's also useful to
`look at the market share within a larger market,
`like prostate cancer market itself, where the
`market share is closer to 5 percent of Zytiga®.
`That gives one a context for where Zytiga® is in
`the universe of all the prostate cancer drugs.
` Q We agree that Zytiga® doesn't compete
`Page 30
`
`with all prostate drugs within the prostate cancer
`market, correct?
` A Those are not the -- all drugs in the
`prostate cancer market are not its primary
`competitors.
` Q Its primary competitors are within the
`mCRPC universe, correct?
` A One needs to be careful when one says
`the mPRPC [sic] universe, because it's not clear
`what drugs belong in the mPRPC [sic] universe.
` Janssen, in the exhibit that
`Dr. Vellturo uses to show market share, Janssen
`chooses various drugs. Some are antiandrogen
`drugs, some are chemotherapy drugs, some are --
`such as Xtandi®, which is I guess considered an
`antiandrogen. And it's not clear at all from that
`exhibit how and why Janssen chose the drugs it did
`within the mCRPC universe.
` So doing the market share analysis
`correctly involves first defining the market, and
`then defining who are the competitors within that
`market, which drugs are competing, and I have no
`Page 31
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`idea, and I don't think Dr. Vellturo does either,
`how and why Janssen chose some of those drugs and
`not others.
` Q But your starting point -- looking at
`the relevant market, the starting point is what
`drugs are in the mCRPC market, correct?
` A Right, but I just said that that's not
`an easy question. It could be many, many more
`drugs than Janssen put in that market in their IMS
`analysis that Dr. Vellturo depends on.
` Q But the relevant question is what
`drugs are competing in the mCRPC market, correct?
` A That would certainly be one of the
`factors I'd want to look at. And I'm simply
`saying that Dr. Vellturo hasn't convincingly
`discussed or provided evidence that he knows or
`that Janssen knows why it chose the drugs that he
`chose to put into that market in trying to come up
`with the market shares that Vellturo presents --
`Dr. Vellturo presents in his report.
` Q Well, are you -- in the first sentence
`of paragraph 12 of your reply declaration said
`Page 32
`
`that Dr. Vellturo's selection of the mCRPC market
`was arbitrary; isn't that right?
` A That sentence was meant to convey, by
`the