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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` WOCKHARDT BIO AG,
` Petitioner,
` vs. No. IPR2016-01582
` Patent 8,822,438
` JANSSEN ONCOLOGY, INC.,
` Patent Owner.
` ____________________________/
`
` VIDEOTAPED DEPOSITION OF ROBERT D. STONER, PH.D.
`
` San Francisco, California
`
` Friday, February 10, 2017
`
` Veritext Legal Solutions
` Mid-Atlantic Region
` 1250 Eye Street NW - Suite 350
` Washington, D.C. 20005
`
`REPORTED BY:
`LESLIE ROCKWOOD, RPR, CSR 3462
`Pages 1 - 121 Job No. 2538747
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`Veritext Legal Solutions
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`JANSSEN EXHIBIT 2160
`Wockhardt v. Janssen IPR2016-01582
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`

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`Page 4
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`1 I N D E X
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`FRIDAY, FEBRUARY 10, 2017
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`2 3 4
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`5 6
`
`WITNESS EXAMINATION
`7 ROBERT D. STONER, PH.D.
`
` BY MR. ZEGGER 7
`
`8 9
`
`10
`11 QUESTIONS WITNESS INSTRUCTED NOT TO ANSWER:
`12
`13 Page Line
`14 117 23
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`16
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`Page 2
`1 UNITED STATES PATENT AND TRADEMARK OFFICE
`2 BEFORE THE PATENT TRIAL AND APPEAL BOARD
`3
`
` WOCKHARDT BIO AG,
`
` Petitioner,
`
`4
`
`5
`
` vs. No. IPR2016-01582
`6 Patent 8,822,438
` JANSSEN ONCOLOGY, INC.,
`
`7
`
` Patent Owner.
`8 ____________________________/
`9
`10
`11 Videotaped deposition of ROBERT D. STONER, PH.D.,
`12 taken on behalf of the Patent Owner, at the offices of
`13 Sidley Austin LLP, 555 California Street, Suite 2000, San
`14 Francisco, beginning at 9:03 A.M. and ending at 12:50
`15 P.M., on Friday, February 10, 2017, before Leslie
`16 Rockwood, RPR, CSR No. 3462.
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`Page 3
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`Page 5
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`1 DEPOSITION EXHIBITS
`2 ROBERT D. STONER, PH.D.
`3 NUMBER DESCRIPTION IDENTIFIED
`4 Exhibit JSN 2012 PMLive, Top 50 104
`5 Pharmaceutical Products By
`6 global Sales, 2.1.17
`7 Exhibit JSN 2013 Johnson & Johnson Reports 105
`8 2015 Fourth-Quarter Results,
`9 1.26.16
`10 Exhibit JSN 2014 Johnson & Johnson Reports 106
`11 2016 Fourth-Quarter Results,
`12 1.24.17
`13
`14 PREVIOUSLY MARKED EXHIBITS REFERENCED:
`15
`16 EXHIBIT NUMBER PAGE
`17 Exhibit 1067 96
`18 Exhibit 1070 98
`19 Exhibit 1077 7
`20 Exhibit 1078 25
`21
`22
`23
`24
`25
`
`1 APPEARANCES:
`
`2 3
`
`FOR THE PETITIONER WOCKHARDT BIO AG:
`4 STERNE KESSLER GOLDSTEIN FOX
`5 BY: CHRISTOPHER M. GALLO, PH.D., ESQ.
`6 DENNIES VARUGHESE, PHARM.D., ESQ.
`7 1100 New York Avenue, N.W.
`8 Washington, D.C. 20005
`9 (202) 772-8868 (Dr. Gallo)
`10 (202) 772-8805 (Dr. Varughese)
`11 cgallo@skgf.com
`12 dvarughe@skgf.com
`13
`14 FOR THE PATENT OWNER JANSSEN ONCOLOGY, INC.:
`15 SIDLEY AUSTIN
`16 BY: PAUL J. ZEGGER, ESQ.
`17 1501 K Street N.W.
`18 Washington, D.C. 20005
`19 (202) 736-8060
`20 pzegger@sidley.com
`21
`22
`23 Also Present:
`24 Ramon Peraza, Videographer
`25
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`1 with the issue of commercial success as it relates to the
`2 issue of obviousness or non-obviousness of the '438
`3 patent?
`4 A. That's correct.
`5 Q. Your background is in economics; is that right?
`6 A. It is.
`7 Q. You're not offering any medical opinions?
`8 A. No, I'm not.
`9 Q. You wouldn't be qualified to do that; is that
`10 right?
`11 A. That's correct.
`12 Q. You're not offering any legal opinions; is that
`13 right?
`14 A. That's correct.
`15 Q. And you're not qualified to do so?
`16 A. Correct.
`17 Q. Could you look at your declaration pages 4 to 7,
`18 specifically the table of exhibits that you've
`19 identified?
`20 A. Yes.
`21 Q. Is that a list of the materials you considered
`22 for your declaration?
`23 A. That is a list of the materials I considered for
`24 my declaration, but I -- I also did a good deal of
`25 background reading and familiarizing myself with the
`
`Page 6
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`1 San Francisco, California; Friday, February 10, 2017
`2 9:03 A.M.
`
` PROCEEDINGS
`
`3 4
`
`5 6
`
` THE VIDEOGRAPHER: Good morning. We are on the
`7 record at 9:03 a.m. on February 10th, 2017. This is the
`8 videotaped deposition of Dr. Robert D. Stoner.
`9 My name is Ramon Peraza, here with our court
`10 reporter Leslie Rockwood. We are here from Veritext
`11 Legal Solutions at the request of counsel for the patent
`12 owner.
`13 This deposition is being held at Sidley in San
`14 Francisco. The caption of this case is Wockhardt Bio AG
`15 versus Janssen Oncology, Inc., Case Number IPR2016-01582.
`16 Please note that audio and video recording will
`17 take place unless all parties have agreed to go off the
`18 record. Microphones are sensitive and may pick up
`19 whispers or private conversations.
`20 At this time, Counsel, please identify
`21 yourselves for the record and state whom you represent.
`22 MR. ZEGGER: I'm Paul Zegger with Sidley Austin
`23 for the patent owner Janssen Oncology, Inc.
`24 MR. GALLO: I'm Christopher Gallo, here with me
`25 is Dennies Varughese, for the petitioner Wockhardt Bio
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`Page 7
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`Page 9
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`1 AG, represented by Sterne Kessler.
`2 THE VIDEOGRAPHER: The court reporter may now
`3 swear in the witness.
`4 THE REPORTER: If you'd raise your right hand,
`5 please, Dr. Stoner.
`6 You do solemnly state that the evidence you
`7 shall give in this matter shall be the truth, the whole
`8 truth and nothing but the truth, so help you God?
`9 THE WITNESS: I do.
`10 THE REPORTER: Thank you, sir.
`11 EXAMINATION
`12 BY MR. ZEGGER:
`13 Q. Good morning, sir.
`14 A. Good morning.
`15 Q. Let me put before you a document that has been
`16 previously marked as Wockhardt Exhibit 1077.
`17 Sir, do you recognize this as your declaration
`18 in the present IPR?
`19 A. I do.
`20 Q. Is that your signature on the last page?
`21 A. Yes, it is.
`22 Q. You signed your declaration on August 9th, 2016;
`23 is that right?
`24 A. Correct.
`25 Q. Now, is it correct that your declaration deals
`
`1 general area of prostate cancer.
`2 Q. Were the materials in your table of materials
`3 considered provided to you?
`4 A. They were -- there was an exchange between
`5 myself and the lawyers. I -- I -- you know, I mean, I
`6 wrote the draft of my report. It had certain citations
`7 in it, some of -- some of which were materials that I had
`8 gathered. Those went into this list. In some cases, I
`9 asked the attorneys for assistance in other citations
`10 where I didn't have a good citation for a particular
`11 proposition or where I felt I needed additional
`12 citations.
`13 So the list was -- was -- was begun in my --
`14 when I submitted a draft, and it had a list of all the --
`15 all the articles and citations that I was going to depend
`16 on, but that -- that list was -- was added to over time
`17 between the lawyers and myself.
`18 Q. Okay. Can you identify the exhibits that you
`19 found on your own?
`20 MR. GALLO: Objection. Privilege. I'm going to
`21 caution you not to divulge any information about what we
`22 discussed.
`23 THE WITNESS: Almost all of the exhibits are
`24 ones that I designated myself. There's a few exhibits
`25 here where there were -- where there was a legal citation
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`1 needed or a cite to a case that the lawyers provided.
`2 Much of this was provided to me initially in -- I -- I
`3 was able to take advantage of -- of the -- of some of the
`4 prior filings in the Amerigen proceeding, and so that was
`5 provided to me initially, and I indicated which of those
`6 I was depending on in -- in putting forward this report.
`7 Q. BY MR. ZEGGER: And in the process of putting
`8 together your declaration, you looked at the materials
`9 that had been filed in the Amerigen earlier IPR on the
`10 same '438 patent?
`11 A. Yes. I mean, I don't know that I looked at all
`12 the materials. But I -- I looked at a good -- good
`13 amount of those materials.
`14 Q. Did you also look at materials that had been
`15 filed in the context of a Mylan IPR, also on the
`16 '438 patent?
`17 A. I did look at a few things in -- in that. I
`18 looked at the -- I believe I looked at the expert report
`19 of -- of -- I'm forgetting his name.
`20 Q. Okay. Could you look at your declaration,
`21 page 3, Footnote 1? Are you there?
`22 A. Yes, I am.
`23 Q. Now, that mentions a declaration of
`24 Deforest McDuff in IPR brought by Amerigen; is that
`25 right?
`
`Page 12
`1 Q. Have you compared your declaration to that of
`2 Dr. McDuff's to see if any portions are the same or
`3 substantially the same?
`4 A. I have not done such a comparison. But I've
`5 noted that there -- there are certain elements of the
`6 Amerigen record or the public record that made their way
`7 into my declaration that were also in his.
`8 Q. Now, Footnote 1 in your declaration also
`9 mentions a declaration of Ivan Hofmann, filed by Mylan,
`10 in IPR 2016-01332; is that right?
`11 A. Correct. That's -- that's the gentleman. I was
`12 trying to remember his name a minute ago.
`13 Q. Okay. Did you also review the declaration of
`14 Mr. Hofmann in the Mylan IPR?
`15 A. I -- I do remember reading it, yes.
`16 Q. Okay. Do you understand that Mr. Hofmann was
`17 someone hired by Mylan?
`18 A. I do understand that.
`19 Q. Did you talk to Mr. Hofmann about his
`20 declaration for Mylan?
`21 A. I did not.
`22 Q. Did you rely upon Mr. Hoffman's declaration in
`23 forming your opinions set forth in your declaration?
`24 A. Again, no more so than any other of the
`25 materials that I relied on in putting together my
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`Page 11
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`Page 13
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`1 A. Correct.
`2 Q. And, specifically, Footnote 1 in your
`3 declaration states, quote, "I reviewed the McDuff
`4 declaration," close quote; is that right?
`5 A. Correct.
`6 Q. Did you, in fact, review Dr. McDuff's
`7 December 4th, 2015, declaration in IPR 2016-00286?
`8 A. I believe I did.
`9 Q. Is it your understanding that Dr. McDuff is an
`10 economist hired by Amerigen?
`11 A. I believe that's my understanding.
`12 Q. Okay. Did you rely upon Dr. McDuff's
`13 declaration in forming your opinions set forth in your
`14 declaration?
`15 A. I wouldn't say I relied on it. But I -- I
`16 certainly looked at it and considered the elements of
`17 what he had said. And then I went -- went about the
`18 business of putting down my own opinion.
`19 Q. Okay. But to some extent, it played a part in
`20 forming your opinions?
`21 A. Not any more than any other material that I
`22 considered.
`23 Q. Did you talk to Dr. McDuff about his declaration
`24 for Amerigen?
`25 A. I did not, no.
`
`1 opinion.
`2 Q. Well, to some extent you relied upon it?
`3 A. I mean, I considered it.
`4 Q. Have you compared your declaration to that of
`5 Mr. Hoffman's to see if any portions are the same or
`6 substantially the same?
`7 A. I have not done a direct comparison, no.
`8 Q. Would you be surprised if portions of your
`9 declaration are identical to those in Dr. McDuff's or
`10 Mr. Hoffman's declarations?
`11 A. I -- I wouldn't be surprised if there were
`12 certain similarities, since we were dealing with the same
`13 issues. And it appears that we came to the same
`14 conclusions independently.
`15 Q. Have you read the depositions taken of
`16 Dr. McDuff or Mr. Hofmann?
`17 A. I believe I've read two depositions of
`18 Dr. McDuff, because I think he just supplied a second
`19 report more recently. And I don't remember reading the
`20 deposition of -- of Mr. Hofmann. But I might have.
`21 Q. When were you first retained to work on this
`22 IPR?
`23 A. I think it was sometime in June or July of 2016.
`24 Q. So about a month or two before you signed your
`25 declaration?
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`1 A. A couple of months, I believe.
`2 Q. What were you asked to do?
`3 A. I was asked to consider the -- the commercial
`4 success issues in conjunction with obviousness or
`5 non-obviousness of the '438 patent.
`6 Q. How much time did you spend as of the date of
`7 your declaration, August 9th, 2016?
`8 A. I think I spent somewhere between 50 and
`9 100 hours in -- in putting together the report and
`10 gaining an understanding of -- of the market.
`11 Q. Did anyone help you?
`12 A. In my firm, for example?
`13 Q. Well, just -- in the entire context of putting
`14 together your declaration in this case, did anyone assist
`15 you?
`16 A. No. I -- I put together the declaration. It
`17 was -- you know, I -- I submitted a draft to the lawyers.
`18 They made some comments. I submitted another draft and
`19 went through that process. So in that sense, it was a --
`20 there was a process in putting it together. But I didn't
`21 rely on anybody else in -- in my firm, other than
`22 potentially having a brief conversation with something --
`23 somebody about an issue.
`24 Q. Well, do you recall what that issue was?
`25 A. Not really.
`
`Page 15
`1 Q. Now, as part of your assignment, were you asked
`2 to do an independent evaluation of the commercial success
`3 of the '438 patented invention?
`4 A. I believe I -- I answered that. Yes.
`5 Q. What criteria did you use to determine
`6 commercial success?
`7 MR. GALLO: Objection. Form.
`8 THE WITNESS: Well, commercial success is a --
`9 is a legal construct that -- that, you know,
`10 patentholders sometimes would forward as a -- as a
`11 secondary indicia of -- of non-obviousness.
`12 And though the -- the legal assumption is that
`13 if there's some degree of marketing success of the
`14 product, and, furthermore, that the -- there's an excess
`15 between the novel aspects of the patent and the product's
`16 success, that the fact that a third party didn't come
`17 forward with the innovation before the patentholder, in
`18 certain situations can be an indicator of
`19 non-obviousness.
`20 So my -- my -- my goal was to test that
`21 assumption and to provide a full analysis of whether that
`22 inference made sense or not.
`23 And so in -- in trying to determine whether that
`24 inference made sense, I looked at a number of issues.
`25 The first issue being whether one could say there was a
`
`1 marketing success to start with, whether the product
`2 was -- was likely profitable. And whether a third party
`3 in the position of trying to evaluate whether -- to
`4 undertake the innovation back before the patent was
`5 filed, whether that third party would have viewed the --
`6 the innovation as being a profitable opportunity. That
`7 was the first part of my analysis.
`8 Then the next part was to say, "Okay. Well,
`9 even if there was a profitable opportunity, was it in any
`10 way connected to a novel aspect of the patent?" Because
`11 if it wasn't, then it was a profitable opportunity, but
`12 it wasn't -- it wasn't dependent on any innovation that
`13 was non-obviousness.
`14 And then the third thing I looked at was whether
`15 there were any other impediments to a third party
`16 innovating before the -- back before the patent came
`17 forward.
`18 Was there -- were there any other impediments
`19 besides potential non-obviousness that would explain why
`20 a third party didn't come forward with that innovation at
`21 the same time or before the patentholder?
`22 And the things I looked at there were things
`23 such as: Were there blocking patents? Were there --
`24 were there strategic asymmetries between the position of
`25 the patentholder, Janssen, and a potential third party
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`Page 17
`1 that would explain why Janssen might have come forward
`2 with the -- with the innovation but the third party would
`3 not, besides a non-obviousness?
`4 And, finally, I looked at whether there were
`5 different -- there was -- another obstacle could be
`6 potential difference in the risks that were seen and the
`7 rewards that were seen of coming forward with the
`8 innovation at that time -- at the earlier time that would
`9 explain why the innovation didn't come forward, but that
`10 it may be -- but that Janssen developed it later.
`11 So that was -- that was pretty much the scope of
`12 what I was looking at.
`13 Q. BY MR. ZEGGER: And we'll talk about all of
`14 those as -- as we go on. I wanted to focus on the time
`15 frame before you looked at any documents in the context
`16 of this case, right when you took on the assignment.
`17 A. Yes.
`18 Q. Did you have any preexisting metrics for sales
`19 that would constitute for commercial success?
`20 A. Based on my experience in dealing with the
`21 commercial success in prior cases? Is that what you're
`22 asking? Because you're saying I didn't know anything
`23 about this case.
`24 Q. Right. I'm just wondering, before you looked at
`25 the evidence that -- that you evaluated in the context of
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`1 this case, whether you had a preexisting metric for sales
`2 as a measure of commercial success.
`3 A. Yeah, I think -- so I think I indicated, when I
`4 went through that long description of how I viewed what I
`5 was going to do in this case, that I had a preexisting
`6 view on this, which is that any one measure of success,
`7 whether it's sales or market share or profitability or
`8 trends in market share or whatever, you know, all of
`9 those are in the service of trying to determine whether
`10 there would have been an incentive, a profitable
`11 incentive, for a third party to develop the innovation at
`12 an earlier time.
`13 And so I would want to look at all those
`14 factors. But most importantly I would want to look at
`15 whether the -- whether there was a profitable
`16 opportunity. And one way to try to determine whether
`17 there was a profitable opportunity is to look at the
`18 degree of success of the patentholder in coming out
`19 with -- in coming out with a product. And so that would
`20 be my metric.
`21 I -- I would want to know not did it have a lot
`22 of sales, although that would be one aspect of what I
`23 would be interested in. I'd want to know not did it have
`24 a big market share, but did it -- did it present a
`25 profitable opportunity that actually panned out for
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`Page 19
`1 the -- for the patentholder? And so that -- that would
`2 have been my metric.
`3 And as we can talk about later, I found the
`4 record to be highly missing in terms of that -- that kind
`5 of -- in terms of the raw materials to analyze the
`6 profitability, for example.
`7 Q. Well, you've mentioned profitability a number of
`8 times. Can -- can sales of a drug product be evidence of
`9 commercial success in a patent context?
`10 A. It depends. I mean, you could have sales --
`11 high sales of a product that is highly profitable and --
`12 because when you look at the development costs, when you
`13 look at the R&D costs, when you look at the costs of
`14 getting through the FDA regulation, and then you look at
`15 the operating costs of manufacturing, distributing and --
`16 and marketing the drug, it's -- it's possible that if it
`17 had high sales it could also be profitable.
`18 But it's also possible that sales would be a
`19 misleading indicator of -- of profitability.
`20 Particularly if the level of sales is, let's say, only a
`21 half. Let's say it's a large amount of sales. But let's
`22 say it's only half of what the firm initially forecast
`23 its sales levels would be. Then I would say sales
`24 probably wouldn't be a very good indicator of
`25 profitability.
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`Page 20
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`1 But, unfortunately, in the record in this case,
`2 we have no idea what Janssen was forecasting as the, sort
`3 of, sales level that they expected to get and that
`4 presumably they decided was enough to assure
`5 profitability.
`6 We have no idea -- or at least I have no idea,
`7 based on the record, of whether Janssen, you know,
`8 achieved the sales level that -- that it was expecting.
`9 Because I haven't seen any forecasts of what -- of what
`10 they expected to -- to -- the sales level they expected.
`11 I haven't seen any profitability forecasts.
`12 And I don't know whether it was a close call for
`13 Janssen to bring forth product in terms of other
`14 investment opportunities they might have had. I don't
`15 know whether the sales level they achieved was
`16 significantly below or at or above the level they
`17 expected to achieve.
`18 Q. What's your understanding of what the record is
`19 in -- in this Wockhardt IPR?
`20 A. The record with respect to what?
`21 Q. You mentioned what -- what's in the record.
`22 What is your understanding of what is in the record?
`23 A. There is -- there is -- with respect to the
`24 issue of how successful this product was, what's in the
`25 record is evidence on sales and market share.
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`Page 21
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`1 Q. Okay. Can evidence of sales be relevant in
`2 determining commercial success?
`3 A. It depends. That's the --
`4 Q. Can sales alone demonstrate commercial success?
`5 A. I'd want to see much more than indications of
`6 what the sales were. At the very least, I'd want to know
`7 what the level of sales that was forecast was and how
`8 that compared to the actual level of sales.
`9 Because, presumably, if -- if the actual level
`10 is below the forecast level, you know, one -- one
`11 could -- even if it's a large amount of sales. If it's
`12 below forecast, there is a possibility that the -- that
`13 the investment wasn't profitable.
`14 Q. Can sales alone demonstrate commercial success?
`15 MR. GALLO: Objection. Asked and answered.
`16 THE WITNESS: I -- I stand with my answer, which
`17 is no.
`18 Q. BY MR. ZEGGER: Can market share alone
`19 demonstrate commercial success?
`20 A. The same answer, which is basically that --
`21 looked at by itself, market share isn't enough to tell
`22 you whether the -- the innovation was successful in the
`23 sense that it would provide an incentive for a third
`24 party to develop it.
`25 We have to know what the expectations were of
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`1 market share before the fact and how those relate to what
`2 market share was actually achieved.
`3 And -- and, additionally, we'd have to know
`4 whether -- for example, if the market share is only
`5 achieved by pricing that is lower than they expected to
`6 price, because they found that there's more competition
`7 and they had to lower the price or give discounts, then
`8 market share by itself isn't going to tell you that much.
`9 Because if you have to achieve the market share by making
`10 sales that are not as profitable as you expected -- by
`11 making -- by having prices not as profitable as you
`12 expected, the market share by itself doesn't -- doesn't
`13 tell you enough.
`14 Q. Do you know what this IT of cumulative sales
`15 have been since the launch through the end of 2016?
`16 A. You're talking about US sales or worldwide
`17 sales?
`18 Q. Let's talk about US sales.
`19 A. I don't know the exact figure. But I know that
`20 it's in the billions of dollars.
`21 Q. Do you know approximately how many billions?
`22 A. Well, I know that they had about a billion
`23 dollars of sales in 2015, about -- you know, working
`24 their way up from 3 or 400,000 to 300 or 400 million to a
`25 billion in the previous three or four years. So, you
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`Page 24
`1 50 percent above what net sales are, so -- but I can add
`2 up those figures. As I said, they -- you know, they add
`3 up to something more than $2 billion.
`4 Q. All right. Now, the numbers you're talking
`5 about are coming from Attachment B2 of your declaration;
`6 is that right?
`7 A. Correct.
`8 Q. And you chose to report the gross sales in this
`9 attachment, Attachment B2?
`10 A. That's correct.
`11 Q. And the -- the numbers that you have here in
`12 Attachment B2 for Zytiga gross sales are through the
`13 first half of 2015; is that --
`14 A. Correct.
`15 Q. Okay. Did you update those numbers?
`16 A. I did not.
`17 Q. Is that something that you could have done
`18 either by, you know, looking at the IMS data or looking
`19 at information that J&J provides?
`20 MR. GALLO: Objection. Form.
`21 THE WITNESS: Could I have updated these
`22 numbers?
`23 Q. BY MR. ZEGGER: Correct.
`24 A. I'm not sure whether I had access to the updated
`25 IMS data. If I had access to it, I could have presumably
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`Page 25
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`1 know, you can add that up and -- and figure that it's
`2 getting close to more than -- probably more than
`3 $2 billion.
`4 Q. Okay. Does the -- the total cumulative sales of
`5 Zytiga, from the time it was launched through the end of
`6 last year, does that matter to you in terms of your
`7 analysis?
`8 MR. GALLO: Objection. Form.
`9 THE WITNESS: I mean, you're asking me, again,
`10 whether it's sales alone. Haven't we been through that
`11 one?
`12 Q. BY MR. ZEGGER: Well, is it correct that you
`13 haven't determined the cumulative Zytiga sales?
`14 A. I -- I think I told you that I -- I could add up
`15 those figures and --
`16 Q. Have you added them up?
`17 A. Sure. I just -- you know, it -- what they -- I
`18 don't have the numbers in front of me. I can look at
`19 my -- you know, it says the total here in Exhibit B2 is
`20 $2.8 billion in gross sales.
`21 Now, that doesn't tell me what net sales are.
`22 So that gross sales figure is before discounts and before
`23 couponing and other kinds of -- you know, other price
`24 reductions that -- so I don't know what net sales are.
`25 Gross sales are -- can sometimes be 30, 40,
`
`1 updated those numbers.
`2 Q. Well, is it fair to say that through the end of
`3 2016, the US gross sales of Zytiga are substantially in
`4 excess of the $2.8 million that you report --
`5 A. Billion; right?
`6 Q. Billion.
`7 A. Correct.
`8 Q. Let me show you what has been previously
`9 identified in this IPR as Wockhardt 1078 (indicating).
`10 Sir, is this your CV?
`11 A. It is.
`12 Q. Does it contain a list of public -- of your
`13 publications?
`14 A. It does.
`15 Q. Are any of your publications on the topic of
`16 patent damages?
`17 A. I don't believe that any of my publications are
`18 directly on the issue of patent damages.
`19 Q. Are there any of your listed publications in
`20 your CV on the topic of commercial success as indicia of
`21 non-obviousness?
`22 A. None of my publications are specifically on that
`23 topic. Although, as I indicated in my earlier answer,
`24 the -- the commercial success doctrine is a legal
`25 construct that economists can discuss in the context
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`1 of -- of looking at whether the inferences that that test
`2 suggests makes sense in an economic context.
`3 So I would be bringing my economic expertise to
`4 bear on what is a legal construct.
`5 Q. Now, is it fair to say that you -- you've
`6 published a number of articles relating to antitrust?
`7 A. Correct.
`8 Q. Is that your main area of expertise?
`9 A. That's certainly one of my areas of expertise.
`10 I started my career at the Federal Trade Commission
`11 working on antitrust. But I also worked on IP matters
`12 when I was there.
`13 Q. When you were at the FTC, what did you do in
`14 connection with patent matters?
`15 MR. GALLO: Objection. Form.
`16 THE WITNESS: The FTC was -- I mean, I'm not
`17 really at -- at liberty to divulge all the work I did.
`18 But I think it's publicly known that the FTC was looking
`19 at the -- the conduct of patentholders who submitted
`20 their patents to a standard-setting organization and --
`21 and then were subsequently asked to license the patents
`22 at what's called a FRAND rate. And there were -- there
`23 were allegations that the patent licensing was holding up
`24 potential implementers and the FTC was looking into those
`25 allegations in a number of matters. And I was involved
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`1 in all of those.
`2 Q. BY MR. ZEGGER: When was that?
`3 A. That was in the -- in the 1980s. I was also --
`4 after I left the FTC and started working in the private
`5 sector -- because I worked on those issues at the FTC, I
`6 was -- I appeared a number of times before the FTC in --
`7 in conjunction with those issues.
`8 Q. And by "those issues," are you referring to
`9 generally the -- the idea of patents being used to -- to
`10 hold up players in -- in a particular industry?
`11 A. Correct. The general issue of -- and what were
`12 the obligations of a patentholder that was submitting his
`13 patent to the standards organization?
`14 Q. Have -- have you ever been an expert on a matter
`15 directed to determining patent infringement damages?
`16 A. Have I actually testified or -- I -- I worked on
`17 matters.
`18 Q. Okay. Have you ever testified in a matter on --
`19 A. But I have not testified.
`20 Q. Have you worked as an expert in -- in a matter
`21 specifically addressed to determining commercial success
`22 or lack thereof in the context of an obviousness
`23 determination?
`24 A. I've worked on many, many of those cases, yes.
`25 Q. Okay. Can you give us an estimate of how many?
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`1 A. At least six or seven.
`2 Q. Are those six or seven cases identified in your
`3 CV?
`4 A. I'm not sure if they are. Would you like to
`5 point me to what you think is --
`6 Q. I don't know. That's why I'm asking.
`7 A. Okay.
`8 Q. So you -- you don't think that those specific
`9 six or seven instances are identified in your CV?
`10 A. I was not the testifying expert on those cases.
`11 Q. Okay.
`12 A. So I've only listed matters I worked on -- or
`13 mostly I've listed matters I've worked on that -- where
`14 I've testified.
`15 I believe I indicated, in conjunction with the
`16 section called "Specific industry expertise in
`17 pharmaceuticals, medical devices and drug wholesaling" --
`18 do you see that section starting on page 7.
`19 Q. Page 7?
`20 A. And if you see the -- the last matter -- the
`21 last indication there at the bottom of the page, "2008 to
`22 present."
`23 Do you see that?
`24 Q. Yes.
`25 A. And it says, "Consulting economists on behalf of
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`Page 29
`1 generic drug companies in multiple Hatch-Waxman related
`2 cases involving issues of commercial success, irreparable
`3 harm and public interest."
`4 So that covers what I was just talking to you
`5 about.
`6 Q. Those were the six or seven times?
`7 A. Correct.
`8 Q. Okay. Is it correct that you didn't actually
`9 testify in any of those six or seven matters?
`10 A. That's correct.
`11 Q. Okay. So this is your first time testifying in
`12 a matter relating to commercial success?
`13 A. I was the testifying expert in several of these
`14 cases that didn't go to -- the full distance. And so I
`15 wrote a report. And the cases settled, and so I didn't
`16 testify.
`17 Q. In those six or seven matters that y