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DeForest McDuff, Ph.D.
`
` 1 UNITED STATES PATENT AND TRADEMARK OFFICE
`
` 2 BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` 3 --------------------------------
`
` 4 AMERIGEN PHARMACEUTICALS LIMITED,
`
` 5 ARGENTUM PHARMACEUTICALS LLC,
`
` 6 Petitioner
`
` 7 v.
`
` 8 JANSSEN ONCOLOGY, INC.
`
` 9 Patent Owner
`
` 10 --------------------------------
`
` 11 Case IPR2016-00286
`
` 12 Patent No. 8,822,438 B2
`
` 13 --------------------------------
`
` 14
`
` 15 VIDEO DEPOSITION OF DEFOREST MCDUFF, PH.D.
`
` 16
`
` 17 Crowell & Moring LLP
`
` 18 1001 Pennsylvania Avenue NW
`
` 19 Washington, DC 20004
`
` 20 January 18, 2017 9:09 a.m.
`
` 21
`
` 22 Denise D. Vickery, CRR/RMR
`
` 23 GOLKOW TECHNOLOGIES, INC.
`
` 877.370.3377 ph | 917.591.5672 fax
`
` 24 deps@golkow.com
`
`Golkow Technologies, Inc.
`
`Amerigen Exhibit 1191
`Amerigen v. Janssen IPR 2016-00286
`
`Page 1
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`

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`DeForest McDuff, Ph.D.
`
` 1 A P P E A R A N C E S
`
` 2
`
` 3 Attorneys for Petitioner:
`
` 4 McNEELY, HARE & WAR LLP
`
` 5 5335 Wisconsin Avenue NW
`
` 6 Suite 440
`
` 7 Washington, DC 20015
`
` 8 202.253.4903
`
` 9 BY: RENITA S. RATHINAM, ESQ.
`
` 10 rathinam@miplaw.com
`
` 11
`
` 12
`
` 13 Attorneys for Patent Owner:
`
` 14 SIDLEY AUSTIN LLP
`
` 15 1501 K Street NW
`
` 16 Washington, DC 20005
`
` 17 202.736.8060
`
` 18 BY: PAUL J. ZEGGER, ESQ.
`
` 19 pzegger@sidley.com
`
` 20
`
` 21
`
` 22 Also Present:
`
` 23 Michael Gay, Videographer
`
` 24
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`Golkow Technologies, Inc.
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`DeForest McDuff, Ph.D.
`
` 1 I N D E X
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` 2 EXAMINATION OF
`
` 3 DEFOREST MCDUFF, PH.D. PAGE
`
` 4 BY MR. ZEGGER 5
`
` 5
`
` 6
`
` 7 E X H I B I T S
`
` 8
`
` 9 PREVIOUSLY MARKED EXHIBITS REFERENCED
`
` 10 AMERIGEN 1152 Declaration of 5
`
` 11 DeForest McDuff, Ph.D.
`
` 12 AMERIGEN 1005 U.S. Patent No. 5,604,213 56
`
` 13 Barrie, et al.
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` 14
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` 15
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` 16
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` 17
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` 19
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`DeForest McDuff, Ph.D.
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` 1 P R O C E E D I N G S
`
` 2 - - -
`
` 3 THE VIDEOGRAPHER: We are on the
`
` 4 record. The time now is 9:09.
`
` 5 This marks the beginning of disk
`
` 6 No. 1 for the videotaped deposition
`
` 7 testimony of DeForest McDuff Ph.D. in the
`
` 8 matter of Amerigen Pharmaceutical
`
` 9 Limited, et al. versus Janssen Oncology,
`
` 10 Inc. This case is pending in the United
`
` 11 States Patent and Trademark Office, Case
`
` 12 No. IPR2016-00286.
`
` 13 Today's date is January 18, 2017.
`
` 14 This deposition is being conducted at 10
`
` 15 -- 1001 Pennsylvania Avenue, Northwest,
`
` 16 Washington, DC.
`
` 17 Will all attorneys present please
`
` 18 identify themselves and who they
`
` 19 represent.
`
` 20 MR. ZEGGER: I'm Paul Zegger with
`
` 21 Sidley Austin for the Patent Owner,
`
` 22 Janssen Oncology, Inc.
`
` 23 MS. RATHINAM: I am Renita
`
` 24 Rathinam with McNeely, Hare & War and I
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`DeForest McDuff, Ph.D.
`
` 1 am patent counsel or counsel for
`
` 2 Petitioner, Amerigen Pharmaceuticals
`
` 3 Limited.
`
` 4 THE VIDEOGRAPHER: My name is
`
` 5 Michael Gay. I'm with Golkow
`
` 6 Technologies. Our court reporter today
`
` 7 is Denise Vickery also with Golkow
`
` 8 Technologies and will now swear in our
`
` 9 witness.
`
` 10 - - -
`
` 11 DEFOREST MCDUFF, PH.D.
`
` 12 called for examination, and, after having been
`
` 13 duly sworn, was examined and testified as
`
` 14 follows:
`
` 15 EXAMINATION
`
` 16 THE VIDEOGRAPHER: You may
`
` 17 proceed.
`
` 18 BY MR. ZEGGER:
`
` 19 Q. Sir, let me show you a document.
`
` 20 It's entitled "Declaration of DeForest McDuff,
`
` 21 Ph.D." and it is Amerigen Exhibit 1152 and just
`
` 22 let me ask you whether you recognize that as
`
` 23 your reply declaration in the present IPR.
`
` 24 A. (Witness reviewing document).
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`DeForest McDuff, Ph.D.
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` 1 It appears to be, yes.
`
` 2 Q. And is that your signature on the
`
` 3 last page?
`
` 4 A. It is.
`
` 5 Q. When did you sign it?
`
` 6 A. January 16th of this year.
`
` 7 Q. You signed it on this past
`
` 8 Monday?
`
` 9 A. Yes.
`
` 10 Q. You also signed a previous
`
` 11 declaration in this IPR back in December of
`
` 12 2015; is that right?
`
` 13 A. Yes.
`
` 14 Q. Now, is it correct that your
`
` 15 declarations generally deal with the issue of
`
` 16 commercial success as it relates to the issue of
`
` 17 obviousness or non-obviousness of the '483
`
` 18 patent in this case?
`
` 19 A. I believe you said '483 patent.
`
` 20 The '438 patent, but generally, yes.
`
` 21 Q. '438.
`
` 22 Okay. Do you agree that
`
` 23 commercial success is relevant to the
`
` 24 determination of a patent's obviousness?
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`DeForest McDuff, Ph.D.
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` 1 A. It depends. It's one factor that
`
` 2 may be taken into account, depending on the
`
` 3 circumstances.
`
` 4 Q. Could you look at paragraph 5 of
`
` 5 your reply declaration to the second sentence.
`
` 6 Are you there?
`
` 7 A. Yes.
`
` 8 Q. Okay. In the second sentence,
`
` 9 you state:
`
` 10 "I understand that commercial
`
` 11 success is relevant to the determination of a
`
` 12 patent's obviousness."
`
` 13 Do you see that?
`
` 14 A. Yes.
`
` 15 Q. Is that your understanding?
`
` 16 A. It is, with the explanation that
`
` 17 sometimes it's applicable and sometimes it's not
`
` 18 applicable. It's one factor that's taken into
`
` 19 consideration.
`
` 20 Q. Is it also your understanding
`
` 21 that the law presumes that an idea would have
`
` 22 been brought to market sooner in response to
`
` 23 market forces had it been obvious to a person --
`
` 24 to persons skilled in the art?
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`DeForest McDuff, Ph.D.
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` 1 A. That's my understanding of the
`
` 2 purpose behind commercial success or the ability
`
` 3 to make an inference from commercial success.
`
` 4 Q. Now, is it your understanding
`
` 5 that commercial success of an invention can be
`
` 6 due to a combination of elements found in the
`
` 7 prior art?
`
` 8 MS. RATHINAM: Objection to form.
`
` 9 THE WITNESS: Would you mind just
`
` 10 repeating the question, please?
`
` 11 (The reporter read the record on
`
` 12 page 8 lines 4-7.)
`
` 13 THE WITNESS: I'm not seeking to
`
` 14 provide a legal opinion on that, but my
`
` 15 understanding is that it could. It
`
` 16 depends what the claimed invention was.
`
` 17 BY MR. ZEGGER:
`
` 18 Q. From an economic standpoint, is
`
` 19 it your understanding that the commercial
`
` 20 success of a product might be due to a
`
` 21 combination of elements that are individually
`
` 22 found in the prior art?
`
` 23 A. From an economic perspective,
`
` 24 that could be. It depends on the situation.
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`DeForest McDuff, Ph.D.
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` 1 Q. Okay. One example might be the
`
` 2 iPhone which is a combination of things that
`
` 3 were previously in the prior art?
`
` 4 MS. RATHINAM: Objection to form.
`
` 5 Outside the scope.
`
` 6 THE WITNESS: It would depend on
`
` 7 the circumstance. I'm not providing
`
` 8 opinions with respect to iPhones here.
`
` 9 BY MR. ZEGGER:
`
` 10 Q. Okay. Well, another more
`
` 11 pertinent example is a combination drug where
`
` 12 the individual elements were found in the prior
`
` 13 art, but the success is due to the combination
`
` 14 of those features; correct?
`
` 15 A. That's one example that's
`
` 16 possible. It depends on the circumstances.
`
` 17 Q. Okay. Well, I'm asking these
`
` 18 questions in the context of your last sentence
`
` 19 of paragraph 6 of your reply declaration.
`
` 20 Could you take a look at that?
`
` 21 A. I'm there.
`
` 22 Q. Okay. There you say:
`
` 23 "Finally, I understand that if
`
` 24 commercial success is due to an element in the
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`DeForest McDuff, Ph.D.
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` 1 prior art, no nexus exists."
`
` 2 Do you see that?
`
` 3 A. Yes.
`
` 4 Q. Okay. Does that apply even if
`
` 5 the success of the product is due to the
`
` 6 combination of features that are found in the
`
` 7 prior art?
`
` 8 A. Well, the exercise of evaluating
`
` 9 a connection or nexus from an economic
`
` 10 perspective is to evaluate the alleged
`
` 11 innovative aspects of the patents-in-suit
`
` 12 relative to what existed in prior art or
`
` 13 relative to nonnovel elements. So that's what
`
` 14 I'm trying to convey here.
`
` 15 Q. Okay. And the novel aspects
`
` 16 could be the combination of individual elements
`
` 17 found in the prior art; correct?
`
` 18 A. That's my understanding. Yes, it
`
` 19 could be.
`
` 20 Q. What's your understanding of the
`
` 21 alleged innovative features in the '438 patent
`
` 22 here at issue?
`
` 23 A. Of course I would defer to others
`
` 24 on technical aspects, but my understanding is
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`DeForest McDuff, Ph.D.
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` 1 that it relates to the combination of
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` 2 abiraterone and prednisone in the treatment of
`
` 3 prostate cancer.
`
` 4 Q. Now, as part of your assignment
`
` 5 in this case, were you asked to do an
`
` 6 independent evaluation of the commercial success
`
` 7 of the '438 patent, patented invention?
`
` 8 MS. RATHINAM: Objection to form.
`
` 9 THE WITNESS: It depends what you
`
` 10 mean by that.
`
` 11 I did provide independent
`
` 12 evaluation, yet my opinions are directed
`
` 13 at responding to the claims made by
`
` 14 Dr. Vellturo in the Vellturo declaration.
`
` 15 BY MR. ZEGGER:
`
` 16 Q. All right. Well, that was my
`
` 17 question.
`
` 18 Whether you were asked in this
`
` 19 case to just respond to Dr. Vellturo or whether
`
` 20 you were asked to do an independent assessment
`
` 21 of the level of commercial success of the
`
` 22 patented invention at issue in this case.
`
` 23 A. Well, what I was trying to convey
`
` 24 in the previous response is, it depends what you
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`DeForest McDuff, Ph.D.
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` 1 mean by "independent." Certainly my analysis
`
` 2 was independent. I provided my opinions here,
`
` 3 yet my opinions were limited to reviewing and
`
` 4 responding to the opinions set forth in
`
` 5 Dr. Vellturo's declaration as opposed to
`
` 6 providing a separate conclusion or determination
`
` 7 on commercial success.
`
` 8 Q. Okay. Well, did you do a
`
` 9 separate determination of commercial success,
`
` 10 you know, separate and apart from critiquing
`
` 11 Dr. Vellturo?
`
` 12 MS. RATHINAM: Objection to form.
`
` 13 THE WITNESS: Well, I explained
`
` 14 that more fully in my previous response.
`
` 15 My opinions were limited to
`
` 16 reviewing and responding to Dr. Vellturo.
`
` 17 I did not provide a separate conclusion
`
` 18 of commercial success.
`
` 19 BY MR. ZEGGER:
`
` 20 Q. Okay. Well, were you asked to do
`
` 21 so?
`
` 22 A. No.
`
` 23 Q. Were you asked to evaluate the
`
` 24 absolute success of Zytiga?
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`DeForest McDuff, Ph.D.
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` 1 A. What do you mean by "absolute
`
` 2 success"?
`
` 3 Q. Okay. Well, I'm using that term
`
` 4 as you used that term in paragraph 9 of your
`
` 5 declaration.
`
` 6 A. Okay. I see that.
`
` 7 Q. Okay. Do you see in paragraph 9
`
` 8 of your reply declaration that you referred to
`
` 9 the term "absolute success"?
`
` 10 A. Yes.
`
` 11 Q. And by that you have a
`
` 12 parenthetical you're referring to the sales or
`
` 13 profitability of a product?
`
` 14 A. Yes.
`
` 15 Q. Okay. Using that definition that
`
` 16 you used in paragraph 9 of your reply
`
` 17 declaration, did you -- were you asked to
`
` 18 evaluate the absolute success of Zytiga?
`
` 19 A. Well, I would not describe it
`
` 20 that way.
`
` 21 I was asked to review and respond
`
` 22 to the opinions set forth by Dr. Vellturo. As
`
` 23 described here in paragraph 9, he's not provided
`
` 24 sufficient evidence of absolute success or
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`DeForest McDuff, Ph.D.
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` 1 relative success.
`
` 2 Q. Okay. Were you asked to -- to
`
` 3 assess that on your own?
`
` 4 MS. RATHINAM: Objection. Asked
`
` 5 and answered.
`
` 6 THE WITNESS: I tried to convey
`
` 7 this in my previous response. I'm not
`
` 8 sure how else to convey it. I'm happy to
`
` 9 try to answer it again.
`
` 10 BY MR. ZEGGER:
`
` 11 Q. Well, you used the term "absolute
`
` 12 success" in paragraph 9 of your reply
`
` 13 declaration; right?
`
` 14 A. Yes.
`
` 15 Q. And by that you referred to the
`
` 16 sales and profitability of the product?
`
` 17 A. Yes.
`
` 18 Q. Okay. Did you do an assessment
`
` 19 of the profitability of Zytiga?
`
` 20 A. I did not provide a separate
`
` 21 conclusion on Zytiga's absolute success or
`
` 22 profitability because that information was not
`
` 23 provided by Dr. Vellturo or Janssen.
`
` 24 That's one of the points that I'm
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`DeForest McDuff, Ph.D.
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` 1 making in my declaration, which is that they
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` 2 have not provided a sufficient analysis for
`
` 3 commercial success.
`
` 4 Q. Okay. Well, you had information
`
` 5 about the sales of Zytiga; correct?
`
` 6 A. I did, yes.
`
` 7 Q. Okay. What would you need to
`
` 8 know to assess the profitability of Zytiga?
`
` 9 A. Well, it's described in part in
`
` 10 Section C of my declaration, Section 2C from
`
` 11 pages 8 through 10.
`
` 12 Generally speaking, an evaluation
`
` 13 of Zytiga sales as well as the costs and
`
` 14 profits, such as costs of manufacture,
`
` 15 distribution, sales, marketing, as well as costs
`
` 16 associated with development. Bringing a product
`
` 17 to market, clinical trials, opportunity cost of
`
` 18 capital, all of those factors.
`
` 19 Q. Okay. You have to have access to
`
` 20 all of that information in order to assess the
`
` 21 profitability of Zytiga?
`
` 22 A. I mean, if one did have access to
`
` 23 that information, one could do a better job of
`
` 24 assessing that. It depends what the information
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`DeForest McDuff, Ph.D.
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` 1 looked like.
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` 2 Dr. Vellturo did not analyze any
`
` 3 of that kind of information, to my
`
` 4 understanding.
`
` 5 Q. Okay. But both -- both you and
`
` 6 he had access to -- to sales revenue for Zytiga;
`
` 7 correct?
`
` 8 A. Yes.
`
` 9 Q. Okay. Is it your understanding
`
` 10 that Zytiga has cumulative sales of over 2
`
` 11 billion and counting?
`
` 12 A. That's my understanding, yes.
`
` 13 Q. Okay. Now, is it true that, you
`
` 14 know, if two companies are selling the same drug
`
` 15 and both are making a billion dollars in
`
` 16 revenue, they may have different levels of
`
` 17 profitability depending on their -- their cost
`
` 18 and expense structure?
`
` 19 A. Yes.
`
` 20 Q. So is it correct that assessing
`
` 21 profitability of a particular drug may require
`
` 22 information that is not publicly available?
`
` 23 MS. RATHINAM: Objection to form.
`
` 24 THE WITNESS: It depends how one
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`DeForest McDuff, Ph.D.
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` 1 wants to approach it. Generally
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` 2 speaking, one could evaluate it based on
`
` 3 private information or public
`
` 4 information. One could go about it
`
` 5 several ways, but Dr. Vellturo does not
`
` 6 assess it at all.
`
` 7 BY MR. ZEGGER:
`
` 8 Q. No, I'm just talking in general.
`
` 9 That in assessing the
`
` 10 profitability of some drug company's drug
`
` 11 product, generally that may require information
`
` 12 that is not publicly available?
`
` 13 MS. RATHINAM: Objection to form.
`
` 14 THE WITNESS: It depends on
`
` 15 one -- on how one thinks about it.
`
` 16 Obviously the drug company has
`
` 17 information on the product's profits.
`
` 18 That may be available to some degree but
`
` 19 would typically be thought of as private
`
` 20 information, but one could assess
`
` 21 profitability based on public
`
` 22 information. It depends how one wants to
`
` 23 go about it.
`
` 24 BY MR. ZEGGER:
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`DeForest McDuff, Ph.D.
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` 1 Q. Okay. But in general, assessing
`
` 2 profitability of a drug product is a more
`
` 3 complicated undertaking than looking at revenue
`
` 4 as a marker for the success of a drug product;
`
` 5 right?
`
` 6 A. I agree that it's more
`
` 7 complicated, yet I think it's important to do
`
` 8 so.
`
` 9 Q. Now, are you -- in your work,
`
` 10 have you done studies in connection with the
`
` 11 pharmaceutical industry?
`
` 12 A. Yes.
`
` 13 Q. Okay. And are you familiar with
`
` 14 the term a "Blockbuster Drug"?
`
` 15 A. I am, yes.
`
` 16 Q. Okay. And I think you mentioned
`
` 17 this before in your prior deposition, but that's
`
` 18 generally regarded as a drug that sells over a
`
` 19 billion dollars? That's your understanding?
`
` 20 A. It is, yes.
`
` 21 Q. Now, so is it fair to say that in
`
` 22 the pharmaceutical industry, companies are
`
` 23 looking at revenue as a metric of success?
`
` 24 A. Well, as I indicate in my
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`DeForest McDuff, Ph.D.
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` 1 declaration, companies are ultimately interested
`
` 2 in profits. So the revenue side is one aspect
`
` 3 of profit, but the cost side is, of course, also
`
` 4 important.
`
` 5 Q. Well, do you agree that companies
`
` 6 are using this Blockbuster marker as an indicia
`
` 7 of success?
`
` 8 A. It's -- it's one characterization
`
` 9 or one factor of many that one can consider.
`
` 10 Q. And you'd agree that Zytiga is a
`
` 11 Top 50 drug product?
`
` 12 A. I recall it being described that
`
` 13 way by Dr. Vellturo in some of the underlying
`
` 14 documents. You know, it would depend on what
`
` 15 one means by a "Top 50 drug product."
`
` 16 Q. Okay.
`
` 17 A. I believe that was based on
`
` 18 revenue in just one calendar year. I point out
`
` 19 in my reply declaration that that is not
`
` 20 sufficient to understand lifetime revenues of a
`
` 21 drug. So it's one narrow dimension, but I know
`
` 22 that it's been described that way at least for
`
` 23 certain calendar years.
`
` 24 Q. Okay. Does a drug need to be the
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`DeForest McDuff, Ph.D.
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` 1 market leader in order to be considered a
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` 2 commercial success?
`
` 3 A. Not necessarily. Drugs that are
`
` 4 market leaders are more likely to be
`
` 5 commercially successful, but it's not a
`
` 6 requirement.
`
` 7 Q. All right. Now, are you familiar
`
` 8 with the life -- the concept of a life cycle of
`
` 9 a drug?
`
` 10 A. Yes.
`
` 11 Q. In other words, a drug when it
`
` 12 hits the market may have increasing success but
`
` 13 then peak and then later decline as other
`
` 14 better, superior drugs hit the market?
`
` 15 MS. RATHINAM: Objection to form.
`
` 16 THE WITNESS: Every situation is
`
` 17 different. Sometimes sales do increase
`
` 18 and then decrease. Sometimes sales
`
` 19 continue to increase over time. It
`
` 20 really depends.
`
` 21 BY MR. ZEGGER:
`
` 22 Q. Okay. But are you familiar with
`
` 23 the concept of a drug having rising sales to a
`
` 24 point and then being replaced as time goes on
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`DeForest McDuff, Ph.D.
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` 1 with other better drugs?
`
` 2 MS. RATHINAM: Objection to form.
`
` 3 THE WITNESS: That does happen,
`
` 4 of course. It's not true for every drug.
`
` 5 Oftentimes sales will decline as a result
`
` 6 of generic entry, which is not a superior
`
` 7 alternative per se. It's -- it's the
`
` 8 same product at a cheaper price.
`
` 9 BY MR. ZEGGER:
`
` 10 Q. Now, is it true that a drug
`
` 11 product could be immensely successful even if
`
` 12 the sales on an annual basis ultimately tail off
`
` 13 as time goes on; right?
`
` 14 MS. RATHINAM: Objection to form.
`
` 15 THE WITNESS: It would depend on
`
` 16 the circumstances and the magnitude.
`
` 17 Sometimes that would be true. Sometimes
`
` 18 that wouldn't be true. All else being
`
` 19 equal, sales declining after a certain
`
` 20 point would be less successful than sales
`
` 21 not declining.
`
` 22 BY MR. ZEGGER:
`
` 23 Q. Now, just taking as an example a
`
` 24 drug that has, you know, a billion, 10 billion
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`DeForest McDuff, Ph.D.
`
` 1 dollars in cumulative sales. That would --
`
` 2 could be a very commercially successful product
`
` 3 even though ultimately it's replaced by other
`
` 4 drugs on the market; is that right?
`
` 5 MS. RATHINAM: Objection to form.
`
` 6 THE WITNESS: I agree that that's
`
` 7 theoretically possible. It depends on
`
` 8 the circumstances, and it's hard to say
`
` 9 without knowing all the other aspects of
`
` 10 this hypothetical drug you have in mind.
`
` 11 BY MR. ZEGGER:
`
` 12 Q. Now, on page 7 of your
`
` 13 declaration, you mention that Zytiga represents
`
` 14 3 to 6 percent of the total prostate treatment
`
` 15 market.
`
` 16 Do you see that?
`
` 17 A. Yes.
`
` 18 Q. Now, do you agree that commercial
`
` 19 success can be achieved by a drug in a
`
` 20 particular market segment?
`
` 21 MS. RATHINAM: Objection to form.
`
` 22 THE WITNESS: It depends on the
`
` 23 circumstances, but if I understand your
`
` 24 question, that's possible, yes.
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`DeForest McDuff, Ph.D.
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` 1 BY MR. ZEGGER:
`
` 2 Q. Okay. One example would be,
`
` 3 like, in that BMW sedans could be commercially
`
` 4 success even though they're only a fraction of
`
` 5 the total car market?
`
` 6 MS. RATHINAM: Objection to form.
`
` 7 THE WITNESS: That's possible,
`
` 8 yes. It's not something -- it's not a
`
` 9 specific situation I've considered for my
`
` 10 declaration here.
`
` 11 BY MR. ZEGGER:
`
` 12 Q. Okay. Well, turning to your
`
` 13 situation here, assuming that you're correct
`
` 14 that Zytiga represents 3 to 6 percent of the
`
` 15 total prostate treatment market, that doesn't
`
` 16 necessarily disqualify Zytiga from being a
`
` 17 commercial success; is that right?
`
` 18 A. That figure by itself would not,
`
` 19 not as I think of it, yet I think the context is
`
` 20 helpful and important for someone evaluating
`
` 21 commercial success.
`
` 22 As I point out in my reply
`
` 23 declaration, Dr. Vellturo does not define a
`
` 24 relevant market at all. I found that to be
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`DeForest McDuff, Ph.D.
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` 1 surprising in light of that being a typical
`
` 2 approach in evaluation in a commercial success
`
` 3 analysis. I don't know what relevant market he
`
` 4 or Janssen is putting forth, and I don't know
`
` 5 what market share he is relying upon. So in my
`
` 6 opinion, they have not provided any context.
`
` 7 Q. Okay. Well, I'm not talking
`
` 8 right now about Dr. Vellturo.
`
` 9 I'm trying to find out what your
`
` 10 views and what your opinions are. Can we focus
`
` 11 on that?
`
` 12 A. Sure.
`
` 13 Q. All right. So assuming that
`
` 14 you're correct that Zytiga represents 3 to 6
`
` 15 percent of the total prostate market, it doesn't
`
` 16 necessarily mean that Zytiga is not a
`
` 17 commercially successful product; correct?
`
` 18 A. That factor by itself? I
`
` 19 wouldn't think of that as providing conclusory
`
` 20 information or conclusory evidence of no
`
` 21 commercial success.
`
` 22 Q. Okay. What is Zytiga's share of
`
` 23 the market for drugs approved for treatment of
`
` 24 metastatic castrate-resistance prostate cancer,
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`DeForest McDuff, Ph.D.
`
` 1 or mCRPC for short?
`
` 2 A. Sitting here, I don't know.
`
` 3 That's one of the things I pointed out as a
`
` 4 deficiency of Dr. Vellturo's analysis.
`
` 5 Q. Okay. But sitting here, you
`
` 6 don't know what Zytiga's market share is for
`
` 7 drugs approved for treatment of mCRPC?
`
` 8 A. I do not.
`
` 9 As we've discussed, I've been
`
` 10 responding to Dr. Vellturo. I'm not aware of
`
` 11 him performing that calculation.
`
` 12 Q. Okay. Is it your understanding
`
` 13 that not all patients with prostate cancer have
`
` 14 the same stage of the disease?
`
` 15 MS. RATHINAM: Objection.
`
` 16 Outside the scope and objection to form.
`
` 17 THE WITNESS: I would, of course,
`
` 18 defer to clinical experts, yet that's my
`
` 19 understanding.
`
` 20 BY MR. ZEGGER:
`
` 21 Q. Is it your understanding that
`
` 22 different drugs are used by the medical
`
` 23 community to treat prostate cancer in its
`
` 24 different stages?
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`DeForest McDuff, Ph.D.
`
` 1 MS. RATHINAM: Objection to form.
`
` 2 THE WITNESS: I mean, again, that
`
` 3 strikes me as a clinical issue or
`
` 4 opinion, but I do understand that doctors
`
` 5 may prescribe different drugs in
`
` 6 different circumstances. It may depend
`
` 7 on stage of disease.
`
` 8 BY MR. ZEGGER:
`
` 9 Q. Well, have you read any of the
`
` 10 expert reports by the medical doctors submitting
`
` 11 declarations on behalf of Amerigen in this case?
`
` 12 A. I have, yes.
`
` 13 Q. Okay. Based on what you've
`
` 14 learned in the context of this case, is it your
`
` 15 understanding that different drugs are used to
`
` 16 treat different stages of prostate cancer?
`
` 17 A. It depends what you mean by that.
`
` 18 Some drugs may be used across multiple stages of
`
` 19 cancer. Other drugs may be more focused on
`
` 20 certain stages. It really depends.
`
` 21 Q. Okay. Well, in the case of
`
` 22 prostate cancer at issue here, is it your
`
` 23 understanding that certain drugs might be more
`
` 24 appropriate for early stage cancer compared to
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`DeForest McDuff, Ph.D.
`
` 1 those drugs that are used in later stages of the
`
` 2 cancer?
`
` 3 MS. RATHINAM: Objection to form.
`
` 4 Outside the scope.
`
` 5 THE WITNESS: That may be true.
`
` 6 That's not something I've specifically
`
` 7 evaluated or tabulated for the purpose of
`
` 8 my reply declaration.
`
` 9 BY MR. ZEGGER:
`
` 10 Q. Now, can we shift to the topic of
`
` 11 nexus between commercial success and the
`
` 12 invention claimed in the '438 patent?
`
` 13 A. Of course.
`
` 14 Q. Okay. You mentioned nexus in
`
` 15 your declarations?
`
` 16 A. Yes.
`
` 17 Q. Do you have an understanding as
`
` 18 to what the approved use -- what Zytiga's
`
` 19 approved for by the FDA?
`
` 20 MS. RATHINAM: Objection to form.
`
` 21 THE WITNESS: Yes, I have a
`
` 22 general understanding.
`
` 23 BY MR. ZEGGER:
`
` 24 Q. Okay. And what is it?
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`DeForest McDuff, Ph.D.
`
` 1 A. I would defer to the label for
`
` 2 the specific indication, of course, yet
`
` 3 generally I understand that it is approved for
`
` 4 the treatment of metastatic castrate-resistant
`
` 5 prostate cancer including with use with
`
` 6 prednisone.
`
` 7 Q. Now, is it --
`
` 8 A. You know, but, of course, I would
`
` 9 defer to the label for the exact wording and the
`
` 10 exact indication.
`
` 11 Q. Now, as an economist, do you
`
` 12 sometimes make assumptions in the course of your
`
` 13 work?
`
` 14 A. From time to time, yes.
`
` 15 Q. All right. Now, is it reasonable
`
` 16 to assume that if doctors advise prostate cancer
`
` 17 patients to take Zytiga with prednisone that the
`
` 18 patients will do so? Is that a reasonable
`
` 19 assumption?
`
` 20 A. It depends why one is making that
`
` 21 assumption. That wouldn't be true all the time.
`
` 22 Q. Well, does that strike you as a
`
` 23 reasonable assumption?
`
` 24 A. Well, whether it's reasonable
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`DeForest McDuff, Ph.D.
`
` 1 depends on how one is using it. It's not going
`
` 2 to be universally true. So it wouldn't be
`
` 3 reasonable in all circumstances.
`
` 4 Q. Well, of course, I'm not talking
`
` 5 on a patient-by-patient basis.
`
` 6 But just across the population of
`
` 7 patients that have been advised to take Zytiga
`
` 8 with prednisone for prostate cancer, is it
`
` 9 reasonable to assume that most of them would do
`
` 10 so?
`
`

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