Page 1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`----------------------------------x
`AMERIGEN PHARMACEUTICALS LIMITED
`AND ARGENTUM PHARMACEUTICALS, LLC,
`
` Petitioners,
`
` vs.
`
`JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
`Case IPR2016-00286
`Patent No. 8,822,438 B2
`----------------------------------x
`
` DEPOSITION OF CHRISTOPHER VELLTURO, Ph.D.
`
` New York, New York
`
` Tuesday, December 20, 2016
`
` 9:05 a.m.
`
`Reported by:
`
`Jennifer Ocampo-Guzman, CRR, CLR
`
`JOB NO. 17734
`
`Amerigen Exhibit 1190
`Amerigen v. Janssen IPR2016-00286
`
`TransPerfect Legal Solutions
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 1
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`----------------------------------x
`AMERIGEN PHARMACEUTICALS LIMITED
`AND ARGENTUM PHARMACEUTICALS, LLC,
`
` Petitioners,
`
` vs.
`
`JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
`Case IPR2016-00286
`Patent No. 8,822,438 B2
`----------------------------------x
`
` DEPOSITION OF CHRISTOPHER VELLTURO, Ph.D.
`
` New York, New York
`
` Tuesday, December 20, 2016
`
` 9:05 a.m.
`
`Reported by:
`
`Jennifer Ocampo-Guzman, CRR, CLR
`
`JOB NO. 17734
`
`Amerigen Exhibit 1190
`Amerigen v. Janssen IPR2016-00286
`
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 1
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`
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`Page 2
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` December 20, 2016
`
` 9:05 a.m.
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` Deposition of CHRISTOPHER
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` VELLTURO, Ph.D., held at the offices of Sidley
`
` Austin LLP, 787 Seventh Avenue, New
`
` York, New York, pursuant to notice,
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` before Jennifer Ocampo-Guzman, a
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` Certified Real-Time Shorthand Reporter
`
` and Notary Public of the State of New
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` York.
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 2
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`Page 3
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`A P P E A R A N C E S:
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` MCNEELY, HARE, WAR LLP
`
` Attorneys for Petitioner
`
` 12 Roszel Road, Suite C104
`
` Princeton, New Jersey 08540
`
` (347) 400-1154
`
` BY: RENITA S. RATHINAM, ESQ.
`
` rathinam@miplaw.com
`
` WILLIAM D. HARE, ESQ.
`
` bill@miplaw.com
`
` SIDLEY AUSTIN LLP
`
` Attorneys for Patent Owner
`
` 787 Seventh Avenue
`
` New York, New York 10019
`
` (212) 839-5300
`
` BY: S. ISAAC OLSON, ESQ.
`
` iolson@sidley.com
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`C H R I S T O P H E R V E L L T U R O ,
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`called as a witness, having been duly sworn,
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`was examined and testified as follows:
`
`EXAMINATION BY
`
`MS. RATHINAM:
`
` Q. Good morning, Dr. Vellturo. My
`
` name is Renita Rathinam. I represent the
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` petitioner, Amerigen, in this proceeding, and
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` I will quickly cover a few ground rules.
`
` Do you understand that when I ask
`
` my questions, you must answer -- your answer
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` must be complete and truthful, because you
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` are under oath?
`
` A. Yes.
`
` Q. Do you understand that you are to
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` respond to my questions regardless of your
`
` counsel's stated objection, unless your
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` counsel expressly instructs you not to
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` respond to my question?
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` A. I agree, as long as an answer such
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` as "I don't understand the question" --
`
` Q. Sure.
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` A. -- is legitimate there.
`
` Q. Yeah. And if for any reason you
`
` don't understand the question, you feel free
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 4
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` to ask me for a clarification. You
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` understand that, right?
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` A. Yes.
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` Q. Do you understand that you are not
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` to confer or consult with counsel regarding
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` any questions that I ask you?
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` MR. OLSON: Objection to form.
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` A. While the deposition is currently
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` live or at any time?
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` Q. At any time. Once the deposition
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` has begun, do you understand that you are not
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` to confer or consult with counsel on
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` questions that may come up in this
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` proceeding?
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` A. I don't particularly know that one
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` way or the other, but if you are telling me
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` that's the governing rule, then I will abide
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` by that.
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` MR. OLSON: Renita I'm sorry just
`
` to interject here. I believe to the
`
` extent there are any questions about
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` whether or not Dr. Vellturo may disclose
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` attorney/client communications and
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` wishes to consult with me regarding
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` that, that would be fair game.
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 5
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` MS. RATHINAM: Yes, that is an
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` exception.
`
` Q. And please let me know if you ever
`
` want to take a break, but kindly refrain from
`
` doing that while a question is pending.
`
` A. Understood.
`
` Q. Okay. Can you please state your
`
` full name for the record?
`
` A. Christopher Allan Vellturo.
`
` Q. And are you on any medication today
`
` that might affect your testimony?
`
` A. I am not.
`
` Q. Is there any health or medical
`
` condition that might affect your testimony
`
` here today?
`
` A. No.
`
` MS. RATHINAM: I would like to have
`
` your deposition notice marked. Mark
`
` this as AMG 1087 please.
`
` (AMG Exhibit 1087, Petitioner's
`
` Notice of Deposition of Christopher A.
`
` Vellturo, Ph.D., marked for
`
` identification, this date.)
`
` Q. Please take a look at AMG 1087 and
`
` confirm for me that this is the deposition
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 6
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` notice you received for your testimony here
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` today.
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` A. I believe it is. I'm not sure it
`
` had the certificate of service on the last
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` page when I saw it, but it might have. But
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` it looks familiar as the notice in this case
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` for me.
`
` Q. And am I correct that you're here
`
` today on behalf Janssen Oncology Inc.,
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` Johnson & Johnson and BTG International
`
` Limited?
`
` A. That's my understanding, yeah.
`
` Q. And is it okay if we use the
`
` shorthand "Janssen," when referring to these
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` parties collectively?
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` A. Generally, yes, unless we get into
`
` some of the early history where BTG is kind
`
` of a distinct entity; but other than that,
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` I'm fine with that.
`
` Q. And if there's ever a time where
`
` you want to clarify that for me, just go
`
` ahead.
`
` Okay. I'm going hand you an
`
` exhibit marked AMG 1001.
`
` (Discussion off the record.)
`
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 7
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` Q. Do you recognize this document as
`
` U.S. Patent number 8,822,438?
`
` A. Yes.
`
` Q. And so this is the patent at issue
`
` in this proceeding, correct?
`
` A. That's my understanding.
`
` Q. I'm going to refer to this patent
`
` as the '438 patent; is that okay?
`
` A. Sure.
`
` Q. And I'm also going to hand you your
`
` declaration previously marked JSN 2044.
`
` Do you recognize this document as
`
` your declaration submitted on behalf of the
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` patent owner in this proceeding?
`
` A. Yes.
`
` Q. And that's your signature on the
`
` back page there?
`
` A. It is.
`
` Q. How much time did you spend
`
` preparing your declaration, which is marked
`
` JSN 2044?
`
` A. My recollection would have been
`
` somewhere between 50 and 100 hours. I'm not
`
` sure where in that range.
`
` Q. Okay. Did you conduct your own
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 8
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` search for the materials that you cite in the
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` declaration?
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` A. I did, or people working under my
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` direction, yes.
`
` Q. Did counsel provide you with any of
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` the materials that you cite in your
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` declaration?
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` MR. OLSON: Objection. I just
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` caution the witness not to disclose any
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` communications you've had with counsel.
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` A. I believe some of that would have
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` arrived in my office from counsel.
`
` Q. Can you identify which of those
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` items --
`
` MS. RATHINAM: Let me strike that.
`
` Q. Let's turn to section 1(b) at page
`
` 3 of your declaration.
`
` MS. RATHINAM: I apologize, strike
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` that again.
`
` Q. Can we turn to appendix A of the
`
` declaration.
`
` A. Yes.
`
` Q. And this is the list of items that
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` you've cited or considered in the
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` declaration, correct?
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 9
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` A. That's right.
`
` Q. And are some of these items the
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` items that you mentioned counsel sent you?
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` MR. OLSON: And again, I'll caution
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` the witness not to disclose any
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` communications you've had with counsel.
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` A. Yes, as I recall, some of these
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` would have found their way to me from
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` counsel.
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` Q. And this is the complete list of
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` items you've reviewed and cited in the
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` declaration?
`
` A. Right. As it says in appendix A,
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` this is the set of documents I relied upon.
`
` Q. What is your understanding of your
`
` role in this case?
`
` MR. OLSON: I'll caution the
`
` witness not to disclose any
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` communications you've had with counsel.
`
` A. My nonlegal understanding, as I'm
`
` not a lawyer, is I've been asked to apply my
`
` expertise as an economist generally and as an
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` expert economist in the pharmaceutical
`
` industry more specifically to issues
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` surrounding the commercial success of Zytiga
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 10
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` and its nexus to the inventions claimed in
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` the '438 patent; and, relatedly, to evaluate
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` and assess opinions on that same issue put
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` forward by Dr. McDuff.
`
` Q. Okay. And if you look at
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` paragraphs or paragraph 2 of your
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` declaration, does that accurately state what
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` you've been asked to do by counsel in this
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` case?
`
` A. Yes.
`
` Q. And if you look at paragraph 38,
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` does that also accurately state what you've
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` been asked to do by counsel in this case?
`
` A. Well, that's one of the tasks I was
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` asked to undertake in this case.
`
` Q. Those two paragraphs combined,
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` paragraph 2 and 38, do they --
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` A. No.
`
` Q. -- cover the universe of tasks
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` you've been asked to consider in the case?
`
` MR. OLSON: Objection to form.
`
` A. No, paragraph 2 covers the
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` universe. It identifies two assignments;
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` paragraph 38 identifies one of those two
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` assignments.
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` Q. And paragraph 38 specifically
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` focuses on the affirmative assessment of
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` commercial success and whether there's a
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` nexus between such success and the claims of
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` the '438 patent; is that correct?
`
` A. Essentially, yes.
`
` Q. And you've prepared this testimony
`
` in support of patent owner's rebuttal to
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` petitioner's obviousness showing in this
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` matter; is that correct?
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` MR. OLSON: Objection.
`
` A. Again, I don't get into the legal
`
` standards, as I'm not a lawyer; but generally
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` speaking, that's my understanding of the
`
` purpose of what I've been asked to undertake.
`
` Q. Okay. And what is your
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` understanding of commercial success as it
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` relates to an obviousness analysis?
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` MS. RATHINAM: Objection to form.
`
` Calls for legal conclusion.
`
` A. Well, there is somewhat of an
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` unfortunate misnomer of the phrase
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` "commercial success," because a commercial
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` success analysis, in my view, includes two
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` components. One is establishing the
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` commercial success from a marketplace
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` standpoint and then assessing that success in
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` the context of a nexus to the patent at
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` issue.
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` So when you use commercial success
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` in your question, I'm not sure whether you're
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` asking me about the entirety of the exercise
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` or just the first component. Unfortunately,
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` the first component of a commercial success
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` exercise is often called commercial success.
`
` Q. Okay. So let's look at paragraph
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` 35 of your declaration. And that paragraph,
`
` would you agree, makes the distinction that
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` you just explained to me, in response to my
`
` previous question --
`
` A. Yes.
`
` Q. -- between marketplace success and
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` commercial success?
`
` A. Right, just to give language that
`
` can distinguish between the two exercises.
`
` Q. Okay. Thanks.
`
` So market success is one component
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` of a commercial success inquiry?
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` MR. OLSON: Objection to form.
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` A. I refer to it as marketplace
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` success --
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` Q. Yes.
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` A. -- rather than market success.
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` Q. Okay. So today, if I want to talk
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` about marketplace success, I'll specifically
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` mention marketplace success, just for
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` clarification; is that okay?
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` A. Where "marketplace success" is
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` defined as the first of the two elements of
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` commercial success?
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` Q. Right. In other words, I won't use
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` those terms interchangeably, "commercial
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` success" and "marketplace success."
`
` A. Okay. Understood.
`
` Q. You understand that statements
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` about gross sales are not sufficiently tied
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` to the merits of the invention -- that are
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` not sufficiently tied to the merits of the
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` claimed invention are insufficient to
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` constitute evidence of commercial success,
`
` correct?
`
` MR. OLSON: Objection to form.
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` A. That sounds like a legal
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` sufficiency conclusion. I'm not here as a
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` lawyer.
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` Q. Okay. But you understand that you
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` need to have a showing of a marketplace
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` success and also establish a nexus in the
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` context of a commercial success inquiry?
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` A. In my historic experience there are
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` two parts to the commercial success inquiry.
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` There's marketplace success and then there's
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` nexus, having established marketplace
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` success.
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` Q. And you understand that there must
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` be a nexus, in other words, a causal
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` connection between the characteristics of the
`
` patented invention and the marketplace
`
` success?
`
` MR. OLSON: Objection to form.
`
` A. Again, that sounds more like legal
`
` language, but my understanding, colloquially,
`
` is that nexus is establishing that the patent
`
` invention contributed materially to the
`
` marketplace success identified in the first
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` part of the analysis.
`
` Q. Okay. In declaration -- in your
`
` declaration at paragraph 39, you've stated,
`
` "I understand that under United States patent
`
` law, the commercial success of a patented
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 15
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` invention can be evidence of nonobviousness.
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` I understand further that there must be a
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` nexus or a causal connection between the
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` characteristics of the patented invention and
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` the marketplace success of the product that
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` incorporates the invention for commercial
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` success to be evidence of nonobviousness."
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` Is that correct, did I read that
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` correctly?
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` MR. OLSON: Objection to form.
`
` A. That's the understanding -- I'm
`
` sorry.
`
` MR. OLSON: Objection to form.
`
` A. That's the understanding under
`
` which I conducted my exercise.
`
` Q. Do you have an understanding of
`
` claim scope, as it relates to nexus?
`
` MR. OLSON: Objection to form.
`
` A. No.
`
` Q. Does claim scope have anything to
`
` do with nexus?
`
` MR. OLSON: Objection to form.
`
` A. Well, I'm not sure how you're using
`
` claim scope, so I think you will need to
`
` define it for me in your question.
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 16
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` Q. Well, did you look at the claims
`
` for purposes of your nexus analysis?
`
` A. Well, I read the claims and I
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` received an understanding from technical, a
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` technical expert in particular here, as to
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` what those claims cover; and I used that as
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` inputs into my analysis. I didn't
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` independently evaluate claim terms or claims.
`
` I'm not a technical expert.
`
` Q. How did you use what the cover --
`
` the claims covered as an input into your
`
` analysis?
`
` A. Well, I think that's laid out in
`
` the declaration itself. I received an
`
` understanding of what the inventions cover, I
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` also receive an understanding as to how that
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` manifests itself in terms of the performance
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` of the product; and then from there I looked
`
` to see whether the benefits that I understand
`
` the invention provides have commercial
`
` significance and therefore significantly
`
` contribute to the marketplace success of
`
` Zytiga. Or I should say products more
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` generally. This is how I do a commercial
`
` success analysis. In every case I do it.
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`Page 18
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` Q. Okay. When you say you have an
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` understanding or you received an
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` understanding of what the inventions cover,
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` do you mean what the claims cover?
`
` MR. OLSON: Objection to form.
`
` THE WITNESS: Can I have that
`
` question again?
`
` (A portion of the record was read.)
`
` A. What the invention associated with
`
` the relevant claims is, that's what I
`
` received an understanding on from the
`
` technical expert here, Dr. Rettig.
`
` Q. Do the claims define what the
`
` invention is?
`
` MR. OLSON: Objection to form.
`
` A. That sounds like a legal question
`
` to me. I don't have an opinion on that.
`
` I received an understanding as to
`
` what the claims, how the claims manifest
`
` themselves in terms of the product
`
` attributes. I don't make determinations
`
` myself on that.
`
` Q. What do the inventions cover?
`
` A. Well, as I say in paragraph 44, I
`
` understand the claims of the '438 patent to
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` cover the combination of a therapeutically
`
` effective amount of abiraterone acetate and a
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` therapeutically effective amount of
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` prednisone for the treatment of cancer in the
`
` United States. That's my understanding of
`
` the invention.
`
` Q. And that's what you say you
`
` understand the claims of the '438 to cover?
`
` A. I used the "I understand" qualifier
`
` in that sentence.
`
` Q. Do you have an understanding of
`
` what --
`
` MS. RATHINAM: Okay. Strike that.
`
` Q. Would you agree that the evidence
`
` of commercial success or marketplace success
`
` --
`
` MS. RATHINAM: Strike that.
`
` Q. Would you agree that evidence of
`
` marketplace success must be commensurate in
`
` scope with the asserted claims?
`
` MR. OLSON: Objection to form.
`
` A. I don't know what that question
`
` means.
`
` Q. So the scope -- you have no idea
`
` what the "scope of an asserted claim" means?
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`Page 20
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` MR. OLSON: Objection to form.
`
` A. I've heard that phrase used from
`
` time to time, but what matters to me as an
`
` economist is how the patented invention or
`
` the asserted claims manifest itself in the
`
` product whose commercial success is being
`
` evaluated. Whether one characterizes that as
`
` being within the scope of the claims or not,
`
` seems to me -- or if that's legally distinct
`
` from my understanding, that's why I don't
`
` understand the question.
`
` Q. So you didn't cover --
`
` MS. RATHINAM: Sorry, strike that.
`
` Q. Do you don't understand the term
`
` "claim scope"; is that correct?
`
` MR. OLSON: Objection to form.
`
` A. Well, I have a colloquial
`
` understanding of "claim scope," but I don't
`
` have a legal understanding of it.
`
` Q. Did your colloquial understanding
`
` of claim scope guide your commercial success
`
` analysis?
`
` A. I would have received an
`
` understanding of claim scope from the
`
` technical experts, so my definition of scope
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 20
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`Page 21
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` wouldn't have influenced that understanding.
`
` I didn't make that determination, Dr. Rettig
`
` did, and I used it as an input to my
`
` analysis.
`
` Q. How did you use that as an input to
`
` your analysis?
`
` A. Exactly as explained in paragraph
`
` 44.
`
` Q. Would you agree that evidence
`
` relied upon in a commercial success showing
`
` must trace back to novel aspects of a claim?
`
` MR. OLSON: Objection to form.
`
` A. Again, that sounds like a legal
`
` standard or requirement.
`
` My understanding is that, or for
`
` the purposes of my exercise, I understand
`
` that the commercial success attributable
`
` under nexus needs to be related to the
`
` patented invention being asserted. I'm not
`
` sure whether that meets the same legal
`
` requirement, but that's the understanding
`
` with which I conduct my analysis.
`
` Q. If a patented invention involves a
`
` new component and an old component, can the
`
` commercial success trace back to only the old
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`Page 22
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` component and still be evidence of commercial
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` success?
`
` MR. OLSON: Objection to form.
`
` A. That question needs far more detail
`
` to be answered in any specific circumstance.
`
` Q. Does evidence of commercial success
`
` need to root only in elements of a claim that
`
` are novel?
`
` MR. OLSON: Objection to form.
`
` A. Again, I'm not an attorney, but my
`
` general understanding is that the novel
`
` aspects of the invention are the subject
`
` matter of the nexus inquiry.
`
` Now back to your previous question,
`
` to the extent it enhances the characteristics
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` or value of things known previously, that
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` would still be associated with the novel
`
` features of the invention, even though it may
`
` relate to a characteristic that an older
`
` technology had.
`
` Q. In your commercial success analysis
`
` for this case, did you find that any of the
`
` claims involved things known previously that
`
` were enhanced by a novel feature of the
`
` invention?
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` MR. OLSON: Objection to form.
`
` A. Well, again, I don't conduct that
`
` kind of technical analysis. I had received
`
` an understanding of that from the technical
`
` expert, so the enhanced survival benefit
`
` associated with a Zytiga therapy is an
`
` understanding I received from the technical
`
` expert. I didn't independently assess or
`
` evaluate the underlying science of that
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` manifestation of the invention. I received
`
` that understanding from Dr. Rettig.
`
` Q. So the enhanced survival benefit is
`
` a novel feature of the invention?
`
` MR. OLSON: Objection to form.
`
` A. I wouldn't characterize it that
`
` way. It's an outcome that is generated by
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` what I understand to be the novel features of
`
` the invention.
`
` Q. What do you understand to be the
`
` novel features of the invention?
`
` A. Well, again, as I say in my
`
` declaration, it's the combination of
`
` therapeutically effective amounts of
`
` abiraterone acetate and prednisone for the
`
` treatment of cancer, which I understand is a
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 23
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` combination that maximizes the survival
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` benefit associated with the treatment, from
`
` Dr. Rettig.
`
` Q. Of the combination of the
`
` therapeutically effective amounts of
`
` abiraterone acetate and prednisone for the
`
` treatment of cancer, did you understand, did
`
` you obtain an understanding, in your
`
` commercial success analysis exercise, of
`
` which, if any, of those components are novel?
`
` MR. OLSON: Objection to form.
`
` A. So again, I don't do the technical
`
` aspect of how the patented inventions
`
` manifest their way into the, here, the Zytiga
`
` therapy. That is Dr. Rettig's expertise, and
`
` I relied upon him for that. So when you say,
`
` what did I do in my analysis to establish
`
` that link between the invention and the
`
` therapeutic benefits of the product that is
`
` the Zytiga therapy, I relied on Dr. Rettig
`
` for that. I didn't do an independent
`
` analysis of that science.
`
` Q. So you relied only on Dr. Rettig to
`
` determine what aspects of the patented
`
` invention are novel?
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` MR. OLSON: Objection to form.
`
` A. I think that's basically correct.
`
` Q. Okay. But Dr. Rettig is not a
`
` lawyer, is he?
`
` MR. OLSON: Objection to form.
`
` A. I don't recall. I don't believe he
`
` is. But I'm sure he received legal
`
` understandings under which he did his
`
` analysis. In fact, I remember there's a
`
` whole section of his initial declaration
`
` explaining his understandings under which he
`
` did his analysis.
`
` Q. Let's look at paragraph -- let's go
`
` to section (b) of your affirmative statement
`
` in your declaration, marked JSN 2044 at page
`
` 22.
`
` Can you read the section (b)
`
` heading?
`
` A. Can I leave out the registered
`
` trademark?
`
` Q. Yes.
`
` A. "Zytiga's Commercial Success is Due
`
` in Significant Part to the Claims of the '438
`
` Patent."
`
` Q. Okay. In the second sentence there
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`MYLAN PHARMS. INC. EXHIBIT 1137 PAGE 25
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` you write, "I understand that such use of
`
` Zytiga for the treatment of prostate cancer
`
` is the only FDA-approved indication of Zytiga
`
` and that physicians overwhelmingly prescribe
`
` this combination"; is that correct?
`
` MR. OLSON: Objection to form.
`
` A. Essentially. You skipped a few
`
` words, but that's fine.
`
` Q. And you write next that "I further
`
` understand that this combination is valued by
`
` physicians due to its therapeutic benefit of
`
` enhanced survival in mCRCP patients"; is that
`
` correct?
`
` A. Yes.
`
` Q. And the third sentence says,
`
` "Therefore, I find that the therapeutic
`
` benefit of abiraterone acetate in combination
`
` with prednisone, as covered by the '438
`
` patent, contributes significantly to the
`
` success of Zytiga." Is that correct?
`
` MR. OLSON: Objection to form.
`
` A. I see that as well.
`
` Q. And then your nexus analysis as it
`
` relates to the merits of the invention, in
`
` this declaration, continues at paragraph 46
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` and then goes on until paragraph 50.
`
` Would you agree with that?
`
` A. I'd say paragraph 44 is providing
`
` kind of the basis of my understandings and my
`
` ultimate conclusion, and then from 46 on I'm
`
` providing the details of my analysis.
`
` Q. 46 on to where?
`
` A. Well, certainly on to the end of
`
` paragraph 53. There's the question on where
`
` one would put in your question the idea that
`
` I consider other aspects of marketplace
`
` characteristics that might generate
`
` inordinate amounts of success for a
`
` pharmaceutical product, very high marketing
`
` levels, very low pricing. Those are kind of
`
` work where I reject those specifically as an
`
` economist, as materially contributing to
`
` success. So whether you include that in the
`
` affirmative analysis or not, we can do it
`
` either way.
`
` But certainly through paragraph 53
`
` relates to the direct nexus question.
`
` Q. Okay. But the paragraphs directing
`
` to the merits of the invention, meaning the
`
` subject matter of the invention as you
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` understand it, are discussed in paragraphs 46
`
` through 50; would you agree?
`
` MR. OLSON: Objection to form.
`
` A. Well, there are understandings I
`
` receive on, as you call it, the merits of the
`
` invention that are put forward in paragraph
`
` 44. Some of those are understandings.
`
` Beyond that I've taken those
`
` understandings and I do additional work to
`
` understand, as a matter of usage and
`
` economics, how the benefits that I understand
`
` are associated with the patented invention
`
` contribute to observed success for Zytiga
`
` therapy and Zytiga, the product.
`
` Q. Okay. So section (b), "Zytiga
`
` Commercial Success Due in Significant Part to
`
` the Claims of the '438 Patent," includes
`
` section, subsections 1, 2 and -- let's just
`
` start with 1 and 2, correct?
`
` MR. OLSON: Objection to form.
`
` A. It includes 1 and 2. It has other
`
` sections, but one 1 and 2 are two of the
`
` sections.
`
` Q. And section 1 is entitled, "The
`
` '438 Patent Covers the Only FDA Approved Use
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` of Zytiga," correct?
`
` A. Yes.
`
` Q. And section 2 is entitled,
`
` "Physicians Value Zytiga the Combination of
`
` Abiraterone Acetate and Prednisone For Its
`
` Therapeutic Survival Benefit," correct?
`
` A. Essentially, yes, that's what the
`
` section reads.
`
` Q. Let's discuss your understanding of
`
` the Zytiga product.
`
` What is the active ingredient in
`
` Zytiga?
`
` MR. OLSON: Objection to form.
`
` A. Zytiga, as its own pill, as I
`
` understand it, the actual ingredient is
`
` abiraterone acetate.
`
` Q. Okay.
`
` MS. RATHINAM: Can I have
`
` Exhibit 1065.
`
` Q. And do you agree that this is, this
`
` exhibit is entitled, "Highlights of
`
` Prescribing Information"?
`
` A. I'm not sure I would agree t
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