Mark J. Ratain, M.D.
`
` 1 UNITED STATES PATENT AND TRADEMARK OFFICE
`
` 2 _________________________________________
`
` 3 BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` 4 _________________________________________
`
` 5
`
` Amerigen Pharmaceuticals Limited and
`
` 6 Argentum Pharmaceuticals LLC
`
` 7 Petitioners
`
` 8 v.
`
` 9 Janssen Oncology, Inc.
`
` 10 Patent Owner
`
` 11 ________________________
`
` 12 Case IPR2016-00286
`
` Patent 8,822,438 B2
`
` _______________________
`
` 13
`
` 14
`
` 15
`
` 16
`
` 17 VIDEOTAPED DEPOSITION OF MARK J. RATAIN, M.D.
`
` 18 January 23, 2017
`
` 19 Chicago, Illinois
`
` 20
`
` 21
`
` 22
`
` GOLKOW TECHNOLOGIES, INC.
`
` 23 877.370.3377 ph | 917.591.5672 fax
`
` deps@golkow.com
`
` 24
`
`Golkow Technologies, Inc.
`
`Page 1 (1)
`
`
`
`JANSSEN EXHIBIT 2124
`Mylan v. Janssen IPR2016-01332
`
`

`

`Mark J. Ratain, M.D.
`Page 2
`
`Page 4
`
` 1
`
` 2
`
` 3
`
` 4
`
` 5
` 6 The videotaped deposition of MARK J. RATAIN, M.D.,
` 7 called by the Patent Owner for examination, taken
` 8 before CORINNE T. MARUT, C.S.R. No. 84-1968,
` 9 Registered Professional Reporter and a Certified
`10 Shorthand Reporter of the State of Illinois, at the
`11 offices of Sidley Austin LLP, Suite 3800, One South
`12 Dearborn Street, Chicago, Illinois, on
`13 January 23, 2017, commencing at 8:57 a.m.
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
` 1 I N D E X
` 2 MARK J. RATAIN, M.D. EXAMINATION
` 3 BY MR. KRAUSE................. 6
` 4
` 5 E X H I B I T S
` 6 REFERENCED EXHIBIT FIRST REFERRED TO
` 7 Amerigen Article by O'Donnell, 51
` Exhibit 1003 et al., "Hormonal
` 8 impact," etc.
` 9 Amerigen Article by Tannock, et 90
` Exhibit 1006 al., "Chemotherapy with
`10 Mitoxantrone," etc.
`11 Amerigen Article by Tannock, et 88
` Exhibit 1022 al., "Docetaxel plus
`12 Prednisone," etc.
`13 Amerigen Declaration of Dr. Mark 7
` Exhibit 1091 J. Ratain
`
`14
`
` Amerigen Article by Richards, et 109
`15 Exhibit 1136 al., "Interactions of
` Abiraterone, Eplerenone,
`16 and Prednisolone," etc.
`17 Janssen Article by Krishnan, et 84
` Exhibit 2024 al., "A Glucocorticoid-
`18 Responsive Mutant
` Androgen Receptor," etc.
`
`19
`20
`21
`22
`23
`24
`
`Page 3
`
` 1 APPEARANCES:
` 2
`
` ON BEHALF OF THE PETITIONERS:
` 3 McNEELY, HARE & WAR LLP
` 5335 Wisconsin Avenue, NW, Suite 440
` 4 Washington, DC 20015
` 202-640-1801
` 5 BY: WILLIAM D. HARE, ESQ.
` bill@miplaw.com
` 6 CHRISTOPHER CASIERI, ESQ.
` chris@miplaw.com
`
` 7
` 8
` 9
`
` ON BEHALF OF THE PATENT OWNER:
`10 SIDLEY AUSTIN LLP
` 787 Seventh Avenue
`11 New York, New York 10019
` 212-839-5696
`12 BY: TODD L. KRAUSE, ESQ.
` tkrause@sidley.com
`
`13
`14
`15
`16 VIDEOTAPED BY: TERRY KUPPERMAN
`17
`18
`19 REPORTED BY: CORINNE T. MARUT, C.S.R. No. 84-1968
`20
`21
`22
`23
`24
`
`Page 5
` 1 THE VIDEOGRAPHER: We are now on the record.
` 2 My name is Terry Kupperman. I am a
` 3 videographer for Golkow Technologies.
` 4 Today's date is January 23, 2017. The
` 5 time is now 8:57 a.m.
` 6 This video deposition is being held in
` 7 Chicago, Illinois in the matter of Amerigen
` 8 Pharmaceuticals Limited vs. Janssen Oncology, Inc.,
` 9 for the United States Patent and Trademark Office.
`10 The deponent's name is
`11 Dr. Mark J. Ratain.
`12 Will counsel please identify yourselves
`13 for the record.
`14 MR. KRAUSE: Todd Krause of Sidley Austin
`15 representing Patent Owner, Janssen.
`16 MR. CASIERI: Chris Casieri of McNeely, Hare &
`17 War representing the Petitioners and with me is
`18 William Hare.
`19 THE VIDEOGRAPHER: Will the Court Reporter
`20 please identify yourself and swear in the witness.
`21 THE REPORTER: My name is Corinne Marut.
`22 (WHEREUPON, the witness was duly
`23 sworn.)
`24 ////
`
`Golkow Technologies, Inc.
`
`Page 2 (2 - 5)
`
`

`

`Mark J. Ratain, M.D.
`Page 6
`
` 1 MARK J. RATAIN, M.D.,
` 2 called as a witness herein, having been first duly
` 3 sworn, was examined and testified as follows:
` 4 EXAMINATION
` 5 BY MR. KRAUSE:
` 6 Q. Good morning, Dr. Ratain.
` 7 A. Good morning.
` 8 Q. Can you please state your name and home
` 9 address for the record.
`10 A. Sure. Mark Jeffrey Ratain. 1040 West
`11 Oakdale, Chicago, 60657.
`12 Q. Have you ever been deposed before?
`13 A. Yes.
`14 Q. There are a few points I'd like to
`15 review before we get started.
`16 If I ask a question that's not clear or
`17 you didn't hear me, please let me know so I can ask
`18 the question again. If you answer, I'll assume you
`19 understood and heard my question. Okay?
`20 A. Okay.
`21 Q. We have a Court Reporter taking down
`22 your answers to my questions. So, please try to
`23 give verbal answers to my questions. Okay?
`24 A. Yes.
`
`Page 7
` 1 Q. We'll try to take breaks about every
` 2 hour or so, but please let me know if you need a
` 3 break. I'll finish whatever question I'm on and we
` 4 can take a break.
` 5 Is there any reason you can't give
` 6 complete and accurate testimony here today?
` 7 A. No.
` 8 Q. I've handed you a document that's been
` 9 previously marked Amerigen Exhibit DX 1091.
`10 Do you recognize this document?
`11 A. Yes.
`12 Q. And is this your declaration in this
`13 matter?
`14 A. Yes.
`15 Q. And is that your signature on the first
`16 page of the declaration?
`17 A. Yes.
`18 Q. Is this declaration an accurate
`19 statement of the opinions that you've reached in
`20 this case?
`21 A. Checking to make sure there is no
`22 missing pages.
`23 Q. Sure.
`24 A. Yes.
`
`Page 8
` 1 Q. Are there any errors in your declaration
` 2 that you're aware of?
` 3 A. Well, I was reviewing it in preparation
` 4 for this. I note that Exhibit A is missing and
` 5 never was apparently -- I thought counsel was doing
` 6 that. That's my error. And I -- there is some
` 7 parentheses missing in some places but nothing --
` 8 no substantive errors.
` 9 Q. When were you first asked to provide
`10 opinions on the subject matter in your declaration?
`11 A. It would have been sometime in the fall.
`12 Q. Can you -- a month maybe, November,
`13 December, early fall, late?
`14 A. It would have been October or November.
`15 Q. Okay. When did you begin working on the
`16 opinions that you have expressed in your
`17 declaration?
`18 A. That was probably in November.
`19 Q. About how many hours total did you spend
`20 working on the declaration from the very beginning
`21 of the time until you signed it?
`22 A. Until? I'm sorry.
`23 Q. Until you signed it.
`24 A. Well, let's see. I've invoiced about 40
`
`Page 9
` 1 hours so far, but I haven't invoiced for my recent
` 2 work. So, and that's -- recently it's been at
` 3 least a day a week. So, I don't know. A lot of
` 4 time.
` 5 Q. A day a week since when?
` 6 A. I would have last invoiced sometime in
` 7 December. I don't -- I just don't remember.
` 8 Q. Sure.
` 9 A. I've obviously put in time since I've
`10 signed it as well.
`11 Q. Do you regularly invoice in the
`12 beginning of the month or the end of the month?
`13 A. There is no regularity to that.
`14 Q. Okay. How did you gather the
`15 information that you relied on in your declaration?
`16 A. First of all, I knew a lot of it and,
`17 second of all, I was asked to primarily respond to
`18 Dr. Rettig. So, I reviewed his declaration. I
`19 reviewed his deposition transcript.
`20 And then I did my own independent review
`21 of what I as a physician and professor call the
`22 literature but you in the law call the prior art.
`23 So, I looked at both literature before the filing
`24 in the context of his opinions regarding motivation
`
`Golkow Technologies, Inc.
`
`Page 3 (6 - 9)
`
`

`

`Mark J. Ratain, M.D.
`Page 10
` 1 and expectation of success and then I looked at
` 2 more recent literature in the context of his
` 3 opinions regarding unexpected results.
` 4 And I used the standard approach I use
` 5 in my daily professional work as a professor,
` 6 physician and investigator and used searches with
` 7 PubMed and Google Scholar.
` 8 Q. And how did you decide which references
` 9 you would identify in your declaration based on the
`10 searches that you performed?
`11 A. Well, as I said, I was asked to respond
`12 to Dr. Rettig and so, you know, I cited references
`13 that -- that supported my opinions.
`14 Q. Did you read every page of every
`15 reference that you cite in your declaration?
`16 A. I think so. It's conceivable there is a
`17 book cited that I didn't read every page of, but I
`18 read every page of any article or book chapter that
`19 was relevant.
`20 Q. Did you speak with anyone other than
`21 Petitioner's counsel in preparing the opinions that
`22 you've expressed in your declaration?
`23 A. No.
`24 Q. You didn't speak with any other
`
`Page 12
` 1 relied on in your declaration that you did not
` 2 identify in your declaration?
` 3 A. I would have to go through and sit here
` 4 and go through it word by word to make sure there
` 5 is nothing else missing.
` 6 Q. Was there ever a draft Exhibit A?
` 7 A. Not that I saw.
` 8 Q. Did you keep a list of the references
` 9 that you were reviewing in the preparation of your
`10 declaration?
`11 A. Not -- not in a formal way, no. I was
`12 relying on counsel for -- to legalize my
`13 declaration, so to speak.
`14 Q. What do you mean by that?
`15 A. To get the references in the proper
`16 legal format.
`17 Q. Did you actually draft your declaration?
`18 A. Yes.
`19 Q. About how many hours did you spend
`20 drafting your declaration?
`21 A. I can't tell you that because I spend a
`22 lot of time reviewing the literature and
`23 formulating my opinions and communicating my
`24 opinions with counsel and making sure they
`
`Page 11
`
` 1 colleagues?
` 2 A. No.
` 3 Q. No other experts?
` 4 A. No.
` 5 Q. And I believe you mentioned that you
` 6 read Dr. Rettig's deposition transcript, is that
` 7 right?
` 8 A. Yes.
` 9 Q. You don't identify Dr. Rettig's
`10 deposition transcript in your declaration, do you?
`11 A. Well, in theory it would have been in
`12 Exhibit A because I certainly reviewed it. I do
`13 note -- I guess it's not cited as specifically, but
`14 there are certainly, you know, for example,
`15 paragraph 29, I say, "I first note that Dr. Rettig
`16 admitted in his deposition that he did not perform
`17 a review of any literature other than that provided
`18 to him by counsel for Janssen."
`19 So, you are technically correct in that
`20 my declaration doesn't cite the exhibit number that
`21 would be associated with his deposition transcript,
`22 but I presume that the basis for that sentence
`23 would be clear to the Board.
`24 Q. Are there any other documents that you
`
`Page 13
` 1 understood what my opinions were and making sure
` 2 that my -- that we were on the same page as how my
` 3 opinions would fit into the case legally.
` 4 And I was not asked to provide any
` 5 opinions on primary obviousness, only to respond to
` 6 Dr. Rettig, and that's therefore the scope of my
` 7 declaration.
` 8 Q. And when was your declaration completed?
` 9 A. It was completed on January 16.
`10 Q. Did you read any deposition transcripts
`11 other than Dr. Rettig's?
`12 A. Yes.
`13 Q. What other deposition transcripts did
`14 you read?
`15 A. I read Dr. Auchus' deposition. I read
`16 Dr. Chodak's deposition. I read Dr. Serels'
`17 deposition. I read Dr. McDuff I believe, is the
`18 economist, his deposition. I don't remember if I
`19 reviewed the other economist's, the one that your
`20 client has retained. And then I've reviewed the
`21 deposition transcripts that have been obtained
`22 since I filed this declaration.
`23 Q. And what transcripts are those?
`24 A. Dr. Serels and Dr. Dorin. And I've also
`
`Golkow Technologies, Inc.
`
`Page 4 (10 - 13)
`
`

`

`Mark J. Ratain, M.D.
`Page 14
`
` 1 reviewed the various petitions, the original
` 2 petition I reviewed, the response, the reply. I've
` 3 reviewed the declarations of the various experts.
` 4 Q. And your declaration doesn't identify
` 5 that you reviewed any of those deposition
` 6 transcripts, isn't that correct?
` 7 A. That would have been in Exhibit A.
` 8 Q. Which doesn't exist?
` 9 A. Which does not exist.
`10 Actually, my declaration does address
`11 the deposition transcripts. I'm sorry. It
`12 addresses the declarations, paragraph 16 where I
`13 note that I reviewed the declaration or at least I
`14 note that the materials discussed in the
`15 declarations, which would imply that I reviewed the
`16 declarations.
`17 Q. Why would saying the materials discussed
`18 in the declarations would imply that you read the
`19 deposition transcripts?
`20 A. No. The declaration. No, you're
`21 correct.
`22 Q. Oh, I'm sorry.
`23 A. Yeah. No.
`24 And, you know, my understanding was that
`
`Page 16
` 1 substantive facts in the case. Isn't that fair to
` 2 say?
` 3 A. I would say it was more for my curiosity
` 4 than as being -- my opinions would be no different.
` 5 My declaration would be no different if I had never
` 6 seen Dr. Auchus' declaration or Dr. Auchus'
` 7 deposition transcript, for example.
` 8 Q. And how would you know that?
` 9 A. I'm just telling you now that I -- I
`10 know a lot of things that -- you could ask me if I
`11 didn't have a particular piece of prior art, how
`12 would that change my opinion. I could give you an
`13 answer to that.
`14 So, I can -- I can say here under oath
`15 that if I had never seen Dr. Auchus' deposition
`16 transcript it wouldn't impact my -- my opinions.
`17 Q. You were referring to paragraph 16 in
`18 your declaration, and this paragraph identifies at
`19 least a portion of what you considered in
`20 formulating your opinion.
`21 This paragraph is the only mention of
`22 the Chodak declaration, is that correct?
`23 A. Yes.
`24 Q. And your declaration provides no
`
`Page 15
` 1 also that I reviewed these other documents, but I
` 2 haven't cited them with the exception of Rettig's
` 3 deposition.
` 4 In other words, they're not -- they --
` 5 it was of interest to me to understand what
` 6 everybody was saying, but it doesn't impact my own
` 7 opinions.
` 8 Q. But it informs your understanding of the
` 9 issues in the case, correct?
`10 A. It informs my understanding of the legal
`11 issues, yes.
`12 Q. And the factual issues, correct?
`13 MR. CASIERI: Object to form.
`14 BY THE WITNESS:
`15 A. I think the factual issues I can -- I
`16 can form my opinions regarding the factual issues,
`17 the scientific medical issues, without reviewing,
`18 for example, the deposition transcript of the
`19 endocrinologists, I mean, because I'm -- I'm not
`20 providing opinions, you know, from their
`21 perspective.
`22 BY MR. KRAUSE:
`23 Q. But it gave you a better understanding
`24 of the experts' views with respect to the
`
`Page 17
` 1 opinions with respect to the opinions expressed by
` 2 Dr. Chodak's declaration, is that right?
` 3 A. That's correct.
` 4 Q. And Dr. Auchus' declaration is also
` 5 mentioned in paragraph 16. It's also mentioned in
` 6 paragraph 19 of your declaration when you refer to
` 7 the standard for a person of ordinary skill that he
` 8 applied, and then paragraph 35 where you say
` 9 Dr. Dorin will address Dr. Auchus' opinions, is
`10 that right?
`11 That's a pretty loaded question.
`12 So, Dr. Auchus is mentioned in paragraph
`13 16, his declaration. He's also mentioned in 19 and
`14 35.
`15 But I guess my question is: Is there
`16 any other mention of Dr. Auchus in your
`17 declaration?
`18 A. Now I'm going to have -- if you're going
`19 to ask me a question like "Is there any other," I'm
`20 going to have to go through and read it. So, if
`21 you want to represent to me that there isn't,
`22 that's fine. Otherwise --
`23 Q. I'm not aware of any. Are you aware of
`24 any as you sit here today?
`
`Golkow Technologies, Inc.
`
`Page 5 (14 - 17)
`
`

`

`Page 20
`
`Mark J. Ratain, M.D.
`Page 18
` 1 A. Well, there may be. But I'm not aware
` 2 of any as I sit here without reviewing every
` 3 paragraph.
` 4 Q. Okay. Go ahead.
` 5 A. So, it's up to you whether you want me
` 6 to -- do you want me to go through it?
` 7 Q. Sure.
` 8 A. I do not see any other mention of
` 9 Dr. Auchus.
`10 Q. So, is it fair to say that your
`11 declaration doesn't provide a substantive rebuttal
`12 to the opinions expressed in Dr. Auchus'
`13 declaration?
`14 MR. CASIERI: Object to form.
`15 BY THE WITNESS:
`16 A. That was -- I was not asked to do that
`17 and therefore did not intend to do that.
`18 BY MR. KRAUSE:
`19 Q. And did you rely on all of the documents
`20 cited in the declaration in formulating the
`21 opinions that you've provided?
`22 A. I considered all of them, yes. That
`23 doesn't mean I agree with every word in every
`24 document.
`
` 1 BY MR. KRAUSE:
` 2 Q. Did you refer to any references
` 3 published after August 26 of 2006 with respect to
` 4 the issues of obviousness per se?
` 5 A. Not the issues of primary obviousness.
` 6 Q. Can you briefly describe your college
` 7 and post-Baccalaureate education.
` 8 A. Sure. I went to college at Harvard. I
` 9 majored in I think it was called biochemical
`10 sciences and then went to medical school at Yale,
`11 did my internal medicine at Johns Hopkins, did
`12 training in hematology and oncology -- and medical
`13 oncology at the University of Chicago, and have
`14 been on the University of Chicago faculty since
`15 1986.
`16 Q. And are you a practicing physician now?
`17 A. Yes.
`18 Q. And what areas do you practice in?
`19 A. I'm the director of our developmental
`20 therapeutics clinic and I also see patients on our
`21 inpatient supportive care service. Supportive
`22 oncology I think is what we call it.
`23 Q. Can you tell me what the developmental
`24 therapeutic clinic is?
`
`Page 19
` 1 Q. Understood. Your declaration cites a
` 2 number of references that were published after
` 3 August 26 of 2006, is that right?
` 4 A. They are cited in the context of
` 5 responding to Dr. Rettig's opinions on secondary
` 6 considerations.
` 7 Q. Is it fair to say that you used these
` 8 post-August 26, 2006 references to inform the
` 9 opinions that you've expressed in your declaration?
`10 MR. CASIERI: Object to form.
`11 BY THE WITNESS:
`12 A. I used them to inform my opinions
`13 regarding whether or not there were any unexpected
`14 results.
`15 BY MR. KRAUSE:
`16 Q. So, is it your position here today that
`17 to the extent you referred to any references
`18 published after August 26 of 2006 with respect to
`19 issues going to obvious, obviousness per se as
`20 opposed to secondary considerations, you didn't
`21 rely on those references, is that your testimony?
`22 MR. CASIERI: Object to form.
`23 BY THE WITNESS:
`24 A. I didn't understand your question.
`
`Page 21
`
` 1 A. It's a -- it's basically where we see
` 2 patients for -- that, you know, either have a
` 3 disease for which no standard therapy exists such
` 4 as, for example, carcinoma of unknown primary or
` 5 some rare cancers or patients for whom have had
` 6 standard therapy and are seeking additional
` 7 investigational treatment options.
` 8 Q. So, is it fair to say that you primarily
` 9 see cancer patients?
`10 A. Yes.
`11 Q. And is there a particular type of cancer
`12 that you focus on?
`13 A. Bad.
`14 Q. Is there any good?
`15 A. Well, there are some that are less bad
`16 than others.
`17 Q. Fair enough.
`18 A. It would not be a good sign for someone
`19 to say that they've seen me.
`20 Q. Understood. Do you have any formal
`21 training in law?
`22 A. No.
`23 Q. And I believe you indicated earlier that
`24 you testified before or have been deposed before.
`
`Golkow Technologies, Inc.
`
`Page 6 (18 - 21)
`
`

`

`Mark J. Ratain, M.D.
`Page 22
`
` 1 I'm sorry. Strike that.
` 2 I believe you testified that you had
` 3 been deposed before. About how many times have you
` 4 been deposed?
` 5 A. Oh. It's a good question. 50 plus.
` 6 Q. In about how many patent cases have you
` 7 been deposed?
` 8 A. Gosh. A very small fraction of that.
` 9 It's less than 10 I think.
`10 Q. And as far as the other cases, what
`11 types of cases were those?
`12 A. All but one were oncology cases. I
`13 shouldn't say that because, you know -- all right.
`14 Everolimus case, actually I testified in
`15 that, and that's actually the patent being
`16 litigated. It's the compound, although my opinions
`17 were limited to issues of secondary considerations,
`18 primarily unexpected results as an oncology
`19 product.
`20 The other non-oncology case I testified
`21 in was the iloperidone litigation where my opinions
`22 were related to pharmacogenomics. The patent is a
`23 method-of-use patent that proposed to use CYP2D6
`24 genotyping to guide dosing of the drug. And so
`
`Page 23
` 1 I -- because of my research and experience in
` 2 pharmacogenomics, I was an expert in that case.
` 3 Q. In the patent cases that you've
` 4 testified in, have you generally been an expert for
` 5 the innovators or generics?
` 6 A. I've never been asked to provide an
` 7 opinion for the innovators. So, they have all been
` 8 on behalf of the generics.
` 9 Q. What do you consider yourself an expert
`10 in?
`11 A. That's -- I'm not sure I understand that
`12 question because that, you know -- my family might
`13 say one thing and my colleagues might say one
`14 thing, but I don't think that's what you really
`15 want to know. So...
`16 Q. I guess I am wondering what you perceive
`17 yourself to be an expert in. Presumably oncology?
`18 Is that --
`19 A. You're asking me professionally now.
`20 Q. Yes, sir.
`21 A. So --
`22 Q. Not sports or singing or what have you.
`23 A. So, you know, I'm trained as a
`24 hematologist, a medical oncologist. I'm board
`
`Page 24
` 1 certified in internal medicine, medical oncology,
` 2 hematology and clinical pharmacology. I direct a
` 3 training program in clinical pharmacology.
` 4 I have issued patents that relate to
` 5 oncology, clinical pharmacology and
` 6 pharmacogenomics. I founded a company that relates
` 7 to pharmacogenomics. I have proposed innovative
` 8 trial designs and widely considered an expert in
` 9 that area. I have consulted to the FDA Clinical
`10 Pharmacology Group.
`11 And, so, my expertise is pretty broad
`12 from the standpoint of clinical pharmacology and
`13 medical oncology.
`14 Q. Do you consider yourself an expert in
`15 the treatment of prostate cancer?
`16 A. Yes.
`17 Q. Do you regularly treat patients with
`18 prostate cancer?
`19 MR. CASIERI: Object to form.
`20 BY THE WITNESS:
`21 A. No.
`22 BY MR. KRAUSE:
`23 Q. Has there ever been a time in your
`24 professional career where you've regularly treated
`
`Page 25
`
` 1 patients with prostate cancer?
` 2 MR. CASIERI: Object to form.
` 3 BY THE WITNESS:
` 4 A. Yes.
` 5 BY MR. KRAUSE:
` 6 Q. And when was that?
` 7 A. It was when we had fewer faculty and
` 8 fewer approved drugs. And these days that, you
` 9 know, we have a lot of junior faculty that have
`10 very specific niches and so my job is really to
`11 advise and mentor them and collaborate with them on
`12 clinical trials.
`13 And, so, I don't -- I don't see any
`14 particular disease, but I collaborate across
`15 diseases with many of my colleagues, both at the
`16 University and across the country and, for that
`17 matter, around the world.
`18 Q. So, you refer to an earlier time where
`19 you might have regularly treated patients with
`20 prostate cancer. Is that in the '80s, the '90s?
`21 When? About what time period are we talking about?
`22 A. It was when we had fewer approved drugs,
`23 and sitting here today I'd have -- you know, I
`24 can't tell you off the top of my head when that
`
`Golkow Technologies, Inc.
`
`Page 7 (22 - 25)
`
`

`

`Mark J. Ratain, M.D.
`Page 26
`
` 1 was.
` 2 Q. Not even a ballpark?
` 3 A. It was more than ten years ago. I see
` 4 some patients with prostate cancer.
` 5 But it's, as I said, we've got people
` 6 that just see prostate cancer and just put those
` 7 patients on clinical trials and I will see them,
` 8 you know, and they will contact me and say, "Do you
` 9 have a clinical -- any open clinical trials for
`10 prostate cancer."
`11 And I'll say, "Yes, but you can sign the
`12 patient up for the trial." They are a
`13 co-investigator on the trials that we run through
`14 our developmental therapeutics clinic.
`15 So, my bias as a physician is that if a
`16 patient has seen one of my colleagues, even though
`17 I could see them and enroll them in a trial, I
`18 would rather have them do it because I think it's
`19 better for the patient.
`20 Q. Okay. In your declaration you refer to
`21 a person of ordinary skill in the art, and this is
`22 around paragraph 18 and 19.
`23 A. Yes.
`24 Q. Based on your understanding of a person
`
`Page 27
`
` 1 of ordinary skill in the art, do you consider
` 2 yourself one?
` 3 A. Well, the answer is yes. But if you're
` 4 going to ask me anything further about that, I
` 5 would like to see Dr. Serels' declaration where the
` 6 specific definition is provided.
` 7 Q. Do you feel that your knowledge exceeds
` 8 that of a person of ordinary skill in the art?
` 9 A. In some ways yes, in some ways no.
`10 Q. In what ways yes and in what ways no?
`11 A. I have far more insight into clinical
`12 pharmacology of drugs than most persons of ordinary
`13 skill.
`14 Q. As you understand it, would a person of
`15 ordinary skill in the art have a sophisticated
`16 understanding of endocrinology?
`17 MR. CASIERI: Object to form.
`18 BY THE WITNESS:
`19 A. Well, so, I think I'd, you know --
`20 you've asked me basically a legal question that's
`21 pertinent to this case and so I can't answer that
`22 without looking at the exact definition that I've
`23 been asked to adopt.
`24 BY MR. KRAUSE:
`
`Page 28
` 1 Q. So, you don't recall precisely what the
` 2 definition is. Is that fair to say?
` 3 A. I don't -- I don't remember word for
` 4 word what that definition is.
` 5 Q. And your declaration doesn't cite where
` 6 you cite a definition for a person of ordinary
` 7 skill, is that correct?
` 8 MR. CASIERI: Object to form.
` 9 BY THE WITNESS:
`10 A. My declaration -- my declaration says
`11 I've been asked to adopt Dr. Serels' definition and
`12 it cites Dr. Serels' declaration. But it does not
`13 reproduce in my declaration the definition.
`14 BY MR. KRAUSE:
`15 Q. But sitting here today you don't have a
`16 recollection of exactly what that definition is, is
`17 that correct?
`18 A. Well --
`19 MR. CASIERI: Object to form.
`20 BY THE WITNESS:
`21 A. I remember that the -- that it includes
`22 either a urologist or medical oncologist and I --
`23 an endocrinologist is not a person of ordinary
`24 skill in this matter. I mean, the specification --
`
`Page 29
` 1 one of the inventors is neither a urologist, a
` 2 medical oncologist, nor for that -- not a physician
` 3 and not a scientist.
` 4 So, one of the inventors being the CEO
` 5 of a company basically said, "I've founded a
` 6 company around a drug I've licensed. Let's see if
` 7 we can get a patent combining it with any other
` 8 drug that exists," and that's what the
` 9 specification says. But -- so, one of the
`10 inventors is certainly not a person of ordinary
`11 skill by anybody's definition.
`12 Q. Well, I think you refer to the fact that
`13 a person -- you understood a person of ordinary
`14 skill to include a urologist or a medical
`15 oncologist.
`16 In your view of a person of ordinary
`17 skill, would that person have the sophisticated
`18 understanding of endocrinology?
`19 MR. CASIERI: Object to form.
`20 BY THE WITNESS:
`21 A. I have adopted Dr. Serels' definition,
`22 and I can't answer your question without seeing
`23 Dr. Serels' declaration.
`24 When I write something and I cite a
`
`Golkow Technologies, Inc.
`
`Page 8 (26 - 29)
`
`

`

`Page 32
`
`Mark J. Ratain, M.D.
`Page 30
` 1 document, in order to conserve space, I don't put
` 2 every word from that document into a declaration or
` 3 a report. I rely on the document I've cited to
` 4 have the details.
` 5 Q. A person of ordinary skill in 2006 would
` 6 not believe that the results of clinical trials are
` 7 predictable, would they?
` 8 MR. CASIERI: Object to form.
` 9 BY THE WITNESS:
`10 A. I'm having trouble hearing you.
`11 BY MR. KRAUSE:
`12 Q. Sure. I'll try to speak up. Sorry.
`13 A person of ordinary skill in the art in
`14 2006, and when I talk about a person of ordinary
`15 skill, I'm referring to somebody in that time
`16 period, August 26 of 2006, would not believe that
`17 the results of clinical trials are predictable, is
`18 that correct?
`19 A. I'm not sure I understand that question
`20 because I don't know what you mean by
`21 "predictable." Do you mean absolute certainty or
`22 do you mean that one could have a reasonable
`23 expectation of what the results are?
`24 Q. Let's take it both ways.
`
` 1 BY MR. KRAUSE:
` 2 Q. For just for that -- that reason alone,
` 3 is that your testimony?
` 4 MR. CASIERI: Object to form.
` 5 BY THE WITNESS:
` 6 A. Well, a lot of treatment guidelines are
` 7 based on expert opinion rather than real data and
` 8 expert opinion is often based on what individual
` 9 physicians have done in their own experience and
`10 believe are effective.
`11 So, you know, something like the NCCN
`12 guidelines, which are widely recognized and used by
`13 Medicare in the context of reimbursement decisions,
`14 one of their criteria, if there are no data, if
`15 there are no trials that are reliable, will use
`16 expert opinions including recommendations.
`17 BY MR. KRAUSE:
`18 Q. A person of ordinary skill in the art
`19 wouldn't treat an undiagnosed condition, would it?
`20 MR. CASIERI: Object to form.
`21 BY THE WITNESS:
`22 A. They might.
`23 BY MR. KRAUSE:
`24 Q. Why is that?
`
`Page 31
` 1 A. Well, one never has absolute certainty.
` 2 Q. Okay.
` 3 A. Because any clinical trial that's done,
` 4 even if it's, quote, "positive," there is still a
` 5 false positive rate reflected in the P-value. So,
` 6 even if the P-value is 0.001, what that's saying is
` 7 there is a one chance in a thousand that this is a
` 8 false positive result. So, therefore, one doesn't
` 9 have absolute certainty as to what the results are
`10 even after the trial has been done.
`11 Q. And would a person of ordinary skill in
`12 the art have believ