4/26/2017
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`Wockhardt Bio AG v. Janssen Oncology, Inc.
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`Paul A. Godley
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` __________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________
`WOCKHARDT BIO AG,
` Petitioner,
`v. Case IPR2016-01582
`JANSSEN ONCOLOGY, INC., Patent 8,822,438 B2
` Patent Owner.
`____________________________________________________
`
` VIDEOTAPED DEPOSITION OF
` PAUL A. GODLEY, M.D., Ph.D., MPP
` Chapel Hill, North Carolina
` Wednesday, April 26th, 2017
`
` Reported in Stenotype by
` Amy A. Brauser, RPR, RMR, CRR
` Transcript produced by computer-aided transcription
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`202-232-0646
`
`JANSSEN EXHIBIT 2185
`Wockhardt v. Janssen IPR2016-01582
`
`

`

`4/26/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
`
` INDEX OF EXAMINATIONS
`By Ms. Donovan . . . . . . . . . . . . . . Page 9, 192
`By Mr. Powers . . . . . . . . . . . . . . .Page 186
`
` INDEX OF EXHIBITS
`Janssen Exhibit 2175 Notice of Deposition 11
`Janssen Exhibit 2176 ClinicalTrials.gov 77
` study synopsis
`Janssen Exhibit 2177 Reply Declaration of 138
` Marc B. Garnick, M.D. in support of
` Petition for Inter Partes Review of U.S.
` Patent No. 8,822,428
`
`Page 4
`
` PREVIOUSLY MARKED EXHIBITS
`Wockhardt Exhibit 1002 Declaration of 21
` Paul A. Godley, M.D., Ph.D., MPP
`Wockhardt Exhibit 1004 Prostate Specific 119
` Antigen for Assessing Response to
` Ketoconazole and Prednisone in Patients
` with Hormone Refractory Metastatic
` Prostate Cancer
`Wockhardt Exhibit 1005 Hormonal impact of 127
` the 17-a-hydroxylase/C17,20-lyase
` inhibitor abiraterone acetate (CB7630)
` in patients with prostate cancer
`Wockhardt Exhibit 1013 High-Dose 57
` Ketoconazole in Advanced
` Hormone-Refractory Prostate Cancer:
` Endocrinologic and Clinical Effects
`Wockhardt Exhibit 1022 Selective Inhibition 52
` of CYP17 with Abiraterone Acetate is Highly
` Active in the Treatment of
` Castration-Resistant Prostate Cancer
`Wockhardt Exhibit 1026 Serum Prostate-Specific 127
` Antigen Decline as a Marker of Clinical
` Outcome in Hormone-Refractory Prostate
` Cancer Patients: Association with
` Progression-Free Survival, Pain End
` Points, and Survival
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` APPEARANCES
`ON BEHALF OF THE PETITIONER:
` R. WILSON POWERS III, Ph.D., Esquire
` Sterne, Kessler, Goldstein & Fox PLLC
` 1100 New York Avenue, NW
` Washington, DC 20005
` (202) 371-2600
` (202) 371-2540 Fax
` tpowers@skgf.com
`
`ON BEHALF OF THE PATENT OWNER:
` BINDU DONOVAN, Esquire
` Sidley Austin, LLP
` 787 Seventh Avenue
` New York, New York 10019
` (212) 839-8742
` (212) 839-5599 Fax
` bdonovan@sidley.com
`
`
`
`Page 2
`
` VIDEOTAPED DEPOSITION OF PAUL A. GODLEY,
`M.D., Ph.D., MPP, a witness called on behalf of Patent
`Owner, before Amy A. Brauser, Notary Public, in and
`for the State of North Carolina, at the Rizzo Center,
`150 Dubose Home Lane, Chapel Hill, North Carolina, on
`Wednesday, the 26th day of April, 2017, commencing at
`9:36 a.m.
` * * * * * * * *
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`Page 5
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`202-232-0646
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`

`

`4/26/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
`
` PREVIOUSLY MARKED EXHIBITS (con't)
`Wockhardt Exhibit 1030 United States Patent 175
` 5,604,213
`Wockhardt Exhibit 1040 New England Journal 44
` of Medicine article The Use of
` Ketoconazole as an Inhibitor of Steroid
` Production
`Wockhardt Exhibit 1083 Low Doses of Oral 48
` Dexamethasone for Hormone-Refractory
` Prostate Carcinoma
`Wockhardt Exhibit 1096 Significant and 72
` Sustained Antitumor Activity in
` Post-Docetaxel, Castration-Resistant
` Prostate Cancer with the CYP17 Inhibitor
` Abiraterone Acetate
`Wockhardt Exhibit 1104 Declaration of 16
` Paul A. Godley, M.D., Ph.D., MPP
`Janssen Exhibit 2015 Declaration of 179
` Marc B. Garnick, M.D.
`Janssen Exhibit 2016 Deposition transcript 182
` of Marc B. Garnick, M.D. of
` February 16, 2017
`
`Page 6
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` PREVIOUSLY MARKED EXHIBITS (con't)
`Janssen Exhibit 2057 Eligibility and 116
` Response Guidelines for Phase II
` Clinical Trials in Androgen-Independent
` Prostate Cancer: Recommendations from
` the Prostate-Specific Antigen Working Group
`Janssen Exhibit 2063 Antiandrogen 158
` Withdrawal Alone or in Combination with
` Ketoconazole in Androgen-Independent
` Prostate Cancer Patients: A Phase III
` Trial (CALGB 9583)
`Janssen Exhibit 2064 Randomized Phase-2 167
` trial of ketoconazole and
` ketoconazole/doxorubicin in androgen
` independent prostate cancer
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` P R O C E E D I N G S
` THE VIDEOGRAPHER: We're now on record.
` My name is Brad Smith, a videographer for Golkow
` Technologies. Today's date is April the 26th of
` 2017 and the time on the video monitor is
` 9:36 a.m. This video deposition is being held
` in Chapel Hill, North Carolina. It's being
` taken in the matter of Wockhardt Bio Ag,
` Petitioner, versus Janssen Oncology, Inc.,
` Patent Owner. It's for the United States Patent
` and Trademark Office before the Patent Trial and
` Appeal Board. The deponent today is Dr. Paul A.
` Godley.
` Now will counsel, please, now introduce
` themselves for the record and then our court
` reporter will swear in the witness.
` MR. POWERS: Sure. This is Rob Powers
` III from Sterne Kessler Goldstein & Fox on
` behalf of Wockhardt Bio AG.
` MS. DONOVAN: Okay. And Bindu Donovan
` from Sidley Austin, LLP on behalf of Janssen
` Oncology, Inc.
`
`Page 8
`
` PAUL A. GODLEY, M.D., Ph.D., MPP,
`having been first duly sworn to tell the truth, was
`examined and testified as follows:
` EXAMINATION
`BY MS. DONOVAN:
` Q. Good morning, Doctor.
` A. Good morning.
` Q. Could you, please, state your full name
`and home address for the record?
` A. Paul Alfonso Godley. My home address is
`101 Songbird Lane in Chapel Hill, North Carolina.
` Q. And you've been deposed previously,
`correct?
` A. I have.
` Q. Okay. And, in fact, you were deposed in
`this matter in March of this year; is that correct,
`sir?
` A. I believe it was March.
` Q. So you're generally familiar with the
`procedure?
` A. I'm generally familiar with the procedure,
`yes.
`
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`202-232-0646
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`

`

`4/26/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
`
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` Q. I'm going to just quickly review some
`background items. Most importantly, I'll be asking
`you questions. If there's a question that you don't
`understand, please, let me know and I will clarify it
`for you or rephrase it. I will assume that if you
`answer a question you -- that you have heard and
`understood my question. Is that okay?
` A. That is okay.
` Q. And the court reporter, as you know, is
`transcribing your answers and, therefore, I request
`that you answer the questions verbally. Okay?
` A. Yes.
` Q. And we will try to take a break every
`hour. If you need a break, then, please, let me know
`and we will definitely -- if you request a break, I'll
`be happy to break the proceeding but will request that
`you answer any question that's pending before we take
`a break. Okay?
` A. That is okay.
` Q. All right. Sir, is there any reason why
`you cannot give complete and accurate testimony today?
` A. Not that I know of.
`
`Page 10
`
` (JANSSEN EXHIBIT NUMBER 2175 WAS MARKED FOR
` IDENTIFICATION)
`BY MS. DONOVAN:
` Q. I've placed in front of you a document
`that's been marked Janssen Exhibit 2175. Have you
`seen this document before today, sir?
` MR. POWERS: May I have a copy of it,
` please?
` MS. DONOVAN: And I'll just state for
` the record this document is entitled Patent
` Owner's Notice of Deposition of Paul A. Godley,
` M.D., Ph.D., M.P.P.
` THE WITNESS: This is the first time
` I've seen this document as far as I know.
`BY MS. DONOVAN:
` Q. Okay. Do you understand that you are
`testifying here in this proceeding subject to a Notice
`of Deposition?
` A. I do understand that.
` Q. Okay. Very good.
` What did you do to prepare for your
`deposition today, sir?
`
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` A. I reviewed my declaration, I reviewed the
`exhibits that I cited in the deposition, I worked with
`my attorneys to prepare.
` Q. Okay. And you said you "reviewed my
`declaration," are you referring to your reply
`declaration --
` A. I'm refer --
` Q. -- in this proceeding?
` A. I am referring to my reply declaration,
`yes.
` Q. Did you also review your original
`declaration in preparation for your deposition today?
` A. I did not rereview my original
`declaration.
` Q. Okay. And you, just to clarify the
`record, said "I reviewed the exhibits that I cited in
`the deposition," did you mean to say you reviewed the
`exhibits cited in your reply declaration?
` A. That is correct. I reviewed the exhibits
`I cited in my reply declaration.
` Q. Did you also review, in preparation for
`today, exhibits that were cited in your original
`Page 12
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`declaration?
` A. I did not review those exhibits.
` Q. Okay. And you also stated that you met
`with your counsel, I believe. You worked with your
`attorneys to prepare for your deposition today? Did
`you meet with counsel in preparation for your
`deposition today?
` A. I did.
` Q. Okay. Who did you meet with?
` A. I met with my counsel, Trey.
` Q. Was that one meeting or more than one in
`preparation for your deposition today?
` A. It was at least one.
` Q. Could you -- all right, go ahead.
` A. At least one meeting in person and one
`meeting over the phone.
` Q. And when did you meet with Mr.?
` MR. POWERS: Powers.
`BY MS. DONOVAN:
` Q. Powers in person?
` A. I met with him yesterday.
` Q. Okay. And when did you speak to
`Page 13
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`202-232-0646
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`

`

`4/26/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
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`Mr. Powers by telephone?
` A. That would have been mid April.
` Q. Was that after you submitted your reply
`declaration, sir? And I'll represent to you your
`reply declaration was submitted on April 19th.
` A. That was before I submitted my reply
`declaration.
` Q. Yesterday in your in-person meeting, was
`anyone else present other than Mr. Powers?
` A. No one else was present.
` Q. Okay. And during your telephone
`conversation or telephonic meeting with counsel, were
`there -- was anyone else participating in that
`telephonic meeting?
` A. There were -- there was an associate of
`Dr. -- of Mr. Powers that was also present.
` Q. Do you remember the associate's name?
` A. I couldn't remember Mr. Powers' name.
` Q. He's going to try not to take that
`personally.
` MR. POWERS: I will try.
`
`Page 14
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`BY MS. DONOVAN:
` Q. Okay. And your meeting yesterday in
`person with Mr. Powers, about how long did you meet
`for?
` A. Possibly four hours.
` Q. In preparing for your deposition, other
`than counsel, did you meet with any nonattorneys
`either in person or by telephone, to your knowledge?
` A. Other than the associate -- Mr. Powers'
`associate, I have not met with another person.
` Q. Okay. So you have not had any telephonic
`conversations with someone named Dr. Ian McKeague?
` A. No, I haven't.
` Q. Okay. And not -- no in-person meetings
`with Dr. McKeague either, correct?
` A. No.
` Q. Okay. And you've not had any in-person or
`telephonic meetings with a Dr. Robert Stoner; is that
`correct?
` A. I have not.
` Q. Okay.
` Sir, I'm placing in front of you a copy of
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`Wockhardt Exhibit 1104, and I see that you, in fact,
`have a copy of that in front of you. Do you recognize
`this document, sir?
` A. I do.
` Q. This is your reply declaration that's been
`submitted in this matter, correct?
` A. That is correct.
` Q. Okay. If you could look at the last page
`of Exhibit 1104, please, sir. The very last page.
`It's --
` A. On the back.
` Q. Yes. Is that your signature that appears
`on the very last page of Exhibit 1104?
` A. That is.
` Q. Okay. You signed your declaration on
`April 14th, 2017; is that correct, sir?
` A. That is correct.
` Q. Were additional changes made to the reply
`declaration after you signed it on April 14th, 2017?
` A. Not that I'm aware of.
` Q. Okay. Is WCK 1104, your reply
`declaration, an accurate statement of the reply
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`opinions you have reached in this case?
` A. It is an accurate reflection of my
`opinions, yes.
` Q. And do you have any corrections that you'd
`like to make to -- today to Wockhardt Exhibit 1104?
` A. I do not.
` Q. Okay. And did you write your reply
`declaration yourself, sir?
` A. I wrote it in conjunction with my
`attorneys.
` Q. Who prepared the first draft of the
`declaration, sir?
` A. My attorneys prepared the first draft.
` Q. And about how many drafts were prepared,
`to your recollection?
` MR. POWERS: Objection, relevance.
` THE WITNESS: At least two drafts were
` prepared.
`BY MS. DONOVAN:
` Q. Okay. And about how much time did you
`spend in preparing your reply declaration?
` A. I spent maybe eight hours.
`
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`4/26/2017
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
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` Q. And does that eight hours include review
`of the documents that are -- that you considered as
`part of -- in preparation of the reply declaration?
` A. It does include the documents that I
`reviewed, yes.
` Q. So the total amount of time that you spent
`in preparing your reply declaration, including review
`of cited materials, is approximately eight hours; is
`that correct?
` A. That is correct.
` Q. Could you, please, turn to page 2 of your
`reply declaration, sir?
` Page 2 continues -- contains a table that
`continues through to page 6, correct?
` A. Yes, it does.
` Q. Okay. And pages 2 to 6 list materials
`you've considered in providing the opinions in your
`reply declaration, correct?
` A. That is correct.
` Q. Okay. Other than the documents listed on
`pages 2 to 6, did you consider any other documents
`during your preparation of your reply declaration?
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` (WITNESS REVIEWS DOCUMENT)
` A. I think this is what I considered.
` Q. Okay. And --
` A. This is what I used, yes.
` Q. Okay. The table on pages 2 to 6 does not
`list the declaration submitted in this case -- in this
`matter on behalf of Wockhardt by Dr. Ian McKeague and
`Dr. Stoner, correct?
` A. That is --
` Q. And I'm referring to the reply
`declarations of Dr. McKeague and Dr. Stoner.
` A. As far as I can see, it does not.
` Q. Okay. Did you review the reply -- or
`strike that.
` Did you review a declaration submitted in
`this matter by Dr. Ian McKeague?
` A. I did not review Dr. McKeague's
`deposition.
` Q. Declaration.
` A. I'm sorry.
` Q. That's okay.
` A. Declaration.
`
`Page 19
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`Digital Evidence Group C'rt 2017
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` Q. And did you review any declaration
`authored by Dr. Robert Stoner?
` A. I did not review Dr. Stoner's declaration.
` Q. All right. Yes.
` All right. If you look at Paragraph 4 of
`your --
` A. Uh-huh.
` Q. -- reply declaration, sir. It's on
`page 7. About the middle of the Paragraph 4 you refer
`to a POSA, P-O-S-A, correct?
` A. I do refer to POSA on page 7, Paragraph 4,
`yes.
` Q. And what does POSA stand for?
` A. I think I defined it earlier on in there.
` (WITNESS REVIEWS DOCUMENT)
` So it may have been in my previous
`declaration I may have defined POSA.
` Q. Are you applying the same definition of
`POSA that you set forth in your original declaration,
`sir?
` A. Person of ordinary skill in the art, yes.
` Q. Okay. And -- okay. Do you recall what
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`time frame you are applying with regard to the POSA in
`context of giving your opinions on obviousness?
` A. Can I recall it? I believe the time
`frame -- and again, let's see, I don't think I
`restated it in this declaration.
` Q. Let me show you what has been previously
`marked as --
` A. Uh-huh.
` Q. -- WCK 1002. And do you recognize this,
`sir?
` A. It looks like my declaration.
` Q. Your original declaration --
` A. Original declaration.
` Q. -- correct?
` A. Yes.
` Q. And if you could turn to page 11, please.
`Do you see there's a definition of POSA, person of
`ordinary skill in the art?
` A. POSA, yes.
` Q. Okay. So what is the time frame that
`you're applying for the POSA standard?
` A. So the reference is August 25th, 2006.
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`4/26/2017
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`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
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` Q. Okay. So during the course of our
`conversation today, I will refer to the POSA or a
`skilled person or a person of ordinary skill in the
`art. When I do that, will you understand, sir, that
`I'm referring to the person of ordinary skill in the
`art as of August 2006?
` A. I will understand that.
` Q. Okay. Good.
` Now, in performing your obviousness
`analysis in this matter, both your original
`declaration and your reply declaration, did you use
`the prospective of a POSA as you have defined it?
` MR. POWERS: Objection, form.
` THE WITNESS: Yes, I did use a
` prospective of the POSA in forming my
` obviousness argument.
`BY MS. DONOVAN:
` Q. And in so doing, did you also incorporate
`your current understanding of the art of prostate
`cancer treatment in your analysis?
` MR. POWERS: Objection, form.
` THE WITNESS: In forming my obviousness
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` analysis, I used the -- the experience and
` expertise that I would have had or I had on as
` of August 25th, 2006.
`BY MS. DONOVAN:
` Q. And as of August 25th, 2006, were you a
`person of ordinary skill in the art?
` A. I was not, am not a person of ordinary
`skill in the art at that time or now.
` Q. You're a person of extraordinary skill in
`the art; is that correct?
` A. I am an expert.
` Q. Okay.
` A. I -- I'm an expert in prostate cancer
`treatment and prevention, actually.
` Q. Do you consider yourself an expert in the
`treatment and prevention of metastatic
`castration-resistant prostate cancer?
` A. I do.
` Q. How did you ensure that when you conducted
`your analysis you separated your expert knowledge from
`how an ordinary person -- sorry, strike that.
` How did you ensure when you conducted your
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`analysis you separated your expert knowledge from the
`knowledge that a person of ordinary skill in the art
`would have had in 2006?
` A. Part of my practice of medicine I interact
`with nonexperts in the field of prostate cancer, so I
`have a good impression, both now and in August 25th,
`2006, of what an ordinary person would have done and
`what the general practice of prostate cancer care was
`at that time.
` Q. Okay. And what do you mean by
`"nonexperts"?
` A. Well, a person of ordinary skill in the
`art doesn't actually exist since that person knows all
`of the relevant literature so I'm not sure, you know,
`if I have an example of that person, but I do have an
`example of what the current state of practice is and
`what someone who is not specifically an expert in
`prostate cancer would have done under those
`circumstances.
` Q. During the course of your clinical
`practice and based on your expertise in the matter, do
`you feel you have kept abreast of significant
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`developments in the field of prostate cancer in the
`last few decades?
` A. Decades. Yes, I -- I think that I've kept
`abreast of current advances in the literature in --
`relating to prostate cancer.
` Q. Yeah. And let me clarify the decades a
`little bit. So when did you start practicing, sir?
` A. I started practicing -- I began my
`training in -- in medical oncology in July of 1987 and
`I finished my training in July of 1991, so my practice
`evolved during that period.
` Q. Okay. And about when do you feel you
`became an expert in the field of treating prostate
`cancer?
` A. Probably shortly after 1991 when I
`established my own practice specializing in prostate
`cancer.
` Q. Was the approval of docetaxel chemotherapy
`in 2004 a significant development in the field of
`prostate cancer?
` A. Very much so. The approval of docetaxel
`was the first effective -- well, the first
`
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`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
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`chemotherapy agent that was shown to increase survival
`in prostate cancer, so that was important.
` Q. So was the fact that docetaxel showed an
`increase in survival in prostate cancer a significant
`development -- strike that.
` Was the fact that docetaxel showed an
`increase in survival the reason why it was considered
`a significant development in the field of prostate
`cancer?
` MR. POWERS: Objection, form.
` THE WITNESS: Yes. Well, to extend
` that, it -- it was the fact that docetaxel was
` effective in increasing survival in prostate
` cancer after patients had failed endocrine
` therapy and had become castrate resistant.
` That's what made docetaxel a significant advance
` in the treatment of castrate-resistant
` metastatic prostate cancer.
`BY MS. DONOVAN:
` Q. What is -- why -- why is improving -- or
`increasing survival, why was that considered
`important?
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` MR. POWERS: Objection, form.
` THE WITNESS: Well, certainly, I would
` consider it important because that's one of the
` goals of treating cancer patients is to improve
` their survival and -- and relatively few agents
` in prostate cancer have been shown to improve
` survival, so that's -- it's -- so that's
` important.
`BY MS. DONOVAN:
` Q. And that's because for cancer patients,
`prolonging their life is ultimately the goal of
`treatment; is that correct?
` A. For cancer patients, there are a lot of
`goals. Prolonging life, certainly, is one of them.
`Palliation from side effects is another one.
`Certainly, having tumors respond is, in some fashion,
`it may be another. So there are lots of goals, but
`certainly, prolonging survival, particularly in a
`well-tolerated drug or well-tolerated chemotherapy
`agent, is a goal. In -- well . . .
` Q. Are you done or were you going to say
`anything else?
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` A. I wasn't going to make it any clearer.
` Q. Okay.
` A. A nonclarifying statement was going to
`help.
` Q. Let me -- let me ask you this. You said,
`"Well, certainly I would consider it important," when
`I asked you if survival was considered important. As
`of August 2006, would a person of ordinary skill in
`the art have considered increasing survival to be
`important for metastatic castration-resistant prostate
`cancer patient?
` A. My opinion is that a person of ordinary
`skill in the art would have thought that increasing
`survival for metastatic castrate-resistant prostate
`cancer was important, yes.
` Q. In terms of the selection of a treatment
`for a patient with metastatic prostate-resistant
`prostate cancer -- strike that.
` In terms of the selection of a treatment
`for a patient with metastatic castration-resistant
`prostate cancer, do you agree that a physician would
`prefer a drug that had been shown to prolong life over
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`a drug that had been shown not to prolong life?
` A. I would say that prolonging life would be
`a consideration in choosing a drug, a substantial
`consideration, but not the only consideration.
` Q. Can we refer to metastatic
`castrate-resistant --
` A. Right, so we don't have to say it.
` Q. -- prostate cancer as mCRPC? Let's do
`that, that will make things a lot easier.
` A. No problem.
` Q. Okay. Less of a mouthful.
` In terms of selecting between two
`treatments that are equally well-tolerated, do you
`agree that a physician would prefer a drug that has
`been shown to prolong life over a drug that has been
`shown not to prolong life?
` A. Even in that circumstance, factoring in,
`say, patient wishes and goals, the patient may have a
`preference for palliation over extending life, so
`again, it's a consideration, it's an important
`consideration, but it's difficult to make a blanket
`statement that will cover all patients.
`
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`4/26/2017
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`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
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` Q. Okay. And when you refer to palliation,
`what do you mean by palliation?
` A. When I refer to palliation, I am
`discussing quality of life, relief from pain, relief
`from other symptoms that the patient may find
`difficult to tolerate, fatigue, nausea. So relief
`from these symptoms in some patients is going to be
`their major goal and extending life may not be their
`primary goal.
` Q. And what are the circumstances when a
`patient may decide that palliation is their goal? Is
`that usually because their cancer is no longer getting
`better?
` MR. POWERS: Objection, form.
` THE WITNESS: That is not necessarily
` true.
`BY MS. DONOVAN:
` Q. Can you explain to me, sir, why a patient
`might prefer palliation?
` A. Patients have their own preferences in
`terms of what they consider the most important, so
`there are circumstances where a patient may respond to
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`a drug and may be able to tolerate a drug that would
`increase the length of life but would prefer to either
`get palliative treatment or to get no treatment at
`all. So preferences among patients does differ
`widely.
` Q. What about the preference of the
`physician? Do you agree that in terms of selection of
`a treatment for mCRPC, a physician would prefer a drug
`that had been shown to prolong life over a drug that
`has not been shown to prolong life?
` MR. POWERS: Objection, form.
` THE WITNESS: I'm not sure in this
` context if I have a answer directly for that
` question. The -- as a physician, my preference
` is to do what's best for the patient and what's
` best for the patient is often some combination
` of the patient's desires, wishes as best as I
` can interpret them and, you know, the
` recommendations from my expertise and experience
` that -- that I have. And so putting together
` what's possible, what's advisable, what's
` recommended with what's preferred and what's
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` most likely to get the patient to their goals or
` to address the patient's goals, so that mix is
` sort of the art of medicine --
`BY MS. DONOVAN:
` Q. Yes.
` A. -- I guess is trying to figure out
`what -- what's best.
` Q. I understand. Okay.
` You mentioned various aspects of
`palliation?
` A. Yes.
` Q. Quality of life, relief of pain, relief
`from symptoms that are difficult to tolerate, relief
`from nausea. Do you agree that palliation does not
`encompass an anticancer effect? Or let me strike
`that, let me ask you this.
` In your -- your understanding and how you
`use the term palliation, does that encompass an
`anticancer effect?
` A. It -- when I speak of palliation, it can
`include an anticancer effect, but it does not
`necessarily have to include an -- a -- a measurable
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`effect on the tumor.
` Q. Okay.
` Sir, if you could look at Paragraph 4 of
`your reply declaration, and that's on page 7. And in
`Paragraph 4 you set forth your understanding of the
`terms treat, treating, and treatment?
` A. Yes --
` Q. Correct?
` A. -- I do.
` Q. Now, if you look at the first sentence,
`you quote the board's construction of treat, treating,
`and treatment, correct?
` A. That is correct.
` Q. Could you read that quotation into --
`could you just read that first sentence into the
`record, sir?
` A. (Reading)
` Instead, I understand that the
` board has construed the terms treat,
` treating, and treatment to include the
` eradication, removal, modification,
` management, or control of a tumor or
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`4/26/2017
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`Wockhardt Bio AG v. Janssen Oncology, Inc.
`
`Paul A. Godley
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` primary, regional, or metastatic
` cancer cells or tissue and the
` minimization or delay of the spread of
` cancer.
` Q. So the board's construction of the terms
`treat, treating, and treatment contains the phrase,
`And the minimization or delay of the spread of cancer,
`correct?
` A. Those words are included, correct.
` Q. Okay. What do you understand the phrase,
`Mini