UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
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` * * * * * * * * * * * * * * * * * * * *
` MYLAN PHARMACEUTICALS INC., ET AL. :
` PETITIONERS :
` :
` v. :
` :
` JANSSEN ONCOLOGY, INC, :
` PATENT OWNER :
` Case No. IPR2016-01332 :
` U.S. Patent No. 8,822,438 :
` * * * * * * * * * * * * * * * * * * * *
`
` AUDIO VISUAL DEPOSITION OF MARC B. GARNICK, M.D.,
` a witness called on behalf of the Patent Owner,
` pursuant to the provisions of the U.S. Patent and
` Trademark Office, and applicable Rules of Civil
` Procedure, before Lisa McDonald Valdario, (CSR
` #130093), a Registered Professional Reporter,
` Certified Realtime Reporter, and Notary Public in and
` for the Commonwealth of Massachusetts, held at the
` Eliot Hotel, 370 Commonwealth Avenue, Boston,
` Massachusetts 02115, on Monday, April 24, 2017,
` commencing at 9:33 a.m.
`
` Veritext Legal Solutions
` Mid-Atlantic Region
` 1250 Eye Street NW - Suite 350
` Washington, D.C. 20005
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`JANSSEN EXHIBIT 2185
`Mylan v. Janssen IPR2016-01332
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`1 P R O C E E D I N G S
`2 (Document marked Exhibit JSN 2160 for
`3 identification.)
`4 VIDEO OPERATOR: We are now on the record.
`5 My name is Chris Coughlin and I'm the videographer
`6 for Veritext. Today's date is April 24, 2017 and
`7 the time is 9:33 a.m. This video deposition is
`8 being held in Boston, Massachusetts in the matter
`9 of Mylan Pharmaceuticals Inc. et al versus Janssen
`10 Oncology Inc., Patent Owner, in reference to
`11 Patent Number 8,822,438 B2.
`12 The deponent is Dr. Marc B. Garnick. Will
`13 counsel please identify yourselves for the record
`14 and state who you represent.
`15 MS. DONOVAN: Bindu Donovan on behalf of
`16 Patent Owner, Janssen Oncology, and with me is
`17 Alyssa Monsen, and we are both from Sidley Austin,
`18 LLP.
`19 MR. BEEL: Bryan Beel from Perkins Coie on
`20 behalf of Petitioner, Mylan Pharmaceuticals.
`21 VIDEO OPERATOR: The court reporter is Lisa
`22 M. Valdario and she will now swear in the witness.
`23 MARC B. GARNICK, M.D.
`24 A witness called for examination, having been
`25 duly sworn, testified as follows:
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`1 DIRECT EXAMINATION
`2 BY MS. DONOVAN:
`3 Q Morning, Dr. Garnick.
`4 A Good morning.
`5 Q Could you please state your full name and home
`6 address for the record.
`7 A Marc Bennett Garnick, G A R N I C K, 289
`8 Marlborough Street, Boston, Massachusetts 02116.
`9 Q And you've had your deposition taken before today,
`10 correct?
`11 A Yes, I have.
`12 Q And in fact, you were previously deposed in this
`13 proceeding in February of this year, is that
`14 right?
`15 A I believe so. I can't remember the specific date.
`16 Q Okay. Well, just for background, you're generally
`17 familiar with the deposition procedure, sir?
`18 A Yes, I am.
`19 Q I'd just like to remind you of a couple of items.
`20 I am going to be asking you questions. If
`21 there is a question you don't understand, then
`22 please ask me to repeat it, or let me know if
`23 there is something you don't understand and I will
`24 clarify it. If you answer a question, I'm going
`25 to assume that you have heard and understood the
`
`1 APPEARANCES:
`2 PERKINS COIE, LLP
` 1120 NW Couch Street, 10th floor
`3 Portland, Oregon 97209-4128
` BY: Bryan D. Beel, Ph.D., Esquire
`4 bbeel@perkinscoie.com
` 503.727.2116
`5 Attorney for the Petitioner,
` Mylan Pharmaceuticals Inc.
`
`67
`
` SIDLEY AUSTIN, LLP
` 787 Seventh Avenue
`8 New York, New York 10019
` BY: Bindu Donovan, Esquire
`9 bdonovan@sidley.com
` and Alyssa B. Monsen, Esquire
`10 amonsen@sidley.com
` 212.839.5346
`11 Attorneys for the Patent Owner
`12
`13 ALSO PRESENT: Christopher Coughlin, videographer
`14
`15
`16
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`20
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`25
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`1 I N D E X
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`2 WITNESS DIRECT CROSS REDIRECT RECROSS
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`3 MARC B. GARNICK, M.D.
`
`4 BY MS. DONOVAN 5
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` E X H I B I T S
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`5 6 7
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`8 No. Description Page
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`9 EXHIBIT JSN 2160 Notice of Taking Deposition 4
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`10 EXHIBIT JSN 2161 Clinicaltrials.gov Study 75
`
`11 re: COU-AA-003
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`12 EXHIBIT JSN 2162 Clinicaltrials.gov Study 75
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`13 re: COU-AA-004
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`14 EXHIBIT JSN 2163 NEJM article, 9/24/87 106
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`15 EXHIBIT JSN 2164 Dr. Garnick's '017 patent 136
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`16
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`17
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`18 ***PREVIOUSLY MARKED EXHIBITS THAT WERE REFERENCED IN THE
`
`19 DEPOSITION -- 1104, 1091, 1096, 1117, 1107, 1065, 1002,
`
`20 1003, 1004, 2015, 2014
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`1 question. Is that okay?
`2 A Yes.
`3 Q Okay. And just as a reminder, we have a court
`4 reporter who is transcribing your answers, and I'd
`5 request that you answer your questions orally. Do
`6 you understand that, sir?
`7 A Yes, I do.
`8 Q And we'll take a break every hour. If you need a
`9 break, please do request one, and the only thing I
`10 request is that we -- you finish answering a
`11 question and then we will take a break. Okay?
`12 A Yes.
`13 Q Okay. Is there any reason why you can't give
`14 complete and accurate testimony today, sir?
`15 A Not to my knowledge.
`16 Q What did you do to prepare for your deposition
`17 today?
`18 A I've done an enormous amount of things in
`19 preparation for the deposition. Specifically, I
`20 reviewed the response that Dr. Rettig provided,
`21 basically going through his declaration and the
`22 Exhibits that he provided. I formulated almost a
`23 point by point response to his response to my
`24 initial declaration and portions of my deposition.
`25 I reviewed information that I was aware of to help
`
`1 if I knew the exact date that I received Dr.
`2 Rettig's declaration.
`3 Q Okay.
`4 So Dr. Rettig's -- the patent owner response
`5 and Dr. Rettig's declaration was submitted on
`6 March 8 of this year, so if you can tell me, sir,
`7 about how many telephonic meetings you had with
`8 Perkins Coie from March 8 to the present in
`9 preparation for your deposition.
`10 A Well, assuming that I received Dr. Rettig's
`11 declaration probably sometime within that week or
`12 10 days thereafter, a guesstimate, I would say, so
`13 that would essentially be about five weeks. I
`14 would say we had telephonic conversations at least
`15 twice per week, and in the last week, almost
`16 daily.
`17 Q Okay. And in the last week when you spoke almost
`18 daily, about how long did your conversations last?
`19 A Well, on one day, essentially, I set aside the
`20 entire day as there were -- as I was finalizing my
`21 declaration.
`22 Q Okay.
`23 A So there were stops and starts. So it was
`24 essentially a full day with stops and starts.
`25 Q And other meetings?
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`Page 7
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`Page 9
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`1 support and buttress my opinions, and I met with
`2 counsel from Perkins Coie.
`3 Q Okay.
`4 A As well as preparing my declaration.
`5 Q And in terms of your meetings with counsel from
`6 Perkins Coie, when did you meet with them in
`7 preparation for your deposition today?
`8 A Well, I met on numerous occasions, either
`9 telephonically and yesterday in person. But
`10 telephonically, basically we've had meetings
`11 really since I received Dr. Rettig's declaration
`12 in response to my initial declaration and
`13 deposition.
`14 Q How many telephonic meetings have you had since
`15 you received Dr. Rettig's declaration?
`16 MR. BEEL: I'm going to object just for a
`17 moment and just counsel Dr. Garnick not to reveal
`18 the content of our communications. Go ahead.
`19 A TNTC, too numerous to count.
`20 Q Well, I would love an estimate, sir.
`21 A I can't give you an exact estimate, but I could
`22 provide that information.
`23 Q You can't give me an estimate right now?
`24 A Well, if you give me the date -- I could give
`25 that, I could give that a very reasonable estimate
`
`1 A They could be several minutes to an hour.
`2 Q And you said you -- did you say you met with
`3 counsel yesterday?
`4 A Yes, I did.
`5 Q How long did you meet with counsel for yesterday?
`6 A All day. All day.
`7 Q And who did you meet with?
`8 A I met with the young gentleman sitting to my
`9 right, Attorney Beel.
`10 MR. BEEL: You left out handsome. But go
`11 ahead.
`12 A And Brandon White, Attorney Brandon White.
`13 Q Other than counsel, did you meet with anyone else
`14 in preparation for your deposition today?
`15 A I don't understand the question.
`16 Q Did you have any in-person meeting with anyone
`17 else other than counsel in preparation for your
`18 deposition today?
`19 A When you refer to counsel, you mean Attorney Beel
`20 and White?
`21 Q I mean a lawyer.
`22 A Did I have an in-person meeting with another
`23 lawyer from Perkins Coie?
`24 Q No, with someone other than an attorney.
`25 A About this matter?
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`1 Q That's correct?
`2 A No, I haven't.
`3 Q Okay.
`4 A In person.
`5 Q Let's start with in person.
`6 A Okay.
`7 Q Did you have any meetings with anyone other than
`8 an attorney in preparation for your deposition
`9 today?
`10 A No.
`11 Q Did you speak -- well, did you have any -- strike
`12 that.
`13 Did you have any meeting with anyone other
`14 than counsel in any other form in preparation for
`15 your deposition today?
`16 A I don't understand what you mean of counsel. Does
`17 that mean any attorney within Perkins Coie? Does
`18 that mean any attorney outside of Perkins Coie?
`19 Q You know, it's not a difficult question.
`20 A Well, I find it -- I'm sorry, I find you --
`21 Q Let's do it again.
`22 A All right. Fine.
`23 Q All right. I'm asking whether you had any
`24 meetings with individuals who were not lawyers
`25 that were also not in person in preparation for
`
`1 Dr. Bantle?
`2 A No, I did not.
`3 Q And are you aware Mylan has submitted a
`4 declaration from Doctor Ivan Hofmann in this case?
`5 A Yes, I am.
`6 Q In preparing your declaration, did you have any
`7 discussions with Dr. Hofmann?
`8 A No, I did not.
`9 Q During the course of this matter, have you had any
`10 discussions with Dr. Hofmann?
`11 A No, I have not.
`12 Q And in preparation -- that includes in preparation
`13 for your deposition today, is that right?
`14 A That is correct.
`15 Q Okay. Have you spoken in the course of preparing
`16 your reply declaration or -- strike that.
`17 In the course of your work on this matter,
`18 have you spoken to anyone at Mylan?
`19 A Not to my knowledge.
`20 Q Dr. Garnick, I've placed in front of you an
`21 Exhibit that we had the court reporter mark
`22 earlier for your convenience. It's JSN 2160. It
`23 is the Patent Owner's Notice of Deposition of Marc
`24 B. Garnick M.D. Do you see that, sir?
`25 A Yes, I do.
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`1 your deposition today.
`2 A Well, it's a difficult question for me because
`3 there were certain telephone conversations in
`4 which other people were on the telephone call, and
`5 I do not know if they were or were not attorneys.
`6 Q Okay. Let me ask you this, did you -- are you
`7 aware Mylan has submitted declarations from
`8 someone named Dr. Ian McKeague in this?
`9 A Yes, I am aware.
`10 Q Did you have any discussions with Dr. McKeague in
`11 the context of preparing your declaration?
`12 A No, I did not.
`13 Q And in preparation for your deposition today, did
`14 you have any discussions with Dr. McKeague?
`15 A No, I did not.
`16 Q And are you aware Mylan has also submitted a
`17 declaration from Doctor John Bantle in this
`18 matter?
`19 A Yes, I am.
`20 Q Did you have any discussions with Dr. Bantle in
`21 the course of preparing your declaration for this
`22 matter?
`23 A No, I did not.
`24 Q And in the context of preparing for your
`25 deposition, did you have any conversations with
`
`1 Q Have you seen this document before today, sir?
`2 A No, I have not.
`3 Q Do you understand that you are testifying in this
`4 matter pursuant to the Notice of Deposition that I
`5 have -- that has been marked as JSN 2160?
`6 A Well, I knew I was being deposed for this
`7 deposition and I assumed there was a document to
`8 state such, but I had not seen this document prior
`9 to today.
`10 Q Okay. All right. Let me hand you a document
`11 that's been marked as Mylan Exhibit 1104. Have
`12 you seen Mylan Exhibit 1104 before today, sir?
`13 A Yes, I have.
`14 Q Could you tell me, please, what Mylan Exhibit 1104
`15 is?
`16 A It's my declaration in support of Mylan and
`17 essentially a response to Dr. Rettig's
`18 declaration.
`19 Q And if you could please turn to page 69 of Mylan
`20 Exhibit 1104, sir.
`21 A Okay, yeah. Yes.
`22 Q Is that your signature that appears on page 69,
`23 sir?
`24 A Yes, it is.
`25 Q Okay. Does Mylan Exhibit 1104 contain an accurate
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`1 statement of the reply opinions that you've
`2 reached in this case?
`3 A Yes, it does.
`4 Q Do you have any corrections that you wish to make
`5 to your declaration?
`6 A There were one or two typos.
`7 Q Do you wish to correct them at this time?
`8 A No, they were insignificant.
`9 Q Did you write your -- you see the title, sir, it
`10 says: Reply Declaration of Marc Garnick M.D. In
`11 Support of Petition for Inter Partes Review of
`12 U.S. Patent Number 8,822,438?
`13 A Yes, I do.
`14 Q If I refer to this as your reply declaration, will
`15 you understand I'm referring to Exhibit 1104?
`16 A Yes.
`17 Q Did you write your reply declaration yourself,
`18 sir?
`19 A Yes, I did.
`20 Q Did you write the first draft or did a lawyer
`21 write the first draft?
`22 A It was a combination.
`23 Q Okay. What do you mean by combination?
`24 A Well, as you look at my declaration, there is a
`25 whole series of conventions that provide the
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`Page 16
`1 providing your opinions in your reply declaration,
`2 is that correct?
`3 A Yes, it is.
`4 Q And are there documents that you have considered
`5 in the context of preparing your reply declaration
`6 that are not listed in Exhibit A?
`7 A Yes.
`8 Q What are those?
`9 A There was -- there were several chapters that I
`10 wrote for Scientific American Medicine in the
`11 1980s that we are still looking for source
`12 identification of those chapters.
`13 Q What do you mean by "looking for source
`14 identification of those chapters"?
`15 A Scientific American Medicine basically provided a
`16 textbook of medicine in a notebook format, and
`17 every probably 10 to 12 weeks there was an update
`18 of previous chapters in which you would take from
`19 the binder the chapter and discard that, and put
`20 the new chapter in. And so it's been difficult to
`21 get all of the versions of the things that I wrote
`22 for Scientific American Medicine in the 1980s.
`23 Q I see. Do you have versions of what you wrote in
`24 the 1980s in your possession?
`25 A I may or may not. I just don't know. It may be
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`1 citations and the legal way of which I assume a
`2 patent declaration is provided. I did not
`3 provide -- I did not write those areas.
`4 Q I see.
`5 A But the content is mine.
`6 Q Did you prepare a first draft of the declaration?
`7 A I prepared multiple, multiple components of the
`8 first draft.
`9 Q And about how many drafts did you go through?
`10 A Well, there was constant editing of the corpus of
`11 the declaration. I would not consider a, you
`12 know, an alteration in one of the paragraphs as a
`13 new draft. So it was essentially two drafts.
`14 Q Okay.
`15 A But with multiple edits in each of those drafts.
`16 Q Okay. If you could look at page 70 of your reply
`17 declaration, sir. Page 70 is titled: Exhibit A,
`18 correct?
`19 A Yes.
`20 Q Okay. And Exhibit A continues through page 83 of
`21 Exhibit 1104, correct?
`22 A Through 84 you said?
`23 Q I said 83.
`24 A 83, yes.
`25 Q Exhibit A lists the materials you considered in
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`1 stored away in some boxes someplace.
`2 Q So did you review those Scientific American
`3 notebook format submissions in preparing for your
`4 reply declaration?
`5 A I could not review the specific chapters, but I
`6 cite information that was provided in those
`7 chapters in one of the citations here.
`8 Q Okay. Could you find for me please what you're
`9 referring to, where you've cited it in your
`10 declaration?
`11 A Yeah, sure. It's Paulson. And there's one other
`12 thing I need to answer your question with as well.
`13 Q Is that paragraph 23, sir?
`14 A Do you want me to look at the citation portion or
`15 the text?
`16 Q You mentioned Paulson, and paragraph 23 listed
`17 Paulson.
`18 A Yeah, I was just trying to find what the Exhibit
`19 number is.
`20 Q There is 1105. Is that what you're referring to?
`21 A 1105. Wait a second. Yes, correct, 1105.
`22 Q I see, just to be clear, 1105 is marked as an
`23 Exhibit in this matter.
`24 A Yes.
`25 Q So in the -- when you said you have considered
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`1 information that is not listed in Exhibit A, what
`2 were you referring to?
`3 A Well, as I mentioned, so if you take a look at
`4 page 15 of my declaration, so that is a diagram
`5 that was in the Scientific American Medicine
`6 chapter that I wrote back in late 1980s, okay.
`7 So there may have been additional -- there
`8 may have been additional prose associated with
`9 that diagram. There may have been other
`10 explanations of that diagram that would have been
`11 accompanied in various additions of Scientific
`12 American Medicine and its updates.
`13 Q I see.
`14 A So as relates to the Scientific American Medicine,
`15 the core component is included in my declaration,
`16 but since we could not identify each and every of
`17 the inserts from Scientific American Medicine, I
`18 did not review that.
`19 Q How many updates were there?
`20 A Oh, I wrote for Scientific American Medicine for
`21 years. As I said, the updates were essentially,
`22 in general, not specifically for my particular
`23 thing, but there were generally updates provided
`24 every 10 to 12 weeks.
`25 Q Okay. And until when did that continue, the
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`1 to clarify?
`2 A The other additional thing is, during the 1980s
`3 and 1990s, mainly in the 1980s, we would have
`4 weekly a discussion among the cancer specialists,
`5 at that time at the Dana Farber Cancer Institute
`6 and the Brigham and Women's Hospital, in which
`7 patients would be discussed that were seen by
`8 physicians caring for patients with cancer, in
`9 which specific issues about management would come
`10 up. And that was a weekly -- that was a weekly
`11 synopsis of every patient that was seen either at
`12 the Dana Farber Cancer Institute or at the Brigham
`13 and Women's Hospital in which a discussion -- it
`14 wasn't a formal tumor board, but it was a listing
`15 of the key aspects of the patient, the patient's
`16 history, and what the management and clinical
`17 decisions were.
`18 Q And you participated in those meetings, is that
`19 correct?
`20 A Oh, on a weekly basis, yes.
`21 Q And when did those meetings end?
`22 A Well, I think they -- I think in that form, they
`23 probably formally ended in the late 1980s or early
`24 1990s, but probably late 1980s. I would be
`25 guessing though.
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`1 updates continue?
`2 A I can't remember.
`3 Q Okay. So presently, your declaration does not
`4 cite to a version of Paulson that is later than
`5 1989, is that correct, sir?
`6 A Well, not exactly. So this was a chapter that I
`7 wrote for a textbook of prostate cancer that Dr.
`8 Paulson had invited me to author, okay. So I
`9 don't know if there's another addition of Paulson,
`10 but I do know that there were several updates in
`11 Scientific American Medicine. And I would have
`12 been pleased to give you -- I would have been
`13 pleased to hand you that chapter from Scientific
`14 American Medicine. Since I did not have it, I
`15 referred to Paulson in which I cite my own work
`16 from Scientific American Medicine.
`17 And there is one other thing as well.
`18 Q One moment.
`19 A Okay.
`20 Q I just want to clarify something. But you did not
`21 review any additional chapters other than what is
`22 cited in your declaration, correct?
`23 A That's correct. Because I didn't have them.
`24 Q Gotcha, okay.
`25 Now, what is the additional thing you'd like
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`Page 21
`1 Q Could you be more specific in the timeframe than
`2 late 1980s?
`3 A No, I can't.
`4 Q What do you mean by late 1980s; after 1985 and
`5 before 1990?
`6 A I'd say after 1985 and definitely probably after
`7 1989, but perhaps 1990 or 1991. But that's a
`8 guess.
`9 Q So these meetings ended about 1991, is that
`10 correct, sir?
`11 A The meetings in that format ended, but the
`12 meetings themselves assumed a different format.
`13 Q And explain that.
`14 A The meetings became more formalized in terms of
`15 the program. The programs in cancer were growing.
`16 There were many more physicians, so in the 1980s
`17 was a relatively small group of people caring for
`18 patients with cancer. And as the science of
`19 cancer became more expanded and the faculties were
`20 increasing, it became more formalized. And the
`21 tumor registrar that created this document that I
`22 don't have copies of, was replaced by some other
`23 administrative person.
`24 Q What do you mean by the tumor registrar?
`25 A So as I said, this listing of patients was done by
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`1 a person within the cancer program that looked at
`2 every -- every new patient that was -- came in
`3 that was discussed at the meeting, and actually
`4 provided a synopsis of that patient's issues that
`5 would be discussed by the physicians at that time.
`6 Q And this -- the tumor registrar that you're
`7 referring to relates to these weekly meetings that
`8 you said ended about 1991, correct?
`9 A That's correct. And I may have been mistaken in
`10 calling her tumor registrar but she was the cancer
`11 coordinator for this meeting. Whether she
`12 actually -- whether she actually had a tumor
`13 registrar title, I don't know, but she was
`14 functioning as one.
`15 Q Understood. And then you said the meetings became
`16 more formalized?
`17 A Yeah. So what happened was everyone was becoming
`18 so specialized that, instead of having a general
`19 topic of discussion that included cancers of
`20 various sites, the people in prostate cancer and
`21 other genitourinary cancers would have their own
`22 meeting. The people in breast cancer would have a
`23 similar meeting. The patients dealing with
`24 hematological cancers would have their own
`25 meeting. So it became very super specialized.
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`1 Q So the meetings prior to 1991 were not focused
`2 just on prostate cancer, is that correct?
`3 A That is correct, yeah.
`4 Q And you said the meetings continued after 1991 and
`5 became super specialized. What was your
`6 involvement in those later specialized meetings?
`7 A Well, I was involved in the genitourinary program.
`8 Q And about what timeframe did these genitourinary
`9 program meetings occur?
`10 A I'd say the early 1990s.
`11 Q When did they end?
`12 A I think they continue on. I assume they continue
`13 on.
`14 Q And when did your involvement in them end?
`15 A Well, I left my -- I changed academic affiliations
`16 in 1996.
`17 Q Okay. So you were no longer affiliated with Dana
`18 Farber after 1996, is that correct?
`19 A Well, I'm a member of the Dana Farber Harvard
`20 Cancer Center, but my clinical practice moved to
`21 the Beth Israel Deaconess Medical Center.
`22 Q So your involvement in the genitourinary program
`23 at Dana Farber ended about 1996, is that correct?
`24 A Yes. Correct.
`25 Q Is there anything else that you have considered in
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`1 the context of preparing your declaration that is
`2 not listed on Exhibit A?
`3 A Well, I do refer to, you know, my involvement as a
`4 consultant oncologist in the 1980s that were
`5 either done as part of tumor boards, not only at
`6 the Dana Farber and the Brigham and Women's
`7 Hospital, but also as a participant in tumor
`8 boards from other institutions, as well as
`9 telephonic conversations that I had with my
`10 colleagues.
`11 Q Do you still practice medicine today, sir?
`12 A Yes, I do.
`13 Q Where are you practicing medicine today?
`14 A I'm at the Beth Israel Deaconess Medical Center in
`15 Boston.
`16 Q Is -- does your practice focus on prostate cancer?
`17 A In general, yes.
`18 Q What do you mean by that?
`19 A 90 percent of my patients have prostate cancer.
`20 Q And what percentage of your patients have
`21 metastatic castration-resistant prostate cancer?
`22 A Of the 90 percent?
`23 Q Yes.
`24 A I would say probably 70 percent of those patients,
`25 60 to 70 percent.
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`Page 25
`1 Your question is metastatic prostate cancer.
`2 Q Metastatic castration-resistant prostate cancer.
`3 A Yeah.
`4 Q 70 percent, is that correct?
`5 A 60 to 70 percent.
`6 Q And what is the remaining 30, 20 to 30 percent?
`7 A Of the prostate cancer patients?
`8 Q Yes.
`9 A Generally, patients with metastatic,
`10 hormonally-sensitive prostate cancer, and patients
`11 with regionally-advanced prostate cancer, and
`12 patients with early stage prostate cancer.
`13 Q What do you mean by "hormonally-sensitive"?
`14 A So those are patients with metastatic prostate
`15 cancer who are responding to first line hormonal
`16 therapy.
`17 Q Do you mean patients who have had androgen
`18 deprivation therapy?
`19 A They're currently receiving androgen deprivation
`20 therapy as their first line therapy.
`21 Q If you could look at your declaration, sir,
`22 please, on page 6, paragraphs 8 to 9.
`23 A Okay.
`24 Q You have a definition there of a person of
`25 ordinary skill in the art, correct?
`
`7 (Pages 22 - 25)
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`Page 28
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`1 A Yes, I do.
`2 Q Am I correct, on paragraph 8, you refer to a
`3 person of ordinary skill in the art, POSA, at the
`4 time of filing of the '438 patent, is that right?
`5 A Yes.
`6 Q And is the time of filing of the '438 patent that
`7 you're referring to there, 2000 -- August 2006?
`8 A I'm sorry, I didn't understand the question.
`9 Q When you refer to a person of ordinary skill in
`10 the art at the time of filing of the '438 patent,
`11 what is the timeframe that you are focusing on?
`12 A Well, my understanding is, my opinions and
`13 declaration deal with someone, a person of
`14 ordinary skill in the art practicing any one of a
`15 variety of disciplines as of the time of the
`16 filing of the '438 patent.
`17 Q Right. And what timeframe are you applying there?
`18 A 2006.
`19 Q Okay.
`20 A Or before.
`21 Q So I will, during the course of our deposition
`22 today, your deposition today, refer to the skilled
`23 person or the person of ordinary skill in the art.
`24 So when I do that, will you understand that I'm
`25 referring to the person of ordinary skill in the
`
`1 medicine since the late 1970s, and I've seen an
`2 extraordinary history of developments, and each of
`3 those developments really, you know, came into --
`4 were significant developments in various time
`5 periods.
`6 So, and with the perspective of decades of
`7 caring for patients, and knowing what was or was
`8 not available, what treatments were or were not
`9 recommended, what side effects were or were not
`10 present, I mean I can remember, I can provide an
`11 evolution of the treatment of patients with
`12 prostate cancer and, you know, so there were
`13 certain significant milestones in the treatment of
`14 patients with prostate cancer, so I'm able to sort
`15 of compartmentalize what happened when.
`16 I was intimately involved and the principal
`17 investigator on one of the most significant drugs
`18 in prostate cancer, so obviously, when that drug
`19 became widely available, that was a very important
`20 milestone.
`21 I remember going to various lectures, both
`22 in the United States and abroad, in which we would
`23 discuss findings of therapies in prostate cancer.
`24 So I can sort of separate pre-2006 and post-2006.
`25 Q When you say you were a principal investigator on
`
`Page 27
`
`1 art as of August 2006?
`2 A Yes.
`3 Q Okay. Now, in providing your analysis, and the
`4 opinions in your reply declaration and your
`5 earlier declaration, did you apply the perspective
`6 of a person of ordinary skill in the art?
`7 A Yes.
`8 Q But you continue to practice medicine today, is
`9 that right?
`10 A Yes.
`11 Q Okay. So in formulating your opinions in your
`12 reply declaration and your earlier declaration,
`13 did you incorporate any of your current
`14 understanding of the art of prostate cancer
`15 treatment into your analysis?
`16 A Well, there's one citation that I have in my
`17 declaration that appeared after 2006, but I
`18 thought it was an extremely important citation to
`19 put in because it was very important to my
`20 opinions.
`21 Q How did you, in conducting your analysis, separate
`22 your knowledge after 2006 from the knowledge of a
`23 person of skill in the art prior to 2006?
`24 MR. BEEL: Objection to form.
`25 A Well, you know, I've been practicing cancer
`
`Page 29
`1 one of the most important developments in prostate
`2 cancer, could you tell me please what you're
`3 referring to?
`4 A I was the academic principal investigator on a
`5 drug called Leuprolide, L E U P R O L I D E, which
`6 was approved in 1984, and remains one of the
`7 mainstays in the management of patients with
`8 prostate, some 30 to 40 years later.
`9 Q And Leuprolide is what you mentioned, a first line
`10 hormonal th