`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, )
`INC., AND WEST-WARD )
`PHARMACEUTICALS INTERNATIONAL )
`LIMITED, )
` )
` Petitioners, )
` ) Case No. IPR2017-01592
` vs. ) Patent No. 8,410,131
` ) Volume I
`NOVARTIS PHARMACEUTICALS )
`CORPORATION, )
` )
` Patent Owner. )
`_________________________________)
`
` DEPOSITION OF ALLAN J. PANTUCK, M.D.
` Los Angeles, California
` Friday, July 27, 2018
`
`Reported by:
`ELIZABETH BORRELLI, CSR No. 7844, CCRR, CLR
`JOB NO. 145237
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` Deposition of ALLAN J. PANTUCK, M.D.,
`Volume I, taken on behalf of Novartis
`Pharmaceuticals Corporation, at 200 UCLA
`Medical Plaza, Suite 140, Los Angeles,
`California 90095, commencing at 8:26 a.m.,
`Friday, July 27, 2018, before Elizabeth
`Borrelli, a Certified Shorthand Reporter in the
`State of California, License No. 7844.
` * * *
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`APPEARANCES OF COUNSEL:
`
`For the Petitioner:
` MERCHANT & GOULD
` BY: DANIEL EVANS, Ph.D.
` Attorney at Law
` 191 Peachtree Street N.E.
`
` Atlanta, Georgia 30303
`
`For the Patent Owner:
`
` Fitzpatrick, Cella, Harper & Scinto
` BY: JARED STRINGHAM
` BY: CHRISTINA SCHWARZ
` BY: SHANNON CLARK
` Attorneys at Law
` 1290 Avenue of the Americas
` New York, New York 10104
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` I N D E X
`WITNESS EXAMINATION
`ALLAN J. PANTUCK, M.D.
`By MR. STRINGHAM ***
`By MR. EVANS ***
`
`Page 4
`
` EXHIBITS
`
`PANTUCK PAGE
`Exhibit 1162 Pantuck Second Declaration List 16
` of Exhibit Paragraph Citations
`
`Exhibit 2112 Article titled "Constitutive 122
` Secretion of Soluble
` Interleukin-2 Receptor by Human
` T Cell Lymphoma Xenografted
` into SCID Mice"
`
` R E F E R E N C E D E X H I B I T S
`
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1007 Document used at the 29
` AACR-NCI-EORTC International
` Conference held in November
` 1999
`
`Exhibit 1081 Hutchinson Reference 33
`
`Exhibit 1083 Document used at 11th 35
` NCI-EORTC-AACR symposium on new
` drugs in cancer therapy
`
`Exhibit 2058 Hidalgo ASCO 2000 abstract 42
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`Exhibit 1082 Hidalgo NCI abstract 44
`Exhibit 1150 Article titled "Pharmaceutical 82
` compositions based on rapamycin
` for treatment of cancerous
` tumors"
`Exhibit 1140 Article titled "Prognostic 105
` Relevance of the mTOR Pathway
` in Renal Cell Carcinoma"
`Exhibit 1063 Document titled "Differences in 117
` phosphorylation of the IL-2R
` associated JAK/STAT proteins
` between HTLV-1 (+),
` IL-2-independent and
` IL-2-dependent cell lines and
` uncultured leukemic cells from
` patients with adult T-cell
` lymphoma/leukemia"
`Exhibit 1075 Article titled "The 127
` immunosuppressive macrolide RAD
` inhibits growth of human
` Epstein-Barr virus-transformed
` B lymphocytes in vitro and in
` vivo"
`Exhibit 1009 Article titled 138
` "Entry-into-human study with
` the novel immunosuppressant SDZ
` RAD in stable renal transplant
` recipients"
`Exhibit 1003 International Application 163
` Published Under the Patent
` Cooperation Treaty
`Exhibit 1153 U.S. Utility Patent Application 174
`Exhibit 1126 Deposition transcript of Dr. 189
` Howard A. Burris
`Exhibit 1006 Article titled "The 198
` rapamycin-sensitive signal
` transduction pathway as a
` target for cancer therapy"
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`Exhibit 1005 Document titled "Abstract #428, 199
` Sirolimus Prevents Tumor
` Progression: mTOR Targeting for
` the Inhibition of Neoplastic
` Progression"
`Exhibit 1147 Ribomustin Product Monograph 204
`Exhibit 1160 Document titled "Amendment" for 213
` Treatment of Solid Tumors with
` Rapamycin Derivatives
`Exhibit 1031 Boni reference from European 215
` Journal of Cancer
`
`Exhibit 1041 Article titled "Spectrum of 217
` Tumor Angiogenesis in the Bone
` Marrow of Children with Acute
` Lymphoblastic Leukemia"
`Exhibit 1021 Patent Application for A61K 221
` 38/31
`
` INFORMATION REQUESTED
`
` (None)
`
` UNANSWERED QUESTIONS
`
` (None)
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`Page 7
` LOS ANGELES, CALIFORNIA; FRIDAY, JULY 27, 2018
` 8:26 A.M.
`
` ALLAN J. PANTUCK, M.D.,
` having been duly administered an oath in
` accordance with CCP 2094, was examined
` and testified as follows:
`
` EXAMINATION
`BY MR. STRINGHAM:
` Q Good morning, Dr. Pantuck.
` A Good morning.
` Q How are you?
` A Good. How are you?
` Q Good. So we introduced ourselves briefly,
`but for the record, my name is Jared Stringham, and
`I'll be asking you questions today.
` And you've been deposed previously in this
`IPR proceeding, correct?
` A Correct.
` Q And is there any reason you cannot testify
`truthfully and to the best of your ability today?
` A No.
` Q You've been deposed before, right?
` A Yes.
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` Q So I'll just briefly go over some ground
`rules for the deposition.
` As you know, we have a court reporter here
`who's recording everything that we say. And so in
`order to keep a clear record, I ask that you try not
`to speak over -- that we try not to speak over each
`other and that you wait until I've finished my
`question before you answer; is that fair?
` A That's fair.
` Q And I'll try to do the same: I'll wait
`until you answer before I ask my next question,
`okay?
` A Okay.
` Q Now, if you I don't understand any of my
`questions, will you ask me to rephrase the question?
` A I will.
` Q And if you don't ask me to rephrase, I'll
`assume that you understood the question, okay?
` A Okay.
` Q Now, I've placed in front of you a stack
`of exhibits that have already been submitted in the
`IPR, and so can you just confirm for me that the top
`exhibit, Exhibit 1159, is a copy of your second
`declaration submitted in IPR 2017-01592?
` A It is.
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` Q All right. And if you turn to the last
`page of your declaration, is that your signature on
`the last page?
` A Yes, it is.
` Q All right. And did you sign your
`declaration on June 20, 2018?
` A That's the -- that's the date that I see
`here.
` Q Okay. And what time of day did you sign
`your declaration?
` A I don't recall.
` Q Was it morning? Afternoon?
` A I have no recollection --
` Q Evening?
` A -- of the time.
` Q No? Okay.
` Do you recall when you sent your signature
`to counsel for Breckenridge?
` A No recollection.
` Q No?
` Now, just, if we look through in the
`stack, if you look through below that, you --
`there's an Exhibit 2080 which is the expert
`declaration of Dr. Krishna V. Komanduri.
` Do you see that?
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` A I see it.
` Q And then you also have Exhibit 2092, which
`is the corrected expert declaration of Dr. Howard A.
`Burris, III.
` Do you see that?
` A I see it.
` Q And then, lastly, you have Exhibit 1010,
`which is the declaration of Allan J. Pantuck, MD, in
`support of petition for inter partes review of U.S.
`Patent No. 8,410,131, right?
` A Correct.
` Q Now, Dr. Pantuck, did you prepare for this
`deposition?
` A I did.
` Q And what did you do to prepare?
` A I reviewed some of these declarations and
`as well as some of the primary references.
` Q Which declarations did you review?
` A My second declaration, parts of Dr.
`Burris' declaration.
` Q Is that it on the declarations?
` A That's what I recall.
` Q Okay. Did you review Dr. Komanduri's
`declaration?
` A I mean, not specifically for in
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`preparation for this deposition, but I have reviewed
`it.
` Q Okay. In the past?
` A Yes.
` Q And when did -- when did you review that
`declaration?
` A Within the last several months.
` Q Okay. Now, you said you reviewed some of
`the primary references in the IPR; is that right?
` A That's correct.
` Q And what do you mean by "primary
`references"?
` A The cite -- the references that are cited
`in the -- in the declaration that are in some of
`these binders. So, for instance, if the patents --
` Q Okay.
` A -- like the '131 patent, for example.
` Q And did you review the references that are
`cited in the grounds of the IPR?
` A I reviewed some of those.
` Q All right. Which ones?
` A Was I can, for example.
` Q Okay.
` A Wasik.
` Q Okay. Anything else?
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` A Surely, Cottens.
` Q Anything else?
` A Those are the ones that I can recall off
`the top of my head.
` Q Did you review any documents that were not
`already submitted in the IPR?
` A I believe everything I reviewed has been
`cited.
` Q Okay. Everything had an exhibit number,
`either a 2000 series exhibit number or a 1000
`exhibit series number?
` A I reviewed some of the citations in some
`of the citations, so -- so some of the things I
`reviewed were cited in the documents but not
`necessarily enumerated with a document number.
` Q And which documents were those?
` A For example, there was a paper cited in
`Russo and Motzer review published by Martin Gleave
`and other authors.
` Q You said that the first author was Martin
`Gleave?
` A I believe he was the first author.
` Q Is that G-L-E-E-V-E?
` A G-L-E-A-V-E.
` Q And do you have a copy of that document in
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`your possession?
` A I don't have it.
` Q Did counsel for Breckenridge give you that
`document?
` A No.
` Q How did you obtain the Martin Gleave
`reference?
` A I have access to MedNet, and I can look up
`scientific publications.
` Q Okay. Any other documents that you
`reviewed in addition to -- that were not
`specifically -- that were not previously submitted
`in this IPR?
` A That's the only one I can recall.
` Q All right.
` MR. STRINGHAM: And, Dan, we'd ask that
`you guys produce a copy of that document, the Martin
`Gleave reference.
` MR. EVANS: As soon as I get it, yes.
`BY MR. STRINGHAM:
` Q Okay. Now, did you meet with any
`attorneys to prepare for this deposition?
` A Yes.
` Q Who did you meet with?
` A Mr. Evans.
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` Q Did you meet with anyone else?
` A No.
` Q Did you meet with any counsel for
`West-Ward?
` A No.
` Q Did you speak with counsel for West-Ward
`on the phone?
` A No.
` Q And are you testifying or did you submit
`your declaration on behalf of all the petitioners in
`this IPR?
` A I don't how to answer that. I'm
`submitting on behalf of myself, I suppose.
` Q Okay. Are you -- when you submitted it,
`you were -- as far as you're aware, you were not
`submitting it on behalf of the Westward petitioners?
` A I don't know how to -- I don't know the
`answer to that.
` Q How much time did you spend preparing for
`your deposition?
` A About a dozen hours.
` Q And over what period of time?
` A Over several days.
` Q Okay. And how many days did you meet with
`counsel for Breckenridge?
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` A Over -- over two days.
` Q Okay. And those, two consecutive days?
` A Yes.
` Q And how many hours each day?
` A About six hours or so.
` Q So just following up on the question about
`the Westward petitioners. So you're not aware of
`any specific submissions that you've provided on
`behalf of the West-Ward petitioners; is that fair?
` A As far as I know, they're both parties to
`the matter, so -- but I don't understand the
`logistics of how that works, but...
` Q Have they retained you to testify in this
`IPR?
` A I'm not retained by West-Ward.
` Q Let's look at your second declaration.
` MR. EVANS: Jared, if you don't mind, I
`would like to introduce 1162 at this time. This is
`a table, if you will, that provides citations to the
`various references that are cited in his second
`declaration.
` MR. STRINGHAM: Why don't we have the
`court reporter mark Dr. Pantuck's copy.
` MR. EVANS: 1162.
` THE WITNESS: This is my copy?
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`Page 16
` (Whereupon Exhibit 1162 was marked for
` identification.)
`BY MR. STRINGHAM:
` Q All right. So, Dr. Pantuck, if we turn to
`paragraph 18 of your second declaration, which is
`Exhibit 1159.
` Are you there?
` A Yeah.
` Q Now, looking at paragraph 18 of your
`second declaration, it's your current position --
` A Are we paragraph 18 or page 18?
` Q Sorry, paragraph 18.
` Yeah I'll generally try to refer to the
`paragraph numbers because it gives us maybe a little
`bit more specific location where we're at, but feel
`free to -- you can always clarify if you're not sure
`whether I'm talking about the paragraphs or the
`pages.
` A Okay.
` Q So in paragraph 18 of your second
`declaration, it's your current position that a POSA
`would have several years of experience in the
`treatment of solid excretory system tumors such as
`kidney tumors and/or RCC, right?
` A So the definition of -- that I offered for
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`POSAs in paragraph 18, and this would be, "A POSA
`would possess either a medical degree, such as an
`MD, with several years of specific experience in
`medical or surgical oncology which may include board
`certification as well as knowledge of oncology, drug
`development and clinical pharmacology or a PhD in
`cancer biology, molecular biology" --
` [Reporter asks witness to slow down when
` reading.]
` THE WITNESS: -- "medicinal chemistry, or
`a regulated field with several years of experience
`in oncology, drug development and clinical
`pharmacology, including evaluating cancer
`therapeutics in in vitro or in vivo assays as well
`as familiarity with the practice of medical
`oncology.
` "Further, as I explained in my previous
`deposition, it's my view that several years of
`practical experience described above would include
`specific experience in the treatment of solid
`excretory system tumors, including advanced solid
`excretory system tumors such as kidney tumors" --
` You doing okay?
` THE REPORTER: Slow down, please.
` THE WITNESS: -- "and/or RCC."
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`BY MR. STRINGHAM:
` Q All right. Thank you, Dr. Pantuck.
` Now, can we go back to my question which
`is based on what you've just reviewed from your
`second declaration, it's your current position that
`a POSA would have several years of experience in the
`treatment of solid excretory system tumors such as
`kidney tumors and/or RCC, right?
` A Yeah, correct.
` Q Now, is it your current position that a
`POSA in 2001 and 2002 in the field of solid
`excretory system tumors would have specific
`experience treating transplant patients with
`immunotherapies?
` A Well, that's not part of my definition.
` Q Okay. So it's not your current position
`that a POSA in 2001 and 2002 in the field of solid
`excretory system tumors would have specific
`experience treating transplant patients with
`immunotherapies, correct?
` A Correct.
` Q Now, in paragraph -- sorry, actually,
`let's strike that.
` Now, can you turn to paragraph 22 of your
`second declaration. Do you want to just read that
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`to yourself?
` A (Witness complies.)
` Okay.
` Q At the bottom of page 12 of your second
`declaration, is it your current position that a POSA
`would obviously have some understanding of treatment
`of liquid tumors or lymphoma tumors as well?
` A Yes.
` Q What do you mean by "some understanding"?
` A Some education, training and experience
`with matters relating to liquid tumors.
` Q Is it your position that a POSA would have
`experience treating liquid tumors?
` A I don't know that you would have to
`specifically treat them yourself.
` Q So if a POSA in 2001 and 2002 working in
`the field of solid excretory system tumors did not
`have understanding of liquid tumors or lymphomas,
`could he or she consultant with someone having
`experience treating liquid tumors or lymphomas?
` A I think a POSA, because liquid tumors can
`sometimes involve excretory system organs, you would
`have some experience as it relates to your expertise
`in solid excretory system tumors.
` Q All right. I understand that.
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` But if a POSA in 2001 or 2002 was not --
`did not have understanding of liquid and solid
`tumors, could he or she consult with someone that
`did have experience treating liquid or solid tumors?
` A I'm not what your question is getting at,
`so consult for what purpose?
` Q To understand the management and care of
`liquid tumors or lymphomas?
` A I mean, I think you could refer a patient
`to an expert in that area to treat them, but I think
`a POSA again would have some understanding of liquid
`tumors and their treatment.
` Q So is it your position that a POSA in 2001
`and 2002 working in the field of solid excretory
`system tumors would be precluded from consulting
`with someone having experience treating liquid
`tumors or lymphomas?
` A I would -- I don't understand why you
`would be precluded from that.
` Q Okay. Let's turn to paragraph 25 of your
`second declaration. Do you want to review that to
`yourself?
` A (Witness complies.)
` Okay.
` Q So at the top of page 15 of your second
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`declaration, it's your current position that the
`POSA, or that the experience of a POSA, would
`definitely include knowledge about rapamycin and its
`analogs.
` Do you see that?
` A Yes.
` Q By experience, do you mean that a POSA in
`2001 and 2002 would have knowledge of rapamycin and
`its analogs or would have conducted testing with
`rapamycin and its analogs?
` MR. EVANS: Objection to form.
` THE WITNESS: As it says in the -- I think
`it says here in the declaration that you would -- a
`POSA would have knowledge about rapamycin and its
`analogs.
`BY MR. STRINGHAM:
` Q So it's not your position that a POSA in
`2001 and 2002 would have specific experience
`conducting preclinical or clinical testing with
`rapamycin and its analogs?
` A No, you wouldn't have to have specific
`experience with it.
` Q Now, in paragraph 25 of your second
`declaration, rapamycin and its analogs are the only
`compounds with which you said a POSA in 2001 and
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`2002 would have experience, right?
` MR. EVANS: Objection to form.
`Mischaracterizes the document.
` THE WITNESS: I don't think it means you
`would have exclusively knowledge of rapamycin and
`its analogs, only that knowledge of rapamycin and
`its analogs would be included in the knowledge that
`one would possess.
`BY MR. STRINGHAM:
` Q All right. So you agree that a POSA in
`2001 and 2002 would have knowledge about all
`compounds that were in either preclinical or
`clinical development as an antitumor agent, right?
` A Well --
` MR. EVANS: Objection to form. Vague.
` THE WITNESS: I mean, it's a little vague
`to say "all compounds," but -- but compounds that
`show that are having activity in solid excretory
`system tumors or either in preclinical space or in
`the clinical space.
`BY MR. STRINGHAM:
` Q Okay. And you understand that a POSA is
`a -- is a fictitious person that is presumed to be
`aware of all the prior art?
` A Yes, you're correct.
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` Q And so just to make sure we're on the same
`page, you agree that a POSA in 2001 and 2002 would
`have knowledge about different compounds that were
`in preclinical or clinical development as antitumor
`agents; is that fair?
` A That is fair.
` Q And the POSA's knowledge wouldn't be
`limited to only mTOR inhibitors in 2001 and 2002,
`correct?
` A Correct.
` Q Let's turn to page 1 -- or, sorry,
`paragraph 100 of your second declaration. This is
`on page 50.
` Are you there?
` A Yes.
` Q Okay. Now, in paragraph 100 on pages 51
`to 53, you have a table that references various
`abstracts and reports for the temsirolimus Phase 1
`clinical trials, right?
` A Correct.
` Q Now, you agree that there were only two
`Phase 1 clinical trials reported in the references
`that you cite in paragraph 100, correct?
` A Correct.
` Q And you refer to one of those studies as
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`the "EP study"?
` A So one is a European clinical study and
`one is a U.S. study.
` Q Okay. And in your table, you refer to the
`European study as the "EP study"?
` A Correct.
` Q Now, according to your table on pages 51
`to 53, the EP temsirolimus Phase 1 study was
`reported in Alexandre, which is Exhibit 1007;
`Alexandre A-A-C-R abstract, which is Exhibit 1131;
`the Raymond ASCO, A-S-C-O, abstract, which is
`Exhibit 1145; the Raymond E-S-M-O presentation; the
`Hutchinson, which is Exhibit 1081; and the Raymond
`NCI abstract, which is Exhibit 1083; is that right?
` A Well, you went through them a little
`quickly for me, but that's --
` Q That's fine. Well, do you want to take
`them one at a time?
` A Okay. Do you want to go through them more
`slowly so I can follow?
` Q Okay. So the EP Temsirolimus Phase 1
`Study was reported in Alexandre, which is
`Exhibit 1007?
` A Correct.
` Q And the EP Temsirolimus Phase 1 Study was
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`reported in Alexandre AACR abstract, which is
`Exhibit 1131?
` A Correct.
` Q And Ray -- strike that.
` The EP Temsirolimus Phase 1 Study was
`reported in Raymond ASCO abstract, which is
`Exhibit 1145?
` A Okay.
` Q And then there was a Raymond ESMO
`presentation, that -- which reported the EP
`Temsirolimus Phase 1 Study?
` A Yes.
` Q And the EP Temsirolimus Phase 1 Study was
`reported in Hutchinson, which is Exhibit 1081?
` A Okay.
` Q Is that correct?
` A Correct.
` Q And --
` MR. EVANS: Just to correct, you're saying
`the Hutchinson, Raymond ESMO --
` MR. STRINGHAM: Yes.
` MR. EVANS: -- 1081?
` MR. STRINGHAM: Yes.
` MR. EVANS: Okay, thank you. My -- my
`apologies. I'm having problems with the realtime
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`here.
` THE REPORTER: Can we go off for a minute?
` MR. EVANS: Yes.
` MR. STRINGHAM: Sure.
` (Discussion off the record.)
`BY MR. STRINGHAM:
` Q All right. And then the last abstract
`from the EP Temsirolimus Phase 1 Study was the
`Raymond NCI abstract, which is Exhibit 1083,
`correct?
` A Correct.
` Q And those abstracts that we just discussed
`are all reporting on the same EP Temsirolimus Phase
`1 Study, just at different stages of the study,
`correct?
` A Correct.
` Q And all of the EP Temsirolimus Phase 1
`abstracts were reporting preliminary results, right,
`not the final results of the study?
` A Correct.
` Q And as of February 2001 and 2002, the
`final results of the EP Temsirolimus Phase 1 Study
`were not published; is that right?
` A That's correct.
` Q Now, let's look at the U.S. Phase 1 Study.
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` So according to your table, the U.S.
`Temsirolimus Phase 1 Study was reported in the
`Hidalgo ASCO 2000 abstract, which is Exhibit 2058?
` A Correct.
` Q And the U.S. Temsirolimus Phase 1 Study
`was reported in the Hidalgo ESMO abstract, which is
`Exhibit 1080?
` A Correct.
` Q And the U.S. Temsirolimus Phase 1 Study
`was reported in the Raymond NCI -- or, sorry, strike
`that.
` The U.S. Temsirolimus Phase 1 Study was
`reported in the Hidalgo NCI abstract, which is
`Exhibit 1082?
` A Correct.
` Q And the different U.S. Temsirolimus Phase
`1 abstracts were just reporting on that study at
`different stages of the study, correct?
` A Correct.
` Q And all of the Temsirolimus U.S. Phase 1
`abstracts were reporting just preliminary results,
`correct?
` A Correct.
` Q Now, on page 51 of your declaration, you
`note other places where the Temsirolimus Phase 1
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`studies were reported in the right column. Do you
`see that?
` A I see it.
` Q And according to your table, the Hidalgo
`reference, which is Exhibit 1006, reported the
`results of the Temsirolimus Phase 1 studies from the
`May 2000 ASCO conference; is that correct?
` A Sorry, show me -- tell me again what
`you're -- which one you're referring to?
` Q So if you look in the left column, there's
`a date, correct? And there's the May 2000 date?
` A Yes.
` Q And so the Hidalgo Exhibit 1006 reference
`was reporting the results from the May 2000 Hidalgo
`ASCO 2000 abstract, correct?
` A Correct.
` Q And at the bottom of page 51, the Hidalgo
`Exhibit 1006 reference was reporting the results
`from the May 2000 Raymond ASCO abstract, correct?
` A Correct.
` Q And Hidalgo the Hidalgo reference, which
`is Exhibit 1006, didn't report the results from any
`of the other abstracts; is that correct?
` A Does not appear to.
` Q All right. So I'd like to look at -- now,
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`as of February 2001 and 2002, the final results of
`the Temsirolimus Phase 1 Study were not published,
`right?
` MR. EVANS: Asked and answered. Objection
`to form.
` THE WITNESS: Correct.
`BY MR. STRINGHAM:
` Q Now, I'd like to look at some of these
`abstracts more closely for the EP and the U.S.
`Temsirolimus Phase 1 studies.
` And the first published abstract from the
`EP study was Alexandre Exhibit 1007 published in
`November 1999, correct?
` A Correct.
` Q So, Dr. Pantuck, I'm handing you a copy of
`Exhibit 1007, which is the Alexandre refer