Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 1
`
`?K OFF C1
`
`fiAR %OARD
`
`Wo.
`
`I)R20l6—OO3l8l
`
`?aten: 7,772,209
`
`fiX
`
`NC.
`
`JRE }
`
`?MACfiUT CARS RT
`
`TAG1 } ARMA RA%S NC.,
`
`TAG1 } A?MACfiUT CARS "NC.,
`
`ENMA?< Q ARMACfiUT CARS,
`
`"NC., USA,
`
`ENMA?<
`
`DIWG SA, GLENMARK LTARMACZ
`
`WYLAN LABORATOR fiS R M T13,
`
`{ARMACfiUT CARS USA,
`
`INC.
`
`US KA
`
`USA, LLC,
`
`Petitioners
`
`?ANY,
`
`tent Owner.
`
`fifiOTAP1D DfiPOS T ON OE %RUCfi A.
`
`%NfiR,
`
`Thursday, November 10, 2016 8:16 a.m.
`
`Foley Hoag LL?
`
`155 Seaport Roulevard, Roston, MA
`
`Reporter:
`
`Janet M. Sambataro, RMR, CRR,
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0001
`
`
`
`11/10/2016
`
`Page 1
`
`?K OFF C1
`
`fiAR %OARD
`
`Wo.
`
`I)R20l6—OO3l8l
`
`?aten: 7,772,209
`
`fiX
`
`NC.
`
`JRE }
`
`?MACfiUT CARS RT
`
`TAG1 } ARMA RA%S NC.,
`
`TAG1 } A?MACfiUT CARS "NC.,
`
`ENMA?< Q ARMACfiUT CARS,
`
`"NC., USA,
`
`ENMA?<
`
`DIWG SA, GLENMARK LTARMACZ
`
`WYLAN LABORATOR fiS R M T13,
`
`{ARMACfiUT CARS USA,
`
`INC.
`
`US KA
`
`USA, LLC,
`
`Petitioners
`
`?ANY,
`
`tent Owner.
`
`fifiOTAP1D DfiPOS T ON OE %RUCfi A.
`
`%NfiR,
`
`Thursday, November 10, 2016 8:16 a.m.
`
`Foley Hoag LL?
`
`155 Seaport Roulevard, Roston, MA
`
`Reporter:
`
`Janet M. Sambataro, RMR, CRR,
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0001
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 2
`
`EARANCU
`
`3R NKS G:LSON & R ON:
`
`(By Ralph J. Gabrio, Esquire,
`
`Laura A. Lydigsen, Esquire)
`
`NBC Tower
`
`455 N. Cityfront Plaza
`
`Chicago,
`
`IL 60611
`
`312.321.4200
`
`rgabric@brinksgilson.oom
`
`llydigsen@brinksgilson.com
`
`Counsel for Sandoz,
`
`Inc.
`
`W RR AMS
`
`& CONNOLLY
`
`(%y
`
`Iov B. Grossman, Esquire,
`
`Adam L. Perlman, Esquire)
`
`725 TweljLh SLree-, N.W.
`
`Washington, D.C. 20005
`
`202.434.5000
`
`dgrossman@wo.oom
`
`aperlman@wo.oom
`C
`'—I
`‘or «1i Lilly and Company
`
`Counsel
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0002
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 3
`
`APPEARANCE :
`
`(Continued)
`
`ALSTON &
`
`(By Thomas J. Parker, Esquire, and
`
`Charles A. Naggar, Esqiire)
`
`90 Park Avenue,
`
`;5th Floor
`
`New York, NY l00;6-l387
`
`2l2-2l0-9400
`
`thomas.parker@alston.oom
`
`Counsel for Mylan
`
`RAKOCZY MOLINO MAHHOCH
`
`S W K REP
`
`(By Patrick C. Kilgore, Esquire)
`
`6 West Hubbard Street
`
`Chicago, Illinois 60654
`
`3l2.527.2l57
`
`pkilgore@rmmslegal.Com
`
`Counsel for Apotex Corp.
`
`& Apotex
`
`B LRS%URY W_NTHROE SHAW PITTMAN LLP
`
`(By
`
`vavid Patariu, Esquire)
`
`l200 Seventeenth Street, NW
`
`Washington, DC 20036
`
`202.663.8000
`
`david.pa:ariu@pillsburylaw.com
`
`Counsel for Wookhardt Bio AG
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0003
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 4
`
`EARANCJ
`
`:
`
`(Continued)
`
`ERMONT
`
`)fiR%Y
`
`By Paul Siiermont, Esquire,
`
`Sarah Spires, Esquire, and
`
`Mieke Malmberg, Esquire)
`
`2200 Ross Avenue, Suite 4800W
`
`Dallas, Texas 75201
`
`214.978.6600
`
`pskiermont@skiermontderby.com
`
`sspires@skiermontderby.com
`
`mmalmberg@skiermontderby.com
`
`Counsel for Neptune Generics, LLC
`
`“ER LLB
`
`Cottler, Esquire)
`
`(Via telephone)
`
`Building
`
`Eighth Avenue
`
`New York, NY 10018
`
`212.8'3.88OO
`
`mcott;er@goodwinlaw.com
`
`Counsel for Fresenius
`
`+'.N'l':
`
`ty, Videographer
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0004
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 5
`
`TNESS
`
`%RUC*1ZX. CHA%N1
`
`By Mr. Gabric
`
`BY Mr. Grossman
`
`SAN (V. EXH
`
`Description
`
`Printout
`
`from
`
`ClinicalTrials.goV
`
`Excerpt o: transcrip
`
`Dr. Chabner's triai
`
`from August 26, 20l3
`
`Exhibit
`
`Article entitled "Trends in
`
`the Risks and Eenetits to
`
`Patients With Cancer
`
`Participating in Phase l
`
`Clinical Trials"
`
`40
`
`Exhibit
`
`Article entitled "Phase l and
`
`Pharmacokinetic Study of the
`
`Multidrug Resistance Modulator
`
`Dexverapamil With EPOCH
`
`Chemotherapy"
`
`Exhibit
`
`lO67 Worzalla Demonstratives
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0005
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 6
`
`SAN)OH fiXH
`
`Description
`
`Page
`
`Document 3ates—stamped
`
`)PfiM2_OOO23l7 throigh -2322
`
`l35
`
`Article entitled "Diagnosis
`
`o: Cobalamin Deticiency
`
`Usefulness o: Serum Methymalonic
`
`Acid and Total Homocysteine
`
`Concentrations"
`
`?XCe?pv ”rom the May l6—l9
`
`Annual Meeting o:
`
`the American
`
`Society o: Clinical Oncology 254
`
`Drugs@FDA printout regarding
`
`Weupogeq
`
`Product insert for Neupogen
`
`Deposition transcript o:
`
`Bruce Chabner, dated
`
`April 23, 20l3
`
`Tf"LFY fiXH %
`
`Descriptioi
`
`Page
`
`Article entitled "Tissue
`
`Distribution o: Methylcobalamin
`
`in Qats Fed Amino Acid—De‘ined,
`
`Methyl—De‘icient Diets"
`
`3l9
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0006
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 7
`
`T."T.T.Y *'.XH %
`
`Number
`
`Description
`
`ixhibit 2141 Transcript o_ -rial
`
`proceedings dated
`
`August 26, 2013
`
`ixhibit 2142 Transcript o_ -rial
`
`proceedings dated
`
`August 27, 2013
`
`OUST.Y MARK*'.
`
`I SAN 'O'.
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0007
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 8
`
`OUST.Y MARK *1
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0008
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 9
`
`P R O C
`
`1
`
`1
`
`)
`
`W G S
`
`TH£ V )%OGRAP{ER:
`
`{ere begins the
`
`videotape No.
`
`l
`
`in the deposition o‘
`
`Rruce A.
`
`Chabner, M.D.,
`
`in the matter o: Sandoz versus Eli
`
`Lilly.
`
`In the U.S. Patent and Trademark o
`
`ice
`
`before the patent trial appeals board, Case No.
`
`ZPR20l6—00240 [sic].
`
`The date today is November
`
`l0, 20l6,
`
`and the time is 8:l6 a.m.
`
`The video operator
`
`today is Steven 3aty. This video deposition is
`
`taking place at Foley Hoag,
`
`l55 Seaport
`
`Roulevard, Qoston, Massachusetts.
`
`Counsel please voice identify
`
`yourselves and state whom you represent.
`
`MR. GROSSMAN:
`
`This is Dov Grossman o:
`
`"illiams & Connolly, on behal
`
`o patent owner,
`
`'T.l1'T.1'lly.
`
`And,
`
`just to clarity,
`
`this is in
`
`"PR?0l6-OO3l8.
`
`TH£ V )%OGRAPHI
`
`:
`
`.
`
`I had the wrong
`
`formation.
`
`00?
`
`M?. GROSSMAN:
`
`318.
`
`Tifi V )fiOGRAPHER:
`
`318.
`
`Thank you.
`
`MR.
`
`SK fiRMONT:
`
`Paul Skiermont.
`
`I'm
`
`representing Neptine Generics, LLC.
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0009
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page lO
`
`We'll just go around the
`
`%OGRAPHER: We'll go around the
`
`W8. MALM%fiRG: Mieke Malmberg o:
`
`Skiermont Derby, also for Neptune.
`
`W8. SP RfiS:
`
`Sarah Spires o: Skiermont
`
`Derby, also for Nep ine.
`
`MR. K“LGO’?:
`
`Patrick Kilgore
`
`Apotex.
`
`MR. NAGGAR: Charles Naggar of Alston &
`
`‘or Mylan.
`
`MR. PARKER:
`
`Tom Parker, Alston &
`
`‘or Mylan defendants.
`
`MS. LY) GSfiN:
`
`Laura Lydigsen from
`
`Rrinks Gilson & Lione for Sandoz,
`
`Inc.
`
`And on
`
`the phone we have Michael Cottler from Goodwin
`
`Procter for Fresenius.
`
`MR. GA%R C:
`
`Good morning. Ralph
`
`<s Ho:er, on behal
`
`o
`
`Sandoz,
`
`THfi V
`
`fiOGRAPHER:
`
`The court
`
`reporter —— oh, one more.
`
`MR. PATARIU:
`
`And David Patariu,
`
`Pillsbury Winthrop Shaw Pittman,
`
`for Wockhardt
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0010
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page ll
`
`Tifi V )fiOGRAPHER:
`
`Thank you.
`
`The
`
`court reporter today is Janet Sambataro o‘
`
`)T
`
`Would you please swear in the wit
`
`%RUCfi CHA%NfiR, M.D.,
`
`having been dily sworn, after presenting
`
`identification in the "orm o“ a driver's license,
`
`deposes and says as
`
`'o‘lows:
`
`CROSS—fiXAM NAT
`
`%R C:
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Dr. Chabner.
`
`Hi.
`
`You've had your deposition taken
`
`fore. Correct?
`
`A.
`
`Yes.
`
`Q.
`
`All right.
`
`And you are familiar with
`
`the ground rules.
`
`I get
`
`to ask some questions
`
`and --
`
`A
`
`Q.
`
`A
`
`get
`
`to answer.
`
`Correc .
`
`Yeah.
`
`Q.
`
`Any reason why you are compromised in
`
`your ability to Lestijy today?
`
`A.
`
`Q.
`
`A husky voice.
`
`But you're not on any medication that
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0011
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 12
`
`"ect your ability to testi:
`
`No.
`
`Nothing else that would a
`
`A.
`
`Q.
`
`ability to testify?
`
`A.
`
`No. Only my intelligence.
`
`Okay. Well, you've got plenty oz
`
`can tell.
`
`Hopefully.
`
`All right.
`
`ll me your first name.
`
`I'm sorry.
`
`My first name is Ralph.
`
`Zph.
`
`(Lilly ixhibit 9170 incorporated
`
`by reference.)
`
`QY MR. GA%R C:
`
`Q.
`
`I'm going to show you what has been
`
`<ed as Exhibit 2l2O in this matter and ask you
`
`-haL's a declaration you prepared for this
`
`fer?
`
`A.
`
`It does look like it.
`
`I haven't
`
`I
`
`at every page or it.
`
`I won't, but it does I
`
`like it, yes.
`
`Q.
`
`All right.
`
`And have you reviewed that
`
`declaration since it was prepared?
`
`A.
`
`I have.
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0012
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 13
`
`Q.
`
`Okay. And did you find any errors in
`
`it or anything like that?
`
`A.
`
`Yes.
`
`Some spelling errors and some --
`
`there are some errors in it. Yes.
`
`Q.
`
`A.
`
`How about substantive errors?
`
`Not really.
`
`I mean,
`
`there was one
`
`place where the crcatinine,
`
`instead —— it was
`
`creatinine clearance instead o: creatinine and
`
`serum creatinine, which makes a di
`
`"erence,
`
`to me
`
`at least, but it's just an error.
`
`Q.
`
`A.
`
`Okay. Where in that declaration?
`
`I don't know.
`
`I can't tell you.
`
`don't have the page number.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`O<ay.
`
`"‘ we ge'
`
`I'll show it to you.
`
`All righ .
`
`And there are several other spelling
`
`errors and things. Yes.
`
`(Li11y ixhibit 7171
`
`incorporated
`
`by reference.)
`
`BY MR. GA%R C:
`
`Q.
`
`I'm going to show you Lilly
`
`ixhibit 7171.
`
`To you recognize that document?
`
`A.
`
`Q.
`
`Tha'
`
`—— yes.
`
`Tha'
`
`—
`
`is that a current copy o:
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0013
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 14
`
`It's a copy as o:
`
`last year.
`
`Q. GROSSMAN:
`
`Do you have a copy
`
`Counsel?
`
`MR. GA%R C:
`
`Oh,
`
`I'm sorry.
`
`Q.
`
`Anything significant to add to your CV
`
`since last year that we should be aware of, as
`
`far as you're concerned?
`
`A.
`
`Yeah.
`
`A number o: papers and a --
`
`maybe a significant honor. Yeah.
`
`Q.
`
`A.
`
`Any o_
`
`-hose papers on pemetrexed?
`
`Oh,
`
`that's go— —— an interesting
`
`question.
`
`Probably not.
`
`Probably relative to
`
`some o:
`
`the issues, but not on pemetrexed.
`
`Q.
`
`What
`
`issues would those papers be
`
`relevant
`
`to from your perspective?
`
`A.
`
`Approval process for new drugs.
`
`FDA.
`
`And one important paper,
`
`I
`
`think, on —— on
`
`how to screen for antitumor activity using cell
`
`lines.
`
`Q.
`
`A.
`
`Any other papers?
`
`Yeah.
`
`A couple o: others, but not
`
`relevant
`
`to this,
`
`I
`
`think.
`
`Q.
`
`Now,
`
`judging from your CV, you worked
`
`previously at
`
`the National Cancer Institute, NCI.
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0014
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 15
`
`A
`
`Q.
`
`A
`
`That's right.
`
`For about 20 years?
`
`Almost 27 years.
`
`Q.
`
`And the NCI,
`
`is that part o:
`
`National InsLi-uLe oj Health?
`
`A.
`
`It's part of the National Institutes o:
`
`It's one o_ _he institutes.
`
`Q.
`
`And at
`
`the NCI,
`
`just generally, what
`
`did your duties involve?
`
`A. Well,
`
`I came there,
`
`jirst,
`
`jor training
`
`in medical oncology and then a period o: research
`
`in drug development and pharmacology. And after
`
`spending two years away, one year in the junior
`
`‘aculty at Yale in the pharmacology department,
`
`came back there as an attending in the medical
`
`oncology group, but also as a laboratory person
`
`studying anticancer drugs and I became the
`
`laboratory chie
`
`o
`
`clinical pharmacology and
`
`then the head of the intermural clinical service,
`
`director o:
`
`the c'inica' oncology program.
`
`And then in ’98l,
`
`" was appointed as the
`
`head o:
`
`the division or cancer
`
`-rea-menL,
`
`in an
`
`acting role, and then shortly a_ -erward became
`
`the permanent director. Add in that capacity,
`
`was responsible for the national program “or
`
`800-868-0061
`
`DTI Court Reporting Solutions
`
`- Chicago
`www.deposition.com
`
`Sandoz Inc. IPR2016-00318
`
`Sand0zv.EHiIjHy,ExhflMt1074-0015
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 16
`
`cancer drug development and cancer drug
`
`discovery,
`
`the programs _ha_ the Federal
`
`Government sponsored. Add the clinical trials
`
`network outside, plus intermural
`
`research.
`
`And
`
`continued in that
`
`job for l3 years until l995.
`
`And then I was
`
`in the Public Health Service at
`
`that
`
`time.
`
`Q.
`
`Now,
`
`in the period leading up to June
`
`o:
`
`the l999 time frame, what role, it any, did
`
`the NIH have in setting standards ‘or clinical
`
`trials?
`
`A. Well, it was
`
`the major force in
`
`sponsoring clinical trials, wor<ing with
`
`industry, both in cancer and A )8.
`
`We were
`
`responsible, we were really the sole drug
`
`development program in the —— in the Federal
`
`Government for cancer, and then later ‘or A )8,
`
`drug discovery, drug development. And then we
`
`ran the clinical trial system that —— that tested
`
`these compounds that we came up with.
`
`Q.
`
`And what is the clinical trial system?
`
`A. Well, it was cooperative group sys'
`
`and the intermural research system at
`
`the N:
`
`which was quite large.
`
`And 25,000 patients on
`
`trial a year,
`
`through that federal system.
`
`800-868-0061
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`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page l7
`
`Q.
`
`I want
`
`to jump in a time machine and go
`
`back to June o:
`
`l999 time frame.
`
`A.
`
`Q.
`
`phases?
`
`Yeah.
`
`Were clinical
`
`trials segregated into
`
`A.
`
`Yes. Certainly.
`
`So there were the
`
`typical drug went
`
`through three phases o_ -esLing
`
`and we were responsible, we had conLrac-s jor the
`
`first Phase l and Phase 2 trials. And then
`
`Phase 3s were usually done in the cooperative
`
`groups, which were also one o: our
`
`responsibilities.
`
`Q.
`
`And you used the terms Phase l,
`
`Phase 2, and I believe Phase 3. Correct?
`
`A.
`
`Q.
`
`Right.
`
`What is a Phase l trial, as o:
`
`l999 time frame?
`
`A. Well,
`
`the —— Phase l trial was
`
`the
`
`‘irst initia'
`
`trial ot a drug that goes into the
`
`clinic, where we're trying to determine what is
`
`the appropriate dose and schedule and whether
`
`there's any early evidence o‘ c'inical activity.
`
`And there are a number o: studies that are done
`
`in conjunction with tha .
`
`L999 was a transition
`
`time when di
`
`"erent sor
`
`_ drugs were coming
`
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`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page l8
`
`into the clinic,
`
`so they were called targeted
`
`drugs.
`
`And with those drugs,
`
`there was a
`
`somewhat di
`
`"erent approach to the Phase l trial,
`
`where biomar<ers were used and patients were
`
`highly selected to go into that —— that trial.
`
`And probably,
`
`I guess in the mid '90s, were
`
`putting maybe tour or ‘ive drugs into Phase
`
`coming from our program and there were some
`
`industry that came through oar program.
`
`Q.
`
`And what would be the primary
`
`objectives o:
`
`the Phase l?
`
`A. Well, as I said,
`
`to establish a sate
`
`and e
`
`"ective rou-e o_ administration and to do
`
`pharmacokinetic studies and to look at evidence
`
`o: clinical activity and toxicity.
`
`Q.
`
`And when you say "clinical activity,"
`
`what are you referring to?
`
`Tumor responses.
`._‘——-1
`
`"icacy?
`
`Wo.
`
`Tumor responses.
`
`Okay.
`
`Is that
`
`e "icacy in --
`
`Well,
`
`that's what you're trying to do.
`
`And it's your testimony that that's one
`
`the primary objectives o: Phase l
`
`in the June
`
`l999 time frame?
`
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`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 19
`
`A.
`
`Yes. Certainly it's one o_ -he
`
`objectives. Whenever you give a drug to a cancer
`
`:ient, you're hoping that
`
`the patient gets
`
`:ter.
`
`I mean, we wouldn't just give a drug
`
`because we were interested in what happened to
`
`the drug without knowing what happened to the
`
`patient.
`
`Q.
`
`Yeah.
`
`I under— —— I understand what
`
`you're hoping :or.
`
`My question is a little
`
`di""erent,
`
`though, Doctor.
`
`Is it your testimony that a primary
`
`objective in a Phase l study,
`
`in June of
`
`was
`
`to evaluate --
`
`lt's always that --
`
`e ”icacy?
`
`—— in a clinical trial.
`
`You know,
`
`the
`
`‘irst time you put a drug into the patient, you
`
`do a lot o: other things, certainly.
`
`And you
`
`want
`
`to certainly establish the regimen that
`
`you're going to use is sa:e.
`
`And it gives you
`
`drug levels that are going to be, you hope will
`
`be e "ective. You're extrapolating from animal
`
`studies, but you're also watching what happens to
`
`the patient and the tumor.
`
`And there was a
`
`certain degree, at
`
`that
`
`time, of tumor selection
`
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`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 20
`
`went
`
`into the Phase l trials, based on what we
`
`knew about
`
`the drug in the preclinical
`
`experience.
`
`These are therapeutic trials.
`
`(Printout
`
`from
`
`ClinicalTrials.gov marked Exhibit
`
`lO63.)
`
`BY MR. GA%? C:
`
`Q.
`
`Doctor,
`
`I'm going to show you
`
`Exhibit —— what we've marked as Exhibit
`
`A.
`
`Yes.
`
`Q.
`
`And I'll represent
`
`to you tor the
`
`record that this is a printoue jrom the Wayback
`
`Machine website from January o: 200l,
`
`a couple o:
`
`years after June o:
`
`l999.
`
`"'1' give you a chance
`
`to look at that.
`
`And I want
`
`to focus on --
`
`MR. GROSSMAN: Counsel, before you show
`
`him this exhibit,
`
`I'm going to object.
`
`You
`
`haven't established this as prior art.
`
`And under
`
`the rules you need to cure that objection.
`
`MR. GA%R C:
`
`I'm not representing this
`
`is prior art.
`
`I'm using this to —— I don't have
`
`to give any explanation, but
`
`I don't have to
`
`prove this is prior art to use this with this
`
`witness.
`
`I believe this document
`
`is inconsistent
`
`with the witness's testimony. That's why I'm
`
`showing it to him.
`
`800-868-0061
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`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 21
`
`MR. GROSSMAN: Well,
`
`I'm going to
`
`object, based on your representation, A, it's not
`
`prior art.
`
`3, you have no documentation from the
`
`Wayback Machine,
`
`such as a declaration
`
`accompanying this showing that this is from the
`
`time period you say it is, which is not prior
`
`art.
`
`Your objection is noted,
`
`Q.
`
`This is a —— are you familiar with the
`
`Wayback Machine?
`
`A.
`
`Q.
`
`No,
`
`I'm tot.
`
`Okay.
`
`It's a service that goes back
`
`and captures website —— pages, website pages that
`
`existed at certain time frames. And we went back
`
`and captured a website page from the National
`
`"nsLiLu-e oj Health. Okay? And --
`
`A.
`
`Q.
`
`This is --
`
`—— they discuss here Phase l trials.
`
`Do you see that?
`
`A.
`
`Yes.
`
`Q.
`
`All right.
`
`And can you read into the
`
`record what it says with respect
`
`to Phase l
`
`trials?
`
`A.
`
`"Clinical
`
`trials in which researchers
`
`800-868-0061
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`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 22
`
`testing new drug or treatment —— treatment
`
`in a
`
`small group o_ paLien-s or people jor the first
`
`time to evaluate sa_e-y, determine a safe dosage
`
`range, and ideitify side e
`
`"ects."
`
`Q.
`
`Right.
`
`So on this —— on its website,
`
`the NIH is basically saying the purpose o:
`
`Phase l clinical
`
`trial
`
`is to, "evaluate i
`
`safety." Right?
`
`MR. GROSSMAN: Objection.
`
`A.
`
`It doesn't say "purpose."
`
`It says
`
`proceed through phases.
`
`It doesn't say purpose.
`
`Q.
`
`Okay.
`
`Do you see where it says "in
`
`clinical
`
`trials." Correct?
`
`A.
`
`Q.
`
`I do.
`
`All right.
`
`And it says "evaluate."
`
`you see that?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`Okay. And, "Evaluate its sa:
`
`fety. Correct?
`
`Right. That's what
`
`I said.
`
`Okay.
`
`Then it says "determine a sa:
`
`dosage range."
`
`Do you see that?
`
`A.
`
`Q.
`
`Right.
`
`And it says, "identify side e
`
`Do you see that?
`
`800-868-0061
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`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 23
`
`Right.
`
`It doesn't say "identi
`
`It says --
`
`MR. GROSSMAN: Objection.
`
`—— treatment, doesn't it?
`
`So is it your testimony --
`
`What is a treatment?
`
`I want
`
`to make sure I understand your
`
`A
`
`Q.
`
`A
`
`Q.
`
`testimony.
`
`So your testimony is,
`
`is the statement here
`
`"treatment" means evaluate evidence?
`
`A.
`
`So you always want
`
`to get a look a‘
`
`what it does to the tumor.
`
`I mean, you don"
`
`think people take x—rays when they're doing this?
`
`They don't do physical exams on patients while
`
`they're getting it? That's a very important part
`
`of it.
`
`It's a treatment experiment.
`
`Q.
`
`Okay.
`
`So it's —— your testimony that a
`
`primary objective o: a Phase l trial is --
`
`A.
`
`One of the objectives. Yes.
`
`MR. GROSSMAN: Dr. Chabner, it might be
`
`easier it you let Mr. Gabric finish his question
`
`before preceding with your answer.
`
`wH« w TNfiSS: Okay.
`
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`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 24
`
`R. GROSSMAN:
`
`Plus give me
`
`time to
`
`Iecessary.
`
`Tifi w TNfiSS:
`
`Oh, okay.
`
`%R C:
`
`Q.
`
`Now you see now the entry for Phase 2
`
`clinical trials?
`
`A.
`
`Q.
`
`I do.
`
`Okay. And here they say, "the studied
`
`drug or treatment
`
`is given to larger group or
`
`people to see it it is e "ective and to further
`
`evaluate safety." Right?
`
`A.
`
`Q.
`
`Yes. That's right.
`
`All right.
`
`So Phase 2,
`
`the Nil uses
`
`the term to see it it's e "ective. Right?
`
`A.
`
`And that's because you have a larger
`
`group o: patients,
`
`so you get
`
`some statistical
`
`idea or more solid statistical idea.
`
`By the way,
`
`this is a rather brie;
`
`description o: Phase l trials. What happens
`
`after a Phase l
`
`is we can go back and do Phase
`
`trials, which try other regimens or changes in
`
`the regimen that we've established for Phase l.
`
`And a Phase lb does have di""erent connotations.
`
`Q.
`
`"
`
`'1 get
`
`to Phase lb in a second.
`
`Thank you, Doctor.
`
`800-868-0061
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`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 25
`
`You said this was kind o:
`
`: summary.
`
`Is it inaccurate?
`
`It's —— it's not complete.
`
`Is it inaccurate?
`
`Do you disagree?
`
`didn't say --
`
`MR. GROSSMAN: Objection. Asked and
`
`answered.
`
`A.
`
`I didn't say it was
`
`inaccurate in what
`
`it says, but it's incomplete.
`
`Q.
`
`So it's your
`
`testimony that
`
`the NIH has
`
`incomplete discussion ot Phase l and Phase 2
`
`trials here?
`
`A. Well,
`
`this is a very brie: thing.
`
`don't know who wrote this,
`
`I have no idea who
`
`wrote this.
`
`It wasn't —— I certainly didn't
`
`write it.
`
`would say this:
`
`That when yo; give a drug
`
`to a patient, whether it's experimental or not,
`
`an anticancer drug, you're always interested in
`
`whether it has antitumor e "icacy. That's one o:
`
`the —— I mean, it would be unethical
`
`to give it
`
`otherwise.
`
`Q.
`
`A.
`
`Q.
`
`You used the term "Phase lb."
`
`Yes.
`
`Okay.
`
`I don't see the Phase lb trial
`
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`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 26
`
`ted on this Exhibit 63 [sic].
`
`Is that a term
`
`t was used in June o:
`
`l999?
`
`Abso';te'y.
`
`Abso';te'y?
`
`‘YES.
`
`3y who?
`
`Ry all
`
`o‘ us.
`
`"hat is a Phase I
`
`—— Phase lb trial?
`
`lb.
`
`What is that?
`
`W(3C5(3C5(3C5(D[F
`
`It's a —— it's a derivative trial,
`
`in
`
`which you change the schedule.
`
`You may focus the
`
`trial on a specific subset of patients, but it's
`
`not
`
`the first Phase l.
`
`So a Phase l,
`
`the first time you put it into
`
`patients,
`
`that's Phase L. You're mostly
`
`interested in safety and pharmacokinetics and
`
`yoi're also looking at —— at whether you get a
`
`tumor response when you get
`
`to a dose that you
`
`think is —— is reasonable.
`
`A number of trials wil'
`
`follow it you want
`
`to change the regimen.
`
`So let's say I want
`
`to
`
`give intermittent dosing rather than a single
`
`large bolus, daily times five, or a —— another
`
`regimen, and it could be, you know,
`
`a significant
`
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`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 27
`
`variation.
`
`But it builds on wha' you've learned
`
`from the Phase l trial. And tha"s called a
`
`Phase lb trial.
`
`And those,
`
`in fact, can lead to drug
`
`approval.
`
`There are many examples now of drugs
`
`that go through a very shortened development
`
`phase because suddenly we understand who to give
`
`the drug to.
`
`And it's called Phase lb and then
`
`it leads into an early Phase 2 or you may not
`
`need the Phase 2.
`
`Q.
`
`As you sit here today, can you identi:
`
`any publication, pre—June of ’999,
`
`that defines
`
`or refers to what you are calling a Phase Lb
`
`trial?
`
`A.
`
`I'm —— I'm certain I can find the
`
`protocols which describe Phase lb trials. Yes.
`
`Q.
`
`Is there anything in your declaration,
`
`:
`
`those papers cite those protocols?
`
`—— I don't
`
`remember.
`
`I don't know i:
`
`the issue came up.
`
`Q.
`
`And was —— as of June o:
`
`there any definition of Phase lb
`
`A.
`
`Q.
`
`Oh,
`
`I'm sure.
`
`—— on the Nil website?
`
`A. Well,
`
`I don‘: know.
`
`I can't tell you.
`
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`
`11/10/2016
`
`Page 28
`
`:'s a rather large question,
`
`isn't
`
`{I1OW.
`
`Is that a term that
`
`the NZ
`
`Yes.
`
`I used it.
`
`You used it.
`
`Q A
`
`.
`
`Q
`
`A.
`
`All my people, all people that worked
`
`me used it.
`
`Q.
`
`Was
`
`that a '
`
`rinition that
`
`the
`
`was
`
`the person that set
`
`the standard,
`
`MR. GROSSMAN: Counsel,
`
`just —— just
`
`‘or the record, you're required at a deposition
`
`when you introduce a document
`
`like this to cure
`
`any objections.
`
`I've objected to i- jor the
`
`grounds I stated earlier.
`
`You didn't cure it,
`
`so
`
`we reserve the right
`
`to strike —— to strike all
`
`testimony concerning the document.
`
`QY MR. GA%R C:
`
`Q.
`
`So could you summarize your expertise
`
`with antifolates?
`
`A.
`
`Yes.
`
`In l969 I went
`
`to —— into the
`
`laboratory at Yale, worked with a Dr. Joseph
`
`3ertino, who was one o:
`
`the leading people in
`
`terms o: understanding the mechanism or action o:
`
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`
`11/10/2016
`
`anLi_ola-es and methotrexate, which is one o.
`
`firs- an_ifolaLes.
`
`And I worked on a projec
`
`develop a bacterial enzyme that would cleave
`
`folates and would produce fola-e deficiency.
`
`we did it, we
`
`took a Pseudomonas etzyme, pirified
`
`it, wor<ed with the people to New England Enzyme
`
`Center to produce large quantities of
`
`the enzyme
`
`and them actually gave it to patients.
`
`It was
`
`one of
`
`-he firs- —— I
`
`think it may have been the
`
`first examp'e o‘
`
`an exogenous enzyme given to a
`
`human for treating a —— a disease.
`
`The people I worked with went on _o found
`
`Genzyme, which is —— I was sad to see them leave
`
`the project.
`
`The drug actually proved to be
`
`useful
`
`in dealing with methotrexate toxicity,
`
`because it cleaves folates. And it's now
`
`approved for clinical use for that use.
`
`Q. Methotrexate?
`
`A.
`
`Q.
`
`A.
`
`No.
`
`The enzyme.
`
`The enzyme?
`
`Yes.
`
`It's called glucarpidase. And
`
`after that,
`
`I went
`
`to WZH.
`
`I was working on that
`
`specific project at NIT.
`
`%ut
`
`worked on a lot
`
`of other projects rela-ed -o antifolates,
`
`including pharmacokinetics, high—dose
`
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`Sandoz Inc. IPR2016-00318
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`Sand0zv.EHiIjHy,ExhflMt1074-0029
`
`
`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 30
`
`pharmacokinetics and how it related to the
`
`toxicity we were seeing with high—dose
`
`methotrexate.
`
`developed a monitoring system that was
`
`used to tol'ow patients and to predict toxicity.
`
`We discovered the mechanism o: renal damage
`
`related to methotrexate and developed a regimen
`
`o: alkalinization and hydration that prevented
`
`that —— that toxicity.
`
`It's a rather complicated
`
`regimen, and the toxicity was overwhelming in
`
`some patients.
`
`And so it was a very useful
`
`measure.
`
`We also studied the interac— —— the
`
`interrelationship o_ me-hoLrexate and reduced
`
`‘olates that were used for rescue and established
`
`the principle that this was a reciprocal —— not a
`
`reciprocal, but a competitive relationship.
`
`We studied the process o: polyglutamation o:
`
`antifolates and showed that
`
`the polyglutamation
`
`led to enhancement o_ acLivi-y against
`
`thymidylate synthase and some o:
`
`the other purine
`
`enzymes.
`
`And we conducted some studies with
`
`antifolates in people, one of which led to the
`
`approval of a new antijolate jor treating
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`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 31
`
`pneumocystis pneumonia, which was occurring in
`
`A )8 patients.
`
`And that's —— that's pretty much
`
`the summary.
`
`Q.
`
`Than< you, Doctor.
`
`So is it fair to say that
`
`the bulk of your
`
`hands—on research activity was with respect
`
`to
`
`methotrexate?
`
`A.
`
`Q.
`
`Most o:
`
`And --
`
`There were a few other antifolates that
`
`we were interested in?
`
`Did you do any hands—on research on
`
`pemetrexed?
`
`A.
`
`Q.
`
`Hands—on, no.
`
`And if " understand your tes
`
`correctly, your work on methotrexate,
`
`pre—June of '999?
`
`A. Well,
`
`the laboratory work was certainly
`
`prior to l999.
`
`I: was
`
`l999 and below —— and
`
`prior to that.
`
`I: was probably mostly l995
`
`— and earlier.
`
`Q.
`
`And is it fair to say that toxicity was
`
`a concern with respect
`
`to methotrexate?
`
`A.
`
`Oh, it's always a concern with all the
`
`cancer drugs.
`
`We were fortunate that, because we
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`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 32
`
`understood a good deal about it and had ways o:
`
`using antidotes and the enzyme that
`
`I described,
`
`that we could —— we could actually manipula'
`
`methotrexate much better than some o:
`
`the o
`
`drugs that we were working with.
`
`Q.
`
`And so as of June of
`
`l999,
`
`toxicity was
`
`also a concern with respect
`
`to pemetrexed as
`
`well?
`
`A.
`
`Yes, it was. Yeah.
`
`pemetrexed was mainly in the ha
`
`that
`
`time, not with the NCI.
`
`Q.
`
`Now,
`
`I'm looking at your CV.
`
`Let me back up for a second. While you were
`
`doing your work on me_ho_rexate, it sounds like
`
`you have a fair amoun- o_ research experience in
`
`that area.
`
`A.
`
`Q.
`
`I would say so, yes.
`
`All right.
`
`And did you make it your
`
`practice to stay abreast o:
`
`the relevant
`
`publications in that area?
`
`A.
`
`Q.
`
`I tried.
`
`It would be important
`
`to keep abreast
`
`o_
`
`-he important publications in that area so
`
`that you knew what was going on with respect
`
`to
`
`methotrexate. Right?
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`
`Bruce A. Chabner, M.D.
`
`11/10/2016
`
`Page 33
`
`A.
`
`Yes.
`
`And I had a more general interest
`
`in this because I was writing textboo
`
`Q.
`
`Okay.
`
`So did you make an e
`
`monitor the publications in the area o:
`
`methotrexate prior to June of l999?
`
`A. Well, of course. Yes.
`
`Q.
`
`Now, you have a heck o:
`
`publications listed on your CV.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Most of --
`
`Seventy or so.
`
`Most o:
`
`them are authentic, yes.
`
`And so is it fair to say,
`
`I'm not going
`
`to ask you to count
`
`them all, but
`
`I mean,
`
`ballpark, you have about 200 peer—reviewed
`
`publications --
`
`A. Well --
`
`Q.
`
`A.
`
`—— does that SOJDd about right?
`
`It's —— it's not really complete in the
`
`sense that
`
`the system in the university where
`
`am segregates publications into chapters, books,
`
`editorials and so jor-h so that
`
`they don't all
`
`count.
`
`But
`
`there are probably, you know,
`
`in the
`
`200s in terms o: peer—reviewed publications in
`
`journals, yes.
`
`Those are the ones that
`
`the
`
`university cares about, because when they look at
`
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`
`11/10/2016
`
`Page 34
`
`for promotion,
`
`that's where they really look.
`
`Q.
`
`A.
`
`Publish or perish,
`
`I
`
`think is the term?
`
`Publish in peer—reviewed journals, yes.
`
`haven't perished.
`
`Q.
`
`No, you haven't,
`
`thankfully.
`
`Now, do you have —— currently have an active
`
`practice?
`
`A.
`
`I have —— my primary role is clinical
`
`research, mentoring young faculty, attending
`
`patient conferences and helping in making
`
`decisions about patients through conferences, and
`
`then a brief period o_ a--ending during the year
`
`in the medical service at Mass. General.
`
`I'm a
`
`medical attending on the inpatient service there.
`
`Yes.
`
`And maybe of all the things I do,
`
`I enjoy
`
`that
`
`the most.
`
`Q.
`
`And if it's varied, you can let me
`
`know, but
`
`in the last five years, about what
`
`percentage of your time is devoted to
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