Transcript of Hannah K. Batchelor,
`Ph.D.
`
`Date: September 19, 2023
`Case: Apotex Inc. -v- Celgene Corporation (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`CELGENE 2049
`APOTEX v. CELGENE
`IPR2023-00512
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`
`Ph.D.
`
`Date: September 19, 2023
`Case: Apotex Inc. -v- Celgene Corporation (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`CELGENE 2049
`APOTEX v. CELGENE
`IPR2023-00512
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - x
`APOTEX, INC., :
` Petitioner, : Case No. IPR2023-00512
` v. : U.S. Patent No.
`CELGENE CORPORATION, : 8,846,628
` Patent Owner. :
`- - - - - - - - - - - - - X
`
` Videotaped Deposition of
` HANNAH K. BATCHELOR, Ph.D.,
` Conducted Virtually
` Tuesday, September 19, 2023
` 8:07 a.m. EDT
`
`Job No.: 507038
`Pages 1 - 190
`Reported by: Debra A. Whitehead
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`2
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` Videotaped Deposition of HANNAH K. BATCHELOR,
`Ph.D., conducted virtually.
`
` Pursuant to notice, before Debra Ann Whitehead,
`E-Notary Public in and for the State of Maryland.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`3
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` A P P E A R A N C E S
`ON BEHALF OF PETITIONER AND THE WITNESS:
` VISHAL C. GUPTA, ESQUIRE
` TYLER DOH, Ph.D., ESQUIRE
` MICHAEL I. GREEN, ESQUIRE
` STEPTOE & JOHNSON LLP
` 1114 Avenue of the Americas
` New York, New York 10036
` (212) 506-3900
`
`ON BEHALF OF PATENT OWNER:
` LAURA MACRO, ESQUIRE
` GABRIEL ROSANIO, ESQUIRE
` WILMER CUTLER PICKERING HALE and DORR LLP
` 7 World Trade Center
` 250 Greenwich Street
` New York, New York 10007
` (212) 230-8800
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`4
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` A P P E A R A N C E S C O N T I N U E D
`ON BEHALF OF PATENT OWNER:
` HEATHER M. PETRUZZI, ESQUIRE
` WILMER CUTLER PICKERING HALE and DORR LLP
` 2100 Pennsylvania Avenue, NW
` Washington, DC 20037
` (202) 663-6000
`
`ALSO PRESENT:
` JACK DUNN, A/V Technician
` BO HAN, ESQ., Bristol Myers Squibb
` BRENDON SKIPPER, Video Specialist
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`5
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` C O N T E N T S
`EXAMINATION OF HANNAH K. BATCHELOR, Ph.D. PAGE
` By Ms. Macro 8
` By Mr. Gupta 179
` By Ms. Macro 184
`
` EXHIBITS MARKED IN TODAY'S SESSION
` (Attached to the Transcript)
`PATENT OWNER CELGENE EXHIBIT PAGE
` Exhibit 2048 Paper, "Integration of 155
` Biorelevant Pediatric Dissolution
` Methodology into PBPK Modeling to
` Predict In Vivo Performance and
` Bioequivalence of Generic Drugs
` in Pediatric Populations: A
` Carbamazepine Case Study," by
` Pawar, et al.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`6
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` EXHIBITS MARKED IN PRIOR SESSIONS
` (Not attached)
`PETITIONER APOTEX EXHIBIT PAGE
` Exhibit 1003 2/10/23 Declaration of Hannah K. 12
` Batchelor, Ph.D.
` Exhibit 1014 Chen Reference 130
` Exhibit 1017 Marcucci Reference 50
` Exhibit 1027 GastroPlus Manual 61
` Exhibit 1042 IARC Monographs on the 82
` Evaluation of Carcinogenic Risks
` To Humans, Volume 50
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`7
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` P R O C E E D I N G S
` VIDEO SPECIALIST: Here begins the remote
`video deposition of Hannah Batchelor in the matter
`of Apotex, Inc., V Celgene Corporation, in the
`Patent Trial and Appeal Board of the United States
`Patent and Trademark Office; Case Number
`IPR2023-00512.
` Today's date is September 19, 2023. The
`time on the video monitor is 8:07 a.m. eastern
`standard time. The remote videographer today is
`Brendon Skipper, representing Planet Depos. All
`parties of this video deposition are attending
`remotely.
` Would counsel please voice-identify
`themselves and state whom they represent.
` MS. MACRO: My name is Laura Macro. I
`represent Patent Owner Celgene and BMS. I'm
`joined by my colleagues today Heather Petruzzi,
`also from WilmerHale, and Gabriel Rosanio, also
`from WilmerHale. And today we also have Bo Han,
`in-house counsel for Patent Owner Celgene and BMS.
` MR. GUPTA: Hi. This is Vishal Gupta
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`8
`
`from the law firm of Steptoe & Johnson. I
`represent Apotex in this litigation. With me
`today is Tyler Doh, also from Steptoe & Johnson.
`And from time to time Michael Green may also be
`present, he's another associate at my firm.
` I also represent the witness.
` VIDEO SPECIALIST: The court reporter
`today is Debbie Whitehead, representing Planet
`Depos.
` The witness will now be sworn.
` HANNAH K. BATCHELOR, Ph.D.,
` having been duly sworn, testified as follows:
` EXAMINATION BY COUNSEL FOR PATENT OWNER
`BY MS. MACRO:
` Q Hi, Dr. Batchelor. Can you please state
`your name, for the record.
` A Yeah. It's Hannah Batchelor.
` Q How are you today?
` A Well, thank you.
` Q And can you hear me okay?
` A Yes.
` Q Great. Thank you for taking the time to
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`9
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`be here today.
` Do you have an understanding of why
`you're being deposed?
` A Yes, I do.
` Q And what is that understanding?
` A It's based on the declaration that I've
`written, and I understand that I'll be questioned
`on the declaration and the contents of it.
` Q And you submitted that declaration in
`connection with IPR2023-00512. Correct?
` A Yes.
` Q Have you been deposed before?
` A No.
` MR. GUPTA: And, Ms. Macro, just for the
`record, Dr. Batchelor has an unmarked copy of her
`declaration in paper with her. She doesn't have
`other documents.
` MS. MACRO: Okay. Thanks. I'll ask
`Dr. Batchelor that question.
` Q So did you bring any documents or notes
`with you to today's deposition?
` A No, apart from the unmarked copy I have.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`10
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`I just prefer a paper copy sometimes.
` Q And so just to confirm, you have a paper
`copy of your declaration with you?
` A Correct.
` Q And you don't have any notes or anything
`on it?
` A Correct.
` Q No markings on it?
` A No markings.
` Q And did you bring anything else with you
`to today's deposition?
` A No.
` Q I want to briefly just go over some
`ground rules. As you know, the deposition is
`being transcribed by the court reporter. So it's
`important that you answer with an audible response
`rather than nodding or shaking your head.
` Does that make sense?
` A Yes.
` Q And we should also try not to talk over
`each other.
` Does that make sense?
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`11
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` A Yes.
` Q If I ask you a question and you don't
`understand the question, can you please tell me
`and I'll rephrase the question?
` A Yeah.
` Q Unless you tell me that you don't
`understand the question, I'll assume that you do.
` Is that fair?
` A Yes, that's fair.
` Q If you need a break at any time please
`just ask, and we'll take a break. The only rule
`is that we cannot take a break while a question is
`pending.
` Do you understand?
` A Yes. I'm quite keen to make breaks short
`where possible just due to the time differences so
`that I'm alert and giving you a best possible
`response.
` Q Okay. Do you understand that your
`testimony here today is given under oath?
` A Yes.
` Q And do you have any reason you cannot
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`12
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`provide complete and accurate testimony today?
` A No reason.
` Q I am going to introduce the first
`exhibit.
` MS. MACRO: So, Jack, that's going to be
`Exhibit 1003.
` (Exhibit 1003, previously marked, not
`attached.)
` (Discussion off the record with the A/V
`technician.)
` Q Dr. Batchelor, can you just let me know
`when you see it on your end.
` A Yeah, I can see that.
` Q Do you recognize the document?
` A I do, yes.
` Q What is it?
` A It's the copy of my declaration dated
`February the 10th, 2023.
` Q And so this is the expert declaration
`that you filed in connection with IPR2023-00512
`for Celgene Patent 8,846,628. Correct?
` A That's correct.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`13
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` Q Will you understand if I refer to the
`patent 8,846,628 as the '628 patent?
` A Yes, I will.
` Q I have some questions about the materials
`you considered in forming your opinions in this
`matter.
` Do you have that in mind?
` A The materials I considered. Do you mean
`the documents that are listed in the -- in the
`report?
` Q Yes. So your declaration contains
`Section IV on Pages 6 to 8.
` A Yeah.
` Q Listing the materials you considered in
`forming your opinions. Correct?
` A Yes.
` Q Does the documents in Section IV
`represent the materials you considered in forming
`your opinions contained in the declaration?
` A Yes, the documents that I reviewed are
`the ones that I reviewed and relate to my
`declaration are all listed here.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`14
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` Q And did you consider anything other than
`the materials included in Section IV?
` A So putting myself in the position of sort
`of a person skilled in the art at the time, I
`obviously considered the general knowledge around
`that time. And when I was provided with the task
`by my counsel, that we spoke about the patent as
`well, '628.
` Q Have you reviewed the patent?
` A I didn't need to review it in detail to
`undertake the task that I was asked to do.
` Q So have you reviewed it?
` A In terms of the definition of "review," I
`haven't reviewed it because I didn't need to for
`the task I was given to do. I'm aware of the
`overview of the context, but I haven't reviewed
`it.
` Q Have you ever seen a copy of the '628
`patent?
` A I haven't reviewed it independently. I
`may have seen parts of it in my discussions with
`counsel.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`15
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` Q Are there any other materials that you've
`seen parts of that aren't listed in Exhibit 4?
` MR. GUPTA: Objection, to the extent it
`calls for privileged information.
` Dr. Batchelor, all that I caution you is
`not to reveal discussions between counsel.
` You can answer.
` A I think this refers a little bit to my
`earlier answer, when as an expert I've seen a lot
`of materials and I had to put myself in the
`position of someone skilled in the art at the
`time.
` So there's materials that would be
`generally known that I've used to form this
`declaration that I didn't need to list. The ones
`that I listed here are the ones I specifically
`refer to in the declaration.
` Q Other than the '628 patent, is there any
`other document you can identify that you
`considered in forming your opinions, other than
`the ones in Section IV?
` A The ones listed in Section IV are the
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`16
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`ones that I've referred to in my declaration, so
`they would be the ones I would consider pertinent
`to what's written in this declaration and the
`opinion laid out in it.
` Q Have you reviewed the claims of the '628
`patent?
` A I haven't reviewed the patent, so I
`haven't specifically reviewed the claims, no.
` Q Have you ever seen the claims of the '628
`patent?
` A I don't recall seeing them as during the
`preparation of this report. I was given a task to
`undertake, and that's really what this report
`focuses on. That was the task I was given.
` Q Do you have an understanding of what the
`claims of the '628 patent are?
` A My understanding was that I was given the
`task to look at the overall pharmacokinetics of
`azacitidine and that the patent referred to the
`oral azacitidine. So that's my understanding.
` Q Did you review the court's -- strike
`that. I'll start again.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`17
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` Have you ever reviewed a claim
`construction order from a district court
`litigation related to this matter?
` A No.
` Q Did you review Celgene's patent owner
`preliminary response?
` A Sorry, I didn't hear the last part of
`that question.
` Q Did you review Celgene's patent owner
`preliminary response?
` A No, it's not listed in the documents that
`I reviewed, so I didn't review it.
` Q Did you review Dr. Buckton's declaration?
` A Again, it's not listed in the documents I
`reviewed, so I didn't review it.
` Q Did you ever speak with Dr. Buckton?
` A I did not. So I know Professor Buckton,
`but I did not speak to him about this case.
` Q How do you know Dr. Buckton?
` A When I did my Ph.D., Professor Buckton
`worked at the same institution, which was
`pre-2000.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`18
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` Q And which institution was that?
` A It was the School of Pharmacy, University
`of London.
` Q So you were a student at the London
`School of Pharmacy at the same time Dr. Buckton
`worked at that institution. Correct?
` A That's correct.
` Q What type of relationship? Did you have
`any relationship with him?
` A The laboratory I was working in was
`shared with some of his students, so I would know
`him to say hello to, and our professional paths
`have crossed over the years. I wouldn't say I
`have a strong relationship with him. But we know
`each other.
` Q Okay. Did you review Dr. Berkland's
`declaration?
` A I didn't quite catch the name. Sorry.
` Q Dr. Berkland, B-E-R-K-L-A-N-D?
` A No. Again, it's not listed in the list
`of documents.
` Q Did you review the board's Institution
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`19
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`Decision for this IPR?
` A It's not listed in the documents. No.
` Q Did you review the Iyanowski (phonetic)
`reference which is Exhibit 1004?
` A Again, it's not listed in the documents,
`so I didn't review it.
` Q Did you review the Atadja reference,
`A-T-A-D-J-A, Exhibit 1005?
` A No, it's not listed in the documents, so
`I didn't review it.
` Q Did you review the Gibson reference,
`Exhibit 1006?
` A No. Again, it's not listed.
` Q Did you review the Pharmion press
`release, Exhibit 1010?
` A The documents that I did review are
`listed, and those are the ones necessary to
`conduct the task. So it's not listed, so I didn't
`review it.
` Q Were you familiar with the 5-azacitidine
`before working on this matter?
` A Just -- I'm just going to repeat. I
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`20
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`struggled to hear again. Did you ask if I was
`familiar with the 5-azacitidine or working on it?
` Q Yeah, I'll repeat the question. The
`question was, were you familiar with 5-azacitidine
`before working on this matter?
` A So my expertise is in pharmacokinetics
`and broadly pharmaceutical development, so I'm
`aware of a great number of drugs, including
`azacitidine.
` Q So you were aware of 5-azacitidine before
`working on this matter. Correct?
` A In the way that I'm aware of a great
`number of drugs that I use in my teaching, I would
`have had knowledge of drug names, passing
`knowledge.
` Q So other than a passing knowledge of the
`drug name of 5-azacitidine, do you have any other
`knowledge on 5-azacitidine before working on this
`matter?
` A My expertise for this matter is really
`about the pharmacokinetic modeling and
`interpretation, and I have expertise on this that
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`21
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`can be applied to all small molecules, including
`5-azacitidine.
` Q What did you know about 5-azacitidine
`before working on this matter?
` A In terms of the task that I was asked to
`do, I'm just trying to work out where that is in
`the declaration, my prior knowledge of the drug.
` Q You can take a minute to look at your
`declaration, that's fine. Let me know when you're
`done.
` A So in the declaration the part that I
`think is relevant is about the person -- the POSA.
`And it's saying, really, the expertise and the
`skills that they would have would be experiencing
`candidate drug selection clinical use, and it's in
`Paragraph 16. And that's the expertise I've
`applied to this. So you can apply it to any
`candidate drug.
` Q Did you say cancer drug or candidate
`drug?
` A It says candidate drug.
` Q Okay.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`22
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` A And candidate drug selection.
` Q Before working on this matter, have you
`ever worked on 5-azacitidine?
` A In providing the expert opinion, I needed
`to do a task that required me to have worked on
`pharmacokinetic predictions for candidate drugs,
`and I have experience on that, without needing to
`have direct experience on 5-azacitidine.
` Q Have you ever done pharmacokinetic
`predictions for 5-azacitidine before working on
`this matter?
` A I had done numerous pharmacokinetic
`simulations and predictions, but prior to working
`on this I had not considered 5-azacitidine.
` Q And in your prior work have you
`considered 5-azacitidine in any other context?
` A So my prior work is extensive. It may
`well have featured in part my teaching activities
`when discussing the range of drugs.
` Q Do you remember an instance where you
`taught about 5-azacitidine in your teaching
`activities?
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`23
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` A I didn't review all my teaching materials
`as part of the declaration. I would have to go
`back and review them to see what --
` Q But sitting here today -- sorry. Sorry.
`Do you want to finish? I'm sorry. I didn't mean
`to cut you off.
` A No. I think I had finished. It's okay.
` Q Sitting here today, you can't think of a
`particular instance of teaching about
`5-azacitidine. Correct?
` A So my teaching career spanned over 23
`years on various courses, with multiple lectures.
`I'm unable to recall every -- the context of it
`all.
` Q Did you review any documents that are not
`on your documents considered list in preparing for
`the deposition today?
` A The documents that I've reviewed are
`listed in the -- in the Section IV of the
`declaration.
` Q All right. Besides the modeling done to
`generate the results reported in your declaration,
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
`
`24
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`did you perform any other modeling of
`5-azacitidine?
` A All the modeling that I conducted is
`contained within this declaration.
` Q You ran the model twice. Correct?
` A I ran -- I don't know where -- where does
`it say I ran the model twice? I'm not completely
`sure I understand the question.
` Q You ran the model once for a
`200-milligram dose. Correct?
` A That's correct. So I developed the
`model, and then applied the model based on a 200-
`and 400-milligram dose.
` Q So you applied the model once for a
`200-milligram dose. Correct?
` A Yes.
` Q And you applied the model once for a
`400-milligram dose. Correct?
` A Yes.
` Q And those two were the only times you
`applied the model. Correct?
` A Yes.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`25
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` Q So just to confirm, you only ran the
`model -- sorry. Withdraw.
` To confirm, you only applied the model
`twice. Correct?
` A Yes, all of the modeling is contained
`within the declaration.
` Q You said you developed the model. Can
`you explain what you mean by that?
` A So the description of how the model was
`built is in the declaration. It requires certain
`inputs that we put into the model. Once those
`inputs are there for a drug, you can apply it to
`dosing scenarios. So the same model was used.
`The input that changed was the dose.
` Q You provide no opinion on whether any
`claims of the '628 patent are obvious. Correct?
` A I'm just reviewing the declaration.
` I didn't refer to the claims in my
`declaration.
` Q But you don't have an opinion of whether
`the claims of the '628 patent are obvious.
` Correct?
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`26
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` A Having not reviewed the patent, I don't
`know the specifics of the claims, so I don't know
`that I can provide an opinion.
` Q And I'm going to ask the same question
`about anticipation. So you provide no opinion on
`whether any claims of the '628 patent are
`anticipated. Correct?
` A As I've not reviewed the patent, I can't
`form an opinion on the contents of it.
` Q The modeling in your declaration was
`performed using GastroPlus Version 5.2. Correct?
` A Yes.
` Q So you decided to use GastroPlus Version
`5.2 to complete the modeling?
` A I did as part of my task as a person
`skilled in the art at that time.
` Q Why did you select GastroPlus Version
`5.2?
` A So I put myself back to the time, the
`dates of relevance in this case, and recalled the
`softwares that were available at the time where
`GastroPlus was the preferred software for this
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`27
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`type of analysis at that time, and 5.2 was the
`version available at the time.
` Q What other programs did you consider?
` A At that time there were two major
`commercial programs, Simcyp and GastroPlus. So I
`considered Simcyp as an alternative, but
`GastroPlus at that time would be superior for this
`type of analysis because it's based on the
`gastrointestinal system, the gastro part, so it
`would be the most suitable to use at that time for
`this type of analysis.
` Q Can you just spell the name of the other
`program?
` A It's Simcyp. It's S-I-M, which is short
`for simulation, and then cyp is C-Y-P, which
`relates to cytochrome P450.
` MS. MACRO: Sorry. There's a noise in
`this room.
` (A discussion was held off the record.)
` Q How did you obtain GastroPlus Version
`5.2?
` A Access was arranged via Steptoe.
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`28
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` Q Did Steptoe send you the GastroPlus
`Version 5.2 software?
` A The access was arranged by a temporary
`license for remote access.
` Q And who was the temporary license from?
` A Do you mean the supplier of the software?
` Q Yes.
` A So Simulations Plus are the owners of the
`software.
` Q And so Steptoe arranged access to
`GastroPlus Version 5.2 with Simulations Plus.
` Is that right?
` A They own the software, Simulations Plus,
`they're the software owners.
` Q And then you were given access to that
`software?
` A I was given access, remote access to the
`software, to run the simulation.
` Q And you said Steptoe arranged that access
`to the Simulations Plus software?
` A Yes, that's correct.
` Q And so did Steptoe communicate with
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`Transcript of Hannah K. Batchelor, Ph.D.
`Conducted on September 19, 2023
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`29
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`Simulations Plus?
` A My part of it was to run the software
`remotely.
` Q Maybe -- I think did you communicate
`directly with Simulations Plus?
` A No; access was arranged by Steptoe.
` Q Did anyone help you develop the
`GastroPlus model?
` A No.
` Q Besides the software, did you receive any
`documents from Simulations Plus about the
`software?
` A So within the software there's a user
`manual. But I've used GastroPlus, I'm familiar
`with the software.
` Q If you look at your declaration on Page
`7, do you see a reference to Exhibit 1027,
`GastroPlus Version 5.2 manual?
` A Yes.
` Q Where did you get the copy of the manual
`from?
` A It's embedded within the versions of the
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