`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`----------------------------------------------------x
`EISAI INC.,
` Petitioner,
` v.
`CRYSTAL PHARMACEUTICAL (SUZHOU) CO., LTD.,
`and BERGEN PHARMACEUTICAL, LLC,
` Patent Owner.
`----------------------------------------------------x
`PGR2021-00047
`Patent No. 10,759,779 B2
`----------------------------------------------------x
`
` REMOTE DEPOSITION OF
` ROBIN DON ROGERS, Ph.D.
` January 6, 2022
`
`
`
`
`
`
`REPORTED BY:
`BRANDON R. RAINOFF, RPR, RMR, CRR, FCRR
`Ref: 3914
`
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`EISAI EXHIBIT 1048
`Eisai v. Crystal Pharm.
`PGR2021-00047
`
`
`
`Page 2
`
` January 6, 2022
` 9:07 a.m. Eastern Standard Time
`
` Remote deposition of ROBIN DON ROGERS,
` Ph.D., on behalf of Patent Owner Crystal
` Pharmaceutical (Suzhou) Co., Ltd. and Bergen
` Pharmaceutical, LLC, taken by Petitioner Eisai
` Inc., before Brandon Rainoff, a Federal
` Certified Realtime Reporter and Notary Public of
` the State of New York.
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`A P P E A R A N C E S:
`
`PAUL HASTINGS, LLP
`Attorneys for Petitioner Eisai Inc.
` 200 Park Avenue
` New York, New York 10166
` 212.318.6000
`BY: BRUCE M. WEXLER, ESQ.
` 212.318.6020
` brucewexler@paulhastings.com
` CHRISTOPHER P. HILL, ESQ.
` 212.318.6782
` christopherhill@paulhastings.com
` SUSAN S. HWANG, ESQ.
` 212.318.6056
` susanhwang@paulhastings.com
` -and-
` 1170 Peachtree Street, N.E.
` Suite 100
` Atlanta, Georgia 30309-9998
` 404.815.2400
`BY: DANNY D. PATTERSON, ESQ.
` 404.815.2307
` dannypatterson@paulhastings.com
`
`BARTLIT BECK LLP
`Attorneys for Patent Owner Bergen Pharmaceutical, LLC
` Courthouse Place
` 54 West Hubbard Street
` Chicago, Illinois 60654
` 312.494.4400
`BY: KATHERINE E. RHOADES, ESQ.
` 312.494.4472
` katherine.rhoades@bartlitbeck.com
`
`ALSO PRESENT:
`
`DONNA M. MEUTH, ESQ., Eisai Inc.
`DAIZO SASAKI, Eisai Inc.
`RON H. BIHOVSKY, Ph.D., Key Synthesis LLC
`
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` I N D E X O F E X A M I N A T I O N
`
`Page 4
`
`Witness:
`Robin Don Rogers, Ph.D.
`
`Examination:
`By Mr. Wexler.........................Page 9
`By Ms. Rhoades......................Page 205
`By Mr. Wexler.........................Page 211
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`Index of Exhibits....................Page 5
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` I N D E X O F E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`
`Eisai 1006 Multipage document entitled: 11
` United States Patent No.: US
` 9,416,109 B2, dated August
` 16, 2016 (no Bates Nos.)
`
`Bergen 2006 Multipage document entitled: 11
` Declaration of Professor
` Robin D. Rogers in Support of
` Patent Owner's Preliminary
` Response, dated May 10, 2021
` (no Bates Nos.)
`
`Bergen 2044 Multipage document entitled: 11
` Second Declaration of
` Professor Robin D. Rogers in
` Support of Patent Owner's
` Response, dated October 29,
` 2021 (no Bates Nos.)
`
`Bergen 2007 Multipage document bearing 20
` heading: Dr. Robin D. Rogers
` (no Bates Nos.)
`
`Bergen 2046 Multipage document bearing 32
` handwritten notations (no
` Bates Nos.)
`
`Bergen 2045 Multipage document entitled: 40
` Rogers Experimental Report
` (no Bates Nos.)
`
`Bergen 2054 Two-page document bearing 48
` photographs (no Bates Nos.)
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`Exhibit 1046 Three-page document entitled: 51
` Suzhou PengXu PharmaTech Co.,
` Ltd. Product
` Catalog_Page1_ChemicalBook
` (no Bates Nos.)
`
`Eisai 1001 Multipage document entitled: 56
` United States Patent No.: US
` 10,759,779 B2, dated
` September 1, 2020 (no Bates
` Nos.)
`
`Eisai 1008 Multipage patent document 56
` Application No.:
` CN2017106481352, filing date
` August 1, 2017, with attached
` single-page certificate of
` translation (no Bates Nos.)
`
`Eisai 1007 Multipage document entitled: 93
` International Publication
` No.: WO 2016/0763995 A1,
` dated April 28, 2016 (no
` Bates Nos.)
`
`Bergen 2019 Multipage document entitled: 114
` Disappearing Polymorphs,
` dated November 1, 1994 (no
` Bates Nos.)
`
`Bergen 2012 Multipage document entitled: 119
` Nucleation of Crystals from
` Solution: Classical and
` Two-Step Models, dated
` October 6, 2008 (no Bates
` Nos.)
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`Bergen 2008 Multipage document entitled: 124
` Analysis of Organic
` Polymorphs: A Review, dated
` February 23, 1995 ( no Bates
` Nos.)
`
`Bergen 2014 Multipage document entitled: 127
` Characteristics and
` Significance of the Amorphous
` State in Pharmaceutical
` Systems, dated April 26, 1996
` (no Bates Nos.)
`
`Bergen 2015 Multipage document entitled: 132
` Amorphous pharmaceutical
` solids: preparation,
` characterization and
` stabilization, dated October
` 18, 2000 (no Bates Nos.)
`
`Bergen 2038 Multipage document bearing 134
` title on first page:
` Polymorphism in
` Pharmaceutical Solids (no
` Bates Nos.)
`
`Bergen 2053 Multipage document bearing 148
` graphical tables (no Bates
` Nos.)
`
`Bergen 1047 Two-page document bearing 150
` graphical tables (no Bates
` Nos.)
`
` (All exhibits were provided
` electronically to the court reporter.)
` -o0o-
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` * * *
` P R O C E E D I N G
` Thursday, January 6, 2022
` Remote Deposition
` 9:06 a.m. Eastern Standard Time
` * * *
` THE COURT REPORTER: Good morning. My
` name is Brad Rainoff. I am a Certified
` Shorthand Reporter in the states of New York and
` California, and a Notary Public in the state of
` New York. I am also a Registered Merit Reporter
` and Federal Certified Realtime Reporter. I am
` the deposition officer for today's deposition.
` Today's date is Thursday, January 6,
` 2022, and the time is approximately 9:06 a.m.
` Eastern Standard Time.
` This is the deposition of Robin Don
` Rogers, Ph.D., being taken in the matter of
` Eisai Inc. v. Crystal Pharmaceutical (Suzhou)
` Co., Ltd., et al. This case is venued in the
` United States Patent and Trademark Office Before
` the Patent Trial and Appeal Board.
` All parties in today's deposition are
` appearing remotely to comply with the guidance
` of the Centers for Disease Control in response
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` to the COVID-19 pandemic occurring in our
` country at this time. I have collected
` everyone's appearances off the record and they
` will appear on the appearance page of the
` transcript.
` Before we proceed, I will ask counsel
` to stipulate on the record that we are
` proceeding according to the Federal Rules of
` Civil Procedure, and that I as the deposition
` officer may swear in the deponent even though I
` am not in the physical presence of the deponent,
` and that there is no objection to that at this
` time, nor will there be an objection to it at a
` future date.
` Mr. Wexler?
` MR. WEXLER: Yes.
` THE COURT REPORTER: Ms. Rhoades?
` MS. RHOADES: Yes.
`ROBIN DON ROGERS, Ph.D.,
` having been duly sworn, was examined and
` testified as follows:
`EXAMINATION
`BY MR. WEXLER:
` Q. Good morning, Dr. Rogers.
` A. Good morning. Can you hear me okay? 09:07
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` Q. I can. Thank you for asking. Can you 09:07
` hear me okay?
` A. Yes, it's fine.
` Q. All right. So my name is Bruce
` Wexler, an attorney for the petitioner in this 09:07
` matter with Paul Hastings law firm.
` I appreciate you doing this remotely.
` And my associate, Danny, is in the
` room to hand you documents.
` So why don't we get started? 09:08
` Would you please state your full name
` and address for the record?
` A. My name is Robin Don Rogers. I live
` at 9 Oakwood Court, in Tuscaloosa, Alabama,
` 35401. 09:08
` Q. Would you please give us your business
` address?
` A. That is my personal and business
` address. I do have a company.
` I don't know if that's what you meant. 09:08
` Q. Any business address you may have,
` I'll take now.
` A. 525 Solutions is at Post Office Box
` 2206, Tuscaloosa, Alabama, 35403.
` MR. WEXLER: Danny, if you could hand 09:09
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` the witness what we have marked previously as 09:09
` Exhibit 1006, and Exhibits 2006, and 2044.
` (Exhibit Eisai 1006, Multipage
` document entitled: United States Patent No.: US
` 9,416,109 B2, dated August 16, 2016 (no Bates 09:09
` Nos.), marked for identification)
` (Exhibit Bergen 2006, Multipage
` document entitled: Declaration of Professor
` Robin D. Rogers in Support of Patent Owner's
` Preliminary Response, dated May 10, 2021 (no 09:09
` Bates Nos.), marked for identification)
` (Exhibit Bergen 2044, Multipage
` document entitled: Second Declaration of
` Professor Robin D. Rogers in Support of Patent
` Owner's Response, dated October 29, 2021 (no 09:09
` Bates Nos.), marked for identification)
` (Pause)
` MR. WEXLER: So three exhibits: 1006,
` 2006, 2044.
` (Pause) 09:09
`BY MR. WEXLER:
` Q. Okay. I just -- I'm going to come
` back and ask you questions about these later.
` But I just want to show you -- Exhibit
` 1006 you can confirm for me is U.S. Patent No. 09:10
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` 9,416,109? 09:10
` A. That's correct.
` Q. And during this deposition, can we
` refer -- we can refer to that as "the '109
` patent"? 09:10
` A. Yes, that would be fine.
` Q. Exhibit 2006 and 2044 are your two
` declarations in this matter, correct?
` A. That's correct.
` Q. And would you confirm that it's your 09:10
` signature appearing at the end of each of the
` declarations?
` A. 2006, yes.
` 2044, yes.
` Q. Just so the record is clear, 2006 is 09:11
` your first declaration and 2044 is your second
` declaration, right?
` A. That's correct.
` Q. The first declaration you signed on
` May 10, 2021, right? 09:11
` A. That's correct.
` Q. And the second declaration you signed
` on October 29, 2021, right?
` A. That's correct.
` Q. Okay. 09:11
`
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` MR. WEXLER: You can put those aside 09:11
` for a minute, we are going to come back and talk
` about those.
`BY MR. WEXLER:
` Q. Have you ever been deposed before? 09:11
` A. I have.
` Q. About how many times?
` A. I wouldn't know the exact number, but
` I would think it would be at least in the
` twenties, mid-twenties, 25. 09:11
` Q. Were all those depositions in the
` capacity of an expert witness?
` A. Yes.
` Q. Were all those patent cases?
` A. No. 09:11
` Q. What other kinds of cases have you
` testified by deposition in?
` A. Oh, about 20 years ago, I was asked to
` be an expert in a case that involved
` environmental radiological contamination in 09:12
` Florida.
` And there was a case that may have
` been equally as long ago that involved chemical
` formulation of a wood preservative.
` Q. So other than those, is it fair to say 09:12
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` that most of your expert witnessing involves 09:12
` patent matters?
` A. Yes.
` Q. Have you testified remotely before,
` like we are doing today, or fully remote? 09:12
` A. I have done a fully remote deposition
` and trial.
` Q. Okay.
` And you understand you are under an
` oath to tell the truth today? 09:12
` A. I do.
` Q. And you will tell the truth today,
` right?
` A. Yes, I will.
` Q. Anything affecting your ability to 09:12
` testify truthfully today?
` A. No, I don't think so.
` Q. Now, I know you have been through the
` deposition many times, so you probably don't
` need a refresher. 09:13
` But I'm going to ask you series of
` questions. You need to provide a response
` that's verbal in some way.
` And you understand those are the basic
` rules? 09:13
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` A. I do. 09:13
` Q. Counsel can object during these
` proceedings, but you need to respond unless you
` are instructed not to answer.
` Do you understand? 09:13
` A. I do.
` Q. Now, you are being paid $700 per hour
` for your work on this matter.
` Is that correct?
` A. That is correct. 09:13
` Q. And to whom is the money paid?
` A. To me.
` Q. You, personally?
` A. Yes.
` Q. Do you distribute that money to anyone 09:13
` else?
` A. No.
` Q. Now, are you familiar with someone
` named Dr. Gurau?
` A. It's Gurau. Dr. Gabriela Gurau. 09:14
` Yes, I am.
` Q. Gabriela Gurau.
` Is Dr. Gurau receiving compensation
` for time spent in this matter?
` A. I am paying Dr. Gurau as my technician 09:14
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` in this matter. 09:14
` Q. How much?
` A. It's $150 an hour.
` Q. Where is that money coming from?
` A. It's coming from me. 09:14
` Q. Is that her usual rate for expert
` consulting?
` A. It's not really expert consulting.
` It's the usual rate that I pay her for
` being my technician. 09:14
` I want to clarify something because I
` wasn't sure of your answer.
` I pay her, but I am reimbursed for her
` expense.
` Q. By whom? 09:14
` A. By Bartlit Beck.
` Q. So you are getting more than $700 per
` hour, then?
` A. No, my consulting rate is $700 an
` hour; and then I also charge expenses. 09:15
` Q. I see.
` So you charge Bartlit Beck her
` consulting rate as an expense, correct?
` A. I do, but I actually pay her.
` Q. Right. 09:15
`
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` But she's being paid via you by 09:15
` Bartlit Beck for her time, right?
` A. I don't look at it that way.
` I understand what you are saying. I'm
` not sure I see the difference, but I consider it 09:15
` that I'm paying her, and that's one of my
` expenses, and I get reimbursed for it.
` Q. Has she ever served as an expert
` witness in any matters, to your knowledge?
` A. I don't know the particulars. 09:15
` But I do think that she has been
` retained in a matter.
` I don't know if it's as an expert.
` Q. Does she have an engagement in this
` matter -- an engagement letter -- in this 09:16
` matter?
` A. No.
` Q. About how many hours have you worked
` on this matter?
` A. I would not being able to give you an 09:16
` estimate of the number of hours. I just don't
` keep track of that.
` I mean, I don't remember it.
` Obviously, I keep track of it. I just don't
` remember the number of hours. 09:16
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` Q. Okay. Good. 09:16
` And about how much money have you
` earned in this matter -- just ballpark?
` A. I think it would be close to $200,000.
` Q. And how much has Dr. Gurau earned in 09:16
` this -- in connection with her work on this
` matter through you, approximately?
` A. That I haven't -- actually, this
` January I have to come up with that number for
` 1099s. 09:16
` I don't actually -- I don't actually
` know.
` I would estimate that it would be
` under $50,000.
` (Pause) 09:17
` Q. Okay.
` Why don't we talk a little bit about
` today's deposition further?
` What did you do to prepare for today's
` deposition? 09:17
` A. I studied the -- my reports and the
` exhibits.
` I met with the lawyers of Bartlit Beck
` yesterday.
` I studied the documents in the case -- 09:17
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`Page 19
` the exhibits in the case. 09:17
` Q. With whom did you meet from Bartlit
` Beck? Just names.
` A. It would be Adam, and Katherine, and
` Taylor. 09:17
` Q. Did you also study Dr. Bihovsky's
` reports and exhibits?
` A. I did. And that's what I meant -- I
` studied the other documents that -- of the case.
` That would include Dr. Bihovsky's documents and 09:18
` Dr. Mayo's.
` Q. Did you also look back over your own
` materials?
` A. I did, yes.
` Q. Did you speak or meet with Dr. Gurau 09:18
` in preparation for the deposition?
` A. No.
` Q. Did you receive any information from
` Dr. Gurau in preparation for the deposition?
` A. No. No. 09:18
` Q. Do you know if Dr. Gurau conveyed any
` information to the counsel you met with or
` provisioned to you?
` A. I don't believe she's ever spoken to
` the counsel, to the lawyers. 09:18
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` Q. Okay. 09:18
` MR. WEXLER: Let's look -- Danny, if
` you could hand Dr. Rogers Exhibit 2007, which
` should be folder 17.
` (Exhibit Bergen 2007, Multipage 09:19
` document bearing heading: Dr. Robin D. Rogers
` (no Bates Nos.), marked for identification)
` (Pause)
` THE WITNESS: Thank you.
`BY MR. WEXLER: 09:19
` Q. Dr. Rogers, Exhibit 2007 is your CV?
` A. It is, yes.
` Q. Is it current?
` A. I have just gotten a new -- approved a
` new title at the university as professor 09:19
` emeritus.
` Q. So does that mean that you are now
` retired?
` A. I am formally retired, but professor
` emeritus allows me to continue to do research 09:19
` and conduct -- and carry grants at the
` university.
` Q. Okay. Congratulations on your new
` position.
` A. Thank you. 09:20
`
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` Q. All right. 09:20
` So you have a B.S. in chemistry from
` the University of Alabama?
` A. Yes.
` Q. And a Ph.D. in inorganic chemistry 09:20
` from the University of Alabama?
` A. That's correct.
` MR. WEXLER: I want to do that for the
` reporter, because it's -- the" in" was twice.
` It's "in." And then the degree is inorganic 09:20
` chemistry. I want to make sure the reporter has
` got that.
`BY MR. WEXLER:
` Q. Right?
` Are we good, Dr. Rogers? 09:20
` A. Yes.
` Q. You don't have a degree in
` biochemistry, medicinal chemistry, or organic
` chemistry, correct?
` A. I do not. 09:20
` Q. Have you ever designed a compound that
` was approved by the FDA as an active ingredient
` in a pharmaceutical?
` A. I don't believe that I have, no.
` Q. Have you ever been responsible for 09:20
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` creating a particular solid form of a compound 09:21
` that was approved by the FDA as an active
` ingredient?
` A. That was approved by the FDA? No.
` Q. Do you know the legal standards for 09:21
` inherent anticipation?
` A. My understanding of the legal
` standards for inherent anticipation are what I
` put into my first report -- as explained to me
` by counsel, since I am not a lawyer. 09:21
` Q. Is there anything sitting here today
` now you can say to us about your
` understanding? -- recognizing you are not a
` lawyer?
` A. I can open up my report and read to 09:21
` you what I said in the document.
` Q. No, I'm not -- I can read the report,
` too.
` Sitting here today, just based on your
` understanding, without looking at the 09:21
` document -- recognize you are not a lawyer -- is
` there any you can tell us about the legal
` standard for inherent anticipation?
` MS. RHOADES: I'll just caution the
` witness -- you can testify as to your 09:21
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` understanding, but otherwise don't reveal the 09:21
` substance of communications with counsel.
` MR. WEXLER: And counsel, please --
` let's just be clear.
` Counsel, the instructions are limited 09:22
` to form or instruction not to answer.
` I did not -- I am not asking the
` witness to read to me what's in the report.
` I understand that counsel explained
` things to you and you put it in the report. I'm 09:22
` asking you a different question, sir, Dr.
` Rogers.
` MS. RHOADES: And counsel, I am also
` entitled to make cautionary privilege objections
` on the record. 09:22
`BY MR. WEXLER:
` Q. Dr. Rogers, I'm asking you right now:
` Separate and apart from what's in your report,
` do you have an understanding right now that you
` can explain to us about the standard for 09:22
` inherent anticipation?
` A. I do, but it's not separate from my
` report.
` Q. So right now, is there anything you
` can say without reading the report about 09:22
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` inherent anticipation? 09:22
` A. Yes.
` Q. Okay.
` What?
` A. So my understanding of inherent 09:22
` anticipation is -- well, first, for
` anticipation, that the claim elements have to be
` included in a single piece of prior art; and
` that if the exact element of a claim is not
` there, but is inherently there, it's always 09:23
` there -- for example, as we are talking about in
` this case, a product following the prior art,
` that it must be there -- that it could be
` considered inherent participation.
` Q. And do you have any understanding of 09:23
` the legal standards for obviousness of a patent?
` A. Again, this is what I put into my
` report.
` In terms of obviousness, if you can
` put together several reference -- I have had 09:23
` these cited against me in my own patents on
` occasion by the Patent Office -- if you can
` reasonably put together all of the elements from
` more than one prior art reference, that that
` could be considered obviousness. 09:24
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` Q. Okay. 09:24
` Your first declaration was May 20,
` 2021, right?
` A. I think we -- May 10, did you say?
` Q. May 10? Was it May 10? May 10, 09:24
` sorry. Yeah, May 10, 2021. Thank you.
` A. Yes.
` Q. About how long before your declaration
` did you start working on this matter?
` A. I believe I was retained in March of 09:24
` that year -- last year.
` I don't remember when I actually
` started doing work.
` Q. Did you draft your declaration?
` A. Yes, that's -- I didn't actually do 09:24
` the first draft of this.
` The process was to go through my
` opinions with the lawyers; have technical help
` from the lawyers to put a draft together.
` And then I was able to work directly 09:25
` on the draft in that fashion.
` Q. Now, you said you were retained by
` Bergen Pharmaceutical.
` Is that right?
` A. I think that was the original -- I 09:25
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` only remember Bartlit Beck, to be honest with 09:25
` you.
` Q. Do you know if you were retained by
` Crystal Pharmaceutical (Suzhou) Company,
` Limited? -- S-U-Z-H-O-U? 09:25
` A. I do know of the company, and I would
` have to go back and look at the retention
` letter.
` I was retained in this particular
` case. 09:25
` Q. How do you know of that company?
` A. That was my understanding of whom
` Bartlit Beck was representing.
` Q. Is it okay if I refer to them as
` "Crystal Pharmaceutical" today? 09:25
` A. Yes.
` Q. Okay.
` MR. WEXLER: If you look at your
` declaration, paragraph 1?
` THE WITNESS: Which declaration, 09:26
` please?
` MR. WEXLER: Sorry, first declaration.
` (Pause)
` THE WITNESS: I'm there.
`BY MR. WEXLER: 09:26
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` Q. Your declaration says that you were 09:26
` retained to submit this declaration -- you were
` retained as an expert to consult and to submit
` this declaration.
` Do you see that? 09:26
` A. I do.
` Q. I don't really see any other
` description of an assignment in this case.
` Can you tell me what your assignment
` was with respect to this first declaration? 09:26
` A. The assignment was to review Dr.
` Bihovsky's declaration, Dr. Mayo's declaration,
` and to consider its validity.
` (Pause)
` Q. What facts or data did counsel provide 09:27
` you that you considered in forming your
` opinions?
` A. I had the documents that were
` submitted by Eisai, which I believe included a
` petition and documents from Dr. Bihovsky, Dr. 09:27
` Mayo, patents.
` I don't remember the entire list --
` Q. Was there anything --
` A. -- of exhibits that were submitted.
` Q. -- was there anything that you found 09:27
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` on your own in preparing the declaration? 09:27
` A. Yes. A lot of literature to support
` my opinions.
` Q. Were there any assumptions counsel
` provided that you relied on in forming your 09:27
` opinion?
` A. I don't think so.
` I don't understand what you mean by
` "assumptions."
` Q. Something you assumed to be true 09:28
` without actually having any facts establishing
` it.
` Anything like that?
` A. No.
` Q. In preparing your first declaration 09:28
` and working towards that, did you communicate or
` get any information from Crystal Pharmaceutical
` or the inventors?
` A. No, I don't believe I've ever had
` contact with Crystal Pharmaceutical. 09:28
` Q. Have you gotten any information,
` though, from the inventors, directly or
` indirectly?
` A. No, I have not.
` Q. After you submitted your first 09:28
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` declaration, what was the next occasion you had 09:28
` to consult in this matter?
` A. After my first declaration, then I was
` asked about an experiment to replicate the
` process in the '109 -- let's see -- the '109 09:28
` patent, Example G.
` Q. Was that by the Bartli