UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________________________
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`v.
`MERCK SERONO S.A.,
`Patent Owner.
`_____________________________________
`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`* CONFIDENTIAL *
`DEPOSITION OF
`BERND MEIBOHM, PH.D.
`New York, New York
`Wednesday, March 6, 2024
`9:02 a.m. EST
`
`Job No.: 524918
`Pages: 1 - 139
`Reported by: Monique Vouthouris, CCR, RPR, CRR
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`Hopewell EX1062
`Hopewell v. Merck
`IPR2023-00481
`
`1
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________________________
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`v.
`MERCK SERONO S.A.,
`Patent Owner.
`_____________________________________
`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`* CONFIDENTIAL *
`DEPOSITION OF
`BERND MEIBOHM, PH.D.
`New York, New York
`Wednesday, March 6, 2024
`9:02 a.m. EST
`
`Job No.: 524918
`Pages: 1 - 139
`Reported by: Monique Vouthouris, CCR, RPR, CRR
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`Hopewell EX1062
`Hopewell v. Merck
`IPR2023-00481
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`1
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`Confidential
`Transcript of Bernd Meibohm, Ph.D.
`Conducted on March 6, 2024
`
`2
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` Deposition of BERND MEIBOHM, PH.D., held at
`the offices of:
`
` WILMER CUTLER PICKERING HALE AND DORR LLP
` 7 World Trade Center
` 250 Greenwich Street
` 45th Floor
` New York, New York 10007
` 212.230.8800
`
` Pursuant to notice, before Monique
`Vouthouris, Certified Court Reporter, Register
`Professional Reporter, Certified Realtime Reporter,
`and Notary Public in and for the States of New York
`and New Jersey.
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` A P P E A R A N C E S
`ON BEHALF OF PETITIONER
`HOPEWELL PHARMA VENTURES, INC.:
` CHRISTINA E. DASHE, ESQ. (Via Zoom)
` MADELEINE BOND, ESQ.
` ELDORA L. ELLISON, PH.D., ESQ. (Via Zoom)
` OLGA A. PARTINGTON, PH.D., ESQ. (Via Zoom)
` STERNE KESSLER GOLDSTEIN & FOX, PLLC
` 1100 New York Avenue, NW
` Washington, D.C. 20005
` 202.371.2600
`
`ON BEHALF OF PATENT OWNER MERCK SERONO S.A.:
` DAVID B. BASSETT, ESQ. (Via Zoom)
` MARY PHENG, ESQ.
` WILMER CUTLER PICKERING HALE AND DORR LLP
` 7 World Trade Center
` 250 Greenwich Street
` 45th Floor
` New York, New York 10007
` 212.230.8800
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`ALSO PRESENT:
` ALEJANDRO GOMEZ, Planet Depos Technician
` RACHEL CARRICK, Remote Planet Depos Technician
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`C O N T E N T S
`EXAMINATION OF BERND MEIBOHM, PH.D.
`By Ms. Dashe
`By Mr. Bassett
`
`E X H I B I T S
`(Previously marked exhibits.)
`DEPOSITION EXHIBIT
`Exhibit 2052 Declaration of
`Dr. Bernd Meibohm.
`Exhibit 1001 U.S. Patent No. 7,713,947 B2.
`Exhibit 1001 U.S. Patent No. 8,377,903 B2.
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` P R O C E E D I N G S
`
` BERND MEIBOHM, PH.D.,
`being first duly sworn or affirmed by the Notary,
`testifies as follows:
`
` MS. DASHE: Hello. I am Christina Dashe
`from Sterne Kessler on behalf of petitioner Hopewell.
`With me today remotely are Eldora Ellison and Olga
`Partington, also Sterne Kessler. My colleague
`Pratibha Khanduri of Sterne Kessler may also join
`later remotely. And with me today in person with the
`witness is my colleague Madeleine Bond, also with
`Sterne Kessler.
` MR. BASSETT: And I am Dave Bassett from
`WilmerHale on behalf of the patent owner Merck Serono
`and the Merck entities. I'm joined by my colleague
`Mary Pheng, who is in person with Dr. Meibohm.
`
` EXAMINATION
`BY MS. DASHE:
` Q Good morning, Dr. Meibohm.
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` Could you please state your name for the
`record.
` A Good morning. My name is Bernd Meibohm.
` Q And you live in Tennessee; is that right?
` A That is correct.
` Q Have you ever been deposed before?
` A Yes, I have.
` Q About how many times?
` A Twice.
` Q And were any of those depositions in a case
`or proceeding related to patents?
` A No.
` Q So then you have not had any depositions in
`a proceeding before the Patent Office; is that right?
` A That is correct.
` Q Who were the parties in the cases where you
`gave deposition testimony?
` A I gave testimony for the University of
`Tennessee.
` Q Anyone else?
` A Both cases were for the university; one was
`a personnel issue and the other one was a contract
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`partner of the university.
`Q Did you give testimony on behalf of the
`University of Tennessee?
`A That is correct.
`Q So you have been deposed before, but I'll
`go over some ground rules for today's deposition.
`I will be asking you some questions and
`your counsel may object. It is important for the
`court reporter that we don't all talk over one
`another.
`
`Will you agree to that?
`A I will do my best.
`Q Similarly, the court reporter cannot take
`down non-verbal answers like shaking your head or
`saying "mm-hmm."
`Can you agree to give only verbal answers
`
`today?
`A Yes.
`Q Sometimes your counsel may object to my
`questions but you still have to answer them unless
`your counsel directs you not to answer them.
`Will you agree to abide by this rule?
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` A Yes.
` Q We will take breaks reasonably often, and
`if at any point you need a break, please let me know
`and I will try to accommodate, but I do ask that you
`answer any pending questions before we take a break.
` Will you agree to that?
` A Yes.
` Q If I ask a question you don't understand or
`need further clarification, will you agree to let me
`know and I can try to clarify or ask a better
`question?
` A Yes.
` Q However, if you answer my question, I will
`assume that you understood it.
` Do you agree?
` A I agree.
` Q Because we are operating on a remote basis
`for today's deposition, there may be some technical
`difficulties. If anything happens that interferes
`with your ability to hear or answer my questions,
`will you agree to let me know?
` A I will.
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` Q For example, it might happen that part of
`my question gets cut off or garbled. If that
`happens, will you agree to let me know?
` A Yes, I will.
` Q And will you agree to let me know even if
`you think you generally understand what I'm asking?
` A I will let you know if I think I do not
`understand fully the question.
` Q Now, the Patent Office rules require that I
`tell you that during my questioning today you are not
`permitted to discuss your testimony with counsel
`unless you are discussing an issue related to
`privilege.
` Do you understand that rule?
` A I do.
` Q Will you agree to abide by the rule?
` A I do.
` Q Is there any reason you cannot give
`truthful and accurate testimony today?
` A No, not that I'm aware of.
` Q Where are you located for today's
`deposition?
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`In New York City.
`A
`Besides counsel and the court reporter and
`Q
`technicians, is there anyone else in the room with
`you today?
`A
`Your representative.
`Q
`That would be a representative for
`petitioner; is that right?
`A
`That is correct.
`Q
`Okay. Anyone else?
`A
`No.
`Q
`Whose computer are you using for today's
`deposition, do you know?
`A
`I do not know. I assume this is a computer
`that belongs to WilmerHale.
`Q
`So it's not your computer?
`A
`It's not my computer.
`Q
`Okay. Do you have any files or programs
`open on the computer besides the deposition video
`platform?
`I only see Zoom.
`A
`So you do not have any documents, PDFs,
`Q
`email, web browsers open in front of you?
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` A No.
` Q Do you have access to any files or
`programs -- I'm sorry. Strike that.
` Will you agree that you will not access any
`documents, PDFs, emails, web browsers or the like
`during today's deposition?
` A I will.
` Q Including during breaks?
` A Yes.
` Q Do you have any other electronic devices
`with you today, such as cell phone, other laptops, or
`a smart watch?
` A Cell phone.
` Q Will you agree that you will not access any
`files, programs, or communications on that device?
` A I agree.
` Q So no text messages or phone calls?
` A It's on flight mode. It's switched over
`anyway.
` Q So you will not be accessing your cell
`phone during breaks; is that right?
` A That is correct.
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` Q Okay. Did you bring anything else with you
`to your deposition today?
` A Not in this room, no. My reading glasses.
` Q That's important.
` What did you do to prepare for your
`deposition today?
` A I met with counsel the last two days.
` Q Who specifically did you meet with?
` A With Mary Pheng and Dave Bassett.
` Q Anyone else?
` A No.
` Q Did you communicate with anyone else to
`prepare for your deposition besides Mary and Dave?
` A No.
` Q And where did you meet?
` A In the WilmerHale offices in New York City.
` Q For approximately how long did you meet
`with your counsel to prepare for today's deposition?
` A Twice, half a day.
` Q So you spent about one full day preparing
`for today's --
` A That's correct.
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` Q -- deposition; is that right?
` A That's correct.
` Q And during your preparation for today's
`deposition, did you consider any documents not
`mentioned in your declaration in this matter?
` A No.
` Q And have you communicated with anyone
`besides counsel regarding the substance of your
`deposition today?
` A No.
` MS. DASHE: Rachel, if you could please
`introduce tab 1 onto the screen, which is the
`declaration of Dr. Bernd Meibohm in Case IPR2023-480
`and Case IPR2023-481.
` And if you could also make Dr. Meibohm's
`declaration available in the chat, that is Exhibit
`2052.
` Q So, Dr. Meibohm, on the screen, Exhibit
`2052, this is your declaration that you submitted in
`both Case IPR2023-480, as well as Case IPR2023-481?
` A It is the first page of that declaration.
` MS. DASHE: And, Rachel, if you could flip
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`through the document so that Dr. Meibohm can confirm
`that this is, in fact, his full declaration and not
`just the first page.
` Q And, Dr. Meibohm, please let me know when
`you agree this is your full declaration.
` MR. BASSETT: And, Christina, I would just
`offer we have a hard copy of his declaration with
`attachments there and available for Dr. Meibohm to
`also consult, in addition to the electronic copy.
` MS. DASHE: Yes, if counsel -- do those
`copies have any markings or other annotations or is
`it just a clean copy?
` MR. BASSETT: Just a clean copy.
` MS. DASHE: If you would like to provide
`the clean paper copy to the witness, that would be
`helpful for all of us.
` Rachel, I believe you can stop scrolling,
`if you just want to go back to the first page. Thank
`you.
`BY MS. DASHE:
` Q So, Dr. Meibohm, I will have your
`declaration, Exhibit 2052, up on the screen in the
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`platform, but you can feel free to follow along in
`your paper copy, if you would like.
` A Yes.
` Q So just to make the record clear, then,
`Exhibit 2052 that's up on the screen, as well in
`paper form in front of you, this is your declaration
`that you submitted in both Case IPR2023-480, as well
`as Case IPR2023-481; is that right?
` A Yes, it is.
` Q And if I refer to "this case" or "this
`proceeding," will you understand that I am
`collectively referring to both of these IPR
`proceedings?
` A Yes, that's understood.
` Q And do you understand that unless I
`specifically indicate, my questions today will relate
`to both IPR proceedings?
` A Yes.
` Q If you could please go to page 41 of the
`document PDF, it's after paragraph 96.
` Dr. Meibohm, your declaration is signed and
`dated December 21st, 2023?
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` MS. DASHE: Rachel, if you could scroll
`back, please.
` A Yes, it is. But it's page 40, not 41.
` Q Right. On the PDF, I think that I'm
`working off of the electronic copy. There we go.
` So page 40 of your declaration, page 41 of
`the PDF of Exhibit 2052, is that your signature?
` A Yes, it is.
` Q Dr. Meibohm, do you stand by your testimony
`in your declaration in this case?
` A Yes, I do.
` Q When were you first approached to provide
`your declaration in this case?
` A Sometime in the I think summer or fall of
`last year. I do not exactly recall.
` Q That would be sometime in the summer or
`fall of 2023?
` A That is correct.
` Q So sometime between roughly June of 2023 to
`October, November of 2023. Does that sound about
`right?
` A I think so. Most of my interactions were
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`later, of course.
` Q Who -- who first approached you to provide
`your declaration in this case?
` A I do not remember.
` Q Was it someone from Merck or Merck's
`counsel?
` A No. It was someone from WilmerHale that
`reached out to me.
` Q And you understand that WilmerHale is
`representing Merck in these proceedings?
` A I do.
` Q But you do not recall the specific name of
`the person who reached out to you to provide your
`declaration in this case?
` A No. I would have to look at my records.
` Q Okay. How much time did you spend
`preparing your declaration?
` A I worked through, I would say, approximately
`15 to 20 hours.
` Q Did you perform any literature searches in
`preparing your declaration?
` A I did one search.
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` Q And what did you search for?
` A I searched for an example of an approved
`drug that is dosed on a body weight-based dosing
`regimen.
` Q Was that limited to any specific condition
`or treatment or was that any drug?
` A That was any drug.
` Q And what were the results of your search?
` A Well, it was a directed search, because I
`remembered from my professional background that low
`molecular weight heparins are dosed based on body
`weight, and I was looking for a publication that
`would support that for one of the low molecular
`weight heparins.
` Q What is a low molecular weight heparin?
` A A low molecular weight heparin is a
`specific class of agents of drugs that are used to
`produce or to reduce the coagulation of the blood.
` Q Did you find any publications that
`supported that low molecular weight heparins were
`dosed based on body weight?
` A Yes. I found a paper where I also knew
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`some of the authors, which basically made me believe
`that this is a good quality publication to cite.
` Q What was the date of the paper that you
`found?
` A I don't remember. I think it's in the --
`in the -- in the appendix to my declaration.
` Q Actually, if you want to turn to Appendix B
`of your declaration, maybe we can find it. That
`would be I think starting on page 135 of the PDF,
`Rachel. And I think that's page 93 of 95 in the
`appendices.
` Let me know when you're there, Dr. Meibohm.
` A Yes, I'm there. Second to last in the
`list.
` Q Okay. So if we flip to page 95 of 95, is
`that the Hainer reference that you're referring to?
` A That is correct.
` Q And while we're on the subject of Appendix
`B, in preparing your declaration in this case, you
`reviewed and considered a number of documents that
`are listed in Appendix B to your declaration, right?
` A That is correct.
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`Confidential
`Transcript of Bernd Meibohm, Ph.D.
`Conducted on March 6, 2024
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`21
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` Q Does Appendix B contain a complete list of
`documents that you considered in preparing your
`declaration in this case?
` A Yes.
` Q And in forming your opinions in your
`declaration, did you rely on any other documents that
`are not cited in Appendix B?
` A No.
` Q And so besides the one literature search
`that you referred to regarding heparins, did you
`perform any other literature searches in preparing
`your declaration in this case?
` A No, I did not.
` MS. DASHE: Rachel, you can take down
`Exhibit 2052. Thank you.
` Q Dr. Meibohm, do you know who else provided
`a declaration in this case in support of Merck?
` A I -- there is background noise. Sorry.
` Q Yes, I was hearing that as well.
` A Can you repeat the question, please.
` Q Yes, yes. Do you know who else provided a
`declaration in this case in support of Merck?
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`Conducted on March 6, 2024
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`22
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` A I was told that there was an individual
`that is referred to in the declaration as the person
`of ordinary skill in the art that is a physician that
`provided deposition.
` Q Do you know who that individual is?
` A I think the name was -- was mentioned to me
`yesterday. I do not remember the name.
` Q Before yesterday, did you know who that
`individual --
` A Sorry. It was on Monday, not yesterday.
` Q Excuse me. So to clarify, before Monday,
`did you know who that other individual who provided a
`declaration in this case in support of Merck is?
` A No.
` Q So then you did not know who that
`individual is before you signed your declaration in
`this case, right?
` A That is correct.
` Q Okay. And so then it's fair to say that
`you have not read that individual's declaration; is
`that right?
` A That is correct.
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` Q And you also have not communicated with
`this other individual who provided the declaration in
`this case on behalf of Merck; correct?
` A That is correct.
` Q Besides counsel, did you communicate with
`anyone else in order to create your declaration in
`this case?
` A No, I did not.
` Q Have you heard of Dr. Alain Munafo, spelled
`A-l-a-i-n, M-u-n-a-f-o?
` A Yes, I do.
` Q How have you heard of Dr. Munafo?
` A Dr. Munafo was an employee at Serono, that
`then was acquired by Merck KGaA to become Merck
`Serono in the, I think, early 2000s. And I did
`consulting work for Merck Serono at that time and I
`had interactions with Dr. Munafo.
` Q And what were your interactions with
`Dr. Munafo about?
` A About development projects that Merck was
`working on.
` Q When were these interactions with
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`Dr. Munafo?
` A They were in the early -- in the late
`2000s. So I would say somewhere between 2005, 2006,
`and probably 2014 or '15.
` Q Were any of your interactions with
`Dr. Munafo about cladribine?
` A No.
` Q When was the last time you interacted with
`or communicated with Dr. Munafo?
` A I do not recall. As I said, probably
`around 2015 or 2016. I have met him afterwards at a
`professional meeting, and I think I had an email
`exchange with him a few years ago because he had
`retired and I wished him well.
` Q Your interactions with Dr. Munafo at Merck,
`did any of them have any relation to multiple
`sclerosis drugs or treatments?
` A No.
` Q So the last time you interacted with
`Dr. Munafo with respect to Merck development products
`was about eight years ago, but you've had two
`interactions since then; is that right?
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` A I do not know whether I had two
`interactions with him, but interactions with him that
`were not related to Merck, that were related to --
`well, scientific conferences and general scientific
`exchange.
` Q And the last time you interacted with
`Dr. Munafo you said was about a couple years ago?
` A I had my last consulting interactions with
`Merck in 2017. After that, I had a training session
`in 2022, but that was not related to consulting and
`was a completely different group.
` So the last that I had interacted with
`Dr. Munafo was perhaps 2017, perhaps earlier than
`that. I'm not sure if he was still at the company in
`2017.
` Q So then you've never interacted with
`Dr. Munafo about cladribine or MS drugs or
`treatments; is that right?
` A That is correct.
` Q Have you heard of Dr. Yogesh Dandiker?
`Spelled Y-o-g-e-s-h, D-a-n-d-i-k-e-r.
` A Not that I'm aware of.
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` Q And have you heard of Dr. Fred Lublin?
`Spelled F-r-e-d, L-u-b-l-i-n.
` A Not that I'm aware of.
` Q Were you aware that Dr. Fred Lublin's
`deposition was taken yesterday in this case?
` A I think, as I said, someone else was
`mentioned. I couldn't remember the name. If you
`tell me so, yes, that's probably the name that was
`mentioned to me.
` Q Okay. And without revealing the contents
`of any privileged communications, just did you learn
`about this deposition from counsel?
` A I was not -- I'm not sure that I knew that
`until -- yes.
` Q Just so the record is clear, you learned
`about Dr. Fred Lublin's dep -- pardon me.
` You learned about the deposition that
`occurred yesterday from counsel; that's right?
` A I think I did this morning.
` Q Okay. And did you review the deposition
`transcript from yesterday's deposition?
` A No.
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` Q Are you aware of any of the questions that
`were asked in yesterday's deposition?
` A No.
` Q And besides counsel, did you discuss
`Dr. Lublin's deposition with anyone else in
`preparation for your deposition today?
` A No.
` Q Were you aware that Dr. Yogesh Dandiker's
`deposition was taken in this case last month?
` A No.
` Q Were you aware that Dr. Nicholas' -- strike
`that.
` Were you aware that Dr. Nicholas Bodor's
`deposition was taken in this case last month?
` A I think it was mentioned while we were
`already online this morning.
` Q And was that mentioned by counsel?
` A I'm not sure who mentioned that. If
`anybody can remember?
` Q So you don't recall who mentioned that
`Dr. Bodor was deposed earlier in this case?
` A I think it was about the -- it may have
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`been you because it was about the -- the cut-off of
`the -- of your questions, the technical difficulties
`you had yesterday, you mentioned that when we were
`starting.
` Q Oh, okay. So you actually learned it
`before today's deposition, when I mentioned that I
`had deposed Dr. Bodor, that was the first time you
`were aware that Dr. Bodor had been deposed in this
`case?
` A Yes.
` Q Okay. I see what you're saying.
` Dr. Meibohm, your current rate is $600 an
`hour; is that right?
` A That is correct.
` Q And how much have you billed for your work
`so far in this case approximately?
` A Approximately $11,000.
` Q Are you owed any other money for work that
`you have performed in this case?
` A Yes.
` Q Approximately how much?
` A Well, the time that I spent the last two
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`days.
` Q So that would be about $600 an hour times
`roughly eight hours. Does that sound about right?
` A That is about right.
` Q Okay. Now, you mention in your
`declaration, and earlier today as well, that you have
`consulted for and been invited to present your
`research by Merck.
` So my question for you is when did you
`first begin consulting with Merck or any related
`entity?
` A I started working with Merck in 1998.
` Q And I believe you said both earlier in the
`deposition, as well in your declaration, that your
`last consulting work with Merck was in 2022.
` But have you consulted with any other
`entity related to Merck since 2022?
` A No, I have not. And as I mentioned
`earlier, my consulting work on development projects
`really ended in 2017. In 2022, was a training
`session for Merck scientists.
` Q What was that training session about in
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`2022?
` A About the general concepts of
`pharmacokinetics and pharmacodynamics in the
`development of therapeutic proteins.
` Q So you've consulted for Merck for about 24
`years. Does that sound right?
` MR. BASSETT: Objection.
` You may answer.
` A Between '98 and 2017, so it is 19 years.
` Q So you've consulted for Merck for about 19
`years, plus the occasional additional work after
`2017; is that right?
` A That is correct.
` Q How often have you been invited to present
`your research by Merck or any related entity?
` A I think, after going through my CV, that I
`have been 14 or 15 times on the premises of Merck,
`either in Europe or the U.S., and have given on those
`occasions sometimes more than one presentation at one
`visit.
` Q Have you been invited to present your
`research by Merck in any other location besides their
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`premises?
` A Not that I remember. I think we were one
`time in a hotel on Lake Geneva, but it was also a
`Merck internal event.
` Q And what were these invited presentations
`at Merck generally about?
` A They were either based on results from
`consulting work where I did analysis for Merck and I
`would present those results, or they were related to
`general topics relevant in clinical pharmacology and
`pharmacokinetics and pharmacodynamics of relevant to
`clinical drug development.
` Q What was your consulting work on behalf of
`Merck generally about?
` A About pharmacokinetic and
`pharmacokinetic/pharmacodynamic analysis.
` Q Have you worked on any specific drug
`development projects on behalf of Merck?
` A Yes, I did.
` Q And what were those about?
` A Can you be more specific?
` Q What drug development projects did you work
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`on on behalf of Merck?
` A There were multiple indications. Some of
`the publicly-available results are, for example,
`related to a glycoprotein IIb/IIIa inhibitor and the
`name is Gantofiban.
` Q Could you please spell that I think for us
`spelling challenged folks on the record, that would
`be helpful.
` A If I remember correctly, it's
`G-a-n-t-o-f-i-b-a-n.
` Q Any other publicly-available projects that
`you can list on behalf of Merck that you worked on?
` A Yeah. We published on cetuximab which is a
`monoclonal antibody.
` Q Could you spell that?
` A C-e-t-u-x-i-m-a-b.
` And we may have worked and may have
`published on other compounds that had EMD codes
`rather than drug names. So developmental projects
`that usually have a start with EMD and then a number
`series.
` Q The EMD code, is that internal to Merck?
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` A As far as I understand, yes.
` Q Has any of your work on development
`projects for Merck involved drugs or treatments for
`multiple sclerosis or cladribine?
` A No.
` Q And have you received any financial
`compensation from Merck for either your presentations
`or your consulting work, or both?
` A Yes.
` Q Approximately how much?
` A I don't know. Over 25 years, I really
`don't know.
` Q Can you give me a ballpark roughly?
` A No.
` Q Is it more than $10,000?
` A Over -- what did I say, 19 years? Over 19
`years, yes, it's more than $10,000.
` Q Is it more than a hundred thousand dollars?
` A I doubt it, but it could be.
` Q So over the course of your consulting
`relationship with Merck, you have received more than
`$10,000 in compensation with a ceiling of maybe
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`roughly $100,000.
` Does that sound right?
` A Over the 17-year period, that may be right.
` Q Approximately how m
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