`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`
`Date: June 7, 2024
`Case: TWI Pharmaceuticals, Inc. -v- Merck Serono SA (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ___________________________________________
` TWI PHARMACEUTICALS, INC.
` Petitioner,
` v.
` MERCK SERONO SA
` Patent Owner.
` _______________________________________
` IPR2023-00049 (Patent 7,713,947 B2)
` IPR2023-00050 (Patent 8,377,903 B2)
` ______________________________________
`
` PROTECTIVE ORDER MATERIAL
` Deposition of
` ALAIN MUNAFO, Ph.D.
` Conducted Virtually
` Friday, June 7, 2024
` 1:06 p.m. CEST
`
`Job No.: 541019
`Pages: 1 - 179
`Reported by: Cassidy Western, RPR
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`2
`
` Deposition of ALAIN MUNAFO, Ph.D., conducted
`virtually.
`
` Pursuant to notice, before Cassidy Western,
`RPR, Notary Public in and for the Commonwealth of
`Pennsylvania.
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`3
`
` A P P E A R A N C E S
` ON BEHALF OF THE PETITIONER, TWI
` PHARMACEUTICALS, INC.:
` PHILIP SEGREST, ESQUIRE
` HUSCH BLACKWELL, LLP
` 120 South Riverside Plaza, Suite 2200
` Chicago, IL 60606
` (312) 655-1500
`
` ON BEHALF OF ALAIN MUNAFO, PH.D., AND THE
` PATENT OWNER:
` ASHER S. McGUFFIN, ESQUIRE
` VINITA FERRERA, ESQUIRE
` WILMERHALE
` 60 State Street
` Boston, MA 02109
` (617) 526-6000
`
`ALSO PRESENT:
`Gabriel Martin, A/V Technician
`Dr. Matthias Dotzauer
`Willem de Weerd
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`4
`
` C O N T E N T S
`EXAMINATION OF ALAIN MUNAFO, Ph.D. PAGE
` By Mr. Segrest 5
` By Mr. McGuffin 154
` By Mr. Segrest 167
`
` E X H I B I T S
` (Not attached to transcript.)
`EXHIBIT PAGE
`Exhibit 2053 Declaration of Alain Munafo, 15
` Ph.D.
`Exhibit 2049 Email with attachment 22
` "Cladribine Briefing Document,
` "17 December 2003.doc; Review
` sheet_BD for Sweden.doc"
`Exhibit 1001 United States 29
` Patent No. 7,713,947
`Exhibit 1008 "Cladribine and progressive MS 35
` Clinical and MRI outcomes of a
` multicenter controlled trial," George
` P.A. Rice, MD, for the Cladribine
` Clinical Study Group; and Massimo
` Filippi, MD,and Giancarlo Comi, MD,
` for the Cladribine MRI Study Group
`Exhibit 2050 Oral Cladribine for MS Project, 45
` Meeting on 27 August 2003 in
` Amsterdam
`Exhibit 1003 11/722,018 File Wrapper 132
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`5
`
` ALAIN MUNAFO, Ph.D.,
`of lawful age, being first duly sworn or affirmed
` to testify to the truth, the whole truth, and
`nothing but the truth, was examined and testified
` as follows:
` EXAMINATION BY COUNSEL FOR THE PETITIONER,
` TWI PHARMACEUTICALS, INC.
`BY MR. SEGREST:
` Q Good morning, Doctor. My name's Philip
`Segrest, and I'm representing the party TWi
`Pharmaceuticals in this case. I'm going to be
`asking you some questions this morning.
` My first question, how do I pronounce
`your last name, please?
` A Good morning, Counsel. My last name is
`Munafo, M-u-n-a-f-o. Munafo.
` Q Munafo. Munafo. Am I saying that
`correctly?
` A That's -- that's good enough. Thank
`you.
` Q Thank you, Doctor.
` Would you --
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`6
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` A I -- I would like just -- just before
`starting, I would like to comment on one thing.
`English is not at all my mother language. You can
`see -- you can hear it from my accent. But also
`in this case, I'm going to ask you to speak slowly
`and intelligently so that I can make sure that I
`understand what you are saying and be able to
`address your question as -- as I should.
` So please be -- be conscious that I need
`you to speak slowly and make sure that I
`understand. Thank you.
` Q And if you have any questions about your
`understanding, will you ask me for clarification?
` A I will.
` Q So if you don't ask me for
`clarification, I'll assume that you understood my
`question. Does that make sense?
` A I will -- I may have to, you know,
`iterate some question later on while I'm trying to
`make up my mind that I do understand clearly what
`you are asking for.
` Q Now, Dr. Munafo, you understand that
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`7
`
`you're here today in connection with a declaration
`that you submitted in a case that is brought by
`TWi. Right?
` A Yes, I do.
` Q And you were previously deposed in
`another case involving these same patents that was
`brought by a company called Hopewell. Right?
` A I had a deposition a couple of months
`ago now in -- when -- in relation with an IPR
`by -- with -- by Hopewell, yes.
` Q Okay. And that was about March 27th
`that you had that deposition?
` A Sitting here today, I do not recall the
`exact date, but it was a couple of months ago.
` Q And just in terms of ground rules, we'll
`be operating the same today. I'll ask questions,
`I'll try to speak clearly and distinctly so that
`you can understand. You'll need to give a verbal
`response on the record so the court reporter can
`write it down. There is a video recording being
`made for backup, but the official record is the
`written, stenographic record that the court
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`8
`
`reporter provides. So it's very important to give
`verbal answers, not just nod or shake your head.
` Your counsel may object to some
`questions, but unless you are given an instruction
`not to answer, you'll need to go ahead and answer.
`And there will be a ruling on any objections
`later.
` Do you have any questions about the
`process this morning?
` A No, I don't have any question at this
`moment.
` Q And where are you physically located for
`your testimony this morning?
` A So we are sitting here in a conference
`room in a hotel in Divonne-les-Bains, which is in
`France.
` Q And you say "we are sitting here." Who
`else is present with you?
` A I am here together with Willem de Weerd,
`who introduced himself --
` Q And who is that?
` A He introduced himself a moment ago. He
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`9
`
`is working and representing Merck Serono and
`RS Trading.
` Q And I understand you have some copies of
`exhibits there with you. Is that correct?
` A This is correct.
` Q What papers do you have with you?
` A I have in front of me my declaration
`with respect to TWi, Petitioner. I have the
`so-called '947 patent. I have the so-called '903
`patent. I have what we refer to as Bodor patent,
`last three digit being '100 -- '101. I have the
`product development and license agreement by and
`between IVAX and RS Trading. I have the meeting
`minutes of -- the minutes of the meeting hold in
`August 2003 in Amsterdam, named Oral Cladribine
`for MS Project. And I have the cladribine
`briefing documents for review that's together with
`the cover email, the cover email having a date of
`December 17, 2003.
` And this is all I have with me.
` Q In preparing your declaration, did you
`review any documents that are not cited in your
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`10
`
`declaration?
` MR. McGUFFIN: I'm going to object to
`privilege.
` Dr. Munafo, to the extent you reviewed
`anything by yourself, you can answer, but don't
`reveal the contents of communications with
`counsel.
` THE WITNESS: So yes, I did.
`BY MR. SEGREST:
` Q And what documents did you review that
`are not cited in your declaration?
` MR. McGUFFIN: I'm going to give the
`same objection, the same instruction. You can
`talk about anything you reviewed separately, but
`you should not talk about what we -- what you
`discussed with counsel.
` MR. SEGREST: And I'll note for the
`record that the witness is required to provide
`whatever facts were sent by counsel. You can't
`shield that as privileged. I'm not asking him
`what you provided him, I'm not asking what he
`provided himself. I'm asking him what he reviewed
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`11
`
`and he's required to answer that.
` MR. McGUFFIN: So, Mr. Segrest, he is
`definitely required to talk about the facts, but
`asking specifically what documents he has looked
`at could reveal communications with counsel. And
`I'm just cautioning him not to reveal any
`communications with counsel.
` MR. SEGREST: But he has to say what
`documents he's looked at without saying where he
`got them from.
` MR. McGUFFIN: I don't necessarily
`agree. I think anything that he reviewed himself
`without counsel and anything that is cited in his
`declaration, he can talk about. But I'm going to
`instruct him not to reveal the contents of
`communication with counsel.
`BY MR. SEGREST:
` Q You can answer the question, Doctor.
` A I have reviewed a few documents, but
`sitting here today, I'm not able to -- to give you
`an exhaustive list.
` Q Do you remember looking at any documents
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`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`12
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`that are not cited in your declaration?
` MR. McGUFFIN: I'm going to give the
`same objection, the same instruction. Just don't
`talk about the contents of communications with
`counsel.
` THE WITNESS: I have seen a few
`documents, but sitting here today, I would not be
`able to list exhaustively what I have seen or
`reviewed.
`BY MR. SEGREST:
` Q So even if you can't give a complete
`list, do you remember what any of those documents
`are?
` MR. McGUFFIN: Same objection, same
`instruction.
` THE WITNESS: Sitting here today, I
`would not be able to name precisely these
`document. I would feel more at ease if you
`present a document and ask me whether I have
`reviewed or seen it before.
`BY MR. SEGREST:
` Q Yes. Doctor, I'm asking you about
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`13
`
`things that were not cited in your declaration.
`So I can't tell you what you didn't say.
` Can you remember anything about those
`documents that you did review that you chose not
`to cite in your declaration?
` MR. McGUFFIN: Same objection, same
`instruction.
` THE WITNESS: Sitting here today, and
`given the time lapse since I wrote this
`declaration, I'm unsure of what I had seen by then
`or after then. And I cannot give you -- cannot be
`more specifically than that in total honesty and
`being -- having sworn that I can tell the truth
`and only the truth.
`BY MR. SEGREST:
` Q Other than your deposition for the
`Hopewell IPRs, have you given any other testimony
`about these patents? Given any other depositions
`about these patents?
` A I am going to ask you to repeat the
`first part at least of your question to make sure
`that I understand completely.
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`14
`
` Q Yes. Other than your deposition in the
`Hopewell IPRs, which we mentioned before, have you
`given any other depositions about the '947 and
`'903 patents?
` A So yes, I have.
` Q And when was that?
` A Sitting here today, I am not able to
`state the exact date, but this was within the last
`few month.
` Q And was that a deposition for a lawsuit
`in federal district court in the United States?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Could you please repeat
`your question?
`BY MR. SEGREST:
` Q Was that a deposition for a lawsuit
`pending in federal district court in the United
`States?
` MR. McGUFFIN: Object to form.
` THE WITNESS: I'm not an expert in legal
`terms, so I'm not sure how to address your
`question precisely. Yet I have deposed in
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`15
`
`relation with this case. And, again, excuse for
`my naivete and lack of knowledge of legal terms,
`but the terms "district court" was indeed
`mentioned.
`BY MR. SEGREST:
` Q Let's turn to your declaration, which is
`Exhibit 2053.
` THE TECHNICIAN: Would you like that on
`the screen, Counsel?
` MR. SEGREST: I think the witness has a
`copy of this. It may be useful to display a copy
`so that we can make sure we're on the same page .
` And let's go to page -- page number 25
`at the bottom, but I think it's going to be the
`26th page of the PDF. You're on the 27th page of
`the PDF. That's page 25 at the bottom, 26th page.
`Has paragraph 56 on it.
` (MUNAFO Exhibit 2053 was marked for
`identification.)
` Q So, Dr. Munafo, are you at the page that
`has the number 25 of your declaration?
` A Yes, I see that.
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`16
`
` Q Is that your signature?
` A Yes. This is -- this is my signature.
` Q And where were you physically when you
`signed this declaration?
` MR. McGUFFIN: Object to scope.
` THE WITNESS: I was at home.
`BY MR. SEGREST:
` Q And where is home?
` MR. McGUFFIN: Object to scope.
` THE WITNESS: I live in Switzerland. Do
`you need the exact address?
`BY MR. SEGREST:
` Q No. So you were in Switzerland when you
`signed this declaration. Is that correct?
` MR. McGUFFIN: Object to scope.
` THE WITNESS: Yes, this is correct.
`BY MR. SEGREST:
` Q And just to be clear, you were outside
`the United States when you signed this
`declaration. Correct?
` MR. McGUFFIN: Objection; asked and
`answered. Object to scope.
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`17
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` THE WITNESS: I was in Switzerland.
`BY MR. SEGREST:
` Q Now, I'll direct you to paragraph 56,
`the last paragraph of your declaration.
` Do you see the first line there has a
`statement that "all statements made herein of my
`knowledge are true"?
` A Yes, I do.
` Q And then in the next line, you see
`another clause and it says that "statements made
`on information and belief are believed to be
`true."
` Do you see that?
` MR. McGUFFIN: Object to form.
` THE WITNESS: I see the second line
`reads, indeed, "and that all statements made on
`information and belief are believed to be true."
` And there's a continuation on that, yes,
`I do.
`BY MR. SEGREST:
` Q Yes. So those statements made on
`information and belief are not based on your
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`18
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`personal knowledge. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Sitting here today, I am
`not able to make a difference between information
`that I have, belief that I have, and knowledge
`that I have.
`BY MR. SEGREST:
` Q Let's go to paragraph 54 of your
`declaration that begins on page 23.
` Do you see this paragraph begins with
`the phrase, "to the best of my knowledge"?
` A I see on page 23 the paragraph 54
`starting, "to the best of my knowledge," yes.
` Q And the rest of this paragraph describes
`work at IVAX. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: You are talking about the
`rest of the whole paragraph 54?
`BY MR. SEGREST:
` Q Let's say the rest of that -- this
`sentence. The rest of that first sentence is
`about what IVAX did not design or develop. Right?
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`19
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` MR. McGUFFIN: Object to form.
` THE WITNESS: This whole sentence reads,
`to make sure that I'm with you:
` "To the best of my knowledge, IVAX did
`not design or develop any regimen for treating MS
`using cladribine, let alone the regimen of
`administering 10-milligram of oral cladribine
`tablets per day for five to seven days per month
`for two months followed by a 10-month
`cladribine-free period that I and my team at
`Serono designed and communicated to IVAX before
`February 2004."
`BY MR. SEGREST:
` Q All right. You did not work at IVAX.
`Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: I did not work at IVAX,
`this is correct.
`BY MR. SEGREST:
` Q Now, you have information on which you
`based a belief that this statement is true, but
`you don't have personal knowledge of what IVAX did
`
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`20
`
`and didn't develop. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: I do not have knowledge of
`what IVAX was doing, but given the principle of
`the collaboration, given what we shared at
`meetings where IVAX was present, given the
`agreed-upon distribution of responsibilities, and
`given all what I understand and recall sitting
`here today, it is my conviction that we at Serono
`developed a dosing regimen, and that is mentioned
`in this sentence. And that it was not developed
`by IVAX.
`BY MR. SEGREST:
` Q You were in charge of a team of people
`that were working at Serono. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: This is a vague question.
`I would like you to clarify what you mean with --
`whether this is in relationship with cladribine,
`whether this is altogether my work at Serono, and
`at what time you refer to.
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`21
`
`BY MR. SEGREST:
` Q In your work at Serono between 2001 and
`2004, when it was developing a cladribine product,
`you had a team that you worked with. Right?
` A Between the period 2001 to 2004, I was
`part of a team at Serono. A project team at
`Serono that was working on developing oral
`cladribine for the treatment of multiple
`sclerosis.
` Q Let me direct you to paragraph 18 of
`your declaration on page 7.
` That team at Serono included many people
`other than the named inventors on the '947 and
`'903 patents, didn't it?
` MR. McGUFFIN: Object to form.
` THE WITNESS: The team at Serono
`included experts and colleagues from various
`expertise within Serono. And yes, it was larger
`than the three co-inventors of the '947 and '903
`patent.
`BY MR. SEGREST:
` Q Let me direct you to Exhibit 2049.
`
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`22
`
` (MUNAFO Exhibit 2049 was marked for
`identification.)
` THE WITNESS: Can you let me know what
`this is exhibit?
`BY MR. SEGREST:
` Q I think you referred to it as the
`briefing document, and it's got a cover email.
`It's the one displayed on the screen.
` A I have it, yes, thank you.
` Q And looking at this very first page,
`which I think you've described as a cover email,
`it has addresses for the sender, from, the
`addressees, to, and the CC list for additional
`recipients. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: This cover memo does,
`indeed -- was initiated from Isabelle Emery and
`lists a whole series of people either as
`addressees or in CC, correct.
`BY MR. SEGREST:
` Q And Isabelle Emery was one of the people
`on your team at Serono that you referenced in
`
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`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`23
`
`paragraph 18 of your declaration. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Sitting here today, I
`cannot be sure of -- of the exact composition of
`the team as it fluctuated to some extent along
`the -- along the time. So being part of the team
`is related to an exact time period. But, again,
`sitting here today, I'm not able to address
`formally your question.
`BY MR. SEGREST:
` Q Well, at the time of this email which
`has a date of December 17th, 2003, 11:23:17 a.m.,
`was Isabelle Emery on your team?
` MR. McGUFFIN: Object to form.
` THE WITNESS: This is more than 20 years
`ago, and sitting here today, I'm not able to say
`exactly at what time Isabelle Emery or what month
`Isabelle Emery was on the project team or not.
`BY MR. SEGREST:
` Q So is it your belief that this email was
`distributed from and to people other than those
`who were on that specific product team?
`
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`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`24
`
` MR. McGUFFIN: Object to form.
` THE WITNESS: If I re- -- rephrase your
`question to make sure I understand it correctly,
`you are asking if all the addressees here, all the
`people listed in the "to" or "CC" were part of the
`Serono project team?
`BY MR. SEGREST:
` Q Okay. Let me ask a different question.
` Looking at the email addresses, you can
`see that some of them are listing Serono as the
`organization for that person. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: In the list of people in
`the "to," there -- and in the "CC," there are
`several people listed with a Serono address.
`BY MR. SEGREST:
` Q Okay. And there are others like Yogesh
`Dandiker in the recipient list who were at
`different organizations. Right?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Yogesh Dandiker is listed
`with a IVAX address.
`
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`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`25
`
`BY MR. SEGREST:
` Q Okay. Would this email have been sent
`to people at Serono who were not on the team that
`you describe in your declaration?
` MR. McGUFFIN: Object to form,
`foundation.
` THE WITNESS: This email was distributed
`to the people listed in "to" and "CC." I am not
`able to say here whether this has been distributed
`to other people or seen by other people.
`BY MR. SEGREST:
` Q Are there people on the "to" and "CC"
`list in the Serono organization that were not on
`your team in December of 2003?
` MR. McGUFFIN: Object to form.
` THE WITNESS: If I understand your
`question, whether in the list of "to" and "CC"
`people, there are people from Serono that are not
`on the project team, I am not able, sitting here
`today, to reply definitely because I do not
`recall, as of today, who was on the team by that
`date of December 2003.
`
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`26
`
`BY MR. SEGREST:
`
`Q
`
`So looking at the -- starting with the
`
`"to" list of addressees, was Gordon Francis on the
`
`team that you referred to?
`
`A
`
`Inasmuch as I recall sitting here today,
`
`Gordon Francis was involved in this -- in many
`
`discussions that we had with this development
`
`program. But, again, sitting here today,
`
`I do not
`
`recall whether he was formally on the team or not.
`
`Q
`
`Was Maria Lopez-Bresnahan on the team
`
`the team at the date of December 2003.
`
`that you testified about?
`
`A
`
`Sitting here today I had -- I know that
`
`Maria Lopez-Bresnahan has been working extensively
`
`on this project, and I have collaborated with her,
`
`but I am not able to say whether she was formally
`
`part of the team or not.
`
`Q
`
`Was Samir Shah on this team that you
`
`testified about?
`
`A
`
`Samir Shah was working on the cladribine
`
`oral for treatment of MS, but sitting here today,
`
`I'm not able to state whether he was formally on
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`27
`
`Q
`
`Was Alain Micaleff on the team that you
`
`testified about?
`
`A
`
`Alain Micaleff has contributed and
`
`worked on the project of development of oral
`
`cladribine for the treatment of MS, but sitting
`
`here today,
`
`I am not able to recall whether he was
`
`formally on the product team as of the date of
`
`December 2003.
`
`Q
`
`Would your answer that you don't recall
`
`if the person was on the product team at that time
`
`be the same for the other email recipients listed
`
`with a Serono email address?
`
`MR. McGUFFIN: Object to form.
`
`MR. McGUFFIN: Object to form.
`
`THE WITNESS: Sitting here today more
`
`than 20 years later,
`
`I do not recall,
`
`remember,
`
`who was formally on the product
`
`team by that date.
`
`BY MR. SEGREST:
`
`Q
`
`And sitting here today, if you don't
`
`remember who was on the team, you also don't
`
`personally remember who made exactly what
`
`contributions on the team. Right?
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`28
`
`Objection; mischaracterizes testimony. Objection;
`
`argumentative.
`
`THE WITNESS:
`
`I'm sorry.
`
`I'm going to
`
`ask my advise -- my counsel to repeat his
`
`objection.
`
`BY MR. SEGREST:
`
`remember who was on the team, you also don't
`
`Q
`
`His objection should not affect your
`
`answer, Sir.
`
`A
`
`I -- I just want to make sure that I
`
`understand everything that is said during this
`
`deposition please.
`
`MR. McGUFFIN: Yeah, Mr. Segrest is
`
`right. You should answer. My objections are just
`
`to note my objections on the record.
`
`THE WITNESS: Okay.
`
`So excuse me for
`
`this diversion. Could you please repeat your
`
`question?
`
`BY MR. SEGREST:
`
`Q
`
`Sure. And I'm trying to read it from
`
`the realtime.
`
`And sitting here today, if you don't
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
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`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`29
`
`personally remember who made exactly what
`
`contributions to the team. Right?
`
`MR. McGUFFIN:
`
`Same objections.
`
`THE WITNESS: Sitting here today,
`
`I have
`
`I'm not aware whether the number
`
`a good recollection of contribution I had with
`
`several colleague at Serono. But I cannot list
`
`exhaustively all the contribution that all
`
`colleagues have had on this project.
`
`BY MR. SEGREST:
`
`Q
`
`Let's turn to the Exhibit 1001.
`
`Dr. Munafo,
`
`the Exhibit 1001 is the '947
`
`patent.
`
`Do you have that in front of you now?
`
`A
`
`I have the -- a reprint of the '947
`
`patent in front of me, yes. And I can see it on
`
`screen.
`
`(MUNAFO Exhibit 1001 was marked for
`
`identification.)
`
`Q
`
`And you're listed as the third-named
`
`inventor on this patent. Right?
`
`A
`
`The inventors are four, Giampiero De
`
`Luca, Arnaud Ythier, myself, and Maria
`
`Lopez-Bresnahan.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
`
`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
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`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`30
`
`is relative or not.
`
`Q
`
`And the first name on that list,
`
`Giampiero De Luca, he's the chief intellectual
`
`property counsel at Serono. Right?
`
`MR. McGUFFIN: Object to form.
`
`THE WITNESS: Sitting here today and
`
`more than 20 years later,
`
`I do not recall his
`
`title at the company at that time.
`
`BY MR. SEGREST:
`
`Q
`
`Let's go back to your declaration,
`
`Exhibit 2053.
`
`Go to paragraph 21 of your
`
`declaration.
`
`A
`
`Q
`
`Yes.
`
`And here you testify that Dr. De Luca
`
`was Serono's chief intellectual property counsel.
`
`Did you not have a recollection of what his
`
`position was when you gave this testimony?
`
`MR. McGUFFIN: Object to form.
`
`THE WITNESS: My memory had been -- my
`
`recollection has been refreshed by the time I
`
`wrote this -- this declaration. And now that I
`
`I can positively answer your
`
`read what I wrote,
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
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`EXHIBIT 1045, TWi
`IPR2023-00049, -00050
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`
`
`PROTECTIVE ORDER MATERIAL
`Transcript of Alain Munafo, Ph.D.
`Conducted on June 7, 2024
`
`31
`
`previous question that,
`
`indeed, at that time
`
`Gia
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