`
`Transcript of Fred Lublin, M.D.
`
`Date: June 14, 2024
`Case: TWI Pharmaceuticals, Inc. -v- Merck Serono SA (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
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`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` - - - - - - - - - - - - x
`TWI PHARMACEUTICALS, :
`INC. :
` Petitioner, : IPR2023-00049
`v. : (Patent 7,713,947 B2)
`MERCK SERONO SA : IPR2023-00050
` Patent Owner. : (Patent 8,377,903 B2)
` - - - - - - - - - - - - x
`
` Deposition of FRED D. LUBLIN, M.D.
` New York, New York
` Friday, June 14, 2024
` 9:31 A.M.
`
` Job No.: 538578
` Pages: 1 - 102
` Reported By: Anita M. Trombetta, RMR, CRR,
` CSR No. 14647
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
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`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`2
`
` Deposition of FRED D. LUBLIN, M.D., produced
`as a witness at the instance of the Petitioner,
`and duly sworn, was taken in the above-styled
`and numbered cause on June 14, 2024, from 9:31
`A.M. to 2:48 P.M., 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
`
`Before Anita M. Trombetta, RMR, CRR, California
`Shorthand Reporter, and Notary Public in and for
`the State of New York.
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`
`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`3
`
` A P P E A R A N C E S
` ON BEHALF OF THE PETITIONER:
` PHILIP D. SEGREST, JR., ESQ.
` HUSCH BLACKWELL, LLP
` 120 South Riverside Plaza, Suite 2200
` Chicago, Illinois 60606
` (312) 655-1500
`
` ON BEHALF OF FRED D. LUBLIN, M.D., AND THE
` PATENT OWNER:
` CINDY KAN, ESQ.
` DAVID B. BASSETT, ESQ.
` WILMER CUTLER PICKERING HALE AND DORR
` 7 World Trade Center
` 250 Greenwich Street
` New York, New York 10007
` (212) 295-6470
`
`ALSO PRESENT:
`Willem De Weerd, Merck Serono (remote)
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`4
`
`--------------------I N D E X------------------
`WITNESS
`FRED D. LUBLIN, M.D.
`EXAMINATION BY PAGE
`
` ATTORNEY SEGREST 5
` ATTORNEY KAN 89
` ATTORNEY SEGREST 97
`---------------E X H I B I T S-----------------
`(Previously marked.)
` EXHIBIT DESCRIPTION PAGE
` Exhibit 19 Declaration of Dr. 7
` Fred Lublin
` Exhibit 2025 Document Entitled, 26
` Immunotherapy of
` Multiple
` Sclerosis--Current
` Practice and
` Future Directions.
` Exhibit 2012 Chapter from 43
` Multiple
` Sclerosis, a
` Comprehensive Text
` Exhibit 2040 Sipe 1996 Study 45
` Exhibit 1027 Beutler 1995 Study 46
` Exhibit 1016 Romine 1999 47
` Exhibit 1029 Bodor Reference 51
` Exhibit 1031 Selby 1998 Article 52
` Exhibit 1026 Tortorella Article 52
` Exhibit 1001 '947 Patent 73
` Exhibit 1046 Lublin Article 82
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`5
`
` P R O C E E D I N G S
`F R E D D. L U B L I N, M. D.,
` called as a witness, having been duly
` sworn by a Notary Public, was examined and
` testified as follows:
`EXAMINATION BY
`ATTORNEY SEGREST:
` Q Good morning. I'm Philip Segrest. I'm
`representing the petitioner, TWi in this case.
`I'll be asking you some questions this morning.
` Can you state your name for the record,
`spelling your name, please.
` A Fred Lublin, L-U-B-L-I-N.
` Q And it's Dr. Lublin, right?
` A That's correct.
` Q Are you an M.D. or Ph.D.?
` A M.D.
` Q Now, you're familiar with these IPR
`proceedings and you understand why you're here
`this morning, right?
` A Pretty much.
` Q And is there any reason you couldn't
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`6
`
`testify fully and accurately today?
` A No.
` Q You mentioned that you're getting over a
`cold. Are you on any kind of medication that
`could affect your testimony or your ability to
`answer questions?
` A I'm not.
` Q Now, this case concerns two patents called
`the '947 patent and the '903 patent. You've also
`given testimony in another proceeding about those
`two patents, right?
` A That's correct.
` Q And that involved a company called
`Hopewell?
` A Yes.
` Q And did you give a deposition in that case
`on about March 5, 2024?
` A I don't recall the exact date, but I did
`give a deposition.
` Q So our proceedings this morning will be
`similar, and similar instructions. I'll ask
`questions, you'll answer. We've got a court
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`7
`
`reporter who is transcribing things
`stenographically for us, so it's important we try
`not to talk over each other.
` Your attorney may object to some questions
`at some point, but unless you're specifically
`instructed not to answer -- those objections will
`be something that will be sorted out later -- you
`should go ahead and answer the questions even if
`there is an objection, unless there is an
`instruction not to answer.
` If you need to take breaks at any point --
`and again, I understand you're getting over a
`cold, so we can take breaks as often as you need.
`It's not an endurance contest. If there is a
`question pending, I may ask you to go ahead and
`answer whatever question is pending before we take
`the break.
` Do you have any questions about how the
`proceedings will go this morning?
` A I don't.
` Q I'll hand you this notebook, which is a
`document that was previously marked as Exhibit
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`8
`
`2019.
` Is this Exhibit 2019 your declaration
`that's filed in these two IPR proceedings?
` A It looks like it.
` Q And one is case IPR 2023-00049 concerning
`patent 7,713,947. If I refer to that as the 049
`case or the 049 IPR and the '947 patent, will you
`understand what I'm talking about?
` A I will.
` Q And the other case is IPR 2023-000050,
`Patent 8,377,903. And again, if I refer to that
`as the 050 case or the 050 IPR on the '903 patent,
`will you understand what I'm talking about?
` A I do.
` Q Turn to page 157 of the document, please.
` Did you sign this document about March 13,
`2024?
` A Yes.
` Q Is that your signature?
` A It is.
` Q Have you had occasion to review this
`declaration since then?
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`9
`
` A I have.
` Q Is there anything in it that you need to
`change or update?
` A No.
` Q Let's go back to the beginning, page 1.
`I'm looking at paragraph 3.
` Does this paragraph 3 of your declaration
`indicate what your compensation is for your
`participation in these proceedings?
` A It does.
` Q And so you're being paid your consulting
`rate of $900 an hour for non-deposition time and a
`$9,000 flat fee per day of deposition time, right?
` A That's correct.
` Q So the time -- well, let me ask you, what
`did you do to prepare for the deposition today?
` A I reread my declaration. I looked over
`the articles or references cited in the
`declaration. I met with counsel.
` Q And about how long did you spend on those
`preparations?
` A I don't have an exact tally.
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`10
`
` Q Approximately how long?
` A Again, I don't have an exact tally of how
`many hours. I haven't billed them.
` Q How many days did you meet?
` A We met for four and a half days.
` Q And how long did you meet each day?
` A Each day was seven to eight hours, except
`for the half day, which was a half that.
` Q Is that considered non-deposition time,
`your prep time?
` A No, I consider that same as deposition
`time.
` Q Okay. So were those -- was that prep time
`compensated at 9,000 per day?
` A Yes.
` Q And the $900 per hour, is that the time
`spent in preparing your declaration?
` A Yes.
` Q Other than preparing your declaration, the
`prep time for your deposition and your testimony,
`is there any other time that you're being paid for
`on these cases?
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`11
`
` A No.
` Q Were you paid at the same rate for your
`testimony and deposition in the Hopewell case?
` A Yes.
` Q And have you submitted invoices for your
`time spent on that case?
` ATTORNEY KAN: Objection. Relevance.
` A I'm not sure.
` Q Okay. Do you know how much you would be
`compensated for your time on that case?
` A I don't.
` Q Now, you have given deposition testimony a
`number of times before, right?
` A That's correct.
` Q Have you ever testified at trial?
` A I have.
` Q How many times?
` A Are you referring to trial on patent
`matters?
` Q No, how many trials?
` A Maybe six or seven.
` Q Now, how many of those were patent
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`12
`
`matters?
` A Two.
` Q Other than these IPRs and the Hopewell
`IPRs, have you done any other consulting or expert
`work regarding the '947 patent or the '903 patent?
` A I don't believe so.
` Q Have you done anything for the district
`court cases that are pending related to those
`patents?
` ATTORNEY KAN: Objection. Relevance.
` A Yes.
` Q And have you been compensated for your
`time spent related to those district court
`matters?
` A No.
` Q Do you expect to be compensated for your
`time related to those district court matters?
` A Yes.
` Q And will that compensation be at the same
`$900 per hour consulting rate?
` A Yes.
` Q Have you been deposed in any of those
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`13
`
`district court matters?
` A No.
` Q Other than for this case, for the Hopewell
`IPRs, for the district court case, have you
`received or do you expect to receive any other
`compensation from Merck Serono, the patent owner
`in this case?
` A No.
` Q And have you received, or do you expect to
`receive, any other compensation from any other
`entities that you know were affiliated with the
`patent owner in this case?
` A No.
` Q Looking at paragraph 6 of your
`declaration. On page 2, you're the director at
`the Corinne Goldsmith Dickinson Center for
`Multiple Sclerosis at Icahn School of Medicine at
`Mount Sinai, New York?
` A I'm sorry. I didn't hear a question.
` Q Yeah, I asked: Are you the director of
`the Corrine Goldsmith Dickinson Center For
`Multiple Sclerosis at the Icahn School of Medicine
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`14
`
`at Mount Sinai in New York City?
` A I am.
` Q Has that institution, Corrine Goldsmith
`Dickinson Center ever received any funding from
`Merck or Serono or Merck Serono, any of the -- any
`parties affiliated with the patents in this case?
` ATTORNEY KAN: Object to form.
` A Yes.
` Q What funding has that organization
`received?
` A EMD Serono has provided funding to the
`institution to support the fellowship program.
` Q And how much is that funding?
` A None this year. Last year, somewhere
`between 125,000 and 250-. I don't recall the
`exact amount.
` Q Has it provided other funding in the past?
` A Some years ago it provided funding for a
`clinical trial that we did, but that goes back to,
`I believe the early 2000s.
` Q Have you ever received speaker fees or
`similar compensation from Merck Serono, Serono
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`15
`
`EMD, or any of the companies that are affiliated
`with the patents?
` A I have.
` Q And when was that?
` A In 2022, I received -- I gave two talks,
`one for Merck Serono, one for EMD Serono.
` Q And how much were you paid for those?
` A Somewhere between -- somewhere in the
`4,000 range for each.
` Q Referring to paragraph 4 on the same page,
`does this indicate that the materials you've --
`that -- in forming your opinion, in addition to
`your knowledge and experience, you've considered
`the materials cited in your declaration and listed
`in Appendix A?
` A Yes.
` Q Okay. Do you know of anything that's
`cited in your declaration that's not listed in
`Exhibit A or Appendix A?
` A Not that I'm aware of.
` Q Okay. And other than your knowledge and
`experience, did you consider any materials that
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`16
`
`are not cited in your declaration or listed in
`Appendix A?
` A No.
` Q Let's turn to page 158, please.
` Are pages 158 through 165 the Appendix A
`referred to in paragraph 4 of your declaration?
` A Yes.
` Q And so is this table the list of materials
`you considered?
` A Yes.
` Q So on page 158, about the seventh row of
`that table, do you see in Exhibit No. 1003, file
`history of U.S. Serial No. 11/722,018 (U.S. Patent
`No. 7,713,947)?
` A Are you referring to the 1003?
` Q Yes.
` A Yes, I see it.
` Q Okay. And do you cite that exhibit
`anywhere in your testimony in your declaration?
` A I don't recall.
` Q Are you aware of any testimony in your
`declaration that refers to that file history?
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`17
`
` A I don't recall.
` Q And then is Exhibit 1004, the next row the
`file history for that application which issued as
`the '903 patent?
` A It's the same question. I don't recall.
` Q Okay. So actually, I hadn't asked that
`question yet, but I was going to ask if you cited
`this in your testimony or if you recall -- if
`you're aware of any testimony you gave about this
`exhibit. If you can go ahead and answer it now
`that I've asked the question.
` A I don't recall.
` Q Did you review and consider those
`prosecution history files for your testimony in
`the two Hopewell IPRs?
` A I don't believe so.
` Q Why did you add --
` (Reporter clarification.)
` Q Why did you add them to the materials
`considered for these IPRs?
` A The advice of counsel.
` Q Did you review those prosecution histories
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`18
`
`between March 5 when you gave your deposition in
`the Hopewell IPRs and March 13 when you signed
`your declaration in these IPRs?
` A I probably did.
` Q Do you remember anything about those file
`histories that you reviewed?
` A You'd have to be more specific.
` Q Did you notice anything in reviewing those
`two file histories that you thought was relevant
`to your opinions in these matters?
` ATTORNEY KAN: Object to form.
` A What I saw was the file history, the
`arguments being made in terms of the patent, the
`comments from the patent office reviewer, the
`responses to those comments, the responses and
`such.
` Q And you don't remember if you put anything
`about that in your testimony in this declaration
`in that week between your deposition in the
`Hopewell IPRs and when you signed this
`declaration, right?
` ATTORNEY KAN: Objection to form.
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`19
`
` A I don't recall.
` Q Let's turn to page 166.
` Now, is page 166 of this Exhibit 2019, the
`beginning of Appendix B, your CV?
` A Yes.
` Q Turn over to page 191, please.
` Is this still in your CV, page 191 that
`you're looking at?
` A I'm sorry. I couldn't understand the
`question.
` Q Is this page 191 that we're looking at
`still part of your CV?
` A Yes.
` Q Let's look at the heading "bibliography"
`at the top. What is this list that starts on this
`page?
` A These are the peer-reviewed articles that
`I published over my career.
` Q Is that under the heading, "original
`articles"?
` A Yes.
` Q And so did you consider yourself an author
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`20
`
`or a co-author of all of these articles?
` A Yes.
` Q And does this list go from No. 1 on
`page 191 of Exhibit 2019 to No. 255 on page 219 of
`Exhibit 2019?
` A Yes.
` Q So then on page 220, what's the list that
`starts at the top of this page?
` A Editorials and opinion pieces.
` Q Okay. And these are numbered separately,
`right?
` A Yes.
` Q And then below that there is only one item
`under the heading texts; is that correct?
` A That's correct.
` Q And then what is it that starts at the top
`of page 221?
` A Those would be chapters from textbooks.
` Q And does that list go from -- list of
`chapters and textbooks go from No. 1 on page 221
`to number 33 on page 224 of Exhibit 2019?
` A Yes.
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`21
`
` Q And then what's that last item under
`"other publications" on page 224?
` A It's a publication put out by the
`Consortium of Multiple Sclerosis Centers of a
`document called, "Best Practices in Multiple
`Sclerosis" that I edited and chaired.
` Q Do you consider yourself an author of that
`publication?
` A Yes.
` Q And what's the list that starts on the top
`of page 225?
` A That would be abstracts and letters.
` Q And do you also consider yourself an
`author or co-author of the abstracts and letters
`that are listed below that heading?
` ATTORNEY KAN: Object to form.
` A I do.
` Q So going back to the original articles on
`page 191, have any of these articles that you're
`listed as an author or co-author on ever had to be
`retracted?
` A No.
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`22
`
` Q Have you ever had to publish corrections
`about the contents of any of the articles that are
`listed here?
` A No.
` Q So as far as you can recall, did you
`believe that the statements in these articles that
`are on this list were true and accurate at the
`time that they were published?
` A Yes.
` Q Now, you'd agree that multiple sclerosis
`has multiple different clinical subtypes, right?
` A Yes.
` Q And I'd direct you to paragraph 46 in your
`declaration. It's on page 17.
` And so do those subtypes include
`relapsing-remitting multiple sclerosis, secondary
`progress multiple sclerosis, primary progressive
`multiple sclerosis, and progress relapsing
`multiple sclerosis?
` ATTORNEY KAN: Object to form.
` A As of 2004.
` Q Have other clinical subtypes been defined
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`23
`
`since 2004?
` A Yes.
` Q And what are those other clinical
`subtypes?
` A The clinically isolated syndrome was added
`in 2013, and progressive relapsing was dropped
`because it became subsumed in a subtype of
`progressive MS.
` Q Is primary progressive multiple sclerosis,
`which you abbreviate PPMS, a progressive form of
`multiple sclerosis?
` A Yes.
` Q Is it also subsumed as a subtype of
`progressive multiple sclerosis?
` A It's one of the progressive forms of
`multiple sclerosis.
` Q So I think you said the progressive
`relapsing was dropped because it became subsumed
`in a subtype of progressive multiple sclerosis --
`progressive MS, right?
` A Yes, a primary progressive MS.
` Q Okay. So it's considered a subtype of
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`24
`
`what was previously a separate clinical type now?
` A So we dropped progressive relapsing
`because we added additional clinical
`characterizations to the other existing subtypes.
`One of those was called active, and active
`referred to having had either a relapse or a new
`MRI activity over a fixed period of time. And so
`if a primary progressive patient was active, then
`that would become the same as progressive
`relapsing. And so we dropped progressive
`relapsing. It then became primary progressive
`with activity.
` Q Is a secondary progressive MS still a
`separate clinical subtype?
` A Yes.
` Q Is it also a form --
` I'm sorry. Secondary progressive multiple
`sclerosis is also a progressive form of multiple
`sclerosis, right?
` A Yes.
` Q So of the four clinical subtypes listed in
`paragraph 46 of your declaration, is RRMS
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`25
`
`relapsing-remitting MS, the only one that's not a
`progressive form of multiple sclerosis?
` A Could I hear that question again?
` Q Of the four clinical subtypes listed in
`paragraph 46 of your declaration, is RRMS,
`relapsing-remitting MS, the only one that is not a
`progressive form of multiple sclerosis?
` A Yes.
` Q Now, do you agree that not all patients
`with MS have a progressive form of the disease?
` ATTORNEY KAN: Object to form.
` A I do.
` Q Is RRMS the most common form of MS?
` A Yes.
` Q Well, in the published literature, do
`authors sometimes use the term "multiple
`sclerosis" even when they're referring
`specifically to RRMS?
` ATTORNEY KAN: Object to form.
` A I don't know if I can answer that
`question.
` Q I'll hand you a document previously marked
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`26
`
`as Exhibit 2025. And I'll read page 201 of
`Exhibit 2019.
` Is Exhibit 2025, the article that's listed
`as No. 111 on page 201 of your declaration in your
`CV?
` A Yes.
` Q So you're a co-author of this article,
`this Exhibit 2025, right?
` A Yes.
` Q And the lead -- the lead author was a
`Dr. Tullman, right?
` A That's correct.
` Q And was this published in 2002?
` A Yes.
` Q Does the first line of the abstract of
`Exhibit 2025 read, "over the past decade, multiple
`sclerosis (MS) has become a treatable neurological
`disease"?
` A That's what it says.
` Q And when it says "multiple sclerosis"
`there in the abstract, that's referring to RRMS as
`a treatable neurological disease, isn't it?
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`EXHIBIT 1042, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`27
`
` A In part.
` Q Were there any approved treatments for
`progressive forms of multiple sclerosis in 2002
`when Exhibit 2025 was published?
` A Yes.
` Q And what treatments were available for
`progressive forms of the disease in 2002?
` A Mitoxantrone.
` Q And for what clinical subtypes of MS was
`mitoxantrone approved in 2002?
` A Secondary progressive MS, progressive
`relapsing MS, and worsening relapse remitting MS.
` Q Does that statement appear on page 279 of
`this article that's Exhibit 2025?
` A Yes.
` Q Were there any approved treatments for
`primary progressive MS in 2002?
` A No.
` Q Are there any now?
` A Yes.
` Q When was the first approved treatment for
`primary progressive MS?
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`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`28
`
` ATTORNEY KAN: Object to form.
` A I believe it was 2017.
` Q And what treatment was that?
` A A molecule called ocrelizumab, the brand
`name is Ocrevus, O-C-R-E-V-U-S.
` Q So might -- or was mitoxantrone approved
`for secondary progressive multiple sclerosis,
`primary relapsing multiple sclerosis and worsening
`relapsing-remitting multiple sclerosis in 2000?
` A No, something you said there didn't make
`sense to me.
` Q Okay. What didn't make sense?
` A You used the term, "primary
`relapsing-remitting."
` Q I didn't mean to say remitting.
` Primary relapsing multiple sclerosis; is
`that the correct term?
` A No.
` Q I'm sorry. What is PRMS?
` A Progressive relapsing.
` Q Progressive relapsing. I apologize.
` So -- in 2000, is that when the FDA
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`IPR2023-00049, -00050
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`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`29
`
`approved mitoxantrone for the treatment of SPMS,
`PRMS, and worsening RRMS?
` ATTORNEY KAN: Object to form.
` A It was approved in 2000.
` Q I'll direct you to Paragraph 71 of your
`declaration. It's on page 28.
` Now, does this paragraph immediately
`follow the heading labeled "outcome measures in MS
`clinical trials"?
` A Yes.
` Q And then in the first sentence you say,
`"relapse rate and physical disability status are
`the primary outcome measures in most MS clinical
`trials."
` A Yes.
` Q Is relapse rate used as a primary outcome
`measure in a clinical trials concerning RRMS?
` A Yes.
` Q Is relapse rate used as a primary outcome
`measure in clinical trials concerning progressive
`forms of MS?
` A That would be unusual.
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`IPR2023-00049, -00050
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`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`30
`
` Q Is physical disability status used as a
`primary outcome measure in clinical trials
`concerning progressive forms of MS?
` A Usually.
` Q Is physical disability status used as a
`primary outcome measure in clinical trials
`concerning RRMS?
` A It has been.
` Q Is relapse rate used as a primary outcome
`measure in clinical trials concerning RRMS more
`often than physical disability status is used as a
`primary outcome measure in clinical trials
`concerning RRMS?
` ATTORNEY KAN: Object to form.
` A Yes.
` Q And by 2004, had MRI scans become an
`established method of monitoring disease
`progression in clinical trial for MS?
` ATTORNEY KAN: Object to form.
` A I'm struggling with the way you asked that
`question because you said "disease progression,"
`and disease progression was primarily monitored
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`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`31
`
`clinically. So MRIs were used for evaluating
`disease, but I don't think I've used the term
`disease progression.
` Q I'll hand you what's been previously
`marked as Exhibit 2013.
` Is Exhibit 2013, an article from the
`Journal of Neurology in 2005?
` A Yes.
` Q And you're the author of this article,
`right?
` A I am.
` Q And this is in your declaration on
`page 202, this is item 121 on your list of
`published articles, right? That's page 202 of
`your declaration, Exhibit 2019, and Item No. 121
`on page 202.
` Is that Item No. 121 this article that's
`marked as Exhibit 2013?
` A Yes.
` Q And then turning to page 161 of your
`declaration, this article, Exhibit 2013 is in your
`list of materials you considered in preparing your
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`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`32
`
`declaration, right?
` A That's correct.
` Q So the page numbers at the top look like
`they have a Roman numeral III and a slash and an
`Arabic number 3 through 9. I'm looking now at
`page 3/4. It's the second page of the article, of
`the exhibit.
` Do you see the heading "a brief history"
`in the column on the left?
` A I do.
` Q And does the second paragraph under that
`heading talk about MRI and the use of MRI in
`multiple sclerosis studies?
` A Yes.
` Q And the last sentence there, does that
`state that -- the last sentence in the second
`paragraph, does that state, "MRI has become an
`established method of monitoring disease
`progression in clinical trials"?
` A Yes. Do you want me to explain the
`difference?
` Q Sure.
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`IPR2023-00049, -00050
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`
`Transcript of Fred Lublin, M.D.
`Conducted on June 14, 2024
`
`33
`
` A So back in 2004 and up until 2013, disease
`worsening and disease progression were considered
`synonymous. In 2013, we published a paper saying
`that we would limit the term, "progression --
`progressing," to those patients who had a
`progress
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