July 29, 2019
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`Page 1
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`- - - - - - - - - - - - - - - -X
`MYLAN PHARMACEUTICALS INC., :
` Petitioner, : Case Number
` v. : IPR2018-01403
`BIOGEN MA INC., :
` Patent Owner. :
`- - - - - - - - - - - - - - - -X
`
` VIDEO DEPOSITION OF MARTIN DUDDY
`
` Washington, DC
` Monday, July 29, 2019
`
`REPORTED BY:
` CARMEN SMITH
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 1
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`Page 1
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`- - - - - - - - - - - - - - - -X
`MYLAN PHARMACEUTICALS INC., :
` Petitioner, : Case Number
` v. : IPR2018-01403
`BIOGEN MA INC., :
` Patent Owner. :
`- - - - - - - - - - - - - - - -X
`
` VIDEO DEPOSITION OF MARTIN DUDDY
`
` Washington, DC
` Monday, July 29, 2019
`
`REPORTED BY:
` CARMEN SMITH
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 1
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`Page 2
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` Video deposition of MARTIN DUDDY, called for
`examination pursuant to notice of deposition, on
`Monday, July 29, 2019, in Washington, DC, at the
`offices of Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP, 901 New York Avenue, NW, at 9:11 a.m.,
`before CARMEN SMITH, a Notary Public within and for
`the District of Columbia, when were present on
`behalf of the respective parties:
`
` BARBARA C. MC CURDY, ESQ.
` MARK J. FELDSTEIN, PhD, ESQ.
` PAUL W. BROWNING, PhD, ESQ.
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202.408.4000
` barbara.mccurdy@finnegan.com
` On behalf of Biogen
`
` -- continued --
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 2
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`July 29, 2019
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`Page 3
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`APPEARANCES (Continued):
`
` EMILY J. GREB, ESQ.
` Perkins Coie LLP
` 33 East Main Street, Suite 201
` Madison, Wisconsin 53703
` 608.663.7494
` egreb@perkinscoie.com
` On behalf of Mylan
`
` COURTNEY PROCHNOW, PhD, ESQ.
` Perkins Coie LLP
` 633 West 5th Street, Suite 5850
` Los Angeles, California 90071
` 310.788.3284
` cprochnow@perkinscoie.com
` On behalf of Mylan
`
`Also Present: DAVID VOIGTSBERGER, Video Operator
` MATTHEW GREINERT, ESQ., Mylan
` WENDY PLOTKIN, ESQ., Biogen
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 3
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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` P R O C E E D I N G S
` VIDEO OPERATOR: Good morning. We're now
`on the record. This is the deposition of Martin
`Duddy, MD, in the matter of Mylan Pharmaceuticals
`Incorporated, versus Biogen MA Incorporated,
`IPR2018-01403, in the United States Patent and
`Trademark Office.
` Deposition is being taken at 901 New York
`Avenue, Northwest, Washington, D.C., and the time is
`9:11 a.m. Today's date is July 29th, 2019.
` The court reporter is Carmen Smith with
`the firm of Ace-Federal Reporters. I'm the video
`operator, David Voigtsberger from Ace-Federal
`Reporters, 555 12th Street, Northwest, Washington,
`D.C.
` Will counsel please identify yourselves
`and who you represent.
` MS. GREB: Emily Greb of Perkins Coie on
`behalf of Petitioner Mylan Pharmaceuticals Inc.
`With me today is Courtney Prochnow from Perkins Coie
`on behalf of Mylan, as well as Matt Greinert,
`in-house counsel for Mylan.
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`09:11:16
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 4
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` MS. MC CURDY: Barbara McCurdy, Finnegan
`Henderson, representing Biogen MA Inc., here with my
`colleagues Mark Feldstein, Paul Browning, also with
`Finnegan Henderson, and Wendy Plotkin with Biogen.
`Whereupon,
` MARTIN DUDDY
`was called as a witness and, having first been duly
`sworn, was examined and testified as follows:
` EXAMINATION
` BY MS. GREB:
` Q Morning, Doctor.
` A Good morning.
` Q Could you please start by stating your
`name for the record.
` A I am Martin Duddy.
` Q Thank you.
` Doctor, have you been deposed before?
` A No.
` Q Okay. Have you ever been an expert
`witness in any legal proceeding before?
` A No.
` Q Aside from your work in this case or the
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 5
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`
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`co-pending district court case, have you ever
`received payment for any services from Biogen?
` A I have done Biogen advisory boards, and
`for them and other forms of the companies, I have
`given talks on behalf of Biogen for which I received
`payment. As for a number of other drug companies.
`And --
` Q And you understand that your testimony
`today is under oath; correct?
` A I do.
` Q Just a couple -- a couple sort of ground
`rules today. If you don't understand a question,
`please let me know. If you don't tell me you don't
`understand it, I'll assume that you do.
` Is that fair?
` A Thank you.
` Q As you probably know, your counsel may
`object to certain questions from time to time today.
`Notwithstanding that, you understand that unless
`you're instructed not to answer, you should go ahead
`and answer the question; correct?
` A I do.
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 6
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Q And just a housekeeping thing. As you
`know, there's a court reporter here, so it's
`important we don't talk over each other. That will
`make her job much easier.
` Is that fair?
` A That's fair.
` Q Okay. If you want to take a break at any
`point, please just let me know and we can take a
`break. If there's a question pending, I would ask
`that you answer the question before we take a break.
` Is that okay?
` A That's okay.
` Q Doctor, what did you do to prepare for
`your deposition today?
` A So I've been asked to prepare a rebuttal
`for the statements and from the -- from Mylan's
`experts. So I've looked at those, and I have
`reviewed some of the literature around that. I have
`looked at the documents which I listed in my
`statement and prepared this declaration.
` Q It looks like you've brought a document in
`with you today that you're referring to. Is that
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 7
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`
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 29, 2019
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`Page 8
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`Exhibit 2058?
` A Exhibit 2058 is my declaration, yes.
` (Previously identified Exhibit 2058
` presented.)
` BY MS. GREB:
` Q So it's the declaration that you submitted
`in the IPR between Mylan and Biogen; is that
`correct?
` A Yes.
` Q Okay. So my understanding is that's 2058.
`Is it a full copy of your declaration?
` A It is.
` Q Did you meet with anybody to prepare for
`your deposition?
` MS. MC CURDY: I'll instruct the witness
`to not disclose any confidential attorney-client
`privileged information in answering that question.
` THE WITNESS: Yes, but I'm happy to say we
`have met. I have met with the legal team, and most
`of them are here today.
` BY MS. GREB:
` Q Okay. Which lawyers did you meet with to
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 8
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`prepare for your deposition?
` A So I have met with Barbara and Paul, Mark,
`and Erin Sommers.
` Q And for how long did you meet with those
`attorneys?
` A Oh, and Li Feng. Sorry.
` Q No worries. For how long did you meet
`with those attorneys?
` A So we have met a number of occasions. I
`cannot add up all those hours, but we have met face
`to face on at least four occasions that I can
`remember.
` Q And were all four of those occasions to
`prepare for your deposition today?
` A No. The first meeting was a scoping one
`when we met and discussed views.
` MS. MC CURDY: Objection. I instruct you
`not to answer any questions that will disclose
`attorney-client privileged information.
` THE WITNESS: Okay. Apologies.
` BY MS. GREB:
` Q So would you be able to answer my question
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`July 29, 2019
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 9
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`Page 10
`about which occasions you met with attorneys to
`1
`prepare for your deposition? Just referring to
`meeting with attorneys to preparing for your
`deposition today.
` A To prepare for this deposition today, so I
`can --
` Q How long did you meet with them?
` A I can recall three occasions of meeting
`where the purpose was to discuss this declaration.
` Q Okay. When were those meetings?
` A We met -- without my calendar, so we have
`met over the last two days. We met in Philadelphia
`to coincide with the AAN, which was in -- mind has
`gone blank -- May. And we met in -- we met earlier
`this year on one occasion face to face before that.
` Q When you say "over the last two days," was
`that Saturday and Sunday just before today?
` A Yes.
` Q Other than the attorneys for Biogen that
`you mentioned, have you talked with anyone else to
`prepare for your deposition?
` A No.
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 10
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Q When preparing for your deposition today,
`did you review any documents that were not cited in
`Exhibit 2058?
` A Anything that is in this is cited. May I
`have -- there may be other references which are
`involved in some of the on-reference conclusions
`that we come to, which I might rely on today and
`bring up, but I'll let you know when we get there.
` Q As you are sort of sitting here right now,
`do you remember any specific documents that you
`reviewed to prepare for your deposition that are not
`cited in your declaration that's Exhibit 2058?
` A No. But just for example, I have
`paragraphs there on MS as a disease which I have not
`given you references for because these are commonly
`accepted views on multiple sclerosis.
` Q Have you reviewed any deposition
`transcripts of other experts that have been deposed
`in the IPR?
` A No. I have seen their declarations.
` Q And when you say you've seen their
`declarations, which experts are you referring to?
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`MYLAN PHARMS. INC. EXHIBIT 1125 PAGE 11
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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` A So the three that I comment on in my
`1
`report. So I cite Corboy, Benet and McKeague.
` Q Have you reviewed the declarations of
`other of Biogen's expert witnesses?
` A I have not.
` Q Looking at your declaration, Exhibit 2058,
`there is an appendix A attached that states it's
`your CV?
` A Yes.
` Q Is that right?
` A Yes.
` Q And that starts at page 95 of the exhibit?
` A Yeah, page 95.
` Q Is this a current copy of your CV?
` A It was current at the time of submitting
`the declaration, so it's dated the 25th of February.
` Q Are there any updates or corrections to
`your CV that you would need to make to have it be
`accurate as of today?
` A There's nothing substantive that changes,
`no. There would be small differences in the
`clinical trials at the end, but nothing I could
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`foresee having any impact on what we're discussing.
` Q Any additional publications?
` A Ooh, this one is up to and including Phase
`X. I'm keen not to give an incorrect answer off the
`top of my head.
` I know that the Hudson paper was accepted
`and included in this one. The year 10 data. I'm
`sorry, I can't give you a completely certain answer
`to that question as to whether something that has
`been accepted or submitted has got into paper since
`then. I would need to check, sorry.
` Q Do you currently treat patients for
`multiple sclerosis?
` A Yes.
` Q What is your approximate patient load?
` A So as we practice in the U.K., I am
`currently one of a four-man team that manages an
`annual patient load of about 2000. My personal
`patient load in that is around about 700 patients
`that I would see on an annual basis.
` Q When did you first begin treating patients
`for multiple sclerosis?
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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` A So my first neurology job, you're going
`1
`right back to 1995. So I was seeing patients with
`MS then. As a registrar in urology from '96 onward,
`starting to make more independent decisions.
` Again, to run through the CV, I would have
`then done by MDV, at the periods of the MD were
`again in the late '90s, looking after patients with
`MS then.
` Independently, I have been a consultant
`from 2003, so making decisions without supervision
`from 2003 to current day.
` Q What drugs do you commonly prescribe to MS
`patients as a disease modifying therapy?
` A So we are a big prescribing center using
`all currently licensed drugs within the U.K. So if
`you want a full list, for the interferons, we have
`Betaseron, Extavia, Rebif, Avonex, glatiramer
`acetate and -- prescribed as Copaxone and as Brabio.
`We have teriflunomide, Fingolimod, dimethyl
`fumarate, Cladribine. And in the biologics, we have
`ocrelizumab, alemtuzumab and natalizumab.
` Over the period of time that I've been
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`there, we have had mitoxantrone that was briefly
`used and isn't used anymore, and attempted
`therapeutic strategies, again, to be complete, we've
`had one patient who we're working up at the minute
`to go for autologous hematopoietic stem cell
`transplantation.
` Q When you say "we," are you referring to
`the group of doctors that you work with?
` A It is. So, again, the way we would work
`in the U.K., I will have my own patient load, which
`is roundabout 700. We have roughly 1300 patients on
`therapy between the four of us. All major decisions
`in the U.K., particularly around the Euro drugs and
`biologics, have to go through a multidisciplinary
`team meeting. So there will be decisions that I
`will make on my own, but I will also have oversight
`of a lot of the decisions made by the team.
` Historically for the biggest number we
`ever had for a period of a year, there was just me.
` Q So I guess my first question was maybe a
`little different. I was asking about your personal
`prescriptions rather than the group as a whole.
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`What prescriptions do you personally write for
`1
`patients?
` A So of the drugs that I have just given you
`the list of, I would currently have patients for
`whom I am prescribing on all those drugs except for
`mitoxantrone.
` Q For what -- what percentage of patients
`would you say you've prescribed Interferon for?
` A I'm sitting here without my prescribing
`database, so the best I can give you here are
`ballpark figures. So of the prescriptions that we
`have, and I'm sorry if those don't add up to 100
`percent when we get down the list without getting
`pen and paper out, I would say maybe about 30
`percent of our patients are on interferons now and a
`lot of these will be patients who have historically
`started on them and remain on the drug.
` Q What about glatiramer acetate?
` A Glatiramer acetate, again, I'm trying not
`to look foolish by giving you figures that don't add
`up to 100 percent. Maybe about 5 percent of
`patients now at the time are on glatiramer acetate.
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Q What would you say your most commonly
`prescribed drug is?
` A So none of the drugs is over 50 percent,
`and of the single drug prescribed Tecfidera the
`number would be coming in roundabout 25 percent of
`our prescribing. So we're just short of 300
`patients on Tecfidera out of roundabout 1300 in
`therapy. Again, these figures are changing on a
`weekly basis, so I'm only giving you ballpark
`figures.
` Q What does the term "therapeutically
`efficacious" mean to you?
` A That's a question which is impossible to
`answer without applying it to a specific situation.
` Q So you don't have an understanding of what
`the term "therapeutically effective" means?
` A There is no definition of therapeutically
`effective that I could give you that would cover
`every scenario.
` Q What would it depend on?
` A What disease we're talking about, what
`time course we're talking about, what patient group
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`July 29, 2019
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`Page 18
`we were talking about, among other matters.
`1
` Q With respect to RRMS, what does
`therapeutic efficacy mean? I'm sorry, with respect
`to treating RRMS, what does therapeutically
`effective mean?
` A It's a question that you can answer in a
`number of different ways. The ultimate goal of
`treating MS long-term is to prevent disability,
`maintain independence.
` When we look at measuring the efficacy of
`any MS drug, clearly, we're often looking at
`short-term measures that might take us towards that
`long-term goal.
` Q Would a reduction in relapse rate play
`into the definition of therapeutically efficacious
`with respect to treating RMMS?
` A One of the goals of treating MS is to
`reduce relapse.
` Q Is there a particular percent reduction in
`relapse rate that you would expect in a drug that
`was therapeutically efficacious to treat RRMS?
` MS. MC CURDY: Objection; beyond the
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`scope.
` THE WITNESS: It's a question which is --
`I can't think I would ever think of in that way. I
`look at how well a drug reduces relapse, and that is
`how good I think it is at reducing relapses.
` BY MS. GREB:
` Q Would you consider a drug therapeutically
`efficacious to treat RRMS if it reduced relapse rate
`by 15 percent?
` MS. MC CURDY: Objection; beyond the scope
`of his testimony.
` THE WITNESS: All I can say to is that I
`would accept that that drug would reduce the relapse
`rate by 15 percent.
` BY MS. GREB:
` Q Would you believe that a reduction in
`relapse rate by 15 percent would be efficacious
`enough to treat a patient with RRMS?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: Again, I have not in any
`part of what I've commented on say what we're
`looking for as target or sufficient therapy for MS.
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`So a drug that reduced the relapse rate by 15
`1
`percent reduces the relapse rate by 15 percent.
` BY MS. GREB:
` Q If you were treating one of your patients
`who had RRMS and you had a drug that reduced the
`relapse rate by 15 percent, would you think that was
`appropriate to treat your patient?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: This really isn't a thing
`that I've come prepared to talk about. And as I
`said before, when we think about therapeutic
`efficacy in MS, this is a difficult, multifaceted
`concept. So I have no particular idea in my mind of
`what relapse reduction I'm looking for, except if
`you asked me what do I expect to get from a drug
`that reduces relapse rate by 15 percent, if that was
`the only fact that I have on that drug, I expect it
`to reduce the relapse rate by 15 percent in a group
`of patients.
` BY MS. GREB:
` Q Would you feel comfortable prescribing
`that drug to one of your patients?
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` MS. MC CURDY: Objection; scope.
` THE WITNESS: It's a very hypothetical
`situation in that of the drugs that I'm familiar
`working with, I am not aware of a drug whose
`published data reduces the relapse rate by 15
`percent.
` BY MS. GREB:
` Q So would it be fair to say that 15 percent
`would be too low for you to treat a patient?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: It's completely
`hypothetical. That would depend on that drug
`existing and me having a full profile of what that
`drug did.
` BY MS. GREB:
` Q Okay. What if the reduction in relapse
`rate was 25 percent? Would that change your
`opinion?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: I haven't really given an
`opinion on whether I would use the 15 percent drug,
`and the answer comes to the 25 percent drug. All I
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`July 29, 2019
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`Page 22
`know is if you tell me a drug reduces it by 25
`1
`percent, giving it to a group of people, I would
`expect there to be 25 percent fewer relapses. I can
`say nothing else about that drug.
` BY MS. GREB:
` Q So you don't have an opinion about the
`percent of reduction in relapse rate that you would
`need to see in order to find a treatment for RRMS
`therapeutically efficacious; is that right?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: This is really not a thing I
`have dealt with in my report. It's quite a
`different matter if we're getting into the
`completely well outside the scope of what we're here
`to talk about, is what is sufficient efficacy on any
`one of a number of parameters to predict a long-term
`effect of the drug.
` And there are no -- you can push on the
`threshold of relapse is going to do that, but I
`would need to look at the full profile of this
`hypothetical drug's outcome across a number of
`measures, with its safety, with its efficacy and
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`with the burden of monitoring the treatment, before
`I could have any confidence of use of that drug.
`You cannot judge an MS drug on one fact alone.
` BY MS. GREB:
` Q You would agree with me that reduction in
`relapses is a common endpoint in Phase III trials
`testing DMTs to treat RRMS, though; correct?
` A Yes, it is one of the most commonly used
`endpoints is a reduction in the annualized relapse
`rate, and very typically one of the primary outcome
`measures, and another version of that being the
`percentage of patients that remain relapse-free.
` Q So you would agree that reduction in
`relapses is an important component of efficacy for
`DMTs to treat RRMS; is that right?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: Again, really not what this
`document is about. And -- but I am prepared to say,
`because I've talked about relapse rate reductions in
`terms of how we think about the drug, and clearly,
`it was a secondary outcome measure in the Phase II
`study, so it is, as you nicely put it, a component
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`July 29, 2019
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`Page 24
`of one of the -- of the range of outcome measures
`1
`that we would look for in a Phase III study.
` BY MS. GREB:
` Q But you don't have an opinion about what
`threshold -- what a threshold would be to find a
`drug therapeutically efficacious in terms of
`reduction of relapse rate to treat an RRMS patient;
`is that right?
` MS. MC CURDY: Objection to form; scope.
` THE WITNESS: Can you ask me that again in
`a simpler way?
` BY MS. GREB:
` Q You don't have an opinion about what a
`potential threshold would be for therapeutic
`efficacy in terms of reducing relapse rate in
`treating an RRMS patient; is that right?
` MS. MC CURDY: Objection; form, scope.
` THE WITNESS: Let me try to deal with the
`topics in your question, which is I'll take you back
`to my earlier answer, which is when we look at
`therapeutic efficacy in MS, our ultimate goal is to
`protect patients from long-term disability.
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Are you asking me as a shorthand, is there
`a reduction in relapse rate as a sole factor in a
`clinical trial and do I have a figure in my head
`that a drug would need to exceed to give me
`assurance that it would prevent long-term
`disability? No, I have no idea what that would be.
` BY MS. GREB:
` Q Is there a range of relapse rates that you
`would think would be acceptable for a finding of
`therapeutic efficacy in reduction of relapse?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: This really is not what
`we're looking to talk about. And again, you're
`pulling back to this notion that there is something
`about a figure on one outcome measure which will
`give me assurance of a drug is efficacious.
` And again, your question, as I hear it,
`has asked the notion that a drug is effective or not
`effective. And that really is not the way I think
`about MS drugs.
` BY MS. GREB:
` Q So would you agree that there could be a
`
`July 29, 2019
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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`Page 26
`drug effect that doesn't reach a threshold of
`1
`therapeutic efficacy?
` MS. MC CURDY: Objection; form, scope.
` THE WITNESS: Yeah, so -- the question as
`I hear it is any drug in any clinical situation.
`That's not a question that I can answer.
` BY MS. GREB:
` Q Would you agree that it's possible for a
`drug to affect, for example, Gd+ lesions but not be
`therapeutically effective?
` MS. MC CURDY: Objection; form, scope.
` THE WITNESS: Your questions are hovering
`around how do we establish in short-term trial of a
`duration we have not discussed, for an effect that
`we have not discussed, and how that might affect a
`multifaceted disease like MS. These are not
`questions to which I can give easy answers.
` BY MS. GREB:
` Q So you can't answer the question?
` A I think I've explained why your question
`is unanswerable.
` Q Would the term "clinical efficacy" have
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`any different meaning to you than therapeutic
`efficacy?
` MS. MC CURDY: Objection; beyond the
`scope.
` THE WITNESS: You would be -- these are
`not terms which have a definition in the medical
`literature. I would look at them in the context in
`which they appeared.
` BY MS. GREB:
` Q So therapeutic efficacy does not have a
`definition in the medical literature?
` MS. MC CURDY: Objection; form.
` THE WITNESS: So the words "therapeutic"
`have a meaning and "efficacy" has a meaning. But
`what efficacy means is entirely dependent on the
`context, the disease, the outcome measure, what
`you're looking for.
` BY MS. GREB:
` Q If you were looking to treat RRMS with
`dimethyl fumarate, does therapeutic efficacy have a
`meaning in that context?
` A Not a single meaning, no.
`
`July 29, 2019
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`Martin Duddy
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`July 29, 2019
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` Q Does it have several meanings?
`1
` A So when we talk about MS drugs to other
`doctors, or we talk about MS drugs to patients, what
`we say is that ultimately, our long-term hope is to
`reduce disability. We have indicators that a drug
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