July 10, 2019
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`Page 1
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`Richard Brundage
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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
` vs. : IPR2018-01403
`BIOGEN MA INC., :
` Patent Owner. :
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` VIDEOTAPED DEPOSITION OF
` RICHARD C. BRUNDAGE
`
` Washington, DC
` Wednesday, July 10, 2019
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`REPORTED BY:
` CARMEN SMITH
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 1
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`Page 1
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`Richard Brundage
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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
` vs. : IPR2018-01403
`BIOGEN MA INC., :
` Patent Owner. :
`- - - - - - - - - - - - - - x
`
` VIDEOTAPED DEPOSITION OF
` RICHARD C. BRUNDAGE
`
` Washington, DC
` Wednesday, July 10, 2019
`
`REPORTED BY:
` CARMEN SMITH
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 1
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`July 10, 2019
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`Page 2
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`Richard Brundage
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Videotaped deposition of RICHARD C. BRUNDAGE,
`called for examination pursuant to notice of
`deposition, on Wednesday, July 10, 2019, in
`Washington, DC, at the offices of Finnegan,
`Henderson, Farabow, Garrett & Dunner, LLP, 901 New
`York Avenue NW, at 9:05 a.m., before CARMEN SMITH, a
`Notary Public within and for the District of
`Columbia, when were present on behalf of the
`respective parties:
`
` EMILY J. GREB, ESQ.
` Perkins Coie LLP
` 33 East Main Street, Suite 201
` Madison, Wisconsin 53703-3095
` 608.663.7494
` egreb@perkinscoie.com
` On behalf of Petitioner
`
` -- continued --
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 2
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 2
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`July 10, 2019
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`Richard Brundage
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`APPEARANCES (Continued):
`
` ERIN M. SOMMERS, PhD, ESQ.
` MARK J. FELDSTEIN, PhD, ESQ.
` LAURA P. MASUROVSKY, ESQ.
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202.408.4000
` erin.sommers@finnegan.com
` On behalf of Patent Owner
`
`ALSO PRESENT: Carol Loeschorn, Esq.
` Larry Flowers, video operator
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 3
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 3
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`Richard Brundage
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` P R O C E E D I N G S
` VIDEO OPERATOR: Good morning. We are now
`on the record. Please note that the microphones are
`sensitive and may pick up whispering and private
`conversations. Please turn off all cell phones or
`place them away from the microphones as they may
`interfere with the deposition audio. Recording will
`continue until all parties agree to go off the
`record.
` This is the deposition of Dr. Richard
`Brundage, in the matter of Mylan Pharmaceuticals,
`Inc., Petitioner, versus Biogen MA, Inc., Patent
`Owner, Patent Number 8,399,514, before the United
`States Patent and Trademark Office.
` This deposition is being held at the
`offices of Finnegan, Henderson, 901 New York Avenue,
`Northwest, Washington, D.C.
` The date today is July 10, 2019. Our
`court reporter is Carmen Smith with the firm of
`Ace-Federal Reporters, Inc. I am the video
`operator, Larry Flowers, also with Ace-Federal, 555
`12th Street, Northwest, Washington, D.C.
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`July 10, 2019
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 4
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 4
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Will all counsel identify themselves and
`who they represent.
` MS. GREB: Emily Greb of Perkins Coie on
`behalf of Petitioner Mylan Pharmaceuticals, Inc.
` MS. SOMMERS: Erin Sommers from Finnegan
`on behalf of Patent Owner Biogen. And with me today
`is also Mark Feldstein and Laura Masurovsky of
`Finnegan and Carol Loeschorn of Biogen.
`Whereupon,
` RICHARD C. BRUNDAGE
`was called as a witness and, having first been duly
`sworn, was examined and testified as follows:
` EXAMINATION
` BY MS. GREB:
` Q Good morning, Dr. Brundage.
` A Good morning.
` Q Thank you for your time today. Can you
`just please start by stating and spelling your name
`for the record.
` A Stating my name, it's Richard Clyde
`Brundage, spelled B-r-u-n-d-a-g-e.
` Q And you've been deposed before; is that
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`MYLAN PHARMS. INC. EXHIBIT 1131 PAGE 5
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`correct?
` A I have, yes.
` Q Okay. Just a couple things for today, I'm
`sure you're familiar with everything, but we'll
`quickly go through things.
` As you know, the court reporter is here
`taking everything down, so you need to answer
`questions fully with a yes or no. She can't get
`uh-huhs or things like that.
` I would ask that you wait until I finish
`my question to answer. And if you need to take any
`breaks today, we can absolutely accommodate that.
`Just let me know. I like to take a break about
`every hour and we'll try to do that. If I forget or
`you would like to break sooner, please just tell me.
` A Thank you. I may need to.
` Q Okay. So you mention you've had your
`deposition taken before. Was that in a proceeding
`in which you were retained by an expert on behalf of
`Biogen?
` A I don't recall who I was retained on
`behalf of.
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` Q Okay. Have you had your deposition taken
`before in connection with Biogen?
` A I don't honestly recall the parties
`involved.
` Q Okay. How many times have you been
`deposed before?
` A I don't recall the exact number. One,
`two, three -- four times perhaps.
` Q And in all of those depositions, were you
`testifying as an expert witness?
` A Excuse me, could you give me another
`alternative that I might recognize?
` Q Sure. I'm just wondering whether it was
`depositions where you were working for a company
`kind of in your capacity as an expert and testifying
`about, you know, things related to the claims or
`whether you were a fact witness, for example, if you
`were -- some examples would include if you were an
`inventor on a patent that would be in litigation or
`if you were involved in a contract dispute or
`something like that.
` A To the best of my knowledge, I have been
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`an expert witness in all cases, or providing expert
`testimony. That's the same?
` Q Correct.
` A To the best of my knowledge, that's what
`they have been.
` Q Do you know whether those cases were
`pending in front of the Patent Office or in other
`courts?
` A I believe this is the first deposition
`that's from the Patent Office.
` Q Other than your work as an expert witness
`in this case or any other cases, have you done any
`other sort of work with Biogen?
` A No, I have not. Not to my immediate
`knowledge.
` Q Have you ever testified at a trial?
` A I have not.
` Q What did you do to prepare for your
`deposition today?
` A To prepare for the deposition, I came to
`Washington on Sunday night and I met with lawyers on
`Monday and Tuesday.
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Q Which lawyers did you meet with?
` A I met both Erin Sommers, Mark, Laura,
`Carol. I can't remember all the names exactly.
` There was Paul Browning came in at one
`point. I don't recall others.
` Q Did you review documents in preparation
`for your deposition today?
` A Yes.
` Q Did those documents refresh your
`recollection?
` A Are you asking if the documents I reviewed
`refreshed my memory of what -- I think you might
`need to be more specific.
` Q Sure. Did the documents you reviewed in
`preparing for your deposition today refresh your
`recollection of the opinions you rendered and the
`underlying scientific articles you reviewed?
` A Yes.
` Q And what documents were those?
` A Specifically that I reviewed Monday and
`Tuesday in preparation?
` Q Yes.
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` A I can tell you I reviewed Schimrigk
`2004 --
` Q And just to make the record clear, it
`looks like you're looking at a document that you --
` A Appendix B.
` Q -- brought in with you today?
` A I did not bring it in. The lawyer brought
`it in.
` Q Okay. And is that a copy of your
`declaration submitted in the IPR? This is a full
`copy?
` MS. SOMMERS: It is, Counsel.
` MS. GREB: Okay. So just for the record,
`Dr. Brundage is looking at Exhibit 2057, which is
`the declaration of Richard Brundage in the pending
`IPR. Thank you.
` (Biogen Exhibit 2057 previously
`identified.)
` THE WITNESS: It is Brundage.
` BY MS. GREB:
` Q Brundage, I'm sorry.
` A It's all right. It just sounds odd.
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` Q My apologies. Brundage. I promise I will
`endeavor to get that correct.
` A To the best of your ability is fine.
` Q Yes, thank you.
` So I was asking what documents you had
`looked at to prepare for today, and I think you
`mentioned Exhibit 1006?
` A Exhibit 1 --
` MS. SOMMERS: And I'll just object to that
`to the extent it's not limited to the documents that
`refreshed his recollection.
` Otherwise, if there were documents that
`didn't refresh your recollection, I would instruct
`you not to answer.
` THE WITNESS: Yes, I'm having trouble
`making a distinction as to what you mean by refresh
`my recollection. I recalled many of the things we
`looked at. So maybe there was really nothing that
`refreshed or made me think of things in a new way.
` If you could ask it perhaps a different
`way, I could be helpful.
` BY MS. GREB:
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` Q Did you look at anything not listed on
`your appendix B that refreshed your recollection?
` A I don't recall looking at anything that's
`not on the appendix.
` Q When you were preparing for your
`deposition today, were you also at the same time
`preparing for a deposition that you'll be giving in
`the co-pending district court litigation?
` MS. SOMMERS: Objection.
` I'm going to instruct you not to answer on
`the basis of attorney work product.
` BY MS. GREB:
` Q Is it true that when a drug is
`dose-dependent, that means that the effect changes
`when a dose changes?
` A It is not an absolute truth, no.
` Q How is it not an absolute truth?
` A You may be taking the dose of a drug that
`has almost no effect for a particular situation and
`doubling the dose may not change the effect at all
`to any measurable extent.
` Q So sort of setting aside extreme
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`situations where there would be almost no effect,
`would it generally be true that when a drug is
`dose-dependent, that means that the effect changes
`when a dose changes?
` A That is generally a maxim, but that does
`not at all imply we know the extent of the change in
`effect for any given change in dose. And that's
`what I was re -- one of the items I was -- or one of
`the situations I was thinking about when I gave my
`first answer.
` Q If you were going to determine whether a
`drug is dose-dependent, is it true that you would
`need to see the effect of a drug at different doses?
` A Can you repeat that question once more,
`please?
` Q Sure. If you were going to determine
`whether a drug is dose-dependent, is it true that
`you would need to see the effect of the drug at
`different doses?
` A That question is a little more complicated
`than I think you probably intend it to be, because
`there are many different kinds of effects that may
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`be dose-dependent.
` For example, we have
`concentration-dependent elimination. Some drugs
`like phenytoin, the higher the concentration, the
`slower the clearance.
` We have some drugs that are dose-dependent
`absorption and at higher doses you may absorb more
`drug.
` But I think that to answer your question,
`you need to observe whatever it is you're looking
`for as a function of dose at several different
`doses.
` Q So would it be fair to say that to state
`that a drug is dose-dependent with respect to
`efficacy, you would need to see efficacy at more
`than one dose?
` MS. SOMMERS: Objection to form.
` THE WITNESS: That is -- on the face it's
`not true, because I don't exactly know what you're
`meaning by efficacy. Are you just talking about a
`drug effect, a magnitude of effect?
` I want to make sure we're separating a
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`therapeutic effectiveness from just an effect.
` BY MS. GREB:
` Q Sure. So I'll ask the question with
`respect to therapeutic efficacy. Would it be fair
`to state that to determine that a drug is
`dose-dependent with respect to therapeutic efficacy,
`you would need to see therapeutic efficacy at more
`than one dose?
` A I don't believe that would be true.
` Q How could you determine dose dependency if
`you only saw therapeutic efficacy at one dose?
` A You may see nontherapeutic efficacy at
`multiple doses.
` Q What is nontherapeutic efficacy?
` A You may see a minimal effect or no effect
`different from placebo at several doses before you
`see an effect from the drug or a therapeutic effect
`that could be used clinically.
` Q So you're saying that a drug is
`dose-dependent -- you could say that a drug is
`dose-dependent if you saw no therapeutic efficacy at
`one dose and therapeutic efficacy at a second dose.
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`Do I understand that correctly?
` A You're going to have to state that again,
`please.
` Q Are you saying that if you saw no
`therapeutic efficacy at one dose and then saw
`therapeutic efficacy at a second dose, you could
`make the conclusion that the drug acts in a
`dose-dependent way?
` A I am hesitating because you're using
`terminology that is not consistent with
`pharmacology. It's not the drug that's
`dose-dependent. It's an effect that can be
`dose-dependent. It can be elimination that's
`dose-dependent. It can be absorption that's
`dose-dependent.
` But we don't usually refer to the drug as
`being dose-dependent. We give a dose of a drug.
` Q Okay.
` A And so I get confused by your questions.
`And I apologize I'm not able to translate that. So
`you're going to have to help me with more
`explanation.
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` Q No problem. Let me try to make my
`question clearer.
` A Okay.
` Q So asking it a different way, if you see a
`therapeutic efficacy at a particular dose --
` A Okay.
` Q -- but you don't see a therapeutic
`efficacy at a different dose, can you say that there
`is dose dependency?
` A That sounds to me like a definition of
`dose dependency. You see an effect at one dose and
`you don't see -- you don't see an effect at one
`dose, you do see it at another dose. So it depends
`on which dose you give.
` Q But you wouldn't know -- if you only had
`two doses, how would you know whether there is some
`sort of curve that it's acting on or whether you
`just have either like an on or off switch, either
`you have an effect or you don't?
` MS. SOMMERS: Objection to form.
` THE WITNESS: On/off switches are not
`common, and I don't exactly understand the question
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`again. With only two data points, that -- those --
`the curve between those two data points could take
`on an infinite number of possible trajectories.
` So I don't know that you could possibly
`know what the shape of that curve is with only those
`two data points that you -- I think two data points
`you mentioned.
` BY MS. GREB:
` Q So would it be fair to say, then, that you
`wouldn't know whether they were dose-dependent if
`you had only those two data points?
` MS. SOMMERS: Objection to form.
` THE WITNESS: I think I answered that
`already in that that to me sounds like a definition
`of dose dependency. You gave one dose, you saw no
`effect; you gave a different dose, and you saw
`efficacy.
` So that means the efficacy depends on the
`dose you give, by definition.
` BY MS. GREB:
` Q So in your view, if there's sort of this
`on/off switch, where you either have an effect or
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`you don't, in your view, that would be dose
`dependency?
` MS. SOMMERS: Objection to form.
` THE WITNESS: Well, I -- I'm not
`referring -- I haven't referred to the on/off
`switch. That's something you referred to.
` So I still go back to if you want a
`description of dose dependency, you give one dose,
`no effect, you give another dose, you get an effect.
`I don't know how you could say anything other than
`just in words that defines a dose dependence on
`effect.
` BY MS. GREB:
` Q So taking out the terminology "on/off
`switch," if you have a drug that has no therapeutic
`effect at one dose and you see a therapeutic effect
`at another dose, in your view, is that sort of
`behavior where it either has an effect or it doesn't
`have an effect a dose-dependent relationship?
` MS. SOMMERS: Objection to form.
` THE WITNESS: As long as you see an effect
`at one dose that's different than the effect at
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`another dose, to me that is defining the term "dose
`dependence," in terms of efficacy. The
`effectiveness depends on the dose you give.
` BY MS. GREB:
` Q So -- and maybe I'm just misunderstanding
`you, but I feel like you're saying something a
`little different than what I'm asking.
` A And perhaps I am. I hope we can resolve
`our difference in terminology here.
` Q Yeah. I'm just trying to understand
`whether if you have a dose that provides no effect
`and you then have a dose that provides an effect, is
`that dose dependency?
` A By definition, I think that is a dose
`dependency.
` Q Okay. Even if you -- even if it's sort
`of -- it's either on or it's off? You view that as
`dose-dependent?
` MS. SOMMERS: Objection to form.
` THE WITNESS: I do, as long as there's an
`effect at one dose and a different effect -- it
`doesn't have to be zero -- at another. One of the
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`basic premises is that as you increase the dose of a
`drug, you will see an increase in the response, but
`that in no way implies for any increase in dose, you
`know what the magnitude of response change will be.
` Did we clear it up at all? Do I need to
`try anything else?
` BY MS. GREB:
` Q That's fine, thank you.
` A Thank you. Thank you for trying, anyway.
` Q Is it your view that for a therapeutically
`efficacious drug of a dose to be obvious, that
`particular dose would need to have been tested in a
`prior art?
` A One more time, please. I'm thinking
`through this.
` Q Is it your view that for a therapeutically
`efficacious dose of a drug to be obvious, that
`particular dose would need to have been tested in
`the prior art?
` MS. SOMMERS: Objection to form.
` THE WITNESS: It -- that is not a
`universally true statement.
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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` BY MS. GREB:
` Q You recall that we're here today to talk
`about dimethyl fumarate; correct?
` A Correct.
` Q Would it be fair for me to refer to that
`as DMF?
` A Yes.
` Q With respect to DMF, is it your view that
`for a therapeutically efficacious dose of DMF to be
`obvious, that particular dose would need to have
`been tested in the prior art?
` MS. SOMMERS: Objection to form.
` THE WITNESS: Now I'm going to ask you to
`be -- to clarify.
` Are we talking about prior art before 2007
`or is this just a general statement? Otherwise, my
`previous answer holds, it's not a universally true
`statement.
` BY MS. GREB:
` Q Why do you say it's not a universally true
`statement?
` A If the prior art contained considerable
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`information and had multiple doses at -- and at
`those doses, you saw a clear dose-response
`relationship and you saw a clear plateauing of that
`dose-response relationship, and at the very two
`highest doses, which gave essentially no difference
`in response, you could choose a dose between those
`two highest doses and expect to see the same
`response without having tested it.
` Q So just to make sure I understand, are you
`saying that for a dose of DMF to be obvious, you
`would need to know the full dose-response curve for
`DMF?
` A For --
` MS. SOMMERS: Objection to form.
` THE WITNESS: For an unknown dose, you
`would either have to have -- well, you would have to
`have tested the dose to know or you would have to
`have a well-defined dose-response curve.
` BY MS. GREB:
` Q So is it your view that in the absence of
`a particular dose being tested or a full
`dose-response curve, a dose of DMF could not be
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`obvious?
` MS. SOMMERS: Objection to form.
` THE WITNESS: I do not know what you mean
`by "obvious." Could you clarify that, please?
` BY MS. GREB:
` Q You submitted an expert report in this
`case stating that it's your belief that the
`480-milligram dose was not obvious; correct?
` MS. SOMMERS: Objection to form.
` THE WITNESS: Yes, I am -- I'm getting
`lost in your legalese. Every dose is obvious in my
`world. 480 is a dose, 500 is a dose, 250 is a dose.
`They're all obvious doses.
` So in the legal term, we're talking about
`an obvious dose to choose to move forward with? Is
`that what you're wanting me to think?
` BY MS. GREB:
` Q I'm just trying to understand your
`opinion. So I guess I would like to use, you know,
`obvious or not obvious in the way that you
`understood them in your expert report. Is that how
`you understood it in your expert report, that
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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`obviousness means a dose to move forward with?
` MS. SOMMERS: Objection to form; outside
`the scope.
` THE WITNESS: I will go to my declaration.
` BY MS. GREB:
` Q Sure.
` A I think there is something on obviousness
`in here. Would you be able to direct me somewhere
`where I talk about obviousness? Because I'm not
`seeing it.
` Q So are you -- are you not opining that the
`dose of DMF was nonobvious?
` A I don't believe I did. Unless we can --
`we can locate it.
` Q Do you not have an understanding of the
`obviousness standard?
` MS. SOMMERS: Objection to form.
` BY MS. GREB:
` Q So one place that may help you is
`paragraphs 19 and 20. You mention you understand
`Petitioner has asserted on four grounds of
`unpatentability that the claims of the '514 patent
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`are obvious, and then in paragraph 20 you note that
`you've been asked to offer opinions regarding
`certain aspects of these grounds.
` Do you see that?
` A I do.
` Q So are you opining that the -- your
`opinions related to obviousness?
` A I have -- I believe that is no. I've been
`asked to opine on certain aspects of the '514
`patent, but not being a lawyer, I don't -- I don't
`know if I can opine on obviousness per se. I
`haven't been asked to opine.
` Q So you are not offering an opinion that
`the claims of the '514 patent are not obvious; is
`that right?
` A May I state it in a different way, and you
`can tell me if they are the same or not? I make
`claims about Mylan's ground providing a reasonable
`expectation of success for the subject matter of the
`'514 patent. I would understand that to be
`different from obviousness.
` Q In your view, for dose of a drug -- sorry,
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`let me start again.
` Is it your view that with respect to
`therapeutic efficacy, for a skilled artisan to have
`a reasonable expectation of success that that dose
`would have therapeutic efficacy, that dose would
`either need to be tested specifically in the prior
`art or have a well-defined dose-response curve?
` A Yes, but I will even go further than that.
`It would need to be tested in that disease in which
`is of interest to be treated right now. So the
`disease of interest has to be in the prior art
`dosing so there is a dose-response curve for that
`drug in that disease.
` Q So just to be clear, in your view, with
`respect to therapeutic efficacy, for a skilled
`artisan to have a reasonable expectation of success,
`a particular dose would have to have been tested in
`a specific disease of question or have a
`well-defined dose-response curve in the disease of
`question; is that right?
` MS. SOMMERS: Objection to form.
` THE WITNESS: To have an expectation of
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`Richard Brundage
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`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
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