Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 1
` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` - - - - -
`MYLAN PHARMACEUTICALS INC., )
` )
` Petitioner, )
` ) Inter Partes Review
` vs. ) IPR2018-01403
` )
`BIOGEN MA, INC., )
` )
` Patent Owner. )
`
` - - - - -
`
` DEPOSITION OF DANIEL WYNN, M.D.
`
` IPR PROCEEDING
`
` Tuesday, July 16, 2019, 9:09 a.m.
`
` PEPPER HAMILTON
` 501 Grant Street, Suite 300
` Pittsburgh, Pennsylvania
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`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 1
`
`
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 1
` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` - - - - -
`MYLAN PHARMACEUTICALS INC., )
` )
` Petitioner, )
` ) Inter Partes Review
` vs. ) IPR2018-01403
` )
`BIOGEN MA, INC., )
` )
` Patent Owner. )
`
` - - - - -
`
` DEPOSITION OF DANIEL WYNN, M.D.
`
` IPR PROCEEDING
`
` Tuesday, July 16, 2019, 9:09 a.m.
`
` PEPPER HAMILTON
` 501 Grant Street, Suite 300
` Pittsburgh, Pennsylvania
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`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 1
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
` DEPOSITION OF DANIEL WYNN, M.D.,
` (IPR PROCEEDING)
`a witness herein, called by the Petitioner for
`examination, taken pursuant to the Notice, by and
`before Marjorie Peters, a Registered Merit Reporter,
`Certified Realtime Reporter and Notary Public in and
`for the Commonwealth of Pennsylvania, at PEPPER
`HAMILTON, 501 Grant Street, Suite 300, Pittsburgh,
`Pennsylvania, on Tuesday, July 16, 2019, at
`9:09 a.m.
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 2
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 2
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`
`
` A P P E A R A N C E S
`For the Petitioner:
` Emily J. Greb, Esquire
` PERKINS COIE LLP
` 33 East Main Street
` Suite 201
` Madison, WI 53703
` egreb@perkinscoie.com
` 608.663.7494
` Shannon M. Bloodworth, Esquire
` PERKINS COIE LLP
` 700 13th Street, NW, Suite 600
` Washington, DC 20005
` sbloodworth@perkinscoie.com
` 202.654.6204
`
`For the Respondent:
`
` Erin Sommers, Esquire
` Barbara C. McCurdy, Esquire
` Paul Browning, Esquire
` FINNEGAN HENDERSON FARABOW GARRETT & DUNNER, LLP
` 901 New York Avenue, NW
` Washington, DC 20001
` erin.sommers@finnegan.com
` 202.408.4000
`ALSO PRESENT:
`Wendy Plotkin, Biogen MA
`Courtney Prochnow, PERKINS COIE, via telephone
`Matt Martin, videographer
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 3
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`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 3
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 3
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
` I N D E X
`EXAMINATION PAGE
`DANIEL WYNN, M.D.
` By Ms. Greb 7
` Acknowledgement of Witness 229
` Certificate of Reporter 230
` Errata Sheet 231
` I N D E X O F E X H I B I T S
`EXHIBIT PAGE
` Exhibit 1064 Wynn Review Article, 38
` "Enduring Clinical Value
` of Copaxone..." January
` 2019
` Exhibit 1065 Randomized, Double-Blind, 157
` Dose-Comparison Study of
` glatiramer acetate in
` Relapsing-Remitting MS
`
`PREVIOUS EXHIBITS PAGE
` Biogen Wynn Declaration 9
` Exhibit 2061
` Exhibit 1046 Dawson declaration 63
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 4
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 4
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 5
`
` I N D E X O F E X H I B I T S
`EXHIBIT PAGE
` Exhibit 1016 press release, "...BG-12 83
` Achieves Primary
` Endpoint..."
` Exhibit 1034 Kappos/Biogen poster 87
` Exhibit 1005 press release 1.9.2006 102
` Exhibit 1006 20th ECTRIMS 2004, Austria 118
` Exhibit 1018 Exhibit 1018, European 123
` Journal of Neurology 2006,
` Schimrigk article
` Exhibit 1012 Affidavit of Christopher 127
` Butler
` Exhibit 1008 Publication WO 170
` 2006/037,342,2A
` Exhibit 1038 DEFINE study 183
` Exhibit 1039 CONFIRM study 185
` Exhibit 1036 Fox and Gold article, 189
` "Dimethyl fumarate to
` treat multiple sclerosis",
` 2011
` Exhibit 2101 60,888,921 Provisional 200
` Application
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 5
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 5
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`
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 6
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` P R O C E E D I N G S
` THE VIDEOGRAPHER: 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 Daniel
`Wynn, M.D. in the matter of Mylan Pharmaceuticals
`Inc., versus Biogen MA, Inc., Number 1
`IPR2018-01403.
` This deposition is being taken at
`501 Grant Street, Pittsburgh, PA, 15219. The time
`is approximately 9:10 a.m. The date is July 16,
`2019. The court reporter is Marjorie Peters. My
`name is Matt Martin. I am the video operator. We
`represent Ace-Federal Reporters 555, 12th Street,
`Northwest, Washington, DC, 20004.
` Will counsel please identify
`themselves and state whom they represent?
` MS. GREB: Emily Greb on behalf of
`petitioner Mylan Pharmaceuticals. With me today is
`Shannon Bloodworth and via telephone, Courtney
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 6
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 6
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 7
`
`Prochnow.
` MS. SOMMERS: I'm Erin Sommers from
`Finnegan here on behalf of Biogen MA, Inc. With me
`today are my colleagues from Finnegan, Barbara
`McCurdy and Paul Browning, and also present is Wendy
`Plotkin from Biogen MA, Inc.
` THE VIDEOGRAPHER: The reporter will
`now swear in the witness.
` DANIEL WYNN M.D.,
`a witness, having been first duly sworn, was
`examined and testified as follows:
` EXAMINATION
`BY MS. GREB:
` Q. Good morning, Dr. Wynn.
` A. Good morning.
` Q. Could you please start by stating your
`name for the record?
` A. Daniel Richard Wynn.
` Q. Okay. And, Dr. Wynn, where are you
`currently employed?
` A. Consultants in Neurology in Northbrook,
`Illinois.
` Q. Okay. You've had your deposition taken
`before; is that correct?
` A. That's correct.
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 7
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 7
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 8
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` Q. Okay. How many times?
` A. A few dozen.
` Q. Have those all been as an expert
`witness?
` A. Sometimes it's as a treating doctor of a
`patient of mine who may have been hurt in a personal
`injury case.
` Q. Do you know about approximately how many
`times you've been deposed as an expert witness?
` A. Less than 10.
` Q. And you've been deposed before as an
`expert witness for Biogen, correct?
` A. That's correct.
` Q. Do you recall how many depositions
`you've given on behalf of Biogen?
` A. I don't recall.
` Q. More than four?
` A. I don't think so.
` Q. Okay. So I know you've been deposed
`before, so I won't take too much time with this, but
`just a couple of reminders for today.
` Obviously, the court reporter is
`here taking everything down, so we need to give
`spoken answers and give each other sort of a chance
`to finish so that she can get everything down. Is
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 8
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 8
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`
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 9
`
`that okay?
` A. Yes.
` Q. Okay. What did you do to prepare for
`your deposition today?
` A. I reviewed my report.
` Q. And when you say your report, it looks
`like you've brought a document with you today that's
`sitting in front of you, is that the declaration of
`Daniel Wynn, which is Biogen Exhibit 2061 in the
`Mylan versus Biogen IPR?
`(Previously marked Biogen Exhibit 2061, Wynn
`Declaration, was presented.)
` A. It is.
` Q. Okay. And is that a full copy of your
`declaration?
` A. To the best of my knowledge.
` Q. Okay. Does it have appendices attached
`to it?
` A. It does.
` Q. Okay. In addition to reviewing your
`declaration that's Exhibit 1061, did you do anything
`else to prepare for your deposition today?
` A. Exhibit 2061, I'm sorry?
` Q. Oh, I'm sorry. Yes, Exhibit 2061.
`Thank you.
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 9
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 9
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 10
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` A. I met with counsel.
` Q. Okay. When did you meet with counsel?
` A. Over the weekend.
` Q. About how much time did you spend
`meeting with counsel?
` A. I know six to eight hours Saturday and
`Sunday.
` Q. Did you review any documents that
`refreshed your recollection?
` A. You know, I looked at documents that are
`referenced in my declaration.
` Q. Did you review any documents that are
`not referenced in Exhibit 2061?
` A. I don't recall.
` Q. Did you review any deposition
`transcripts?
` A. Not recently. Not over the weekend.
` Q. Prior to your -- prior to your
`deposition today, did you review any deposition
`transcript of depositions taken in this IPR?
` A. I previously looked at the declarations
`of Dr. Benet, Dr. McKeague, any other, you know,
`exhibits as listed in the declaration.
` Q. Okay. And you're referring to the
`declarations of Mylan's experts submitted in the
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 10
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 10
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 11
`
`IPR, correct?
` A. That would be correct.
` Q. Did you review any deposition
`transcripts or just the declarations?
` A. I didn't see a deposition of Dr. Corboy,
`Benet or McKeague --
` Q. Okay. Have you --
` A. -- that I recall.
` Q. Thank you.
` Have you reviewed any deposition
`transcripts of Mylan's expert witnesses in the
`co-pending district court litigation?
` MS. SOMMERS: Objection.
` I'm just going to instruct you not
`to answer.
` MS. GREB: On what grounds?
` MS. SOMMERS: On the basis of
`attorney work product.
` Q. In rendering your opinions here today
`and as set forth in your declaration, are you
`relying on any documents that are not listed in
`Appendix B to Exhibit 2061?
` A. The declaration is based upon the review
`of the documents as listed in Appendix B of my
`declaration.
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 11
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 11
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`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 12
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` Q. And in testifying here today about that
`declaration, you're not relying on anything that's
`not listed in Appendix B; is that correct?
` A. I rely on my training and experience and
`treatment of individuals with multiple sclerosis and
`research over many years as listed in my
`declaration.
` Q. But there are no additional documents
`other than listed on Appendix B that you're relying
`on in testifying here today; is that correct?
` A. I mean, only the documents that a
`physician in my position would normally be aware of
`as part of doing what I do.
` Q. You mentioned that you are a physician
`that treats MS; is that correct?
` A. Yes, I do treat patients with multiple
`sclerosis.
` Q. Approximately -- and is that -- is that
`true today?
` A. That's my present position. Of course
`I'm here with you today, so I'm not seeing patients
`today.
` Q. Fair enough.
` But in your present job other than
`in your role as an expert witness, you treat
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 12
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`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 13
`
`patients with MS?
` A. Yes. My time is spent essentially
`full-time clinical practice.
` Q. Okay. Approximately how many MS
`patients would you say you treat?
` A. I see about 1500 unique individuals with
`MS annually, there are a little over 5,000 patient
`visits in our MS center each year.
` Q. What drug do you most commonly prescribe
`to those patients?
` A. For multiple sclerosis?
` Q. Correct.
` A. As their disease-modifying therapy?
` Q. Yeah. As a disease-modifying therapy.
` A. Probably glatiramer acetate.
` Q. Why is that?
` A. Combination of safety, efficacy and the
`fact that it's been on the market for over 20 years.
`But I use the majority of medications that are
`presently FDA approved.
` Q. When you say that GA is your most
`commonly prescribed disease-modifying therapy, about
`what percentage of patients would you say that you
`prescribe GA as their disease-modifying therapy to?
` A. I could only guess. I don't really keep
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`MYLAN PHARMS. INC. EXHIBIT 1126 PAGE 13
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
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`track of these things. I couldn't even say for sure
`that glatiramer acetate is the most commonly
`prescribed drug that I use. I'm just guessing.
` Q. Do you prescribe Tecfidera?
` A. I do.
` Q. Do you have a sense of how many patients
`you prescribe Tecfidera to?
` A. I do.
` Q. Approximately how many patients do you
`prescribe Tecfidera to?
` A. Less than 25.
` Q. Why is that?
` A. Because there are less than 25
`individuals that I presently take care of who it
`seems to be an appropriate medication for.
` Q. What type of patient do you believe it's
`appropriate to prescribe Tecfidera to?
` A. Patients who have relapsing forms of MS.
` Q. So when you said you believed that
`Tecfidera is appropriate for less than 25 percent of
`the individuals that you presently take care of,
`what did you mean?
` A. I think that's not what I said.
` Q. And I apologize if I misunderstood, but
`I thought you said that you prescribe Tecfidera to
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
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`Page 15
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`less than 25 percent of individuals that you
`presently take care of because that is who it seems
`to be an appropriate medication for.
` Did I misunderstand?
` A. You misunderstood.
` Q. Okay. Could you please explain again?
` A. Yes. There are less than 25 individual
`patients I've prescribed Tecfidera to.
` Q. And why did you -- why did you prescribe
`Tecfidera to less than 25 individuals?
` A. Majority of people that I presently
`prescribe Tecfidera to were on it when they
`initially came to see me and were tolerating it and
`doing well on it, but it's not a common go-to
`medication for me.
` Q. Why is it not a common go-to medication
`for you?
` A. I think we have many, highly effective
`therapies that patients find either more convenient
`or have a greater sense of safety with.
` Q. So do I understand you correctly that
`for your patients that you start treating and aren't
`transferred to you, you've never prescribed
`Tecfidera?
` MS. SOMMERS: Objection, form.
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`Daniel Wynn, M.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
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`Page 16
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` A. No. That's not correct.
` Q. Have you ever prescribed Tecfidera in
`the first instance?
` A. Yes, I have.
` Q. Approximately how many times?
` A. Maybe 10 to 15. Again, these are
`approximations. I don't keep track of these
`numbers.
` Q. In the 10 to 15 times that you
`prescribed Tecfidera in the first instance, what was
`the reason for it?
` A. Some of it was patient's failure with
`other medications and/or a combination of patient's
`preference or choice. I mean, it's certainly a
`highly effective, easy to take therapy for
`individuals living with relapsing multiple
`sclerosis.
` Q. But in your view, you prefer to
`prescribe glatiramer acetate, correct?
` A. I have some people who have been on
`glatiramer acetate for 20 years who have done quite
`well and have no interest in switching medications,
`and of course, Tecfidera has not been available as
`long as injectable medications. And if a person is
`doing very well clinically and radiographically,
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 17
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`both the patient and myself are commonly simply
`reluctant to switch medications.
` Q. Even taking into account the fact that
`GA is an injectable and Tecfidera is an oral,
`correct?
` MS. SOMMERS: Objection, form.
` A. That would be correct.
` Q. Is it your understanding that for a drug
`to be reasonably expected to be therapeutically
`efficacious, that dose must have been tested in the
`prior art?
` A. I'm not sure I understand your question.
` Q. Do you have an understanding of what it
`means for a dose of a drug to be reasonably expected
`to be therapeutically effective?
` A. Maybe you could break that down a little
`bit. I'm not sure I understand the common use of
`the words you're using.
` Are you using a word like a common
`usage or in a more legal definition? Maybe there's
`an area in my report you'd like to refer me to.
` Q. Do you have an understanding of the
`phrase "reasonable expectation"?
` A. I assume you're referring to its common
`and ordinary meaning?
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
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`Page 18
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` Q. Is there some specific way you define
`"reasonable expectation"?
` A. I think I would -- I'd use that phrase
`differently in different contexts.
` Q. In the context of determining whether or
`not a dose would be therapeutically effective, how
`would you define "reasonable expectation"?
` MS. SOMMERS: Objection.
` A. I think if there was, you know, in
`certain contexts that there's evidence to believe by
`the inventor that a dose of a drug would work based
`upon its mechanism of action and/or other aspects.
` Q. So using that definition of reasonable
`expectation, do you believe that for a dose of a
`given drug to be reasonably expected to be
`therapeutically efficacious, that specific dose must
`have already been tested?
` A. No.
` Q. Why not?
` A. Well, in order to test it, as a
`physician, I would want to have a reasonable
`expectation that I'm doing well by my patients.
` Q. So you wouldn't, for example, prescribe
`or -- strike that. I'm sorry.
` You wouldn't, for example, give a
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 19
`drug to a patient in a clinical trial if you did not
`have a reasonable expectation that that drug would
`work?
` MS. SOMMERS: Objection, form.
` A. One of the rules of research is the rule
`of beneficence, there should be a reason why a drug
`would be beneficial to an individual or
`participation in a clinical trial would be
`beneficial.
` Certainly patients in trials get --
`in the past, commonly receive placebos, and other
`than the placebo effect, one would not expect
`patient on a placebo to get better in that phase of
`the trial.
` Q. Right. My question was a little bit
`different. I was talking about in the active arm of
`a trial and whether or not you believe you would
`give an active drug to a patient in a trial without
`a reasonable expectation of it working.
` MS. SOMMERS: Objection, form.
` A. I think doses commonly are not used in
`trials unless there's a reason to think they might
`work/not work; however, if we knew they worked, we
`wouldn't do trials, because then there would be no
`basis for having a comparison.
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`
`
`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 20
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` Q. Right. But knowing something is going
`to work and having a reasonable expectation that
`it's going to work are two different questions,
`correct?
` A. It could easily be interpreted that way.
` Q. So it would be your view that for a dose
`to be reasonably expected to be therapeutically
`efficacious, you would not need to have proven to
`any degree of statistical significance that that
`dose is effective in a clinical trial, correct?
` MS. SOMMERS: Objection, form.
` A. Is that -- maybe I missed the first part
`of your question. Are you asking is that what I
`think?
` Q. Yeah.
` A. Maybe you could simply restate the
`question for me.
` Q. Sure. Would it be fair to say that for
`a dose to be reasonably expected to be
`therapeutically efficacious, you would not need to
`have proven to any degree of statistical
`significance that that dose is effective?
` A. If --
` MS. SOMMERS: Objection.
` A. If you simplify the question, I think I
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`
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 21
`
`can give you a better answer.
` Q. Would it be fair to say that you would
`not need to prove to a degree of statistical
`significance that a dose is effective for a skilled
`artisan to have a reasonable expectation that that
`drug would be -- that that dose would be
`therapeutically effective?
` MS. SOMMERS: Objection.
` A. Maybe you could break it down yet
`further because it seemed like the same question to
`me.
` Q. So do you have an understanding what of
`what I mean when I say statistical significance?
` A. Yes.
` Q. And what is your understanding of that?
` A. That, like in a clinical trial, if a
`drug was shown to be statistically significantly
`effective, for example, that the results could not
`be explained by chance alone.
` Q. And so for a person such as yourself to
`have a reasonable expectation of therapeutic
`efficacy, you would not need to have proven
`statistical significant efficacy, correct?
` MS. SOMMERS: Objection.
` A. Before what? Before using it in a
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 22
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`clinical trial? Before clinical trial, we don't
`have results, of course.
` Q. Before having a reasonable expectation
`of a drug being -- a dose of a drug being
`therapeutically efficacious, you do not need to
`prove statistical significance with respect to
`efficacy, correct?
` A. I'm not sure at what point you're
`referring to, at what time. I mean, there are
`clinical trials of drugs we have used where we have
`changed the dosage, and prior to trial we've perhaps
`used different dosages which were shown to be
`effective. But we didn't know before lowering a
`dose, for example, or lowering a frequency of a
`dosing of a drug that we knew it would necessarily
`be effective, but we had theoretical reasons why it
`might be effective. For whatever reason or
`expectation, to use your word, that it would be
`effective.
` Q. Right. So when you say -- for example,
`you said lowering the frequency of a dose of a drug,
`you're referring to trials comparing 20-milligram
`daily GA to three times weekly 40-milligram GA?
` A. That would be good example.
` Q. Okay. And would it be fair to say that
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
`
`Page 23
`
`when moving to three times weekly GA, you didn't
`know for sure that it would work, but you thought it
`probably would?
` A. Based on prior art at that time, yes.
` Q. Okay. And so it would be common to look
`at the prior art of a certain dose and expect that
`changing the dose would work, and then do a trial to
`test whether or not your reasonable expectation of
`success was correct?
` MS. SOMMERS: Objection, form.
` A. That was true for glatiramer acetate, I
`don't know that it's relevant to dimethyl fumarate
`in the situation we're talking about today.
` Q. As a general matter in drug development,
`that would be a fairly common thing to do, though,
`right?
` MS. SOMMERS: Objection, form.
` A. I'm not sure what you mean by "common
`thing to do."
` Q. To take results from one trial, expect a
`different dose to work and then test that dose?
` MS. SOMMERS: Same objection.
` A. I think it's highly individual based
`upon the product we're looking at and the
`circumstance we're looking at and what we're looking
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`July 16, 2019
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`Page 24
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`at the drug to do. And there are trials where we
`have used lower doses and it has failed.
` Q. But you didn't go into those trials
`thinking the lower dose would fail, right?
` A. I think there's some trials I thought
`that would be the case and there's some trials where
`I didn't think it would be the case.
` Q. Would you personally put a lower dose in
`a trial that you thought would fail?
` A. Well, we don't do placebo-controlled
`trials very much anymore because we don't expect
`placebos to work as well as an active therapy, but I
`have been involved in many trials as you see from my
`curriculum vitae where we used placebos. That was a
`common practice, of course, in the past.
` Q. Right. I think my question was a little
`bit different than placebo. You wouldn't personally
`put a lower dose of an active drug in a trial if you
`thought that lower dose would fail, would you?
` A. I guess I would say that it's -- one of
`the things I know is that I don't know everything,
`and there are trials we've participated in where
`others thought a lower dose than had been used in
`the past might have a reasonable expectation to
`work, but I didn't. And for example, the one I'm
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`Daniel Wynn, M.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`July 16, 2019
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`Page 25
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`thinking of, it didn't.
` Q. In that case, though, your view was
`different than others that were designing the trial.
`Do I understand?
` A. Right. I mean, of course, in any given
`trial, there are large numbers of team members in
`designing the trial and carrying out the trial and
`analyzing the trial and deciding whether or not
`trial would be carried forward.
` Q. And when that group of people is
`deciding whether or not to pursue a particular dose
`in a trial, it would be the case that the group's
`decision would be they thought that the doses chosen
`were likely to be successful, correct?
` MS. SOMMERS: Objection, form.
` A. I don't think I know. I mean, the
`example, if you don't mind my simply saying, is
`trials of finolimod, there were several trials which
`sequentially lowered the dose of the drug. The
`initial lowering of the doses worked, and the last
`trial, a yet lower dose than the marketed dose
`seemed to not be that much different than placebo.
`Or let's say the comparatory wasn't a
`placebo-controlled trial against the comparator.
` Q. In any event, you would not put a drug
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`Daniel Wynn, M.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`July 16, 2019
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`Page 26
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