August 22, 2016 Deposition of Daniel Wynn, M.D.
`Patent Interference 106,023
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
`
` COALITION FOR AFFORDABLE DRUGS V LLC; et al.,
` Petitioners,
` v.
` BIOGEN MA, INC.,
` Patent Owner
` _________________________
` Case IPR2015-01993
` Patent 8,339,514 B2
` __________________________
` COMPLETE CAPTION ON PAGE 2
` __________________________
`
` DEPOSITION OF DANIEL WYNN, M.D.
` Monday, August 22, 2016
`
` Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
` Two Seaport Lane
` Boston, Massachusetts 02210
`
` Reporter: Cheryll A. Kerr, RPR, SHR
` Registered Professional Reporter
` Henderson Legal Services, Inc.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Coalition Exhibit 1050
`Coalition v. Biogen
`IPR2015-01993
`
`Page 1 of 140
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`Patent Interference 106,023
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`1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
`
` COALITION FOR AFFORDABLE DRUGS V LLC; et al.,
` Petitioners,
` v.
` BIOGEN MA, INC.,
` Patent Owner
` _________________________
` Case IPR2015-01993
` Patent 8,339,514 B2
` __________________________
` COMPLETE CAPTION ON PAGE 2
` __________________________
`
` DEPOSITION OF DANIEL WYNN, M.D.
` Monday, August 22, 2016
`
` Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
` Two Seaport Lane
` Boston, Massachusetts 02210
`
` Reporter: Cheryll A. Kerr, RPR, SHR
` Registered Professional Reporter
` Henderson Legal Services, Inc.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Coalition Exhibit 1050
`Coalition v. Biogen
`IPR2015-01993
`
`Page 1 of 140
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`August 22, 2016 Deposition of Daniel Wynn, M.D.
`Patent Interference 106,023
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
` COALITION FOR AFFORDABLE DRUGS V LLC;
` HAYMAN CREDES MASTER FUND, LP;
` HAYMAN ORANGE FUND SPC - PORTFOLIO A;
` HAYMAN CAPITAL MASTER FUND, L.P.;
` HAYMAN CAPITAL MANAGEMENT, L.P.;
` HAYMAN OFFSHORE MANAGEMENT, INC.;
` HAYMAN INVESTMENTS, LLC;
` NXN PARTNERS, LLC;
` IP NAVIGATION GROUP, LLC;
` J KYLE BASS, and ERICH SPANGENBERG,
`
` Petitioners,
`
` v.
`
` BIOGEN MA, INC.,
`
` Patent Owner
` __________________________
`
` Case IPR2015-01993
` Patent 8,339,514 B2
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`August 22, 2016 Deposition of Daniel Wynn, M.D.
`Patent Interference 106,023
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`APPEARANCES:
`
`Carmichael IP, PLLC
`BY: CAROL A. SPIEGEL, ESQ.
`8000 Towers Crescent Drive, 13th Floor
`Tysons Corner, VA 22182
`(703) 646-9249
`carol@carmichaelip.com
` for the Petitioners;
`
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`BY: MICHAEL J. FLIBBERT, ESQ.
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`(202) 408-4000
`michael.flibbert@finnegan.com
`
`Also Present:
`Theresa Devlin, Biogen
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`August 22, 2016 Deposition of Daniel Wynn, M.D.
`Patent Interference 106,023
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` INDEX
`EXAMINATION BY PAGE
`Ms. Spiegel 5
`
` EXHIBITS
`FOR ID DESCRIPTION PAGE
`Biogen Exhibit 2046 Declaration of Daniel 10
` Wynn, MD, FACNS, FAASM
`Biogen Exhibit 2047 Curriculum Vitae 12
`Coalition Exhibit 1001 8,399,514 Patent 20
`Coalition Exhibit 1012 Certified copy of 21
` provisional application
` for 60/888,921
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`August 22, 2016 Deposition of Daniel Wynn, M.D.
`Patent Interference 106,023
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`D A N I E L W Y N N, M. D.,
`called as a witness, having been duly
`sworn, was examined and testified
`as follows:
` THE SHORTHAND REPORTER: Please state
` your full name and your address for the
` record, sir.
` THE WITNESS: Daniel Richard Wynn,
` M.D., 1535 Lake Cook Road, Northbrook,
` Illinois 60062.
` THE REPORTER: Thank you, please
` proceed.
`BY MS. SPIEGEL:
` Q. Good morning, Dr. Wynn. I'm with the
`Carmichael IP Law Firm, and I'm going to be asking
`you a series of questions this morning.
` I ask that you answer them to the best of your
`ability. If you don't understand one of my
`questions, just let me know, and I will try to
`rephrase it or restate it to make it a little
`clearer.
` This is not a marathon, so you can ask for
`breaks whenever you need them. The only request I
`have is that if there's a question pending, would
`you please answer it before we break?
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` The court reporter is transcribing the record
`today, and so it's important that we get verbal
`answers and that we don't speak over each other. Is
`that okay?
` A. Yes.
` Q. All right. Again, full name, for the
`record, please?
` A. Daniel Richard Wynn, M.D.
` Q. You understand that your testimony today
`is being given under oath?
` A. I do.
` Q. I'm going to be referring to the patent
`at issue here by its last three numbers and call it
`the '514 patent.
` Would you understand what we're talking about
`if I use that abbreviation?
` A. Yes, I do.
` Q. This is an inter partes review patent
`proceeding, also calls an IPR, so I might use the
`term "IPR."
` Would you be comfortable with that?
` A. Yes.
` Q. I may also refer to multiple sclerosis
`simply as "MS." Would you be comfortable with that?
` A. I would.
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` Q. Is there any reason that you cannot give
`full and truthful testimony today?
` A. No.
` Q. Are you taking any medications that would
`impair your ability to testify today?
` A. No, I'm not.
` Q. Have you provided any declarations in any
`other patent matters?
` A. I have.
` Q. Can you tell me the nature of those
`patent matters?
` A. I don't know if these are privileged or
`not.
` Q. Just subject area.
` A. Different medications for multiple
`sclerosis, both symptomatic as well as
`disease-modifying therapies.
` Q. But they were not declarations for
`Biogen?
` A. One was.
` Q. Without telling me anything privileged,
`could you give me some idea of the nature of that
`declaration?
` For example, was it for a court litigation?
`Was it for a Patent Office appeal? Just a general
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`idea.
` A. A Patent Office matter.
` Q. Was it in an office before the Patent
`Trial and Appeals Board?
` A. I believe so, but I don't know all the
`details.
` Q. Was this some time ago?
` A. In the last few months.
` Q. Without breaking privilege, is there
`anything else you could tell me about that matter?
` A. I don't really know what you want to know
`or what I'm -- what -- you know.
` Is it another matter with regard to the same
`drug we're here to talk about today? Other than
`that...
` That's all I'm allowed to say.
` Q. Okay.
` Have you provided any expert reports in any
`other patent matters, other than dealing with DMF or
`MMF, by which I mean dimethyl, one word, fumarate,
`second word, and then monomethyl fumarate?
` (Informal discussion held off the
` record.)
` THE WITNESS: Yes, I have.
`BY MS. SPIEGEL:
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` Q. Have you ever been deposed before?
` A. Yes, I have.
` Q. When?
` A. Several times, in the course of my
`career.
` Q. Can you give me the approximate times you
`were deposed? A month ago, a year ago, 10 years
`ago?
` A. I have given testimony and/or prepared
`reports a couple times this calendar year, and
`perhaps another total of 10 times over the course of
`my 28-year career.
` Q. Okay. What kind of cases were these that
`you were deposed in?
` A. The majority of times, I have been asked
`to give testimony as a personal injury case, simply
`involving a patient who I take care of in my regular
`office practice.
` Q. Okay.
` A. I've given testimony as an expert witness
`in personal injury cases where the patient was not a
`patient of mine.
` I've given expert witness in divorce trials.
`I've given expert witness in other patent trials.
` Q. Did you prepare for your deposition
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`today?
` A. I did.
` Q. What did you do to prepare?
` A. I read several documents, and I discussed
`these documents as I prepared a declaration with
`counsel.
` Q. Are they the documents that -- which were
`the documents that you reviewed?
` A. Do you mind if I request a copy of my
`declaration from you, ma'am?
` (Pause)
` MS. SPIEGEL: Okay.
` I'm handing the witness a copy of
` Biogen -- premarked Biogen Exhibit 2046,
` which is the declaration of Daniel Wynn,
` M.D., FACNS, FAASM.
` THE WITNESS: Thank you.
`BY MS. SPIEGEL:
` Q. Sure.
` A. So in answer to your question -- thank
`you for providing the document to me.
` Q. Before we go there, can we just take one
`side step?
` Could you please take a look at the exhibit I
`just handed you and confirm that that is, in fact,
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`the declaration that you submitted during this IPR
`proceeding?
` (Pause)
` THE WITNESS: Yes. I believe my
` curriculum vitae may have been attached to
` edition.
` But yes, this is the declaration I
` prepared and submitted on behalf of this
` matter.
`BY MS. SPIEGEL:
` Q. Can you confirm that it is your signature
`on page 35 of 56?
` When I talk about "pages," I'm talking about
`pages in the lower left-hand corner of the documents
`(indicating).
` A. Yes. That is my signature on page 35 of
`56.
` Q. Are you aware of any errors in your
`declaration?
` A. No, I'm not.
` Q. Did you review your declaration before
`signing it?
` A. Yes, I did.
` Q. Since you brought up your CV --
` MS. SPIEGEL: I'm handing the witness
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` a copy of a document premarked as Biogen
` Exhibit 2047, marked as the curriculum
` vitae.
` THE WITNESS: Thank you very much.
`BY MS. SPIEGEL:
` Q. Okay.
` Would you kindly look at that copy and see if
`that's a copy of your CV and if there are any errors
`in it?
` A. This is my curriculum vitae as when -- as
`of when it was prepared, and there are --
` There are additions to it, but none that I
`think are specifically relevant to today's matter.
` Q. But what is in your CV is correct?
` A. As when it was written.
` I mean, a small example of change is the -- in
`my -- in the title, where it has my name on the top
`of the CV --
` Q. Okay.
` A. -- it says, "Daniel Wynn, MD, FACN, and
`the organization which I am a fellow changed
`their --
` They changed it to Fellow of the American
`Clinical Neurophysiology Society, and now it's an
`FACNS. In the second line of my CV, there's a small
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`change, but I don't think that would make too much
`difference to the patent board.
` Q. All right.
` Returning to the previous question, I asked you
`if you recalled which documents you reviewed in
`preparation for today's deposition.
` A. Yes. The documents which I reviewed for
`the purposes of today's deposition are listed in
`Section 3, paragraph 12, page 7 of 56.
` In forming my opinions, I reviewed one,
`Biogen's '514 patent; two, Biogen's '921
`provisional; three, Biogen's international patent
`application, No. PCT/US2008/001602 for the
`declaration of Steven Linberg, Ph.D.;
` The petition paper; 6, Biogen's preliminary
`response; 7, Petitioner's reply to Biogen's
`response; and 8, the institutional decision.
` Q. Do you recall if you reviewed any other
`written document?
` A. Not for the purposes specifically of
`today's discussion.
` Q. And --
` A. Or in preparing my declaration, I should
`say. Please allow me to correct myself. I
`apologize.
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` Q. Well, the question was specifically in
`preparation for today's deposition.
` A. For the purposes of preparing my
`declaration, these are the documents I reviewed, as
`listed in my declaration (indicating).
` Q. You indicated that you had met with
`counsel. Is that counsel who is here today?
` A. Yes.
` Q. Can you identify them for me?
` A. Mr. Flibbert of Finnegan, and an attorney
`from Biogen.
` Q. Okay. Was anyone else besides counsel
`present with you when you met to prepare for today's
`deposition?
` A. There was an additional attorney from
`Biogen who was also present during my preparation
`and who I had discussions with during preparation of
`my declaration.
` Q. Do you recall his or her name?
` A. I recall her first name. I don't recall
`her last name.
` Q. Her first name being?
` A. Erin.
` (Informal discussion held off the
` record.)
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`BY MS. SPIEGEL:
` Q. About how long did you meet with counsel
`to prepare for today's deposition?
` A. I would say there were numerous
`conversations that I had both in present as well as
`a teleconference since I was first retained in this
`matter.
` Q. But specifically preparing for today's
`deposition?
` A. I guess I interpret what you have asked
`me, "preparing for today's deposition," would
`include preparing my declaration.
` Because my declaration -- preparation of my
`declaration was for today.
` Q. If I could separate those two out, about
`how long did you prepare -- take to prepare your
`declaration?
` A. I don't know. I mean -- you know, many
`hours.
` Q. More than 10?
` A. Yes.
` Q. More than 20?
` A. Yes.
` Q. More than 50?
` A. I -- I don't really recall. I haven't
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`calculated it.
` Q. But it's up there?
` A. It's more than two or three hours.
` Q. Yes?
` And then coming to meet for the deposition
`today, about how long did you prepare?
` A. Well, I'm including all of those hours in
`my preparation, and then I talked with counsel --
`you know, before today, again, reviewing my
`declaration.
` Q. Perhaps a better question is:
` About how long did you spend reviewing your
`declaration for today's deposition?
` A. Again, the number of hours that we just
`discussed. Perhaps 50 hours or more from preparing
`the manuscript and reviewing this since the
`preparation of my declaration -- you know, was part
`of my preparation for today.
` In addition, after this was submitted in late
`June of this year, there were additional times spent
`over the telephone as well as face-to-face with
`counsel.
` Q. So after late June, it was about how much
`time?
` A. Oh, again, perhaps 50 hours.
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` Q. Okay. Do you have any questions before
`we proceed?
` A. No.
` Q. Okay. I am going to turn to your CV.
` I'll be asking you a couple of questions that
`begin with: What's the full name of your employer?
` A. Consultants in Neurology, Limited.
` Q. And your current position is?
` A. I am a neurologist at Consultants in
`Neurology. I am the director of clinical research
`and the director of the Multiple Sclerosis Center.
` Q. To clarify, you are the director of
`clinical research at the Consultants in Neurology,
`or at the Multiple Sclerosis Center, or both?
` A. Both.
` Q. Let's turn to your declaration, please,
`at paragraph 20. I'm sorry. Paragraph 2. Excuse
`me. It's on page 3 of 56.
` It begins with the statement, "I understand
`that the patent involved in this proceeding is U.S.
`Patent No. 8,399,514."
` What do you mean by "understand"?
` (Pause)
` THE WITNESS: I -- I've been
` instructed that the patent involved in
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` these proceedings is Patent No. 8,399,514
` as opposed to another patent.
`BY MS. SPIEGEL:
` Q. Okay.
` I would like you to turn the page to paragraph
`4 of your declaration.
` A. Yes.
` Q. Could you read that sentence into the
`record for me, please?
` A. "Four, I understand that the" -- sorry,
`apostrophe, "602 application," apostrophe, "296
`application," apostrophe, "426 application share a
`substantially identical written description."
` Q. My question for you is:
` Does the '602 application share a substantially
`identical written description with the '921
`provisional application?
` (Pause)
`BY MS. SPIEGEL:
` Q. Sorry. Let me just back up a second.
` In paragraph 3 of your declaration, you are
`listing a series of applications --
` A. Yes.
` Q. -- so the first is -- and I'll use the
`abbreviations in the far right-hand corner -- is the
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`'921 provisional. The second is a '602 application.
`The third is a '296 application, and the fourth is a
`'426 application.
` In paragraph 4 of your declaration, you stated,
`"The '462, the '296, and the '602 applications share
`a substantially identical written description." My
`question to you now is:
` Do the '921 provisional and the '602
`application share a substantially identical written
`description?
` A. Largely, yes.
` Q. Does the '921 provisional share a
`substantially identical written description with the
`'296 application?
` A. Can you tell me what you mean
`specifically by "largely contain"?
` Q. The --
` A. You know, identical. They cover the
`same...
` Q. Your statement in paragraph 4 says that
`the referenced three applications shared a
`substantially identical written description.
` What did you mean by "substantially identical
`written description"?
` A. That the specifications in the
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`applications are largely the same.
` Q. What does "largely the same" mean?
` A. With full respect, I think that was the
`question I had for you. They are not word for word
`the same.
` The written descriptions cover this same points
`regarding the claimed invention.
` Q. This might be helpful. I am going to
`hand you copies of two additional documents.
` (Pause)
` MS. SPIEGEL: I am handing the
` witness a copy of premarked Coalition
` Exhibit 1001, which is the involved '514
` patent, and it --
`BY MS. SPIEGEL:
` Q. I'll just hand it to you. If you look at
`the little number in parentheses -- 21 -- on there,
`you will see that this is the '462 application.
` So the '462 application in parenthetical 21 on
`the cover sheet is the application that the '514 --
`that became the '514 patent upon approval by the
`Patent Office.
` So the specification in here and the figures,
`and now your specification would start on page 16 of
`30 and go to 29 of 30. That would be the
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`specification.
` At the end, 29 to 30, there are the claims, and
`in the beginning, there are two figures on pages 12
`and 13 of 30.
` Looking at the figures and the specification, I
`am now handing you a copy of Coalition Exhibit 1012,
`which is a certified copy of the provisional
`application '921.
` A. Thank you.
` (Pause)
`BY MS. SPIEGEL:
` Q. Now, the specification portion of this
`document begins on page 8 of 49 and continues on to
`page 43 of 49.
` There are two figures on page 48 and 49 of 49.
`Now, take your time. If you compare the '462
`application and looking at the specification in
`Figures --
` A. Four -- excuse me, but '462 or '426, did
`you say? I'm sorry.
` Q. The '426.
` A. Okay. Thank you.
` Q. If you compare that specification and
`figures with the '921 provisional specification
`figures, are they substantially identical? Take as
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`much time as you need.
` (Pause)
` THE WITNESS: I am happy to take a
` substantial amount of time and literally
` review page by page each of these two
` documents, if you would like me to, and
` see if they are word for word the same.
` Since they are formatted differently,
` I think they are not.
` Would you like me to do that, or were
` there specific questions about each of
` these questions that you want me to answer
` for you?
`BY MS. SPIEGEL:
` Q. Well, if something is -- you used the
`phrase "substantially identical."
` If they are substantially identical, would you
`agree that they have about the same disclosure? One
`does not add material other than perhaps a small
`reference to an earlier application?
` MR. FLIBBERT: Objection to form.
` THE WITNESS: There are issues added
` in the written description in the '514
` document that do not exist in the
` provisional application. However, the
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` written description provided in these
` different documents is substantially the
` same.
`BY MS. SPIEGEL:
` Q. By "added issues" in the '514 document,
`can you give me an example of what you're talking
`about?
` A. Sure.
` (Pause)
` THE WITNESS: In the '514 document,
` there's the in vivo experimental
` autoimmune encephalomyelitis model of
` multiple sclerosis.
`BY MS. SPIEGEL:
` Q. Sorry? What page is that?
` A. On page 14 of 30 and 15 of 30, there are
`figures referencing an example of Nrf2 activation in
`the EAE model of multiple sclerosis which references
`page 25 of 30, column 20, line 62, example 3.
` The EAE model is in the '514 document, which I
`don't recall is in the provisional application, so
`that additional example was supplemented.
` Q. Thank you. Now, I am looking at your
`paragraph 5 of your declaration, and it spans pages
`4 to 5 of 56.
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` You used a series of words when you were
`talking about the claims. You said, "Claim 1 of
`'514 patent states."
` In the next paragraph, you say, "Claims 11, 15,
`and 20 describe." You say "Claims 6 and 12 focus,"
`that "Claim 2 specifies," that "Claims 8 and 10
`provide."
` Are you using the terms "state, describe," and
`"focus" and "provide" interchangeably?
` A. I'm -- I'm using these terms that are
`common, ordinary meaning.
` Q. So it means the same to you?
` A. Well, Claims 11, 15, 20 describe
`additional methods of treating MS by administering
`about 480 milligrams per day of dimethyl fumarate,
`monomethyl fumarate, or a combination thereof.
` Claims 6 and 12 focus on administering DMF as
`opposed to a different compound.
` Q. If I could stop you there, please, so I
`could -- you would just as easily say Claims 11, 15,
`and 20 focus on additional methods of treating MS or
`that Claims 6 and 12 specify administering the
`DMF --
` A. As a --
` Q. -- just as a general matter?
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` A. As a technical expert, I am using these
`terms in common language.
` Q. Okay. Fair enough.
` Going to paragraph 6 of your declaration, you
`say that you are "the director of clinical research
`and director of the Multiple Sclerosis Center at
`Consultants in Neurology, Northbrook, Illinois,"
`correct?
` A. I did, yes.
` Q. About how large an entity is the MS
`Center within the Consultants in Neurology?
` A. In terms of patients that we see? In
`terms of --
` Q. Is it a major component of the
`Consultants in Neurology, or is it relatively minor
`in terms of resources, patients?
` A. It's a large component.
` Q. Staying with that paragraph, you state
`that "as director of clinical research and
`development," you "supervise clinicians and oversee
`operations at the MS Center," correct?
` A. Yes.
` Q. What do you mean by "supervising
`clinicians"?
` A. I'm responsible for training them, for
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`overseeing their activities, for directing their
`day-to-day activities on projects that they work on,
`for building their skill set;
` For ensuring the collaboration with other
`clinicians within the practice and within the MS
`Center with physicians outside of our practice who
`work with us.
` Q. So clinicians are medical doctors, or
`they are medical students? Please define
`"clinician."
` A. They are medical doctors, nurse
`practitioners, nurses, research associates. There
`are medical students and other students that
`occasionally are in the center.
` I help train and supervise these individuals as
`well, but that's not a major component of my
`activities relative to directly working with the
`full-time staff.
` Q. So overseeing operations is -- you are
`overseeing the work product of these clinicians?
` A. That's one part of what I do, yes.
` Q. And possibly what other parts might you
`do as part of your overseeing operations?
` A. I help train them in the activities that
`they are responsible for to which degree that I
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`interact with them in research, for example.
` I help build their skill set such that they are
`able to train and supervise others as well, and to
`foster the spirit of collaboration and congeniality
`among the staff;
` To help develop relationships with clinicians
`outside of our MS Center in both the Chicago area,
`where our practice is located, as well as in other
`parts of the country and outside the United States.
` Q. Thank you.
` Continuing on with your declaration, you state
`that "You train and manage research staff." Can you
`please define who the "research staff" is?
` A. Yes. The research staff are the other
`individuals who work in research with us.
` These include both physicians, nurse
`practitioners, nurses, individuals who work in our
`laboratory, physicians with different medical
`specialties.
` Q. What do you mean by "training" them?
` A. Well, just as an example, when we are
`getting ready to start participation in a research
`trial, one of my responsibilities is to ensure that
`they understand what we're studying, the procedures
`required to carry out the study, their
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`responsibilities in carrying these out, who to go to
`when problems come up and how to solve them, and to
`oversee interactions between the different
`individuals.
` So all activities in a clinical trial, for
`example, for which I am the principal investigator,
`I am responsible, ultimately.
` Q. Okay. What is a "principal
`investigator"?
` A. So the -- for a given research cite in a
`clinical trial, there is -- there are some
`investigators who work and report to the principal
`investigator.
` The principal investigator is the position that
`signs off on the FDA Form 482 that ensures matters
`such as I just described and is the primary person
`who is interacting with the head of the study
`they're responsible for, one of the things, the
`integrity of the data produced in the study.
` Q. And by "study," you're referring to
`clinical trials?
` A. Well, principal investigator, as it
`refers to clinical trials, refers to FDA Form 482.
` Q. Okay.
` A. However, there are research trials we do
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