throbber
Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` IPR2018-01403
`
`- - - - - - - - - - - - - - - X
`MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
`BIOGEN MA INC.,
` Patent Owner.
`- - - - - - - - - - - - - - - X
` VOLUME I
` VIDEO DEPOSITION OF REBECCA CONAGHAN
` Friday, July 19, 2019, 9:05 a.m.
` Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
` Two Seaport Lane
` Boston, Massachusetts 02210
`
` --- Reporter: Kimberly A. Smith, CRR, CRC, RDR ---
` Realtime Systems Administrator
` Ace-Federal Reporters, Inc.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 1
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 2
`1
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` APPEARANCES:
`
` Perkins Coie LLP
` By: Brandon M. White, Esq.
` 701 13th Street, N.W., Suite 600
` Washington, D.C. 20005-3960
` (202) 654-6200
` bmwhite@perkinscoie.com
` for the Petitioner;
`
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` By: Barbara C. McCurdy, Esq.
` and Cora R. Holt, Esq.
` 901 New York Avenue, N.W.
` Washington, D.C. 20001
` (202) 408-4000
` barbara.mccurdy@finnegan.com
` cora.holt@finnegan.com
` for the Patent Owner.
` Also Present: Carol Loeschorn, Biogen Idec
` Robert Lawson, Video Operator
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`Ace-Federal Reporters, Inc.
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 2
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 2
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 3
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` I N D E X
`
` WITNESS: Rebecca Conaghan
`
` CROSS-EXAMINATION Page
` By Mr. White 6
`
` EXHIBITS FOR IDENTIFICATION:
` Mylan Pharms. Inc. Page
` Exhibit 1007 5/2016 Sixteenth Meeting of 16
` the European Neurological
` Society abstracts
` Exhibit 1016 5/30/06 Business Wire press 46
` release
` Exhibit 1046 10/31/11 Dawson declaration 47
` (In re Lukashev application)
`
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 3
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
` EXHIBITS FOR IDENTIFICATION: (Continued)
` Biogen Description Page
` Exhibit 2088 2/19/04 CTRB agenda item 17
` meeting minutes
` Exhibit 2092 2/1/06 email string with 43
` attached 9/8/04 C-1900 SAC
` meeting minutes
` Exhibit 2098 Witness's 5/16/19 declaration 7
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 4
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 4
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 5
`
` THE 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 and place them away from the microphones as
` they may interfere. Recording will continue until
` all parties agree to go off the record.
` This is the deposition of Rebecca
` Conaghan, and this is in the matter -- oops -- I'm
` trying to get her in focus here. Sorry about that.
` And this is in the matter of Mylan
` Pharmaceuticals Inc. Vs. Biogen Mass [sic], Inc.
` It is Patent No. 8,399,514. And I think this is a
` different number, 1PR2018-01403 [sic].
` This is taken -- this deposition is
` taken before the U.S. Patent and Trademark Office
` before the Patent Trial and Appeal Board.
` This deposition is being taken at
` Finnegan Henderson at Two Seaport Lane, Boston,
` Massachusetts. The time is 9:06 a.m. The date is
` July 19, 2019. Our court reporter is Kimberly
` Smith. She's working with Ace-Federal Court
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`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 5
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 6
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` Reporters. And I am Robert Lawson, the video
` operator, also working with Ace-Federal.
` Will counsel present now please state
` their appearances and whom they represent for the
` record.
` MR. WHITE: Brandon White from Perkins
` Coie on behalf of petitioner Mylan Pharmaceuticals
` Inc.
` MS. McCURDY: Barbara McCurdy from
` Finnegan Henderson on behalf of patent owner Biogen
` MA Inc. And I'm here with my colleague, Cora Holt,
` also of Finnegan Henderson, and Carol Loeschorn from
` Biogen.
` THE VIDEO OPERATOR: Thank you. Will
` the court reporter now please swear in the witness.
` REBECCA CONAGHAN,
` having been satisfactorily identified by the
` production of her U.K. Passport, and
` duly sworn by the court reporter, was deposed
` and testified as follows:
` CROSS-EXAMINATION
` BY MR. WHITE:
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 6
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 6
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 7
`
` Q. Good morning, Ms. Conaghan.
` A. Good morning.
` Q. And is "Ms. Conaghan" fine?
` A. Yes, that's fine.
` Q. Thank you. My name's Brandon White and I'm
` going to be asking you a few questions today. Can
` you please state and spell your name for the record.
` A. Spell, did you say?
` Q. Yes.
` A. The full name?
` Q. Yes.
` A. Okay. R-e-b-e-c-c-a. And surname,
` C-o-n-a-g-h-a-n.
` (Biogen Exhibit 2098 was presented
` to the witness.)
` Q. And I think you have a document before you.
` Is that the declaration you signed in this case?
` A. Yes, that's correct, yeah.
` Q. That's Exhibit 2098?
` A. Um --
` Q. On the bottom.
` A. Yes. Yes, it is.
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`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 7
`
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 8
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` Q. And feel free to look at that at any time
` if I ask you a question and you need to make
` reference to that.
` A. Okay.
` Q. Have you been deposed before?
` A. No, never. No.
` Q. So I just want to go over a few ground
` rules to make sure we're on the same page to make
` everyone's life easier.
` A. Um-hum.
` Q. If there's a question that I ask and you
` don't understand it, please feel free to ask for
` clarification. I will try to provide that the best
` I can.
` A. Um-hum.
` Q. Please try to give audible, clear answers
` so the court reporter can have a clean transcript
` and avoid head nods or "ums." That will make the
` court reporter's life easier and provide a clear
` transcript.
` A. Okay.
` Q. If your counsel objects, unless she
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 8
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 8
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 9
`
` instructs you not to answer, you should try to
` answer the question to the best of your ability.
` We should avoid trying to speak over
` each other so the court reporter can take down the
` record cleanly. If I cut you off, it will be
` inadvertent. Feel free to let me know and I'll
` allow you to finish. And I'll also ask that you
` allow me to finish my question for the same reasons.
` Are there any reasons you can't testify
` accurately today?
` A. No.
` Q. When did you graduate from college?
` A. Ninety -- well, my first -- my
` undergraduate, I believe '93, I think.
` Q. And what did you do after your
` undergraduate?
` A. I did a postgraduate in human applied
` physiology.
` Q. When did you finish that program?
` A. It's just a yearlong program, so '94.
` Q. And after your graduate program, what did
` you do next?
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`Ace-Federal Reporters, Inc.
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`202-347-3700
`
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 10
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` A. I worked for Merck Sharp & Dohme.
` Q. And how long were you at Merck?
` A. I think about -- I mean, this is roughly,
` about three years, I think.
` Q. And just generally without revealing any
` confidential information, what type of work did you
` do at Merck?
` A. So I was a clinical research associate, so
` working in the clinical department.
` Q. What did you do after you left Merck?
` A. I then went to Schering-Plough.
` Q. And how long were you there?
` A. Roughly about five years.
` Q. And what type of work did you do at
` Schering-Plough?
` A. Similar. I went in as a CRA, the clinical
` research associate, and then whilst I was there --
` when I left, I was a clinical research manager.
` Q. And what did you do when you left
` Schering-Plough?
` A. That's when I started working for Biogen.
` Q. And was that around 2002?
`
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`
`Ace-Federal Reporters, Inc.
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 11
`
` A. Yes, exactly.
` Q. And how long did you stay at Biogen?
` A. Well, I'm still there. So I've been and
` gone. I've left and gone back. Been as a
` contractor, had various maternity leaves. So I've
` been on and off working for Biogen since 2002, but
` with long periods of time off as well, but not
` working anywhere else.
` Q. Were you at Biogen consistently until you
` took -- from 2002 until you took your first
` maternity leave in 2005?
` A. No. My first maternity leave was in 2003.
` Q. And when did you return?
` A. The end of 2003.
` Q. And then you were at Biogen until you left
` in 2005?
` A. Yes.
` Q. And when you returned from your second
` maternity leave, you were a contractor for a period
` of time; is that right?
` A. Yes. So actually -- yes, that's when I
` left as a permanent employee, and then I came back
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`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 12
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` as a contractor just a couple of days a week, and
` that was just for a few months, yeah.
` Q. And then there's a period of time when you
` were not at Biogen, you were --
` A. Then I had another maternity leave.
` There's a theme. So that was at the end of 2006.
` And then I had two and a half years off work.
` Q. And you returned to Biogen around 2009?
` A. Exactly, yes. And I've been with them as a
` contractor and then as a permanent employee since
` then.
` Q. What was your job responsibility when you
` first joined Biogen?
` A. I went back into the compliance department.
` Q. And, again, just generally, what were your
` job responsibilities in the compliance department?
` A. Working to set up agency inspections and
` assisting colleagues with compliance issues on
` clinical trials.
` Q. And how long were you in that compliance
` role?
` A. Around a year and a half.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 12
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 13
`
` Q. What was your next position?
` A. Clinical trial applications, it's called
` CTAs. So working -- that's when I moved into
` regulatory.
` Q. How long were you in the CTA position?
` A. Gosh. I sort of -- probably it was several
` years, yeah. Sort of molded into the next job. So
` it wasn't sort of a definite line between roles,
` yeah.
` Q. So what was the next job?
` A. Then I was working more in the regulatory
` development, which is where I am now.
` Q. As a CTA, what were your job
` responsibilities generally?
` A. Working with CROs, which is contract
` research organizations, to put together the CTA
` applications that you have to send to regulatory
` agencies prior to starting a clinical trial.
` Just one of the approvals you need to gain.
` And answering questions. And may have
` amendments, submitting amendments to protocols, that
` sort of thing, all to the regulatory authorities.
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`202-347-3700
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 14
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` So FDA equivalents.
` Q. And how did your job change as you moved to
` the regulatory development?
` A. So regulatory development, particularly the
` role I'm in, is more preparing for market- -- well,
` is a strategy and preparation towards marketing
` authorization applications.
` Q. In your time at Biogen, did your
` responsibilities include determining the clinical
` trial protocols?
` MS. McCURDY: Objection, relevance.
` A. As a project manager, you wouldn't have
` overall responsibility for determining the content
` of a clinical trial.
` Q. Other than the documents that you cite in
` your declaration, did you review any additional
` materials in preparing your declaration?
` A. No, I did not.
` Q. Other than your lawyers, did you speak with
` anyone in preparing your declaration?
` A. Not in the preparing of the declaration,
` no.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 15
` Q. Did you speak with anyone other than your
` lawyers in preparing for your deposition?
` A. I -- well, I spoke to my boss about it.
` But that was it. But that was after the declaration
` had been signed.
` Q. Was that on the substance of your
` declaration or just logistics of your travel?
` A. He did see my declaration, yes.
` Q. Who was Gilmore O'Neill?
` A. He was the medical director on the C-1900
` clinical trial.
` Q. When did you first meet Dr. O'Neill?
` A. I can't remember when I first met him, but
` I started working with him when I returned to Biogen
` at the end of 2003.
` Q. Did you report to Dr. O'Neill?
` A. He was not my manager, if that's what you
` mean.
` Q. Yes.
` A. That reporting line, no.
` Q. And what kind of interactions did you have
` with Dr. O'Neill?
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`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
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` A. Well, because he was the medical director
` on the study, he was absolutely the touchpoint for
` everything that we were organizing. So we would
` have regular teleconferences, emails. We would meet
` up when there were meetings that had been organized.
` So it was regular contact.
` Q. The C-1900 study, that is the Phase II
` study that is referenced in the Kappos article that
` is the subject of your declaration; is that correct?
` A. So which article are you referring to?
` (Mylan Pharms. Inc. Exhibit 1007
` was presented to the witness.)
` Q. So I've handed you what's been previously
` marked as Exhibit 1007. Do you recognize that
` document?
` A. I do, yes.
` Q. And if you could turn to what's marked on
` the bottom right as page 27. Do you recognize the
` 018 [sic] abstract?
` A. I recognize it because I've seen it in the
` preparation for today, yes.
` Q. And is that the C-1900 clinical trial?
`
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 16
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 16
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 17
` A. I understand, yeah, that is relating to the
` C-1900 trial.
` Q. And when you refer in your declaration to
` Exhibit 1007, you're referring to this abstract;
` is that fair?
` A. Sorry. I'm not familiar with all the
` different numbers. Yes. That's this one, yes.
` (Biogen Exhibit 2088 was presented
` to the witness.)
` Q. So I've handed you what's been previously
` marked as Biogen Exhibit 2088. Do you recognize
` this document?
` A. I do, yes.
` Q. And you discuss this document in your
` declaration?
` A. Yes.
` Q. On page 2 of the document -- it's double-
` sided -- there are four dosing regimens; do you see
` that?
` A. Yes.
` Q. When did you first learn of those dosing
` regimens?
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`Ace-Federal Reporters, Inc.
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 17
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 17
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 18
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` A. I don't remember when I first learned of
` them.
` Q. Did you learn of them before the
` February 19, 2004 meeting?
` A. Oh, absolutely, yes.
` Q. And how did you learn of them prior to the
` meeting?
` A. Because they would have been discussed in
` great detail by the SMT with Gil -- sorry -- with
` Dr. O'Neill when we were pulling together the
` preparation for the CTRB meeting.
` Q. What is the term "SMT"?
` A. Study Management Team.
` Q. Were you a member of the Study Management
` Team?
` A. I was, yes.
` Q. How many people roughly were on the Study
` Management Team?
` A. It really would be rough. I couldn't give
` you the exact number. And it would vary possibly on
` the agenda. But there would be a core SMT of people
` like myself, the medical director, statistician.
`
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 18
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 18
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 19
` And then you'd have other people, maybe the person
` managing the contracts, there's administrative
` support.
` It could be anything from five people to
` 15 people depending on what was being discussed.
` And that's really a rough. I can't remember off the
` top of my head.
` Q. Sure. The proposed dosing regimens were
` discussed at SMT meetings --
` A. Um-hum.
` Q. -- prior to the February 19, 2004 meeting;
` is that correct?
` A. Yes.
` Q. And you didn't review any meeting minutes
` from those prior SMT meetings in preparing your
` declaration?
` A. No, I did not.
` Q. The members of the SMT that had discussed
` the dosing regimens prior to the meeting, they would
` have provided input and their views on the dosing
` regimen as well, right?
` MS. McCURDY: Objection, relevance.
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`866-928-6509
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 19
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 19
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 20
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` A. Well, I can't remember -- you know, it's
` 2004, I can't remember the exact details. But we
` were a Study Management Team working under
` Dr. O'Neill's guidance and supervision. So they
` would have provided the information that he needed.
` Q. Was Dr. O'Neill in charge of the SMT?
` A. Well, he was in charge of the protocol, of
` designing the protocol, yes.
` Q. Who would have been -- whether it's a chair
` or the leader of the SMT?
` A. That was me as the project manager.
` Q. Do you recall specifically any of the
` people that would have been on the SMT with respect
` to the C-1900 study?
` A. I can remember a few. No, I can't remember
` all of them.
` Q. That's okay. Can you name the few that you
` remember?
` A. I remember Minhua Yang, the statistician;
` Simon Bennett was a contracts organizer; Helen
` Gilliland, a clinical trial coordinator. I think
` Anne Read was a medical writer. And I can't really
`
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 21
`
` remember beyond that, to be honest.
` Q. Were you present at the February 19, 2004
` meeting that is the subject of Exhibit 2088?
` A. Yes.
` Q. At that meeting, I understand from the
` first bullet point under the chart on page 2, there
` was -- the commercial, regulatory, and research
` groups had provided input on what dosing regimen
` should be adopted; is that correct?
` MS. McCURDY: Objection, form.
` A. I actually can't remember the detail of the
` conversation. What I remember for the meeting is
` what's here. But this is how I remember the
` meeting. I don't remember it other than from here,
` yeah.
` Q. Do you recall who the commercial
` representatives would have been at that meeting?
` A. I do not, no.
` Q. Do you recall who the regulatory
` representatives would have been?
` A. No, sorry.
` Q. Do you recall who the research
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`866-928-6509
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 21
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 21
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 22
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` representatives would have been?
` A. No.
` Q. Do you recall why the commercial
` representatives were not in favor of a 240 mg dose?
` A. I could surmise, but I can't remember, no.
` Q. Do you recall why the regulatory
` representatives were concerned that bypassing a
` 240 mg dose might raise questions with regulatory
` agency reviewers?
` A. I couldn't give you accurate details, no, I
` wouldn't remember. Sorry.
` Q. And do you recall why research
` representatives felt that a true dose ranging study
` was only reflected in Option 3?
` A. I do not, no.
` Q. If you look under the heading "Summarized
` action plan" at the bottom of the page --
` A. Um-hum.
` Q. -- there's a reference to an ad hoc CTRB
` meeting?
` A. Yes.
` Q. What does "CTRB meeting" mean?
`
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 22
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 23
`
` A. Clinical Trial Review Board.
` Q. What was the purpose of the ad hoc CTRB
` that was referenced in this bullet?
` A. Well, obviously it hasn't -- by this point,
` it hasn't yet occurred, so I can't tell you what the
` outcome of the meeting or the purpose of the actual
` meeting was when it occurred.
` Q. Did you attend the meeting?
` A. I don't know. I imagine I would have done,
` but I don't remember. Sorry.
` Q. Would there have been meeting minutes from
` that meeting?
` A. Yes, there would have been, I'm sure.
` Q. Do you recall when it was ultimately
` determined which dosing regimen to use in the C-1900
` study?
` A. I don't recall the exact -- the exact time,
` no, sorry.
` Q. Do you recall who made that decision of
` what dosing regimen to use in the C-1900 study?
` A. I do not, no.
` Q. Do you recall who determined how many
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`866-928-6509
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 23
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 23
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 24
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` patients should be included in the C-1900 study?
` A. So that would have been within the Study
` Management Team, so with Dr. O'Neill as the medical
` director, he would have made that final decision
` with input from the relevant members of the SMT.
` Q. Do you recall who determined what the
` clinical endpoints would have been for the C-1900
` study?
` A. Again, that absolutely would have been
` Dr. O'Neill's responsibility as the MS expert on the
` team.
` Q. If you look at the abstract that's in
` Exhibit 1007, the first referenced author is
` L. Kappos.
` A. Um-hum.
` Q. Do you know that to be Dr. Ludwig Kappos?
` A. That's correct, yes.
` Q. Do you know Dr. Kappos?
` A. I don't know him, no. I know who he is,
` but I don't know him.
` Q. Who is Dr. Kappos?
` A. He's a well-known physician in the field of
`
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 24
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 25
`
` multiple sclerosis.
` Q. Is it fair to say in the 2004 time frame,
` he was a highly regarded multiple sclerosis
` researcher?
` A. Certainly in the field of MS, absolutely he
` was, yeah, well known.
` Q. Do you recall when Dr. Kappos first became
` involved in the C-1900 study?
` A. I don't remember the exact date when he
` became involved.
` Q. Do you have any estimate of when he became
` involved?
` A. Well, it would have had to have been before
` the investigator meeting, but I couldn't have told
` you, you know, when before the investigator meeting.
` Q. Do you know if Dr. Kappos provided any
` input on the clinical trial design?
` A. I wouldn't be able to remember the details.
` He's likely to have reviewed it. But ultimately
` it's a Biogen protocol, so that final decision would
` have come from Dr. O'Neill and the SMT.
` Q. If Dr. Kappos would have had discussions
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`866-928-6509
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`Ace-Federal Reporters, Inc.
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 25
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 25
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 26
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` with Dr. O'Neill regarding the clinical trial design
` for the C-1900 study, would you have been included
` on those communications?
` A. Not necessarily.
` Q. And what institution was Dr. Kappos
` associated with in this time frame: 2004-ish?
` A. I can't remember -- he was in Switzerland,
` but I can't remember the name of his hospital.
` Q. He was not with Biogen?
` A. Oh, no. Absolutely not, no.
` Q. So I want to go through the other names on
` the abstract, the other authors --
` A. Sure.
` Q. -- and just get a sense of who they were.
` So maybe just take them one at a time and . . .
` Who was D.H. Miller?
` A. That's David Miller. So he ran an MRI
` reading center at Queen Square in London.
` Q. Who was D.G. MacManus?
` A. I believe that's also David MacManus.
` Again, I think he worked with David Miller at the
` reading center.
`
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 27
`
` Q. And who was R. Gold?
` A. One of the principal investigators,
` I believe.
` Q. And E. Havrdova?
` A. Eva Havrdova, she was also one of the
` investigators.
` Q. V. Limmroth?
` A. I believe he was on the scientific advisory
` committee.
` Q. C. Polman, who was that?
` A. A principal -- one of the investigators.
` Q. And who was K. Schmierer?
` A. I believe they worked with David Miller.
` Q. Doing MRI reading?
` A. I believe. I'm not 100 percent sure of
` that one. Yeah, I think so. I'm not 100 percent
` sure on that one.
` Q. Who was T. Yousry?
` A. Again, they're the two that I'm not as
` familiar with. I believe they were both from the
` MRI center. I would need to check on that.
` Q. Who was M. Yang?
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`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 27
`
`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 27
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`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 28
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` A. Oh, that's Minhua Yang. She was a
` statistician on the study.
` Q. Who was M. Eraksoy?
` A. I believe that was one of the investigators.
` Q. And who was E. Meluzinova?
` A. Investigator.
` Q. And then I. Rektor?
` A. Again, I think investigator.
` Q. And the last author, Dr. O'Neill, that's
` Dr. O'Neill from Biogen?
` A. Yes.
` Q. Other than Dr. O'Neill and Dr. Yang, was
` anyone else on this list of authors from Biogen?
` A. No. No.
` Q. Was Dr. O'Neill involved in performing the
` clinical trial in terms of giving the medication to
` patients?
` A. Sorry. Say that again.
` Q. Was Dr. O'Neill involved in actually
` administering the clinical trial, the patients?
` A. He did not give treatment to patients, no.
` Q. Was he involved in the analysis of the
`
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`MYLAN PHARMS. INC. EXHIBIT 1129 PAGE 28
`
`

`

`Rebecca Conaghan
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`July 19, 2019
`
`Page 29
`
` results of the clinical trial?
` A. He would have been involved in reviewing
` the analysis, absolutely.
` Q. At the last line of the abstract, it states
` that "This study was sponsored by Biogen Idec and
` Fumapharm AG."
` What was Fumapharm's role with respect
` to this clinical trial?
` A. I honestly don't know.
` Q. Do you know if anyone from Fumapharm was
` involved in the development of the clinical trial?
` A. Not that I remember.
` Q. Other than the C-1900 study, were you
` involved in other clinical trials for dimethyl
` fumarate?
` A. Yes, I helped. Not in the same capacity as
` for this study, but I helped set up the Phase III.
` But that was when I went back first as a contractor.
` Q. So other than the Phase III studies, had
` you been involved in any of

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