Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` IPR2018-01403
`
`Page 1
`
`- - - - - - - - - - - - - - - X
`MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
`BIOGEN MA INC.,
` Patent Owner.
`- - - - - - - - - - - - - - - X
` VOLUME I
`
` VIDEO DEPOSITION OF GILMORE NEIL O'NEILL, M.B.
` Friday, September 13, 2019, 11:39 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.
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`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 1
`
`
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` IPR2018-01403
`
`Page 1
`
`- - - - - - - - - - - - - - - X
`MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
`BIOGEN MA INC.,
` Patent Owner.
`- - - - - - - - - - - - - - - X
` VOLUME I
`
` VIDEO DEPOSITION OF GILMORE NEIL O'NEILL, M.B.
` Friday, September 13, 2019, 11:39 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.
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`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 1
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 2
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` APPEARANCES:
`
` Perkins Coie LLP
` By: Courtney M. Prochnow, Ph.D., Esq.
` 633 West 5th Street, Suite 5850
` Los Angeles, CA 90071
` (310) 788-9900
` cprochnow@perkinscoie.com
` and
` Perkins Coie LLP
` By: David L. Anstaett, Esq.
` 33 East Main Street, Suite 201
` Madison, WI 53703-3095
` (608) 663-7460
` danstaett@perkinscoie.com
` for the Petitioner;
`
`866-928-6509
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`Ace-Federal Reporters, Inc.
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`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 2
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
` APPEARANCES: (Continued)
`
`September 13, 2019
`
`Page 3
`
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` By: Barbara C. McCurdy, Esq.
` and Pier D. DeRoo, Esq.
` 901 New York Avenue, N.W.
` Washington, D.C. 20001
` (202) 408-4000
` barbara.mccurdy@finnegan.com
` pier.deroo@finnegan.com
` for the Patent Owner.
`
` Also Present: Wendy Plotkin, Biogen
` Bart Newland, Biogen
` Gayle Ashton, Video Operator
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 3
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
` I N D E X
`
` WITNESS: Gilmore Neil O'Neill, M.B.
`
`September 13, 2019
`
`Page 4
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` CROSS-EXAMINATION Page
` By Ms. Prochnow 7
` AFTERNOON SESSION
` By Ms. Prochnow 76
`
` EXHIBITS FOR IDENTIFICATION:
` Mylan Pharms. Inc. Page
` Paper 56 Petitioner's deposition notice 11
` Paper 58 Petitioner's amended 11
` deposition notice
` Exhibit 1006 10/2004 20th Congress of the 31
` European Committee for
` Treatment and Research in
` Multiple Sclerosis abstracts
` Exhibit 1007 5/2016 Sixteenth Meeting of 116
` the European Neurological
` Society abstracts
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`Ace-Federal Reporters, Inc.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 4
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 5
`
` EXHIBITS FOR IDENTIFICATION: (Continued)
` Mylan Pharms. Inc. Page
` Exhibit 1016 5/30/06 Business Wire press 117
` release
`Exhibit 1046 10/31/11 Dawson declaration 117
` (In re Lukashev application)
` Exhibit 1048 10/25/08 Kappos article 120
` Exhibit 1073 Biogen Exhibit 2309 49
` (Coalition v. Biogen)
` Exhibit 1074 Witness's copy of his 117
` 5/24/19 declaration with
` attached exhibits
` Original exhibits retained by reporter to be
` returned to Perkins Coie
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 5
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 6
`
` 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 or place them away from the microphones, as
`they may interfere with deposition audio. Recording
` will continue until parties agree to go off the
` record.
` This is the deposition of Gilmore
` O'Neill, M.D. [sic], in the matter of Mylan
` Pharmaceuticals Inc. Vs. Biogen MA, Inc., Case
` No. IPR2018-01403, in the U.S. Patent and Trademark
` Office, Patent Trial and Appeal Board.
` This deposition is being taken at
` Finnegan, 2 Seaport Lane, Boston, Massachusetts.
` The time is approximately 11:40 a.m. The date is
` September 13, 2019.
` The court reporter is Kimberly Smith
` with the firm of Ace-Federal Reporters. I am the
` video operator, Gayle Ashton, representing
` Ace-Federal Reporters, 555 Twelfth Street,
` Northwest, Washington, D.C. 20004.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 6
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 7
` Will counsel please identify themselves
` and state whom they represent.
` MS. PROCHNOW: Courtney Prochnow from
` Perkins Coie on behalf of Mylan Pharmaceuticals,
` petitioner.
` MR. ANSTAETT: David Anstaett of Perkins
` Coie on behalf of Mylan.
` MS. McCURDY: Barbara McCurdy of
` Finnegan representing Biogen. I'm here with my
` colleague, Pier DeRoo, and also Wendy Plotkin and
` Bart Newland from Biogen.
` THE VIDEO OPERATOR: Will the court
` reporter please swear in the witness.
` GILMORE NEIL O'NEILL, M.B.,
` having been satisfactorily identified by the
` production of his driver's license, and
` duly sworn by the court reporter, was examined
` and testified as follows:
` CROSS-EXAMINATION
`BY MS. PROCHNOW:
` Q Hello, Dr. O'Neill.
` A Hi. How are you?
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`202-347-3700
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 7
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 8
` Q Thank you for your time today. Would you
` please state your full name for the record, please.
` A Gilmore Neil O'Neill.
` Q What is your home address?
` A 17 Grove Street in Medford.
` Q I'd like to just start off by going over a
` few ground rules just to make sure we're
`on the same
` page today. I know that you've been
`deposed before.
` Now, you've been given an oath by the court
`reporter, which is the same oath that you would have
` had as if you were testifying in court.
` Do you understand that the oath
`requires
` you to tell the truth?
` A I do.
` Q Will you tell the truth today?
` A I will.
` Q And I'm going to ask you a question. Your
` counsel may object. But unless instructed not to
` answer, you may answer. Okay?
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`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 8
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 9
`
` A Yes.
` Q As you can see, we have a court reporter
` here. And it's important that we don't talk over
` one another so she can take every -- take down
` everything we're saying. So I'll make sure when
` you're answering a question not to interrupt you,
` and I'd appreciate it if you'd do the same for me:
`not interrupt me when I'm answering -- or asking you
` a question.
` Is that okay?
` A Yes.
` Q Also, so we can generate a clean record
` please make sure you give verbal responses like
` "Yes" and "no" and refrain from shaking your head
` and using gestures or words like "uh-uh" or
` "uh-huh."
` Will you do that for me today?
` A Yes.
` Q And I'll be asking you a lot of questions
`today. So if you need to take a break, feel free to
` let me know. All I ask is that you don't take a
` break while a question is pending.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 9
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 10
`
` Will you do that for me today?
` A Yes.
` Q And I want to make sure that you
`understand
` all of the questions that I ask today. So if you
` don't understand a question that I ask, will you
` please ask me to clarify the question and I'll ask
` it in a different way?
` A I will.
` Q I understand that you've been deposed
`before in proceedings with the Patent Office related
` to the patent at issue here, which is U.S. Patent
` No. 8,399,514.
` Is that correct?
` A Yes.
` Q And that was for the Biogen vs. Forward
` Pharma Patent Interference No. 106,023 and a
` Coalition for Affordable Drugs vs. Biogen Inter
` Partes Review IPR2015-01993.
` Is that correct?
` A I would be at -- it would be difficult to
` remember the specific numbers you read out. But I
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 10
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 11
` do recall being deposed in relation to this patent.
` Q And you were also deposed more recently
`this
` year over the course of two days for the
`Biogen vs.
` Mylan and Biogen vs. Amneal
`Pharmaceuticals District
` Court cases; is that correct?
` A I have been deposed in relation to the
` District Court cases.
` Q Have you ever been deposed in any other
` proceeding?
` A In a -- coroners' cases in Ireland.
` Q Have you ever provided testimony in any
`court proceeding other than at deposition, such as a
` trial or hearing?
` A No. Other than what I just said about the
` coroners' cases in Ireland.
` MS. PROCHNOW: Now, I'm going to start
` out by handing you a couple documents. And these
` are documents that are already on the record.
` Paper 56 is the first document. This is
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`Ace-Federal Reporters, Inc.
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`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 11
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 12
`
` petitioner's
` notice of deposition of Gilmore O'Neill.
` (Mylan Pharms. Inc. Paper 56 was
` presented to the witness.)
` MS. PROCHNOW: And then the second
` document I'm going to give you, this would be Paper
` No. 58. This is petitioner's amended notice of
` deposition of Gilmore O'Neill.
` (Mylan Pharms. Inc. Paper 58 was
` presented to the witness.)
` Q Have you seen these documents before?
` MS. McCURDY: Excuse me, counsel.
` There's no number on this.
` MS. PROCHNOW: Okay. These were filed
` with the Patent Office. So this is -- these are
` Papers 56 and 58.
` MS. McCURDY: So you're making a
` representation?
` MS. PROCHNOW: Yes. Yes.
` Q Have you seen these documents before?
` A I don't believe so.
` Q These are notices that just say that Mylan
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`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 12
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 13
`
` will cross-examine you today, okay?
` And I see that you've brought documents
` with you today, a binder of documents.
` Can you tell me what that is?
` A This binder contains my declaration and
`the
` exhibits that are cited in the declaration.
` Q Can I take a look at them? Thank you.
` So these are all of the exhibits that
` were cited in your declaration, Exhibit No. 2097?
` MS. McCURDY: The witness doesn't have
` the paper in front of him.
` Q Just take a look here. Thank you. Let's
` go ahead and take a look at Exhibit 2097. So that
` is your declaration. I think that's the . . .
` Is that correct?
` A 2097?
` Q Yes.
` A Is my declaration.
` Q And if you turn to page 10 of Exhibit
`2097,
` can you confirm that that's your signature?
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`
`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 13
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 14
`
` A Yes, that is my signature.
` Q And did you review your declaration before
` you signed it?
` A I did.
` Q Are you aware of any errors in your
` declaration that you believe need to be corrected?
` A The only one is that -- and this keeps
` floating in in the U.S. -- my degree is an M.B.
` I've tried to correct this.
` Q And what does "M.B." stand for?
` A It's a Bachelor of Medicine. Medicine is
` undergraduate training in Ireland.
` Q So you're saying that on the -- your
` signature page, instead of "M.D.," it should say
` "M.B."?
` A Yes.
` Q And also on the cover page then of your --
` A Yes.
` Q -- declaration.
` And did you speak with anyone else
`other
` than your attorneys about the substance of your
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`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 14
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 15
`
` declaration while you were preparing it?
` A No.
` Q Did you -- you didn't speak with anybody
`at
` Biogen?
` A No.
` Q Anybody external to Biogen?
` A No.
` Q All right. Let's turn to your declaration
` at paragraph 1. And paragraph 1 provides a very
` brief overview of your employment history; is that
` correct?
` A It summarizes my employment history, yes.
` Q And paragraph 2 provides a very brief
` overview of your education, correct?
` A It's a summary of my education.
` Q And did you submit a CV with your
` declaration, Dr. O'Neill?
` A I don't recall.
` Q But there's no CV attached to this
` declaration, correct?
` A There's no CV attached to this
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 15
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 16
`
`declaration.
` Q Do you recall your declarations in the IPR
` proceedings and the interference proceedings?
` A I -- No.
` Q Did you not think it was important to
` provide a CV in this case with your declaration?
` A I did not consider that.
` Q Did you provide a list of your
`publications
` and presentations with your declaration in this
` case?
` A There is a -- there are some abstracts
`here
` on which I'm an author.
` Q You're referring to page 2 -- or I guess
`it
` would be page 4 of Exhibit 2097?
` A Yes.
` Q And this is the Kappos abstract,
` Exhibit 1007? Is that what you're referring to?
` A Exhibits 1007, 1046 are two abstracts on
` which I'm senior author.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 16
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`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 17
` Q But you didn't provide any list of your --
` all of your publications or presentations?
` A I don't see them attached here.
` Q Let's go ahead and start with your
` educational background in paragraph 2. So this is
` on page 3 of Exhibit 2097. And it says here you
` received your medical degree from the University
` College Dublin in 1988.
` Is that correct?
` A Yes.
` Q And then you completed residencies and
` fellowship training in internal medicine,
` pulmonology, and neuropathology in 1993 at Beaumont
` Hospital Dublin; is that correct?
` A Yes.
` Q So during your residencies and fellowship
` training, were you ever involved in conducting a
` clinical trial for multiple sclerosis?
` A Are you asking that question pertaining to
` my training in Ireland or --
` Q Yes.
` A I do not recall participating in MS
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 17
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`
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`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 18
`
`trials.
` Q And so were you involved in designing any
` clinical trials for MS?
` A I was not involved in designing clinical
` trials in MS in Ireland.
` Q And then next you state that you completed
`your residency in neurology at Massachusetts General
`Hospital in 1997 and was chief resident from 1996 to
` 1997.
` Is that correct?
` A That is correct.
` Q And when you were chief resident in 1996
`to
` 1997, were you ever involved in conducting a
` clinical trial for multiple sclerosis?
` A So as a resident at Mass. General
`Hospital,
` I was not involved in designing or executing
` clinical trials in multiple sclerosis.
` Q Next at the bottom of page 3, it says you
` received a Master of Medical Science degree from
` Harvard Medical School in 1999.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 18
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`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 19
`
` Is that correct?
` A That is correct.
` Q And what was the focus of your thesis
` project?
` MS. McCURDY: Objection, relevance.
` Q You can answer.
` A So the thesis of my -- or my theme of my
` thesis was around the genetics and biochemistry of
` X-linked adrenoleukodystrophy.
` Q Can you explain what that is.
` A It is an inherited disorder of -- that
` impacts white matter of the central nervous system.
` Q Did you conduct research in a laboratory
` during your master's program?
` A I did.
` Q And what type of research did you conduct?
` A I carried out molecular genetics and
` molecular biology research.
` Q Did you publish any papers on this work?
` A I did.
` Q Do you know how many papers you published?
` A At least one paper and several abstracts.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 19
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 20
` Q And this was the time period around 1999,
` it would be, or after 1999 the papers were
` published?
` A Around that time.
` Q Did this work relate to clinical trials in
` any way?
` A It involved the collection of clinical
` samples from patients, including evaluating their
` neurologic status and correlating it with genetic
` mutations and the biochemistry of those mutations.
` Q Did this work involve designing a clinical
` trial?
` A I did not design interventional clinical
` trials.
` Q Was it involved in -- Did this work
`involve
` conducting a clinical trial for MS?
` A I did not in that thesis work or lab work
` conduct clinical trials in MS. However, in my
` master's training, I did receive substantial
`didactic training, over two years, in the design and
`execution of clinical development programs, clinical
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 20
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 21
`
` pharmacology statistics, and the design and
`execution analysis and reporting of clinical trials.
` Q Did that pertain to multiple sclerosis?
` A It pertained to clinical trials in
`general.
` Q So on page 4, you state, "I am a
`neurologist
` at Massachusetts General Hospital and have
`held that
` position since 1997."
` Is that correct?
` A That is correct.
` Q So in 1997, what were your
`responsibilities
` as a neurologist at Massachusetts General Hospital?
` A I was a -- I had two responsibilities.
` I was in the lab and I was a practicing
`neurologist
` with a specialty or subspecialty interest in
` neuromuscular diseases and inherited disorders of
` white matter. Of the brain. Otherwise known as
` leukodystrophies.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 21
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 22
`
` Q Were you treating patients?
` A Yes.
` Q How many patients do you think you treated
` over the year?
` A I can't recall.
` Q And it says here, "I am a neurologist at
` Massachusetts General Hospital."
` So how have your responsibilities at
` Mass. General changed throughout the years?
` A Initially when I was a full-time member of
`faculty, I saw patients weekly and worked in the lab
` and also had responsibilities for inpatient service
` at least one month every year.
` And then as I -- when I moved to
` industry, my inpatient responsibilities changed.
`By the way, through that time, I maintained teaching
` responsibilities.
` And then I reduced the frequence of my
` outpatient visits and I currently have that
` position, but I'm on sabbatical.
` Q So going back to paragraph 1 of your
`declarations -- this is on page 3 of Exhibit 2097 --
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 22
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 23
` you discuss your employment at Biogen beginning in
` 2003; is that correct?
` A Yes.
` Q So what did you do after you received your
` Master of Medical Science degree in 1999 until you
` began working at Biogen in 2003? Is that when you
` were working as a neurologist at Mass. General
` Hospital?
` A Yes. And in the lab doing research.
` Q About how much time did you spend in the
` lab doing research between 1999 and 2003?
` A I can't give you specific hours, but it
`was
` approximately 75 percent in the lab and 25 percent
` of my time in the clinic. Much of the time the
` weekly hours would have exceeded 40 hours, so . . .
` Q And so you say you were spending 75
`percent
` of the time in the lab. Does this pertain to your
` master's research?
` A Well, it pertained to research that
` continued after I had completed my master's.
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 23
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 24
` Q But this is research that was related to
` your thesis project?
` A No. It expanded beyond it. I actually
` also did research in amyotrophic lateral sclerosis,
` or Lou Gehrig's disease, and the genetics of
` muscular dystrophies.
` Q And this is the type of molecular biology
` research in the lab you were working on?
` A Yes.
` Q And then the other 25 percent you're
`saying
` you were a neurologist at Massachusetts General?
` A I was -- well, 100 percent of the time I
` was a neurologist at Mass. General. And 25 percent
` of the time I was in the outpatient clinic on the
` average week.
` And then I also supervised at the
` inpatient service for at least a month every year.
` And that comprised rounding on the entire patient
` service on the neurology department for every day,
` seven days a week for at least four weeks.
` Q So prior to working at Biogen, had you
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 24
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 25
`
`ever
` been involved in designing a clinical trial for
` multiple sclerosis?
` A No, I had not.
` Q And prior to working at Biogen, had you
` ever been involved in conducting a clinical trial
` for multiple sclerosis?
` A I don't believe I had as a PI. But as a
` resident, it is likely that I would have
` participated.
` Q So in paragraph 2 of your declaration, you
` state that you joined Biogen as associate director,
` medical research from 2003 to 2005.
` Is that correct? I'm sorry. That's
` paragraph 1. Excuse me.
` A Sorry. Paragraph 1.
` Q Yeah.
` A That -- so I joined Biogen as an associate
` director in 2003, yes.
` Q So why did you decide to work at Biogen?
` A Because I was disappointed with the
`therapeutics that we could offer my patients and was
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 25
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`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 26
`frustrated by the lack of advance in therapeutics in
` neurology.
` Q And you thought at Biogen you would be
`able
` to help with the therapeutics of multiple sclerosis
` or . . .
` A I believed that going to industry and a
` company like Biogen would enable me to advance the
` development of therapeutics for serious neurologic
` diseases.
` Q Do you remember what month in 2003 you
` started working at Biogen?
` A Approximately it was probably April/May
` 2003.
` Q And who did you report to as associate
` director of medical research?
` A Alfred Sandrock.
` Q And was he the director of medical
`research?
` A I can't remember his title back then.
` I know he's chief medical officer at Biogen now.
` Q Did you report to anybody else?
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 26
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`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 27
` A Well, up through the chain, but I reported
` directly to him.
` Q And who's Alfred Sandrock?
` A Alfred Sandrock is the chief medical
` officer at Biogen.
` Q Who was he in 2003? He was the director
`of
` medical research?
` MS. McCURDY: Objection, asked and
` answered.
` A I don't remember his exact title. He was
`in the neurology group, the clinical neurology group
` at Biogen.
` Q And what were his job responsibilities?
` MS. McCURDY: Objection, relevance.
` A As I would recall, his responsibilities
` were to run the neurology clinical group.
` Q And as associate director of medical
` research, what were your job responsibilities when
` you started working at Biogen?
` A I had a number of responsibilities. My
`key
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 27
`
`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 28
`
` responsibilities were to actually help in
` identifying
`new opportunities to bring to the clinic. And my --
` one of my first programs was working on translating
` or moving a molecule for peripheral neuropathy from
` the laboratory to the clinic.
` Q Do you remember what the name of that drug
` was?
` A We called it neublastin.
` Q And how long did you work on neublastin?
` A It's very hard for me to remember the
` details because I worked on numerous programs over
` those years. So I worked on that program for
` several years in addition to other programs.
` Q Did you work on any other drugs at the
`time?
` MS. McCURDY: Objection.
` I'm just going to caution the witness
` that this is a public record. And to the extent
` counsel's questions ask for confidential Biogen
`information, I'd caution the witness not to disclose
` such on the record but instead to identify that
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`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 29
`
` information as confidential, if applicable.
` Q And I just want to say I'm definitely not
` looking for any confidential information. I'm just
`trying to get a kind of general overview of how many
`drugs you were working on at the time when you first
` started at Biogen in 2003.
` A So the other drug that I recall -- and
`which I think is public -- is I was working on BG-12
` very soon after I joined.
` Q Any others?
` A There are several other compounds I worked
` on later in the time period. And unfortunately,
` I can't recall -- you know, some of those programs
` didn't go anywhere, so I don't know how much we
` disclosed publicly, but I can't recall.
` Q But when you first started in 2003, were
` you working on BG-12?
` A I think within my recollection is that
` within a few weeks of joining Biogen, I went on a
` confidential diligence trip to Switzerland to look
` at a drug that we later called BG-12.
` Q And looking back to paragraph 1 of your
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`MYLAN PHARMS. INC. EXHIBIT 1127 PAGE 29
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`
`
`Gilmore Neil O'Neill
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`September 13, 2019
`
`Page 30
`
` declaration, you were then director of medical
` research from 2005 to 2007; is that correct?
` A Yes. I was a director from 2005 to 2007.
` Q And how did your role as director change
` from your role as associate director?
` A My recollection is that I just had more
` programs and more responsibilities.
` Q What do you mean by, you had more
`programs?
` A I was working on several programs at that
` time that included neu- -- neublastin and BG-12 and
` several other programs. I also was doing other
` diligence projects.
` Q And so in paragraph 7 -- I'll just skip
` ahead a little bit -- that's on page 5 of
` Exhibit 2097 of your declaration -- you state that,
` "I was Biogen's medical director for its MS BG-12
` program"; is that correct?
` A That is correct.
` Q What was the MS BG-12 program at Biogen?
` A It was the program in which the compound
` designated as BG-12 was developed for the treatment
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