August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
`
`1
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` COALITION FOR AFFORDABLE DRUGS V LLC; et al.,
` Petitioners,
` v.
` BIOGEN MA, INC.,
` Patent Owner
` _________________________
` Case IPR2015-01993
` Patent 8,399,514 B2
` __________________________
` COMPLETE CAPTION ON PAGE 2
` __________________________
`
` DEPOSITION OF CARA CHRISTANN LANSDEN
` Wednesday, August 24th, 2016
` 9:50 a.m.
`
` 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
`
`Page 1 of 50
`
`Coalition Exhibit 1055A
`
`Coalition v. Biogen
`IPR2015-01993
`
`MYLAN PHARMS. INC. EXHIBIT 1128 PAGE 1
`
`

`

`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`2 (Pages 2 to 5)
`3
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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
` Counsel for 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
`
` Counsel for Respondents
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
`
`2
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` 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.,
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`Also Present:
`Carol Loeschorn, Biogen
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`C A R A C H R I S T A N N L A N S D E N,
`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.
` THE WITNESS: Cara Christann Lansden.
` My address is 145 Boardman Avenue,
` Melrose, Massachusetts 02176.
` THE SHORTHAND REPORTER: Thank you.
` Please proceed.
`
` DIRECT EXAMINATION
` BY MS. SPIEGEL:
`
` Q. Okay. I'm with Carmichael IP Law Firm,
`and I will be asking you a series of questions here
`today.
` I want you to answer them to the best of your
`ability. If there is something about the way I
`phrase a question that you don't understand, just
`say so, and I will try and rephrase it or restate
`it.
`
` If you need a break, we can take one at any
`
` Patent Owner
`
` __________________________
`
` Case IPR2015-01993
` Patent 8,399,514 B2
`
` INDEX
`EXAMINATION BY
`Ms. Spiegel
`
` PAGE
`
` 5
`
`BIOGEN
`FOR ID
`
` EXHIBITS
`
` DESCRIPTION
`
` PAGE
`
`Exhibit 2079 Declaration of Cara Christann 7
` Lansden
`Exhibit 2318 Email Fumapharm Update
` October 10, 2003
`
` 16
`
`Exhibit 2309 Email chain CTRB Meeting
` regarding BG-12/MS dated
` February 19, 2004
`
` 31
`
`Exhibit 2316 Email to Cara Christann 43
` Lansden dated July 6, 2006
`Exhibit 2310 Redacted Clinical Trial Review 54
` Board Meeting Agenda, Item:
` Meeting Minutes dated February
` 19th, 2004
`
`Exhibit 2255 Redacted e-mail, BG-12 IND
` Hold Response dated May 1st,
` 2006
`
`Exhibit 2131 Redacted BG-12 MS Clinical
` Development Team Minutes dated
` May 17th, 2006
`
` 79
`
` 81
`
`Exhibit 2115 Redacted BG 00012 SMT Kickoff 83
` Meeting dated May 2006
`Exhibit 2126 Email chain with top email 85
` from Gilmore O'Neill
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 2 of 50
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`MYLAN PHARMS. INC. EXHIBIT 1128 PAGE 2
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`

`

`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`6
`
`8
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`time. The only thing I ask is if I have asked you a
`question, would you please complete the answer
`before we break?
`A.
`(Nodding).
`Q. Now, the court reporter is transcribing
`our deposition, so it's important you give verbal
`answers and we don't talk over each other.
` Is that okay?
`A. Yes.
`Q. Would you please state your full name for
`the record?
`A. Cara Christann Lansden.
`Q. Do you understand your testimony is under
`oath today?
`A.
`I do.
`Q.
`I will be referring to the patent at
`issue here as the '514 patent.
` Is that okay?
`A. That is fine.
`Q.
`I will also refer to the Patent Office
`inter partes review proceeding as an IPR.
` Is that okay?
`A. Could you explain that, please?
`Q. The name of the proceeding that we are
`involved in is called an inter partes IPR.
`
`BY MS. SPIEGEL:
`Q. Can you confirm that it is your signature
`on page 30 of 31, and by "page numbers," I am
`referring to the numbers in the lower left-hand
`corner of the document.
`A.
`It is my signature.
`Q. Looking at your declaration, are you
`aware of any errors or mistakes in your declaration?
`A. No.
`Q. Did you review your declaration before
`signing it?
`A.
`I did.
`Q. Have you provided any declarations in any
`other patent matters, other than in Biogen's
`Interference No. 106023, as stated in your
`declaration of Footnote 2 on page 10 of 31?
` (Informal discussion held off the
` record.)
` THE WITNESS: Could you repeat the
` question?
` (Thereupon, the requested portion of
` the record was read back by the shorthand
` reporter.)
` THE WITNESS: No, I have not. Thank
` you.
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`3 (Pages 6 to 9)
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`A. Okay.
`Q.
`I will just be referring to it by the
`first three initials of those words.
`A.
`(Nodding) that is fine. Thank you.
`Q.
`I will probably just say MS instead of
`multiple sclerosis.
` Is that okay?
`A. That is fine.
`Q.
`Is there any reason you cannot give a
`full and truthful testimony today?
`A. No reason.
`Q. Are you taking any medications that would
`impair your ability to testify today?
`A. No.
` (Thereupon, a document was presented
` as Biogen Exhibit 2079 for identification.)
`BY MS. SPIEGEL:
`Q.
`I am handing Ms. Lansden --
`A. Yes.
`Q.
`-- a copy of a document premarked as
`Biogen Exhibit 2079.
` Is this the declaration that you submitted in
`the IPR proceeding?
` (Pause)
` THE WITNESS: It is.
`
`9
`
`BY MS. SPIEGEL:
`Q. Have you --
` Have you provided any expert reports in any
`other patent matters other than this Biogen IPR
`proceeding and the interference No. 106023?
`A.
`I don't --
` MR. FLIBBERT: Objection, lack of
` foundation.
` THE WITNESS: I don't know.
` (Informal discussion held off the
` record.)
`BY MS. SPIEGEL:
`Q. Have you ever been deposed before?
`A. Prior to this?
`Q. Yes.
`A. Yes. The 106063.
`Q. So you were deposed in the Biogen
`Interference No. 106023, correct?
`A. Yes.
`Q. Do you remember about when that was?
`A. April --
`Q. Okay.
`A.
`-- of this year.
`Q. How did you prepare for your deposition
`today?
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 3 of 50
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`MYLAN PHARMS. INC. EXHIBIT 1128 PAGE 3
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`

`

`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`10
`
` A. I reviewed my declaration.
` Q. Was that the extent of it? Did you
`review any documents?
` A. Only documents that were cited in my
`declaration.
` Q. Did you meet with counsel?
` A. I did.
` Q. And who was the counsel you met with?
` A. Lawyers from Finnegan and Biogen.
` Q. Do you recall their names?
` (Pause)
` THE WITNESS: Sorry. I'm trying to
` remember the -- the first Finnegan lawyer.
` Well, Carol Loeschorn and Michael
` Flibbert, here, as well as Wendy Plotkin
` from Biogen, and Erin, I'm not sure what
` her last name is, from Finnegan.
`BY MS. SPIEGEL:
` Q. Was anyone else present that helped you
`prepare for your deposition besides counsel that was
`here today?
` A. No.
` Q. Do you recall reviewing anything --
`anything other than the written documents you cited
`in your declaration in preparation for today's
`
`12
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` A. I have worked at other biotech companies,
`and for a short time, a -- a trading company.
` Q. Do you recall the name of the biotech
`companies?
` A. Biopure and Vertex, and those were the
`only ones prior to Biogen.
` Q. Can you give me a general idea of what
`your responsibilities were at the biotech companies?
` A. I managed clinical trials. At those
`studies, I did --
` At those companies, I did stability studies and
`I managed people.
` Q. Okay. When you started working at Biogen
`in 1999, generally speaking, what were your
`responsibilities?
` A. I managed clinical trials, initially.
`Then I managed clinical programs, and then I became
`a line manager.
` Q. Do you recall the area of clinical -- the
`clinical area you were involved in?
` Was it just clinical studies in general, or
`clinical studies related to a specific area such as
`neurology or immunology?
` A. I managed immunology and neurology
`studies.
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`4 (Pages 10 to 13)
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`deposition?
` A. Not that I recall.
` Q. How long did you meet with counsel to
`prepare for your deposition?
` A. Three to four hours on two separate days.
` Q. Each day, or total?
` A. Each day.
` Q. Okay.
` Do you have any questions, before we begin?
` A. No.
` Q. Can you describe your higher education
`for me?
` A. I went to Vassar College.
` Q. And did you receive a degree?
` A. I did.
` Q. What was the degree?
` A. Bachelor's in biology.
` Q. Do you have any postgraduate degrees?
` A. I do not.
` Q. You were employed by Biogen from 1999 to
`2013, correct?
` A. That is correct.
` Q. From the time you graduated from college
`until your employment at Biogen, how were you
`employed, generally speaking?
`
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` Q. Were any of the studies that you managed
`involving therapeutic drug products?
` A. Yes.
` Q. If I use the abbreviation "DMF" for
`dimethyl fumarate, would you understand that?
` A. Yes, I would.
` Q. Okay, so were any of these drug products
`DMF?
` A. Not at the study level. At the program
`level.
` Q. This is in the 1999 to 2002 time frame?
` A. Oh, the 1999 to 2002 time frame? No,
`they did not involve DMF.
` Q. Okay.
` When you became a senior clinical project
`manager in 2002, how did your responsibilities
`change?
` A. I was then responsible for clinical
`programs rather than the individual studies within a
`clinical program.
` Q. What do you mean by being "responsible"
`for clinical programs?
` A. I was the clinical operations
`representative and ensured consistency and guidance
`to the clinical operations staff who were involved
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 4 of 50
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`MYLAN PHARMS. INC. EXHIBIT 1128 PAGE 4
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`

`

`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`14
`
`in the studies themselves.
` Q. In 2003, you became a clinical program
`lead.
` Do you remember when in 2003 that occurred?
` A. Not precisely.
` Q. Did you become a clinical program leader
`in any particular clinical area?
` A. Yes, neurology.
`BY MS. SPIEGEL:
` Q. When did you start working on Biogen's
`drug development program BG-12?
` A. At the very end of 2003.
` Q. Could you be more specific than "the very
`end"?
` A. December.
` Q. Okay. What is BG-12?
` A. BG-12 is the internal designation of the
`drug that would eventually be known as Tecfidera.
` Q. Was the only active pharmaceutical
`ingredient in BG-12 DMF?
` A. To my knowledge, yes.
` Q. When we are talking about BG-12, we are
`just talking about the drug DMF, and not a specific
`specification -- specific dose or a specific
`indication, are we?
`
`16
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` (Pause)
`BY MS. SPIEGEL:
` Q. Could you please refer to paragraph 5 of
`your declaration on page 8 of 31?
` (Pause)
` THE WITNESS: Which paragraph?
` Sorry.
`BY MS. SPIEGEL:
` Q. Five.
` A. Oh, five?
` Q. And I'm talking about the lower left-hand
`corner numbers, page 8 of 31.
` A. Yes, thank you.
` Q. I'm asking you to confirm that when
`you're talking about Tecfidera, we're referring to a
`drug product containing DMF as the sole, active
`ingredient, and one or more pharmaceutically
`acceptable excipients that are used as an oral
`therapy to treat MS using 480 milligrams per day of
`DMF.
` A. Yes, thank you.
` (Thereupon, a document was presented
` as Biogen Exhibit 2318 for identification.)
`BY MS. SPIEGEL:
` Q. I am handing you a copy of a document
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`5 (Pages 14 to 17)
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` A. When I refer to BG-12, I am referring to
`D -- the drug, not a dosage.
` Q. Or a specific indication?
` A. Or a specific indication, correct.
` Q. Now, when we're talking about Tecfidera,
`we are talking about the drug product that was
`approved by the FDA as an oral therapy using 480
`milligram per day of DMF, and one or more
`pharmaceutically acceptable excipients to treat MS;
`is that correct?
` A. Is that a question?
` Q. I am asking you if that is the correct
`definition of Tecfidera as we are using it today?
` A. I cannot speak to how Tecfidera is
`defined in a general -- in a -- in a pharmaceutical
`company manner. If that is how you are defining it
`for today to clarify, then that's different.
` Q. Well, I would like to clarify whether
`BG-12 and Tecfidera are identical in terms of their
`composition?
` A. I'm not sure I understand the question.
`Tecfidera -- the way you defined Tecfidera --
` Q. Is Tecfidera --
` A. -- seemed different than the drug -- just
`the drug product itself.
`
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`premarked as Biogen Exhibit 2318.
` It's an email with redactions sent to you,
`among others, with a subject line that reads
`"Fumapharm Update," and is dated October 10th, 2003.
`Do you see that?
` A. I do.
` Q. Did Biogen obtain a drug product, which
`Biogen referred to as BG-12, from Fumapharm by at
`least October 10th, 2003?
` A. From this announcement, yes.
` Q. Was BG-12 to be developed for psoriasis
`and MS?
` A. According to this email, that is what it
`says.
` Q. So in 2003, there was already a drug
`product containing BG-12; is that correct?
` A. I don't think that's accurate.
` The product was BG-12. It wasn't containing
`BG-12.
` Q. Well, according to Exhibit 2318, it says,
`"We have brought a new product into our pipeline.
`The product, BG00012, will be developed in psoriasis
`and MS"; is that correct?
` A. Yes.
` Q. So did Biogen obtain that drug product
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 5 of 50
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`MYLAN PHARMS. INC. EXHIBIT 1128 PAGE 5
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`

`

`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`18
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`from Fumapharm?
` (Pause)
` THE WITNESS: I'm not sure that's an
` accurate --
`BY MS. SPIEGEL:
` Q. It's a question.
` A. Oh. I'm not sure that's the accurate way
`to say it. There was a -- to my understanding,
`there was a -- it was some sort of partnership as
`according to the program team.
` Q. Could you tell me more what you mean
`about "partnership"? What was involved?
` A. We -- that -- well, the program team was
`responsible for whatever relationship is as
`described in this email. I was not specifically
`involved in that partnership.
` Q. You worked on Biogen's BG-12 program from
`at least late 2003, maybe December of 2003 to
`July 2006; is that correct?
` A. That is correct.
` Q. Do you recall --
` MS. SPIEGEL: Let me restart.
`BY MS. SPIEGEL:
` Q. Can you explain to me what the BG-12
`program was?
`
`20
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`program, did you actually work on BG-12 every day?
` A. On the program itself?
` Q. On the program itself, yes.
` A. Yes. It took up a lot of time.
` Q. BG-12 in 2003 and beyond was being
`developed for both MS and psoriasis, correct?
` A. That is correct.
` Q. When you started working on the BG-12
`program in 2003, it was already part of the
`licensing relationship with Fumapharm, correct?
` A. I'm not familiar with the licensing part,
`but yes, there was already a relationship when I
`joined.
` (Pause)
`BY MS. SPIEGEL:
` Q. Do you have any understanding of whether
`Fumapharm was already developing BG-12 for MS before
`Biogen's involvement?
` A. I do not.
` Q. What was your involvement with the
`psoriasis indication for BG-12?
` A. I was initially the clinical program lead
`also for psoriasis until they brought in someone
`dedicated to take that over.
` Q. So in 2003, then, you were managing the
`
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`6 (Pages 18 to 21)
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` A. The clinical program?
` Q. The BG-12 program you were involved in
`between late 2003 and July 2006.
` A. I can't speak to the clinical program.
`The overall program team was led by a different
`person, and I was -- my role in that team was to
`provide information from the BG-12 clinical
`development team, which I managed.
` (Informal discussion held off the
` record.)
` THE WITNESS: It is much broader than
` my own functional area.
`BY MS. SPIEGEL:
` Q. I see.
` Without revealing any privileged information,
`proprietary, that sort of thing, can you give me a
`general idea of what type of information from the
`BG-12 clinical team you managed?
` A. I managed the development of the clinical
`development plan for BG-12 in MS and oversaw the
`management of the studies within that program.
` Q. So you managed the development of the
`clinical development plan, correct?
` A. Yes.
` Q. When you were working on the BG-12
`
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`clinical development of both psoriasis and MS
`indications, but then you said they brought someone
`else in to take over the psoriasis indication.
` Do you know how -- about when the psoriasis
`indication was transferred to someone else?
` A. I would say roughly about a year.
` Q. After you left your position as clinical
`development manager in 2007 -- in July of 2007, how
`did your responsibilities change?
` A. When I became a line manager? Is that
`the question?
` (Pause)
`BY MS. SPIEGEL:
` Q. In 2007, according to paragraph 2 of your
`declaration --
` A. Uh-huh.
` Q. -- you became senior manager of global
`clinical operations; is that correct?
` (Pause)
` THE WITNESS: Uh, yes.
`BY MS. SPIEGEL:
` Q. So the question was:
` How did your responsibilities change when you
`changed positions?
` A. I specifically became a line manager.
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Page 6 of 50
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`

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`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`22
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` Q. Okay.
` A. I was no longer responsible for specific
`programs.
` Q. Would you clarify for me what a line
`manager does, just generally?
` A. A line manager is responsible for
`resourcing and developing the people that report to
`him or her, and ensuring appropriate training and
`compliance with SOP, standard operating procedures.
` Q. Is there any significance to the word
`"global" in your -- in the position you assumed in
`2007 as senior manager of global clinical
`operations?
` A. The department was called global clinical
`operations, and I did manage people in offices in
`other countries.
` Q. Did you have any further involvement with
`the BG-12 program after July of 2006?
` A. Direct involvement? No.
` Q. Why did you leave Biogen in 2013?
` A. I was laid off.
` Q. So was there a general layoff at the
`company?
` A. Yes. About -- over 50 people in the
`department.
`
`24
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` Q. Was there any overlap in terms of drug
`related studies that would be used in both MS and
`psoriasis, irrespective?
` A. I do not know where that overlap would
`be. Probably regulatory could say which studies
`would fall under both that were not indication
`specific.
` Q. Right, so --
` So when you speak to "regulatory," would it be
`fair to say we might be talking about safety or
`toxicology studies?
` A. I can't speak to safety or toxicology or
`regulatory.
` Q. Okay.
` (Pause)
`BY MS. SPIEGEL:
` Q. So, then, if I asked you if some aspects
`of the program for both MS and psoriasis, for
`example, animal studies, could be used in either
`study, you wouldn't feel comfortable answering that
`question, would you?
` A. It is not my area.
` Q. Okay.
` Looking at paragraph 4 in the second sentence
`of your declaration, on page 7 of 31, you say, "By
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`7 (Pages 22 to 25)
`23
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` Q. And what is your current employer?
` A. My current employer is Takeda
`Pharmaceutical.
` Q. Can you tell me what your position and
`responsibilities are there?
` A. I am a line manager with the same line
`management responsibilities as I had at Biogen,
`except that I do not manage people in other
`countries.
` Q. Do you currently own stock in Biogen?
` A. I do not.
` Q. You are being paid as an hourly
`consultant in this case.
` Other than that hourly fee, do you have any
`other interest in the outcome of this IPR or the
`Biogen interference?
` A. No, I do not.
` Q. Going back to 2003, when you were the
`clinical development manager for both MS and
`psoriasis, was there an overlap between the MS and
`psoriasis BG-12 drug development programs?
` A. What do you mean by "overlap"?
` Q. BG-12 was the common drug being developed
`for both MS and psoriasis, correct?
` A. Yes.
`
`25
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`at least February 2004, Dr. O'Neill conceived of
`treating multiple sclerosis (MS) with 480 milligrams
`per day of dimethyl fumarate (DMF) by orally
`administering to a human patient a pharmaceutical
`composition containing DMF and one or more
`pharmaceutically acceptable excipients."
` Do you see that?
` A. I do.
` Q. What is the basis for this statement?
` A. Dr. O'Neill brought his idea of dosing
`with 480 milligrams of DMF to the clinical
`development team to incorporate into the clinical
`development of the drug, which is the appropriate
`place to bring it.
` Q. How do you know that Dr. O'Neill was the
`one who conceived of treating MS with that specific
`dose in the way that's stated in that sentence of
`your declaration?
` A. He brought it to the meeting, and from
`the discussions, it was the first that it had been
`incorporated into any documents that I am aware of.
` Q. Could you just clarify for me what is the
`"meeting" you are talking about?
` A. The clinical development meeting.
` That is the meeting that I ran as clinical
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`202-220-4158
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`www.hendersonlegalservices.com
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`Page 7 of 50
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`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`26
`program lead, and where we discussed the creation
`and population of the clinical development plan.
` Q. Do you recall the date of the first
`meeting that he presented this?
` A. I do not recall the date.
` Q. Okay.
` A. Which is why it says at least by
`February 2004.
` Q. When you say that he conceived of
`treating MS with 480 milligrams per day of DMF, as
`stated in that sentence, are you saying that it's
`your understanding that entire sentence was his idea
`as opposed to only a part of that sentence?
` MR. FLIBBERT: Objection to form.
`BY MS. SPIEGEL:
` Q. When you say that he conceived of
`treating MS with 480 milligrams per day of DMF, as
`stated in that sentence, do you have an
`understanding of which portions of that sentence
`were his idea as opposed to what previously existed?
` A. My understanding is that it was his idea.
` Q. The entire sentence?
` A. Yes.
` Q. When you used the word "conceived" in
`that sentence, what do you mean by "conceived"?
`
`28
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`for the entire program from any early research,
`manufacturing, legal, anything involved in the
`development of the drug, and even after that.
` That is what I meant by the research and
`development in the BG-12 program's responsibilities
`to it.
` MS. SPIEGEL: Can we just take a
` 30-second break, please?
` (Informal discussion held off the
` record.)
` MS. SPIEGEL: Okay.
` Having solved the computer gremlin
` issue, if you could read my last question
` back, please?
` THE REPORTER: Sure.
` (Thereupon, the requested portion of
` the record was read back by the shorthand
` reporter.)
` (Informal discussion held off the
` record.)
`BY MS. SPIEGEL:
` Q. All right, so by "research and
`development," you are not referring to solely
`clinical research and development, are you?
` A. When I say, "clinical research and
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`8 (Pages 26 to 29)
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` A. I mean came up with, thought of.
` Q. Okay. In paragraph 6 of your
`declaration, you state you are familiar with
`Dr. O'Neill's contribution to the subject matter
`claimed in the '514 patent.
` Do you feel competent to give an opinion on the
`subject matter claimed in the '514 patent?
` A. There is a lot of subject matter in the
`'514 patent, and most of it, I am not qualified to
`speak to at all.
` Q. Do you feel qualified to speak to any of
`the subject matter in the '514 patent?
` A. Not as an expert in any way, but any
`part -- the part that says that Dr. O'Neill --
` The part that Dr. O'Neill had contributed to
`the 480 mg dose of DMF, that is what I know to be
`his contribution.
` I don't know any of his other contributions to
`that patent.
` Q. In the last sentence of paragraph 6 in
`your declaration says, "The BG-12 program relates to
`the research and development of Tecfidera."
` What do you mean by "research and development"?
` A. The program team, which is the higher
`umbrella above the team that I ran, is responsible
`
`29
`
`development," I mean the human studies.
` Q. Okay, but the research and development of
`Tecfidera as related to the BG-12 program was
`broader in scope than just the clinical development
`areas;
` Is that correct?
` A. That's correct.
` Q. When you say that "Tecfidera itself was
`previously referred to as BG-12, both internally and
`externally," what do you mean?
` A. That the drug product was referred to as
`BG-12 both in internal documents and documents that
`were sent to, for example, investigators or
`agencies.
` Q. So just to be clear, when you say, "BG-12
`was the identifier used in internal documents," that
`refers to the DMF only drug product without regard
`to indication or dose or anything; is that correct?
` A. That is correct.
` Q. In paragraph 8, you state that you
`witnessed Dr. O'Neill's conceiving the idea of using
`480 milligrams per day DMF for treating MS by orally
`administering to a human patient a pharmaceutical
`composition containing DMF and one or more
`pharmaceutically acceptable excipients by at least
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 8 of 50
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`MYLAN PHARMS. INC. EXHIBIT 1128 PAGE 8
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`

`

`August 24, 2016 Deposition of Cara Christann Lansden
`Patent 8,399,514 B2
`
`30
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`February 2004.
` Do you see that statement?
` A. I do.
` Q. What did you personally witness?
` A. I witnessed Dr. O'Neill coming to the
`clinical development team meeting, talking about the
`480 mg per day DMF dose and voicing his desire to
`include it in the presentation for Phase II.
` Q. So you were actually physically present
`at that meeting?
` A. Yes. I ran that meeting.
` I ran all of the clinical development team
`meetings --
` Q. Okay.
` A. -- from the time I was assigned to the
`program.
` Q. Turning to paragraph 24 of your
`declaration, it talks about a clinical trial review
`board meeting in February 2004.
` Who was on the clinical trial review board?
` A. The review board consists of functional
`heads of the different R&D groups.
` Q. I am specifically talking about the
`clinical trial review board people who were present
`at the February 2004 meeting.
`
`32
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`in preparation for the February 19th meeting,
`correct?
` A. Yes.
` Q. With respect to the slides, and we'll
`just take the first slide after the title slide on
`page 14 of 50. Did you have --
` You said that you were involved in putting
`those slides together; is that correct?
` A. I was.
` Q. Were you substantively involved, or just
`procedurally involved?
` A. Are you asking if my contributions were
`to content or --
` Q. Yes. To content, it would be
`substantive. To formatting, it would be
`procedurally.
` A. Oh, thank you.
` For content, I only contributed the operational
`information. For administrative and formatting, I
`did a lot of it.
` Q. So, for example --
` Can you give me an example of the operational
`information you're referring to?
` (Pause)
` THE WITNESS: The operational pieces
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` Do you recall who was present?
` A. Specifically, no. That would be in the
`meeting notes.
` Q. Okay.
` (Thereupon, a document was presented
` as Biogen Exhibit 2309 for identification.)
` THE WITNESS: Thank you.
`BY MS. SPIEGEL:
` Q. I am handing you a document premarked as
`Biogen Exhibit 2309, which is an email chain
`attaching slides for an ad hoc CTRB meeting
`regarding BG-12/MS on February 19th, 2004.
` (Pause)
`BY MS. SPIEGEL:
` Q. Did you participate in that meeting?
` A. I attended that meeting. I was not one
`of the presenters.
` Q. Did you have any input into that meeting?
` A. I had input into the slides. That was
`my -- the extent of my contributions.
` Q. But you personally attended the meeting?
` A. I did.
` (Pause)
`BY MS. SPIEGEL:
` Q. So the slides were forwarded to the CTRB
`
`33
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` are generally timeline and budget, which I
` do not see here.
`BY MS. SPIEGEL:
` Q. So your substantive operational
`information is probably in the redacted materials?
`Th