Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ___________________________
`
`Page 1
`
` MYLAN PHARMACEUTICALS INC.
` Petitioner, v.
` BIOGEN MA, INC.
` Patent Owner.
` ___________________________
` Patent No. 8,399,514
` ___________________________
` Inter Partes Review IPR2018-01403
` ___________________________
`
` DEPOSITION OF MATVEY LUKASHEV, M.D.
` Tuesday, August 27, 2019 11:08 a.m.
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
` Two Seaport Lane, Boston, MA 02210
`
` Reporter: Janet M. Sambataro, RMR, CRR, CLR
`
`1
`
`2
`
`3
`
`4 5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 1
`
`
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ___________________________
`
`Page 1
`
` MYLAN PHARMACEUTICALS INC.
` Petitioner, v.
` BIOGEN MA, INC.
` Patent Owner.
` ___________________________
` Patent No. 8,399,514
` ___________________________
` Inter Partes Review IPR2018-01403
` ___________________________
`
` DEPOSITION OF MATVEY LUKASHEV, M.D.
` Tuesday, August 27, 2019 11:08 a.m.
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
` Two Seaport Lane, Boston, MA 02210
`
` Reporter: Janet M. Sambataro, RMR, CRR, CLR
`
`1
`
`2
`
`3
`
`4 5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 1
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 2
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`APPEARANCES:
` PERKINS COIE LLP
` (By Maria A. Stubbings, Esquire)
` 700 13th Street, NW
` Washington, DC 20005-3960
` 202.654.1742
` mstubbings@perkinscoie.com
` Counsel for the Petitioner
`
` FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
` (By Barbara C. McCurdy, Esquire, and
` Pier D. DeRoo, Esquire)
` 901 New York Avenue, NW
` Washington, DC 20001
` 202.408.4047
` barbara.mccurdy@finnegan.com
` pier.deroo@finnegan.com
` Counsel for the Patent Owner
`
` ALSO PRESENT:
` Wendy Plotkin, In-house counsel, Biogen
` Robert Lawson, Videographer
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 2
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
` I N D E X
` WITNESS DIRECT CROSS REDIRECT
` MATVEY LUKASHEV, M.D.
` By Ms. Stubbings 5
`
`Page 3
`
` PREVIOUSLY MARKED EXHIBITS
` Number Page
` Exhibit 2100 8
` Exhibit 1001 22
` (Exhibits retained by Attorney Stubbings)
`
`1
`
`2
`
`3
`
`4
`
`5 6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 3
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 4
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` P R O C E E D I N G S
` THE VIDEOGRAPHER: Good morning. This
` is the deposition of Matvey Lukashev, and this is
` in the matter of Mylan Pharmaceuticals, Inc.
` versus Biogen Massachusetts, Inc. This is Case
` No. -- well, it's Patent No. 8,399,514, and I
` also have IPR2018-01403. And this is for the
` U.S. Patent and Trademark Office and it's before
` the Patent Trial and Appeal Board.
` This deposition is taking place at
` Finnegan Henderson in Boston, Massachusetts. The
` time is 11:08 a.m. and the date is August 27,
` 2019.
` Our court reporter this morning is
` Janet Sambataro and she is with Ace-Federal
` Reporters. I am Robert Lawson, the video
` operator, also representing Ace-Federal Reporters
` out of Washington, D.C.
` Will counsel present now please
` identify themselves and state whom they represent
` for the record, please.
` MS. STUBBINGS: This is Maria Stubbings
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 4
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 5
` from Perkins Coie, representing petitioner, Mylan
` Pharmaceuticals, Inc.
` MS. MCCURDY: Barbara McCurdy from
` Finnegan Henderson, representing Biogen MA, Inc.
` I'm here with Pier DeRoo, also of Finnegan
` Henderson, and with Wendy Plotkin from Biogen.
` THE VIDEOGRAPHER: Thank you.
` Will the court reporter now please
` swear in the witness.
` MATVEY LUKASHEV, M.D.,
` having been duly sworn, after presenting
` identification in the form of a driver's license,
` deposes and says as follows:
` DIRECT EXAMINATION
` BY MS. STUBBINGS:
` Q. Good morning, Dr. Lukashev.
` A. Good morning.
` Q. Could you please state and spell your
` name for the record?
` A. Matvey Lukashev, M-A-T-V-E-Y,
` L-U-K-A-S-H-E-V.
` Q. Have you ever been deposed before?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 5
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 6
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` A. Yes.
` Q. How many times?
` A. Once.
` Q. And was it in -- what proceeding was
` that in?
` A. I don't remember the exact name of it,
` but the subject matter was the same.
` Q. Okay. So I'm just going to go over a
` few deposition rules since you've only been
` deposed once. Let me know if you have any
` questions about anything.
` But I'm going to do my best today to ask
` clear questions, so let me know if you don't
` understand anything I'm asking, if you don't
` understand my question, or if you don't hear it,
` and I'll repeat, speak louder, clarify, whatever
` you request.
` If you don't ask me to clarify a question,
` I'll assume that you understand what I'm asking.
` Is that okay?
` A. It is.
` Q. Okay. And please make sure to answer
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 6
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 7
`
` my questions verbally today, instead of either
` nodding or --
` A. Yes.
` Q. -- yeah, just so the court reporter can
` take down our answers.
` And also let's try not to talk over each
` other. So I'll try to make sure to let you
` finish your answers when you're giving them and
` then if you can make sure to let me finish my
` question and then give your counsel time to
` object and then start your answer, that will make
` the court reporter's job a little easier here
` today.
` And your counsel may object from time to
` time today. Please make sure to answer unless
` she directs you specifically not to answer.
` We can take breaks whenever you need them.
` I'll try to take breaks every hour or so, but let
` me know if you need a break at any specific time.
` I'll just ask you to -- if there's a pending
` question, I'll ask you to finish the answer to
` the question and then we can go ahead and take a
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 7
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 8
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` break.
` Does that sound okay?
` A. It does.
` Q. Okay. Is there any reason you can't
` testify accurately or truthfully today?
` A. Not that I can think of.
` Q. Okay. Do you understand the nature of
` this proceeding?
` A. I believe I do, within limits
` sufficient for my purposes.
` Q. Okay. Can you just describe generally
` what you understand the nature of this proceeding
` to be?
` A. The declaration I signed with Biogen
` would be -- that's my understanding is the scope
` of the discussion.
` (Previously marked Exhibit 2100
` incorporated by reference.)
` BY MS. STUBBINGS:
` Q. Okay. And is that your declaration in
` front of you today?
` A. Yes, it is.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 8
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 9
`
` Q. And just for the record, is that
` declaration Exhibit 2100?
` A. That's what it says on the --
` Q. Okay.
` A. -- front page.
` Q. Sorry.
` And then if you could flip to the third page
` of the document.
` Can you just confirm for me that that's your
` signature?
` A. It does look like my signature.
` Q. Okay. Thanks.
` Do you understand that this proceeding
` relates to U.S. Patent No. 8,399,514?
` A. I guess, yes. That's what it says on
` the page.
` Q. Okay. So if I refer to that today as
` the '514 patent, do you understand that to mean
` U.S. Patent No. 8,399,514?
` A. I should be able to.
` Q. Okay. Did you meet and speak with
` counsel in preparation for your deposition today?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 9
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 10
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` A. Yes, I did.
` Q. Was it the people in this room?
` A. Yes.
` Q. And about how long did you meet with
` them to prepare for your deposition?
` A. I don't remember the exact duration.
` Longer than an hour, but that's the best I can
` say.
` Q. Sure.
` Aside from attorneys, did you speak with
` anyone else in preparation for your deposition
` today?
` A. No.
` Q. What about in preparation for your
` declaration that's in front of you? Aside from
` attorneys, did you speak with anyone to prepare
` the declaration that's in front of you?
` A. No.
` Q. Okay. So you did not speak with
` Dr. O'Neill in preparation for your declaration
` today?
` MS. MCCURDY: Objection. Asked and
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 10
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 11
`
` answered.
` THE WITNESS: Pardon?
` MS. MCCURDY: Objection. Asked and
` answered.
` A. Again, no, I did not speak with anyone.
` BY MS. STUBBINGS:
` Q. Okay. Who is Dr. O'Neill?
` A. I don't know his -- I don't know where
` he is right now. He's no longer with Biogen.
` He's a clinician.
` Q. Okay. And did you work with
` Dr. O'Neill when you were at Biogen?
` A. Yes, I did.
` Q. How closely did you work with
` Dr. O'Neill while you were at Biogen?
` MS. MCCURDY: Objection. Vague.
` A. I'm not sure how to answer this. We
` were colleagues.
` Q. For example, did you talk to
` Dr. O'Neill every day?
` A. Probably not every day, but, yes, he
` and I did talk.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 11
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 12
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` Q. When was the last time you talked to
` Dr. O'Neill?
` A. I cannot remember. It was a long time
` ago.
` Q. Was it when you were still at Biogen?
` A. Yes, it was.
` Q. Okay. Let's go over your background a
` little bit.
` Can you describe your education for me post
` undergraduate?
` A. A Ph.D. from the Russian Academy of
` Medical Sciences, then postdoctoral studies at
` Johns Hopkins and UCSF, followed by the joining
` of Biogen.
` Q. When did you join Biogen?
` A. In the fall of 1998.
` Q. Okay. And what was your position when
` you first joined Biogen?
` A. Scientist II.
` Q. Did you --
` A. Scientist II.
` Q. Scientist II. Okay.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 12
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 13
` And what does the position of Scientist II
` entail?
` A. Doing what scientists do. Research.
` Q. Okay. And what type of research were
` you doing when you first started working at
` Biogen?
` A. Drug discovery, basically. I mean,
` some of it is reflected in my public profile.
` Angiogenesis, other things.
` Q. Okay.
` COURT REPORTER: I didn't hear that.
` What other genesis?
` THE WITNESS: Oh. Angiogenesis.
` Sorry. I'll try to refrain from intelligent
` words like that. Angio, A-N-G-I-O, genesis, one
` word.
` Q. And how long were you at Biogen?
` A. Until the end of summer of 2012.
` Q. And when did you start working on
` BG-12?
` A. To the best of my recollection, the end
` of 2005.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 13
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 14
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` Q. Okay. And BG-12 is dimethyl fumarate;
` is that correct?
` A. Yes, it is. That was the code name for
` it.
` Q. Okay. And that's what ended up
` becoming the drug Tecfidera; is that correct?
` (Reporter clarification.)
` MS. MCCURDY: Objection. Vague.
` A. To the best of my understanding of the
` question, yes, that's -- BG-12 became Tecfidera.
` That's the commercial name.
` Q. Okay. So when you started working on
` BG-12 at around the end of 2005, was the Phase II
` trial involving BG-12 already started?
` A. I actually do not remember.
` Q. Okay. Were -- sorry. Were you going
` to -- okay.
` A. Please continue.
` Q. Were you going -- or strike that.
` Were you involved in Biogen's Phase II trial
` involving or studying BG-12?
` A. No.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 14
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 15
`
` Q. Were you on any correspondence
` regarding Biogen's Phase II trial involving
` BG-12?
` A. I don't recall being on one. I simply
` don't remember, but definitely not directly
` involved in any way.
` Q. Okay. What about any other Biogen
` trials involving BG-12? Were you involved in any
` of those?
` A. I'm not a clinician, so in my line of
` work, one doesn't get directly involved in the
` running of clinical trials.
` Q. Were you indirectly involved in any of
` Biogen's clinical trials involving BG-12?
` A. I don't know how to answer the question
` because of the "indirectly."
` Q. Sure.
` So in -- when you say you weren't directly
` involved in any of Biogen's clinical studies
` involving BG-12, are you excluding any sort of
` involvement that may be further removed from, for
` example, a group running the clinical study?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 15
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 16
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` MS. MCCURDY: Objection to the form of
` the question. Vague.
` A. I was responsible for the research
` support for the Phase III -- for -- actually,
` for -- generally for clinical development of
` BG-12, but on the research side.
` Q. Okay. And what does research support
` entail in that context?
` A. Elucidation of the mechanism --
` molecular and cellular mechanism of action of the
` active ingredient and candidate biomarker
` discovery.
` Q. So you mentioned you were responsible
` for the research support for the Phase III trial
` of BG-12.
` Were you also involved in the research
` support of the -- Biogen's Phase II study
` involving BG-12?
` A. I cannot tell, simply because I don't
` remember the timing of the Phase II.
` Q. Okay. Do you recall what doses were
` studied in Biogen's Phase II and Phase III trials
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 16
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 17
`
` involving BG-12?
` A. I didn't follow that. It was outside
` of my line of responsibility.
` Q. Okay. Did your work elucidating the
` mechanisms of action of BG-12 have any impact on
` what doses were selected in Biogen's Phase II or
` Phase III studies?
` MS. MCCURDY: Objection. Vague.
` A. Not to the best of my understanding.
` Q. So can you describe to me, just in
` general terms, how -- strike that.
` So you said earlier that you and Dr. O'Neill
` worked together at Biogen. Were you and
` Dr. O'Neill in the same group within Biogen?
` A. We were in different departments.
` Q. Okay. And what department were you in?
` A. At the time, immunology.
` Q. And approximately what time period were
` you in the immunology department at Biogen?
` A. I -- without actually -- because of the
` internal dynamics, I was through three
` departments and I do not remember the exact
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 17
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 18
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` timing of it. I think I was already in
` immunology formally at the time. Yeah, at the
` end of 2005, yeah, it should be immunology, and
` then I stayed within the department until the
` end.
` Q. Okay. And you said you were through
` three departments at Biogen.
` Can you remember the other two departments
` that you were in at Biogen?
` A. Yes, I can. The first one is viruses
` growth control and I can't remember what else,
` three things; the second was molecular and cell
` biology; and the third one was immunology.
` Q. Okay. Thanks.
` And what department or departments do you
` recall Dr. O'Neill being in when you were at
` Biogen?
` A. Gilmore is a clinician, so he was
` always in the -- on the clinical side and I was
` on the research side, so I do not know the exact
` dynamics of Gilmore's affiliation within the
` clinical.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 18
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 19
` Q. So how frequently did you work with the
` clinical department at Biogen when you were
` there?
` A. I cannot put a number on it. As
` needed.
` Q. Were there ever emails within Biogen
` that included individuals from both the clinical
` department and the immunology department?
` MS. MCCURDY: Objection. Relevance.
` A. There probably were, but, you know,
` I -- again, it's been 15 years. So --
` Q. Sure.
` A. -- most likely, but I don't know for a
` fact.
` Q. Do you ever recall attending meetings
` that included individuals in the clinical
` department at Biogen?
` A. Yes.
` Q. How frequently did you attend those
` meetings?
` A. There were different kinds. There was
` one regular one, which was the program team
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 19
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 20
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` meeting, I believe. They were weekly, but -- I
` believe so. I'm not 100 percent certain anymore.
` So -- plus various ad hoc offline
` interactions.
` Q. Sure.
` And what was the program team meeting?
` MS. MCCURDY: Objection. Vague.
` A. It's a meeting where all key members of
` the -- all representatives of different functions
` involved in the development of the drug candidate
` get together to provide updates and discuss
` important issues.
` Q. Do you ever remember being at a program
` team meeting for BG-12 in which the Phase II
` clinical study was discussed?
` A. I do not remember.
` Q. What about the Phase III clinical study
` of BG-12?
` A. Yes.
` Q. Do you know Dr. Kappos?
` MS. MCCURDY: Objection. Relevance.
` Beyond the scope of his direct testimony.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 20
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 21
`
` A. I know the name. I don't know the
` person.
` Q. So you've never met Dr. Kappos?
` A. No.
` Q. What about Dr. Havrdova? Do you know
` her?
` A. No.
` Q. Do you know Rebecca Conaghan?
` A. No.
` Q. I know this was a long time ago, but do
` you recall when you first heard of Biogen's
` Phase II clinical trial involving BG-12?
` A. Unfortunately, I cannot remember.
` Q. Were you involved in selecting the
` doses administered in Biogen's Phase II clinical
` trial?
` A. No, I was not.
` Q. Were you involved in selecting the
` doses administered in Biogen's Phase III clinical
` trials?
` A. I was not.
` Q. And did you have any input in selecting
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 21
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 22
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` the dose ultimately claimed in the '514 patent?
` A. No.
` Q. Do you know who was responsible for
` selecting the doses administered in Biogen's
` Phase II clinical trial involving BG-12?
` A. That was done within the clinical, so I
` cannot -- I had no way of knowing exactly.
` Q. Okay. If you could turn to Page 2 in
` your declaration. That's Exhibit 2100 again.
` And, specifically, I'm looking at Paragraph 7 of
` your declaration.
` A. Mm-hmm.
` Q. And you state in Paragraph 7,
` "Dr. O'Neill is solely responsible for
` discovering the subject matter of Claims 1
` through 16 and 20 of the '514 patent"; right?
` A. That's my understanding.
` Q. And I can go ahead and give you the
` '514 patent just -- if you want to refer to it.
` (Previously marked Exhibit 1001
` incorporated by reference.)
` MS. STUBBINGS: And for the record, I
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 22
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 23
`
` just handed the '514 patent, which is
` Exhibit 1001.
` BY MS. STUBBINGS:
` Q. So if you flip to Exhibit 1001, the
` '514 patent, looking all the way at the back, at
` Page 28.
` So of these claims on Pages 28 and 29, which
` claims were you involved in inventing?
` A. I contributed to the Claims 17 through
` 19.
` Q. Okay. And what aspects of Claims 17
` through 19 did you contribute to?
` A. Elucidation of the MOA that led to
` identification of NQO1 as a candidate
` pharmacodynamic marker of BG-12 activity.
` Q. And what aspects of Claims 17 through
` 19 did Dr. O'Neill contribute to?
` A. I actually do not know exactly how it's
` defined in the legal sense, but, obviously, the
` clinical application, clinical validation of
` those had to be in Gilmore's purview.
` Q. Okay. So for Claims 1 through 16 and
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 23
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 24
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` 20 of the '514 patent, do you know if anyone else
` contributed to those claims?
` MS. MCCURDY: Objection.
` Mischaracterizes his testimony.
` A. I don't.
` Q. Okay. So let's go back to Paragraph 7
` of your declaration, Exhibit 2100. And, again,
` I'm going back to the sentence in Paragraph 7
` where you state, "Dr. O'Neill is solely
` responsible for discovering the subject matter of
` Claims 1 through 16 and 20."
` What is your basis for understanding that
` Dr. O'Neill is solely responsible for discovering
` the subject matter of those claims?
` A. That's my understanding of who -- you
` know, how things were defined within Biogen.
` Q. And how did that become your
` understanding?
` MS. MCCURDY: Objection.
` I'll instruct the witness not to answer
` to the extent it discloses conversations you may
` have had with attorneys for Biogen.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 24
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 25
`
` A. Yes, I'm afraid I cannot answer this
` without violating my confidentiality agreement
` with Biogen.
` Q. Sure.
` So is it fair to say that nothing other than
` conversations with your attorneys contributed to
` your basis for understanding that Dr. O'Neill is
` solely responsible for discovering the subject
` matter of Claims 1 through 16 and 20 of the '514
` patent?
` MS. MCCURDY: Objection.
` Mischaracterizes the testimony. Objection to the
` form of the question. Calls for a legal
` conclusion.
` A. If you could perhaps rephrase the
` question, maybe I'd be able to answer it then.
` Q. Sure.
` So I don't want you to disclose, obviously,
` any conversations you had with attorneys, but I'm
` trying to understand what -- the basis of your
` understanding for your statement here that
` Dr. O'Neill is solely responsible for discovering
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 25
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 26
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` the subject matter of these claims.
` So is there anything other than
` conversations with your attorneys that has
` contributed to that understanding that
` Dr. O'Neill was solely responsible for
` discovering the subject matter of Claims 1
` through 16 and 20?
` MS. MCCURDY: Objection to the form of
` the question.
` A. My understanding of what Gilmore was
` doing for the program related to -- based on the
` work with him, which I cannot disclose.
` Q. When you were working at Biogen, did
` you provide any input on how the mechanism of
` action of BG-12 would support selection of any
` particular dose of BG-12?
` MS. MCCURDY: Object to the form of the
` question. Vague.
` A. The answer to the question as phrased
` is no.
` Q. Okay. And why is that?
` A. Why is -- why is it a no?
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 26
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 27
` Q. Sure. Why -- why did you never provide
` any input on how the mechanism of action of BG-12
` would support selection of any particular dose of
` BG-12?
` MS. MCCURDY: Object to the form of the
` question.
` A. The scope and nature of the work I had
` to do for the program were not related to dose
` selection.
` Q. Okay. Does the mechanism of action of
` BG-12 impact which doses of BG-12 may or may not
` be therapeutically effective in humans?
` MS. MCCURDY: Objection. Beyond the
` scope of his declaration. Calls for expert
` testimony.
` A. I have difficulty answering this
` question because it would require -- the full
` answer would require clinical expertise that I do
` not possess.
` Q. If you can go back to the Exhibit 1001,
` the '514 patent, specifically to the last page,
` Page 29.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 27
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 28
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` In your understanding, does the expression
` level of NQO1 in a subject depend on the
` particular dose of BG-12 administered to that
` subject?
` MS. MCCURDY: Objection. Beyond the
` scope of his testimony. Calls for expert
` testimony.
` A. It's published now that it does seem to
` respond to the exposure. Exactly how dose
` dependent it is wasn't -- well, I think that that
` requires more work than -- and it generally is a
` pharmacodynamic marker, so it does respond to the
` exposure. That's all I can say.
` Q. When you were at Biogen, did you ever
` do any research to answer the question of whether
` the expression of NQO1 in a subject was dependent
` on the dose administered to the subject?
` MS. MCCURDY: Objection. Beyond the
` scope of his testimony.
` A. In a human subject?
` Q. We don't have to limit it to human
` subjects, so either in vitro, in vivo.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 28
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 29
` MS. MCCURDY: Objection to the form of
` the question.
` A. To the concentration, yes.
` Q. Can you elaborate on that a little bit?
` MS. MCCURDY: Objection to the form of
` the question.
` A. Could you ask a more specific question?
` Q. I'm just trying to figure out what you
` mean by "to the concentration."
` So when I previously asked did you ever do
` any research to answer the question of whether
` NQO1 expression was dose dependent --
` A. Mm-hmm.
` Q. -- did you do any research to elucidate
` that potential dose dependency?
` MS. MCCURDY: Object to the form of the
` question.
` A. Are you asking about the clinical dose?
` Q. Let's start with the non -- not -- I'm
` not asking about the clinical dose.
` A. Concentration dependence, yes, of
` course we did -- we did investigate that in
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1132 PAGE 29
`
`
`
`Matvey Lukashev
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`August 27, 2019
`
`Page 30
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` vitro.
` Q. And what did you find?
` MS. MCCURDY: Objection. Relevance.
` Beyond the scope of his testimony.
` A. We did find that -- you know, it's
` published. We did find that it was -- that the
` activation of Nrf2 was concentration dependent.
` Q. And, in your opinion, did that finding
` affect the clinical doses ultimately selected by
` the clinical department of Biogen to study in
` Biogen's Phase II or Phase III trials?
` MS. MCCURDY: Objection. Beyond the
` scope. Calls for expert testimony.
` A. I cannot tell you how exactly the
` clinical colleagues arrived at the dose
` selection. To the best of my understanding, it
` did not contribute to those decisions.
` Q.
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
