`
`Page 1
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`- - - - - - - - - - - - - - - -X
`MYLAN PHARMACEUTICALS INC., :
` Petitioner, : Case Number
` v. : IPR2018-01403
`BIOGEN MA INC., :
` Patent Owner. :
`- - - - - - - - - - - - - - - -X
`
` VIDEO DEPOSITION OF EVA K. HAVRDOVA
`
` Washington, DC
` Tuesday, August 20, 2019
`
`REPORTED BY:
` CARMEN SMITH
`
`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 1130 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 1
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 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
`
` Video deposition of EVA K. HAVRDOVA, called for
`examination pursuant to notice of deposition, on
`Tuesday, August 20, 2019, in Washington, DC, at the
`offices of Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP, 901 New York Avenue, NW, at 8:10 a.m.,
`before CARMEN SMITH, a Notary Public within and for
`the District of Columbia, when were present on
`behalf of the respective parties:
`
` BARBARA C. MC CURDY, ESQ.
` CORA R. HOLT, ESQ.
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202.408.4000
` barbara.mccurdy@finnegan.com
` On behalf of Biogen
`
` -- continued --
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 2
`
`
`
`August 20, 2019
`
`Page 3
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`APPEARANCES (Continued):
`
` BRANDON WHITE, ESQ.
` Perkins Coie LLP
` 700 13th Street, Suite 600
` Washington, DC 20005-3960
` 202.654.6200
` bwhite@perkinscoie.com
` On behalf of Mylan
`
`Also Present: NATHANIEL MOLLICK, Video Operator
` WENDY PLOTKIN, ESQ., Biogen
` KATARINA COCKRELL, Interpreter
` JANA GIBELOVA, Check Interpreter
`
`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 1130 PAGE 3
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 3
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 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
` VIDEO OPERATOR: We are now on record.
`Please note that microphones are sensitive and may
`pick up whispers and private conversations. Please
`turn off all cellphones and place them away from the
`microphones as they may interfere with the
`deposition audio. Recording will continue until all
`parties agree to go off record.
` This deposition is of Eva Havrdova, in the
`matter of Mylan Pharmaceuticals, Incorporated,
`versus Biogen, MA, Inc., Patent Number 8,399,514,
`for the United States Patent and Trademark Office.
`Today's location is 901 New York Avenue Northwest,
`Washington, D.C., 20001. The time is approximately
`8:10 a.m. The date is August 20, 2019. The court
`reporter is Carmen Smith with Ace-Federal Reporters.
`My name is Nathaniel Mollick. I am the video
`operator.
` Will counsel please identify yourselves
`after which our court reporter will swear in the
`witness.
` MR. WHITE: Brandon White from Perkins
`
`08:10:16
`
`08:10:31
`
`08:10:56
`
`08:11:12
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 4
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 4
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Coie on behalf of Petitioner Mylan.
` MS. MC CURDY: Barbara McCurdy from
`Finnegan, Henderson on behalf of Biogen, I am here
`with my colleague Cora Holt, and also Wendy Plotkin
`from Biogen is present.
`Whereupon,
` KATARINA COCKRELL and JANA GIBELOVA
`were called as interpreters and, having first been
`duly sworn, interpreted the testimony as follows:
`Whereupon,
` EVA K. HAVRDOVA
`was called as a witness and, having first been duly
`sworn, was examined and testified as follows:
` EXAMINATION
` BY MR. WHITE:
` Q Could you please state your name for the
`record.
` A Eva Kubala Havrdova.
` Q Where are you currently employed?
` A Charles University in Prague.
` Q What is your role at Charles University?
` A I am the head of multiple sclerosis
`
`August 20, 2019
`
`Page 5
`
`08:11:27
`
`08:12:02
`
`08:12:17
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 5
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 5
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 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
`
`department at the Department of Neurology.
` Q Have you been deposed before?
` A No.
` Q So I just want to go over a few rules to
`make sure we're on the same page. I will ask you a
`series of questions today. And if you could, when I
`ask you the question, give me a verbal answer as
`opposed to a head nod or some other nonverbal
`gesture.
` If you have any questions or don't
`understand my question, please let me know and I
`will try to clarify the question.
` A Thank you.
` Q Your counsel may object to my question.
`But unless she instructs you not to answer, you
`should try to answer the question.
` Is there any reason you cannot give
`truthful testimony today?
` A No.
` Q Do you have in front of you the
`declaration that you submitted in this case?
` A Yes.
`
`08:12:48
`
`08:13:20
`
`08:13:38
`
`08:13:58
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 6
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 6
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` (Exhibit 2099 previously identified.)
` BY MR. WHITE:
` Q And that's Exhibit 2099 at the bottom?
` A Yes.
` Q And in this declaration, you discuss,
`among other things, a Phase II clinical trial
`related to DMF; is that correct?
` A Yes.
` (Exhibit 1007 previously identified.)
` BY MR. WHITE:
` Q I'm going to go ahead and give you another
`document.
` So I've handed you what's been previously
`marked as Exhibit 1007. And do you recognize this
`as the abstract of the Phase II clinical trial that
`is the subject of your declaration?
` MS. MC CURDY: Objection; form.
` THE WITNESS: Yes.
` BY MR. WHITE:
` Q And specifically, the abstract that's
`referenced in your declaration is on page 27
`referenced as 0108; is that correct?
`
`August 20, 2019
`
`Page 7
`
`08:14:22
`
`08:14:43
`
`08:15:10
`
`08:15:30
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 7
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 7
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 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
`
` A Yes.
` Q Do you recall when you first became aware
`of the potential for this Phase II study?
` MS. MC CURDY: Objection; vague.
`Objection; form.
` THE WITNESS: I think it was around 2004.
` BY MR. WHITE:
` Q Do you recall how you heard about the
`study?
` A I was contacted by Gilmore O'Neill.
` Q What did Dr. O'Neill -- why did
`Dr. O'Neill contact you?
` A Because he wanted our site to become one
`of the sites that would conduct the study.
` Q Did you know Dr. O'Neill before he
`contacted you?
` A I don't recall.
` Q When Dr. O'Neill first contacted you, do
`you recall what you were told about the study?
` MS. MC CURDY: Objection; form.
` THE WITNESS: He told us that Biogen is
`going to try this substance and asked us if we were
`
`08:16:02
`
`08:16:22
`
`08:16:53
`
`08:17:19
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 8
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 8
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`interested and have the capability to participate in
`the Phase II part of the study.
` BY MR. WHITE:
` Q Did Dr. O'Neill tell you what -- what drug
`would be used in the study?
` A Yes, he mentioned fumarate.
` Q Did Dr. O'Neill tell you what doses of the
`drug would be used in the study?
` A No.
` Q Do you recall when you first learned what
`doses would be used in the study?
` A Yes. When he sent us the protocol.
` Q And do you recall when he sent you the
`protocol?
` A Not exactly.
` Q Do you recall if it was before or after
`the meeting in Versailles, France, that is
`referenced in your declaration?
` A Definitely before.
` Q Do you recall what was included in the
`protocol that was sent to you?
` A It has been 15 years, and it's an entire
`
`August 20, 2019
`
`Page 9
`
`08:17:54
`
`08:18:14
`
`08:18:37
`
`08:19:07
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 9
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 9
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 10
`book.
`1
` Q If you look at Exhibit 1007, there is an
`"Objective" paragraph.
` INTERPRETER: Is that the first --
` BY MR. WHITE:
` Q That's the first paragraph.
` A On page 27?
` Q On page 27.
` A Are we talking about 0108?
` Q Correct. Do you see the paragraph titled
`"Objective"?
` A Yes.
` Q Do you recall if that was -- if a
`similar -- if the same or similar paragraph was
`included in the protocol that was sent to you by
`Dr. O'Neill?
` A I don't recall.
` Q Do you see the next paragraph titled
`"Methods"?
` A Yes.
` Q Do you recall if that paragraph or a
`similar paragraph was included in the protocol sent
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:19:42
`
`08:20:03
`
`08:20:18
`
`08:20:35
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 10
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 10
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`to you by Dr. O'Neill?
` MS. MC CURDY: Objection; vague.
` THE WITNESS: I don't remember.
` BY MR. WHITE:
` Q Were you involved in preparing the
`protocol?
` A No.
` Q Do you know who at -- do you know who
`prepared the protocol?
` A Gilmore O'Neill, who was also stated as
`the author of the protocol.
` Q And how do you know that he prepared the
`protocol?
` A I would think that if his name was stated
`as the author on the front page, that it would be
`him, plus the people who helped him from Biogen.
` Q Do you recall approximately how large this
`protocol was? And by large, the length.
` MS. MC CURDY: Objection; compound.
` THE WITNESS: Maybe about
`1-centimeter-thick book.
` BY MR. WHITE:
`
`August 20, 2019
`
`Page 11
`
`08:20:52
`
`08:21:04
`
`08:21:32
`
`08:21:58
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 11
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 11
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 12
` Q Did you review the protocol that
`1
`Dr. O'Neill sent you when you prepared your
`declaration in this case?
` MS. MC CURDY: Objection.
` I'd caution the witness not to disclose
`any attorney-client privileged information in
`answering that question.
` THE WITNESS: So am I supposed to answer?
` MS. MC CURDY: You may answer without
`disclosing any discussions you have had with
`attorneys.
` THE WITNESS: I had the opportunity to
`review the protocol.
` BY MR. WHITE:
` Q The protocol is not cited in your
`declaration; is that correct?
` A I am not citing it because every study has
`a protocol.
` Q You were not personally involved in
`determining what doses would be administered in the
`Phase II study; correct?
` MS. MC CURDY: Objection; vague.
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:22:16
`
`08:22:31
`
`08:22:43
`
`08:23:13
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 12
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 12
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Objection.
` THE WITNESS: No.
` BY MR. WHITE:
` Q Do you know who determined the doses that
`would be administered in the Phase II study?
` A No.
` Q Were you involved in the development of
`the methods for the Phase II study as disclosed in
`Exhibit 1007?
` A No.
` Q Do you know who developed the methods as
`disclosed in Exhibit 1007?
` MS. MC CURDY: Objection; vague.
` THE WITNESS: No.
` BY MR. WHITE:
` Q Have you ever been employed at Biogen?
` A No.
` Q Have you ever performed any other clinical
`trials for Biogen?
` MS. MC CURDY: Objection; beyond the scope
`of her testimony.
` THE WITNESS: Yes.
`
`August 20, 2019
`
`Page 13
`
`08:23:35
`
`08:24:01
`
`08:24:12
`
`08:24:39
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 13
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 13
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 14
` BY MR. WHITE:
`1
` Q Were they before or after the Phase II
`study that's referenced in Exhibit 1007?
` A Before and after.
` Q Approximately how many clinical trials
`have you been involved with for Biogen?
` A At least five.
` Q Were any of the other clinical trials you
`were involved with related to dimethyl fumarate?
` MS. MC CURDY: Objection; scope.
` THE WITNESS: Phase III.
` BY MR. WHITE:
` Q I understand you were on the Scientific
`Advisory Committee for the Phase II clinical trial
`that's referenced in Exhibit 1007?
` MS. MC CURDY: Objection; form.
` BY MR. WHITE:
` Q Is that correct?
` A Yes.
` Q What was the role of the Scientific
`Advisory Committee?
` A To ensure that the study is conducted
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:24:58
`
`08:25:22
`
`08:25:47
`
`08:26:00
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 14
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 14
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`exactly according to the protocol.
` Q Who was on the Scientific Advisory
`Committee?
` A I don't recall all of the members, but
`most of them are listed as coauthors.
` VIDEO OPERATOR: I'm sorry, can we take a
`short break? We are off record at 8:26 a.m.
` (Recess.)
` VIDEO OPERATOR: We are back on record at
`8:29 a.m.
` BY MR. WHITE:
` Q How frequently did the Scientific Advisory
`Committee meet?
` A It has been 15 years. I don't recall
`exactly. We had teleconferences and face-to-face
`meetings.
` Q Would the meetings of the Scientific
`Advisory Committee be documented in meeting minutes?
` A Yes.
` Q Did you review any of the meeting minutes
`from the Scientific Advisory Committee before
`preparing your declaration?
`
`August 20, 2019
`
`Page 15
`
`08:26:32
`
`08:29:13
`
`08:29:30
`
`08:29:51
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 15
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 15
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 16
` A No. No, I have no idea where they are.
`1
` Q So what type of issues did the Scientific
`Advisory Committee address?
` A The beginning of the study, the course of
`enrollment, and during the study, whether there were
`any violations of the protocol at any sites.
` Q Do you recall any other issues the
`Scientific Advisory Committee addressed?
` A I don't recall.
` Q What was the role -- well, do you know
`Dr. Kappos?
` A Yes.
` Q What was Dr. Kappos's role in the Phase II
`study?
` A He was -- his job was the coordinator of
`the clinical trial.
` Q What does the job of coordinator entail in
`a Phase II clinical trial?
` A If the person -- if people from other
`countries could not come to an agreement with their
`country coordinator, they could contact him.
` Q Did the Scientific Advisory Committee
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:30:27
`
`08:30:58
`
`08:31:16
`
`08:31:43
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 16
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 16
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`provide input on the design of the Phase II study?
` MS. MC CURDY: Objection; vague.
` THE WITNESS: The job of the Scientific
`Advisory Committee was to monitor whether the study
`was being conducted according to the protocol.
` BY MR. WHITE:
` Q So is it your understanding that the
`Scientific Advisory Committee did not provide input
`into the design of the study?
` MS. MC CURDY: Objection; asked and
`answered.
` THE WITNESS: The committee itself, no.
` BY MR. WHITE:
` Q Do you know if Dr. Kappos provided any
`input into the design of the Phase II study?
` A I don't know.
` Q Do you know if Dr. Kappos -- strike that.
` Do you know why Dr. Kappos was -- strike
`that.
` What was Dr. Kappos's position again?
` MS. MC CURDY: Objection; asked and
`answered.
`
`August 20, 2019
`
`Page 17
`
`08:32:28
`
`08:32:47
`
`08:32:57
`
`08:33:30
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 17
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 17
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 18
` THE WITNESS: He coordinated the work of
`1
`the clinical sites.
` BY MR. WHITE:
` Q Sure. Do you know why he was chosen as
`the coordinator?
` A He is considered one of the leading
`experts in the area of multiple sclerosis.
` Q Do you know when Dr. Kappos first became
`involved in the Phase II study?
` A I don't know.
` Q Do you know if he was involved with the
`Phase II study before you became involved?
` MS. MC CURDY: Objection; asked and
`answered.
` THE WITNESS: I don't know.
` BY MR. WHITE:
` Q Is it fair to say that Dr. O'Neill may
`have had conversations with Dr. Kappos that you
`would not have been involved with?
` MS. MC CURDY: Objection; vague.
` THE WITNESS: I have no information about
`that.
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:33:50
`
`08:34:08
`
`08:34:23
`
`08:34:43
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 18
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 18
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` BY MR. WHITE:
` Q So in paragraph 8 of your declaration, you
`reference a meeting in Versailles, 2004. Is that
`the first time you'd met Dr. O'Neill in person?
` A No.
` Q When did you first meet Dr. O'Neill in
`person?
` A I would think sometime before then,
`probably during the year 2004.
` Q So in paragraph 8, Dr. O'Neill and Biogen
`formally introduce us to the study plan, procedures
`and provide a training to support the execution of
`the trial. Who else from -- well, did anyone else
`other than Dr. O'Neill speak at the Versailles
`meeting?
` A I don't recall exactly.
` Q Do you recall if anyone else from Biogen
`other than Dr. O'Neill spoke at the meeting?
` A I don't remember.
` Q Do you recall that there was training
`given at the meeting by Dr. Kappos and Dr. Miller?
` A Yes.
`
`August 20, 2019
`
`Page 19
`
`08:35:26
`
`08:35:53
`
`08:36:34
`
`08:36:58
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 19
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 19
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 20
` Q Is it your understanding that Dr. Kappos
`1
`and Dr. Miller were not associated -- were not
`employed by Biogen?
` MS. MC CURDY: Objection; vague, form of
`the question.
` INTERPRETER: Dr. Kappos and what's the --
` MR. WHITE: Dr. Miller.
` THE WITNESS: That's the way I understood
`it.
` BY MR. WHITE:
` Q If you could turn to paragraph 11 of your
`declaration. If you look at the second sentence,
`it's "I can attest that the content of Exhibits
`1007, 1046, and 1016, which describe certain results
`of Biogen's Phase II BG-12 MS clinical trial, is
`solely the work of Dr. O'Neill, and those working
`under his direction and supervision."
` Do you see that?
` A Yes.
` Q What is your basis to know that the -- the
`three exhibits you referenced in that sentence are
`solely the work of Dr. O'Neill and those working
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:37:28
`
`08:37:39
`
`08:38:34
`
`08:38:53
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 20
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 20
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`under his supervision and direction?
` A They were sent to us for comments from his
`address.
` Q Any other basis by which you know that
`those three exhibits are the work of Dr. O'Neill and
`those working under his direction and supervision?
` A No.
` (Exhibits 1016 and 1046 previously
`identified.)
` MS. MC CURDY: Would you like us to have
`two exhibits in front of the witness?
` MR. WHITE: Yes.
` BY MR. WHITE:
` Q So Doctor, I've handed you two exhibits.
`They are the two additional exhibits referenced in
`paragraph 11. One is Exhibit 1016 and the other is
`Exhibit 1046.
` Do you recognize these documents?
` A Yes.
` Q You were not involved in the preparation
`of either Exhibit 1016 or Exhibit 1046; correct?
` A I reviewed this one. I'm not sure which
`
`August 20, 2019
`
`Page 21
`
`08:39:39
`
`08:40:50
`
`08:41:00
`
`08:41:21
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 21
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 21
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 22
`number that is.
`1
` Q So I believe you're referring on the
`bottom right to 1046.
` A Yes.
` Q You did -- you reviewed Exhibit 1046?
` A Yes.
` Q And that was before it was finalized?
` A Yes.
` MS. MC CURDY: Objection; form of the
`question, vague.
` THE WITNESS: Yes.
` BY MR. WHITE:
` Q Did you provide any input into Exhibit
`1046?
` A No.
` Q And just to be clear, when you say you
`reviewed Exhibit 1046, are you just referring to the
`slides that start on page 8?
` A Yes.
` Q And you did not review the Patent Office
`declaration that goes from page 1 to page 7; is that
`correct?
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:41:57
`
`08:42:12
`
`08:42:24
`
`08:42:55
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 22
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 22
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` A No.
` Q Do you know if the others -- would you
`turn to page 8. Do you see others listed on that
`page? Bottom right.
` Do you know why your name is listed --
`that is your name listed on page 8, "E. Havrdova"?
` A Yes.
` Q Do you know why your name was listed?
` A Yes, because the agreement was that the
`authors of the article would be the members of the
`Scientific Advisory Committee.
` Q Do you know if the others that are
`identified on page 8 also reviewed this slide set?
` A I believe so, because otherwise it would
`not be sent for publication.
` Q Do you know if any of the others that are
`identified on page 8 provided input or comments?
` A I don't know.
` Q Do you know when this slide show was
`presented?
` A At the meeting in Lausanne. Lausanne,
`Switzerland.
`
`August 20, 2019
`
`Page 23
`
`08:43:43
`
`08:44:07
`
`08:44:35
`
`08:45:03
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 23
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 23
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 24
` Q What was the purpose of that meeting?
`1
` MS. MC CURDY: Objection; vague.
` THE WITNESS: It's a European neurological
`conference.
` BY MR. WHITE:
` Q And that is the -- is that the 16th
`meeting of the European Neurological Society that is
`referenced in Exhibit 1007?
` A Yes.
` Q Were you at that meeting?
` A No.
` Q If you could look at Exhibit 1016, the
`press release. You were not involved in the
`preparation of this document; is that correct?
` A No.
` Q Before your work on this case, had you
`seen this document before?
` A No.
` Q When the Phase II results were announced,
`did you recall seeing any public press releases
`about the results?
` MS. MC CURDY: Objection; beyond the scope
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`08:45:36
`
`08:46:03
`
`08:46:31
`
`08:46:56
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 24
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 24
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`of her testimony.
` THE WITNESS: I don't recall.
` MR. WHITE: Take a short break.
` MS. MC CURDY: That should be fine, sure.
` VIDEO OPERATOR: We are off record at 8:47
`a.m.
` (Recess.)
` VIDEO OPERATOR: We are back on record at
`9:01 a.m.
` BY MR. WHITE:
` Q Doctor, if you could turn to your
`declaration and paragraph 11. And if you could look
`at the second sentence. And you reference the three
`exhibits and state that they are solely the work of
`Dr. O'Neill and those working under his direction
`and supervision.
` Do you see that?
` A Yes.
` Q Who were you referring to when you said
`"those working under his direction and supervision"?
` A Each study is a work of many people, and
`in any pharmaceutical company, it's not only one
`
`August 20, 2019
`
`Page 25
`
`08:48:01
`
`09:01:20
`
`09:01:52
`
`09:02:06
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 25
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 25
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Page 26
`person that is responsible for the study.
`1
` Q Did you speak -- were you finished?
` Did you speak to Dr. O'Neill when you
`prepared your declaration?
` A No.
` Q Did you speak with Dr. Kappos when you
`prepared your declaration?
` A No.
` Q Did you speak to any of the other authors
`of the abstract that is referenced in Exhibit 1007?
` A No.
` Q In preparing your declaration?
` A No.
` MR. WHITE: Thank you, Doctor. I don't
`have anything further.
` MS. MC CURDY: We'd like to take a short
`break.
` MR. WHITE: Sure.
` VIDEO OPERATOR: We are off record at 9:03
`a.m.
` (Recess.)
` VIDEO OPERATOR: We are back on record at
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`09:02:46
`
`09:03:02
`
`09:03:18
`
`09:03:27
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 26
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 26
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`9:15 a.m.
` EXAMINATION
` BY MS. MC CURDY:
` Q Dr. Havrdova, during questioning earlier,
`you were asked -- is there a way to freeze it on a
`certain spot?
` MS. MC CURDY: Off the record for a
`second.
` VIDEO OPERATOR: We are off record at 9:16
`a.m.
` (Discussion off the record.)
` VIDEO OPERATOR: We are back on record at
`9:17 a.m.
` BY MS. MC CURDY:
` Q Dr. Havrdova, earlier you were asked the
`question, did you review the protocol that
`Dr. O'Neill sent you when you prepared your
`declaration in this case. And you responded "I had
`the opportunity to review the protocol."
` Will you please clarify when you reviewed
`the protocol?
` A I may have misheard. I may not have heard
`
`August 20, 2019
`
`Page 27
`
`09:15:43
`
`09:16:03
`
`09:17:59
`
`09:18:21
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 27
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 27
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`Page 28
`the part "when I was preparing the declaration." I
`1
`reviewed the protocol before the beginning of the
`study, in 2004.
` Q And so you did not review the protocol in
`preparing your declaration; correct?
` A No, the protocol is in the archive.
` MS. MC CURDY: Thank you.
` I have no further questions.
` MR. WHITE: Nothing further.
` VIDEO OPERATOR: We are off record at 9:19
`a.m.
` (Whereupon, at 9:19 a.m., the deposition
`was concluded.)
`
`09:18:57
`
`09:19:12
`
`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 1130 PAGE 28
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 28
`
`
`
`August 20, 2019
`
`Page 29
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
` I HEREBY CERTIFY that I have read this
`transcript of my deposition and that this transcript
`accurately states the testimony given by me, with
`the changes or corrections, if any, as noted.
`
` X
`
`Subscribed and sworn to before me this day of
` , 20 .
`
` X
` Notary Public
`
`My commission expires: .
`
`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 1130 PAGE 29
`
`MYLAN PHARMS. INC. EXHIBIT 1130 PAGE 29
`
`
`
`Eva Havrdova
`
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
`
`August 20, 2019
`
`Page 30
` C O N T E N T S
`1
`
`WITNESS EXAMINATION
`EVA HAVRDOVA
` by Mr. White 5
` by Ms. McCurdy 27
`
` E X H I B I T S
`
`EXHIBIT NUMBER IDENTIFIED
`Exhibit 2099 PREVIOUSLY IDENTIFIED 7
`Exhibit 1007 PREVIOUSLY IDENTIFIED 7
`Exhibit 1016 PREVIOUSLY IDENTIFIED 21
`Exhibit 1046 PREVIOUSLY IDENTIFIED 21
`
`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 1130 PAGE 30
`
`MYLAN PHARMS. INC