Transcript of Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`
`Alderson Reporting
`1-800-367-3376
`info@aldersonreporting.com
` http://www.aldersonreporting.com
`
`Alderson Reference Number: 67630
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 1/265
`
`
`
`December 14, 2016
`
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`
`Alderson Reporting
`1-800-367-3376
`info@aldersonreporting.com
` http://www.aldersonreporting.com
`
`Alderson Reference Number: 67630
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 1/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` - - -
`
`ARGENTUM PHARMACEUTICALS LLC, :
`
`MYLAN PHARMACEUTICALS INC., :
`
`BRECKENRIDGE PHARMACEUTICALS :
`
`INC., AND ALEMBIC :
`
`PHARMACEUTICALS, LTD., :
`
` Petitioners, : Case No. IPR2016-00204
`
` vs. : Patent No. RE 38,551
`
`RESEARCH CORPORATION :
`
`TECHNOLOGIES, INC., :
`
` Patent Owner. :
`
` - - -
`
` Deposition of KATHRYN A. DAVIS, M.D.,
`
` held at the offices of BAKER HOSTETLER, 2929
`
` Arch Street, Cira Center, Philadelphia,
`
` Pennsylvania, on Tuesday, December 14, 2016,
`
` beginning at approximately 8:32 a.m., the
`
` proceedings being recorded stenographically by
`
` Gail Inghram Verbano, Registered Diplomate
`
` Reporter, Certified Realtime Reporter,
`
` Certified Shorthand Reporter-CA (No. 8635), and
`
` transcribed under her direction.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 2/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 2
`
` A P P E A R A N C E S
`
`On behalf of Petitioner:
`
` MATTHEW J. DOWD, ESQ.
`
` mjdowd@dowdpllc.com
`
` DOWD PLLC
`
` 1717 Pennsylvania Avenue NW
`
` Suite 1025
`
` WASHINGTON, D.C. 20006
`
`On behalf of Petitioner Mylan Pharmaceuticals:
`
`(Telephonically appearing)
`
` JAD MILLS, ESQ.
`
` jmills@wsgr.com
`
` WILSON SONSINI GOODRICH & ROSATI
`
` 701 5th Ave., Suite 5100
`
` Seattle, Washington 98104
`
`On behalf of the Patent Owner:
`
` ANDREA G. REISTER, ESQ.
`
` areister@cov.com
`
` PRISCILLA G. DODSON, ESQ.
`
` pdodson@cov.com
`
` COVINGTON & BURLING, LLP
`
` One City Center, 850 10th Street NW
`
` Washington, D.C. 20001-4956
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 3/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 3
`
` C O N T E N T S
`
`EXAMINATION OF: PAGE
`
`KATHRYN A. DAVIS, M.D.
`
` By Ms. Reister 6
`
` By Mr. Dowd 216
`
` By Ms. Reister 259
`
` E X H I B I T S
`
`DAVIS PAGE
`
`Exhibit 1: Letter from the Food and Drug 57
`
` Administration to UCB, 3/19/2007
`
`Exhibit 2: Article "Efficacy and 63
`
` Tolerability of Lacosamide in the
`
` Treatment of Children with
`
` Refractory Generalized Epilepsy"
`
`Exhibit 3: Letter from Russell Katz of the 66
`
` FDA, 6/21/2005
`
`Exhibit 4: Letter to the editor appearing in 87
`
` the Journal of Clinical
`
` Gastroenterology from August of
`
` 2014
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 4/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 4
`
` E X H I B I T S (continued)
`
`DAVIS PAGE
`
`Exhibit 5: Abstract entitled "Control of 162
`
` Seizures in Different Stages of
`
` Partial Epilepsy: LACO-EXP, a
`
` Spanish Retrospective Study of
`
` Lacosamide"
`
`Exhibit 6: Letter regarding nonepileptic 186
`
` hallucinations in use of
`
` levetiracetam from
`
` November/December 2007
`
`Exhibit 7: Article entitled "Discontinuation 188
`
` of Levetiracetam Because of
`
` Behavioral Side Effects, a
`
` Case-Controlled Study"
`
`Exhibit 8: Article entitled "Acute 191
`
` Pancreatitis and Elevated Liver
`
` Transaminases After Rapid
`
` Titration of Oral Levetiracetam"
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 5/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`PREVIOUSLY MARKED EXHIBITS REFERENCED: PAGE
`
`Exhibit 1048 . . . . . . . . . . . . . .153
`
`Exhibit 1070 . . . . . . . . . . . . . .172
`
`Exhibit 1072 . . . . . . . . . . . . . .178
`
`Exhibit 1073 . . . . . . . . . . . . . . 86
`
`Exhibit 1079 . . . . . . . . . . . . . .151
`
`Exhibit 1092 . . . . . . . . . . . . . . 91
`
`Exhibit 1099 . . . . . . . . . . . . . .130
`
`Exhibit 1100 . . . . . . . . . . . . . .132
`
`Exhibit 1101 . . . . . . . . . . . . . .133
`
`Exhibit 1102 . . . . . . . . . . . . . .140
`
`Exhibit 1103 . . . . . . . . . . . . . .136
`
`Exhibit 1105 . . . . . . . . . . . . . .137
`
`Exhibit 1106 . . . . . . . . . . . . . .138
`
`Exhibit 1123 . . . . . . . . . . . . . . 91
`
`Exhibit 1133 . . . . . . . . . . . . . .183
`
`Exhibit 1135 . . . . . . . . . . . . . . 55
`
`Exhibit 1141 . . . . . . . . . . . . . .200
`
`Exhibit 1154 . . . . . . . . . . . . . .101
`
`Exhibit 2078 . . . . . . . . . . . . . . 70
`
`Exhibit 2122 . . . . . . . . . . . . . .145
`
`INSTRUCTION NOT TO ANSWER:
`
`PAGE LINE
`
` 31 17
`
` 32 10
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 6/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 6
`
` Philadelphia, Pennsylvania,
`
` Tuesday, December 14, 2016; 8:32 a.m.
`
` - - -
`
` KATHRYN A. DAVIS, M.D., having first
`
` been duly sworn according to law, was examined
`
` and testified as follows:
`
` - - -
`
` EXAMINATION
`
` BY MS. REISTER:
`
` Q. Good morning, Dr. Davis.
`
` A. Good morning.
`
` Q. Thank you for being here. As you know
`
` from the court reporter, you're under oath
`
` today, and is there anything that might
`
` interfere with your ability to testify
`
` truthfully and accurately today?
`
` A. No.
`
` Q. Are you on any medications today?
`
` A. No.
`
` Q. Any illness?
`
` A. No. A minor cold.
`
` Q. But nothing that would interfere with
`
` your ability to testify truthfully and
`
` accurately?
`
` A. No, there's nothing.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 7/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
` Q. Have you ever been deposed before?
`
`Page 7
`
` A. Yes.
`
` Q. And how many times?
`
` A. Approximately four.
`
` Q. And of those four times that you were
`
` deposed, were any of those in relation to a
`
` patent proceeding?
`
` A. No.
`
` Q. The four times that you were deposed
`
` before, were those related to a medical
`
` proceeding?
`
` A. Yes.
`
` Q. Could you tell me about each of those,
`
` please.
`
` A. To my recollection, the first one was
`
` a case that was then subsequently dropped from
`
` my residency that I was asked to -- I was
`
` deposed regarding that case. I don't know that
`
` I actually am allowed to talk about details
`
` regarding it.
`
` Second one was, I believe, related to
`
` an independent medical evaluation I had done on
`
` a patient. Another one was also another
`
` independent medical evaluation.
`
` Might have only been three. I'm not
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 8/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 8
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` entirely sure. I haven't looked at my records
`
` to clarify the exact number.
`
` Q. And the two that you spoke about that
`
` were independent medical evaluations,
`
` approximately when did those occur?
`
` MR. DOWD: I'll object based on
`
` relevance and the scope.
`
` You can answer.
`
` THE WITNESS: Approximately --
`
` one was within the last six months. And then
`
` the other one was maybe a year and a half ago.
`
` BY MS. REISTER:
`
` Q. And with respect to any of the three
`
` proceedings in which you recall being deposed,
`
` did you testify at trial?
`
` A. No.
`
` Q. With respect to the three proceedings
`
` in which you were deposed, did any of those
`
` proceedings involve epilepsy?
`
` MR. DOWD: Objection; relevance
`
` and scope.
`
` THE WITNESS: Yes, they did.
`
` BY MS. REISTER:
`
` Q. And how many of those three
`
` proceedings involved epilepsy?
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 9/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` MR. DOWD: Same objections.
`
` THE WITNESS: Two.
`
` BY MS. REISTER:
`
` Q. And of the two that involved epilepsy,
`
` did they also involve the particular drug that
`
` was administered to the patient?
`
` A. No.
`
` Q. So for the two that involved epilepsy,
`
` did any of them involve Vimpat?
`
` MR. DOWD: Objection; relevance,
`
` scope.
`
` THE WITNESS: Not to my
`
` recollection.
`
` BY MS. REISTER:
`
` Q. With respect to the two that involved
`
` epilepsy, did any of them involve Keppra?
`
` MR. DOWD: Same objections.
`
` THE WITNESS: The most recent one
`
` definitely did. I don't recall with the other
`
` one. However, I would say that Keppra -- that
`
` wasn't the question at hand. It was just that
`
` I recall that the patient was -- received
`
` Keppra at some time during her treatment time
`
` course.
`
` BY MS. REISTER:
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 10/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 10
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. But the issue at hand in that most
`
` recent proceeding where the patient was being
`
` administered Keppra was different than an issue
`
` relating to Keppra itself?
`
` MR. DOWD: Object to that based
`
` on the scope of the question, the relevancy of
`
` the question, and to this entire line of
`
` questioning. I'll caution Dr. Davis to not
`
` provide any answers that might provide
`
` confidential information or information that
`
` cannot be disclosed publicly.
`
` THE WITNESS: I think it's safe
`
` to say that the question at hand was regarding
`
` a traumatic brain injury.
`
` BY MS. REISTER:
`
` Q. And for the two of the proceedings in
`
` which you were deposed that involved epilepsy,
`
` was the issue at hand in any of those related
`
` to the particular antiepileptic drug that was
`
` being administered?
`
` A. No.
`
` MR. DOWD: Same objections.
`
` BY MS. REISTER:
`
` Q. Dr. Davis, you've been deposed before.
`
` I'm sure you're familiar with the format. I'd
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 11/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 11
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` just like to set forth the ground rules, just
`
` so that we're clear today.
`
` This is a question and answer format,
`
` and your attorney may object, but you still
`
` have to answer the question.
`
` Do you understand the ground rules?
`
` A. Yes, I do.
`
` Q. If you need a break, please let me
`
` know and we'll try to take one at the next
`
` available moment that we can. Okay?
`
` A. Okay.
`
` Q. What did you do to prepare for your
`
` deposition today?
`
` A. So I reviewed, I believe, all the
`
` documents that were disclosed, including Carl
`
` Bazil's declaration, and the literature and
`
` other documents that were provided.
`
` My declaration was completed many
`
` weeks ago, so in the last few days I reread
`
` several of those documents to prepare.
`
` Q. In your answer you made reference to
`
` "literature and other documents that were
`
` provided."
`
` Can you tell me what those were?
`
` MR. DOWD: Objection; form of the
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 12/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 12
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` question.
`
` THE WITNESS: So I believe it's
`
` all of the -- forgive me for maybe using the
`
` wrong word, but the exhibits. I had to cheat.
`
` BY MS. REISTER:
`
` Q. That's quite all right.
`
` And you've made reference to a
`
` document that's in front of you. Can you tell
`
` me what that document is, please?
`
` A. The document in front of me is the
`
` declaration that I made in support of/reply
`
` for -- in this case. I don't know if -- do you
`
` want me to read out the entire front page?
`
` Q. If you could just tell me what the
`
` exhibit number is in the lower right-hand
`
` corner, please.
`
` A. It's 1087.
`
` Q. And that document that you have in
`
` front of you, is that a clean copy of your
`
` declaration, Exhibit 1087?
`
` A. Yes, it is.
`
` MS. REISTER: Mr. Dowd, is that a
`
` true and correct and clean copy of
`
` Exhibit 1087?
`
` MR. DOWD: To the best that it's
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 13/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 13
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` been printed out, yes.
`
` MS. REISTER: May I have a look?
`
` MR. DOWD: Please.
`
` MS. REISTER: Thank you. Here
`
` you go.
`
` THE WITNESS: Thank you.
`
` BY MS. REISTER:
`
` Q. So in preparing for your deposition,
`
` you reviewed your declaration, Exhibit 1087,
`
` and the exhibits that were cited in your
`
` declaration; is that correct?
`
` A. That's correct. In addition, I
`
` reviewed Dr. Bazil's declaration.
`
` Q. Were there any other documents that
`
` you reviewed in preparation for your
`
` deposition?
`
` MR. DOWD: Objection to the form
`
` of the question.
`
` THE WITNESS: Not directly
`
` related, but I just went to the American
`
` Epilepsy Society meeting, so I updated myself
`
` as I would with -- in my standard clinical
`
` practice regarding different epilepsy
`
` medications, and there were some more recent
`
` abstracts in that setting.
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 14/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 14
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` So that was not in direct review
`
` for today, but that was some of that knowledge
`
` that's not present in my declaration.
`
` BY MS. REISTER:
`
` Q. And the more recent abstracts in the
`
` setting of the American Epilepsy Society
`
` meeting, do you recall what the subject matter
`
` of those abstracts was?
`
` MR. DOWD: Objection to the form
`
` of the question and objection to the relevancy
`
` of the question.
`
` THE WITNESS: So at American
`
` Epilepsy Society there are thousands of
`
` abstracts, and they are only abstracts, so
`
` they're not published and sometimes the data
`
` that's presented doesn't hold true once it's
`
` looked at in more depth.
`
` But I did -- I can recall
`
` reviewing -- I was particularly interested in
`
` some cannabidiol abstracts because that's a
`
` very hot topic in epilepsy that my patients ask
`
` a lot about.
`
` There were some lacosamide
`
` abstracts as well, and I reviewed some of
`
` those.
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 15/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 15
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` I personally had about five
`
` abstracts, so I went and saw a bunch of -- just
`
` kind of strolled around and looked at what
`
` other investigators were doing throughout the
`
` country.
`
` BY MS. REISTER:
`
` Q. And with respect to the lacosamide
`
` abstracts, can you tell me what the subject
`
` matter was of those?
`
` MR. DOWD: Objection to the form
`
` of the question and the scope of the question
`
` and the relevance.
`
` THE WITNESS: There was
`
` particularly one abstract that I thought was
`
` interesting, didn't have very much information,
`
` honestly, on it regarding lacosamide and
`
` pregnancy registry data. What I found really
`
` interesting about that abstract is that a
`
` very -- the extremely low rate of live births
`
` that were reported, so I think that there's a
`
` lot more that I need to know in order to
`
` interpret that particular abstract.
`
` BY MS. REISTER:
`
` Q. And do you recall any abstracts at
`
` this meeting that involved Keppra?
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 16/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. I didn't particularly see any. There
`
` probably were.
`
` Q. In addition to reviewing documents in
`
` preparation for your deposition today, did you
`
` do anything else?
`
` MR. DOWD: Object to the form of
`
` the question.
`
` THE WITNESS: I've discussed --
`
` had a discussion with Mr. Dowd on the telephone
`
` regarding just kind of what would happen today
`
` and where to go, things like this.
`
` Nothing else in particular.
`
` BY MS. REISTER:
`
` Q. And when did the discussion with
`
` Mr. Dowd take place?
`
` A. Monday.
`
` Q. Approximately how long was that?
`
` A. 45 minutes.
`
` Q. Did you meet with Mr. Dowd in person
`
` prior to your deposition today?
`
` MR. DOWD: Objection to the
`
` relevance.
`
` THE WITNESS: No, we just met
`
` this morning.
`
` BY MS. REISTER:
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 17/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. Did you speak with anyone else in
`
` preparation for your deposition today?
`
` MR. DOWD: Objection. I'll
`
` object to the form of the question, the
`
` relevancy of the question. I'll caution the
`
` witness, to the extent answering the question,
`
` not to divulge any confidential or privileged
`
` information.
`
` THE WITNESS: So I was on one
`
` conference call with several of the other
`
` lawyers that I believe are on -- are involved
`
` right now; and I don't know their names.
`
` But that's my -- or I don't
`
` recall their names. That's the only other
`
` discussion.
`
` BY MS. REISTER:
`
` Q. And when did that discussion take
`
` place?
`
` MR. DOWD: Objection. Same
`
` objections as before.
`
` THE WITNESS: I don't recall the
`
` specific date. It was in later November, prior
`
` to my finalizing my declaration. And I could
`
` find out the date if you needed it, because I
`
` remember where I was. I was at a conference in
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 18/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 18
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` San Diego. It was prior to Thanksgiving.
`
` BY MS. REISTER:
`
` Q. And approximately how long was that
`
` telephone call?
`
` MR. DOWD: Objection to the form
`
` of the question and the relevancy of the
`
` question. And the same objection with respect
`
` to not disclosing or divulging confidential and
`
` privileged information.
`
` THE WITNESS: I don't recall the
`
` exact length. Approximately a half hour.
`
` BY MS. REISTER:
`
` Q. And to the best of your recollection,
`
` Mr. Dowd was on that phone call; correct?
`
` A. Correct.
`
` Q. And to the best of your recollection,
`
` was counsel for Mylan on that phone call?
`
` MR. DOWD: Objection to the scope
`
` of the question and the relevancy of the
`
` question.
`
` THE WITNESS: I don't know.
`
` BY MS. REISTER:
`
` Q. Was counsel for Alembic on that phone
`
` call?
`
` MR. DOWD: Same objections.
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 19/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 19
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` THE WITNESS: I also don't know.
`
` BY MS. REISTER:
`
` Q. Counsel for Breckenridge, were they on
`
` that phone call?
`
` MR. DOWD: Same objections.
`
` THE WITNESS: I also don't know.
`
` BY MS. REISTER:
`
` Q. Is it fair to say that there were
`
` other lawyers in addition to Mr. Dowd on that
`
` phone call; is that correct?
`
` MR. DOWD: Same objections.
`
` Again, caution the witness, to the extent
`
` answering the question, not to divulge
`
` privileged or confidential information.
`
` THE WITNESS: That is correct. I
`
` just am not good with names, and I don't know
`
` who else was on the call.
`
` BY MS. REISTER:
`
` Q. In preparing for your deposition
`
` today, did you speak with anyone other than the
`
` attorneys?
`
` MR. DOWD: Same objections.
`
` THE WITNESS: Not in particular.
`
` My colleagues -- several of my colleagues knew
`
` that I was coming here today because I'm not
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 20/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 20
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` going to be at work; but other than that, I
`
` didn't have any in-depth conversations.
`
` BY MS. REISTER:
`
` Q. So did you discuss the substance of
`
` the deposition with your colleagues?
`
` MR. DOWD: Objection to the form
`
` of the question and the relevancy of the
`
` question.
`
` THE WITNESS: They only knew that
`
` it was regarding lacosamide and the patent --
`
` and it was a patent issue. Beyond that,
`
` nothing else specifically.
`
` BY MS. REISTER:
`
` Q. You've been retained in this
`
` proceeding on behalf of Argentum
`
` Pharmaceuticals; is that correct?
`
` MR. DOWD: Objection to the form
`
` of the question and the foundation and the
`
` relevancy of the question.
`
` THE WITNESS: That is correct, as
`
` stated on this front page that we reviewed.
`
` BY MS. REISTER:
`
` Q. Could you look at Paragraph 2 of your
`
` declaration, please, Dr. Davis. And do you see
`
` in the first sentence it says, "I have been
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 21/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 21
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` retained as an expert witness on behalf of
`
` Argentum Pharmaceuticals, LLC"?
`
` A. I see that.
`
` Q. And you understand that Mylan,
`
` Breckenridge and Alembic are now joined as
`
` petitioners in this proceeding; is that
`
` correct?
`
` MR. DOWD: Objection to the form
`
` of the question, the scope of the question, the
`
` relevancy; the fact that it calls for a legal
`
` conclusion; and the lack of foundation for the
`
` question.
`
` THE WITNESS: That is my
`
` understanding, but I am not a lawyer and I
`
` don't understand the specifics of it.
`
` BY MS. REISTER:
`
` Q. Have you been retained by any of
`
` Mylan, Breckenridge or Alembic in this
`
` proceeding?
`
` MR. DOWD: I'll object to the
`
` form of the question, the relevancy of the
`
` question, foundation of the question and
`
` calling for a legal conclusion.
`
` THE WITNESS: I don't know how to
`
` answer that question, because I don't know the
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 22/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 22
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` underlying law surrounding it. I was asked
`
` to -- I just was asked to make this
`
` declaration. I don't understand kind of the
`
` companies behind it.
`
` BY MS. REISTER:
`
` Q. But you do understand, as you state in
`
` Paragraph 2, that you've been retained as an
`
` expert witness on behalf of Argentum
`
` Pharmaceuticals; correct?
`
` MR. DOWD: I'll object to the
`
` question, lacking foundation, being asked and
`
` answered and seeking a legal conclusion and the
`
` relevancy of the question.
`
` THE WITNESS: As I said prior,
`
` that was my understanding and I don't
`
` understand the legal specifics surrounding
`
` these questions regarding the various different
`
` companies.
`
` BY MS. REISTER:
`
` Q. So sitting here today, you don't have
`
` an understanding one way or the other whether
`
` you've been retained on behalf of Mylan,
`
` Breckenridge and Alembic; is that correct?
`
` MR. DOWD: Same objections; and
`
` asked and answered.
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 23/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
` THE WITNESS: I believe I already
`
` answered that question. I don't know the legal
`
` language that's appropriate to answer these
`
`Page 23
`
` kind of questions.
`
` BY MS. REISTER:
`
` Q. Prior to the present proceeding, had
`
` you ever heard of Argentum Pharmaceuticals?
`
` MR. DOWD: I'll object to the
`
` relevancy of the question, lack of foundation
`
` for the question, the fact the question goes
`
` beyond the scope of the witness' testimony and
`
` the form of the question.
`
` THE WITNESS: I had not heard of
`
` Argentum prior, to my knowledge.
`
` BY MS. REISTER:
`
` Q. Have you ever collaborated with anyone
`
` at Mylan Pharmaceuticals?
`
` MR. DOWD: I'll object to the
`
` form of the question, the relevancy of the
`
` question, and the lack of foundation for the
`
` question. Instruct the witness not to answer
`
` to the extent that it elicits or attempts to
`
` elicit confidential and/or privileged
`
` information.
`
` THE WITNESS: Not to my
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 24/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 24
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` knowledge. I would say that Penn -- the Penn
`
` Epilepsy Center has a very active clinical
`
` trials division, of which I am a coinvestigator
`
` on some of those trials but not directly
`
` involved; and I frequently don't know the full
`
` scope of all of the trials.
`
` So to the best of my knowledge,
`
` no.
`
` BY MS. REISTER:
`
` Q. Have you ever collaborated with anyone
`
` at Breckenridge Pharmaceutical?
`
` MR. DOWD: I'll object to the
`
` question based on the form of the question,
`
` lack of foundation for the question, the lack
`
` of relevancy of the question; and instruct the
`
` witness not to answer to the extent it elicits
`
` or attempts to elicit confidential and or
`
` privileged information.
`
` THE WITNESS: My answer would be
`
` the same as for Argentum, which I can repeat if
`
` you'd like.
`
` BY MS. REISTER:
`
` Q. I believe the answer that you just
`
` gave was with respect to Mylan Pharmaceutical.
`
` A. Oh, you're correct. I'm sorry.
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 25/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 25
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` It's the same answer. I don't know of
`
` any time that I've collaborated with that
`
` pharmaceutical company; but the caveat is that
`
` there's a very active clinical trials division
`
` within the epilepsy center, of which, because
`
` I'm an attending I am listed as a
`
` coinvestigator. But I don't have direct
`
` contact or input into those studies.
`
` Q. And would your answer be the same for
`
` Alembic Pharmaceuticals?
`
` MR. DOWD: Well, repeat my
`
` objections to the previously stated question.
`
` THE WITNESS: So Lundbeck is the
`
` same Lundbeck that makes clobazam; is that
`
` correct?
`
` BY MS. REISTER:
`
` Q. My question refers -- if you look at
`
` the first page of your declaration, my question
`
` now is --
`
` A. Oh, Alembic, okay. Sorry.
`
` Q. Yes.
`
` MR. DOWD: Same objections.
`
` THE WITNESS: I apologize. I
`
` misheard the name. My answer would be the
`
` same.
`
`1-800-FOR-DEPO
`
`www.aldersonreporting.com
`
`Alderson Court Reporting
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2195 - 26/265
`
`
`
`Kathryn A. Davis, M.D.
`
`December 14, 2016
`
`Philadelphia, PA
`
`Page 26
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` BY MS. REISTER:
`
` Q. Are you aware of any clinical trials
`
` at the Penn Epilepsy Center that are currently
`
` being conducted by Mylan?
`
` MR. DOWD: Object to the question
`
` as lacking foundation, the scope of the
`
` question, and the relevancy of the question;
`
` and, again to the extent that the question
`
` elicits confidential and/or privileged
`
` information, instruct the witness not to
`
` answer.
`
` THE WITNESS: No, I am not aware
`
` of any clinical trials ongoing.
`
` BY MS. REISTER:
`
` Q. Are you aware of any clinical trials
`
` at the Penn Epilepsy Center that are currently
`
` being conducted by Breckenridge Pharmaceutical?
`
` MR. DOWD: I object to the
`
` question as lacking foundation, going beyond
`
` the scope of direct, the relevancy of the
`
` question; and, again, to the extent the
`
` question elicits or attempts to elicit
`
` confidential
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
