throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`HOPEWELL PHARMA VENTURES, INC.
`
`Petitioner,
`
`v.
`
`MERCK SERONO S.A.,
`
`Patent Owner.
`____________
`IPR2023-00480 (Patent 7,713,947 B2)
`IPR2023-00481 (Patent 8,377,903 B2)
`____________
`
`CONFIDENTIAL
`VIDEOTAPED DEPOSITION OF
`Nicholas Bodor, PhD, DSc, dhc, HoF
`
`Pages 1 to 143
`
`Thursday, February 15, 2024
`9:34 a.m. - 2:03 p.m.
`
`Bodor Laboratories
`4400 Biscayne Boulevard
`11th Floor
`Miami, Florida
`
`STENOGRAPHICALLY REPORTED BY:
`NANCY E. PAULSEN, CRR, CRC, RPR
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`
`12
`
`13
`
`14
`
`15
`16
`
`17
`
`18
`19
`20
`
`21
`22
`
`Hopewell EX1059
`Hopewell v. Merck
`IPR2023-00481
`
`1
`
`

`

`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`2
`
` APPEARANCES:
` On Behalf of the Petitioner
` CHRISTINA E. DASHE, ESQUIRE (via Zoom)
` ELDORA L. ELLISON, ESQUIRE (via Zoom)
` OLGA A. PARTINGTON, ESQUIRE (via Zoom)
` TYLER C. LIU, ESQUIRE (via Zoom)
` MADELEINE C. BOND, ESQUIRE (in person)
` Sterne Kessler Goldstein Fox
` 1101 K Street NW, 10th Floor
` Washington, DC 20005
` 202-772-8525
` Cdashe@sternekessler.com,
` eellison@sternekessler.com,
` opartington@sternekessler.com,
` tliu@sternekessler.com,
` Mbond@sternekessler.com
`
` On Behalf of the Patent Owner
`
` DAVID MLAVER, ESQUIRE (In person)
` ASHER MCGUFFIN, ESQUIRE (In person)
` WilmerHale
` 60 State Street
` Boston, Massachusetts 02109
` 617-526-6197
` David.mlaver@wilmerhale.com,
` asher.mcguffin@wilmerhale.com
`
`Also Present:
` Willem de Weerd, Merck KGaA (via Zoom)
` Lhassan Elmilki, Videographer (In person)
` Emil White, Remote Zoom Technician (via Zoom)
` Michael Pietanza, In-room Zoom Technician
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`17
`18
`19
`20
`21
`22
`
`2
`
`

`

`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`3
`
` I N D E X
`Deponent Page
`Nicholas Bodor, PhD, DSc, dhc, HoF
` DIRECT EXAMINATION BY MS. DASHE 6
`
` CERTIFICATE OF REPORTER 141
` CERTIFICATE OF OATH 143
`
` E X H I B I T S
`No. Description Page
` Exhibit 1022 Bodor PCT application.............. 101
` Exhibit 1055 IVAX Corporation's Form 10-K for 79
` fiscal year 2003...................
` Exhibit 1056 IVAX Corporation's Form 10-K for 83
` fiscal year 2004...................
` Exhibit 1057 US Patent Number 7,888,328......... 111
` Exhibit 1058 File history for US Patent 116
` Number 8,785,415...................
` Exhibit 2029 US Patent Number 8,785,415......... 114
` Exhibit 2054 Bodor declaration.................. 14
` Exhibit 2069 US Patent Number 7,888,328......... 109
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`3
`
`

`

`09:32:33
`09:32:33
`09:32:36
`09:32:41
`09:32:42
`09:32:45
`09:32:47
`09:32:50
`09:32:51
`09:32:53
`09:32:56
`09:32:58
`09:33:01
`09:33:04
`09:33:07
`09:33:09
`09:33:10
`09:33:13
`09:33:20
`09:33:23
`09:33:26
`09:33:33
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`4
`
` REMOTE ZOOM TECHNICIAN WHITE: Thank you to
`everyone for attending this proceeding remotely and
`in person. We anticipate things will run smoothly
`going forward.
` Please remember to speak slowly and do your
`best not to talk over one another. Please be aware
`that we are recording this proceeding for backup
`purposes as well.
` Any off-the-record discussion should be had
`away from the computer, and please remember to mute
`your mic for those conversations.
` Please have your video enabled to help the
`reporter identify who is speaking, but if you are
`unable to connect video and you are connecting via
`phone, we just ask that you identify yourself each
`time before speaking.
` I apologize in advance for any more
`technical-related interruptions. Thank you.
` VIDEOGRAPHER ELMILKI: Here begins Media
`Number 1 in the videotape of Dr. Nicholas Bodor in
`the matter Hopewell Pharma Venture, Inc., versus
`Merck Serono, SA, in the Court of the United
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`4
`
`

`

`09:33:38
`09:33:41
`09:33:53
`09:33:55
`09:34:01
`09:34:04
`09:34:10
`09:34:13
`09:34:17
`09:34:22
`09:34:23
`09:34:26
`09:34:29
`09:34:29
`09:34:32
`09:34:36
`09:34:43
`09:34:45
`09:34:48
`09:34:50
`09:34:52
`09:34:56
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`5
`
`States -- of the United States Patent and Trial
`Office, Case Number IPR2023-2 -- 00480 and
`IPR2023-00481.
` Today is Thursday, February 15, 2024, and the
`time -- the time on the video monitor is 9:34 a.m.
`Eastern Time. The videographer for today is
`Lhassan Elmilki, representing Planet Depo, and the
`video deposition is taking place at 440 [sic]
`Biscayne Boulevard, Suite 980, Miami, Florida, ZIP
`Code is 33137.
` Would the counsel please voice identify
`themselves and state whom them -- who -- who they
`represent.
` MS. DASHE: I'm Christina Dashe from Sterne
`Kessler on behalf of Petitioner Hopewell. With me
`today remotely are Eldora Ellison, Olga Partington,
`and Tyler Lui, also of Sterne Kessler. And with me
`today in person with the witness is Madeleine Bond,
`also of Sterne Kessler.
` MR. MLAVER: Good morning, this is David
`Mlaver of WilmerHale on behalf of the patent owner.
`With me are Asher McGuffin and by remote Willem de
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`5
`
`

`

`09:35:03
`09:35:18
`
`09:35:19
`
`09:35:22
`09:35:26
`09:35:27
`09:35:34
`09:35:35
`09:35:36
`09:35:41
`09:35:50
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`6
`
` Weerd of Merck KGaA.
` THE COURT REPORTER: Doctor, would you raise
` your right hand, please.
` Do you swear or affirm the testimony you are
` about to give will be the truth and nothing but the
` truth?
` THE WITNESS: I do.
` THE COURT REPORTER: Thank you.
`THEREUPON,
` NICHOLAS BODOR, PHD, DSC, DHC, HOF,
`having been duly sworn to tell the truth, was examined
`and testified as follows:
` DIRECT EXAMINATION
`BY MS. DASHE:
` Q. Dr. Bodor, could you please state and spell
`your name for the record?
` A. I am Nicholas Bodor, N-I-C-H-O-L-A-S,
`B-O-D-O-R.
` Q. What is your address?
` A. Home address is 10225 Collins Avenue,
`Apartment 1002, Bal Harbour, Florida, 33154.
` Q. Have you ever been deposed before?
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`6
`
`

`

`09:35:57
`09:35:58
`09:36:02
`09:36:04
`09:36:05
`09:36:14
`09:36:20
`09:36:26
`09:36:26
`09:36:35
`09:36:39
`09:36:40
`09:36:40
`09:36:45
`09:36:47
`09:36:51
`09:36:53
`09:36:56
`09:36:57
`09:36:58
`09:37:03
`09:37:06
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`7
`
` A. Not like this.
` Q. ... this?
` Have you ever sat for a deposition in any
`capacity?
` A. I have to ask opinion. About 40 years ago, I
`was involved in a patent interference case and I was
`deposed, but not like this, it was just the counsel on
`both sides.
` Q. The deposition 20 years ago -- or 40 years
`ago, excuse me, in the patent interference case, have
`you ever been deposed before?
` A. No.
` Q. Okay. I would like to go over some ground
`rules for today's deposition. To start, I'll be asking
`you some questions, and your counsel may object, but
`it's important for the court reporter that we don't all
`talk over one another today.
` Is that all right?
` A. Yes.
` Q. And similarly, the court reporter cannot
`really take down nonverbal answers, like shaking your
`head or saying "um-hum." Can you please agree to give
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`7
`
`

`

`09:37:11
`09:37:11
`09:37:12
`09:37:16
`09:37:19
`09:37:22
`09:37:23
`09:37:23
`09:37:29
`09:37:32
`09:37:35
`09:37:37
`09:37:40
`09:37:40
`09:37:45
`09:37:48
`09:37:51
`09:37:52
`09:37:52
`09:37:57
`09:38:01
`09:38:01
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`8
`
`verbal answers today?
` A. Yes.
` Q. Sometimes your counsel may object to my
`questions, but you still have to answer them unless
`counsel directs you not to answer them. Will you agree
`to abide by this rule?
` A. Yes.
` Q. Now, if at any point today you need a break,
`please let me know and I will try to accommodate, but
`the patent office rules require that you do answer any
`pending questions before we take a break.
` Will you agree to abide by this rule?
` A. Yes.
` Q. If I ask a question today that you don't
`understand or need further clarification, will you agree
`to let me know, and I can try to clarify and ask a
`better question?
` A. Yes.
` Q. However, if you answer a question that I ask,
`I will assume that you understood it. Is that okay?
` A. Yes.
` Q. Now, because we are operating on a remote
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`8
`
`

`

`09:38:05
`09:38:08
`09:38:12
`09:38:15
`09:38:16
`09:38:20
`09:38:23
`09:38:26
`09:38:31
`09:38:32
`09:38:36
`09:38:41
`09:38:45
`09:38:46
`09:38:49
`09:38:52
`09:38:53
`09:38:54
`09:38:57
`09:38:58
`09:38:59
`09:39:08
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`9
`
`basis for today's deposition, there might be some
`technical difficulties. If anything happens that
`interferes with your ability to understand or answer my
`questions, will you agree to let me know?
` A. Yes.
` Q. Now, the patent office rules require that I
`tell you that during my questioning today, you are not
`permitted to discuss your testimony with counsel unless
`you are discussing an issue relating to privilege.
` Will you agree to abide by that rule?
` A. Yes.
` Q. ... why you cannot give truthful testimony
`today?
` A. I -- I don't understand.
` MR. MLAVER: Christina, the first few words of
` your question were cut off.
`BY MS. DASHE:
` Q. Is there any reason, Dr. Bodor, that you
`cannot give truthful testimony today?
` A. No reason.
` Q. Where are you located for today's deposition?
` A. You mean the -- this room? It's --
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`9
`
`

`

`09:39:12
`09:39:13
`09:39:18
`09:39:21
`09:39:26
`09:39:28
`09:39:31
`09:39:31
`09:39:32
`09:39:36
`09:39:38
`09:39:39
`09:39:42
`09:39:42
`09:39:49
`09:39:53
`09:39:54
`09:40:01
`09:40:05
`09:40:08
`09:40:11
`09:40:15
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`10
`
` Q. Yes, please.
` A. It's 4400 Biscayne Boulevard, on the 11th
`Floor, conference room.
` Q. And besides the counsel and videographer and
`court reporter that already announced their presence on
`the record today, is there anyone else in the room with
`you?
` A. No.
` Q. Okay. Whose computer are you using for
`today's deposition?
` A. I don't know.
` Q. It's someone else's?
` A. Yes.
` Q. Do you have any files or programs open on your
`computer besides the deposition video platform?
` A. I don't have any file with me.
` Q. Do you have access to any other files or
`programs besides today's deposition video platform?
` A. No. No. Not here. I don't have anything.
` MR. MLAVER: Counsel, if it's helpful, we're
` using Planet Depo's computer.
` MS. DASHE: Thank you.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`10
`
`

`

`09:40:16
`09:40:16
`09:40:18
`09:40:20
`09:40:24
`09:40:25
`09:40:29
`09:40:31
`09:40:31
`09:40:40
`09:40:40
`09:40:42
`09:40:46
`09:40:50
`09:40:52
`09:40:54
`09:41:00
`09:41:01
`09:41:09
`09:41:13
`09:41:17
`09:41:21
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`11
`
`BY MS. DASHE:
` Q. Do you have any other electronic devices with
`you today, like a cell phone, things of that nature?
` A. I have a cell phone. It was just put away by
`the counsel.
` Q. You won't be accessing your cell phone to
`receive messages or phone calls during the deposition
`today?
` A. I don't plan to, unless I am directed to do
`so.
` But it is turned off, by the way.
` Q. And including on breaks, you won't be
`accessing your cell phone for text messages, phone calls
`relating to the deposition today?
` A. I don't plan to, no.
` Q. Okay. Did you bring anything else with you to
`your deposition today?
` A. No, just my medication if I need it.
` MR. MLAVER: And, Counsel, we do have an
` otherwise unmarked copy of Dr. Bodor's declaration
` with us, if -- if that will assist. So we can
` provide that to him if -- if you need.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`11
`
`

`

`09:41:25
`09:41:27
`09:41:28
`09:41:30
`09:41:31
`09:41:33
`09:41:35
`09:41:38
`09:41:39
`09:41:41
`09:41:45
`09:41:48
`09:41:50
`09:41:51
`09:41:55
`09:41:57
`09:42:00
`09:42:02
`09:42:02
`09:42:09
`09:42:11
`09:42:17
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`12
`
` MS. DASHE: And, Counsel, that is unmarked, no
` notes or anything like that?
` MR. MLAVER: That's correct.
` MS. DASHE: Okay.
` MR. MLAVER: And Ms. Bond has had an
` opportunity to inspect it and see if that's the
` case.
` MS. DASHE: Okay. Thank you.
` THE WITNESS: One more thing I want to
` ment- -- I don't know if my iWatch, it does matter?
` MR. MLAVER: It -- not if you're not using it.
` THE WITNESS: Okay.
`BY MS. DASHE:
` Q. To totally clarify, Dr. Bodor, will you agree
`not to access your cell phone, or your Apple watch, or
`any other electronic device to receive messages or
`discuss your deposition today?
` A. Yes.
` Q. Okay, thank you.
` What did you do to prepare for this
`deposition?
` A. I reviewed my deposition [sic] and my patent,
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`12
`
`

`

`09:42:21
`09:42:32
`09:42:40
`09:42:45
`09:42:45
`09:42:47
`09:42:47
`
`09:42:57
`09:42:57
`09:43:03
`09:43:05
`09:43:06
`09:43:09
`09:43:09
`09:43:18
`09:43:22
`09:43:33
`09:43:35
`09:43:37
`09:43:51
`09:43:55
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`13
`
`and I had discussion with my counsel yesterday.
` Q. Patent, do you mean the Bodor PCT application?
` A. Yes, the Bodor PCT and the other two at-issue
`patents.
` Q. US patents, like Bodor --
` A. Yes.
` Q. Yes?
` A. Yes, patents which I am the sole inventor.
`Not with Dandiker.
` Q. So you reviewed two issued US patents where
`you were the sole inventor?
` A. I think, yes.
` Q. Do you recall what numbers those were?
` A. No.
` Q. You also said that you met with counsel
`yesterday. Who was that counsel?
` A. Next to me, David and Asher.
` Q. These patents that you reviewed, what were the
`titles of the patents that you reviewed?
` A. I think it's "Cladribine Oral Formulation" or
`something like that. I don't know the exact title.
` It was "Oral formulation of cladribine" --
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`13
`
`

`

`09:43:55
`09:43:59
`09:43:59
`09:44:02
`09:44:02
`09:44:12
`09:44:12
`09:44:16
`09:44:19
`09:44:22
`09:44:31
`09:44:33
`09:44:44
`09:44:46
`09:44:49
`09:44:53
`09:45:02
`09:45:03
`09:45:05
`09:45:07
`09:45:10
`09:45:11
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`14
`
` Q. Did you meet with your counsel yesterday?
` A. Yes.
` Q. I'm sorry, I talked over you. What did you
`say?
` A. I think it was "Oral Formulation for
`Cladribine."
` Q. For how long did you meet with counsel
`yesterday to prepare for today's deposition?
` A. I would say it was about three to four hours.
` Q. ... counsel, did you talk to anyone else
`regarding the substance of your deposition today?
` A. No.
` MS. DASHE: Emil, I would like you to
` introduce tab 1, which is the Bodor declaration,
` it's been marked as Exhibit 2054 in these
` proceedings.
` REMOTE ZOOM TECHNICIAN WHITE: Stand by.
` MR. MLAVER: Counsel, if we're going to ask
` questions about the declaration, is it all right if
` I hand him the paper copy of his declaration so he
` can refer to it?
` MS. DASHE: That is just fine, Counsel.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`14
`
`

`

`09:45:13
`09:45:14
`09:45:19
`09:45:20
`09:45:27
`09:45:28
`09:45:30
`09:45:31
`09:45:31
`09:45:36
`09:45:52
`09:45:52
`09:45:53
`09:45:55
`09:45:59
`09:46:02
`09:46:04
`09:46:07
`09:46:08
`09:46:12
`09:46:15
`09:46:15
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`15
`
` MR. MLAVER: Thank you.
` THE WITNESS: Thank you.
` REMOTE ZOOM TECHNICIAN WHITE: Now showing
` what has been marked as Exhibit 2054.
`BY MS. DASHE:
` Q. Dr. Bodor, can you see the document on the
`screen as well?
` A. Yes.
` Q. And Exhibit 2054, this is your declaration
`that you submitted in Cases IPR2023-00480 and
`IPR2023-00481?
` A. Yes.
` Q. And if I refer to "this case" or "this
`proceeding," I will be collectively referring to both of
`these IPRs. Will you understand that?
` A. Yes.
` Q. If you could please turn to the last page of
`your declaration.
` MS. DASHE: Which is page 13 of the PDF on the
` screen, Emil.
` A. Yes.
`BY MS. DASHE:
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`15
`
`

`

`09:46:15
`09:46:19
`09:46:24
`09:46:26
`09:46:27
`09:46:30
`09:46:31
`09:46:38
`09:46:39
`09:46:40
`09:46:43
`09:46:50
`09:46:53
`09:46:54
`09:46:56
`09:47:00
`09:47:07
`09:47:08
`09:47:08
`09:47:11
`09:47:11
`09:47:23
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`16
`
` Q. Let me know when you're there. Okay.
` And your declaration is signed and dated
`December 21st, 2023?
` A. Yes.
` Q. That's your signature that we see on the page?
` A. Yes.
` Q. Do you stand by your testimony in your
`declaration in this case?
` A. Yes.
` Q. You were asked to provide this declaration as
`an inventor of the Bodor PCT patent application titled
`"Oral Formulations to Cladribine"?
` A. Yes.
` Q. When were you first approached to provide your
`declaration in this case?
` A. I don't remember the exact date, but must have
`been some -- sometime in December.
` Late --
` Q. And that would be December 2023?
` A. Yes.
` Q. Who approached you to provide your declaration
`in this case?
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`16
`
`

`

`09:47:23
`09:47:25
`09:47:27
`09:47:30
`09:47:35
`09:47:43
`09:47:46
`09:47:46
`09:47:51
`09:47:53
`09:47:53
`09:47:55
`09:48:01
`09:48:04
`09:48:08
`09:48:10
`09:48:10
`09:48:16
`09:48:19
`09:48:20
`09:48:29
`09:48:29
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`17
`
` MR. MLAVER: If you recall who it was, you can
` answer, but I'll caution you not to reveal the
` substance of any communication with counsel.
` A. I really don't remember with who. It was
`maybe my assistant who took the -- the message from the
`patent office -- I mean the law office.
`BY MS. DASHE:
` Q. So was it Merck or its counsel, then, that
`reached out to you to provide your declaration in this
`case?
` Yes-or-no question.
` A. I assume so. Yeah.
` Q. So you have no reason to believe anybody
`besides Merck's counsel reached out to you to provide
`your declaration in this case; right?
` A. No.
` Q. How long did you spend preparing your
`declaration?
` A. I think about four or five hours.
` Q. Was that over the course of multiple days?
` A. Yes.
` Q. Do you know who else provided a declaration in
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`17
`
`

`

`09:48:35
`09:48:41
`09:48:47
`09:48:50
`09:48:56
`09:48:57
`09:48:59
`09:49:00
`09:49:07
`09:49:08
`09:49:08
`09:49:16
`09:49:18
`09:49:18
`09:49:21
`09:49:25
`09:49:28
`09:49:38
`09:49:45
`
`09:49:46
`09:49:47
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`18
`
`this case?
` A. I -- I just learned that I believe Yogesh
`Dandiker did too, my coinventor.
` Q. Just learned, how recently was that?
` A. I think yesterday.
` Q. And so you learned that from counsel?
` A. Yes.
` Q. And have you read Dr. Dandiker's declaration
`in this case?
` A. No.
` Q. And are you aware of anyone else who provided
`a declaration in this case?
` A. No.
` Q. And so because you just learned yesterday that
`Dr. Dandiker provided a declaration, you did not assist
`him in drafting his declaration; correct?
` A. I didn't talk to Dr. Dandiker for 20 years.
` Q. And so Dr. Dandiker also did not help you
`draft or provide your declaration --
` A. No.
` Q. -- in this case; correct?
` A. No.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`18
`
`

`

`09:49:47
`09:49:52
`09:49:59
`09:50:00
`09:50:07
`09:50:10
`09:50:10
`09:50:21
`09:50:24
`09:50:26
`09:50:31
`09:50:39
`09:50:49
`09:50:52
`09:50:55
`09:50:58
`09:51:03
`09:51:11
`09:51:12
`09:51:12
`09:51:20
`09:51:20
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`19
`
` Q. Besides counsel, did you communicate with
`anyone else in order to create your declaration?
` A. My assistant in my office.
` Q. And do you know what the substance of
`Dr. Dandiker's declaration is in this case?
` A. No.
` Q. So besides your assistants in your office and
`counsel, you did not communicate with anyone else in
`order to create your declaration in this case; right?
` A. To prepare the declaration?
` I did ask my former director of research at
`IVAX to send me files related to cladribine.
` Q. And -- and who -- what was that person's name?
` A. That is Dr. Peter Buchwald.
` Q. Could you spell that for the record, please?
` A. B-U-C-H-W-A-L-D.
` Q. ... speak or communicate with Dr. Buchwald in
`the presence of counsel?
` A. No.
` Q. So what did you speak with Dr. Buchwald about
`specifically?
` A. Just to send me -- actually, my assistant
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`19
`
`

`

`09:51:23
`09:51:32
`09:51:39
`09:51:40
`09:51:42
`09:51:43
`09:51:45
`09:52:00
`09:52:01
`09:52:02
`09:52:05
`09:52:11
`09:52:14
`09:52:18
`09:52:18
`
`09:52:18
`09:52:18
`09:52:37
`09:52:42
`09:52:54
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`20
`
`called him to send me the -- if he has any file on the
`cladribine work we have done in the research institute
`in Hungary.
` Q. Did he send you any files?
` A. Yes.
` Q. What files did he send you?
` A. Monthly reports.
` Q. Monthly reports?
` A. Yes.
` And two annual reports too.
` Q. How did Dr. Buchwald send you these reports?
`Was it by email? Mail? Something else?
` A. I think by email, and my assistant then made
`copies.
` Q. ... is Dr. Buchwald?
` THE COURT REPORTER: Excuse me, you broke off.
` This is the court reporter.
`BY MS. DASHE:
` Q. Where is Dr. Buchwald?
` A. He is a professor at University of Miami.
` Q. When you say University of Miami, that's in
`Florida?
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`20
`
`

`

`09:52:54
`09:52:54
`09:53:07
`09:53:10
`09:53:10
`09:53:28
`09:53:33
`09:53:34
`09:53:39
`09:53:39
`09:53:46
`09:53:52
`09:53:59
`09:54:03
`09:54:09
`09:54:13
`09:54:21
`09:54:30
`09:54:36
`09:54:39
`09:54:48
`09:54:50
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`21
`
` A. Yes.
` Q. And did you provide these monthly reports and
`annual reports Dr. Buchwald sent you to counsel?
` A. Yes.
` Q. And so -- and Dr. Buchwald, did he work with
`you on the cladribine project at IVAX?
` A. No. No, he did not.
` Q. How would Dr. Buchwald have had these files,
`then?
` A. Because he was my assistant at IVAX. He had
`the position of assistant director of research. And so
`he was contact in between the researchers in Budapest
`and me and my assistants. So he was part of my team,
`but he did not work on cladribine here, I don't believe
`he had any involvement of any kind.
` Q. ... a cladribine team at IVAX?
` A. Yes, well, there was not really a team, but
`most of the work was done, actually, at Budapest, at the
`research institute, where they developed the analytical
`methods and then the pharmacokinetic and bioavailability
`studies.
` But Buchwald was not part of it.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`21
`
`

`

`09:54:51
`09:54:55
`09:54:55
`09:54:56
`09:54:59
`09:55:01
`09:55:02
`09:55:04
`09:55:04
`09:55:07
`09:55:12
`09:55:19
`09:55:20
`09:55:22
`09:55:22
`09:55:25
`09:55:28
`09:55:29
`09:55:43
`09:55:50
`09:55:57
`09:55:58
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`22
`
` Q. ... talk to Dr. Buchwald about your
`cladribine --
` A. He was not part of this.
` Q. Okay. So Dr. -- so Dr. Buchwald was not part
`of the actual cladribine research?
` A. Right.
` Q. He was part of --
` A. Correct.
` Q. Okay. And when you reached out to
`Dr. Buchwald about your cladribine files, did you
`discuss those files with him at all?
` A. No.
` Q. Their substance?
` A. No.
` Q. And before you reached out to Dr. Buchwald
`about these documents, when was the last time you had
`spoken with him?
` A. Last fall sometime. His father, who was my
`best friend at the university, passed away, and then we
`talked about his memories and...
` Q. I'm sorry to hear that.
` Besides reaching out to Dr. Buchwald about his
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`22
`
`

`

`09:56:02
`09:56:06
`09:56:06
`09:56:12
`09:56:22
`09:56:29
`09:56:32
`09:56:33
`09:56:42
`09:56:45
`09:56:50
`09:56:51
`09:56:53
`09:56:55
`09:56:57
`09:57:06
`09:57:09
`09:57:12
`09:57:15
`09:57:15
`09:57:25
`09:57:29
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`23
`
`father, when was the last time you had spoken with him
`before that?
` A. We spoke in -- occasionally last year, because
`I nominated him to be member of the Florida Academia of
`Sciences, and so I needed update his CV.
` But I talked to him on the phone. I -- I
`don't remember when I met him in person.
` Q. And so do you know if Merck provided these
`documents you received from Dr. Buchwald to Hopewell?
` A. I'm sorry, can I have -- you ask again?
` Q. Yeah.
` Do you know if Merck provided these --
` A. Merck. Yeah.
` Q. -- documents to Hopewell?
` A. No. No. These were our files in my I- -- in
`IVAX office.
` Q. And did you provide all of the files you
`received from Dr. Buchwald to Merck's counsel?
` A. Yes.
` Q. Do you recall -- is it that you don't know
`whether or not Merck provided the documents to Hopewell?
`Or Merck did not provide the documents to Hopewell?
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`23
`
`

`

`09:57:34
`09:57:42
`09:57:46
`09:57:50
`09:57:56
`09:57:58
`09:58:03
`09:58:07
`09:58:12
`09:58:14
`09:58:22
`09:58:23
`09:58:27
`09:58:31
`09:58:32
`09:58:34
`09:58:38
`09:58:38
`09:58:42
`09:58:47
`09:58:51
`09:58:52
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`24
`
` A. I really don't know if Merck had these
`reports, because these were in Hungarian, internal
`reports of the Hungarian research institute, which I was
`director of, and which they did the analytical and
`pharmacokinetic development.
` Q. ... was a little bit different.
` My question was did Merck not provide these
`documents from Dr. Buchwald to Hopewell? Or do you not
`know whether or not Merck provided these documents to
`Hopewell?
` A. I -- again, I said I don't know if Merck had
`these reports, because these were Hungarian reports
`internal to the institute. So I don't think Merck had
`these reports.
` Q. ... one way or another whether or not Merck
`provided these reports from Dr. Buchwald to Hopewell;
`correct?
` A. I don't know.
` Q. Okay. But Merck's counsel has these reports
`from Dr. Buchwald at this point in time; correct?
` A. Yes.
` Q. Okay. Do you know what the substance of these
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`24
`
`

`

`09:58:58
`09:59:00
`09:59:00
`09:59:03
`09:59:07
`09:59:08
`09:59:16
`09:59:24
`09:59:27
`09:59:34
`09:59:45
`09:59:46
`09:59:46
`09:59:49
`
`09:59:55
`09:59:59
`09:59:59
`10:00:02
`10:00:02
`10:00:09
`10:00:12
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`25
`
`reports are from Dr. Buchwald?
` A. Yes.
` Q. And what is that?
` MR. MLAVER: Objection, form.
` You can answer.
` A. I mentioned before that the bioavailability
`and pharmacokinetic studies were done by the research
`institute in Hungary. And these monthly and then annual
`report related to the findings of animal and then human
`studies of the very formulation which we developed in
`my -- in our patent.
`BY MS. DASHE:
` Q. That formulation you're referring to in your
`patent in your declaration is the complex --
` A. Complex --
` Q. -- cladribine-cyclodextrin complex; correct?
` A. Yes.
` Q. Okay. And that's the formu- -- that --
`scratch that.
` The complex cladribine-cyclodextrin complex
`described in your Bodor PCT application and your
`declaration, that's your invention; right?
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`25
`
`

`

`10:00:15
`10:00:21
`10:00:21
`10:00:29
`10:00:34
`10:00:37
`10:00:39
`10:00:47
`10:00:48
`10:00:53
`10:00:58
`10:01:01
`10:01:01
`10:01:05
`10:01:14
`10:01:15
`10:01:24
`10:01:26
`10:01:40
`10:01:42
`10:01:43
`10:01:48
`
`CONFIDENTIAL
`Transcript of Nicholas Bodor, Ph.D., DSc, dhc, HoF
`Conducted on February 15, 2024
`
`26
`
` A. That's my invention and Dr. Dandiker's
`invention.
` Q. And you just referred to bioavailability and
`pharmacokinetic studies related to the findings of
`animal and human studies. What were those findings?
` A. Well, actually, all of those findings or
`almost all you can find in our patents, in the PCT
`patent.
` Q. The reports you received from Dr. Buchwald
`contain study results that were ultimately disclosed in
`your Bodor PCT application?
` A. Correct.
` Q. And when were these reports prepared?
` A. As I remember, it was in 2003, '4, '5. Mostly
`'4.
` Q. And how many documents did you receive from
`Dr. Buchwald?
` A. As I remember, about five or six monthly
`reports, or -- monthly, and two annual reports in
`English.
` Q. How many pages are the reports apiece?
` A. I would estimate about six or seven pages.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`26
`
`

`

`10:01:53
`10:02:01
`10:02:04
`10:02:04
`10:02:14
`10:02:19
`10:02:26
`10:02:32
`10:02:35
`10:02:35
`10:02:39
`10:02:45
`10:02:50
`10:02:51
`10:02:57
`10:02

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket