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`
`Transcript of Rodolfo Pinal, Ph.D.
`
`Date: April 26, 2024
`Case: Hopewell Pharma Ventures, Inc. -v- Merck Serono, S.A. (PTAB)
`
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`
`Merck 2080
`Hopewell v Merck
`IPR2023-00480
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`
`
`Reported by: Karen Young
`
`0
`048048
`
`I PR2023-
`3,9
`7,
`71
`Patent
`48
`ITPR2023-00
`377,903
`U.S. Patent 8,
`
`S.
`
`Deposition of RODOLFO PINAL, PH.D.
`
`Washington, D.C.
`
`Friday, April 26, 2024
`
`9:03 a.m.
`
`Job No. 534629
`
`Pages 1 - 134
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES,
`
`INC.
`
`Petitioner,
`
`Vv.
`
`MERCK SERONO S.A.,
`
`Patent Owner.
`
`4’]
`
`1 7
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`
`
`Deposition of RODOLFO PINAL, PH.D., held at
`
`the offices of:
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`2
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Notary Public of the District of Columbia.
`
`STERNE, KESSLER,
`
`GOLDSTEIN & FOX, P.L.L.C.
`
`1101 K Street, Northwest
`
`Washington, D.C. 20005
`
`(202) 371-2600
`
`Pursuant to notice, before Karen Young,
`
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`
`
`3
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`APPEARANCES
`
`ON BEHALF OF HOPEWELL PHARMA VENTURES,
`
`INC.:
`
`PRATIBHA KHANDURI, PH.D., ESQUIRE
`
`ELDORA L. ELLISON, PH.D., ESQUIRE
`
`OLGA A. PARTINGTON, ESQUIRE
`
`STERNE, KESSLER,
`
`GOLDSTEIN & FOX, P.L.L.C.
`
`1101 K Street, Northwest
`
`Washington, D.C. 20005
`
`(202) 371-2600
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Emil White, Remote Technician
`
`ON BEHALF OF MERCK SERONO S.A.:
`
`SCOTT BERTULLI, ESQUIRE
`
`DERIC X. GENG, ESQUIRE
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`
`60 State Street
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`Boston, Massachusetts 02109
`
`(617) 526-6000
`
`PRESENT:
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`4
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`Cc
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`O
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`N
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`T
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`E
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`N TS
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`EXAMINATION OF RODOLFO PINAL, PH.D.
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`By Mr. Bertulli.... ee. cee eee ee ee ee ee eee
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`By Ms. Khanduri....... cee eee ee eee ee eee
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Paper by Liliemark et al.......
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`EXHIBITS REFERRED TO
`
`(Retained by Counsel)
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`Exhibit 1013
`
`Paper by Stelmasiak et al......
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`Exhibit 1018
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`Paper by Rice et al............
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`Exhibit 1022 World Intellectual Property
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`Organization Publication No. WO
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`2004/087101 AZ... eee ee ee eee ee ee eee
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`Exhibit 1080 Declaration in IPR2023-00480...
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`Exhibit 1080 Declaration in IPR2023-00481...
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`Exhibit 2043
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`(Exhibits were marked prior to the deposition.)
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`PROCEEDINGS
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`RODOLFO PINAL, PH.D.,
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`having been duly sworn, was examined as follows:
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`EXAMINATION BY COUNSEL FOR MERCK SERONO S.A.
`
`BY MR. BERTULLI:
`
`Good morning, Dr. Pinal.
`
`Good morning.
`
`Thank you for joining us today.
`
`Thank you.
`
`You understand that you're under oath
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`And it's not a quiz, but one of them is
`
`I do.
`
`Q
`
`Is there any reason that you cannot
`
`provide complete and truthful testimony today?
`
`A
`
`Q
`
`There is no reason.
`
`Okay. And -- well,
`
`let me ask you this
`
`guestion.
`
`You understand that today's deposition
`
`is covering two IPR proceedings, right?
`
`That is my understanding.
`
`A
`
`Q
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`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Correct.
`
`we're covering today is IPR2023-00481.
`
`Is that
`
`also your understanding?
`
`A
`
`Q
`
`That is also my understanding.
`
`Okay, and you've also consulted a hard
`
`copy of your declaration in that second proceeding;
`
`is that right?
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`A
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`6
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`IPR2023-00480. Does that sound right?
`
`A
`
`Q
`
`That sounds right.
`
`And I see that you've consulted a
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`document to answer my question. What is that
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`document you've got there with you?
`
`A
`
`The document I'm holding in my hands
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`right now is a copy of my declaration on
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`IPR2023-00480.
`
`Q
`
`And does that copy of your declaration
`
`have an exhibit number in the bottom right-hand
`
`corner on the cover?
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`It does.
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`And what's that number?
`
`The number is EX1080.
`
`Okay. And then the other proceeding that
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`A
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`Q A
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`Q
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`
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`QO
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`And does it have an exhibit number in the
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`7
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`lower right-hand corner?
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`It does.
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`And what's that number?
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`EX1080.
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`counsel. Subject to that instruction, you can
`
`Q
`
`Do you have any other hard copies of
`
`documents with you today?
`
`A
`
`The only hard copies of documents that I
`
`have with me today are the two documents for which
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`I read the exhibit number for you.
`
`QO
`
`Q
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`Your declarations.
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`That is correct.
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`Are those clean copies of your
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`declarations?
`
`A
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`Both copies are clean. There are no
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`annotations by anyone on either of them.
`
`Q
`
`Great.
`
`Do you recall when you were
`
`contacted to participate in this case?
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`MS. KHANDURI: Objection. Dr. Pinal,
`
`I
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`will remind you to -- I will caution you to not
`
`divulge the substance of communications with
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
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`That is correct.
`
`answer the question.
`
`A
`
`I have a recollection of being contacted
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`for the first time to work on this case.
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`8
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`Do you recall when that was?
`
`Not precisely.
`
`Do you have an estimate of when that was?
`
`A good estimate that I would give is a
`
`QO
`
`A Q
`
`O
`
`A
`
`few months ago.
`
`Q
`
`A few months ago? And that's a few
`
`months ago from today, April 26th, 2024.
`
`A
`
`Q
`
`A few months prior to April 26th, 2024.
`
`And without sharing any content of any
`
`privileged communications, do you recall who
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`reached out to you to participate in this case?
`
`I do.
`
`Who was that?
`
`Ms. Bond.
`
`is Ms. Bond?
`
`Bond is a person that works at the
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`I'm working with.
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`Okay, and that firm's Sterne Kessler?
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`9
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`Q
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`Okay.
`
`How many times have you provided a
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`declaration in an inter partes review proceeding
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`before this case?
`
`A
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`I cannot give you a precise number, but I
`
`know that there is at least one.
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`QO
`
`A
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`estimate.
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`Less than ten times?
`
`Less than ten times would be an adequate
`
`Q
`
`And do you recall how many times, if any,
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`you've given deposition testimony before today?
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`A
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`Deposition testimony in general or for
`
`IPR proceedings?
`
`Q
`
`That was going to be my next question.
`
`So you can answer in general, and then we can break
`
`it up if that would be helpful, but how about
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`generally first, how many times have you sat for a
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`this is
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`deposition?
`
`A
`
`Q
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`In general, about 15 times.
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`And to your point of clarification, how
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`many of those times were for an inter partes review
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`proceeding?
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`A
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`To the best of my recollection,
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`10
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`the first time that I'm deposed on a IPR
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`proceeding.
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`Q
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`Okay,
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`so for the rest of those 15
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`depositions, were those District Court litigations
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`that you gave testimony for?
`
`A
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`I don't know the specific legal
`
`Situations, but
`
`I would say that I believe so.
`
`Q
`
`Has every deposition that you've
`
`participated in been with regard to a patent
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`My preparation for this deposition
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`dispute?
`
`A
`
`Q
`
`I believe so.
`
`Let's -- I'm going to ask you questions
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`about your declaration shortly, but some more
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`housekeeping. Did you prepare for today's
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`deposition?
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`MS. KHANDURI:
`
`I will caution the witness
`
`not to divulge the substance of the communications
`
`with counsel. Subject to that instruction, you can
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`answer the question.
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`A
`
`Q
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`I did.
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`Yes or no, did you prepare with counsel?
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`ie
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`included meeting with counsel.
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`Q
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`The part of your preparation that
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`included meeting with counsel, did that take place
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`in one meeting?
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`A
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`Q
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`It did not.
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`How many meetings did your -- strike
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`that.
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`How many times did you meet with counsel to
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`prepare for your deposition?
`
`A
`
`QO
`
`My estimate is about five times.
`
`Did all five meetings with counsel take
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
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`present for your preparation?
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`place in person?
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`A
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`Q
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`They did not.
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`How many of the five meetings with
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`counsel
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`took place in person?
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`A
`
`Q
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`Three.
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`Without disclosing any privileged
`
`communications or the content of your discussions,
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`which counsel was present for your preparation for
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`this deposition?
`
`A
`
`QO
`
`The three attorneys here present.
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`Was anyone else who was not an attorney
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`12
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`A
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`There was no one else other than the
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`three attorneys here present.
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`QO
`
`And is that true for all five meetings
`
`that you conducted to prepare for today's
`
`deposition?
`
`A
`
`It is true for the three meetings we had
`
`in person.
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`To the best of my knowledge, it was
`
`also true for the meetings we have video
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`conference.
`
`Q
`
`Understood. And so what preparation did
`
`you do for your deposition that did not include
`
`meeting with counsel?
`
`A
`
`It included reading my declaration and
`
`reviewing the materials considered for the most
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`than counsel as part of my preparation.
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`part.
`
`Q
`
`A
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`What do you mean by for the most part?
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`It also involved thought process of
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`connecting concepts.
`
`Q
`
`Did you speak with anyone besides counsel
`
`during your preparation?
`
`A
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`I have not spoken with any person other
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`13
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`Q
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`Have you ever spoken with anyone other
`
`than counsel about this case at all since you've
`
`begun working on it?
`
`A
`
`I have not spoken about this case with
`
`anybody outside counsel.
`
`Q
`
`Why don't you pick up your copy of
`
`Exhibit 1080, which I think is your declaration in
`
`the IPR2023-00480 proceeding.
`
`I have it in front of me.
`
`And if I could ask you to please turn to
`
`That's the very end. Are you there?
`
`I am there.
`
`Okay, and page 45 of your declaration
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`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
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`jumping
`
`shows your signature.
`
`Do you see that?
`
`I see it.
`
`Is that your signature?
`
`That is my Signature.
`
`Q
`
`And you signed this declaration on April
`
`3rd, 2024.
`
`A
`
`Q
`
`That is correct.
`
`Okay, and I'm hoping to just have us
`
`stick with one declaration so you're not
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`14
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`back and forth all day, but if you go to your other
`
`declaration in the 00481 proceeding --
`
`I have it in front of me.
`
`Can you please go to the last page there?
`
`IT am on the last page.
`
`And does the last page of your second
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`your declarations are true and correct to the best
`
`declaration also bear your signature?
`
`This is also my signature.
`
`And you signed it?
`
`I did sign it.
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`And you signed it on April 3rd, 2024.
`
`I signed it on April 3rd, 2024.
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`And you said you reviewed your
`
`A
`
`Q A Q A
`
`Q
`
`declarations as part of your preparation;
`
`is that
`
`right?
`
`A
`
`Q
`
`That is correct.
`
`Are there any opinions in either of your
`
`declarations that you'd like to change today?
`
`A
`
`The opinions presented in my declarations
`
`have not changed as of this moment.
`
`Q
`
`So each of your opinions contained in
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`of your understanding.
`
`A
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`To the best of my understanding,
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`they are
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`true and correct.
`
`Q
`
`Are you equally confident in every one of
`
`your opinions?
`
`A
`
`QO
`
`Could you clarify the question?
`
`Sure.
`
`So each of your declarations
`
`includes more than one of your opinions.
`
`Is that
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`At paragraph 21, you write, "In
`
`fair?
`
`A
`
`My declaration contains different aspects
`
`of my general opinion.
`
`Q
`
`And are you equally confident in every
`
`aspect of your opinions in your declarations?
`
`A
`
`All the opinions that I present as part
`
`of my general opinion represent my level of
`
`confidence on them.
`
`Q
`
`Why don't we stick with the Exhibit 1080
`
`declaration in the 00480 case, okay?
`
`Okay.
`
`Could you please turn to page 8?
`
`I am on page 8.
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`16
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`formulating my opinions,
`
`I considered the following
`
`documents."
`
`Do you see that?
`
`A
`
`Q
`
`I see it.
`
`And then there is a table that reads from
`
`the bottom of page 8 it looks like all the way
`
`through pages 9, 10 and 11.
`
`Do you see that table?
`
`A
`
`Q
`
`I do.
`
`Did you consider any documents in
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`read that correctly?
`
`formulating your opinions that are not included in
`
`this table?
`
`A
`
`The documents considered in forming my
`
`opinion are listed on this document.
`
`Q
`
`And you considered every document that's
`
`listed in this table?
`
`A
`
`I read and considered every document in
`
`forming my opinion.
`
`Q
`
`Okay,
`
`so looking at the bottom of page 8,
`
`do you see an Exhibit Number 1002?
`
`A
`
`Q
`
`I see it.
`
`And the description of that exhibit
`
`reads, “Declaration of Aaron Miller, M.D." Did I
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`A
`
`Q
`
`You did.
`
`So in formulating your opinions in your
`
`declaration, you considered Dr. Miller's
`
`declaration, Exhibit 1002;
`
`is that right?
`
`A
`
`Q
`
`I did consider Dr. Miller's declaration.
`
`Did you agree with all of the opinions
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`declaration?
`
`that Dr. Miller set forth in Exhibit 1002?
`
`MS. KHANDURI: Objection, scope.
`
`A
`
`My opinion as per what I was asked to
`
`opine on refer to the formulation and the dosage
`
`form and the times of treatment regimen without
`
`extending to the therapy of multiple sclerosis.
`
`QO
`
`Did Dr. Miller's declaration of Exhibit
`
`1002 include any opinions as to formulation?
`
`A
`
`Could I have a copy of Dr. Miller's
`
`declaration?
`
`Q
`
`I'm just asking you questions about your
`
`review. You reviewed it, right?
`
`A
`
`Q
`
`I review it.
`
`I did not memorize it.
`
`Okay.
`
`Do you recall if Dr. Miller
`
`provided any opinions about formulation in his
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`A
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`Could I have a copy of Dr. Miller's
`
`declaration?
`
`Q
`
`I just asked if you recalled, and I hear
`
`you requesting a copy, but your deposition's not
`
`about Dr. Miller's declaration.
`
`It's about your
`
`declaration and your review of Dr. Miller's
`
`declaration.
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`his declaration, would that have stuck with you?
`
`A
`
`As
`
`I sit here right now,
`
`I cannot give
`
`you a precise recollection of what
`
`I read in
`
`Dr. Miller's declaration.
`
`QO
`
`Do you think that if you had read
`
`something in Dr. Miller's declaration that you
`
`disagreed with, you would have remembered it?
`
`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`A
`
`QO
`
`I don't understand your question.
`
`Well, you read Dr. Miller's declaration,
`
`Exhibit 1002;
`
`is that right?
`
`A
`
`Q
`
`That is correct.
`
`So in your reading it, if you had
`
`encountered something that you disagreed with in
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`19
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`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`A
`
`Dr. Miller's declaration bases on the
`
`therapy of multiple sclerosis for a person of skill
`
`in the art who had chosen to utilize cladribine.
`
`I
`
`have not been asked to opine on that subject, and
`
`as such,
`
`I don't disagree.
`
`I have no reason to
`
`disagree with Dr. Miller's opinion.
`
`Q
`
`Okay,
`
`so that's fair.
`
`So then let me ask
`
`it this way. You don't have any reason to dispute
`
`anything that was included in Dr. Miller's
`
`declaration of Exhibit 1002.
`
`Is that fair?
`
`A
`
`I have found no reason to dispute the
`
`opinions of Dr. Miller.
`
`Q
`
`What is your understanding of
`
`Dr. Miller's expertise?
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`IT have not memorized Dr. Miller's
`
`A
`
`Could I have a copy of Dr. Miller's
`
`declaration?
`
`Q
`
`Do you need a copy of Dr. Miller's
`
`declaration to identify your understanding of his
`
`expertise?
`
`A
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`20
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`declaration.
`
`QO
`
`Dr. Miller's a neurologist;
`
`is that
`
`right?
`
`A
`
`I have not memorized the career path of
`
`Dr. Miller.
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`So you did not see Dr. Miller's second
`
`Q
`
`Q
`
`Have you ever talked to Dr. Miller?
`
`I have not.
`
`Have you ever communicated with
`
`Dr. Miller through other electronic means like
`
`e-mail or text message?
`
`A
`
`QO
`
`I have not.
`
`Has Dr. Miller ever consulted with you
`
`with respect to this case?
`
`A
`
`QO
`
`He has not.
`
`Are you aware if Dr. Miller has submitted
`
`any other declarations in support of this case?
`
`A
`
`I am aware that Dr. Miller submitted,
`
`to
`
`the best of my knowledge,
`
`two declarations.
`
`Q
`
`Have you ever seen Dr. Miller's second
`
`declaration in this case?
`
`I have not.
`
`A
`
`Q
`
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`21
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`declaration at the time that you signed your
`
`declaration in this case.
`
`A
`
`QO
`
`I did not.
`
`Do you know if Dr. Miller has ever
`
`reviewed your declaration in this case?
`
`A
`
`I don't have direct or firsthand
`
`knowledge on the answer to that question.
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`one.
`
`Q
`
`And that's totally fair.
`
`I just want to
`
`know if you know. Who knows what he's done on his
`
`own or otherwise.
`
`Just you, do you know if
`
`Dr. Miller has ever reviewed your declaration in
`
`this case?
`
`A
`
`Q
`
`To my knowledge,
`
`I don't know.
`
`In your declaration, can you please turn
`
`to paragraph 13?
`
`A
`
`Q
`
`I have paragraph 13 in front of me.
`
`You are an expert in the field of
`
`pharmacology;
`
`is that right?
`
`A
`
`I refer to myself as a pharmaceutical
`
`scientist, and as such, pharmacology is one of the
`
`subjects of my expertise, but it is not the only
`
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`
`Q
`
`Is pharmacokinetics an aspect of your
`
`expertise in pharmacology?
`
`A
`
`Pharmacokinetics is a subset of the
`
`pharmaceutical sciences,
`
`like pharmacology.
`
`It is
`
`part of the expertise of a pharmaceutical
`
`scientist.
`
`Q
`
`Are you comfortable if I refer to
`
`pharmacokinetics today as PK?
`
`A
`
`I will be comfortable with that.
`
`Is formulation an aspect of PK?
`
`A
`
`Formulation is another subject that falls
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`form.
`
`under pharmaceutical sciences.
`
`QO
`
`So -- so that I understand,
`
`so
`
`formulation falls outside the scope of PK
`
`specifically?
`
`A
`
`In the pharmaceutical sciences,
`
`the
`
`different subjects or sub-subjects are
`
`interconnected, but they have somewhat different
`
`focus because each one covers a slightly different
`
`aspect.
`
`QO
`
`So what is,
`
`in your words,
`
`formulation?
`
`MS. KHANDURI: Objection,
`
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`A
`
`Formulation in the pharmaceutical context
`
`is the design of -- the design, preparation,
`
`manufacture of compositions used in pharmaceutical
`
`processes.
`
`@)
`
`And how does formulation factor into the
`
`design, preparation and manufacture of compositions
`
`used in pharmaceutical processes?
`
`A
`
`Q
`
`Can you repeat your question please?
`
`Sure.
`
`How does formulation factor into
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`the word "absorption," into the body of the
`
`the design, preparation and manufacture of
`
`compositions used in pharmaceutical processes?
`
`MS. KHANDURI: Objection,
`
`form, scope.
`
`A
`
`I absolutely don't understand your
`
`question.
`
`Q
`
`Okay. What is drug absorption in the
`
`context of pharmaceutical sciences?
`
`A
`
`In the context of pharmaceutical
`
`sciences, drug absorption is the process that
`
`follows administration of a drug into a subject or
`
`patient such that the drug, for lack of a better
`
`term, gets incorporated, not to be redundant with
`
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`24
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`subject.
`
`Q
`
`And you looked at drug absorption as part
`
`of your analysis in this case;
`
`is that right?
`
`A
`
`Drug absorption is one of the phenomena
`
`involved in considering the attributes of
`
`pharmaceutical formulations and pharmaceutical
`
`products.
`
`Q
`
`In the context of pharmaceutical
`
`sciences, what is solubility?
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Solubility is one of the parameters that
`
`A
`
`Solubility is a property of chemical
`
`substances that refers to the maximum concentration
`
`that can be achieved for a given substance ina
`
`liquid solution.
`
`Q
`
`And you looked at solubility as part of
`
`your analysis in this case.
`
`Is that true?
`
`A
`
`The solubility phenomenon is part of the
`
`parameters that are taken into account when
`
`considering pharmaceutical products or
`
`pharmaceutical dosage forms.
`
`QO
`
`And you would have taken solubility into
`
`account
`
`in your analysis in this case.
`
`A
`
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`25
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`is taken into account.
`
`Q
`
`Is permeability another parameter that
`
`would have been taken into account
`
`in your analysis
`
`in this case?
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`in the context of pharmaceutical sciences?
`
`A
`
`Permeability is another parameter that is
`
`taken into account when considering pharmaceutical
`
`products or pharmaceutical dosage forms.
`
`Q
`
`A
`
`And what is permeability in this context?
`
`Permeability can be put as the ability of
`
`a molecule,
`
`in this case a drug molecule,
`
`to
`
`penetrate tissues of the body of the subject to
`
`whom a drug has been administered.
`
`Q
`
`Is dosage form another parameter that you
`
`would have taken into account
`
`in your analysis in
`
`this case?
`
`A
`
`Q
`
`Could you clarify your question?
`
`Sure. Well, are you familiar with the
`
`phrase "dosage form"?
`
`A
`
`I am, and that is why I'm asking you to
`
`clarify your question.
`
`Q
`
`Well, what does dosage form mean to you
`
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`A
`
`Dosage form is the physical
`
`form, for
`
`example, a tablet or a capsule, which is used to
`
`administer a formulation to a patient or subject.
`
`Q
`
`Were you consulting a particular
`
`paragraph of your declaration while arriving at
`
`your answer?
`
`A
`
`I was consulting a footnote.
`
`Which footnote was that?
`
`It is footnote number 2.
`
`Q
`
`You mentioned tablets and capsules as
`
`examples of dosage form;
`
`is that right?
`
`A
`
`In my previous answer,
`
`those are the two
`
`terms that I used.
`
`Q
`
`Is a solution another example of dosage
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Did you analyze any examples of
`
`MS. KHANDURI: Objection,
`
`form.
`
`Dosage forms include solutions.
`
`Is sublingual film an example of a dosage
`
`MS. KHANDURI: Objection,
`
`form.
`
`Dosage forms include sublingual films.
`
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`sublingual films as part of your analysis in this
`
`case?
`
`A
`
`I have no precise recollection of that.
`
`Can you describe what a sublingual film
`
`Iocan.
`
`Could you please?
`
`A sublingual film in general terms is a
`
`Q
`
`A
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`sublingual films were first developed in
`
`thin layer of a material,
`
`typically polymeric
`
`material or a material that has the ability to form
`
`films, and in that thin layer, a drug is embedded,
`
`and that piece of material is placed in the mouth
`
`cavity, and if it is sublingual, it is under the
`
`tongue, and when placed in there,
`
`that is how it is
`
`administered.
`
`QO
`
`Do you recall when you first encountered
`
`sublingual films in your work in the field?
`
`MS. KHANDURI: Objection, scope.
`
`A
`
`I don't recall when I first encountered
`
`sublingual films in my work.
`
`Q
`
`Do you have any understanding of when
`
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`28
`
`pharmaceutical sciences?
`
`MS. KHANDURI: Objection, scope.
`
`A
`
`The subject of sublingual -- sublingual
`
`films has been around for many years in the
`
`pharmaceutical sciences, so if you can be more
`
`specific in your question,
`
`I may be able to answer.
`
`Q
`
`What do you mean by many years in your
`
`answer?
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`The amorphous form of a material is one
`
`A
`
`The reason I do not recall exactly when I
`
`first encountered sublingual films is that to the
`
`best of my recollection, it happened at some time
`
`when I was a student,
`
`so your question about some
`
`specific development of films, if I'm able to
`
`answer it,
`
`I need you to be more precise in your
`
`question.
`
`Q
`
`Okay. Well, we can come back to that
`
`because I have a few other parameters that I want
`
`to cover. What does it mean if a drug or a
`
`compound iS in an amorphous form?
`
`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`A
`
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`29
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`in which the crystalline composition of that
`
`material has been disrupted.
`
`Q
`
`What do you mean when you say the
`
`crystalline composition of that material has been
`
`disrupted?
`
`A
`
`When a material such as a drug substance,
`
`which almost as a rule are produced in crystalline
`
`form, meaning as crystals, when that crystalline
`
`arrangement is ameliorated so that it's no longer
`
`present,
`
`the material takes the amorphous form.
`
`Q
`
`Is stability another parameter considered
`
`in the pharmaceutical sciences?
`
`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`the capacity of a drug in a drug product to remain
`
`A
`
`The stability of drugs is one
`
`consideration in the development of pharmaceutical
`
`drugs.
`
`Q
`
`In the context of pharmaceutical drugs,
`
`what is stability?
`
`A
`
`In the context of the pharmaceutical
`
`sciences and the pharmaceutical field, stability is
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`30
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`chemically intact for a prolonged period of time.
`
`Q
`
`Is higher stability for a drug
`
`preferable?
`
`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`A
`
`With everything else equal, if the drug
`
`lasts longer chemically intact in one product as
`
`opposed to another product,
`
`the one that lasts
`
`chemically intact longer would be preferable.
`
`Q
`
`Which form of drug has a hire stability,
`
`amorphous or crystalline?
`
`MS. KHANDURI: Objection to form.
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`effect of other ingredients in the formulation.
`
`It depends.
`
`On what?
`
`It depends on what the environment of the
`
`amorphous drug happens to be.
`
`QO
`
`What aspects of the environment of the
`
`amorphous drug are considered when looking at
`
`stability?
`
`A
`
`One of the aspects that is considered
`
`when looking at a stability is the presence and
`
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`31
`
`Q
`
`And what do you mean by other
`
`ingredients?
`
`A
`
`Pharmaceutical products contain an active
`
`compound, which is the drug.
`
`It is the main use in
`
`the field.
`
`They also contain other ingredients
`
`which are not pharmacologically active.
`
`Q
`
`So you called the -- the drug in a -- I'm
`
`sorry, strike that.
`
`You called the drug the active
`
`compound?
`
`Am I following that correctly?
`
`A
`
`That is a common term used in the
`
`pharmaceutical field,
`
`so can be used with the word
`
`"drug" or the word "active compound" to refer to
`
`the pharmacologically active compound, which is the
`
`drug.
`
`Q
`
`Is there a common term used in the
`
`pharmaceutical field to refer to the other
`
`ingredients which are not pharmacologically active?
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`excipient.
`
`A
`
`Q
`
`A
`
`There is.
`
`What's that term?
`
`The term used for non-pharmacologically
`
`active ingredients in pharmaceutical products is
`
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`
`Q
`
`A few moments ago, you talked about
`
`tablets. When -- when studying dosage form, does
`
`the size of a tablet matter?
`
`A
`
`Q
`
`Can you clarify your question please?
`
`Sure. Well,
`
`let me ask it differently.
`
`I guess if all else being equal, if a
`
`pharmacologist is developing a tablet, do they --
`
`does that person consider the size of the resultant
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Patients, when they have to take
`
`tablet at all?
`
`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`A
`
`With everything else equal,
`
`tablets are
`
`made taking into consideration the person who is
`
`going to use them.
`
`In that sense,
`
`the size of the
`
`tablet is something that can be handled by the
`
`patient with ease, and it can also be swallowed by
`
`the patient with ease.
`
`Q
`
`So that's a helpful clarification.
`
`I was
`
`going to ask you if when you said handled by the
`
`patient with ease, if you meant swallowing it, but
`
`I think it means something different.
`
`A
`
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`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`tablet?
`
`had many small pills myself that I've dropped down
`
`the sink and I didn't mean to, so I'm thinking as
`
`you're describing this that a smaller pill like a
`
`tiny pill would be harder to handle, and I think
`
`that's what you're getting at when you say that one
`
`aspect to consider is how the patient handles the
`
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`33
`
`medication,
`
`they need to grab with their hands
`
`their medication, and subsequently,
`
`take it,
`
`ingest
`
`it.
`
`So aspects of holding them in hand is
`
`something that is relevant to the use of
`
`medications.
`
`Q
`
`So it seems like a smaller sized tablet
`
`could be harder to handle for certain types of
`
`patients.
`
`MS. KHANDURI: Objection,
`
`form.
`
`BY MR. BERTULLI:
`
`Is that fair?
`
`Can you clarify?
`
`Yeah.
`
`What kind of --
`
`I'm just trying to explore this.
`
`I have
`
`Q A Q A
`
`Q
`
`
`
`34
`
`MS. KHANDURI: Objection to form, scope.
`
`A
`
`The physical design of a tablet takes
`
`into account several factors.
`
`One of them is the
`
`ability to swallow.
`
`The other one is the ability
`
`to handle, among other things.
`
`Q
`
`And when we -- when you talk about the
`
`ability to swallow a pill,
`
`is it fair to say that a
`
`large size pill might be harder for a human patient
`
`to swallow?
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`cannot recall if they were for horses or not.
`
`MS. KHANDURI: Objection, scope,
`
`form.
`
`Can you define what do you mean by large
`
`Well, sure.
`
`So I mean,
`
`this may sound
`
`size?
`
`A
`
`Q
`
`casual, but like have you heard the term a horse
`
`pill?
`
`A
`
`Q
`
`I have.
`
`So as a layman in this field, when I hear
`
`"horse pill," I think of a large sized pill for
`
`horses.
`
`Is that what a horse pill is?
`
`MS. KHANDURI: Objection,
`
`form.
`
`A
`
`I have seen veterinary tablets, but
`
`I
`
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`
`Q
`
`Were the veterinary tablets that you have
`
`seen large in size?
`
`A
`
`They were larger than the traditional
`
`pills that you find for human use.
`
`QO
`
`Do you think that pills that are the size
`
`of a veterinary tablet are desirable in size for
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`Let me ask you a couple more questions about dosage
`
`human use?
`
`MS. KHANDURI: Objection,
`
`form,
`
`foundation.
`
`A
`
`I don't want to get into speculations.
`
`That is not what I'm here to do, but it's not what
`
`I've been asked to do, and that's something that I
`
`would rather not do.
`
`To answer your question is
`
`there is a range of sizes that is adequate for
`
`humans, and that is known in the pharmaceutical
`
`industry. There is a range of sizes that is
`
`adequate for cows, and that is known in the
`
`pharmaceutical industry, and I could go on with
`
`other species.
`
`Q
`
`What about going -- and let me pause
`
`there.
`
`I see we've been going for about an hour.
`
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`
`form, and then do you want to take a break?
`
`A
`
`Q
`
`questions?
`
`A
`
`Q
`
`I would like to take a break.
`
`Like right now or a couple more
`
`I would leave it up to you.
`
`Okay, I'll try to be quick. Going the
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`would be able to answer.
`
`other direction, you're familiar with pill cutters,
`
`right?
`
`A
`
`QO
`
`MS. KHANDURI: Objection, scope.
`
`I am.
`
`And what is your understanding of what a
`
`pill cutter is?
`
`A
`
`A pill cutter is a device that in very
`
`Simple terms has the blade and a lever and then
`
`rotational -- like a hinge type of thing, and it is
`
`used to cut -- cut it.
`
`Q
`
`Do you think that having to use a pill
`
`cutter to cut a tablet would contribute to the
`
`convenience for a patient to take that tablet?
`
`MS. KHANDURI: Objection, scope,
`
`form.
`
`A
`
`That would be a question that the patient
`
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`
`Q
`
`That wouldn't be a question that you as
`
`the pharmacologist would consider?
`
`A
`
`The tablet cutter was created to be used
`
`in concert with a scoring in dosage forms.
`
`@)
`
`And I think I know what you mean, but
`
`just so that we're on the same page, when you say
`
`the scoring in dosage forms, what do you mean by
`
`scoring?
`
`A
`
`The physical scoring seen in dosage
`
`forms.
`
`Transcript of Rodolfo Pinal, Ph.D.
`Conducted on April 26, 2024
`
`form.
`
`Q
`
`So like if I had a pill in my hand that
`
`had a little line across the center of it,
`
`that's
`
`the scoring you're thinking of?
`
`MS. KHANDURI: Objection,
`
`form, scope.
`
`The term used for those lines is scoring.
`
`What if a patient had to use a pill
`
`A
`
`Q
`
`cutter to cut a pill somewhere else on the pill
`
`that wasn
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