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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________________________________________
` AQUESTIVE THERAPEUTICS, INC.
` Petitioner,
` v.
` NEURELIS, INC.
` Patent Owner
` _____________________________________
`
` Case IPR2019-00451
` Patent No. 9,763,876
` _____________________________________
`
` DEPOSITION OF DR. NICHOLAS A. PEPPAS
` Parsippany, New Jersey
` Thursday, October 24, 2019
`
`Reported by:
`EILEEN MULVENNA, CSR/RMR/CRR
`Job No. 170865
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`Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00451
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________________________________________
` AQUESTIVE THERAPEUTICS, INC.
` Petitioner,
` v.
` NEURELIS, INC.
` Patent Owner
` _____________________________________
`
` Case IPR2019-00451
` Patent No. 9,763,876
` _____________________________________
`
` DEPOSITION OF DR. NICHOLAS A. PEPPAS
` Parsippany, New Jersey
` Thursday, October 24, 2019
`
`Reported by:
`EILEEN MULVENNA, CSR/RMR/CRR
`Job No. 170865
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` October 24, 2019
` 9:00 a.m.
`
` DEPOSITION of DR. NICHOLAS A. PEPPAS,
`held at the offices of Hoffman & Baron, 4 Century
`Drive, Suite 300, Parsippany, New Jersey, before
`Eileen Mulvenna, CSR/RMR/CRR, Certified Shorthand
`Reporter, Registered Merit Reporter, Certified
`Realtime Reporter and Notary Public within and for
`the State of New Jersey.
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
` HOFFMANN & BARON
` 4 Century Drive
` Parsippany, New Jersey 07054
`
` By: MICHAEL CHAKANSKY, ESQ.
`
` DANIEL SCOLA, JR., ESQ.
`
` MATTHEW SOLOW, ESQ.
`
`
`ON BEHALF OF THE PATENT OWNER:
`
` WILSON SONSINI GOODRICH & ROSATI
` One Market Plaza
` Spear Tower
` San Francisco, California 94105
`
` By: WENDY DEVINE, ESQ.
`
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`A P P E A R A N C E S (Continued):
`
`AND
`
`WILSON SONINI GOODRICH & ROSATI
` 12235 El Camino Real
` San Diego, California 92130
`
` By: LORELEI WESTIN, Ph.D.
`
` ALINA LITOSHYK, ESQ.
`
` (Witness sworn.)
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` I N D E X
`WITNESS EXAMINATION BY PAGE
`
`DR. NICHOLAS A. PEPPAS
`
` MS. DEVINE 7
` MR. CHAKANSKY 150
` MS. DEVINE 151
` E X H I B I T S
`AQUESTIVE PAGE
`
`Exhibit 1041 Previously marked 15
`Exhibit 1002 Previously marked 79
`Exhibit 1007 Previously marked 91
`Exhibit 1008 Previously marked 122
`Exhibit 2006 Previously marked 125
`Exhibit 1045 Previously marked 128
`Exhibit 1011 Previously marked 140
`Exhibit 1015 Previously marked 142
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` NICHOLAS A. PEPPAS
` MS. DEVINE: Good morning. Would you
` like to introduce yourself first?
` MR. CHAKANSKY: Sure. My name is
` Michael Chakansky. I'm here representing
` Dr. Peppas and the Aquestive Therapeutics.
` Matt, you want to introduce yourself?
` MR. SOLOW: Matt Solow, also here
` representing Dr. Peppas and Aquestive
` Therapeutics.
` MS. DEVINE: Good morning. My name is
` Wendy Devine. I'm with Wilson Sonsini
` Goodrich & Rosati, and I'm representing
` Neurelis. And with me are my colleagues Lori
` Westin and Alina Litoshyk of the same firm.
` I'd like credit for pronouncing Alina's name
` correctly.
` MR. CHAKANSKY: And we have one new
` addition.
` MR. SCOLA: Dan Scola for Aquestive
` Therapeutics.
`DR. NICHOLAS PEPPAS,
` having been duly sworn by Eileen Mulvenna,
` a Notary Public of the State of New York,
` was examined and testified as follows:
`
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` NICHOLAS A. PEPPAS
`EXAMINATION
`BY MS. DEVINE:
` Q. Good morning, Dr. Peppas.
` A. Good morning.
` Q. Would you please state your full name
`for the record.
` A. My name is Nicholas Athanassiou
`Peppas.
` MS. DEVINE: I'd just like to correct
` the record. I'm here representing Hale
` BioPharma Ventures LLC.
`BY MS. DEVINE:
` Q. And would you please state your --
` MR. CHAKANSKY: You're representing --
` I thought it was Neurelis. They changed
` their name, didn't they?
` MS. WESTIN: Yes, that's correct.
` MS. DEVINE: Formerly known as Hale,
` let's put it that way.
`BY MS. DEVINE:
` Q. Dr. Peppas, would you please state
`your current address.
` A. 3217 Lating, L-A-T-I-N-G, Stream Lane,
`Austin, Texas 70 -- 78746.
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` Q. Is there any reason that you cannot
`testify truthfully and completely today?
` A. No, there's no reason.
` Q. Have you been deposed before?
` A. Yes, I have been deposed before.
` Q. How many times?
` A. I don't recall the number. A few
`times.
` Q. More than five?
` A. Probably more than five, yes.
` Q. More than ten?
` A. I will have to check my documents --
` Q. Okay.
` A. -- but in principle, not more than
`ten.
` Q. When's the last time you were deposed?
` A. I do not recall the exact time. I'm
`sorry.
` Q. Was it within the last year?
` A. Deposition. No, it was not.
` Q. Was it within the last five years?
` A. Yes, it was.
` Q. If you do not understand my question
`today, will you let me know so I can change the
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` NICHOLAS A. PEPPAS
`question or modify it in some way so that you do
`understand it?
` A. Of course I will.
` Q. If you do answer my question, do you
`understand that I will accept that you did
`understand my question and that your answer is
`responsive?
` A. Yes.
` Q. Also, will you wait for me to finish
`my question before your answer so that we can allow
`our court reporter to take down both my question and
`your answer?
` A. Yes, I will.
` Q. Great.
` Have you previously testified at trial
`or any other proceeding?
` A. What do you mean by "proceeding"?
` Q. Arbitration, anything like that.
` A. To be exact, what do you mean by
`"testified at a trial"?
` Q. Somewhere where you were under oath as
`you are today, but not a deposition.
` A. Yes.
` Q. Let's start with trial.
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` Have you testified at trial?
` A. Yes.
` Q. How many times?
` A. One time.
` Q. Is that as an expert?
` A. As an expert witness?
` Q. Yes.
` A. Yes.
` Q. Did it involve a patent proceeding?
` A. What do you mean by "proceeding,"
`"patent proceeding"?
` Q. So do you understand that you're here
`today as an expert witness regarding a patent
`dispute?
` A. Yes.
` Q. When you testified at trial, were you
`testifying as an expert witness regarding a patent
`dispute?
` A. That's true, yes, I was.
` Q. And did it involve a pharmaceutical?
` A. It involved a pharmaceutical product.
` Q. Was that pharmaceutical a
`benzodiazepine?
` A. Not that I recall, no.
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` Q. And the other proceedings where you
`have testified under oath other than that trial,
`what type of proceedings were they?
` A. Can you be more specific. What do you
`mean what "type of proceedings"?
` Q. I believe you told me that you've
`testified under oath not at deposition --
` A. Yes.
` Q. -- other than that one trial.
` A. Yes.
` Q. What were the circumstances of that
`testimony?
` A. The other cases were depositions.
` Q. Depositions?
` A. Yes.
` Q. How many depositions have you given,
`roughly?
` A. I think I answered that before.
` Q. Between five and ten?
` A. Probably. You know, I don't keep a
`note of everything.
` Q. Sure.
` And were those all as an expert
`witness?
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` A. Again, could you specify -- I mean,
`expert witness versus what? What else is there?
` Q. Sure.
` Sometimes people give testimony as a
`lay witness. Let's say you witness a car accident.
`You might give a deposition testimony as to what you
`saw versus giving testimony as you are here today as
`an expert witness.
` Were any of your five to ten
`depositions as an expert witness?
` A. I believe so.
` Q. Were they all in matters involving a
`patent dispute?
` A. Yes, they were.
` Q. Were they all in matters involving a
`pharmaceutical?
` A. No.
` Q. Roughly, how many of the five to
`ten -- roughly, it doesn't have to be exact --
`involved a pharmaceutical?
` A. It's difficult for me to say. I will
`have to go back to my documents.
` Q. Would you say the majority of them
`involved a pharmaceutical?
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` A. More were pharmaceutical, yes.
` Q. Were any of them, other than the one
`we're here for today, about a benzodiazepine?
` A. Not that I recall, no.
` Q. So today is the first time you are
`offering testimony under oath as an expert regarding
`a benzodiazepine pharmaceutical product; is that
`correct?
` MR. CHAKANSKY: Objection; misstates
` his testimony.
` THE WITNESS: Can I continue?
`BY MS. DEVINE:
` Q. You can answer the question.
` MR. CHAKANSKY: You can answer.
` THE WITNESS: As far as I recall, this
` is the first time I am giving testimony on
` benzodiazepine.
`BY MS. DEVINE:
` Q. Dr. Peppas, to your knowledge, has
`your credibility regarding any expert opinions or
`testimony you have been given [sic] ever been
`questioned?
` A. Ever been questioned by whom?
` Q. By anyone.
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` A. Not to my knowledge, no.
` Q. To your knowledge, has the veracity of
`any of your opinions or testimony that you've given
`as an expert witness ever been questioned?
` A. Could you please define "veracity."
` Q. Sure.
` So the reliability, the truthfulness.
` A. Not that I know of.
` Q. Dr. Peppas, have you testified in an
`inter partes review proceeding before?
` A. Again, to be exact, what do you mean
`by "testify"? In court?
` Q. In deposition.
` A. I have participated. I'm trying to
`recall if it went all the way to the deposition.
` Q. Okay. I'm going to hand you some
`exhibits. And understanding that you have been
`deposed in District Court proceedings before, a lot
`of times we will mark them with a sticker and then
`hand them to you. Here they're premarked. I'm
`going to hand you an exhibit that already has a
`number on it, which means that the court reporter
`doesn't have to mark it.
` So this one I'm going to hand you is
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` NICHOLAS A. PEPPAS
`going to be Aquestive Exhibit 1041.
` (Exhibit 1041, Previously marked.)
`BY MS. DEVINE:
` Q. Okay. So we've got Exhibit 1041.
` And my first question, Dr. Peppas, is,
`do you recognize Exhibit 1041?
` A. Yes, I do.
` Q. Could you tell me what it is, please.
` A. It is my declaration that I prepared
`in a case -- an IPR of Aquestive versus Hale
`BioPharma.
` Q. And that's regarding US Patent
`No. 9,763,876; correct?
` A. That's correct.
` Q. And if you turn -- turn to your CV,
`which is in here.
` MR. CHAKANSKY: Is there a page you
` can direct him to?
` MS. DEVINE: Yes, it is on page 255.
` THE WITNESS: Of the CV? Yes. Or
` Bates number?
`BY MS. DEVINE:
` Q. So at the bottom, it says, "Aquestive
`Exhibit 1041, Page," and then there are paginations.
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` NICHOLAS A. PEPPAS
`And it's 0255.
` A. Zero --
` Q. 255, please.
` A. Yes.
` Q. I'm just going to ask you, is this
`your current CV?
` A. This is the CV I submitted at the time
`I wrote this particular declaration.
` Q. And has your CV changed since the time
`you wrote this declaration and presented it?
` A. Yes, it has.
` Q. How has it changed?
` A. I will have to go through line by
`line, but already on page 0256, I can see that some
`of my recent awards are not included.
` Q. Okay. We'll come back to that in just
`a moment.
` Let's turn to paragraph -- page 0287
`of your CV. And under "Current Research
`Interests" -- do you see that?
` A. Yes.
` Q. "Biomedical Engineering," did I read
`that correctly?
` A. Uh-huh.
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` Q. Have any of your current research
`interests changed since your CV was written?
` A. My recent -- my -- could you repeat
`your question if you can.
` Q. Sure.
` Here you list a number of research
`interests; is that correct?
` A. That's right.
` Q. Have any of those changed since this
`CV was written?
` A. These have not changed. Additional
`interests have been added.
` Q. What additional interests have been
`added?
` A. It's delivery of drugs for treatment
`of autoimmune diseases, is one of them.
` Q. Anything specific to intranasal
`delivery of drugs?
` A. Nothing has been added.
` Q. Okay. Has anything been added
`specific to delivery of benzodiazepine drugs?
` A. No.
` Q. Just to be specific to my last
`question, has anything been added to your current
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`research interests regarding delivery of drugs via
`an intranasal route?
` A. I am answering exactly your question.
`Nothing has been added.
` Q. Got it.
` Dr. Peppas, do you have any knowledge
`of the physiology and anatomy of the nasal cavity?
` A. Yes, I do.
` Q. How did you gain that knowledge?
` A. I have an experience in the drug
`delivery field that starts around -- roughly around
`1975. And in the past, I got interested in nasal
`delivery as one of possible administration routes.
`And at that time, I started reading about such,
`documents about the nasal cavity and physiology.
` Q. And that was around 1975; is that
`correct?
` A. It was after 1975.
` Q. Can you tell me roughly when that was?
` A. In the early '80s, but I will have to
`really check a lot of documents.
` Q. Sure.
` Let's turn, within the context of your
`declaration that comes before your CV, to
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`paragraph 16, which is right at the beginning.
` (Discussion off the record.)
` MR. CHAKANSKY: Just to be clear,
` we're at paragraph 16 --
` MS. DEVINE: Paragraph 16.
` MR. CHAKANSKY: -- of Exhibit 1041,
` Dr. Peppas' declaration.
` MS. DEVINE: Correct.
`BY MS. DEVINE:
` Q. So paragraph 16 -- and I'm just going
`to read it here. It starts, "Since 1979," do you
`see that?
` A. Yes.
` Q. And it reads, "Since 1979, I have also
`worked on the design, development and investigation
`of the pharmaceutical and medical applications of
`bioadhesive and mucoadhesive polymers and drug
`delivery formulations based on mucoadhesive
`polymers."
` Did I read that correctly?
` A. Yes.
` Q. Is that a correct statement?
` A. It is a correct statement.
` Q. Can you tell me, Dr. Peppas, what is a
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`bioadhesive polymer, as you referred to in
`paragraph 16 of your declaration?
` A. First, I have defined or described
`such bioadhesive polymers in my documents, and you
`can see. But it is a carrier, a biomolecular and
`biopolymer system that interacts with the mucosa, in
`general, with all mucosas, and aids in better
`administration of the incorporated active
`ingredient.
` Q. Could you tell me what a polymer
`system is, please?
` A. Only in a very general term. If you
`are referring to a specific document, I will have to
`see the document and be able to tell you if that
`definition would require certain characterizations
`and so on.
` Q. I can give you more context for my
`question.
` So when I asked earlier what a
`bioadhesive polymer is, as you refer to it in your
`declaration, I believe that you told me that it is a
`carrier and it has a polymer system that interacts
`with mucosa. So I'm just asking for some further
`detail on what you mean by polymer system.
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` NICHOLAS A. PEPPAS
` A. Polymer system can be macromolecular
`structure that carries the active agent. But,
`again, this is a very general term. And if we are
`going to specific publications of mine, I will have
`to give you a better -- better attributes, so on.
` Because when I say macromolecular,
`oligo molecular -- O-L-I-G-O -- oligo molecular
`systems are also polymers. They are in these
`carriers that we are discussing here.
` Q. You also mention in this paragraph 16
`of your declaration mucoadhesive polymers; is that
`correct?
` A. Yes.
` Q. Could you tell me, is there a
`difference between a bioadhesive polymer and a
`mucoadhesive polymer?
` A. In the field of drug delivery, some
`investigators, many investigators will use
`bioadhesion as the general term that encompasses
`mucoadhesion as one possible aspect of bioadhesion.
` Q. So is it fair to say that a
`mucoadhesive polymer is a type of bioadhesive?
` A. Yes.
` Q. Have you ever formulated a bioadhesive
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` NICHOLAS A. PEPPAS
`polymer for a drug delivery formulation to deliver a
`benzodiazepine?
` A. What do you mean by "formulated"?
` Q. Have you ever created a drug
`formulation where the active ingredient is
`benzodiazepine and the delivery vehicle is one of
`these bioadhesive polymers?
` A. When you say have I formulated, do you
`mean I personally gone in the laboratory and done
`that?
` Q. Let's break it down. I'll ask a
`series of questions.
` A. I am a professor you know.
` Q. I do.
` So have you ever personally created a
`drug formulation where the active ingredient is a
`benzodiazepine and the delivery vehicle is one of
`these bioadhesive polymers?
` A. Not personally, I -- that I remember,
`that I recall offhand.
` Q. Has anyone at your direction ever
`created a drug formulation where the active
`ingredient is a benzodiazepine and the delivery
`vehicle is one of these bioadhesive polymers?
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` NICHOLAS A. PEPPAS
` A. I would like to further define under
`my direction.
` Q. Okay. What does that mean to you?
` A. In my 45 years of research, I have
`directly supervised students, postdocs, who have
`worked in my laboratory. At the same time, I have
`collaborated with several other institutions, which
`you might see from the CV.
` So I will need further definition from
`you what do you mean under my direction because "my
`direction" is a very broad term.
` Q. Sure.
` Have you also supervised graduate
`students that are not in the postdoc level yet?
` A. I have supervised graduate students in
`general.
` Q. Yes.
` A. Not for -- yes.
` Q. Not for?
` A. Because the initial question did not
`say, have you supervised graduate students. It was
`like have you -- can you please repeat the question.
` Q. Sure.
` I'm just asking, separate from my
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` NICHOLAS A. PEPPAS
`prior questions, have you within your career
`supervised graduate students?
` A. Yes, I do have.
` Q. Ph.D. and masters-level students?
` A. Mostly Ph.D.s, some master's, and many
`undergraduate students who work under my direction
`for quite a few semesters.
` Q. Let's break this down.
` So in the context of your supervising
`postdocs, have any postdocs at your direction ever
`created a drug formulation where the active
`ingredient is a benzodiazepine and the delivery
`vehicle is a bioadhesive polymer?
` A. Not under my -- not to my knowledge.
` Q. And in the context of your
`collaboration with other institutes, has anyone
`other than you, in the context of that
`collaboration, ever created a drug formulation where
`the active ingredient is a benzodiazepine and the
`delivery vehicle is a bioadhesive polymer?
` A. It's a long list of publications.
`It's many investigators. If you had posed that
`question and given me one day, I could be exact, but
`I do not recall offhand any such case.
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` NICHOLAS A. PEPPAS
` Q. Okay. In the context of your
`supervision of graduate-level students, either Ph.D.
`or masters-level students, has any of those students
`at your direction ever created a drug formulation
`where the active ingredient is a benzodiazepine and
`the delivery vehicle is a bioadhesive polymer?
` A. No.
` Q. And in the context of your work with
`undergraduate students and teaching and supervision
`of undergraduate students, has any of those
`undergraduate students -- strike that. I need
`correct grammar.
` In the context of your supervision and
`work with undergraduate students and your teaching
`and work and supervision of those undergraduate
`students, have any of those undergraduate students
`at your direction ever created a drug formulation
`where the active ingredient is a benzodiazepine and
`the delivery vehicle is a bioadhesive polymer?
` A. Not that I recall off...
` Q. Have you personally formulated any
`drug formulations for intranasal delivery?
` A. What do you mean by "personally"
`again?
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` NICHOLAS A. PEPPAS
` Q. Personally you making the --
` A. Actually going into the laboratory and
`doing it myself?
` Q. Yes.
` A. Yes.
` Q. How many?
` A. I'm sorry. It's, with all due
`respects, a very long career. I cannot tell you
`what that is. I would have to check my documents.
` Q. Sure.
` Can you give me a rough estimate?
`Five?
` A. No, I cannot because we don't work --
`today we work on this, tomorrow we work on that. So
`it's -- it's a continuous process. And you don't
`sit down and say, how many did I develop.
` Q. Sure. I understand.
` Can you recall personally developing
`any drug formulations for intranasal delivery that
`contained a benzodiazepine?
` A. No, I'm not aware of it.
` Q. Can you remember personally developing
`any drug formulation for intranasal delivery that
`was a solution?
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` NICHOLAS A. PEPPAS
` A. I recall that I have developed
`formulations that were solutions.
` Q. For intranasal delivery?
` A. For intranasal delivery.
` Q. And did those contain the
`bioadhesive -- strike that.
` Did the solutions for intranasal
`delivery that you have personally developed contain
`the bioadhesive polymers that are mentioned in
`paragraph 16 of your declaration?
` A. I want to be truthful. I want to be
`accurate. We're talking about technology that was
`done between '79 and about '90. I will have to
`consult my own papers, documents. And let me add
`something. It's not only papers. It's many
`documents that never saw the light, you know.
` Q. Did any of the formulations that
`you've personally developed for intranasal delivery
`that were solutions ever become commercial?
` A. Let me think. Could you please
`rephrase your question. I want to be accurate in my
`answer.
` Q. I believe you told me that you have
`personally developed solutions for intranasal
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` NICHOLAS A. PEPPAS
`delivery; correct?
` A. Yes.
` Q. Did any of them become commercial
`products?
` A. It is difficult for me to answer the
`question because I'm the inventor. I do not know
`what the company to which they were transferred did.
`So I can say I do not recall. That is the correct
`answer.
` Q. Let me ask it this way: Are you aware
`of any of the products that you personally developed
`as solutions for intranasal delivery becoming
`commercial products?
` A. I'm not aware.
` Q. Of these products that you personally
`developed as solutions for intranasal delivery, none
`of them contained benzodiazepine; correct?
` A. That is correct, none of them were.
` Q. Going back to these bioadhesive
`polymers in paragraph 16 of your declaration that we
`were discussing, do they function -- these
`bioadhesive polymers, do they function as
`penetration enhancers?
` A. We will have to identify specific
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` NICHOLAS A. PEPPAS
`systems that I worked with, specific polymers that I
`worked with, and then I may be able to, after some
`thinking, to give you an answer. The reason is very
`simple, the mechanisms are different for different
`systems.
` Q. So is it fair to say that the
`bioadhesive polymers that are referenced in
`paragraph 16 of your declaration function
`differently in different formulation systems?
` A. I do not believe I said that, with all
`due respect. I said I will have to know the
`specific system we are discussing to tell you if in
`that system -- I'm rephrasing it in a better way --
`to tell you, in that system, if the mucosa polymer
`was also a penetration enhancer.
` Q. So is it possible that a mucoadhesive
`polymer could not function as a penetration enhancer
`in a particular system?
` A. The way -- I can imagine -- that
`doesn't mean I have worked with them. I can imagine
`that there is some system that some company calls it
`mucoadhesive -- be careful in my statement here --
`some company, that doesn't mean I call it
`mucoadhesive -- that is not a penetration enhancer.
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`That's what I can tell you, nothing more.
` Q. Okay. Dr. Peppas, did you rely on any
`of your publications regarding bioadhesive polymers
`in writing your declaration?
` A. I think my answer is I wrote this
`declaration with a lot of consideration. And,
`frankly -- I don't know if that's the right word --
`with a lot of love because this is a very important
`field for me. And it will not take you long t
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