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`Page 1
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` GUNTHER HOCHHAUS
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`----------------------------------- )
`
`NALOX-1 PHARMACEUTICALS, LLC,
`
` )
`
` Petitioner,
`
` )IPR No.
`
` vs.
`
` )2019-00688
`
`OPIANT PHARMACEUTICALS, INC.,
`
` Patent Owner.
`
` )
`
` )
`
`----------------------------------- )
`
` DEPOSITION OF GUNTHER HOCHHAUS
`
` Washington, D.C.
`
` December 6, 2019
`
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR
`
`Job No. 172401
`
`TSG Reporting - Worldwide 877-702-9580
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`

`

`Page 2
`
`Page 3
`
` GUNTHER HOCHHAUS
`APPEARANCES:
` ON BEHALF OF THE PETITIONER:
` ARENT FOX
` BY: RICHARD BERMAN, ESQ.
` BRADFORD FRESE, ESQ.
` YELEE KIM, ESQ.
` 1717 K Street, N.W.
` Washington, D.C. 20006
`
` ON BEHALF OF THE PATENT OWNER:
` WILLIAMS & CONNOLLY
` BY: JESSAMYN BERNIKER, ESQ.
` KEVIN HOAGLAND-HANSON, ESQ.
` 725 12th Street, N.W.
` Washington, D.C. 20005
`
`and
` GREEN GRIFFITH
` BY: JESSICA TYRUS MacKAY, ESQ.
` 676 North Michigan Avenue
` Chicago, Illinois 60611
`
`Page 5
`
` GUNTHER HOCHHAUS
` PREVIOUSLY MARKED EXHIBITS
` (cont'd)
`
`EXHIBITS
`
` PAGE
`
`Exhibit 1036
` 2009 Kerr paper
`Exhibit 1040
` 2010 Merlin paper
`
` 295
`
` 280
`
`Exhibit 1044
` PDR
`Exhibit 1049
` 2012 FDA meeting transcript
`
` 21
`
` 24
`
`Exhibit 1051
` Sabzghabaee paper
`
` 286
`
` NOTE: Exhibit 2059 not tendered
` for inclusion with transcript
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` GUNTHER HOCHHAUS
` Deposition of GUNTHER HOCHHAUS, held at the
`offices of:
`
` Arent Fox
` 1717 K Street, NW
` Washington, D.C. 20006
`
` Taken pursuant to notice before Tina M.
`Alfaro, a Notary Public within and for the District
`of Columbia.
`
` PAGE
`
` GUNTHER HOCHHAUS
` I N D E X
` EXAMINATION
`WITNESS
`GUNTHER HOCHHAUS
` By Ms. Berniker
` By Mr. Berman
` EXHIBITS
`PATENT OWNER EXHIBITS
`Exhibit 2059 40
` "Concepts in Clinical Pharmacokinetics"
`
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` 334
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`Page 4
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` PAGE
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` 67
`Exhibit 2060
` Chapter co-authored with Dr. Derendorf
`Exhibit 2061
` 77
` Paper: "Current concepts in
` pharmacokinetics and their implications
` for clinical medicine"
`
`Exhibit 2062 103
` Diagram of concentration time profile
` PREVIOUSLY MARKED EXHIBITS
`EXHIBITS
` PAGE
`Exhibit 1007
` 201
` Wyse patent
`
`Exhibit 1013
` Kushwaha paper
`Exhibit 1032
` Presentation
`
`Exhibit 1035
` 2008 Kerr paper
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` 213
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`TSG Reporting - Worldwide 877-702-9580
`
`2
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`

`

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` GUNTHER HOCHHAUS
` (Witness sworn.)
`WHEREUPON:
` GUNTHER HOCHHAUS,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MS. BERNIKER:
` Q. Good morning, Doctor. My name is Jessamyn
`Berniker, and I represent the Patent Owner in this
`case. Nice to meet you.
` A. Hello.
` Q. I understand that you've been deposed
`before?
` A. A few times, yes.
` Q. And you understand that you're under oath
`today?
` A. Yes.
` Q. And you understand that you're testifying
`under penalty of perjury; is that right?
` A. Yes.
` Q. And you have to provide the most complete
`and truthful answers; is that right?
` A. Yes.
` Q. They need to be both truthful and complete;
`
`Page 8
`
` GUNTHER HOCHHAUS
`one that I'm going to be referring to when we talk
`about paragraph numbers.
` MS. BERNIKER: Counsel, did you want a
`copy?
` MR. BERMAN: I'll take one, please.
`BY MS. BERNIKER:
` Q. Okay. Can I refer you, please, to
`paragraph 64 -- I'm sorry -- yes, paragraph 64 of
`your declaration in that case. Did you draft the
`declaration, sir?
` A. We did it together. So I found my opinion
`and then I got, of course, help.
` Q. Is it your view the words in here are your
`own?
` A. Yeah.
` Q. You stand by them?
` A. Yeah.
` Q. You stand by the choices of what you cited
`and what you didn't cite?
` A. Yeah.
` Q. And you stand by what you reviewed in
`preparing these opinions?
` A. Yeah. I tried my best, yes.
` Q. Do you believe that you reviewed any
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` GUNTHER HOCHHAUS
`do you understand that?
` A. I understand.
` Q. I thought you might say that. You
`understand that the testimony that you provided by
`way of declaration, which you have in front of you,
`to the Patent Office was also under penalty of
`perjury, right?
` A. Yes.
` Q. And that you also had an obligation to
`provide complete and truthful answers there; is that
`right?
` A. Yes.
` Q. And you understood that when you signed it?
` A. Yes.
` Q. And did you review your declaration
`carefully to confirm that you believed that
`everything you said in there was complete and
`truthful?
` A. Yes.
` Q. Okay. Well, I'd like to direct your
`attention -- I'm going to work off of the
`'747 Patent, Case No. IPR 2019-0688 version of your
`declaration for today. So you're welcome to
`reference the other ones if you want, but that's the
`
`Page 9
`
` GUNTHER HOCHHAUS
`materials that would have been -- a reasonable
`person would have reviewed in preparing the opinions
`that you submitted here?
` A. I believe so.
` Q. Did you go out of your way to try to make
`sure that you reviewed everything that you think
`would have been relevant to your opinions?
` A. Yeah. I mean, I did quite a bit of Google
`searches. I did some literature searches by myself.
` Q. You did independent research beyond what
`the attorneys provided to you?
` A. Yes.
` Q. Okay. So I want to direct your attention
`to paragraph 64 and something that you say in
`paragraph 64, and you said -- in 64 you're talking
`about your position that "In emergency situations in
`general and in naloxone therapy" --
` A. Where are you?
` Q. Paragraph 64. You say "As I mentioned
`above" --
` A. Yes.
` Q. -- "in emergency situations in general, and
`in naloxone therapy in particular, rapid onset of
`action and high drug exposure are desired to get the
`
`TSG Reporting - Worldwide 877-702-9580
`
`3
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 3
`
`

`

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` GUNTHER HOCHHAUS
`overdose victim breathing normally as quickly as
`possible"; do you see that?
` A. I see that.
` Q. And when you talk about overdose victim,
`you're talking about opioid overdose victims, right?
` A. Let me just read through the sentence
`again. You're pretty fast.
` Q. Sorry.
` (Witness reviewing document.)
` A. That sentence says that "In emergency
`situations in general" --
` Q. Yes.
` A. -- "and in naloxone therapy in particular,
`rapid onset of action and high drug exposure" --
` THE REPORTER: I'm sorry.
` THE WITNESS: Sorry.
` A. It says that "In emergency situations in
`general" -- so it's not totally focused alone on the
`therapy -- "and naloxone therapy in particular,
`rapid onset of action and high drug exposure are
`desired to get the overdose victim breathing
`normally as quickly as possible."
` Q. And with respect to naloxone, the overdose
`victim has overdosed on what?
`
`Page 12
`
` GUNTHER HOCHHAUS
` Q. I'm asking are you aware today about
`whether naloxone -- how about this. Is naloxone
`indicated for the use of reversing any kind of
`overdose aside from opioid overdose?
` A. I would have to look into the label
`directly.
` Q. You haven't considered that question in
`forming your opinions today?
` A. Not yet. I would -- I would have -- right
`now I would need to look at the label.
` Q. Okay. Well, here's my question for you.
`In the 65 or so pages of your expert report were
`they based on the premise that naloxone is being
`used to treat opioid overdose?
` A. That would include it, yes.
` Q. Were they based on the premise that
`naloxone was being used for some other purpose?
` A. Can you slow down?
` Q. Sure. Were they based on the premise that
`naloxone was being used for some other purpose?
` A. I would need to clearly read very, very
`much through my declaration and see whether there
`was something else in it.
` Q. When's the last time you read your
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` GUNTHER HOCHHAUS
` A. In this case opioids.
` Q. Okay. You're talking about people who have
`overdosed on opioids, right?
` A. That would include people with opioid
`overdose.
` Q. With respect to naloxone, the drug is being
`used to treat people who have opioid overdose, not
`some other kind of overdose, right, sir?
` A. The overdose would be included, yes.
` Q. Right. I'm asking now a separate question
`from your sentence. When we're talking about the
`use of naloxone to reverse overdose, that is about
`reversing opioid overdose, right?
` A. If you only say overdose, that would
`include -- that would not specify it. If you say
`that naloxone is being used for a very, very
`specific situation, then it would include the very,
`very specific situation.
` Q. Is naloxone used to treat different kinds
`of overdose apart from opioid overdose?
` A. I would have to think about it.
` Q. Sitting here today, you're not aware of
`that right, sir?
` A. I would have to think about it.
`
`Page 13
`
` GUNTHER HOCHHAUS
`declaration?
` A. Fully? A long time ago.
` Q. You did not read your declaration fully
`before coming for a deposition about your
`declaration that is all of 65 pages, sir?
` MR. BERMAN: Objection to form.
` MS. BERNIKER: In preparing for coming here
`to testify today, is it your testimony that you
`didn't bother to read your 65-page declaration?
` MR. BERMAN: Objection to form.
` MS. BERNIKER: You can answer.
` A. Huh?
` Q. You can answer even though he objects.
` A. I certainly read significant portions of
`it.
` Q. Okay.
` A. But it's 65 pages. It's a lot. So -- and
`I'm getting older. So I would need to go through it
`and clearly see whether other things were included
`or not.
` Q. I assume that you're not suggesting that
`your age prevents you from being able to digest the
`information in your 65-page declaration, right?
` MR. BERMAN: Objection to form.
`
`TSG Reporting - Worldwide 877-702-9580
`
`4
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 4
`
`

`

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` GUNTHER HOCHHAUS
` A. No.
` Q. Okay. You have the mental capacity to
`understand what you said here?
` A. Absolutely.
` Q. And you plan to defend it today, right?
` A. Yes.
` Q. Okay. So my question to you, sir, is is
`your declaration about what a person of skill in the
`art would have done in connection with using
`naloxone to treat opioid overdose, or is it in
`connection with something else?
` A. It includes opioid overdose.
` Q. Okay. Is there any other type of overdose
`that you intended to include by your declaration?
` A. It certainly includes the overdose,
`absolutely.
` Q. You're not answering my question. Is there
`another kind of overdose that you intended to
`include in terms of what the person of skill in the
`art would have been focused on in connection with
`your declaration?
` A. To just be on the safe side I would need to
`see the label.
` Q. Okay. I'm not sure we have the label. We
`
`Page 16
`
` GUNTHER HOCHHAUS
`covers the background and qualifications, it talks
`about certain legal standards, it describes the
`state-of-the-art. I then discuss the motivation to
`design a nasal formulation having high
`bioavailability with a reasonable expectation of
`success, and it goes through --
` Q. Is your expert -- is your declaration about
`what a person of skill in the art as of March of
`2015 would be thinking in connection with the
`development of an intranasal naloxone product?
` A. Certainly not in the entirety. I mean,
`that probably would not be able to be captured in 65
`pages.
` Q. It wouldn't, would it?
` A. No.
` Q. Okay. Well, which aspects of that were you
`intending to capture in your 65 pages?
` A. As I said, I talk about the motivation to
`design a naloxone nasal formulation having high
`bioavailability with a reasonable expectation of
`success. I talk about claim construction, I talk
`about some other things, but the main portion
`certainly deals with the prior art patent
`application disclosure. It talks about the known
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`have the PDR. Let's hold on that question. We'll
`come back to it.
` A. Okay.
` Q. In selecting -- in the comments that you
`make about the appropriate dose of intranasal
`naloxone, sir, was there some particular clinical
`effect that you thought the person of skill in the
`art would be trying to achieve?
` A. I don't understand what you mean. Can you
`rephrase?
` Q. Okay. You have a bunch of opinions in here
`about the dose of intranasal naloxone that a person
`of skill in the art would have considered; is that
`fair?
` A. Yeah. Can you direct me to those?
` Q. It's your entire report, isn't it?
` MR. BERMAN: Objection to form.
` A. You are asking me a very specific question,
`and I would like to know what section of my report
`you are referring to.
` Q. Okay. Let's try another question. What
`are the opinions in your report about generally?
` A. About the things that are in here. Let's
`go through them. It's the table of contents. So it
`
`Page 17
`
` GUNTHER HOCHHAUS
`physico-chemical and biopharmaceutical and
`pharmacological properties of naloxone --
` Q. Okay. I don't need you to read the entire
`table of contents into the record.
` A. You were asking me what my declaration is
`about.
` Q. What would a person of skill in the art be
`trying to achieve in 2015?
` A. That's a very, very -- I can't really --
`you need to be more specific.
` Q. Okay. It's your testimony that the person
`of skill in the art would be trying to achieve
`something in doing whatever it is that you say that
`they need to do, right?
` MR. BERMAN: Objection to form.
` A. You need to be -- a person -- a POSA --
`there are lots of POSA's. So you need to be more
`specific.
` Q. Is it your view that there are different
`POSA's for the same obviousness analysis so that you
`could have one POSA doing one thing and another POSA
`doing something else and another POSA doing
`something else?
` A. Well, as I -- as I stated in my
`
`TSG Reporting - Worldwide 877-702-9580
`
`5
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 5
`
`

`

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` GUNTHER HOCHHAUS
`declaration, we defined what POSA's would be
`necessary within a very, very broad product
`development process.
` Q. What do you mean by "broad development
`process"?
` A. I mean there are lots of areas involved.
`There's formulation work, and I'm certainly not an
`expert in that area. I was asked to reflect my
`opinion with respect to the clinical pharmacology.
`So that's why I was asking what you meant by POSA
`and my statement that there are lots of them.
` Q. There are lots of pieces of qualification
`that go together to form the hypothetical POSA; is
`that what you mean?
` A. Can you --
` Q. There are different technical
`qualifications that comprise the team that is the
`hypothetical POSA?
` A. I would refer to the section where this is
`being discussed.
` Q. Sure. Page 10 of your declaration.
` A. Yes.
` Q. And that is where you define the POSA,
`right?
`
`Page 20
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` GUNTHER HOCHHAUS
`on page 24.
` A. Uh-huh.
` Q. We had been talking about what naloxone was
`approved for, right? We had been talking about the
`indication, remember that?
` A. We really didn't talk about it, but --
` Q. I raised it, I referred to it.
` A. Yes.
` Q. And at the beginning of paragraph 45 you
`wrote "Naloxone was approved by the FDA in 1971 and
`has been marketed as Narcan (naloxone hydrochloride
`injection) for the 'complete or partial reversal of
`opioid depression, including respiratory depression'
`and 'diagnosis of suspected or known acute opioid
`overdosage'"; do you see that?
` A. Yes.
` Q. You understand that the indication for
`naloxone, as you set forth here in your declaration,
`is in connection with opioid overdose, right?
` A. One indication would be, yes.
` Q. Is it your view that there are other such
`indications?
` A. As I said, I would need to look at the
`label to just make sure that I don't tell the
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` GUNTHER HOCHHAUS
` A. Yes.
` Q. And one of the things you say is that
`there's a -- some pieces of a POSA are the
`pharmacologist POSA, right?
` A. Can you refer me to that section?
` Q. Sure. Paragraph 23.
` A. Okay.
` Q. That's where you define the pharmacologist
`POSA, right?
` A. Yes.
` Q. And one of the things you say about that
`person is that they would have particular
`experience -- or an advanced degree, right, and
`experience, right?
` A. "A clinical pharmacologist member of the
`development team (hereinafter a 'pharmacologist
`POSA') would have an advanced degree in pharmacy,
`clinical pharmacology, pharmaceutics, or a similar
`field and would have several years of experience in
`product development, including development of
`solution-based dosage forms, including nasal spray
`dosage forms."
` Q. I want to turn now to paragraph 45 of your
`report, please. We had been talking about -- it's
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` GUNTHER HOCHHAUS
`untruth.
` Q. I'm going to hand you what's been
`previously marked as Nalox 1044. This is the
`physician's -- sorry. I was trying to be efficient.
`I completely failed. I apologize. Would you like
`another copy?
` A. I can pick it up for you.
` Q. I apologize. This is the PDR exhibit that
`you cited in connection with your quote; do you see
`that?
` A. Yes.
` Q. Okay. And in your quote -- if you look at
`the PDR on the first page of substance, which is
`designated page 3 of 10 at the bottom -- is it okay
`if I refer to the page numbers at the bottom of the
`exhibit as we move forward so that it --
` A. Page 3. Yeah. Sure.
` Q. So when I give you exhibit numbers today
`I'm going to try to refer to those for ease of use.
` Do you see right above the page number it
`says "Indications and usage"; do you see that?
` A. Yes.
` Q. Okay. And do you see how it also says that
`"Narcan is indicated for the complete or partial
`
`TSG Reporting - Worldwide 877-702-9580
`
`6
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 6
`
`

`

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` GUNTHER HOCHHAUS
`reversal of opioid depression, including respiratory
`depression, induced by natural and synthetic
`opioids, including," and then it names some opioids;
`do you see that?
` A. Yes.
` Q. And then it says "Narcan is also indicated
`for the diagnosis of suspected opioid tolerance or
`acute opioid overdosage"; do you see that?
` A. Yes. So that's a different indication,
`isn't it?
` Q. It also relates to opioid use, correct?
` A. But it's a diagnostic.
` Q. Understood. In both cases the indication
`is about the use by the patient of opioids, right?
` A. It uses -- on one hand clearly it will use
`naloxone to reverse opioid overdose effects, but it
`also has here a diagnostic section in here. So it
`might be also given to patients who are not opioid
`dependent.
` Q. Okay. In connection with the reversal of
`the overdose, that's the first part of the
`indication, right? Not the diagnostic one, but the
`first part is about the overdose, right?
` A. It says "Narcan is indicated for the
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` GUNTHER HOCHHAUS
` Q. Okay. It's not about treating some other
`kind of overdose, right?
` A. It's certainly not being used for the
`overdosing of aspirin, absolutely.
` Q. Okay. Great.
` Why don't we go back now to your
`paragraph 64, please. Are you with me?
` A. Uh-huh.
` Q. And looking at the second sentence, you say
`"In addition, the prior art" --
` A. (Inaudible.) Uh-huh.
` Q. -- "the prior art discloses that naloxone
`has a broad therapeutic window and serious adverse
`events are reportedly rare"; do you see that?
` A. Yes.
` Q. I want to focus on the second document you
`cite there, 2012 FDA meeting; do you see that?
` A. Yes.
` Q. Okay. Why don't we take a look at that
`exhibit, Nalox 1049. I'm going to give you the
`complete copy. Okay. Everybody gets a complete
`copy.
` A. Don't throw it now.
` Q. I will not throw it. I apologize.
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` GUNTHER HOCHHAUS
`complete or partial reversal of opioid depression,
`including respiratory depression, induced by natural
`and synthetic opioids."
` Q. And even when you talk about -- in the
`second indication when we're talking about
`overdosing, it's about opioid overdosing, not
`overdosing on something else, right?
` A. Let me first read through it again.
`"Synthetic opioids including propoxyphene,
`methadone, and certain mixed agonist-antagonist
`analgesics, nalbuphine, pentaxocine and butorphanol.
`Narcan is also indicated for the diagnosis of
`suspected, suspected opioid tolerance or acute
`opioid overdosage."
` What was your question?
` Q. My question is when it talks about the use
`of Narcan to reverse overdoses, it's about opioid
`overdoses, right?
` A. For the treatment portion, yes.
` Q. And in your report when you talk about what
`the person of skill in the art is doing, it's in
`connection with what they would do to develop a
`product to treat opioid overdose, right?
` A. Yes.
`
`Page 25
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` GUNTHER HOCHHAUS
` Apparently we have not internalized the
`climate change activist message. You have a
`complete copy, but I'd like to direct your attention
`to the page you cite for the first quotation,
`pages 58 through 59. Are you with me, sir?
` A. I'm on page 58 and 59.
` Q. Okay. There's a quote -- looking back to
`compare this to your report, if you would, what you
`say in your report is "Using 700 times as much as
`the indicated dose (of naloxone) you will not see
`any adverse events..."; do you see that?
` A. In my report?
` Q. Yes. The quote that you put in your
`report -- you understood that this report was going
`to the Patent Trial and Appeal Board, right?
` A. I knew what?
` Q. You knew that this declaration was going to
`the Patent Trial and Appeal Board, right?
` A. It might have been mentioned to me.
` Q. It's probably something that you actually
`attested to in your declaration, right?
` A. It might be, yeah, if you want to show it
`to me.
` Q. Okay. You understood it was going to be
`
`TSG Reporting - Worldwide 877-702-9580
`
`7
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 7
`
`

`

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` GUNTHER HOCHHAUS
`relied on by a deciding authority, right, by judges?
` A. Yeah.
` Q. Okay. And you -- and what you said in your
`report was that -- the quote was "700 times as much
`as the indicated dose of naloxone you will not see
`any adverse events...."; do you see that?
` A. Yes.
` Q. Okay. And you put the dot dot dot dot in
`there because you wanted to convey the impression
`that the words that came afterwards didn't matter,
`right?
` MR. BERMAN: Objection to form.
` A. I don't think so. I tried to be very
`truthful.
` Q. You tried to be truthful, but let's see
`what you left out. What you left out were the words
`in the ellipses which actually said -- the entire
`quote actually says "But if you use 700 times" --
`we're looking at page 59 at the top of the exhibit.
` A. Uh-huh.
` Q. "If you use 700 times as much as the
`indicated dose, you will not see any adverse
`events -- adverse effects," that's where you stop
`the quote, but what it actually says is "In
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` GUNTHER HOCHHAUS
`sentence, please.
` A. The portions around the sentence. I'll
`start on page 58, line 8.
` (Witness reviewing document.)
`BY MS. BERNIKER:
` Q. Have you read the whole sentence now,
`sir?
` A. Yes.
` Q. Okay. And the sentence says that "700
`times as much as the indicated dose you will not see
`any adverse events" -- excuse me. Let me try that
`again. What the sentence actually says is "But if
`you use 700 times as much as the indicated dose, you
`will not see any adverse effects in opiate-naive
`subjects who are not having pain"; do you see that?
` A. Yes.
` Q. And the language "in opiate-naive subjects
`who are not having pain" is the language that you
`deleted and replaced with an ellipsis in your expert
`report, right?
` MR. BERMAN: Objection to form.
` A. I did not delete it.
` Q. Well, you replaced it with an ellipsis,
`right?
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` GUNTHER HOCHHAUS
`opiate-naive subjects who are not having pain"; do
`you see that?
` A. 59, you said?
` Q. Uh-huh.
` A. Yes.
` Q. The words you deleted were "In opiate-naive
`subjects," right?
` MR. BERMAN: Objection to form.
` A. Let me just read through not just one
`sentence.
` Q. I just want to know about the sentence
`because this is the sentence that you decided to put
`in your declaration.
` A. I would need to read through the full
`section.
` Q. To understand the whole context, right?
` A. Absolutely.
` Q. And the Patent Office would need to read
`the full sentence to understand the whole context
`too, right?
` MR. BERMAN: Objection to form.
` A. I need to read this sentence in order to
`answer your question.
` Q. I agree with you. Go ahead and read the
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`Page 29
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` GUNTHER HOCHHAUS
` MR. BERMAN: Objection to form.
` MS. BERNIKER: Paragraph 64 in the middle,
`you replaced it with an ellipsis, right?
` A. What means ellipsis?
` Q. The four dots. You replaced the words with
`dots, right?
` MR. BERMAN: Objection to form.
` A. I've used four dots.
` Q. You've used four dots instead of the actual
`words, right?
` A. I didn't -- that doesn't show it. I've
`used four dots and stopped there. I didn't replace.
` Q. Okay. You used four dots instead of the
`words "opiate-naive subjects," right?
` A. I didn't use -- I used four dots.
` Q. Right. Is it your testimony, sir, that
`that is complete and truthful testimony that you
`provided to the Patent Office, that it was totally
`legitimate to delete the words "in opiate-naive
`subjects"?
` MR. BERMAN: Objection to form.
` MS. BERNIKER: That's how you applied the
`obligation to be truthful is by deleting critical
`words, in this case "in opiate naive subjects"?
`
`TSG Reporting - Worldwide 877-702-9580
`
`8
`
`Opiant Exhibit 2066
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 8
`
`

`

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` GUNTHER HOCHHAUS
` MR. BERMAN: Objection to form.
` A. Can you define critical?
` Q. Okay. Well, let's put it this way. The
`people who you were directing your entire set of
`opinions to were people who had actually overdosed
`on opioids, right?
` A. Can you please repeat?
` Q. We just talked about the fact that the
`indication that you've been focused on in your
`report is the use of opioids -- I'm sorry -- is the
`use of naloxone to reverse opioid depression, right?
` A. Uh-huh.
` Q. Those patients have taken opioids, right?
` A. Yes.
` Q. Those patients are not opiate naive, right?
` A. Very likely that is true.
` Q. Okay. And so this sentence doesn't -- this
`sentence that you're quoting from the FDA meeting,
`on page 59 of the FDA meeting doesn't apply to the
`patients who have overdosed on opioids, right?
` A. I don't see it fully like that because I --
`there's certainly the possibility that naloxone
`might be given also to patients who have not taken
`opioids.
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` GUNTHER HOCHHAUS
`only applies to people who have not taken opioids,
`right?
` MR. BERMAN: Objection to form.
` A. I don't think so.
` Q. You think that this sentence can be read to
`describe people who have been taking opioids?
` MR. BERMAN: Objection to form.
` MS. BERNIKER: What does "opiate-naive
`subjects" mean, sir?
` A. Subjects who have not taken opioids.
` Q. Okay. Thank you. That's the language you
`didn't put into your report, right?
` A. There are four dots.
` Q. That's a yes, that's the language that you
`did not put in your report, right?
` MR. BERMAN: Objection to form.
` A. But it's the --
` Q. That's a yes-or-no question. You did not
`put that Language in your report, right?
` MR. BERMAN: Objection to form.
` A. I can't answer it with yes or no.
` Q. You can't answer whether you put the words
`"opiate-naive subject" in this quote in your report?
` A. I can answer that there are four dots.
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` Q. Okay. So as to patients who have not taken
`opioids who are accidentally administered naloxone,
`this sentence applies, right?
` MR. BERMAN: Objection to form.
` A. That certainly is one, and you also need to
`consider that this statement states that naloxone
`and there certainly will be -- it's a very, very
`safe drug with respect to the common side effects.
` Q. With respect to people who have not taken
`opioids, right, sir? That's what this statement
`says?
` A. That would also include those patients who
`have not taken opioids.
` Q. It would only include those patients who
`have not taken opioids, right?
` A. No.
` Q. It says "in opiate-naive subjects." That's
`patients who have not taken opioids, right?
` A. Yeah, but from a pharmacological point of
`view --
` Q. Hold on. I'm not askin