4/14/2020
`
` REMOTE VIDEO CONFERENCE
` CONTINUED VIDEOTAPED DEPOSITION OF
` GUNTHER HOCHHAUS, Ph.D. Volume 2
`Gainesville, Florida
` April 14, 2020, 9:46 a.m.
`
`Reported by: Michele E. Eddy, RPR, CRR, CLR
`________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
`(202) 232-0646
`
`Page 339
`A P P E A R A N C E S
`
`ON BEHALF OF THE PETITIONER:
` RICHARD J. BERMAN, ESQUIRE
` YELEE Y. KIM, ESQUIRE
` JOSHUA H. HARRIS, ESQUIRE
` Arent Fox LLP
` 1717 K Street, Northwest
` Washington, D.C. 20036
` Telephone: (202) 857-6000
` Richard.Berman@arentfox.com
` Yelee.Kim@arentfox.com
` Joshua.Harris@arentfox.com
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`EXAMINATION INDEX
`PAGE
`EXAMINATION BY MS. REYES
`
`Page 341
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`344
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`E X H I B I T S
` (Attached to the Transcript)
`DEPOSITION EXHIBIT PAGE
`Exhibit 1 "San Francisco EMS Agency Protocol 381
` Manual" dated January 30, 2017
`
`Exhibit 2 "Naloxone Distribution and 392
` Cardiopulmonary Resuscitation
` Training for Injection Drug Users
` to Prevent Heroin Overdose Death:
` A Pilot Intervention Study" by
` Karen H. Seal, Robert Thawley
`
`Exhibit 3 "Basic Principles of Dose 540
` Optimization"; PHA 5127
` Simulations; Excel Pharmacokinetic
` Simulations
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`1 (Pages 338 to 341)
`202-232-0646
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 338
`Page 340
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ----------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------
` NALOX-1 PHARMACEUTICALS, LLC
`Petitioner
`v.
` ADAPT PHARMA OPERATIONS LIMITED, and
` OPIANT PHARMACEUTICALS, INC.,
`Patent owners
` -----------------------------
` Case No. IPR2019-00685
` Case No. IPR2019-00688
` Case No. IPR2019-00694
`
`ATTENDANCE, Continued
`
`ON BEHALF OF THE PATENT OWNER ADAPT PHARMA OPERATIONS:
` ANA C. REYES, ESQUIRE
` KEVIN HOAGLAND-HANSON, ESQUIRE
` JESSAMYN S. BERNIKER, ESQUIRE
` DAVID M. KRINSKY, ESQUIRE
` YOULIN YUAN, ESQUIRE
` Williams & Connolly LLP
` 725 Twelfth Street, Northwest
` Washington, D.C. 20005
` Telephone: (202) 434-5000
` areyes@wc.com
` KHoagland-Hanson@wc.com
` JBerniker@wc.com
` DKrinsky@wc.com
` YYuan@wc.com
`
`- AND -
`
` JESSICA TYRUS MACKAY, ESQUIRE
` Green, Griffith & Borg-Breen, LLP
` 676 N. Michigan Avenue, #3900
` Chicago, Illinois 60611
` Telephone: (312) 883-8000
` jmackey@greengriffith.com
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`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 1
`
`

`

`4/14/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 342
`Page 344
`EXHIBIT INDEX CONTINUED
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`PAGE
`DEPOSITION EXHIBIT
`Exhibit 4 Skoog|West "Fundamentals of 606
` Analytical Chemistry 9E"
`
`Exhibit 5 Propagated absolute SD formula 618
`
`Exhibit 6 Wyse Spreadsheet with Cmax and SD 667
` figures
`
`Exhibit 7 "Standard deviations and standard 668
` errors" by Douglas G. Altman and
`J. Martin Bland
`
`Page 343
`
`P R O C E E D I N G S
`April 14, 2020
`- - -
` THE VIDEOGRAPHER: This is Video No. 1
`in the video-recorded deposition of Dr. Günther
`Hochhaus, taken in the matters of Nalox-1
`Pharmaceuticals, LLC versus Opiant
`Pharmaceuticals, Inc. It is pending before the
`United States Patent and Trademark Office before
`the Patent Trial and Appeal Board, with the
`following IPR numbers: 2019-00685, 00688, 00694.
` This deposition is being recorded by
`remote video by Zoom, and the physical recording
`is being taken place in Culpeper, Virginia, on
`April 14th, 2020. The time on the video screen is
`9:46 a.m.
` My name is Daniel Holmstock, and I am
`the legal video specialist. Our court reporter
`today is Michele Eddy. Counsel for appearances
`will be noted on the stenographic record. At this
`point now the court reporter will administer the
`oath.
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`GÜNTHER HOCHHAUS,
`
`having been duly sworn, testified as follows:
`
`EXAMINATION BY COUNSEL FOR PATENT OWNER ADAPT PHARMA
`
`BY MS. REYES:
`
` Q Doctor, this is Ana Reyes. I'm an
`
`attorney at Williams & Connolly. Can you hear me?
`
` A Yes.
`
` Q Okay. Good morning, how are you?
`
` A I'm doing fine.
`
` Q All right.
`
` You do not have clinical expertise in
`
`the administration of opioid antagonists to treat
`
`opioid overdoses, correct?
`
` A No, I don't practice medicine.
`
` Q You are not a medical practitioner with
`
`knowledge and experience relating to the treatment
`
`of opioid overdoses, correct?
`
` A I'm not treating patients, no. I'm a
`
`clinical pharmacologist.
`
` Q Right. And that's because you're not a
`
`medical practitioner at all, correct?
`
`Page 345
`
` A That is correct.
` Q You are not board certified in emergency
`medicine, correct?
` A That's absolutely correct.
` Q You are not board certified in any
`medical field, correct?
` A That is correct.
` Q You have never served as the medical
`director of any Department of Health, correct?
` A Correct.
` Q You have never treated a patient
`suffering from an opioid overdose, correct?
` A Correct.
` Q You have never administered any route of
`naloxone to any patient, correct?
` A Correct.
` Q You have never supervised others
`administering naloxone, correct?
` A I did some animal experiments, actually.
`I delivered naloxone by myself, but that was more
`in a basic science environment --
` Q And that was in the 1980s?
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`2 (Pages 342 to 345)
`202-232-0646
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 2
`
`

`

`4/14/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 346
`Page 348
` A -- but just to be correct, not with
` A I have never observed. Again, I've read
`patients.
`literature from practitioners who have practical
` Q That was in the 1980s?
`experience.
` A Yes.
` Q In connection with this litigation. I
` Q Okay. Now, just let me rephrase my
`understand that we can all read, but I'm asking
`question, then.
`about your treatment or lack of treatment of any
` You have never administered any route of
`patient. You don't have any firsthand experience
`naloxone to any human being, correct?
`observing administering naloxone to an individual
` A Correct.
`who is overdosing and then seeing what the
` Q You have never supervised others
`withdrawal or side effects are, correct?
`administering naloxone to human beings, correct?
` MR. BERMAN: Objection.
` A Correct.
` A I have not.
` Q You have never had to make any decision
` Q You have never handed out MAD kits to
`as to what initial dose of naloxone to give a
`lay individuals and taught them how to use them,
`patient, correct?
`correct?
` A Correct.
` A What is a MAD kit?
` Q You have never been asked to make a
` Q You don't know what a MAD kit is?
`medical assessment as to the dose for
` MR. BERMAN: Object to form.
`administering naloxone sufficient to restore
` Q I'm sorry, sitting here today, do you
`breathing in an overdosing patient, correct?
`know what a MAD kit is?
` A Asked by whom?
` A Well, as I said, the audio is not very,
` Q By anyone.
`very good so I understood kid as in child.
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`Page 347
` A I have to think about it. I might have
`had conversations with colleagues about that, and
`I would use then my knowledge that I obtained from
`the literature, reading medical articles, reading
`opinions of medical doctors and form opinions
`towards the correct dose.
` Q That was -- that was in an -- I'm sorry,
`that was in connection with this litigation?
` A Certainly, and also with respect to this
`litigation, of course, that one talked about it,
`but dose finding, more than I --
` Q Let me rephrase the question, then.
` You have never had to make a medical
`assessment as to the dose for administering
`naloxone sufficient to restore breathing in an
`overdosing patient, correct?
` A Yes. As I said, I have never treated an
`overdose patient.
` Q Okay. And you have never observed or
`treated the withdrawal and side effects of
`administering naloxone to an overdosing patient,
`correct?
`
`Page 349
` Q No, I'm sorry, MAD kit, K-I-T.
` A Okay, no.
` Q Okay. You have never published any
`paper on the administration of naloxone, correct?
` A Correct.
` Q You have never been asked to and you
`have never served on an expert panel to conduct a
`review of the literature on naloxone
`administration and published the results and
`recommendation for that use, correct?
` A Correct.
` Q Throughout your report, you reference
`what a "pharmacologist POSA" would find obvious,
`correct?
` A I was asked to serve as a pharmacologist
`POSA, correct.
` Q Correct. And that's the perspective
`that you bring to the litigation.
` A That's very, very clearly written in my
`declarations, yes.
` Q Yes. We're in heated agreement about
`that.
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`3 (Pages 346 to 349)
`202-232-0646
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 3
`
`

`

`4/14/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 350
`Page 352
`clinicians, to achieve a target pharmaceutical
`profile, correct?
` A If you -- as I said, I really would like
`to see what I have written in the declaration.
` Q Well, I don't -- I'm not -- I have your
`declaration. I'm not here for you to read your
`declaration to me. I'm here for you to answer my
`questions.
` A Yes, but I would --
` Q I have -- I have a question that's not
`dependent on his declaration.
` MR. BERMAN: Hang on, please.
` Q It's dependent on his experience. So
`let me ask the question again.
` MR. BERMAN: Excuse me, hang on.
`Dr. Hochhaus, can you please slow down your
`answers and allow me to object.
` THE WITNESS: Yes.
` MR. BERMAN: Okay. Thank you.
`BY MS. REYES:
` Q All right. As the link between the
`formulator and the clinician, the clinical
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` A Yes.
` Q Of the available experts in this case,
`if the Board wanted the viewpoints of a clinician
`POSA as opposed to a pharmacologist POSA, they
`would have to go to Dr. Williams, right, not you?
` MR. BERMAN: Objection to form.
` A I'm sure that the Board could go to
`somebody else, too.
` Q Well, they would not be able to go to
`you, right, because you are not a clinician POSA?
` MR. BERMAN: Objection.
` A I am not a clinician POSA, no, but there
`are lots of clinician POSAs besides Dr. Williams.
` Q Of the experts in this litigation,
`Dr. Williams is the only clinician POSA, correct?
` A As far as I know, yes.
` Q And, in your view, the clinical
`pharmacologist generally serves as a link between
`formulators and clinicians, correct?
` A That's written in my first declaration.
` Q Okay. And, in your view, for this case
`the POSA team would include a clinician, correct?
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`Page 351
`
` A I don't think that I said in my
`declaration the POSA team. And we might want to
`take a look exactly at the section that deals with
`that. Maybe you can help me find that section.
` Q Let me withdraw that question, and let
`me go back to the previous question.
` You agree that the clinical
`pharmacologist generally serves as a link between
`formulators and clinicians, correct?
` A During drug development, yes.
` Q Okay. And you are not a formulator and
`you are not a clinician, correct?
` A I made that very, very clear in my
`declaration, yes.
` Q Okay. And you are just the link between
`the two.
` A I would probably not say "just."
` Q But you are the link between the two.
` A That sounds much better.
` Q Okay. And as the link between the two,
`a clinical pharmacologist would routinely
`collaborate with others, such as formulators and
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`Page 353
`pharmacologist would routinely collaborate with
`others, such as formulators and clinicians, to
`achieve a target pharmaceutical profile, correct?
` A Yes.
` Q And here you collaborated with a
`formulator, Dr. Donovan, correct?
` A Can you define collaboration?
` Q Well, how do you define collaboration?
` A It depends on what area. If I
`collaborate within research, then I work together
`with other research groups to answer a question.
` Q Okay. And so in that terminology, here
`you collaborated with Dr. Donovan, who's a
`formulator, correct?
` MR. BERMAN: Objection to form.
` A I never talked to Dr. Donovan.
` Q You never talked to Dr. Donovan?
` A Correct.
` Q Okay. And you never talked to any
`clinician either, right?
` A I read --
` Q No, I'm not asking about reading. We
`4 (Pages 350 to 353)
`202-232-0646
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 4
`
`

`

`4/14/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 354
`Page 356
`can all read, sir. I'm asking if you talked to
` And as between you and Dr. Williams,
`any clinician in forming your opinions.
`Dr. Williams has more experience in observing and
` MR. BERMAN: Objection to form.
`dealing with withdrawal and side effects in
` A As I said, I did not talk, but I -- I
`patients given naloxone, right?
`have to object a little bit. Reading literature
` MR. BERMAN: Objection to form.
`from medical people is truly time to learn from
` A He has more firsthand experience seeing
`them and trying to see their viewpoint, which I
`patients, yes.
`then can use with my clinical pharmacological
` Q And that's because he has decades of
`background to come up with my own opinion. My
`experience and you have none, right?
`opinions --
` MR. BERMAN: Objection to form.
` Q Sorry, sir. I'm not going to let you
` A I don't know that he has decades of
`just talk on and on. I appreciate that viewpoint,
`experience. I assume. He has certainly been
`but I am asking you a very specific question and I
`treating -- he is certainly treating patients.
`would like an answer to my specific question.
` Q Okay.
` That is, as part of this work that you
` Now, in your report, you reference a
`did on this case, you did not consult with or talk
`number of pharmacokinetic studies and you do some
`to any live clinician, correct?
`modeling based on those studies, correct?
` MR. BERMAN: Objection.
` A What report?
` A I did not.
` Q Good point, thank you.
` Q Correct?
` In your first supplemental report.
` A I did not talk to any clinician,
` A Yes.
`correct.
` Q And those pK studies were conducted on
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`Page 357
`
` Q Thank you.
` Now, as between you and Dr. Williams,
`Dr. Williams has more experience in assessing the
`lowest effective dose of naloxone to treat a
`patient suffering from an opioid overdose,
`correct?
` MR. BERMAN: Objection to form.
` A He treats patients. As I said, I don't.
` Q Right. So the answer to my question is
`yes, Dr. Williams has lots more experience because
`you have never done it, right?
` MR. BERMAN: Objection to form.
` A I've never treated a patient.
` Q And so, therefore, Dr. Williams, who has
`treated patients on narcotics for decades, has
`more experience than you do treating patients with
`naloxone, right?
` A Yes.
` MR. BERMAN: Objection to form.
` Q Right?
` A Yes.
` Q Thank you.
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`opioid-naive individuals, correct?
` A Yes.
` Q And naloxone does not generate
`withdrawal effects on opioid-naive individuals,
`correct?
` A Correct.
` Q And the pK studies do not reflect what
`withdrawal symptoms an opioid overdose individual
`will experience or at what dose of the naloxone
`they will experience those, correct?
` A pK studies have a very, very clear
`goal. They want to look at the concentration time
`profiles of naloxone after a given administration.
`The goal of pK studies is not to investigate
`potential side effects in patients.
` Q And they can't tell you anything about
`the potential side effects in patients for that
`reason, right? That's not what they're designed
`to do.
` A That's -- that's -- yeah, those studies
`are not interested in evaluating that.
` Q Now, the priority date for this matter
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`5 (Pages 354 to 357)
`202-232-0646
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 5
`
`

`

`4/14/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 358
`Page 360
`literature. I cannot fully say yes or no.
` Q Sitting here today, can you name me a
`single clinical study that tested an intranasal
`naloxone dose above 2 milligrams?
` A No. As I said, I would need to go back
`into my declarations and double-check exactly what
`I cited, what I have seen in the literature.
` Q But sitting here today, in terms of what
`you know sitting here today, you can't cite for me
`a single clinical study in which more than 2
`milligrams of intranasal naloxone was tested as an
`initial dose, right?
` MR. BERMAN: Objection to form.
` A Well, if you look at Wyse's patent, he
`did pharmacokinetic studies with 2 plus 2
`milligrams.
` Q Well, there's two problems with that
`answer, sir. First, Wyse is not a clinical study,
`right?
` MR. BERMAN: Objection to form.
` Q Wyse was not a clinical study, right?
` A But Wyse was a study, so --
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`is March 16th, 2015, correct?
` A Yes.
` Q And as of the priority date, there were
`a number of studies testing the effectiveness of
`intranasal dosing, correct?
` A Yes.
` Q I'm sorry, one second.
` A Yes.
` Q And those studies --
` A You also should make a little bit
`clearer what studies, what -- studies is a very,
`very broad area of things that you can do.
` Q Sure. As of the priority date, there
`were a number of clinical studies testing the
`effectiveness of intranasal dosing, correct?
` A Yes.
` Q And those clinical studies were
`conducted primarily using the MAD device, right?
` A Yes.
` Q And the MAD system usually contained a
`2-milligram dose of naloxone in 2 milliliters of
`fluid, right?
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`Page 359
`
` A Yes.
` Q And it was typically administered in
`half doses and to each nostril of the patient, so
`1 milliliter of liquid containing 1 milligram of
`naloxone to each nostril?
` A Yes.
` Q And most of the fluid sprayed using the
`MAD was lost either out of the patient's nose or
`down the patient's throat, right?
` A Yes.
` Q As of the priority date, no clinical
`study tested an initial dose above 2 milligrams
`intranasal, correct?
` A Would you please repeat?
` Q Sure.
` As of the priority date, no clinical
`study tested an initial dose above 2 milligrams
`intranasal, correct?
` A "No clinical study tested."
` Q An initial dose of naloxone above 2
`milligrams intranasal, correct?
` A I would not -- need to look at the
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`Page 361
` Q I'm asking about clinical studies, sir.
`Wyse was not a clinical study, correct?
` MR. BERMAN: Objection to form.
` A That is correct, yes.
` Q Okay. And Wyse did not test any initial
`dose above 2 milligrams as an initial starting
`dose, right?
` A What do you define as initial?
` Q The first dose. Wyse tested a
`2-milligram intranasal dose followed by five
`minutes and then another 2-milligram intranasal
`dose, correct? But he never tested a 4-milligram
`dose or a dose initially above 2 milligrams,
`correct?
` A That is correct.
` Q Thank you.
` Now, as of the priority date, there was
`not a single piece of literature identifying
`redosing as a problem that needed to be solved,
`correct?
` MR. BERMAN: Objection to form.
` A As far as I remember, there were
`6 (Pages 358 to 361)
`202-232-0646
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 6
`
`

`

`4/14/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 362
`Page 364
` MR. BERMAN: Objection to form.
`statements made that for laypersons, it may be a
` A And without letting me go through my
`problem. In the medical field, administration by
`declaration and directing you to cases where that
`medical doctors or trained personnel, there is, of
`was done, as I said, if we are --
`course, the possibility of titrating, and that's
` THE REPORTER: We're not getting the
`well-established and that's -- I fully agree is
`full answer. It's cutting in and out.
`certainly something that can be done and should be
` THE WITNESS: Is it now better? I'm a
`done by medical personnel.
`little bit closer to the computer.
` Q Sir, sitting here today, can you name me
` THE REPORTER: Yes. If you would please
`a single publication that indicating that redosing
`repeat that.
`was a problem that needed to be solved?
` MS. REYES: Actually, let me withdraw
` MR. BERMAN: Objection to form.
`the question because I'm going to get to his
` A Again, can you be more specific?
`declaration later on so I'll just come back to it
` Q That's a very specific question, sir. I
`then.
`can't make it any more specific.
` Sir, let me ask you this. In your
` Sitting here today, can you name me a
`supplemental report, you opine that a POSA would
`single publication which indicating that redosing
`be motivated to choose an intranasal dose higher
`was a problem that needed to be solved?
`than 2 milligrams, correct?
` MR. BERMAN: Objection to form.
` A Can you specify what supplemental report
` A Yes, there -- there are statements --
`you mean -- declaration you mean?
` Q Which publication has such a statement?
` Q Sure. The first supplemental
` A Can you -- can you please let me finish?
`declaration.
` Q Sure, go ahead.
`
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`Page 363
` A That would be very polite, thank you.
` Can you please repeat your question
`because you interrupted me.
` Q Sitting here today, can you name for me
`a single piece of literature that indicating --
`indicated that redosing was a problem that needed
`to be solved?
` A There are quite a number of statements
`that clarified that redosing for lay personnel is
`a challenge and might be a problem.
` Q Can you name me one of those
`publications?
` A I put them into my declaration.
` Q Well, there actually is no -- we're
`going to go into what you put into your
`declaration, and you're changing my question a
`bit, so let me -- let me ask this specific
`question because I've asked it now three times and
`you're giving me a different answer.
` Can you cite for me a single piece of
`literature that identified redosing as a problem
`that needed to be solved?
`
`Page 365
`
` A I believe so.
` Q Okay. And you first opine that "prior
`to March 16, 2015, emergency medical personnel
`routinely administered initial doses of 2
`milligrams IM and IV to opioid overdose patients."
` And if you would like to look at your
`declaration, that's at paragraph 21.
` A I'm at paragraph 21.
` Q Okay. And you see the first sentence is
`that "contrary to Dr. Williams' opinion, prior to
`March 16, 2015, emergency medical personnel
`routinely administered initial," which you
`italicized, "doses of 2 milligrams IM and IV to
`opioid overdose patients."
` Do you see that?
` A Yes.
` Q And then the -- what you cite for that
`proposition is the Sporer 1996 article.
` Do you see that?
` A Yes, it says, "Sporer provided a" --
` THE REPORTER: It's cutting in and out,
`Doctor.
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`7 (Pages 362 to 365)
`202-232-0646
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 7
`
`

`

`4/14/2020
`
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`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 366
`Page 368
` A "For presumed-opioid-overdose" --
` Q Dr. Hochhaus, you're cutting in and out
`again. And I think your video --
` A Yeah, I'm sorry. I'm really absolutely
`in front of my computer, and I'm talking
`relatively loud. So if that's the case --
` MS. REYES: Can we go off the record for
`a moment.
` THE VIDEOGRAPHER: The time is
`10:09 a.m. We're going off the record.
` (Discussion off the record.)
` THE VIDEOGRAPHER: The time is
`10:13 a.m., and we're back on the record.
`BY MS. REYES:
` Q And then, Doctor -- we're back on
`paragraph 21 -- after you discuss Sporer, at the
`very last line of 16, you write, "Because Sporer
`reported the routine and effective use of an
`initial IM or IV dose of 2 milligrams of naloxone
`for opioid overdose patients, a pharmacologist
`POSA would have recognized that the dose of
`naloxone in an intranasal formulation would have
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` Q Okay.
` A (Document review.)
` Okay. Yes, let me just continue also
`reading a couple of sentences after "effective."
` Q Okay.
` A (Document review.)
` Okay.
` Q Okay. So your view is that Sporer
`indicated the routine and effective use of 2
`milligrams IM and IV, and, therefore, that's what
`the POSA would try to match in an intranasal on
`exposure levels.
` MR. BERMAN: Objection to form.
` A The emergency medical system in San
`Francisco -- and I also would like to see a copy
`of the Sporer paper if you can --
` Q Yes, we're going to go through the
`Sporer paper, don't worry. We're going to go
`through it at length. I just want to make sure
`we're on the same page as to that's your opinion,
`right?
` MR. BERMAN: Objection to form.
`
`Page 367
`to be higher than a 2-milligram IM or IV dose."
`Right?
` A Well, you seem to have a different copy.
`You used one word that I didn't write.
` Q Which one is that?
` A I have here in line 2 "expected," and
`you said something different.
` Q "Would have expected"?
` A Yes, you didn't say "expected."
` Q I apologize. That was just my mistake.
` A Looks like it.
` Q Okay. But other than that, that's --
`that's -- I just want to make sure I understand
`your opinion. Your opinion is if there is a
`routine and initial dose -- if there's a routine
`and effective initial dose of IM or IV, the POSA
`would try to meet that dose, the exposure for that
`dose?
` A Yes. I would really like me to read the
`whole paragraph 21.
` Q You can read it to yourself, sir.
` A Yes, I will.
`
`Page 369
`
` A Well, let me just -- let me just
`rephrase my opinion. So the emergency medical
`system in San Francisco -- and, as I said, I would
`rather see the method description of that paper,
`but as far as I remember -- used on a routine
`basis as a starting dose, 2 milligrams IM or IV of
`naloxone in the hands of paramedics.
` So that tells me that this is on one
`hand safe to do or that the responsible person of
`the emergency medical system in San Francisco felt
`it was safe to do and that it was a very good,
`effective dose to give as a starting dose.
` So, contrary to Dr. Williams' opinions
`that you need to start with .4 milligrams, those
`folks in San Francisco started with 2 milligrams.
`And if you go through not only the Sporer paper
`but also the other literature, that seems to be
`the case.
` Q Okay. Well, let's go through -- let's
`go through the Sporer paper, then.
` Could we pull up Exhibit 1233, please.
` THE VIDEOGRAPHER: I'm sorry, what
`
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`8 (Pages 366 to 369)
`202-232-0646
`
`Opiant Exhibit 2214
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 8
`
`

`

`4/14/2020
`
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`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Gunther Hochhaus, Ph.D., Vol. 2
`Page 370
`Page 372
`questions. I need you to answer my questions and
`not give extraneous thoughts that I haven't asked
`for. And it's a little bit difficult for me
`because I can't see you right now. As well, it's
`a little bit of a delay on the hearing.
` So if I'm talking over you, I apologize,
`but it would help if you would just answer my
`questions.
` So my question was very simple. My
`question was very simple, and it has a simple
`answer. Sporer was a study conducted in 1993,
`correct?
` A That's what it says.
` Q Okay. Now, if we go to page 2 of
`Sporer, and if we start at the column 1, paragraph
`2 that starts "Although potentially fatal" -- do
`you see where I am?
` A Yes, but, as I said, I was -- I was in
`the process of reading sections that I think I
`should read. And you interrupted me so --
` Q Sir, I didn't mean to interrupt you. So
`let me ask this question and then you can read
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`number did you say? That cut out.
` MS. REYES: 1233.
` THE VIDEOGRAPHER: Oh, Nalox, right?
` Does everybody see that?
` MS. REYES: Dr. Hochhaus, can you read
`that, or do you need him to make it bigger?
` THE WITNESS: Bigger woul