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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
` U.S. Patent No. 9,763,876
`
` DEPOSITION OF SVEINBJORN GIZURARSON, Ph.D.
` San Diego, California
` Tuesday, January 14, 2020
` Volume 1
`
`Reported by:
`LESLIE JOHNSON
`RPR, CCRR, CSR No. 11451
`Job No.: 3794962
`PAGES 1 - 136
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`www.veritext.com
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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
` U.S. Patent No. 9,763,876
`
` DEPOSITION OF SVEINBJORN GIZURARSON, Ph.D.
` San Diego, California
` Tuesday, January 14, 2020
` Volume 1
`
`Reported by:
`LESLIE JOHNSON
`RPR, CCRR, CSR No. 11451
`Job No.: 3794962
`PAGES 1 - 136
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`212-267-6868
`
`Veritext Legal Solutions
`516-608-2400
`www.veritext.com
`AQUESTIVE EXHIBIT 1149 Page 0001
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 2
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` AQUESTIVE THERAPEUTICS, INC.
` Petitioner
` v.
` NEURELIS, INC.
` Patent Owner
`
` Case: IPR2019-00451
` U.S. Patent No. 9,763,876
`
` DEPOSITION OF SVEINBJORN GIZURARSON, Volume 1, taken
`on behalf of Petitioner, at 12235 El Camino Real,
`Suite 200, San Diego, California, beginning at 8:59 a.m.
`and ending at 4:31 p.m., on Tuesday, January 14, 2020,
`before LESLIE JOHNSON, Certified Shorthand Reporter
`No. 11451.
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`APPEARANCES:
`
`For the Petitioner:
` HOFFMANN & BARON LLP
` BY: MICHAEL I. CHAKANSKY, ESQ.
` 4 Century Drive, Suite 300
` Parsippany, New Jersey 07054
` (973)331-1700
` mchakansky@hbiplaw.com
`For the Patent Owner:
` WILSON SONSINI GOODRICH & ROSATI
` BY: NATALIE J. MORGAN, ESQ.
` LORI P. WESTIN, ESQ.
` ALINA LITOSHYK, ESQ.
` 12235 El Camino Real
` San Diego, California 92130-3002
` (858)350-2303
` nmorgan@wsgr.com
` lwestin@wsgr.com
` alitoshyk@wsgr.com
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` I N D E X
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`WITNESS EXAMINATION
`SVEINBJORN GIZURARSON, Ph.D.
`Volume 1
`
` BY MR. CHAKANSKY 5, 131
` BY MS. MORGAN 125
`
` EXHIBITS REFERENCED
` SVEINBJORN GIZURARSON, Ph.D.
`NUMBER DESCRIPTION PAGE
`Exhibit 1001 U.S. Patent No. 9,763,876 11
`Exhibit 1008 Provisional Patent Application 41
`Exhibit 1011 U.S. Patent Application Publication 11
` No. US 2006/00469692 A1
`
`Exhibit 1014 Patent No. WO 2009/120933 A2 11
`
`Exhibit 1015 U.S. Patent Application Publication 11
` No. US 2008/0279784 A1
`Exhibit 1065 Provisional Application for Patent 86
`Exhibit 1069 Florida Regional Common EMS 24
` Protocols Field Guide
`
`Exhibit 2006 SIGMA Catalog 49
`
`Exhibit 2012 Expert Declaration of Professor 11
` Sveinbjorn Gizurarson in Support of
` Patent Owner's Response to Petition
` for Inter Partes Review of U.S.
` Patent No. 9,763,876
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`Page 5
` San Diego, California, Tuesday, January 14, 2020
` 8:59 a.m.
`
` SVEINBJORN GIZURARSON, Ph.D.,
` having been first duly sworn, was examined
` and testified as follows:
`
` EXAMINATION
`BY MR. CHAKANSKY:
` Q Good morning, Dr. Gizurarson.
` A Good morning.
` Q Am I saying it correctly or --
` A Gizurarson. It's difficult.
` Q Can I call you "Doctor"?
` A Yes.
` Q Thank you. Okay.
` A Maybe before we start, I need to add three
`additions to my declaration.
` Q Three -- well --
` A Do I have a chance for a correction -- one
`correction and two additions?
` Q Well, we have -- we'll discuss it as we go
`through.
` A Okay.
` Q Basically, your declaration, as we discuss it,
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`will be -- you know, will be fine, but --
` A Okay.
` Q -- it was filed.
` A Yeah. That's . . .
` Q All right. Dr. Gizurarson, have you --
` MR. CHAKANSKY: Could I ask you to put in his
`last name after I say "Doctor"?
` Would that be okay?
` MS. MORGAN: Yes. That's fine.
` MR. CHAKANSKY: In the transcript? It will
`kind of make it -- thank you. Because we might have
`other doctors we're talking about.
`BY MR. CHAKANSKY:
` Q Okay. Dr. --
` MS. MORGAN: Will you make it clear on the
`record when you're talking about another doctor, though?
` MR. CHAKANSKY: Absolutely. Absolutely.
`There will be a last name. Okay.
`BY MR. CHAKANSKY:
` Q Dr. Gizurarson?
` A Yes.
` Q Good morning.
` A Good morning.
` Q Have you been deposed before?
` A I have to admit, there's a few words that I'm
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`Page 7
`not familiar with all the words to what you mean by
`"deposed."
` Q Okay. I will explain it in a second. But
`during the deposition -- this is a deposition --
` A Yeah.
` Q -- if you have any question about the meaning
`of a term that I use --
` A Uh-huh.
` Q -- please let me know.
` A I will do that.
` Q All right. I'm not here to trick you or
`anything.
` A Okay.
` Q Now, you can speak English, correct?
` A Yes.
` Q And you can understand English?
` A Yes.
` Q Well, a deposition is an examination in front
`of a court reporter under oath --
` A Uh-huh. Yes.
` Q -- where I'll ask some questions and get your
`truthful and honest responses. And that's a deposition.
` There are depositions -- in our case, it's in
`connection with a proceeding before the Patent and
`Trademark Office of the United States.
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` A Okay.
` Q This is called an inter partes review
`proceeding. And this deposition is in connection with
`that.
` You might also be deposed -- it's called
`deposed -- in connection with litigations. Patent
`litigations, for example, there are many depositions.
` A Yeah.
` Q With that understanding, that you're being
`questioned under oath in connection with a proceeding,
`have you been deposed before?
` A I have.
` Q Okay. Can you tell us, how many times were
`you deposed?
` A Only once.
` Q Once. And that deposition was in connection
`with what?
` A It was in connection with Sumatriptan nasal
`spray.
` Q And was that deposition in connection with a
`proceeding before the Patent Office?
` A The -- I'm not sure if it was for the Patent
`Office, but there was a judge involved at the -- no.
`The deposition was just when my lawyers and I, and the
`other lawyers were questioning me.
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` Q Okay. Do you identify that deposition or that
`proceeding in your declaration at the end in your CV?
` A Not in my CV.
` Q Okay.
` A I don't think so. I'm not showing it in my
`CV.
` Q Do you recall if you mentioned it in your
`declaration?
` A Yes, I did.
` Q Okay. So when we go through your declaration
`and I get to the point, I will bring it up.
` A Okay.
` Q Other than that, you have not been deposed; is
`that correct?
` A No.
` Q And the rules are, just to familiarize you
`with it, is I'll ask questions. I'll ask for your
`honest response.
` A Uh-huh.
` Q Your attorney will -- can make objections.
`They won't be speaking objections, but they'll be
`objections. But you need to answer anyway --
` A Okay.
` Q -- after the objection, unless your attorney
`directs you not to answer, okay, in which case you don't
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`Page 10
`answer. And there will be some colloquy between me and
`your attorney.
` A Okay.
` Q During this deposition, while I'm
`cross-examining you, you're not supposed to be talking
`to your attorney about the subject matter of this
`deposition.
` A I understand.
` Q Okay. Is there any reason, Dr. Gizurarson,
`that you can't testify clearly and with understanding?
`And, for example, have you taken any drugs that would
`cause you to perhaps not be able to be responsive to
`questions?
` A No.
` Q Okay. Dr. Gizurarson, have you prepared for
`this deposition?
` A Yes.
` Q And how many days did you prepare for this
`deposition?
` A It started the 6th of January.
` Q Okay. And when you say "it started the 6th of
`January," were you in the United States at that time?
` A No.
` Q Okay. You were back home?
` A I was back home, yeah.
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` Q And in preparation for your deposition while
`you were back home, did you review any documents?
` A That was part of my preparation.
` Q Okay. And did that document -- any of those
`documents include your declaration?
` A Yes.
` Q Okay. Did they include the -- what we call
`the Gwozdz patent, G-W-O-Z-D-Z?
` A Yes.
` Q Did it include the Meezan, M-E-E-Z-A-N,
`patent?
` A Yes.
` Q I think it's an application, actually.
` And the Cartt '784.
` A Yeah. I don't remember the number, but the
`Cartt.
` Q Let me give you these. And I should -- I
`apologize. Meezan is Exhibit 1011.
` A Yes.
` Q And Cartt '784 is Exhibit 1015?
` A Yes.
` Q And Gwozdz is Exhibit 1014?
` A Yes.
` Q And your declaration -- I might as well put it
`before you -- has been marked as Exhibit 2012. And I'll
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`ask you to take a look at it.
` Dr. Gizurarson, having looked at Exhibit 2012,
`do you recognize it?
` A Yes, I do.
` Q Okay. Do you recognize that as your
`declaration?
` A Yes. It is signed by me.
` Q Okay. And it's signed by you on page --
` A 73.
` Q -- 73. Okay.
` Okay. On page 73 of the exhibit, that is your
`signature?
` A Correct.
` Q Okay. And it was executed on or about
`November 4th, 2019?
` A That is also correct.
` Q Okay. Did you review any other documents
`while you were in -- at home?
` A Some of the articles that were discussed in my
`declaration.
` Q Do you recall those documents?
` A For example, Li (sic).
` Q Okay. And that's Exhibit -- I'll get the
`list.
` Excuse me for one second. When you said Li,
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`you meant Lau, L-A-U?
` A Yeah. L-A-U.
` Q And that's Exhibit 2009?
` A Yes.
` Q I'm sorry. Continue, please.
` A The next one also. Yeah, Schols and Hendriks,
`Exhibit 2010.
` Q 2010. And that is Schols, S-C-H-O-L-S,
`hyphen, Hendriks?
` A Yes.
` Q H-E-N-D-R-I-K-S?
` A Yes.
` I looked at a few others, but I don't remember
`exactly.
` Q Okay. And, while you were at home, did you
`talk with anybody other than your attorneys about this
`deposition?
` A No. My family knows what I'm doing, but I did
`not talk about the subject matter.
` Q Okay. And did you prepare for your deposition
`in the United States?
` A Yes, I did.
` Q And when did you do so?
` A I came here Friday, spent time with this team
`here.
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` Q Your attorneys?
` A Yes.
` Q And you've been -- you prepared on Friday,
`Saturday, Sunday?
` A No. Saturday and Sunday I went to Chicago.
` Q Saturday and Sunday. Oh, Saturday and Sunday
`you went to Chicago?
` A Yes.
` Q And you prepared on Monday?
` A Yes.
` Q Okay. And, while you were here in the States,
`did you talk to anybody other than your attorneys about
`your deposition?
` A No.
` Q Dr. Gizurarson, I'd like to direct your
`attention to your declaration, Exhibit 2012, and page 3.
` A Okay.
` Q And in particular, Footnote No. 2. If you'd
`take a chance and read it, please.
` A Yes.
` Q Okay. What did you mean by, to your
`knowledge, Rhinocort, R-H-I-N-O-C-O-R-T, was never
`approved for the treatment of the flu?
` A I lived in Tokyo and met with those people
`that were developing this project, at least the second
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`Page 15
`generation of this project -- product. And the
`ingredient is not to treat flu, but it may be used to
`treat some of the symptoms that flu causes.
` Q Okay. And you stated that it was never --
`Rhinocort was never approved. Approved by whom?
` MS. MORGAN: Objection. Form.
`BY MR. CHAKANSKY:
` Q You can answer.
` A According to -- I need to look at the exact
`description of what it is aimed for, but this is to
`treat allergy or allergic symptoms. So flu can --
`causes rhinorrhea and symptoms that are -- that you can
`get when you have flu. So it doesn't -- it's not
`intended to treat flu, but it may minimize some of the
`symptoms due to the broad effect of the active
`ingredient.
` Q So Rhinocort can treat some of the symptoms
`associated with flu; is that correct?
` MS. MORGAN: Objection to form.
` THE WITNESS: Some of them, if they come up.
`BY MR. CHAKANSKY:
` Q And, when you said "approved," did you mean
`something like FDA approval?
` A All drugs have a certain indication. And, to
`my knowledge, it is not indicated for treating flu.
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` Q And who or what gives the indication?
` MS. MORGAN: Objection. Form.
` THE WITNESS: In order to put an indication on
`a drug, you have to prove that it does what the
`indication is supposed to -- what the indication is said
`that it's supposed to do.
`BY MR. CHAKANSKY:
` Q Uh-huh.
` A So if it is supposed to treat flu, you have to
`prove that it treats flu.
` Q Okay. And who or what, if anyone, do you have
`to prove it to?
` A The authorities.
` MS. MORGAN: Same objection.
`BY MR. CHAKANSKY:
` Q Okay. That would be the drug authorities?
` MS. MORGAN: Same objection.
` THE WITNESS: The authorities that approves
`what you put on the label. That is the indication.
`BY MR. CHAKANSKY:
` Q Have you ever heard of the term "off-label
`use"?
` A I have.
` Q Okay. And would that be the same as
`off-indication use?
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` MS. MORGAN: Same objection.
` THE WITNESS: I have not heard this term
`"off-indication use."
`BY MR. CHAKANSKY:
` Q Is the indication for the drug part of the
`drug label?
` MS. MORGAN: Objection. Form.
` THE WITNESS: The indication is part of -- now
`you're asking questions that are a little bit outside my
`expertise because I am not a regulatory expert.
`BY MR. CHAKANSKY:
` Q Uh-huh.
` A So exactly what -- how you file to FDA and all
`the authorities, I am not involved in things like that.
` Q In your statement in Footnote 2 where you say
`"To my knowledge, Rhinocort was never approved for the
`treatment of flu," was the approval -- or strike that.
` Is it correct to say that, to your knowledge,
`Rhinocort was never approved by a regulatory agency for
`the treatment of flu?
` MS. MORGAN: Objection. Form.
` THE WITNESS: Maybe. When I look at this
`product, I look at the indications that have been
`submitted by the company and approved by the -- in the
`States, FDA, for example. And, to my knowledge, it is
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`Page 18
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`not registered as a product to treat flu.
`BY MR. CHAKANSKY:
` Q Okay. I'd like to direct your attention to
`page 4 of your declaration --
` A Yes.
` Q -- Exhibit 2012, paragraph 5.
` If you'd take a look at that, please.
` A Yes.
` Q Okay. Does Nayzilam work as a rescue drug for
`cluster seizures and acute repetitive seizures in
`patients 12 years of age or older?
` A Yes, it does.
` Q Okay. Is there a need for another -- strike
`that.
` Are you familiar with the drug Valtoco?
` A I am not so much involved in trade names. I
`know this one because this is my own work that is behind
`that one. But many other trade names, you have to
`inform me what the content is.
` Q I'd like to direct your attention to page 17
`of your declaration, going onto 18, and in particular
`paragraph 36.
` A Yes. I'm familiar with this. Not the name
`Valtoco, but . . .
` Q Excuse me?
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`AQUESTIVE EXHIBIT 1149 Page 0018
`
`
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`Page 19
` A I am not familiar with the name Valtoco.
` Q Are you familiar with this paragraph --
` A Yes, I am.
` Q -- and the NRL-1 designation?
` A Not NRL-1.
` Q Okay. What do you know about Valtoco?
` A As far as I know, that is what Neurelis is
`going -- that is the name Neurelis will use on their
`product.
` Q Okay. What do you know about the product that
`goes by the name of Valtoco?
` MS. MORGAN: Objection. Form.
` THE WITNESS: I only know what is described in
`the patent that we are discussing.
`BY MR. CHAKANSKY:
` Q Do you know the formulation for Valtoco?
` MS. MORGAN: Same objection.
` THE WITNESS: I know what is described in the
`patent. And, if they have -- I expect that they are
`using that formulation within a certain range, I expect.
`BY MR. CHAKANSKY:
` Q Do you have any independent knowledge of the
`formulation of Valtoco?
` A No. Nothing except what is described in this
`document.
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`AQUESTIVE EXHIBIT 1149 Page 0019
`
`
`
`Page 20
` Q How do you know that Valtoco is described in
`what we've called this patent, Exhibit 1001? And it's
`given the designation U.S. Patent No. 9,763,876.
` MS. MORGAN: Objection. Form.
`BY MR. CHAKANSKY:
` Q Is this the patent you were talking about?
` A This is the patent I was talking about, yes.
` Q Okay. I'll ask the question again.
` How do you know that Valtoco is described in
`this patent, Exhibit 1001?
` MS. MORGAN: Objection. Form.
` THE WITNESS: I have not looked at the
`application for this trade name, so I cannot say
`100 percent that it -- that is the -- what the
`formulation is.
`BY MR. CHAKANSKY:
` Q Dr. Gizurarson, you stated earlier that
`Nayzilam, N-A-Y-Z-I-L-A-M, okay, is a -- works as a
`rescue drug for cluster seizures and acute repetitive
`seizures in patients 12 years of age and older.
` Do you recall?
` A Yes.
` Q If Nayzilam works, is there a need for
`Valtoco?
` MS. MORGAN: Objection. Form.
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`AQUESTIVE EXHIBIT 1149 Page 0020
`
`
`
`Page 21
` THE WITNESS: These drugs is actually on
`market now.
`BY MR. CHAKANSKY:
` Q I'm sorry?
` A This drug entered the market in December.
`Nayzilam was marketed in the month of December. There
`is space for more than one drug to treat epileptic
`seizures. And companies have known this need for
`decades.
` So, since I was one of the first groups -- I
`participated in one of the first groups that started
`focusing on this need. That was back in 1987. So
`people have recognized the importance of having a rescue
`drug like this on the market. And it's always good to
`have a second option.
` Q So, in your opinion, does Valtoco satisfy a
`long-felt need?
` A Here I would like to say that I have not seen
`what Valtoco is -- the description of Valtoco, so I
`cannot say what that drug is supposed to do.
` Q Are you aware of the use of benzodiazepines in
`intranasal spray administrations prior to Nayzilam or
`Valtoco?
` MS. MORGAN: Objection. Form.
` THE WITNESS: On the market?
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`AQUESTIVE EXHIBIT 1149 Page 0021
`
`
`
`Page 22
`
`BY MR. CHAKANSKY:
` Q Let's ask two questions.
` First, on the market.
` MS. MORGAN: Same objection.
` THE WITNESS: Not that have been registered on
`the market. Not that I am aware of. I am aware of
`product that is compounded in the Netherlands, but that
`is not used -- that has not been registered as a drug.
`BY MR. CHAKANSKY:
` Q Does that product have a name?
` A I don't remember.
` Q Okay. Do you know the formulation of that
`compound?
` A No.
` Q Do you know whether it's used intranasally?
` A Yes, I think it's used intranasally.
` Q And does it contain a benzodiazepine in it?
` A Yes.
` Q Do you know the benzodiazepine?
` A Midazolam.
` Q Midazolam?
` A Yeah.
` Q Do you know whether it contains any alcohols?
` A No.
` Q Are you aware of any other uses?
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`AQUESTIVE EXHIBIT 1149 Page 0022
`
`
`
`Page 23
`
` A I know that --
` MS. MORGAN: Objection. Form.
` THE WITNESS: Based on articles, published
`articles, I have seen people using midazolam injection
`as an intranasal spray.
`BY MR. CHAKANSKY:
` Q Is that in connection with a MAD product, a
`mucosal atomization device product?
` A I am not -- I don't know.
` Q How is it used? Are you aware of how it's
`used, an intranasal administration of a benzodiazepine?
` MS. MORGAN: Objection. Form.
` THE WITNESS: You open the vial, put it into a
`syringe. Then you attach some nasal device on top of
`the syringe and put it into the nose of the person you
`are -- that is supposed to get the drug.
`BY MR. CHAKANSKY:
` Q And, in this case, the midazolam IV
`formulation is used?
` A In the articles that I have seen, IV
`formulation midazolam is used, yes.
` Q Are you aware of any intranasal formulations
`containing diazepam that have been used?
` A I am not aware of that.
` MS. MORGAN: Same objection.
`
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`AQUESTIVE EXHIBIT 1149 Page 0023
`
`
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`Page 24
`
`BY MR. CHAKANSKY:
` Q The articles that you refer to that discuss
`midazolam being used in an intranasal spray, do you
`recall when those were published?
` A I think -- I'm not fully sure. I cannot give
`you dates. But, if I recall correctly, you may find
`references on the Web back to 1992 or -3.
` Q Uh-huh.
` Are you aware of the use of diazepam IV
`formulation administered intranasally as directed by
`those in charge of EMS workers in Florida?
` MS. MORGAN: Objection. Form.
` THE WITNESS: I don't recall I have seen that.
` MR. CHAKANSKY: I'm handing the witness what
`has been previously marked as Exhibit 1069. And it's
`entitled "Florida Regional Common EMS Protocols Field
`Guide."
`BY MR. CHAKANSKY:
` Q Have you seen that document before?
` A No.
` Q Okay. I'd like to direct your attention --
`well --
` MS. MORGAN: Counsel, is this the complete
`exhibit?
` MR. CHAKANSKY: Excuse me?
`
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`AQUESTIVE EXHIBIT 1149 Page 0024
`
`
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`Page 25
`
` MS. MORGAN: Is this complete?
` MR. CHAKANSKY: Yes, it is.
` Off the record for a second.
` (Discussion held off the record.)
` MR. CHAKANSKY: In response, that's a complete
`document, a copy of a complete document.
` MS. MORGAN: Thank you. And the publication
`date?
` MR. CHAKANSKY: Yeah. The publication date
`can be found on page 0003. And it's copyrighted 2005.
` MS. MORGAN: Thank you.
`BY MR. CHAKANSKY:
` Q And, while we're at it, I would direct your
`attention to page 30, 0030. These are the numbers we
`put on. Requested Exhibit 1069, page 0030. And direct
`your attention to the top of the page where it begins
`"Seizure Disorders."
` And when you were talking about the intranasal
`use of midazolam IV formulation, was it to address
`seizure disorders like in that first paragraph there?
` A Not necessarily. I don't recall exactly the
`indication they were using this. Because midazolam is
`also used prior to operation as a preanesthesia.
` Q Okay. Is it your testimony that, when you
`were talking about midazolam IV formulation used
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`AQUESTIVE EXHIBIT 1149 Page 0025
`
`
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`Page 26
`intranasally, you were talking about pre-operation?
` MS. MORGAN: Objection. Form.
` THE WITNESS: No.
`BY MR. CHAKANSKY:
` Q You were talking about for seizure, correct?
` MS. MORGAN: I'm going to object that this
`line is outside the scope of his declaration.
` MR. CHAKANSKY: I'm sorry. We'll get details
`later. The witness testified he is unaware of and that
`there were no solutions. And the diazepam wasn't used,
`and that certain formulations of diazepam are not
`successful in the nose. This points out that they are.
` MS. MORGAN: No. But you're asking him his
`opinion based on this document, which was for EMS
`workers. He's not an M.D. This is outside the scope of
`his declaration. Is this cited in his declaration?
` MR. CHAKANSKY: No, of course it's not. Then
`that's your objection. You have it.
` MS. MORGAN: It's outside the scope of his
`declaration.
` MR. CHAKANSKY: It's not -- I argue it is
`within the scope. It doesn't have to be a document
`cited therein.
` That being said, we'll put this aside for a
`moment.
`
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`AQUESTIVE EXHIBIT 1149 Page 0026
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`
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`Page 27
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` THE WITNESS: I am testifying that
`midazolam -- there are publications showing that
`midazolam has been used intranasally using IV
`formulation. But I am not testifying -- I'm not
`claiming the indication because I don't remember what
`indication exactly that has been used for.
`BY MR. CHAKANSKY:
` Q Okay. Dr. Gizurarson, in your opinion, can
`diazepam in a solution with benzyl alcohol and ethanol
`be used successfully in the intranasal administration of
`the diazepam to arrest seizures?
` MS. MORGAN: Objection to form.
` THE WITNESS: That is something that need to
`be tested before I can answer that.
`BY MR. CHAKANSKY:
` Q You would need to test it?
` A It would need to be tested.
` Q Dr. Gizurarson, have you ever recommended in
`any of your patents or patent applications the use of
`alcohols, including ethanol and benzyl alcohol, as
`solubilizers for solutions to be used intranasally?
` MS. MORGAN: Objection. Form.
` THE WITNESS: Ethanol and benzyl alcohol are
`mentioned in many of my patents, yes.
`/ / / /
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`AQUESTIVE EXHIBIT 1149 Page 0027
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`BY MR. CHAKANSKY:
` Q Dr. Gizurarson, could you turn to page 11 of
`your declaration. That's Exhibit 2012, paragraph 22,
`please.
` A Yes.
` Q Okay. The last sentence, you discuss your
`understanding from Neurelis' counsel that long-felt need
`should be based on inadequacies and the technical
`knowledge of those skilled in the art, not due to
`business-driven market forces.
` Do you see that?
` A Yes.
` Q What's your understanding of business-driven
`market forces?
` MS. MORGAN: Objection. Form.
` THE WITNESS: My understanding of this is to
`try to make a market -- making a market for something,
`not necessarily looking at what is real and needed.
`And, in this situation, there is a real, real severe
`need for a drug to treat seizures.
`BY MR. CHAKANSKY:
` Q Is there anything else that you considered?
` A I am not involved in --
` MS. MORGAN: Objection. Form.
` Go ahead.
`
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`AQUESTIVE EXHIBIT 1149 Page 0028
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`
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`Page 29
` THE WITNESS: I am not involved in business as
`such.
`BY MR. CHAKANSKY:
` Q Okay. As you applied this understanding in
`paragraph 22 to your analysis of long-felt need, did you
`consider the cost of the product?
` MS. MORGAN: Objection. Form.
` THE WITNESS: I realized that doing
`something --
` MS. MORGAN: And I'm going to object that it's
`outside the scope of his declaration.
` MR. CHAKANSKY: The witness's declaration says
`that he, at your direction, excluded certain
`considerations. I am trying to ascertain what
`considerations he excluded.
` MS. MORGAN: His declaration identifies what
`he included. So it's outside the scope.
` MR. CHAKANSKY: Well, we can agree to
`disagree.
`BY MR. CHAKANSKY:
` Q Could you please answer.
` A I know that developing a product is costly.
`You have to do Phase 1, 2, 3, drug studies, all kinds of
`validating tests. That is really, really costly. So I
`am fully aware of that fulfilling a need is something
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`AQUESTIVE EXHIBIT 1149 Page 0029
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`
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`Page 30
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`that can cost money.
` Q Did you exclude the final cost of the product
`from your consideration of whether the
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