1 UNITED STATES PATENT AND TRADEMARK OFFICE
`2 ____________________
`3 BEFORE THE PATENT TRIAL AND APPEAL BOARD
`4 ____________________
`5 PADAGIS US LLC
` Petitioner,
`6
` v.
`7
` NEURELIS, INC.
`8 Patent Owner.
` ____________________
`9
` Case No. IPR2025-00465
`10
` Patent 11,241,414
`11 ____________________
`12
`13
`14
` REMOTE ORAL DEPOSITION OF
`15
` MARC BROWN, PhD
`16
` MARCH 17, 2026
`17
`18
`19
`20
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`22 Veritext Job No.: 7950193
`23 Court Reporter: Julie C. Brandt, Texas CSR, RMR, CRR
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`1 * * *
`2
`3 ORAL DEPOSITION OF MARC BROWN, PhD, produced
`4 as a witness at the instance of the Petitioner, and duly
`5 sworn, was taken in the above-styled and numbered cause
`6 on the 17th day of March, 2026, from 9:12 a.m. to 5:03
`7 p.m. Central Time, before Julie C. Brandt, RMR, CRR, and
`8 CSR in and for the State of Texas, reported by machine
`9 shorthand at McDermott Will & Schulte LLP, 2801 Harwood
`10 Street, Suite 2600, Dallas, Texas, with the questioning
`11 attorney appearing remotely via Zoom.
`12
`13 * * *
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`1 APPEARANCES
`2 FOR THE PETITIONER:
`3 Chad A. Landmon (Remote via Zoom)
`4 Christopher Jones (Remote via Zoom)
`5 POLSINELLI
`6 1401 Eye ("I") Street, N.W.
`7 Suite 800
`8 Washington, D.C. 20005
`9 clandmon@polsinelli.com
`10 chris.jones@polsinelli.com
`11
`12 FOR THE PATENT OWNER:
`13 David Tobin
`14 McDERMOTT WILL & SCHULTE
`15 2801 Harwood Street
`16 Suite 2600
`17 Dallas, Texas 75201
`18 dtobin@mwe.com
`19 -and-
`20 Hannah Hurley
`21 McDERMOTT WILL & SCHULTE
`22 650 Live Oak Avenue
`23 Suite 300
`24 Menlo Park, California 94025-4885
`25 hhurley@mwe.com
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`1 INDEX
`2 PAGE
`3 Appearances.................................... 3
`4 Proceedings.................................... 6
`5 Stipulations................................... 214
`6
`7 MARC BROWN, PhD
`8 Examination by Mr. Landmon................ 7
`9 Examination by Mr. Tobin.................. 214
`10
`11 Signature and Changes.......................... 215
`12 Reporter's Certificate......................... 217
`13
`14 DEPOSITION EXHIBITS IDENTIFIED
`15 Exhibit 1010 Meezan Patent Application 152
`16 Exhibit 1040 '876 Patent IPR 67
`17 Exhibit 1064 Gwozdz Provisional Patent 146
`18 Exhibit 1071 U.S. Patent No. 9,763,876 69
`19 Exhibit 1072 Gizurarson Declaration for '876 84
`20 Exhibit 1073 Excerpts from Enhancement in 130
`21 Drug Delivery
`22 Exhibit 1074 U.S. Patent No. 6,962,691 160
`23 Exhibit 1075 Meezan Specification Amendment 171
`24 Exhibit 1076 Maggio Declaration 184
`25 Exhibit 2049 Curriculum Vitae 14
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`1 Exhibit 2051 Streitwieser excerpts from 92
`2 Introduction to Organic
`3 Chemistry, Fourth Edition
`4 Exhibit 2072 Brown Declaration Patent '546 19
`5 Exhibit 2073 Brown Declaration Patent '414 20
`6 Exhibit 2074 Brown Declaration Patent '786 21
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`1 P R O C E E D I N G S
`2 (Witness was placed under oath.)
`3 THE REPORTER: This deposition of
`4 Dr. Marc Brown is being conducted remotely via Zoom.
`5 Today's date is March 17, 2026, and the time
`6 is 9:07 a.m. Central Time.
`7 The witness is located at the offices of
`8 McDermott Will & Schulte in Dallas, Texas.
`9 My name is Julie Brandt, Texas Certified
`10 Shorthand Reporter No. 4018. I have administered the
`11 oath and I am in person with the witness and will be
`12 reporting the deposition through stenographic means.
`13 Counsel, please state your appearances for the
`14 record, beginning with the taking attorney, and then we
`15 may proceed.
`16 MR. LANDMON: Good morning. This is Chad
`17 Landmon with Polsinelli. With me today also is Chris
`18 Jones on behalf of Padagis.
`19 MR. TOBIN: Good morning, everyone. This
`20 is David Tobin from McDermott Will & Schulte. With me
`21 in the room is Hannah Hurley form the same firm. We're
`22 here on behalf of patent owner. We're also here on
`23 behalf of the witness, Dr. Brown.
`24 And just for the record, we understand that
`25 video is not being recorded on today's deposition.
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`1 THE REPORTER: Actually, if we could go
`2 off the record.
`3 (Discussion off the record.)
`4 MARC BROWN, PhD,
`5 having been first duly sworn, testified as follows:
`6 EXAMINATION
`7 BY MR. LANDMON:
`8 Q. Good morning, Dr. Brown. Can you just state
`9 your name for the record?
`10 A. Yeah. Dr. Marc Barry Brown.
`11 Q. Great. I'm going to start by going just over
`12 some ground rules for the deposition. I'll do my best,
`13 obviously, to ask some clear questions. But if you
`14 don't understand a question, can you please stop me and
`15 ask me to clarify? Otherwise, I'll assume that you
`16 understand my question. Does that make sense?
`17 A. Yeah, that's fine.
`18 Q. It's important, obviously, that we try not to
`19 talk over one another so the court reporter can take
`20 down all of your testimony. Also, you may hear some
`21 objections from your counsel as well from time to time.
`22 So let's try and do that. I know it gets harder over
`23 Zoom. And certainly, if I ever interrupt you, let me
`24 know. But we'll try; let's do our best.
`25 Unless counsel instructs you not to answer,
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`1 you should still go ahead and answer the questions if
`2 you can. Does that make sense?
`3 A. Yes, it does, thank you.
`4 Q. We'll try and take a break, you know, call it
`5 every hour, hour and a half. But certainly if you need
`6 to take a break, just let me know. We might try and
`7 finish out a question or two, but we can certainly go
`8 off the record whenever you do need a break.
`9 Because we are doing this remotely now, given
`10 my travel issues yesterday, I'm going to ask you just a
`11 few unique questions to doing this remotely. And I
`12 guess first I understand that in the room with you is
`13 the court reporter, Mr. Tobin and Ms. Hurley. Is there
`14 anyone else in the room with you?
`15 A. No, there isn't. No.
`16 Q. Okay. I also understand that you have in
`17 front of you your three declarations that you submitted
`18 in the IPR proceedings. Is that right?
`19 A. I do, yeah.
`20 Q. Okay. Do you have any other documents with
`21 you?
`22 A. I do have other documents with me. I have the
`23 three patents, and the prior art and my CV.
`24 Q. Okay. And is there any highlighting --
`25 A. No.
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`1 Q. -- or writing or notes on any of these
`2 documents?
`3 A. No, absolutely nothing.
`4 Q. Other than the laptop in front of you and your
`5 phone, do you have any other devices that are open in
`6 front of you today?
`7 A. As -- yeah, I have my phone in front of me,
`8 which is purely there to monitor my sugars. And for the
`9 avoidance of any doubt, I have a CGM, which is a
`10 continuous glucose monitor, in my skin, and that's
`11 attached to a pump which is operated Bluetooth by my
`12 phone. I also have a banana and a bottle of water, but
`13 I guess they're not devices.
`14 Q. Yeah. Certainly let me know if --
`15 MR. TOBIN: Chad, the audio cut out.
`16 You said certainly let me know and then --
`17 THE WITNESS: He's frozen on the screen.
`18 MR. TOBIN: -- the audio cut out.
`19 Your audio cut out, Chad. You said certainly
`20 let me know, and then there was about a 10-second pause
`21 where you were doing your best mime impression.
`22 Q. (BY MR. LANDMON) Sorry about that. I was
`23 saying certainly let me know if you need to take a
`24 break, if any of your devices are letting you know that
`25 you need to take a break.
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`1 A. Okay.
`2 Q. So other than potentially conferring with your
`3 counsel on privilege issues, can you agree not to
`4 communicate with anyone about the substance of your
`5 deposition, including any of my questions, during the
`6 course of today?
`7 A. I can.
`8 Q. And have you been deposed before?
`9 A. I have, yes.
`10 Q. Okay. About how many times?
`11 A. In the UK, I would say probably around four or
`12 five times.
`13 Q. And are those in conjunction with doing --
`14 well, sorry, let me back up.
`15 You said in the UK. Have you ever been
`16 deposed in a US proceeding?
`17 A. Yeah, the four or five I gave you were US
`18 proceedings, because in the UK, you're not -- I don't
`19 understand the technical differences legally, but it
`20 goes straight to court. So there isn't a deposition.
`21 Q. Were you serving as an expert witness in those
`22 cases?
`23 A. Yes, apart from one when I was a factual
`24 witness.
`25 Q. Okay. What was -- obviously, without breaking
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`1 any confidentiality agreements you may have had in
`2 place, in the issue that was a fact witness, what was
`3 the nature of that proceeding?
`4 A. I was a -- an inventor on the patent.
`5 Q. What was that patent directed to?
`6 A. It was a formulation patent.
`7 Q. What type of formulation?
`8 A. A topical skin formulation.
`9 Q. Do you recall -- do you recall what that
`10 patent was directed to in terms of what the substance of
`11 the patent was?
`12 A. I'm not sure I understand the question, but it
`13 was a formulation composition patent, yeah.
`14 Q. Do you recall what was in that formulation?
`15 A. I recall the drug, but not everything that was
`16 in it. This was a long time ago.
`17 Q. Okay. What was the drug?
`18 A. The drug was Picato.
`19 Q. Can you spell that for me?
`20 A. P-I-C-A-T-O. Believe me, that's better than
`21 the actual drug name, which is ingenol mebutate. But,
`22 yeah, that's the name of the product.
`23 Q. I'll stop with Picato then.
`24 So did that product go to market?
`25 A. Yeah, it was on the market for a few years,
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`1 yes, in the US and Europe.
`2 Q. Who marketed that?
`3 A. Leo. Although --
`4 Q. Is that -- sorry.
`5 A. I was going to say, although the work I did
`6 was for a company before Leo. It was invented with a
`7 company called Peplin.
`8 Q. Is that patent listed in your CV?
`9 A. I am pretty sure it must be, yeah.
`10 Q. Okay. We can take a look at that in a little
`11 bit.
`12 A. Okay.
`13 Q. Do you know -- so you testified in a
`14 deposition in that case. Did you testify in court as
`15 well?
`16 A. No.
`17 Q. Okay. Do you know, was there a trial
`18 proceeding related to that patent?
`19 A. Off the top of my head, I couldn't tell you
`20 how it ended up. The deposition was in the UK. It came
`21 to the UK for the deposition.
`22 Q. And was that a proceeding that was a patent
`23 litigation or an IPR proceeding like we have here?
`24 A. As far as I recall, that was patent
`25 litigation, but I'm not a lawyer. And it was a long
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`1 time ago. So, as I remember -- I can look in my CV,
`2 because I think it's detailed in there you if you wanted
`3 confirmation.
`4 Q. Why don't we turn to that in a bit. I'll ask
`5 you about your other deposition experience, and then
`6 we'll turn back to that.
`7 A. Okay.
`8 Q. So you mentioned being deposed in I think it
`9 was four other cases then?
`10 A. Yeah, around that. I'm just getting the page
`11 up on my CV.
`12 Q. Okay. We can turn to that then. And maybe
`13 that's easier anyways.
`14 A. So in my CV, it's the one referenced in 2014
`15 on page 24, which is the English patent cause in the
`16 case of Leo v. Teva.
`17 And then the one that I was -- it's the one in
`18 2017, and where it was a United States District Court,
`19 Delaware, in the case of Leo Pharma versus Perrigo,
`20 civil action fact witness for a patent family which I
`21 co-invented. So that's the one I was talking about,
`22 2017.
`23 Q. And just for the record, so your CV that we're
`24 talking about, it's Exhibit 2049 in this proceeding.
`25 Just wanted to --
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`1 A. Sorry. Yes. It's the one in 2017.
`2 Q. It's my job, not yours, to make sure we get
`3 the exhibit numbers down. So I appreciate it.
`4 (Exhibit 2049 marked.)
`5 Q. (BY MR. LANDMON) So is this a complete -- so
`6 back up, sorry. We're referring to your CV,
`7 Exhibit 2049. And we're on page 24, as you mentioned.
`8 A. Yeah.
`9 Q. Is this a complete list of every case that
`10 you've given deposition testimony in?
`11 A. As far as I remember, yes, that is a complete
`12 list.
`13 Q. Okay. And are any of these IPR proceedings?
`14 A. So the one in 2021, which is for Dermavant,
`15 that was a US PTO patent prosecution. I don't know
`16 whether that's the IPR that you're asking about.
`17 And then the one in 2024 where I -- for
`18 Madera, which was where I was giving an opinion for the
`19 US PTO.
`20 Q. And in all of the cases you served as an
`21 expert witness, have you -- has your work always been
`22 done on behalf of the patentholder?
`23 A. I believe that's the case, yeah.
`24 Q. Okay. Have you ever given expert opinion --
`25 strike that.
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`1 You've never given an expert opinion that a
`2 patent is invalid, right?
`3 A. Not as far as I recall, no.
`4 Q. Okay. And just so I kind of finish some of
`5 the ground rules today, I probably should have finished
`6 these earlier, but you understand today your testimony
`7 is under oath and has the same force and effect as if
`8 you were in court, right?
`9 A. I do, yes.
`10 Q. Okay. And you understand that the court
`11 reporter is taking a transcript of your testimony and
`12 that you may review -- that testimony may be reviewed
`13 and relied on by parties and the judges in this
`14 proceeding, right?
`15 A. I do.
`16 Q. And is there anything today preventing you
`17 from providing truthful and accurate testimony?
`18 A. No.
`19 Q. What did you do to prepare for your
`20 deposition?
`21 A. Are you talking in -- since -- are you talking
`22 the last few days or during the entire process I was
`23 engaged?
`24 Q. So I guess I would say let's focus now just on
`25 preparing for the deposition. I don't know how far back
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`1 you started preparing, but, obviously, you issued some
`2 declarations. You know, we've got those. Those are in
`3 the record.
`4 A. Yeah.
`5 Q. So I guess I'm wondering maybe when did you
`6 start preparing for your deposition, and what did you
`7 do?
`8 A. In terms of discussions, obviously, I did my
`9 own reading around the subject and again refreshed my
`10 memory because this is -- as is the way with these kind
`11 of cases, been going on for a while. And I flew in on
`12 Saturday, and I met my attorneys, my counsel on Sunday
`13 and Monday. I mean, maybe three hours each time at the
`14 most.
`15 Q. And were those meetings with Mr. Tobin and
`16 Ms. Hurley?
`17 A. They were, yes.
`18 Q. Did you meet with anyone else?
`19 A. Tim West was there, too.
`20 Q. Is he an attorney with McDermott Will?
`21 A. Yes.
`22 Q. Did you meet with anyone else?
`23 A. No.
`24 MR. TOBIN: Chad, just for the record, so
`25 we're clear, I think his last name was Best.
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`1 A. Sorry. Best, not West. Me being an idiot. I
`2 don't know where that came from.
`3 Q. (BY MR. LANDMON) No worries.
`4 Have you spoken to anyone else to prepare for
`5 your deposition today?
`6 A. Not as far as I recall.
`7 Q. So in preparing either for your -- strike
`8 that.
`9 In any work that you've done for these matters
`10 for Neurelis, have you spoken with Steve Cartt,
`11 C-A-R-T-T?
`12 A. No.
`13 Q. Have you spoken with Mark Mitchnick?
`14 A. No.
`15 Q. Have you spoken with David Hale?
`16 A. No.
`17 Q. Other than counsel, have you spoken with
`18 anyone else about your declarations or any of your work
`19 in this proceeding?
`20 A. No, I haven't. No.
`21 Q. And you mentioned reviewing documents to
`22 prepare today. Other than your declarations, what other
`23 documents did you review?
`24 A. Obviously, in the beginning I wrote some of my
`25 notes, notes down and my opinions historically through
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`1 the time. And I looked at some of those. I also read
`2 some documents on -- basically around diazepam, you
`3 know, the key components of this discussion. I looked
`4 at the IID from 2009, 2008. I think that's really --
`5 and then there were -- obviously, during that time as
`6 exhibits have come up, I've looked at those as I found
`7 them and also read them. So, yeah, I also read the
`8 Donovan Declaration.
`9 Q. Did you read the Donovan deposition
`10 transcript?
`11 A. I think I did, yes.
`12 Q. And the different documents you've mentioned,
`13 are those documents all referenced somewhere in your
`14 declarations?
`15 A. Yeah, all the exhibits are the external
`16 documents and the drafts. The drafts I submitted as
`17 part of my declaration, yeah, are all embedded within
`18 the final declaration, so yeah.
`19 Q. Okay. And in preparing either for today or
`20 declarations, did you review any documents that are not
`21 listed as being considered in your declarations?
`22 A. I don't recall so, no, but it's been -- it's
`23 been quite a while.
`24 Q. Sure. Well, if you happen to think of any
`25 during the course of our discussions today, if you could
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`1 just let me know.
`2 A. Yeah.
`3 Q. So I just want to -- just so we're kind of all
`4 on the same page of what we're talking about, we've
`5 mentioned your declarations a few times. I do know you
`6 said you have paper copies in front of you.
`7 A. Yeah.
`8 Q. We can certainly pull them up on the screen,
`9 too, but I think for purposes it's probably easier on
`10 your part and certainly easier on my part to just deal
`11 with the paper documents. But if I can just have you
`12 first look at what's Exhibit 2072, which is the
`13 Declaration of Marc Brown relating to the U.S. Patent
`14 No. 8,895,546.
`15 (Exhibit 2072 marked.)
`16 Q. (BY MR. LANDMON) And just so we're all on the
`17 same page today, is it okay if I refer to U.S. Patent
`18 No. 8,895,546 as the '546 patent?
`19 A. Absolutely.
`20 Q. Okay. And if you want to turn just to the
`21 last page of your declaration, I just wanted to confirm
`22 that --
`23 Sorry. I am looking for your signature. I'm
`24 wanting to confirm that this is your signature on there.
`25 So if you'll look at the last page, is that your
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`1 signature, Dr. Brown?
`2 A. It is my signature, yes.
`3 Q. Thank you.
`4 And to your knowledge, is your declaration
`5 that addresses the '546 patent accurate?
`6 A. To my knowledge, yes, indeed.
`7 Q. Are there any corrections you would like to
`8 make?
`9 A. None I can think of at the moment.
`10 (Exhibit 2073 marked.)
`11 Q. (BY MR. LANDMON) So now if I could have you
`12 turn to Exhibit 2073, which is your declaration relating
`13 to U.S. Patent No. 11,241,414.
`14 A. Yeah.
`15 Q. And is it okay today if I refer to U.S. Patent
`16 No. 11,241,414 as the '414 patent?
`17 A. Yes, it is.
`18 Q. And if we could look at the last page of this
`19 declaration, can you confirm that that's your signature?
`20 A. I can confirm that's my signature, yes.
`21 Q. And to your knowledge, is your declaration
`22 addressing the '414 patent accurate?
`23 A. To my knowledge it is, yeah.
`24 Q. Are there any corrections you would like to
`25 make?
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`1 A. Not that I can think of at the moment.
`2 (Exhibit 2074 marked.)
`3 Q. (BY MR. LANDMON) And now I would just like to
`4 turn to Exhibit 2074, which is your expert declaration
`5 relating to U.S. Patent No. 11,793,786.
`6 A. Okay.
`7 Q. And is it okay today if when I refer to the
`8 U.S. Patent No. 11,793,786 that I refer to it as just
`9 the '786 patent?
`10 A. Yes, it is.
`11 Q. And if you would turn to the last page of that
`12 declaration, can you confirm whether that's your
`13 signature?
`14 A. I can confirm that's my signature.
`15 Q. And to your knowledge, is your declaration
`16 relating to the '786 patent accurate?
`17 A. To my knowledge, yes.
`18 Q. Do you have any corrections you would like to
`19 make to that declaration?
`20 A. Not at the moment.
`21 Q. And just so we're all on the same page, you
`22 understand you're here today to testify about your
`23 opinions in all three of these declarations, right?
`24 A. I do.
`25 Q. So since the issues you've addressed in all
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`1 three of these declarations were pretty similar, most of
`2 my questions today will apply to all three declarations
`3 and patents. Unless I specify that I'm speaking about a
`4 specific declaration, you can assume my questions are
`5 relevant to all three of those declarations. Does that
`6 make sense?
`7 A. I understand, yeah.
`8 Q. And, obviously, if you need clarification
`9 throughout that, just let me know.
`10 A. Okay.
`11 Q. So let's turn back to Exhibit 2049, which is
`12 your CV. Are there any updates or changes to your CV
`13 since you submitted it with your declarations in this
`14 proceeding?
`15 A. If you'll ask -- well, what I can say is there
`16 may be some more papers that have come out since I
`17 submitted it. I couldn't tell you what they were, but I
`18 knew there were some being submitted. I know that
`19 recently and actually in the week before last there was
`20 some updated editions of book chapters, but I can't
`21 think of anything else at the moment.
`22 Q. Okay. Do any of those updates to either book
`23 chapters or new papers deal with nasal formulations?
`24 A. No, I don't believe so.
`25 Q. Okay. And do any of those updates to chapters
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`1 or papers relate to diazepam?
`2 A. No.
`3 Q. Okay. So if you look at the first page of
`4 your CV, there's a heading that says, education and
`5 qualifications. Do you see that?
`6 A. I do.
`7 Q. As part of your education, did you study or
`8 research nasal formulations?
`9 A. As a postdoc, I did a small amount of work as
`10 a -- on mucus, on mucosal delivery. My research on
`11 education and qualifications was about medicinal
`12 pharmaceutical chemistry in general. So there was some
`13 nasal delivery aspects in that. My PhD was about ligon
`14 proteins or protein interactions in general, so that was
`15 fundamentally systemic.
`16 Q. And in any of -- as part of your education,
`17 did you study or research benzodiazepines?
`18 A. In my education and qualifications,
`19 benzodiazepines would be -- bearing in mind, we're
`20 talking about 1986 to '90, but I'm sure benzodiazepines
`21 would have been part of that, as they're an important
`22 group of drugs that we would have studied.
`23 Q. Okay. Do you recall studies you did with
`24 benzodiazepines during your education?
`25 A. I mean, it's 40 -- nearly 40 years ago. So if
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`1 you're asking -- no, I don't recall. Did we study the
`2 various drug targets and drug characteristics, yes, we
`3 did through those entire four years.
`4 Q. And you see you have a section titled, present
`5 positions, right?
`6 A. Yeah.
`7 Q. And on the second page of your CV, you then
`8 have a section entitled, previous positions?
`9 A. Yeah.
`10 Q. During your present or previous positions,
`11 have you done any research or developed any intranasal
`12 formulations?
`13 A. Well, if we look at 2022 to 2025, Mosanna
`14 Therapeutics, that is a nasal formulation for sleep
`15 apnea. And that research continues. And I continue to
`16 advise those in my current position of -- in MLBT. We
`17 also -- I also worked for a number of companies
`18 developing nasal formulations for delivery of -- for the
`19 treatment of migraines, for the treatment of pain
`20 relief. We also looked at various projects on
`21 benzodiazepines in the mucosal epithelium. And now as
`22 I'm within MLBT, I am doing some more support work on
`23 nasal formulation development. And in -- when I founded
`24 and up until 2023, when I stepped down, there was at
`25 least ten projects working on nasal formulation
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`1 development.
`2 MR. TOBIN: And Mr. Landmon, just while
`3 there isn't a question pending, Dr. Brown, if you have
`4 any confidentiality concerns with any of the research,
`5 let me know, and then Mr. Landmon and I can discuss.
`6 THE WITNESS: Okay.
`7 MR. LANDMON: Yeah, that makes sense.
`8 Q. (BY MR. LANDMON) When was the earliest point
`9 in time during your career that you did any work on
`10 nasal formulations?
`11 A. I would say that that was in the first few
`12 years of MedPharm. So probably early 2000s.
`13 Q. And in any of that work, did you use
`14 permeation enhancers in the formulations?
`15 MR. TOBIN: Objection to form.
`16 A. I honestly couldn't recall that far back going
`17 forward. And I think it would be wrong of me to talk
`18 about what was in -- what is the Mosanna formulation
`19 because that's proprietary.
`20 Q. (BY MR. LANDMON) Okay. So that was in 2022.
`21 So prior to Mosanna, you don't recall whether any
`22 products used any permeation enhancers?
`23 A. Well, that's an interesting question and
`24 mainly because it's a long way back and I literally
`25 cannot -- cannot remember. What I can say, that
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`1 penetration enhancers are a class of excipients that
`2 have various uses, but it's also, I believe, a fair
`3 point to say some penetration enhancers are actually
`4 solvents. Some penetration enhancers could be something
`5 in there to stabilize the formulation. And so it's
`6 really hard for me to recall.
`7 Q. Do you recall at any point in time prior to
`8 2009 having discussions or putting thought into using
`9 penetration enhancers with a nasal formulation?
`10 A. Honestly, no, I don't recall.
`11 Q. And you mentioned working on nasal
`12 formulations involving benzodiazepines. Did any of that
`13 work occur prior to 2009?
`14 A. Again, I'm sorry, I just don't remember. I'm
`15 just looking back at my publications to see if that's
`16 any help.
`17 So did you say prior to 1998? Was that the --
`18 Q. 2009.
`19 A. 2009. Sorry.
`20 So I did do some work on nasal delivery with a
`21 PhD student where we tested the delivery of certain
`22 actives and we looked at the effect of things, some
`23 polymers, including, as far as I recall, chitosan, which
`24 was -- which was considered to be a possible penetration
`25 enhancer. I think that's why it was in the study. And
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`1 that was also with hyaluronic acid or hyaluronan. And
`2 they're the three references, M18 to M20, where
`3 hyaluronic acid and chitosan would be considered as
`4 potential penetration enhancers.
`5 Q. And what page are you looking at on your CV?
`6 A. Sorry. Page 13.
`7 Q. And I think you just said this, but just so I
`8 I'm clear, those are identified M18 through M20?
`9 A. Yes.
`10 Q. And what was the active ingredient that was
`11 involved there?
`12 A. It was -- as far as I recall -- I'd need to
`13 read the references, and I honestly don't have it in
`14 front of me -- we were looking at numerous drugs in that
`15 system. I think one was gentamicin. Well, actually it
`16 definitely was because it's listed. So I don't recall
`17 what else we were looking at in those studies.
`18 Q. What does gentamicin do?
`19 A. It's an antibiotic, a quite strong one.
`20 Q. And why were you looking at nasal delivery
`21 relating to gentamicin?
`22 A. I think one of the reasons why it was an easy
`23 drug to measure because all this was -- and apologies to
`24 anybody that finds this inappropriate, but these were
`25 all -- a lot of these were animal studies, and
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`1 gentamicin is a relatively simple drug to measure in the
`2 bloodstream. And the focus on these were actually -- I
`3 was -- I had at the time a reputation of working on
`4 polymers like hyaluronic acid. As you can see from the
`5 previous work, I was looking at how they hydrated and
`6 stuck to the nasal mucosa and enabled increased
`7 delivery. So we were looking at mucosity and also
`8 charge on absorption.
`9 Q. And these studies, were they directed to
`10 finding kind of more general nasal delivery systems that
`11 could be used with other actives as well?
`12 MR. TOBIN: Objection to form.
`13 A. Sorry, can you repeat that question?
`14 Q. (BY MR. LANDMON) Sure. So were these studies
`15 being conducted to develop nasal delivery systems that
`16 could be used with other actives in addition to
`17 gentamicin?
`18 A. Actually, these studies were based around the
`19 use of hyaluronic acid as an excipient, which is linked
`20 into -- if you look at a lot of the other references,
`21 there's quite a bit on there on hyaluronic acid, because
`22 that work was sponsored by a company called Hyal
`23 Pharmaceutical Corporation, who I worked for, and then
`24 came back to the UK as PhD student. And the companies
`25 that brought that out. So it was more about polymeric
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`1 effects on drug delivery.
`2 And we didn't only just look at the nose. We
`3 looked at the skin. I think we looked at also
`4 parenteral. There were a number of studies done.
`5 Q. Now that you've kind of looked at some of your
`6 publications, do you recall any nasal delivery systems
`7 you worked on that used penetration enhancers prior to
`8 2009?
`9 A. Well, sorry. I've obviously not made myself
`10 clear.
`11 Those references were about retaining and
`12 enhancing drug delivery in the nose, yeah. So
`13 penetration enhancers, you could call some part of the
`14 studies about that. Other studies you could talk about
`15 how we hydrated the nose. Other studies were how we
`16 retained the drug at the site of action, because it's
`17 difficult to say there was a particular focus on just
`18 penetration enhancement.
`19 When you're delivering drugs, you know, you
`20 need to be looking at concentration, the ability to
`21 stabilize the drug, the ability to delive