Page 1
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________________________
` COALITION FOR AFFORDABLE DRUGS V LLC;
` HAYMAN CREDES MASTER FUND, L.P.;
` HAYMAN ORANGE FUND SPC - PORTFOLIO A;
` HAYMAN CAPITAL MASTER FUND, L.P.;
` HAYMAN CAPITAL MANAGEMENT, L.P.;
` HAYMAN OFFSHORE MANAGEMENT, INC.;
` HAYMAN INVESTMENTS, LLC;
` NXN PARTNERS, LLC;
` IP NAVIGATION GROUP, LLC;
` J KYLE BASS, and ERICH SPANGENBERG,
` Petitioner
` v.
` BIOGEN MA INC.,
` Patent Owner
` _____________________________
` Case No. IPR2015-01993
` U.S. Patent No. 8,399,514
` _____________________________
` DEPOSITION OF STEVEN E. LINBERG, Ph.D.
` Washington, D.C.
` June 13, 2016
`Reported by: Mary Ann Payonk, Job No. 107123
`
`TSG Reporting - Worldwide 877-702-9580
`
`Page 1 of 52
`
`Biogen Exhibit 2071
`Coalition v. Biogen
`IPR2015-01993
`
`

`
`Page 2
`
`Page 3
`
`1 APPEARANCES:
`2 ON BEHALF OF PETITIONER:
`3
` JAMES CARMICHAEL, ESQUIRE
`4
` CAROL SPIEGEL, ESQUIRE
`5
` CARMICHAEL IP
`6
` 8000 Towers Crescent Drive
`7
` Tysons Corner, VA 22182
`
`ON BEHALF OF PATENT OWNER:
` MICHAEL FLIBBERT, ESQUIRE
` KASSANDRA OFFICER, ESQUIRE
` FINNEGAN HENDERSON FARABOW
` GARRETT & DUNNER
` 901 New York Avenue, N.W.
` Washington, D.C. 20001
`
`Page 5
`
`89
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` June 13, 2016
` 9:00 a.m.
`
` Deposition of STEVEN E. LINBERG, Ph.D.,
`held at the offices of Finnegan, Henderson,
`Farabow, Garrett & Dunner, LLP, 901 New York
`Avenue, N.W., Washington, D.C., pursuant to
`Notice before Mary Ann Payonk, Nationally
`Certified Realtime Reporter and Notary Public
`of the District of Columbia, Commonwealth of
`Virginia, States of Maryland and New York.
`
`Page 4
`
`12345
`
`6
`
`78
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
` S. Linberg
`2
`STEVEN LINBERG,
`3
` called as a witness, having been duly
`4
` sworn, was examined and testified as
`5
` follows:
`6
` EXAMINATION
`7
`BY MR. FLIBBERT:
`8
` Q. Good morning. Mike Flibbert and
`9 Kassie Officer from Finnegan for the patent
`10
`owner.
`11
` Good morning, Dr. Linberg. Could you
`12
`please state your name for the record?
`13
` A. Steven Linberg.
`14
` Q. As you understand, I'll be asking you
`15
`a series of questions today. And all I ask is
`16
`that you answer to the best of your ability.
`17 And if you don't understand a question, just
`18
`please ask me to repeat it or clarify it. Is
`19
`that okay?
`20
` A. Yes.
`21
` Q. And as you know, the court reporter
`22
`is transcribing everything that we say, so it's
`23
`important that you give verbal answers such as
`24
`yes and no and that we not speak over each
`25
`other. Is that okay?
`
`1
` S. Linberg
`2
` A. Yes.
`3
` Q. And if you need a break at any time,
`4
`just let me know; we can take a break. The
`5
`only thing that I would ask is that if we're in
`6
`the middle of a question, that you finish
`7
`answering the question before we take the
`8
`break.
`9
` A. Yes.
`10
` Q. Is that fine?
`11
` Is there any reason that you cannot
`12
`testify fully and accurately today?
`13
` A. No.
`14
` Q. Are you taking any medication that
`15 would impair your ability to testify today?
`16
` A. No.
`17
` Q. And during the day I'll be referring
`18
`to the patent at issue here by the last three
`19
`numbers, as the '514 patent. Would you
`20
`understand that abbreviation?
`21
` A. Yes.
`22
` Q. And I'll also refer to this
`23
`inter partes review Patent Office proceeding as
`24
`an IPR. Would you understand that
`25
`abbreviation?
`
`TSG Reporting - Worldwide 877-702-9580
`
`2 (Pages 2 to 5)
`
`Page 2 of 52
`
`

`
`Page 6
`
`Page 7
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` S. Linberg
` A. Yes.
` Q. And I'll probably refer to multiple
`sclerosis frequently as MS. I assume you'd
`understand that.
` A. Yes.
` Q. Have you been deposed before?
` A. Yes.
` Q. And in what case or cases?
` A. It was a case approximately 15 years
`ago, Abbott was a patent holder and I was
`involved as a -- someone who had done work on
`that drug and was asked questions about the
`development of that product.
` Q. Can you tell me what the product was?
` A. The product was called Curosurf,
`C-U-R-O-S-U-R-F.
` Q. And is that a pharmaceutical drug?
` A. Yes.
` Q. What is it indicated to treat?
` A. It's indicated for prevention and
`treatment of neonatal respiratory distress.
` Q. That testimony was essentially as a
`fact witness in connection with a litigation?
` A. Correct.
`
`Page 8
`
`1
` S. Linberg
`2
` Q. Have you been engaged as an expert in
`3
`any other patent matters?
`4
` A. I have not.
`5
` Q. Have you provided any declarations in
`6
`any other patent matters?
`7
` A. I have not.
`8
` Q. Any expert reports in any patent
`9 matters other than what you've done for the
`10
`Biogen IPRs?
`11
` A. In patent matters, no.
`12
` Q. Have you done expert reports for any
`13 matters other than patent matters?
`14
` A. Expert reports in scientific terms,
`15
`in reviewing scientific findings.
`16
` Q. I understand. And what was the
`17
`subject matter of that scientific analysis or
`18
`analyses you've done?
`19
` A. I couldn't recall exactly what the --
`20 what it was. I've been involved in a number of
`21
`scientific reviews over the years.
`22
` Q. Okay. Did you prepare for your
`23
`deposition today?
`24
` A. Yes.
`25
` Q. And what did you do to prepare?
`
`1
` S. Linberg
`2
` Q. Was it a patent litigation?
`3
` A. I believe it was.
`4
` Q. And Abbott was the patent holder; is
`5
`that correct?
`6
` A. Yes.
`7
` Q. Do you remember who the other side
`8 was in that case?
`9
` A. Dey, D-E-Y. Dey LP.
`10
` Q. Did you testify at trial in that
`11 matter?
`12
` A. No.
`13
` Q. Did it settle or get resolved, or go
`14
`to trial?
`15
` A. I have no idea.
`16
` Q. That's fine. So other than the
`17 Abbott case where you testified as a fact
`18 witness, have you testified in any other
`19 matter?
`20
` A. I have not.
`21
` Q. Have you ever testified in a trial?
`22
` A. I have not.
`23
` Q. Have you testified as an expert in
`24
`any prior case?
`25
` A. I have not.
`
`Page 9
`
`1
` S. Linberg
`2
` A. Reviewed the declaration and reviewed
`3
`a number of the exhibits, primarily.
`4
` Q. Did you meet with counsel?
`5
` A. Yes.
`6
` Q. Did you meet with the counsel who are
`7
`here today?
`8
` A. Yes.
`9
` Q. And was there anyone besides counsel
`10
`present when you met with them?
`11
` A. No.
`12
` Q. Okay. And for how long did you meet
`13 with counsel to prepare for the deposition?
`14
` A. We met on Thursday and Friday all day
`15
`and for a couple hours yesterday.
`16
` Q. Now, you indicated you reviewed some
`17
`documents in preparing for today's deposition?
`18
` A. Yes.
`19
` Q. And could you be specific as to what
`20
`documents you reviewed?
`21
` A. I reviewed my declaration, the '514
`22
`patent, the two patents by Joshi, the 2002 and
`23
`the 2008.
`24
` Q. Okay.
`25
` A. The article by Wakkee. The article
`3 (Pages 6 to 9)
`
`TSG Reporting - Worldwide 877-702-9580
`
`Page 3 of 52
`
`

`
`Page 10
`
`Page 11
`
`1
` S. Linberg
`2
`by Kappos. The ICH Guidance E4. The article
`3
`by Werdenberg. The ClinicalTrials.gov entry.
`4 And the article by Begleiter.
`5
` Q. Thank you.
`6
` And other than those documents, do
`7
`you recall reviewing anything else, any other
`8 written documents in preparing?
`9
` A. I have reviewed some, I guess what is
`10
`called the file history.
`11
` Q. And that was for the '514 patent, I
`12
`assume.
`13
` A. Yes.
`14
` Q. Okay. And anything else beside the
`15
`file history and the documents you've
`16
`identified?
`17
` A. Not that I recall at the moment.
`18
` Q. Have you reviewed the patent owner
`19
`Biogen's preliminary response that was filed in
`20
`this case?
`21
` A. I did, as part of the file history.
`22
` Q. May not be in the file history. That
`23 would be a paper filed in the IPR proceeding
`24
`apart from the file history of the patent.
`25
` A. I believe I did, I'm -- I believe I
`
`Page 12
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` S. Linberg
`did.
` Q. Do you remember when you may have
`looked at it?
` A. No.
` Q. Okay. Have you reviewed any of the
`patent owner Biogen's exhibits that have been
`filed in this IPR proceeding other than the
`documents you -- any documents you've already
`listed?
` A. There was a -- I guess a declaration
`by a Dawson and a Riddick that I reviewed.
` Q. Dr. Rudick?
` A. Yes, Rudick.
` Q. And when did you review the Dawson
`Rudick declarations?
` A. Within the last week.
` Q. Do you recall if you have read the
`petitioner's reply to the patent owner's
`preliminary response?
` A. I don't recall offhand. I'd have to
`see it and I could tell you.
` Q. Do you recall reading the institution
`decision that the Patent Office issued to
`initiate the IPR proceeding?
`
`Page 13
`
`1
` S. Linberg
`2
` A. I don't recall reading that.
`3
` Q. And that would be a document stating
`4
`the grounds of unpatentability that have been
`5
`instituted by the Patent Office. Do you
`6
`remember seeing that?
`7
` A. I -- it -- I don't recall.
`8
` Q. Do you recall -- you mentioned you
`9
`reviewed your own declaration in preparing for
`10
`the deposition. Do you recall approximately
`11
`how much time you took in reviewing the
`12
`declaration?
`13
` A. No, I couldn't put a number on it.
`14 Number of hours? No. I certainly didn't
`15 memorize it.
`16
` MR. FLIBBERT: Understood.
`17
` I'm going to hand you what's been
`18
` previously marked as the Coalition
`19
` Exhibit 1005.
`20
` (Coalition Exhibit No. 1005, previously
`21
` marked, was referenced and indexed.)
`22
`BY MR. FLIBBERT:
`23
` Q. And if you'd take a moment to look at
`24
`this and confirm that this is a copy of the
`25
`declaration that you've submitted in this
`
`1
` S. Linberg
`2
`proceeding.
`3
` A. It has my electronic signature at the
`4
`back.
`5
` Q. Thank you. And did you review the
`6
`declaration before you signed it?
`7
` A. Yes.
`8
` Q. Do you recall when you began
`9
`preparing the declaration?
`10
` A. This declaration, approximately a
`11
`year ago.
`12
` Q. And do you recall approximately how
`13 many days or weeks it took you to prepare the
`14
`declaration? When you started, when you
`15
`finished?
`16
` A. I don't recall. I don't recall.
`17
` Q. Did you write the first draft
`18
`yourself?
`19
` A. I was -- it was an interactive
`20
`process. I approved everything that was in
`21
`here. These became my own words.
`22
` Q. Okay. Is there anything in the
`23
`declaration that, sitting here now, you would
`24
`like to change?
`25
` A. There were a couple of typos that I'd
`4 (Pages 10 to 13)
`TSG Reporting - Worldwide 877-702-9580
`
`Page 4 of 52
`
`

`
`Page 14
`
`Page 15
`
`1
` S. Linberg
`2
`like to change. I made a note. One of them is
`3
`on page 9, paragraph 18.
`4
` Q. Okay.
`5
` A. Let me get to that. There is a
`6
`reference to Exhibit 1001, column 2, lines 12
`7
`to 14 that should be column 4, lines 65 to 67.
`8
` Q. Okay, thank you.
`9
` A. There's another on page 23, paragraph
`10
`40, four zero. Let's see, the second line from
`11
`the bottom, Exhibit 19, page 4, columns -- or
`12
`column 2, lines 6 to 10 should be lines 5
`13
`through 9.
`14
` Q. And I think you said Exhibit 19, but
`15
`you mean Exhibit 1019?
`16
` A. 1019, yes, I'm sorry. Yes.
`17
` Q. So other than those two corrections
`18
`is there anything else that you'd like to
`19
`correct or change?
`20
` A. Yes, one on 31 that -- page 31 --
`21
` Q. Okay.
`22
` A. -- that corrects a misunderstanding
`23 where I talked about at the time concluded that
`24
`there was a capsule of the 240-milligram dose,
`25
`a single capsule that contained that dose.
`Page 16
`
`1
` S. Linberg
`2
`I've since learned that it is two capsules that
`3
`contain that dose.
`4
` Q. Okay. And so in preparing your first
`5
`opinion you had an assumption that a
`6
`240-milligram capsule was available; correct?
`7
` A. I did.
`8
` Q. And you now understand that that was
`9
`incorrect; right?
`10
` A. I understand that the dose of 240
`11 milligrams, instead of being given as one
`12
`capsule, is given as two capsules.
`13
` Q. So when you prepared for your
`14
`deposition did you consult with anyone else
`15
`besides counsel?
`16
` A. No.
`17
` Q. Did you communicate with anyone who
`18
`had any knowledge about MS?
`19
` A. No.
`20
` Q. So after you signed your declaration
`21
`in September 2015, did you review any documents
`22
`to increase your knowledge about the topics
`23
`relevant to this case?
`24
` A. I at some time would have used PubMed
`25 MEDLINE search to get some feel or some
`Page 17
`
`1
` S. Linberg
`2
`additional feel for MS, and in particular for
`3
`the pharmacokinetics, to see what information
`4 was available.
`5
` Q. So you ran some electronic searches?
`6
` A. Yes.
`7
` Q. And what were those searches?
`8
` A. I don't recall exactly what they
`9 were. I'm on PubMed most days and it's sort of
`10
`a normal part of my life.
`11
` Q. But the reason you ran those was to
`12
`get some familiarity with MS for this case?
`13
` A. To address this case, yes.
`14
` Q. And do you recall the particular
`15
`publications that you identified?
`16
` A. I do not, but I recall that there was
`17
`one study of pharmacokinetics published prior
`18
`to 2008 that I believe was the only one that
`19
`offered me any kind of information to use in
`20
`this. I could find it again easily.
`21
` Q. Do you remember the authors?
`22
` A. I don't recall the author, no.
`23
` Q. Or the research group?
`24
` A. I do not.
`25
` Q. Do you recall the title?
`
` S. Linberg
` A. I do not recall the title.
` Q. Do you recall the journal?
` A. No.
` Q. So how would you find it if you don't
`know --
` A. By searching for pharmacokinetics of
`dimethyl fumarate. And there was a -- one
`article that popped out of the number of hits
`that looked most appropriate and most recent to
`that time.
` Q. And that was in PubMed?
` A. I located it in PubMed, that's
`correct.
` Q. You did that search after your
`declaration was completed?
` A. I did it more recently, but I would
`have done it at the time to help form an
`opinion. I just don't recall that first time.
` Q. Do you cite that in your declaration?
` A. I do not.
` Q. And why not?
` A. No particular reason.
` Q. I guess I'm trying to understand if
`you actually relied on it in forming your
`5 (Pages 14 to 17)
`TSG Reporting - Worldwide 877-702-9580
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Page 5 of 52
`
`

`
`Page 18
`
`Page 19
`
`1
` S. Linberg
`2
`opinions or not.
`3
` A. It didn't provide me with any
`4
`information that would guide me in a particular
`5 way. I was hoping to find some answers and
`6
`didn't discover anything that was really
`7
`informative that would help guide me.
`8
` Q. Okay. But it sounds like you looked
`9
`at the same publication more than once. You
`10
`looked at it while you were preparing the
`11
`declaration and then more recently?
`12
` A. Yes, just went back in my review.
`13
` Q. So why did you go back to look at it
`14
`a second time?
`15
` A. I didn't record what it was the first
`16
`time, and just to go double-check as part of
`17
`the review.
`18
` Q. So you've looked at it twice but you
`19
`don't remember any of the authors or the title?
`20
` A. Correct.
`21
` Q. So other than that one article, did
`22
`you identify anything else through any
`23
`electronic searching that you have used in
`24
`connection with this project, this consulting
`25
`project on this case?
`
`Page 20
`
`1
` S. Linberg
`2
` A. I don't believe so, no.
`3
` Q. Did the article you found, did it
`4
`discuss MS?
`5
` A. I don't believe it did. I believe it
`6
`only discussed the pharmacokinetics of dimethyl
`7
`fumarate.
`8
` Q. Do you remember approximately when
`9
`you were engaged to assist with this
`10
`proceeding?
`11
` A. Roughly a year and a half ago.
`12
` Q. And do you have an idea of
`13
`approximately how many hours you've billed for
`14
`your work on this case?
`15
` A. I do not.
`16
` Q. And what's your current billing rate?
`17
` A. $250 an hour.
`18
` Q. Okay. Do you have any estimate of
`19 what -- how many hours or how much you billed
`20
`for to prepare your declaration?
`21
` A. No.
`22
` Q. You don't have any estimate at all?
`23
` A. No.
`24
` Q. So when you were -- this was a while
`25
`back, but when you were approached by counsel
`Page 21
`
`1
` S. Linberg
`2
`to work on this case, at that time did you
`3
`review any documents to try to increase your
`4
`knowledge about anything relevant to this case
`5 when you were approached initially?
`6
` A. Initially approached? I don't recall
`7
`looking at anything in particular.
`8
` Q. Were you provided with documents to
`9
`review?
`10
` A. Yes.
`11
` Q. And do you remember what you
`12
`reviewed?
`13
` A. I'm sure that there was a patent and
`14
`I was provided with some articles which have
`15
`been included as exhibits.
`16
` Q. And did you receive any literature
`17
`relating to multiple sclerosis?
`18
` A. In --
`19
` Q. Other than what's cited in the
`20
`declaration.
`21
` A. Other than what's cited? I don't
`22
`believe so, no.
`23
` Q. Just to be clear, going back from the
`24
`time you were first contacted by counsel to
`25 work on this matter, have you conferred with
`
` S. Linberg
`anyone who has knowledge about MS other than
`counsel?
` A. No, I have not.
` Q. And just to be clear, other than the
`one publication you've identified generally in
`your testimony today, have you considered any
`other documents in connection with this
`proceeding other -- other than the ones cited
`in your declaration?
` A. Not that I recall.
` Q. You're currently a consultant at SE
`Linberg Consulting; correct?
` A. Yes.
` Q. And what are your responsibilities in
`that position?
` A. I help companies with various aspects
`of drug development, starting with planning
`before an Investigational New Drug Application
`is submitted, through preparation for FDA
`advisory committee meetings.
` Q. Okay. And approximately how many
`consulting matters do you typically have at any
`particular time?
` A. I try not to exceed more than three
`6 (Pages 18 to 21)
`TSG Reporting - Worldwide 877-702-9580
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Page 6 of 52
`
`

`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Page 22
`
`Page 23
`
` S. Linberg
`or four at most.
` Q. And are you able to identify your
`clients without revealing confidential
`information? Any public information?
` A. I don't know that any of them would
`necessarily object if you need to know the
`company names.
` Q. Well, I'm not asking for anything
`confidential, but if you can identify company
`names without revealing confidential
`information, I'd like to know the names.
` A. Okay. One company is ImmunogenX,
`I-M-M-U-N-O-G-E-N-X. Another company is
`Hightide, all one word, Hightide
`Biopharmaceutical. And another company is
`Zambon, Z-A-M-B-O-N. Those are three current
`companies that I am engaged with. There are
`others that I have offered small pieces of
`advice but without a contract.
` Q. I understand. So for ImmunogenX,
`what -- generally what product are they seeking
`to develop?
` A. ImmunogenX has a product that they
`hope will work in celiac disease.
`
`Page 24
`
`1
` S. Linberg
`2
` Q. And what is celiac disease generally?
`3
` A. Celiac disease is a digestive
`4
`disease. Patients are unable to tolerate
`5
`gluten. They form an allergic reaction to
`6
`gluten.
`7
` Q. And Hightide Biopharmaceuticals, what
`8
`product are they trying to advance?
`9
` A. They are advancing a couple of
`10
`products. One is a nasal spray that has a
`11
`surfactant in it for -- they hope is going to
`12 work for otitis media.
`13
` Q. And what is that? I'm not familiar
`14 with that.
`15
` A. It's inflammation of the middle ear.
`16
` Q. Okay.
`17
` A. Earaches in children is the most
`18
`common.
`19
` Q. You mentioned they have a second
`20
`product they're interested in developing.
`21
` A. A second product they're developing
`22
`for diabetes.
`23
` Q. And Zambon, what are they seeking to
`24
`advance?
`25
` A. Zambon is working in bronchodilators
`Page 25
`
` S. Linberg
`for asthma.
` Q. And other than the work you've done
`in connection with these IPR proceedings, have
`you ever provided consulting services to a
`client for an MS drug?
` A. I don't recall an MS drug
`specifically.
` Q. Have you provided any consulting
`services to a client for a neurological drug?
` A. Yes.
` Q. And what drug was that?
` A. Eteplirsen, E-T-E-P-L-I-R-S-E-N, for
`Duchenne's muscular dystrophy. I recently
`worked on a product for Parkinson's disease
`psychosis. And I believe there were other
`products in my distant past that I just don't
`recall at present.
` Q. So for the products that you've just
`identified relating to neurological drugs, what
`was your role in that project? Or those
`projects?
` A. Yeah. It was in preparing the
`company for FDA advisory committee meetings, so
`I reviewed with the company all of the work
`
`1
` S. Linberg
`2
`that they had done, and my job was to prepare
`3
`them for a public presentation where they
`4
`presented their data and defended that data at
`5
`a public meeting of experts.
`6
` Q. In terms of those meetings, did you
`7
`actually attend those meetings?
`8
` A. I did.
`9
` Q. And what was your role in the
`10 meeting?
`11
` A. In the meeting I was an observer.
`12
`The preparation was complete.
`13
` Q. Did you provide any expert opinions
`14
`or views during those meetings?
`15
` A. During the meetings, no.
`16
` Q. Did you advise the FDA of any
`17
`scientific issues relating to the neurological
`18
`drugs at issue?
`19
` A. No.
`20
` Q. And your teams had other individuals
`21 who were tasked with the scientific aspects of
`22
`the neurology, correct, in those meetings?
`23
` A. There's always a neurologist at
`24
`the -- not always a neurologist at the company
`25
`but there are -- between the company and
`7 (Pages 22 to 25)
`TSG Reporting - Worldwide 877-702-9580
`
`Page 7 of 52
`
`

`
`Page 26
`
`Page 27
`
`1
` S. Linberg
`2
`advisors to the company, there are many
`3
`neurologists. My role is in probing and
`4
`questioning what they're doing, what they did,
`5
`to find the strengths and the weaknesses within
`6 what they did.
`7
` Q. Okay. And then in terms of the
`8
`actual advisory meetings, at each of those
`9 meetings was someone present who was an expert
`10
`in the neurological science in order to answer
`11
`questions from the FDA?
`12
` A. The company was responsible for that.
`13
` Q. Yes.
`14
` A. The company makes the presentation,
`15
`and they would have the neurologists either on
`16
`staff or as consultants or both.
`17
` Q. And they would bring someone of
`18
`that -- with that background to these -- this
`19
`type of a meeting; right?
`20
` A. Yes.
`21
` Q. Do you have any employees who work
`22
`for you for your consulting company?
`23
` A. No.
`24
` Q. About how many hours a week do you
`25
`work for your Linberg Consulting entity?
`
`Page 28
`
`1
` S. Linberg
`2
` A. It varies widely from more than 60
`3
`hours to 10 hours.
`4
` Q. Are you currently employed as a
`5
`principal at PharmApprove?
`6
` A. That is a company that I consult for.
`7
`So I'm not employed by PharmApprove; I am a
`8
`consultant to them.
`9
` Q. Okay, thank you.
`10
` And is it PharmApprove one word with
`11
`a capital A?
`12
` A. Sometimes they use capitals,
`13
`sometimes not.
`14
` Q. Understood.
`15
` What are your responsibilities in
`16
`consulting for PharmApprove?
`17
` A. PharmApprove is a company that has
`18
`the infrastructure that is required to prepare
`19
`a sponsor for an FDA advisory committee
`20 meeting, and what they contract out is the lead
`21
`of that group. So I come in as the lead to
`22
`lead their team, one of their teams. They have
`23
`a number of teams, and that would include a --
`24
`sometimes a clinical regulatory person who's
`25 more specific to the disease or not,
`
`Page 29
`
`1
` S. Linberg
`2
`audiovisual people, slide people,
`3
`videographers, speech coaches is a typical team
`4 makeup. I would lead that team for
`5
`PharmApprove. So they'd have all of those
`6
`people within their organization, but they
`7
`bring in the lead for that from outside.
`8
` Q. Are PharmApprove's clients typically
`9
`pharmaceutical companies?
`10
` A. They are, yes.
`11
` Q. And they are typically companies that
`12
`are seeking to obtain approval for a drug
`13
`they're investigating?
`14
` A. Yes.
`15
` Q. Sounds like PharmApprove assists them
`16
`to provide the strongest possible presentation
`17
`to the FDA during advisory meetings, for
`18
`example?
`19
` A. Yes.
`20
` Q. And PharmApprove is in New Jersey; is
`21
`that right?
`22
` A. They are.
`23
` Q. And you reside in Maryland; right?
`24
` A. Yes.
`25
` Q. Do you commute to PharmApprove or do
`
`1
` S. Linberg
`2
`you work remotely?
`3
` A. I work from home.
`4
` Q. How long have you consulted for
`5
`PharmApprove?
`6
` A. Two years, I believe.
`7
` Q. So in connection with consulting for
`8
`PharmApprove, have you ever worked on an MS
`9
`drug project?
`10
` A. It's quite likely that I did in the
`11
`past at one point but I don't recall. I've
`12 worked with many different therapeutic areas.
`13
` Q. But you can't recall anyone that was
`14
`an MS drug?
`15
` A. I cannot.
`16
` Q. And for PharmApprove have you worked
`17
`on neurologic drugs that you do recall?
`18
` A. The two products that I mentioned to
`19
`you were through PharmApprove.
`20
` Q. Okay. Are there any others you can
`21
`remember at this point?
`22
` A. I can't at this point.
`23
` (Coalition Exhibit No. 1017, previously
`24
` marked, was referenced and indexed.)
`25
`BY MR. FLIBBERT:
`8 (Pages 26 to 29)
`TSG Reporting - Worldwide 877-702-9580
`
`Page 8 of 52
`
`

`
`Page 30
`
`Page 31
`
`1
` S. Linberg
`2
` Q. So, Dr. Linberg, I've handed you what
`3 was previously marked as Coalition
`4
`Exhibit 1017. What is this document?
`5
` A. This is my curriculum vitae.
`6
` Q. Is it current?
`7
` A. I believe so, yes.
`8
` Q. Is your consulting work for
`9
`PharmApprove included here?
`10
` A. I'm sorry, it's -- no, it does not
`11
`include consulting for PharmApprove
`12
`specifically. That is part of the last entry,
`13
`consultant, SE Linberg Consulting. One of the
`14 many companies I consult -- not many, but one
`15
`of the companies I consult for.
`16
` Q. Okay, I understand.
`17
` Is there any detail from your
`18
`professional experience that is not included
`19
`here?
`20
` A. I'm sure there's detail, but I don't
`21
`know that it significantly adds to the intent.
`22
` Q. Are there any changes that you would
`23 make to the current CV?
`24
` A. Not that I'm aware of.
`25
` Q. Okay.
`
`Page 32
`
`1
` S. Linberg
`2
` A. Although I would change that. The
`3
`advisory board, the first entry there on page
`4
`3, 2014 to present, member of the advisory
`5
`board. I have not actually met at a -- been at
`6
`a meeting with them. I was asked to serve on
`7
`that board but have never participated.
`8
` Q. Okay, thank you.
`9
` Your CV indicates that you are a
`10
`cofounder and member of Airway Therapeutics
`11
`LLC; correct?
`12
` A. Yes.
`13
` Q. What is Airway Therapeutics?
`14
` A. Airway Therapeutics is a company that
`15
`is developing a protein called surfactant
`16
`protein D that is a normal protein found in our
`17
`lungs, would normally be in a premature baby's
`18
`lung, but when a baby is born before the
`19
`seventh month, they lack the surfactant, and so
`20
`they're treated with an exogenous surfactant
`21
`that comes from a pig or a cow or a calf.
`22
`Lungs -- the lungs are -- the surfactant
`23 materials are extracted from there.
`24
` In the manufacturing process, the
`25 water soluble proteins are removed and were not
`Page 33
`
`1
` S. Linberg
`2
`felt to be important, so that only two
`3
`surfactant proteins are contained in the
`4
`surfactants used to treat premature babies
`5
`today. Surfactant protein D is one of those
`6
`surfactant proteins that was removed
`7
`inadvertently and not known to be important.
`8
` It was discovered at Cincinnati
`9
`Children's Hospital that that particular
`10
`surfactant protein has some properties that
`11 would be beneficial to the baby, not only in
`12
`just stabilizing the surfactant itself but
`13
`adding antiinfective properties also. So the
`14
`intent was to take the surfactant protein D,
`15
`add that back into one of the three marketed
`16
`surfactants that are available, one or more of
`17
`them, and make an improved product.
`18
` Q. Okay. Thank you. I just wanted to
`19
`note, to make sure that again I'm not asking
`20
`for any confidential information, and I assume
`21
`these are details you can provide publicly,
`22
`because this transcript will be filed publicly,
`23
`just to clarify.
`24
` A. Yes.
`25
` Q. Thank you. Does Airway Therapeutics
`
` S. Linberg
`do any research in the field of MS?
` A. They do not.
` Q. Do they do any work on autoimmune
`diseases?
` A. No.
` Q. Do they work on any neurological
`disease solutions?
` A. No.
` Q. And what is your particular role -- I
`know you explain it in your CV somewhat here,
`but what's your role at Airway Therapeutics?
` A. Now I am merely a member of the LLC.
` Q. Okay. And what did you do
`previously?
` A. I was president and CEO.
` Q. And what were your responsibilities
`as president and CEO?
` A. It started off with figuring the path
`forward for that product, and along that way,
`identifying the safety of the product,
`identifying the proper dose that would be
`given, and planning out any confirmatory trials
`of that dose.
` Q. And you planned and conducted the
`9 (Pages 30 to 33)
`TSG Reporting - Worldwide 877-702-9580
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Page 9 of 52
`
`

`
`Page 34
`
`Page 35
`
`1
` S. Linberg
`2
`pre-IND meeting with the FDA?
`3
` A. Yes, to confirm what we had come up
`4 with as a plan for development.
`5
` Q. And when you attended that meeting,
`6
`did Airway Therapeutics have someone with them
`7 who was a scientist or an expert in that
`8
`technical field?
`9
` A. In neonatology?
`10
` Q. Yes.
`11
` A. I'm not sure if one of the inventors
`12
`came or not. I don't believe so. It's more of
`13
`a regulatory meeting. There's not science
`14
`discussed there, generally speaking.
`15
` Q. Because it's a pre-IND meeting?
`16
` A. Correct.
`17
` Q. So in terms of your background and
`18
`your CV, other than the IPR proceedings that
`19
`you've worked on relating to the '514 patent,
`20
`have you ever worked on a project related to
`21 MS?
`22
` A. Again, not that I recall, but it's
`23
`highly likely that that was an issue in the
`24
`past.
`25
` Q. But you don't remember any particular
`Page 36
`
`1
` S. Linberg
`2
`drug or any particular company that asked you
`3
`to consult on that?
`4
` A. I don't. This would have been during
`5