`
`Transcript of Boni E. Elewski, M.D.
`
`Date: October 20, 2017
`Case: Acrux DDC PTY Ltd., et al. -v- Kaken Pharmaceuticals Co., Ltd., et al.
`(PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email:: transcripts@planetdepos.com
`www.planetdepos.com
`
`WORLDWIDE COURT REPORTING | INTERPRETATION | TRIAL SERVICES
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1508
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
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`Page 1 of 276
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`
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` UNITED STATES PATENT AND TRADEMARK
` OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CASE NUMBER: IPR2017-00190
`U.S. PATENT NO. 7,214,506
`
`ACRUX DDS PTY LTD. & ACRUS LIMITED,
` Petitioners,
`vs.
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL,
`INC.,
` Patent Owner and Licensee.
`
` DEPOSITION TESTIMONY OF
` BONI E. ELEWSKI, M.D.
`October 20, 2017
`9:00 A.M.
`COURT REPORTER:
`MELANIE L. PETIX, CCR
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`2
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` S T I P U L A T I O N S
`
` It is hereby stipulated and
`agreed, by and between the parties
`through their counsel, that the
`deposition of BONI E. ELEWSKI, M.D., may be
`taken before Melanie L. Petix, Certified
`Court Reporter and Notary Public for the
`State of Alabama at Large, at Hilton
`Garden Inn Liberty Park, 2090 Urban
`Center Parkway, Birmingham, Alabama on
`October 20, 2017, commencing at 9:00
`a.m.
`
` In accordance with Rule 5(d) of
`The Alabama Rules of Civil Procedure, as
`amended, effective May 15, 1988, I,
`Melanie L. Petix, Certified Court
`Reporter, am hereby delivering to E.
`Anthony Figg, the original transcript of
`the oral testimony taken on October 20,
`2017, along with exhibits.
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`3
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` Please be advised that this is
`the same and not retained by the Court
`Reporter, nor filed with the Court.
` --oOo--
`
` A P P E A R A N C E S
`
`FOR THE PETITIONER:
` E. ANTHONY FIGG, Esq.
` AYDIN H. HARSTON, Ph.D., Esq.
` ROTHWELL FIGG
` 607 14th Street, N.W., Suite 800
` Washington, DC 20005
`
`FOR THE PATENT OWNER AND LICENSEE:
` JOHN D. LIVINGSTONE, Esq.
` ASHLEY WINKLER, Esq.
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 271 17th Street, NW, Suite 1400
` Atlanta, Georgia 30363-6209
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`ALSO PRESENT (via phone):
` TYLER C. LIU, Esq.
` Associate General Counsel
` Argentum Pharmaceuticals LLC
`
` I N D E X
`
`EXAMINATION BY: PAGE
` MR. FIGG 7
` MR. LIVINGSTONE 205
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`FURTHER EXAMINATION BY:
` MR. FIGG 220
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` E X H I B I T S
`
`Petitioner's PAGE
`No. 1500 - Clinical Infectious
` Diseases 88
`No. 1501 - Onychomycosis
` Publication 90
`No. 1502 - Trends in the
` Management of Cutaneous Fungal
` Infections 102
`No. 1503 - Guidelins for Treatment
` Of Onychomycosis 140
`No. 1504 - Meeting Minutes 187
`No. 1505 - United States
` Patent 5,962,476 199
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`Conducted on October 20, 2017
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`6
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` --oOo--
` I, Melanie L. Petix, a
`Certified Court Reporter and Notary
`Public for the State of Alabama at
`Large, acting as Commissioner, certify
`that on this date, pursuant to the
`Alabama Rules of Civil Procedure, and
`the foregoing stipulations of counsel,
`there came before me at Hilton Garden
`Inn Liberty Park, 2090 Urban Center
`Parkway, Birmingham, Alabama, on October
`20, 2017, commencing at or about 9:00
`a.m., BONI E. ELEWSKI, M.D., witness in
`the above cause, for oral examination,
`whereupon, the following proceedings
`were had:
`
` BONI E. ELEWSKI, M.D.,
`having been first duly sworn (affirmed),
`was examined and testified as follows:
`
`EXAMINATION BY MR. FIGG:
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` Q. Good morning, Dr. Elewski.
`Please say your full name for the
`record.
` A. My name is Boni Elewski.
` Q. And have you had your
`deposition taken before?
` A. Yes.
` Q. So you have some familiarity
`with the process, I take it. I will go
`over some of the ground rules that apply
`to this sort of a proceeding. As you
`know, my name is Tony Figg. I'm
`representing Acrux, the petitioner in
`this case. And my college, Aydin
`Harston, is with me as well. And I will
`be asking you questions today, as is
`apparent.
` The questions and answers will
`be taken down verbatim, so you and I
`have to be careful to try not to talk at
`the same time. And I'll let you finish
`your answer, or I'll try to, before I
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`ask another question, and I would
`appreciate if you would do the same. Is
`that okay?
` A. Yes, sir.
` Q. And your counsel may from time
`to time make objections to questions I
`ask. That's his right to preserve his
`record. And you understand that you are
`to respond to my questions as best you
`can, subject to his objections, unless
`you are advised not to answer the
`questions. Do you understand that?
` A. Yes, sir.
` Q. And if any of my questions
`today are unclear to you, I would ask if
`you would tell me that and ask me to
`clarify it and I'll be happy to try to
`do that, okay?
` A. Yes, sir.
` MR. FIGG: I don't know if you
`two would like to enter appearances and
`maybe also the gentleman on the phone.
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` MR. LIVINGSTONE: That would be
`great. My name is John Livingstone from
`Finnegan. We represent Dr. Elewski and
`Kaken Pharmaceuticals in this matter.
`And with me today is my colleague,
`Ashley Winkler.
` MR. FIGG: And Argentum
`representative, would you like to
`identify yourself?
` MR. LIU: Yes, Tyler Liu,
`in-house counsel at Argentum
`Pharmaceuticals.
` MR. FIGG: Thank you.
` Q. (BY MR. FIGG:) So Dr. Elewski,
`you are here today because you have
`submitted a declaration in support of
`the petitioner's -- or excuse me, the
`patent owner's position in the case and
`I'll be asking you questions about that.
`I'll provide a copy of it to you in just
`a moment.
` You are a medical doctor,
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`correct?
` A. Yes.
` Q. A dermatologist?
` A. Yes, sir.
` Q. And you are the chair of the
`department of dermatology at UAB?
` A. Yes, sir.
` Q. Okay. You're involved in
`supervising clinical studies, clinical
`trials of drugs?
` A. I have done that, yes, sir.
` Q. It appears that you are
`currently conducting some clinical
`trials involving Jublia; is that
`correct?
` A. We finished a couple of trials
`recently. I think there's one that's
`finishing up right now, yes, sir.
` Q. And are those trials being
`sponsored by Valeant?
` A. Yes, sir.
` Q. Did you participate in the
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`clinical trials that were submitted by
`Valeant in support of the application
`for FDA approval of Jublient [sic]?
` A. I did.
` Q. I'm sorry, of Jublia.
` A. Yes, sir.
` Q. Thank you. I take it you're
`also a practicing dermatologist?
` A. Yes, sir.
` Q. So you see patients on a
`regular basis?
` A. Absolutely.
` Q. And you treat them for
`disorders of the nail as well as the
`skin, correct?
` A. Yes, sir.
` Q. And when did you first start
`treating patients with nail problems?
` A. Well, I first started treating
`patients with nail problems when I was a
`resident in dermatology in the late
`'70s.
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` Q. And did those nail problems
`include onychomycosis?
` A. They did.
` Q. We're going to get into this in
`some detail, but from reading the
`materials in this case, I understand
`there are different types or degrees of
`onychomycosis; is that correct?
` A. Yes, sir.
` Q. Can you summarize what those
`are?
` A. Yes.
` Q. Please do.
` A. Okay. So the first type is
`called distal lateral subungual
`onychomycosis. It's when the fungus, a
`dermatophyte, starts at the plantar
`surface of the foot and works its way
`under the nail from the distal tip of
`the nail, the hyponychium, and it can
`work its way all the way through the
`nail bed and up into the nail plate.
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`That's the most common type of
`onychomycosis and it's usually caused by
`the fungus Trichophyton rubrum.
` The second type we'll call
`white superficial onychomycosis when the
`fungus attacks directly the nail plate
`leaving a white debris on the nail. The
`nail becomes a little white and crumbly,
`and that's caused by a dermatophyte
`Trichophyton mentagrophytes and several
`nondermatophytes.
` The third type is proximal
`subungual onychomycosis where the fungus
`originally was thought to work its way
`under the cuticle and from the proximal
`area of the nail bed to the distal, but
`more recent information makes us believe
`that it actually may disseminate to the
`nail from the blood because those
`patients are generally
`immunocompromised.
` The fourth type is Candida
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`onychomycosis, and it occurs in people
`with chronic mucocutaneous candidiasis,
`also known as CMCC. And Candida
`albicans works its way through the nail
`plate, but all 20 nails usually are
`terribly thick. And there's a recent,
`another type called endodonyx,
`e-n-d-o-d-o-n-y-x, I think, and the
`whole nail plate becomes thick and
`there's no subungual debris.
` Q. There's no --
` A. Debris under the nail plate,
`subungual.
` Q. And that is a form, that last
`one that you mentioned, is a form that's
`been discovered recently?
` A. It's been described recently,
`yes, sir.
` Q. The first four that you
`described, were those all known in the
`late 1990s?
` A. Yes, sir.
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` Q. And the progression of the
`disease in the various forms in those
`first four was known in the late 1990s?
` A. Yes, sir.
` Q. And you mentioned two
`organisms, T. rubrum and T.
`mentagrophytes?
` A. Yes, sir.
` Q. Are those common causes of
`onychomycosis?
` A. The most common is trichophyton
`rubrum or T. rubrum. It's by far much
`more common than T. mentagrophytes, but
`the latter does occur, yes.
` Q. Okay. And was it known in the
`late 1990s that those two organisms were
`commonly associated with onychomycosis?
` A. Yes.
` Q. Doctor, have you served as an
`expert in any other patent cases before
`this one?
` A. Yes.
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` Q. Can you just generally describe
`what those cases were?
` A. I can say that there might have
`been confidential --
` Q. I'm not asking --
` A. Okay.
` Q. Yeah.
` A. Okay. So I'm guessing, there
`was one other patent case and it was
`about 10 years ago. And Dr. Reddy was
`looking to make generic terbinafine and
`the patent on oral terbinafine had not
`yet expired, it still had a few years of
`life. It was probably more than 10
`years ago. And I worked with a group of
`lawyers from Washington to do that.
` Q. And this was oral terbinafine
`for the treatment of onychomycosis?
` A. Yes, it is, yes, sir.
` Q. And that was the only other
`patent case on which you've worked?
` A. Yes, sir.
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` Q. Was your deposition taken in
`that case?
` A. It was.
` Q. And obviously you submitted an
`expert report in this case?
` A. I think I must have.
` Q. Did you work with the attorneys
`representing Dr. Reddy's laboratories or
`the patent owner?
` A. I was approached by the patent
`owner.
` Q. Was that Novartis?
` A. They were the patent owner at
`the time, yes.
` Q. Doctor, what have you done to
`prepare for today's deposition?
` A. Well, the attorneys sitting
`with me, we worked yesterday on
`preparing for it, went over some files.
`And I read my report again and went
`through articles and textbooks over the
`last week and maybe two weeks.
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` And prior to that, in July, I
`met with one of the attorneys that
`aren't here. I think attorney
`Jacobstein. It's Jeff. And he met with
`me here over a weekend and we went
`through some literature and worked on my
`declaration.
` Q. That was before your
`declaration was prepared?
` A. That's how we came up with the
`declaration.
` Q. I see. Okay. Have you, over
`the course of this case, met with any
`employees of Valeant?
` A. I saw employees of Valeant last
`week.
` Q. I'm sorry?
` A. Yes, I did. I've seen people
`from Valeant.
` Q. Have you met with Valeant
`people with regard to your testimony in
`this case?
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` A. No.
` Q. You were working with them on
`other projects?
` A. Yes, sir.
` Q. And maybe this is clear. But
`you have not worked with them on this
`case, in-house Valeant people?
` A. No, sir, I have not.
` Q. Okay. Thank you. And have you
`met with any employees of Kaken?
` A. Not that I know of.
` Q. It's apparent you haven't
`worked with any in-house people at Kaken
`in connection with this case?
` A. Not that I know, no.
` Q. Okay. Do you know Dr. Tatsumi?
` A. I do not.
` Q. So in your preparation for this
`deposition, you indicated you reviewed
`documents that are referenced in your
`declaration, correct?
` A. Yes, sir.
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` Q. And do you believe you have
`reviewed all of them?
` A. I reviewed most of them.
` Q. Okay. Had you reviewed all of
`them prior to the submission of your
`declaration?
` A. I believe I have.
` Q. How were the documents, the
`exhibits that are referenced in your
`declaration, selected for inclusion in
`the declaration?
` A. Well, when I met with attorney
`Jacobstein, Jeffery, I had some
`literature that I had prepared by going
`through the literature. And I brought
`articles. I brought textbook. We met
`with a computer, access to PubMed, and
`we started looking for articles.
` MR. LIVINGSTONE: Just be
`careful not to disclose any privileged
`communications you might have had with
`Mr. Jacobstein.
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` THE WITNESS: Okay.
` MR. LIVINGSTONE: Thank you.
` Q. (BY MR. FIGG:) There's a
`document that was filed in this case
`called the patent owner response which
`is basically the response that Kaken and
`Valeant filed to the petition for review
`that was filed by my client. Have you
`had an opportunity to review that
`document?
` A. Yes.
` Q. Did you review that document
`before you filed your declaration?
` A. After.
` Q. Doctor, products for treating
`diseases like onychomycosis include an
`active ingredient, an active
`pharmaceutical ingredient that is
`combined with other ingredients to form
`what we sometimes call a formulation; is
`that right?
` A. That is correct.
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` Q. I understand you've had a lot
`of experience on clinical research on
`products like that. Have you conducted
`research on developing formulations of
`active pharmaceutical ingredients?
` A. No, I don't think I have.
` Q. And I take it you haven't ever
`patented a formulation, a drug
`formulation?
` A. I have not patented a
`formulation.
` Q. Do you have any patents?
` A. I might. But we looked it up
`and I don't think I do, so.
` Q. In your experience, it is
`pharmaceutical companies who usually do
`the formulation development work, right?
` A. Absolutely.
` Q. And then they come to
`physicians like you to help with
`clinical research to establish the
`safety and efficacy of those
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`formulations?
` A. Generally.
` Q. And it's usually the
`pharmaceutical company who is involved
`in the steps necessary to secure
`regulatory approval, like FDA approval,
`right?
` A. Would you repeat your question,
`please?
` Q. Let me rephrase it. I'm trying
`to draw a distinction between what you
`do and what the pharmaceutical companies
`do. And it is normally the
`pharmaceutical companies who conduct the
`activities required for securing
`regulatory approval of a new
`pharmaceutical product?
` A. Yes.
` Q. They help design the clinical
`studies and then they use the results of
`those clinical studies in support of
`their application for regulatory
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`approval?
` A. Often, however, the design is
`modified by investigators.
` Q. So, for example, a
`pharmaceutical company would come to you
`and say, here's a clinical protocol we
`would like to follow, you may have some
`ideas on how that could be modified or
`improved?
` A. Yes.
` Q. But then they are the ones who
`then take that data, analyze it, put it
`in a form that is suitable to support
`their application for approval?
` A. Yes.
` Q. And that's a fairly significant
`investment of time and resources,
`wouldn't you agree?
` A. Yes.
` Q. Aside from your work on Jublia
`trials, what other clinical trials have
`you participated in for onychomycosis
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`therapies?
` A. Okay. Many trials. So I did
`in the early '90s the oral terbinafine
`trial. I did the oral itraconazole
`trial. I did the oral fluconazole
`trial. Also in that -- in the '90s, I
`did the amorolfine trial in the U.S.,
`the drug that became Loceryl in Europe.
`It was not approved in the U.S. I don't
`remember if I did the ciclopriox trial.
`I don't think I did that.
` There was a trial however in
`the late '90s on butenafine topical for
`the nail. I did the -- there was
`another study from Japan. I think the
`product is ME-1111 topical and I did
`that trial. I did ionophoresis trial.
`It was a device. There was an econazole
`trial topically. Tavaborole trial.
`I've done work on laser on
`onychomycosis. I might be missing
`something.
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` Q. Okay. Those are the ones you
`can remember?
` A. Yes, sir.
` Q. Are you a consultant to
`Valeant?
` A. I have been, yes.
` Q. Are you currently?
` A. Yes.
` Q. Aside from your involvement in
`this case?
` A. Yes.
` Q. How long have you been a
`consultant for Valeant?
` A. Before I go further, can you
`define consultant?
` Q. Well, do you have a consulting
`agreement with Valeant?
` A. I have a consulting agreement
`for a limited event, like a meeting,
`which then expires when the meeting is
`over.
` Q. Are you on Valeant's speaker's
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`bureau?
` A. I am not.
` Q. So when you say you have a
`consulting agreement for a meeting, does
`that involve your attending the meeting
`and presenting clinical results?
` A. Generally attending a meeting
`and listening to other people's
`discussion and add my own information
`that they ask me. That's usually called
`an advisory board.
` Q. So this wouldn't be -- I
`misunderstood your answer then.
` A. Yes.
` Q. This wouldn't be a public
`meeting like the National Academy --
` A. No.
` Q. -- of Dermatologists?
` A. No. It would be a small closed
`advisory board. And they usually send
`you a consulting agreement for that
`meeting.
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` Q. Okay. So at those advisory
`board meetings you hear about research
`that Valeant either has ongoing or is
`planning or thinking about doing and you
`offer your advice on that?
` A. Yes, sir.
` Q. How long have you been doing
`that type of work?
` A. For Valeant?
` Q. Yes.
` A. For several years. Probably
`five, six years since the birth of this
`drug.
` Q. Aside from your consulting
`agreements for advisory board meetings,
`have you had any other kind of
`consulting type relationship with
`Valeant?
` A. That would be the consulting
`arrangement doing the advisory boards.
` Q. Now, in connection with your --
`the clinical studies that you
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`participate in and that are sponsored by
`Valeant, does your institution have a
`separate agreement with Valeant on that?
` A. For the clinical trials, they
`receive the funds from the clinical
`trial, yes, sir.
` Q. Okay. Are you personally
`consulting for Valeant in connection
`with those clinical trials?
` A. No.
` Q. So that's an agreement between
`Valeant and your institution?
` A. Correct.
` Q. And you recruit patients for
`those trials?
` A. Yes.
` Q. Am I correct that your
`institution receives a payment from
`Valeant for patients that it brings into
`those trials?
` A. Yes.
` Q. So the more patients you're
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`able to recruit, the more payment the
`institution receives?
` A. Well, that's true except you're
`given a limit of how many people you're
`allowed to recruit.
` Q. Of course, yes. How would you
`estimate your time as divided between
`conducting clinical studies and actual
`patient care?
` A. Currently I have patient care
`half time. Five clinics a week I see my
`clinical patients. And the other times
`when I'm not seeing patients, I do
`administrative work, I teach residents,
`and I supervise clinical trials.
` Q. Do you own any stock or stock
`options in Valeant?
` A. I do not.
` Q. I assume the same would be true
`for Kaken Pharmaceuticals?
` A. I do not.
` MR. FIGG: Can we mark the
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`declaration -- off the record.
`
` (Discussion off the record.)
`
` Q. (BY MR. FIGG:) By the way,
`Doctor, we took a little break there to
`get some technical issues dealt with. I
`did want to mention, if you would like
`to take a break at any time over the
`course of the day, just let me know.
` A. Sure.
` Q. It's not an endurance test. I
`would only ask that we not do that in
`the sort of a middle of a question and
`answer.
` A. Yes, sir.
` Q. So I've handed you what has
`been marked previously as Kaken Exhibit
`2027. Do you recognize this as the
`declaration that you submitted in this
`case?
` A. Yes.
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` Q. If you turn to Paragraph 14 on
`Page 5 of that document you indicate
`there what you had considered in
`arriving at the opinions and conclusions
`in your declaration, right?
` A. Yes, yes.
` Q. And you listed some documents
`there and then you say other documents
`that are referred to in your
`declaration, correct?
` A. Yes.
` Q. So if we want to understand the
`documentary exhibits upon which your
`opinions and conclusions were based, we
`look at Paragraph 14 and the other
`documents that are cited throughout your
`declaration?
` A. Yes.
` Q. Okay. I notice that the
`deposition transcript of Dr. Walters'
`deposition was not mentioned anywhere in
`here, so have you not seen that?
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` A. I saw that.
` Q. You did --
` A. No, I did not see that. I'm
`sorry. I saw his declaration.
` Q. You saw his declaration?
` A. Yes.
` Q. But you didn't see his --
` A. No.
` Q. -- deposition testimony?
` A. I did not.
` Q. Do you know Dr. Walters?
` A. No, I do not.
` Q. You've never met him?
` A. No.
` Q. You're familiar with his
`publications?
` A. Some of them.
` Q. Do you understand he was one of
`the leading researchers in studying the
`permeation characteristics of the nail?
` MR. LIVINGSTONE: Object to the
`form.
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` A. He was a formulation scientist.
` Q. He published early on, and on
`several occasions the permeation
`characteristics of the human nail,
`correct?
` A. He published things regarding
`the human nail.
` Q. I'm sorry?
` A. He did publish permeation
`through the human nail in the past, yes.
` Q. And those publications went
`back into the 1990s, correct?
` A. I thought there was a
`publication even in the '80s, '83, if I
`recall.
` Q. I think you're right. They
`continued in the '90s.
` A. Yes.
` Q. And there have been even some
`more recent ones.
` A. Yes.
` Q. Do you have any reason to
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`question Dr. Walters' expertise in the
`area of permeation characteristics of
`the human nail?
` A. One of my concerns on his
`expertise is that even back in 1983, he
`made a comment that you can't
`extrapolate what happens, the permeation
`through the skin to the nail. He said
`you couldn't do that. Yet when I read
`his declaration, he said that you could.
`So that bothered me a little bit.
` Q. Okay. Well, we'll let him
`respond to that.
` A. Okay.
` Q. And it may be -- is one
`possible explanation for that that your
`definition of the nail and his
`definition of the nail may be different?
` A. Well, the nail is the nail.
` Q. Okay. Well, we'll go into that
`in some detail.
` I didn't see identified in your
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`declaration any of the declarations
`submitted by Dr. Tatsumi in this case;
`is that correct?
` A. Yes.
` Q. And you did not consider any of
`the evidence that was submitted
`regarding Dr. Tatsumi's date of
`invention, correct? That's just not
`something you weren't asked to look at I
`assume?
` A. I looked at the date of the
`patents.
` Q. Okay. But you didn't look at
`evidence that was submitted by Dr.
`Tatsumi alleging work that he had done
`prior to the patent?
` A. I did look at reports yesterday
`that Dr. Tatsumi had from the ICAAC
`meeting in 1996 where he was giving
`out -- he or his colleagues were giving
`out information.
` Q. None of the opinions or
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`conclusions in your expert declaration
`were based on those ICAAC meeting
`abstracts, correct?
` A. Well, the ICAAC meeting
`abstracts summarized what was in the
`Kaken extracts, so it was essentially
`the same thing. I have looked at that
`already.
` Q. But just so we're clear, now
`you've seen some more recent ICAAC
`abstracts?
` A. They were some of the 1996
`ICAAC.
` Q. I misspoke. I apologize. We
`have learned more recently that there
`were some additional ICAAC abstracts in
`addition to what we have been calling
`the Kaken abstracts?
` A. Yes, sir.
` Q. And nothing in your -- none of
`the opinions or conclusions in your
`declaration were based on those more
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`recent ICAAC abstracts?
` A. That is correct.
` Q. More recently produced ICAAC
`abstracts. Okay. Thank you.
` Doctor, just so the record is
`clear, I provided to you a document that
`has been marked previously as Kaken
`Exhibits 2036, 2037 and 2038. Can you
`confirm that those are the ICAAC
`abstracts that you have reviewed
`recently?
` A. Yes, sir.
` Q. And just to confirm, the
`opinions and conclusions in your
`declaration were not based on these
`documents?
` A. In many ways -- no, I did not
`see these document
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