Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ______________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ______________
` ACRUX DDS PTY LTD. & ACRUX LIMITED
` Petitioners,
` v.
`
` KAKEN PHARMACEUTICAL CO., LTD. and
` VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
` Patent Owner and Licensee
` ________________
` Case IPR2017-00190
` U.S. Patent No. 7,214,506
` Monday, December 11, 2017
` 9:06 a.m.
` DEPOSITION OF
` JEFFREY M. WEINBERG, M.D.
`
`Reported by: Donna A. Peterson, Notary Public
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
`
`1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ______________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ______________
` ACRUX DDS PTY LTD. & ACRUX LIMITED
` Petitioners,
` v.
`
` KAKEN PHARMACEUTICAL CO., LTD. and
` VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
` Patent Owner and Licensee
` ________________
` Case IPR2017-00190
` U.S. Patent No. 7,214,506
` Monday, December 11, 2017
` 9:06 a.m.
` DEPOSITION OF
` JEFFREY M. WEINBERG, M.D.
`
`Reported by: Donna A. Peterson, Notary Public
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`
`
`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
`
` A P P E A R A N C E S
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` ON BEHALF OF PETITIONERS:
` LISA N. PHILLIPS, ATTORNEY at LAW
` AYDIN H. HARSTON, Ph.D., ATTORNEY at LAW
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` Suite 800, 607 14th Street, N.W.
` Washington, D.C. 20005
` Telephone: (202) 783-6040
` lphillips@rfem.com
` aharston@rfem.com
`
` ON BEHALF OF PATENT OWNER AND LICENSEE:
` BARBARA R. RUDOLPH, Ph.D., ATTORNEY at LAW
` ASHLEY M. WINKLER, ATTORNEY at LAW
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 901 New York Avenue, N.W.
` Washington, D.C. 20001-4413
` Telephone: (202) 408-8000
` barbara.rudolph@finnegan.com
` ashley.winkler@finnegan.com
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
`
` A P P E A R A N C E S C O N T I N U E D
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` ALSO PRESENT BY TELEPHONE:
` TYLER LIU, In-House Counsel for Argentum
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
`
`4
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` Expert Deposition of JEFFREY M. WEINBERG,
`M.D., taken at the law offices of:
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` Suite 800
` 607 14th Street, N.W.
` Washington, D.C. 20005
` Telephone: (202) 783-6040
`
` Pursuant to agreement, before Donna Ann
`Peterson, Notary Public in and for the District of
`Columbia.
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
`
`5
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` C O N T E N T S
`EXAMINATION OF JEFFREY M. WEINBERG, M.D. PAGE
` By Ms. Rudolph 7
` By Mr. Harston 272
` By Ms. Rudolph 276
`
` E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`2201 Journal article, Study of 223
` Clinically Suspected Onychomycosis
` in a Podiatric Population,
` Journal of the American Podiatric
` Medical Association, Vol. 92,
` No. 6, June 2002, pp 327-330
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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` P R O C E E D I N G S
`Thereupon,
` JEFFREY WEINBERG, M.D.,
`was called as a witness by counsel for Patent Owner
`and Licensee, and having been duly sworn by the
`Notary Public, was examined and testified as follows:
` MS. RUDOLPH: I'm Barbara Rudolph, with
`Finnegan, on behalf of Patent Owner.
` MS. WINKLER: I'm Ashley Winkler, with
`Finnegan, on behalf of Patent Owner.
` MR. HARSTON: I'm Aydin Harston, with
`Rothwell Figg, on behalf of Petitioners, and joining
`me is Lisa Phillips.
` MR. LIU: Tyler Liu, counsel for Argenta.
` MS. RUDOLPH: Just a couple of initial
`comments. As you know, we moved to strike all of
`Dr. Weinberg's declaration except for paragraphs 28,
`64, 72, and 73. Acrux has opposed this, and that
`motion is pending. We're taking this deposition
`without any waiver of our rights, arguments, or
`positions with respect to that motion.
` And the fact that we cover material in any
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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`of the paragraphs that we've asked to -- asked the
`Board to strike doesn't mean that we acquiesce or
`agree that that material should not be stricken, so I
`just wanted to make that clear on the record before
`we began.
` MR. HARSTON: And we oppose, you know,
`that motion, and any statements, and the Board will
`decide the motion in due course.
` EXAMINATION BY COUNSEL FOR
` PATENT OWNER AND LICENSEE
`BY MS. RUDOLPH:
` Q. Okay. Doctor, could you please state your
`name for the record?
` A. Jeffrey Weinberg.
` Q. Let's start with the chemical classes of
`antifungal agents that were known prior to July of
`2000. Are you familiar with the term allylamine?
` A. Yes.
` Q. And I'm just going to say from the outset,
`I'm not good on pronunciation, so if there's
`something I say that's pronounced wrong, I would
`appreciate if you would correct my pronunciation, or
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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`if you don't recognize a term because I'm
`mispronouncing it so badly, I'll try to spell it out
`for you, so that we're on the same page.
` Okay. So what does the term allylamine
`refer to?
` A. Allylamine are a group of antifungal
`agents that work by blocking lanosterol synthase, I
`believe, which is a component of a -- of the cell
`membrane. And they're fungicidal, and they wind up,
`when they're used, they wind up killing the fungus.
` Q. Do you know what the substrates for
`allylamine is?
` A. Not offhand, no.
` (Cell phone rings.)
` MS. RUDOLPH: Sorry about that.
` THE WITNESS: But it's something -- it's
`cell wall. I mean, it's cell wall composition. It
`pops holes in the cell wall.
`BY MS. RUDOLPH:
` Q. Does -- do you know the chemical feature
`that distinguishes allylamines from other classes of
`antifungals?
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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` MR. HARSTON: Objection, relevance.
` THE WITNESS: I mean, I've seen this
`information in the past, but I did not look at it
`recently in preparation for this case.
`BY MS. RUDOLPH:
` Q. Okay. Are you familiar with the term
`imidazole?
` A. I'm familiar with the term imidazole.
` Q. And what does the term imidazole refer to?
` A. Imidazoles are a group of azole
`antifungals.
` Q. What is an azole?
` A. An azole antifungal is a group that blocks
`ergosterol synthetase. These agents are fungistatic.
`They prevent cell membrane composition. They do not
`kill fungus, but they are static, so they stop fungal
`growth, because of the -- you know, in terms of
`building the cell wall.
`BY MS. RUDOLPH:
` Q. Are you familiar with the chemical feature
`that distinguishes imidazoles from other chemical
`classes?
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`Weinberg, M.D., Jeffrey M.
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`December 11, 2017
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` A. I mean, again, I don't -- for the purposes
`of this case, I did not familiar -- familiarize
`myself with the biochemistry and the chemical
`structure of this, so I don't recall the exact
`chemical structure.
` Q. Is that same statement, that you didn't
`review those aspects of the various classes of
`antifungals, is that true for all of the classes of
`antifungals that you're aware of?
` A. Well, for the -- for the purposes of this
`case, I did not review the chemical structures
`specifically, and the biochemistry. That was not my
`task in this case, was not to opine on the chemical
`structures of these.
` Q. Sorry, I didn't mean to interrupt you.
`Were you finished?
` A. Yes.
` Q. Are you familiar with the term triazole?
` A. Yes.
` Q. Are you familiar with the difference in
`chemical structure between triazoles and imidazoles?
` A. Again, I did not specifically familiarize
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
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`December 11, 2017
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`myself with the structures per se. I believe there's
`a ring that differentiates these. I am aware,
`however, that the patent that I did study did
`consider both imidazoles and triazoles broadly. But
`in terms of the -- I could not draw the chemical
`structure for you, if you asked me to do that at this
`moment.
` Q. I won't ask you to do that.
` What are some of the other classes of
`antifungals that were known prior to July 11th, 2000?
` A. I mean, in terms of dermatologic use, I
`think the azoles broadly, and the allylamines were
`the two major classes of antifungals that we used in
`our practice at that time.
` Q. Okay. What about the morpholine class?
` A. Can you be more specific?
` Q. Are you familiar with that term,
`morpholine?
` A. I think that I've heard the term.
` Q. Okay. Have you heard the term in
`connection with antifungals that were used for
`dermatological purposes?
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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` A. I mean, potentially amorolfine, if that's
`what you're referring to, as part of that class.
` Q. Is that an agent that you used in your
`practice prior to July 11th, 2000?
` A. Well, this medication was not FDA-approved
`in the United States. However, it was available in
`other countries, and was well-known in the literature
`relating to antifungal agents.
` Q. Okay. Do you know what class of compound
`terbinafine is a member of?
` A. Terbinafine is an allylamine.
` Q. And just to close the loop, can you think
`of any other classes of compounds that had known
`antifungal agents as its members?
` A. Again, I'm aware of other antifungals, but
`I don't specifically remember the classes, aside from
`the ones that we were using at that time.
` Q. Okay. Are you familiar with the term,
`enantiomer?
` A. Yes.
` Q. What does that mean?
` A. Again, I'm not a biochemist, but an
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
`
`December 11, 2017
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`enantiomer is a -- to put it in -- the term is a --
`an alternative chemical structure or an opposite
`chemical structure or related chemical structure of
`one molecule. And an enantiomer is the enantiomer of
`that molecule.
` Q. Does it refer to stereochemistry?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Again, I have not done
`organic chemistry since 1987. I'm a clinical
`dermatologist, so I do not want to speculate as to my
`memory from 30 years ago.
`BY MS. RUDOLPH:
` Q. Okay. Do you have any understanding as to
`whether enantiomers of a particular chemical compound
`can have different chemical properties?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Again, I -- I mean, I know
`that there are examples, where an enantiomers, you
`know, as in -- you know, some of the literature I
`reviewed for this case, you know, such as the Kaken
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
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`December 11, 2017
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`abstracts, where enantiomers do have different
`properties. But I don't -- I cannot speak broadly on
`that topic.
`BY MS. RUDOLPH:
` Q. Do you have an understanding of the term,
`keratin?
` A. Yeah. Yes.
` Q. What does that refer to?
` A. Keratin is one of the materials that is
`present in hair, skin, and nails.
` Q. Is there more than one type of keratin?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Again, not in terms of
`materials that I reviewed for this case, but yes,
`there are multiple types of keratin.
`BY MS. RUDOLPH:
` Q. Okay. Is the keratin in hair the same as
`the keratin in skin?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: I don't -- again, not being
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
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`December 11, 2017
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`a basic scientist, again, I don't recall exactly
`whether the keratins are the same. However, I do
`believe that when it comes to keratin binding, you
`can use -- you can -- when you look at, for example,
`lack of keratin binding in the hair, I think that
`this would give a POSA in the area a motivation to
`further investigate whether the impact was similar
`with keratin of the nails.
` Q. When you said the term "POSA," what did
`you mean by that?
` A. A person of ordinary skill in the area.
` Q. Okay. And then I'm going to ask the same
`question, do you know whether the keratin composition
`in skin is the same as the keratin composition in
`nails?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Again, I can't speak to the
`specifics of it, but I think, again, that general
`principles of keratin binding that are relevant in
`this case, I think that the binding of keratin or
`lack of binding in keratin in one model would, again,
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
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`December 11, 2017
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`motivate a POSA to certainly explore other models of
`keratin binding.
`BY MS. RUDOLPH:
` Q. And when you're talking about a POSA, are
`you referring to a POSA as of a certain timeframe?
` A. I'm referring to a POSA which was defined
`in the institutional board decision.
` Q. Do you -- but do you have a particular
`date with respect to when you considered what a POSA
`would be motivated by?
` MR. HARSTON: Objection, out -- asked and
`answered.
`BY MS. RUDOLPH:
` Q. You have to give me a response. You can't
`do a head shake or anything like that --
` A. Well, let's say --
` Q. -- because the court reporter can't --
` A. Well --
` Q. Let me finish. We can't talk over each
`other, because she can only take one of us?
` A. Understood.
` Q. So you have to make an oral response,
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`Case IPR2017-00190
`Weinberg, M.D., Jeffrey M.
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`December 11, 2017
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`because she can't record a head shake and other
`nonverbal gesture?
` MR. HARSTON: We didn't go through all the
`instructions in the beginning.
` MS. RUDOLPH: Pardon me?
` MR. HARSTON: Maybe the instructions for
`the witness, it would be a good reminder to tell him
`those.
` MS. RUDOLPH: Can you read the question,
`the original question back?
` (Thereupon, the Reporter read as follows:
` "Do you -- but do you have a
` particular date with respect to when you
` considered what a POSA would be motivated
` by?")
` THE WITNESS: In the years prior to 1999.
`BY MS. RUDOLPH:
` Q. Have you ever been deposed before?
` A. Yes.
` Q. How many times?
` A. Approximately five.
` Q. Have any of them been in a patent
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`infringement case?
` A. Yes.
` Q. All of them?
` A. No.
` Q. How many have involved patent
`infringement?
` A. This is the third case that involves
`patent infringement.
` Q. Okay. So when you refer to patent
`infringement, are you including proceedings before
`the Patent Office?
` A. No.
` Q. Okay. So what is your understanding as to
`the nature of this particular matter?
` A. Well, again, I -- my role here was to
`rebut Dr. Elewski's report, and not specifically --
`again, I am not as familiar with the legal
`proceedings in the Patent Office and the process
`there.
` Q. Okay. Are you familiar with the term KP
`103?
` A. Yes.
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` Q. What does KP 103 refer to?
` A. K --
` MR. HARSTON: Object to form.
` THE WITNESS: KP 103 is a chemical term
`relating to efinaconazole.
`BY MS. RUDOLPH:
` Q. Is KP 103, in fact, efinaconazole?
` A. It is the -- it is the molecule
`efinaconazole, yes.
` Q. So it has two names for the same thing?
` A. Well, I mean, again, it's -- you know, it
`depends whether you're referring to the chemical
`entity or the drug itself. So it's relating more to
`the chemical entity, independent of the drug form as
`we know it today.
` Q. Okay. Is it your understanding that
`efinaconazole has a particular formulation associated
`with it?
` And I'm going to withdraw that because it
`was a little ambiguous.
` So is it your understanding that
`efinaconazole refers to just the active
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`pharmaceutical ingredient in a particular
`formulation?
` A. Well, efinaconazole can refer to a
`molecule, efinaconazole. It can also refer as the
`generic name of the drug Jublia, but I would consider
`those two different entities.
` Q. Okay. So for purposes of this deposition,
`can we agree that when I refer to efinaconazole, I'm
`also referring to KP-103? In other words,
`efinaconazole and KP-103 refer to the molecule
`itself, for purposes of this deposition? I want to
`make sure that my questions to you are clear.
` A. Yes.
` Q. Okay. And when I'm referring to the
`formulation, I will use the term Jublia. Is that
`fair?
` A. Yes.
` Q. Okay. Are you familiar with the -- well,
`let's just -- let me go back and make sure
`everything's clear.
` So with that understanding, is it your
`understanding that efinaconazole is the active
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`pharmaceutical ingredient in Jublia?
` A. It is one of the -- I mean, it is -- it is
`one of the opponents of Jublia, yes.
` Q. Is it, in fact, the active pharmaceutical
`ingredient?
` A. I mean, as one -- again, active
`pharmaceutical ingredient is very broad. It is the
`antifungal within Jublia. I mean, obviously, there
`are other pharmaceutical ingredients within Jublia.
` Q. What is your understanding of the term
`"active pharmaceutical ingredient"?
` A. Any -- any ingredient that's contained in
`something is a pharmaceutical ingredient. I mean, if
`you're speaking, again, more specifically antifungal,
`yes, but there are, obviously, if we would pull out
`the package inserts, there are a lot of ingredients
`with there.
` Q. Okay. So would you agree that
`efinaconazole is the sole antifungal ingredient in
`Jublia?
` A. Yes, I would agree to that.
` Q. Okay. Are you familiar with the term
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`"debridement"?
` A. Yes, I am.
` Q. What does that mean?
` A. Debridement means that -- some way of
`treating the nail to scrape down -- scrape the nail
`down and take tissue off of the nail.
` Q. Are you familiar with the term phase I
`clinical trial?
` A. Yes.
` Q. Are you familiar with the term phase II
`clinical trial?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Yes.
`BY MS. RUDOLPH:
` Q. And are you familiar with phase III
`clinical trial?
` A. Yes.
` Q. What is a phase III clinical trial?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Again, you know, just to
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`comment that, obviously, you know, the clinical trial
`is not necessarily relevant to the patent issue here,
`but a phase III clinical trial is a large trial,
`usually double blinded, usually with active drug.
`The FDA requires active drug versus a placebo compare
`for which, in the case of a topical, may be the
`solution or the -- you know, the base of the -- of
`the -- what the active ingredient is in.
` And, you know, individuals are treated for
`a certain amount of time, so that they can compare
`the benefit of drug versus placebo.
`BY MS. RUDOLPH:
` Q. Have you ever acted as a principal
`investigator on a phase III trial?
` A. Yes.
` Q. Have you acted as a principal investigator
`on any phase III trial involving any onychomycosis
`treatments?
` A. Yes.
` Q. What were the onychomycosis treatments in
`the clinical trials that you acted as principal
`investigator?
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` A. Years ago, we did a trial looking at
`Penlac plus oral terbinafine for treatment. More
`recently, we did a study for a company called Viamet,
`where we looked, but we did not enroll -- well, we --
`we had screened patients in that trial, but we did
`not enroll anybody because none of the patients had
`positive fungal tests, so they could not be enrolled.
` Most recently, we were involved with a
`pediatric study for efinaconazole, but we were unable
`to identify any children with onychomycosis, so our
`site was closed.
` Q. What is the purpose of conducting a phase
`III clinical trial?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: The purpose of a clinical
`trial is to demonstrate sufficient benefit-risk to
`the FDA to allow for drug approval.
`BY MS. RUDOLPH:
` Q. And when you use the term "benefit," are
`you referring to efficacy?
` A. Yes.
`
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` Q. And when you use the term "risk," are you
`referring to adverse events?
` A. Safety overall.
` Q. And that includes adverse events, side
`effects?
` A. Yes.
` Q. You mentioned the study involving Penlac,
`the one that you participated in the phase III trial,
`do you recall that?
` A. Yes.
` Q. What was your role in that study?
` A. I was the principal investigator at our
`site.
` Q. And what does that mean?
` A. It means I was the head physician.
`Usually on the site, you have a physician and you may
`or may not have a subinvestigator, who is another
`physician, but usually you need a principal
`investigator at every site.
` Q. Did you help design the study?
` A. No, I did not.
` Q. Did you select the treatments that were to
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`be used in that study?
` A. No.
` Q. Did you decide the appropriate end points
`for that study?
` A. No.
` Q. Did you decide the inclusion criteria?
` A. No.
` Q. The exclusion criteria?
` A. No.
` Q. Did you analyze the results?
` A. I don't recall if I was involved in
`looking at the results after the study, prior to
`publication.
` Q. Are you familiar with the term "complete
`cure"?
` A. Yes.
` Q. What does that refer to?
` A. Complete cure is -- comprises mycological
`cure, plus complete clinical cure.
` Q. And what does the term "mycological cure"
`refer to?
` MR. HARSTON: Object to form.
`
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` THE WITNESS: Mycological cure refers to
`the fact that after a study, when you test for fungus
`by 8 and culture, it's negative.
`BY MS. RUDOLPH:
` Q. When you test for fungus -- when you test
`by fungus by KOH and culture, what are you actually
`testing?
` MR. HARSTON: Objection to form,
`mischaracterizes.
` THE WITNESS: You're basically testing to
`see that the fungus is not there anymore.
`BY MS. RUDOLPH:
` Q. What is the subject of that test?
` MR. HARSTON: Object to form.
`BY MS. RUDOLPH:
` Q. Did you understand that question?
` A. I don't understand.
` Q. That's a fair comment. So are you taking
`a sample from a patient to test?
` A. When you do a culture, what you do is you
`cut the nail and you scrape down as deep as you can
`underneath the nail, and you put the material in a
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`culture. Then you send that out. When you do a KOH,
`you take some of that material, you put it on a
`slide, you put some potassium hydroxide on it, heat
`it a little bit, you put it under a microscope, and
`you evaluate for the presence or absence of fungus.
` Q. And KOH is potassium hydroxide?
` A. Correct.
` Q. You also used the term "complete clinical
`cure." What does that refer to?
` A. Complete clinical cure means that the nail
`is normal afterwards.
` Q. And how is that assessed?
` A. It's a clinical determination by looking
`at the nail after the therapy is completed.
` Q. How is -- strike that.
` You said that it's a clinical
`determination by looking at the nail after the
`therapy is completed. How long after the therapy is
`completed do you make that determination?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: I don't recall exactly in
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`these trials, and every trial may differ, but it's at
`some point after the completion of the therapy.
`BY MS. RUDOLPH:
` Q. Can the results that you obtain differ,
`depending on the timing as to when you make that
`determination?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: You know, that -- that would
`be speculative. I -- I think that the expectation
`would be that what -- one of the things they look at
`is the nail growth, in terms of when we -- when we
`look at it, in terms of that, you know, the nail
`grows at a certain speed. So it needs to grow out.
` But the -- a lot of the -- a lot of the
`trials have shown people are disease free for a
`while, a long period of time after treatment. So I
`would not expect a lot of variation, depending on if
`you looked at it at small periods. But, again,
`that's speculation.
`BY MS. RUDOLPH:
` Q. And what do you mean by small periods?
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` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: Well, what do you mean by
`different times?
`BY MS. RUDOLPH:
` Q. Well, you said small periods, so I'm
`asking you --
` A. Well, you --
` Q. -- what your --
` A. So I want to know what you mean.
` Q. What about "different times" don't you
`understand?
` A. Well, different times could mean weeks,
`months, years. So I'm trying to understand what you
`meant.
` Q. Well, let me ask a different question. At
`what length of time would you expect the complete
`cure rate to change?
` MR. HARSTON: Objection, outside the
`scope.
` THE WITNESS: I'd have to -- I'd have to
`look at study data to look at recurrence, so I'm
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`not -- that would be speculative.
`BY MS. RUDOLPH:
` Q. Would you expect the complete cure rate to
`change, depending on whether you assessed the end
`point at the end of the study, immediately at the end
`of the study, versus one month after the study?
` MR. HARSTON: Objection, outside the
`scope, calls for speculation.
` THE WITNESS: Again, it's speculative,
`because there are a lot of -- a lot of variables
`here. Was -- was it an oral medication or was it a
`topical medication? Was the patient compliant? How
`old is the patient? So, again, there are -- there
`are too many variables here to -- to really answer
`that question adequately.
`BY MS. RUDOLPH:
` Q. When you said oral or topical, why would
`that make a difference?
` MR. HARSTON: Objection, outside the
`scope, calls for speculation.
` THE WITNESS: Well, I mean, oral -- oral
`medications have a much shorter course that they're
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`given for. For example, you know, the -- the gold
`standard of treatment, which is oral terbinafine is a
`12-week course versus the topical medications are a
`48-week courses. So it's a different -- it's a
`different course of treatment.
` MS. RUDOLPH: So my un
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