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` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS, )
`LLC AND AMNEAL )
`PHARMACEUTICALS OF NEW )
`YORK, LLC, )
` )
` Petitioners, )
` ) CASE: IPR2018-00608
` vs. )
` ) PATENT: 9,161,926
`ALMIRALL, LLC )
` )
` Patent Owner. )
`
` DEPOSITION OF JULIE C. HARPER, M.D.
` BIRMINGHAM, ALABAMA
` MONDAY, MARCH 11, 2019
`
`REPORTED BY: TANYA L. VERHOVEN-PAGE
`JOB NO: 156069
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`TSG Reporting - Worldwide - 877-702-9580
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`AMN1049
`Amneal v. Almirall, LLC
`IPR2018-00608
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` APPEARANCES OF COUNSEL
`On behalf of the Petitioners:
` STERNE KESSLER GOLDSTEIN & FOX
` 1100 New York Avenue Northwest
` Washington, DC 20005
` BY: ADAM LAROCK, ESQ.
` BY: JOSHUA MILLER, ESQ.
`
`On behalf of the Patent Owner:
` FENWICK & WEST
` 1191 Second Avenue
` Seattle, WA 98101
` BY: ELIZABETH HAGAN, ESQ.
`
` - - -
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` March 11, 2019
` 9:02 a.m.
`
` Deposition of
`JULIE C. HARPER, M.D., held at the offices
`of Regus - Birmingham, 420 North 20th Street,
`Suite 2200, Birmingham, Alabama before
`Tanya L. Verhoven-Page, Certified Court
`Reporter and Notary Public of the State of
`Georgia.
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` EXHIBITS:
`
` AMN
` Exhibit Description Page
`
`Exhibit 1023 "Pharmacokinetics of
` Dapsone Gel 5% for
` the Treatment of Acne
` Vulgaris" (Article) 138
`Exhibit 1009 "Diethylene glycol
` monoethyl ether: An
` Emerging Solvent in
` Topical Dermatology
` Products" (Article) 142
`Exhibit 1041 Dollars for Docs
` July to December 2011 152
`
`Exhibit 1043 Dollars for Docs
` year 2013 156
`Exhibit 1044 Dollars for Docs
` year 2014 157
`
`Exhibit 1046 Dollars for Docs
` year 2016 159
`Exhibit 1047 Dollars for Docs
` year 2017 160
`
`Exhibit 1042 Dollars for Docs
` January to December 2012 168
`Exhibit 1048 Dollars for Docs
` Top Doctors Receiving
` payment related to
` Aczone 168
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` I N D E X
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` WITNESS: JULIE C. HARPER, M.D.
`
` Examination Page
`BY MR. LAROCK 6
`BY MS. HAGAN 166
`
` EXHIBITS:
` Almirall
` Exhibit Description Page
`
`Exhibit 2023 Julie C. Harper, M.D.
` curriculum vitae 8
`
`Exhibit 2022 Declaration of
` Julie C. Harper, M.D. 45
`Exhibit 2017 Article from American
` Family Physician 101
`
`Exhibit 2013 Article from Journal of
` the Pharmacy Society of
` Wisconsin 101
`
`Exhibit 2016 "Emerging Drugs for
` Acne" (Article) 101
`Exhibit 2040 "Finding a Place for
` Topical Anti-inflammatory
` Acne Therapy" (Article) 102
`Exhibit 2006 International Publication
` Number WO 2009/108147 A1 121
`
`2 (Pages 2 to 5)
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` J. HARPER
` Q And what was that patent case about?
` A It was a patent, the '219 patent.
` Q And what do you mean by the '219 patent?
` A The '219 patent -- I honestly don't
`remember details about that.
` Q Okay.
` A That was a while ago.
` Q Okay. That's a different than --
` A It's a different patent than today, yes.
`I'm not prepared to talk about that one again right
`now.
` Q Okay. And who were you -- were you an
`expert in that case?
` A Yes, sir, I was.
` Q And who were you an expert on behalf of?
` A Allergan slash Almirall.
` Q Now, if I say Allergan and Almirall,
`you'll understand the companies that I'm referring
`to?
` A Yes, sir.
` Q Okay. So I guess you have some
`familiarity with the ground rules for a deposition, I
`take it?
` A I do.
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` J. HARPER
`Almirall Exhibit 2023.
` A Yes. Before we go over this, I do have a
`couple of changes that were typographical errors in
`my declaration.
` Q Okay.
` A Could I make those corrections?
` Q We'll get there.
` A Okay. I don't want to forget that.
` Q And do you recognize this as -- this
`exhibit?
` A Yes, very well.
` Q Okay. And what is this exhibit?
` A This is my curriculum vitae.
` Q And is it accurate?
` A Yes, it is.
` Q Okay. And on page three of your CV --
`are you there?
` A I am.
` Q -- several publications and posters are
`listed, right?
` A Uh-huh.
` Q And were these peer reviewed
`publications?
` A Let me take a minute to look at these,
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`Page 6
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` J. HARPER
` BIRMINGHAM, ALABAMA; MONDAY, MARCH 11, 2019
` 9:02 A.M.
`
`Thereupon -
` JULIE C. HARPER, M.D.,
`called as a witness, having been first duly sworn,
`was examined and testified as follows:
`
` EXAMINATION
`BY MR. LAROCK:
` Q Good morning, Dr. Harper.
` A Good morning.
` Q Have you been deposed before?
` A I have.
` Q How many times?
` A Once.
` Q Okay. And when was that deposition?
` A December.
` Q Of 20 --
` A '18.
` Q -- 18?
` A Uh-huh.
` Q And was that a patent case?
` A Yes.
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` J. HARPER
` Q Okay. You understand you're under oath?
` A I do.
` Q Right. And I'm going to ask you
`questions and you're going to give truthful, honest
`answers to the best of your ability, right?
` A Yes, I will.
` Q We have a court reporter, so I just ask
`you not to talk over one another. Is that fair?
` A Yes. Challenging, but yes.
` Q And if you don't ask -- or if you don't
`understand one of my questions, you'll agree to ask
`for clarification?
` A Absolutely.
` Q Okay. And if you don't ask for
`clarification to one of my questions, is it fair to
`assume that you've understood it?
` A Seems fair.
` Q Okay. Is there any reason that you can't
`testify truthfully today?
` A There is not.
` (Almirall Exhibit No. 2023 was
` identified for the record.)
`BY MR. LAROCK:
` Q I'm going to hand you what's been marked
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` J. HARPER
`please.
` Q Sure.
` A I believe all of those on the first page
`were. The majority of these would be peer reviewed
`journals.
` Q And is there a difference between a
`publication and a poster?
` A Yes, there is.
` Q Okay. What's that difference?
` A So the posters are going to be presented
`at a meeting and they would be there like in abstract
`form, where people would come by and actually read
`the poster.
` Sometimes those posters go on to be
`publications, but they would be listed separately.
` Q Is a poster different than a
`presentation?
` A Yes, it is.
` Q Okay. What's that difference?
` A So you could present a poster and so
`those could go together, but a publi -- poster,
`excuse me, is a written document that truly is a
`poster.
` Q A poster?
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` J. HARPER
`was one of the authors for the guidelines of the
`management of acne --
` Q And just so we're clear, it's page three,
`the third one down?
` A This is the third one down on page three,
`right.
` Q Okay.
` A So this was a consensus paper that took
`us probably about a year, and so different authors
`were writing different portions of this guidelines
`for the management of acne.
` Q And by a year, do you mean a year to
`write?
` A A year to research, gather the
`information and write.
` Q Okay. And then it was submitted?
` A Correct.
` Q And then how long between submission and
`publication?
` A I don't know the answer to that.
` Q Okay.
` A I could guess.
` Q Yes.
` A Based on experience, probably six months.
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` J. HARPER
` A Yes, that's attached to a place in a
`meeting, usually, where people can walk by and read
`them.
` A presentation is from the podium.
` Q Okay. So there may not be a poster
`associated with a presentation?
` A It could go either way.
` Q And how does -- I guess, before these
`publications are actually published, they are first
`researched and then submitted for publication, right?
` A Repeat what you said at first there.
` Q Before these publications are published?
` A Before the publications, but not posters.
` Before the publications are published --
` Q Yeah. They are researched and then
`submitted for publication?
` A That would be true.
` Q How long does that process take?
` A Well, I have, I think, 40 publications on
`here, so it would be different for each one of those.
` Q Okay. About how long would the process
`take?
` A Could we pick an article and look at it?
`For example, the Zaenglein article, which is when I
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` J. HARPER
` Q Okay.
` A Or longer.
` Q Is there an average amount of time? It's
`not instantaneous, right? There's some lag time
`between publication?
` A I am comfortable saying it's not
`instantaneous. I am not comfortable with giving you
`an average because I did not go back and look at
`those time periods. I would be guessing.
` Q Is it like weeks?
` A I would say not instantaneous.
` Q Okay. And how do you decide who -- I
`guess before we go there.
` A number of these publications have
`multiple authors, right?
` A That is correct.
` Q And how do you decide who you want to
`collaborate with in terms of drafting a publication?
` A Well, I appreciate your compliment, that
`I would be deciding that. On many of these, that is
`not the way that that happens.
` Now, I did volunteer through the American
`Academy of Dermatology for the guidelines. I
`volunteered on that. For several of these where I'm
`
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` J. HARPER
`part of a work group -- this was from the American
`Acne and Rosacea Society, which I've recently served
`as president, and so people in that area who would
`volunteer their time to write the paper would be
`included.
` On some of these, if it's actually a
`study that I participated in, then the authors are
`going to be the people who participated in the study.
`And so it's not something where I'm on the phone or
`e-mail trying to --
` Q Call up a colleague?
` A Exactly. That is not usually the way
`that works.
` Q Okay. So besides situations where there
`were a group of people involved in a study and then
`you're writing up a publication about that study
`or -- I think it was the American Academy of
`Dermatology?
` A Uh-huh, yes.
` Q Besides those two situations, is there a
`system that you go through where you would figure
`out, I'm going to be involved in this paper and not
`some other paper?
` A There is no system for that.
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` J. HARPER
`Gel in Patients with Facial Acne Vulgaris: Gender as
`Clinical Relevant Outcome Variable?
` A Correct.
` Q And so you took this publication on
`yourself because you just had an interest in that
`area?
` A Right.
` Q Are any of these publications sponsored
`by drug companies or other entities?
` A I would have to know what you meant by
`sponsored by.
` Q Where they had asked you -- are there
`situations on your CV where you published a
`publication as a result of a drug company asking you
`to publish an article, for example?
` A Yes, there are.
` Q And can you point me to one of those
`examples?
` A Well, the one that we just mentioned
`would be an example of that.
` Q Okay. Oh, I thought you had said that
`you were interested in that area?
` A I was, but I was asked by the company on
`that drug. And I was not one of their trialists, I
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` Q Okay.
` A I think you would be able to see on here
`that mine are all, for the most part, about acne and
`rosacea.
` Q Uh-huh. But I guess are there
`publications on your CV where they're a publication
`not about a study you were associated with and not
`about the American -- and not a result of your
`participation in the American Academy of Dermatology?
` A Yes, there are.
` Q And can you point me to one of those?
` A Sure. Let's see here. Well, no, that
`was a study. Hang on. I'm starting at the bottom
`here.
` Third from the bottom. And so I did not
`participate in that study, but because I am
`interested in gender issues and acne, I was asked to
`author that paper.
` Q And this is third from the bottom on page
`three?
` A Yes.
` Q Which is entitled Efficacy and
`Tolerability of a Fixed Combination of Clindamycin
`1.2 Percent and Benzoyl Peroxide 3.75 Percent Aqueous
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` J. HARPER
`did not do the clinical trials, but I was asked
`because of this subject if I would be willing to
`write the paper.
` Q And who was the company that asked you to
`write this?
` A At the time they were Valiant, and that
`company is now Ortho. Same company.
` Q And how often does that happen where drug
`companies will ask you to write a publication?
` A At this point in my career, a fair
`amount.
` Q And what do you mean by at this point in
`your career?
` A I've practiced now for about 19 years and
`I've had a special interest in acne through that
`entire time, starting my career in full-time
`academics for seven years. So because of that
`background in academia and my interest over time, I'm
`an author that gets asked to write papers.
` Q And besides this example that we just
`talked about with the fixed dose combination of
`clindamycin and benzoyl peroxide, any other examples
`where you were asked by a drug company to author a
`paper?
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` A Yes. We could go to the one right above
`it.
` Q This is Hudgens --
` A Yes.
` Q -- et al.?
` A Yes.
` Q Still on page three?
` A That is correct.
` Q And who was the drug company there?
` A This was Allergan.
` Q And for the record, the title is
`Validation of a New Patient-Reported Outcome Measure
`for Facial Acne: The Acne Symptom and Impact Scale.
` A That is correct.
` Q ASIS.
` A That is correct.
` Q And what were the drugs that were studied
`there?
` A There were no drugs that were studied in
`that.
` Q Okay. What was the -- I guess, the
`content?
` A So the content is we are trying to, as
`a -- as a specialty, and really in medicine in
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` J. HARPER
`This was really a portion of the same information.
` Tanghetti, on page four.
` Q Okay. That's the -- one, two, three --
`fourth one down from the top on page four?
` A Yes, that's correct.
` I think I can comfortably say those
`three.
` Q Okay. And on page five of your CV,
`Exhibit 2023, you identify several presentations,
`right?
` A Yes.
` Q And that goes on for a number of pages?
` A Yes.
` Q From 2018 through year 2000?
` A That is correct.
` Q What are these presentations?
` A So the vast majority of these -- I'd have
`to look at them all in detail -- are going to be CME
`lectures.
` Q Okay.
` A So continuing medical education lectures
`where I am asked to come in and give a teaching
`lecture to an audience of dermatologists or
`dermatology prescribers.
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`general, to move to patient-reported outcomes. And
`we don't have an acne -- a good scale to do that.
` And so a scale has to be developed that
`can then be used by multiple companies and in
`multiple studies, but something that is validated
`that can then be used and useful.
` Q Okay. How often have you been asked by
`Allergan to author papers on their behalf?
` A Well, I would like to give you an
`accurate number, so if you'll give me a minute, I
`will try to answer that question accurately.
` So two on that page, but they are
`basically very similar. It was the same -- largely
`the same group of authors. But Hudgens, which is the
`one that we just looked at, and then Alexis. You'll
`see that he was the last author on the publication
`that we had just talked about. Those two.
` Q And Alexis is the second to last entry
`from the bottom --
` A That is correct.
` Q -- on page three?
` A That is correct. But if you look at the
`title of that also: So Development of a New
`Patient-Reported Outcome Measure for Facial Acne.
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` J. HARPER
` For example, we have our annual American
`Academy of Dermatology meeting that hosts about
`15,000 people at the meeting every year, and I have
`spoken at it every year since 2000. I haven't missed
`a year. And recently in DC I gave six lectures at
`that one big meeting. So the vast majority of this
`is that.
` Q And so those CME presentations, those
`are you are speaking to, I guess, peer dermatologists
`out there in the field?
` A That is correct.
` Q And you give a teaching lecture to an
`audience of dermatologists. So would you be telling
`them about new things in the field, new trends, best
`practices? What would --
` A All kinds of things that relate to acne
`and rosacea. So the way I look at it is I started my
`career as an academic doctor. I'm now in private
`practice. I own my own private practice. I
`understand what you need to know in private practice
`to do this well, but because I have the background in
`academics I'm able to translate a lot of what's new
`in the medical literature and make it practical for
`people who are practicing in the clinic.
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` And as I look at this, all of these are
`CME.
` Q Okay. And how do you -- are you asked to
`give these presentations or how -- do you volunteer?
`How does that work?
` A There's a combination of things here.
`Many of them are invited. I would say the majority
`are invited, but every now and then I volunteer. And
`if I volunteer, it's at the American Academy of
`Dermatology.
` Q Okay. So if you're asked -- if you're
`invited, who are you -- who does the inviting? Who
`are inviting you?
` A The medical education company that runs
`the meeting.
` Q Okay. So these presentations are
`sponsored by a company, right?
` A A medical education company.
` Q Oh, a medical education company?
` A A medical education company.
` Q So they may not be a manufacturer of --
` A They most certainly should not be.
` Q Are the -- are the drug manufacturers
`there sponsoring?
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` Q Okay.
` A And so if we start in 2017, I was one of
`two investigators in that. So I actually enrolled
`patients, randomized the study, gave the patients the
`treatment, did their lesion counts, did their IGA
`assessment. So I was very intimately involved in
`that.
` Similar on 2013. I believe I was one of
`two on the 2010 to 2011.
` Q And that's a -- you're a principal
`investigator for the study from 2010 to 2011?
` A I don't recall. I was a principal
`investigator. I don't know if I was the only PI.
`There might have been more than one. Dr. Jim Del
`Rosso was involved in that study with me, and I don't
`know if we were co-PIs or if I was the only PI. I
`was a PI.
` Q So some of these list investigator,
`others list principal investigator. What's the
`difference?
` A The principal investigator is the lead
`on -- that's all, on the study.
` Q So as an investigator, you are running
`one of the study sites?
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` A They can be.
` Q Okay. Do they sponsor presentations?
` A No.
` Q Okay.
` A No.
` Q So these presentations aren't like
`promotional?
` A Absolutely not. And they have to be kept
`very separate from that.
` Q Okay.
` A We sign lots of documentation that
`asserts that.
` Q Okay. On the last page of your CV,
`Exhibit 2023, you list under the heading Research
`several entries and -- is that a fair
`characterization?
` A Yes, it is.
` Q And are these clinical studies that
`you've been involved in?
` A Yes.
` Q And what's your involvement in these
`clinical studies?
` A Well, it's different depending on each
`study.
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` J. HARPER
` A You are at least a part of the study
`site. As the investigator you may not even be the
`lead in your own institution, but you may be one, for
`example, of two investigators.
` And you don't like to have a lot of
`investigators because we really want one person doing
`the counts, to keep it similar throughout the study.
`But you would be doing things like that, counting
`acne lesions, for example, doing an IGA assessment.
` Q So working back in, I guess, reverse
`chronological order, we talked about the 2017 study
`and the 2013 study --
` A Yes.
` Q -- and the study from 2010 to 2011.
` The study from -- the other study from
`2010 to 2011, you're also listed as a principal
`investigator, right?
` A Are you talking about the phase four?
` Q Yes, the fourth one down.
` A Uh-huh.
` Q What about studies that you are not
`listed as the investigator or principal investigator,
`what was your participation there?
` A Could you show me an example of that?
`
`7 (Pages 22 to 25)
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`Like on 2004?
` Q Yeah, 2004.
` A With dapsone?
` Q Yes.
` A Okay. 12-week, multicenter, double
`blind, randomized. I was an investigator on that.
`That may be my error for not including that in my
`curriculum vitae.
` I would not have been a lead, though, I
`believe. This was when I was still in faculty
`full-time at the University of Alabama-Birmingham,
`where we have a whole segment of the clinic that does
`nothing but clinical trials. We would have a
`full-time clinical trial coordinator and I would have
`worked with her. I would have been an investigator.
` Q And this is studying Aczone 5 Percent?
` A This is studying Aczone 5 Percent. This
`was the pivotal trial.
` Q So this is the phase three trial?
` A Correct.
` Q Just can you describe what a phase three
`is?
` A A phase three trial are the trials that
`are done in order to get a product FDA approved.
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` J. HARPER
`her.
` Q And can you spell your -- where -- your
`mentor?
` A Oh, my mentor.
` Q Yes.
` A Would you like me to spell that name?
` Q Yes, please.
` A Okay. Elewski; Boni, B-o-n-i, and her
`last name is E-l-e-w-s-k-i, and she is now the
`chairman at the University of Alabama-Birmingham.
` Q So she asked you to be a part of --
` A She did.
` Q -- this? And how did -- I guess, why was
`she -- was she already involved in the study before
`you?
` A She would not have been involved in this
`study before me. She was involved in many studies
`because that's a big part of what she does.
` Q Okay.
` A And so as new studies come into the
`department of dermatology, she would -- A, she would
`have wanted help with the study, and she would want
`to promote younger faculty.
` And so if you have an area of an interest
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`They're the large -- large trials.
` Q And how large was this trial?
` A About 3,000 patients.
` Q Three thousand patients. And they were
`not all studied as part of your site?
` A Thankfully, no.
` Q So about how many patients can you say
`were studied at your site?
` A Oh, I don't remember that. I would
`honestly be guessing. I don't even remember how many
`sites there were across the U.S. or if this was even
`just U.S., but I do remember the total number was
`3,000. It would have been -- I would be guessing. I
`don't recall.
` Q And how do you come to be involved in
`this Aczone 5 Percent study in 2004?
` A The honest answer there is because I was
`on faculty at the University of Alabama-Birmingham,
`and one of my senior faculty members there is
`Dr. Boni Elewski, who is very esteemed in clinical
`trials and does a lot of them.
` And as an encourager of my young career
`with an interest in acne, she would have helped to
`make that happen for me. And I'm appreciative to
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` J. HARPER
`in acne and we have a new acne study coming in and
`she wouldn't mind a little help, you're it.
` Q So when you were -- and how long did this
`study last, this Aczone 5 Percent study in 2004?
` A I have no idea. So that was 14 years
`ago? I don't remember how long we had -- you have a
`certain amount of time to recruit patients in. Not
`everybody starts the study at the same time.
` The study was 12 weeks. I don't remember
`if there was a little two-week follow-up or anything
`like that. But people would have been coming in and
`going out of the study over a period of time and I do
`not recall how long that was.
` Q Okay. And what was the result of that
`study?
` A Well, we actually could look at that if
`you would like to, the pivotal trial results.
` Q Uh-huh.
` A We could look at that. If you want
`specific numbers, I think probably the easiest place
`to look at the pivotal trial results is in the
`package insert, if that's what you mean.
` Q Yes, before we look there, I'm just
`guessing -- well, let he rephrase.
`
`8 (Pages 26 to 29)
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` J. HARPER
` Before we look there, do you know what
`the results are, before looking at the label?
` A The -- so this study would have gotten
`the product FDA approved, which it was FDA approved
`in 2005. And it was FDA approved in 2005 because
`there was some improvement in acne, but it also came
`with a stipulation that we would have to check G6PD
`in everyone.
` Q And so, I guess, the big picture result
`of the study was that Aczone 5 Percent was effective
`at treating acne vulgaris?
` MS. HAGAN: Objection.
` THE WITNESS: That is correct.
`BY MR. LAROCK:
` Q So I just want to go back to your CV,
`2023, to page five, where you list the presentations
`that we discussed earlier.
` A To page five. Okay.
` Q And were any of these studies -- or, I
`guess, were any of these presentations done on behalf
`of a drug company?
` A I don't believe any of these are. And I
`have done those, but I did not list these here.
`These are CME, not promotional, not sponsored
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` J. HARPER
` Q Okay. So you're speaking about a drug to
`these prescribers, right?
` A That is correct.
` Q And do you put the deck together or is
`that provided to you?
` A It is provided to us.
` Q And that's provided by the manufacturer
`of the drug?
` A That is correct.
` Q And the manufacturer of the drug
`determines what content goes into those
`presentations?
` A That is correct.
` Q And then you are educating them on the
`drug?
` A I am educating them on the drug.
` Q What do you mean by educating them on the
`drug?
` A Well, for example, if you have a new
`entity to the market and it has a new mechanism of
`action, I would be educating people about the
`mechanism of action of how the drug would work.
` The same new drug we would look at
`efficacy data. So we would look at lesion count
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` J. HARPER
`presentations.
` Q Would there be other presentations not
`listed on your CV that were promotional?
` A I have done promotional speaking.
` Q Okay. And that's not reflected on your
`CV?
` A That is correct.
` Q And how often do you do promotional
`speaking?
` A It varies. Once to twice a month.
` Q Speaking about what?
` A Acne and rosacea.
` Q And speaking to whom?
` A Dermatologists and dermatology
`prescribers.
` Q And what are you saying to dermatology
`and -- dermatologists and dermatology prescribers as
`part of these speaking engagements?
` A You mean the promotional speaking
`engagements?
` Q Yes.
` A So, in the promotional speaking
`engagements, you would be giving a slide deck that
`educates your audience about a drug.
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` J. HARPER
`reductions. We would look at investigators' global
`assessment. We would actually look at photographs of
`people who had been