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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
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`Robert Schleimer
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`Page 1
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
` MEDA PHARMACEUTICALS, INC., )
` and CIPLA, LTD., )
` )
` Plaintiffs, )
` ) Civil Action No.
` vs. ) 1:15-cv-785
` )
` APOTEX, INC., )
` )
` Defendant. )
` _________________________ )
`
` Videotaped deposition of DR. ROBERT SCHLEIMER,
` taken in the above-captioned cause, at
` Winston & Strawn, 35 West Wacker Drive,
` Chicago, Illinois, before Rachel F. Gard, CSR,
` RPR, CLR, CRR, commencing at the hour of
` 9:04 a.m. on Thursday, September 29, 2016.
`
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`202-232-0646
`
`1
`
`1
`
`CIP2025
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
`
`Robert Schleimer
`
`Page 1
`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
` MEDA PHARMACEUTICALS, INC., )
` and CIPLA, LTD., )
` )
` Plaintiffs, )
` ) Civil Action No.
` vs. ) 1:15-cv-785
` )
` APOTEX, INC., )
` )
` Defendant. )
` _________________________ )
`
` Videotaped deposition of DR. ROBERT SCHLEIMER,
` taken in the above-captioned cause, at
` Winston & Strawn, 35 West Wacker Drive,
` Chicago, Illinois, before Rachel F. Gard, CSR,
` RPR, CLR, CRR, commencing at the hour of
` 9:04 a.m. on Thursday, September 29, 2016.
`
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`202-232-0646
`
`1
`
`1
`
`CIP2025
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`9/29/2016
`
`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
`
`Robert Schleimer
`
`Page 2
`
`APPEARANCES:
`ON BEHALF OF THE PLAINTIFFS:
` STERNE KESSLER GOLDSTEIN & FOX
` BY: MS. UMA N. EVERETT
` MR. JOSHUA I. MILLER
` 1100 New York Avenue, NW
` Washington, DC 20005
` 202.371.2600
` ueverett@skgf.com
` jmiller@skgf.com
`
`ON BEHALF OF THE DEFENDANT:
` WINSTON & STRAWN, LLP
` BY: MR. KEVIN E. WARNER
` 35 West Wacker Drive
` Chicago, Illinois 60601
` 312.558.5852
` 312.558.5116
` kwarner@winston.com
`
`ALSO PRESENT:
` Matthew Holley (Meda Pharmaceuticals)
` Martin Oltman (Videographer)
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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
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`Robert Schleimer
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` I N D E X
`WITNESS PAGE
`DR. ROBERT SCHLEIMER
` Examination by Ms. Everett 6
`
` E X H I B I T S
`DEPOSITION EXHIBITS PAGE
` Exhibit 1 Expert Report of Robert P. 9
` Schleimer, Ph.D.
` Exhibit 2 Expert Rebuttal Report of 9
` Robert P. Schleimer, Ph.D.
` Exhibit 3 Expert Reply Report of 9
` Robert P. Schleimer, Ph.D.
` Exhibit 4 Article by Pipkorn, et al. 87
` Exhibit 5 Review for the Middleton 96
` Textbook of Allergy
` Exhibit 6 Middleton's Allergy 104
` Principles and Practices,
` Volume I, 6th Edition
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`Robert Schleimer
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` E X H I B I T S (Continued)
`DEPOSITION EXHIBITS PAGE
` Exhibit 7 Paper by Richard Martin 111
` Exhibit 8 Paper by Schleimer, et 116
` al., re: in vitro
` comparison
` Exhibit 9 Review by Lars Peter 143
` Nielsen, Niels Mygind, and
` Ronald Dahl
` Exhibit 10 ARIA guidelines 152
` Exhibit 11 Grief, et al., article 158
` Exhibit 12 Berger article 167
` Exhibit 13 John Weiler and Eli 172
` Meltzer article
` Exhibit 14 Study by Ratner, et al. 182
` Exhibit 15 Juniper study 190
` Exhibit 16 Ratner study of 203
` fluticasone and loratadine
` Exhibit 17 Paper by Brooks 208
` Exhibit 18 Paper by Drouin, et al. 214
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`Robert Schleimer
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`Page 5
` THE VIDEOGRAPHER: This is Tape No. 1 to the
`videotaped deposition of Robert Schleimer being
`taken on September 29th, 2016, at 9:04 a.m., in the
`matter of Meda Pharmaceuticals, Incorporated, et
`al., versus Apotex, Incorporated, et al. Case
`number is 14-1453-LPS.
` My name is Marvin Oltman, the legal
`videographer. The court reporter is Rachel Gard.
`We are located at 35 West Wacker Drive, Suite 4800,
`in Chicago, Illinois.
` Will counsel please introduce themselves
`and the parties they represent, beginning with the
`party noticing this proceeding.
` MS. EVERETT: I'm Uma Everett from Sterne,
`Kessler, Goldstein & Fox on behalf of plaintiffs.
`With me today is Josh Miller, also of Sterne
`Kessler, and Matthew Holley from Meda
`Pharmaceuticals.
` MR. WARNER: Kevin Warner from Winston & Strawn
`on behalf of Apotex and the witness.
` THE VIDEOGRAPHER: Will the court reporter
`please swear in the witness.
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` (Witness sworn.)
`WHEREUPON:
` DR. ROBERT SCHLEIMER,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MS. EVERETT:
` Q. Good morning, Dr. Schleimer.
` A. Good morning.
` Q. Can you please state your full name.
` A. Robert Paul Schleimer.
` Q. What is your work address?
` A. 240 East Huron is where my office is
`located.
` Q. And that's at Northwestern University?
` A. That's correct.
` Q. Have you ever been deposed before?
` A. I have.
` Q. What was the nature of the case where you
`were deposed?
` A. It was a patent interference case.
` Q. So it was in front of the Patent Office?
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` A. In a situation such as this.
` Q. Yes. Have you been deposed in any other
`cases?
` A. I've testified in a case in court, but it
`wasn't a medical case.
` Q. What was the nature of the case where you
`testified in court?
` A. It had to do with a traffic accident that
`injured my mother.
` Q. In the patent interference, were you an
`inventor on one of the patents at issue?
` A. No.
` Q. Did you testify as an expert?
` A. I did.
` Q. Do you recall the parties involved in the
`patent interference?
` A. The primary companies were Dynavax and
`Coley Pharmaceutical Companies.
` Q. Who were you retained by?
` A. Dynavax.
` Q. What was the nature of the opinion that
`you gave in that case?
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`Page 8
` A. Well, it was a complicated case. But it
`was -- in essence, it was about the use of a series
`of molecules as adjuvants in vaccines.
` Q. So before we go any further, it's a good
`time to stop and go over just the general outline or
`guidelines for a deposition. I'm sure your counsel
`has gone through them with you.
` Today I'll ask a series of questions, and
`you'll give a series of answers. The court reporter
`is taking down what we say. So I ask you allow me
`to finish my question, and I will allow you to
`finish your answer and, so that way, the court
`reporter can take down a clean record rather than us
`speaking over one another.
` If you need a break at any time, please
`ask for a break and we'll endeavor to get you one.
`I'll just ask that you not take a break while a
`question is pending.
` And if you have a question about or any
`issue about my question, please ask or ask me to
`clarify or rephrase and I will do so. If you answer
`my question, I will assume that you understood it.
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`Robert Schleimer
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`Page 9
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` Is that fair?
` A. Yes.
` Q. Okay. Great.
` (Schleimer Exhibit Number 1 marked
` for identification.)
` (Schleimer Exhibit Number 2 marked
` for identification.)
` (Schleimer Exhibit Number 3 marked
` for identification.)
`BY MS. EVERETT:
` Q. I have given to the court reporter to be
`marked your expert reports in this case. The
`reporter that is marked as Schleimer Exhibit 1,
`Expert Report of Robert P. Schleimer, which I
`believe is your opening report.
` Schleimer Exhibit 2 is Expert Rebuttal
`Report of Robert P. Schleimer, Ph.D., which is your
`second-round report.
` And marked as Schleimer Exhibit 3 is
`Expert Reply Report of Robert P. Schleimer, Ph.D.,
`which I believe is your third-round report.
` So please take a minute, if you need to --
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`Page 10
`I see you flipping through -- just to re-familiarize
`yourself with your report.
` A. I just wanted to make sure they are what
`you say they are, and they appear to be so.
` Q. Okay. Terrific. So I'm just going to
`take them one by one. So we're going to go through
`Exhibit 1, your opening report.
` A. Okay.
` Q. Can you just -- You prepared this report;
`is that correct?
` A. Yes. I prepared it with the attorneys and
`Winston & Strawn together.
` Q. But you reviewed it for accuracy; is that
`correct?
` A. Yes.
` Q. And you made sure it was accurate and true
`to the best of your ability?
` A. Yes.
` Q. And you signed that report?
` A. Yes.
` Q. Are there any modifications you wish to
`make with Schleimer 1?
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` A. No.
` Q. Okay. Now, looking at Schleimer 2, you
`prepared this report?
` A. Yes.
` Q. And you reviewed it to make sure it was
`accurate --
` A. Yes.
` Q. -- to the best of your ability?
` You signed this report?
` A. I did.
` Q. Are there any changes or modifications you
`wish to make to this report?
` A. No.
` Q. Okay. And then finally Schleimer 3, you
`prepared this report?
` A. I did.
` Q. And you reviewed it to make sure it was
`accurate, to the best of your ability?
` A. Yes.
` Q. And you signed this report?
` A. I have.
` Q. Are there any modifications you wish to
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`make to Schleimer 3?
` A. No.
` Q. Okay. So Schleimers 1, 2, and 3 contain
`the sum of your opinions in this case; is that
`correct?
` A. The sum of my opinions that are written
`down in the reports, yes.
` Q. Are there opinions you are -- have in this
`case that you have not written that you plan to
`offer?
` A. No. But I assume as we discuss these
`reports, lots of things may come up.
` Q. But you -- Sitting here today, what is
`disclosed in Schleimer 1, 2, and 3 is the sum of
`your opinion?
` A. It's what I wish to disclose, yes.
` Q. And if -- I'm going to have you turn to
`Schleimer 1. In the last set of pages, there's your
`Materials Considered list, Exhibit B. I'm going to
`have you turn to that.
` A. Is that after my CV?
` Q. It is, yes. It is the end, I believe.
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`Page 13
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` A. Okay.
` Q. Did you prepare this Materials Considered
`list?
` A. I didn't build the file, if that's what you
`mean. But these are all materials that are
`discussed or referenced in the document.
` Q. So you reviewed the materials considered
`list?
` A. I reviewed the materials that are on the
`list, yes.
` Q. Okay. But you didn't review the list
`itself?
` A. I'm sure I went through it and didn't see
`anything out of order.
` Q. Are there any materials that you
`considered in preparation of Schleimer 1 that are
`not either listed in Exhibit B or cited within the
`report?
` A. Well, when we were discussing the concepts
`of it, there were a lot of papers that I thought
`might be relevant. But they didn't make it to the
`final cut.
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` Q. Did you consider them in your opinion?
` A. Well, my opinion is based on the totality
`of my learnings over the last 35 or 40 years, so I
`considered the totality of my learnings.
` Q. Sure. But to the extent you intend to --
`strike that.
` So but to the extent you considered or
`relied upon a written material for your opinion,
`have you included it either in the text of
`Schleimer 1 or in Exhibit B?
` A. Yes.
` Q. Okay. Great. You can put that to the
`side.
` A. Okay.
` Q. Now we're going to do the same for
`Schleimer 2.
` A. The same is true for 2 and 3.
` Q. Okay. Just wanted to have you -- give you
`a chance to go through them.
` A. Okay.
` Q. At the end of your report, there is a
`Materials Considered list for your rebuttal report.
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`Page 15
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`Do you see that?
` A. Yes.
` Q. And does this Materials Considered list
`include all of the materials you considered in
`forming the opinions in Schleimer 2?
` A. In the document, yes.
` Q. So any material you considered or relied
`upon for your rebuttal expert report is either cited
`in your expert rebuttal report or is listed in your
`materials considered list; is that correct?
` A. Yes, with the same caveats we went through
`with No. 1.
` Q. Right. But to the extent you intend to
`rely on documentary support --
` A. Yes, correct.
` Q. -- it's either in your report or in your
`Materials Considered listed.
` A. Yes.
` Q. Okay. I'm going to have you put that to
`the side and go to Schleimer 3.
` And the same set of questions. Please, if
`you can go towards your Materials Considered list,
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`does this Materials Considered list include all the
`material you considered in forming -- strike that.
` Does this Materials Considered list
`include all the written material you considered in
`forming your opinions that are disclosed in
`Schleimer 3?
` A. Yes.
` Q. And if you intend to rely on any written
`document, documentation for your opinions in
`Schleimer 3, it's either in the text of your report
`or in the Materials Considered list; is that
`correct?
` A. Yes.
` Q. Okay. Now I'm going to have you turn
`to -- back to Schleimer 1. I believe your CV is in
`there.
` A. Yes.
` Q. In the middle middle. And I understand
`this is the CV you submitted with your opening
`report?
` A. Yes.
` Q. Have there been any changes since you
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`submitted this CV?
` A. I'm sure there have. I publish a lot of
`papers, and this is months ago. This is May.
` Q. Do you recall what papers you've published
`since May?
` A. I could probably list some of them.
` Q. Okay.
` A. I publish about 10 or 20 papers a year.
`I've given a lot of lectures since then as well. So
`those are not listed here, but I'm not sure that
`they tangibly alter the relevance of the CV.
` Q. What publications do you recall publishing
`since preparing this CV?
` A. Well, there's several publications on the
`pathogenesis of chronic rhinosinusitis. We can do a
`PubMed search and check against the dates. I can't
`tell you exactly which ones were published after
`May 12th and which ones weren't.
` Q. Okay. So you recall some publications on
`pathogenesis of chronic rhinosinusitis?
` A. Yeah.
` Q. Are there any other publications that you
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`recall?
` A. Well, that's the main thing that we study.
`There may be -- Well, there's a paper on epithelial
`activation by CRAC channels, which was published in
`Scientific Reports. I'm sure that one just come
`out. The problem some of them come out e-published
`before they're officially published. So again, I
`can't tell you exactly which officially appeared in
`the literature after May 12th, but I'm sure there's
`several.
` Q. Okay. You said you may have given some
`lectures since May 12th as well?
` A. Yes.
` Q. Do you recall what those lectures -- the
`topics of those lectures?
` A. Can I look at my calendar?
` Q. Sure.
` MR. WARNER: Just -- I guess that's fine.
`BY THE WITNESS:
` A. I can tell you what lectures I gave since
`May 12th. Well, actually this is probably not up to
`date as of May 12th, but ... I spoke at the European
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`Academy of Allergy in Vienna where I gave two talks
`in June.
` Q. What were the -- strike that.
` What was the topic of those talks?
` A. One was on the role of loss of epithelial
`barrier in allergic diseases. And the other was on
`the pathogenesis of chronic rhinosinusitis. The
`summer is usually slower, but I think that may -- I
`also served as an advisor to the Atopic Disease
`Research Network in September. That's a National
`Institutes of Health-sponsored network. Gave a
`presentation there. In terms of lectures, that's
`it.
` Q. Okay. So have -- do you recall whether --
`strike that.
` Do you recall whether any of your papers
`or lectures related to the treatment of allergic
`rhinitis since preparing your CV?
` A. I would say not, they don't. Allergic
`rhinitis, which I've studied greatly, is not
`something I've published on in the last 5 months.
` Q. Have you either published papers or
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`presented lectures on azelastine?
` A. I'm not sure if azelastine showed its face
`in one of my papers over the years. But I've not
`studied azelastine per se as the main topic of one
`of my studies.
` Q. And now you're speaking about ever? Are
`you speaking about ever or since May 12th?
` A. Since May 12th.
` Q. Okay. Have you studied azelastine before
`May 12th, outside the context of this litigation?
` MR. WARNER: Objection to the form of the
`question. It's vague as to "studied."
` THE WITNESS: I should answer?
` MR. WARNER: Yeah. If you understand, you can
`answer.
`BY THE WITNESS:
` A. Sure, I'm very aware of azelastine. It's
`one of the more important antihistamines. It's
`topically very effective, potent, and it has an
`interesting and unusual action. So I've studied it
`over the years.
` Q. Have you published any papers on
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`azelastine or given any lectures?
` A. I'm not sure. It's possible that it's
`shown up in some of the studies that we did earlier.
` Q. Since preparing your CV, have you
`published any papers or given any lectures on
`antihistamines?
` A. No.
` Q. Since preparing your CV, have you
`published any papers or given any lectures on
`fluticasone?
` A. Not -- no, not since the CV was prepared.
` Q. Have you published any papers or given any
`lectures on corticosteroids since your CV was
`prepared?
` A. I don't believe I discussed steroids in
`either of those two lectures that I mentioned, so
`no.
` Q. Okay. And since preparing your CV, have
`you given any lectures or prepared any papers on
`Dymista?
` A. No.
` Q. Okay. What is your current position,
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`Dr. Schleimer?
` A. I'm the Roy and Elaine Patterson professor
`and chief of allergy/immunology at the Northwestern
`University School of Medicine.
` Q. Are those two positions or one position?
` A. It's one position. I'm the chief of
`allergy/immunology. But the Roy and Elaine
`Patterson professor is an endowed chair.
` Q. And what does it mean to have an endowed
`chair or ...
` A. An endowed chair is -- it's an endowment.
`Usually it's a bequeath made at one point or
`another. Often they grow to be quite large. And a
`certain amount of money spins off every year,
`depending how it's invested. 3 to 5 percent of the
`assets of the chair come to the endowed professor to
`use for their research or salary or whatever. I
`mean, they also have honorary -- honorific value in
`academy to have an endowed chair. They're not
`common.
` Q. What are your responsibilities for the
`chief of allergy/immunology?
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` A. I'm responsible for the direction and
`running, growth, maintenance of the division of
`allergy/immunology, which includes over 20 faculty
`members, both clinicians and scientists, as well as
`clinician scientists and total employees probably
`between 90 and 100.
` We run the -- one of the largest clinical
`academic allergy practices in the country, so I'm
`responsible for that as well. And our research
`funding, if one totals NIH and philanthropic gifts,
`is probably also one of the two or three largest in
`the country.
` Q. Do you have -- strike that.
` Do you currently teach any courses?
` A. I do. We offer an immunology course every
`year and -- which I teach. And I'm invited to teach
`in other courses throughout the course of time. We
`have a lot of other courses like journal club
`manuscript review, and I often teach there
`presenting current manuscripts and dissecting the
`data and giving my views of the relevance of the
`work, et cetera.
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` Q. You don't have a medical degree; is that
`correct?
` A. That's correct.
` Q. Is it fair to say you have not diagnosed
`or treated patients?
` A. It's fair to say I've not treated patients,
`but I've been involved in diagnosis for decades. My
`colleagues at Johns Hopkins and Northwestern come to
`me with challenging cases all the time for my
`insight, my opinions, my questions. I've attended
`the clinical conferences at Johns Hopkins for the
`25 years I was there, the allergy rounds. And I'm
`aware of the treatment approaches to allergic
`diseases, a variety of allergic diseases.
` As a pharmacologist, that's one of my
`interests, I'm also particularly interested in drug
`treatments, although there are other treatment
`modalities that are used for allergic diseases in
`general.
` So I'm not allowed by law to treat
`patients, but I often help my colleagues treat their
`patients by making suggestions for either diagnostic
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`Page 25
`tests that should be ordered and/or therapies that
`might help them with difficult patients. They
`generally don't consult me with garden-variety
`allergic diseases.
` Q. And so you said you provide consultation
`to your physician colleagues on treating patients;
`is that a fair summary?
` A. I have.
` Q. But ultimately, it's the physician who
`makes the decision on how to go treat a patient?
` A. Yes, of course.
` Q. Have you ever prescribed medication to a
`patient?
` A. No.
` Q. Have you ever formulated a pharmaceutical
`drug product?
` A. Yes. Actually, I've been involved in some
`of that. Years ago we did some studies, testing a
`compound called glycyrrhetnic acid. And we got
`approval, got an IND, obtained the compound from
`Japan, and we did a study on it.
` And I've been involved in other studies
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`over the years that have involved the development of
`new drugs, including a startup company that I'm a
`founder of and patentholder that now has three
`clinical trials. I did not personally formulate,
`but I've been involved in the process.
` Q. When you say you've been involved in the
`process of formulation, what role have you taken?
` A. Well, in the study with glycyrrhetnic acid,
`we did the study in my lab and the lab of one of my
`colleagues.
` Q. And when you say study, do you mean the
`clinical trial study? Or what study are you
`referring to?
` A. It was a small single-site evaluation of a
`hypothesis that we had at the time where we gave
`drug to a small number of people, including
`ourselves.
` Q. So you were involved in determining the
`efficacy of the drug; is that accurate?
` A. No, I wouldn't say that's the case. We
`were testing a hypothesis that this drug would alter
`levels of glucocorticoid metabolites in the nose.
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`So it was just looking at biomarkers. It was not an
`efficacy trial.
` Q. So earlier, a few minutes ago I think you
`said you weren't personally involved in formulation
`but you have been involved. So have you been
`involved as a formulator might select the excipients
`and the variations in the excipients and active
`ingredients?
` A. No, not really.
` Q. Okay.
` A. Not in a complex preparation.
` Q. Have you been involved in it in any
`preparation?
` A. The one I was telling you about.
` Q. Okay. So did you select the active --
`inactive ingredients in that case?
` A. Yes, but they were minimal. It was mostly
`a buffered saline preparation adjusted for pH.
` Q. Is that the only example where you've
`selected excipients for a formulation?
` A. Yes. Where I personally in my lab, yes,
`that's the only example.
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` Q. Earlier you explained how your physician
`colleagues consult with you when deciding what
`treatment approach to take with a patient. Is that
`an accurate assessment?
` A. Yes, especially with difficult patients.
` Q. With difficult patients. In that course
`of that, did you review the patient records? Do
`you ...
` A. Typically they tell me what they think I
`need to know of the records. I don't look at charts
`generally, no.
` Q. Okay. Have you been consulted in
`treatment of allergic rhinitis?
` A. By pharmaceutical companies, yes, for
`years.
` Q. Okay. In -- when you were discussing
`treatment -- strike that.
` When you were discussing consultation with
`your physician colleagues --
` A. Yes.
` Q. -- have they consulted you in treating
`patients with allergic rhinitis?
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` A. I'm sure they have, but typically not. I
`don't think that particularly difficult cases arise
`with the same frequency as other diseases.
` Q. Do you ever recall consulting with your
`physician colleagues on the use of azelastine and
`fluticasone for patients with allergic rhinitis?
` A. Consulting with my colleagues as opposed to
`consulting with pharmaceutical companies?
` Q. Yes.
` A. No, I don't have specific recollections of
`consulting with them over azelastine and
`fluticasone.
` Q. Do you have any specific recollections,
`again outside of this lawsuit, of any physician
`colleagues discussing the treatment of allergic
`rhinitis -- strike that.
` Outside of this lawsuit, do you have any
`recollections of discussing with fellow physicians
`the treatment of allergic rhinitis using azelastine
`and fluticasone?
` A. Yeah, these drugs were discussed a lot in
`the '90s, 2000, and subsequently. I was more likely
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`to discuss fluticasone than azelastine just because
`I'm recognized as an expert in glucocorticoid
`action, and I'm more interested in the
`glucocorticoids. But all of the major drugs that
`are used in the armamentar
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