11/16/2018
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`Amneal, et al. v. Allergan, Inc.
`
`Elaine S. Gilmore, MD, PhD
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Page 1
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS LLC AND AMNEAL
`
`PHARMACEUTICALS OF NEW YORK LLC
`
`Petitioner
`
`v.
`
`ALLERGAN,
`
`INC.
`
`Patent owner
`
`Case No. IPR2018-00608
`
`U.S. Patent 9,161,926
`
`DEPOSITION OF ELAINE S. GILMORE, M.D., Ph.D.
`
`Washington, D.C.
`
`November 16, 2018
`
`9:03 a.m.
`
`Reported by: Michele E. Eddy, RPR, CRR, CLR
`
`DIGITAL EVIDENCE GROUP
`
`1730 M Street, NW, Suite 812
`
`Washington, D.C. 20036
`
`(202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`1 of 103
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`Almirall EXHIBIT 2052
`Amneal v. Almirall
`IPR2018-00608
`
`
`
`Amneal, et al. v. Allergan, Inc.
`
`Elaine S. Gilmore, MD, PhD
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Page 1
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS LLC AND AMNEAL
`
`PHARMACEUTICALS OF NEW YORK LLC
`
`Petitioner
`
`v.
`
`ALLERGAN,
`
`INC.
`
`Patent owner
`
`Case No. IPR2018-00608
`
`U.S. Patent 9,161,926
`
`DEPOSITION OF ELAINE S. GILMORE, M.D., Ph.D.
`
`Washington, D.C.
`
`November 16, 2018
`
`9:03 a.m.
`
`Reported by: Michele E. Eddy, RPR, CRR, CLR
`
`DIGITAL EVIDENCE GROUP
`
`1730 M Street, NW, Suite 812
`
`Washington, D.C. 20036
`
`(202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`1 of 103
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`Almirall EXHIBIT 2052
`Amneal v. Almirall
`IPR2018-00608
`
`
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`11/16/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Elaine S. Gilmore, MD, PhD
`
`Deposition of ELAINE S. GILMORE, M.D.,
`
`Page 2
`
`Ph.D., held at the offices of:
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`1100 New York Avenue, Northwest
`
`Suite 600
`
`Washington, D.C.
`
`20005
`
`(202) 371-2600
`
`Pursuant to Notice, before Michele E.
`
`Eddy, Registered Professional Reporter, Certified
`
`Realtime Reporter, and Notary public in and for
`
`the District of Columbia.
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`A P P E A R A N C E S
`
`Page 3
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`ON BEHALF OF THE PETITIONER:
`
`DENNIES VARUGHESE, PHARM.D., ESQUIRE
`
`Sterne, Kessler, Goldstein & Fox,
`
`P.L.L.C.
`
`1100 New York Avenue, Northwest
`
`Washington, D.C.
`
`20005
`
`Telephone:
`
`(202) 371-2600
`
`dvarughe@sternekessler.com
`
`ON BEHALF OF THE PATENT OWNER:
`
`ELIZABETH B. HAGAN, Ph.D., ESQUIRE
`
`Fenwick & West, LLP
`
`1191 Second Avenue, 10th Floor
`
`Seattle, Washington 98101
`
`Telephone:
`
`(206) 389-4510
`
`ehagan@fenwick.com
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`EXAMINATION INDEX
`
`EXAMINATION BY DR. HAGAN
`
`EXAMINATION BY DR. VARUGHESE
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`Page 4
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`PAGE
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`6
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`98
`
`E X H I B I T S
`
`(Attached to the Transcript)
`
`DEPOSITION EXHIBIT
`
`Exhibit 1 Declaration of Elaine S. Gilmore,
`
`M.D., Ph.D.
`
`Exhibit 2 Curriculum Vitae of Elaine S.
`
`Gilmore, M.D., Ph.D., AMN1019
`
`Exhibit 3 U.S. Patent No. 9,161,926; AMN1001
`
`Exhibit 4
`
`International Publication No.
`
`WO 2009/061298; AMN1004
`
`Exhibit 5 Article titled "Use of Topical
`
`PAGE
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`35
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`35
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`38
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`47
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`77
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`Corticosteroids for Dermatologic
`
`Conditions Reviewed" by Laurie
`
`Barclay, M.D.; AMN1027
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`EXHIBIT INDEX CONTINUED
`
`Page 5
`
`DEPOSITION EXHIBIT
`
`PAGE
`
`Exhibit 6 Article titled "Pharmacokinetics of
`
`94
`
`Dapsone Gel, 5% for the Treatment
`
`of Acne Vulgaris" by Diana M.
`
`Thiboutot, Jonathan Willmer, Harry
`
`Sharata, Rebat Halder, and Steven
`
`Garrett; AMN1023
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`Page 6
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`P R O C E E D I N G S
`
`Washington, D.C.
`
`November 16, 2018
`
`ELAINE S. GILMORE, M.D., Ph.D.,
`
`having been duly sworn, testified as follows:
`
`DR. HAGAN:
`
`I'm Elizabeth Hagan, of
`
`Fenwick & West, for patent owner Almirall, LLC.
`
`DR. VARUGHESE:
`
`For Petitioner Amneal,
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`Dennies Varughese from Sterne, Kessler,
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`11 Goldstein & Fox.
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`EXAMINATION BY COUNSEL FOR PATENT OWNER
`
`BY DR. HAGAN:
`
`Q
`
`A
`
`Q
`
`Good morning.
`
`Good morning.
`
`Thank you for coming this morning. Can
`
`you please state your full name.
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Elaine Sheila Gilmore.
`
`Where do you live?
`
`Fairport, New York.
`
`And how are you employed?
`
`I'm a dermatologist.
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`Page 7
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`Q
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`A
`
`What's the address of your work office?
`
`6800 Pittsford Palmyra Road, Suite 150,
`
`Fairport, New York, 14450.
`
`Q
`
`Have you ever had your deposition taken
`
`previously?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes.
`
`What type of proceeding was that for?
`
`A patent trial, litigation.
`
`Have you ever -- did you testify at
`
`trial there?
`
`A
`
`Q
`
`A
`
`Q
`
`No.
`
`Was it just one, or were there multiple?
`
`Multiple.
`
`My questions and your answers will be
`
`transcribed by the reporter.
`
`I will try not to
`
`speak over you, and I would ask that you also wait
`
`until I'm finished asking a question before you
`
`answer and try not to speak over me.
`
`Is that okay?
`
`Yes.
`
`Did you do anything to prepare for your
`
`A
`
`Q
`
`deposition?
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`Page 8
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`A
`
`Q
`
`A
`
`Yes.
`
`What did you do?
`
`I reviewed my declaration and
`
`references, the patent.
`
`Q
`
`Did you review anything that's not cited
`
`in your declaration?
`
`A
`
`Q
`
`I don't believe so.
`
`You have a Ph.D. and an M.D. from the
`
`9 University of North Carolina, correct?
`
`10
`
`11
`
`A
`
`Q
`
`Yes.
`
`And you earned the Ph.D. in 2001 and the
`
`12 M.D. in 2003, correct?
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`A
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`Q
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`A
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`Q
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`A
`
`Q
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`A
`
`Yes.
`
`What is your Ph.D. in?
`
`Cell and molecular physiology.
`
`And what did you do after your M.D.?
`
`Residency.
`
`Where was that?
`
`Internal medicine internship at Stanford
`
`20 University and dermatology residency at Yale
`
`21 University.
`
`22
`
`Q
`
`When did the Stanford residency end, or
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`Page 9
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`internship, rather?
`
`A
`
`Q
`
`A
`
`Q
`
`2004.
`
`And the residency at Yale?
`
`2006.
`
`And you also did a research fellowship
`
`at Yale; is that correct?
`
`A
`
`Q
`
`Yes.
`
`Was that at the same time or different
`
`from the residency?
`
`A
`
`Q
`
`It followed the residency.
`
`What did you research in your research
`
`fellowship at Yale?
`
`A
`
`I worked in a neurology lab studying ion
`
`channels in nerves.
`
`Q
`
`A
`
`Q
`
`And this was related to dermatology?
`
`Yes.
`
`Were you looking at any particular
`
`drug's effects on ion channels or was it more
`
`basic research?
`
`A
`
`In some cases we studied drug effects on
`
`ion channels.
`
`Q
`
`Any other particular ion channels that
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`you were looking at?
`
`A
`
`Q
`
`Nav 1.7.
`
`And what did you do after your
`
`dermatology research fellowship?
`
`A
`
`I joined the faculty at the University
`
`of Rochester.
`
`Q
`
`Can you tell me about that? What was
`
`your position?
`
`A
`
`I was an assistant professor of
`
`dermatology.
`
`Q
`
`A
`
`And what did that job entail?
`
`Seeing patients, giving lectures, seeing
`
`inpatient consults, teaching residents, teaching
`
`14 medical students.
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`15
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`18
`
`Q
`
`A
`
`Q
`
`And what did you do after that?
`
`I formed a company.
`
`While you were assistant professor of
`
`dermatology, you were also the medical director of
`
`19 University Dermatology Associates; is that
`
`20
`
`21
`
`22
`
`correct?
`
`A
`
`Q
`
`Yes.
`
`And what did that entail?
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`Page 11
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`1
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`2
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`A
`
`Q
`
`Overseeing clinic functions.
`
`Was the University Dermatology
`
`3 Associates associated with the University of
`
`4
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`6
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`7
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`s
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`Rochester?
`
`A
`
`Q
`
`Yes.
`
`At the same time you were also director
`
`of medical student dermatology course and
`
`clerkship at the University of Rochester School of
`
`9 Medicine; is that correct?
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`A
`
`Q
`
`A
`
`Yes.
`
`What did that entail?
`
`I lectured to the -- I can't remember if
`
`it was first -- first- and second-year medical
`
`students regarding dermatology.
`
`Q
`
`You're board certified in dermatology,
`
`correct?
`
`A
`
`Q
`
`A
`
`Yes.
`
`What does that mean?
`
`It means that I completed an ACGME
`
`certified residency and sat for the board exam as
`
`administered by the American Board of Dermatology,
`
`and passed.
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`Page 12
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`1
`
`2
`
`3
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`4
`
`Q
`
`And would you mind telling me what the
`
`acronym ACGME stands for.
`
`A
`
`Oh, gee whiz.
`
`I think maybe American
`
`College of Graduate Medical Education, but the C
`
`5 might not be correct.
`
`6
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`7
`
`8
`
`9
`
`Q
`
`What's involved in maintaining a board
`
`certification in dermatology?
`
`A
`
`Continuing medical education. There are
`
`different steps.
`
`It's called MOC, Maintenance of
`
`10 Certification, that you go through.
`
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`22
`
`Q
`
`So do you have to do a certain number of
`
`credits every year?
`
`A
`
`Right. Every ten years you need to
`
`retake the board exam.
`
`Q
`
`You said that you were teaching when you
`
`were an assistant professor. You taught courses
`
`in dermatology as well as in cell and molecular
`
`physiology; is that right?
`
`A
`
`Q
`
`No.
`
`Did you ever teach any courses in
`
`dermatology?
`
`A
`
`Yes.
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`1
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`Q
`
`Did you teach any courses in -- and I
`
`2 might have this wrong -- cell and molecular
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`Page 13
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`physiology?
`
`A
`
`Q
`
`A
`
`No.
`
`What did you teach in dermatology?
`
`At the patient bedside, diagnosis,
`
`clinical findings.
`
`I gave lectures to the
`
`residents in their morning conference.
`
`I gave
`
`lectures to medical students in their large group
`
`sessions.
`
`I taught medical students at the
`
`bedside.
`
`Q
`
`And just to clarify, have you ever
`
`taught any courses in cell and molecular
`
`physiology?
`
`I don't remember.
`
`Okay. That's fine.
`
`Can you show me what
`
`A few more questions before we get to
`
`A
`
`Q
`
`A
`
`Q
`
`that.
`
`You've been a clinical investigator on
`
`clinical trials; is that correct?
`
`A
`
`Yes.
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`Page 14
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`8
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`9
`
`Q
`
`A
`
`Q
`
`How many?
`
`I'm not sure.
`
`Did these take place while you were
`
`associated with the University of Rochester,
`
`before that, since you were in private practice?
`
`I guess in what time frame did these clinical
`
`trials take place?
`
`A
`
`Q
`
`Through the past ten years.
`
`So before you were associated with the
`
`10 University of Rochester and continuing, or do I
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`11
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`13
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`15
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`16
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`17
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`18
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`have my dates wrong?
`
`A
`
`After the University of Rochester and
`
`continuing.
`
`Q
`
`Got it.
`
`So are you still involved in clinical
`
`trials?
`
`A
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`Q
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`Yes.
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`What trials are you currently involved
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`19 with?
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`20
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`A
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`Q
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`A
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`Some cutaneous lymphoma trials.
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`And what are these trials investigating?
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`Treatments.
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`A
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`Q
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`Any particular treatments?
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`I can't go into details.
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`In these trials, are you looking at --
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`let me take that back.
`
`In your clinical trials, have you ever
`
`looked at the efficacy of treatments?
`
`A
`
`Q
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`Yes.
`
`Have you ever looked at the safety of
`
`treatments?
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`A
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`Q
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`Yes.
`
`You've put yourself forward or Amneal
`
`has put you forward as an expert in the field of
`
`dermatology, correct?
`
`A
`
`Q
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`Yes.
`
`What would you say the authoritative
`
`text is in the dermatological field on current
`
`trends in research?
`
`A
`
`Current trends in research?
`
`I'm not
`
`sure there is a text for research. That would be
`
`too quickly moving.
`
`Q
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`So if I was a dermatologist and I wanted
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`to keep abreast on current trends in the field,
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`where would I look?
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`A
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`Probably "Dermatology" by Bolognia, et
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`al.
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`Q
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`A
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`Q
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`look to?
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`A
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`Q
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`A
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`Is that a book or is that a --
`
`A very large book.
`
`Are there any journals that you would
`
`Sure.
`
`What journals?
`
`"Journal of the American Academy of
`
`11 Dermatology."
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`12
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`Q
`
`You're now in full-time practice at the
`
`13 Universal Dermatology, PLLC; is that correct?
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`A
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`Q
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`A
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`Q
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`A
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`Q
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`Yes.
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`You've been there since when?
`
`2015.
`
`What is Universal Dermatology, PLLC?
`
`We're a private dermatology practice.
`
`How large is your -- how many
`
`practitioners are involved?
`
`A
`
`Q
`
`Three.
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`What does your job entail at that
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`practice?
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`A
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`Q
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`A
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`Q
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`I see patients.
`
`I oversee operations.
`
`What type of patients do you treat?
`
`All comers.
`
`What -- what type of dermatological
`
`issues do the patients have that come to you?
`
`A
`
`Q
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`Everything.
`
`Are there any particular disorders that
`
`you see more than others?
`
`A
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`I see warts, acne, rosacea, skin
`
`cancers.
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`And those are the four most common?
`
`Yes.
`
`And you treat for all of those?
`
`Yes.
`
`Could you give a number to what percent
`
`of patients you see that have acne as opposed to
`
`other types of dermatological issues?
`
`A
`
`Probably 30 percent, 40 percent,
`
`somewhere in that range.
`
`Q
`
`A
`
`What about rosacea?
`
`Maybe 25, 30 percent.
`
`I've never
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`counted.
`
`Q
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`Sure.
`
`Prior to 2015, you were treating
`
`patients as well as your academic duties; is that
`
`correct?
`
`A
`
`Q
`
`Yes.
`
`What portion of the time -- let's look
`
`at the University of Rochester time period. What
`
`portion of the time were you treating patients as
`
`opposed to teaching or serving in your directorial
`
`positions?
`
`A
`
`Q
`
`I saw patients 80 percent of my time.
`
`Okay.
`
`Did you also see patients during your
`
`internship?
`
`A
`
`Q
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`A
`
`Q
`
`Yes.
`
`And during your residency?
`
`Yes.
`
`What about during your research
`
`fellowship?
`
`A
`
`Q
`
`Yes.
`
`During your research fellowship, can you
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`tell me what the time split was between the
`
`patients seen and research?
`
`A
`
`Q
`
`I was in clinic one day per week.
`
`And you were seeing patients for
`
`dermatological issues?
`
`Yes.
`
`How long have you been treating patients
`
`A
`
`Q
`
`for acne?
`
`A
`
`I would say since internship, so 2003 to
`
`current.
`
`Q
`
`Could you give a number to the number of
`
`patients that you've seen or treated for acne over
`
`the years?
`
`A
`
`Q
`
`A
`
`Q
`
`In the past 15 years?
`
`Yes, just a great ballpark.
`
`Hundreds, thousands, millions?
`
`Probably tens of thousands.
`
`Thanks.
`
`So you said that as of now, patients
`
`20 with acne take up approximately 30 to 40 percent
`
`21
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`22
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`of your practice, just ballparking there.
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`Is that
`
`accurate?
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`A
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`Q
`
`Yes.
`
`Is there any particular type of acne
`
`that you see or treat more frequently than others?
`
`A
`
`The most common being comedonal and
`
`inflammatory.
`
`Q
`
`A
`
`Q
`
`A combination?
`
`Yes.
`
`So if a patient comes into your practice
`
`to see you, presenting with acne, what do you do?
`
`A
`
`I evaluate them, determine what type of
`
`treatments they might need, and discuss options.
`
`Do you prescribe treatments for acne?
`
`Sure.
`
`What treatments?
`
`It depends on the patient.
`
`Name a treatment that you prescribe for
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`acne.
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Tretinoin.
`
`What is that?
`
`A topical retinoid.
`
`Anything else?
`
`Topical antibiotics.
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`Page 21
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`Q
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`Can you give an example?
`
`Clindamycin, dapsone.
`
`Anything else?
`
`That I might use?
`
`Yes.
`
`Oral antibiotics.
`
`Can you give an example?
`
`Doxycycline.
`
`So we talked about topical retinoids,
`
`topical antibiotics, oral antibiotics. Are there
`
`any other categories of treatment that you might
`
`pres er ibe?
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`Isotretinoin.
`
`What is that?
`
`Oral retinoid.
`
`Any others?
`
`Spironolactone.
`
`Which is a?
`
`Potassium-sparing diuretic.
`
`Are there any other categories?
`
`Washes containing benzoyl peroxide.
`
`Anything else?
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`Page 22
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`A
`
`Q
`
`A
`
`Q
`
`Azelaic acid.
`
`Anything else?
`
`Adapalene.
`
`Anything else?
`
`A Minocycline.
`
`Q
`
`A
`
`Q
`
`And that is a
`
`Oral antibiotic.
`
`Are there any other categories of
`
`treatments that we haven't touched on yet that you
`
`would prescribe for acne?
`
`A
`
`Q
`
`No,
`
`I think that's a good list.
`
`Do you always prescribe a medicament if
`
`patients come in with acne?
`
`A
`
`Q
`
`No, some products are over-the-counter.
`
`Have you ever prescribed a -- either
`
`prescribed or told somebody to take an
`
`over-the-counter version of a product with more
`
`than one active ingredient?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes.
`
`Can you give me an example?
`
`BenzaClin.
`
`What is that?
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`Page 23
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`A
`
`A combination benzoyl
`
`peroxide/clindamycin gel.
`
`Q
`
`Anything else? Any other combination
`
`therapies?
`
`A
`
`Q
`
`A
`
`I'm not a big fan of them.
`
`Why is that?
`
`Because sometimes you don't want to give
`
`both of the medications at the same time or at the
`
`same frequency.
`
`Q
`
`A
`
`Q
`
`Have you ever prescribed Epiduo?
`
`Rarely, but yes.
`
`Do you ever prescribe two treatments
`
`13 with single active ingredients to a patient for
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`use during the same period of time?
`
`A
`
`Q
`
`Yes.
`
`Can you give me an example of a
`
`combination treatment like that that you would
`
`pres er ibe.
`
`A
`
`Q
`
`A
`
`Q
`
`Clindamycin gel and tretinoin.
`
`Any other examples that come to mind?
`
`Dapsone gel and tretinoin.
`
`Other than the benzoyl peroxide and
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`Page 24
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`clindamycin product and occasionally Epiduo, are
`
`there any other combination single product
`
`therapies that you prescribe for acne?
`
`A
`
`I used to prescribe Benzamycin, which is
`
`benzoyl peroxide with erythromycin.
`
`Q
`
`You said "used to." Do you no longer
`
`prescribe it?
`
`A
`
`Q
`
`A
`
`Right.
`
`Why is that?
`
`It needed to be stored in the
`
`refrigerator, which was not really convenient for
`
`people to apply to their face.
`
`Q
`
`Have you ever prescribed oral dapsone to
`
`a patient for a dermatological condition?
`
`A
`
`Q
`
`Yes.
`
`What type of condition would you
`
`prescribe oral dapsone for?
`
`A
`
`Dermatitis herpetiformis, dissecting
`
`cellulitis of the scalp.
`
`Q
`
`Do you frequently prescribe oral
`
`dapsone?
`
`A
`
`No.
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`Q
`
`You mentioned that you've prescribed
`
`dapsone gel. Have you ever prescribed the Aczone
`
`5 percent formulation?
`
`Page 25
`
`Yes.
`
`When did you first prescribe that?
`
`First?
`
`Yes.
`
`I don't remember.
`
`Give me a ballpark year. Ten years ago?
`
`Yeah, 2007, 2008.
`
`I forget exactly
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`when.
`
`Q
`
`When would you prescribe Aczone
`
`5 percent gel for a patient? What would make you
`
`prescribe Aczone 5 percent gel for a patient?
`
`A
`
`Q
`
`If they had inflammatory acne.
`
`Would you prescribe it for any other
`
`type of acne?
`
`A
`
`I wouldn't use it on only comedonal
`
`acne.
`
`Q
`
`Would you prescribe it for acne that
`
`presents with a mixture?
`
`A
`
`Yes.
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`Page 26
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`Q
`
`Is the Aczone 5 percent -- do you still
`
`prescribe the Aczone 5 percent formulation?
`
`A
`
`Q
`
`Yes.
`
`Is Aczone 5 percent formulation your
`
`first choice for treating acne in any patients?
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`No.
`
`Why is that?
`
`It can be expensive.
`
`Are there any other reasons?
`
`Not my habit.
`
`What would you pick for a first choice?
`
`Usually clindamycin gel.
`
`Why would you move a patient from
`
`clindamycin gel to Aczone 5 percent?
`
`A
`
`If they did not have good efficacy with
`
`clindamycin.
`
`Q
`
`Would you ever -- if there wasn't good
`
`efficacy with the clindamycin gel, would you
`
`substitute the Aczone 5 percent, or would you
`
`prescribe the Aczone 5 percent in combination?
`
`A
`
`Q
`
`I would substitute it.
`
`And would you substitute -- let's say
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`the procedure is a patient has been using the
`
`clindamycin gel and not responding well. When you
`
`substitute it for the Aczone 5 percent, is that
`
`the only thing that you prescribe, or do you
`
`prescribe something else in combination with it
`
`then?
`
`A
`
`Usually I have patients on a topical
`
`retinoid as well.
`
`Q
`
`Would they have been on the retinoid in
`
`addition to the clindamycin also?
`
`A
`
`Q
`
`Most likely.
`
`In your experience, do patients seem to
`
`comply with the application instructions for the
`
`5 percent gel, for the Aczone 5 percent?
`
`A
`
`Q
`
`Yes.
`
`Do you prescribe it for once daily or
`
`twice daily or some other?
`
`A
`
`Q
`
`Usually I say one to two times daily.
`
`In your experience, have you found the
`
`Aczone 5 percent product to be effective for
`
`treating inflammatory acne?
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`A
`
`Yes.
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`Page 28
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`Q
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`How would you measure that
`
`effectiveness? What would make you say that it
`
`was an effective treatment in a patient?
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`A
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`If, on follow-up, patients had fewer
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`active inflammatory lesions.
`
`Q
`
`How long does a treatment regimen with
`
`Aczone 5 percent usually last?
`
`A
`
`Q
`
`Last?
`
`I can't answer that.
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`Is it something that a patient would
`
`stop taking after a while, or is it a continuing
`
`type of
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`A
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`It depends on the patient. Teenagers
`
`sometimes outgrow their acne. Sometimes adults
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`develop acne for the first time in their 20s.
`
`Q
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`So if it was an adult, it's more likely
`
`that the treatment would be ongoing for a longer
`
`duration than for a teenager?
`
`A
`
`Q
`
`It's possible.
`
`Do you have patients who have stopped
`
`taking the Aczone 5 percent product?
`
`A
`
`Q
`
`Yes.
`
`Why?
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`Page 29
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`A
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`Either it was not effective for them or
`
`it was effective for them.
`
`Q
`
`So you have some patients in which the
`
`acne problem has completely cleared up after using
`
`the Aczone 5 percent?
`
`A
`
`Q
`
`Yes.
`
`Do you have any patients who have
`
`stopped taking the Aczone 5 percent for another
`
`reason not associated with efficacy?
`
`A
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`Sometimes cost is an issue and they
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`can't afford the medicine.
`
`Q
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`Has anyone stopped taking it, that
`
`you're aware of, because of a side effect of its
`
`use?
`
`A
`
`Sometimes people complain of dryness,
`
`but I'm not sure if that has led to them not using
`
`the medicine.
`
`Q
`
`Have you ever had patients complaining
`
`about the feel of the product?
`
`A
`
`Q
`
`No.
`
`I mean, just dryness.
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`Have you heard anybody complaining about
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`the grittiness of the product?
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`202-232-0646
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`Page 30
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`A
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`Q
`
`A
`
`Q
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`Not much.
`
`A little bit, though?
`
`Yes.
`
`But, to your knowledge, nobody has
`
`stopped taking the product on account of its
`
`grittiness?
`
`A
`
`I don't remember a conversation that
`
`I've had with a patient that said that.
`
`Q
`
`Have you ever prescribed the Aczone
`
`7.5 percent dapsone product?
`
`A
`
`Q
`
`Yes.
`
`What would make you prescribe the
`
`7.5 percent versus the 5 percent product?
`
`A
`
`Q
`
`Sometimes patients request it.
`
`And is patient request the only reason
`
`you would prescribe the 7.5 percent product?
`
`A
`
`Sometimes I have samples in the office
`
`and they try it and like it.
`
`Q
`
`Without a patient either requesting the
`
`7.5 percent product or trying a sample and liking
`
`it in your office, would you prescribe the
`
`7.5 percent product to a patient over the
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`5 percent product?
`
`Page 31
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`company.
`
`Q
`
`A
`
`Q
`
`Usually I can't.
`
`Usually you can't?
`
`Correct.
`
`Why is that?
`
`Because of step edits from the insurance
`
`Are there instances in which you can?
`
`Maybe.
`
`Have you ever prescribed the 7.5 percent
`
`product in such an instance?
`
`A
`
`Q
`
`A
`
`Q
`
`Probably.
`
`Can you say for certain?
`
`I don't remember.
`
`If there weren't step edits from the
`
`insurance company telling you, directing you to
`
`prescribe the 5 percent product, would you
`
`prescribe the 7.5 percent product?
`
`A
`
`I might.
`
`Some people, it matters.
`
`Some
`
`people, it doesn't matter.
`
`Q
`
`A
`
`What makes it matter?
`
`Some people want things to be more
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`Elaine S. Gilmore, MD, PhD
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`Page 32
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`simple and use it once a day.
`
`Some people are
`
`more geared toward the price.
`
`Q
`
`Have you found the 7.5 percent product
`
`effective when patients use it?
`
`A
`
`Q
`
`Yes.
`
`Would you be able to say whether you
`
`found it similarly effective to the 5 percent
`
`product?
`
`A
`
`Q
`
`A
`
`Q
`
`That's hard to answer.
`
`Sure.
`
`People are on multiple treatments.
`
`Have you prescribed any topical dapsone
`
`formulations other than Aczone?
`
`A
`
`Q
`
`I believe the 5 percent is generic now.
`
`Sure.
`
`Have you ever prescribed a topical
`
`dapsone formulation to treat rosacea?
`
`A
`
`Q
`
`No.
`
`Have you ever prescribed a topical
`
`dapsone formulation to treat any other
`
`dermatological issues?
`
`A
`
`Yes.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`Amneal, et al. v. Allergan, Inc.
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`Elaine S. Gilmore, MD, PhD
`
`Page 33
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`21
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`22
`
`Q
`
`A
`
`Q
`
`A
`
`What?
`
`Pyoderma gangrenosum.
`
`Can you tell me what that is?
`
`It's a chronic inflammatory condition
`
`that leads to ulcerations that are very, very slow
`
`to heal.
`
`Q
`
`When you say "chronic inflammatory
`
`condition," what is inflamed?
`
`A
`
`Q
`
`The skin.
`
`Is it the papillae? And I apologize if
`
`my pronunciation is incorrect.
`
`A
`
`Q
`
`A
`
`Q
`
`It's a big hole in the skin.
`
`Oh, okay.
`
`There are no more papillae there.
`
`Got it.
`
`Have you found the topical dapsone
`
`formulation effective for treating that condition?
`
`A
`
`Q
`
`It can be.
`
`Are there any other conditions that you
`
`would prescribe it for other than acne and the
`
`pyro
`
`and I apologize for not getting the name.
`
`A
`
`I don't think I've used it in any other
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`33 of 103
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`Amneal, et al. v. Allergan, Inc.
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`Elaine S. Gilmore, MD, PhD
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`Page 34
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`instances.
`
`Q
`
`When prescribing a topical formulation
`
`for treating a patient's dermatological condition,
`
`what characteristics of the treatment do you
`
`consider?
`
`A
`
`How much body surface area needs to be
`
`covered, whether the condition is acute or
`
`chronic, how long we would anticipate treatment
`
`would be required, age of the patient. There are
`
`a lot of different factors that go into treating.
`
`Q
`
`What characteristics of the formulation
`
`itself, the product, would you consider?
`
`A
`
`The vehicle of the product.
`
`In treating
`
`patients with psoriasis, sometimes we use
`
`solutions, foams, creams, ointments.
`
`Q
`
`So it's accurate to say that you
`
`consider the excipients as well as the active
`
`ingredients?
`
`A
`
`The overall vehicle choice can play a
`
`role depending on body site and disease.
`
`Q
`
`A
`
`Does it play a role for acne?
`
`It can.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
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`202-232-0646
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`Amneal, et al. v. Allergan, Inc.
`
`Elaine
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