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`
`(cid:38)(cid:68)(cid:86)(cid:72)(cid:3)(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:20)(cid:26)(cid:16)(cid:19)(cid:19)(cid:27)(cid:24)(cid:23)
`
`(cid:50)(cid:70)(cid:87)(cid:82)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:15)(cid:3)(cid:21)(cid:19)(cid:20)(cid:26)
`
`(cid:20)
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
` APOTEX INC., APOTEX CORP., and
` ARGENTUM PHARMACEUTICALS LLC,
` Petitioners,
` v.
` NOVARTIS AG.,
` Patent Owner.
` ____________
` Case IPR2017-00854
` Patent 9,187,405 B2
` ____________
`
` VIDEOTAPED DEPOSITION OF BARBARA S. GIESSER, M.D.
` LOS ANGELES, CALIFORNIA
` OCTOBER 2, 2017
`
`MARLA SHARP, RPR, CLR, CCRR, CSR
`CERTIFICATE NO. 11924
`
`(cid:21)(cid:19)(cid:21)(cid:16)(cid:21)(cid:21)(cid:19)(cid:16)(cid:23)(cid:20)(cid:24)(cid:27)
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`(cid:90)(cid:90)(cid:90)(cid:17)(cid:75)(cid:72)(cid:81)(cid:71)(cid:72)(cid:85)(cid:86)(cid:82)(cid:81)(cid:79)(cid:72)(cid:74)(cid:68)(cid:79)(cid:86)(cid:72)(cid:85)(cid:89)(cid:76)(cid:70)(cid:72)(cid:86)(cid:17)(cid:70)(cid:82)(cid:80)
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2039
`
`
`
`(cid:38)(cid:68)(cid:86)(cid:72)(cid:3)(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:20)(cid:26)(cid:16)(cid:19)(cid:19)(cid:27)(cid:24)(cid:23)
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`(cid:50)(cid:70)(cid:87)(cid:82)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:15)(cid:3)(cid:21)(cid:19)(cid:20)(cid:26)
`
`(cid:20)
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
` APOTEX INC., APOTEX CORP., and
` ARGENTUM PHARMACEUTICALS LLC,
` Petitioners,
` v.
` NOVARTIS AG.,
` Patent Owner.
` ____________
` Case IPR2017-00854
` Patent 9,187,405 B2
` ____________
`
` VIDEOTAPED DEPOSITION OF BARBARA S. GIESSER, M.D.
` LOS ANGELES, CALIFORNIA
` OCTOBER 2, 2017
`
`MARLA SHARP, RPR, CLR, CCRR, CSR
`CERTIFICATE NO. 11924
`
`(cid:21)(cid:19)(cid:21)(cid:16)(cid:21)(cid:21)(cid:19)(cid:16)(cid:23)(cid:20)(cid:24)(cid:27)
`
`(cid:43)(cid:72)(cid:81)(cid:71)(cid:72)(cid:85)(cid:86)(cid:82)(cid:81)(cid:3)(cid:47)(cid:72)(cid:74)(cid:68)(cid:79)(cid:3)(cid:54)(cid:72)(cid:85)(cid:89)(cid:76)(cid:70)(cid:72)(cid:86)(cid:15)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)
`(cid:90)(cid:90)(cid:90)(cid:17)(cid:75)(cid:72)(cid:81)(cid:71)(cid:72)(cid:85)(cid:86)(cid:82)(cid:81)(cid:79)(cid:72)(cid:74)(cid:68)(cid:79)(cid:86)(cid:72)(cid:85)(cid:89)(cid:76)(cid:70)(cid:72)(cid:86)(cid:17)(cid:70)(cid:82)(cid:80)
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2039
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`2
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
` APOTEX INC., APOTEX CORP., and
` ARGENTUM PHARMACEUTICALS LLC,
` Petitioners,
` v.
` NOVARTIS AG.,
` Patent Owner.
` ____________
` Case IPR2017-00854
` Patent 9,187,405 B2
` ____________
`
`VIDEOTAPED DEPOSITION OF BARBARA S. GIESSER,
`M.D., taken on behalf of the Patent Owners, at
`Irell & Manella, 1800 Avenue of the Stars,
`ninth floor, Los Angeles, California,
`commencing at 9:10 a.m., Monday, October 2,
`2017, before Marla Sharp, RPR, CLR, CCRR, CSR
`No. 11924.
`
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`3
`
`A P P E A R A N C E S:
`FOR PETITIONERS:
` WILSON SONSINI GOODRICH & ROSATI
` BY: JAD A. MILLS, ESQ.
` 1800 Avenue of the Stars, Suite 900
` Los Angeles, California 90067
` 310-277-1010
` jmills@wsgr.com
`
`FOR PATENT OWNERS NOVARTIS AG:
` GIBSON DUNN & CRUTCHER
` BY: JANE LOVE, ESQ.
` ROBERT TRENCHARD, ESQ.
` 200 Park Avenue
` New York, New York 10166
` 212-351-4000
` jlove@gibsondunn.com
` rtrenchard@gibsondunn.com
`
`FOR TEVA:
` KIRKLAND & ELLIS
` BY: RUI LI, ESQ.
` 555 California Street
` San Francisco, California 94104
` 415-439-1400
` rui.li@kirkland.com
`
`FOR SUN PHARMACEUTICALS:
` WINSTON & STRAWN
` BY: SHARICK NAQI, ESQ. (via teleconference)
` 35 West Wacker Drive
` Chicago, Illinois 60601
` 312-558-3262
` snaqi@winston.com
`
`ALSO PRESENT:
` David Kim, videographer
` Lawrence Steinman
` Tyler Liu, Argentum in-house counsel
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`Case IPR2017-00854
`
`October 2, 2017
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`4
`
` I N D E X
`EXAMINATION PAGE
`BARBARA S. GIESSER, M.D.
` BY MS. LOVE 7, 106
` (afternoon session) 86
` BY MR. MILLS 102
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1008 Paper entitled "First Human 60
` Trial of FTY720, a Novel
` Immunomodulator, in Stable
` Renal Transplant Patients," by
` Budde et al.
`Exhibit 2014 Paper entitled "Sphingosine 68
` 1-phosphate receptor agonists
` attenuate relapsing-remitting
` experimental autoimmune
` encephalitis in SJL mice," by
` Webb et al.
`Exhibit 1002 Declaration of Barbara S. 88
` Giesser in Patent No. 9,187,405
`
` INSTRUCTIONS NOT TO ANSWER
` PAGE LINE
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`Giesser, M.D., Barbara S.
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`Case IPR2017-00854
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`October 2, 2017
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`5
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` I N D E X
` (continued)
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` INSTRUCTIONS NOT TO ANSWER
` (continued)
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`Case IPR2017-00854
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`October 2, 2017
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`09:11:33
`
` LOS ANGELES, CALIFORNIA; MONDAY, OCTOBER 2, 2017
` 9:10 A.M.
` THE VIDEOGRAPHER: We are now going on the
`video record. Today is October 2nd, 2017. And the
`time is approximately 9:10 a.m.
` The location is 1800 Avenue of the Stars,
`Los Angeles, California. My name is David Kim. I'm
`the video specialist representing Henderson Legal
`Services.
` The civil action number is IPR2017-00854,
`patent 9,187,405 B2 in the matter of Apotex Inc.,
`Apotex Corp., and Argentum Pharmaceuticals v.
`Novartis AG. And the deponent is
`Barbara S. Giesser, MD.
` The video deposition is requested by
`Gibson, Dunn & Crutcher, LLP.
` Will counsel please identify themselves for
`the record.
` MS. LOVE: My name is Jane Love. And with
`me is my partner, Robert Trenchard, both from
`Gibson, Dunn & Crutcher, representing Novartis AG.
`And also with us today is Dr. Larry Steinman.
` MR. MILLS: Jad Mills, with the law firm of
`Wilson Sonsini Goodrich & Rosati, representing
`Apotex Inc. and Apotex Corp. And also here with
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:11:36
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`7
`Dr. Giesser.
` MS. LI: Rui Li with Kirkland & Ellis on
`behalf of Teva.
` THE VIDEOGRAPHER: And on the telephone?
` MR. NAQI: Sharick Naqi from Winston &
`Strawn on behalf of Sun.
` MR. LIU: Tyler, last name L-i-u, on behalf
`of Argentum Pharmaceuticals.
` THE VIDEOGRAPHER: The deponent may now be
`sworn in.
` * * *
` BARBARA S. GIESSER, M.D.,
` having been duly administered an
` oath in accordance with CCP 2094, was
` examined and testified as follows:
` * * *
` EXAMINATION
`BY MS. LOVE:
` Q Good morning, Doctor.
` A Good morning, ma'am.
` Q Would you please state your full name and
`address for the record, please.
` A Barbara Giesser. Work address is 710
`Westwood Plaza, Los Angeles 90095.
` Q Okay. And do you understand that you are
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:12:28
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`8
`under oath today?
` A Yes, ma'am.
` Q Is there any reason that would prevent you
`from testifying fully and truthfully today, such as
`a health condition or you being on any medication?
` A No.
` Q When was the last time you consumed
`alcohol?
` A About a week ago.
` Q Okay. Your answers to my questions must be
`verbal and audible. Do you understand?
` A Yes, ma'am.
` Q So in response to my questions, we want to
`avoid nodding or inaudible or nonword answers.
`Okay?
` A Yes, ma'am.
` Q Okay. We also don't want to speak over one
`another so the stenographer can take down everything
`each person is saying. Okay?
` A Yes, ma'am.
` Q I'll ask you questions today. And if you
`don't understand my question, please ask me to
`clarify. Okay?
` A Yes, ma'am.
` Q If you don't ask me to clarify, I'll assume
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
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`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
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`9
`that you understand the question.
` A I understand.
` Q Okay. Have you had your deposition taken
`before?
` A Yes.
` Q How many times?
` A I don't recall exactly. Once or twice.
` Q In connection with -- strike that.
` Was your deposition taken in connection
`with a patent matter?
` A No.
` Q Have you offered any testimony previously
`by affidavit?
` A I don't believe so.
` Q Have you offered any testimony previously
`by declaration?
` A No.
` Q Have you ever appeared at a trial as a
`witness?
` A No.
` Q Have you ever appeared before the patent
`office as a witness?
` A No.
` Q Have you ever appeared before in a matter
`as an expert?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
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`10
` A No.
` Q Other than counsel in this matter, have you
`consulted with anyone else in carrying out your
`analysis?
` A I have not.
` Q Have you reviewed the declaration of
`Dr. Lublin?
` A No.
` Q Do you know Dr. Lublin?
` A I know of Dr. Lublin.
` Q How do you know of him?
` A He is an MS specialist.
` Q Have you reviewed the declaration of
`Dr. Jesco?
` A I have not.
` Q Do you know Dr. Jesco?
` A I do not.
` Q Do you know Dr. Steinman?
` A Yes.
` Q How do you know Dr. Steinman?
` A Dr. Steinman is an MS specialist.
` THE COURT REPORTER: Keep your voice up for
`me.
`BY MS. LOVE:
` Q You have an MD degree, correct?
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
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` A Yes, ma'am.
` Q Do you have any other postgraduate degrees?
` A I have a master's degree.
` Q In what subject is your master's degree?
` A Tumor virology.
` Q You do not have a PhD, correct?
` A I do not have a PhD.
` Q You are not a lawyer, correct?
` A I am not an attorney.
` Q You are not a patent agent, correct?
` A I am not a patent agent.
` Q You are not a pharmacologist, correct?
` A I am not a pharmacologist.
` Q Have you done any laboratory testing in
`connection with your work on this case?
` A No.
` Q In your career, have you ever worked with
`fingolimod?
` A Could you clarify "worked with"?
` Q Have you ever administered fingolimod to a
`patient?
` A I have prescribed fingolimod for patients.
` Q Generally, about how many times have you
`prescribed fingolimod for patients?
` A Could you clarify, please?
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
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` Q Approximately how many times have you
`prescribed fingolimod for a patient?
` A I treat patients -- I treat some patients
`with MS with fingolimod.
` Q Approximately how many times have you
`written prescriptions for Gilenya?
` A I don't know the number of prescriptions
`I've written. I have approximately nine or ten
`patients currently taking fingolimod who are under
`my care.
` Q Apart from prescribing Gilenya, have you
`done any other research connected with fingolimod?
` A I have done no research consoling --
`concerning fingolimod.
` Q Okay. Approximately how many patients --
`strike that.
` Approximately how many multiple sclerosis
`patients are currently under your care?
` A This would be a very approximate number.
`If we include just patients who are under my
`continuing care, approximately 3 to 400.
` Q Of that approximate number of 3 to 400,
`about how many have relapsing-remitting multiple
`sclerosis as opposed to other forms of multiple
`sclerosis?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:20:01
`09:20:05
`09:20:15
`09:20:17
`09:20:23
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`09:20:31
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` A This would be a very approximate number.
`Perhaps 200 or so.
` Q Have you discussed this case with anyone
`with research experience in fingolimod?
` A No.
` Q Have you discussed this case with anyone
`with experience in pharmacology?
` A No.
` Q Approximately how many people are affected
`by multiple sclerosis?
` A The current estimate is that, in the United
`States, there are 400 to 500,000 people who
`currently have MS. That number's probably a little
`on the low side.
` Q And of those, approximately how many have
`relapsing-remitting multiple sclerosis?
` A I do not know that figure.
` Q There is no cure for multiple sclerosis at
`this point, correct?
` A There is no treatment that is currently
`designated as a cure.
` Q The cause of the disease -- strike that.
` The cause of multiple sclerosis is not
`known presently, correct?
` A Could you clarify "cause," please?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:22:20
`09:22:26
`09:22:28
`09:22:35
`09:22:39
`09:22:43
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`09:23:09
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` Q The scientific reason behind a person
`becoming afflicted with multiple sclerosis is not
`known presently, correct?
` A We have not identified a precise trigger
`that causes someone to develop MS. We have
`identified what we think may be some predisposing
`factors.
` Q What are the factors?
` A Gender appears to be a factor. Ethnicity
`appears to be a factor. Certain lifestyle practices
`such as smoking may be a risk factor. Obesity may
`be a risk factor. Place of birth may be a risk
`factor.
` There may be certain genetic elements that
`increase somebody's risk. Having a first-degree
`family member affected by MS increases an
`individual's risk.
` Q What are the symptoms of
`relapsing-remitting multiple sclerosis?
` A Multiple sclerosis produces symptoms
`referable to impairments in the central nervous
`system. These could include difficulties with
`thinking, vision, speaking, mobility, sensation,
`balance, coordination, and genital urinary
`dysfunction.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:25:16
`09:25:18
`09:25:19
`09:25:26
`09:25:28
`09:25:34
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` Q How are these symptoms measured by a
`physician?
` MR. MILLS: Objection. Form.
` THE WITNESS: Could you clarify "measured,"
`please?
`BY MS. LOVE:
` Q How does a physician assess a patient's
`status in terms of their disease of
`relapsing-remitting multiple sclerosis?
` A Are you referring to a patient's clinical
`status?
` Q Yes, I am.
` A The assessment -- the assessment of a
`patient's clinical status is done by history. What
`symptoms is the patient experiencing? It's done by
`neurologic examination. What abnormalities or
`impairments does the neurologist find on neurologic
`exam? And it's done by a functional assessment.
`What can the patient do?
` For some functions, such as vision, for
`example, you can use a standardized test, such as
`visual acuity. Or you might measure the time it
`takes a patient to walk a standardized distance.
` Q Is there a standardized scale to measure
`the clinical status of patients with
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:27:11
`09:27:16
`09:27:21
`09:27:23
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`relapsing-remitting multiple sclerosis?
` A There are several scales. An older one
`that is still used is the Expanded Disability Status
`Scale, which is a measure of a patient's disability
`that is derived solely from the neurologic
`examination.
` Q Are there any other scales?
` A Yes.
` Q What are they?
` A I can describe some of the more common
`ones. There's a measure called the Multiple
`Sclerosis Functional Composite, the MSFC, which has
`three parts. One is a test of cognition, one is a
`test of walking, and one is a test of upper
`extremity function. So that's a composite measure.
` There are scales that can measure fatigue,
`which is a common symptom of MS. There are scales
`that can measure pain. Those would be some of the
`more common ones. There are also other walking
`scales.
` Q Dr. Giesser, I forgot to mention. We'll
`take breaks during the day. I noticed you stood up.
`And just let me know if you want to take a break. I
`think we have plenty of time.
` A Thank you.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:29:25
`09:29:30
`09:29:32
`09:29:32
`09:29:55
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` Q So we're happy to do that.
` A It's okay if I stretch occasionally?
` Q Of course.
` A Thank you.
` Q Just to be clear, going back to something
`we talked about earlier, you understand that
`fingolimod is the active ingredient in the product
`Gilenya?
` A I understand that.
` Q And do you also understand that fingolimod
`had a prior name in literature, which was FTY720?
` A I understand that their use is pretty
`synonymous. FTY20 [sic] means fingolimod.
` Q And do you understand sometimes researchers
`in the literature have referred to FTY720 as simply
`"FTY"?
` A Yes.
` Q Have you ever conducted any research on
`FTY720?
` A I have not.
` Q Can you describe your educational
`background following undergraduate school?
` A I received a master's degree at the
`University of Texas. I attended medical school at
`the University of Texas. I did an internship and
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:31:49
`09:31:53
`09:31:56
`09:31:59
`09:32:05
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`residency in New York at the Albert Einstein College
`of Medicine.
` Following that, I did a fellowship in
`multiple sclerosis. And following that, I was
`faculty at the Albert Einstein College of Medicine,
`the University of Arizona, and my current position,
`which is faculty at UCLA.
` Q Currently, at UCLA, you have a medical
`practice; is that right?
` A I am a member of the Department of
`Neurology at UCLA. In that capacity I see patients
`with multiple sclerosis.
` Q Okay. Do you also have a research
`laboratory?
` A I do not.
` Q In your career, have you ever had a
`research laboratory?
` A I worked in a research laboratory when I
`was getting my master's degree. That was a basic
`science laboratory.
` Q And that master's degree you mentioned
`earlier was in tumor virology?
` A That is correct.
` Q Did that have anything to do with multiple
`sclerosis?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:33:21
`09:33:33
`09:33:36
`09:33:40
`09:33:40
`09:33:44
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`09:33:57
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` A No.
` Q Okay. Have you been involved in human
`clinical trials related to possible therapeutics for
`multiple sclerosis?
` A Yes, I have.
` Q Can you describe your role -- strike that.
` What trials have you been involved in?
` A I've been involved in a number of trials.
`In some of the trials, I was a coinvestigator,
`meaning the clinical research had been initiated by
`someone else and I would be generally in the role of
`a treating physician helping to screen patients and
`monitor patients.
` I've been involved in a couple of trials
`where I was the primary investigator where I
`initiated and secured funding for the research.
` Q In the trials for which you were a primary
`investigator, what treatments were being
`investigated?
` A We were exploring the effects of different
`exercise modalities on patients with multiple
`sclerosis. We had a trial where we investigated the
`effects of a cooling device on patients with
`multiple sclerosis.
` Q Have you been involved in any clinical
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`Giesser, M.D., Barbara S.
`
`Case IPR2017-00854
`
`October 2, 2017
`
`09:35:28
`09:35:33
`09:35:36
`09:35:39
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`trials testing pharmaceutical or drug therapies?
` A Yes.
` Q What drug therapies?
` A I was briefly involved with a trial
`concerning the drug formally known as Antegren,
`which is now known as natalizumab. And more
`recently I've been a coinvestigator on a colleague's
`trial of a sex hormone called estriol.
` Q What was your role in the natalizumab
`trial?
` A Quite honestly, I don't remember because it
`was about 20 years ago. But I believe it was
`treating physician. And it was very brief. It was
`only a few months.
` Q What was your role in the es- --
` A -- -triol.
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