`M.D.
`
`Date: February 26, 2024
`Case: TWI Pharmaceuticals, Inc. -v- Merck Serono SA (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`Merck 2009
`TWi v Merck
`IPR2023-00049
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
` _______________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________________________
` TWI PHARMACEUTICALS, INC.
` Petitioner,
` V.
` MERCK SERONO SA
` Patent Owner.
` _______________________________
`
` IPR2023-00049 (Patent 7,713,947 B2)
` IPR2023-00050 (Patent 8,377,903 B2)
` _______________________________
`
` -----------------------------------
` ORAL DEPOSITION OF
` BENJAMIN GREENBERG, M.D.
` FEBRUARY 26, 2024
` -----------------------------------
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`2
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` ORAL DEPOSITION OF BENJAMIN GREENBERG, M.D., produced
`as a witness at the instance of the Patent Owner, Merck
`Serono SA, and duly sworn, was taken in the above-styled
`and numbered cause on February 26, 2024, from 9:06 a.m.
`to 3:28 p.m., before Kim A. McCann, CSR in and for the
`State of Texas, reported by machine shorthand, at the
`offices of Husch Blackwell, 1900 N. Pearl Street, Suite
`1800, Dallas, Texas, pursuant to the Federal Rules of
`Civil Procedure.
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`3
`
` A P P E A R A N C E S
`FOR THE PETITIONER:
` Philip Segrest, Esq.
` HUSCH BLACKWELL, LLP
` 120 South Riverside Plaza
` Suite 2200
` Chicago, Illinois 60606
` (312) 655-1500
` (312) 655-1501 fax
`
`FOR THE PATENT OWNER MERCK SERONO SA:
` Cindy Kan, Esq.
` Emily R. Whelan, Esq.
` WilmerHale
` 7 World Trade Center
` 250 Greenwich Street
` New York, New York 10007
` (212) 295-6470
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`4
`
` I N D E X
` PAGE
`Examination by Ms. Kan 6
`
` E X H I B I T S
` NUMBER DESCRIPTION PAGE
`Exhibit 2004 Article entitled "Cladribine in 26
` treatment of chronic
` progressive multiple sclerosis"
` by Sipe
`Exhibit 2005 Excerpt from Pharmacology and 60
` Therapeutics - Principles to
` Practice
`Exhibit 2006 Article co-authored by Dr. 96
` Greenberg "Reduction of Disease
` Activity Disability With
` High-Dose Cyclophosphamide in
` Patients With Agressive
` Multiple Sclerosis
`Exhibit 2007 Article entitled "Defining 123
` Success in Multiple Sclerosis,
` Treatment Failures and
` Nonresponders"
`Exhibit 2008 Article from "Continuum" 145
` co-authored by Dr. Greenberg
`
` P R E V I O U S E X H I B I T S
` NUMBER DESCRIPTION PAGE
`Exhibit 1005 IPR 2023-00049 8
`Exhibit 1008 Rice study "Cladribine and 32
` progressive MS: Clinical and
` MRI outcomes of a multicenter
` controlled trial
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`5
`
` INDEX (Cont.)
`Exhibit 1016 Romine study "A Double-Blind, 19
` Placebo-Controlled, Randomized
` Trial of Cladribine in
` Relapsing-Remitting
` Multiple Sclerosis
`Exhibit 1017 Package insert for Novantrone 51
`Exhibit 1024 Cursiefen article "Escalating 90
` Immunotherapy with
` mitoxantrone in Patients with
` Very Active
` Relapsing-Remitting or
` Progressive Muscular
` Sclerosis"
`Exhibit 1028 Coles article " Campath-lH 13
` treatment of multiple
` sclerosis: Lessons
` From the bedside for the
` bench"
`Exhibit 1029 Copy of U.S. Patent 7,888,328, 131
` Bodor, et al.
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`6
`
` P R O C E E D I N G S
` (Witness duly sworn.)
` MS. KAN: Good morning. My name
`is Cindy Kan. I'm an attorney at the law firm of
`Wilmer Hale, and with me today is Emily Whelan,
`also an attorney at Wilmer Hale.
` MR. SEGREST: And just -- if we're
`doing appearances, Philip Segrest of
`Husch Blackwell representing the Petitioner, TWi,
`and the witness, Dr. Greenberg.
` MS. KAN: And we represent patent
`owner, Merck Serono SA.
` BENJAMIN GREENBERG, M.D.,
`Having been first duly sworn, testified as
`follows:
` EXAMINATION
`BY MS. KAN:
` Q. Good morning.
` A. Good morning.
` Q. Please state your full name for the
`record.
` A. Benjamin Greenberg,
`G-r-e-e-n-b-e-r-g.
` Q. Is there any reason that you cannot
`provide complete and accurate testimony today?
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`7
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` A. No.
` Q. Do you understand that your testimony
`here today is given under oath?
` A. Yes.
` Q. Have you ever been deposed before?
` A. Yes.
` Q. How many times?
` A. Somewhere between four and eight.
` Q. Have you ever testified in court
`before?
` A. Yes.
` Q. How many times?
` A. Twice.
` Q. And when?
` A. One was approximately 19 years ago,
`and one was more than 10 years ago.
` Q. What's --
` A. And I apologize. A third around
`about six years ago.
` Q. What sort of matters did you give
`testimony in?
` A. The first case was a vaccine injury
`compensation case, one was a medical malpractice
`case where I served as an expert witness, and one
`was a case relative to a patent.
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`8
`
` Q. You understand that we are taking
`today's deposition in two IPR proceedings: IPR
`2023-00049 and IPR 2023-00050; correct?
` A. Yes.
` Q. And unless I know otherwise, all
`exhibits that we use today are being introduced
`with the same numbers in both proceedings.
` A. Yes.
` Q. I'm going to hand you what has
`previously been marked as Exhibit 1005 in IPR
`2023-00049.
` MR. SEGREST: Thank you.
` Q. I may refer to IPR 2023-00049 as
`the '049 IPR. Okay?
` A. Okay.
` Q. Do you recognize the document?
` A. Yes.
` Q. Are you familiar with this document?
` A. Yes.
` Q. This is your declaration providing
`your opinions regarding U.S. Patent 7,713,947;
`correct?
` MR. SEGREST: Object. Form.
` A. Yes.
` Q. I may refer to U.S. Patent 7,713,947
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`9
`
`as the '947 patent. Okay?
` A. Okay.
` Q. This is also your declaration
`providing your opinions regarding U.S. Patent
`8,377,903; correct?
` A. Yes.
` Q. I may refer to U.S. Patent 8,377,903
`as the '903 patent. Okay?
` A. Okay.
` Q. Could you confirm that this
`declaration which addresses both the '947 and
`the '903 patents is the same declaration as was
`submitted in IPR 2023-00050?
` A. It appears to be so.
` Q. Could you turn to page 126 of
`Exhibit 1005.
` A. Yes.
` Q. Is that your signature on the
`declaration?
` A. Yes.
` Q. And you stand by the opinions you
`provided in your declaration?
` A. Yes.
` Q. Could you turn to page 11 of
`Exhibit 1005.
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`Transcript of Benjamin Greenberg, M.D.
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`10
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` A. Okay.
` Q. At paragraph 12 you state: I have
`considered the facts and data contained in the
`references cited herein, as well as my
`experience, education, and training in providing
`the opinions contained herein. Correct?
` A. Yes.
` Q. The references cited herein are
`limited to exhibits in the '049 IPR; correct?
` A. Yes.
` Q. So every time you cite a reference in
`your declaration, you provide an exhibit number;
`correct?
` A. I believe that to be true.
` Q. Are there any materials you
`considered in forming your opinions that are not
`cited in the declaration?
` A. None that I specifically recall at
`this moment.
` Q. In forming your opinions for the '049
`IPR, did you search for any literature yourself?
` A. I do not recall a specific search.
` Q. Your opinion is that the challenged
`claims of the '947 and '903 patents are
`anticipated by Bodor; correct?
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`Transcript of Benjamin Greenberg, M.D.
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`11
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` A. Yes.
` Q. Your further opinion is that the
`challenged claims of the '947 and '903 patents
`would have been obvious over Bodor; correct?
` A. Yes.
` Q. And your opinion is that the
`challenged claims of the '947 and '903 patents
`would have been obvious over Bodor and Rice;
`right?
` A. Yes.
` Q. How did you become aware of the Bodor
`and Rice references?
` A. So the Bodor reference was made
`available to me after I was asked to review the
`case. The Rice material may have been familiar
`to me in the course of my practice and work as a
`neurologist. I don't specifically recall.
` Q. Did you talk to anyone other than
`counsel for TWi in forming the opinions that are
`in your declaration for the '049 and '050 IPRs?
` A. Nobody else than counsel's office or
`staff.
` Q. Did you do anything to prepare for
`today's deposition?
` A. Yes.
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`12
`
` Q. What did you do?
` A. I reviewed my declaration. I
`reviewed the '943 and '907 patent -- actually,
`'903 and '947 patent and Bodor and Rice, as well
`as looking at the IPR decision allowing the case
`to move forward.
` Q. Did you meet with anyone to prepare
`for your deposition?
` A. Yes.
` Q. Who did you meet with?
` A. I met with counsel from
`Husch Blackwell in preparing.
` Q. When?
` A. Over the last week and a half, there
`were a few meetings.
` Q. And how long in total do you think
`you met with counsel for?
` A. Each meeting lasted anywhere from one
`to two hours.
` Q. So in total?
` A. In total, up to six hours.
`Approximately.
` Q. Did you bring any documents with you
`to today's deposition?
` A. No.
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`13
`
` Q. Did you make -- and you didn't
`communicate with anyone other than counsel for
`TWi to prepare for this deposition; correct?
` A. Correct.
` Q. And aside from the documents that you
`noted earlier, have you reviewed any documents
`other than the exhibits in this IPR?
` A. Only the exhibits or, for example, if
`the patent referred to an article like Rice,
`anything contained in the patent.
` Q. I'd like to introduce what has
`previously been marked as Exhibit 1028, an
`article by Coles.
` MR. SEGREST: Thank you.
` Q. Do you recognize Exhibit 1028 as a
`Coles article you relied on in your declaration?
` A. Yes.
` Q. Coles describes treatment of multiple
`sclerosis patients with Campath-1H; correct?
` A. Yes.
` THE REPORTER: Can you say that
`again? I'm not familiar with the terminology, so
`if you just say that again.
` MS. KAN: Coles describes treatment
`of multiple sclerosis patients with Campath-1H;
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`14
`
`correct?
` THE REPORTER: Thank you.
` Q. Please turn to page 271 of Coles.
` A. Okay.
` Q. Please go to the left column, first
`full paragraph, first sentence.
` A. Okay.
` Q. Here Coles states: We administered
`100 milligrams of Campath-1H as five daily doses
`of 20 milligrams given intravenously over four
`hours. Correct?
` A. Correct.
` Q. The paragraph goes on to say:
`Subsequently, we offered elective retreatment
`after 12 to 18 months giving a fixed total dose
`of 60 milligrams over 3 consecutive days
`(20 milligrams per day), again premedicated with
`corticosteroids. 9 of 22 of the acute relapsing
`group have now received a second course of
`Campath-1H. Correct?
` A. Yes.
` Q. Retreatment that is elective means
`that retreatment is optional; correct?
` A. I'm not sure that in -- in terms of
`the word "optional," but elective can be for a
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
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`15
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`variety of reasons. Technically every treatment
`is always optional, but I'm not sure those are
`exactly the same.
` Q. Could a patient decline retreatment?
` A. It -- a patient can decline any
`treatment.
` Q. The patients who received retreatment
`received a fixed total dose of 60 milligrams of
`Campath-1H; correct?
` A. That is what it says.
` Q. And this fixed total dose of
`60 milligrams was referred to as a second course
`of Campath-1H; correct?
` A. I'm not sure I see the term "second
`course." I don't disagree that it was a
`subsequent course, but I don't see that
`terminology you're referring to, unless I'm
`missing a piece pointed out.
` Q. So I had read a sentence that started
`with, Subsequently we offered elective
`retreatment.
` Do you see that?
` A. Yes.
` Q. And it ends with, 9 of 22 of the
`acute relapsing group have now received a second
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`Transcript of Benjamin Greenberg, M.D.
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`16
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`course.
` A. Ah, yes.
` Q. So the fixed total dose of
`60 milligrams was referred to as a second course
`of Campath-1H; correct?
` A. Yes.
` Q. And these patients who had received
`the first course of Campath-1H; correct?
` A. Yes.
` Q. So the dose of Campath-1H during
`retreatment was lower than the initial
`100-milligram dose of Campath-1H; correct?
` A. Yes.
` Q. The second course of Campath-1H was a
`lower dose than the initial 100-milligram dose of
`Campath-1H; correct?
` A. Yes.
` Q. Some of these patients received
`retreatment 12 months after receiving the initial
`dose; correct?
` A. I believe that's what's stated.
` Q. And some of these patients received
`retreatment 18 months after the -- receiving the
`initial dose; correct?
` A. Yes.
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`Conducted on February 26, 2024
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`17
`
` Q. For patients who received
`retreatment, they did not all receive retreatment
`at the same time; correct?
` A. Yes.
` Q. Please turn to page 270 of Coles.
` A. Okay.
` Q. Please go to the right column, bottom
`paragraph. If you count nine lines from the
`bottom --
` A. Okay.
` Q. -- Coles states: Seven patients in
`this cohort received a second dose of Campath-1H
`two to four years after the first treatment.
` Correct?
` A. Yes.
` Q. The cohort that the seven patients
`were in was a progressive cohort; correct?
` A. Yes.
` Q. These seven patients in the
`progressive cohort received a second dose of
`Campath-1H in order to maintain or increase
`perceived improvements; correct?
` A. Could you re-ask that. Sorry.
` Q. These seven patients in the
`progressive cohort received a second dose of
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`Conducted on February 26, 2024
`
`18
`
`Campath-1H in order to maintain or increase
`perceived improvements; correct?
` MR. SEGREST: Objection. Form.
` A. I'm not seeing that specific
`sentence. If you'd like to point it out, I'm
`happy to address it.
` Q. If you'd turn to page 271, left
`column, first full paragraph, four lines in
`starting with the word "Seven."
` A. I see it.
` Q. So these seven patients in the
`progressive cohort received a second dose of
`Campath-1H in order to maintain or increase
`perceived improvements; correct?
` A. That's what's stated here, yes.
` Q. Do you agree that these seven
`patients who received a second dose of Campath-1H
`received retreatment?
` A. Yes.
` Q. For those seven patients, Coles did
`not specify the amount of the second dose of
`Campath-1H; correct?
` A. Could you ask that again.
` Q. For these seven patients, Coles did
`not specify the amount of the second dose of
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`19
`
`Campath-1H; correct?
` MR. SEGREST: Objection. Foundation.
` A. It does not appear so.
` Q. Some of these seven patients received
`a second dose two years after the first
`treatment; correct?
` A. Yes.
` Q. And some of these seven patients
`received a second dose four years after the first
`treatment; correct?
` A. Yes.
` Q. For the seven patients that received
`a second dose, they did not all receive a second
`dose at the same time; correct?
` A. Yes.
` Q. Let's look at Romine. This is an
`exhibit that has been previously marked as
`Exhibit 1016.
` MR. SEGREST: Thank you.
` Do you recognize Exhibit 1016 as
`Romine article you relied on in your declaration?
` (Brief interruption.)
` Q. I'm going to repeat that question.
` A. Please do.
` Q. Do you recognize Exhibit 1016 as a
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
`
`20
`
`Romine article you relied on in your declaration?
` A. Yes.
` Q. Exhibit 1016 is a publication by
`Romine from 1999; correct?
` A. Yes.
` Q. Please turn to page 35 of Romine.
` A. Yes.
` Q. Please go to the abstract. The first
`two sentences, Romine states: We conducted an
`18-month, placebo-controlled, double-blind study
`to evaluate cladribine in the treatment of 52
`patients with relapsing-remitting multiple
`sclerosis. Patients received either placebo or
`cladribine 0.07 milligrams per kilograms per day
`by subcutaneous injection for five consecutive
`days as six monthly courses for a total
`cumulative dose of 2.1 milligrams per kilogram.
`Correct?
` A. Yes.
` Q. Romine's study as disclosed in
`Exhibit 1016 was on relapsing-remitting multiple
`sclerosis patients; correct?
` A. Yes.
` Q. These patients received a total dose
`of 2.1 milligrams per kilogram of cladribine
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`21
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`subcutaneously; correct?
` A. Yes.
` Q. Please turn to page 43 of Romine.
` A. Okay.
` Q. Please go to the right column, three
`lines down. Here Romine states: The lengthy but
`permanent duration of effect of cladribine means
`that retreatment will be necessary if cladribine
`is to become a practical long-term therapy for
`MS; correct?
` A. That is what it says.
` Q. You rely on this statement in Romine
`to teach retreatment with cladribine; correct?
` A. I rely on a variety of sources, as
`outlined in my declaration, about the notion of
`retreatment.
` Q. One of those sources that you rely on
`is Romine; correct?
` A. Romine is used for a variety of
`reasons in forming my opinions, but concept of
`retreatment is here and elsewhere.
` Q. So staying at Romine, page 44 --
`well, page 43, right column, nine lines down,
`Romine states: Twenty-four patients from our
`initial study of cladribine in chronic
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`Transcript of Benjamin Greenberg, M.D.
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`22
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`progressive MS have been retreated, 0.07
`milligrams per kilogram times five days times
`four courses because of a recurrence of disease
`worsening. Correct?
` A. Yes.
` Q. Romine selected patients for
`retreatment with cladribine because they had a
`recurrence of disease worsening; correct?
` A. I can't speak to selection criteria.
`It just states that they were retreated because
`of recurrence of disease worsening.
` Q. So Romine treated patients -- strike
`that.
` So Romine administered treatment with
`cladribine of patients because they had a disease
`worsening; correct?
` A. That's what it says.
` Q. Romine discloses retreatment of
`chronic progressive MS patients from their
`initial study of cladribine; correct?
` A. Yes.
` Q. Romine does not disclose retreatment
`of the relapsing-remitting multiple sclerosis
`patients that we referenced from page 35 earlier
`of Romine; correct?
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`23
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` A. I don't believe so.
` Q. During retreatment the chronic
`progressive MS patients received 0.07 milligrams
`per kilogram for five days for four courses for a
`total dose of 1.4 milligrams per kilogram
`cladribine; correct?
` A. I believe that math is correct.
` Q. In forming your opinions regarding
`retreatment, did you consider the initial
`treatment dose that was given to the chronic
`progressive MS patients from Romine's initial
`study?
` A. As outlined in my declaration, I rely
`on a variety of sources to come to the
`conclusions that I did. Romine plays one role
`relative to the notion of retreatment and to the
`effect of cladribine.
` Q. And with respect to Romine's role in
`the notion of retreatment with cladribine, in
`forming your opinions regarding retreatment, did
`you consider the initial treatment dose that was
`given to the chronic progressive MS patients from
`Romine's initial studying?
` A. Amongst a variety of other features
`in Romine and articles, it was one piece
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`24
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`considered.
` Q. Your declaration does not address the
`initial treatment dose; correct?
` A. I'm sorry, the initial treatment dose
`referring to?
` Q. So referring to the initial treatment
`dose of chronic progressive MS treatments from
`Romine's initial study, your declaration does not
`address that initial treatment dose; correct?
` A. I'd have to look back specifically
`for it to be confident in my answer.
` Q. Staying in the same paragraph in
`Romine, the paragraph goes on to say: There were
`no instances of marrow suppression or
`thrombocytopenia in these patients, but six
`(25 percent) developed herpes zoster with a
`second course of cladribine as compared to 2 of
`51 (4 percent) with the first treatment.
` Correct?
` A. That is what it says.
` Q. And in that initial study, 2 of 51
`also developed herpes zoster with the first
`treatment; correct?
` A. Yes.
` Q. In Romine's initial study, there were
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`25
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`51 patients?
` A. I believe so.
` Q. Romine did not give retreatment to
`all 51 patients in that initial study; correct?
` A. Correct.
` Q. Romine only gave retreatment to a
`subset of the patients included in that study;
`correct?
` A. Correct.
` Q. Please turn to page 36 of Romine.
` A. Okay.
` Q. In the right column, first paragraph,
`full sentence -- first full paragraph, first
`sentence, Romine states: In contrast to our
`earlier study of intravenous cladribine in
`progressive MS, the drug was administered
`subcutaneously. Correct?
` A. Yes, that is what it says.
` Q. Romine cites the reference 5 for
`their earlier study of intravenous cladribine in
`progressive MS; correct?
` A. Yes.
` Q. Please turn to page 44 of Romine.
` A. Okay.
` Q. Reference 5 is cited as: Sipe JC,
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`26
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`Romine JS, Koziol JA, et al. Cladribine in
`treatment with chronic progressive multiple
`sclerosis. Lancet 344; 9 to 13, 1994.
` Correct?
` A. Yes.
` Q. So I would like to introduce an
`exhibit. I'm going to mark this Exhibit 2004.
` (Exhibit 2004 was marked.)
` A. Sorry. Where --
` Q. Preferably where it's not covering
`text.
` A. Okay.
` Q. Dr. Greenberg, do you recognize
`Exhibit 2004?
` A. I believe so.
` Q. This is a publication listing JC Sipe
`as a first author; correct?
` A. Yes.
` Q. This publication is co-authored by
`Romine; correct?
` A. Yes.
` Q. The same Romine who was the first
`author of the study we just discussed; correct?
` A. I believe so.
` Q. The title of Exhibit 2004 is
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`27
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`"Cladribine in treatment of chronic progressive
`multiple sclerosis." Correct?
` A. Yes.
` Q. The publication is from 1994?
` A. Yes.
` Q. This is a publication you did not
`cite in providing your opinions for this IPR;
`correct?
` A. I don't recall.
` Q. Have you reviewed this 1994 Sipe
`publication before?
` A. Sitting here today, I don't recall.
` Q. You did not discuss Exhibit 2004,
`this publication by Sipe in your declaration;
`correct?
` A. Again, I don't recall. I would need
`to go through it to give a firm answer.
` Q. This 1994 publication is the same
`reference that Romine cites to as reference 5 in
`Exhibit 1016 that we previously were looking at;
`correct?
` A. Yes.
` Q. Please turn to page 9 of
`Exhibit 2004.
` A. Okay.
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`Transcript of Benjamin Greenberg, M.D.
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`28
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` Q. Please go to the left column, second
`paragraph, first sentence. Here Sipe and Romine
`state: 51 patients (48 entered as matched pairs)
`received four monthly courses of 0.7 milligrams
`per kilogram of cladribine or placebo (saline)
`given through a surgically implanted central
`line. Correct?
` A. Correct.
` Q. There were 51 patients in this
`initial 1994 study of Sipe and Romine; correct?
` A. Correct.
` Q. These patients in this initial 1994
`study of Sipe and Romine were chronic multiple --
`chronic progressive multiple sclerosis patients;
`correct?
` A. That appears to be so.
` Q. The total amount of cladribine
`administered was four monthly courses of
`0.7 milligrams of kilograms of cladribine;
`correct?
` A. That appears to be so.
` Q. This corresponds to a total dose of
`2.8 milligrams per kilogram; correct?
` A. I believe so.
` Q. If you would please turn to page 11
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`29
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`of Exhibit 2004.
` A. Okay.
` Q. If you go to the right column, last
`full paragraph, here you see the beginning of the
`Results section of Sipe and Romine's 19 --
`1999 -- excuse me -- 1994 study; correct?
` A. Yes.
` Q. The Results section continues to the
`next page; correct?
` A. Yes.
` Q. So at the right column of page 12 is
`a subsection within Results entitled
`"Side-effects and complications." Correct?
` A. On page 12, yes.
` Q. And that is a subsection of the
`Results section; correct?
` A. Yes.
` Q. The last paragraph in the
`Side-effects and complications states:
`2 patients who had received cladribine had mild
`episodes of herpes zoster restricted to one or
`two dermatomas, and these subsided rapidly on
`treatment with oral acyclovir. Correct?
` A. Yes.
` Q. So two patients out of Sipe and
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`30
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`Romine's patients developed herpes zoster;
`correct?
` A. It said they had mild symptoms of
`herpes zoster.
` Q. If you'd turn to Exhibit 1016, the
`Sipe and Romine publication.
` A. Yes.
` Q. At page 43.
` A. Yes.
` Q. The right column which we read
`earlier and which states: 24 patients from our
`initial study of cladribine in chronic
`progressive MS have been retreated (0.7
`milligrams per kilogram for five days for four
`courses) because of a recurrence of disease
`worsening. Correct?
` A. That's what it says.
` Q. The paragraph continued with there
`were no instances of marrow suppression or
`thrombocytopenia in these patients, but 6
`(25 percent) developed herpes zoster with the
`second course of cladribine as compared to 2 of
`51 (4 percent) with the first treatment.
` Correct?
` A. Yes.
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`Transcript of Benjamin Greenberg, M.D.
`Conducted on February 26, 2024
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`31
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` Q. As discussed in Exhibit 1016 Romine's
`1999 publication, 2 of 51 patients in Romine's
`initial study developed herpes zoster with the
`first treatment; correct?
` A. Yes.
` Q. We saw from Romine and Sipe's 1994
`publication on 51 chronic progressive multiple
`sclerosis patients, that two patients who had
`received cladribine had mild episodes of herpes
`zoster; correct?
` A. Yes.
` Q. So the initial study referenced in
`Romine's 1999 study was the same study reported
`and cited in Romine's 1994 publication; correct?
` A. I'm sorry, could you ask that one
`more time.
` Q. The initial st