`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TARO PHARMACEUTICALS U.S.A., )
`INC., )
` )
` Petitioner, )
` ) IPR2017-01446
` vs. )
` ) U.S. Patent No. 7,049,328 B2
`APOTEX TECHNOLOGIES, INC., )
` )
` Patent Owner. )
`-------------------------------)
`
` VIDEOTAPED
` DEPOSITION OF JAYESH MEHTA, M.D.
` New York, New York
` Thursday, February 15, 2018
`
`Reported by:
`FRANCIS X. FREDERICK, CSR, RPR, RMR
`JOB NO. 137317
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` February 15, 2018
` 9:00 a.m.
`
` Videotaped deposition of JAYESH
`MEHTA, held at the offices of Cozen
`O'Connor, 277 Park Avenue, New York, New
`York, pursuant to Notice, before Francis
`X. Frederick, a Certified Shorthand
`Reporter, Registered Merit Reporter and
`Notary Public of the States of New York
`and New Jersey.
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`A P P E A R A N C E S:
`
` GOODWIN PROCTER
` Attorneys for Petitioner
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
` BY: HUIYA WU, ESQ.
` CHRISTOPHER MORTEN, ESQ.
`
` COZEN O'CONNOR
` Attorneys for the Patent Owner
` 1200 Nineteenth Street, N.W.
` Washington, D.C. 20036
` BY: W. BLAKE COBLENTZ, ESQ.
` KERI SCHAUBERT, ESQ.
`
`ALSO PRESENT:
` DALE SWINDELL, Videographer
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` PROCEEDINGS
` THE VIDEOGRAPHER: This is the
`start of media labeled number one of the
`video recorded deposition of Jayesh
`Mehta, MD in the matter Taro
`Pharmaceuticals USA, Inc., versus Apotex
`Technologies, Inc.
` This deposition is being held at
`277 Park Avenue, New York, New York, on
`February 15th, 2018 at approximately 9:04
`a.m.
` My name is Dale Swindell. I am
`the certified legal video specialist from
`TSG Incorporated, headquartered at 747
`Third Avenue, New York, New York. The
`court reporter is Francis Frederick in
`association with TSG Reporting.
` Will counsel please introduce
`yourself.
` MR. COBLENTZ: Blake Coblentz from
`Cozen O'Connor. I'm here on behalf of
`Patent Owner and with me here today is
`Keri Schaubert also from Cozen O'Connor
`and on behalf of Patent Owner.
` MS. WU: Huiya Wu from Goodwin
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` J. MEHTA
` Procter on behalf of Petition, Taro.
` THE VIDEOGRAPHER: Will the court
` reporter please swear in the witness.
` * * *
`J A Y E S H M E H T A, called as a
` witness, having been duly sworn by a
` Notary Public, was examined and
` testified as follows:
`EXAMINATION BY
`MR. COBLENTZ:
` Q. Good morning, Dr. Mehta.
` A. Good morning.
` Q. Can you give me your full name for
`the record, please.
` A. Jayesh Mehta, J-A-Y-E-S-H, last
`name, M-E-H-T-A.
` Q. Can you give me the city and state
`where you live?
` A. Chicago, Illinois.
` Q. Where are you employed?
` A. Northwestern University and
`Northwestern Memorial Healthcare Corporation.
` Q. Now, have you ever been deposed
`before?
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` J. MEHTA
` A. Yes.
` Q. How many times?
` A. I'd say probably about five or
`six.
` Q. And when was the last time you
`were deposed?
` A. Perhaps four or five months ago.
` Q. Was that involving a patent
`litigation?
` A. It was.
` Q. Have you ever been deposed as part
`of a inter partes review proceeding?
` A. I have not.
` Q. And you understand that your
`testimony here today is under oath; is that
`correct?
` A. That's correct.
` Q. So let me go through just a couple
`of ground rules and I'm not going to spend a
`lot of time on them since this is something
`you've been through before. But we'll just
`kind of establish some ground rules so we're
`on the same page.
` Is there any reason that you can't
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` J. MEHTA
`testify here truthfully today, any medications
`or conditions that we need to be aware of?
` A. None.
` Q. Now, I'll be asking you some
`questions. If my questions are unclear, then
`please tell me and I will do my best to
`rephrase those questions. Do you understand
`that?
` A. I understand.
` Q. And your counsel may object to
`some of my questions. But unless your counsel
`instructs you not to answer, then you need to
`answer the question that is posed. Do you
`understand that?
` A. That's correct.
` Q. One thing that's very important is
`to let me finish my questions before you
`answer the question. That'll help the court
`reporter out tremendously. Do you understand
`that?
` A. I do.
` Q. And one more thing. Please make
`your answers audible. No uh-huhs or head nods
`because that can't get picked up by the court
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` J. MEHTA
`reporter. Do you understand that?
` A. Absolutely.
` Q. The last thing I'll say is that we
`will endeavor to take breaks periodically.
`But if there -- if you need a break, please
`ask us for a break. But if there's a question
`pending I ask you to please answer that
`question before we take a break. Do you
`understand that?
` A. Of course.
` Q. All right. So let the fun begin.
` Dr. Mehta, I'm going to hand you
`the first exhibit that we will look at today.
`This is going to be Exhibit 2019.
` (Deposition Exhibit 2019, Patent
` Owner's Notice of Deposition of Jayesh
` Mehta, M.D., Under 37 C.F.R. ยง 42.53,
` marked for identification as of this
` date.)
`BY MR. COBLENTZ:
` Q. For the record, Exhibit 2019 is
`the Notice of Deposition -- Patent Owner's
`Notice of Deposition of Jayesh Mehta, MD under
`37 C.F.R. Section 42.53.
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` J. MEHTA
` Dr. Mehta, have you seen this
`document before?
` A. I don't believe I have.
` Q. But you do understand that you are
`here today pursuant to this particular Notice
`of Deposition; is that correct?
` A. That is correct.
` Q. Now, I'm going to hand you what's
`already been marked as Exhibit 1002.
` And, for the record, this --
`Exhibit 1002 is the Declaration of Jayesh
`Mehta, MD, in Support of the Petition For
`Inter Partes Review of US Patent Number
`7,049,328 B2.
` Dr. Mehta, I'm assuming you
`recognize this document.
` A. I do.
` Q. And if we turn to page 48 of
`Exhibit 1002, is that your signature on page
`48?
` A. It is.
` Q. So let me remind you to let me
`finish my questions and then you answer.
` And it's dated May 14th of 2017?
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` J. MEHTA
` A. That's correct.
` MR. COBLENTZ: I'm going to hand
` you what's going to be marked as Exhibit
` 2020.
` (Deposition Exhibit 2020,
` Supplemental Declaration of Jayesh Mehta,
` M.D., marked for identification as of
` this date.)
`BY MR. COBLENTZ:
` Q. For the record, this --
`Exhibit 2020 is the Supplemental Declaration
`of Jayesh Mehta, MD.
` Dr. Mehta, do you recognize this
`document?
` A. I do.
` Q. If we turn to page 6 then we see
`on page 6 that's your signature; is that
`correct?
` A. That's correct.
` Q. And that is dated December 27th,
`2017; is that correct?
` A. That's correct.
` Q. Now, looking at both your
`Declaration and your Supplemental Declaration,
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` J. MEHTA
`I don't believe I saw a Materials Considered
`in these Declarations. Is that correct?
` A. I would have to look to see if
`this was there or not.
` (Document review.)
` A. No. There does not appear to be a
`specific section that lists that.
` Q. Did you consider any materials in
`preparation of your Declaration that are not
`mentioned in your Declaration?
` A. We studied a lot of material but
`everything that is cited in here is stuff that
`has been considered. And I don't believe we
`have derived any material opinions from things
`that have not been cited here.
` Q. And that would go for your
`Supplemental Declaration as well?
` A. I believe so. With the exception
`of the document in response to which this was
`done. So that is obviously not listed in
`this.
` Q. And what document is that?
` A. The Declaration of I think Dr.
`Cotes and maybe even Dr. Pennell.
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` J. MEHTA
` Q. Do you know Dr. Cotes and Dr.
`Pennell?
` A. No. I don't know them personally.
` Q. Dr. Mehta, have you treated a
`blood transfusion dependent patient that had
`iron-induced cardiac disease before?
` A. Yes.
` Q. How many patients?
` A. Blood transfusion induced iron
`overload and cardiac disease as a result of
`that, probably less than ten.
` Q. And what when was that?
` A. I have patients under my care
`right now who fit that profile. Although, not
`with thalassemia.
` Q. So non -- currently you have
`patients that fit that profile but that are
`non-thalassemia patients? Is that your
`testimony?
` A. That is correct.
` Q. How many?
` A. Perhaps half a dozen.
` Q. And are those patients patients
`that you are treating with an iron chelator?
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` J. MEHTA
` A. That is correct.
` Q. And what iron chelator are you
`treating them with?
` A. Deferasirox.
` Q. So that would be the same thing as
`Desferal?
` Or, no. I'm sorry. That's not.
` It's Exjade; is that correct?
` A. That is correct.
` Q. All these names are so similar.
`It's just hard.
` So the patients that you are
`presently treating that are blood transfusion
`dependent patients with iron-induced cardiac
`disease, you're treating those patients with
`the drug Exjade; is that correct?
` A. That is correct.
` Q. Now, the present patients that you
`have that are blood transfusion dependent
`patients with iron-induced cardiac disease,
`how did you assess that that patient had
`iron-induced cardiac disease?
` A. Partly clinically based upon
`symptomatology and findings. And partly based
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` J. MEHTA
`upon MRI scans.
` Q. And would that be the T2 Star MRI
`scans?
` A. T2 Star MRI scans because we have
`access to that technology now.
` Q. Do you have access to that
`technology in your particular facility?
` A. We do.
` Q. Now, how many patients prior to
`the year 2000 did you treat that were blood
`transfusion dependent patients with
`iron-induced cardiac disease?
` A. I would suspect that was more in
`the treatment of probably somewhere between 25
`and 50 patients with thalassemia, and probably
`half of whom had some evidence or the other of
`heart iron overload.
` Q. And before the year 2000 how did
`you assess that they had iron-induced cardiac
`disease?
` A. Purely clinically because these
`patients are all treated in India where we do
`not have access to MRI scanning and the T2
`imaging which was the standard at that time.
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` J. MEHTA
` Q. Now, that was the T2, not the T2
`Star imaging? Is that what you're referring
`to?
` A. That's correct. T2 is the
`mathematical -- or the radiologic quantity
`based upon which T2 Star is derived
`mathematically.
` Q. Now, you said you would assess
`these patients clinically. Can you explain
`how would you assess these patients
`clinically?
` A. Based upon their symptoms.
`Shortness of breath. Chest discomfort. Fluid
`retention in the feet. Certain clinical
`signs. Evidence of fluid in the chest.
`Jugular veins being distended. Liver being
`enlarged. Heart beating fast. A number of
`different things.
` Q. And these were all signs that you
`use clinically to diagnose iron-induced
`cardiac disease, correct?
` A. They are signs of heart disease.
`And in the right clinical setting, you will
`assume that it is iron-induced heart disease.
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` J. MEHTA
` Q. But you weren't measuring cardiac
`iron; you were just looking at the clinical
`symptoms what were cardiac disease and
`assuming that it could be iron-induced cardiac
`disease; is that correct?
` A. Well, it would be based also upon
`serum ferritin, which is a standard way of
`measuring iron content in the body.
` Q. And somehow you knew that was
`going to be my next question.
` So prior to 2000 were you using
`serum ferritin levels to diagnose a patient
`with iron-induced cardiac disease?
` A. We use serum ferritin in the
`appropriate clinical context to diagnose
`iron-induced cardiac disease.
` Q. What is the appropriate clinical
`context?
` A. The appropriate clinical context
`would be an inadequately reticulated patient
`with thalassemia who has had transfusions and
`who has the appropriate symptoms of cardiac
`disease that is actually progressed that far
`which, of course, is not all my patients with
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` J. MEHTA
`thalassemia.
` Q. Now, I know we'll look at this
`later but there's a magic number 2,500 that
`we've seen in the literature for serum
`ferritin. Is that kind of the scale that you
`would use in your assessment for serum
`ferritin levels?
` A. That is correct. But you could
`have patients with ferritin of less than 2,500
`where you might occasionally see heart
`disease. Over 2,500, there is a higher risk.
`And over a serum ferritin of roughly 5,000, I
`would think there is a guarantee that there
`will be a heart disease.
` But there's also a caveat. One
`doesn't look simply at the serum ferritin but
`one looks at the direction the serum ferritin
`is going in. So a patient who has a serum
`ferritin of 2,500 and that is on its way up
`because they are being transfused but not
`being chelated is more likely to have heart
`iron overload. But a patient who has a serum
`ferritin of 2,500 which is on its way down
`because of chelation might be a little less
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` J. MEHTA
`likely to have heart iron overload. And, of
`course, the presence of heart iron overload
`doesn't imply that they necessarily have a
`heart that is not functioning normally or they
`have clinical symptoms and so on.
` Q. Now, hepatic iron concentrations,
`did you use hepatic iron concentrations prior
`to the year 2000 to diagnose a patient with
`iron-induced cardiac disease?
` A. Rarely because my practice with
`thalassemia patients was in India, Bombay.
`And these patients were, you know, really
`quite resource -- were -- and we really had to
`rely on less invasive investigations to try
`and get answers.
` So we did not routinely do liver
`biopsies. But if we found that there was a
`significant abnormality in terms of liver
`function tests then, of course, we did liver
`biopsy.
` But it was rare for us to do a
`liver biopsy purely to measure iron
`concentration.
` Q. Now, let's turn to your
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` J. MEHTA
`Declaration, Exhibit 1002. And the first
`place that I want to turn is on paragraph 8
`which is on page 5 of your Declaration.
` Now, in paragraph 8 here it says
`that you were practicing in India from 1989 to
`1991 and you were directly involved in
`treating blood transfusion patients with
`deferiprone; is that correct?
` A. That is correct.
` Q. Now, is that the only period of
`time that you were actively treating patients
`with the deferiprone?
` A. That is correct.
` Q. Now, in the same paragraph 8 you
`state that the patients that you treated from
`1989 to 1991, they were treated with a regimen
`of deferiprone at a dose range of 75 to
`99 milligrams per kilogram of body weight per
`day.
` Do you see that?
` A. That is correct.
` Q. So why did you not just choose a
`dose of 75 milligrams per kilogram per day to
`give to these patients?
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` A. Depending upon the pill size,
`although you want to give 75 kilogram per
`milligram, you would actually end up dosing
`the patient at a milligram per kilogram dose
`that turns out to be different from 75
`milligrams per kilogram.
` So let's say you have a
`500-milligram sized tablet and you have a
`patient that weighs 50 kilograms and you want
`to give 75 milligram mer kilogram, the dose
`that you would have to give is -- you know,
`what is it? -- 37.50 or something of that
`sort. And you will not be able to give
`exactly 37.50. You would have to give a
`little bit more than that because we had
`capsules rather than tablets.
` So depending upon the nearest
`capsule size that the patient received, the
`dose would have been different from 75
`milligrams per kilogram.
` Q. So it was based on the size of the
`capsule or the tablet? Is that the reason?
` A. That is correct. The milligram
`strength.
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` Q. Now, did you ever have a situation
`where you would adjust the dose based upon
`dose response?
` A. Yes. We would adjust it based
`upon the serum ferritin levels potentially.
` Q. And so how would you adjust the
`dose based on dose response?
` A. If the feeling was that the serum
`ferritin was not coming down adequately or
`rapidly enough, one would increase the dose by
`a capsule or two. It's a time-honored
`practice in iron chelation dating back to the
`1960s with deferoxamine.
` The response of the body in an
`individual patient in terms of excretion of
`iron is not the same as another individual.
` And so you have to customize the
`treatment to an extent by following things
`that can be more easily followed like serum
`ferritin.
` Q. So if 75 milligrams per kilogram
`per day was not achieving a proper dose
`response in a particular patient, you may add
`another 25 milligram tablet to go up to a
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`hundred, for instance, to see if that would
`provide a better dose response; is that
`correct?
` A. That is correct. 250 milligram --
`excuse me. 250 milligram capsule. So on a
`milligram per kilogram basis it would not
`immediately jump from 75 to 100. But it could
`jump from 75 to, shall we say, 80 milligrams
`per kilogram.
` Q. Now, what sort of test would you
`run to determine whether you should stay at a
`particular dose or adjust the dose up or down?
` A. As far as titrating the dose up is
`concerned, it would be based upon the serum
`ferritin level. As far as titrating the dose
`down it would depend on the serum ferritin.
`If the level started normalized, which was
`exceptional at least in India. Although, we
`see it more frequently now with deferasirox.
` Or it could be based upon blood
`counts going down, joint pains, and other
`tolerance issues.
` Q. And just to be clear, we're
`talking about this 1989 to 1991 period that
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`you were dosing in India; is that correct?
` A. That is correct.
` Q. Would you run any other tests to
`determine whether you should stay at a current
`dose or adjust the dose up or down besides
`serum ferritin levels?
` A. These patients are monitored
`with -- they were monitored with blood counts,
`chemistry panel to look at liver function
`tests, kidney function tests, and so on.
` But I think the primary
`adjustments were really based upon serum
`ferritin, blood counts, and symptoms.
` Q. How about cardiac function? Would
`you make that assessment to determine whether
`you should adjust dose up and down?
` A. The cardiac assessment was always
`intimately related with serum ferritin in
`those patients. So I do not recall having
`made adjustments based purely upon cardiac
`function.
` But certainly we made adjustments
`based upon serum ferritin, which moved in
`tandem with cardiac function or cardiac
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`function moved in tandem with -- in
`conjunction with serum ferritin.
` Q. Now, I think you had talked about
`earlier that if you saw a serum ferritin level
`above 2,500 that that would show that a
`patient's at risk of cardiac disease, and then
`above 5,000 there was a guarantee. I don't
`want to misstate testimony but was that what
`you had stayed?
` A. That is correct.
` Q. Okay. And so risk is definitely
`different than a guarantee. A risk would be
`buy they may not necessarily have it but
`they're at risk of having it. Is that fair?
` A. That is fair.
` Q. But what you mean by guarantee is
`that -- do you mean that they're going to have
`cardiac disease because they have levels of
`5,000 or is there still a chance they wouldn't
`have it?
` A. At a level of -- serum ferritin
`level of 5,000, you will have heart iron
`overload. Whether it is done on a biopsy or
`it is done on cardiac T2 imaging or these days
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`cardiac T2 Star imaging, which are -- T2 and
`T2 Star are really interchangeable for all
`practical purposes. But they might not have
`symptomatic heart disease. Whether they have
`symptomatic heart disease or not is dependent
`upon a number of other factors including
`physical activity levels, their overall
`fitness, and so on.
` But, generally, with increasing
`serum ferritin levels, the risk of symptomatic
`cardiac disease increases. But you will
`always see heart iron overload over a ferritin
`of 5,000.
` Q. And just because they have iron in
`the heart doesn't necessarily mean they have
`the iron-induced heart disease. They could
`just have iron in the heart. It may not be at
`the heart disease stage; is that correct?
` A. That is correct.
` Q. Now, back to paragraph 8 of your
`Declaration. I think it says you left India
`in 1991. Is that correct?
` A. That is correct.
` Q. And you left the practice in
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`Jerusalem and London. Did you first go to
`Jerusalem and then to London or were you going
`back and forth?
` A. No. I trained in Jerusalem for a
`year and in London for about almost five
`years.
` Q. And what were you doing Jerusalem?
` A. I did a fellowship in bone marrow
`transplantation.
` Q. And so bone marrow transplantation
`is, did that have anything to do with blood
`transfusion dependent patients and treating
`them with iron chelators or was it a
`completely different field?
` A. In many ways different. But we
`actually did transplant patients with
`thalassemia. So we were using chelators in
`those patients. What was not appreciated then
`but is appreciated now is that a number of
`non-thalassemia diseases that we treat with
`bone marrow transplantation that I treat now
`are associated with iron overloads requiring
`iron chelation therapy.
` Q. For those kind of conditions such
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`as like sickle cell anemia or what are you --
`what conditions are you referring to?
` A. The main condition we treat is
`myeloplastic syndrome and occasionally chronic
`aplastic anemia.
` Q. Now, I think you say here in
`paragraph 8 that when you were practicing in
`Jerusalem and London, that you continued to
`collaborate with your Indian colleagues and,
`thus, continued your involvement with your
`treatment of these patients through 1995.
` Is that correct?
` A. That is correct.
` Q. And what do you mean you continued
`to collaborate with your Indian colleagues?
` A. The story of deferiprone, or L1 as
`it was known then, was very interesting. It
`was the first oral iron chelator. And at a
`time when everybody was extolling the virtues
`of the drug we were the first to describe
`certain side effects of L1. And I found it
`quite fascinating that we were seeing things
`that others were not.
` So it was a -- I wanted to keep up
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`with the field to see what was going on. So I
`was involved in trying to possibly design
`studies in terms of safety monitoring, looking
`at data, analyzing some of the data, and even
`getting involved in some of the publications
`and so on.
` Q. Is it fair to say that you were
`seeing some discrepancies between what you
`were seeing with deferiprone or L1, as it was
`called back then, another name for it I guess,
`and some of the data that was coming out about
`deferiprone?
` A. There were discrepancies then. I
`cannot recall another drug where there have
`been so many discrepancies at every stage of
`development of this drug, with everything to
`do with the drug.
` Q. So you can't recall another drug
`that has had so many discrepancies in data
`presented by one group versus data presented
`by another group; is that correct?
` A. That is --
` MS. WU: Objection to form. Go
` ahead.
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` A. That is correct. Including data
`coming out of pharmaceutical companies
`developing the drug.
` Q. Now, did your involvement with
`these patients, did it stop in 1995?
` A. It did.
` Q. Why is that?
` A. By then I was already thinking of
`moving to the US because we were -- my wife
`and I were offered positions in the US, in
`Little Rock. And that, we knew, was going to
`be intense enough that we really could not do
`justice to continuing work with this anymore.
` Also, one of the collaborators in
`India was my own father who was a hematologist
`who has done a lot of work in the field of
`iron. And by that time he had decided to step
`back from involvement in these type of
`patients and concentrate on other areas of
`hematology.
` So I think the circumstances all
`came together for us to stop our work in the
`field.
` MR. COBLENTZ: I think we're on
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` J. MEHTA
` 2021.
` (Deposition Exhibit 2021, The
` Lacent paper Volume 341: June 5, 1993
` Future of oral iron chelator deferiprone
` (L1), marked for identification as of
` this date.)
`BY MR. COBLENTZ:
` Q. Dr. Mehta, you've been handed
`what's been marked as Exhibit 2021. Do you
`recognize this document? I recognize it might
`have been several years since you've seen it.
` A. I do.
` Q. And what is it?
` A. It's a copy of the correspondence
`pages from The Lancet in 1993 showing
`basically the polarization and the controversy
`to do with L1.
` Q. Now, if we're looking at page 1479
`of this particular document, we see there's a
`section on here called The future of oral iron
`chelator deferiprone, and in parentheses it
`says L1.
` Do you see that?
` A. I do.
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` Q. And in this section wee see there
`are a number of doctors that are talking about
`Ciba-Geigy's decision to stop development of
`the deferiprone or L1, do you see that?
` A. I do.
` Q. And here there are a couple of
`doctors who actually disagreed with
`Ciba-Geigy's decision; is that correct?
` A. That is correct.
` Q. And one of the reasons that these
`doctors disagreed at that particular time was
`because there was only one chelator available,
`the desferrioxamine; is that correct?
` A. That is correct.
` Q. And there was a compliance problem
`with desferrioxamine because it was given as
`an infusion; is that correct?
` A. That is correct.
` Q. And at that time there also were a
`lot of patients that couldn't afford
`desferrioxamine; is that correct?
` A. That is correct.
` Q. And I believe -- well, it says
`right here that there were over 90 percent of
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`the patients in the world couldn't afford
`desferrioxamine; is that correct?
` A. I couldn't be certain about the
`percentage but if that's what is mentioned
`here, I will take that percentage. But it's
`fair to say that a substantial portion of
`patients could not afford the drug.
` Q. And these -- this group of
`doctors, they wanted to have clinical trials
`to continue on deferiprone to alleviate these
`concerns; is that correct?
` A. Could you repeat that question?
` Q.