Mehta, M.D., Jayesh
`
`IPR2017-01446
`
`June 19, 2018
`
`1
`
` ________________________________
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________
`
` TARO PHARMACEUTICALS U.S.A., INC.,
` Petitioner
` vs.
` APOTEX TECHNOLOGIES, INC.,
` Patent Owner
`
` _________________________________
`
` IPR2017-01446
` Patent No. 7,049,328 B2
` __________________________________
`
` Second Deposition of JAYESH MEHTA, MD
` Tuesday, June 19, 2018
` Chicago, Illinois
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
`
`
`
`IPR2017-01446
`
`June 19, 2018
`
`1
`
` ________________________________
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________
`
` TARO PHARMACEUTICALS U.S.A., INC.,
` Petitioner
` vs.
` APOTEX TECHNOLOGIES, INC.,
` Patent Owner
`
` _________________________________
`
` IPR2017-01446
` Patent No. 7,049,328 B2
` __________________________________
`
` Second Deposition of JAYESH MEHTA, MD
` Tuesday, June 19, 2018
` Chicago, Illinois
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
`
`
`
`Mehta, M.D., Jayesh
`
`IPR2017-01446
`
`June 19, 2018
`
`2
`
` The second deposition of JAYESH MEHTA, MD,
`taken in the above-entitled cause, before
`Deralyn Gordon, a notary public of Cook County,
`Illinois, on the 19th day of June, 2018, at
`123 North Wacker Drive, Suite 1800, Chicago,
`Illinois, beginning at approximately 10:51 AM,
`pursuant to Notice.
`
`REPORTED BY: DERALYN GORDON, CSR, RPR, CRR
`LICENSE NO: 084-003957
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
`
`
`
`Mehta, M.D., Jayesh
`
`IPR2017-01446
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`June 19, 2018
`
`3
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` PRESENT:
`
` GOODWIN PROCTER LLP
` BY HUIYA WU, ESQ.,
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
` (212) 813-8864
` hwu@goodwinlaw.com
` appeared on behalf of petitioner;
`
` COZEN O'CONNOR
` BY AARON LUKAS, PhD, ESQ., and
` W. BLAKE COBLENTZ, ESQ.,
` 1200 Nineteenth Street NW
` Washington, DC 20036
` (202) 912-4800
` alukas@cozen.com
` wcoblentz@cozen.com
` appeared on behalf of Patent Owner.
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
`
`
`
`Mehta, M.D., Jayesh
`
`IPR2017-01446
`
`June 19, 2018
`
`4
`
` I N D E X
` VOLUME I
`
`Tuesday, June 19, 2018
`
`WITNESS EXAMINATION
`JAYESH MEHTA, MD
` By Mr. Lukas 5, 72
` By Ms. Wu 68
`
` SECOND DEPOSITION EXHIBIT
` JAYESH MEHTA, MD
`
`NUMBER DESCRIPTION IDENTIFIED
`Exhibit 2038 Videotaped Deposition of 8
` Jayesh Mehta, MD, taken on
` 5/18/18
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
`
`
`
`Mehta, M.D., Jayesh
`
`IPR2017-01446
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`June 19, 2018
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` (Whereupon the witness was
` sworn.)
` JAYESH MEHTA, MD,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MR. LUKAS:
` Q. Good morning, Dr. Mehta.
` I'm going to hand you what's been
`marked as Exhibit 1060, or 1-0-6-0, which is
`your Expert Declaration in Support of
`Petitioner's Reply.
` I'll have you turn to the last page of
`this document, page 2626; that's your signature?
` A. That's correct.
` Q. And, as you sit here today, is there
`anything you want to change or anything that's
`inaccurate in this reply declaration?
` A. No.
` Q. Now, you were previously deposed in
`this case a couple of times in the District Court
`and in the IPR. Do you remember that?
` A. Yes, I do.
` Q. Is there any reason for me to go over the
`ground rules with you today?
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Apotex Tech.
`Ex. 2040
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`Mehta, M.D., Jayesh
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`IPR2017-01446
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`June 19, 2018
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` A. No.
` Q. Is there any reason that you can't give
`complete and accurate testimony today?
` A. None.
` Q. Thank you.
` I'd like to just look at a few paragraphs
`of this reply declaration with you this morning,
`Doctor.
` First, if we could turn to paragraph 15 --
`and I'm going to get my glasses out as well.
` So you state here -- and I'm looking at
`the discussion about the 75 milligrams per
`kilogram per day that's discussed in the
`'328 patent. Do you recall that?
` A. Yes, I do.
` Q. And there was no dosage modification for
`any of the patients that were treated with
`deferiprone in the '328 patent; is that right?
` A. That's correct. Nothing was mentioned.
` Q. Okay.
` And the study in the '328 patent
`that's described in the example there, that was
`a retrospective analysis, wasn't it?
` A. That is correct.
` Q. Is it possible to adjust dosing as a
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`202-220-4158
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`Apotex Tech.
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`Mehta, M.D., Jayesh
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`IPR2017-01446
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`June 19, 2018
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`part of a retrospective analysis?
` A. Certainly not.
` Q. Now, if you were doing a
`prospective analysis, obviously depending on
`the setup for the clinical study you were doing,
`it could be possible to adjust the dose; is that
`right?
` A. That is correct.
` Q. And, in fact, in practice physicians
`regularly adjust the dose in response to how
`a patient is responding to a given medicine. Is
`that fair?
` A. That's correct.
` Q. So if a thalassemia major patient who
`was taking an iron chelator was developing
`signs of cardiac iron loading or cardiac disease,
`for example, a physician could increase the dose
`of that chelator; is that fair?
` A. It's certainly possible and logical
`that, in response to anything that suggests
`inadequate chelation, that those would be
`increased in keeping with time-honored practices
`in chelation, whether it is deferoxamine or
`deferiprone, and mostly with Deferasirox.
` Q. Okay.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
`
`
`
`Mehta, M.D., Jayesh
`
`IPR2017-01446
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`June 19, 2018
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` MR. LUKAS: I'm going to mark -- or
`not mark. Actually, this will probably be the
`one exhibit that gets marked this morning.
` (Deposition Exhibit 2038
` marked for identification.)
`BY MR. LUKAS:
` Q. This is a copy of your deposition from
`May 18, 2018. Do you recall we were in New York
`for that one?
` My colleague, Mr. Coblentz, was asking you
`questions during this one.
` And, just for the record, Exhibit 2038
`is a multi-page document captioned United States
`District Court, Eastern District of Texas,
`Apopharma Inc., et al., Plaintiffs, v.
`Taro Pharmaceuticals Industries Limited,
`Defendants, in Civil Action No. 2:16-cv-528.
` And this was the videotaped deposition of
`Jayesh Mehta, MD, dated Friday, May 18, 2018.
` And I'd like to direct your attention to
`the beginning of this document on page 10.
` Do you recall that you were under oath
`on May 18, 2018, when you gave this testimony?
` A. I do.
` Q. And, as far as you can recall, this
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
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`
`
`Mehta, M.D., Jayesh
`
`IPR2017-01446
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`June 19, 2018
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`testimony was accurate and complete?
` A. That's correct.
` Q. I'd like to direct your attention to
`page 224.
` MS. WU: Counsel, this was not previously
`part of the IPR record?
` MR. LUKAS: It was not.
` MS. WU: It was not.
` And is this part of any motion for
`discovery to make it part of the IPR record?
` MR. LUKAS: No. And MAYBE we can
`talk about that off the record here, whether or
`not this is going to be an exhibit.
` We don't believe that this will be
`actually an exhibit.
` MS. WU: Okay.
` MR. LUKAS: I just intend to read him
`the questions and confirm that these were
`answers that he gave under oath in a parallel
`proceeding.
` MS. WU: That's fine. So let's do that.
` I guess I want to reserve my right to
`object to the inclusion of this transcript as
`an exhibit in the IPR proceeding.
` MR. LUKAS: Yeah.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Apotex Tech.
`Ex. 2040
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`
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`Mehta, M.D., Jayesh
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`IPR2017-01446
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`June 19, 2018
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` MS. WU: But go ahead and ask your
`questions.
` MR. LUKAS: And that's not our intent,
`to include the entirety of the transcript as part
`of the IPR proceedings.
` MS. WU: Okay.
`BY MR. LUKAS:
` Q. So on page 224 at line 22, you were asked
`some questions about the therapeutically effective
`amount of deferiprone. And I'll just read these
`to you and confirm that these were the answers you
`gave.
` Beginning on line 22 when Mr. Coblentz
`asked:
` "Question: And the asserted claims of the
` '328 patent, do they require a therapeutically
` effective amount of deferiprone to achieve a
` specific outcome?
` Answer: The use of therapeutically
` effective amount obviously means that end
` result, the desirable end result is going to be
` achieved. So the answer is yes, but the two
` are intimately connected to each other."
` Is that correct?
` A. That's correct.
`
`202-220-4158
`
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`www.hendersonlegalservices.com
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`Apotex Tech.
`Ex. 2040
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`June 19, 2018
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` Q. And then you were asked:
` "Question: Does the ability of
` deferiprone to bind iron and remove it from the
` body depend on the dose?"
` And you answered: "Almost certainly."
` Is that right?
` A. That's correct.
` Q. And then you were asked:
` "Question: So will a dose of
` 75 milligrams per kilogram per day of
` deferiprone, will it bind iron and reduce iron
` overload in each and every patient treated with
` that dose?
` And you answered: "No."
` Is that right?
` A. I agree with that.
` Q. And you were asked:
` "Question: And it will bind cardiac iron
` and reduce cardiac iron overload in each and
` every patient treated with that dose?
` And you answered: "No."
` Is that right?
` A. Correct.
` Q. And, finally, you were asked:
` "Question: And will 75 milligrams per
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`IPR2017-01446
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`June 19, 2018
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` kilogram per day of deferiprone, would it
` reduce further body iron in the heart normally
` associated with iron-induced cardiac disease in
` each and every patient treated with that dose?
` And you answered: "No."
` Is that correct?
` A. That's correct.
` Q. Thanks, Doctor.
` Now, in the Patent Office proceedings,
`there's three, I'll call them, primary prior art
`references. I'm going to hand you copies of
`each of those, the first one being Exhibit 1007.
` And do you recognize that document?
` A. I do.
` Q. Is it okay if I refer to that as the
`Hoffbrand reference?
` A. Correct.
` Q. And then there is what has been marked
`as Exhibit 1010. Do you recognize that document,
`Doctor?
` A. Olivieri '95 abstract.
` Q. That's correct.
` And is it okay if I refer to that
`Exhibit 1010 as the Olivieri 1995 abstract?
` A. Yes.
`
`202-220-4158
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`Apotex Tech.
`Ex. 2040
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`Mehta, M.D., Jayesh
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`IPR2017-01446
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`June 19, 2018
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` Q. And then, lastly, there is Exhibit 1012.
` And do you recognize this document,
`Doctor?
` A. I do.
` Q. This is the Olivieri 1995 paper?
` A. That's correct.
` Q. Now, let's start with the Exhibit 1010,
`which is the Olivieri abstract.
` The thalassemia major patients that were
`described in this document, they were treated with
`75 milligrams per kilogram per day of deferiprone;
`right?
` A. That's correct.
` Q. And that's the same for the Olivieri
`1995 paper; is that right? It's --
` A. I believe so.
` Q. Sorry.
` -- also 75 milligrams per kilogram per
`day?
` A. That's correct, yes.
` Q. And, in fact, is it fair to say the
`same patient cohort that is described in the
`abstract, is it your understanding that that was
`also the same patient cohort described in the
`1995 paper?
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`Apotex Tech.
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`Mehta, M.D., Jayesh
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`IPR2017-01446
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`June 19, 2018
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` A. I think there may have been some overlap,
`but I'm not completely certain. That's something
`I'd have to look it up.
` Q. Okay.
` A. I'm happy to look it up now, if you want
`me to.
` Q. Well, let's just take a look at the front
`page of these documents.
` So if we first look at the abstract,
`Exhibit 1010, this is from the Hospital for
`Sick Children in Toronto as well as the Metro
`Health Medical Center in Cleveland; is that right?
` A. Correct.
` Q. And, if we look at the front of the
`Exhibit 1012 at the bottom, that's also from the
`Hospital for Sick Children in Toronto; is that
`right?
` A. Correct.
` Q. So there may have been some differences in
`patients dropped out of the study or came into the
`study. Is that fair?
` A. Yes.
` But I think the biggest difference is
`that I thought the paper here, the NEJM paper
`describes the compassionate use study; whereas the
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`Apotex Tech.
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`IPR2017-01446
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`June 19, 2018
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`other one is UI study.
` So, by definition, they would actually be
`completely different patient populations.
` Q. Okay.
` So it's your understanding that there
`were different groups of patients, one that
`was treated with the compassionate use study
`that's described in Exhibit 1012, and a second
`group that was described in Exhibit 1010?
` A. I believe so.
` Q. Feel free to look at any portions of
`the document, if it helps.
` A. I have always thought of them as
`two completely different populations of
`patients, because it is not universal to have
`a prospective study, and then describe only
`one arm of that prospective study, particularly
`in a journal like the New England Journal of
`Medicine.
` So my thought has -- my interpretation
`has always been that the New England Journal of
`Medicine paper was a phase II open-label study,
`single-arm prospective, and the abstract describes
`a subsequent or a concurrent study, which was a
`randomized study of the two chelators.
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` So I think they're different populations
`of patients.
` Q. Okay.
` In either case both those groups of
`patients were administered 75 milligrams
`per kilogram per day of deferiprone; is that
`right?
` A. That's correct.
` Q. And, also, the patients that were in
`Exhibit 1007, the Hoffbrand reference, those
`patients were also administered, the ones
`that took the deferiprone, were administered a
`daily dose of 75 milligrams per kilogram; is
`that right?
` A. That's correct.
` Q. I'd like to turn with you for a
`second back to your District Court deposition,
`and specifically go to page 64.
` And on line 20, beginning on line 20, if
`you see that?
` A. I do.
` Q. Mr. Coblentz asked you:
` "Question: Now, you're aware that the
` District Court in this particular case found
` that that last clause, that sufficient to
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` clause is a limitation of the claim; correct?"
` A. That's correct.
` Q. And, just to be clear, we're talking
`about the -- if you look at your Exhibit 1060
`and the table in there --
` A. The third part.
` Q. -- we're talking about the third part,
`what you have captioned as "The Intended Result."
`Is that right?
` A. Yes.
` Q. You were then asked at page 64, line 25,
`Mr. Coblentz asked you:
` "Question: Now, what does that mean to
` you?
` Answer: That implies to me that
` demonstration of the effectiveness of the
` claim, of the treatment is a part of the claim.
` In other words, mere intent is not sufficient.
` The result has to be achieved."
` Is that correct?
` A. That's correct.
` Q. And then he asked you:
` "Question: Now, do you know if it's
` part of the Court's claim construction that
` that's sufficient to clause defines the
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` therapeutically effective dose in these claims?
` Answer: That is correct."
` Right?
` A. Yes.
` Q. Okay.
` Now, is it fair to say that it's your
`opinion that these intended results that you
`have on pages 8 to 9 of Exhibit 1060, that
`those are inherently achieved by practicing the
`prior art methods of dosing deferiprone to blood
`transfusion-dependent patients?
` A. I think your choice of words implies that
`it's guaranteed to achieve those results.
` And the answer is that that will not
`occur in every single patient. It will occur in
`some patients, and it will not occur in other
`patients.
` Q. And that's simply because the dose is
`not always sufficient to achieve that result?
` A. Not necessarily.
` It is simply because not all diseases
`in all patients respond to the treatment in
`exactly the same way.
` I'm sure that there are going to be
`patients who received a lower dose than
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`75 milligrams per kilogram who responded.
` And I'm certain that there are patients
`who received a significantly higher dose and
`did not respond, just like you give antibiotics
`for pneumonia, and not every single patient always
`responds.
` The important thing to bear in mind
`with the 75 milligram per kilogram is that that is
`the end target dose.
` But the actual dose the patient gets
`is not necessarily going to be 75 milligram per
`kilogram, as we have pointed out in one of
`our declarations with a table, that there is
`a certain tablet size.
` And, depending upon the patient's weight,
`you aim for 75, but you might end up getting
`somewhere between 69 and 90-something milligrams
`or kilogram body weight.
` Q. So let me just ask you this. To the
`extent that the results would be achieved by
`the dosing, they would naturally flow from
`successfully administering deferiprone to a
`patient, is that fair, in your opinion?
` A. That is -- that is fair. The word
`successfully implies that.
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` Q. Okay.
` I'd like to turn briefly again to
`the District Court litigation deposition
`transcript at page 44 now, Doctor. And at
`line 25 on page 44 -- let me know when you're
`there.
` A. Uh-huh.
` Q. Okay.
` You were asked:
` "Question: So you're saying a possibility
`or a probability of something happening, that
`would meet the standard for inherent anticipation
`in your mind?"
` And you answered: "In my mind, it would."
` Right?
` A. That's correct.
` Q. Now, turning back to Exhibit 1060 --
`sorry this is a lot of shuffling of papers -- your
`declaration again at paragraph 15. In the
`second-to-last sentence you say:
` "This statistical evidence of efficacy
`does not reflect success in every patient treated
`with deferiprone."
` Do you see that?
` A. Correct.
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` Q. And is this going to what we were
`just discussing about it not being achieved in
`every patient?
` A. That's correct.
` Q. Are you referring there to deferiprone
`in general or deferiprone dosed at 75 milligrams
`per kilogram per day?
` A. I'm talking about 70 -- deferiprone dose
`at any level at all.
` So in a given patient, you pick a dose of
`75 milligram per kilogram, because that has been
`described in the literature.
` And if there is no response, you might
`increase the dose, as suggested by a number of
`people, practiced by a number of people, as
`mentioned in Hoffbrand, and you might see a
`response, in which case you realize that the
`right dose for this patient for iron overload is
`higher than 75.
` And if that still does not work, that
`tells you that is not the right drug for that
`particular patient.
` Q. So you might try a chelator; is that
`right?
` A. That is correct.
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` Q. Okay.
` And would that have generally been known
`by POSA as of the year 2000?
` A. While trying a different chelator or while
`varying the dose and seeing --
` Q. Let's try the first one. The first one
`would be changing the dose and the dose response.
` A. Yes. In -- these patients have always
`been treated by hematologists.
` And a number of the diseases that
`are treated by hematologists rely upon
`variable dosing of medications to achieve a
`certain effect.
` So the prototype diseases at that
`time that a typical hematologist would have
`been treating would have been chronic myeloid
`leukemia and chronic lymphocytic leukemia.
` With the products at that time,
`there's a certain dose that you would start with.
`And then you would increase or decrease the dose
`depending on how the patient's leukemia, the white
`cell count, responded.
` So it's very much a part of standard
`training and standard practice that when you
`have a nonbinary outcome -- binary outcome being,
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`let's say, a patient with lymphoma or acute
`leukemia, whether they achieve complete remission
`or don't achieve remission -- you give an
`explosive burst of treatment, and see what the
`effect is.
` Whereas long, drawn-out treatments,
`like iron collection or treatment of chronic
`leukemia, you start with a certain dose, and
`then see what the response is, and then adjust the
`dose based upon that.
` Q. Okay.
` And at least as of the year 2000,
`going back to the second part of the question,
`in terms of changing the chelator, that
`wouldn't have been possible in the United States.
` But post 2000, once Deferasirox was
`approved, and now deferiprone has also been
`approved, doctors can change the chelation therapy
`as well; is that right?
` A. That is correct.
` But I think in the old days for
`patients who did not respond to deferiprone,
`and they went to deferiprone because they were
`either not willing to take deferoxamine or
`did not have access to deferoxamine, one tried to
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`pursue them to continue with the deferiprone,
`one tried to ensure that they were complying,
`and that is actually how combination therapy was
`started.
` People started empirically adding
`deferoxamine to deferiprone. A patient who was
`not willing to take deferoxamine five or seven
`days of the week could potentially tolerate it
`for a day or two or three. And the added effect
`of that would combine with the deferiprone.
` So you have a not-quite-effective
`treatment with one drug combined with not-quite-
`effective treatment with the second drug, but
`the two add up together to make it a more
`effective treatment.
` Q. And the important thing being that
`the patient continues with chelation therapy;
`correct?
` A. That is correct.
` Q. Because, if they don't, they're going to
`inevitably die?
` A. That is correct.
` Q. Yeah.
` So is it fair to say that doctors treat
`individual patients, not groups of patients?
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` A. I'm not quite sure I understand your
`question.
` But if you mean that you apply the
`same rule to every individual in a group, I
`think it's sort of partially true.
` There is a certain -- you have to take
`the first step. And unless there are very
`compelling reasons, the first steps in all of
`the patients you treat are going to be identical.
`It's going to be the same first step; there might
`be mild variation this way and that.
` But then, depending upon how a
`patient's disease behaves, how they respond to
`treatment, how they tolerate the treatment,
`you make adjustments.
` Going back to the same example we
`talked about with deferoxamine or with the
`chronic leukemias.
` Q. And so the adjustments, the tweaks to
`a dose regimen, for example, those would be based
`on individual patients, not necessarily a group of
`patients?
` A. That is correct.
` Q. I just want to hand you what we've
`previously marked as Exhibit 1001, which is
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`the '328 patent.
` And I just want you to go to the
`last page. You can flip the whole document over.
`This is the claim beginning at column 27.
` And if you look at claim 1 there,
`Dr. Mehta, it recites:
` "A method of treating iron induced
`cardiac disease in a blood transfusion dependent
`patient..."
` Do you see that?
` A. I do.
` Q. And is it fair to say, is it your
`understanding, that the method of treating
`that's recited in claim 1 of the '328 patent
`is directed to the treatment of an individual
`patient?
` A. That is correct.
` Q. And that would be the same for claims 2,
`4, 5, 6, 7, 8, 9, and 10; right?
` A. That's fair.
` Q. And so would it also be fair to say
`that a physician, a PROSA, reading claim 1 of
`the '328 patent, and trying to understand if
`they were successfully practicing the claim
`method, they would look at the results in an
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`individual patient. Is that fair?
` A. One always looks at results in
`an individual patient; right?
` I mean, if I'm being treated, there's
`not much point in looking at results. So that's
`always the case, no matter what the disease is
`being treated.
` Q. Okay.
` Let's turn to Hoffbrand, if you can find
`that in your stack of documents there. That's
`Exhibit 1007.
` So if we look at -- and this is some
`discussion of this. If you want to, feel free
`to look at your declaration, Exhibit 1060,
`beginning at paragraph 37 and running through
`paragraph 43.
` But I just want to talk to you about
`the -- some of the patients in Hoffbrand. And
`in particular there were five patients that
`died during the dosing of deferiprone and
`deferoxamine to this group of patients; is that
`right?
` A. That's correct.
` Q. And at page 296 of Hoffbrand, the
`second column there about halfway down,
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`there's the beginning of the section. It
`says "Fatalities during the study." Do you see
`that?
` A. I do.
` Q. Now, it's your opinion that, even
`though -- and correct me if I'm wrong here --
`even though four of these patients died, it's
`your opinion that they were nonetheless
`successfully treated with deferiprone; is that
`right?
` A. That is correct.
` Q. And is that because they would have
`died earlier had they not been administered
`deferiprone?
` A. That is entirely possible based upon
`the clinical history that has been given.
` In fact, I would say it is probable
`that they would have died because of the
`congestive heart failure.
` Q. And -- well, go ahead. I don't want to
`cut you off.
` A. Right.
` So the interpretation is that, again,
`death is, obviously, an undesirable outcome.
` But if you end up delaying death -- and
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`we deal with this all the time in hematology with
`cancer patients -- that itself is a measure of
`success.
` And it is not necessarily a reflection
`of modality of therapy used being ineffective; it
`was just effective up to a point and not beyond
`that.
` Q. Okay.
` Is it your understanding that any of
`the claims of the '328 patent recite an
`extension of lifetime as a part of their
`intended results?
` A. They don't.
` But they do talk about stabilization of
`iron overload, stabilization of cardiac disease,
`and so on. And the obvious implication of that
`is extension of life.
` I'm not quite certain that extension of
`life is something that is patentable, kind of
`like a perpetual motion machine. I mean, how do
`you quantify something of that sort?
` I would think it would be an immediate
`flag for rejection by the examiner.
` Q. So if we look at the first patient, the
`23-year-old male who had thalassemia major and
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`diabetes, it says here --
` Do you see that, where I'm referring to?
` A. I do, yes.
` Q. -- "Four months before his death
`deferiprone treatment was stopped and an
`attempt was made to reintroduce subcutaneous
`deferoxamine with poor compliance." Is that
`right?
` A. Yes.
` Q. DFX being deferoxamine; correct?
` A. That's correct.
` Q. So is it fair to say that, if the
`deferiprone was stopped, that that patient was
`not responding to chelation with deferiprone?
` A. When you look at the -- when you look
`at the table, it talks about the fact that
`deferiprone therapy was continued for 26 months.
`And the initial serum ferritin was 4122, and the
`final serum ferritin was 4,024.
` As measured by serum ferritin,
`despite ongoing transfusions, the disease at
`the very least to an extent remained stable. So
`the drug was certainly successful in preventi
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