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` THE UNITED STATES PATENT AND TRADEMARK OFFICE
` _____________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________
` COALITION FOR AFFORDABLE DRUGS VIII LLC
` Petitioner
` v.
` THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
` Patent Owner
` _____________________
` Case IPR2015-01836
` U.S. Pat. No. 7,932,268
` Case IPR2015-01835
` U.S. Pat. No. 8,618,135 B2
` ________________________
`
` DEPOSITION OF THOMAS A. BAILLIE, Ph.D., D.Sc.
` Boston, Massachusetts
` Tuesday, October 25, 2016
`
`Reported by: Dana Welch, CSR, RPR, CRR, CRC
`Job No: 114462
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`Page 1
` THE UNITED STATES PATENT AND TRADEMARK OFFICE
` _____________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________
` COALITION FOR AFFORDABLE DRUGS VIII LLC
` Petitioner
` v.
` THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
` Patent Owner
` _____________________
` Case IPR2015-01836
` U.S. Pat. No. 7,932,268
` Case IPR2015-01835
` U.S. Pat. No. 8,618,135 B2
` ________________________
`
` DEPOSITION OF THOMAS A. BAILLIE, Ph.D., D.Sc.
` Boston, Massachusetts
` Tuesday, October 25, 2016
`
`Reported by: Dana Welch, CSR, RPR, CRR, CRC
`Job No: 114462
`
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`Page 2
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` October 25, 2016
` 8:59 a.m.
`
` Deposition of THOMAS A. BAILLIE, Ph.D.,
`D.Sc., held at the offices of GOODWIN PROCTER LLP, 100
`Northern Avenue, Boston, Massachusetts, pursuant to
`Notice, before Dana Welch, a Certified Shorthand
`Reporter, Registered Professional Reporter,
`Certified LiveNote Reporter, a Certified Realtime
`Reporter, and a Notary Public of the Commonwealth
`of Massachusetts.
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`A P P E A R A N C E S:
`McNEELY, HARE & WAR
`Attorneys for Coalition for Affordable Drugs
`12 Roszel Road
`Princeton, NJ 08540
`BY: CHRISTOPHER CASIERI, ESQ
`
`GOODWIN PROCTER
`Attorneys for Trustees of the University
`of Pennsylvania
`100 Northern Avenue
`Boston, MA 02210
`BY: NICHOLAS MITROKOSTAS, ESQ.
` ERIC ROMEO, ESQ.
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` BAILLIE
` P R O C E E D I N G S
` THOMAS A. BAILLIE, Ph.D., D.Sc., sworn
` EXAMINATION
`BY MR. CASIERI:
` Q. Good morning, Dr. Baillie.
` A. Good morning, Mr. Casieri.
` Q. I know you've had your deposition, so
`we'll keep this introduction brief. I just want to
`remind you that if you don't understand a question
`I ask or it's not clear, just let me know and I'll
`try and clarify it.
` A. Okay.
` Q. If you need a break, let me know and you
`can take a break.
` I'm going to hand you what's been marked
`Penn Exhibit 2305, and it's entitled "Supplemental
`Declaration of Thomas A. Baillie, Ph.D., D.Sc."
` Could you just turn to the back page and
`confirm for me that that's your signature.
` A. Yes, it is.
` Q. Okay. So I'm also going to hand you
`what's also been marked Exhibit 2305, the
`Supplemental Declaration of Thomas A. Baile in case
`IPR2015-01836.
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` Can you take a look at that? Can you tell
`me if the signature on the back page is your
`signature?
` A. Yes, it is again.
` Q. Okay. So I think we went through this
`exercise last time. Do you know the differences
`between these two documents?
` A. Yes. I am aware of the differences. They
`differed by two claims, I believe, but they are
`functionally identical.
` Q. What I'd like to do today is just focus on
`one of the declarations, and I'll tell you it's the
`one for case IPR2015-01835. Okay?
` A. That's fine.
` Q. And if your answer for any of the
`questions apply to the declaration for 01835
`declaration but it doesn't apply to the 01836
`declaration, can you let me know?
` A. I will.
` Q. Okay. I think you can put that aside for
`now. And you're welcome to flip through it if
`you're unsure. I just essentially don't want to
`ask you each question today twice.
` A. I understand.
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` Q. Okay. So let's take a look at this
`declaration. When I just refer to the declaration,
`we understand that I'm referring to your
`supplemental declaration?
` A. Yes.
` Q. Okay. Did you prepare this declaration?
` A. I prepared this declaration in
`collaboration with counsel.
` Q. Okay. Did you have any assistance from
`anyone other than your counsel?
` A. No, I did not.
` Q. Did you confer with anyone about any of
`the content of the declaration, with anyone other
`than your counsel?
` A. No one other than counsel.
` Q. Okay. So why don't we turn to paragraph
`11 of your declaration. Okay? I'm going to read
`from parts of your declaration throughout the day
`or the morning, and I'm not going to read the whole
`paragraph. But at any time I read a part of your
`declaration and I ask you a question about it, feel
`free to read the whole paragraph. Okay? I know
`counsel probably instructed you to do that. I'm
`just telling you feel free if you need to, to
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` BAILLIE
`answer the question.
` A. Okay. Thanks.
` Q. But in the middle of it, it starts -- in
`the middle of paragraph 11, it states,
`"Additionally, I opine that because both the
`original and substitute claims of the patent at
`issue are based on the same underlying concept of
`using a step-wise forced titration dosing regimen
`to promote biological adaptation, the substitute
`claims would be non-obvious for the same reasons
`that the original claims are non-obvious."
` And then at paragraph 144, "My opinions
`regarding the validity of the substitute claims
`have not changed after reading Dr. Zusman's
`supplemental declaration."
` Do you see that?
` A. Yes, I do.
` Q. Did Dr. Zusman identify the differences
`between the substitute claims and the original
`claims?
` A. I'd have to refer back to Dr. Zusman's
`declaration in order to fully answer your question.
` Q. Okay. Did you identify the differences
`between the substitute claims and the original
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`claims?
` A. Yes. I'm familiar with the differences.
` Q. Are they described anywhere on the
`declaration; do you know?
` A. And which declaration are you referring
`to?
` Q. This declaration that we're looking at,
`the supplemental declaration.
` A. The original claims?
` Q. No. The differences between the
`original --
` A. The differences between?
` I don't believe that the differences are
`laid out in this supplemental declaration.
` Q. Okay. Is it fair to say there are
`differences between the substitute claims and the
`original claims?
` A. Yes.
` Q. Okay. And in your opinion, those
`differences don't affect the same underlying
`concept of using a step-wise forced titration
`dosing regimen to promote biological adaptation?
` A. That's correct.
` Q. So we know what we're talking about or
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`we're talking about the same thing, can you give me
`a definition of what you mean by "step-wise forced
`titration dosing regimen"?
` A. A forced titration dosing regimen would
`apply to a regimen whereby patients were
`administered an initial dose of the drug for some
`specified period of time, after which they would be
`required to proceed to a second dose, which would
`be higher than the first dose by some defined
`amount, and there could be subsequent elevations at
`fixed intervals of time, but that the subjects or
`the patients would have to complete that sequence
`of doses in order to achieve the desired ultimate
`effect of the drug.
` Q. Okay. And in the second part of your
`sentence here where you refer to "to promote
`biological adaptation," can you tell me what you
`mean by to promote biological adaptation?
` A. In this particular case, with lomitapide,
`there was evidence of an unexpected adaptation or
`tolerance to the undesirable side effects of the
`drug, such that using a forced titration dosing
`regimen it was possible to achieve doses of
`lomitapide which would have been otherwise
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`intolerable had that particular forced titration
`regimen not been applied.
` Q. And were there -- you said in this
`particular case with lomitapide "There was evidence
`of unexpected adaptation or tolerance to
`undesirable side effects with the drug."
` Were there specific undesirable side
`effects that you're referring to?
` A. The two major toxicities of concern with
`lomitapide related to gastrointestinal side effects
`and side effects involving the liver.
` Q. Okay. Could you turn to paragraph 24 for
`me. I'm going to skip down to the end of this
`paragraph where it begins "finally."
` Do you see that?
` A. I do see that, yes.
` Q. Okay. You indicate, "Finally, as
`described above, Dr. Zusman testified at his
`deposition that a 'low and slow' non-forced
`titration was 'a very well established and obvious
`strategy' to determine the safe and effective dose
`for an MTP inhibitor with known toxicity issues."
` Do you see that?
` A. Yes.
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` Q. "Non-forced titration," that's not in
`quotes in this paragraph, correct?
` A. Correct.
` Q. Is that a term that you used or did you
`see that in Dr. Zusman's deposition?
` A. I don't believe that Dr. Zusman used that
`terminology, "non-forced titration"; that would be
`my description of what he had written in his
`deposition.
` Q. Is non-forced titration a term of art?
` A. The term "forced titration" is. I think
`it would be understandable broadly that non-forced
`titration meant that it was a regimen other than
`forced titration.
` Q. What is the difference between a
`non-forced titration and a forced titration?
` MR. MITROKOSTAS: Objection to the form.
` A. Well, as I explained earlier, the forced
`titration involves a requirement that the patient
`comply with the series of sequential dose
`escalations.
` What I was referring to by this
`terminology of non-forced titration was some other
`dose escalation regimen where the patient would not
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`be required to complete a particular sequence of
`escalating doses.
` Q. What circumstances in a non-forced
`titration would a patient not be required to
`complete the step-wise dosing titration?
` MR. MITROKOSTAS: Objection to the form.
` A. Well, I think that the most likely
`situation would be where some kind of adverse
`effect was encountered at a particular dose which
`would require either stopping an escalation or even
`reducing the dose in order to minimize the side
`effects.
` Q. Do you know if the substitute claims
`require the patient to continue the dose escalation
`even if the patient experiences side effects?
` A. That would be my reading of the claim.
`Even though the claims would not specify that the
`dose could not be temporarily interrupted or even
`reduced temporarily, but ultimately, the subject
`would have to continue with the dose escalation to
`fulfill the requirements of the forced-dose
`titration.
` Q. Would you turn to paragraph 15. Okay.
`Right at the top there in paragraph 15 you
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`indicate, "Third, Dr. Zusman argues that the
`two-fold sequential dose increases required by the
`substitute claims are taught by Stein."
` Do you see that?
` A. Yes.
` Q. And then you indicate that you disagree.
` So my question is, is the two-fold
`sequential dose increase important to the
`underlying concept of using a step-wise forced
`titration dosing regimen to promote biological
`adaptation?
` MR. MITROKOSTAS: Objection to the form.
` A. Could you repeat your question?
` Q. Yes.
` Is the two-fold sequential dose increase
`that is required by the substitute claims important
`to the underlying concept of using a step-wise
`forced titration dosing regimen to promote
`biological adaptation?
` A. So the -- the question here relates to
`"two-fold." I think that's what is implied in your
`question. And that factor of two-fold is not
`necessarily applicable to all types of forced-dose
`titrations. The fact it could be less, conceivably
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`it could be somewhat more. In the case of
`lomitapide, it was found by Dr. Rader's clinical
`studies that that was an appropriate dose
`escalation factor.
` Q. So when you say it "was an appropriate
`dose escalation factor," how critical is the
`two-fold sequential dose to actually promoting
`biological adaptation?
` A. I can't answer that question because I am
`not familiar with any clinical data where different
`escalation factors were explored. I know that
`Dr. Rader's clinical trials implied two-fold
`increases at each step of his forced-dose
`titration. I haven't seen any data where factors
`widely different from that were implied, although
`there was one clinical -- a Phase II clinical trial
`that was conducted relatively early on in the
`development of lomitapide by Cuchel and co-workers
`that was published in the New England Journal of
`Medicine in 2007, if I recall, in which the dose
`escalation factor was somewhat higher. It was
`almost three-fold, if I recall. That's the only
`other example of where a dose escalation factor
`other than two-fold was implied, to my knowledge.
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` Q. So skipping down a couple of sentences,
`you say, "What Stein suggests instead is a much
`more gradual dose escalation from 10 milligrams a
`day to 45 milligrams a day in seven, 5-milligram
`increments."
` Do you see that?
` A. Yes.
` Q. And do you call that a more gradual dose
`escalation because the increases are less
`significant?
` MR. MITROKOSTAS: Objection to the form.
` A. That would be -- that would be what I
`would say in this case, that you're going up from
`10 milligrams a day in 5-milligram increments, it's
`a relatively modest increase from one step to the
`next.
` Q. If a two-fold sequential dose increase
`promotes biological adaptation for lomitapide,
`would you expect a more gradual dose increase to
`also promote biological adaptation for lomitapide?
` A. It's hard to tell. I don't really know of
`any clinical data where the gradual dose escalation
`was evaluated in terms of its effect on the adverse
`effects that were trying to be minimized, so I
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`can't really answer on the basis of any
`experimental data.
` Q. Do you know if the original claims allow
`for a more gradual dose escalation?
` A. The original claims if I recall correctly,
`involved similar two-fold increments in the
`forced-dose titration regimen.
` Q. Okay. In the next sentence you indicate,
`"Notably, the magnitude of the largest step-to-step
`increase in Stein's proposed regimen is 50 percent,
`four times smaller than that required by the
`claims."
` Do you see that?
` A. Yes. I see that.
` Q. The substitute claims appear, just so we
`-- you know, not trying to trick you here -- the
`substitute claims appear in paragraph -- or at
`least the first substitute claim appears in
`paragraph 42, if you want to just sort of -- here,
`you want to mark that? If you want to.
` So my question is, I'm trying to
`understand how you arrived at the idea that the
`step increase in Stein's proposed regimen is
`50 percent and that is four times smaller than that
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`required by the claims.
` A. Well, the four-fold difference is the
`difference between 50 percent and 200 percent.
`200 percent being a doubling.
` Q. So Stein suggests you can go from 10
`milligrams per day to 15 milligrams per day,
`correct?
` A. Correct.
` Q. And that is the largest dose escalation or
`step increase in Stein's proposed regimen?
` A. As a percentage of the previous dose, it
`is, yes.
` Q. And that's 50 percent?
` A. Correct. 5 milligrams on top of 10.
` Q. And the substitute claims, you can go
`from, say, 5 milligrams to 10 milligrams?
` A. Or to be -- to compare with what is
`written here, 10 to 20 would be another example.
` Q. 10 to 20?
` A. So Stein would go from 10 to 15; the
`substitute claims would go from 10 to 20.
` Q. And that's four times smaller?
` A. That's a doubling.
` Q. Isn't the 50 percent step-to-step increase
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`two times smaller than that required by the claims?
` A. Well, it's kind of awkward when you're
`comparing percentages. Percentage of a starting
`dose versus percent of some higher dose, because
`that number is going to change with the gradual
`increment. So 10 to 15 is a 50 percent increase;
`15 to 20 is less than a 50 percent increase, and as
`you go up, of course, the percentage number will be
`reduced, right?
` Q. Right.
` A. In the forced-dose titration regimen,
`every single succeeding dose is double the one you
`came from.
` Q. Right.
` So what I was trying to understand here
`is, are you comparing the largest step-to-step
`increase in Stein's proposal to the largest
`step-to-step increase in the substitute claims?
` A. Yes. That is correct.
` Q. And that, in your opinion, is the largest
`step-to-step increase in Stein's proposal is four
`times smaller than the largest step-to-step -- four
`times smaller than the largest step-to-step
`required by the claims?
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` A. As a percentage, that's correct. So the
`10 to 15 milligrams would be the largest percentage
`increase in Stein's proposal, and as you go up in
`the Stein regimen, that percentage increase will go
`down; whereas in the forced dosing titration
`regimen, the percentage increase will remain fixed,
`if that clarifies things.
` Q. It does. Thank you.
` If you could turn to paragraph 29. I
`think we just sort of covered most of what's in
`here, but you indicate sort of towards the end
`there, "Dr. Zusman's failure to provide a rationale
`for his selection of a two-fold geometric dose
`escalation instead of numerous other potential
`strategies discussed in Reigner is clear evidence
`of impermissible hindsight."
` Do you see that?
` A. Yes.
` Q. And in your opinion, the two-fold
`geometric dose escalation is important because you
`don't know if any other dose escalation strategy
`would work in terms of biological adaptation?
` MR. MITROKOSTAS: Objection to form.
` Q. For lomitapide.
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` BAILLIE
` A. The context of this portion of the
`declaration relates to a person of ordinary skill
`in the art, a POSA, and how they might decide to
`use a dosing regimen, and the different options
`that would be available to a POSA, the arithmetic,
`geometric, and the Fibonacci regimens. And the
`issue here is what would be a safe dosing regimen
`for a compound that was known to have side effect
`liabilities.
` So on the one hand, an investigator would
`want to escalate doses relatively rapidly to
`achieve a pharmacological readout, while at the
`same time balancing the concerns with too rapidly
`increasing the dose and running into toxicity
`issues. So in that context, specifically with
`lomitapide, since it had been abandoned essentially
`by BMS due to toxicity problems, a POSA would be, I
`think, very cautious in projecting an appropriate
`dose escalation regimen. Two-fold is a fairly
`aggressive escalation regimen as called for by the
`claims, so that relates to the context here.
` Q. What benefit would there be to a POSA to
`have a fairly aggressive escalation regimen as
`opposed to a low and slow dose escalation regimen?
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` BAILLIE
` MR. MITROKOSTAS: Objection to the form.
` A. An advantage would be that you would
`achieve, hopefully, pharmacologically active doses
`relatively quickly, that the -- the clinical trial
`would potentially be accelerated because you are
`achieving active doses relatively quickly. So you
`would reduce the duration, potentially, of the
`clinical study. So these would be some of the
`advantages of going up rapidly as opposed to going
`up very gradually in dosage.
` You would be reducing the exposure of
`subjects to more frequent doses of the drug and
`that's always a desirable thing in any clinical
`experimentation for ethical reasons. So there's a
`few advantages of going up rapidly. And the
`clinical investigator would have to weigh these
`advantages against the potential hazards of
`escalating too rapidly and running into toxicity.
` Q. Let's take a look at the next paragraph,
`paragraph 30. You indicate, "Fourth, Dr. Zusman
`argues that guidance for industry would have
`allowed a POSA to derive the third dosing level in
`the claimed regimen, about 0.2 to 0.59 milligrams
`per kilogram per day from the 10 milligram per
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` BAILLIE
`kilogram dose used in Wetterau's rabbit model."
` Do you see that?
` A. Yes, I do.
` Q. Is this third dosing level in the claimed
`regimen critical to promoting biological adaptation
`for lomitapide?
` MR. MITROKOSTAS: Objection to the form.
` A. I don't know if it's critical or not
`critical. I assumed that it was derived from
`clinical experimentation, but that's my assumption.
` Q. Let's take a look at paragraph 39. At the
`very end of the paragraph, there's a sentence that
`starts "A POSA."
` Do you see that?
` A. Yes, I see that.
` Q. Okay. I'll just read that: "A POSA,
`therefore, would have no reasonable expectation
`that any quantitative analysis based on Wetterau's
`rabbit data could result in a safe and effective
`human dosing regimen."
` Do you see that?
` A. Yes.
` Q. Hand you what's been marked as PENN
`Exhibit 2077. I'll just read the title here:
`
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` BAILLIE
`"Phase I/II Open Label Dose Escalation Study to
`Determine the Safety, Tolerability, and Efficacy of
`Microsomal Triglyceride Transfer Protein (MTP)
`Inhibitor BMS-201038 in Patients with Homozygous
`Familial Hypercholesterolemia."
` You've seen this document before, correct?
` A. I did. Yes.
` Q. Other than me just reading the title, do
`you know what this is?
` A. Yes, this document is a clinical
`protocol -- the description of the clinical
`protocol for the Phase I/II dose escalation study
`in question.
` Q. So this was performed by Dr. Rader?
` A. That is correct.
` Q. This protocol was not performed by
`Bristol-Myers Squibb, correct?
` A. That's correct, yes. This was dated
`December 2nd, 2002, which was two years after BMS
`discontinued the development of lomitapide.
` Q. Can you turn to page 17 of 72. There's
`two page numbers, so I'm going to refer to 17 of
`72, which is also page 14 of 57.
` Are you there?
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` BAILLIE
` A. Yes, I'm there.
` Q. At the very top towards the end of the
`first paragraph it indicates, "We picked an upper
`dose of 1 milligram per kilogram based on data from
`the animal study by Wetterau revealing greater than
`80 percent LDL cholesterol reduction using 10
`milligrams per kilogram with an ED50 of
`1.9 milligram per kilogram."
` Do you see that?
` A. Yes.
` Q. Did you consider this statement when you
`concluded that a person of ordinary skill in the
`art would have no reasonable expectation that any
`quantitative analysis based on Wetterau's rabbit
`data could result in a safe and effective human
`dosing regimen?
` A. I did not read that particular statement
`when I arrived at my conclusions. Although, seeing
`this here, I think it's important to distinguish
`between safety and efficacy because my comments
`with regard to the translation of the animal data
`in Wetterau to what would be a safe human dose was
`really based on the concern about how applicable
`the rabbit model is to human with regard to safety.
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` BAILLIE
` This rabbit model that is described by
`Wetterau is used as a pharmacodynamic model for
`human HoFH, and so it is being cited here in this
`clinical protocol as the basis for the target LDL
`cholesterol reduction, if I'm reading this
`correctly.
` Q. Is it fair to say that they used the study
`by Wetterau to pick a dose that they thought would
`produce effective human dosing regimen?
` MR. MITROKOSTAS: Objection to the form.
` Q. For lomitapide.
` A. I think that what Rader is doing in this
`document is using the published data from Wetterau
`that was based on this genetic rabbit model to
`project what kind of a human dose might give rise
`to an 80 percent LDL cholesterol reduction.
` Q. But you will agree that Dr. Rader used
`data from Wetterau to pick his dose for the study,
`correct?
` MR. MITROKOSTAS: Objection to the form.
` A. It seems that he used data from Wetterau
`to project a ballpark dose that would give rise to
`an 80 percent LDL cholesterol reduction. He says
`in this sentence, "an upper dose of 1 mg per kg,"
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` BAILLIE
`so presumably that was derived from these animal
`studies at a higher dose of 10 milligrams per
`kilogram per day, I think it was. So he's looking
`for an upper bound.
` Q. Okay. Right above that, the document
`indicates, "The remaining three doses were chosen
`by calculating one-half log units of the previous
`dose."
` Do you see that?
` A. Yes.
` Q. Now, is that a two-fold sequential dose
`increase?
` A. A half-log unit would not necessarily
`correspond to a doubling of the dose. It would be
`more like three-fold, and that would correspond to
`the three-fold increments that I mentioned a few
`minutes ago that were reported in that clinical
`paper by Cuchel and co-workers in the New England
`Journal of Medicine, who started at .03 mgs per kg,
`then went to .1 mg per kg, and then worked up to 3,
`and then, I think -- to .3 and then to 1, if I
`recall correctly. So that would be more akin to a
`half-log escalation.
` So the answer to your question is that
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` BAILLIE
`this half-log unit increment here is not doubling,
`but it's slightly more aggressive than that.
` Q. So does this change your opinion as to
`whether the two-fold sequential dose increase is
`important to the underlying concept of using a
`step-wise forced titration dosing regimen to
`promote biological adaptation in lomitapide?
` A. It suggests to me that the two-fold number
`is not absolute, that the two-fold number is one
`that clearly was effective in accomplishing the
`goals of the study, but the number of two is not an
`absolute number. It could have been two and a half
`or perhaps three or perhaps one and a half, but
`two-fold worked, as demonstrated by Dr. Rader's
`clinical studies. So I don't think it's absolute.
` Q. Well, is this document that we're looking
`at, is this Dr. Rader's studies?
` A. This is a study in which Dr. Rader was the
`principal investigator. And I suspect that the
`study was the study that ultimately resulted in
`that publication I've been describing in the New
`England Journal, simply because of the title here,
`the nature of the study, and the time frame in
`which it was presumably conducted.
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` BAILLIE
` MR. CASIERI: I know it's not even an hour
`yet. Can we take a little break? I'm moving along
`at a good quick clip here.
` (Proceedings interrupted at 9:50 a.m. and
`reconvened at 9:59 a.m.)
`BY MR. CASIERI:
` Q. Okay. I want to turn to a section of your
`declaration, it's "Unexpected Results." It starts
`on about page 37.
` A. Yes, I have that.
` Q. Okay. At the end of paragraph 73, okay,
`there's a sentence that starts "Accordingly."
` Do you see that?
` A. I do see that, yes.
` Q. Okay. You say, "Accordingly, Dr. Zusman
`has no basis to support his opinions that
`Dr. Rader's positive clinical results were
`attributed entirely to a low-fat diet."
` Do you see that?
` A. I do.
` Q. And then in the next paragraph you
`indicate, "If anything, the available clinical data
`squarely contradicts Dr. Zusman's conclusions. The
`record clearly demonstrates that both Dr. Rader's
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` BAILLIE
`and BMS's clinical trials with lomitapide required
`that the patients adhere to a low-fat diet."
` Do you see that?
` A. Yes.
` Q. Okay. So my first question is, do you
`know if the patients in the BMS clinical trials
`were on the same low-fat diet as the patients in
`Dr. Rader's clinical trials?
` MR. MITROKOSTAS: Objection to the form.
` A. You're asking about patients in the BMS
`studies with lomitapide? Did I understand you
`correctly?
` Q. Yeah.
` I'm trying -- okay. So you indicate here
`that "the record clearly demonstrates that both
`Dr. Rader's and BMS's clinical trials with
`lomitapide required that the patients adhere to a
`low-fat diet."
` Do you see that?
` A. I see where it says about Dr. Rader's
`trials required adherence to a low-fat diet, and
`that is based on protocols such as the one that we
`were just discussing.
` Q. Right.
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` BAILLIE
` So my question was, do you know if the BMS
`clinical trials with lomitapide required the same
`low-fat diet as that of Dr. Rader's clinical trials
`for lomitapide?
` A. I don't know if they required the same
`low-fat diet.
` Q. Do you know if -- did you --
` MR. CASIERI: Strike that.
` Q. Going to hand you what's been marked PENN
`Exhibit 2078. And it's entitled "Investigator
`Brochure General Addendum Bristol-Myers Squibb
`Company, BMS-201038."
` Do you see that?
` A. Yes.
` Q. And this is actually a document that you
`cite to in your declaration, correct?
` A. Yes.
` Q. If you would turn to page 2 of 4 of this
`document, in the middle of the middle paragraph,
`sentence begins with "All subjects"; do you see
`that?
` A. I do see that, yes.
` Q. It says, "All subject
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