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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 IPR2015-01835 & IPR2015-01836
`U.S. Pat. No. 7,932,268
`_____________________
`
`DEPOSITION OF FRANK SACKS
`New York, New York
`August 12, 2016
`
`Reported by:
`MARY F. BOWMAN, RPR, CRR
`JOB NO. 111201
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`TSG Reporting - Worldwide 877-702-9580
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`CFAD Exhibit 1054
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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 IPR2015-01835 & IPR2015-01836
`U.S. Pat. No. 7,932,268
`_____________________
`
`DEPOSITION OF FRANK SACKS
`New York, New York
`August 12, 2016
`
`Reported by:
`MARY F. BOWMAN, RPR, CRR
`JOB NO. 111201
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` August 12, 2016
` 9:00 a.m.
`
` Deposition of FRANK SACKS, held
` at the offices of Goodwin Procter LLP,
` 620 Eighth Avenue, New York, New York,
` before Mary F. Bowman, a Registered
` Professional Reporter, Certified
` Realtime Reporter, and Notary Public of
` the State of New Jersey.
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` APPEARANCES:
`
`McNEELY HARE & WAR
`Attorneys for Coalition for Affordable Drugs
` 12 Roszel Road
` Princeton, New Jersey 08540
`BY: CHRISTOPHER CASIERI, ESQ
`
`GOODWIN PROCTER
`Attorneys for Trustees of the University
`of Pennsylvania
` 620 Eighth Avenue
` New York, New York 10018
`BY: CYNTHIA LAMBERT HARDMAN, ESQ.
` KRUPA PARIKH, ESQ.
`
`Also Present:
` KEVIN S. PRUSSIA, ESQ.
` WilmerHale
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` SACKS
`FRANK SACKS,
` called as a witness by the parties,
` having been duly sworn, testified as
` follows:
`EXAMINATION BY
`MR. CASIERI:
` Q. Good morning, Dr. Sacks.
` A. Good morning, Mr. Casieri.
` Q. Have you had your deposition
` taken before?
` A. Yes.
` Q. About how many times?
` A. Six to eight, I'd say.
` Q. I'm sure you know all the rules,
` so I'm not going to go through them all.
` Just remind you, if I ask a question and
` you don't understand it or you don't think
` it is clear, let me know and I'll try and
` clarify it. But if not, I will assume you
` understand the question. OK?
` A. Yes.
` MS. HARDMAN: Objection to form.
` Q. So you said you have had your
` deposition taken six to eight times?
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` A. Correct.
` Q. How many cases were those in?
` A. A variety of cases. Let's see,
` there was -- well, some are patent, a few
` of them were patent litigation in which I
` was on the side of plaintiffs or
` defendants, both, in various cases, and
` then I was a witness for the Federal Trade
` Commission in a false advertising suit
` against Pom Wonderful, the pomegranate
` company, and then there was a short
` class -- short-lived class action suit
` against Pom Wonderful that, for a brief
` time, I was on the side of the plaintiff
` against Pom Wonderful.
` Let me see any other type of
` case? If it comes to me, I'll let you
` know.
` Q. OK. The patent litigations, you
` said three or four of them?
` A. Well, possibly, if -- let's say
` if I did eight, probably six of them, you
` know, would be patent infringement cases.
` Q. Did you give trial testimony in
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` those?
` A. On those, no.
` Q. Were you an expert witness on
` those patent cases?
` A. Correct.
` Q. Do you remember the drugs that
` were at issue in those cases?
` A. Sure. Let's see the first case,
` was a prescription omega 3 fatty acid drug
` or preparation. And it -- so I was an
` expert witness for the generic side. I
` guess that's the defendant in those cases.
` So I was an expert witness on the
` generic side, Par Pharmaceuticals, that
` wanted to market a generic version of a
` drug, a Glaxo drug that was actually a fish
` oil, omega 3 fatty acid preparation.
` Then, there was a niacin case
` that kind of, one kind of a low release
` niacin called Niaspan. So there were
` actually several very similar cases on the
` Niaspan patent and that one I was on the
` plaintiff or patent holder's side.
` Q. Do you know who you -- who the
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` plaintiff was?
` A. In the Niaspan case, there was a
` whole group of, a whole group of
` plaintiffs. I don't -- it is like one of,
` you know, the usual cast of characters,
` Barr and Teva and so forth, Impax. I don't
` remember specifically.
` Q. But you were on the plaintiff's
` side in that case?
` A. Well, in that case, I was on the
` patent holder's side, the defendant,
` defendant's side in the niacin cases. So
` the patent holders Abbott or AbbVie, was,
` is the patent holder. And those other
` generic companies wanted to market a
` generic equivalent.
` Q. Any other drugs that you were
` involved in the patent litigation?
` A. There is some short case relating
` to a fibroid drug, fenofibrate, also the
` patent holder was Abbott, and it was -- it
` was in relation to fenofibrate being used
` in combination with a statin. And I think
` there was a combination drug.
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` I actually don't really remember
` that clearly about that. It was kind of a
` short-lived case that I went to deposition
` very quickly.
` Q. Is that it for the patent
` litigations?
` A. Well, that's what I can remember
` now. I think that's it.
` Q. I'm going to hand you what has
` been marked as Penn Exhibit 2023 and case
` IPR 2015-01835.
` (Penn Exhibit 2023, Declaration
` of Frank Sacks marked for
` identification, as of this date.)
` Q. Just take a look at that. It is
` double-sided, so just so you are aware. On
` the very back page, can you take a look and
` tell me, is that your signature?
` A. Yes.
` Q. This is your, as it says on the
` front, your declaration for the patent
` owner's response to petition?
` A. Yes.
` Q. Next, I'm going to hand you what
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` has been marked Penn Exhibit 2023 and case
` IPR 2015-01836.
` I guess I would just ask you
` again to turn to the back, just confirm
` that that's your signature.
` A. Yes.
` Q. So to try to make things simple
` today, I'm going to ask you, with regard to
` the substance of your opinion, are these
` the same?
` MS. HARDMAN: Objection to form.
` A. Are these the same?
` Q. Yeah.
` A. I was wondering why you gave me
` what looks on the face a duplicate. But I
` don't know, I would have to page through
` it.
` Q. I'll represent to you that one
` decoration was submitted in one IPR and if
` you look, the number IPR 2015-1835 and the
` second one was submitted in IPR 2015-1836.
` Do you see that?
` A. Right.
` Q. OK. So I'm just trying to
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` confirm that the substance of these two
` declarations are the same.
` MS. HARDMAN: Objection to form.
` Q. Do you know?
` A. I don't know. I'd have to -- as
` far as my recollection, I just remember
` signing a declaration. I don't -- I mean,
` I only wrote one declaration. So if
` this -- if this is the one declaration I
` wrote that has two different numbers, then
` it's the same.
` Q. OK. Let's put that aside for
` now.
` We can just use one, the one that
` has the 1835, just for the sake of
` simplicity, and maybe we can go back later
` and establish what the differences between
` the two declarations are. OK?
` A. Yes.
` Q. So in preparing this declaration,
` who did you speak to?
` A. Who did I speak to? I spoke with
` the three lawyers that are here now.
` Q. Is it -- just so I'm clear, in
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` preparing the declaration, you spoke to the
` three lawyers that are in the room now?
` A. In preparing the deposition?
` Q. No, no.
` A. I mean, in preparing the report?
` Q. Yeah.
` A. Yeah.
` Q. OK. Anyone else?
` A. Anyone else? No.
` Q. Are you aware if anyone else gave
` declarations in support of the patent
` owner's response?
` A. The declarations by Dr. Bailey
` and Dr. Kimball.
` Q. Did you speak to Dr. Bailey or
` Dr. Kimball before you prepared your
` declaration?
` A. No.
` Q. Did you have -- did you ever
` review their declarations?
` A. Yes.
` Q. When did you review them?
` A. A few days ago.
` Q. Is that the first time?
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` A. Correct.
` Q. Did you review Dr. Gregg's
` declaration?
` A. No.
` Q. Did you review Dr. Rader's
` declaration?
` A. No.
` Q. If you would turn to paragraph
` 40, which is on page 21, paragraph 40, you
` give your definition, your opinion of what
` a person of ordinary skill in the art would
` be, correct?
` A. I'll read that paragraph.
` OK. yes.
` Q. And now, down in paragraph 41, in
` about the middle of the paragraph, you
` indicate, "In my view, the '135 and '268
` patents are focused more on the treating,
` more on a treating physician."
` Do you see that?
` A. Yes.
` Q. What do you mean by treating
` physician?
` A. A physician that is treating
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` patients, is prescribing medicine, treating
` patients.
` Q. Is that as opposed to some other
` physician?
` A. Well, that's not what I meant by
` that. What I meant is I didn't mean
` that -- I meant the treating physician, as
` opposed to say a Ph.D. in medicinal
` chemistry or something like that.
` Q. How about a physician that's
` focused on research, he is not necessarily
` a treating physician, correct?
` MS. HARDMAN: Objection to form.
` A. That, that's correct.
` Q. I'm just trying to establish, you
` know, what a treating physician is as
` opposed to any other physician or any other
` doctor. I think you said it's a physician
` that's treating patients.
` A. That's --
` MS. HARDMAN: Objection form.
` A. Again, my reading of the patent
` is that it is directed toward establishing
` a dose regimen to treat patients, so that's
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` why, to me, it's -- it's focused on a
` treating physician. It's not like a
` chemistry patent, let's say.
` Q. So in paragraph 40, where you say
` an MD and several years of experience in
` treating patients with lipid disorders
` including hyperlipidemia and
` hypercholesterolemia, that's a treating
` physician?
` A. Yes.
` MS. HARDMAN: Objection to form.
` Q. OK, turn the page, still in
` paragraph 41. Right in the second sentence
` there, you say, "I disagree with this
` portion of Dr. Zusman's analysis. While
` physicians remain abreast of current
` developments in their field, this is
` typically achieved by reading scientific
` journals and attending conferences and
` lectures."
` Do you see that?
` A. Yes.
` Q. And then you say you disagree
` that "physicians routinely read the pink
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` SACKS
` sheet and follow the activities of
` pharmaceutical companies."
` Do you see that?
` A. Yes.
` Q. When you say "physicians" here,
` are you talking about person of ordinary
` skill in the art or just physicians
` generally?
` A. Actually, I'm going to back up
` one sentence.
` Q. Sure.
` A. So I can see exactly what it says
` here.
` OK. So I read that section. And
` your question is on the type of physician?
` Q. When you say "physicians" instead
` of "person of ordinary skill in the art,"
` I'm trying to ask you, is there a
` distinction when you say physicians as
` opposed to person of ordinary skill in the
` art?
` A. No.
` Q. By the way, if I -- as we go
` through this, I'm going to read portions of
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` paragraphs and you're free to read whatever
` you want to read or whatever you need to
` read. I'm not trying to trick you or
` anything. I just don't want to read every
` paragraph. OK? So if you need to read
` something, just read it.
` A. Sure, I understand.
` Q. Just let me know that.
` A. I understand.
` Q. OK, so now, do you dispute that
` the pink sheet is a publicly available
` document?
` MS. HARDMAN: Objection to form.
` A. I certainly don't -- I mean, it
` requires a subscription as far as I know.
` So inasmuch as somebody could sign up, pay
` the subscription fee, it's available.
` Q. So you say, "In fact, prior to my
` reading documents in this proceeding, I
` have never used or even heard of the pink
` sheet." Correct?
` A. Yes.
` Q. Did the fact that you never heard
` or used the pink sheet, did it impact your
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` opinion in any way in this declaration?
` A. Well, sure. I mean, I -- getting
` myself acquainted with pink sheet in
` reviewing the proposed prior art, I mean I
` had to learn something about the pink sheet
` and my opinion about the pink sheet is that
` it's not any good prior art for
` developing -- you know, for the -- for
` developing a drug to treat people.
` It's just a breezy, kind of a
` breezy document for investors and people
` working in the drug -- in pharmaceutical
` companies may want if they are like in
` marketing, they may want to look at that to
` get some inkling of what's going on outside
` their company.
` Q. I guess my question is
` specifically the fact that you disagree
` that physicians read, routinely read the
` pink sheet. Did that specific opinion that
` you have an influence one way or the other
` on your overall opinion?
` MS. HARDMAN: Objection to form.
` A. I don't see it as good prior art
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` for the purpose that if -- you know, if I
` was a POSA in 2003-2004, I wouldn't
` consider that good prior art to go develop
` a, go develop a dosing regimen. So that's
` what I mean.
` Q. Would you consider it to be prior
` art at all?
` MS. HARDMAN: Objection to form.
` Q. Would you consider it to be prior
` art to the patents at issue in this case?
` MS. HARDMAN: Objection to form.
` A. Well, to a POSA -- well, you're
` actually asking a technical, legal question
` about prior art. So, you know, as I look
` at this, from my expertise and experience,
` I don't see that the pink sheet as useful
` in the aim that I would have to design a
` dosing regimen for an MTP.
` Q. Let's take a look at paragraph
` 44. You -- I'm going to ask this, but you
` are a treating physician, correct?
` A. I was until I retired from
` treating -- from medical practice.
` Q. When did you retire?
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` A. In 2010. Well, let me just
` clarify. I didn't retire from -- I didn't
` relinquish my medical license because I use
` that in relation to clinical research.
` But as of 2010, I retired from my
` clinic that -- it was a specialty clinic in
` hyperlipidemia in Brigham and Women's
` Hospital. That's what I mean.
` Q. So prior to 2010, you were
` treating patients?
` A. Correct.
` Q. What did you say, at a clinic?
` A. At a clinic. A hyperlipidemia
` clinic in the Division of Cardiology at
` Brigham and Women's Hospital.
` Q. Now, is a treating physician
` involved in selecting a drug for clinical
` trials?
` MS. HARDMAN: Objection to form.
` A. If that treating physician is
` also a research physician.
` Q. Just so we are talking about the
` same thing, did you define clinical trials?
` A. Yes, the clinical trial,
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` "clinical" is a term of art and it refers
` to humans. In other words, in other words,
` experiments, studies in humans. So that's
` the clinical part. And the trial is a test
` of a drug or a diet or anything that alters
` something in a patient and it's very
` desirable that a clinical trial is also
` randomized and has a control group.
` Q. OK, so I think you said that
` treating physician is a research physician,
` he could be involved in selecting a drug
` for clinical trials, right, is that what
` you said?
` A. Correct, in other words, if a
` physician both treats patients and conducts
` research.
` Q. Were you a research physician?
` A. Yes.
` Q. At what time frames were you a
` research physician?
` A. Well, my entire career, including
` now.
` Q. Were you involved in selecting
` drugs for clinical trials?
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` A. Yes.
` Q. What was your role?
` A. Well, in several studies, several
` trials, I was the principal investigator
` and I had the job of selecting the specific
` drug and dosage levels to test in a
` clinical trial.
` Q. Where would you get involved in
` the process; right from the beginning,
` before animal studies or after animal
` studies? Just explain to me where you get
` involved.
` A. Well, let's divide that. To give
` you a good explanation, I'll divide that
` into two parts.
` One part is what I do in my job
` as a professor at Harvard and a physician,
` a staff physician at Brigham and Women's
` Hospital. That's my main job. And I
` conduct their clinical research, research
` in humans. I don't do research in animals.
` So I'm, in that setting, if I
` want to study a drug or a mechanism or
` something, I would get involved with the
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` available drugs or conceivably an
` experimental drug, select that and design a
` clinical protocol to test some property of
` that drug. For example, statins and
` cholesterol levels.
` Let me just answer completely. I
` do consult for the pharmaceutical industry
` and that consultation will often involve
` evaluation and -- on animal experiments.
` Q. You said in there that you would
` design a clinical protocol. What does that
` entail?
` A. OK, a protocol is a detailed
` description of the clinical trial by which
` anybody could read it, if it is written
` well, anybody could read the protocol and
` know how the study was conducted and
` conceivably could reproduce the study if
` the researcher wanted to.
` Q. OK, let's move on to paragraph
` 44. Why don't you take a look and read
` that and I'll ask you some questions.
` A. OK.
` Q. So about in the middle of the
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` paragraph, you said, "However, I note a
` POSA would have understood that the method
` of treating a subject suffering from
` hyperlipidemia or hypercholesterolemia, the
` method comprising administering to the
` subject an effective amount of an MPT
` inhibitor, wherein said administration
` comprises at least three step-wise
` increasing dose levels of the MPT
` inhibitor."
` Did I read that right?
` A. Yes.
` Q. That language, that comes from
` the claim?
` A. Well, I'd have to compare it
` directly, but it sounds like the claim.
` Q. And then you said, "It means that
` the claimed method of treating a human
` patient requires a forced-dose titration
` regimen including but not limited to at
` least three step-wise increasing dose
` levels of lomitapide. Do you see that?
` A. Yes.
` Q. What is a forced-dose titration
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` regimen?
` A. It is an increased, it's a
` progressive increase in dose to the goal
` level.
` Q. Now, the term "forced-dose
` titration," is that something that was
` familiar to the POSA?
` A. Yes.
` Q. Do you know, does that term,
` "forced-dose titration regimen," appear in
` the claims at all?
` A. I don't recall seeing that in the
` claim.
` Q. I guess the same question is, do
` you know if that term "forced-dose
` titration" appears in either of the
` specifications?
` A. It's an interesting question. To
` be a hundred percent sure, I'd have to dig
` around there. But my recollection at this
` point is that I don't recall forced-dose
` titration in the specs.
` Q. So when you said, "This means
` that the claim method of treating a human
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` patient requires a forced-dose titration
` regimen, including but not limited to at
` least three step-wise increasing dose
` levels of lomitapide," is this the claim
` construction that you used in forming your
` opinions that are given in your
` declaration?
` A. Correct.
` Q. Why don't we flip to paragraph
` 50. Paragraph 50 and 51, is it fair to say
` that you are describing
` hypercholesterolemia?
` A. Yes.
` Q. Is hypercholesterolemia different
` from homozygous familial
` hypercholesterolemia?
` A. Well, homozygous familial
` hypercholesterolemia is a subtype of
` hypercholesterolemia.
` Q. Would it be fair to say it is a
` relatively rare subtype of
` hypercholesterolemia?
` A. Yes.
` Q. When you used the term
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` "hypercholesterolemia," are you necessarily
` including people with homozygous familial
` hypercholesterolemia?
` MS. HARDMAN: Objection to form.
` A. I may or may not be, depending on
` the context. I might say
` hypercholesterolemia and be thinking of a
` common hypercholesterolemia.
` So I'd have to -- I mean, I
` think -- I wouldn't -- I couldn't say that
` every time I used "hypercholesterolemia," I
` included homozygous familial
` hypercholesterolemia.
` Q. What do you mean by common
` hypercholesterolemia?
` A. Anybody's cholesterol level above
` our guidelines for an optimal level.
` Q. OK. So with relation to common
` hypercholesterolemia, is it -- is 200 about
` the standard for high cholesterol?
` MS. HARDMAN: Objection to form.
` A. That's a good number. It's in --
` it's in various guidelines.
` Q. What would someone with
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` homozygous familial hypercholesterolemia,
` what would their number be like?
` A. It could be 500, 600, 700.
` Q. Do you have any idea about how
` many patients have -- is there any
` shortened version we can use for homozygous
` familial hypercholesterolemia that you use
` or do you say the whole thing?
` A. No. You could say -- let's see,
` you know, HoFH. You could say --
` Q. If I say that, you will
` understand I'm referring to homozygous
` familial hypercholesterolemia?
` A. Yes.
` Q. To go back to my question, is
` there -- did you know the number of
` patients with HoFH in the United States?
` MS. HARDMAN: Objection to form.
` A. Well, the approximate prevalence
` of HoFH is about one in a million.
` Q. What is the approximate
` prevalence of someone with
` hypercholesterolemia?
` MS. HARDMAN: Objection to form.
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` A. Well, that depends on age. If we
` are thinking of say an older person,
` probably 75 percent of us have levels of
` cholesterol that are higher than is good
` for us.
` Q. OK. I didn't see, and you can
` correct me if I am wrong, but I didn't see
` a similar background section on
` hyperlipidemia. Is that right?
` A. I think you're right. I think
` you're right.
` Q. What's the distinction between
` hyperlipidemia -- to the extent that there
` is one -- what's the distinction between
` hyperlipidemia and hypercholesterolemia?
` A. Well, hypercholesterolemia is a
` subtype of hyperlipidemia.
` Q. So you can have hyperlipidemia
` without having hypercholesterolemia?
` A. Correct.
` Q. It is a subtype, since
` hypercholesterolemia is a subtype of
` hyperlipidemia, is it fair to say even more
` people might have hyperlipidemia than
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` hypercholesterolemia?
` MS. HARDMAN: Objection to form.
` A. Yes.
` Q. Let's skip ahead to paragraph 69.
` Actually, if you take a look at paragraph
` 70, you mentioned a CURVES study, right?
` A. Yes.
` Q. That's a study of statins?
` A. Yes.
` Q. I have it here if you need it.
` A. OK, I'll ask you if I need it.
` Q. So if I just call it the CURVES
` study, will you know what I'm talking about
` Exhibit -- you know, let's get it out.
` I'm going to hand what you has
` been marked as Penn Exhibit 2019.
` (Penn Exhibit 2019, CURVES study
` marked for identification, as of this
` date.)
` Q. So I think in paragraphs 70
` through maybe 73, you reference the CURVES
` study.
` MS. HARDMAN: Objection to form.
` A. Correct.
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` Q. And you're talking about, when
` you say the CURVES study, you're talking
` about Exhibit 2019?
` A. Right.
` Q. So if I say CURVES study, you
` will know we are talking about Penn Exhibit
` 2019?
` A. Yes.
` Q. So are the statins that are
` identified in the CURVE study in the same
` structural class as lomitapide?
` A. No.
` Q. Are the statins identified in the
` CURVE study in the same therapeutic class
` as lomitapide?
` A. Well, they are not in the same
` drug class, but they are used for the
` same -- similar conditions.
` Q. OK, let's talk about therapeutic
` class. Can you give a definition of
` therapeutic class?
` A. Sure, therapeutic class of a drug
` that acts on a specific target to achieve a
` beneficial change in a patient's condition.
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` So for example, the MTP
` inhibitors act on a transport protein
` called MPT that -- to have a beneficial
` effect on cholesterol or lipids, and
` statins act on totally different thing,
` HMG-CoA reductase and that inhibits
` cholesterol synthesis. But both of them
` can be used to treat a medical condition,
` hypercholesterolemia.
` Q. OK, so I understand, just for --
` to make sure we are talking about the same
` thing, are they -- is MPT inhibitors, is it
` in the same therapeutic class as statins?
` A. No. Because -- I mean, we
` have -- we can have many therapeutic
` classes to treat the same -- to treat one
` condition.
` So for example, antihypertensive
` drugs could, I mean, there are six or eight
` different therapeutic classes that are used
` to treat hypertension. It is the same kind
` of thing with lipids.
` Q. Do you know if drugs that are in
` the same therapeutic class have similar
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` structures?
` A. They may. Sometimes the
` structures are really very different but
` they act on the target in a beneficial way
` nonetheless.
` Q. Would a -- would a treating
` physician make a dosing decision based on
` the structure of one drug in a therapeutic
` class compared to the structure of another
` drug in a therapeutic class, same
` therapeutic class?
` MS. HARDMAN: Objection to form.
` A. Well, the, you know, the person
` of ordinary skill as it's defined in my
` report that really only requires a treating
` physician to be treating for several years.
` So let's say -- so a physician
` that would be designing a dosage regimen
` would be conducting research like I do, as
` well as at least at some point have gotten
` experience to treat patients.
` Q. So I guess if we go back to your
` definition of person of ordinary skill in
` the art, and it's on paragraph 40, so an MD
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` with several years of experience in
` treating patients, would they be able to
` make dosing decisions based on the
` structure of a drug?
` A. Well, if that physician is also
` involved in drug development, then I
` would -- then my answer would be yes.
` Q. And if they're not involved in
` drug development --
` A. Well, then probably not because
` those physicians have, you know, very clear
` specifications in the drug labeling from
` the FDA on what to do.
` Q. If the treating physician didn't
` have access to, let's say, the labels of
` the statins, would they be able to look at
` the structure of the statins and make a
` dosing regimen for those statins?
` A. Oh, I -- the structures are just
` one consideration that goes into developing
` a dosage regimen.
` So if we are thinking -- if a
` treating physician is actually treating
` patients with that particular drug, they'd
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` have to have clear specifications.
` Q. You said the structures are just
` one consideration that goes into developing
` a dosing regimen. Can you tell me some of
` the other considerations?
` A. Well, another consideration is
` the pharmacokinetics, the ADME. the ADME
` that goes into defining a dosage regimen.
` For example, if the -- the
` absorption is very important to finding a
` dose and then the distribution is very,
` very important because you want the drug --
` you want to know where the drug is going in
` the body so that it goes to making sure
` that that drug and that structure of the
` molecule goes to the place
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