`
`S. Narasimha Murthy, Ph.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` CASE NO. IPR2018-00168
` U.S. PATENT NO. 9,549,938
`
`FLATWING PHARMACEUTICALS, LLC
`AND MYLAN PHARMACEUTICALS, INC.
`
` PETITIONERS
`
`VERSUS
`
`ANACOR PHARMACEUTICALS, LLC PATENT OWNER
`**************************************************
` DEPOSITION OF
`S. NARASIMHA MURTHY, PH.D.
`**************************************************
` APPEARANCES NOTED HEREIN
`
` DATE: JANUARY 11, 2019
` PLACE: MAYO MALLETTE PLLC
` 2094 OLD TAYLOR ROAD, STE 200
` OXFORD, MISSISSIPPI
` TIME: 9:37 A.M.
`
`REPORTED BY: TODD J. DAVIS
` BCR, CSR #1406, RPR
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`JOB NO. 153636
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`Anacor Exhibit 2046
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc.
`IPR2018-00170
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`Page 2
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`S. Narasimha Murthy, Ph.D.
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`APPEARANCES:
`
` PHILIP SEGREST, JR., ESQ.
` Husch Blackwell
` 120 South Riverside Plaza
` Chicago, Illinois 60606
`
` COUNSEL FOR FLATWING
` PHARMACEUTICALS, LLC
`
` JAD MILLS, ESQ.
` Wilson Sonsini Goodrich & Rosati
` 701 Fifth Avenue
` Seattle, Washington 98104
`
` COUNSEL FOR MYLAN
` PHARMACEUTICALS, INC.
`
` AARON MAURER, ESQ.
` ANTHONY SHEH, ESQ.
` Williams & Connolly
` 725 Twelfth Street, NW
` Washington, D.C. 20005
`
` COUNSEL FOR PATENT OWNER
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`Anacor Exhibit 2046
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc.
`IPR2018-00170
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`S. Narasimha Murthy, Ph.D.
` INDEX
` 1
`Style and Appearances .....................
` 3
`Index .....................................
` 4
`Examination by Mr. Sheh ...................
`Examination by Mr. Segrest ................ 71
`Further Examination by Mr. Sheh ........... 85
`Certificate of Court Reporter ............. 86
`Certificate of Deponent ................... 87
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`Anacor Exhibit 2046
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc.
`IPR2018-00170
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` S. Narasimha Murthy, Ph.D.
` S. NARASIMHA MURTHY, Ph.D.,
`having been first duly sworn, was examined and
`testified under oath as follows:
`EXAMINATION BY MR. SHEH:
` Q. Good morning, Dr. Murthy.
` A. Good morning.
` Q. Would you please state your full name
`for the record?
` A. S. Narasimha Murthy. Sathyanarayana
`Narasimha Murthy.
` Q. Okay. Could you spell that for the
`court reporter?
` A. S-A-T-H-Y-A-N-A-R-A-Y-A-N-A. And middle
`name, N-A-R-A-S-I-M-H-A. Last name, Murthy,
`M-U-R-T-H-Y.
` Q. Okay. My name is Tony Sheh. I'm from
`Williams & Connolly. And with me today is Aaron
`Maurer. We're representing the patent owner,
`Anacor Pharmaceuticals, Inc.
` A. Okay.
` Q. Is it your understanding that you're
`testifying today as a witness on behalf of
`Flatwing Pharmaceuticals?
` A. Yes, I am.
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`Anacor Exhibit 2046
`Flatwing Pharmaceuticals, Inc. v. Anacor Pharmaceuticals, Inc.
`IPR2018-00170
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` S. Narasimha Murthy, Ph.D.
` Q. And do you understand that you're
`testifying and for -- in your party's review
`proceedings pending before the patent trial and
`appeal board?
` A. Yes, I do.
` Q. And you understand Flatwing to be the
`petitioner in these proceedings?
` A. That's correct.
` Q. And you understand Anacor to be the
`patent owner?
` A. That's right.
` Q. Showing Exhibit 1048.
` MR. SEGREST: Are these just the
` patents?
` MR. SHEH: Yeah.
`BY MR. SHEH:
` Q. Dr. Murthy, do you recognize Exhibit
`1048?
` A. Yes, I do.
` Q. What is Exhibit 1048?
` A. It is my declaration.
` Q. Is that your reply declaration filed in
`all four of the inter partes review proceedings?
` A. That's correct.
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` S. Narasimha Murthy, Ph.D.
` Q. Is it okay if I refer to Exhibit 1048 as
`your reply declaration?
` A. Yes.
` Q. And you filed this reply declaration
`in -- just going in case number -- first case
`number IPR 2018-00168; is that correct?
` A. Correct.
` MR. SEGREST: Object to form.
`BY MR. SHEH:
` Q. And IPR 2018-00168 involves U.S. Patent
`No. 9549938; is that correct?
` A. Can you come again? What was the patent
`number?
` Q. Yes. IPR -- does IPR 2018-00168 --
` A. Uh-huh (affirmative response).
` Q. -- involve or concern U.S. Patent
`No. 9549938?
` A. That's correct.
` Q. And the second IPR, is that IPR
`2018-00169?
` A. Right.
` Q. And does IPR 2018-00169 involve U.S.
`Patent No. 9566289?
` A. Correct.
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`Anacor Exhibit 2046
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` S. Narasimha Murthy, Ph.D.
` Q. And is the third IPR, IPR 2018-00170?
` A. Correct.
` Q. And does IPR 2018-00170 concern U.S.
`Patent No. 9566290?
` A. Correct.
` Q. And, finally, the fourth IPR, is that
`IPR 2018-00171?
` A. Yes, sir.
` Q. And does IPR 2008-00171 concern U.S.
`Patent No. 9572823?
` A. Correct.
` Q. And will you understand if I refer to
`the patents at issue by the last three digits of
`their patent number?
` A. Yes, sir.
` Q. Do you recall being previously deposed
`in this matter?
` A. Yes, sir. I recall.
` Q. Do you remember when that deposition
`was?
` A. I think sometime late August.
` Q. Okay. Was that August 2018?
` A. 2018. Correct.
` Q. And prior to your deposition in August
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` S. Narasimha Murthy, Ph.D.
`2018, did you file declarations in support of
`Flatwing's petition for inter partes review?
` A. Yes, I did.
` Q. Okay. And were those declarations
`subject of your August 2018 deposition?
` A. Come again, please.
` Q. Were those declarations the subject of
`your August 2018 deposition?
` A. Deposition. That's correct.
` Q. Did you review your deposition
`transcripts to prepare your reply declaration?
` A. I did review the deposition transcript.
` Q. To prepare -- did you review it to
`prepare for your reply declaration?
` A. Not to prepare. But I -- in general, I
`review my deposition transcripts just for my
`information.
` Q. Okay. So did you review your deposition
`transcripts prior to preparing or submitting your
`reply declaration?
` A. Yes, I did.
` Q. Okay. So I'm going to assume that --
`for today, that you're generally familiar with
`your previous deposition and declarations, but if
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`you don't understand a question, please let me
`know. Otherwise, I'll assume that you understand
`my questions.
` Is that all right?
` A. Come again?
` Q. I'm going to assume that you're familiar
`with the subject matter of your prior deposition
`in this case and your declarations, but if you
`don't understand a question, please me know.
` A. Okay.
` Q. Is that all right?
` A. Sure. Sure.
` Q. Were you also a witness on behalf of the
`Coalition of Affordable Drugs -- or Coalition for
`Affordable Drugs in three other inter partes
`review proceedings?
` A. I was.
` Q. And the Coalition for Affordable Drugs
`was the petitioner in those proceedings, correct?
` MR. SEGREST: Objection. Relevance.
` Scope.
` A. I was hired by March & Goff as an expert
`witness, yes. They wrote the petition.
` Q. Was that Merchant & Gould --
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` S. Narasimha Murthy, Ph.D.
` A. Merchant & Gould.
` Q. -- who retained you?
` A. That's right.
` Q. Okay. And were the patents involved in
`those other proceedings related to the four
`patents that are the subject of your reply
`declaration?
` MR. SEGREST: Same objection.
` A. That's correct.
`BY MR. SHEH:
` Q. Are you aware that another petitioner,
`Mylan Pharmaceuticals, has joined these
`proceedings since your August 2018 deposition?
` A. The question is again, please?
` Q. Are you aware that another petitioner,
`Mylan Pharmaceuticals, Inc., has joined these
`proceedings since your August 2018 deposition?
` A. Yes, I am.
` Q. Have you been retained by Mylan?
` A. No, I have not.
` Q. So you don't have a retainer agreement
`with Mylan?
` A. No, I don't.
` Q. And you don't have a confidentiality
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`agreement with Mylan?
` A. No, I don't.
` Q. Okay. When was the last time that you
`reviewed your reply declaration?
` A. Sometime, I believe, December 2018.
` Q. And after December 2018, you didn't look
`at your reply declaration?
` A. No.
` Q. What materials did you review in
`preparing your reply declaration?
` A. In preparing the reply declaration, I
`reviewed my -- I reviewed Dr. Lane's declaration.
`I reviewed Austin patent, Brehove patent, Freeman
`patent. That is all I can recall now.
` Q. Did you review Dr. Reider's declaration?
` A. Not -- at that time, I did not review
`Dr. Reider's declaration.
` Q. Have you reviewed Dr. Reider's
`declaration?
` A. I reviewed the -- I reviewed
`Dr. Reider's declaration just recently. That is
`correct. After submission of the declaration --
`my declaration.
` Q. So the first time that you -- was the
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` S. Narasimha Murthy, Ph.D.
`first time that you -- sorry. Strike that.
` Was the first time that you
`reviewed Dr. Reider's declaration after you
`submitted your reply declaration?
` A. Correct.
` Q. Did you review the patent owner's
`response?
` A. No. Not -- not prior to submission of
`the declaration.
` Q. Did you review -- did you review the
`patent owner's exhibits?
` A. No, sir, I didn't.
` Q. Did you review declarations from
`Dr. Kahl, including his reply declaration?
` A. I don't recall reviewing his
`declaration.
` Q. Are you familiar with Dr. Kahl?
` A. Yes. I know that he's one of the expert
`witness on this case.
` Q. Okay. Without disclosing any privileged
`information, can you tell me what you did to
`prepare for today's deposition?
` A. I reviewed my declaration. Again, I
`reviewed the patent claims, and I reviewed Austin,
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`Brehove, and Freeman patents. I also reviewed
`Dr. Reider's declaration, Dr. Lane's declaration,
`as well.
` Q. Okay. Was your review of Dr. Reider's
`declaration, in preparation for today's
`deposition, the first time that you reviewed
`Dr. Reider's declaration?
` A. That's right.
` Q. Sorry. Let's take a step back.
` In preparing your reply
`declaration, did you review Samour?
` A. I did review Samour.
` Q. Okay. Did you meet with counsel to
`prepare for your deposition today?
` A. Yes, I did.
` Q. Okay. How long did you meet with
`counsel?
` A. About five hours yesterday.
` Q. Okay. Did you review any documents or
`materials that haven't been cited in your reply
`declaration in preparation for your deposition
`today?
` A. Basically, we went over my declaration,
`and my counsel was trying to make me -- my
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` S. Narasimha Murthy, Ph.D.
`counsel --
` MR. SEGREST: I'm going to instruct you
` not to answer go into specifics of what we
` discussed.
` THE WITNESS: Okay.
` MR. SEGREST: He's asking if you -- I
` think the question was whether you reviewed
` any other materials.
`BY MR. SHEH:
` Q. Yes. Materials -- material or
`documents.
` A. No, I did not.
` Q. Okay. Showing what's been marked as
`Exhibit 1006.
` A. Okay.
` Q. Dr. Murthy, do you recognize Exhibit
`1006?
` A. Yes, I do.
` Q. Could you -- what is Exhibit 1006?
` A. It's my CV.
` Q. Okay. And this is the CV that you
`submitted in this case, correct?
` A. Right. That's correct.
` Q. Okay. Since your deposition in August
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`2018, has there been any updates to your CV?
` A. Not in this exhibit. I did not update
`the CV --
` Q. Right. I understand.
` A. -- submitted as an exhibit.
` Q. So my question, you keep copy of -- you
`keep a copy -- sorry. Strike that.
` You have a version of your
`curriculum vitae that up to date; is that right?
` A. That's correct. Yeah.
` Q. And my question is, are there any things
`on that CV, the one you keep current, that aren't
`reflected in Exhibit 1006?
` A. No.
` Q. So there have been no updates?
` A. No.
` Q. Okay. So there have been no updates to
`your CV since August 2018?
` A. On this -- this version. The exhibit
`version was not updated. It is the same version
`since I submitted.
` Q. Okay. Are there any differences between
`the version of your curriculum vitae that you keep
`current and Exhibit 1006?
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` S. Narasimha Murthy, Ph.D.
` A. Yes.
` Q. What differences are there -- strike
`that.
` What differences appeared after
`your deposition in August 2018?
` A. I updated my CV. But a few
`publications -- recent publications.
` Q. Were there any other updates besides
`publications?
` A. I probably included a couple of awards
`that I received on the CV.
` Q. Off the top of your head, were any of
`the publications that you added related to
`transungual or ungual penetration?
` A. I don't think was there -- there was
`anything that was transungual.
` Q. Were any of those publication -- did any
`of those publication that you added after August
`2018 relevant to onychomycosis?
` A. Can't recall any of the publications
`that I added related to onychomycosis.
` Q. Okay. So can't recall whether those
`publications were relevant to onychomycosis?
` A. Right. Most likely, I did not do any
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`work on onychomycosis in the past six months. So
`it's likely that I didn't have any publications.
` Q. I see.
` And with respect to the awards you
`mentioned, what awards were those?
` A. One of the awards was by American
`Association of Pharmaceutical Scientists. And the
`other -- a couple of grant awards from the
`granting agencies.
` Q. Were any of those grants related to
`transungual or ungual drug delivery?
` A. No.
` Q. Did any of those grants concern
`onychomycosis or treatments for onychomycosis?
` A. No.
` Q. Okay. In your experience and/or
`training, have you ever participated in any
`dose-ranging studies?
` MR. SEGREST: Object to the form.
` A. I want to know what you mean by
`participated in dose ranges study.
`BY MR. SHEH:
` Q. What do you think participated means or
`could mean?
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` A. I want to know what exactly you -- how
`do define participation in a dose range study,
`before I answer the question.
` Q. Right. I'm happy to use whatever
`meaning you choose. So I'm asking what your
`meaning -- or what meaning you would ascribe to
`the word "participate."
` A. I think I would need a clearer question,
`if you don't mind.
` Q. Okay.
` MR. SEGREST: So I think the confusion
` is participants can the people who are the
` subjects being studied, as opposed to the
` people who are conducting the study. So
` maybe you can clarify the question.
` MR. SHEH: Sure. I'm happy to. And
` thank you for that, Philip.
`BY MR. SHEH:
` Q. Have you ever participated in any
`dose-ranging studies as part of conducting the
`dose-ranging study?
` A. So, again, when you're asking me
`participating in a dose-ranging study, as the
`conductor of the study, would that mean that it is
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`a clinical study or a preclinical study?
` Q. Well, have you participated in any
`dose-ranging studies as part of a clinical trial?
` A. No.
` Q. Okay. Have you participated in any
`dose-ranging studies as part of clinical trials to
`obtain FDA approval of a new drug product?
` A. I did not.
` Q. Have you performed a dose-ranging study
`to assist you in arriving at your opinions in this
`case?
` A. Question, please?
` Q. Have you performed a dose-ranging study
`to assist you in arriving at your opinions in this
`case?
` A. I did not do any dose-ranging study on
`tavaborole.
` Q. What was that last word? I'm sorry?
` A. Tavaborole.
` Q. As a?
` A. As such on tavaborole.
` Q. I understand. Thank you.
` Did you perform any independent
`experiments or analytical measurements in
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`connection with your opinions in this case?
` A. Unders the --
` MR. SEGREST: Objection. Compound.
`BY MR. SHEH:
` Q. Did you perform any independent
`experts --
` A. Uh-huh (affirmative response).
` Q. -- in connection with forming your
`opinions in this case?
` A. I did not conduct any experiments to
`arrive at the conclusion.
` Q. Did you perform any analytical
`measurements in connection with forming your
`opinions in this case?
` A. I did not do any analytical measurements
`on tavaborole to arrive at conclusions in this
`case.
` Q. Okay. Have you opined in this case that
`dose-ranging studies are a routine part of the
`drug development process and well understood by
`those in -- those skilled in the art?
` A. Correct.
` Q. And have you opined in this case that
`dose-ranging studies are a part of the
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`standardized process for obtaining regulatory
`approval from the FDA?
` A. Correct.
` Q. So does the fact that dose-ranging
`studies are, quote, a routine part of the drug
`development process and part of the standardized
`process for obtaining regulatory approval from the
`FDA mean that the dose of any FDA approved drug is
`obvious because of the -- because of those facts?
`Strike that. I'll rephrase it.
` Does this mean that the dose of any
`FDA approved drug is obvious because it was
`arrived at through what you opine to be a routine
`and standardized process?
` MR. SEGREST: Objection. Calls for
` legal conclusion.
` A. Could you rephrase the question, please?
`BY MR. SHEH:
` Q. Sure.
` You opined that dose-ranging
`studies are routine, correct?
` A. That is correct.
` Q. That they're a routine part of the drug
`development process, correct?
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` A. That's right.
` Q. And you also opined that dose-ranging
`studies are part of the standardized process for
`obtaining regulatory approval from the FDA,
`correct?
` A. Correct.
` Q. So do those facts mean that the dose
`arrived for a drug product that is FDA approved is
`always obvious?
` MR. SEGREST: Same objection.
` A. I didn't understand the word "always
`obvious." What do you mean by that?
`BY MR. SHEH:
` Q. Do you opine that --
` A. Uh-huh (affirmative response).
` Q. You opined that the 5 percent
`limitation -- strike that.
` Do you understand -- will you -- do
`you understand -- sorry.
` Do you understand the claims of the
`patents at issue to recite a concentration of
`tavaborole at 5 percent weight by weight?
` A. Correct.
` Q. That's your understanding, correct?
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` A. That's correct.
` Q. That's a dose of tavaborole, correct?
` A. That is the strength of Kerydin
`formulation.
` Q. Right.
` And you've opined that that
`strength or concentration is obvious, correct?
` A. That is the strength at which Kerydin is
`approved by FDA.
` Q. Have you opined that the 5 percent
`concentration is obvious?
` A. 5 percent concentration is the strength
`of Kerydin that is approved by FDA.
` Q. In this case, have you at any point in
`time opined that the 5 percent concentration
`recited in the claims of the patents at issue is
`obvious?
` MR. SEGREST: Objection to form.
` A. Question again, please. I can't recall
`the question. Please come back again.
` (Question was read back.)
` MR. SEGREST: Objection to form.
` Relevance. And misstates the legal standard.
` A. 5 percent concentration is obvious in --
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`in the context that, you know, we generally test
`formulations of different concentrations of the
`drug. 5 percent is -- is inclusive of the
`concentration -- the dose range that we generally
`test the product when we are developing the
`product.
`BY MR. SHEH:
` Q. And that testing that you're referring
`to just now are the dose-ranging studies, correct?
` A. The dose-ranging studies, when you
`say -- are you again referring to the clinical
`trials? Do you mean it is clinical trials or...
` Q. I'm happy to take it as dose-ranging
`studies as part of a clinical trial.
` A. The dose-ranging studies as a part of
`the clinical trial is not required to arrive at an
`optimum concentration of drug in the formulation.
`That is only an FDA requirement for approval of
`the product.
` Q. And that testing or those dose-ranging
`studies are -- you opine to be routine, correct?
` A. That is correct.
` Q. And you opine that they're part of the
`standardized process for obtaining FDA approval,
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`correct?
` A. Dose-ranging studies is also a part of
`the FDA -- FDA process of approving the drug.
` Q. And so does that mean that the dose that
`is arrived at through those studies is obvious?
` MR. SEGREST: Objection. Relevance.
` Legal conclusion.
` A. Again, the question is not clear to me.
`So the dose-ranging studies that FDA requires
`would be run in a clinical setting. It's a human
`subject study. So to arrive at 5 percent strength
`in your formulation, there are other factors to be
`considered.
`BY MR. SHEH:
` Q. So are you distinguishing -- so those
`other factors are not being considered in the FDA
`dose-ranging study? Sorry. I'll strike that.
` Are the factors to which you refer
`not considered during the FDA dose-ranging
`studies?
` MR. SEGREST: Objection to form.
` A. I only know that dose-ranging studies
`are required when you want to get the product
`approved.
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`BY MR. SHEH:
` Q. And does going through that process
`necessarily mean that the dose strength or
`concentration of the resulting drug product is
`obvious?
` MR. SEGREST: Same objection.
` A. Could you tell me how would that be
`obvious?
` MR. SHEH: Strike as nonresponsive.
`BY MR. SHEH:
` Q. There's a question pending. Do you know
`the answer to the question?
` A. No. The question is not clear to me.
` Q. Why isn't it clear to you?
` A. So you're asking me like, you know, when
`a new product need to be approved, the
`dose-ranging studies are performed, and you arrive
`at a dose that's good for human use. So that's
`what it is. I have no idea what you mean by is
`that dose obvious.
` Q. You have no idea what I mean when I'm
`asking whether the dose -- that word concentration
`or strength --
` A. Uh-huh (affirmative response).
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` Q. -- that's arrived at --
` A. Right.
` Q. -- at the end of that dose-ranging study
`is obvious? Is that what you don't understand?
` A. Yeah. I think it's -- that's part of --
`that part is not clear to me.
` Q. So you've opined on the question of
`obviousness in this case, correct?
` A. That's correct.
`BY MR. SHEH:
` Q. Okay.
` MR. SEGREST: Objection. Foundation.
` Go ahead.
`BY MR. SHEH:
` Q. You've opined in this case on the
`question of obviousness, correct?
` MR. SEGREST: Objection. Foundation.
` A. Correct.
` MR. SEGREST: Go ahead.
`BY MR. SHEH:
` Q. And my question is, does the facts -- in
`the same way that you opined in the meaning of
`obviousness, does the fact that a -- that a drug
`product goes through the FDA required dose-ranging
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`study mean that the dose or concentration would
`have been obvious?
` MR. SEGREST: Objection. Foundation.
` Relevance. Legal conclusion.
` A. I only opined that dose-ranging studies
`is a part of product approval process by FDA. I
`mean, that department...
`BY MR. SHEH:
` Q. So with respect to the FDA dose-ranging
`studies, your opinion -- sorry. Strike that.
` So with respect to the parts of
`your reply declaration that discuss FDA required
`dose-ranging studies, those opinions are limited
`to the fact that those dose-ranging studies are
`required?
` A. They are routine and required.
` Q. What do you mean by routine?
` A. Like you follow a standard protocol to
`do the studies.
` Q. What is the standard protocol?
` A. As per the FDA guidance.
` Q. Did you review any FDA guidance?
` A. No.
` Q. Have you ever reviewed an FDA guidance
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`for dose-ranging studies?
` A. Again, I think we are talking two
`different things here. I know that FDA requires a
`dose-ranging study to be performed before you
`submit a new drug application. So that doesn't
`require me to go over every details in the
`guidelines.
` MR. SHEH: Let's take a break.
` (A short recess was taken.)
`BY MR. SHEH:
` Q. In arriving at your opinions in this
`case, have you reviewed any FDA guidance?
` A. I'm generally aware of the guidelines.
`I'm -- I -- my experience, I review a lot of new
`drug application -- applications that are
`submitted to FDA. So I'm aware that dose-ranging
`studies is a requirement by FDA when you want to
`get that new drug application -- the new drug
`application approved.
` Q. Okay. You didn't cite any FDA guidance
`in your reply declaration, did you?
` A. I'm not sure if -- I did not cite those.
` Q. You did not cite those?
` A. No.
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` Q. Okay. What form does the FDA supply its
`guidance in?
` A. What do you mean by what form?
` Q. How does the FDA supply guidance?
` A. Not -- not a fair question.
` Q. You don't understand what the -- how the
`FDA supplies guidance?
` MR. SEGREST: Objection.
` Mischaracterizes his testimony.
` A. FDA guidelines are available on the --
`on the website.
`BY MR. SHEH:
` Q. Okay.
` A. That's all I know.
` Q. Did you review any of those guidelines
`on the we