Page 1
`
` NED H. KALIN, M.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEPTUNE GENERICS, LLC, ) IPR No.
` Petitioner, ) 2018-01494
`vs. )
`CORCEPT THERAPEUTICS, INC., ) U.S. Patent No.
` Patent Owner. ) 8,921,348
`
` VIDEOTAPED DEPOSITION OF NED H. KALIN, M.D.
` Madison, Wisconsin
` July 30, 2019
`
`REPORTED BY:
`Deborah Habian, RMR, CRR, CBC, CLR
`Job No. 163993
`
`TSG Reporting - Worldwide 877-702-9580
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`NEPTUNE GENERICS - Ex. 1036
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`Page 2
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` NED H. KALIN, M.D.
`APPEARANCES:
`
` ON BEHALF OF THE PETITIONER:
` MASSEY & GAIL
` BY: CHRISTOPHER MAY, ESQ.
` KENNETH GOLDMAN, ESQ.
` 1000 Maine Avenue, SW
` Washington, DC 20024
`
` ON BEHALF OF THE PATENT OWNER:
` LATHAM & WATKINS
` BY: MICHELLE ERNST, ESQ.
` 885 Third Avenue
` New York, NY 10022
`
`ALSO PRESENT:
` Jon Hansen, Certified Legal Video Specialist
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` NED H. KALIN, M.D.
`
` JULY 30, 2019
` 8:34 A.M. CST
`
` Videotaped Deposition of
`NED H. KALIN, M.D., held at the law offices of
`Husch Blackwell, LLP, 33 East Main Street,
`Madison, Wisconsin, 53701, taken pursuant to
`notice before Deborah Habian, RMR, CRR, CBC,
`CLR, Illinois Certified Shorthand Reporter,
`Missouri Certified Court Reporter.
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` NED H. KALIN, M.D.
`(CONTINUING)
` INDEX OF EXHIBITS
` PETITIONER'S EXHIBITS TO DR. KALIN DEPOSITION
`NUMBER DESCRIPTION PAGE
`Exhibit 3 Kalin Lab Recent Publications 27
`
`Exhibit 4 5/20/19 Patent Owner's 31
` Response in Case IPR2018-01494
`
`Exhibit 5 U.S. Patent 8,598,149 44
`
`Exhibit 6 3/20/07 news release: 81
` Corcept Therapeutics Announces
` Phase 3 Study Evaluating CORLUX
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` NED H. KALIN, M.D.
` I N D E X
`WITNESS: PAGE
`NED H. KALIN, M.D.
` Examination by Mr. May ................. 9
`
`INSTRUCTIONS AND REQUESTS OF COUNSEL
` By Ms. Ernst ........................... 34
`
` INDEX OF EXHIBITS
` PETITIONER'S EXHIBITS TO DR. KALIN DEPOSITION
`NUMBER DESCRIPTION PAGE
`Exhibit 1 Thaddeus S. Block, et al. 20
` article Combined Analysis of
` Mifepristone for Psychotic
` Depression: Plasma Levels
` Associated with Clinical Response
`
`Exhibit 2 Block, et al. article 23
` Mifepristone Plasma Level
` and Glucocorticoid Receptor
` Antagonism Associated with
` Response in Patients with
` Psychotic Depression
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` NED H. KALIN, M.D.
`(CONTINUING)
` INDEX OF EXHIBITS
` PREVIOUSLY MARKED PETITIONER'S EXHIBITS
`NUMBER DESCRIPTION PAGE
`Exhibit 1001 U.S. Patent 8,921,348 39
`
`Exhibit 1006 1993 Murphy et al., article 67
`
`Exhibit 1007 Belanoff article titled 59
` An Open Label Trial of C-1073
` (Mifepristone) For Psychotic
` Major Depression
`
`Exhibit 1010 U.S. Patent 6,964,953 61
`
`Exhibit 1023 September 2001 Chu and 66
` Belanoff article Successful
` Long-Term Treatment of Refractory
` Cushing's Disease With High-Dose
` Mifepristone (RU486)
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` NED H. KALIN, M.D.
`(CONTINUING)
` INDEX OF EXHIBITS
` PREVIOUSLY MARKED PETITIONER'S EXHIBITS
`NUMBER DESCRIPTION PAGE
`Exhibit 1024 United States Patent 64
` Application publication
` to Belanoff, publication
` No. US2004/0029848
`
`Exhibit 2016 Declaration of Dr. Ned H. 14
` Kalin, M.D. in Support of
` Patent Owner's Response re
` Case IPR2018-01494
`
`Exhibit 2017 Curriculum Vitae of 30
` Ned H. Kalin, M.D.
`
`Page 8
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`Page 9
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` NED H. KALIN, M.D.
`Doctor.
` THE WITNESS: (Complying.)
` (Oath administered.)
` THE WITNESS: I do.
` THE REPORTER: Thank you.
`
` NED H. KALIN, PH.D.,
`called as a witness herein by the petitioner,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. MAY:
` Q. Dr. Kalin, have you had your deposition
`taken before?
` A. For this?
` Q. No. In any matter.
` A. Yes.
` Q. How many times?
` A. I don't know.
` Q. Okay. 10, 20?
` A. Oh, no. I would say maybe five --
` Q. Okay.
` A. -- something like that.
` Q. Okay. So you're something of an old
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` NED H. KALIN, M.D.
` THE VIDEOGRAPHER: Good morning. We're
`on the record. This is the start of tape
`labeled No. 1 of the videotaped deposition of
`Dr. Ned H. Kalin in the matter of Neptune
`Genetics [sic], LLC vs. Corcept Therapeutics,
`Inc., United States Patent and Trademark Office,
`Case No. IPR2018-01494.
` This deposition is being held in
`Madison, Wisconsin. Today's date, July 30th,
`2019. The time is 8:34.
` My name's Jon Hansen, CLVS from TSG
`Reporting, Inc., and I am the legal
`videographer.
` At this time if counsel can please
`state their appearances for the record, after
`which our reporter will swear in the witness and
`we can proceed.
` MR. MAY: Christopher May of
`Massey & Gail for the Petitioner Neptune
`Generics, and with me is Ken Goldman.
` MS. ERNST: Michelle Ernst from
`Latham & Watkins on behalf of Corcept
`Therapeutics and the witness.
` THE REPORTER: Raise your right hand,
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`NEPTUNE GENERICS - Ex. 1036
`Page 3
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`Page 10
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` NED H. KALIN, M.D.
`hand at this. I mean, I'm sure your attorney
`has talked with you about this, but just to kind
`of give you the ground rules for today, I'm
`going to be asking you a series of questions and
`I'd like for you to answer them as fully and
`completely as you can.
` The court reporter and the videographer
`here will be taking down my questions and your
`answers for the record. If I happen to
`answer -- ask you a yes-or-no question, try to
`answer "yes" or "no." Nods, "um-hums," they
`don't show up very well on the record.
` Unless your attorney actually says
`"Please don't answer the question," I'd ask you
`to answer the question. She may object
`periodically. That's something that we'll all
`work out far in the future from here other than
`her saying "Please don't answer the question."
` We're using either 60- or 90-minute
`tapes. I don't know which one it is. So we'll
`be naturally taking a break at those points. I
`also understand that you need a break at
`11 o'clock. I'm fine with that. If you need a
`break at any other time, please let me know.
`
`Page 12
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` NED H. KALIN, M.D.
` Q. All right. Is there any reason you
`can't give truthful or complete testimony today?
` A. No.
` Q. So can you tell me what your occupation
`is, please?
` A. I'm a psychiatrist.
` Q. And what exactly is the kind of
`research that you do as a psychiatrist?
` A. So I --
` MS. ERNST: Dr. Kalin, just give me an
`opportunity to object.
` THE WITNESS: Okay.
` MS. ERNST: I'm going to object to
`form.
`BY MR. MAY:
` Q. You can answer.
` A. I -- the research that I do is related
`to understanding why some children are at risk
`to develop anxiety and depression and others are
`not.
` Q. Okay. And how long have you been doing
`that kind of research?
` A. Let's see, probably for about 35,
`40 years.
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`Page 11
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` NED H. KALIN, M.D.
` A. Okay.
` Q. I can give you a break at any point.
`The one thing I would ask is that if I have a
`question pending, you go ahead and answer that
`question and then we can take a break.
` A. Sure.
` Q. If you don't answer -- oh, excuse me.
`If you don't understand one of my questions,
`please let me know. I'll try and rephrase it.
`But if you don't tell me you don't understand
`the question, I have to assume that you
`understood it.
` A. Okay.
` Q. Other than that, I think we're pretty
`much ready to go.
` I believe you mentioned that you
`brought your declaration with you today?
` A. Yes.
` Q. Okay. Did you bring any other
`documents with you today?
` A. No.
` Q. Okay. Have you ever been convicted of
`a crime other than a traffic offense?
` A. No.
`
`Page 13
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` NED H. KALIN, M.D.
` Q. So do you -- does your research involve
`adults at any point?
` A. It does.
` Q. Okay. How long have you been doing
`research involving adults?
` A. Probably about the same amount of time.
` Q. Okay. Have you prepared an expert
`declaration before?
` A. No.
` Q. Okay. And you said you've been deposed
`about five times or so?
` A. It's hard for me to be specific over
`the years.
` Q. Can you give me any specific cases that
`you were deposed in?
` A. I can't give you the specifics. I can
`tell you that it was related mostly to mental
`illness, competency types of things.
` Q. Okay. So you've never been deposed in
`a patent case before?
` A. No.
` Q. Have you ever testified in court
`before?
` A. Yes.
`
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` NED H. KALIN, M.D.
` Q. Okay. About how many times?
` A. Oh, maybe three or four.
` Q. Okay.
` A. Actually, it may be more than that.
` Q. Has your opinion ever been rejected or
`not credited by a judge in a court case?
` MS. ERNST: Objection, foundation.
` THE WITNESS: Probably.
`BY MR. MAY:
` Q. Okay. Do you remember what that was?
` A. No.
` Q. Okay. When did you agree to serve as
`an expert witness in this case?
` A. I'm not sure. I believe in April or
`May.
` Q. Okay. And about how long did you spend
`preparing your declaration? Just for the
`record, that's Exhibit 2016, which you've
`already been handed.
` A. I'm not exactly sure of that either.
` Q. Can you give me an estimate, 10,
`20 hours?
` A. I would say maybe five to -- five
`hours, seven hours, something like that.
`
`Page 16
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` NED H. KALIN, M.D.
` Q. Okay. Do you remember when the stock
`options were exercised?
` A. They never were exercised.
` Q. So -- so do you still have them or do
`you not have them?
` A. They expired.
` Q. Okay. You are a member of Corcept's
`Scientific Advisory Board?
` A. At some point I was.
` Q. Okay. Do you remember when you were on
`the board?
` A. No.
` Q. Okay. Do you remember when you left
`the board?
` A. No.
` Q. Okay.
` A. I'm not even sure I was a member of the
`scientific advisory board. I may have been.
` Q. Was being on the scientific advisory
`board a paid position?
` A. I'm not sure I was on it. I was paid
`to consult.
` Q. Okay. And how much were you paid to
`consult?
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` NED H. KALIN, M.D.
` Q. And you're being paid $500 an hour for
`your time in this project?
` A. That's correct.
` Q. Okay. So you made somewhere between
`2,500 and 3,500 dollars preparing this
`deposition?
` A. That's my estimate.
` Q. Okay. Have you ever owned stock in
`Corcept?
` A. I've had stock op- -- yes.
` Q. Okay. Do you still own stock in
`Corcept?
` A. No.
` Q. Okay. When did you sell the stock that
`you have in Corcept?
` A. I'm not sure.
` Q. Okay. Was it more than a few years --
`a couple -- earlier than 2016?
` A. Ah, I'm not sure.
` Q. Okay.
` A. I also had stock options.
` Q. Okay. And do you remember the total
`number of stock options that you had?
` A. No.
`
`Page 17
`
` NED H. KALIN, M.D.
` A. Over the last ten years, roughly
`$5,700.
` Q. Okay. Do you have any ongoing
`consulting projects with Corcept?
` A. I'm involved with -- yes.
` Q. And to the extent that you can tell me,
`that you're not bound by a secrecy agreement,
`what are those?
` A. I'm involved in a safety advisory board
`for a drug addiction study.
` Q. Okay. And is -- are you being paid for
`that consulting?
` A. Yes.
` Q. Okay. How much?
` A. I'm not sure.
` Q. Are you the head of University of
`Wisconsin Psychiatry Department?
` A. I'm the chair.
` Q. Okay. What -- what are your
`responsibilities as the chair of the department?
` A. My responsibilities are to oversee the
`operations of the department.
` Q. Okay. And what are the operations of
`the department?
`
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`Page 18
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` NED H. KALIN, M.D.
` A. So the operations of the department
`include clinical programs, teaching programs,
`research and outreach.
` Q. Has Corcept donated to the psychiatry
`department?
` A. Yes.
` Q. Okay. How much has it donated?
` A. I'm not sure.
` Q. Okay. Do you know the time period over
`which they've donated?
` A. I can't tell you specifically.
` Q. And in your declaration, you said some
`of the Corcept grants have been used to fund
`your research team?
` A. Yes.
` Q. Okay. Does that support directly
`support any graduate students?
` MS. ERNST: Objection to form.
`BY MR. MAY:
` Q. You can answer.
` MS. ERNST: You can answer.
` THE WITNESS: I don't know.
`BY MR. MAY:
` Q. Do you know how much those grants are?
`
`Page 20
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` NED H. KALIN, M.D.
` A. The majority.
` Q. Have you served as an expert witness
`for Corcept in the past?
` A. No.
` Q. Okay.
` (Kalin Exhibit 1 was marked
` for ID.)
`BY MR. MAY:
` Q. Dr. Kalin, you're being handed what's
`been marked Kalin Exhibit 1, and this is an
`article from Biological Psychiatry dated
`July 1st, 2018, titled "Combined Analysis of
`Mifepristone for Psychotic Depression: Plasma
`Levels Associated With Clinical Response."
` Do you see that?
` A. Yes.
` MS. ERNST: And for the record, I'm
`going to object to this exhibit on the basis of
`hearsay, authenticity, relevancy and scope.
` MR. MAY: Okay.
`BY MR. MAY:
` Q. So, Dr. Kalin, can you look at the
`third name on there?
` A. Yes.
`
`Page 19
`
` NED H. KALIN, M.D.
` A. I'm not sure.
` Q. Does Corcept provide any direct grants
`to your lab?
` A. Corcept provided a -- I believe a
`contract to the department, which in part was
`used for some research in my lab, but I'm not
`totally certain about the structuring of all
`that.
` Q. Okay. Do you remember when that was?
` A. It was probably four or five years ago,
`something like that or maybe longer.
` Q. Between direct and indirect grants,
`about how much support has Corcept provided your
`lab in the last five years?
` MS. ERNST: Objection, asked and
`answered.
`BY MR. MAY:
` Q. You can answer the question.
` A. I would estimate maybe $150,000 but not
`all to my lab, I don't think.
` Q. Do you know how much of that is to your
`lab?
` A. No.
` Q. Okay.
`
`Page 21
`
` NED H. KALIN, M.D.
` Q. And it says Ned Kalin. Is that you?
` A. Yes.
` Q. Okay. And if you could look at the
`fifth name on there, Joseph Belanoff, is that
`the Joseph Belanoff that's the inventor of the
`'348 patent?
` A. Yes.
` Q. Was this article listed in your CV?
` A. No.
` Q. Okay. And why was it not listed in
`your CV?
` A. It was a mistake.
` Q. So this was just an error on your part,
`not including this in your CV?
` A. Yes.
` Q. Okay. So if you could go to page 47
`which is the second page of the article.
` A. (Witness complying.)
` Q. And could I take you to the second
`paragraph, column 1. And it says: "We provide
`a combined analysis of the five similarly
`designed double-blind Phase 2 and 3 studies of
`mifepristone to treat PD sponsored by Corcept
`Therapeutics."
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`Page 22
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` NED H. KALIN, M.D.
` Do you see that?
` A. Yes.
` Q. Can you tell me what PD means?
` A. Psychotic depression.
` Q. Okay. And the Phase 2 and 3 studies
`that are referred to in this sentence, are any
`of those studies the studies that are discussed
`in the '348 patent?
` MS. ERNST: Objection, form.
` THE WITNESS: I don't know. I don't
`know.
`BY MR. MAY:
` Q. Okay.
` A. I mean, I could look at -- let's see...
` Q. If you need to take a look at the '348
`patent, please feel free in order to answer the
`question.
` A. (Reviewing document.)
` Because the study numbers are not on
`here, I can't be certain about the data that is
`in here in relation to the data that is here
`(indicating to document).
` Q. Okay. Do you believe that the studies
`that are mentioned in here are the same studies
`
`Page 24
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` NED H. KALIN, M.D.
`that.
` MS. ERNST: And for the record, I
`object to this exhibit on the basis of hearsay,
`authenticity, relevance and scope.
` MR. MAY: Okay.
` THE WITNESS: (Reviewing document.)
`BY MR. MAY:
` Q. Just let me know when you're done
`taking a look.
` A. Okay. (Reviewing document.)
` I'm done.
` Q. Okay. So if you could take a look at
`the fourth name at the top of the document, it
`says Ned Kalin, MD.
` Is that you?
` A. Yes.
` Q. And the name after that is Joseph
`Belanoff, MD.
` Do you see that?
` A. Yes.
` Q. Is that the Mr. Belanoff who's the
`inventor of the '348 patent?
` A. Yes.
` Q. Was this document on your CV?
`
`Page 23
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` NED H. KALIN, M.D.
`that are in the actual re- -- patent?
` A. I believe --
` MS. ERNST: Objection, asked and
`answered.
`BY MR. MAY:
` Q. You can answer.
` A. I believe that some of the patients --
`the data from some of the patients that are in
`here are in here, but I'm not sure exactly the
`study numbers or how they exactly relate to the
`studies here (indicating to document).
` Q. Okay.
` MR. MAY: Mark this Kalin Exhibit 2.
` (Kalin Exhibit 2 was marked
` for ID.)
`BY MR. MAY:
` Q. Dr. Kalin, you're being handed what's
`been marked as Kalin Exhibit 2. This is an
`article from the Journal of Clinical
`Pharmacology dated October 2017 and entitled
`"Mifepristone Plasma Level and Glucocorticoid
`Receptor Antagonism Associated With Response in
`Patients With Psychotic Depression."
` And just take a moment to look over
`
`Page 25
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` NED H. KALIN, M.D.
` A. No.
` Q. And why was it not on the CV?
` A. From time-to-time there will be papers
`that are written that for whatever reasons, I
`don't get to my secretary and they don't get put
`on my CV. So it's an oversight.
` Q. And so this is a -- this is a study
`involving mifepristone, agreed?
` A. Yes.
` Q. Okay. And if you could go down -- let
`me stop here.
` Are any of the studies that are
`discussed here, the studies that are in the '348
`patent?
` A. I --
` MS. ERNST: Object to form.
` THE WITNESS: I'll give you the same
`answer that I gave before, which is my guess --
`I don't -- I don't know.
`BY MR. MAY:
` Q. Okay. If you could go down to the
`footnotes that are in the first column.
` A. Of the paper?
` Q. Yes.
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`Page 26
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` NED H. KALIN, M.D.
` A. Yes.
` Q. So -- and I believe it's the fourth
`paragraph that starts "Course of
`therapeutics..."
` And it says: "Course of therapeutics
`had a role in the design and conduct of the
`study, the collection management analysis and
`interpretation of the data, preparation review
`or approval of the manuscript and decision to
`submit the article for publication."
` Do you see that?
` A. Yes.
` Q. Okay. I'd like to start with the last
`piece. "The decision to submit the article for
`publication," can you explain what that means?
` MS. ERNST: Objection to form, calls
`for speculation.
`BY MR. MAY:
` Q. You can answer the question.
` A. The first author of any manuscript is
`the person who decides whether to submit it and
`where to submit it.
` Q. Okay. And so Mr. Block -- or excuse
`me -- Dr. Block was the person who decided
`
`Page 28
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` NED H. KALIN, M.D.
` MS. ERNST: And I'll -- I'm -- just
`give me a chance to review this.
` MR. MAY: Okay.
` THE WITNESS: Yes.
`BY MR. MAY:
` Q. Okay.
` MS. ERNST: Wait. Wait. I'm sorry.
`I'm still reviewing.
` THE WITNESS: Okay.
` MS. ERNST: And I'll object to this
`exhibit as hearsay on the basis of authenticity,
`relevance and scope.
` MR. MAY: Okay.
`BY MR. MAY:
` Q. Dr. Kalin, can you tell me what this
`is, what this document is, please?
` A. It looks like it's from my website,
`from the lab's website.
` Q. Okay. Let the record reflect that this
`is a printout of a website that can be reached
`at
`https://kalinlab.psychiatry.wisc.edu/recent
`publications, and it was obtained on May the
`21st, 2019.
`
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` NED H. KALIN, M.D.
`whether to submit it?
` A. I assume so. That's typically the way
`it works.
` Q. So you weren't involved in any way in
`the decision to publish this paper?
` A. I was involved with discussions about
`the paper and about what the publication would
`look like.
` Q. Were you involved in any of the
`research in this paper?
` A. I don't believe so.
` Q. Can you tell me why your name is on the
`paper then?
` A. Because I have consult -- was
`consulting to them and was looking at their data
`and trying to understand it.
` MR. MAY: I'm going to mark this as
`Kalin 3.
` (Kalin Exhibit 3 was marked
` for ID.)
`BY MR. MAY:
` Q. And, Dr. Kalin, do you recognize this
`particular printout?
` A. Yes.
`
`Page 29
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` NED H. KALIN, M.D.
` Dr. Kalin, if you could go to the
`second page.
` A. (Witness complying.)
` Q. And go to the sixth under "Recent
`publications 2018."
` A. Yes.
` Q. Do you see that?
` A. Yes.
` Q. All right. And is this the document
`that we just marked as Kalin Exhibit 1?
` A. Yes.
` Q. Okay. And if you could go to page 3?
` A. (Witness complying.)
` Q. And the first document that's listed on
`page 3, is that the document that we just marked
`as Kalin Exhibit 2?
` A. Yes. This looks like the E -- I mean,
`this looks like it was -- because the number on
`the DOI, it looks like it was maybe before it
`was published and out in print, but yes.
` Q. Okay. Thank you.
` So you didn't look at your recent
`publications on your website prior to preparing
`your CV?
`
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` NED H. KALIN, M.D.
` A. No.
` Q. Okay. If you could, I'd like to go to
`Exhibit 2016, which is your declaration.
` A. (Witness complying.)
` Q. And you prepared this declaration,
`correct?
` A. Correct.
` Q. You agree with everything that was
`written here when it was written?
` A. Yes.
` Q. Okay. Do you still agree with
`everything that's written here?
` A. Yes.
` Q. Okay. You mentioned that there were
`two omissions to your CV. Is there anything
`else you want to change or correct in your
`declaration before we start discussing it?
` A. No.
` Q. Okay. So if we could go to the back of
`the deposition, the last page -- excuse me, the
`declaration.
` A. (Witness complying.)
` Q. And is that a complete list of the
`materials that you reviewed in preparing this
`
`Page 32
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` NED H. KALIN, M.D.
` A. No.
` Q. Okay. So going back to the materials
`that you reviewed on the last page of your
`declaration.
` A. (Witness complying.)
` Q. Did you look at these documents from
`the perspective of a person of ordinary skill in
`the art?
` A. Yes.
` Q. Okay. And do you consider yourself a
`person of ordinary skill in the art?
` A. Yes.
` Q. And if you could go to the
`second-to-last document on your Materials
`Reviewed?
` A. Second-to-last document?
` Q. Um-hum.
` A. What are you referring to? I'm not --
` Q. On that -- on that last page, go down
`to the second-to-last document --
` A. Oh, right here. You mean right here.
` Q. Yes.
` A. Okay.
` Q. And this is the declaration of Hartmut
`
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` NED H. KALIN, M.D.
`declaration?
` A. Yes.
` Q. So you didn't look at anything else in
`preparing it?
` A. I don't believe so.
` Q. Okay. Have you seen the patent owner's
`response that's been filed in this inter partes
`review?
` A. The what?
` Q. The patent owner's response that's been
`filed in this inter partes review?
` A. What is a that? I'm not sure if I have
`or not.
` (Kalin Exhibit 4 was marked
` for ID.)
`BY MR. MAY:
` Q. So I'm handing you what's been marked
`as Kalin Exhibit 4, which is the patent owner's
`response in this inter partes review. I'll just
`ask you again, have you seen this document
`before?
` A. No.
` Q. So you didn't rely on this in any way
`for your analysis?
`
`Page 33
`
` NED H. KALIN, M.D.
`Derendorf, Ph.D. in support of the patent
`owner's response. Do you see that?
` A. Yes.
` Q. Okay. You relied on that to formulate
`your opinion?
` A. I don't --
` MS. ERNST: Objection to form.
` THE WITNESS: I don't remember that.
`BY MR. MAY:
` Q. Did you have any discussions with
`Dr. Derendorf --
` A. No.
` Q. -- during...
` Okay. Do you remember disagreeing with
`any of the conclusions in Dr. Derendorf's
`declaration?
` A. I don't remember if I reviewed it.
` Q. Are there any other documents in these
`Materials Reviewed that you don't remember
`whether or not you reviewed?
` A. I reviewed all -- I remember that I
`reviewed all the rest of them.
` Q. Now, for this question, I just need a
`yes-or-no answer. Did your attorneys instruct
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` NED H. KALIN, M.D.
`you on how to construe the claim terms of the
`'348 patent?
` MS. ERNST: Objection to form. I'm
`just going to caution the witness not to
`disclose any communications that you may have
`had with counsel.
` THE WITNESS: What is -- I don't know.
`I don't know what that means.
`BY MR. MAY:
` Q. What we're asking you is don't tell me
`anything that you and Michelle might have
`discussed or that you may have discussed with
`any of Michelle's colleagues. I just want a
`yes-or-no answer.
` A. What is the question again? Can you
`repeat it?
` Q. Did your attorneys instruct you on how
`to construe any of the claim terms in the '348
`patent?
` A. No.
` Q. So you didn't apply any specific
`constructions to the claim terms for the
`purposes of your declaration?
` A. I don't know what you mean by
`
`Page 36
`
` NED H. KALIN, M.D.
`something specific.
` A. Yes.
` MS. ERNST: Objection to form.
`BY MR. MAY:
` Q. Okay. Where are those in your
`declaration?
` A. Where are they?
` Q. Yes.
` A. I don't know.
` Q. Please take a look and just let me
`know.
` A. One thing that came to mind was the
`discussion about the person -- let me see if I
`can look here. (Reviewing document.)
` Q. So you're referring to the discussion
`that starts on paragraph 13?
` A. No. No. The definition of a POSA, for
`example.
` Q. Okay. There were no specific
`interpretations of the '348 patent that you were
`told to use for the analysis in your
`declaration?
` A. No.
` MS. ERNST: Objection, vague.
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` NED H. KALIN, M.D.
`"constructions." What do you mean?
` Q. Okay. I mean, did they tell you that
`any words in the claims of the patent meant
`something specific?
` MS. ERNST: I'm going to object. I
`think that calls for attorney-client
`communications.
` MR. MAY: I'm just asking for "yes" or
`"no."
` MS. ERNST: I think it's asked and
`answered.
` THE WITNESS: Do I -- am I supposed to
`answer the question?
` MS. ERNST: You can answer "yes" or
`"no."
` THE WITNESS: So yes.
`BY MR. MAY:
` Q. Okay. Now, are those constructions in
`your declaration?
` A. Can you define "constructions" one more
`time for me?
` Q. Sure. The words in the claim --
` A. Right.
` Q. -- that you would have been told mean
`
`Page 37
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` NED H. KALIN, M.D.
` Dr. Kalin, just give me a second. I
`know it's hard with the timing.
` THE WITNESS: Sorry.
`BY MR. MAY:
` Q. Could you go to page -- excuse me -- to
`paragraph 49 of your declaration. That's
`page 19 going over into 20.
` A. (Witness complying.)
` Q. Do you have that?
` A. Yes.
` Q. Okay. And you say in that paragraph
`that "The '348 patent's optimization methodology
`is different than those traditionally used by
`psychiatrists for treating mental disease."
` Do you see that?
` MS. ERNST: Objection to form.
` THE WITNESS: Yes.
`BY MR. MAY:
` Q. Okay. Can you explain what you mean by
`"the '348 patent's optimization methodology"?
` MS. ERNST: I'll object to the extent
`it calls for a legal conclusion.
` MR. MAY: They're his words.
`
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`

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` NED H. KALIN, M.D.
`BY MR. MAY:
` Q. You can answer.
` A. Could you repeat the question?
` Q. Yes. Can you explain what you mean by
`"the '348 patent's optimization methodology"?
` MS. ERNST: Same objection.
` THE WITNESS: The optimization
`methodology that I was referring to is related
`to using the blood levels, the plasma levels of
`mifepristone to guide treatment.
`BY MR. MAY:
` Q. Okay. Is there a reason that you
`limited your analysis in paragraph 49 to mental
`diseases?
` A. Yes.
` MS. ERNST: Objection to fo