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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
` ________________________
`
` VIDEOTAPED DEPOSITION OF MICHAEL MAYERSOHN, PH.D.
` New York, New York
` Monday, May 16, 2016
`
`Reported by: ANNETTE ARLEQUIN, CCR, RPR, CRR, CLR
`Job No: 107335
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` May 16, 2016
` 9:00 a.m.
`
` Video deposition of MICHAEL MAYERSOHN,
`Ph.D., held at the offices of GOODWIN
`PROCTER, 620 Eighth Avenue, New York, New
`York, pursuant to Notice, before Annette
`Arlequin, a Certified Court Reporter, a
`Registered Professional Reporter, a
`Certified LiveNote Reporter, a Certified
`Realtime Reporter, and a Notary Public of
`the State of New York.
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`A P P E A R A N C E S:
`
` GONSALVES LAW FIRM
` Attorneys for Coalition for Affordable Drugs
` 2216 Beacon Lane
` Falls Church, VA 22043
` BY: GREGORY GONSALVES, ESQ.
`
` GOODWIN PROCTER
` Attorneys for Trustees of the University
` of Pennsylvania
` The New York Times Building
` 620 Eighth Avenue
` New York, NY 10018
` BY: CYNTHIA HARDMAN, ESQ.
` ERIC ROMEO, ESQ.
` WILLIAM JAMES, ESQ.
` - and -
` WILMER CUTLER PICKERING HALE and DORR
` 60 State Street
` Boston, MA 02109
` BY: MARY SCOZZAFAVA, Ph.D., ESQ.
`ALSO PRESENT:
` ROBERT RINKEWICH, Legal Video Specialist
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` M. Mayersohn, Ph.D.
` THE VIDEOGRAPHER: This is the start
`of media labeled No. 1 of the
`video-recorded deposition of Michael
`Mayersohn in the matter of Coalition for
`Affordable Drugs, Roman number VIII LLC
`versus The Trustees of the University of
`Pennsylvania in the United States Patent
`and Trademark Office for the Patent Trial
`and Appeal Board.
` This deposition is being held at 620
`Eighth Avenue, New York, New York, on
`May 16th, 2016, at approximately 9:06 a.m.
` My name is Robert Rinkewich. I am
`the legal video specialist from TSG
`Reporting, Inc., headquartered of 747 Third
`Avenue, New York, New York.
` The court reporter is Annette
`Arlequin, in association with TSG
`Reporting.
` Counsel, please introduce yourselves.
` MS. HARDMAN: Cynthia Hardman of
`Goodwin Procter for the patent owner, and
`with me are Eric Romeo and Bill James.
` MR. GONSALVES: Gregory Gonsalves
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` M. Mayersohn, Ph.D.
` from the Gonsalves Law Firm representing
` the petitioner.
` THE VIDEOGRAPHER: Will the court
` reporter please swear in the witness.
` * * *
`M I C H A E L M A Y E R S O H N, Ph.D., called
` as a witness, having been duly sworn by a
` Notary Public, was examined and testified
` as follows:
`EXAMINATION BY
`MS. HARDMAN:
` Q. Good morning, sir.
` Would you please state your full
`name.
` A. Good morning, Ms. Hardman. Michael
`Mayersohn.
` Q. I know you've given depositions
`before, so I'll keep it short. But if I ask you
`a question today that you don't understand,
`would you please ask me to clarify?
` A. Certainly.
` Q. Is there any reason today that you
`can't give truthful and accurate testimony?
` A. No, ma'am.
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` M. Mayersohn, Ph.D.
` Q. Who retained you for this matter?
` A. Originally I was contacted by the law
`firm Rakoczy Molino about a year ago, as I
`recall.
` Q. And when did you connect with the
`Gonsalves Law Firm?
` A. I don't recall the exact date.
`Probably it would have been within the last four
`or so months.
` Q. And when did you begin substantive
`work on this matter?
` A. Well, at the time or prior to having
`authored a declaration.
` Q. Do you have an understanding of why
`the Rakoczy firm approached you in connection
`with this case?
` A. I assume they were retained by the
`petitioner.
` Q. And the petitioner, that's the
`Coalition for Affordable Drugs?
` A. As I understand it, yes.
` Q. Do you have an understanding of what
`it was -- why they chose you in particular?
` A. And by "they" you mean Rakoczy?
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` M. Mayersohn, Ph.D.
` Q. Yes.
` A. Well, I've worked with them before.
` Q. How many times have you worked with
`Rakoczy?
` A. It's an estimate, Ms. Hardman. I'd
`say about four times.
` Q. Have you done any previous work with
`the Gonsalves Law Firm?
` A. No.
` Q. How about a law firm McNeely, Hare
`and War?
` A. Yes.
` Q. How many times have you worked with
`the McNeely firm?
` A. One time at trial.
` Q. What trial was that?
` A. What you're asking is the drug
`involved?
` Q. Yes.
` A. As I recall, it was Fesoterodine.
` Q. When did that trial take place
`approximately, what year?
` A. I believe it would have been the
`spring of 2015.
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` M. Mayersohn, Ph.D.
` Q. How many depositions have you given
`in lawsuits during the last four years?
` A. I don't recall exactly. You should
`have a copy of it appended to my declaration.
` Q. Your CV lists your prior testimony?
` A. Not my CV. There should be a list of
`prior testimony that I provided.
` Q. So how many times have you given
`trial testimony in the last four years?
` A. You said trial?
` Q. Yes.
` A. Do you happen to have a copy of that
`listing? Because I can't recall.
` Q. I'm not sure if we received such a
`listing, but I guess without that list, you
`aren't able to recall the number of depositions
`or trials in the last four years; is that
`correct?
` A. I thought the question was trials.
`I'd have to offer an approximation.
` In the last four years, two to three
`bench trials. And the number of depositions in
`the last four years would probably be in the
`range of 12.
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` M. Mayersohn, Ph.D.
` Q. And was that approximately 12
`depositions in 12 separate cases?
` A. In one or two of the cases, there
`were more than one deposition.
` Q. How many litigations are you
`currently retained on?
` A. Approximately five.
` Q. And you understand that the preceding
`we are here for today is an inter partes review?
` A. I do.
` Q. And is it okay if we sometimes call
`that an IPR?
` A. That's fine.
` Q. How many IPR proceedings are you
`currently involved in?
` A. This is the only one, as I recall.
` Q. The only one --
` A. IPR.
` Q. Have you been involved with any IPRs
`prior to this one?
` A. No.
` Q. Those are for you. And I'm going to
`give you one in a moment.
` I'm going to hand you what was
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` M. Mayersohn, Ph.D.
`previously marked as CFAD Exhibit 1003 in the
`IPR relating to U.S. Patent No. 8618135, and
`what's been previously marked as CFAD 1003 in
`the IPR relating to U.S. Patent 7,932,268.
` (Handing.)
` A. Thank you.
` Q. Before we get to those documents, let
`me just ask you, when you mentioned the Rakoczy
`firm, who was the attorney who reached out to
`you?
` A. The reason I'm hesitating is because
`I think the person who first contacted me is no
`longer with the firm. The person I worked with
`was Jeffrey Marx.
` Q. And in terms of the approximately two
`or three trials that you've testified in the
`last four years, was that -- were you always
`testing on behalf of the patent challenger in
`those cases?
` A. The defendant, yes.
` Q. And with regard to the approximately
`12 or so depositions you mentioned, is that
`always on behalf of the patent challenger as
`well?
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` M. Mayersohn, Ph.D.
` A. And, again, your reference frame is
`the last four years, correct?
` Q. Correct.
` A. The answer is yes.
` Q. And when you were working with
`Mr. Marx, what was the subject matter of what
`you were working with Mr. Marx on?
` A. What resulted in my declaration.
` Q. Is it the case that you began working
`on your declaration with the Rakoczy firm?
` A. Correct.
` Q. Are they still involved in your work
`on this today?
` A. Not to the best of my knowledge.
` Q. At some point did you transition from
`working with the Rakoczy firm to working with
`the Gonsalves firm?
` A. That's correct.
` Q. Now turning back, please, to the
`documents I handed you. Exhibit 1003 in the
`'135 matter, if you can take a look at that
`document, please.
` A. Where would you like me to turn?
` Q. If you can take a look at the last
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` M. Mayersohn, Ph.D.
`page of that document, please, page 57.
` A. Yeah, I did.
` Q. And is that your signature that
`appears there?
` A. It is.
` Q. And the other document that relates
`to the --
` A. '132.
` Q. -- the '268 patent?
` A. Yes, ma'am.
` Q. Is that also your signature that
`appears at the end of that declaration?
` A. I did check it and it is.
` Q. Okay. Are there any -- just so we
`can sort of ease the discussion today, are there
`any differences between these two documents
`substantively?
` A. I don't believe so.
` Q. Are any differences just related to
`the specifics of the patent claims in each of
`the patents?
` MR. GONSALVES: Objection.
` A. That would be my understanding.
` Q. So we'll be turning a lot to the
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` M. Mayersohn, Ph.D.
`declaration today, but let's just use the
`version that was submitted in the '135 IPR.
` Do you currently have any additional
`opinions that you're working on for this matter?
` A. No.
` Q. I'll hand you what's been marked as
`CFAD 1030.
` A. Thank you.
` Q. And is this the list of materials
`considered that you submitted in connection with
`this IPR?
` A. I'm not certain why it's different
`than the material appended to my declaration.
` Do you want me to check it, one
`against the other?
` Q. Check it for what?
` A. Well, listing in my declaration was
`my list of references. What you gave me looks
`to be a reusing of that information or that
`list. The numbers are different obviously. The
`order is different. That's why I asked.
` Q. Okay.
` A. Let me ask you, is there anything
`different in this document list than the one
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` M. Mayersohn, Ph.D.
`that's in my exhibit?
` Q. I don't have the answer to that, but
`let me just ask you this: There is a table of
`exhibits in your declaration, correct?
` A. That's correct.
` Q. And then you also have a second
`document of a list of materials or documents
`considered, correct? And that is the second
`smaller document that I just handed you.
` A. Correct.
` Q. So of the two list of materials, is
`that a complete listing of all the documents
`that you relied on in connection with preparing
`your opinions?
` A. And you're referring to the document
`list that you just handed me?
` Q. Yes. Exhibit 1030.
` A. Do you mind if I write on this?
` Q. No, you can go ahead and write on
`that.
` (Document review.)
` Q. And just to be clear, you can
`continue doing what you are doing, but I'm just
`asking if there are -- I'm not necessarily
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` M. Mayersohn, Ph.D.
`asking if there's overlap between the two
`documents, but what I want to know is whether we
`have identification of everything that you've
`considered in forming your opinions.
` A. Let me continue this exercise and
`I'll answer the question.
` Q. Sure.
` (Document review.)
` A. Ms. Hardman, the list that you gave
`me corresponds to the '135 report that I
`submitted?
` Q. That's our understanding, yeah,
`despite the caption at the top.
` (Document review.)
` Q. Is something confusing you about the
`content of Exhibit 1030?
` A. They don't match with the list that I
`had tabled exhibits.
` Q. So in your view, which -- is one of
`these lists the correct lists of the materials
`you considered?
` MR. GONSALVES: Objection.
` A. Let me ask first, where is this
`document description list from? Is that
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` M. Mayersohn, Ph.D.
`something that was submitted by counsel? The
`one you handed me.
` Q. So Exhibit 1030 --
` A. Yeah.
` Q. -- is filed as one of the exhibits in
`the IPR, filed by the Coalition for Affordable
`Drugs.
` A. And your question to me is, is this a
`complete list?
` Q. My question is: I want to understand
`exactly -- I want to understand the universe of
`documents that you considered in preparing your
`opinions that were submitted in this matter.
` And so I'm trying to, you know -- I
`guess what is universe of documents that you
`considered in preparing your opinions in this
`matter?
` A. Well, certainly they would at least
`correspond to the tabled exhibits in my
`declaration, which is more or less consistent
`with the document description list that you gave
`me.
` There is, to the best of my
`knowledge, nothing beyond that that I recall
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`other than perhaps background reading that I
`might have done.
` Q. And did you, in fact, do any
`background reading in connection with preparing
`your opinions in this matter?
` A. Nothing that had direct bearing on my
`opinions, no.
` Q. Do you know why the Rakoczy firm is
`no longer involved in this proceeding?
` A. It was never explained to me. I
`thought there might have been some conflict of
`interest, but I don't know.
` Q. But no reasoning was conveyed to you?
` A. No.
` Q. Okay. So let's focus on the tabled
`exhibits that appears in your declaration,
`Exhibit 1003, please.
` A. Okay.
` Q. Where did -- were all of the
`documents cited in this table provided to you by
`counsel?
` A. No.
` Q. Why do you say no?
` A. Because some of them I provided to
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`counsel.
` Q. Which did you provide to counsel?
` A. I believe what has been indicated as
`CFAD 1023.
` Q. And that's guidance From the FDA,
`correct?
` A. Correct. Now I'm not certain of
`that, but it's a document I'm familiar with.
` CFAD 1026, CFAD 1029, CFAD 1032.
`Those would have been provided by me.
` Q. The remainder of the documents listed
`in this table of exhibits, were those provided
`to you by counsel?
` A. Yeah, they were.
` Q. So in terms of any materials that you
`reviewed that you don't see listed here, do you
`remember any specific documents that you
`reviewed but didn't list?
` MR. GONSALVES: Objection.
` A. It's my general procedure to get
`background information relevant to the materials
`being presented in the declaration. So I would
`most likely have referred to either or medicinal
`chemistry textbook, a pharmacology textbook, and
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`perhaps the Merck Index.
` Q. What information would be of interest
`in the Merck Index?
` A. It would be background information
`relevant to the structure of the compound, dates
`of synthesis, some physical chemical properties.
` Q. Why would that information be
`relevant to the issues here?
` A. Well, you asked if those materials
`were used in forming my opinions. My answer was
`no, they would not. They simply informed me
`about the nature of these chemicals.
` Q. Did you do a literature search for
`MTP inhibitors?
` A. It's not uncommon for me to do a
`literature search independent of counsel. In
`this case, I don't believe I did.
` Q. Why did you not do such a search in
`this case?
` MR. GONSALVES: Objection.
` A. Again, to the best of my knowledge, I
`don't believe I conducted that literature
`search. I thought I had in hand all of the
`material that I needed.
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`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 20
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` M. Mayersohn, Ph.D.
` Q. Why did you feel that you had in hand
`all of the materials you needed for this case?
` A. Well, the literature that was
`provided or that I provided had direct relevance
`on the issue.
` Q. Did you think it would be prudent to
`look for other literature to see if that had
`additional information that was relevant to the
`issues?
` MR. GONSALVES: Objection.
` A. Well, because I -- to the best of my
`knowledge, I did not conduct a literature
`review. Obviously I thought it was not
`necessary. And I can't remember if there was
`also a time constraint with regard to the
`preparation of the declaration.
` This was authored in the summertime,
`August of last year. I have a nine-month
`appointment, and I spend the summer months in
`New York State where I don't have immediate
`access to any of my books, journals, and it's a
`challenge to get library information. So that
`may have been part of the reason as well.
` Q. Were these declarations prepared
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 21
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` M. Mayersohn, Ph.D.
`while you were in New York State?
` A. At least part of the time, yes.
` Q. When you say part of the time, what
`did the other part of the time, where were you
`at that point?
` A. I would have been in Tucson at the
`university.
` Q. And when you say time constraints,
`you recall that -- was there a particular
`deadline by which you had to finish these
`documents that you were trying to meet?
` A. Oh, I think as you know, there's
`always a deadline. I can't recall if it was a
`tight deadline or not, but there's always a
`deadline.
` Q. I think you said there was a time
`crunch. What did you mean by that?
` A. No, I think I offered there may have
`been a time constraint. And by that, I mean
`meeting the deadline.
` Q. And the time constraint was in part
`was because you were in New York while you were
`preparing this and didn't have access to your
`typical research materials?
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

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`Page 22
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` M. Mayersohn, Ph.D.
` MR. GONSALVES: Objection.
` A. I'm surmising that that might have
`been part of the case, yes.
` Q. And you're surmising that based on
`the date that this document was signed?
` A. Correct.
` Q. How were these declarations prepared?
` A. They would have been prepared in the
`way in which I've always prepared reports for
`counsel. It was a collaborative arrangement
`where counsel deals with legal issues. I deal
`with the science issues. I would have drafted a
`substantial portion of these declarations.
` And then during the creation of
`several drafts, we would come up with the final
`document.
` Q. Are you able to identify, looking at
`Exhibit 1003, what portions you actually
`drafted?
` A. This would be difficult to do, but
`let me give you some examples. Obviously,
`qualification and background, running through
`page 4.
` (Document review.)
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 23
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` M. Mayersohn, Ph.D.
` A. Aspects of what followed from that
`page through page 10, the scientific and
`technical background beginning on 11 and running
`through 13 -- excuse me, running through page
`17, those were based on my drafts, initial
`drafts. And the rest was coordinated between
`counsel and myself.
` Q. So, like, for example, the Section C
`that begins on page 17, that was part of the
`coordination with counsel; is that correct?
` (Document review.)
` A. I think the paragraph 39, for
`example, I would have written, to the best of my
`knowledge. That applies to paragraph 40 and 41.
`So I would have been responsible for drafting
`most of those paragraphs.
` Q. And then the rest was more of a
`collaboration between you and counsel; is that
`correct?
` A. I think that's a fair statement.
` Q. Did you talk with anybody at the
`Coalition for Affordable Drugs in preparing your
`opinions in this case?
` A. No.
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 24
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` M. Mayersohn, Ph.D.
` Q. So all of your conversations were
`with counsel; is that correct?
` A. Correct.
` Q. And besides counsel, did you
`collaborate with anybody else in preparing your
`declarations in this case?
` A. No.
` Q. Or more broadly, did you collaborate
`with anybody aside from counsel in developing
`your opinions in this case?
` A. No.
` Q. Did you do anything to prepare for
`today's deposition?
` A. Yes.
` Q. What did you do?
` A. I lost a lot of sleep.
` Q. Why is that?
` A. I'm being facetious.
` Before coming to this venue, I would
`have reviewed my declarations, the PTAB opinion,
`plaintiff's submission to PTAB, the response
`from plaintiff, the prior art literature. And I
`would have done that mostly on my own and then
`at some point when meeting with counsel.
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 25
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` M. Mayersohn, Ph.D.
` Q. When you said you would have reviewed
`the prior art literature, do you mean the prior
`art cited in your report?
` A. Correct.
` Q. Did you review any other prior art
`literature?
` A. No. I've listed all the prior art
`that I referred to.
` Q. When did you meet with counsel to
`prepare for the deposition today?
` A. Yesterday afternoon.
` Q. How long did you meet with counsel?
` A. 1:30 to 4.
` Q. And who did you meet with?
` A. Dr. Gonsalves.
` Q. Anybody else?
` A. No.
` Q. And did you have any telephone prep
`sessions with counsel for the deposition?
` A. Thank you. You reminded me.
`Yesterday there was a very brief phone
`conversation with Mr. Casieri.
` Q. And who is that?
` A. He's with other law firm you asked me
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 26
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` M. Mayersohn, Ph.D.
`about.
` Q. McNeely?
` A. Yes.
` Q. And how long was that phone call?
` A. Maybe ten minutes.
` Q. And what generally did you discuss
`during that call?
` A. I don't recall if it was a specific
`issue or just generalities, what to expect at
`the deposition.
` Q. And aside from meeting with
`Mr. Gonsalves yesterday and the phone call
`yesterday with the gentleman from the McNeely
`firm, did you have any other meetings or
`discussions with counsel to prepare for the
`deposition today?
` A. No.
` Q. Have you ever spoke to Dr. Randall
`Zusman?
` A. In this matter or ever?
` Q. Ever.
` A. Yes, I know Dr. Zusman.
` Q. How do you know him?
` A. We were working together on a trial a
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 27
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`
` M. Mayersohn, Ph.D.
`number of years ago.
` Q. What trial was that?
` A. It was a cardiovascular drug whose
`name escapes me. Oh, Ranolazine.
` Q. Is that the extent of your
`relationship with Dr. Zusman and having worked
`with him on a prior trial?
` A. Correct.
` Q. Did you suggest to counsel that they
`reach out to Dr. Zusman for this proceeding?
` A. I don't believe so, no.
` Q. Is it coincidence that you found
`yourself working with Dr. Zusman again?
` A. I think, as you know, Ms. Hardman,
`this is a pretty small community of people whose
`footsteps cross each other all the time. I
`would say most likely it's a coincidence, yes.
` Q. Was the prior trial that you worked
`on with Dr. Zusman handled by the Rakoczy firm?
` A. I believe so, yes.
` Q. Have you reviewed Dr. Zusman's
`declaration that he submitted in this matter?
` A. I have.
` Q. And when did you review those?
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 28
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` M. Mayersohn, Ph.D.
` A. In my declarations, I cite to some of
`his commentary in his declaration, but I'm not
`sure I reviewed his entire declaration at that
`time. I have since reviewed it completely.
` Q. In terms of the commentary that you
`cite in your declaration, how did you get access
`to that in connection with finalizing your
`declarations?
` A. How do I get ahold of Zusman's
`information?
` Q. Yes.
` A. From counsel.
` Q. And were you provided with just
`portions of Dr. Zusman's declarations at that
`time?
` A. I do not recall. I suspect it was a
`draft, but I don't recall.
` Q. How is it that you came to review
`only portions of his declarations?
` A. Well, I was only commenting on
`certain aspects of this case in my declaration,
`and some of his declaration commentary had
`direct bearing on some of the things about which
`I was offering an opinion, so it was appropriate
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 29
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` M. Mayersohn, Ph.D.
`to review that information.
` Q. And how did you locate that
`information?
` A. Again, it would have been provided by
`counsel.
` Q. And did they direct you to specific
`portions that they wanted you to review?
` A. That's what I'm not remembering.
`Either I had a substantial draft of the entire
`declaration of Zusman or I had components, and I
`just don't remember.
` Q. Is it your recollection that you had
`a draft as opposed to a completed signed copy of
`Dr. Zusman's declarations?
` A. Because these were submitted I think
`on the same date, I suspect I didn't have a
`completed signed company. It could have been a
`penultimate copy, but I just don't know.
` Q. Have you ever been involved in
`designing a clinical trial?
` A. Can you define clinical trial for me?
` Q. Maybe you can help us with that.
` Do you have a definition of clinical
`trial?
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 30
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` M. Mayersohn, Ph.D.
` A. No.
` Q. What would you call a study of a drug
`in a human?
` A. A clinical study.
` Q. Have you ever been involved in
`designing a clinical study?
` A. Could I have a copy of my CV?
` Q. Sure.
` I handed you what's been previously
`marked as CFAD Exhibit 1029.
` A. Thank you.
` Q. Is that your CV?
` A. As of January 2012, yes.
` (Document review.)
` A. I'm sorry, Ms. Hardman, did you
`offer me a definition of a clinical trial or
`clinical study?
` Q. No, but let me just back up for a
`moment.
` You said this is current as of
`January 2012?
` A. No, 2015. The last page there.
` Did we just agree on a definition?
` Q. No, we talked about a clinical study.
`
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`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 31
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` M. Mayersohn, Ph.D.
` Is it clinical study and clinical
`trial the same thing in your mind?
` A. No, no.
` Q. Why not?
` A. It's not. A clinical study is more
`of an umbrella term which implies an examination
`of something in a human subject. "Clinical"
`typically means human.
` Clinical trial usually means
`something more -- it falls under that umbrella,
`but it is a substantial -- more substantial
`examination of certain aspects of a drug or of a
`medical condition.
` So, for example, in responding to
`your question, I'm just going to read off
`reference numbers, and you stop me when you want
`to.
` Starting on page 5 of my resumé under
`Research Publications, No. 3, that was a human
`study.
` Number 9 was a theoretical analysis
`of literature in -- done in humans.
` No. 11 was a human study.
` Number 12 is a human study.
`
`TSG Reporting - Worldwide - 877-702-9580
`
`PENN EX. 2021
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Page 32
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` M. Mayersohn, Ph.D.
` No. 16 was a human study.
` No. 18 was a human study.
` No. 23, human study.
` 24, 25, 26, 28, 29, 30, 31, 32, 33,
`34, 35.
` Now let me just mention with regard
`to 35, that was a new drug

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