throbber
Page 1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEW JERSEY
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`CASE NO.
`—
`—
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`1—14—CV—O6893
`—
`—
`—
`—x
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`SENJU PHARMACEUTICAL CO, LTD.,
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`BAUSCH & LOMB INCORPORATED, and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.:
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`Plaintiffs,
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`LUPIN, LTD and LUPIN
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`PHARMACEUTICALS,
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`INC.
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`Defendants.
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`INNOPHARMA LICENSING,
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`INC.,
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`INNOPHARMA LICENSING, LLC,
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`INNOPHARMA,
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`INC.,
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`INNOPHARMA, LLC,
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`February 19, 2016
`10:08 a.m.
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`620 Eighth Avenue
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`New York, New York
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`VIDEOTAPED DEPOSITION OF CLAYTON
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`HEATHCOCK, Ph.D., held at the above—mentioned
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`time and place, before Randi Friedman, a
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`Registered Professional Reporter and Notary
`Public within and for the State of New York.
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`Job No. NJ223854l
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`800-227-8440
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`Page 1 of 273
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`I \_/er-itext Legal Solutions
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`973-410-4040
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`SENJU EXHIBIT 2266
`lnnopharma v Senju,
`IPR2015-00902 & IPR20l5-00903
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`Page 1 of 273
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`

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`APPEARANCES:
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`C. Heathcock, Ph.D.
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`Page 2
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`FINNEGAN, HENDERSON, FARABOW,
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`GARRETT & DUNNER, LLP
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`Attorneys for Plaintiffs
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`901 New York Avenue, NW
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`Washington, D.C. 20001
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`BY:
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`JUSTIN J. HASFORD, ESQ.
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`GOODWIN PROCTER, LLP
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`Attorneys for Defendants, Lupin
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`620 Eighth Avenue
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`New York, New York 10018
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`BY:
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`DANIEL P. MARGOLIS, Ph.D.
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`ALSTON & BIRD, LLP
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`Attorneys for Defendants,
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`Innopharma
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`4721 Emperor Boulevard, Suite 400
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`Durham, North Carolina 27703
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`BY:
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`JITENDRA MALIK, Ph.D.
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`ALSO PRESENT:
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`Dan McC1utchy — Videographer
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`Terrence Kim
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`53>-(.\J|.\)|—‘
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`Page 3
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`C. Heathcock, Ph D.
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`MR. MCCLUTCHY: Good morning. We
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`are now on the record.
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`Please note that the
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`microphones are sensitive and can pick up
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`whispering and private conversations.
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`Please turn off all cellphones or place them
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`away from the microphones, as they can
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`interfere with the deposition audio.
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`Recording will continue until all parties
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`agree to go off the record. My name is --
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`MR. MARGOLIS: You might want to
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`go off the record for a minute.
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`MR. MCCLUTCHY: Okay. Going off
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`the record.
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`The time is 10:05.
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`(Whereupon there was a beverage
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`spill.)
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`MR. MCCLUTCHY: We are back on the
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`record.
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`To continue, my name is Daniel
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`McClutchy, representing Veritext New Jersey.
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`The date today is February 19, 2016, and the
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`time is approximately 10:08 a.m. This
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`deposition is being held at Goodwin Procter,
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`located at 620 Eighth Avenue in New York,
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`New York.
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`The caption of this case is Senju
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`800-227-8440
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`973-410-4040
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`Veritext Leg—a1 Solutiouns
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`C. Heathcock, Ph D.
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`Pharmaceutical versus Lupin Ltd. and Lupin
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`Pharma and Innopharma Licensing. This Case
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`is filed in the U.S. District Court,
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`District of New Jersey, Case No.
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`1—l4—CV—O6893.
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`The name of the witness is
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`Dr. Clayton Heathcock.
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`At this time,
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`the attorneys
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`present will identify themselves and the
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`parties they represent, and then our court
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`reporter, Randi Friedman,
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`representing
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`Veritext, will swear in the witness and we
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`can proceed.
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`MR. HASFORD:
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`Justin Hasford of
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`Finnegan, on behalf of plaintiffs. And I'm
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`here with my colleague, Terrence Kim.
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`MR. MARGOLIS: Dan Margolis from
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`Goodwin Procter,
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`for Lupin.
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`DR. MALIK:
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`Jitendra Malik of
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`Alston & Bird, for the Innopharma
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`defendants.
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`*
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`*
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`~k
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`CLAYTON HEATHCOCK, Ph.D.,
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`the
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`witness herein, having been duly sworn, was
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`examined and testified as follows:
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`800-227-8440
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`C. Heathcock, Ph.D.
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`EXAMINATION
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`BY MR. HASFORD:
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`Q
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`A
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`Q
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`Good morning, Dr. Heathcock.
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`Good morning.
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`Would you please state your name and
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`address for the record.
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`A
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`My name is Clayton Heathcock,
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`H—e—a—t—h—c—o—c—k. My address is Martinez,
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`California.
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`Q
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`How many times have you been deposed
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`before?
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`A
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`Something between 15 and 20.
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`I don't
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`know an exact number.
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`I'm not sure.
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`Q
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`Do you understand the deposition
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`process?
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`A
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`Q
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`Yes,
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`I do.
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`Let me tell you how today's deposition
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`will proceed.
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`I represent plaintiffs in this
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`case.
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`Today I will ask you questions, and I ask
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`that you answer my questions truthfully and
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`accurately.
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`If you need a break,
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`just let me
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`know, but
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`I would ask that if I have asked a
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`question, please first answer the question and
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`then we can take a break.
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`1 '
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`C. Heathcock, Ph.D.
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`Page 6
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`If for any reason you do not
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`understand a question that I ask, please let me
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`know.
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`If you answer a question,
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`I will assume
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`that you understood the question;
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`is that okay?
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`A
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`Q
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`Yes.
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`Is there any reason why you cannot
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`testify truthfully and accurately today?
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`A
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`No.
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`MR. HASFORD:
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`I am handing the
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`court reporter what I would ask to be marked
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`as Heathcock Exhibit 1.
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`For the record,
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`Heathcock Exhibit 1 is entitled "Responsive
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`Expert Report of Clayton H. Heathcock,
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`Ph D."
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`It includes Appendices A, B and C.
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`(Heathcock Exhibit 1 was marked.)
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`BY MR. HASFORD:
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`Q
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`Is Heathcock Exhibit 1 your responsive
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`report and appendices in this case?
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`A
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`Q
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`A
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`Q
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`Yes, it is.
`
`Please turn to Page 29.
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`Yes.
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`Does your signature appear on Page 29
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`of your responsive report for this case?
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`A
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`Yes, it does.
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`C. Heathcock, Ph D.
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`Q
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`Who prepared your responsive report
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`Page 7
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`for this case?
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`A
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`I did.
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`MR. MARGOLIS: Objection,
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`form.
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`THE WITNESS:
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`I prepared it along
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`with a lot of help from the attorneys that
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`I'm working for.
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`BY MR. HASFORD:
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`Q
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`How did the attorneys help you prepare
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`this report?
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`I
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`MR. MARGOLIS: Objection.
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`Just be
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`careful not to reveal
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`the substance of any
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`communications with the attorneys, but you
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`can answer the question.
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`THE WITNESS:
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`I understand.
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`The
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`way this report was constructed was that we
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`had several meetings via telephone
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`conference.
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`I was provided with documents
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`to review; mainly Dr. Bailey's expert report
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`and the art that he cited in it. And I
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`was —— and we held conference about my
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`responses and my opinions with regard to
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`what he had opined.
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`They then took my —— my ideas.
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`Veritext Legal Solutions
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`

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`Page 8
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`C. Heathcock, Ph.D.
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`Put
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`them into a draft of a report, which was
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`provided to me.
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`I then revised it, provided
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`some chemical illustrations to illustrate
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`some of the things that I said and then back
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`and forth. That's the way it was prepared.
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`BY MR. HASFORD:
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`Q
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`Did defendants‘ counsel provide you
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`the documents on which you are relying on your
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`opinions in this case?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS:
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`They provided me
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`with Dr. Davies‘ report and the prior art
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`that he cited. And as I recall,
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`I did some
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`limited amount of literature work on my own
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`and turned up,
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`I think, a couple of things
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`that they had not provided me. But
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`I don't
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`remember the details of that.
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`BY MR. HASFORD:
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`Q
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`Do you remember what those two
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`documents were?
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`A
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`Q
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`I don't.
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`Please turn to Paragraph 6 on Page 2
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`24-
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`of your responsive report for this case.
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`25
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`A
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`Okay.
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`800-227-8440
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`973-410-4040
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`Page 9
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`C. Heathcock, Ph.D.
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`Q
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`It reads,
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`"I am a chemist with over 50
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`years of experience in organic chemistry and
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`medicinal chemistry.
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`I am currently Emeritus
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`Professor at the University of California at
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`Berkeley.
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`A copy of my curriculum vitae and list
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`of publications is attached as Appendix A."
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`Do you see that?
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`Yes.
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`Do you consider yourself an expert in
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`A
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`Q
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`organic chemistry and medicinal chemistry?
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`A
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`Yes.
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`BY MR. HASFORD:
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`MR. MARGOLIS: Objection, vague.
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`Q
`
`Do you consider yourself an expert in
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`other areas besides organic chemistry and
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`medicinal chemistry?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: Yes,
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`I do.
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`I
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`consider myself an expert in genealogy and
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`an expert in breeding Ridgeback show dogs,
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`for example.
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`Q
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`Do you consider yourself an expert in
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`any other scientific areas besides organic
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`chemistry and medicinal chemistry?
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`C. Heathcock, Ph.D.
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: Yeah,
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`that would
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`depend how you define expert.
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`I,
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`for about
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`ten years, have operated a seminar in the
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`QB3, which is a quantitative biosciences
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`institute.
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`I know a lot about biological
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`science. And I do consider that I have some
`expertise. Not as much as inorganic
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`chemistry and medicinal chemistry, but you
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`know,
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`I can carry out very comfortably
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`conversations with people about topics in
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`those fields as well.
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`'
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`BY MR. HASFORD:
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`Q
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`Have you ever held yourself out to the
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`public as an expert
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`in any other areas besides
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`organic chemistry and medicinal chemistry?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS:
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`I don't recall that
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`I've been asked to before.
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`BY MR. HASFORD:
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`Q
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`Have you ever been qualified by any
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`court or by the patent office as an expert
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`in any
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`other areas besides organic chemistry and
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`medicinal chemistry?
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`:
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`.
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`C. Heathcock,
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`Ph.D.
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`MR. MARGOLIS: Objection, vague.
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`Calls for legal conclusion.
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`THE WITNESS: Yeah.
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`Not that I
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`can recall.
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`In the court appearances I have
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`made,
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`I have been qualified as a medicinal
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`chemist or an organic chemist.
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`BY MR. HASFORD:
`
`Q
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`Is Appendix A to your responsive
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`report a copy of your curriculum vitae?
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`A
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`Q
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`Yes,
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`it is.
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`Does your curriculum vitae list your
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`relevant professional experience?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: Yeah.
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`I guess that
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`would depend on what you mean by "relevant."
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`It does list my —— the positions I've held
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`and some but not all of the important
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`positions I've held outside the University
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`of California. And some but not all of the
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`honors that I've received.
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`BY MR. HASFORD:
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`Q
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`Does your curriculum vitae list your
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`professional experiences as is relevant to this
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`case?
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`_
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`C. Heathcock, Ph.D.
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`MR. MARGOLIS: Objection, vague.
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`Calls for a legal conclusion.
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`BY MR. HASFORD:
`
`Q
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`A
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`You may answer.
`
`Yes.
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`I consider my contribution to
`
`I
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`this case to be in the area of organic chemistry,
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`and it does —— my CV does give a good summary of
`
`my background in organic chemistry.
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`Q
`
`Please turn to your curriculum vitae
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`at Appendix A to your responsive report.
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`A
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`Q
`
`Yes.
`
`And let me direct your attention to
`
`the first page.
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`A
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`Q
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`A
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`Q
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`Okay .
`
`Are you there?
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`Yes.
`
`On the first page of your curriculum
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`vitae,
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`let me direct your attention to the
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`section entitled "Professional History."
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`A
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`Q
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`Ri ght .
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`In particular,
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`let me direct your
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`attention to a line that begins "Organic
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`Chemistry Division;" do you see that?
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`A
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`Yes.
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`_____
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`Page 13
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`Q
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`Have you been a member of the Organic
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`Chemistry Division of the American Chemical
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`Society?
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`A
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`Q
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`Yes.
`
`Is there a separate Medicinal
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`Chemistry Division of the American Chemical
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`Society?
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`A
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`Q
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`Yes,
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`there is.
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`Have you ever been a member of the
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`11 Medicinal Chemistry Division of the American
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`A
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`Q
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`No.
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`5
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`Please turn to the next page of your
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`curriculum vitae, and let me direct your
`
`attention to the section entitled "Research
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`Interests."
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`Do you see that?
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`A
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`Q
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`Yes,
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`I do.
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`Do your research interests include
`
`drug discovery?
`
`A
`
`Q
`
`NO.
`
`Is organic synthesis your field of
`
`specialty, and are most of your publications in
`that area?
`
`MR. MARGOLIS: Objection. Vague.
`
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`C. Heathcock, Ph.D.
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`THE WITNESS: Yes. That's
`
`correct.
`
`BY MR. HASFORD:
`
`Page 14
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`:
`
`Q
`
`Let me direct your attention to the
`
`section of your curriculum Vitae entitled
`
`"Publications." Does the "Publications" section
`
`of your curriculum vitae list all of your
`
`publications?
`
`2008?
`
`A
`
`Q
`
`A
`
`Q
`
`A
`
`Q
`
`since 2004?
`
`A
`
`Q
`
`Yes, it does.
`
`Did you publish your last paper in
`
`Yes,
`
`I did.
`
`How many years ago is that?
`
`That would be eight years ago.
`
`Have you published only one paper
`
`Yes.
`
`Have you published only two papers in
`
`the Journal of Medicinal Chemistry?
`
`A
`
`I don't remember that, but I could
`
`read through this list and see.
`
`Q
`
`A
`
`Please do.
`
`Okay, yes, you're right.
`
`Two papers
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`on my Compactin with Levinolin(sic.), a synthetic
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`C. Heathcock, Ph.D.
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`Page 15
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`project.
`
`I
`
`Q
`
`Did both of the papers that you
`
`published in the Journal of Medicinal Chemistry
`
`involve statins?
`
`A
`
`Q
`
`Yes.
`
`Have you ever published any papers
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`1
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`involving bromfenac?
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`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS:
`
`NO.
`
`BY MR. HASFORD:
`
`Q
`
`Have you ever published any papers
`
`involving any non~steroidal anti—inflammatory
`
`drug?
`
`A
`
`NO.
`
`BY MR. HASFORD:
`
`MR. MARGOLIS: Objection, vague.
`
`Q
`
`Have you ever published any papers
`
`involving tyloxapol?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS:
`
`NO.
`
`BY MR. HASFORD:
`
`Q
`
`Have you ever published any papers
`
`involving any non—ionic surfactant?
`
`MR. MARGOLIS: Objection, vague.
`
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`C. Heathcock, Ph.D.
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`THE WITNESS: Yes.
`
`BY MR. HASFORD:
`
`Q
`
`Have you ever published any papers
`
`involving benzalkonium chloride?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS: No,
`
`I have not.
`
`BY MR. HASFORD:
`
`Q
`
`Take a look,
`
`if you would, at
`
`Paragraph 22 in your responsive report.
`
`It's on
`
`page 5?
`
`A
`
`Q
`
`Yes.
`
`It states "During the last four years,
`
`I have testified as an expert, either at
`
`deposition or trial as set forth in Appendix B."
`
`Please turn to Appendix B to your
`
`responsive report. Does Appendix B to your
`
`responsive report list the cases over the past
`
`four years in which you have testified at
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`deposition and trial?
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`A
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`Q
`
`Yes.
`
`Over the past four years, have you
`
`testified at deposition and trial in 12 separate
`
`cases besides this case?
`
`A
`
`I counted 11. Oh, 12. There's
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`C. Heathcock, Ph.D.
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`another page.
`
`Sorry about that. Yes, 12. Let's
`
`see -- so what was the question?
`
`Q
`
`Over the past four years, have you
`
`testified at deposition and trial in 12 separate
`
`cases besides this case?
`
`A
`
`Q
`
`Yeah. Deposition and/or trial, yes.
`
`In all the cases in which you have
`
`testified at deposition and trial, have you
`
`testified on behalf of the generic pharmaceutical
`
`company?
`
`A
`
`Q
`
`Yes,
`
`that's correct.
`
`Have you ever testified that a
`
`pharmaceutical patent was novel and non—obvious?
`MR. MARGOLIS: Objection.
`
`I
`
`THE WITNESS:
`
`I have not testified
`
`to that.
`
`MR. MARGOLIS: Calls for a legal
`
`conclusion.
`
`THE WITNESS:
`
`In fact, I've given
`
`that opinion to lawyers, but
`
`I have not been
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`asked to testify in those cases.
`
`23 .
`
`BY MR. HASFORD:
`
`24
`
`25
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`Q
`
`Just to be clear, have you ever
`
`testified that a pharmaceutical patent was novel
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`C. Heathcock, Ph.D.
`
`and non—obvious?
`
`Page 18
`
`MR. MARGOLIS: Objection. Calls
`
`for a legal conclusion.
`
`THE WITNESS:
`
`I have not testified
`
`I
`
`that a patent in suit was novel.
`
`I've
`
`testified that other patents were novel.
`
`BY MR. HASFORD:
`
`Q
`
`Is it fair to say that your specialty
`
`in your career has been synthetic organic
`
`chemistry?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS: Yes. Synthetic
`
`organic chemistry is involved in lots of
`
`other disciplines. Most notably medicinal
`
`chemistry. And my expertise has been in the
`
`synthesis of complex compounds.
`
`MR. HASFORD:
`
`I'm handing the
`
`court reporter what I would ask to be marked
`
`as Heathcock Exhibit 2.
`
`'
`
`For the record, Heathcock Exhibit
`
`2 is the transcript of the trial in
`
`Astrazeneca, et al. v. Mylan, et al.
`
`In Re,
`
`Rosuvastatin Calcium Patent Litigation, case
`
`number 08 MD 1949, Monday, February 22nd,
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`C. Heathcock, Ph.D.
`
`2010, 9:30 a.m., U.S. District Court for the
`
`District of Delaware.
`
`(Heathcock Exhibit 2 was marked.)
`
`BY MR. HASFORD:
`
`Q
`
`Doctor,
`
`turn, if you would,
`
`in
`
`Heathcock Exhibit 2,
`
`to Page 215 in the small
`
`numbered pages.
`
`It's going to be Page 55 toward
`
`the bottom of the big numbered pages.
`
`A
`
`Q
`
`Okay.
`
`Do you see about halfway down, it says
`
`"Cross—examination by Ms. Bourke"? And she says,
`
`"Good afternoon, Dr. Heathcock.
`
`Is it Heathcock
`
`or Heathcock?"
`
`And you say, you answer, "Heathcock;"
`
`you see that?
`
`A
`
`Q
`
`Yes.
`
`Are you the Dr. Heathcock who
`
`testified at trial that was transcribed in
`
`Heathcock Exhibit 2?
`
`A
`
`Q
`
`Yes.
`
`Turn,
`
`if you would,
`
`to page 218.
`
`It's
`
`going to be the next page of the document. Let
`
`me direct your attention to Page 218, Line 6
`
`through 10.
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`C. Heathcock, Ph.D.
`
`You were asked: "Question: And in
`
`'
`
`those cases that we just mentioned, you testified
`
`that your specialty in your career has been
`
`synthetic organic chemistry;
`
`is that right?"
`
`And you answered:
`
`"That's correct."
`
`That was your sworn testimony;
`
`Yes,
`
`that's right, yeah.
`
`You can put this document aside for
`
`I think that's what I just told you
`
`correct?
`
`A
`
`Q
`
`A
`
`now.
`
`too, but...
`
`Q
`
`Aside from your work in this case,
`
`151
`
`have you ever consulted for any party on a matter
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`involving bromfenac?
`
`A
`
`Q
`
`NO.
`
`Aside from your work in this case,
`
`have you ever consulted for any party in a matter
`
`involving a non—steroidal anti—inflammatory drug?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS:
`
`You have to give me
`
`time to think this over, because I've served
`
`as a consultant for almost 50 years with
`
`companies, and it is possible that one of my
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`C. Heathcock, Ph.D.
`
`consulting appointments may have exposed me,
`
`but
`
`I can't put my finger on a specific
`
`case.
`
`It would have been with Abbott or
`
`I
`
`Merck or one of these companies that may
`
`have been —— very likely core developing
`
`NSAIDS. And I probably did consult with
`
`chemists about, but
`
`I don't remember
`
`details.
`
`BY MR. HASFORD:
`
`Q
`
`Aside from your work in this case,
`
`have you ever consulted for any party on a matter
`
`involving tyloxapol?
`
`A
`
`Q
`
`No.
`
`Aside from your work in this case,
`
`have you ever consulted for any party on a matter
`
`involving any non—ionic surfactant?
`
`MR. MARGOLIS: Objection, Vague.
`
`THE WITNESS: Not that I can
`
`recall.
`
`BY MR. HASFORD:
`
`Q
`
`Aside from your work in this case,
`
`have you ever consulted for any party on a matter
`
`involving benzalkonium chloride?
`
`A
`
`No, not that I can recall.
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`C. Heathcock, Ph.D.
`
`Q
`
`Have you ever given any presentations
`
`I
`
`on any matters involving bromfenac?
`
`A
`
`Q
`
`No.
`
`Have you ever given any presentations
`
`on any matters involving any non—steroidal
`
`anti—inflammatory drug?
`
`MR. MARGOLIS: Objection. Vague.
`
`THE WITNESS:
`
`I think I probably
`
`have as a part of a chemistry course when I
`
`was teaching organic chemistry.
`
`I'm sure
`
`that I've explained NSAIDS and what they
`
`generally are and how they generally work to
`
`my students.
`
`BY MR. HASFORD:
`
`Q
`
`Do you remember which NSAIDS you were
`
`referring to?
`
`A
`
`It would likely have been the most
`
`well—known ones.
`
`Probably ibuprofen and
`
`indomethacin, and, you know, examples that would
`
`have illustrated the chemistry.
`
`Q
`
`Why are ibuprofen and indomethacin the
`
`most well—known examples of NSAIDS?
`
`MR. MARGOLIS: Objection,
`
`form.
`
`THE WITNESS: Because they were --
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`C. Heathcock, Ph.D.
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`they were compounds that were widely used
`
`both as prescriptions and over—the—counter,
`
`so...
`
`BY MR. HASFORD:
`
`Q
`
`Have you ever given any presentations
`
`on any matters involving tyloxapol?
`
`A
`
`Q
`
`Not that I can recall.
`
`Have you ever given any presentations
`
`on any matters involving any non—ionic
`
`surfactant?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS: Not really, except
`
`perhaps as an example, when explaining how
`
`surfactants behave and what they're used for
`
`in a class.
`
`BY MR. HASFORD:
`
`Q
`
`Do you remember which surfactants
`
`those were?
`
`A
`
`Q
`
`I don't.
`
`Have you ever given any presentations
`
`on any matters involving benzalkonium chloride?
`
`A
`
`' No.
`
`MR. MARGOLIS: Objection, vague.
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`C. Heathcock, Ph.D.
`
`BY MR. HASFORD:
`
`Q
`
`Are you an expert in pharmaceutical
`
`formulation?
`
`MR. MARGOLIS: Objection, vague.
`
`Calls for a legal conclusion.
`
`THE WITNESS:
`
`I am not.
`
`I don't
`
`hold myself out to be an expert
`
`in
`
`formulations, except to the extent that
`
`chemistry and the interaction of ingredients
`
`would be involved.
`
`Q
`
`Have you ever held yourself out to the
`
`public as an expert in pharmaceutical
`
`formulation?
`
`A
`
`No.
`
`MR. MARGOLIS: Objection, vague.
`
`Q
`
`Are you an expert in the field of
`
`pharmacy?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS: Could you define
`
`21.
`
`what you mean by "pharmacy"?
`
`22
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`23
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`24
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`25
`
`Q
`
`What's your understanding of the field
`
`of pharmacy?
`
`A
`
`Well, pharmacy to me would encompass a
`
`number of different areas. And certainly the
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`C. Heathcock, Ph.D.
`
`medicinal chemistry aspect,
`
`I consider myself an
`
`expert in.
`
`The delivery of medicinals,
`
`I
`
`certainly have sufficient knowledge to consider
`
`myself an expert in.
`
`Is that sufficient?
`
`Q
`
`A
`
`Q
`
`Have you ever practiced pharmacy?
`
`No.
`
`Have you ever held yourself out to the
`
`public as an expert in the practice of pharmacy?
`
`A
`
`Q
`
`No.
`
`Are you an expert
`
`in pharmacology?
`
`MR. MARGOLIS: Objection, vague.
`
`Calls for a legal conclusion.
`
`THE WITNESS:
`
`I have some
`
`considerable expertise in pharmacology to
`
`the extent that pharmacokinetic properties
`
`of drugs are part of pharmacology.
`
`I
`
`understand that.
`
`I understand absorption,
`
`distribution, metabolism.
`
`So I do consider
`
`I have expertise in that part of
`
`pharmacology.
`
`Q
`
`Have you ever held yourself out to the
`
`public as an expert in pharmacology?
`
`MR. MARGOLIS: Objection, vague.
`
`THE WITNESS:
`
`I have not been
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`C. Heathcock, Ph.D.
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`asked before whether —— I think you're the
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`first person who's asked me that question.
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`BY MR. HASFORD:
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`Q
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`So just to be clear, have you ever
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`held yourself out to the public as an expert
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`in
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`pharmacology?
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`A
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`Not previously.
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS:
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`NO.
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`MR. MARGOLIS: Dr. Heathcock, can
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`you slow down and give me a chance to object
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`so we're not talking over each other,
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`thank
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`you.
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`BY MR. HASFORD:
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`Q
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`Have you ever held yourself out to the
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`public as an expert in pharmacokinetics?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS:
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`I have not, but
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`I
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`would have if I had been asked.
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`BY MR. HASFORD:
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`Q
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`Have you ever taught any courses in
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`pharmacokinetics?
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`A
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`Q
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`Not where that was the single topic.
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`Are you an expert
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`in pharmacodynamics?
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`C. Heathcock, Ph.D.
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`MR. MARGOLIS: Objection, vague.
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`Calls for a legal conclusion.
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`THE WITNESS: No.
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`BY MR. HASFORD:
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`Q
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`Are you an expert in ophthalmology?
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`MR. MARGOLIS: Objection, vague.
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`Calls for a legal conclusion.
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`THE WITNESS: No,
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`I'm not.
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`BY MR. HASFORD:
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`Q
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`Are you an expert
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`in any field of
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`medicine?
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`MR. MARGOLIS: Objection, vague.
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`Calls for a legal conclusion.
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`THE WITNESS: No,
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`I have no
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`medical training and no medical practice in
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`my background.
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`:
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`j
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`a patient?
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`Have you ever treated an inflammatory
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`disease of the eye?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: No,
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`I have not.
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`BY MR. HASFORD:
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`Q
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`Have you ever administered any
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`bromfenac product to a patient?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: No,
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`I have not.
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`Q
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`Have you ever dispensed any bromfenac
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`product to a parent?
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`No.
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`Have you ever administered any
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`non—steroidal anti—inflammatory drug product to a
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`patient?
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: Well,
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`if I'm the
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`patient, yes,
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`I do that regularly. And I
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`do —— I have administered NSAIDS to other
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`members of my family. And so, yes. But not
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`as a doctor.
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`Have you ever dispensed any
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`patient?
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`Q
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`Same answer.
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`Have you ever administered any product
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`containing tyloxapol to a patient?
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`,
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`I
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`'
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`C. Heathcock, Ph.D.
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`MR. MARGOLIS: Objection, vague.
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`THE WITNESS: No,
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`I have not.
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`BY MR. HASFORD:
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`Q
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`Have you ever dispensed any product
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`containing tyloxapol to a patient?
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`A
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`Q
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`No,
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`I have not.
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`Have you ever administered any product
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`containing any non—ionic surfactant to a patient?
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`MR. MARGOLIS: Objection. Vague.
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`Calls for speculation.
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`THE WITNESS: Yeah,
`
`I don't know.
`
`I mean,
`
`I may have because I had four
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`children and I administered all sorts of
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`things to them that were prescribed by their
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`doctors, and some of them may have been
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`surfactants.
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`BY MR. HASFORD:
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`Q
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`Have you ever dispensed any product
`
`containing any non—ionic surfactant to a patient?
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`MR. MARGOLIS: Objection, vague.
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`Calls for speculation.
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`THE WITNESS: Only under the same
`
`sort of circumstances.
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`BY MR. HASFORD:
`
`Q
`
`Have you ever administered any product
`
`containing benzalkonium chloride to a patient?
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`MR. MARGOLIS: Objection, vague.
`
`Calls for speculation.
`
`THE WITNESS: Well, again,
`
`if I am
`
`the patient,
`
`I probably have because I've
`
`used lots of eyedrops.
`
`I've had cataract
`
`surgery. And actually other eye surgery,
`
`so
`
`I've administered these things to myself,
`
`I'm sure.
`
`BY MR. HASFORD:
`
`Q
`
`Have you ever dispensed any product
`
`containing benzalkonium chloride to a patient?
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`MR. MARGOLIS: Objection, vague.
`
`Lacks foundation.
`
`THE WITNESS:
`
`I guess it would be
`
`under the same circumstances.
`
`I've never
`
`sold it.
`
`BY MR. HASFORD:
`
`Q
`
`Have you ever conducted any research
`
`on any bromfenac product?
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`A
`
`Q
`
`No.
`
`Have you ever conducted any research
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`C. Heathcock, Ph.D.
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`on any non—steroidal anti—inflammatory drug
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`product?
`
`A
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`Q
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`I don't think so.
`
`Have you ever conducted any research
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`on any product containing tyloxapol?
`
`A
`
`Q
`
`NO.
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`Have you ever conducted any research
`
`on any product containing any non—ionic
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`surfactant?
`
`A
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`Q
`
`I don't think so, no.
`
`Have you ever conducted any research
`
`on any product containing benzalkonium chloride?
`
`A
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`Q
`
`No.
`
`Have you ever designed a drug in which
`
`you replaced a carboxylic acid group with a
`
`tetrazole group?
`
`MR. MARGOLIS: Objection,
`
`lacks
`
`I
`
`foundation. And vague.
`
`THE WITNESS:
`
`In a way, yes,
`
`I've —— in my capacity as consultant to
`
`medicinal chemists who were developing new
`
`drug products,
`
`I have certainly suggested to
`
`medicinal chemists that they make that
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`substitution because tetrazole is an
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`C. Heathcock, Ph.D.
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`isosteric replacement for carboxyl group.
`
`I
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`have not carried out
`
`those experiments
`
`myself. But professors usually don't carry
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`out experiments. We usually suggest them to
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`students, and they do it.
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`So in interacting with medicinal
`
`chemists, Pfizer, Merck or one of the main
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`companies,
`
`they might make those kinds of
`
`suggestions and they do it, it's like the
`
`same as if my students had done it, so...
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`So that's something where I can say I have
`
`had that kind of experience.
`
`BY MR. HASFORD:
`
`Q
`
`Just to be clear, have you yourself
`
`ever carried out a synthesis in which you
`
`replaced a carboxylic acid group with a tetrazole
`
`group?
`
`A
`
`Q
`
`Not with my own hands, no.
`
`Are you an expert
`
`in clinical testing?
`
`MR. MARGOLIS: Objection, vague.
`
`Calls for a legal conclusion.
`
`THE WITNESS:
`
`NO,
`
`I'm not —— I've
`
`not done any -— I'm an expert to the extent
`
`that my expertise has to do with evaluation
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`C. Heathcock, Ph.D.
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`of clinical testing results of our —— well,
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`about 20 years,
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`I was a member of advisory
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`boards for either Abbott Laboratories or
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`Plexxikon, and part of my responsibility was
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`to review clinical test data. And these
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`would be presentations that would be
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`presented by scientists who were gathering
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`the data. And so I understand how clinical
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`presented and evaluated, but it's not been
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`my responsibility to make decisions other
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`than just make observations.
`
`BY MR. HASFORD:
`
`Q
`
`Take a look,
`
`if you would, again at
`
`Heathcock Exhibit 2. And let me direct your
`
`attention to Page 222 on the small numbered
`
`pages.
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`Its Page 57 at the bottom of the large
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`numbered pages.
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`A
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`Q
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`Okay.
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`Let me direct your attention on Page
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`22.
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`222 to Lines 12 —— sorry, Lines 9 through 13.
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`Yes.
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`You were asked:
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`"Question:
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`You do
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`not consider yourself an expert
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`in clinical
`
`—
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`—.—
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`Ver

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