David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
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`Page 1
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`· · · 1· · · · UNITED STATES PATENT AND TRADEMARK OFFICE
`· · · 2· · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`· · · 3
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`· · · 4· · · · · · · ·____________________________
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`· · · 5· · · · · COALITION FOR AFFORDABLE DRUGS VII LLC
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`· · · 6· · · · · · · · · · · · Petitioner
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`· · · 7· · · · · · · · · · · · · · v.
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`· · · 8· · · · · · · · · · · · POZEN INC.
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`· · · 9· · · · · · · · · · · ·Patent Owner
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`· · ·10· · · · · · · _____________________________
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`· · ·11· · · · · · · · · Case No. IPR2015-01718
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`· · ·12· · · · · · · · · ·Patent No. 8,945,621
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`· · ·13· · · · · · · _____________________________
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`· · ·14
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`· · ·16· · · · · ·DEPOSITION OF DAVID A. JOHNSON, M.D.
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`· · ·17· · · · · · · · · · ·Washington, D.C.
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`· · ·18· · · · · · · · · · ·August 27, 2016
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`· · ·24· · · · Reported by:· Mary Ann Payonk
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`· · ·25· · · · Job No. 179557
`2
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`CFAD EXHIBIT 1037
`CFAD v. Pozen
`IPR2015-01718
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`YVer1f
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`

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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
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`· · · 1
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`· · · 2
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`· · · 3
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`Page 2
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`· · · 1· · · · APPEARANCES (Cont'd.):
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`· · · 2· · · · Danielle C. Pfifferling, Esq.
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`· · · 3· · · · Finnegan, Henderson, Farabow,
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`2 to 5
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`Page 4
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`· · · 4· · · · · · · · · · · · · · August 27, 2016
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`· · · 4· · · · · ·Garrett & Dunner LLP
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`· · · 5· · · · · · · · · · · · · · 9:00 a.m.
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`· · · 5· · · · 901 New York Avenue, N.W.
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`· · · 6
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`· · · 6· · · · Washington, D.C. 20001
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`· · · 7· · · · · · · ·Deposition of DAVID A. JOHNSON, M.D.,
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`· · · 7· · · · danielle.pfifferling@finnegan.com
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`· · · 8· · · · held at the offices of Cooley LLP, 1299
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`· · · 8
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`· · · 9· · · · Pennsylvania Avenue, N.W., Washington, D.C.,
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`· · · 9· · · · Jeffrey S. Gritton
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`· · ·10· · · · pursuant to Notice before Mary Ann Payonk,
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`· · ·10· · · · BAKER BOTTS LLP
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`· · ·11· · · · Nationally Certified Realtime Reporter and
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`· · ·11· · · · 98 San Jacinto Blvd., Suite 1500
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`· · ·12· · · · Notary Public of the District of Columbia,
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`· · ·12· · · · Austin, TX 78701-4078
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`· · ·13· · · · Commonwealth of Virginia, States of Maryland
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`· · ·13· · · · Tel: (512) 322-2624
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`· · ·14· · · · and New York.
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`· · ·14· · · · Jeff.Gritton@bakerbotts.com
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`· · · 1· · · · APPEARANCES:
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`· · · 2· · · · ON BEHALF OF PETITIONER:
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`· · · 3· · · · Amy E. LaValle, Esq.
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`· · · 4· · · · WICK PHILLIPS GOULD & MARTIN, LLP
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`· · · 5· · · · 3131 McKinney Avenue, Suite 100
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`· · · 6· · · · Dallas, TX 75204
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`· · · 7· · · · (214) 692-6200
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`· · · 8· · · · amy.lavalle@wickphillips.com
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`· · ·10· · · · ON BEHALF OF PATENT OWNER:
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`· · ·11· · · · Ricardo Rodriguez, Esq.
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`· · ·12· · · · COOLEY LLP
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`· · ·13· · · · 3175 Hanover Street
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`· · ·14· · · · Palo Alto, CA 94304-1130
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`· · ·15· · · · Tel: (650) 843-5046
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`· · ·16· · · · rr@cooley.com
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`· · ·18· · · · Lauren L. Stevens, Ph.D.
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`· · ·19· · · · HORIZON PHARMA USA, INC.
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`· · ·20· · · · 150 S. Saunders Road
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`· · ·21· · · · Lake Forest, Illinois 60045
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`· · ·22· · · · Tel: (224) 383-3265
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`· · ·23· · · · lstevens@horizonpharma.com
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`Page 5
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`· · · 1· · · · DAVID A. JOHNSON, M.D.,
`· · · 2· · · · · · · ·called as a witness, having been duly
`· · · 3· · · · · · · ·sworn, was examined and testified as
`· · · 4· · · · · · · ·follows:
`· · · 5· · · · · · · · · · · ·EXAMINATION
`· · · 6· · · · BY MS. LaVALLE:
`· · · 7· · · · · · ·Q.· ·Hi, Dr. Johnson.
`· · · 8· · · · · · ·A.· ·Good morning.
`· · · 9· · · · · · ·Q.· ·As I stated a minute ago, my name is
`· · ·10· · · · Amy LaValle and I'm an attorney for the
`· · ·11· · · · petitioner Coalition for Affordable Drugs.
`· · ·12· · · · · · · · · Could you please state your full name
`· · ·13· · · · for the record.
`· · ·14· · · · · · ·A.· ·Sure.· David Alan Johnson.
`· · ·15· · · · · · ·Q.· ·And could you state your current home
`· · ·16· · · · address?
`· · ·17· · · · · · ·A.· ·7464 North Shore Road, Norfolk,
`· · ·18· · · · Virginia 23505.
`· · ·19· · · · · · ·Q.· ·Have you ever been deposed?
`· · ·20· · · · · · ·A.· ·Yes.
`· · ·21· · · · · · ·Q.· ·How many times?
`· · ·22· · · · · · ·A.· ·I don't know that I have the number
`· · ·23· · · · off the top of my head, but several.
`· · ·24· · · · · · ·Q.· ·Are you experiencing any medical
`· · ·25· · · · issues today that may affect your testimony?
`6
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
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`6 to 9
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`Page 6
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`· · · 1· · · · · · ·A.· ·No.
`· · · 2· · · · · · ·Q.· ·Do you have any legal issues that
`· · · 3· · · · would prohibit you from providing answers
`· · · 4· · · · today?
`· · · 5· · · · · · ·A.· ·No.
`· · · 6· · · · · · ·Q.· ·Are you doing any consulting
`· · · 7· · · · work -- other than this, for this proceeding,
`· · · 8· · · · are you doing any consulting work for the
`· · · 9· · · · patent owners?
`· · ·10· · · · · · ·A.· ·Yes.
`· · ·11· · · · · · ·Q.· ·Could you tell me about that?
`· · ·12· · · · · · ·A.· ·It's in the -- involved with
`· · ·13· · · · litigation.
`· · ·14· · · · · · ·Q.· ·So other legal expert work?
`· · ·15· · · · · · ·A.· ·Correct.
`· · ·16· · · · · · ·Q.· ·For other legal proceedings?
`· · ·17· · · · · · ·A.· ·Correct.
`· · ·18· · · · · · ·Q.· ·And that is for POZEN?
`· · ·19· · · · · · ·A.· ·Correct.
`· · ·20· · · · · · ·Q.· ·And for Horizon Pharma as well?
`· · ·21· · · · · · ·A.· ·Correct.
`· · ·22· · · · · · ·Q.· ·Other than legal work, are you doing
`· · ·23· · · · any consulting work for the patent owners?
`· · ·24· · · · · · ·A.· ·No.
`· · ·25· · · · · · ·Q.· ·Have you ever done any consulting
`7
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`Page 8
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`· · · 1· · · · BY MS. LaVALLE:
`· · · 2· · · · · · ·Q.· ·Dr. Johnson, I did see on page, I
`· · · 3· · · · think, 98, if you could turn to page 98 -- or
`· · · 4· · · · at the bottom of 97 starts a listing of some
`· · · 5· · · · research activities that you conducted for
`· · · 6· · · · AstraZeneca.
`· · · 7· · · · · · · · · Is this what you were referring to a
`· · · 8· · · · few minutes ago?
`· · · 9· · · · · · ·A.· ·In part, yes.
`· · ·10· · · · · · ·Q.· ·Can you explain what you did for
`· · ·11· · · · AstraZeneca in the study at the bottom of page
`· · ·12· · · · 97?
`· · ·13· · · · · · ·A.· ·This was a -- as I recall, have not
`· · ·14· · · · reviewed this protocol for quite some time.
`· · ·15· · · · This was a pharmaceutical investigative study.
`· · ·16· · · · I was the primary investigator at my site, not
`· · ·17· · · · in the study, so we were participating in a
`· · ·18· · · · pharmaceutical clinical trial at which I was
`· · ·19· · · · the primary investigator at my site, not for
`· · ·20· · · · the entire trial.
`· · ·21· · · · · · ·Q.· ·Can you explain what your
`· · ·22· · · · responsibilities were?
`· · ·23· · · · · · ·A.· ·Well, the primary investigator at any
`· · ·24· · · · site, as well as the associates, to maintain
`· · ·25· · · · clinical conduct in accordance with the
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`Page 7
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`· · · 1· · · · work for the patent owners in the past?
`· · · 2· · · · · · ·A.· ·No.
`· · · 3· · · · · · ·Q.· ·Have you done any consulting work in
`· · · 4· · · · the past for AstraZeneca?
`· · · 5· · · · · · ·A.· ·Yes.
`· · · 6· · · · · · ·Q.· ·What type of consulting work have you
`· · · 7· · · · done for AstraZeneca?
`· · · 8· · · · · · ·A.· ·Typical consulting work and advice on
`· · · 9· · · · clinical trials and participation in scientific
`· · ·10· · · · development.
`· · ·11· · · · · · ·Q.· ·Do you recall which drugs?
`· · ·12· · · · · · ·A.· ·I've been involved in Omeprazole and
`· · ·13· · · · with -- as well it was -- at that time was
`· · ·14· · · · Merck and then AstraMerck, and then
`· · ·15· · · · AstraZeneca, as well as esomeprazole and
`· · ·16· · · · involved in some of the other developmental
`· · ·17· · · · drugs which haven't come to market.
`· · ·18· · · · · · · · · MS. LaVALLE:· I was provided a copy
`· · ·19· · · · · · ·of your CV a couple of days ago, and I'd
`· · ·20· · · · · · ·like to mark that as an exhibit in this
`· · ·21· · · · · · ·deposition.· It will be Exhibit 1.· I'll
`· · ·22· · · · · · ·hand you a copy.
`· · ·23· · · · · · · · · THE WITNESS:· Oh, okay.
`· · ·24· · · · · · ·(Johnson Exhibit No. 1 was marked for
`· · ·25· · · · · · ·identification.)
`8
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`Page 9
`· · · 1· · · · clinical trial design, ensure patient safety
`· · · 2· · · · and ensure reporting as outlined in the
`· · · 3· · · · protocol.
`· · · 4· · · · · · ·Q.· ·And at the top of the next page
`· · · 5· · · · listed as .8.11, there's another study there
`· · · 6· · · · where it states you were the primary
`· · · 7· · · · investigator.· Is that a similar type of study?
`· · · 8· · · · · · ·A.· ·Well, similar type of study as a
`· · · 9· · · · primary investigator at the site in a
`· · ·10· · · · pharmaceutical-sponsored trial.
`· · ·11· · · · · · ·Q.· ·So when you say
`· · ·12· · · · "pharmaceutical-sponsored," do you mean
`· · ·13· · · · AstraZeneca sponsored and paid for this trial?
`· · ·14· · · · · · ·A.· ·They were as listed there, yes.
`· · ·15· · · · · · ·Q.· ·And were you compensated for your
`· · ·16· · · · work?
`· · ·17· · · · · · ·A.· ·No.
`· · ·18· · · · · · ·Q.· ·Do you recall the dates of these
`· · ·19· · · · trials?
`· · ·20· · · · · · ·A.· ·I do not.· Sorry.
`· · ·21· · · · · · ·Q.· ·Do you recall what you were doing at
`· · ·22· · · · the time, where you were employed?
`· · ·23· · · · · · ·A.· ·I was employed with my same group. I
`· · ·24· · · · have been there since 1989.
`· · ·25· · · · · · ·Q.· ·Okay.· Are you also employed as a
`10
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
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`10 to 13
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`Page 10
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`·1· ·professor?
`·2· · · · A.· ·Well, I'm employed by my division.
`·3· ·I'm appointed as a professor.· I'm not paid for
`·4· ·my role at the medical school.· I'm the
`·5· ·division director but I'm not directly paid for
`·6· ·that.
`·7· · · · Q.· ·Okay.· Your group that you're
`·8· ·referring to where you are employed is the
`·9· ·Gastrointestinal and Liver Disease Specialists
`10· ·of Tidewater?
`11· · · · A.· ·Correct.
`12· · · · Q.· ·Prior to this proceeding, have you
`13· ·ever served as an expert witness in a
`14· ·proceeding in which you provided an expert
`15· ·report or declaration?
`16· · · · A.· ·Yes.
`17· · · · Q.· ·Which proceeding was that?
`18· · · · A.· ·A number of proceedings.· I -- off
`19· ·the top of my head, I can't recall the
`20· ·specifics, but I've been involved in a number
`21· ·of different proceedings.
`22· · · · Q.· ·Were they patent cases?
`23· · · · A.· ·Some of which, yes.
`24· · · · Q.· ·Have you ever testified at a
`25· ·deposition or trial in a patent case?
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`Page 12
`·1· ·don't understand the -- don't participate in
`·2· ·direct patent application and the proceedings
`·3· ·that I have been involved in have been in
`·4· ·legal.· And beyond that, no.
`·5· · · · · · ·MS. LaVALLE:· Okay.· I'm going to
`·6· · · · hand you a copy of the patent that is at
`·7· · · · issue in this proceeding.· It's
`·8· · · · U.S. Patent 8,945,621.· We will mark it
`·9· · · · as Exhibit 2 in this deposition.
`10· · · · (XX Exhibit No. 2 was marked for
`11· · · · identification.)
`12· ·BY MS. LaVALLE:
`13· · · · Q.· ·Have you seen this patent before?
`14· · · · A.· ·I have.
`15· · · · Q.· ·Can you confirm that this is the
`16· ·patent that is at issue in this proceeding?
`17· · · · A.· ·It is.
`18· · · · Q.· ·On the first page, in the top
`19· ·left-hand corner, near the top left-hand
`20· ·corner, there's a list of the named inventors.
`21· ·Can you review that list?
`22· · · · A.· ·Yes.
`23· · · · Q.· ·Are you familiar with any of these
`24· ·names?
`25· · · · A.· ·Yes.
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`Page 11
`·1· · · · A.· ·I've testified at deposition, never
`·2· ·at the trial.
`·3· · · · Q.· ·In a patent case?
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·Just once before?
`·6· · · · A.· ·Some of these get muddied into a
`·7· ·continuation of different iterations so I don't
`·8· ·recall if it was with one product or whether or
`·9· ·not it was several iterations in the same
`10· ·litigation, but several depositions.
`11· · · · Q.· ·Did it involve the product at issue
`12· ·in this case?
`13· · · · A.· ·No.
`14· · · · Q.· ·Do you have any patents of your own?
`15· · · · A.· ·Do not.
`16· · · · Q.· ·Do you have any experience in the
`17· ·patent process and applying for patents?
`18· · · · A.· ·Not directly.
`19· · · · Q.· ·Do you have any experience that gives
`20· ·you a -- do you have any experience with the
`21· ·patent process in any work setting other than
`22· ·these legal proceedings?
`23· · · · A.· ·Not directly.
`24· · · · Q.· ·What do you mean by "not directly"?
`25· · · · A.· ·Well, I mentioned the first time I
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`Page 13
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`·1· · · · Q.· ·Which ones?
`·2· · · · A.· ·Mark Sostek, directly -- as far as
`·3· ·directly familiar with the others by name, but
`·4· ·not directly knowing.
`·5· · · · Q.· ·Okay.· So do you personally know Mark
`·6· ·Sostek?
`·7· · · · A.· ·I do.
`·8· · · · Q.· ·How do you know him?
`·9· · · · A.· ·Through prior involvement with
`10· ·AstraZeneca.· He was an employee at
`11· ·AstraZeneca.
`12· · · · Q.· ·Did you work with him when he was an
`13· ·employee at --
`14· · · · A.· ·And I don't understand what you mean
`15· ·when -- "work with."
`16· · · · Q.· ·Could you explain how you came to
`17· ·know him?
`18· · · · A.· ·We were involved in a number of
`19· ·clinical trial designs and applications and
`20· ·Mark Sostek was one of the physicians at
`21· ·AstraZeneca, so I had met him in --
`22· ·periodically at different meetings.· Don't
`23· ·recall specifically working with him, but the
`24· ·best of my knowledge.
`25· · · · Q.· ·Do you recall him being involved in
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
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`14 to 17
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`Page 14
`·1· ·the clinical trials that you were involved in?
`·2· · · · A.· ·Not off the top of my head.· Maybe --
`·3· ·sometimes investigators get listed in the
`·4· ·lineage, but I don't recall that, best of my
`·5· ·knowledge.
`·6· · · · Q.· ·Other than that interaction through
`·7· ·your consulting work for AstraZeneca, do you
`·8· ·have any other interactions with Dr. Sostek?
`·9· · · · A.· ·No.
`10· · · · Q.· ·And the other named inventors, have
`11· ·you ever met any of them personally?
`12· · · · A.· ·No.
`13· · · · Q.· ·Have you ever heard of them?
`14· · · · A.· ·Not beyond the context of this patent
`15· ·review.
`16· · · · Q.· ·When is the last time you
`17· ·communicated with Dr. Sostek?
`18· · · · A.· ·It has to be several years.· I can't
`19· ·recall specifically.
`20· · · · Q.· ·You never communicated with him about
`21· ·this proceeding?
`22· · · · A.· ·No.
`23· · · · Q.· ·Have you communicated with anyone
`24· ·about this proceeding other than attorneys?
`25· · · · A.· ·No.
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`Page 16
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`·1· ·with my CV, but that was submitted.
`·2· · · · Q.· ·Could you confirm that the document
`·3· ·that we marked earlier as Exhibit 1 is your CV?
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·Is that the document that you are
`·6· ·discussing there in paragraph 4?
`·7· · · · A.· ·Yes.
`·8· · · · Q.· ·Your declaration at paragraph 2 says
`·9· ·that you have been retained as an expert
`10· ·opinion witness on behalf of patent owners
`11· ·POZEN, Inc. and Horizon Pharma, Inc.
`12· · · · · · ·Could you explain to me how that
`13· ·engagement came to be?· For example, could you
`14· ·tell me who hired you, who called you?
`15· · · · · · ·MR. RODRIGUEZ:· Let me just caution
`16· · · · you not to reveal any actual
`17· · · · communications other than general stuff
`18· · · · about the engagement.
`19· · · · A.· ·Sure.· And the honest answer is I
`20· ·don't recall how the communication developed.
`21· · · · Q.· ·Were you contacted by attorneys?
`22· · · · A.· ·Yes.
`23· · · · Q.· ·Did you ever speak with anyone other
`24· ·than attorneys for POZEN and Horizon?
`25· · · · A.· ·No.
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`Page 15
`·1· · · · · · ·MS. LaVALLE:· I'm now handing you a
`·2· · · · copy of your declaration that you
`·3· · · · prepared for this proceeding.· We will
`·4· · · · mark this document as Exhibit 3.
`·5· · · · (XX Exhibit No. 3 was marked for
`·6· · · · identification.)
`·7· ·BY MS. LaVALLE:
`·8· · · · Q.· ·Can you confirm that this is your
`·9· ·declaration, Dr. Johnson?
`10· · · · A.· ·Yes.
`11· · · · Q.· ·And if you could turn to the last
`12· ·page, can you confirm that that is your
`13· ·signature?
`14· · · · A.· ·Yes.
`15· · · · Q.· ·Could you turn to paragraph 4.
`16· ·That's page 1 of your declaration.· The last
`17· ·sentence there states that "A full description
`18· ·of my background and qualifications is set
`19· ·forth in my curriculum vitae attached hereto."
`20· · · · · · ·Do you see that?
`21· · · · A.· ·Yes.
`22· · · · Q.· ·Did you attach your curriculum vitae
`23· ·to this document?
`24· · · · A.· ·I presume when it was submitted. I
`25· ·don't know the process of what was submitted
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`Page 17
`·1· · · · Q.· ·Did you communicate by email or in
`·2· ·any other manner with anyone other than
`·3· ·attorneys for POZEN and Horizon?
`·4· · · · A.· ·No.
`·5· · · · Q.· ·Do you recall when you were engaged?
`·6· · · · A.· ·I do not.
`·7· · · · Q.· ·Approximately how long ago?
`·8· · · · A.· ·Again, as stated, I don't -- I don't
`·9· ·recall.
`10· · · · Q.· ·Less than a year?
`11· · · · A.· ·In the last -- whatever the time of
`12· ·the proceedings began.· I don't remember the
`13· ·scope of the exact date.
`14· · · · Q.· ·Did you write this declaration
`15· ·yourself?
`16· · · · A.· ·No.
`17· · · · Q.· ·Who prepared the declaration?
`18· · · · A.· ·It was prepared in concert with
`19· ·counsel.
`20· · · · Q.· ·When you say "in concert with
`21· ·counsel," do you mean you prepared it in
`22· ·concert with counsel?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·Did anyone other than the attorneys
`25· ·assist you in preparing the declaration?
`
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
`
`18 to 21
`
`Page 18
`
`·1· · · · A.· ·No.
`·2· · · · Q.· ·Did anyone other than the attorneys
`·3· ·review the declaration?
`·4· · · · A.· ·Not to the best of my knowledge.
`·5· · · · Q.· ·Since the time that you completed
`·6· ·this declaration, have you discussed it with
`·7· ·anyone other than the attorneys?
`·8· · · · A.· ·No.
`·9· · · · Q.· ·Can you turn to page 2 of the
`10· ·declaration, paragraph 7.· You state here that
`11· ·since 1984, you have been practicing
`12· ·gastroenterology, and the second sentence says
`13· ·there that you are a practicing physician.· Is
`14· ·that statement still true today?
`15· · · · A.· ·Yes.
`16· · · · Q.· ·And you still currently see patients
`17· ·virtually every day?
`18· · · · A.· ·Correct.
`19· · · · Q.· ·The second-to-the-last sentence of
`20· ·that paragraph says "I treat all aspects of
`21· ·adult patient disease."
`22· · · · · · ·As part of the treatment of your
`23· ·patients, do you prescribe medications?
`24· · · · A.· ·It says that I treat all aspects of
`25· ·adult patient disease from a primary GI disease
`
`Page 20
`·1· · · · Q.· ·When you treat your patients, do you
`·2· ·ask them if they're currently taking any other
`·3· ·medications?
`·4· · · · A.· ·As it relates to GI disease, yes.
`·5· · · · Q.· ·Have you ever had a patient tell you
`·6· ·that they have taken Vimovo?
`·7· · · · A.· ·I don't recall.
`·8· · · · Q.· ·Do you recall if any of your patients
`·9· ·are ever taking low-dose aspirin?
`10· · · · A.· ·Yes.
`11· · · · Q.· ·Have you ever prescribed PPIs to
`12· ·treat GI injury as a result of patients taking
`13· ·low-dose aspirin?
`14· · · · A.· ·As a consequence of ulcerations, yes.
`15· · · · Q.· ·Do you ever prescribe any other types
`16· ·of drugs besides PPIs to treat the ulcerations
`17· ·caused by low-dose aspirin?
`18· · · · A.· ·Again, in the context of treating
`19· ·ulcerations, I have been doing this for a long
`20· ·time so proton pump inhibitors haven't been
`21· ·around the tenure of my career so of course I
`22· ·have in the context of time.
`23· · · · Q.· ·Currently, are proton pump inhibitors
`24· ·your first choice of treatment for ulcerations
`25· ·due to G-- or GI injury due to low-dose aspirin
`
`Page 19
`·1· ·to symptoms or otherwise have GI consequences,
`·2· ·so I think it was a little bit out of context
`·3· ·to say I treat all patient disease.
`·4· · · · Q.· ·Right.· I apologize.· I'll restate my
`·5· ·question.
`·6· · · · · · ·Just as part of your practice in
`·7· ·treating patients, do you ever prescribe
`·8· ·medications?
`·9· · · · A.· ·As it relates to GI diseases, yes.
`10· · · · Q.· ·Do you ever prescribe medication for
`11· ·any other types of diseases?
`12· · · · A.· ·Not to the best of my knowledge.
`13· · · · Q.· ·Have you ever prescribed proton pump
`14· ·inhibitors, or PPIs?
`15· · · · A.· ·Yes.
`16· · · · Q.· ·Have you ever prescribed
`17· ·esomeprazole?
`18· · · · A.· ·Yes.
`19· · · · Q.· ·Is that a drug that you commonly
`20· ·prescribe to your patients?
`21· · · · A.· ·Yes.
`22· · · · Q.· ·Have you ever prescribed Vimovo?
`23· · · · A.· ·No.
`24· · · · Q.· ·Have you ever prescribed Naproxen?
`25· · · · A.· ·No.
`
`Page 21
`
`·1· ·use?
`·2· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`·3· · · · A.· ·Again, I don't know the context of
`·4· ·low-dose aspirin use and what other factors are
`·5· ·involved in that individual patient.
`·6· · · · Q.· ·What are other factors that you look
`·7· ·at when treating patients that have GI
`·8· ·injuries?
`·9· · · · A.· ·What their disease state is; what the
`10· ·location of the ulceration is; is there an acid
`11· ·involved in the ulceration.· Some patients have
`12· ·no acid and have no -- and have ulcerations due
`13· ·to NSAIDs.
`14· · · · Q.· ·So use of NSAIDs is a factor that you
`15· ·look at when treating your patients?
`16· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`17· · · · A.· ·I don't understand in treating a
`18· ·patient.· What context?
`19· · · · Q.· ·When evaluating a patient, do you
`20· ·inquire whether your patients are taking
`21· ·NSAIDs?
`22· · · · A.· ·Again, in evaluating the patient for
`23· ·what?· In what context?
`24· · · · Q.· ·When you're evaluating them for GI
`25· ·injury.
`
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
`
`22 to 25
`
`Page 22
`·1· · · · A.· ·In what -- in what regard to GI
`·2· ·injury?
`·3· · · · Q.· ·When you're treating and just in your
`·4· ·normal daily practice and you're engaged in
`·5· ·patient care, do you generally ask your
`·6· ·patients whether they are taking NSAIDs?
`·7· · · · A.· ·In routine practice, I do, yes.
`·8· · · · Q.· ·Have you ever recommended to a
`·9· ·patient to stop NSAID use?
`10· · · · A.· ·Yes.
`11· · · · Q.· ·What was the reason for recommending
`12· ·that they stop use of NSAIDs?
`13· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`14· · · · A.· ·Again, the patient -- you said that
`15· ·patient, and I'd have to refer to what was
`16· ·specific indication for that individual
`17· ·patient.
`18· · · · Q.· ·Can you give me an example?
`19· · · · A.· ·Sure.· Somebody that had an
`20· ·ulceration due to a consequence of an exposure
`21· ·with NSAID use.
`22· · · · Q.· ·Have you ever recommended to a
`23· ·patient to stop taking Vimovo?
`24· · · · A.· ·Again, not to the best of my
`25· ·recollection, have -- I have been -- recall
`
`Page 24
`·1· · · · Q.· ·As part of your regular curriculum,
`·2· ·do you cover the use of low-dose aspirin and
`·3· ·how that may cause GI injury?
`·4· · · · A.· ·That would be included in the
`·5· ·discussion, yes.
`·6· · · · Q.· ·Included in the discussion, do you
`·7· ·discuss the use of low-dose aspirin with other
`·8· ·NSAIDs such as Naproxen?
`·9· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`10· · · · A.· ·Again, in the context of other PP --
`11· ·other NSAIDs, low-dose aspirin is well
`12· ·recognized to cause incremental injury so it
`13· ·would be included in that discussion.
`14· · · · Q.· ·As part of your teaching discussion,
`15· ·has Vimovo ever come up?
`16· · · · A.· ·Not to the best of my knowledge.
`17· · · · Q.· ·The next paragraph at the top of page
`18· ·3 of your declaration states that you're
`19· ·extremely active in clinical research.
`20· · · · · · ·Have you ever done any clinical
`21· ·research involving the drug Vimovo?
`22· · · · A.· ·Not to the best of my knowledge.
`23· · · · Q.· ·When is the first time you heard
`24· ·about the drug Vimovo?
`25· · · · A.· ·I can't recall.· A while ago.
`
`Page 23
`
`·1· ·specific discussion about Vimovo.
`·2· · · · Q.· ·Paragraph 8 of your declaration
`·3· ·discusses your involvement as Chief of
`·4· ·Gastroenterology and Professor of Medicine at
`·5· ·Eastern Virginia Medical School.· Do you see
`·6· ·that?
`·7· · · · A.· ·Yes.
`·8· · · · Q.· ·That first sentence says that you're
`·9· ·involved in teaching clinical gastroenterology
`10· ·to medical students and residents.· My question
`11· ·is, as part of your teaching to medical
`12· ·students and residents, have you ever taught
`13· ·any students or residents about treating GI
`14· ·injury as a result of NSAID use?
`15· · · · A.· ·Yes.
`16· · · · Q.· ·Is that something you regularly
`17· ·cover?
`18· · · · A.· ·Regularly in what context?
`19· · · · Q.· ·In your teaching programs.
`20· · · · A.· ·Again, the -- regularly means is it a
`21· ·core element of description?
`22· · · · Q.· ·Right.
`23· · · · A.· ·There is -- if -- in discussion of
`24· ·peptic ulcer disease, that would be a regular
`25· ·topic to be covered.
`
`Page 25
`·1· · · · Q.· ·Prior to being engaged as an expert
`·2· ·in this proceeding?
`·3· · · · A.· ·Yes.
`·4· · · · Q.· ·Do you know in what context you would
`·5· ·have heard about the drug Vimovo?
`·6· · · · A.· ·Well, I follow the literature quite
`·7· ·closely and review the standard journals on a
`·8· ·monthly basis so I'm sure that it was in the
`·9· ·context of scientific discovery in that regard.
`10· · · · · · ·I'm sure there were some other
`11· ·presentations that may have been discussed. I
`12· ·don't recall.· But for sure, the scientific
`13· ·studies that I review regularly and the
`14· ·journals that I do.
`15· · · · Q.· ·Do any of your colleagues prescribe
`16· ·Vimovo?
`17· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`18· · · · A.· ·I don't ask my colleagues what they
`19· ·prescribe.
`20· · · · Q.· ·Have you ever discussed Vimovo with
`21· ·any of your colleagues?
`22· · · · A.· ·Again, not to the best of my
`23· ·knowledge.
`24· · · · Q.· ·Would you please turn to page 10 of
`25· ·your declaration.· Paragraph 25 at the bottom
`
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
`
`26 to 29
`
`Page 26
`·1· ·of page 10 states that "I understand that the
`·2· ·'621 patent must be considered from the
`·3· ·viewpoint of a person --"
`·4· · · · A.· ·I'm sorry, page 10 on my declaration
`·5· ·has references, not -- I'm sorry.
`·6· · · · Q.· ·I'm sorry.· Sorry, it's page 12.
`·7· ·There's two different --
`·8· · · · A.· ·Okay, got it.
`·9· · · · Q.· ·Yeah.· Sorry about that.
`10· · · · · · ·There's two different page numbering
`11· ·on this document.· It's the page 12 of 31.
`12· · · · · · ·Paragraph 25 states:· "I understand
`13· ·that the '621 patent must be considered from
`14· ·the viewpoint of a person of ordinary skill in
`15· ·the relevant art, POSA, as of June 25th, 2009."
`16· · · · · · ·Can you tell me why you included that
`17· ·date, June 25th, 2009?
`18· · · · A.· ·That's the date of the patent.
`19· · · · Q.· ·The date the patent --
`20· · · · A.· ·Was filed.
`21· · · · Q.· ·-- was filed.
`22· · · · · · ·And why is that date relevant?
`23· · · · · · ·MR. RODRIGUEZ:· Objection, calls
`24· · · · for a legal conclusion.
`25· · · · A.· ·Again, that is not my point of
`
`Page 28
`·1· ·inventors of the '621 patent to be a POSA under
`·2· ·your definition?
`·3· · · · A.· ·Again, that would be a legal question
`·4· ·beyond the scope of my interpretation.
`·5· · · · Q.· ·Do you think that an inventor would
`·6· ·need to be a POSA, in general, to be able to
`·7· ·invent the subject matter at issue?
`·8· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`·9· · · · A.· ·Again, that's more of a legal
`10· ·question.· I'm not asked for an opinion on what
`11· ·the development of an inventor is.· In
`12· ·specific, my interpretation of this patent and
`13· ·along the lines of a specific question, I am a
`14· ·POSA in that regard.
`15· · · · Q.· ·So your definition of POSA is
`16· ·relevant to interpreting the patent once it's
`17· ·issued?
`18· · · · · · ·MR. RODRIGUEZ:· Objection, vague,
`19· · · · calls for a legal conclusion.
`20· · · · A.· ·Can those -- yeah, I'm not -- I'm not
`21· ·a lawyer.· My definition of POSA is stated
`22· ·there and carefully thought.
`23· · · · Q.· ·The second sentence of your paragraph
`24· ·25 states:· "A POSA is a hypothetical person
`25· ·who is presumed to be aware of all pertinent
`
`Page 27
`
`·1· ·opining in this discussion.
`·2· · · · Q.· ·Your next sentence states:· "A POSA
`·3· ·is a hypothetical person who is presumed to be
`·4· ·aware of all pertinent art."
`·5· · · · · · ·And then the next sentence states:
`·6· ·"It is my opinion that a POSA would have the
`·7· ·following qualifications."
`·8· · · · · · ·And you list two qualifications:
`·9· ·First, an MB or equivalent degree; and, two,
`10· ·gastroenterology experience, or experience in
`11· ·treating patients at risk for developing
`12· ·gastric ulcer.
`13· · · · · · ·Did you formulate this definition of
`14· ·a POSA?
`15· · · · A.· ·I did, in concert with counsel.
`16· · · · Q.· ·How did you come up with this
`17· ·definition?
`18· · · · A.· ·Because I thought that's what the
`19· ·implications to interpret this patent in the
`20· ·specifics of my opinion being requested were
`21· ·focusing on.
`22· · · · Q.· ·Do you consider yourself to be a POSA
`23· ·under your definition of a POSA for this case?
`24· · · · A.· ·Yes.
`25· · · · Q.· ·Do you consider each of the named
`
`Page 29
`
`·1· ·art."
`·2· · · · · · ·What is pertinent art in this case?
`·3· · · · A.· ·Pertinent art would be knowledge of
`·4· ·the literature surrounding the topic of
`·5· ·interest and the state of understanding for
`·6· ·what the standard knowledge would be at the
`·7· ·time around that relevant topic.
`·8· · · · Q.· ·What is the topic for this case that
`·9· ·would be relevant for a POSA to have an
`10· ·awareness of?
`11· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`12· · · · A.· ·In what context?
`13· · · · Q.· ·In the context of this case, what
`14· ·pertinent art must a POSA be aware of in order
`15· ·to be a POSA?
`16· · · · · · ·MR. RODRIGUEZ:· Objection, vague.
`17· · · · A.· ·Again, my comments are more the
`18· ·description of the patent and the reduction of
`19· ·gastric ulcers associated with NSAIDs who are
`20· ·also taking low-dose aspirin.
`21· · · · Q.· ·The next paragraph of your
`22· ·declaration, paragraph 26, states that you have
`23· ·been advised of the following legal principles
`24· ·and have applied those principles to your
`25· ·analysis.· Paragraphs 27, 28, and 29 contain
`
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`David A. Johnson, M.D.
`David A. Johnson, M.D.
`August 27, 2016
`August 27, 2016
`
`30 to 33
`
`Page 30
`
`·1· ·those legal principles.
`·2· · · · · · ·Are these the only legal principles
`·3· ·that you considered in writing your
`·4· ·declaration?
`·5· · · · A.· ·Again --
`·6· · · · · · ·MR. RODRIGUEZ:· Objection, calls
`·7· · · · for a legal conclusion.
`·8· · · · A.· ·-- I'm not a lawyer.· These are done
`·9· ·in concert with counsel.
`10· · · · Q.· ·Were you provided any legal
`11· ·principles regarding inherency?
`12· · · · A.· ·Not to the best of my knowledge.
`13· · · · Q.· ·Do you recall if you were provided
`14· ·any legal principles that state that an
`15· ·invention may be unpatentable if the invention
`16· ·is disclosed in the inherent teaching of a
`17· ·prior art reference?
`18· · · · A.· ·I don't believe that's in my
`19· ·statement unless you're reading that.· If you
`20· ·could point me to that direction.
`21· · · · Q.· ·No, I did not see it in your
`22· ·declaration.· My question is if you recall
`23· ·being provided with any legal principle that
`24· ·was related to inherency.
`25· · · · · · ·MR. RODRIGUEZ:· I'm just going to
`
`Page 32
`
`·1· ·BY MS. LaVALLE:
`·2· · · · Q.· ·Dr. Johnson, could you turn to
`·3· ·paragraph 42 of your declaration.· At paragraph
`·4· ·42 you state that you understand that Vimovo is
`·5· ·a pharmaceutical dosage form according to the
`·6· ·'621 patent.
`·7· · · · · · ·Do you see that?
`·8· · · · A.· ·Yes.
`·9· · · · Q.· ·How did you come to understand tha