·1
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
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`1
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`Page 1
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`·2· · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·3· · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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
`·7· · · · · · · vs.· · · · Case No. IPR2015-01718
`·8· · · · · · · · · · · · ·Patent No. 8,945,621
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`·9· ·POZEN, INC.,
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`10· · · · · · · · · · · · ·Patent Owner.
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`11· ·------------------------------------------
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`12
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`13
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`14· · · DEPOSITION OF ROBERT W. MAKUCH, PH.D.
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`15
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`16
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`17
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`18· · · · · · Monday, September 19, 2016
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`19· · · · · · · · · · 9:00 a.m.
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`20
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`21
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`22· ·Reported by:
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`23· ·Joan Ferrara, RMR, CRR
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`24· ·Job No. 181513
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`25
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`U.S. LEGAL SUPPORT
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`CFAD EXHIBIT 1038
`CFAD v. Pozen
`IPR2015-01718
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`YVer1f
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`

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`·1
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`·2
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
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`Page 2
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`·1
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`·2· ·A P P E A R A N C E S :· (Continued)
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`2 to 5
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`Page 4
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`·3· · · · · · · · · · · September 19, 2016
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`·4· · · · · · · · · · · 9:00 a.m.
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`·3
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`·4
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`·5· · · · · · · · · · · New York, New York
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`·5· ·COOLEY, LLP
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`·6
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`·7
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`·8
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`·6· ·Attorneys for Horizon Pharma and The Witness
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`·7· · · · · · ·3175 Hanover Street
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`·8· · · · · · ·Palo Alto, California 94304-1130
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`·9· · · · · · Deposition of Robert W. Makuch,
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`·9· ·BY:· · · ·RICARDO RODRIGUEZ, ESQ.
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`10· ·Ph.D., held at the offices of Cooley, LLP,
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`10· · · · · · ·rr@cooley.com
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`11· ·1114 Avenue of the Americas, New York,
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`12· ·New York, Pursuant to Notice, before Joan
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`13· ·Ferrara, a Registered Merit Reporter and
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`11
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`12
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`13
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`14· ·Notary Public of the State of New York.
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`14· ·FINNEGAN HENDERSON FARABOW GARRETT & DUNNER
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`15
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`16
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`·1
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`·2· ·A P P E A R A N C E S:
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`·3
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`·4
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`·5· ·WICK PHILLIPS
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`·6· ·Attorneys for Petitioner - Coalition for
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`·7· ·Affordable Drugs VII LLC
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`·8· · · · · · ·3131 McKinney Avenue, Suite 100
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`·9· · · · · · ·Dallas, Texas 75204
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`10· ·BY:· · · ·AMY E. LaVALLE, ESQ.
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`11· · · · · · ·amy.lavalle@wickphillips.com
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`12
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`13
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`14
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`15· ·BAKER BOTTS, LLP
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`16· ·Attorneys for Patent Owner - Pozen
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`17· · · · · · ·98 San Jacinto Boulevard
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`18· · · · · · ·Suite 1500
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`19· · · · · · ·Austin, Texas 78701-4078
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`20· ·BY:· · · ·JEFF GRITTON, ESQ.
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`21· · · · · · ·jeff.gritton@bakerbotts.com
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`Page 3
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`15· ·Attorneys for Horizon Pharma
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`16· · · · · · ·901 New York Avenue, N.W.
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`17· · · · · · ·Washington, D.C. 20001-4413
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`18· ·BY:· · · ·DANIELLE C. PFIFFERLING, ESQ.
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`19· · · · · · ·danielle.pfifferling@finnegan.com
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`20
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`21
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`22
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`23· ·ALSO PRESENT:
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`24· · · · · · ·Laura Stevens, Horizon Pharma
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`25
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`Page 5
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`·1
`·2· ·R O B E R T· ·M A K U C H ,
`·3· · · · · called as a witness, having been
`·4· · · · · duly sworn by a Notary Public, was
`·5· · · · · examined and testified as follows:
`·6· ·EXAMINATION BY
`·7· ·MS. LaVALLE:
`·8· · · · ·Q· · ·Hi, Dr. Makuch.· Is that right?
`·9· · · · ·A· · ·Yes.
`10· · · · ·Q· · ·Sorry.
`11· · · · · · · ·I'm Amy LaValle.· I represent
`12· · the petitioner Coalition for Affordable
`13· · Drugs.
`14· · · · · · · ·Could you please state your full
`15· · name for the record.
`16· · · · ·A· · ·My name is Robert W. Makuch,
`17· · M-A-K-U-C-H.
`18· · · · ·Q· · ·Could you please state your
`19· · current home address?
`20· · · · ·A· · ·My current home address is 8
`21· · Greenbrier Road in Westport, Connecticut.
`22· · · · ·Q· · ·Do you have any medical issues
`23· · that might affect your testimony today?
`24· · · · ·A· · ·I do not.
`25· · · · ·Q· · ·Are you taking any medication?
`
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`
`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
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`6 to 9
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`Page 6
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`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·I take no medications.
`·3· · · · Q· · ·Have you ever been deposed?
`·4· · · · A· · ·Yes, I have.
`·5· · · · Q· · ·When was that?
`·6· · · · A· · ·It's been quite a while ago, so
`·7· ·I don't recall the exact date, but it might
`·8· ·be 4 years ago in one particular case.
`·9· · · · Q· · ·Were you deposed just one time
`10· ·before?
`11· · · · A· · ·No.· I've been deposed in the
`12· ·more distant past as well.
`13· · · · Q· · ·Just one other time?
`14· · · · A· · ·No, other times, plural.· And
`15· ·again, I can't recall.· It's not something
`16· ·that I tend to do.· I really don't recall
`17· ·the dates.
`18· · · · Q· · ·When you were deposed
`19· ·previously, were you working as an expert
`20· ·witness in a legal proceeding?
`21· · · · A· · ·I can't even tell you whether I
`22· ·was an expert witness or I was a fact
`23· ·witness.· I really don't recall.
`24· · · · Q· · ·Have you ever testified in a
`25· ·patent case before?
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`Page 7
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`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Yes, I have.
`·3· · · · Q· · ·Was that the case 4 years ago,
`·4· ·approximately?
`·5· · · · A· · ·That is the case roughly 4 years
`·6· ·ago.· Again, I could be off by as much as a
`·7· ·year or two on either side.
`·8· · · · Q· · ·What type of case was that?
`·9· · · · A· · ·I tend to recall it was involved
`10· ·in a drug-related issue for HIV.
`11· · · · Q· · ·And did you represent the patent
`12· ·owner?
`13· · · · A· · ·I tend to recall that I did.
`14· · · · Q· · ·Do you recall if you testified
`15· ·on any issues of patent validity?
`16· · · · A· · ·I don't recall.
`17· · · · Q· · ·Other than that representation
`18· ·that you did and that was related to your
`19· ·deposition, have you ever served as an
`20· ·expert witness or consultant in a legal
`21· ·proceeding?
`22· · · · A· · ·Yes, I have.
`23· · · · Q· · ·How many times before?
`24· · · · A· · ·I really couldn't say.· Again,
`25· ·it's not something that I do consistently
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`Page 8
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`·1· · · · · · · · · · R. Makuch
`·2· ·and I could not even give you a rough
`·3· ·estimate, actually.
`·4· · · · Q· · ·Do you recall ever having done
`·5· ·an expert declaration or a written expert
`·6· ·report?
`·7· · · · A· · ·I know that I have done expert
`·8· ·reports in the past.
`·9· · · · Q· · ·Do you recall ever in the past
`10· ·doing an expert report on the issue of
`11· ·patent validity?
`12· · · · A· · ·I don't believe so, but I can't
`13· ·really state for sure.· I simply just don't
`14· ·recall.
`15· · · · Q· · ·And you did provide an expert
`16· ·declaration for this proceeding, correct?
`17· · · · A· · ·That I did, yes.
`18· · · · Q· · ·So other than the declaration
`19· ·that you provided for this proceeding, you
`20· ·do not recall whether you've provided any
`21· ·expert written reports or declarations in
`22· ·other prior legal proceedings?
`23· · · · A· · ·Not really.· I just, I think,
`24· ·again, the last one was 4 years ago or
`25· ·more, and so I just don't recall.
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`Page 9
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`·1· · · · · · · · · · R. Makuch
`·2· · · · Q· · ·Do you have any patents of your
`·3· ·own?
`·4· · · · A· · ·Not that I'm aware of.
`·5· · · · Q· · ·So to your knowledge, you are
`·6· ·not a named inventor on any patents?
`·7· · · · A· · ·To my knowledge, I am not a
`·8· ·named inventor on any patent.
`·9· · · · Q· · ·Any pending patent applications?
`10· · · · A· · ·Not that I'm aware of.
`11· · · · Q· · ·Do you have any experience with
`12· ·the patent process?
`13· · · · A· · ·I don't have any direct
`14· ·experience with the Patent Office or
`15· ·individuals who work there.
`16· · · · Q· · ·I didn't really mean to ask
`17· ·about the Patent Office.
`18· · · · · · · Do you have any experience
`19· ·dealing with applicants for patents or
`20· ·patents after they issue through your work
`21· ·or anything like that?
`22· · · · A· · ·I just simply do not do those
`23· ·kinds of activities.· Whether someone spoke
`24· ·to me about something that they then used,
`25· ·I have no idea.
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`
`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
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`10 to 13
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`Page 10
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`·1· · · · · · · · · · R. Makuch
`·2· · · · Q· · ·Prior to your preparation for
`·3· ·this legal proceeding, have you done any
`·4· ·consulting or other type of work for the
`·5· ·patent owners in this case?
`·6· · · · A· · ·I know I shouldn't ask a
`·7· ·question, but to be clear, who is the
`·8· ·patent owner?
`·9· · · · Q· · ·No problem.· When I say patent
`10· ·owners, I mean it plural, Pozen and Horizon
`11· ·Pharma.
`12· · · · A· · ·Okay.· So please ask your
`13· ·question again.
`14· · · · Q· · ·Prior to this engagement for
`15· ·this legal proceeding, have you ever done
`16· ·any consulting or other type of work for
`17· ·either Pozen or Horizon Pharma?
`18· · · · A· · ·Yes, I have.
`19· · · · Q· · ·Was it for Pozen or Horizon
`20· ·Pharma?
`21· · · · A· · ·It was for Horizon Pharma, that
`22· ·I recall.
`23· · · · Q· · ·What type of work did you do for
`24· ·Horizon Pharma?
`25· · · · A· · ·A long time ago, I recall that I
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`Page 12
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`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·As part of my work, I
`·3· ·occasionally am invited by sponsors to
`·4· ·either work with them on what are called
`·5· ·mock advisory committees or going with them
`·6· ·on actual advisory committees to the FDA.
`·7· · · · Q· · ·Are you formally paid for that
`·8· ·type of work?
`·9· · · · A· · ·I am paid for that kind of work.
`10· · · · Q· · ·And so that one project that you
`11· ·did with Horizon Pharma, were you paid for
`12· ·that?
`13· · · · A· · ·I would assume so.
`14· · · · Q· · ·Are you normally paid by the
`15· ·hour?
`16· · · · A· · ·I am generally paid by the hour.
`17· · · · Q· · ·Would you have been paid by the
`18· ·hour for that project?
`19· · · · A· · ·I don't recall.
`20· · · · Q· · ·Have you ever done any
`21· ·consulting or other type of work for
`22· ·Astrazeneca?
`23· · · · A· · ·I tend to recall that, again, in
`24· ·the fairly distant past, I did work with
`25· ·them on one project.
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`Page 11
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`·1· · · · · · · · · · R. Makuch
`·2· ·was contacted to provide input into some
`·3· ·advisory committee activities that Horizon
`·4· ·was invited by the FDA to attend.
`·5· · · · Q· · ·What type of advisory committee
`·6· ·was it?
`·7· · · · A· · ·I actually don't recall the
`·8· ·title, nor the intent.· I just remember
`·9· ·going with the Horizon people to the
`10· ·meeting and working with them beforehand in
`11· ·preparation for it.
`12· · · · Q· · ·Was this related to a certain
`13· ·type of drug product?
`14· · · · A· · ·I tend to recall it was more of
`15· ·a general discussion by the FDA about ways
`16· ·to examine products, more generally,
`17· ·because I tend to recall there were several
`18· ·other companies invited by the FDA.
`19· · · · Q· · ·What would your role have been
`20· ·in providing input for an advisory
`21· ·committee?
`22· · · · A· · ·I can't recall.· It was a long
`23· ·time ago.
`24· · · · Q· · ·Is that something that you would
`25· ·normally do as part of your work?
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`Page 13
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`·1· · · · · · · · · · ·R. Makuch
`·2· · · · ·Q· · ·Do you remember what the subject
`·3· · matter of that project was?
`·4· · · · ·A· · ·I believe I served on a data
`·5· · monitoring committee for a trial that I
`·6· · don't even remember.
`·7· · · · ·Q· · ·The trial would have been for a
`·8· · drug product?
`·9· · · · ·A· · ·I recall that the trial was for
`10· · a drug product.· I can't even tell you what
`11· · disease it was for.
`12· · · · ·Q· · ·Okay.
`13· · · · · · · ·So you do not recall the name of
`14· · the drug?
`15· · · · ·A· · ·No.
`16· · · · · · · ·(Whereupon, Exhibit 1 was marked
`17· · · · ·for Identification.)
`18· ·BY MS. LaVALLE:
`19· · · · ·Q· · ·I'm going to hand you a document
`20· · that is Patent No. 8,945,621.· This is the
`21· · patent that is at issue in this proceeding.
`22· · · · · · · ·Can you confirm that this is a
`23· · copy of the patent that's at issue in this
`24· · proceeding?
`25· · · · ·A· · ·I do see the signees and I
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
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`14 to 17
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`Page 14
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`·1· · · · · · · · · · R. Makuch
`·2· ·imagine this is referred to as the '621
`·3· ·Patent?
`·4· · · · Q· · ·Correct, yes.· If I do refer to
`·5· ·this document as the '621 Patent, I'm
`·6· ·talking about this.
`·7· · · · A· · ·Okay.· Then I'm comfortable to
`·8· ·indicate that this is the '621 Patent that
`·9· ·I have been involved with.
`10· · · · Q· · ·And you have reviewed this
`11· ·document before, is that correct?
`12· · · · A· · ·Yes, I have.
`13· · · · Q· · ·On the first page, if you look
`14· ·in the upper left-hand column, there is a
`15· ·listing of the inventors.
`16· · · · · · · Do you see that?
`17· · · · A· · ·Yes, I do.
`18· · · · Q· · ·Do you recognize any of those
`19· ·names?
`20· · · · A· · ·I recognize none of those names.
`21· · · · Q· · ·You do not personally know any
`22· ·of the named inventors on this patent?
`23· · · · A· · ·I do not recognize the names of
`24· ·any of these individuals.
`25· · · · Q· · ·To your knowledge, you haven't
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`Page 16
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`·1· · · · · · · · · · ·R. Makuch
`·2· · · · ·A· · ·I do not.
`·3· · · · · · · ·(Whereupon, Exhibit 2 was marked
`·4· · · · ·for Identification.)
`·5· ·BY MS. LaVALLE:
`·6· · · · ·Q· · ·I'm going to hand you another
`·7· · document that we've marked as Exhibit 2.
`·8· · · · · · · ·The title of this document is
`·9· · Declaration of Robert W. Makuch, Ph.D, in
`10· · Support of Patent Owner's Response.
`11· · · · · · · ·Can you confirm that this is the
`12· · declaration that you prepared for this
`13· · proceeding?
`14· · · · ·A· · ·Yes, this appears to be the
`15· · declaration I did prepare for this group
`16· · and for this activity.
`17· · · · ·Q· · ·And it appears that there are
`18· · two sets of page numbering, but if you
`19· · could turn to page 21 of 52, if you look in
`20· · the lower left-hand corner.
`21· · · · ·A· · ·Sure, yes.
`22· · · · ·Q· · ·Can you confirm there on that
`23· · page that that is your signature?
`24· · · · ·A· · ·Yes, I confirm that's my
`25· · signature.
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`Page 15
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`·1· · · · · · · · · · R. Makuch
`·2· ·ever met these individuals?
`·3· · · · A· · ·To my knowledge, I have not
`·4· ·approached or met these individuals.
`·5· · · · Q· · ·Have you ever communicated with
`·6· ·anyone who is an employee of Pozen?
`·7· · · · A· · ·I do not recall such discussion.
`·8· ·It could have happened, but I don't recall.
`·9· · · · Q· · ·Since you've been hired to work
`10· ·on this proceeding, do you recall ever
`11· ·communicating with an employee of Horizon
`12· ·Pharma?
`13· · · · A· · ·Since the time of this
`14· ·proceeding and my involvement, I've spoken
`15· ·to no one at Horizon Pharma.
`16· · · · Q· · ·And before you were engaged to
`17· ·work on this proceeding, had you
`18· ·communicated with the anyone from Horizon
`19· ·other than the one project you told me
`20· ·about?
`21· · · · A· · ·In the distant past, I did work
`22· ·with Horizon on other issues, but that
`23· ·would be a long time ago, again.
`24· · · · Q· · ·Do you recall what other issues
`25· ·you worked on?
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`Page 17
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`·1· · · · · · · · · · R. Makuch
`·2· · · · Q· · ·Going back to the title page,
`·3· ·the title states that this declaration is
`·4· ·in support of patent owner's response.
`·5· · · · · · · My question is, have you
`·6· ·reviewed patent owner's response brief?
`·7· · · · A· · ·I recall looking at some of
`·8· ·those documents, but again, that was not my
`·9· ·primary response in this report.
`10· · · · Q· · ·Do you recall reviewing the
`11· ·portions of the response brief that cite to
`12· ·your declaration?
`13· · · · A· · ·I'm sorry, what part of the
`14· ·report?
`15· · · · Q· · ·Part of the patent owner's
`16· ·response brief that cites to your
`17· ·declaration, do you recall reviewing those
`18· ·portions?
`19· · · · A· · ·I'd have to see what portions
`20· ·those are, but I'd be glad to look at them.
`21· · · · Q· · ·Is that not something that you
`22· ·did as part of your job when you were hired
`23· ·to prepare this declaration?
`24· · · · A· · ·Yes, and it was a while ago and
`25· ·I just don't know which items you're
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
`
`18 to 21
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`Page 18
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`·1· · · · · · · · · · ·R. Makuch
`·2· · referring to.· So I think I could -- it
`·3· · would be helpful if you do have something
`·4· · in mind, I'd be happy to look at it.
`·5· · · · ·Q· · ·After you prepared and submitted
`·6· · this declaration, have you communicated
`·7· · with anyone about the patent at issue or
`·8· · your opinions?
`·9· · · · · · · ·MR. RODRIGUEZ:· I'll just
`10· · · · ·caution you not to reveal any
`11· · · · ·privileged information.
`12· ·BY MS. LaVALLE:
`13· · · · ·Q· · ·I'll clarify my question.
`14· · · · ·A· · ·Okay.
`15· · · · ·Q· · ·Other than with the attorneys,
`16· · have you spoken with anyone about your
`17· · opinions that you prepared and provided in
`18· · your declaration or the patent at issue?
`19· · · · ·A· · ·I have not.
`20· · · · ·Q· · ·And when I ask the question, I
`21· · mean by phone, or in person, or in e-mail.
`22· · · · ·A· · ·In any form of communication, I
`23· · have not.
`24· · · · ·Q· · ·Did you write this declaration
`25· · yourself?
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`Page 20
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`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Yes, starting at page 22 and
`·3· ·then continuing through to the remainder of
`·4· ·my report ending at page 52.
`·5· · · · Q· · ·Could you turn to page 6 of 52?
`·6· · · · A· · ·Yes.
`·7· · · · Q· · ·Do you see at the top of the
`·8· ·page there is a section titled Materials
`·9· ·Considered?
`10· · · · A· · ·Yes, I do.
`11· · · · Q· · ·And paragraph 18 covers the
`12· ·materials that you considered in
`13· ·formulating your opinions, is that correct?
`14· · · · A· · ·That is correct, as well as my
`15· ·general knowledge and clinical trials and
`16· ·regulatory affairs, yes.
`17· · · · Q· · ·Since completing this
`18· ·declaration, have you considered any
`19· ·additional materials?
`20· · · · A· · ·At this time, I have considered
`21· ·no additional materials.
`22· · · · Q· · ·Did you read the deposition
`23· ·transcript from the deposition of patent
`24· ·owner's other expert Dr. Johnson?
`25· · · · A· · ·I did not.· I don't recall
`
`Page 19
`
`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Yes, I did.
`·3· · · · Q· · ·Did you have any assistance in
`·4· ·preparing the declaration?
`·5· · · · A· · ·The assistance was provided in
`·6· ·terms of, you know, typing up my remarks
`·7· ·and putting together my CV with the
`·8· ·information that I wrote.
`·9· · · · · · · The attorneys then, obviously,
`10· ·helped put together this report in terms of
`11· ·format and all that, but all the content is
`12· ·what I've written myself.
`13· · · · Q· · ·Did you have any assistance in
`14· ·preparing the declaration other than from
`15· ·the attorneys?
`16· · · · A· · ·I had no other assistance.
`17· · · · Q· · ·If you turn to page 3 of 52, at
`18· ·paragraph 4 of your declaration, you state
`19· ·that your CV is attached, your curriculum
`20· ·vitae is attached.
`21· · · · · · · Can you confirm that your CV is,
`22· ·indeed, attached to this document?
`23· · · · A· · ·It is attached to this document.
`24· · · · Q· · ·And that is the attachment
`25· ·starting at page 22 of 52, is that correct?
`
`Page 21
`
`·1· · · · · · · · · · R. Makuch
`·2· ·reading it.
`·3· · · · Q· · ·Have you ever communicated with
`·4· ·Dr. Johnson?
`·5· · · · A· · ·I do know some Johnsons, but
`·6· ·I've never communicated with this
`·7· ·individual.· I don't even know his first
`·8· ·name, his or her first name actually.
`·9· · · · Q· · ·Okay.· Thank you.
`10· · · · · · · Could you turn to the next page,
`11· ·page 7 of 52.· At the top of the page is a
`12· ·title Understanding of Relevant Legal
`13· ·Principles.
`14· · · · · · · Do you see that?
`15· · · · A· · ·Yes, I do.
`16· · · · Q· · ·That top paragraph 23, the first
`17· ·sentence states:· "I understand that the
`18· ·'621 Patent must be considered from the
`19· ·viewpoint of a person of ordinary skill in
`20· ·the relevant art (POSA) as of June 25,
`21· ·2009."
`22· · · · · · · My question is, what is the
`23· ·relevance of that date June 25, 2009?
`24· · · · A· · ·You know, this is an
`25· ·understanding based on the discussion I had
`
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
`
`22 to 25
`
`Page 22
`
`·1· · · · · · · · · · R. Makuch
`·2· ·with the lawyers.· So it's my understanding
`·3· ·based on what they informed me that this
`·4· ·was a pertinent date.
`·5· · · · Q· · ·Did they tell you why it is
`·6· ·important, or they just gave you the date
`·7· ·and said we need to think about that date,
`·8· ·it's important?
`·9· · · · A· · ·I really don't recall the
`10· ·discussion I had with them.
`11· · · · Q· · ·Do you know what that date
`12· ·coincides with?
`13· · · · A· · ·I couldn't say at this time what
`14· ·that date corresponds to.
`15· · · · Q· · ·The next sentence states:· "A
`16· ·POSA is a hypothetical person who is
`17· ·presumed to be aware of all pertinent art."
`18· · · · · · · Are you familiar with patent
`19· ·owner's definition of a POSA as set forth
`20· ·in patent owner's response brief?
`21· · · · A· · ·I don't recall actually reading
`22· ·their definition of a POSA.
`23· · · · Q· · ·Do you know whether or not you
`24· ·would be a POSA under their definition of a
`25· ·POSA?
`
`Page 24
`
`·1· · · · · · · · · · R. Makuch
`·2· ·products you would have worked with in
`·3· ·conducting any clinical studies?
`·4· · · · A· · ·I do recall a long time ago my
`·5· ·involvement with Celebrex.
`·6· · · · Q· · ·The next paragraph, paragraph
`·7· ·29, states:· "It has further been explained
`·8· ·to me that the commercial embodiment of the
`·9· ·'621 Patent, the pharmaceutical drug
`10· ·product, VIMOVO, was designed to reduce the
`11· ·risk of upper GI injury due to NSAID use."
`12· · · · · · · Prior to being hired as an
`13· ·expert in this proceeding, had you ever
`14· ·heard of the drug product VIMOVO?
`15· · · · A· · ·I heard of it just as part of my
`16· ·general interest and knowledge in this
`17· ·area, but nothing specific.
`18· · · · Q· · ·You hadn't ever worked with it
`19· ·or worked on any clinical studies involving
`20· ·VIMOVO?
`21· · · · A· · ·I can't even tell you because
`22· ·it's the registered trademark.· And so
`23· ·whether or not I was involved earlier on
`24· ·with its development, I really couldn't
`25· ·say.
`
`Page 23
`
`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Since I don't know their
`·3· ·definition, I can't say whether or not I
`·4· ·would fall into that category.
`·5· · · · Q· · ·So I take it you did not assist
`·6· ·the attorneys in formulating their
`·7· ·definition of a POSA for this proceeding?
`·8· · · · A· · ·I don't recall my involvement in
`·9· ·that area.
`10· · · · Q· · ·Could you please turn to the
`11· ·next page, page 8 of 52.
`12· · · · · · · Take a look at paragraph 28.
`13· ·The first sentence states:· "It has been
`14· ·explained to me that non-steroidal
`15· ·anti-inflammatory drugs (NSAIDS) are a
`16· ·class of drugs used to treat pain and
`17· ·inflammation associated with arthritis and
`18· ·other musculoskeletal disorders."
`19· · · · · · · My question is, have you ever
`20· ·conducted any clinical studies involving
`21· ·NSAIDs or participated in such studies?
`22· · · · A· · ·I have participated only in
`23· ·terms of the design or analysis or
`24· ·interpretation of such studies.
`25· · · · Q· · ·Do you recall which drug
`
`Page 25
`
`·1· · · · · · · · · · R. Makuch
`·2· · · · Q· · ·You haven't gone back to look to
`·3· ·see if you maybe worked with any trials
`·4· ·before the brand name came about?
`·5· · · · A· · ·I did not go back and look, no.
`·6· · · · Q· · ·Do you recall ever working on
`·7· ·any combination drug products that involve
`·8· ·two drugs in one unit dosage form?
`·9· · · · A· · ·I do not recall at this time
`10· ·doing that.· I could have, but I don't
`11· ·recall.
`12· · · · Q· · ·The next sentence there, the
`13· ·second sentence of paragraph 29 states:
`14· ·"As I understand it, VIMOVO consists of a
`15· ·combination of a delayed-release
`16· ·enteric-coated NSAID core (Naproxen)
`17· ·surrounded by an immediate-release acid
`18· ·inhibitor (Esomeprazole magnesium)."
`19· · · · · · · And then the next sentence
`20· ·states:· "The acid inhibitor is released
`21· ·before the NSAID which allows the acid
`22· ·inhibitor's gastro-protective effects to
`23· ·take hold before Naproxen is released."
`24· · · · · · · My question is, what do you mean
`25· ·there by take hold?
`
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
`
`26 to 29
`
`Page 26
`
`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Again, this was explained to me
`·3· ·by the lawyers, but for me, the phrasing
`·4· ·"to take hold" is for the effectiveness of
`·5· ·the gastro-protective effect to begin
`·6· ·working before Naproxen, the NSAID then is
`·7· ·released.
`·8· · · · Q· · ·Do you know how much time it
`·9· ·would take for the acid inhibitor's
`10· ·gastro-protective effects to start working?
`11· · · · · · · MR. RODRIGUEZ:· Objection.
`12· · · · Outside the scope.
`13· · · · A· · ·I do not know.
`14· · · · Q· · ·Do you know how long it would
`15· ·take for Naproxen to be released?
`16· · · · · · · MR. RODRIGUEZ:· Objection.
`17· · · · Outside the scope and vague.
`18· · · · A· · ·I do not know.
`19· · · · Q· · ·But it is your opinion that the
`20· ·gastro-protective effects take place before
`21· ·the Naproxen is released?
`22· · · · A· · ·That is my understanding, that
`23· ·that is the mechanism for this combination.
`24· · · · Q· · ·The next paragraph, paragraph 30
`25· ·states that you understand that before the
`
`Page 28
`
`·1· · · · · · · · · · R. Makuch
`·2· ·I just don't recall it now.
`·3· · · · Q· · ·If you could turn to the next
`·4· ·page, page 9 of 52, paragraph 32 there in
`·5· ·the middle states that it is your
`·6· ·understanding that the '621 Patent is one
`·7· ·of the patents listed in the FDA's Orange
`·8· ·Book -- and I'm shortening this -- as
`·9· ·covering the pharmaceutical product VIMOVO.
`10· · · · · · · My question is, did you review
`11· ·any of the other patents listed in the
`12· ·Orange Book for VIMOVO, or did you just
`13· ·focus on the '621 Patent?
`14· · · · · · · MR. RODRIGUEZ:· Objection.
`15· · · · Outside the scope.
`16· · · · A· · ·I focused on the '621 Patent and
`17· ·it is really reflective of the
`18· ·understanding that I had in discussions
`19· ·with the lawyers.
`20· · · · Q· · ·But you did review the prior art
`21· ·reference that is referred to as Plachetka,
`22· ·right?· Do you recall that?
`23· · · · A· · ·I imagine Plachetka might have a
`24· ·lot of different things.· So I did review
`25· ·one thing by Plachetka.· So if you could
`
`Page 27
`
`·1· · · · · · · · · · R. Makuch
`·2· ·invention claimed in the '621 Patent, it
`·3· ·was accepted that a patient's concomitant
`·4· ·use of an NSAID and LDA increased the risk
`·5· ·of gastrointestinal injury."
`·6· · · · · · · Is this something that you were
`·7· ·told to prepare your declaration, this
`·8· ·understanding, or is this something that
`·9· ·you had as part of your own knowledge?
`10· · · · A· · ·It was both an understanding as
`11· ·indicated to me by the lawyers and also my
`12· ·general knowledge of that statement.
`13· · · · Q· · ·And the sentence says that it
`14· ·was before the invention claimed in the
`15· ·'621 Patent that it was accepted that
`16· ·concomitant use of NSAID and LDA increased
`17· ·the risk of gastrointestinal injury.
`18· · · · · · · Could you tell me what the
`19· ·invention date is?
`20· · · · · · · MR. RODRIGUEZ:· Objection.
`21· · · · Calls for a legal conclusion.
`22· · · · A· · ·I do not know what the invention
`23· ·date was.
`24· · · · Q· · ·You were not provided that date?
`25· · · · A· · ·I may have been provided it, but
`
`Page 29
`
`·1· · · · · · · · · · ·R. Makuch
`·2· · show me the document you're referring to --
`·3· · but I did review a document by Plachetka.
`·4· · · · ·Q· · ·If you turn to paragraph 43 of
`·5· · this declaration, you discuss there a
`·6· · document called Plachetka, that you
`·7· · reviewed Plachetka.
`·8· · · · · · · ·Do you know if that is a patent
`·9· · that is also listed in the Orange Book for
`10· · the drug product VIMOVO?
`11· · · · · · · ·MR. RODRIGUEZ:· Objection.
`12· · · · ·Outside the scope.
`13· · · · ·A· · ·I recall reviewing an article by
`14· · Plachetka.· I'm not sure if you and I are
`15· · talking about the same document, but I do
`16· · not recall reviewing the Orange Book, per
`17· · se.
`18· · · · · · · ·MS. LaVALLE:· Why don't we take
`19· · · · ·a short break, maybe 10 minutes.
`20· · · · · · · ·Go off the record.
`21· · · · · · · ·(Recess taken 9:37 a.m.)
`22· · · · · · · ·(Resumed 9:48 a.m.)
`23· ·BY MS. LaVALLE:
`24· · · · ·Q· · ·Dr. Makuch, if you could turn to
`25· · page 12 of your declaration.
`
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`Robert W. Makuch, Ph.D.
`Robert W. Makuch, Ph.D.
`September 19, 2016
`September 19, 2016
`
`30 to 33
`
`Page 30
`
`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Yes.
`·3· · · · Q· · ·In the middle of the page starts
`·4· ·a section of your declaration titled "The
`·5· ·Prior Art Does Not Render Claims 1 through
`·6· ·16 of the 621 Patent Obvious."
`·7· · · · · · · Under that heading, you discuss
`·8· ·two prior art references called Graham and
`·9· ·Goldstein.
`10· · · · A· · ·Yes, I see that.
`11· · · · Q· · ·On the last page of your
`12· ·declaration, the last paragraph 63, that's
`13· ·page 21 of 52, you conclude that it is your
`14· ·opinion that a POSA would not rely on
`15· ·Goldstein to draw any conclusions about LDA
`16· ·use and any difference in rates of NSAID
`17· ·associated GI injury.
`18· · · · · · · My question is, is it also your
`19· ·opinion that a POSA would not rely on
`20· ·Graham to draw any conclusions about LDA
`21· ·use and any difference in rates of NSAID
`22· ·associated GI injury?
`23· · · · A· · ·So I'm sorry, the part that you
`24· ·were reading was in paragraph 62?
`25· · · · Q· · ·63?
`
`Page 32
`
`·1· · · · · · · · · · R. Makuch
`·2· ·reports the results of the larger clinical
`·3· ·trial, and the Goldstein paper just
`·4· ·discusses a very small post hoc
`·5· ·sub-analysis of that large study.
`·6· · · · · · · I don't know if, per se, they do
`·7· ·anything about teaching away or anything.
`·8· ·It's really a report of those studies.
`·9· · · · Q· · ·The papers do indicate that the
`10· ·patients are permitted to take low dose
`11· ·aspirin, is that correct?
`12· · · · A· · ·That would be my recollection.
`13· ·But again, if you showed me, that would be
`14· ·fine, exactly where.
`15· · · · Q· · ·Yes.· If you turn to paragraph
`16· ·45 of your declaration, that is page 13 of
`17· ·52.
`18· · · · A· · ·Yes.
`19· · · · Q· · ·You noted that -- Graham notes
`20· ·that patients were permitted to take low
`21· ·dose aspirin for cardiovascular protection.
`22· · · · A· · ·That's correct.· I have that in
`23· ·quotes in paragraph 45.
`24· · · · · · · MS. LaVALLE:· I have no further
`25· · · · questions.
`
`Page 31
`
`·1· · · · · · · · · · R. Makuch
`·2· · · · A· · ·Oh, 63.
`·3· · · · Q· · ·The very last sentence.
`·4· · · · A· · ·Okay.
`·5· · · · Q· · ·You reference Goldstein there,
`·6· ·and I understand this is the section on
`·7· ·Goldstein, but I did not see a
`·8· ·corresponding conclusion about Graham.
`·9· · · · · · · So my question is, is it also
`10· ·your opinion that a POSA would not rely on
`11· ·Graham to draw any conclusions about LDA
`12· ·use and any difference in rates of NSAID
`13· ·associated GI injury?
`14· · · · A· · ·I can't speak for what others
`15· ·would do, but in my opinion the Graham
`16· ·paper is a larger study and so it is
`17· ·something that I believe a POSA would at
`18· ·least consider.
`19· · · · Q· · ·Is it your opinion that either
`20· ·Graham or Goldstein teaches away from
`21· ·administering a combination of an acid
`22· ·inhibitor in an NSAID while a patient is
`23· ·also taking low dose aspirin?
`24· · · · A· · ·I think they're just describing
`25· ·the results of the study.· The Graham paper
`
`Page 33
`
`·1· · · · · · · ·R. Makuch
`·2· · · · ·MR. RODRIGUEZ:· I have no
`·3· ·questions.
`·4· · · · ·MS. LaVALLE:· That concludes the
`·5· ·deposition.· Thank you very much.
`·6· · · · ·THE WITNESS:· Thank you.
`·7· · · · ·THE COURT REPORTER:· Would you
`·8· ·like a copy of the transcript?
`·9· · · · ·MR. RODRIGUEZ:· Yes.
`10· · · · ·MS. PFIFFERLING:· Yes.
`11· · · · ·MS. LaVALLE:· Yes, please.
`12· · · · ·THE COURT REPORTER:· Regular
`13· ·delivery?
`14· · · · ·MS. LaVALLE:· Well, actually,
`15· ·no.· We're kind of on a short fuse, so
`16· ·I need to do it expedited.
`17· · · · ·THE COURT REPORTER:· Okay.
`18· ·Would you like a rough draft?
`19
`20· · · · ·(Continued on next page to
`21· ·include signature and jurat.)
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`23
`24
`25
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