`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.§
` §
` Petitioner §
` §
`VS. § CASE IPR2015-02002
` § Patent 6,743,413
`3M COMPANY, et al. §
` §
` Patent Owner §
`
` ORAL DEPOSITION OF HUGH D.C. SMYTH, Ph.D.
`
` Austin, Texas
`
` June 14, 2016
`
` 9:02 a.m.
`
`Reported by:
`
`Micheal A. Johnson, RDR, CRR
`
`Job No. 16436
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`3M COMPANY 2014
`Mylan Pharmaceuticals Inc. v. 3M Company
`IPR2015-02002
`
`
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`Page 2
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` ORAL DEPOSITION OF HUGH D.C. SMYTH, Ph.D.,
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`produced at the instance of the Respondent, in the
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`above-styled and numbered cause on the 14th day of
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`June, 2016, at 9:02 a.m., before Micheal A. Johnson,
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`RDR, CRR, Notary Public in and for the State of
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`Texas, reported by realtime stenographic means, at
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`the AT&T Executive Education and Conference Center,
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`1900 University Avenue, Austin, Texas, pursuant to
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`Notice of Oral Deposition.
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` A P P E A R A N C E S
`ON BEHALF OF THE PETITIONER
`MYLAN PHARMACEUTICALS INC.:
`
` Jitendra "Jitty" Malik, Ph.D., Esq.
` ALSTON & BIRD LLP
` 4721 Emperor Boulevard, Suite 400
` Durham, North Carolina 27703-8580
` (919) 862-2200
` jitty.malik@alston.com
` H. James Abe, Esq.
` ALSTON & BIRD LLP
` 333 South Hope Street, Sixteenth Floor
` Los Angeles, California 90071
` (213) 576-1000
` james.abe@alston.com
`
`ON BEHALF OF THE PATENT OWNER
`3M COMPANY:
`
` John R. Lane, Esq.
` FISH & RICHARDSON, P.C.
` 1221 McKinney, Suite 2800
` Houston, Texas 77010
` (713) 654-5300
` jlane@fr.com
` Dorothy P. Whelan, Esq.
` FISH & RICHARDSON, P.C.
` 60 South Sixth Street, Suite 3200
` Minneapolis, Minnesota 55402
` (612) 335-5070
` whelan@fr.com
`
` James P. Reik, Esq.
` GLAXOSMITHSKLINE, ASSISTANT GENERAL COUNSEL
` Five Moore Drive
` Research Triangle Park, North Carolina 27709
` (919) 483-8022
` jim.p.riek@gsk.com
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`
`
` INDEX
` HUGH D.C. SMYTH, Ph.D.
` June 14, 2016
`
` APPEARANCES 3
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` PROCEEDINGS 7
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`Page 4
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`EXAMINATION OF HUGH D.C. SMYTH, Ph.D.:
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` BY MR. LANE 7
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` BY MR. MALIK 120
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` CORRECTIONS AND SIGNATURE 126
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` REPORTER'S CERTIFICATION 127
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` DEPOSITION EXHIBITS
` HUGH D.C. SMYTH, Ph.D.
` June 14, 2016
`
`NUMBER DESCRIPTION MARKED
`
`Exhibit 1001 United States Patent 42
` 6,743,413 B1, Jun. 1, 2004
`
`Exhibit 1006 Declaration of Hugh Smyth 22
`
`Exhibit 1007 International Application 47
` Published under the Patent
` Cooperation Treaty,
` International Publication
` Number W) 91/04011
`
`Exhibit 1011 International Application 47
` Published under the Patent
` Cooperation Treaty,
` International Publication
` Number W) 90/07333
`
`Exhibit 1012 Curriculum Vitae of Hugh 29
` David Charles Smyth, Ph.D.
`
`Exhibit 2021 Article Entitled "2001: An 53
` Odyssey in Inhaler
` Formulation and Design" by
` H.D.C. Smyth, et al.
`
`Exhibit 2022 Article Entitled 56
` "Alternative Propellant
` Aerosol Delivery Systems"
` by Hugh D.C. Smyth, et al.
`
`Exhibit 2023 Article Entitled "The 61
` influence of formulation
` variables on the
` performance of alternative
` propellant-driven metered
` dose inhalers" by Hugh D.C.
` Smyth
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` DEPOSITION EXHIBITS
` HUGH D.C. SMYTH, Ph.D.
` June 14, 2016
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`NUMBER DESCRIPTION MARKED
`
`Exhibit 2024 Research Article "Tuning 63
` Aerosol Particle Size
` Distribution of
` Metered-Dose Inhalers Using
` Cosolvents and Surfactants"
` by Hugh D.C. Smyth, et al.
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` PROCEEDINGS
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` HUGH D.C. SMYTH, Ph.D.
`
` having been first duly sworn,
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` testified as follows:
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` EXAMINATION
`
`BY MR. LANE:
`
` Q. Good morning.
`
` A. Morning.
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` Q. Can you please state your name for the
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`record.
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` A. Hugh David Charles Smyth.
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` Q. What's your work address?
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` A. 2409 University Avenue.
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` Q. That's here in Austin?
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` A. Yes.
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` Q. What's the ZIP code?
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` A. 78712.
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` Q. Have you ever been deposed before?
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` A. Yes.
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` Q. How many times?
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` A. Twice.
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` Q. You're represented by Mylan is counsel
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`in this deposition?
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` A. Yes.
`
` Q. Who is that?
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` A. The two gentlemen sitting here, Jitty
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`Malik, James Abe.
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` MR. LANE: Do we want to identify
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`who's in the room for the record, please? I think
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`we should do that.
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` I'm John Lane from Fish & Richardson
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`representing the patent owner, and with me is
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`Dorothy Whelan also from Fish & Richardson, and Jim
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`Riek from GSK.
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` MR. MALIK: Good idea. Jitendra
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`Malik from the law firm of Alston & Bird on behalf
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`of Mylan. With me is James Abe also from Alston &
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`Bird also representing Mylan.
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`BY MR. LANE:
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` Q. I know you've been deposed before but
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`we'll go through some of the ground rules here at
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`the start just to make sure we're on the same page.
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` If you need a break at any time
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`today, just let me know and we'll break at the next
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`convenient spot. I just ask that you don't take a
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`break while the question is pending. You need to go
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`ahead and answer the question if there's a question
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`pending before we take a break.
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` You understand there's a transcript
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`being made today of the deposition?
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` A. Yes.
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` Q. It's important for the court reporter
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`and so we get a clean record that we don't talk over
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`each other during the deposition. Do you understand
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`that?
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` A. Yes.
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` Q. It's important that you answer orally
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`for the transcript and not with gestures too so that
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`the court reporter can take down the answers as
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`words because he can't write down your gestures.
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`You understand that?
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` A. Yes.
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` Q. Periodically today, Mylan's counsel may
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`object to some of my questions, but unless they
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`instruct you not to answer, you still need to answer
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`the question even if there's an objection. You
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`understand that?
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` A. Yes.
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` Q. If, during the deposition today, I ask
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`you a question and you remember something later
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`during the deposition after you've already answered
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`the question and what you remember later means that
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`you need to correct or further explain your previous
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`answer, please let me know and I'll give you an
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`opportunity to correct or further explain your
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`previous answer on the record. Do you understand
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`that?
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` A. Yes.
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` Q. Under the patent office's rules for
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`depositions and IPRs, now that we've begun the
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`deposition, you cannot consult or confer with
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`Mylan's lawyers at the breaks regarding the
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`substance of testimony that you've already given or
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`testimony that you or Mylan's attorneys anticipate
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`you may give later in the deposition, other than
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`specifically to ascertain whether a privilege
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`exists. Do you understand that?
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` A. Yes.
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` Q. You understand you're under oath today?
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` A. Yes.
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` Q. Is there any reason you can't testify
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`here today completely and truthfully?
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` A. No.
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` Q. You said you've been deposed twice
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`before?
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` A. Yes.
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` Q. What matters were those in?
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` A. They were -- one was in a matter -- I
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`was representing Goodwin Proctor relating to a
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`district court litigation around the product ProAir.
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` Q. Was Goodwin Proctor's client TEVA in
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`that case?
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` A. Yes.
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` Q. When were you deposed?
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` A. That was in 2014.
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` Q. Where was that deposition?
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` A. In Boston.
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` Q. Did you submit a declaration opining on
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`claim constructions in that case?
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` A. I don't believe so.
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` Q. Do you remember who the opposing counsel
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`in that case was?
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` A. No.
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` Q. About how long were you deposed?
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` A. Five, six hours.
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` Q. Had you provided an expert report in
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`that case before you were deposed?
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` A. Yes.
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` Q. What generally was your expert report
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`on? Was it on infringement or invalidity?
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` A. You know, I can't remember.
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` Q. When was the second time you were
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`deposed?
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` A. I think it was in 2015.
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` Q. What matter was that in?
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` A. It was to do with Mometasone, again,
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`representing TEVA on behalf of Goodwin Proctor.
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` Q. Was TEVA seeking to bring a generic
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`version of the drug onto the market in that case?
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` A. I believe so.
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` Q. What about in the ProAir case? Was TEVA
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`seeking to bring a generic version of that drug to
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`market in that case?
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` A. No.
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` Q. Where was your 2015 deposition?
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` A. It was in Austin.
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` Q. About how long were you deposed for?
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` A. Five, six hours.
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` Q. Do you remember who the opposing counsel
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`was in that case?
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` A. It was from Baker Botts.
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` Q. Is this the first time you've been
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`deposed in the context of an IPR?
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` A. Yes.
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` Q. Have you ever testified at a trial
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`before?
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` A. No.
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` Q. Do you understand that we're here today
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`regarding an IPR petition that Mylan filed for US
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`patent number 6,743,413?
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` A. Yes.
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` Q. Do you understand that 3M is the patent
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`owner?
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` A. Yes.
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` Q. What other IPRs have you worked on?
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` A. I have been -- I worked with Finnegan on
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`a -- actually, I don't think the IPR began; they
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`were anticipating it to begin, but it never began or
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`something.
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` Q. Who is Finnegan -- I'm sorry, go ahead.
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` A. I think that's essentially the only IPR.
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` Q. Who was Finnegan's client in that
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`matter?
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` A. I can't remember.
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` MR. MALIK: I will -- obviously I
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`don't represent Finnegan nor that client, but there
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`may be some privilege issues if it wasn't public.
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` A. Yeah, I'm not sure who the client was.
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`BY MR. LANE:
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` Q. Other than matters we've discussed so
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`far, have you ever done any other work as an expert
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`witness?
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` A. Yes.
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` Q. And in what matters?
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` A. These are ongoing matters which may not
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`be public, I guess, so I may not be able to disclose
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`exactly who I'm working for and on what matter.
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` Q. Are they litigation matters?
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` A. Yes.
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` Q. Have you submitted expert reports in any
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`of those matters?
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` A. I do not believe so.
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` Q. Are you working on any ongoing IPR
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`matters that we haven't discussed?
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` A. I don't believe so.
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` Q. You're being compensated in this matter
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`at $650 an hour; is that correct?
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` A. Yes.
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` Q. Is that the same amount that you're
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`being compensated in the other matters that you're
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`currently working on?
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` A. There is one other that is not, which
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`I'm being compensated at 500, which had started
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`before this matter.
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` Q. When did that matter start?
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` A. I can't remember.
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` Q. About, to the best of your recollection.
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` A. 2015, sometime in 2015.
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` Q. How were you first contacted about this
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`matter?
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` A. I can't recall.
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` Q. Do you recall who first contacted you
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`about this matter?
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` A. I remember having a phone call with
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`Jitty early on.
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` Q. Do you recall about when that was?
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` A. No.
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` Q. Do you recall when you were engaged for
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`this matter?
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` A. It would have -- late 2015, second half
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`of 2015.
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` Q. When did you start working on this
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`matter?
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` A. Around about the same time.
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` Q. Do you have any more specific
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`recollection than late 2015?
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` A. Would've been maybe a month or two
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`before my declaration was submitted.
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` Q. All right. And your declaration, I
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`think it was submitted late September. Is that
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`consistent with your recollection?
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` A. I think so.
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` Q. So you were engaged and started working
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`around July or August; is that accurate?
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` A. Perhaps, yeah.
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` Q. Have you ever done any work for Mylan
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`before?
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` A. Not that I know of or can remember.
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` Q. Have you ever worked with Alston & Bird
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`before?
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` A. No.
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` Q. Have you ever worked with any of the
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`attorneys that are working with Mylan on this matter
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`to the extent that you know who they are?
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` A. No.
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` Q. When did you start working on your
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`declaration?
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` A. Yeah, like I said, probably a couple of
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`months, month or two, before it was submitted.
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` Q. How much time have you spent working on
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`this matter?
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` A. I would have to consult my records for
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`how many hours I've spent time on it.
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` Q. Can you give me an estimate?
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` A. Maybe 30 hours.
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` Q. That 30 hours, that includes the time
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`you spent working on your declaration; is that
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`correct?
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` A. Yes.
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` Q. Does that include the time you spent
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`preparing for today's deposition?
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` A. It would include that.
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` Q. Of those approximately 30 hours, how
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`many were spent working on your declaration?
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` A. Maybe 20, 25, something like that.
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` Q. What, if anything, have you spent time
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`on for this matter, other than working on your
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`declaration and preparing for today's deposition?
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` A. I think that's pretty much all I've
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`done, is preparing my declaration and preparing for
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`a deposition.
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` Q. What did you do to prepare for today's
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`deposition?
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` A. I reviewed my declaration and the
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`references that I cite within that declaration.
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` Q. Did you meet with anyone to prepare for
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`your deposition?
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` A. Yesterday I met with Jitty and James.
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` Q. How long did you meet with them?
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` A. About five, six hours.
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` Q. Did you meet with anybody else?
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` A. No.
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` Q. You just had one meeting with them?
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` A. Yes.
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` Q. Did you have any phone calls with anyone
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`to prepare for your deposition?
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` A. There was a few phone calls before they
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`arrived here in Austin, logistics and --
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` Q. Did you have any phone calls before
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`yesterday's meeting regarding the substance of your
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`deposition?
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` A. Regarding the substance of my
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`deposition? Yes, I guess, we talked over the phone
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`about --
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` MR. MALIK: Don't talk specific --
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`sorry. Don't get into any specifics with
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`discussions with counsel.
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`BY MR. LANE:
`
` Q. When did you have those phone calls with
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`Mylan's counsel to prepare for your deposition?
`
` A. I had one on Friday.
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` Q. How long did that last?
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` A. Thirty minutes, an hour.
`
` Q. Who was on the call, besides you?
`
` A. James.
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` Q. Any other phone calls?
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` A. Not that I recall.
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` Q. When did you review your declaration and
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`the references cited therein in preparation for your
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`deposition?
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` A. I started refreshing my memory maybe in
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`the last week or so.
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` Q. Have you ever reviewed Mylan's petition
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`seeking inter partes review of the '413 patent?
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` A. I have not.
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` Q. Have you ever reviewed 3M's preliminary
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`response?
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` A. I did briefly read that yesterday.
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` Q. You read that yesterday?
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` A. Yes.
`
` Q. In preparing for your deposition?
`
` A. Yes.
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` Q. So what other documents -- so I asked
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`you before and you told me the declaration
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`references and now you're telling me the preliminary
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`response. What other documents did you review in
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`preparing for your deposition?
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` MR. MALIK: Don't get into any
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`specific documents that you were shown by counsel.
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` Counsel, if you have specific
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`documents in mind, you can ask him whether he's
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`looked at them.
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` MR. LANE: He's testifying as an
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`expert here. I can ask him what documents he's
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`reviewed.
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` MR. MALIK: My instruction stands.
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` To the extent you can recall any
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`that you have reviewed, you can go ahead.
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` MR. LANE: Objection, that's a
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`speaking objection. It's not permitted under PTAB's
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`rules.
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` A. I looked at the -- so my declaration,
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`the references, looked at the preliminary response
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`and the decision.
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`BY MR. LANE:
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` Q. Did you look at any of the exhibits to
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`the preliminary response?
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` A. I may have quickly glanced at a couple
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`of them.
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` Q. Did you speak to anyone at Mylan
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`regarding your deposition?
`
` A. No.
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` Q. Did you have any discussions about your
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`deposition with anyone other than Mylan's counsel?
`
` A. No.
`
` Q. Did you look at anything on the Internet
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`in preparation for your deposition?
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` A. I may have pulled up the patents on the
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`Internet.
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` Q. When was that?
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` A. Within the last week.
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` Q. When you say "the patents," which
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`patents are you talking about?
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` A. The '413, the '011.
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` Q. That's it?
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` A. Yes.
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` Q. If you had any questions for Mylan's
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`counsel about today's deposition, did you ask
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`Mylan's counsel those questions before the
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`deposition?
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` MR. MALIK: You can -- I suppose you
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`can answer that question yes or no.
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` A. Sorry, can you repeat the question?
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` MR. LANE: Can you read it back,
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`please.
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` Or I'll just -- strike it. I'll
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`just ask it again.
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`BY MR. LANE:
`
` Q. If you had any questions for Mylan's
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`counsel today -- let me strike that.
`
` If you had any questions for Mylan's
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`counsel about today's deposition, did you ask
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`Mylan's counsel those questions before the
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`deposition?
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` MR. MALIK: Vague and ambiguous.
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` MR. LANE: I'll object. That's an
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`objection that's not allowed under PTAB's rules.
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`You're making speaking objections, and objections
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`are specifically not required -- allowed under the
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`rules.
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` MR. MALIK: Objections are allowed.
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` MR. LANE: Not "objection, vague."
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`Those are specifically called out as not allowed
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`under the rules.
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` MR. MALIK: Well, at a break you can
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`show me where that specific objection is called out
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`under the rules.
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` MR. LANE: Okay. I'll be happy to
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`send that to you.
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` A. I asked them some logistical
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`information; you know, we discussed some of the
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`patents.
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` MR. LANE: Can you mark that as
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`Exhibit 1006.
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` (Deposition Exhibit 1006 marked for
`
`identification.)
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`BY MR. LANE:
`
` Q. So I've handed you there what's been
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`marked as Exhibit 1006, which is your declaration.
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`Do you see that? Do you want to flip through that
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`and make sure it's your declaration?
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` A. Sure.
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` (Witness reviews document.)
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` A. Looks like you've highlighted a few
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`things in there.
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`BY MR. LANE:
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` Q. Oh, did I? Let me see that.
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` A. At the front.
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` MR. MALIK: Yeah, I also have
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`highlighting.
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` MR. LANE: If those are the only two
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`highlighted things, that's -- we can live with that.
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` MR. MALIK: You can have my copy.
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` MR. LANE: Thanks. I appreciate
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`that. I think that's all.
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` Sorry about that, but I think we can
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`live with that.
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` MR. MALIK: Thank you.
`
`BY MR. LANE:
`
` Q. You can see that we've read your
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`declaration.
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` MR. MALIK: At least the first page.
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` MR. LANE: Yeah, at least the first
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`couple of pages, right.
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`BY MR. LANE:
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` Q. So starting kind of at the back of your
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`declaration, your Exhibit 1006, can you turn to the
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`very last page there. Is that your signature there
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`at the very end?
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` A. Yes.
`
` Q. Okay. And you signed this on
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`September 29, 2015?
`
` A. Yes.
`
` Q. Do you see the paragraph right above
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`that, paragraph 235?
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` A. Yes.
`
` Q. It says, "I hereby declare that all
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`statements made herein of my own knowledge are true
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`and that all statements made on information and
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`belief are believed to be true."
`
` Do you see that?
`
` A. Yes.
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` Q. Was that true when you signed this?
`
` A. Yes.
`
` Q. Is it true today, still?
`
` A. Yes.
`
` Q. You said before, you reviewed 3M's
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`preliminary response?
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` A. Briefly.
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` Q. About how long did you review that
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`document?
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` A. Maybe, you know, 30 minutes to an hour.
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` Q. And you reviewed the PTAB's decision on
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`institution?
`
` A. I did look at that.
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` Q. About how long did you spend reviewing
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`that document?
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` A. Maybe 20 to 30 minutes.
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` Q. Did any of your opinions that are stated
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`in your declaration change after you submitted your
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`declaration based on 3M's preliminary response?
`
` A. No.
`
` Q. Did any of your opinions that are stated
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`in your declaration change after you submitted your
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`declaration based on the PTAB's decision on
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`institution?
`
` A. No.
`
` Q. Have any of your opinions that are
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`stated in your declaration changed after you
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`submitted your declaration for any reason?
`
` A. No.
`
` Q. Can I turn your attention over to page 4
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`of your declaration, Exhibit 1006.
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` A. Which page 4?
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` Q. The regular page 4 that starts, "List of
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`Materials Considered," has paragraph 11 on it.
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` A. Got it.
`
` Q. Yeah, sorry about that; there's two
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`page 4s. In paragraph 11, it says at the beginning
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`there, "In formulating my opinions, I have
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`considered the following materials, and any other
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`materials referenced in this Declaration or the
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`Petition."
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` You see that?
`
` A. Yes.
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` Q. Was that true when you signed the
`
`declaration?
`
` A. Yes.
`
` Q. The opinions that you were referring to
`
`there in that statement in paragraph 11, are those
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`the opinions expressed in your declaration?
`
` A. Yes.
`
` Q. Do you see Exhibit 1001, that's US
`
`patent 6,743,413?
`
` A. Yes.
`
` Q. Had you ever reviewed that patent before
`
`you started your work in this matter?
`
` A. I may have, but I can't recall.
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` Q. Exhibit 1002, had you ever reviewed that
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`document before your work in this matter? That's
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`the patent application number 07809791.
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` A. I may have. I can't recall.
`
` Q. Did Mylan's counsel provide you with
`
`that document for your work in this matter?
`
` A. Yes.
`
` Q. What about Exhibit 1003? Did Mylan's
`
`counsel provide you with that document for your work
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`in this matter?
`
` A. I'll have to look at that document. I
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`don't -- I would have to look at that document to
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`look at the specifics of it.
`
` Q. Okay. What about Exhibit 1007? Had you
`
`reviewed that document before your work in this
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`matter?
`
` A. Yes.
`
` Q. What about Exhibit 1009? Have you ever
`
`reviewed that document before your work in this
`
`matter?
`
` A. I can't recall reviewing that one, but I
`
`may have.
`
` Q. Exhibit 1010?
`
` A. I may have. I'm not sure.
`
` Q. Exhibit 1011, have you ever reviewed
`
`that document before your work in this matter?
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` A. I can't recall reviewing that document
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`before this matter, but I may have.
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` Q. Did Mylan's counsel provide you with
`
`that document for your work in this matter?
`
` A. Yes.
`
` Q. Exhibit 1014, had you ever reviewed that
`
`document before your work in this matter?
`
` A. Yes.
`
` Q. That's a pretty common reference in the
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`pharmaceutical industry?
`
` A. Yes.
`
` Q. Did Mylan's counsel provide you with
`
`that document?
`
` A. No.
`
` Q. What about Exhibit 1015? Had you
`
`reviewed that document before your work in this
`
`matter?
`
` A. Yes.
`
` Q. Did Mylan's counsel provide you that
`
`document for your work in this matter?
`
` A. No.
`
` Q. Are there any prior art references that
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`you've considered during the course of your work on
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`this matter that are not cited in the Table 1 in
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`paragraph 11 or cited in your declaration of the
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`petition?
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` A. Not at the time of writing my
`
`declaration.
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` MR. LANE: Can I get that marked as
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`1012, please.
`
` (Deposition Exhibit 1012 marked for
`
`identification.)
`
`BY MR. LANE:
`
` Q. Dr. Smyth, I've handed you what's been
`
`marked as Exhibit 1012, which is the copy of your CV
`
`that was submitted with your declaration. Is this
`
`version of your CV still accurate, or are there
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`updates since it was submitted with your declaration
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`back in September 2015?
`
` A. No doubt there will be updates to the
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`CV, yes.
`
` Q. And not trying to go blow by blow, but
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`can you -- in general, can you just tell me what the
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`updates will be? Are there additional papers you've
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`published?
`
` A. There may be a few additional papers,
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`different students advised, different kinds of
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`professional activities, some students that
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`graduated; yeah, updates to the -- my publications.
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`That probably would be the majority of the updates.
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` Q. On page 14 there you have a list of
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`published and issued patents. Do you see that?
`
` A. Yes.
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` Q. Are there any additional patents that
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`have been issued since you submitted this
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`declaration that are related to aerosol inhalation
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`products?
`
` A. Not that I'm aware of or I can remember.
`
` Q. Any patent applications?
`
` A. Not that I'm aware of.
`
` Q. Do you have any publications that are
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`not listed here that you've submitted or worked on
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`since your declaration was submitted regarding
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`aerosol inhalation products?
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` MR. MALIK: Objection, form.
`
` A. Yes, probably several conference
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`presentations, maybe some research papers.
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`BY MR. LANE:
`
` Q. Do you recall any of the conference
`
`presentations?
`
` A. Not off the top of my head.
`
` Q. Do you recall any of the topics more
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`specifically those conference presentations related
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`to?
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` A. I remember one presentation we -- I was
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`23
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`24
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`25
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`an author on at a respiratory drug delivery
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`conference in Phoenix, Arizona, this year that
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`related to dry powder inhaler device design.
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` Q. Any other conference presentations you
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`recall?
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` A. We would have presented several at the
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`American Association of Pharmaceutical Sciences'
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`annual me