throbber
Page 1
`
` 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
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`1
`
`3M COMPANY 2014
`Mylan Pharmaceuticals Inc. v. 3M Company
`IPR2015-02002
`
`

`
`Page 2
`
` ORAL DEPOSITION OF HUGH D.C. SMYTH, Ph.D.,
`
`produced at the instance of the Respondent, in the
`
`above-styled and numbered cause on the 14th day of
`
`June, 2016, at 9:02 a.m., before Micheal A. Johnson,
`
`RDR, CRR, Notary Public in and for the State of
`
`Texas, reported by realtime stenographic means, at
`
`the AT&T Executive Education and Conference Center,
`
`1900 University Avenue, Austin, Texas, pursuant to
`
`Notice of Oral Deposition.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`2
`
`

`
`Page 3
`
`1
`2
`
`3
`
`4
`
`5
`
`6
`7
`
`8
`
`9
`
`10
`11
`
`12
`
`13
`
`14
`
`15
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`23
`24
`25
`
` 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
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`3
`
`

`
` INDEX
` HUGH D.C. SMYTH, Ph.D.
` June 14, 2016
`
` APPEARANCES 3
`
` PROCEEDINGS 7
`
`Page 4
`
`EXAMINATION OF HUGH D.C. SMYTH, Ph.D.:
`
` BY MR. LANE 7
`
` BY MR. MALIK 120
`
` CORRECTIONS AND SIGNATURE 126
`
` REPORTER'S CERTIFICATION 127
`
`1
`
`2
`
`3
`
`4
`
`5 6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`4
`
`

`
`Page 5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` 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
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`5
`
`

`
`Page 6
`
` DEPOSITION EXHIBITS
` HUGH D.C. SMYTH, Ph.D.
` June 14, 2016
`
`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.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`6
`
`

`
`Page 7
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` PROCEEDINGS
`
` HUGH D.C. SMYTH, Ph.D.
`
` having been first duly sworn,
`
` testified as follows:
`
` EXAMINATION
`
`BY MR. LANE:
`
` Q. Good morning.
`
` A. Morning.
`
` Q. Can you please state your name for the
`
`record.
`
` A. Hugh David Charles Smyth.
`
` Q. What's your work address?
`
` A. 2409 University Avenue.
`
` Q. That's here in Austin?
`
` A. Yes.
`
` Q. What's the ZIP code?
`
` A. 78712.
`
` Q. Have you ever been deposed before?
`
` A. Yes.
`
` Q. How many times?
`
` A. Twice.
`
` Q. You're represented by Mylan is counsel
`
`in this deposition?
`
` A. Yes.
`
` Q. Who is that?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`7
`
`

`
`Page 8
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. The two gentlemen sitting here, Jitty
`
`Malik, James Abe.
`
` MR. LANE: Do we want to identify
`
`who's in the room for the record, please? I think
`
`we should do that.
`
` I'm John Lane from Fish & Richardson
`
`representing the patent owner, and with me is
`
`Dorothy Whelan also from Fish & Richardson, and Jim
`
`Riek from GSK.
`
` MR. MALIK: Good idea. Jitendra
`
`Malik from the law firm of Alston & Bird on behalf
`
`of Mylan. With me is James Abe also from Alston &
`
`Bird also representing Mylan.
`
`BY MR. LANE:
`
` Q. I know you've been deposed before but
`
`we'll go through some of the ground rules here at
`
`the start just to make sure we're on the same page.
`
` If you need a break at any time
`
`today, just let me know and we'll break at the next
`
`convenient spot. I just ask that you don't take a
`
`break while the question is pending. You need to go
`
`ahead and answer the question if there's a question
`
`pending before we take a break.
`
` You understand there's a transcript
`
`being made today of the deposition?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`8
`
`

`
`Page 9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. Yes.
`
` Q. It's important for the court reporter
`
`and so we get a clean record that we don't talk over
`
`each other during the deposition. Do you understand
`
`that?
`
` A. Yes.
`
` Q. It's important that you answer orally
`
`for the transcript and not with gestures too so that
`
`the court reporter can take down the answers as
`
`words because he can't write down your gestures.
`
`You understand that?
`
` A. Yes.
`
` Q. Periodically today, Mylan's counsel may
`
`object to some of my questions, but unless they
`
`instruct you not to answer, you still need to answer
`
`the question even if there's an objection. You
`
`understand that?
`
` A. Yes.
`
` Q. If, during the deposition today, I ask
`
`you a question and you remember something later
`
`during the deposition after you've already answered
`
`the question and what you remember later means that
`
`you need to correct or further explain your previous
`
`answer, please let me know and I'll give you an
`
`opportunity to correct or further explain your
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`9
`
`

`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`previous answer on the record. Do you understand
`
`Page 10
`
`that?
`
` A. Yes.
`
` Q. Under the patent office's rules for
`
`depositions and IPRs, now that we've begun the
`
`deposition, you cannot consult or confer with
`
`Mylan's lawyers at the breaks regarding the
`
`substance of testimony that you've already given or
`
`testimony that you or Mylan's attorneys anticipate
`
`you may give later in the deposition, other than
`
`specifically to ascertain whether a privilege
`
`exists. Do you understand that?
`
` A. Yes.
`
` Q. You understand you're under oath today?
`
` A. Yes.
`
` Q. Is there any reason you can't testify
`
`here today completely and truthfully?
`
` A. No.
`
` Q. You said you've been deposed twice
`
`before?
`
` A. Yes.
`
` Q. What matters were those in?
`
` A. They were -- one was in a matter -- I
`
`was representing Goodwin Proctor relating to a
`
`district court litigation around the product ProAir.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`10
`
`

`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. Was Goodwin Proctor's client TEVA in
`
`Page 11
`
`that case?
`
` A. Yes.
`
` Q. When were you deposed?
`
` A. That was in 2014.
`
` Q. Where was that deposition?
`
` A. In Boston.
`
` Q. Did you submit a declaration opining on
`
`claim constructions in that case?
`
` A. I don't believe so.
`
` Q. Do you remember who the opposing counsel
`
`in that case was?
`
` A. No.
`
` Q. About how long were you deposed?
`
` A. Five, six hours.
`
` Q. Had you provided an expert report in
`
`that case before you were deposed?
`
` A. Yes.
`
` Q. What generally was your expert report
`
`on? Was it on infringement or invalidity?
`
` A. You know, I can't remember.
`
` Q. When was the second time you were
`
`deposed?
`
` A. I think it was in 2015.
`
` Q. What matter was that in?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`11
`
`

`
`Page 12
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. It was to do with Mometasone, again,
`
`representing TEVA on behalf of Goodwin Proctor.
`
` Q. Was TEVA seeking to bring a generic
`
`version of the drug onto the market in that case?
`
` A. I believe so.
`
` Q. What about in the ProAir case? Was TEVA
`
`seeking to bring a generic version of that drug to
`
`market in that case?
`
` A. No.
`
` Q. Where was your 2015 deposition?
`
` A. It was in Austin.
`
` Q. About how long were you deposed for?
`
` A. Five, six hours.
`
` Q. Do you remember who the opposing counsel
`
`was in that case?
`
` A. It was from Baker Botts.
`
` Q. Is this the first time you've been
`
`deposed in the context of an IPR?
`
` A. Yes.
`
` Q. Have you ever testified at a trial
`
`before?
`
` A. No.
`
` Q. Do you understand that we're here today
`
`regarding an IPR petition that Mylan filed for US
`
`patent number 6,743,413?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`12
`
`

`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. Yes.
`
` Q. Do you understand that 3M is the patent
`
`Page 13
`
`owner?
`
` A. Yes.
`
` Q. What other IPRs have you worked on?
`
` A. I have been -- I worked with Finnegan on
`
`a -- actually, I don't think the IPR began; they
`
`were anticipating it to begin, but it never began or
`
`something.
`
` Q. Who is Finnegan -- I'm sorry, go ahead.
`
` A. I think that's essentially the only IPR.
`
` Q. Who was Finnegan's client in that
`
`matter?
`
` A. I can't remember.
`
` MR. MALIK: I will -- obviously I
`
`don't represent Finnegan nor that client, but there
`
`may be some privilege issues if it wasn't public.
`
` A. Yeah, I'm not sure who the client was.
`
`BY MR. LANE:
`
` Q. Other than matters we've discussed so
`
`far, have you ever done any other work as an expert
`
`witness?
`
` A. Yes.
`
` Q. And in what matters?
`
` A. These are ongoing matters which may not
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`13
`
`

`
`Page 14
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`be public, I guess, so I may not be able to disclose
`
`exactly who I'm working for and on what matter.
`
` Q. Are they litigation matters?
`
` A. Yes.
`
` Q. Have you submitted expert reports in any
`
`of those matters?
`
` A. I do not believe so.
`
` Q. Are you working on any ongoing IPR
`
`matters that we haven't discussed?
`
` A. I don't believe so.
`
` Q. You're being compensated in this matter
`
`at $650 an hour; is that correct?
`
` A. Yes.
`
` Q. Is that the same amount that you're
`
`being compensated in the other matters that you're
`
`currently working on?
`
` A. There is one other that is not, which
`
`I'm being compensated at 500, which had started
`
`before this matter.
`
` Q. When did that matter start?
`
` A. I can't remember.
`
` Q. About, to the best of your recollection.
`
` A. 2015, sometime in 2015.
`
` Q. How were you first contacted about this
`
`matter?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`14
`
`

`
`Page 15
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. I can't recall.
`
` Q. Do you recall who first contacted you
`
`about this matter?
`
` A. I remember having a phone call with
`
`Jitty early on.
`
` Q. Do you recall about when that was?
`
` A. No.
`
` Q. Do you recall when you were engaged for
`
`this matter?
`
` A. It would have -- late 2015, second half
`
`of 2015.
`
` Q. When did you start working on this
`
`matter?
`
` A. Around about the same time.
`
` Q. Do you have any more specific
`
`recollection than late 2015?
`
` A. Would've been maybe a month or two
`
`before my declaration was submitted.
`
` Q. All right. And your declaration, I
`
`think it was submitted late September. Is that
`
`consistent with your recollection?
`
` A. I think so.
`
` Q. So you were engaged and started working
`
`around July or August; is that accurate?
`
` A. Perhaps, yeah.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`15
`
`

`
`Page 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. Have you ever done any work for Mylan
`
`before?
`
` A. Not that I know of or can remember.
`
` Q. Have you ever worked with Alston & Bird
`
`before?
`
` A. No.
`
` Q. Have you ever worked with any of the
`
`attorneys that are working with Mylan on this matter
`
`to the extent that you know who they are?
`
` A. No.
`
` Q. When did you start working on your
`
`declaration?
`
` A. Yeah, like I said, probably a couple of
`
`months, month or two, before it was submitted.
`
` Q. How much time have you spent working on
`
`this matter?
`
` A. I would have to consult my records for
`
`how many hours I've spent time on it.
`
` Q. Can you give me an estimate?
`
` A. Maybe 30 hours.
`
` Q. That 30 hours, that includes the time
`
`you spent working on your declaration; is that
`
`correct?
`
` A. Yes.
`
` Q. Does that include the time you spent
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`16
`
`

`
`Page 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`preparing for today's deposition?
`
` A. It would include that.
`
` Q. Of those approximately 30 hours, how
`
`many were spent working on your declaration?
`
` A. Maybe 20, 25, something like that.
`
` Q. What, if anything, have you spent time
`
`on for this matter, other than working on your
`
`declaration and preparing for today's deposition?
`
` A. I think that's pretty much all I've
`
`done, is preparing my declaration and preparing for
`
`a deposition.
`
` Q. What did you do to prepare for today's
`
`deposition?
`
` A. I reviewed my declaration and the
`
`references that I cite within that declaration.
`
` Q. Did you meet with anyone to prepare for
`
`your deposition?
`
` A. Yesterday I met with Jitty and James.
`
` Q. How long did you meet with them?
`
` A. About five, six hours.
`
` Q. Did you meet with anybody else?
`
` A. No.
`
` Q. You just had one meeting with them?
`
` A. Yes.
`
` Q. Did you have any phone calls with anyone
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`17
`
`

`
`Page 18
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`to prepare for your deposition?
`
` A. There was a few phone calls before they
`
`arrived here in Austin, logistics and --
`
` Q. Did you have any phone calls before
`
`yesterday's meeting regarding the substance of your
`
`deposition?
`
` A. Regarding the substance of my
`
`deposition? Yes, I guess, we talked over the phone
`
`about --
`
` MR. MALIK: Don't talk specific --
`
`sorry. Don't get into any specifics with
`
`discussions with counsel.
`
`BY MR. LANE:
`
` Q. When did you have those phone calls with
`
`Mylan's counsel to prepare for your deposition?
`
` A. I had one on Friday.
`
` Q. How long did that last?
`
` A. Thirty minutes, an hour.
`
` Q. Who was on the call, besides you?
`
` A. James.
`
` Q. Any other phone calls?
`
` A. Not that I recall.
`
` Q. When did you review your declaration and
`
`the references cited therein in preparation for your
`
`deposition?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`18
`
`

`
`Page 19
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. I started refreshing my memory maybe in
`
`the last week or so.
`
` Q. Have you ever reviewed Mylan's petition
`
`seeking inter partes review of the '413 patent?
`
` A. I have not.
`
` Q. Have you ever reviewed 3M's preliminary
`
`response?
`
` A. I did briefly read that yesterday.
`
` Q. You read that yesterday?
`
` A. Yes.
`
` Q. In preparing for your deposition?
`
` A. Yes.
`
` Q. So what other documents -- so I asked
`
`you before and you told me the declaration
`
`references and now you're telling me the preliminary
`
`response. What other documents did you review in
`
`preparing for your deposition?
`
` MR. MALIK: Don't get into any
`
`specific documents that you were shown by counsel.
`
` Counsel, if you have specific
`
`documents in mind, you can ask him whether he's
`
`looked at them.
`
` MR. LANE: He's testifying as an
`
`expert here. I can ask him what documents he's
`
`reviewed.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`19
`
`

`
`Page 20
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` MR. MALIK: My instruction stands.
`
` To the extent you can recall any
`
`that you have reviewed, you can go ahead.
`
` MR. LANE: Objection, that's a
`
`speaking objection. It's not permitted under PTAB's
`
`rules.
`
` A. I looked at the -- so my declaration,
`
`the references, looked at the preliminary response
`
`and the decision.
`
`BY MR. LANE:
`
` Q. Did you look at any of the exhibits to
`
`the preliminary response?
`
` A. I may have quickly glanced at a couple
`
`of them.
`
` Q. Did you speak to anyone at Mylan
`
`regarding your deposition?
`
` A. No.
`
` Q. Did you have any discussions about your
`
`deposition with anyone other than Mylan's counsel?
`
` A. No.
`
` Q. Did you look at anything on the Internet
`
`in preparation for your deposition?
`
` A. I may have pulled up the patents on the
`
`Internet.
`
` Q. When was that?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`20
`
`

`
`Page 21
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. Within the last week.
`
` Q. When you say "the patents," which
`
`patents are you talking about?
`
` A. The '413, the '011.
`
` Q. That's it?
`
` A. Yes.
`
` Q. If you had any questions for Mylan's
`
`counsel about today's deposition, did you ask
`
`Mylan's counsel those questions before the
`
`deposition?
`
` MR. MALIK: You can -- I suppose you
`
`can answer that question yes or no.
`
` A. Sorry, can you repeat the question?
`
` MR. LANE: Can you read it back,
`
`please.
`
` Or I'll just -- strike it. I'll
`
`just ask it again.
`
`BY MR. LANE:
`
` Q. If you had any questions for Mylan's
`
`counsel today -- let me strike that.
`
` If you had any questions for Mylan's
`
`counsel about today's deposition, did you ask
`
`Mylan's counsel those questions before the
`
`deposition?
`
` MR. MALIK: Vague and ambiguous.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`21
`
`

`
`Page 22
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` MR. LANE: I'll object. That's an
`
`objection that's not allowed under PTAB's rules.
`
`You're making speaking objections, and objections
`
`are specifically not required -- allowed under the
`
`rules.
`
` MR. MALIK: Objections are allowed.
`
` MR. LANE: Not "objection, vague."
`
`Those are specifically called out as not allowed
`
`under the rules.
`
` MR. MALIK: Well, at a break you can
`
`show me where that specific objection is called out
`
`under the rules.
`
` MR. LANE: Okay. I'll be happy to
`
`send that to you.
`
` A. I asked them some logistical
`
`information; you know, we discussed some of the
`
`patents.
`
` MR. LANE: Can you mark that as
`
`Exhibit 1006.
`
` (Deposition Exhibit 1006 marked for
`
`identification.)
`
`BY MR. LANE:
`
` Q. So I've handed you there what's been
`
`marked as Exhibit 1006, which is your declaration.
`
`Do you see that? Do you want to flip through that
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`22
`
`

`
`Page 23
`
`and make sure it's your declaration?
`
` A. Sure.
`
` (Witness reviews document.)
`
` A. Looks like you've highlighted a few
`
`things in there.
`
`BY MR. LANE:
`
` Q. Oh, did I? Let me see that.
`
` A. At the front.
`
` MR. MALIK: Yeah, I also have
`
`highlighting.
`
` MR. LANE: If those are the only two
`
`highlighted things, that's -- we can live with that.
`
` MR. MALIK: You can have my copy.
`
` MR. LANE: Thanks. I appreciate
`
`that. I think that's all.
`
` Sorry about that, but I think we can
`
`live with that.
`
` MR. MALIK: Thank you.
`
`BY MR. LANE:
`
` Q. You can see that we've read your
`
`declaration.
`
` MR. MALIK: At least the first page.
`
` MR. LANE: Yeah, at least the first
`
`couple of pages, right.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`23
`
`

`
`Page 24
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`BY MR. LANE:
`
` Q. So starting kind of at the back of your
`
`declaration, your Exhibit 1006, can you turn to the
`
`very last page there. Is that your signature there
`
`at the very end?
`
` A. Yes.
`
` Q. Okay. And you signed this on
`
`September 29, 2015?
`
` A. Yes.
`
` Q. Do you see the paragraph right above
`
`that, paragraph 235?
`
` A. Yes.
`
` Q. It says, "I hereby declare that all
`
`statements made herein of my own knowledge are true
`
`and that all statements made on information and
`
`belief are believed to be true."
`
` Do you see that?
`
` A. Yes.
`
` 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
`
`preliminary response?
`
` A. Briefly.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`24
`
`

`
`Page 25
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. About how long did you review that
`
`document?
`
` A. Maybe, you know, 30 minutes to an hour.
`
` Q. And you reviewed the PTAB's decision on
`
`institution?
`
` A. I did look at that.
`
` Q. About how long did you spend reviewing
`
`that document?
`
` A. Maybe 20 to 30 minutes.
`
` Q. Did any of your opinions that are stated
`
`in your declaration change after you submitted your
`
`declaration based on 3M's preliminary response?
`
` A. No.
`
` Q. Did any of your opinions that are stated
`
`in your declaration change after you submitted your
`
`declaration based on the PTAB's decision on
`
`institution?
`
` A. No.
`
` Q. Have any of your opinions that are
`
`stated in your declaration changed after you
`
`submitted your declaration for any reason?
`
` A. No.
`
` Q. Can I turn your attention over to page 4
`
`of your declaration, Exhibit 1006.
`
` A. Which page 4?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`25
`
`

`
`Page 26
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. The regular page 4 that starts, "List of
`
`Materials Considered," has paragraph 11 on it.
`
` A. Got it.
`
` Q. Yeah, sorry about that; there's two
`
`page 4s. In paragraph 11, it says at the beginning
`
`there, "In formulating my opinions, I have
`
`considered the following materials, and any other
`
`materials referenced in this Declaration or the
`
`Petition."
`
` You see that?
`
` A. Yes.
`
` 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
`
`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.
`
` Q. Exhibit 1002, had you ever reviewed that
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`26
`
`

`
`Page 27
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`document before your work in this matter? That's
`
`the patent application number 07809791.
`
` 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
`
`in this matter?
`
` A. I'll have to look at that document. I
`
`don't -- I would have to look at that document to
`
`look at the specifics of it.
`
` Q. Okay. What about Exhibit 1007? Had you
`
`reviewed that document before your work in this
`
`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?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`27
`
`

`
`Page 28
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. I can't recall reviewing that document
`
`before this matter, but I may have.
`
` 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
`
`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
`
`you've considered during the course of your work on
`
`this matter that are not cited in the Table 1 in
`
`paragraph 11 or cited in your declaration of the
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`28
`
`

`
`Page 29
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`petition?
`
` A. Not at the time of writing my
`
`declaration.
`
` MR. LANE: Can I get that marked as
`
`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
`
`updates since it was submitted with your declaration
`
`back in September 2015?
`
` A. No doubt there will be updates to the
`
`CV, yes.
`
` Q. And not trying to go blow by blow, but
`
`can you -- in general, can you just tell me what the
`
`updates will be? Are there additional papers you've
`
`published?
`
` A. There may be a few additional papers,
`
`different students advised, different kinds of
`
`professional activities, some students that
`
`graduated; yeah, updates to the -- my publications.
`
`That probably would be the majority of the updates.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`29
`
`

`
`Page 30
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. On page 14 there you have a list of
`
`published and issued patents. Do you see that?
`
` A. Yes.
`
` Q. Are there any additional patents that
`
`have been issued since you submitted this
`
`declaration that are related to aerosol inhalation
`
`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
`
`not listed here that you've submitted or worked on
`
`since your declaration was submitted regarding
`
`aerosol inhalation products?
`
` MR. MALIK: Objection, form.
`
` A. Yes, probably several conference
`
`presentations, maybe some research papers.
`
`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
`
`specifically those conference presentations related
`
`to?
`
` A. I remember one presentation we -- I was
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`30
`
`

`
`Page 31
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`an author on at a respiratory drug delivery
`
`conference in Phoenix, Arizona, this year that
`
`related to dry powder inhaler device design.
`
` Q. Any other conference presentations you
`
`recall?
`
` A. We would have presented several at the
`
`American Association of Pharmaceutical Sciences'
`
`annual me

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket