DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`1
`
`·1
`
`·2· ·UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·3· ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·4· ·Case IPR2017-01995
`
`·5· ·Patent 9,220,698 B2
`
`·6· ·------------------------------------------
`
`·7· ·MYLAN PHARMACEUTICALS, INC.,
`
`·8· · · · · · · · · · · · ·Petitioner,
`
`·9
`
`10· · · · · · · vs.
`
`11
`
`12· ·POZEN, INC. and HORIZON PHARMA USA, Inc.
`
`13· · · · · · · · · · · · ·Patent Owners.
`
`14· ·------------------------------------------
`
`15
`
`16
`
`17· · VIDEOTAPED DEPOSITION OF DR. DAVID R. TAFT
`
`18
`
`19· · · · · · ·Friday, August 17, 2018
`
`20· · · · · · · · · · 9:00 a.m.
`
`21
`
`22
`
`23· ·Reported by:
`
`24· ·Joan Ferrara, RPR, RMR, CRR
`
`25· ·Job No. J2529078
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 1
`
`
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`1
`
`·1
`
`·2· ·UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·3· ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·4· ·Case IPR2017-01995
`
`·5· ·Patent 9,220,698 B2
`
`·6· ·------------------------------------------
`
`·7· ·MYLAN PHARMACEUTICALS, INC.,
`
`·8· · · · · · · · · · · · ·Petitioner,
`
`·9
`
`10· · · · · · · vs.
`
`11
`
`12· ·POZEN, INC. and HORIZON PHARMA USA, Inc.
`
`13· · · · · · · · · · · · ·Patent Owners.
`
`14· ·------------------------------------------
`
`15
`
`16
`
`17· · VIDEOTAPED DEPOSITION OF DR. DAVID R. TAFT
`
`18
`
`19· · · · · · ·Friday, August 17, 2018
`
`20· · · · · · · · · · 9:00 a.m.
`
`21
`
`22
`
`23· ·Reported by:
`
`24· ·Joan Ferrara, RPR, RMR, CRR
`
`25· ·Job No. J2529078
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 1
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`2
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`·1
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`·2
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`·3
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`·4· · · · · · · · · · · August 17, 2018
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`·5· · · · · · · · · · · 9:00 a.m.
`
`·6· · · · · · · · · · · New York, New York
`
`·7
`
`·8
`
`·9
`
`10· · · · · ·Videotaped Deposition of DAVID R.
`
`11· ·TAFT, held at the offices of Perkins Coie,
`
`12· ·30 Rockefeller Plaza, New York, New York,
`
`13· ·before Joan Ferrara, a Registered Merit
`
`14· ·Reporter and Notary Public of the State
`
`15· ·of New York.
`
`16
`
`17
`
`18
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`19
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`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 2
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`3
`
`·1
`
`·2· ·A P P E A R A N C E S:
`
`·3
`
`·4· ·PERKINS COIE
`
`·5· ·Attorneys for Petitioner
`
`·6· · · · · · ·1120 NW Couch Street, 10th Floor
`
`·7· · · · · · ·Portland, Oregon 97209-4128
`
`·8· ·BY:· · · ·BRYAN D. BEEL, Ph.D., ESQ.
`
`·9· · · · · · ·bbeel@perkinscoie.com
`
`10
`
`11
`
`12· ·COOLEY, LLP
`
`13· ·Attorneys for Horizon
`
`14· · · · · · ·500 Boylston Street
`
`15· · · · · · ·Boston, Massachusetts 02116-3736
`
`16· ·BY:· · · ·ELLEN A. SCORDINO, ESQ.
`
`17· · · · · · ·escordino@cooley.com
`
`18
`
`19
`
`20· ·BUDD LARNER, P.C.
`
`21· ·Attorneys for Dr. Reddy's
`
`22· · · · · · ·150 John F. Kennedy Parkway
`
`23· · · · · · ·Short Hills, New Jersey 07078-0999
`
`24· ·BY:· · · ·ALAN H. POLLACK, ESQ.
`
`25· · · · · · ·apollack@buddlarner.com
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 3
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`4
`
`·1
`
`·2· ·A P P E A R A N C E S :· (Continued)
`
`·3
`
`·4· ·(Via Telephone):
`
`·5· ·BAKER BOTTS
`
`·6· ·Attorneys for Pozen
`
`·7· · · · · · ·98 San Jacinto Boulevard
`
`·8· · · · · · ·Suite 1500
`
`·9· · · · · · ·Austin, Texas 78701-4078
`
`10· ·BY:· · · ·JEFF GRITTON, ESQ.
`
`11· · · · · · ·jeff.gritton@bakerbotts.com
`
`12
`
`13
`
`14· ·ALSO PRESENT:
`
`15· · · · · · ·Marcello Rivera, Videographer
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 4
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`5
`
`·1
`
`·2· · · · ·THE VIDEOGRAPHER:· This is the
`
`·3· ·digitized video deposition of
`
`·4· ·Dr. David Taft in the matter Mylan
`
`·5· ·Pharmaceuticals, Inc. versus Pozen,
`
`·6· ·Inc.
`
`·7· · · · ·This deposition is being held at
`
`·8· ·the law offices of Perkins Coie
`
`·9· ·located at 30 Rockefeller Plaza, New
`
`10· ·York, New York, on August 17, 2018 at
`
`11· ·approximately 9 a.m.
`
`12· · · · ·My name is Marcello Rivera from
`
`13· ·Esquire Solutions and I am the legal
`
`14· ·video specialist.
`
`15· · · · ·The court reporter is Joan
`
`16· ·Ferrara in association with Esquire
`
`17· ·Solutions.
`
`18· · · · ·Will present counsel please
`
`19· ·introduce themselves for the record.
`
`20· · · · ·MR. BEEL:· Sure.· This is Brian
`
`21· ·Beel of Perkins Coie for petitioner
`
`22· ·Mylan Pharmaceuticals.
`
`23· · · · ·MR. POLLACK:· Alan Pollack from
`
`24· ·Budd Larner on behalf of the Dr.
`
`25· ·Reddy's defendants and Consolidated
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 5
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`6
`
`·1
`
`·2· · · · ·IPR.
`
`·3· · · · · · · ·MS. SCORDINO:· Ellen Scordino
`
`·4· · · · ·with Cooley on behalf of patent owner
`
`·5· · · · ·Horizon and the witness.
`
`·6· · · · · · · ·THE VIDEOGRAPHER:· Will the
`
`·7· · · · ·court reporter please swear in the
`
`·8· · · · ·witness -- sorry.
`
`·9· · · · · · · ·MR. GRITTON:· I'm on the phone.
`
`10· · · · ·This is Jeff Gritton from Baker Botts
`
`11· · · · ·on behalf of the patent owner Pozen.
`
`12· ·D A V I D· · ·T A F T ,
`
`13· · · · · called as a witness, having been
`
`14· · · · · duly sworn by a Notary Public, was
`
`15· · · · · examined and testified as follows:
`
`16· ·EXAMINATION BY
`
`17· ·MR. BEEL:
`
`18· · · · ·Q· · ·Good morning, Dr. Taft.
`
`19· · · · ·A· · ·Good morning.
`
`20· · · · ·Q· · ·Could you please state your name
`
`21· · for the record?
`
`22· · · · ·A· · ·My name is David Robert Taft.
`
`23· · · · ·Q· · ·And your current home address,
`
`24· · please?
`
`25· · · · ·A· · ·My address is 833 River Road,
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 6
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`7
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·and the town is two words, Fair Haven, New
`
`·3· ·Jersey.
`
`·4· · · · Q· · ·And where are you currently
`
`·5· ·employed?
`
`·6· · · · A· · ·My current employer is Long
`
`·7· ·Island University.
`
`·8· · · · Q· · ·And what is your position there?
`
`·9· · · · A· · ·My formal title is Professor of
`
`10· ·Pharmaceutics.
`
`11· · · · Q· · ·Okay.
`
`12· · · · · · · And you've been deposed before,
`
`13· ·correct?
`
`14· · · · A· · ·Yes.
`
`15· · · · Q· · ·And you understand that you're
`
`16· ·under oath here today?
`
`17· · · · A· · ·Yes.
`
`18· · · · Q· · ·Okay.
`
`19· · · · · · · And you understand that you're
`
`20· ·required to answer my questions truthfully
`
`21· ·and honestly to the best of your ability as
`
`22· ·if you were testifying in court today?
`
`23· · · · A· · ·Yes.
`
`24· · · · Q· · ·Okay.
`
`25· · · · · · · And you need to provide answers
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 7
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`8
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·to each of my questions unless your counsel
`
`·3· ·specifically instructs you not to answer,
`
`·4· ·correct?
`
`·5· · · · A· · ·Yes.
`
`·6· · · · Q· · ·Thank you.
`
`·7· · · · · · · Now, if I ask a question that
`
`·8· ·you don't understand, please ask me to
`
`·9· ·repeat or clarify the question and I'll do
`
`10· ·my best to do that.
`
`11· · · · · · · Is that okay?
`
`12· · · · A· · ·Yes.
`
`13· · · · Q· · ·Generally, we go about an hour
`
`14· ·between breaks.· But at any time you need a
`
`15· ·break, please let me know and we'll try to
`
`16· ·stop.
`
`17· · · · · · · Is that okay?
`
`18· · · · A· · ·Yes.
`
`19· · · · Q· · ·I just ask not during a question
`
`20· ·when it's pending.· Please answer the
`
`21· ·question first and then we can break.
`
`22· · · · · · · Is that okay?
`
`23· · · · A· · ·Yes.
`
`24· · · · Q· · ·I'm going to give you Exhibit
`
`25· ·2025, which has been designated in our
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 8
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`9
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·proceeding -- previously marked.
`
`·3· · · · · · · So, Dr. Taft, do you recognize
`
`·4· ·Exhibit 2025 as your declaration in our
`
`·5· ·Inter Partes Review Proceeding, IPR
`
`·6· ·2017-01995?
`
`·7· · · · A· · ·Yes, I do.
`
`·8· · · · Q· · ·And you were retained by Pozen,
`
`·9· ·Inc. and Horizon Pharma, USA who are the
`
`10· ·patent owners in this proceeding, is that
`
`11· ·correct?
`
`12· · · · · · · MS. SCORDINO:· Objection to
`
`13· · · · form.
`
`14· · · · A· · ·I'm sorry, what was the question
`
`15· ·again, please?
`
`16· · · · Q· · ·You were retained by patent
`
`17· ·owners Pozen, Inc. and Horizon Pharma, USA
`
`18· ·for this proceeding?
`
`19· · · · A· · ·Yes.
`
`20· · · · Q· · ·And you're offering opinions
`
`21· ·regarding U.S. Patent No. 9,220,698, is
`
`22· ·that correct?
`
`23· · · · A· · ·Yes, that's correct.
`
`24· · · · Q· · ·Okay.
`
`25· · · · · · · Are you aware of any errors or
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 9
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`10
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·corrections that you need to make to your
`
`·3· ·declaration?
`
`·4· · · · A· · ·Sitting here today, I'm not
`
`·5· ·aware of any, any errors or -- corrections
`
`·6· ·that I need to make to any errors, no.
`
`·7· · · · Q· · ·Okay.
`
`·8· · · · · · · So you stand by the substance of
`
`·9· ·your opinions that are cited in your
`
`10· ·declaration?
`
`11· · · · A· · ·Yes, I do.
`
`12· · · · Q· · ·Did you meet with counsel to
`
`13· ·prepare for your deposition?
`
`14· · · · A· · ·I did not meet directly with
`
`15· ·counsel, no.
`
`16· · · · Q· · ·Okay.
`
`17· · · · · · · Did you speak to counsel by
`
`18· ·phone?
`
`19· · · · A· · ·Yes.
`
`20· · · · Q· · ·And other than counsel, did you
`
`21· ·speak to anyone to prepare for your
`
`22· ·deposition?
`
`23· · · · A· · ·No.
`
`24· · · · Q· · ·Did you review your declaration
`
`25· ·to prepare for the deposition?
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 10
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`11
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · A· · ·Yes.
`
`·3· · · · Q· · ·If you could turn to paragraph
`
`·4· ·12, please, on the bottom of page 3.
`
`·5· · · · · · · To prepare your declaration, you
`
`·6· ·reviewed Mylan's petition, is that correct,
`
`·7· ·as recited in this paragraph?
`
`·8· · · · A· · ·Yes, I did read that, yes.
`
`·9· · · · Q· · ·Okay.
`
`10· · · · · · · And you reviewed Dr. Mayersohn's
`
`11· ·declaration?
`
`12· · · · A· · ·I read that, yes.
`
`13· · · · Q· · ·Okay.
`
`14· · · · · · · And you reviewed Dr. Metz'
`
`15· ·declaration?
`
`16· · · · A· · ·I believe I did, yes.
`
`17· · · · Q· · ·And you reviewed patent owner's
`
`18· ·response, correct?
`
`19· · · · A· · ·Yes, I read that as well.
`
`20· · · · Q· · ·Okay.
`
`21· · · · · · · And, finally, you reviewed
`
`22· ·Dr. Johnson's declaration, David Johnson,
`
`23· ·M.D.?
`
`24· · · · A· · ·Yes, I did.
`
`25· · · · Q· · ·And he's another expert with a
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 11
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`12
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·declaration on behalf of the patent owners
`
`·3· ·in this review?
`
`·4· · · · A· · ·Yes, that's my understanding.
`
`·5· ·Yes.
`
`·6· · · · Q· · ·Okay.· Thank you.
`
`·7· · · · · · · You're not providing testimony
`
`·8· ·as a medical doctor, correct?
`
`·9· · · · · · · MS. SCORDINO:· Objection to
`
`10· · · · form.
`
`11· · · · A· · ·Well, I am not a medical doctor.
`
`12· · · · Q· · ·Okay.
`
`13· · · · · · · You rely on Dr. Johnson's
`
`14· ·declaration for medical opinions?
`
`15· · · · · · · MS. SCORDINO:· Objection to
`
`16· · · · form.
`
`17· · · · A· · ·I do refer to Dr. Johnson in my
`
`18· ·declaration.· That's what I -- I can point,
`
`19· ·for example, to paragraph 68 where I have a
`
`20· ·reference to one of the opinions that I
`
`21· ·believe Dr. Johnson has, and there may be
`
`22· ·another location in my declaration where I
`
`23· ·rely on him.· That's the extent to which
`
`24· ·I'm relying on Dr. Johnson.
`
`25· · · · Q· · ·Okay.· Thank you.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 12
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`13
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · · · · There is no materials considered
`
`·3· ·list provided with your declaration,
`
`·4· ·correct?
`
`·5· · · · A· · ·I don't believe so, no.
`
`·6· · · · Q· · ·Okay.
`
`·7· · · · · · · Did you consider any materials
`
`·8· ·that are not cited in your declaration?
`
`·9· · · · A· · ·No.· I don't recall considering
`
`10· ·any other materials unless they're cited in
`
`11· ·my declaration.
`
`12· · · · Q· · ·Okay.
`
`13· · · · · · · I'm going to give you a copy of
`
`14· ·Exhibit 1005, which is U.S. Patent No.
`
`15· ·8,557,285.
`
`16· · · · · · · Dr. Taft, do you recognize
`
`17· ·Exhibit 1005?
`
`18· · · · A· · ·Yes, I do.
`
`19· · · · Q· · ·And you relied on it when
`
`20· ·providing your declaration?
`
`21· · · · · · · MS. SCORDINO:· Objection to
`
`22· · · · form.
`
`23· · · · A· · ·I believe I cite this reference
`
`24· ·in my declaration.
`
`25· · · · Q· · ·Okay.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 13
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`14
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · · · · If you could please turn to
`
`·3· ·claim 1 in the '285 Patent, which is at
`
`·4· ·column 22.· Claim 1 recites an uncoated
`
`·5· ·Esomeprazole, correct?
`
`·6· · · · A· · ·Well, claim 1 states
`
`·7· ·Esomeprazole not surrounded by an enteric
`
`·8· ·coating.
`
`·9· · · · Q· · ·Okay.
`
`10· · · · · · · And claim 1 also recites that
`
`11· ·the Esomeprazole is released regardless of
`
`12· ·the pH of the surrounding medium, is that
`
`13· ·correct?
`
`14· · · · · · · MS. SCORDINO:· Objection to
`
`15· · · · form.
`
`16· · · · A· · ·Well, claim 1 at the last two
`
`17· ·lines states:· At least a portion of said
`
`18· ·Esomeprazole is released regardless of pH
`
`19· ·medium.
`
`20· · · · Q· · ·Okay.· Thank you.
`
`21· · · · · · · And claim 1 also recites an
`
`22· ·enteric-coated Naproxen, is that correct?
`
`23· · · · · · · MS. SCORDINO:· Objection to
`
`24· · · · form.
`
`25· · · · A· · ·I believe claim 1, there is a
`
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 14
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`15
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·subpart in parenthesis B, describes
`
`·3· ·Naproxen surrounded by a coating that
`
`·4· ·inhibits its release from said dosage form
`
`·5· ·unless said dosage form is in a medium with
`
`·6· ·a pH of 3.5 or higher.
`
`·7· · · · Q· · ·And that language is another way
`
`·8· ·of describing an enteric-coated dosage
`
`·9· ·form, correct?
`
`10· · · · · · · MS. SCORDINO:· Objection to
`
`11· · · · form.
`
`12· · · · A· · ·In general, I would say an
`
`13· ·enteric-coated dosage form generally has --
`
`14· ·does not release or dissolve until a
`
`15· ·certain pH.· It's not necessarily
`
`16· ·specifically pH 3.5, but it could be.
`
`17· · · · Q· · ·Okay.
`
`18· · · · · · · Claim 1 recites a combined
`
`19· ·dosage form, unit dosage form, correct?
`
`20· · · · · · · MS. SCORDINO:· Objection to
`
`21· · · · form.
`
`22· · · · A· · ·What claim 1 states is a
`
`23· ·pharmaceutical composition and unit dosage
`
`24· ·form comprising therapeutically effective
`
`25· ·amounts of -- and it lists Esomeprazole and
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 15
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`16
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·Naproxen.
`
`·3· · · · Q· · ·Okay.
`
`·4· · · · · · · If you could look further down
`
`·5· ·column 22, claim 4 recites the
`
`·6· ·pharmaceutical composition of claim 1,
`
`·7· ·correct?
`
`·8· · · · · · · MS. SCORDINO:· Objection to
`
`·9· · · · form.
`
`10· · · · A· · ·Claim 4 states, yes, those words
`
`11· ·exactly.
`
`12· · · · Q· · ·And claim 4 goes on to recite
`
`13· ·that the Naproxen is present in an amount
`
`14· ·between 200 and 600 milligrams, correct?
`
`15· · · · A· · ·That's what it states under
`
`16· ·claim 4, yes.
`
`17· · · · Q· · ·Okay.
`
`18· · · · · · · And that range encompasses 500
`
`19· ·milligrams of Naproxen?
`
`20· · · · A· · ·Yes.
`
`21· · · · Q· · ·If you look just further down,
`
`22· ·claim 4 recites that the Esomeprazole is
`
`23· ·present in an amount between 5 and 100
`
`24· ·milligrams per unit dosage form, is that
`
`25· ·correct?
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 16
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`17
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · A· · ·Yes, that's what it states in
`
`·3· ·claim 4.
`
`·4· · · · Q· · ·Okay.
`
`·5· · · · · · · And that range encompasses 20
`
`·6· ·milligrams of Esomeprazole, correct?
`
`·7· · · · A· · ·Yes.
`
`·8· · · · Q· · ·If we could turn back to your
`
`·9· ·declaration, please, which is Exhibit 2025,
`
`10· ·and I'd like to ask about paragraph 36
`
`11· ·which is at the bottom of page 14 and the
`
`12· ·top of page 15.
`
`13· · · · · · · So the last sentence of
`
`14· ·paragraph 36 reads:· I have been asked to
`
`15· ·assume that the invention claimed by the
`
`16· ·'698 Patent was conceived and actually
`
`17· ·reduced to practice by June 25, 2007,
`
`18· ·correct?
`
`19· · · · A· · ·Yes.
`
`20· · · · Q· · ·Okay.
`
`21· · · · · · · And the '698 Patent is U.S.
`
`22· ·Patent No. 9,220,698, correct -- sorry, the
`
`23· ·subject of the Inter Partes Agreement?
`
`24· · · · A· · ·Yes, that's correct.
`
`25· · · · Q· · ·Okay.· Thank you.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 17
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`18
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · · · · So the beginning of that
`
`·3· ·sentence says:· I have been asked to
`
`·4· ·assume.
`
`·5· · · · · · · You did not perform any
`
`·6· ·independent analysis that the claim subject
`
`·7· ·matter was conceived and reduce to practice
`
`·8· ·by June 25, 2007, correct?
`
`·9· · · · A· · ·What was the question again,
`
`10· ·please?
`
`11· · · · Q· · ·So the lead-in to that last
`
`12· ·sentence says I have been asked to assume,
`
`13· ·correct?
`
`14· · · · A· · ·Yes.
`
`15· · · · Q· · ·So you did not perform any
`
`16· ·independent analysis that the claim subject
`
`17· ·matter in the '698 Patent was conceived and
`
`18· ·reduced to practice by June 25, 2007,
`
`19· ·correct?
`
`20· · · · A· · ·Well, preceding in paragraph 36,
`
`21· ·I do indicate that I did review the
`
`22· ·clinical study report that I believe was
`
`23· ·dated on or has a date affiliated with June
`
`24· ·25, 2007.
`
`25· · · · Q· · ·Okay.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 18
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`19
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · A· · ·And I compared the
`
`·3· ·pharmacokinetic results from that report
`
`·4· ·with data that is contained in the '698
`
`·5· ·Patent, and that comparison confirmed to me
`
`·6· ·that the results match between the clinical
`
`·7· ·study report and the '698 Patent.
`
`·8· · · · · · · So I'm not sure exactly what you
`
`·9· ·mean by my own analysis, but I did review
`
`10· ·that report in the context of what some of
`
`11· ·the tables are in the '698 Patent and saw
`
`12· ·the numbers matched.
`
`13· · · · Q· · ·So your analysis was to look at
`
`14· ·the clinical study report and compare the
`
`15· ·numbers in the report to the numbers in the
`
`16· ·patent to be sure it matched?
`
`17· · · · · · · MS. SCORDINO:· Objection to
`
`18· · · · form.
`
`19· · · · A· · ·What I looked at were some of
`
`20· ·the tables -- if we look at the clinical
`
`21· ·study report, I can certainly point that
`
`22· ·out -- and compared them to some of the
`
`23· ·tables in the '698 Patent, and the data is
`
`24· ·the same.
`
`25· · · · Q· · ·Okay.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 19
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`20
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · A· · ·And I'm referring to the mean
`
`·3· ·pharmacokinetic data from the clinical
`
`·4· ·study matches not only the mean, but I
`
`·5· ·believe also the standard deviations to
`
`·6· ·what is in the '698 Patent.
`
`·7· · · · Q· · ·So what did you mean by your
`
`·8· ·sentence then that says:· I have been asked
`
`·9· ·to assume that the invention claimed by the
`
`10· ·'698 Patent was conceived and actually
`
`11· ·reduced to practice by June 25, 2007?
`
`12· · · · · · · MS. SCORDINO:· Objection to
`
`13· · · · form.
`
`14· · · · A· · ·Well, to begin with, paragraph
`
`15· ·35, I walk through my understanding of
`
`16· ·what -- I'm not a legal expert -- what
`
`17· ·conception and reduction to practice is.
`
`18· · · · · · · And if you look at paragraph 35,
`
`19· ·it does state, if you look at actual
`
`20· ·reduction to practice -- which occurs upon
`
`21· ·proof that the claimed invention works for
`
`22· ·its intended purpose -- in that context,
`
`23· ·this is the comparison to the clinical
`
`24· ·study report dated June 25, 2007.
`
`25· · · · · · · I'm in agreement with my
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 20
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`21
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·conclusion that the pharmacokinetic results
`
`·3· ·of that study report are consistent or
`
`·4· ·match exactly, match those in the '698
`
`·5· ·Patent.
`
`·6· · · · · · · And based upon that, I've been
`
`·7· ·asked to assume that the invention claimed
`
`·8· ·by the '698 Patent was conceived and
`
`·9· ·reduced to practice based on that June 25th
`
`10· ·date.
`
`11· · · · Q· · ·Okay.
`
`12· · · · · · · If you could please turn to
`
`13· ·paragraph 43, which is on page 17.
`
`14· · · · · · · Paragraphs 43, 44, 45 and 46 all
`
`15· ·begin with "I understand from counsel,"
`
`16· ·correct?
`
`17· · · · A· · ·Yes.
`
`18· · · · Q· · ·Okay.
`
`19· · · · · · · So is it correct that you're not
`
`20· ·expressing opinions in those paragraphs,
`
`21· ·but are repeating the legal propositions
`
`22· ·you were told by counsel?
`
`23· · · · · · · MS. SCORDINO:· Objection to
`
`24· · · · form.
`
`25· · · · A· · ·What's the question again,
`
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 21
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`22
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·please?
`
`·3· · · · Q· · ·So each of those paragraphs 43
`
`·4· ·through 46 begins "I understand from
`
`·5· ·counsel," correct?
`
`·6· · · · A· · ·Correct.
`
`·7· · · · Q· · ·Okay.
`
`·8· · · · · · · So is it your intention with
`
`·9· ·those paragraphs to just set forth the
`
`10· ·legal basis of your opinions that you were
`
`11· ·informed of by counsel?
`
`12· · · · · · · MS. SCORDINO:· Objection to
`
`13· · · · form.
`
`14· · · · A· · ·Well again, I'm not a legal
`
`15· ·expert.· And so in looking at this section
`
`16· ·about whether a certain reference qualifies
`
`17· ·as prior art, my understanding is there's
`
`18· ·different -- and that's what paragraphs 43,
`
`19· ·44, 45 get at -- there are different
`
`20· ·regulations that would qualify something
`
`21· ·for prior art.· And I'm not a legal expert,
`
`22· ·so I've been guided that way.
`
`23· · · · · · · As far as issue dates for
`
`24· ·patents, for example in paragraph 43, I
`
`25· ·believe I can render that, make a decision
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 22
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`23
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·that if the '285 Patent was issued on
`
`·3· ·October 25, 2013, that is after the
`
`·4· ·effective filing date of the '698 Patent.
`
`·5· ·So I can match up dates to see whether it
`
`·6· ·meets or doesn't meet that limitation.
`
`·7· · · · · · · And so, again, I'm certainly
`
`·8· ·relying on counsel with anything with legal
`
`·9· ·guidance.· But as far as matching up dates
`
`10· ·and things, I feel I can make that
`
`11· ·determination.
`
`12· · · · Q· · ·Okay.
`
`13· · · · · · · In paragraph 47, you state:· The
`
`14· ·claimed subject matter at issue in the '698
`
`15· ·Patent is comparable to the underlying
`
`16· ·subject matter of the '285 Patent, correct?
`
`17· · · · A· · ·Yes.
`
`18· · · · Q· · ·And what did you mean by that
`
`19· ·statement?
`
`20· · · · · · · MS. SCORDINO:· Objection to
`
`21· · · · form.
`
`22· · · · A· · ·Well, when I look at the subject
`
`23· ·matter of the '698 Patent, it's related to
`
`24· ·a combination product that would have an
`
`25· ·acid inhibitor combined with an NSAID.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 23
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`24
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· · · · · · · And so in my opinion, that
`
`·3· ·subject matter of a formulation which
`
`·4· ·provides essentially coordinated release of
`
`·5· ·one component followed by another is
`
`·6· ·consistent between the two, the two
`
`·7· ·patents.
`
`·8· · · · Q· · ·What do you mean by consistent
`
`·9· ·between the two?
`
`10· · · · · · · MS. SCORDINO:· Objection to
`
`11· · · · form.
`
`12· · · · A· · ·Well, the '285 Patent, the
`
`13· ·subject matter deals with a single unit
`
`14· ·dosage form that has the combined and
`
`15· ·unprotected PPI -- or unprotected acid
`
`16· ·inhibitor and NSAID.
`
`17· · · · · · · And when you look at the '698
`
`18· ·Patent, the '698 Patent discloses results
`
`19· ·or pharmacokinetic and pharmacodynamic
`
`20· ·results stemming from that type of
`
`21· ·formulation
`
`22· · · · Q· · ·Okay.
`
`23· · · · · · · In paragraph 48 --
`
`24· · · · A· · ·I'm sorry, I missed it.
`
`25· · · · Q· · ·Paragraph 48, the next one down,
`
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 24
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`25
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·you provide an opinion that the '285 Patent
`
`·3· ·isn't prior art because there is a common
`
`·4· ·inventor, John R. Plachetka, for both the
`
`·5· ·'285 Patent and the '698 Patent, correct?
`
`·6· · · · A· · ·Yes.
`
`·7· · · · Q· · ·And you don't list any other
`
`·8· ·basis for that opinion, correct?
`
`·9· · · · · · · MS. SCORDINO:· Objection to
`
`10· · · · form.
`
`11· · · · A· · ·In paragraph 48, that's my
`
`12· ·statement.
`
`13· · · · Q· · ·Okay.· I'm going to hand you --
`
`14· · · · · · · MR. BEEL:· Actually, as a matter
`
`15· · · · of formality, this Institution
`
`16· · · · Decision doesn't have an exhibit
`
`17· · · · number of its own.· Should I give it
`
`18· · · · an exhibit number, like Taft Exhibit
`
`19· · · · 1?
`
`20· · · · · · · MS. SCORDINO:· So there is a
`
`21· · · · particular numbering system that you
`
`22· · · · use for the IPRs.· Is this the first
`
`23· · · · depo?· It's not.
`
`24· · · · · · · MR. POLLACK:· No.
`
`25· · · · · · · MR. BEEL:· No, Mayersohn and
`
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 25
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`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`26
`
`·1· · · · · · · · · · · D. Taft
`
`·2· · · · ·Metz were both before.
`
`·3· · · · · · · ·Let's call it Taft Exhibit 1 for
`
`·4· · · · ·now.
`
`·5· · · · · · · ·(Whereupon, Exhibit 1 was marked
`
`·6· · · · ·for Identification, as of this date.)
`
`·7· ·BY MR. BEEL:
`
`·8· · · · ·Q· · ·Dr. Taft, I've handed you what
`
`·9· · we've called Taft Exhibit 1, which is the
`
`10· · Decision on Inter Partes Review for the
`
`11· · case IPR 2017-01995.
`
`12· · · · · · · ·Have you seen this document
`
`13· · before?
`
`14· · · · ·A· · ·I don't recall if I have.
`
`15· · · · ·Q· · ·Okay.
`
`16· · · · · · · ·If you turn to the bottom of
`
`17· · page 10 of the Institution Decision, which
`
`18· · is Taft Exhibit 1, there is a section
`
`19· · called claim construction.
`
`20· · · · · · · ·Do you see that?
`
`21· · · · ·A· · ·Yes.
`
`22· · · · ·Q· · ·Okay.
`
`23· · · · · · · ·And if you turn to page 11, the
`
`24· · first full paragraph begins:· Petitioner
`
`25· · proposes that we construe a single claim
`
`800.211.DEPO (3376)
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`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 26
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`27
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·limitation:· Target.
`
`·3· · · · · · · Do you see that?
`
`·4· · · · A· · ·Yes.
`
`·5· · · · Q· · ·And in the next line, it says:
`
`·6· ·Petitioner proposes that the broadest
`
`·7· ·reasonable construction of target is "with
`
`·8· ·the goal of obtaining," which follows from
`
`·9· ·the term's plain meaning.
`
`10· · · · · · · Do you see that?
`
`11· · · · A· · ·Yes.
`
`12· · · · Q· · ·And at the bottom of page 11,
`
`13· ·going on to page 12, there is a sentence
`
`14· ·that begins:· We accept petitioner's
`
`15· ·construction generally, but alter the
`
`16· ·meaning for grammatical reasons such that
`
`17· ·target means have or set the goal of
`
`18· ·obtaining.
`
`19· · · · · · · Do you see that?
`
`20· · · · A· · ·Yes.
`
`21· · · · Q· · ·Your declaration does not
`
`22· ·include this claim construction, correct?
`
`23· · · · · · · MS. SCORDINO:· Objection to
`
`24· · · · form.
`
`25· · · · A· · ·I don't believe my declaration
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 27
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs POZEN, INC
`MYLAN PHARMACEUTICALS vs POZEN, INC
`
`August 17, 2018
`August 17, 2018
`28
`
`·1· · · · · · · · · · ·D. Taft
`
`·2· ·relies on or cites this document, Taft
`
`·3· ·Exhibit 1.
`
`·4· · · · Q· · ·I'm going to hand you what's
`
`·5· ·Exhibit 1001, which is U.S. Patent No.
`
`·6· ·9,220,698.
`
`·7· · · · · · · If you could turn to column 52
`
`·8· ·in the '698 Patent, please.
`
`·9· · · · · · · Do you see claim 1 begins about
`
`10· ·line 25, correct?
`
`11· · · · A· · ·Yes.
`
`12· · · · Q· · ·And at about line 39, there is a
`
`13· ·phrase that recites the a.m. and p.m. unit
`
`14· ·dose forms target, correct?
`
`15· · · · A· · ·Yes.
`
`16· · · · Q· · ·Your declaration does not use
`
`17· ·the word target, is that correct?
`
`18· · · · · · · MS. SCORDINO:· Objection to
`
`19· · · · form.· Outside the scope.
`
`20· · · · A· · ·I don't believe I refer to
`
`21· ·target in my declaration, no.
`
`22· · · · Q· · ·Okay.
`
`23· · · · · · · Your declaration does not
`
`24· ·include the language of the claims,
`
`25· ·correct?
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1079 PAGE 28
`
`
`
`DR. DAVID R. TAFT
`DR. DAVID R. TAFT
`MYLAN PHARMACEUTICALS vs
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