·1· · · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3
`· · LIQUIDIA TECHNOLOGIES,· · · · )
`·4· · · · · · · · · · · · · · · · )
`· · · · · ·Petitioner,· · · · · · )· Case IPR2020-00770
`·5· · · · · · · · · · · · · · · · )· Patent 9,604,901 B2
`· · · · · ·vs.· · · · · · · · · · )
`·6· · · · · · · · · · · · · · · · )
`· · UNITED THERAPEUTICS· · · · · ·)
`·7· CORPORATION,· · · · · · · · · )
`· · · · · · · · · · · · · · · · · )
`·8· · · · ·Patent Owner.· · · · · )
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`·9
`· · · · · · · · · ·REMOTE VIDEOCONFERENCE
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`· · · · · · · DEPOSITION OF JEFFREY WINKLER Ph.D.
`11
`· · · · · · ·Monday, December 14, 2020, 9:10 a.m.
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`14· · · · · · · · ·Wynnewood, Pennsylvania
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`16
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`17
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`18· Reported By:
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`19· Marjorie Peters, FAPR, RMR, CRR, RSA
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`20· Job No: 10075372
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`·2· · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3
`· · LIQUIDIA TECHNOLOGIES,· · · · )
`·4· · · · · · · · · · · · · · · · )
`· · · · · ·Petitioner,· · · · · · )· Case IPR2020-00770
`·5· · · · · · · · · · · · · · · · )· Patent 9,604,901 B2
`· · · · · ·vs.· · · · · · · · · · )
`·6· · · · · · · · · · · · · · · · )
`· · UNITED THERAPEUTICS· · · · · ·)
`·7· CORPORATION,· · · · · · · · · )
`· · · · · · · · · · · · · · · · · )
`·8· · · · ·Patent Owner.· · · · · )
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`·9
`· · · · · · · · · ·REMOTE VIDEOCONFERENCE
`10
`· · · · · · · DEPOSITION OF JEFFREY WINKLER Ph.D.
`11
`· · · · · · ·Monday, December 14, 2020, 9:10 a.m.
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`14· · · · · · · · ·Wynnewood, Pennsylvania
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`16
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`18· Reported By:
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`19· Marjorie Peters, FAPR, RMR, CRR, RSA
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`20· Job No: 10075372
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`·1· · · · · · · · ·REMOTE VIDEOCONFERENCE
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`·2· · · · · · DEPOSITION OF JEFFREY WINKLER PhD,
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`·3· a witness herein, called by United Therapeutics
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`·4· Corporation for examination, taken pursuant to the
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`·5· Notice, by and before Marjorie Peters, a Registered
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`·6· Merit Reporter, Certified Realtime Reporter and
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`·7· Notary Public in and for the Commonwealth of
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`·8· Pennsylvania, Wynnewood, Pennsylvania, on Monday,
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`·9· December 14, 2020, at 9:10 a.m.
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`·1· · · · · · · · · A P P E A R A N C E S
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`·2· For United Therapeutics Corporation:
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`·3· · ·Richard Torczon, Esquire
`· · · ·Grace A. Winschel, PhD
`·4· · ·WILSON SONSINI
`· · · ·1700 K Street NW, Fifth Floor
`·5· · ·Washington, DC, 20006
`· · · ·rtorczon@wsgr.com
`·6· · ·gwinschel@wsgr.com
`· · · ·202-973-8811
`·7
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`·8· For the Patent Owner:
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`·9· · Daniel R. Shelton, Esquire
`· · · FOLEY & LARDNER LLP
`10· · 975 Page Mill Road
`· · · Palo Alto, California 94304-1013
`11· · dshelton@foley.com
`· · · 650.251.1119
`12
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`13· For Liquidia Technologies:
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`14· · ·Deepa Kannappan, Esquire
`· · · ·COOLEY LLP
`15· · ·3175 Hanover Street
`· · · ·Palo Alto, CA 94304-1130
`16· · ·dkannappan@cooley.com
`· · · ·+1 650 843 5673
`17
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`18· · Erik Milch, Esquire
`· · · COOLEY LLP
`19· · One Freedom Square
`· · · Reston Town Center, 11951 Freedom Drive
`20· · Reston, VA 20190-5640
`· · · emilch@cooley.com
`21· · +1 703 456 8573
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`22· · Sanya Sukduang, Esquire
`· · · COOLEY LLP
`23· · 1299 Pennsylvania Avenue, NW, Suite 700
`· · · Washington, DC 20004-2400
`24· · ssukduang@cooley.com
`· · · +1 202 776 2982
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`·1· · · · · · · · · A P P E A R A N C E S
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`·2· ALSO PRESENT:
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`·3· Chris Landrum
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`·1· · · · · · · · · · · · I N D E X
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`·2· EXAMINATION· · · · · · · · · · · · · · · · · · PAGE
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`·3· JEFFREY WINKLER PhD
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`·4· · By Mr. Torczon· · · · · · · · · · · · · · · · ·6
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`·5· · Certificate of Court Reporter· · · · · · · · 147
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`·6· · Errata Sheet· · · · · · · · · · · · · · · · ·149
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`·7
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`·8
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`·9· · · · · · I N D E X· ·O F· ·E X H I B I T S
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`10· EXHIBIT· · · · · · · · · · · · · · · · · · · · PAGE
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`11· ·Exhibit 1003· · Winkler CV· · · · · · · · · · 14
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`12· ·Exhibit 1002· · Winkler Declaration· · · · · ·16
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`13· ·Exhibit 1009· · JOC Article, Moriarty· · · · ·43
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`14· ·Exhibit 1015· · Hall-Ellis Declaration· · · · 51
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`15· ·Exhibit 1001· · US Patent 9,604,901· · · · · ·65
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`16· ·Exhibit 1006· · file history· · · · · · · · · 76
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`17· ·Exhibit 1004· · US Patent 8,497,393· · · · · ·84
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`18· ·Exhibit 2007· · PTAB file history for US· · · 99
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`19· · · · · · · · · ·Patent 9,604,901 patent
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`20· ·Exhibit 1008· · Phares WO 2005/007081 A9· · · 115
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`21· ·Exhibit 1014· · US Patent 4,306,075· · · · · ·117
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`·1· · · · · · · · · P R O C E E D I N G S
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`·2· · · · · · · · · JEFFREY WINKLER, PhD,
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`·3· a witness, having been first duly sworn, was
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`·4· examined and testified as follows:
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`·5· · · · · · · · · · · EXAMINATION
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`·6· BY MR. TORCZON:
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`·7· · · ·Q.· · ·Good morning, Dr. Winkler.
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`·8· · · ·A.· · ·Good morning.
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`·9· · · ·Q.· · ·Could you state your full name for the
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`10· record, please.
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`11· · · ·A.· · ·Jeffrey David Winkler, W-I-N-K-L-E-R.
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`12· · · ·Q.· · ·Okay.· Very good.
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`13· · · · · · · · · How many times have you testified
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`14· before?
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`15· · · ·A.· · ·I don't know exactly.
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`16· · · ·Q.· · ·Could you give me a ballpark number?
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`17· · · ·A.· · ·What do you mean by testified?
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`18· · · ·Q.· · ·Have you testified in a District Court
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`19· before?
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`20· · · ·A.· · ·Yes, I think I have.
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`21· · · ·Q.· · ·Okay.· About how many times have you
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`22· testified in a District Court?
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`23· · · ·A.· · ·Maybe three or four times.
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`24· · · ·Q.· · ·Have you testified in a deposition like
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`25· this before?
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`·1· · · ·A.· · ·I'm afraid I don't know what you mean.
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`·2· · · ·Q.· · ·Have you testified in a deposition
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`·3· before?
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`·4· · · ·A.· · ·Yes.
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`·5· · · ·Q.· · ·About how many times?
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`·6· · · ·A.· · ·Roughly 10 or 12 times, maybe.· I'm not
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`·7· sure exactly.
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`·8· · · ·Q.· · ·Have you provided testimony in an inter
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`·9· partes review before?
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`10· · · ·A.· · ·I think I have, yes.
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`11· · · ·Q.· · ·In fact, you have provided testimony
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`12· against United Therapeutics before; have you not?
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`13· · · ·A.· · ·I think I have, yes.
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`14· · · ·Q.· · ·Okay.· So you probably know the drill by
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`15· now.· Well, let me back up.
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`16· · · · · · · · · Have you testified by video before?
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`17· · · ·A.· · ·I don't think I have, no.
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`18· · · ·Q.· · ·Okay.· So this is your first time
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`19· testifying in this sort of videoconference platform;
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`20· is that correct?
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`21· · · ·A.· · ·Yes.
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`22· · · ·Q.· · ·Okay.· We're going to try to do things
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`23· pretty much the same way that they're usually done
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`24· in inter partes reviews.
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`25· · · · · · · · · So I'm going to ask you, will you
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`·1· give an audible, verbal answer to all of my
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`·2· questions?
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`·3· · · ·A.· · ·Yes.
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`·4· · · ·Q.· · ·Okay.· Will you wait until I have
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`·5· completed my question, so that we can produce a
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`·6· clean transcript for the reporter?
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`·7· · · ·A.· · ·Yes.
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`·8· · · ·Q.· · ·Okay.· We'll try to take breaks
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`·9· approximately once an hour.· If you need a break
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`10· sooner than that, though, will you let us know?
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`11· · · ·A.· · ·Yes.
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`12· · · ·Q.· · ·Okay.· If you ask for a break while a
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`13· question is pending, you will have to answer the
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`14· question before we take the break.
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`15· · · · · · · · · Do you understand that?
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`16· · · ·A.· · ·Yes.
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`17· · · ·Q.· · ·Okay.· If a question is unclear to you,
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`18· you need to ask me for clarification; do you
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`19· understand that?
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`20· · · · · · · · · MS. KANNAPPAN:· Objection.
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`21· · · ·A.· · ·Yes.
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`22· · · ·Q.· · ·Okay.· If you do not ask for a
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`23· clarification, will it be fair to assume that you
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`24· understand the question?
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`25· · · · · · · · · MS. KANNAPPAN:· Objection.
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`·1· · · ·A.· · ·Yes.
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`·2· · · ·Q.· · ·Okay.· Do you understand that unless
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`·3· Liquidia's counsel instructs you not to answer a
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`·4· question, you must answer the question?
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`·5· · · ·A.· · ·Yes.
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`·6· · · ·Q.· · ·Okay.· Is there any reason why you
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`·7· cannot provide truthful, accurate testimony today?
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`·8· · · ·A.· · ·No.
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`·9· · · ·Q.· · ·Okay.· Are you taking any prescription
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`10· medicine?
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`11· · · ·A.· · ·Yes.
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`12· · · ·Q.· · ·Okay.· What medications are you taking?
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`13· · · ·A.· · ·I'm taking Losartan, Amlodipine, and a
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`14· statin.
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`15· · · ·Q.· · ·Okay.· Is anybody with you in the room
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`16· where you are today?
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`17· · · ·A.· · ·No.
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`18· · · ·Q.· · ·Okay.· I understand physically, you're
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`19· in Wynnewood, Pennsylvania; is that correct?
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`20· · · ·A.· · ·That's correct.
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`21· · · ·Q.· · ·Do you have any open communication
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`22· channels, like chat or e-mail at the moment?
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`23· · · · · · · · · MS. KANNAPPAN:· Objection.
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`24· · · ·A.· · ·No, I do not.
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`25· · · ·Q.· · ·Okay.· Do you have any materials with
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`·1· you today?
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`·2· · · · · · · · · MS. KANNAPPAN:· Objection.
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`·3· · · ·A.· · ·Yes.
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`·4· · · ·Q.· · ·What materials do you have with you
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`·5· today?
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`·6· · · ·A.· · ·I have two binders that were supplied by
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`·7· counsel.
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`·8· · · ·Q.· · ·Okay.· What is the content of those
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`·9· binders?
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`10· · · ·A.· · ·One binder says Case Materials, and the
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`11· other binder says Winkler Declaration and Exhibits
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`12· Cited.
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`13· · · ·Q.· · ·Okay.· So do any of those materials have
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`14· markings on them?
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`15· · · ·A.· · ·Not that I'm aware of.
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`16· · · ·Q.· · ·If you come across any markings in the
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`17· material, will you let us know?
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`18· · · ·A.· · ·Yes.
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`19· · · ·Q.· · ·Okay.· What materials are in the binder
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`20· marked Case Materials?
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`21· · · ·A.· · ·Case Materials has four tabs.· The first
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`22· reads Petition.· The second reads Patent Owner's
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`23· Prelim Response.
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`24· · · · · · · · · The third reads Institution
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`25· Decision.· And the fourth reads, Patent Owner's
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`·1· Request For Rehearing.
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`·2· · · ·Q.· · ·Okay.· Did you review any of those
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`·3· materials in preparing for today's testimony?
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`·4· · · ·A.· · ·I'm afraid I don't understand your
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`·5· question.
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`·6· · · ·Q.· · ·Okay.· Dr. Winkler, you just read me the
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`·7· name of four documents; is that correct?
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`·8· · · ·A.· · ·Yes, I did.
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`·9· · · ·Q.· · ·In preparing for your testimony today,
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`10· did you read or review those four documents?
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`11· · · · · · · · · MS. KANNAPPAN:· Objection.· Vague.
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`12· · · · · · · · · I think the problem is whether he
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`13· reviewed those printed documents, or the documents
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`14· generally.
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`15· · · ·A.· · ·So I'm afraid I -- I don't understand
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`16· whether you're referring to the printed documents or
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`17· the electronic versions of these documents.
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`18· · · · · · · · · MR. TORCZON:· Okay.· I'm going to
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`19· ask counsel not to coach the witness.· This is in
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`20· violation of the practice guide.
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`21· · · ·Q.· · ·Going forward, if you need a
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`22· clarification, Dr. Winkler, and to the practice
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`23· guide, you need to ask me for the clarification.
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`24· · · · · · · · · MS. KANNAPPAN:· And counsel -- go
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`25· ahead and finish, counsel.· I'm sorry.· I didn't
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`·1· mean to interrupt.
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`·2· · · ·Q.· · ·Do you understand?
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`·3· · · · · · · · · MS. KANNAPPAN:· Objection.· And
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`·4· counsel, please don't instruct the witness this way,
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`·5· but I was actually trying to help you, not the
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`·6· witness there.· Just to get the question moving
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`·7· along, but I will --
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`·8· · · · · · · · · MR. TORCZON:· I appreciate the good
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`·9· faith, but you understand how that will sound like
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`10· coaching.
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`11· · · · · · · · · MS. KANNAPPAN:· In this case, I
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`12· disagree with you, but you can continue with your
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`13· question.· Go ahead.
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`14· · · · · · · · · MR. TORCZON:· Okay.
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`15· · · · · · · · · Marjorie, could you read back the
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`16· last question I asked.
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`17· (The record was read back by the Court Reporter.)
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`18· · · · · · · · · MS. KANNAPPAN:· Same objection.
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`19· · · ·A.· · ·So I'm afraid I still don't understand
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`20· whether you mean whether I looked at the hard
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`21· copies, or whether I looked at electronic documents,
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`22· or either, to respond to your question accurately.
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`23· · · ·Q.· · ·To your knowledge, are the paper copies
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`24· different than the electronic copies?
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`25· · · ·A.· · ·I -- I'm afraid I don't understand what
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`·1· you mean.
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`·2· · · ·Q.· · ·Do you understand what different means?
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`·3· · · ·A.· · ·In what sense?
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`·4· · · · · · · · · MS. KANNAPPAN:· Objection.
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`·5· Argumentative.
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`·6· · · ·Q.· · ·Do you understand what paper copies
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`·7· means?
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`·8· · · · · · · · · MS. KANNAPPAN:· Objection.
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`·9· Argumentative.
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`10· · · ·A.· · ·Yes.
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`11· · · ·Q.· · ·Do you understand what electronic copies
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`12· means?
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`13· · · · · · · · · MS. KANNAPPAN:· Objection.
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`14· Argumentative.
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`15· · · ·A.· · ·I -- I think so.
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`16· · · ·Q.· · ·Okay.· Did you review the paper copies
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`17· that are in front of you?
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`18· · · ·A.· · ·No.
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`19· · · ·Q.· · ·Did you review electronic versions of
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`20· those paper copies?
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`21· · · ·A.· · ·I reviewed some of the electronic, but
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`22· not all of them.
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`23· · · ·Q.· · ·Okay.· Which documents did you review
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`24· electronically?
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`25· · · · · · · · · MS. KANNAPPAN:· Objection.· Here I'm
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`·1· just going to instruct the witness not to answer
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`·2· anything about the substance of conversations you
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`·3· had with attorneys, but otherwise, you can answer
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`·4· the question.
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`·5· · · · · · · · · MR. TORCZON:· I'm going to move to
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`·6· strike the objection as coaching, and as totally
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`·7· irrelevant to the question I asked.
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`·8· · · ·Q.· · ·So I'm asking you about the documents,
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`·9· which are public documents, that we have been
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`10· talking about.
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`11· · · · · · · · · Did you read each of those
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`12· documents?
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`13· · · ·A.· · ·I certainly have reviewed each of those
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`14· documents.
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`15· · · ·Q.· · ·Okay.· So earlier when you said you only
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`16· reviewed portions, what did you mean by that?
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`17· · · · · · · · · MS. KANNAPPAN:· Objection.
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`18· Mischaracterizes.
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`19· · · ·A.· · ·I have reviewed each of these four
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`20· documents in preparing for today's deposition. I
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`21· did not re-read each of them.
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`22· · · ·Q.· · ·Okay.· Let's turn to Liquidia Exhibit
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`23· 1003.· Do you have a copy of that with there you?
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`24· (Liquidia Exhibit 1003, Winkler CV, was marked for
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`25· identification.)
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`·1· · · ·A.· · ·Yes, I do.
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`·2· · · ·Q.· · ·Okay.· And you recognize this exhibit?
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`·3· · · ·A.· · ·The document, the paper copy that I have
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`·4· is blank on page 6.
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`·5· · · ·Q.· · ·Okay.· Yeah.· That's, I believe, how it
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`·6· was submitted.
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`·7· · · ·A.· · ·Okay.
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`·8· · · ·Q.· · ·Okay.· With the understanding that page
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`·9· 6, as submitted in the record, is blank, do you
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`10· recognize the document?
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`11· · · ·A.· · ·Yes.
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`12· · · ·Q.· · ·Okay.· Is this exhibit your curriculum
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`13· vitae?
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`14· · · ·A.· · ·Yes.
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`15· · · ·Q.· · ·Okay.· Counting both this inter partes
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`16· review and the second one that was filed with it,
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`17· how many times have you testified against United
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`18· Therapeutics?
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`19· · · · · · · · · MS. KANNAPPAN:· Objection.· Vague.
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`20· · · ·A.· · ·What I have in my CV are my cases going
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`21· back for the last five years.· I don't, sitting
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`22· here, don't remember whether I had any involvement
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`23· opposing United Therapeutics before 2015.
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`24· · · · · · · · · But since 2015, I see two
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`25· examples -- I'm sorry, three examples, including
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`IPR2020-00770
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`·1· this one, in which I am -- have appeared adverse to
`
`·2· United Therapeutics.
`
`·3· · · ·Q.· · ·Okay.· You also submitted testimony
`
`·4· against United Therapeutics in the '066 patent inter
`
`·5· partes review; correct?
`
`·6· · · ·A.· · ·Yes.
`
`·7· · · ·Q.· · ·Okay.· So all told, that would be four
`
`·8· in the last five years?
`
`·9· · · ·A.· · ·I'm sorry.· Did you say four?
`
`10· · · ·Q.· · ·Yes, four.
`
`11· · · ·A.· · ·I think that's correct.· Yes.
`
`12· · · ·Q.· · ·Okay.· Let's turn to Exhibit 1002.
`
`13· (Liquidia Exhibit 1002, Winkler Declaration, was
`
`14· marked for identification.)
`
`15· · · ·A.· · ·I don't think I have a tab for -- oh,
`
`16· 1002 is my declaration.
`
`17· · · ·Q.· · ·Okay.· So what is the title of that
`
`18· document?
`
`19· · · ·A.· · ·I'm just looking through to make sure
`
`20· that it's all here.
`
`21· · · · · · · · · Exhibit 1002 is titled "Declaration
`
`22· of Jeffrey D. Winkler, PhD, In Support of Petition
`
`23· For Inter Partes Review of US Patent Number
`
`24· 9,604,901."
`
`25· · · ·Q.· · ·Okay.· About how much time did you spend
`
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`·1· preparing this declaration?
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`·2· · · ·A.· · ·I don't remember.
`
`·3· · · ·Q.· · ·Could you give me a ballpark estimate?
`
`·4· · · ·A.· · ·I really don't know.
`
`·5· · · ·Q.· · ·Okay.· Did you submit invoices for your
`
`·6· work?
`
`·7· · · ·A.· · ·I did.
`
`·8· · · ·Q.· · ·So you billed by the hour for this?
`
`·9· · · ·A.· · ·Yes.
`
`10· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`11· · · ·A.· · ·I did.
`
`12· · · ·Q.· · ·Okay.· Did you spend more than ten hours
`
`13· on preparing the declaration?
`
`14· · · · · · · · · MS. KANNAPPAN:· Objection.· Vague.
`
`15· · · ·A.· · ·I think so, but I don't remember
`
`16· exactly.
`
`17· · · ·Q.· · ·Okay.· Did you spend more than 15 hours
`
`18· preparing the declaration?
`
`19· · · ·A.· · ·I don't remember.
`
`20· · · ·Q.· · ·Okay.· Does any time in that estimate
`
`21· include time working on the declaration against the
`
`22· '066 Patent?
`
`23· · · ·A.· · ·I'm sorry.· I don't understand your
`
`24· question.
`
`25· · · ·Q.· · ·Okay.· Actually, we'll strike that.
`
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`·1· · · · · · · · · Does any of the time you spent
`
`·2· working on this declaration include time running
`
`·3· chemical experiments?
`
`·4· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`·5· · · ·A.· · ·I don't remember running any chemical
`
`·6· experiments for -- to support this declaration.
`
`·7· · · ·Q.· · ·Okay.· Did you synthesize any product
`
`·8· using the process in the '901 Patent claims?
`
`·9· · · · · · · · · MS. KANNAPPAN:· Objection.· Vague.
`
`10· · · ·A.· · ·No.
`
`11· · · ·Q.· · ·Okay.· Did you write the declaration?
`
`12· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`13· · · ·A.· · ·Yes.
`
`14· · · ·Q.· · ·Do you see the header on this exhibit?
`
`15· · · ·A.· · ·I'm afraid I don't understand what you
`
`16· mean by "header."
`
`17· · · ·Q.· · ·Okay.· Are you familiar with the idea of
`
`18· a header on a document?
`
`19· · · ·A.· · ·Yes.
`
`20· · · ·Q.· · ·Okay.
`
`21· · · ·A.· · ·Oh, I -- I see.· Yes.
`
`22· · · ·Q.· · ·Okay.· What does the header on the
`
`23· declaration say?
`
`24· · · ·A.· · ·"Petition for Inter Partes Review of US
`
`25· Patent 9,604,901 B2."
`
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`·1· · · ·Q.· · ·Okay.· Did you write that header?
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`·2· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`·3· · · ·A.· · ·That header was supplied to me by
`
`·4· counsel.
`
`·5· · · ·Q.· · ·Okay.· That header appears throughout
`
`·6· the declaration; is that correct?
`
`·7· · · ·A.· · ·Yes.· It does.
`
`·8· · · ·Q.· · ·Okay.· Is that document the Petition in
`
`·9· the '901 -- for the '901 Patent?
`
`10· · · ·A.· · ·This document is my declaration in
`
`11· support of the petition.
`
`12· · · ·Q.· · ·Okay.· Could you turn to the last page
`
`13· of that document.
`
`14· · · ·A.· · ·I'm sorry.· Which document, the
`
`15· declaration?
`
`16· · · ·Q.· · ·The declaration, yes.· Please.
`
`17· · · ·A.· · ·Yes.
`
`18· · · ·Q.· · ·Okay.· Is that your signature?
`
`19· · · ·A.· · ·It is my electronic signature, yes.
`
`20· · · ·Q.· · ·Okay.· Did you type it in?
`
`21· · · ·A.· · ·Yes.
`
`22· · · ·Q.· · ·Okay.· Did Liquidia's counsel ask you to
`
`23· use that signature format?
`
`24· · · · · · · · · MS. KANNAPPAN:· Objection, to the
`
`25· extent it calls for any privilege.
`
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`·1· · · ·A.· · ·I don't think so.· I don't remember
`
`·2· that, no.
`
`·3· · · ·Q.· · ·Okay.· How much time did you spend
`
`·4· preparing for this cross-examination?
`
`·5· · · ·A.· · ·I met with counsel electronically on
`
`·6· Thursday and Friday, and then I spent part of the
`
`·7· weekend reviewing my declaration and some of the
`
`·8· other documents.
`
`·9· · · ·Q.· · ·Okay.· We already talked about the case
`
`10· materials that you said you reviewed.· In addition
`
`11· to those materials, what else -- what other
`
`12· materials did you review for this deposition?
`
`13· · · ·A.· · ·I reviewed my declaration.· I reviewed
`
`14· the '901 Patent.· I reviewed both Moriarty and
`
`15· Phares.· And I also reviewed the Pinal declaration.
`
`16· · · ·Q.· · ·Did you review any other materials?
`
`17· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`18· · · ·A.· · ·Not that I can remember.
`
`19· · · ·Q.· · ·Okay.· Did you review any materials that
`
`20· are not exhibits in this case, to the best of your
`
`21· knowledge?
`
`22· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`23· · · ·A.· · ·I -- not that I am aware of.
`
`24· · · ·Q.· · ·Okay.· In Paragraph 3, do you see where
`
`25· it says you're being compensated at a rate of $850
`
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`·1· an hour?
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`·2· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`·3· Foundation.
`
`·4· · · ·A.· · ·Yes.
`
`·5· · · ·Q.· · ·Okay.· Is that the rate that you're
`
`·6· being compensated for this deposition?
`
`·7· · · ·A.· · ·No.
`
`·8· · · ·Q.· · ·Okay.· What rate are you being
`
`·9· compensated at for this deposition?
`
`10· · · ·A.· · ·I -- I would have to check.· I would
`
`11· have to check back on the engagement agreement, but
`
`12· I think that the rate at which I bill my time for
`
`13· deposition is different from the hourly rate.
`
`14· · · ·Q.· · ·Is the deposition rate higher than the
`
`15· hourly rate?
`
`16· · · ·A.· · ·I think that the deposition rate is a
`
`17· daily rate, but I would have to check that.
`
`18· · · ·Q.· · ·Okay.· Do you know approximately what
`
`19· that daily rate is?
`
`20· · · ·A.· · ·I would have to check.
`
`21· · · ·Q.· · ·Okay.· Do you have the ability to check
`
`22· that today?
`
`23· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`24· · · ·A.· · ·Yes.· I think I could.
`
`25· · · ·Q.· · ·Okay.· We may ask you to check that
`
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`·1· during the break.
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`·2· · · · · · · · · Okay.· Are you receiving any other
`
`·3· form of compensation for the deposition?
`
`·4· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`·5· · · ·A.· · ·No.
`
`·6· · · ·Q.· · ·So did you also provide testimony
`
`·7· against the United Therapeutics Patent 9,593,066?
`
`·8· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`·9· · · ·A.· · ·I'm afraid I don't understand what you
`
`10· mean.
`
`11· · · ·Q.· · ·Okay.· Did you work with -- did you --
`
`12· strike that.
`
`13· · · · · · · · · Did you provide a declaration on
`
`14· behalf of Liquidia regarding US Patent 9,593,066?
`
`15· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`16· Outside the scope.
`
`17· · · ·A.· · ·I think I did, yes.
`
`18· · · ·Q.· · ·Are you aware that the Board did not
`
`19· institute inter partes review on that patent?
`
`20· · · · · · · · · MS. KANNAPPAN:· Same objections.
`
`21· · · ·A.· · ·I don't remember.
`
`22· · · ·Q.· · ·Your PhD is in organic chemistry, isn't
`
`23· it?
`
`24· · · ·A.· · ·I think that my PhD is in chemistry.
`
`25· · · ·Q.· · ·Okay.· Is it in any particular kind of
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`·1· chemistry?
`
`·2· · · ·A.· · ·My PhD training, my dissertation
`
`·3· research was in the area of organic chemistry, yes.
`
`·4· · · ·Q.· · ·Okay.· You have worked in academia since
`
`·5· 1983; is that correct?
`
`·6· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`·7· · · ·A.· · ·Well, I've worked in academia since
`
`·8· before 1983, but I have been an independent
`
`·9· investigator since 1983.
`
`10· · · ·Q.· · ·You have no degree in chemical
`
`11· engineering, do you?
`
`12· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`13· · · ·A.· · ·No.
`
`14· · · ·Q.· · ·You have not worked as a chemical
`
`15· engineer, have you?
`
`16· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`17· · · ·A.· · ·No.
`
`18· · · ·Q.· · ·You have not published any scholarly
`
`19· work on chemical engineering, have you?
`
`20· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`21· · · ·A.· · ·I guess it would depend on what you mean
`
`22· here, what the meaning of chemical engineering is.
`
`23· · · ·Q.· · ·Okay.· Have you collaborated with
`
`24· chemical engineers on your publications?
`
`25· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
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`·1· · · ·A.· · ·I would have to review the publications
`
`·2· carefully to be able to answer that question.
`
`·3· · · ·Q.· · ·Okay.· Do you have a degree in
`
`·4· industrial chemistry?
`
`·5· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`·6· · · ·A.· · ·I think it -- I think, as I've already
`
`·7· said, my degree is -- I'm almost sure is simply
`
`·8· stated as PhD in chemistry.
`
`·9· · · ·Q.· · ·Okay.· Have you ever worked as an
`
`10· industrial chemist?
`
`11· · · ·A.· · ·I'm afraid I don't know exactly what you
`
`12· mean by that.
`
`13· · · ·Q.· · ·Have you ever worked as a process
`
`14· chemist?
`
`15· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`16· · · ·A.· · ·Well, I've -- to the extent that I've
`
`17· been involved in consulting at pharmaceutical
`
`18· companies in their process chemistry groups, I would
`
`19· say that, in that sense, I certainly have worked in
`
`20· process chemistry.
`
`21· · · · · · · · · And to the extent that I've spent
`
`22· time -- extended periods of time in industry, for
`
`23· example, I spent a sabbatical year at Bristol Myers
`
`24· Squibb, B-R-I-S-T-O-L, M-Y-E-R-S, S-Q-U-I-B-B, in
`
`25· Lawrenceville, New Jersey.· There, I interacted
`
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`·1· both -- and advised both medicinal chemistry groups
`
`·2· and process chemistry groups.
`
`·3· · · · · · · · · And then recently, my laboratory
`
`·4· developed new compounds that have anti-cancer
`
`·5· properties, and a company has spun off based on the
`
`·6· technology that we developed.· As one of the
`
`·7· co-founders of this company, I have been involved in
`
`·8· overseeing the scale-up of the drugs that we have
`
`·9· been making as part of this project.
`
`10· · · · · · · · · So those are three areas in which I
`
`11· would say I have had significant experience in
`
`12· process chemistry.
`
`13· · · ·Q.· · ·So in each of those experiences, you've
`
`14· worked with process chemists?
`
`15· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`16· · · ·A.· · ·I would say that in each of those
`
`17· experiences, I have worked with or counseled process
`
`18· chemists, yes.
`
`19· · · ·Q.· · ·Have you ever published any scholarly
`
`20· work on process chemistry?
`
`21· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`22· · · ·A.· · ·I guess that depends on what you mean
`
`23· exactly by process chemistry.
`
`24· · · ·Q.· · ·Okay.· Have you published any scholarly
`
`25· works on designing industrial processes for chemical
`
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`·1· products?
`
`·2· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`·3· · · ·A.· · ·Again, I'm not sure that I understand
`
`·4· your question exactly.
`
`·5· · · ·Q.· · ·Have you published scholarly works on
`
`·6· designing industrial processes for chemical
`
`·7· products?
`
`·8· · · · · · · · · MS. KANNAPPAN:· Objection.· Asked
`
`·9· and answered, and also form.
`
`10· · · ·A.· · ·Well, we certainly have done many, many
`
`11· reactions, and published on them in my laboratory,
`
`12· let's say produced multi gram quantities of
`
`13· chemicals and their intermediates.
`
`14· · · · · · · · · And so, to that extent, I would say
`
`15· that we have published certainly on chemical
`
`16· processes.
`
`17· · · ·Q.· · ·Have any of those processes that you
`
`18· have published on, been at commercial scales?
`
`19· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`20· · · ·A.· · ·I'm afraid I don't understand, in this
`
`21· context, what you mean by commercial scales.
`
`22· · · ·Q.· · ·In response to an earlier question, you
`
`23· indicated that you are part of a start-up company;
`
`24· is that correct?
`
`25· · · ·A.· · ·That's correct.
`
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`·1· · · ·Q.· · ·Okay.· Is that start-up company going to
`
`·2· produce a commercial product?
`
`·3· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`·4· · · ·A.· · ·I'm sorry.· I didn't hear your question.
`
`·5· · · ·Q.· · ·Is the start-up company going to produce
`
`·6· a product at commercial scale?
`
`·7· · · · · · · · · MS. KANNAPPAN:· Same objection.
`
`·8· · · ·A.· · ·I think that's the expectation, that
`
`·9· ultimately that's exactly what we would do.
`
`10· · · ·Q.· · ·Okay.· So have any of the papers that
`
`11· you have published addressed production of a
`
`12· chemical product at commercial scale?
`
`13· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`14· · · ·A.· · ·Well, the chemistry that we published
`
`15· has certainly produced sufficient quantities of
`
`16· these compounds that have produced larger amounts of
`
`17· the compounds than the samples that are typically
`
`18· sold commercially of these compounds.
`
`19· · · · · · · · · In other words, these compounds are,
`
`20· in fact, being sold commercially.· So in that sense,
`
`21· we've developed processes for commercial use.
`
`22· · · ·Q.· · ·Have any of the products that you've
`
`23· published on -- strike that.
`
`24· · · · · · · · · In each case of the publications
`
`25· that we're discussing, have any of those products
`
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`·1· actually been sold commercially?
`
`·2· · · ·A.· · ·Yes.
`
`·3· · · ·Q.· · ·Let me get a clarification.
`
`·4· · · · · · · · · So the products that you've produced
`
`·5· in the course of doing the research to prepare the
`
`·6· paper, were themselves sold to the public?
`
`·7· · · · · · · · · MS. KANNAPPAN:· Objection.
`
`·8· Mischaracterizes.
`
`·9· · · ·A.· · ·I'm sorry.· I'm afraid I don't
`
`10· understand your question.
`
`11· · · ·Q.· · ·Okay.· So my question before was not
`
`12· whether a product that you had published on had
`
`13· ultimately been sold.
`
`14· · · · · · · · · My question is, you have -- none of
`
`15· the products that you produced, in the course of
`
`16· writing those papers, was actually sold to the
`
`17· public; was it?
`
`18· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`19· · · ·A.· · ·I'm sorry.· I'm afraid I still don't
`
`20· understand your question.
`
`21· · · ·Q.· · ·Okay.· So you write papers on research
`
`22· that you do; is that correct?
`
`23· · · ·A.· · ·Yes.
`
`24· · · ·Q.· · ·When you produce that research, chemical
`
`25· products result; is that correct?
`
`IPR2020-00770
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`·1· · · ·A.· · ·I'm sorry?
`
`·2· · · ·Q.· · ·Chemical products result from the
`
`·3· research you're doing; correct?
`
`·4· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`·5· · · ·Q.· · ·Strike that.· Strike that.· Strike that.
`
`·6· · · · · · · · · What scale is your start-up company
`
`·7· currently producing product at?
`
`·8· · · ·A.· · ·I'm sorry?
`
`·9· · · ·Q.· · ·Earlier you testified that you are
`
`10· involved in a startup company; is that correct?
`
`11· · · ·A.· · ·That's correct.
`
`12· · · ·Q.· · ·At what scale is that company producing
`
`13· product currently?
`
`14· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`15· · · ·A.· · ·The company has -- is currently
`
`16· preparing compounds on gram scale, up to 4 or 5
`
`17· grams of material at a time.
`
`18· · · ·Q.· · ·Okay.· Have you ever personally
`
`19· performed the synthesis of a product which was
`
`20· commercially sold to the public?
`
`21· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`22· · · ·A.· · ·I can't remember.
`
`23· · · ·Q.· · ·Okay.· Have you ever been employed to
`
`24· implement a commercial scale organic synthesis?
`
`25· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
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`·1· · · ·A.· · ·Well, I guess that depends on what
`
`·2· exactly you mean by implementation.· As I've already
`
`·3· testified, I was employed at Bristol Myers Squibb
`
`·4· during a sabbatical year, in which I worked on
`
`·5· process scale organic chemistry.
`
`·6· · · · · · · · · And I certainly, over-the-course of
`
`·7· my career, have served as a paid consultant to a
`
`·8· number of different pharmaceutical companies,
`
`·9· essentially advising or consulting on process
`
`10· chemistry practices and troubleshooting problems,
`
`11· those kinds of things in their industrial processes.
`
`12· · · ·Q.· · ·Were you ever employed to design an
`
`13· industrial process yourself?
`
`14· · · · · · · · · MS. KANNAPPAN:· Objection.· Form.
`
`15· · · ·A.· · ·Well, again, in the context of the
`
`16· pharmaceutical work that I've done, almost all of
`
`17· that has been rather collaborative, so that I've
`
`18· been brought in as an adviser to, or as part of a
`
`19· team that was working on a particular problem,
`
`20· either in medicinal chemistry or in process
`
`21· chemistry.
`
`22· · · ·Q.· · ·Have you ever been employed to control
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`23· for polymorphs in pharmaceutical manufacturing
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