Deposition of
`Igor Gonda, Ph.D.
`October 26, 2021
`
`Liquidia Technologies, Inc.
`vs.
`United Therapeutics Corp.
`
`IPR2021-00406
`United Therapeutics EX2056
`
`
`Igor Gonda, Ph.D.
`October 26, 2021
`
`Liquidia Technologies, Inc.
`vs.
`United Therapeutics Corp.
`
`IPR2021-00406
`United Therapeutics EX2056
`
`
`
`
`
`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
`
`
`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
`
`·1· · · · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3
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`·4· ·LIQUIDIA TECHNOLOGIES, INC.,
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`·5· · · · · · · · Petitioner,
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`·6· · · · · · · · · · · · · · · · IPR 2021-00406
`· · · · · · · · · vs.· · · · · · ·U.S. Patent No. 10,716,793
`·7
`· · ·UNITED THERAPEUTICS CORPORATION,
`·8
`· · · · · · · · · Patent Owner.
`·9· ·__________________________________
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`10
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`11
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`12
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`13· · · DEPOSITION REMOTELY TAKEN VIA ZOOM CONFERENCE OF
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`14· · · · · · · · · · · IGOR GONDA, PH.D.
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`15· · · · · · · · · TUESDAY, OCTOBER 26, 2021
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`16
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`17
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`18
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`19
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`20
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`21
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`22
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`23· ·Reported by:
`· · ·Linda E. Marquette
`24· ·RPR, CLR, CSR No. 11874
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`25· ·Job No. 10090261
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3
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`·4· ·LIQUIDIA TECHNOLOGIES, INC.,
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`·5
`· · · · · · · · · Petitioner,
`·6
`· · · · · · · · · · · · · · · · · IPR 2021-00406
`·7· · · · · · · · vs.· · · · · · ·U.S. Patent No. 10,716,793
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`·8· ·UNITED THERAPEUTICS CORPORATION,
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`·9· · · · · · · · Patent Owner.
`· · ·__________________________________
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`16
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`17
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`18· · · · · DEPOSITION REMOTELY TAKEN VIA ZOOM CONFERENCE of
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`19· ·IGOR GONDA, PH.D., taken on behalf of Patent Owner, with
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`20· ·everyone appearing at their remote address, and the
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`21· ·witness appearing from Melbourne, Australia, commencing
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`22· ·at 6:03 a.m., (AEDT) and concluding at 11:11 a.m.,
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`23· ·(AEDT), on Tuesday, October 26, 2021, before Linda E.
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`24· ·Marquette, RPR, CLR, Certified Shorthand Reporter No.
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`25· ·11874.
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`·1· ·APPEARANCES:
`
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
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`·2· · · · · (All parties appearing remotely)
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`·3· · · For Petitioner:
`
`·4· · · · · BY:· DEEPA KANNAPPAN, ESQ.
`· · · · · · BY:· SANYA SUKDUANG, ESQ.
`·5· · · · · COOLEY LLP
`· · · · · · 3175 Hanover Street
`·6· · · · · Palo Alto, California· 94304-1130
`· · · · · · 650.843.5673
`·7· · · · · dkannappan@cooley.com
`· · · · · · ssukduang@cooley.com
`·8
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`·9· · · For Patent Owner:
`
`10· · · · · BY:· ART DYKHUIS, ESQ.
`· · · · · · BY:· DOUGLAS H. CARSTEN, ESQ.
`11· · · · · BY:· AMY MAHAN, ESQ.
`· · · · · · MCDERMOTT WILL & EMERY LLP
`12· · · · · 18565 Jamboree Road
`· · · · · · Suite 250
`13· · · · · Irvine, California· 92612-2565
`· · · · · · 949.620.6111
`14· · · · · 949.666.9834 fax
`· · · · · · dcarsten@mwe.com
`15
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`16
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`17· · · · · ALSO PRESENT:
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`18· · · · · Exhibit Technician Aaron Isaacs
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`19
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · · · · · · · · · · · I N D E X
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`·2· ·WITNESS:· · · · · · · · · · · · · · · · · · · · · PAGE
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`·3· · · · · IGOR GONDA, PH.D.
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`·4· ·EXAMINATION BY MR. DYKHUIS· · · · · · · · · · · · ·7
`· · ·EXAMINATION BY MS. KANNAPPAN· · · · · · · · · · ·126
`·5· ·FURTHER EXAMINATION BY MR. DYKHUIS· · · · · · · ·135
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`·6
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`·7· · · · · · · · · · · · · ·EXHIBITS
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`·8· ·NO.· · ·DESCRIPTION· · · · · · · · · · · · · · · PAGE
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`·9· ·Exhibit 1004· · · · · · · · · · · · · · · · · · · 17
`· · · · · · Declaration of Igor Gonda, Ph.D.
`10
`· · ·Exhibit 1005· · · · · · · · · · · · · · · · · · · 24
`11· · · · · Igor Gonda, Ph.D. Resume
`
`12· ·Exhibit 1001· · · · · · · · · · · · · · · · · · · 42
`· · · · · · US Patent No. 10,716,793 B2 date of
`13· · · · · patent July 21, 2020
`
`14· ·Exhibit 1048· · · · · · · · · · · · · · · · · · · 48
`· · · · · · Article "Aerosolised [sic] prostacyclin
`15· · · · · in adult respiratory distress syndrome
`
`16· ·Exhibit 1019· · · · · · · · · · · · · · · · · · · 53
`· · · · · · Article in Journal of Aerosol Medicine
`17· · · · · and Pulmonary Drug Delivery titled "The
`· · · · · · History of Therapeutic Aerosols: A
`18· · · · · Chronological Review:
`
`19· ·Exhibit 1034· · · · · · · · · · · · · · · · · · · 58
`· · · · · · Article titled "Bolus Inhalation of
`20· · · · · rhDNase with the AERx System in Subjects
`· · · · · · with Cystic Fibrosis"
`21
`· · ·Exhibit 1037· · · · · · · · · · · · · · · · · · · 74
`22· · · · · Article titled "OPTINEB-ir"
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`23· ·Exhibit 1002· · · · · · · · · · · · · · · · · · ·101
`· · · · · · Declaration of Nicholas Hill, M.D.
`24
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · · · · · · · · · · · ·EXHIBITS
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`·2· ·NO.· · ·DESCRIPTION· · · · · · · · · · · · · · · PAGE
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`·3· ·Exhibit 1066· · · · · · · · · · · · · · · · · · ·112
`· · · · · · Package insert for AccuNeb Inhalation
`·4· · · · · Solution
`
`·5· ·Exhibit 1050· · · · · · · · · · · · · · · · · · ·115
`· · · · · · Package insert for Pulmozyme dornase
`·6· · · · · alfa inhalation solution
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`·7· ·Exhibit 1029· · · · · · · · · · · · · · · · · · ·116
`· · · · · · Packaging insert for Ventavis
`·8
`· · ·Exhibit 1082· · · · · · · · · · · · · · · · · · ·118
`·9· · · · · Supplemental Declaration of Igor Gonda,
`· · · · · · Ph.D.
`10
`· · ·Exhibit 1083· · · · · · · · · · · · · · · · · · ·122
`11· · · · · Package insert for Ventavis
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`12
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`13
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`14
`· · · · · · · · ·WITNESS INSTRUCTED NOT TO ANSWER
`15· · · · · · · · · · · · · · (NONE)
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`16
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`17
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`18
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`19
`· · · · · · · · · · · REQUESTED INFORMATION
`20· · · · · · · · · · · · · · (NONE)
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · · DEPOSITION REMOTELY TAKEN VIA ZOOM CONFERENCE
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`·2· · · · · · · · TUESDAY, OCTOBER 26, 2021
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`·3· · · · · · ·6:03 A.M.(AEDT) to 11:11 A.M. (AEDT)
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`·4
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`·5· · · · · · ·COURT REPORTER:· Good morning, Counsel.
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`·6· ·Pursuant to Federal Rule 30(b)(5)(A), I am required to
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`·7· ·begin the deposition with the following on-the-record
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`·8· ·statement:
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`·9· · · · · My name is Linda Marquette.· I am a certified
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`10· ·shorthand reporter, working with the offices of Aptus
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`11· ·Court Reporting, located at 600 West Broadway, Suite
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`12· ·300, San Diego, California.
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`13· · · · · The date is October 26, 2021, and the time is
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`14· ·6:03 a.m. (AEDT).
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`15· · · · · This deposition is being taken remotely with the
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`16· ·witness located in Melbourne, Australia in the matter of
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`17· ·Liquidia Technologies v United Therapeutics Corp,
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`18· ·IPR2021-00406.
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`19· · · · · Do all counsel agree that I may swear in the
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`20· ·witness remotely?
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`21· · · · · · ·MR. DYKHUIS:· Yes.
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`22· · · · · · ·MS. KANNAPPAN:· Yes.
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`23· · · · · · · · · · · IGOR GONDA, PH.D.,
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`24· · having been first duly administered an oath remotely,
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`25· · · · · · was examined and testified as follows:
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · · · · ·COURT REPORTER:· Please state your appearances
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`·2· ·and anyone with you, starting with the taking attorney,
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`·3· ·and then you may begin.
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`·4· · · · · · ·MR. DYKHUIS:· Good morning.· Art Dykhuis with
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`·5· ·McDermott Will & Emery.
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`·6· · · · · · ·Along with me is Doug Carsten and Amy Mahan on
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`·7· ·behalf of United Therapeutics.
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`·8· · · · · · ·MS. KANNAPPAN:· Deepa Kannappan on behalf of
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`·9· ·Liquidia Technologies from Cooley LLP.
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`10· · · · · · ·Also with me is Sanya Sukduang also from
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`11· ·Cooley LLP.
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`12· · · · · · ·COURT REPORTER:· You may begin.
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`13· · · · · · ·MR. DYKHUIS:· Thank you.
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`14· · · · · · · · · · · · ·EXAMINATION
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`15· ·BY MR. DYKHUIS:
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`16· · · ·Q.· · Good morning, Dr. Gonda.· My name is Art
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`17· ·Dykhuis.· I'm one of the lawyers for United Therapeutics
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`18· ·and thank you for giving us some time this morning.
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`19· · · · · · ·Could you state your full name for the record,
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`20· ·please?
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`21· · · ·A.· · Igor Gonda.
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`22· · · ·Q.· · And what is your address?
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`23· · · ·A.· · My address is Unit 2, 5862 Marne Street South
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`24· ·Yarra 3141 Australia.· South Yarra is a suburb of
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`25· ·Melbourne.· This is my temporary address in Australia.
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·I also live at an address in the United States when I'm
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`·2· ·in the U.S.
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`·3· · · ·Q.· · Thank you.
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`·4· · · · · · ·And are you -- do you have any documents or
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`·5· ·anything else?· I see books in the background.· But do
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`·6· ·you have any documents or anything with you this morning
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`·7· ·for the deposition?
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`·8· · · ·A.· · I have a copy of my declaration.· I have that
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`·9· ·as a paper copy and I also have electronic copies of the
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`10· ·materials that I listed in my declaration.
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`11· · · ·Q.· · Okay.· So logistically what we are planning to
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`12· ·do is we'll share exhibits as we need them through Zoom.
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`13· ·If you do want to look at your paper copy of the
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`14· ·declaration, that's fine, but if we can just be clear
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`15· ·what you're looking at or when you do that, that would
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`16· ·be helpful.
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`17· · · ·A.· · Sure.· Yeah.
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`18· · · ·Q.· · Okay.· Are there any notes or markings or any
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`19· ·other annotations on the printed copy of your
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`20· ·declaration?
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`21· · · ·A.· · No, there are not.
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`22· · · ·Q.· · Is there anyone else there with you in your --
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`23· ·in your room there for the deposition?
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`24· · · ·A.· · No.· I'm alone in my office and I think that
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`25· ·my family actually moved upstairs with my daughter, so I
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·don't think that there is anybody here right now.
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`·2· · · ·Q.· · Thank you.
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`·3· · · · · · ·First I wanted to go over some ground rules
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`·4· ·for the deposition.· Even though this is being conducted
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`·5· ·remotely, you understand you are under the same oath
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`·6· ·today as you would be if you were in court before the
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`·7· ·judge or the --
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`·8· · · ·A.· · I understand, yes.
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`·9· · · ·Q.· · Thank you.
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`10· · · · · · ·And then, of course, since we're in Zoom --
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`11· ·especially since we're in Zoom, if you could please make
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`12· ·sure to speak clearly and you and I try to not talk over
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`13· ·each other at all so that the court reporter can get
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`14· ·everything down.
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`15· · · · · · ·Okay?
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`16· · · ·A.· · Sure.
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`17· · · ·Q.· · Thank you.
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`18· · · · · · ·As far as my questions, I will try to be as
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`19· ·clear as I can.· If you have any questions or
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`20· ·clarifications, please ask, otherwise I'll understand
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`21· ·that you understood the question.
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`22· · · · · · ·Is that fair?
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`23· · · ·A.· · Thank you.
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`24· · · ·Q.· · And then recognizing we're at very different
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`25· ·hours of the day here, just to talk about breaks,
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·usually I go about an hour before taking a break.· As
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`·2· ·the day goes on, though, if you need a break at any
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`·3· ·time, just let me know and I would just ask you answer
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`·4· ·any pending question first.
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`·5· · · · · · ·Will that work?
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`·6· · · ·A.· · Yep, that's fine.· Thank you.
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`·7· · · ·Q.· · Thank you.
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`·8· · · · · · ·And then I know you had some coffee but are
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`·9· ·you under the influence of any types of drugs, alcohol,
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`10· ·medication, anything that would affect your ability to
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`11· ·testify truthfully this morning?
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`12· · · ·A.· · No.· Thank you.
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`13· · · ·Q.· · Thank you.
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`14· · · ·A.· · It's a little early in the day to be on
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`15· ·anything else but coffee.
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`16· · · ·Q.· · I agree.
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`17· · · · · · ·Have you been deposed before?
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`18· · · ·A.· · I have a very, very long time ago.· Yes.
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`19· ·Probably 15, 16 years ago, yeah.
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`20· · · ·Q.· · And is that -- that deposition is the only
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`21· ·time you've been deposed previously?
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`22· · · ·A.· · I was deposed also earlier, probably around
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`23· ·the year 2000.· So a long time ago.· So two depositions
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`24· ·as far as I know, a long, long time ago.
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`25· · · ·Q.· · What was the -- for each of those what was the
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`·1· ·subject matter?
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·2· · · ·A.· · The subject matter was inhaled insulin.
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`·3· · · ·Q.· · So one deposition around the year 2000 and
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`·4· ·when was the other?
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`·5· · · ·A.· · One was probably around 2005.
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`·6· · · ·Q.· · Both related to inhaled insulin?
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`·7· · · ·A.· · Correct.
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`·8· · · ·Q.· · Did you testify as a fact witness or as an
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`·9· ·expert?
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`10· · · ·A.· · I was the first inventor on the patent that
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`11· ·was being disputed.
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`12· · · ·Q.· · Did you testify, then, only as a fact witness?
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`13· · · ·A.· · You know, I really don't remember.
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`14· · · ·Q.· · And who are the associate -- who are the
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`15· ·companies involved in the litigation?
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`16· · · ·A.· · The two companies.· So I was at the time the
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`17· ·chief scientific officer -- the first time I was the
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`18· ·chief scientific officer at Aradigm Corporation.· And
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`19· ·the other party was Eli Lilly.
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`20· · · · · · ·And the second time I was the CEO and managing
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`21· ·director of an Australian company called Acrux.· And at
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`22· ·the same time I was a board member and chairman of the
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`23· ·scientific advisory board of Aradigm Corporation.· And
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`24· ·the other party was Pfizer, P-F-I-Z-E-R.
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`25· · · ·Q.· · Have you ever testified at a trial?
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · ·A.· · The first deposition went into trial, correct,
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`·2· ·yes, so the Eli Lilly/Aradigm case went into trial.
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`·3· · · ·Q.· · And the second one involving Acrux did not or
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`·4· ·when you were at Acrux did not?
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`·5· · · ·A.· · No, no.· So the second one involved Aradigm
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`·6· ·and Pfizer but -- so I was the inventor of the patent,
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`·7· ·so I was not at the time an employee or director.· I was
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`·8· ·a board member and chair of the scientific advisory
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`·9· ·board.· I was asked to come to -- and that never went to
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`10· ·court.
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`11· · · ·Q.· · Any other testimony in any type of legal
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`12· ·proceedings besides the two depositions and the trial
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`13· ·involving Aradigm and Eli Lilly?
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`14· · · ·A.· · As far as I remember, and I mean this was a
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`15· ·long time ago, sometime in the early 2000s, I was
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`16· ·involved as an expert in a dispute between a generic
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`17· ·company and Merck and that never went to court.
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`18· · · · · · ·And then a long, long time ago I was involved
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`19· ·in a patent dispute on a transdermal delivery of a drug.
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`20· ·And this was a long, long time ago.· And that
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`21· ·involved -- Arza was one of the -- A-R-Z-A was one of
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`22· ·the corporations and I don't even remember what was the
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`23· ·other corporation.· It might have been Cygnum,
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`24· ·C-Y-G-N-U-M.· But honestly this was so long ago.· This
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`25· ·would have been probably in the early 1990s.· So those
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`·1· ·were the cases as far as I remember that I was involved
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`·2· ·in in something like this.
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`·3· · · ·Q.· · Both of those did not involve depositions or a
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`·4· ·trial; is that right?
`
`·5· · · ·A.· · That's correct.
`
`·6· · · ·Q.· · What did you do, Dr. Gonda, in preparation for
`
`·7· ·this deposition today?
`
`·8· · · ·A.· · Well, obviously, I was looking at the
`
`·9· ·materials that I listed in my -- in my deposition [sic]
`
`10· ·so I'm familiar with the materials.· So I was looking at
`
`11· ·those, I was reading those, and I was preparing my
`
`12· ·declaration.
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`13· · · ·Q.· · So I want to distinguish between two things
`
`14· ·here a moment if I may.· If the declaration -- I'm
`
`15· ·checking the date it was signed.· I signed your
`
`16· ·declaration for this case January 7 of 2021.· What did
`
`17· ·you do to prepare for this deposition today after
`
`18· ·writing the declaration?
`
`19· · · ·A.· · I was refreshing my memory with some of the
`
`20· ·materials.
`
`21· · · ·Q.· · Okay.· Did you meet with counsel or anyone
`
`22· ·else in preparation for the deposition today?
`
`23· · · · · · ·MS. KANNAPPAN:· Objection.
`
`24· · · · · · ·Dr. Gonda, you can answer the question, but I
`
`25· ·just caution you not to get into the substance of any of
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·the discussions you had with counsel.
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`·2· · · ·A.· · Well, we cleaned up the declaration, you know,
`
`·3· ·for January.· And then there was a supplementary
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`·4· ·declaration with some corrections.· So, you know, we --
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`·5· ·you know, I provided the substance of the material and
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`·6· ·the counsel helped me to put it together in the right
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`·7· ·form.
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`·8· ·BY MR. DYKHUIS:
`
`·9· · · ·Q.· · You just mentioned a supplementary declaration
`
`10· ·with corrections.· When did you prepare a supplementary
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`11· ·declaration with corrections, Dr. Gonda?
`
`12· · · ·A.· · Let me take a look at the date.· So this is in
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`13· ·my electronic files.· If you allow me to do this.· Let
`
`14· ·me just see.· The date on that, let's see.· You know, I
`
`15· ·honestly -- I can't see the date.· Let me just see where
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`16· ·it could be in the documents.· I'm surprised there is no
`
`17· ·-- doesn't appear to be --
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`18· · · ·Q.· · Just to be clear, you're looking at what you
`
`19· ·think is an electronic copy of your declaration --
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`20· · · · · · ·(Simultaneous cross-talk.)
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`21· · · ·A.· · It's Exhibit 1082.· And it's called
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`22· ·Supplemental Declaration of Igor Gonda.· Let me see.
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`23· ·There may be a date when I signed it at the end.· Let me
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`24· ·just see.· Yes.· Eighth of September.· Eighth of
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`25· ·September.· That's when it was signed.· Okay.
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`·1· ·BY MR. DYKHUIS:
`
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
`
`·2· · · ·Q.· · Okay.· I'll come at this from another
`
`·3· ·direction.· Let's say within the past week or so, have
`
`·4· ·you done anything to prepare for this deposition?
`
`·5· · · ·A.· · Yes.· You know, as I said, I was looking again
`
`·6· ·at some of the materials, key materials in my
`
`·7· ·declaration, yes.
`
`·8· · · ·Q.· · And what key materials in your declaration did
`
`·9· ·you review?
`
`10· · · ·A.· · I was particularly looking at the '793 patent
`
`11· ·and the '212 patent and the Voswinckel papers, the
`
`12· ·Voswinckel articles.· Because they are very similar and
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`13· ·I wanted to memorize, you know, just exactly what were
`
`14· ·the differences between them.· I kind of lost track of
`
`15· ·what the differences between them, the papers were.
`
`16· · · ·Q.· · Did you review any other documents besides the
`
`17· ·'212 patent and the Voswinckel journals?
`
`18· · · ·A.· · I don't remember anything in particular apart
`
`19· ·from them.· Those were the key.
`
`20· · · ·Q.· · Did you have any meetings or phone calls or
`
`21· ·Zooms in preparation for this deposition?
`
`22· · · ·A.· · We were discussing the technicalities and you
`
`23· ·probably know the company that organized the Zoom also
`
`24· ·gave me training on this call.
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`25· · · ·Q.· · Did you have -- other than training with a
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·vendor that's facilitating this call, did you have any
`
`·2· ·other meetings or discussions in preparation for the
`
`·3· ·deposition?
`
`·4· · · ·A.· · Yeah.· I had a phone call to -- with the
`
`·5· ·counsel -- I mean, I wanted to know who you were.· So I
`
`·6· ·was wondering who would be -- who would be on the other
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`·7· ·side and I just wanted to understand, because I haven't
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`·8· ·had a deposition for a long time, just what the process
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`·9· ·was.
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`10· · · ·Q.· · And which counsel did you speak with?
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`11· · · ·A.· · With Ms. Kannappan.
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`12· · · ·Q.· · Anyone else?
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`13· · · ·A.· · No.· I don't recall any other meetings with
`
`14· ·Ms. Kannappan.
`
`15· · · ·Q.· · So to prepare for the deposition today you had
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`16· ·one phone call with counsel and then reviewed documents
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`17· ·on your own; is that correct?
`
`18· · · ·A.· · I think that there were more -- there was more
`
`19· ·than one.· There was more than one phone call, yes. I
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`20· ·don't remember exactly how many but there was more than
`
`21· ·one.
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`22· · · ·Q.· · How many hours did you spend speaking with
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`23· ·counsel in preparation for the deposition today?
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`24· · · ·A.· · I would say it was probably about two or three
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`25· ·hours.
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · ·Q.· · Two or three hours on how many days, sir?
`
`·2· · · ·A.· · Well, I don't remember the exact number, of
`
`·3· ·course.· I think that there were two.· Two calls for
`
`·4· ·this particular ...
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`·5· · · ·Q.· · So would that be four to six hours in total?
`
`·6· · · ·A.· · Probably more like four.
`
`·7· · · ·Q.· · If I reference -- well, let me ask you this.
`
`·8· ·Is the electronic copy of your declaration that you have
`
`·9· ·printed, that's Exhibit 1004; is that correct?
`
`10· · · ·A.· · Let's see.
`
`11· · · · · · ·MR. DYKHUIS:· Actually, I'll just ask
`
`12· ·Mr. Isaacs.· If you could pull up Exhibit 1004, please.
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`13· · · · · · ·(Exhibit 1004 marked for
`
`14· · · · · · ·identification by the Certified
`
`15· · · · · · ·Shorthand Reporter.)
`
`16· · · · · · ·EXHIBIT TECH:· And just to clarify, Counselor,
`
`17· ·that's the document ending with 1004?
`
`18· · · · · · ·MR. DYKHUIS:· Exactly.· Yes.· Thank you.
`
`19· · · · · · ·EXHIBIT TECH:· One moment.
`
`20· · · · · · ·MR. DYKHUIS:· And then if we're able to -- if
`
`21· ·we're able to see the full page.
`
`22· · · · · · ·THE WITNESS:· I see the top -- oh, there's the
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`23· ·full page.
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`24· · · · · · ·EXHIBIT TECH:· Dr. Gonda, you should have
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`25· ·control over my computer so you should be able to scroll
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·through the document as you wish.
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`·2· · · · · · ·THE WITNESS:· Okay.· Thank you.
`
`·3· ·BY MR. DYKHUIS:
`
`·4· · · ·Q.· · Do you recognize Exhibit 1004, Dr. Gonda?
`
`·5· · · ·A.· · I do.
`
`·6· · · ·Q.· · And this is your declaration, correct?
`
`·7· · · ·A.· · That is correct.
`
`·8· · · ·Q.· · And is that the same document as you have
`
`·9· ·printed in front of you this morning?
`
`10· · · ·A.· · I believe so.
`
`11· · · ·Q.· · Okay.· Exhibit 1004, your declaration,
`
`12· ·references Dr. Hill.· Do you recall that?
`
`13· · · ·A.· · Yes, I do recall that.
`
`14· · · ·Q.· · Have you ever spoken with Dr. Hill?
`
`15· · · ·A.· · No, I have not.
`
`16· · · ·Q.· · Have you shared e-mails one way or the other
`
`17· ·with Dr. Hill?
`
`18· · · ·A.· · No, I did not.
`
`19· · · ·Q.· · Have you reviewed Dr. Hill's declaration?
`
`20· · · ·A.· · Yes, I have.
`
`21· · · ·Q.· · When did you review his declaration?
`
`22· · · ·A.· · I reviewed it before I signed my declaration,
`
`23· ·I think, or right about the time when I was finishing
`
`24· ·this declaration in front of us.
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`25· · · ·Q.· · Did you review a final version of his
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`·1· ·declaration?
`
`
`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
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`·2· · · ·A.· · I believe it was the final version of his
`
`·3· ·declaration, yes.
`
`·4· · · ·Q.· · Do you recall one way or another if it had a
`
`·5· ·-- if it was signed by Dr. Hill?
`
`·6· · · ·A.· · I honestly don't remember that.
`
`·7· · · ·Q.· · Dr. Gonda, your declaration is -- excuse me,
`
`·8· ·I'll start over.
`
`·9· · · · · · ·So if we skip ahead to -- well, I'll start
`
`10· ·over twice.
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`11· · · · · · ·Your declaration, Dr. Gonda, is dated on
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`12· ·page 63, January 7, 2021.· Did you review Dr. Hill's
`
`13· ·declaration on January 7 or before?
`
`14· · · · · · ·MS. KANNAPPAN:· Objection to form.
`
`15· · · ·A.· · I believe it was before January 7.
`
`16· ·BY MR. DYKHUIS:
`
`17· · · ·Q.· · And can you explain a bit further?· Why do you
`
`18· ·believe it was before January 7?
`
`19· · · · · · ·MS. KANNAPPAN:· Objection to form.
`
`20· · · · · · ·THE WITNESS:· Sorry.· What was that,
`
`21· ·Ms. Kannappan?
`
`22· · · · · · ·MS. KANNAPPAN:· I was saying objection to
`
`23· ·form.
`
`24· · · · · · ·You can go ahead and answer.
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`25· · · ·A.· · Okay.· Why do I think so, because I don't
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· ·think I would have signed my declaration without being
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`·2· ·aware that I've seen Dr. Hill's declaration without
`
`·3· ·actually seeing it.· I mean, I -- that's why I said that
`
`·4· ·it's unlikely that I would have seen Dr. Hill's
`
`·5· ·declaration for the first time after I signed it.
`
`·6· ·BY MR. DYKHUIS:
`
`·7· · · ·Q.· · Do you think you saw his declaration several
`
`·8· ·days before January 7?
`
`·9· · · ·A.· · I don't remember how many days but, yes, I
`
`10· ·would expect I would have seen it before, yeah.
`
`11· · · ·Q.· · I'd like to go to paragraph 2 in your
`
`12· ·declaration, Exhibit 1004.
`
`13· · · ·A.· · Yes.
`
`14· · · ·Q.· · And so paragraph 2 starts on page 1.· It's
`
`15· ·under the heading about your qualifications and
`
`16· ·experience.· And then actually on the following page it
`
`17· ·mentions, this is at the end of paragraph 2:
`
`18· · · · · · · · "During my time at the University
`
`19· · · · · · ·of Aston and University of Sydney, I
`
`20· · · · · · ·also consulted for pharmaceutical
`
`21· · · · · · ·companies, compendial bodies and
`
`22· · · · · · ·pharmaceutical regulatory
`
`23· · · · · · ·authorities."
`
`24· · · · · · ·Did you see that?
`
`25· · · ·A.· · Yes, I did.
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
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`United Therapeutics Corp.United Therapeutics Corp.
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`·1· · · ·Q.· · And your time at those two universities, was
`
`·2· ·that approximately 1975 through 1992?
`
`·3· · · ·A.· · Sorry.· I didn't get the question.· You said
`
`·4· ·during the time to 1992, what was the question about
`
`·5· ·that time?
`
`·6· · · ·Q.· · Your time at those two universities, was that
`
`·7· ·approximately 1975 through 1992?
`
`·8· · · ·A.· · That is correct.
`
`·9· · · ·Q.· · Over that time period when you consulted for
`
`10· ·pharmaceutical companies in these compendial bodies and
`
`11· ·regulatory authorities were you dealing -- was any of
`
`12· ·that work related to pulmonary hypertension?
`
`13· · · ·A.· · No.· I don't think so.
`
`14· · · ·Q.· · And was any of that work related to
`
`15· ·prostacyclins?
`
`16· · · ·A.· · I don't believe so.
`
`17· · · ·Q.· · And then in paragraph 3 you mention your work
`
`18· ·at Genentech and working on a human recombinant protein
`
`19· ·administered by inhalation called Pulmozyme.
`
`20· · · · · · ·Do you see that?
`
`21· · · ·A.· · Yes, I do see that.
`
`22· · · ·Q.· · The Pulmozyme product, well, it says right
`
`23· ·there, it was a human recombinant protein?
`
`24· · · ·A.· · That's correct.
`
`25· · · ·Q.· · And so a relatively large molecule?
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`·1· · · ·A.· · That is correct.
`
`
`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
`
`·2· · · ·Q.· · What disease does Pulmozyme -- is it used to
`
`·3· ·treat?
`
`·4· · · ·A.· · It is used to treat cystic fibrosis.
`
`·5· · · ·Q.· · It's not used to treat any form of pulmonary
`
`·6· ·hypertension?
`
`·7· · · ·A.· · Not to the best of my knowledge.
`
`·8· · · ·Q.· · At the end of paragraph 3 it mentions you put
`
`·9· ·a significant -- excuse me.
`
`10· · · · · · ·You led -- well, there was a significant
`
`11· ·effort into development of a metered-dose dry powder
`
`12· ·inhaler?
`
`13· · · · · · ·MS. KANNAPPAN:· Objection to form.
`
`14· · · ·A.· · Yes, correct.· Yes.· We were developing
`
`15· ·metered-dose dry powder inhaler for recombinant in human
`
`16· ·DNase.
`
`17· ·BY MR. DYKHUIS:
`
`18· · · ·Q.· · What is the difference between a metered-dose
`
`19· ·dry powder inhaler and a plain dry powder inhaler?
`
`20· · · · · · ·MS. KANNAPPAN:· Objection to form.
`
`21· · · ·A.· · Actually, I think that -- thinking about it, I
`
`22· ·think that all dry powder inhaler systems are metered in
`
`23· ·one way or another.· The metering systems can differ but
`
`24· ·they are metering the doses.
`
`25· ·///
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`·1· ·BY MR. DYKHUIS:
`
`
`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
`
`·2· · · ·Q.· · What do you mean by "metering the doses"?
`
`·3· · · ·A.· · Well, it's either that the dose is put into a
`
`·4· ·separate dosage -- dosage such as a capsule, so one dose
`
`·5· ·could be encapsulated in a capsule, or the device itself
`
`·6· ·in some way meters the dose so the patient is getting
`
`·7· ·the same dose every time they inhale.
`
`·8· · · ·Q.· · Is the metered-dose dry powder inhaler for
`
`·9· ·rhDNase on the market?
`
`10· · · ·A.· · No, it is not.
`
`11· · · ·Q.· · Do you know why not?
`
`12· · · ·A.· · The main reason for the development of the dry
`
`13· ·powder was that Genentech was hoping that the dry could
`
`14· ·have broader use, particularly in adults, relatively
`
`15· ·healthy populations.· And it turned out that those
`
`16· ·attempts to show efficacy outside cystic fibrosis didn't
`
`17· ·work.· So Genentech stayed and did not develop a dry
`
`18· ·powder for that particular compound.
`
`19· · · ·Q.· · So as far as you know Genentech has stayed
`
`20· ·with use of a nebulizer, with Pulmozyme, even though a
`
`21· ·dry powder inhaler could have been an option?
`
`22· · · · · · ·MS. KANNAPPAN:· Objection to form and
`
`23· ·foundation.
`
`24· · · ·A.· · Yes.· I think that, as far as I know,
`
`25· ·Genentech never developed a dry powder inhaler for
`
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`Igor Gonda, Ph.D.Igor Gonda, Ph.D.
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`·1· ·recombinant human DNase.
`
`
`Liquidia Technologies, Inc. vs.Liquidia Technologies, Inc. vs.
`
`United Therapeutics Corp.United Therapeutics Corp.
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`·2· · · · · · ·(Court reporter clarification.)
`
`·3· · · · · · ·THE WITNESS:· Human DNase.· R-H-D-N-A-S-E, so
`
`·4· ·the recombinant human is abbreviated as R-H, recombinant
`
`·5· ·human D-N-A-S-E.
`
`·6· · · · · · ·MR. DYKHUIS:· Okay.· Thank you.
`
`·7· ·BY MR. DYKHUIS:
`
`·8· · · ·Q.· · Let's set aside 1004 for the moment.
`
`·9· · · · · · ·MR. DYKHUIS:· And if we could pull up
`
`10· ·Exhibit 1005, please.
`
`11· · · · · · ·(Exhibit 1005 marked for
`
`12· · · · · · ·identification by the Certified
`
`13· · · · · · ·Shorthand Reporter.)
`
`14· ·BY MR. DYKHUIS:
`
`15· · · ·Q.· · Dr. Gonda, do you recognize Exhibit 1005?
`
`16· · · ·A.· · It looks like my resume.
`
`17· · · ·Q.· · Does it look like an updated copy of your
`
`18· ·resume?
`
`19· · · ·A.· · Yes, I think so.
`
`20· · · · · · ·MS. KANNAPPAN:· Object to form.
`
`21· · · ·A.· · It is, I believe it's up-to-date.
`
`22· ·BY MR. DYKHUIS:
`
`23· · · ·Q.·
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