STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 1
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`·1· · · UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3· ·------------------------------------------------
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`·4· ·STEADYMED LTD.,
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`·5· · · · · · · Petitioner,
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`·6· · · · · ·v.
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`·7· ·UNITED THERAPEUTICS CORPORATION,
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`·8· · · · · · · · Patent Owner.
`
`·9· ·------------------------------------------------
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`10· ·Case IPR2016-00006 (Patent 8,497,393)
`
`11· ·------------------------------------------------
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`12
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`13· · · · · · · · VIDEO DEPOSITION OF
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`14· · · · · · ROBERT R. RUFFOLO, JR., PHD
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`15
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`16· · · · · ·Wilson Sonsini Goodrich & Rosati
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`17· · · · · · · 1700 K Street NW, Suite 500
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`18· · · · · · · · · Washington, DC 20006
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`19
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`20· · · · · · · · Friday, August 19, 2016
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`21· · · · · · · · · · · · ·9:29 a.m.
`
`22
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`23
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`24· ·Reported by:
`
`25· ·Denise D. Vickery, CRR/RMR· · · · JOB NO. 178626
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
` P.1
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 1
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`·1· · · UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·3· ·------------------------------------------------
`
`·4· ·STEADYMED LTD.,
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`·5· · · · · · · Petitioner,
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`·6· · · · · ·v.
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`·7· ·UNITED THERAPEUTICS CORPORATION,
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`·8· · · · · · · · Patent Owner.
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`·9· ·------------------------------------------------
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`10· ·Case IPR2016-00006 (Patent 8,497,393)
`
`11· ·------------------------------------------------
`
`12
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`13· · · · · · · · VIDEO DEPOSITION OF
`
`14· · · · · · ROBERT R. RUFFOLO, JR., PHD
`
`15
`
`16· · · · · ·Wilson Sonsini Goodrich & Rosati
`
`17· · · · · · · 1700 K Street NW, Suite 500
`
`18· · · · · · · · · Washington, DC 20006
`
`19
`
`20· · · · · · · · Friday, August 19, 2016
`
`21· · · · · · · · · · · · ·9:29 a.m.
`
`22
`
`23
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`24· ·Reported by:
`
`25· ·Denise D. Vickery, CRR/RMR· · · · JOB NO. 178626
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
` P.1
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 2
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`·1· · · · ·A P P E A R A N C E S
`
`·2
`
`·3· · · · ·For Petitioner:
`
`·4· · · · ·DLA PIPER LLP (US)
`
`·5· · · · · · · ·1251 Avenue of the Americas
`
`·6· · · · · · · ·New York, NY 10020-1104
`
`·7· · · · ·BY:· ·STUART E. POLLACK, ESQ.
`
`·8· ·-and-
`
`·9· · · · · · · ·33 Arch Street, 26th Floor
`
`10· · · · · · · ·Boston, MA 02110-1447
`
`11· · · · ·BY:· ·MAYA PRAKASH CHOKSI, ESQ.
`
`12
`
`13
`
`14
`
`15· · · · ·For Patent Owner and the Witness:
`
`16· · · · ·WILSON SONSINI GOODRICH & ROSATI
`
`17· · · · · · · ·900 South Capital of Texas Highway
`
`18· · · · · · · ·Las Cimas IV, Fifth Floor
`
`19· · · · · · · ·Austin, TX 78746-5546
`
`20· · · · ·BY:· ·ROBERT DELAFIELD, ESQ.
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
` P.2
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 3
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`·1· · · · ·A P P E A R A N C E S (Continued)
`
`·2
`
`·3· · · · ·For Patent Owner:
`
`·4· · · · ·FOLEY & LARDNER LLP
`
`·5· · · · · · · ·Washington Harbour
`
`·6· · · · · · · ·3000 K Street, NW, Suite 600
`
`·7· · · · · · · ·Washington, DC 20007-5109
`
`·8· · · · ·BY:· ·STEPHEN B. MAEBIUS, ESQ.
`
`·9
`
`10
`
`11
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`12
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`13· · · · ·Also Present:
`
`14· · · · · · · ·Solomon Francis, Videographer
`
`15
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`16
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`17
`
`18
`
`19
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`20
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`21
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`22
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`23
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`24
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`25
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
` P.3
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 4
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`·1· · · · · · · · · · · · · · I N D E X
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`·2
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`·3· · · · ·EXAMINATION OF ROBERT R. RUFFOLO, JR., PHD· ·PAGE
`
`·4· · · · · · · · ·BY MR. POLLACK· · · · · · · · · · · · · 7
`
`·5· · · · · · · · ·AFTERNOON SESSION· · · · · · · · · · ·156
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`·6· · · · · · · · · · · · ·E X H I B I T S
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`·7· · · · ·RUFFOLO· · · · · · ·DESCRIPTION· · · · · · · PAGE
`
`·8· · · · ·Exhibit 1· ·Petitioner's Notice of Deposition· ·9
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`·9· · · · · · ·of Robert R. Ruffolo, Jr., Ph.D.
`
`10· · · · ·Exhibit 2· ·Curriculum Vitae, UT Ex. 2023· · · 26
`
`11· · · · ·Exhibit 3· ·Declaration of Robert R. Ruffolo,· 31
`
`12· · · · · · ·Jr., Ph.D. in Support of Patent Owner
`
`13· · · · · · ·Response to Petition, UT Ex. 2022
`
`14· · · · ·Exhibit 4· ·United States Patent No. 8,497,393 62
`
`15· · · · · · ·Batra et al., SteadyMed Exhibit 1001
`
`16· · · · ·Exhibit 5· ·United Therapeutics Letter Dated· ·75
`
`17· · · · · · ·2 January 2009 to FDA/CDER, UT Ex. 2006
`
`18· · · · ·Exhibit 6· ·CDER Reviewer Guidance,· · · · · ·197
`
`19· · · · · · ·Validation of Chromatographic Methods,
`
`20· · · · · · ·November 1994, UT Ex. 2035
`
`21· · · · ·Exhibit 7· ·JOC Article: The Intramolecular· ·205
`
`22· · · · · · ·Asymmetric Pauson-Khand Cyclization as a
`
`23· · · · · · ·Novel and General Stereoselective Route to
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`24· · · · · · ·Benzindene Prostacyclins, Moriarty et al.
`
`25· · · · · · ·SteadyMed Exhibit 1004
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
` P.4
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 5
`
`·1· · · · · · · · · · · · ·E X H I B I T S
`
`·2· · · · ·RUFFOLO· · · · · · ·DESCRIPTION· · · · · · · PAGE
`
`·3· · · · ·Exhibit 8· ·Guidance for Industry,· · · · · · 241
`
`·4· · · · · · ·Non-Penicillin Beta-Lactam Drugs: A CGMP
`
`·5· · · · · · ·Framework for Preventing Cross-Contamination
`
`·6· · · · · · ·HHS/FDA/CDER April 2013, UT Ex. 2047
`
`·7· · · · ·Exhibit 9· ·Diabetes Care, Clinical· · · · · ·242
`
`·8· · · · · · ·Pharmacology of Human Insulin, UT Ex. 2048
`
`·9· · · · ·Exhibit 10· FDA/HSS Letter Stamped· · · · · · 282
`
`10· · · · · · ·Mar 10, 2014 to Dean Bunce of United
`
`11· · · · · · ·Therapeutics Re Remodulin
`
`12· · · · ·Exhibit 11· Patent Owner Response to Petition 310
`
`13
`
`14
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`15
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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
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`24· · · · · · · · ·(Exhibits attached to transcript.)
`
`25
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.5
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 6
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`·1· · · · · · · · · · · P R O C E E D I N G S
`
`·2· · · · · · · · · · · · · · · - - -
`
`·3· · · · · · · · · · · ·THE VIDEOGRAPHER:· Good morning.
`
`·4· · · · · This begins Media Unit No. 1 of the
`
`·5· · · · · audiovisual deposition of Dr. Robert Ruffolo
`
`·6· · · · · taken in the matter of SteadyMed Limited,
`
`·7· · · · · Petitioner versus United Therapeutics
`
`·8· · · · · Corporation, Patent Owner, before the Patent
`
`·9· · · · · Trial and Appeal Board, IPR No. 2016-00006.
`
`10· · · · · · · · · · · ·This deposition is being held at
`
`11· · · · · the law offices of Wilson Sonsini Goodrich &
`
`12· · · · · Rosati located at 1700 K Street, Northwest,
`
`13· · · · · Washington, DC on August 19, 2016 at
`
`14· · · · · approximately 9:29 a.m.
`
`15· · · · · · · · · · · ·My name is Solomon Francis and
`
`16· · · · · our court reporter, Denise Vickery, for
`
`17· · · · · Elisa Dreier Reporting Corp. located at 950
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`18· · · · · Third Avenue, New York, New York.
`
`19· · · · · · · · · · · ·For the record, would counsel
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`20· · · · · introduce themselves and whom they
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`21· · · · · represent.
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`22· · · · · · · · · · · ·MR. POLLACK:· Stuart E. Pollack,
`
`23· · · · · DLA Piper LLP(US) on behalf of the
`
`24· · · · · petitioner, SteadyMed Limited.
`
`25· · · · · · · · · · · ·MS. CHOKSI:· Maya Choksi, DLA
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.6
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 7
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`·1· · · · · Piper, on behalf of the petitioner.
`
`·2· · · · · · · · · · · ·MR. DELAFIELD:· Bobby Delafield,
`
`·3· · · · · Wilson Sonsini Goodrich & Rosati, on behalf
`
`·4· · · · · of United Therapeutics and the witness.
`
`·5· · · · · · · · · · · ·MR. MAEBIUS:· And Steven Maebius
`
`·6· · · · · from Foley & Lardner LLP on behalf of patent
`
`·7· · · · · owner.
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`·8· · · · · · · · · · · ·THE VIDEOGRAPHER:· At this time,
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`·9· · · · · will the court reporter please swear in or
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`10· · · · · affirm the witness.
`
`11· · · · · · · · · · · · · · · - - -
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`12· · · · · · · · · ROBERT R. RUFFOLO, JR., PHD
`
`13· · · · ·called for examination, and, after having been
`
`14· · · · ·duly sworn, was examined and testified as
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`15· · · · ·follows:
`
`16· · · · · · · · · · · · · · · EXAMINATION
`
`17· · · · · · · · · · · ·THE VIDEOGRAPHER:· Please
`
`18· · · · · proceed, counsel.
`
`19· · · · ·BY MR. POLLACK:
`
`20· · · · · · · Q.· · Good morning, Dr. Ruffolo.
`
`21· · · · · · · A.· · Good morning.
`
`22· · · · · · · Q.· · To get started, if you could just
`
`23· · · · ·state your name and your current position for
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`24· · · · ·the record.
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`25· · · · · · · A.· · Okay.· My name is Robert Richard
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.7
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 8
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`·1· · · · ·Ruffolo, and I am the retired president of
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`·2· · · · ·research and development at Wyeth and the
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`·3· · · · ·retired senior corporate VP of Wyeth and I --
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`·4· · · · ·and self-employed as a pharmaceutical
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`·5· · · · ·consultant.
`
`·6· · · · · · · Q.· · Do you have like a consulting
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`·7· · · · ·company or agency?
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`·8· · · · · · · A.· · Yes, I do.· It's -- it's Ruffolo
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`·9· · · · ·Consulting, LLC.
`
`10· · · · · · · Q.· · And that's a company that you are
`
`11· · · · ·the only member of?
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`12· · · · · · · A.· · Yes, I am.
`
`13· · · · · · · Q.· · Have you been deposed before?
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`14· · · · · · · A.· · Yes, I have.
`
`15· · · · · · · Q.· · How many times have you been
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`16· · · · ·deposed before?
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`17· · · · · · · A.· · Well, maybe 10.
`
`18· · · · · · · Q.· · Just briefly, can you tell me what
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`19· · · · ·kinds of cases those 10 cases were?
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`20· · · · · · · A.· · Yes.· In -- four of those were in
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`21· · · · ·two cases of product liability for companies
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`22· · · · ·that I worked for where I was a company witness
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`23· · · · ·as well as an expert witness in both of those
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`24· · · · ·cases, and then the remaining depositions were
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`25· · · · ·in cases like this.
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.8
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 9
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`·1· · · · · · · Q.· · Those were patent litigation cases?
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`·2· · · · · · · A.· · Yes, they were.
`
`·3· · · · · · · Q.· · Okay.· And about six depositions?
`
`·4· · · · · · · A.· · About -- yeah, about six.
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`·5· · · · · · · · · · · ·MR. POLLACK:· Just to get some
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`·6· · · · · formalities out of the way, I'm going to
`
`·7· · · · · mark as Ruffolo Deposition Exhibit 1 the
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`·8· · · · · Petitioner's Notice of Deposition of Robert
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`·9· · · · · R. Ruffolo, Ph.D.
`
`10· · · · · · · · · · · ·(Document marked for
`
`11· · · · · identification purposes as Ruffolo
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`12· · · · · Exhibit 1.)
`
`13· · · · · · · · · · · ·THE WITNESS:· Thank you.
`
`14· · · · ·BY MR. POLLACK:
`
`15· · · · · · · Q.· · And are you in attendance here
`
`16· · · · ·today for this deposition in response to
`
`17· · · · ·petitioner's notice of deposition?
`
`18· · · · · · · A.· · Yes, I am.
`
`19· · · · · · · Q.· · Have you testified in any other --
`
`20· · · · ·you understand this is a proceeding called an
`
`21· · · · ·inter partes review?
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`22· · · · · · · A.· · Yes, I do.· Yes.
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`23· · · · · · · Q.· · Okay.· Have you testified in any
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`24· · · · ·other inter partes review?
`
`25· · · · · · · A.· · No, I don't believe so.
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.9
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 10
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`·1· · · · · · · Q.· · In the six patent litigations that
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`·2· · · · ·you testified in, what did those concern?
`
`·3· · · · · · · A.· · Do you want the specific company,
`
`·4· · · · ·law firms?
`
`·5· · · · · · · Q.· · Yeah.· Yes.
`
`·6· · · · · · · A.· · Okay.· I'll do the best I can.
`
`·7· · · · · · · Q.· · Okay.
`
`·8· · · · · · · A.· · One was Gardiner Roberts and the
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`·9· · · · ·drug was an ACE inhibitor and Tandrolapril.
`
`10· · · · ·Tandolapril, I think.· Trandolapril, I think.
`
`11· · · · · · · Q.· · Trandolapril?
`
`12· · · · · · · A.· · I think so.· I can't be certain. I
`
`13· · · · ·just simply don't remember.
`
`14· · · · · · · Q.· · Okay.
`
`15· · · · · · · A.· · Then --
`
`16· · · · · · · Q.· · Was that for the brand name company
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`17· · · · ·or for the generic company that you were
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`18· · · · ·testifying?
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`19· · · · · · · A.· · That one was for the generic and --
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`20· · · · · · · Q.· · Do you remember which company?
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`21· · · · · · · A.· · Yes.· It was Novartis.· Sandoz,
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`22· · · · ·their generic division.
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`23· · · · · · · Q.· · Okay.
`
`24· · · · · · · A.· · Then there --
`
`25· · · · · · · Q.· · Let me ask you.· Was that
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.10
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 11
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`·1· · · · ·Sanofi-Aventis on the other side or --
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`·2· · · · · · · A.· · It was Boehringer Ingelheim.
`
`·3· · · · · · · Q.· · Boehringer Ingelheim.
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`·4· · · · · · · A.· · So that's why I'm not sure of the
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`·5· · · · ·drug match.· I don't remember.· That was the
`
`·6· · · · ·first one I did quite a while ago.
`
`·7· · · · · · · Q.· · Okay.· What did you testify about
`
`·8· · · · ·in that case?
`
`·9· · · · · · · A.· · It was mostly about the R&D process
`
`10· · · · ·in that case.· I was an expert on -- on R&D
`
`11· · · · ·process, regulatory requirements, and the FDA.
`
`12· · · · · · · · · · Then there was another case.· The
`
`13· · · · ·law firm was Goodwin Procter.· The drug was
`
`14· · · · ·Azilect, and I represented the patent holder in
`
`15· · · · ·that case, and that the patent holder was Teva,
`
`16· · · · ·a generic company, but they do have --
`
`17· · · · · · · Q.· · Right.
`
`18· · · · · · · A.· · -- some, as you know I'm sure, they
`
`19· · · · ·have a few branded drugs that they developed.
`
`20· · · · ·And then there was --
`
`21· · · · · · · Q.· · Let me ask you.· What was your
`
`22· · · · ·testimony about in that case?
`
`23· · · · · · · A.· · Oh, it was everything basically.
`
`24· · · · ·So I was originally hired -- there were 21
`
`25· · · · ·parts to that case.· So I was originally hired
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
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`YVer1f
`
` P.11
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 12
`
`·1· · · · ·just to do the R&D part, but then I did --
`
`·2· · · · ·ended up doing 17 of the 21 parts.· So I did
`
`·3· · · · ·virtually everything on that.
`
`·4· · · · · · · Q.· · Infringement, invalidity?
`
`·5· · · · · · · A.· · Yes, and all of the science related
`
`·6· · · · ·to stereochemistry and the R&D process and so
`
`·7· · · · ·on.· It was a very long case, and that one did
`
`·8· · · · ·go to trial.
`
`·9· · · · · · · Q.· · Who won?
`
`10· · · · · · · A.· · We did.
`
`11· · · · · · · Q.· · Okay.· What about in the ACE
`
`12· · · · ·inhibitor case?· Who won?
`
`13· · · · · · · A.· · That one was settled and I never
`
`14· · · · ·asked the settlement terms, but I was told that
`
`15· · · · ·the client was -- was pleased with the
`
`16· · · · ·settlement.
`
`17· · · · · · · Q.· · Okay.
`
`18· · · · · · · A.· · So that's all I know.
`
`19· · · · · · · · · · Then I did one with -- and still in
`
`20· · · · ·the process -- Perkins Coie on esomeprazole,
`
`21· · · · ·and I did, I think, two depositions on that one
`
`22· · · · ·and I think I did two on the one with Goodwin
`
`23· · · · ·Procter.· And --
`
`24· · · · · · · Q.· · You were on the generic side then
`
`25· · · · ·not the AstraZeneca side?
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
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`YVer1f
`
` P.12
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 13
`
`·1· · · · · · · A.· · I was on the generic side on that
`
`·2· · · · ·one, yes.
`
`·3· · · · · · · Q.· · You said you did two depositions.
`
`·4· · · · ·Were there two different cases?
`
`·5· · · · · · · A.· · No, there was one case.· I did two
`
`·6· · · · ·and sometimes I do two, and I never know
`
`·7· · · · ·exactly why.
`
`·8· · · · · · · Q.· · Okay.· What was that?· What was
`
`·9· · · · ·your testimony about?
`
`10· · · · · · · A.· · That one was on crystal structure,
`
`11· · · · ·physical properties of molecules.· The, again,
`
`12· · · · ·always the R&D process, FDA regulation as --
`
`13· · · · ·and pharmaceutics in that case as well.
`
`14· · · · · · · Q.· · Let me ask you.· Are you an expert
`
`15· · · · ·on crystal structure?· Is that one of your
`
`16· · · · ·areas?
`
`17· · · · · · · A.· · It depends how you describe expert.
`
`18· · · · ·Being president of research and development, I
`
`19· · · · ·supervised every single group.
`
`20· · · · · · · Q.· · Sure.
`
`21· · · · · · · A.· · And these are groups of thousands
`
`22· · · · ·of people each.· So in the pharmaceutics group,
`
`23· · · · ·it would be thousand -- a thousand people and
`
`24· · · · ·I -- and I've obviously had to review and
`
`25· · · · ·evaluate and assess all that work.· But I also
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.13
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 14
`
`·1· · · · ·had extensive training in physical properties
`
`·2· · · · ·of molecules, physical chemistry, organic
`
`·3· · · · ·chemistry, extensive medicinal chemistry.· So
`
`·4· · · · ·that's -- so I wouldn't -- I'm a pharmacologist
`
`·5· · · · ·by training, so...
`
`·6· · · · · · · Q.· · Right.· What does that mean, to be
`
`·7· · · · ·a pharmacologist?· Does that mean you're
`
`·8· · · · ·basically an animal guy?
`
`·9· · · · · · · A.· · Well, yeah, to put it crudely. I
`
`10· · · · ·study and discover drugs based on animal models
`
`11· · · · ·of disease, and pharmacology is basically the
`
`12· · · · ·study of drugs in living systems.· And it's --
`
`13· · · · ·it's not necessarily animals, but I've studied
`
`14· · · · ·drugs personally from the gene all the way up
`
`15· · · · ·to the animal.· And then, of course, I am
`
`16· · · · ·involved and have always been involved in
`
`17· · · · ·clinical trial design.· So in a sense, I do it
`
`18· · · · ·from the gene to the human but --
`
`19· · · · · · · Q.· · The work that you personally did in
`
`20· · · · ·the lab, was it more animal focused or more
`
`21· · · · ·gene focused or where would you say your work
`
`22· · · · ·was?
`
`23· · · · · · · A.· · It was all of them.· I would say
`
`24· · · · ·it's fairly balanced, and also a good part of
`
`25· · · · ·my career was based on stereochemistry and
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.14
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 15
`
`·1· · · · ·structure activity relationships, which
`
`·2· · · · ·involves a great deal of organic chemistry.· So
`
`·3· · · · ·I have very broad training.
`
`·4· · · · · · · · · · And so to get back to your
`
`·5· · · · ·question, I don't necessarily pass myself off
`
`·6· · · · ·as an expert in all those areas, but I have
`
`·7· · · · ·extensive experience because I've managed,
`
`·8· · · · ·well, tens of thousands of scientists and been
`
`·9· · · · ·responsible for large R&D groups.· At Wyeth, it
`
`10· · · · ·was 7,000 people in every single discipline
`
`11· · · · ·from the gene through the human.
`
`12· · · · · · · · · · So -- so that's my -- my
`
`13· · · · ·experience.
`
`14· · · · · · · Q.· · You said -- which areas do you pass
`
`15· · · · ·yourself off as an expert?
`
`16· · · · · · · A.· · I --
`
`17· · · · · · · · · · · ·MR. DELAFIELD:· Objection.
`
`18· · · · · Vague.
`
`19· · · · · · · · · · · ·THE WITNESS:· The -- certainly I
`
`20· · · · · am a pharmacologist and I feel competent to
`
`21· · · · · deal with all areas of pharmacology in all
`
`22· · · · · therapeutic areas, and I am -- I am, indeed,
`
`23· · · · · recognized worldwide as an expert in
`
`24· · · · · stereochemistry and in structure activity
`
`25· · · · · relationships, which is a complex intermix
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.15
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 16
`
`·1· · · · · between chemistry and pharmacology.· And
`
`·2· · · · · I've directed my own personal chemistry
`
`·3· · · · · laboratories.
`
`·4· · · · ·BY MR. POLLACK:
`
`·5· · · · · · · Q.· · How many people working in those
`
`·6· · · · ·chemistry laboratories that you directed?
`
`·7· · · · · · · A.· · In the -- because those
`
`·8· · · · ·laboratories were involved in making compounds
`
`·9· · · · ·primarily for me in my laboratories because I
`
`10· · · · ·kept my laboratory throughout my entire career
`
`11· · · · ·in the industry, both in the structure activity
`
`12· · · · ·field and in the stereochemistry field.
`
`13· · · · · · · · · · So those laboratories would have
`
`14· · · · ·three or four people, usually a Ph.D. or a
`
`15· · · · ·master's level of person and several technical
`
`16· · · · ·staff, but I also was responsible for all of
`
`17· · · · ·medicinal chemistry at Wyeth, which would have
`
`18· · · · ·about 500 chemists, and all of the analytical
`
`19· · · · ·chemistry laboratories, which would have, oh,
`
`20· · · · ·maybe 3-, 400 chemists.· And as you can
`
`21· · · · ·imagine, I had to resolve issues related to
`
`22· · · · ·those areas which often cause us problems in
`
`23· · · · ·drug development.
`
`24· · · · · · · Q.· · Okay.· In other words, you didn't
`
`25· · · · ·know the details of everything those 8- to 900
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.16
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 17
`
`·1· · · · ·people were doing, I assume, day to day?
`
`·2· · · · · · · A.· · No, I didn't know all the details
`
`·3· · · · ·of everything that they were doing day to day,
`
`·4· · · · ·but ultimately I was responsible for making the
`
`·5· · · · ·decisions with respect to drug discovery and
`
`·6· · · · ·even development that came from all those
`
`·7· · · · ·groups.· Those had to be my personal decisions.
`
`·8· · · · ·I was responsible for that.
`
`·9· · · · · · · Q.· · Right.· You were the decider?
`
`10· · · · · · · A.· · Yes.· So I needed to be deeply
`
`11· · · · ·enough involved in the science to make those
`
`12· · · · ·kinds of decisions.
`
`13· · · · · · · Q.· · Okay.· I assume, though, you relied
`
`14· · · · ·on the advice of the medicinal chemists and
`
`15· · · · ·analytical chemists in making those decisions?
`
`16· · · · · · · A.· · Yes.· I, as an executive, would
`
`17· · · · ·rely on the best people around me, but
`
`18· · · · ·ultimately I had to make those decisions and
`
`19· · · · ·sometimes, actually not uncommonly, experts
`
`20· · · · ·disagree, and I would still have to make that
`
`21· · · · ·decision.
`
`22· · · · · · · Q.· · All right.· We were talking about
`
`23· · · · ·your patent cases.
`
`24· · · · · · · A.· · Oh, I'm sorry.· Could you remind me
`
`25· · · · ·where?
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.17
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 18
`
`·1· · · · · · · Q.· · Yes.· We were last on esomeprazole,
`
`·2· · · · ·which you were doing with Perkins Coie.
`
`·3· · · · · · · A.· · Perkins Coie.· And --
`
`·4· · · · · · · Q.· · Let me ask you.· You said you
`
`·5· · · · ·talked about crystal structure in that case.
`
`·6· · · · · · · · · · What did you talk about in regard
`
`·7· · · · ·to crystal structure in that case?
`
`·8· · · · · · · A.· · Oh, polymorphs, amorphic, amorphous
`
`·9· · · · ·forms.· Mixtures between polymorphs and
`
`10· · · · ·amorphous, X-ray crystal, X-ray
`
`11· · · · ·crystallography, XRPD, Raman spectra.· All of
`
`12· · · · ·the technologies involved in determining
`
`13· · · · ·crystal structure and the pharmaceutics
`
`14· · · · ·involved in formulating crystal structures, and
`
`15· · · · ·there were other.· Also, of course, as I said,
`
`16· · · · ·the R&D process and regulatory process and FDA.
`
`17· · · · · · · Q.· · Okay.· All right.· What's the next
`
`18· · · · ·case on your list?
`
`19· · · · · · · A.· · Oh.· There is a case that just
`
`20· · · · ·happened to be on a drug that I discovered and
`
`21· · · · ·I held the patent on where I testified both as
`
`22· · · · ·an expert witness for a former employer as well
`
`23· · · · ·as an expert scientifically on the drug.· The
`
`24· · · · ·drug is called carvedilol and the law firm was
`
`25· · · · ·Fish, et al.· I don't remember the other names.
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.18
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 19
`
`·1· · · · ·In fact, that's still ongoing and --
`
`·2· · · · · · · Q.· · Fish & Richardson?
`
`·3· · · · · · · A.· · Yes, that's right.
`
`·4· · · · · · · · · · And -- and I testified on behalf of
`
`·5· · · · ·the patent holder, obviously.· And that
`
`·6· · · · ·involved every single aspect of that drug from
`
`·7· · · · ·the first day that I touched it until even now
`
`·8· · · · ·and that included, well, basically everything.
`
`·9· · · · · · · Q.· · Were you the inventor on the patent
`
`10· · · · ·in that case?
`
`11· · · · · · · A.· · Yes.
`
`12· · · · · · · Q.· · So are you an expert in that case
`
`13· · · · ·or you're testifying as the fact witness --
`
`14· · · · · · · A.· · Both.
`
`15· · · · · · · Q.· · -- in that case?
`
`16· · · · · · · A.· · Both.· Because I was a company
`
`17· · · · ·employee and obviously I'm the world's expert
`
`18· · · · ·on that drug and so -- and that turned out to
`
`19· · · · ·be a very, very important, highly visible drug.
`
`20· · · · ·I mean, that drug changed how heart failure is
`
`21· · · · ·treated.· It's now the standard of care for
`
`22· · · · ·this disease.· So -- so I was hired to do both
`
`23· · · · ·roles.
`
`24· · · · · · · Q.· · What's the patent about?· What is
`
`25· · · · ·it that was invented?
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support CompanyElisa Dreier Reporting Corp., A U.S. Legal Support Company
`
`950 Third Avenue, New York, NY 10022· · · (212) 557-5558950 Third Avenue, New York, NY 10022· · · (212) 557-5558
`
`YVer1f
`
` P.19
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo,· Robert on 08/19/2016Ruffolo,· Robert on 08/19/2016
`
`Page 20
`
`·1· · · · · · · A.· · The patent is about congestive
`
`·2· · · · ·heart failure.
`
`·3· · · · · · · Q.· · What about congestive heart
`
`·4· · · · ·failure?
`
`·5· · · · · · · A.· · Well, the contention in that case
`
`·6· · · · ·is that the drug, which is a beta blocker,
`
`·7· · · · ·among many other activities that it has, all of
`
`·8· · · · ·which are relevant to heart failure, were
`
`·9· · · · ·discovered in my laboratory -- my laboratories
`
`10· · · · ·at the time -- was obvious and, of course, beta
`
`11· · · · ·blockers at the time and still are
`
`12· · · · ·contraindicated by the FDA and that's the FDA's
`
`13· · · · ·most significant warning against the use of
`
`14· · · · ·such drugs.
`
`15· · · · · · · · · · And so the company challenging
`
`16· · · · ·that -- and I don't remember, I should, I gave
`
`17· · · · ·my deposition a few months ago, but I don't
`
`18· · · · ·remember -- is arguing that it's obvious.· And,
`
`19· · · · ·of course, how could it be obvious if it's
`
`20· · · · ·contraindicated?· And, of course, I also had
`
`21· · · · ·internal notes of all of the opposition within
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