`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page l
`
`UNITED ST TES PATENT AND TRADEMARK OFFICE
`
`THE PATENT TRIAL AND APPEAL BOARD
`
`STEADYMED
`
`Petitioner,
`
`V.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`.4
`
`[\J
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`
`JOSE-3 NC) A 178626
`
`VIDEO DEPOSITIO \T OF
`
`ROBERT R. RUFFOLO,
`
`JR .
`
`,
`
`PHD
`
`Wilson Sonsini Goodrich & Rosati
`
`1700 K Street NW, Suite
`
`uCO
`
`W
`
`ington, DC 20006
`
`Reported by:
`
`Denise D.
`
`Vickery, CRR/RMR
`
`Elisa Dreier Reporting Corp., A U S“ Legal Suppcrt Company
`950 Third Avenue, New York, NY 10022
`(212) 557»5558
`P-i
`UT Ex. 2058
`SteadylVied v. United Therapeutics
`1PR2016n00006
`
`IPR2020-OO769
`
`United Therapeutics EX2006
`Page 1197 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1197 of 7113
`
`
`
`STEADYMED LTD.,
`Ruffolo,
`Robert on 08/19/2016
`
`UNITED
`
`THERAPE
`
`vs
`
`TimUJ. ICS CORPORATION,
`
`Page 2
`
`U1
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`
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`
`of
`
`the Americas
`
`NY 10020—1104
`
`STUART E“
`
`POLLACK, ESQ.
`
`33 Arch
`
`Street,
`
`26th Floor
`
`Boston,
`
`MA O2llOnléé7
`
`MAYA PEA KASH CH
`
`:OKSI,
`
`E$Q.
`
`Q.
`
`For Patent Owner
`
`and
`
`the
`
`Witness:
`
`WILSON SONSIN:
`
`GOODRICH & ROSATI
`
`900 South
`
`Capital Of Texas Highway
`
`Las Cimas Iv,
`
`Fifith
`
`Floor
`
`Austin,
`
`TX 78746-5546
`
`ROBETT
`
`DELAFIELD, ES
`
`Elisa Dreier Reporting Corp., A C Si Legal Suppert Company
`950 Third Avenue, New York, NY 10022
`(212) 557»5558
`P-2
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1198 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1198 of 7113
`
`
`
`.4
`
`[\J
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`
`Washington Harbour
`
`30 O K Street, NW, Suite 600
`
`Washington,
`
`DC 20007m5109
`
`STEPHEN B.
`
`MAEEIUS, ESQ.
`
`Present:
`
`Solomon Francis,
`
`Videographer
`
`STEADYMED LTD., VS UNIT ED
`THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 3
`
`For Patent Owner:
`
`FOLEY & LARDNER LLP
`
`
`
`Elisa Dreier Reporting Corp., A
`950 Third Avenue, New York, NY
`
`".a.
`
`S Legal Suppcrt Company
`0022
`(212) 557»5558
`
`P3
`
`UT Ex. 2058
`SteedyMed v. United Therapeutics
`1PR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1199 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1199 of 7113
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`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 4
`
`I N D E X
`
`EXAMINATION OF ROBERT R. RUFETHJD, JR.,
`
`PHD
`
`PAGE
`
`U1
`
`0‘!
`
`BY MR. POLLACK
`
`AFTERNOON S SSION
`
`E X H I B I T S
`
`)_J
`
`RU“FOLO
`
`DESCRIPTEON
`
`PAGE
`
`Exhibit 1
`
`Petitioner's Notice of Deposition
`
`of Robert R“ Ruffolo, Jru, Ph.D.
`
`Exhibit 2
`
`Curriculum Vitae, UT EX. 2fl23
`
`Exhibit
`
`3 Declaration of Robert R. RufTolo,
`
`26
`
`31
`
`Jr", Ph.D.
`
`in Support of Patent Owner
`
`Response to Petition, UT Ex. 2022
`
`Exhibit 4
`
`United States Patent NO. 8,497,393 62
`
`Batra et a1", SteadyMed Exhibit 1001
`
`Exhibit 5
`
`United Therapeutics Letter Dated
`
`75
`
`2 January 2009 to FDA/CDER, UT EX“ 2006
`
`Exhibit 6
`
`CDER Reviewer Guidance,
`
`Validation of Chromatographic Methods,
`
`November 1994, UT EX1 2035
`
`Exhibit 7
`
`JOC Article: The Intramolecular
`
`205
`
`ation as a
`
`Novel and General Stereoselective Route to
`
`enzindene Prestacyclins, Moriarty et al.
`
`SteadyMed Exhibit 1004
`
`Elisa Dreier Reporting Corp., A U.S Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557»5558
`P4
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1200 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1200 of 7113
`
`
`
`U1
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`0‘!
`
`)_J
`
`STEADYMED LTD. , VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`RUFFOLO
`
`DESCRIPTION
`
`T S
`
`Exhibit 8
`
`Guidance for industry,
`
`NonnPenicillin BetamLactam Drug’:
`
`Framework for Preventing Cross—Contamination
`
`HHS/FDA/CDER April 2013, UT EX. 2047
`
`Exhibit 9
`
`Diabetes Care, Clinical
`
`Pharmacology of Human insulin, UT EX.
`
`Exhibit 10
`
`FDA/HES Letter Stamped
`
`Mar
`
`i
`
`2014 to Dean Bunce OE United
`
`There
`
`1
`
`J
`
`. Re Remodulin
`
`Exhibit
`
`Patent Owner Response to Petit
`
`fiJ
`
`(Exhibits attached to transcrint.)
`
`
`L p
`Elisa Dr
`eier Reporting Corp., A W.Q.
`950 Third Avenue, New York, NY 1002
`
`Legal Support Company
`557~5598
`(212)
`5
`UT'EX.2058
`
`SteadylVied v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1201 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1201 of 7113
`
`
`
`STEADYMED LTD. , VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`U1
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`
`)_J
`
`THE? VIDEO {RZ‘lPH‘EiR 2 Good
`
`firming .
`
`This begins Media Unit No.
`
`l of the
`
`audiovisual deposition of Dr. Robert Ruffolo
`
`taken in the matter of SteadyMed Limited,
`
`Petitioner versus United Therapeutics
`
`Corporation, Patent Owner, before the Patent
`
`Trial and Appeal Board,
`
`IPR No. 2016—00006.
`
`This deposition is being held at
`
`law offices of Wilson Sonsini Goodrich &
`
`Rosati located at 1700 K Street, Northwest,
`
`Washington, DC on August 19, 2016 at
`
`approximately 9:29 a.m.
`
`My name is Solomon Francis and
`
`our court reporter, Denise Vickery, for
`
`Elisa Dreier Reporting Corp,
`
`located at
`
`Third Avenue, New York, N='
`
`F
`
`the record, would counsel
`
`MS. CHOKQI: Maya Choksi, DLA
`
`introduce themselves and whom they
`
`represent.
`
`MR. POLLACK:
`
`‘
`
`. Pollac ,
`
`DLA Piper LLP<US) on behalf
`
`petitioner, SteadyMed Limited.
`
`
`‘er Reporting Corp., H U.S. Legal Support Comp‘
`950 TL rd Avenue, New York, NY 10022
`(212) 557~55s8
`P6
`UT‘Ex.2058
`
`Stead yMed v.
`
`Unwed Therapeufics
`iPR2016n00006
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1202 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1202 of 7113
`
`
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`STEADYMED LTD. , VS UNITED THERAPEUTICS
`Ruffolo, Robert on 08/19/2016
`
`CORPORATION,
`
`)iper, on behalf of the petitioner.
`
`MR. DELAFIELD:
`
`-elafield,
`
`Wilson Sonsini Goodrich & Rosati, on behalf
`
`of United Therapeutics and the witness.
`
`MR. MAEBIUS:
`
`And Steven Maebius
`
`from Foley & Lardner LLP on behalf of patent
`
`owner“
`
`THE VIDEOGRAPHER: At this time,
`
`will the court reporter please swear in or
`
`affirm the witness.
`
`ROBERT R. RUFFOLO,
`
`called for examination, and,
`
`after having been
`
`duly sworn, was examined and testified as
`
`follows:
`
`EXAMINATIQN
`
`THE VIDEOGRAPHER:
`
`Please
`
`My name is Robert Richard
`
`proceed, counsel.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Q.
`
`Good morning,
`
`Dr. Ruffolo.
`
`Good morning.
`
`To get
`
`started,
`
`if you could just
`
`state your
`
`name and your current position for
`
`the record.
`
`A.
`
`Okay.
`
`Elisa
`950
`
` eier Report
`Dr
`Third Avenue,
`
`ing Corp.,
`New York, NY
`
`2
`
`P-7
`
`l
`
`UT Ex. 2058
`SteadyiVied v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1203 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1203 of 7113
`
`
`
`
`
`
`STEADYMED LTD. , VS UNITTD TH'QRAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Pace 8
`
`l
`
`2
`
`Ruffolo, and I am the retired presiden’ of
`
`research and development at Wyeth and the
`
`it
`
`n
`
`'._
`
`erorate VP of Wyeth and I
`
`~—
`
`and se“fnemployed as a pharmaceutical
`
`consultant.
`
`Q.
`
`Do you have like a consulting
`
`company or
`
`A.
`
`Consulting,
`
`and then the remaining depositions were
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`\3
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`in: (I)
`
`i;
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Q.
`
`And that's a company that you
`
`the only member of?
`
`A“
`
`,-
`
`.
`
`Q.
`
`Ye= _,
`
`I am.
`
`Have you been depoitd o
`
`Yes,
`
`I lave.
`
`How many times have you Deen
`
`deposed before?
`
`Well, maybe 10“
`
`A“
`
`Q“
`
`kinds of
`
`.
`
`.
`
`.
`
`In
`
`four of those were in
`
`' product liability for companies
`
`L'
`
`.
`
`I worked for where I was a company witness
`
`‘
`
`.1
`
`as an expert witness in both of those
`
`“iea Dreier Reporting Corp., A U.s. Legal Support Company
`"r Xvenue, New York, NY 10022
`(212) 557~5558
`P-S
`UT Ex. 2058
`SteadylVied v. United Therapeutics
`iPREOiBnOOOOG
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1204 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1204 of 7113
`
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`
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`)_J
`
`
`
`
`STEADYMED LTD. , VS UNIT?D TH'QRAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Those were patent litigation cases?
`
`Yes,
`
`they were.
`
`And about six depositions?
`
`-_ yeah, about six.
`
`Just to get some
`
`formalities out of the way,
`
`I'm going to
`
`mark as Ruffolo Deposition Exhibit 1 the
`
`Petitioner‘s Notice of Deposition of Robert
`
`other inter partes review.
`
`R. Ruffolo, Ph.D.
`
`(Document marked for
`
`identification purposes as Ruffolo
`
`Exhibit 1.)
`
`THE WITNESS:
`
`Thank you.
`
`BY MR. PDLLACK:
`
`Q.
`
`And are you in attendance here
`
`today for this deposition in response to
`
`petitioner's notice ef deposition?
`
`Ye',
`
`I am.
`
`Q.
`
`Have you testified in any other ~—
`
`you understand this is a proceeding called an
`
`inter partes review?
`
`A.
`
`Q.
`
`Y-s,
`
`I do. Yes.
`
`Okay. Have you testified in any
`
`
`‘er Reporting Corp., H U.o. Legal Support Comrany
`5 8
`2‘
`(
`K
`950 TL rd Avenue, New York, NY 10022
`21”
`P9
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1205 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1205 of 7113
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`
`STEADYMED LTD. _, VS UNIT’TI) TH’QRAPEUTICS CORPORATION,
`Ruffolo,
`Robert on 08/19/2016
`
`"C19}LC: ('3 lA L?
`
`In the six patent Iitigations that
`
`did those concern?
`
`U1
`
`0‘!
`
`)_J
`
`Do you want
`
`the spec7.ic cempany,
`
`law firms?
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Yeah. Yes.
`
`Okay.
`
`I'll do the best
`
`I
`
`Okay.
`
`One was Gardiner Roberts and the
`
`drug was an ACE inhibitor and Tandrolapril.
`
`Tandolapril,
`
`I think. Trandolapril,
`
`I
`
`think.
`
`Q.
`
`Trandolapril?
`
`think so.
`
`I can‘t be certain.
`
`I
`
`remember.
`
`Let me ask yeu. Was that
`
`Q.
`
`Was that for the brand name company
`
`or for the generic eempany that you were
`
`testifying?
`
`That one was for the generic and —~
`
`DO you remember which company?
`
`Yes.
`
`It was Novartis.
`
`Sandoz,
`
`their generic division.
`
`Q.
`
`A.
`
`Okay.
`
`Then there
`
`
`‘er Reporting Corp., n U.e. Legal Support Comrany
`21”
`8
`950 TL rd Avenue, New York, NY 10022
`2‘
`(
`K
`5
`P10
`UT'EX.2058
`
`SieadyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1206 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1206 of 7113
`
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`STEADYMED LTD. , VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`":1p.)LC: (T) Ii ,_
`
`SanofinAventis on the other side or
`
`Eoehringer In“
`
`Boehringer Ingelheim.
`
`So that‘s why I'm not sure of the
`
`drug match.
`
`I don‘t remember. That was the
`
`first one I did quite
`
`a while ago.
`
`Q.
`
`Okay. What did you testify about
`
`cases
`
`A.
`
`It was mostly about the R&D process
`
`in that ca e.
`
`I was an expert
`
`-
`
`on R&D
`
`process, regulatory requirements, and the FDA.
`
`Then there .
`
`‘
`
`,
`
`.i~‘ case.
`
`The
`
`law firm was Goodwin
`
`.
`
`.
`
`The drug was
`
`Azilect, and I
`
`.,f
`
`..t patent holder in
`
`that case, and that the patent holder was Teva,
`
`a generic company, but
`
`they do have ~—
`
`Q«
`
`‘nally hired
`
`as you know I'm sure,
`
`they
`
`have a few branded drugs that they developed.
`
`And then there was e~
`
`Q.
`
`Let me as: you. What was your
`
`testimony about
`
`in that case?
`
`A.
`
`h, it was everything basically,
`
`So I was originally hired mu
`
`there were 21
`
`parts to that case.
`
`So I was or:
`
` ler Reporting Corp.,
`Elisa D
`950 Third Avenue, New York,
`
`
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1207 of 7113
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`United Therapeutics EX2006
`Page 1207 of 7113
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`
`
`STEADYMED LTD. , VS UNITTD TH'QRAPWUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`LG (I) Ii M
`
`Pa
`
`just to do the R&D part, but
`
`then I
`
`ended up doing 17 of the 21 parts.
`
`virtually everything on that.
`
`Q.
`
`A.
`
`Infiringement,
`
`invalidity?
`
`Yes, and all of the scienc
`
`r,lated
`
`to stereochemietry and the R&D proce'.
`
`a d so
`
`on.
`
`It was a very long case, and that one did
`
`go to trial.
`
`not the AstraZeneca side?
`
`Q.
`
`A.
`
`Q.
`
`Who won?
`
`We did.
`
`Okay. What about
`
`in the ACE
`
`inhibitor case? Who won?
`
`A.
`
`That one was settled and I never
`
`the settlement terms, but
`
`I was told that
`
`Client was «~ was
`
`1 5‘ with the
`
`settlement.
`
`Q.
`
`Okay.
`
`So that's all I know.
`
`Then I did one with —— and still in
`
`the process we Perkins Coie on esomeprazole,
`
`and I did,
`
`I think,
`
`two depositions on that one
`
`and I think I did two on th one with Goodwin
`
`Procter. And
`
`Q.
`
`You were on the generic side then
`
`'3‘.
`
`o
`Elisa D
`ier Reporting Corp., H W.e. Legal Su
`
`950 Third Avenue, New York, NY 10022
`P12
`UT'EX.2058
`
`SteedyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1208 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1208 of 7113
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`STEADYMED LTD. , VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`":19;LG (I)
`
`In; La
`
`was on the generic side on that
`
`You said you
`
`Were there two ditferent
`
`A.
`
`No,
`
`there was one case.
`
`I did
`
`ano sometimes I do two, and I never know
`
`exactly why.
`
`Q.
`
`Whi' was that? What was
`
`your testimony about?
`
`BUL I a.so
`
`always the R&D procees,
`
`FDA regulati'
`
`and pharmaceutics in that case
`
`we'
`
`Q.
`
`Let me ask you. Are you an expert
`
`on crystal structure?
`
`Is that one of your
`
`ar
`
`It depends how you describe expext.
`
`president of research and development,
`
`I
`
`Q.
`
`A.
`
`And these are group‘ of thousands
`
`of Deop.e eaci.
`
`So in the pharmaceutics group,
`
`it would be thousand
`
`a thoueand people and
`
`_d I‘ve obviously had to review and
`
`evaluate and ass,
`
`.. Ln
`
`.
`
`...
`
`}..|
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`
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`
`fl ‘.J..1
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`
`r
`~
`isa Dreier Reporting Corp., A o a. Legal Supoort Company
`‘2 V,
`“
`e
`“
`”'r
`) KR7~5558
`xvenue, New York, NY i0022
`(212
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1209 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1209 of 7113
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`
`
`STEADYMED LTD. , VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`£1}LC: ('3
`
`P
`
`in; in.
`
`had extensive training in physical properties
`
`of molecules, physical chemistry, organic
`
`chemistry, extensive medicilal chemistry.
`
`thatis
`
`-
`
`’
`
`wouldn‘t
`
`I’m a pharmacologist
`
`Right. What does that mean,
`
`to be
`
`4
`
`Does that mean you're
`
`my career was based on stereoehemistr”
`
`Well, yeah,
`
`to put it crudely.
`
`study and discover drugs based n animal mO'els
`
`of disease, and pharmacology
`
`study of drugs in living syst:
`
`it's not necessarily animals, but I‘ve studied
`
`drugs personally from the gene all the way up
`
`to the animal. And then, of course,
`
`I am
`
`involved and have always been involved in
`
`I do it
`
`from the
`
`The work that you personally did in
`
`u.
`
`n
`
`was
`
`'; more animal focused or more
`
`gene focused or where wouli you say your work
`
`was?
`
`A.
`
`It was all of them.
`
`it’s fairly balanced, and
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
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`UT Ex. 2058
`SteedyMed v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1210 of 7113
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`IPR2020-00769
`United Therapeutics EX2006
`Page 1210 of 7113
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`
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`APWUTICS
`STEADYMED LTD. , VS UNITTD TH'Q'R
`Ruffolo, Robert on 08/19/2016
`
`CGRPORATION
`
`":1mLC: 11) H m
`
`ipS,
`structure activity relationsh
`
`which
`
`involves a great deal of organi
`
`C
`
`I have very broad training.
`
`And
`
`0 to ge'
`
`don't nece
`
`tens of thousands of
`
`ntists and been
`
`ve managec,
`
`At Wyeth, it
`
`in every
`
`discipline
`
`from the gene through t.
`
`~ so thzt
`
`which i.s a
`
`experience.
`
`Q.
`
`yourself
`
`A.
`
`which areas
`
`do you pass
`
`D E:LA? I E.LID‘
`
`C
`
`)bjectien.
`
`THE WITNESS:
`
`The
`
`—— certainly I
`
`am a pharmacoloqist and I
`
`feel
`
`competent to
`
`d a" wit
`
`of pharmaco
`
`logy in all
`
`therapeutic areas,
`
`and I am
`
`indeed
`
`recognieed worldwide as an
`
`expert
`
`stereochemistry and in
`
`structure
`
`activity
`
`complex
`
`intermix
`
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`5 Legal Supperrt Company
`Reporting Corp., A o.
`venue, New
`0022
`(212) 557~5558
`York, NY 1‘
`
`F315
`
`UT Ex. 2058
`SteedyMed v. United Therapeutics
`1PR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1211 of7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1211 of 7113
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`STEADYMED LTD. , VS UNITTD TH'QRAPWUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`9;LC: (T)
`
`P
`
`in m
`
`between Chemistry and pharmacology.
`
`'
`
`,Cted my own personal
`
`laboratories.
`
`BY MR. POLLACK:
`
`Q.
`
`How many people working in those
`
`chemistry laboratories that you directed?
`
`E.
`
`Tn the
`
`laboratories were '
`
`'
`
`in making compounds
`
`primarily for me in my laboratories because I
`
`kept my laboratory throughout Hg entire career
`
`in the industry, both in the structure activity
`
`field and in the stereoohemistry field.
`
`So those laboratories would have
`
`to 900
`
`three or four people, usually
`
`L
`
`.i or a
`
`master‘s level of person ant t.
`
`.
`
`”echnica
`
`staff, but T
`
`’
`
`.'
`
`"
`
`for all of
`
`medicinal Chemistry at Wyeth,
`
`Ich would have
`
`about 500
`
`1‘
`
`‘
`
`Chemistry
`
`”
`
`1
`
`and all of the analytica'
`
`'
`
`which would have, oh,
`
`maybe 3—,
`
`a
`
`..,‘I)i
`
`And as you can
`
`imagine,
`
`: "
`
`‘
`
`resr"
`
`‘”
`
`‘
`
`'
`
`elated to
`
`those areas which often
`
`,
`
`_
`
`problems in
`
`drug development.
`
`Q.
`
`Okay.
`
`In other words, you didn’t
`
`know the details of everything .
`
`,
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557~5558
`F3316
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`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1212 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1212 of 7113
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`
`STEADYMED LTD. , VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`inLC: 11)
`
`P
`
`[.1 \l
`
`l
`
`2
`
`A.
`
`No,
`
`I didn't know all the details
`
`dey to day?
`
`of everything that they were doing day to day,
`
`but ultimately I was resp01si
`
`le 'or making the
`
`decisions with respect
`
`1
`
`ru discovery and
`
`even development " t came from all f
`
`groups“
`
`11
`
`‘
`
`'
`
`'
`
`‘
`
`ersoqal decisions.
`
`I was
`
`Right.
`
`You were the decider?
`
`So I needed to be deeply
`
`enough i
`
`_
`
`_
`
`f
`
`L“. science to make those
`
`kinds of Ceisi~
`
`Q.
`
`Okay.
`
`on the advice of the medicinal
`
`I'm sorry. Could you remind me
`
`3
`
`4
`
`5
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`6
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`7
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`8
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`\3
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`10
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`11
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`12
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`13
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`14
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`15
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`16
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`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`is an executive, would
`
`people around me, but
`
`I had to make those decisions and
`
`.3
`
`.
`
`mmonly, exp,rts
`
`disagree, anr
`
`I
`
`’
`
`u
`
`'n
`
`.
`
`. to make that
`
`decisix.
`
`Q1
`
`All right.
`
`your patent cas=s.
`
`a
`
`'
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557~5558
`P17
`UT Ex. 2058
`SieedylVied v. United Therapeutics
`1PR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1213 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1213 of 7113
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`STEADYMED LTD. _, VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 18
`
`1
`
`2
`
`Q.
`
`Ye".
`
`e were last on esomeprazole,
`
`which you were doing with Perkins Coie.
`
`A.
`
`Q.
`
`Perkins Coie. And —~
`
`Let me as; you.
`
`You said you
`
`talked about crystal structure in that case.
`
`What did you talk about
`
`in regard
`
`'
`
`‘;
`
`'
`
`7 structure in that case?
`
`_
`
`h, polymorphs, amorphic, amorphous
`
`forms. Mixtures between polymorphs and
`
`amorphous,
`
`.~“
`
`crystal, eray
`
`crystal.ogra'
`
`XRPD, Raman spectra. All of
`
`the technoloair
`
`involved in determining
`
`crystal str1 ture and the pharmaceutics
`
`involved in formulating crystal structures, and
`
`there were other. Also, of course, as I said,
`
`the R&D process and regulatory process and
`
`Okay. All right“ What's
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`\3
`
`10
`
`11
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`12
`
`13
`
`14
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`15
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`16
`
`17
`
`18
`
`1;
`
`20
`
`21
`
`22
`
`23
`
`24
`
`remember the other
`
`'ere is a case that just
`
`H
`
`*,
`
`.
`
`an a drug that I discovered and
`
`". "
`
`ratent on where I testified bot
`
`as
`
`an expert
`
`L
`
`for a former employer as well
`
`‘
`
`‘
`
`ex,ert scientifically on the drug.
`
`The
`
`"
`
`; is called carvedilol and the law firm was
`
`I don't
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557~5558
`F3318
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1214 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1214 of 7113
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`
`STEADYMED LTD. , VS UNITTD TH'QRAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/20‘6
`
`LC: (T) Ii to
`
`Pa
`
`In fact,
`
`that‘s still ongoing and -----
`
`Q.
`
`Fish & Richardson?
`
`A.
`
`on behalf of
`
`the patent holder,
`
`'
`
`'
`
`*=,. And that
`
`involved every single aspect of that drug from
`
`the first day that I
`
`touched it until even new
`
`and that included, well, basica=ly everything.
`
`Q.
`
`Were you the inventor on the patent
`
`in that case?
`
`Les.
`
`it that was invented?
`
`Q"
`
`So are you an expert is that case
`
`or you‘re testifying as the fact witness -—
`
`A.
`
`'\
`,l, ,3
`ease?
`
`A.
`
`Both. Because I was a company
`
`ew9loyee and e viously I'm the world’s expert
`
`on that drug and so ----- and that turned out to
`
`be a very, very important, highly visible drug.
`
`I mean,
`
`that drug changed how heart failure is
`
`treated“
`
`It‘s new the standard of care for
`
`this disease.
`
`do —~ so
`
`was hired to do bwth
`
`Q“
`
`What‘s the patent about? What is
`
`U1
`
`0‘!
`
`)_J
`
`Ex.) LA)
`
`M as
`
`Reporting Corp., n U.S. Legal Su
`
`
`avenue, New York, NY 10022
`,
`UT Ex. 2058
`SteedyMed v. United Therapeutics
`iPR2016n00006
`
`F3719
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1215 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1215 of 7113
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`
`
`iii
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`U1
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`0‘!
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`
`
`
`
`STEADYMED LTD. , VS UNITTIJ TH’QRAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 20
`
`The patent is about congestive
`
`heart failure.
`
`tlu contention in that case
`
`is that “‘
`
`drug, which is a beta blocker,
`
`among many other activities that it has, all of
`
`which are relevant to heart failure, were
`
`discovered in my laboratory ~—
`
`at
`
`the time
`
`was obvious and, of course,
`
`blockers at the time and still are
`
`contraindicated by the FDA and that‘s the FDA‘S
`
`warning against the use of
`
`had to
`
`And so the company challenging
`
`and I don't remember,
`
`I should,
`
`I gov
`
`few months ago, but I don't
`
`remember -
`
`‘s arguing that it‘s obvious. And,
`
`of course, how could it be obvious if it‘s
`
`contraindicated? And, of courie,
`
`I al o had
`
`internal notes of all of the opposition within
`
`at that time GlaxoSmithKline, who was my
`
`t me, against developing that
`
`*ght it would kill people.
`
`as the person wh
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
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`
`United Therapeutics EX2006
`Page 1216 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1216 of 7113
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`
`
`
`STEADYMED LTD. .
`, VS UNITTD TH'Q'R
`APWUTICS CGRPORATTON,
`RuffOlO,
`Robert on 08/19/2016
`
`"C1fl.)LC: ('3 m I—'
`
`that and waking up every morning
`
`everybody says I'm going to kill
`
`people with this drug in these
`
`ical trials
`
`and now it‘s a standard of care, ‘t Clearly
`
`contimal.ndi caa.tion for drugs. ike t1.at in heart
`
`So that's basically what my role
`
`“he patent on the Chemical?
`
`patent is on the u e in heart
`
`Use in heart fai =rC. Okay.
`.‘
`which is mai n=’y what the drug is
`
`It wasn't
`
`invented for that reason.
`
`Someone else inveited the chemical;
`
`Another person. vrtreei7ed —— first
`
`synth-esized that and
`
`the use was in
`
`dispute for a number of years. And when my
`
`lab01.atori
`
`enior vice
`
`the company at that time, but my
`
`were pointing us
`
`into the
`
`dirCction of Heart failure, and hat wasn't. a
`
`very popular deciision given, again,
`
`the FDA’s
`
`[”4
`
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`
`+4 xi
`
`in: (I)
`
`
`
`r Reporting Corp.,
`Avenue, New York, NY i0022
`
`It Company
`I:~57~5558
`UT'EX.2058
`
`Stead yMed v.
`
`Unwed Therapeufics
`iPR2016n00006
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page1217of7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1217 of 7113
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`
`}..|
`
`U1
`
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`
`\D
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`
`STEADYMED LTD. _.
`RuffOlO,
`Robert on 08/19/2016
`
`
`
`
`VS UNIT?D THQRAPEUTICS
`
`CORPORATION,
`
`wmm m [xi m
`
`failure.
`
`So it was quite literally a very
`
`Jitlation fer 17 years, although I
`
`minute of it, but
`
`that drug did not
`
`friends until the FDA approved it
`
`Street Journal inticcted it
`
`Your role in that was in
`
`1g the clinical trials or what was
`
`your role?
`
`A.
`
`It was everything.
`
`My role was
`
`everything.
`
`ran all
`
`f the preclinical
`
`was
`
`In fact,
`
`I
`
`
`
`discovery work.
`
`I
`
`on the team.
`1
`wrote the entire development plan ’or that drug
`
`early on, and I was on th team that monitored
`
`e*ery s
`
`.
`
`' that proc,s , uncladi
`
`clinical trials.
`
`I had input into
`
`Q.
`
`Okay.
`
`And are ther-
`
`A.
`
`There may be, but
`
`I‘m not
`
`they're not coming to mind.
`
`Q.
`
`A.
`
`Okay.
`
`Sorry. That’s mu that’s all I'm
`
`coming
`
`with right now.
`
`TC.
`Reporting Corp., A e.s.
`e, New York, NY 10022
`P22
`
`Legal
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`wort Company
`1:
`‘2 .,
`"3335
`iii?
`
`UT'EX.2058
`
`SteedyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1218 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1218 of 7113
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`
`tut
`
`U1
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`STEADYMED LTD. _.
`Ruffoio,
`Robert on 08/19/2016
`
`
`
`
`VS UNITTD TH'QRAPEUTI CS
`
`CORPORATION,
`
`":1mLC: (T)
`
`iv m
`
`Q.
`
`Okay.
`
`Anything else you‘re working
`
`on right now?
`
`A.
`
`Yes.
`
`Obvieusly this and there
`
`a
`
`others that are just beginnin
`
`right
`
`them I don‘t even know
`
`yet
`
`they fall in my
`
`and SO there are
`
`two
`
`Q.
`
`Other than this particular
`
`proceeding that we‘re doing right
`
`_,
`.S.’
`done any other work for United Therapeutic
`
`A“
`
`NC,
`
`I have not done anything with
`
`United Therapeutics before.
`
`Q.
`
`Okay.
`
`So this is incIuI.
`
`anything else on
`
`nothing on any.
`
`I‘ve ever had any contac.
`
`with United
`
`Therapeutics before.
`
`Q.
`
`And what about with eithe
`
`When did yeu first get
`
`are present here on
`
`Therapeutics, either
`
`Lardner
`
`or
`
`Sensini? Had you worked wi h
`
`them
`
`No,
`
`I had not.
`
`Reporting Corp.,
`e, New York, NY i0022
`
`Supoort Company
`) 557~5558
`UT‘Ex.2058
`
`SteedyiVied v. United Therapeutics
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`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1219 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1219 of 7113
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`STEADYMED LTD. , VS UNITTD TH'QRAPWUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`"C1i3)LC: ('3 m pp.
`
`U1
`
`6
`
`)_J
`
`Yes,
`
`I believe 30. Around that —~
`
`period.
`
`Q.
`
`A.
`
`And how did you get
`
`I was contacted by M“. Delafield,
`
`and that‘s how I get contacted.
`
`What’s your ----- what’s your hourly
`
`$500 an hour.
`
`Q.
`
`And that's what you're being paid
`
`in this case?
`
`you’ve spent working on this IPR?
`
`t what you were paid
`
`in —— approximately in your other cases as
`
`the recent ones, yes, and the
`
`first one or two was a little bit
`
`le
`
`that.
`
`About how much less?
`
`400 I
`
`think.
`
`Q.
`
`Do you have an idea how much time
`
`
`‘er Reporting Corp., H U.S. Legal Support Company
`950 TL rd Avenue, New York, NY 10022
`(212) 557~5558
`P24
`UT Ex. 2058
`SteedyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1220 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1220 of 7113
`
`
`
`THERAPEUTICS CORPORATION,
`STEADYMED LTD. _, VS UNITED
`Ruffolo, Robert on 08/19/2016
`
`"C19}LC: ('3 m L‘I
`
`would guest between 30 and 40
`
`U1
`
`0‘!
`
`)_J
`
`n t's it,
`
`the
`
`30 to 40?
`
`I‘m guessing.
`
`something in that range,
`
`plus or minus.
`
`Q.
`
`Okay.
`
`Have you sent either Wilson
`
`Sonsini or United or Fole
`
`& Lardner
`
`an
`
`invoice?
`
`A.
`
`I sent
`
`Wilson et a1.
`
`two or three
`
`invoices,
`
`I think.
`
`Could be four.
`
`Q.
`
`Okay.
`
`Do you have an est
`
`imate of
`
`how much the invoices
`
`totaled?
`
`MD
`
`DELAFIELD:
`
`Objection.
`
`Relevance.
`
`THE
`
`WITNESS:
`
`I guess
`
`they may
`
`have totaled between
`
`30 and 40 thousand
`
`
`
`dollars maybe.
`
`BY MR. POLLACK:
`
`maybe 60 hot
`
`A.
`
`sounds more like
`
`included
`
`in that and __ and so it
`
`could have been more
`
`than 30 or 40 hours.
`
`I just don‘t
`
`remember.
`
`Q.
`
`Okay.
`
`Somewhere between 30 and 60;
`
`does that sound flair?
`
`
`‘er Reporting Corp.,
`950 TL rd Avenue,
`New York,
`
`H “.5. Legal Support Comrany
`NY 10022
`21”
`8
`(
`2‘
`K
`5
`P25
`UT‘Ex.2058
`
`SteadyMed v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1221 of7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1221 of 7113
`
`
`
`
`
`
`STEADYMED LTD. _, VS UNITTIJ TH’QRAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 25
`
`i'm nrt sure it would be as high as
`
`Okay.
`
`30 and 50?
`
`U1
`
`0‘!
`
`Okay.
`
`I'm sorry.
`
`I meant to say
`
`something at the beginning and I Forgot.
`
`l have one change in my expert
`
`report
`
`that —— that I'd like to make.
`
`)_J
`
`Q.
`
`Okay.
`
`It was ——
`
`Tell you what. Let‘
`
`Wait till then?
`
`Yeah.
`
`Okay.
`
`Iill bring out the expert report
`
`ask you about
`
`that“
`
`Okay.
`
`MR. POLLACK:
`
`I‘m going to mark
`
`as Ruffolo Deposition Exhibit 2 UT Exhibit
`
`2023,
`
`the curriculum Vitae of Robert
`
`Ruffoloh
`
`(Document marked for
`
`identification purposes as Ruffolo
`
`Exhibit 2.)
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557~5558
`P26
`UT Ex. 2058
`SteadylVied v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1222 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1222 of 7113
`
`
`
`
`
`STEADYMED LTD. , VS UNITTD TH'QRAPWUTICS CORPORATION,
`Ruffolo, Robert on 08/19/ 016
`
`"C19}LC: ('3
`
`iv \l
`
`
`
`Thtufit yorn
`
`BY MR. POLLACK:
`
`Q.
`
`Can you confirm
`
`your CV?
`
`A.
`
`Q.
`
`Yes,
`
`this is my CV.
`
`Okay. Are there any corrections
`
`you want to make to the CV?
`
`A.
`
`Not __ not th*.
`
`i know of.
`
`And if you can turn to page 13 in
`
`U1
`
`0‘!
`
`)_J
`
`you mentioned?
`
`wanted to look at the
`
`"Expert Witness in Lawsuits."
`
`So the first two cases, one is a
`
`SmithKline Beeeham litigation?
`
`A
`
`Q.
`
`Yes- .
`
`Okay. And the second
`
`Pharmaceuticals litigation?
`
`A.
`
`Q.
`
`Yes.
`
`fl“-
`
`those both product liability
`
`kinds of cases?
`
`A.
`
`Yet
`
`they were. Tiey were the two
`
`
`‘er Reporting Corp., h U.o. Legal Support Comrany
`21”
`8
`950 TL rd Avenue, New York, NY 10022
`2‘
`(
`K
`5
`P27
`UT'EX.2058
`
`SteedyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1223 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1223 of 7113
`
`
`
`U1
`
`0‘!
`
`in...\J
`
`)_J
`
`
`
`
`STEADYMED LTD. , VS UNITTD TH'QRAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/20‘6
`
`"C1£1}LC: ('3 m m
`
`mentioned earlier, yes.
`
`What was the SmithKline Beecham one
`
`about?
`
`A.
`
`Well,
`
`that was the diet drug
`
`litigation.
`
`The so~called Fen—Phen.
`
`Q.
`
`Fen—Phen?
`
`Ye'.
`
`indirectly acting sympathomimetic amine, and
`
`Q.
`
`What was your testimony about
`
`that case? Were you an expert or a fact
`
`witness?
`
`was both a fact witness and an
`
`exgert witness because it
`
`'a= within my field
`
`of autonomic pharmacology and so I served both
`
`roles“
`
`Q.
`
`Okay. Were you involved at all in
`
`the development of Fen—Phen?
`
`SmithKline Beecham
`
`made phentermine, and I think that drug maybe
`
`hit the market before I was born.
`
`Q .
`
`Uh — huh .
`
`Okay.
`
`So why did they iivolve you
`
`that case?
`
`An
`
`I was the highest ranking scientist
`
`in the organization, and the phentermine is an
`
`Reporting Corp., a U.S. Legal Su
`
`
`xvenue, New York, NY 10022
`P28
`UT'EX.2058
`
`SteedyMed v. United Therapeutics
`iPREOiBnOOOOG
`
`|PR2020-00769
`
`United Therapeutics EX2006
`Page 1224 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1224 of 7113
`
`
`
`l,__\
`
`U?
`
`0‘!
`
`\D
`
`i’"‘
`
`C)
`
`)_J
`
`._.\ ON
`
`+4 xi
`
`in: (I)
`
`i'“ \x
`
`
`
`
`STEADYMED LTD. , VS UNITTD TH'QRAPEUTICS
`Ruffolo, Robert on 08/19/2016
`
`CORPORATION,
`
`":1mLC: (T)
`
`[xi m
`
`1,.
`that happens to be one oi my fielo of
`
`expertise and so I was both a fact witness and
`
`an expert witneos.
`
`Q.
`
`And what did you d
`
`in the Wyeth
`
`‘ically the same type
`
`role.
`
`I
`
`i
`
`'
`
`’7
`
`president oi
`
`development and, as I
`
`and
`
`and so I was obviously
`
`E
`
`he senior
`
`the company, but
`
`t's also an area
`
`I knew a great deal about
`
`o
`wharmacolocical
`
`>
`
`'2
`
`; Cli
`
`1'J.
`
`Q.
`
`And then we have tw§
`
`patent
`
`first two that
`
`
`
`On
`
`Gardiner Robe
`
`Procter one?
`
`correct“
`
`Okay.
`
`I see the other
`
`aren‘t
`
`liSCed.
`
`" 5. Legal Support Company
`isa Dreier Reporting Corp., A o.
`1'r
`”\
`a
`0022
`(212) 557~5558
`, New York, NY l
`
`P29
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`iPR2016n00006
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 1225 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1225 of 7113
`
`
`
`STEADYMED LTD. _.
`Ruffolo,
`Robert on 08/19/2016
`
`
`
`
`VS UNIT?D THQRAPEUTICS
`
`CORPORATION,
`
`wmm m m 0
`
`I don‘t know
`
`what
`
`when I made this ene,
`
`and those others are
`
`very
`
`recent and so I prebably haven‘t
`
`ad
`
`ded —— I
`
`just didn‘t add it yet.
`
`maybe a
`
`Being
`
`year or two agon
`1
`mu C 51
`
`update yeur it‘s -— I'm
`
`at publishing so
`
`anymore and
`
`requently.
`
`EL
`
`I don't
`
`knew when
`
`it
`
`W618,
`
`but
`
`it's relatively current, but
`
`I
`
`haven‘t updated
`
`it
`
`me while.
`
`You
`
`didn't have a chance to
`
`a;
`
`No, and also
`
`don't know
`
`almost all of them,
`
`I
`
`had to sign some
`
`issued by a judge saying you can't
`
`dL close anything about it and
`-v-
`not sure i was allowed to li
`
`530
`
`These were
`
`c.ses that were finished and
`
`think, all still ongoing, and
`
`I‘m ‘llowed to do that.
`
`n.1- T
`is ‘J
`
`r‘P'r‘"
`.3. Legal Supnort Com
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