`STEADYMED LTD.,
`UNITED THERAPEUTICS CORPORATION,
`Ruffolo,
`Robert on 08/19/2016
`
`vs
`
`Page 1
`
`UNITED STATES PATENT AND TRADEMARK
`
`OFFICE
`
`THE PATENT TRIAL AND APPEAL BOARD
`
`STEADYMED L
`
`Petitioner,
`
`Vv.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`bo
`
`ul
`
`he
`
`Vickery,
`
`DEPOSITION
`
`>
`OF
`
`ROBERT RR. RUFFOLO, JR.,
`
`PHD
`
`Wilson
`
`Sonsini Goodrich & Rosati
`
`1700 K Street Nw,
`
`Suite 50
`
`Washington, DC 20006
`
`Friday, August
`
`9:29 a.m.
`
`Reported by:
`
`Denise D.
`
`CRR/RMR
`
`JOB NO.
`
`178626
`
`A U.S
`U
`Elisa Dreier Reporting Corp.,
`0022
`950 Third Avenue, New York, NY 1
`
`P.4
`
`Legal Support Company
`(212) 557-5558
`UTEx. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1197 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1197 of 7113
`
`
`
`
`STEADYMED LTD.,
`UNITED THERAPEUTICS CORPORATION,
`Ruffolo,
`Robert on 08/19/2016
`
`vs
`
`Page 2
`
`Petitioner:
`
`PIPER LLP (US)
`
`1251 Avenue of
`
`the Americas
`
`New York, NY 10020-1104
`
`STUART E. POLLACK, ESQ.
`
`33 Arch Street,
`
`26th Floor
`
`Boston,
`
`MA 02110-1447
`
`MAYA PRAKASH CHORSTI,
`
`ESC.
`
`ul
`
`he
`
`ROBERT DELAFIELD, ESO.
`
`For Patent Owner and the
`
`Witness:
`
`WILSON SONSINT
`
`GOODRICH & ROSAT
`
`500
`
`Las
`
`l of
`
`Texas
`
`Austin, TX 78746-5546
`
`S. Legal Support Company
`Elisa Dreier Reporting Corp., AU.
`10022
`(212) 557-5558
`950 Third Avenue, New York, NY
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`P.2
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1198 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1198 of 7113
`
`
`
` BD THERAPEUTICS CORPORATION,
`STEADYMED LTD.,
`Ruffolo,
`Robert on 08/19/2016
`
`vs UNIT
`
`Page 3
`
`(Cont inued}
`
`For Patent Owner:
`
`OLEY & LARDNER LLP
`
`Washington Harbour
`
`3000 K
`
`treet, NW, Suite 600
`
`Washington,
`
`DC 20007-5105
`
`STEPHEN 8B.
`
`MABRIUS, ESO.
`
`bo
`
`ul
`
`he
`
`Solomon Francis,
`
`Also Present:
`
`Videographer
`
`Corp.,
`rtd
`reier Re
`lisé
`A U.S. Legal Support Company
`Elisa Dreier Reporting Corp
`0022
`(212) 557-5558
`New York, NY 1
`950 Third Avenue,
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`P.3
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1199 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1199 of 7113
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 4
`
`EXAMINATION OF ROBERT R. RUFFOLO, JR.,
`
`PHD
`
`PAGE
`
`BY MR. POLLACK
`
`ul
`
`AFTERNOON SESSION
`
`EX HIBI?TS
`
`RUFFOLO
`
`DESCRIPTION
`
`he
`
`Exhibit 1
`
`Petitioner's Notice of Deposition
`
`of Robert R. Ruffolo, Jr., Ph.D.
`
`Exhibit 2
`
`Curriculum Vitae, UT Ex. 2023
`
`Exhibit
`
`3 Declaration of Robert RK. Ruffolo,
`
`Jxv., Ph.D.
`
`in Support of Patent Owner
`
`Response to Petition, UT Ex. 2022
`
`Exhibit 4
`
`United States Patent No. 8,497,393
`
`Batra et al., SteadyMed Exhibit 1001
`
`Exhibit 5
`
`United Therapeutics Letter Dated
`
`2 January 2009 to FDA/CDER, UT Ex. 2006
`
`Exhibit 6
`
`CDER Reviewer Guidance,
`
`Validation of Chromatographic Methods,
`
`November 1994, UT Ex. 2035
`
`Exhibit 7
`
`Joc Article: The Intramolecular
`
`205
`
`Asymmetric Pauson-Khand Cyclization as a
`
`Novel anc General Stereaselective Route to
`
`enzindene Prostacyclins, Moriarty et al.
`
`SteadyMed Exhibit 1004
`
`Elisa Dreier Reporting Corp., A U.S
`950 Third Avenue, New York, NY 10022
`P.4
`
`Legal Support Company
`(212) 557-5558
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1200 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1200 of 7113
`
`
`
`ul
`
`he
`
`STHADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`TOS
`
`RUFFOLO
`
`DESCRIPTION
`
`Exhibit &
`
`Guidance for Industry,
`
`Non-Penicillin Beta-Lactam Druacs:
`
`Framework for Preventing Cross-Contamination
`
`HHS/FDA/CDER April 2013, UT Ex. 2047
`
`Exhibit
`
`93
`
`Diabetes Care, Clinical
`
`Pharmacology of Human Insulin, UT
`
`Exhibit 10
`
`FDA/HSS Letter Stamped
`
`Mar 10, 2014 to Dean Bunce of United
`
`Re Remodulin
`
`Exhibit 11 Patent Owner Response to Petition
`
`3
`
`
`
`{Exhibits attached to transcript.)
`
` eler Reporting Corp., A U.S. Legal Support Compe
`U.S
`Elisa Dr
`(212) 557-
`950 Third Avenue, New York, NY 1002
`
`UT Ex. 2058
`
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`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
`
`Page 6
`
`ul
`
`aad
`
`he
`
`THE VIDEOGRAPHER: Good morning.
`
`This begins Media Unit No.
`
`1 of the
`
`audiovisual deposition of Dr. Robert Ruffolo
`
`taken in the matter of SteadyMed Limited,
`
`Petitioner versus United Therapeutics
`
`Corporation, Patent Cwner, before the Patent
`
`Trial and Appeal Board,
`
`IPR No.
`
`This deposition
`
`the
`
`law of
`
`fi
`
`+ 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
`
`our
`
`court reporter, Denise Vickery, for
`
`Elisa Dreler Reporting Corp.
`
`located at
`
`Third Avenue, New York, New York.
`
`For the record, would counsel
`
`petitioner, SteadyMed Limited.
`
`introduce themselves and whom they
`
`represent.
`
`MR. POLLACK: Stuart E. Pollack,
`
`DLA Piper LLP(US) on behalf of the
`
`MS. CHOKSI: Maya Choksi, DLA
`
`
`U.S. Legal Support Company
`ier Reporting Corp., A U.S
`2
`(212) 557-5558
`950 Third Avenue, New York, NY 1002
`P.6
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1202 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1202 of 7113
`
`
`
`Page 7
`
`Piper, on behalf of the petitioner.
`
`MR. DELAFIELD: Bobby Delafield,
`
`Wilson Sonsini Goodrich & Rosati, on behalf
`
`of United Therapeutics and the witness.
`
`ul
`
`MR. MAEBIUS: And Steven Maeblus
`
`STEADYMED LTD., vs UNITED THERAPEDTICS CORPORATION,
`Robert on 08/19/2016
`
`he
`
`from Foley & Lardner LEP on behalf cf 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 a
`
`Collows:
`
`EXAMINATION
`
`THE VIDEOGRAPHER:
`
`Please
`
`proceed, counsel.
`
`BY MR. POLLACK:
`
`oO.
`
`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.
`
`My name is Robert Richard
`
` eler Reporting Corp., A U.S. Legal
`s
`Elisa Dr
`2
`950 Third Avenue, New York, NY 1002
`P.?
`
`212}
`
`mm
`
`—-W upport Company
`anull
`5;
`557-555
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1203 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1203 of 7113
`
`
`
`fe
`
`ul
`
`ay
`
`he
`
`ba No
`
`ee
`
`Be as
`
`et ui
`
`KB OV
`
`pt =
`
`he Oo
`
`be VE
`
`23
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Ruffolo, and I am the retired president of
`
`research and development at Wyeth and the
`
`self-employed as a pharmaceutical
`
`consultant.
`
`Q.
`
`Do you have like a consulting
`
`a
`
`A.
`
`Consulting,
`
`Page 8
`
`Q.
`
`And that's a company that you
`
`the oniy member
`
`A.
`
`Yes,
`
`Have you been deposed before?
`
`Yes,
`
`I have.
`
`om
`
`How many times have you been
`
`deposed oefore?
`
`A.
`
`Cc.
`
`kinds of
`
`Well, maybe 10.
`
`ust briefly, can you tell me what
`
`were in
`
`two cases of product liability for companies
`
`that IT worked for where I was a company witness
`
`an expert witness in both of those
`
`then the remaining depositions were
`
`isa Dreier Reporting Corp., A U.S. Legal Support Company
`50 Third Avenue, New York, NY 10022
`(212} 557-5558
`P.8
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1204 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1204 of 7113
`
`
`
`Ruffolo, Robert on 08/19/2016
`
`Page 9
`
`
`
`
`
`ul
`
`aad
`
`he STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Those were patent litigation cases?
`
`Yes,
`
`they were.
`
`Okay. And about six depositions?
`
`About
`
`-- 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
`
`R. Ruffolo, PH.D.
`
`(Document marked for
`
`identification purposes as Ruffoio
`
`Exhibit 1.)
`
`THE WITNESS:
`
`Thank you.
`
`BY MR. POLLACK:
`
`Cc.
`
`And are you in attendance here
`
`today for this deposition in response to
`
`petitioner's notice of deposition?
`
`A.
`
`QC.
`
`Yes,
`
`I am.
`
`Have you testified in any other
`
`you understand thig is a proceeding called an
`
`inter partes review?
`
`A.
`
`Q.
`
`Yes,
`
`I do. Yes.
`
`Okay. Have you testified in any
`
`other inter partes review?
`
`A.
`
`No,
`
`I don't bel
`
` i
`i
`ier Reporting Corp., A U.S. Legal Support Company
`anull
`mm
`950 Third Avenue, New York, NY 10022
`(212) 557-555
`P.9
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1205 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1205 of 7113
`
`
`
`Ruffolo, Robert on 08/19/2016
`
`Page 16
`
`
`
`
`
`ul
`
`aad
`
`Q.
`
`In the glx patent litigations that
`
`u testified in, what dic those concern?
`
`A.
`
`Do you want
`
`the specific company,
`
`law firms?
`
`o.
`
`A.
`
`Yean. Yes.
`
`Okay.
`
`I'll do the best
`
`I
`
`Okay.
`
`A.
`
`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.
`
`he STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`Q.
`
`Was that for the brand name company
`
`ox for the generic company that you were
`
`testifying?
`
`A.
`
`QC.
`
`A.
`
`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
`
`Let me ask you. Was that
`
` i
`i
`ier Reporting Corp., A U.S. Legal Support Company
`anull
`mm
`950 Third Avenue, New York, NY 10022
`(212) 557-555
`P.10
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1206 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1206 of 7113
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page i1
`
`Sanofi-Aventis on the other side
`
`It was Boehrincer Ingelheim.
`
`Boehringer Ingelheim.
`
`So that's why I'm not sure of
`
`drug match.
`
`=F dontt remember. That was
`
`first one I did quite
`
`a while ago.
`
`OG.
`
`Okay. What dic you testify about
`
`case?
`
`he
`
`ul
`
`aad
`
`A.
`
`It was mostly about the R&D process
`
`in that case.
`
`I was an expert
`
`o:
`
`on R&D
`
`process, regulatory requirements, and the FDA.
`
`there was another case.
`
`The
`
`law firm was Goodwin Procter.
`
`The drug was
`
`Azilect, and I represented the patent holder in
`
`that case, and that the patent holder was Teva,
`
`a generic company, but
`
`they do have --
`
`Q.
`
`A.
`
`Right.
`
`some, as you know I'm sure,
`
`they
`
`have a few pranded drugs that they developed.
`
`And then there was --
`
`Q.
`
`Let me ask you. What was your
`
`hestimony about
`
`in that case?
`
`A.
`
`Oh, lt was everything basically.
`
`So I was originally hired -- there were 21
`
`parts to that case.
`
`So I was originally hired
`
`Elisa D
` Ler Reporting Corp.,
`
`950 Third Avenue, New York, N
`
`im
`A U.S. Legal Support Company
`é
`
`Y 10022
`(212
`P11
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`iPR20716-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1207 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1207 of 7113
`
`
`
`ul
`
`aad
`
`he
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEDTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 12
`
`just to do the R&D part, but
`
`then I did
`
`ended up doing 17 of the 21 parts.
`
`So I did
`
`virtually everything on that.
`
`ion
`
`A,
`
`Infringement,
`
`invalidity?
`
`Yes, and all of the
`
`to stereochemistry and the R&D proces
`
`Tt was a very long case, and that one did
`
`trial.
`
`net the AstraZeneca side?
`
`Who won?
`
`We did.
`
`Okay. What about
`
`in the ACE
`
`A.
`
`QO.
`
`inhibitor case? Who won?
`
`A.
`
`That one was settied and I never
`
`asked the settlement terms, but
`
`I was teld that
`
`the client was -- was pleased with the
`
`settiement.
`
`QO.
`
`A.
`
`Gkay.
`
`So that's all I know.
`
`Then I did one with -- and still in
`
`the process -- Perkins Cole on esomeprazole,
`
`and I did,
`
`I think,
`
`two depositions on that one
`
`and I think IT did two on the one with Goodwin
`
`Procter. And
`
`Q.
`
`You were on the generic side then
`
`
`», A U.S. Legal Support Company
`Elisa Dreier Reporting Corp
`x
`
`é
`(212)
`950 Third Avenue, New York, NY 10022
`Z12
`P.12
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1208 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1208 of 7113
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 13
`
`I was on the generic side on that
`
`I also
`
`i
`
`2 3
`
`4
`
`5
`
`5
`
`7
`
`8
`
`3
`
`io
`
`Li
`
`12
`
`13
`
`i4
`
`iS
`
`16
`
`17
`
`128
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`.
`
`You
`
`said you
`
`did
`
`two depositions.
`
`Were there two different cases?
`
`A,
`
`No,
`
`there was one case.
`
`and sometimes I de two, and I
`
`> know
`
`exactly why.
`
`Q.
`
`Okay.
`
`hat
`
`was
`
`that? What was
`
`your testimony about?
`
`on cryst
`
`of moiecules.
`
`always the R&D process,
`
`FDA regulatic
`
`and pharmaceutics in that case a
`
`Cc.
`
`let me ask you. Are you an expert
`
`on crystal structure?
`
`Is that one of your
`
`areas?
`
`A.
`
`Et depends how you describe expert.
`
`ing president of research and development,
`
`I
`
`supervised every single group.
`
`Q.
`
`.
`
`Sure.
`
`And these are groups of thousands
`
`c
`
`.2@
`
`each.
`
`So in the pharmaceutics group,
`
`be thousand
`
`a thousgande people and
`
`and I've obviously had to review and
`
`and agse
`
`ll that
`
`ck. But
`
`Elisa Dreier Reporeens Corp., A U.S. Legal Support Company
`$50 Third Avenue, New York, NY 10022
`(212) 557-5558
`P.13
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1209 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1209 of 7113
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page i4
`
`had extensive training in physical properties
`
`of molecules, physical chemistry, organic
`
`chemistry, extensive medicinal chemistry.
`
`So
`
`Chat's
`
`-- so I wouldnic
`
`I'ma pharmacologist
`
`.
`
`Right. What
`
`that mean,
`
`to be
`
`a pharmacologist? Does that mean you're
`
`basically an animal guy?
`
`A.
`
`Well, yeah,
`
`study and discover drugs based
`
`of disease, and pharmacology
`
`study of drugs in living systems.
`
`Career was
`
`it's not necessarily animais, but
`
`studied
`
`drugs personally from the gene all
`
`way up
`
`te the animal. And then, of course,
`
`I am
`
`and have always been involved in
`
`trial design.
`
`So in
`
`a sense,
`
`I do it
`
`from the
`
`gene
`
`t
`
`The work that you personally did in
`
`was
`
`more animal focused or more
`
`gene focused or where would you say your work
`
`was?
`
`A.
`
`It was all of them.
`
`s fairly balanced, and
`
`based on
`
`stereochem
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
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`1PR2016-00006
`
`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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`fe
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`ul
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`ay
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`he
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`ba No
`
`ee
`
`Be as
`
`et ui
`
`KB OV
`
`pt =
`
`he Oo
`
`be VE
`
`23
`
`
`
`STEADYMED LTD.,
`Ruffolo,
`
`TED THERAP EL
`Robert on 08/19/2016
`
`vse UNI
`
`
`
`
`
`ITI
`
`CS CORPORATION,
`
`Page 15
`
`structure activity
`
`relationships, which
`
`involves
`
`a
`
`great deal
`
`of orga
`
`nic chemistry.
`
`I have very br
`
`ead training.
`
`tens of
`
`thousands
`
`of
`
`scientists and been
`
`ve managed,
`
`responsible for large R&D groups.
`
`At Wyeth, it
`
`was 7,000
`
`people in every sine
`rqieé discipline
`
`from the gene through
`
`the
`
`experience.
`
`do you
`
`MR.
`
`DELAPIELD ;
`
`Objection.
`
`THE
`
`WITNE
`
`SS:
`
`The
`
`certainly I
`
`complex inihermix
`
`am a pharmacologist
`
`deal
`
`wit!
`
`all areas
`
`therapeutic areas,
`4Liu
`
`recog
`
`eo.
`
`worldwide
`
`ompe Lent
`
`of pharmacology in all
`
`and I am
`
`am,
`
`indeed
`
`as an
`
`expert
`
`in
`
`structure activity
`
`which
`
`Ls a
`
`Reporting Corp.,
`aVverTlue, New York,
`
`U.S. Legal Support Company
`10022
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`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1211 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1211 of 7113
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`fe
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`ul
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`ay
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`he
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`ba No
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`ee
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`Be as
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`et ui
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`KB OV
`
`pt =
`
`he Oo
`
`be VE
`
`23
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEDTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`1)
`
`bea oN
`
`between chemistry and pharmacology.
`
`scted my own personal chemistry
`
`laboratories.
`
`BY MR. POLLACK:
`
`Q.
`
`How many people working in tnose
`
`chemistry laboratories that you directed?
`
`In the --
`
`muse
`
`those
`
`laboratories were
`
`in making compounds
`
`primarily for me in my laboratories because I
`
`kept my Laboratory throughout my entire career
`
`in the industry, both in the structure activity
`
`field and in the stereochemistry field.
`
`So those laboratories wouid nave
`
`three or four people,
`
`master's level of person anc
`
`staff, but
`
`T also was responsible for all of
`
`medicinal chemistry at Wyeth,
`
`ich would have
`
`about 5C0
`
`chemists, and ail
`
`' the analytical
`
`chemistry laboratories, which would have, oh,
`
`maybe 3-,
`
`4
`
`chemi
`
`And as you can
`
`Pa
`
`imagine,
`
`those areas which often
`
`drug development.
`
`Q.
`
`Okay.
`
`In other words, you didn't
`
`know the details of everything those 8- ta 960
`
`Lsa Dreier Reporting Corp., A
`hel
`aA
`\
`Avenue, New
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`sort Company
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`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1212 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1212 of 7113
`
`
`
`STEADYMED LTD.,
`THERAPEUTICS CORPORATION,
`Ruffolo,
`Robert on 08/19/2016
`
`VS
`
`UNTTPED
`
`1)
`
`bea ~I
`
`I
`
`fe
`
`ul
`
`ay
`
`he
`
`ba No
`
`ee
`
`Be as
`
`et ui
`
`KB OV
`
`pt =
`
`he Oo
`
`23
`
`
`
`oing,
`
`I
`
`assume, day to day?
`
`No,
`
`I
`
`didn't know ail the details
`
`of everything that they were
`
`but ultimately I
`
`was responsib!
`
`decisions wit
`
`respect
`
`to
`
`arug3
`
`discovery and
`
`even development
`
`came from all
`
`groups.
`
`I was
`
`be my personal decisions.
`
`that.
`
`You were the decider?
`
`A.
`
`So I needed to be deeply
`
`enough involved
`
`kinds of decisic
`
`the science to make those
`
`Q.
`
`Okay.
`
`I assume,
`
`on the advice of
`
`the medicinal
`
`relied
`
`and
`
`analytical cl
`
`A.
`
`an executive, would
`
`rely on the
`
`ultimately =
`
`had
`
`people arcund me, but
`a
`to make those decisions and
`
`ometimes,
`
`actually
`
`nok uncommonly, experts
`
`disagree,
`
`and I
`
`would still
`
`have
`
`Oo make that
`
`All right.
`
`your patent case
`
`5.
`
`A.
`
`Oh,
`
`'m sorry. Could you remind me
`
`Elisa Dreier Report
`950 Third Avenue,
`
`ing Corp., A U.S. Legal Support Company
`hog
`(
`}
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`557-5558
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`SteadyMed v.
`
`United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
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`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1213 of 7113
`
`
`
`STHADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`1)
`
`bea ab
`
`Pa
`
`QC.
`
`Yes. We were last on esomeprazole,
`
`which you were doing with Perkins Cole.
`
`A.
`
`.
`
`Perkins Coie. And --
`
`Let me ask you.
`
`You said you
`
`iked about crystal structure in that case.
`
`What did you talk about
`
`in regard
`
`i
`
`structure in that case?
`
`remember the other
`
`.
`
`polymorphs, amorphic, amorphous
`
`forms. Mixtures between polymorphs and
`
`amorphous, X-ray crystal, X-ray
`
`erystailography, KRPD, Raman spectra. All of
`
`the technologies involved in determining
`
`structure 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'
`
`your List’
`
`Oh. There is a case that just
`
`happens
`
`on a drug that I discovered and
`
`id the
`
`patent on where I testified both
`
`as
`
`QXE
`
`2
`
`or a former employer as well
`
`sclentificaliy on the crug.
`
`The
`
`drug is called carvedilol and the law firm was
`
`I don't
`
`i
`
`2
`
`3
`
`4
`
`5
`
`8
`
`7
`
`8
`
`9
`
`18
`
`it
`
`12
`
`13
`
`14
`
`35
`
`16
`
`17
`
`18
`
`i9
`
`20
`
`21
`
`22
`
`23
`
`24
`
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`$50 Third Avenue, New York, NY 10022
`(212) 557-5558
`P.18
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1214 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1214 of 7113
`
`
`
`ul
`
`ToLU
`
`he
`
`pt ~t
`
`bo tad
`
`
`
`THE TIRAPEUTICS CORPORATION,
`
`STEADYMED LTD., vs UNITED
`Ruffolo, Robert on 08/19/2016
`
`In fact,
`
`that's still ongoing and --
`
`Q.
`
`A.
`
`Fisn & Richardson?
`
`>
`
`that's right.
`
`on benalf of
`
`the patent holder,
`
`And that
`
`invoived every single a
`
`of that drug from
`
`the first day that I
`
`it until even now
`
`and that inciuded, well,
`
`everything.
`
`on
`
`Were you the inventor on the patent
`
`in that case?
`
`Yes.
`
`QO.
`
`So are you an expert in that
`
`case
`
`or you're testifying as the fact witness --
`
`A.
`
`that was invented?
`
`A.
`
`Both. Because
`
`was a company
`
`employee and obvicusly I'm the world's
`
`expert
`
`on that drug and so --
`
`ana that turned
`
`out to
`
`be a very, very important,
`
`highly visible drug.
`
`I mean,
`
`that drug changed how heart failure is
`
`treated.
`
`It's now the
`
`standard
`
`of care for
`
`this disease.
`
`So -- soe
`
`to do both
`
`Q.
`
`What's the patent
`
`about? What is
`
`New York, NY
`
`Reporting Corp., A
`
`U.S. Legal
`10022
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`
`
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`
`SteadyMed v.
`
`United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1215 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1215 of 7113
`
`
`
`fe
`
`ul
`
`ptbaeeBK
`
`bel
`
`ui
`
`KBet OV
`
`pt
`
`fe
`
`bo
`
`boaSGas
`
`ho mM
`
`STEADYMED
`Ruffolo,
`
`
`
`
`LTD., vs UNITED THERAPERUTICS
`Robert on 08/19/2016
`
`CORPORATION,
`
`17
`
`ho oO
`
`The patent
`
`ils about cong
`
`e
`
`heart failure.
`
`A.
`
`Well,
`
`tk
`
`=
`
`CO
`contention in
`
`that case
`
`is that the drug, which is
`
`a beta blocker,
`
`among many other activities that it
`
`has,
`
`all of
`
`which are relevant to
`
`heart failure,
`
`discovered in my laboratory -- my 1
`
`at
`
`the time
`
`was obvious and, of
`
`blockers at the time and still are
`
`contraindicated by the FDA and that
`
`a
`
`t
`
`s
`
`most.
`
`warning against th
`
`e use of
`
`And so the company
`
`that -- and I don't remember i
`
`my deposition a few months ago,
`
`remember -- is arguing that it's
`
`obvious.
`
`And,
`
`° £
`
`s
`course, how could it be obvious
`
`if it's
`
`contraindicated? And, of cour
`
`nad
`
`internal notes of all of the opposi
`
`tion within
`
`at that time GlaxoSmithKline,
`
`who was my
`
`that time,
`
`against ceveloping that
`
`thought it would
`
`Kill people.
`
`had
`
`as the person wh
`
`o
`sa Dreier Reporting Corp., A U.S. Legal Support Company
`Q Third Avenue, New York, NY 10022
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`SteadyMed v.
`
`United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1216 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1216 of 7113
`
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`17
`
`ho He
`
`Pa
`
`live ail that and waking up every morning
`
`thinking everybody says I'm going to kill
`
`people with this drug in these clinical trials
`
`and now it's a standard of care, it clearly
`
`A.
`
`So that's basically what my role
`
`contraindication for drugs like that in heart
`
`.
`
`.
`
`.
`
`Is the patent
`
`on
`
`the chemical?
`
`he patent is
`
`the use in neart
`
`Use in heart failure. Okay.
`
`~~ which is mainly what the drug is
`
`It wasn't
`
`invented for that reason.
`
`Someone else invented the chemical;
`
`Another person synthesized -- first
`
`synthesized that and
`
`and
`
`the use was in
`
`dispute for a number of years. And when my
`
`laboratorie
`
`|
`
`as the senior vice
`
`‘eside
`
`in
`
`the company at that time, but my
`
`laboratories were pointing us into the
`
`direction of heart failure, and that wasn't a
`
`very popular decision given, again,
`
`the FDA's
`
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`
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`United Therapeutics EX2006
`Page 1217 of 7113
`
`i
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`2
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`3
`
`4
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`5 5 7
`
`8 9
`
`io
`
`Li
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`i9
`
`20
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`at
`
`22
`
`23
`
`24
`
`
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1217 of 7113
`
`
`
`fe
`
`ul
`
`ptbaeeBKtadNoRA¢
`
`ft i
`
`bt ua
`
`bo Ge
`
`
`
`
` THERAPEUTICS
`STEADYMED LTD., vs UNITED
`Ruffolo, Robert on 08/19/2016
`
`CORPORATION,
`
`go@(Q D ho Ny
`
`failure.
`
`So it was quite
`
`Situation for 17
`
`years, although I
`
`loved every minute of it,
`
`but
`
`that drug did not
`
`have a lot of friends until
`
`the
`
`FDA approved it
`
`the
`
`Wall Street Journ
`
`al
`
`Your role in that
`
`was
`
`in
`
`uy the clinical trials
`
`Or
`
`what was
`
`your role?
`
`A.
`
`It was everything.
`
`My role was
`
`everything.
`
`preciinical
`
`discovery work.
`
`I
`
`was
`
`on the team.
`
`In fact,
`
`wrote
`
`early
`
`every
`
`clinical trials.
`
`right now.
`
`QC.
`
`And are the
`
`re any
`
`other
`
`There may be, but
`
`I'm not
`
`t coming to mind.
`
`Okay.
`
`Sorry.
`
`That's
`
`that's
`
`all I'm
`
`cOMmMLng
`
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`U.S. Legal Support Company
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`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1218 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1218 of 7113
`
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 23
`
`fe
`
`ul
`
`feboKBetBepeheeSay”OVuibet
`
`co
`
`be
`
`them I don't even know yet
`
`E knew that they fall in my
`
`and -- and so there are two
`
`Q.
`
`Other than this particular
`
`proceeding that we're doing richt
`
`done any other work for United Therapeutics?
`
`A.
`
`No,
`
`I have not done anything with
`
`United Therapeutics before.
`
`Q.
`
`Okay.
`
`Go this is
`
`litigations or amything e
`
`A.
`
`No, nothing on any.
`
`Iive ever had any contact with
`
`Therapeutics before.
`
`Cc.
`
`And what about with
`
`When did you first cet
`
`law firms that are present here on behalt
`
`United Therapeutics, either
`
`sy & Lardner or
`
`Wilson Sonsini? Had you worked with them
`
`before?
`
`A.
`
`No,
`
`I had not.
`
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`IPR2020-00769
`United Therapeutics EX2006
`Page 1219 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1219 of 7113
`
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 24
`
`I believe it was April of last
`
`ul
`
`6
`
`aad
`
`Q.
`
`A.
`
`April 2015?
`
`Yes,
`
`I believe so. Around that --
`
`period.
`
`Q.
`
`A.
`
`And how did you get
`
`I was contacted by Mr. Delafield,
`
`and that's how I got contacted.
`
`what's your hourly
`
`he
`
`Q.
`
`And that's what you're being paid
`
`in this case?
`
`is that what you were paid
`
`in -- approximately in your other cases as
`
`Of
`
`the recent ones,
`
`that.
`
`About how much less?
`
`400 I
`
`think.
`
`CG.
`
`Do you have an idea how much time
`
`you've spent working on this IPR?
`
`
`i
`ier Reporting Corp., A U.S. Legal Support Company
`50 Third Avenue, New York, NY 10022
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`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1220 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1220 of 7113
`
`
`
`STEADYMED LTD.,
`THERAPEUTICS CORPORATION,
`Ruffolo,
`Robert on 08/19/2016
`
`VS UNITED
`
`would guess between 30 and 40
`
`ul
`
`aad
`
`he
`
`nia oat,
`
`the 30 to 46?
`
`I'm guessing.
`
`something
`
`in that
`
`range, plus or minus.
`
`Q.
`
`Okay.
`
`Have you sent either Wilson
`
`Sonsini or United or Foley &
`
`Lardner an
`
`invoice?
`
`A.
`
`I
`
`sent
`
`Wilson et al.
`
`two or three
`
`invoices,
`
`I
`
`think.
`
`Could be four.
`
`Q.
`
`Okay.
`
`Do you have an estimate of
`
`how much the
`
`invoices
`
`totaled?
`
`MR
`
`DELAFIELD: Objection.
`
`Relevance.
`
`THE
`
`WITNESS:
`
`i cues
`
`have totaled between
`
`30 and 4¢ thousand
`
`does
`
`dollars maybe.
`
`BY MR. POLLACK:
`
`Q.
`
`maybe 60
`
`A.
`
`sounds more like
`
`expenses included
`
`in that and --
`
`and
`
`so it could have been more
`
`than 30 or
`
`40 nours.
`
`I just Gon't
`
`remember.
`
`Q.
`
`Okay.
`
`Somewhere between 30 and 60;
`
`that.
`
`sound fair?
`
`
`ier Report
`950 Third Avenue,
`
`ing Corp., A U.S. Legal Support Company
`New York, NY 10022
`(212) 557-5558
`P.25
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1221 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1221 of 7113
`
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 26
`
`I'm not sure it would be as high
`
`ul
`
`he
`
`Okay.
`
`30 and 50?
`
`Maybe.
`
`Okay.
`
`i'm sorry.
`
`I meant to say
`
`something at the beginning and I forgot.
`
`IT have one change in my expert
`
`report
`
`that -- that I'd like to make.
`
`Q.
`
`Okay.
`
`ag --
`
`you what. Let's
`
`till then?
`
`Exhibit 2.)
`
`bring out the expert report
`
`and I'll ask you about that.
`
`Okay.
`
`I'm going to mark
`Q
`as Ruffolo Deposition Exhibit 2 UT Exhibit
`
`MR. POLLACK:
`
`2023,
`
`the curriculum vitae of Robert
`
`Ruffolo.
`
`(Document marked for
`
`identification purposes as Ruffolo
`
`
`Elisa Dreier Reporting Corp., A U.S.
`950 Third Avenue, New York, N¥ 10022
`P.26
`
`Legal Support Company
`5 58
`(2412) 557-5
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1222 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1222 of 7113
`
`
`
`
`
`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`go@(Q D ho ~I
`
`
`
`Thank you.
`
`he
`
`ul
`
`aad
`
`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?
`
`Not -- not that IT know of.
`
`And if you can turn to page 13 in
`
`Okay.
`
`Io just wanted to look at the
`
`ness in Lawsuits."
`
`So the first two cases, one is a
`
`SmithKline Beecham litigation?
`
`A.
`
`Cc.
`
`Yes.
`
`Okay. And the second
`
`Pharmaceuticals litigation?
`
`A.
`
`Ye
`
`those both product liability
`
`kinds of cases?
`
`they were.
`
`They were the two
`
`you mentLloned?
`
`
`i
`ier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557-5558
`P.27
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1223 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1223 of 7113
`
`
`
`
`
`
`THERAPEUTICS
`STEADYMED LTD., vs UNITED
`Ruffolo, Robert on 08/19/2016
`
`CORPORATION,
`
`mentloned
`
`earlier,
`
`yes.
`
`What was the
`
`SmithKiine Beecham one
`
`about?
`
`A.
`
`Well,
`
`that was the diet drug
`
`litigation.
`
`The so-called
`
`Fen-Phen.
`
`Pen- Phen?
`
`@s
`
`What was your testimony about
`
`Were you an expert or a Fact
`
`that cage?
`
`witness?
`
`was
`
`both a
`
`fact
`
`witness
`
`and
`
`expert witness because it
`
`of autonomic pharmacology and s
`
`Q
`
`roles.
`
`C.
`
`Okay. Were you
`
`involved
`
`at
`
`the development of Fen-Phen?
`
`A.
`
`3
`
`19, mo.
`
`SmithKiine
`
`Beecham
`
`indirectly acting sympathomimetic amine,
`
`made phentermine, and I
`
`think that drug maybe
`
`hit the market before
`
`was
`
`born.
`
`QO.
`
`Uh-huh. Yeah,
`
`right.
`
`Oxay.
`
`So why did they involve you
`
`Was
`
`the highest ranking
`
`scientist
`
`in the organization,
`
`and the phentermine is an
`
`and
`
`New York, NY
`
`Reporting Corp., AU.
`10022
`
`8. Legal
`
`P.28
`
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`1PR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1224 of 7113
`
`ul
`
`ToLU
`
`he
`
`pt ~t
`
`bo tad
`
`bo iB
`
`NO in
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1224 of 7113
`
`
`
`Ruffolo, Robert on 08/19/2016
`
`
`
`
`
`(Q D ho oO
`
`Pa
`
`that happens to be one of my fi
`
`expertise and so I was both a fact witness and
`
`witnese.
`
`And what did you do in
`
`basicaliy the same type
`
`role.
`
`I was the president of reseaz
`
`development and, as I
`
`and -- and so I was cbviously
`
`in the company, but it's also an area
`
`fe
`
`ul
`
`ay ¢
`
`he
`
`ba No
`
`ee
`
`Be as
`
`et ui
`
`KB OV
`
`pt =
`
`he Oo
`
`be VE
`
`bo tad STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`
`knew a great deal about.
`
`pharmacological as well as cli
`
`CQ.
`
`And then we have
`
`litigations.
`
`Those
`
`are
`
`the
`
`first two that you
`
`and I
`
`QOpa
`
`Gardiner Robe
`
`And the second
`
`Procter one?
`
`A.
`
`That's correct.
`
`Okay.
`
`I see the other
`
`aren't listed.
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557-5558
`P.29
`UT Ex. 2058
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1225 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 1225 of 7113
`
`
`
`fe
`
`ul
`
`ay ¢
`
`he
`
`ba No
`
`ee
`
`Be as
`
`et ui
`
`KB oN
`
`pt ~~]
`
`he co
`
`be Ao
`
`bo Ge
`
`
`
`
` UNI? ED THERAPEUTICS
`STEADYMED LTD.,
`Ruffolo,
`Robert on 08/19/2016
`
`VS
`
`CORPORATION,
`
`og®(Q D le 2
`
`know what
`
`when I made this
`
`one, and those others are very
`
`recent and so I probably haven't added -- I
`
`just Gidn't add it yet.
`
`jay.
`
`Do you know when this CV was
`
`t updated?
`
`'s gee what publication
`
`maybe a
`
`year or two ago. Being
`4
`publishing so much anymore and
`
`get updated as frequently.
`
`don't
`
`Io don'tt
`
`know when it was, but
`
`reiatively current,
`
`but
`
`T haven't updated
`
`ina
`
`iittie while.
`
`kay.
`
`You didn't have a chance to
`
`itications?
`
`- don': know
`
`aimost all
`
`of them,
`
`I had to sign some
`
`issued by a judge saying you
`
`can't
`
`‘Lose anything about it and so it't@ -- I'm
`+
`not sure I
`
`These were
`
`Tim allowed to
`
`was allowed
`
`to list it.
`
`cases
`
`that were finished
`
`think, all still
`
`engoing, and
`
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