`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`WATSON LABORATORIES,
`
`INC.,
`
`Petitioner,
`
`vs.
`
`UNITED THERAPEUTICS CORP.,
`
`Patent Owner.
`
`)
`
`)
`
`)
`
`)
`
`)
`
`IPR NO. 2017-01621
`
`IPR NO. 2017-01622
`
`The videotaped deposition of MAUREEN
`
`DONOVAN, Ph.D., called as a witness for
`
`examination,
`
`taken pursuant to the Federal
`
`Rules of Civil Procedure of the United States
`
`District Courts pertaining to the taking of
`
`depositions,
`
`taken before ANDREA L. KIM, a
`
`Certified Shorthand Reporter of said state, CSR
`
`No. 84-3722, at Suite 4800, 35 West Wacker
`
`Drive, Chicago, Illinois, on the 4th day of
`
`April, A.D. 2018, at 9:37 a.m.
`
`Job No: 54284
`
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 1 of 201
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`Page 2
`
`PRESENT:
`
`WINSTON & STRAWN, LLP
`
`35 West Wacker Drive
`
`Chicago, Illinois 60601
`
`S12-558-8329
`
`BY: KURT A. MATHAS, ESQ.
`
`kmathas@winston.com
`
`appeared on behalf of the Petitioner;
`
`
`
`WILSON SONSINI GOODRICH & ROSATI
`
`1700 K Street, NW, Fifth Floor
`
`Washington, DC 20006-3817
`
`202-973-8812
`
`BY: VERONICA S. ASCARRUNZ, ESQ.
`
`vascarrunz@wsgr.com
`
`-and-
`
`FOLEY & LARDNER, LLP
`
`3000 K Street, N.W., Suite 600
`
`Washington, D.C. 20007
`
`202-672-5569
`
`BY: STEPHEN B. MAEBIUS, ESQ.
`
`smaebius@foley.com
`
`NATASHA IYER, ESQ.
`
`niyer@foley.com
`
`appeared on behalf of Patent Owner;
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 2 of 201
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`Page 3
`
`ALSO PRESENT:
`
`MR.
`
`JEREMY MANGAN, Videographer.
`
`
`
`REPORTED BY:
`
`ANDREA L. KIM,
`
`Illinois CSR No. 84-3722.
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 3 of 201
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`INDEX
`
`Page 4
`
`PAGE:
`
`MAUREEN DONOVAN, Ph.D.
`
`EXAM by MS.
`
`ASCARRUNZG..............
`
`6
`
`EXAM by MR.
`
`MATHAS..... 2.2.22 eee eee ee
`
`158
`
` WITNESS:
`
`kkekkk
`
`tHDE &
`
`EXHIBIT NUMBER
`
`MARKED
`
`Bh DOO8 2
`
`saw eu wus
`
`Br SWE ee we ee ee ee ec ee eee
`
`13
`
`Bxzhibit L001: w ss
`
`eee 13
`
`Exh TOQ02 «aces wevs
`
`2 WIM ee ee ew tc ee wt ce eee 8
`
`Exhibit 1002....
`
`we eee ee ee ee ee eee
`
`9
`
`Exhibit 1003564.
`
`TTTCT 46
`
`Exhibit 1004....
`
`Hon MM ee ee tc ee et ee ee ee 46
`
`Exhibit L005...
`
`ee 47]
`
`Exhibit LOL2:.....
`
`ee 48
`
`Exhibit 1046....
`
`te ee ee ee ee ee ee eee 86
`
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 4 of 201
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`Page 5
`
`MAUREEN DONOVAN, Ph.D.
`
`THE VIDEOGRAPHER: We are now on
`
`
`
`the record. This marks the beginning of media
`
`number 1
`
`in the deposition of Maureen Donovan
`
`in the matter of Watson Laboratories, Inc.,
`
`versus United Therapeutics Corporation in the
`
`U.S. District Court, District of New Jersey.
`
`This deposition is being held at 35
`
`West Wacker Drive, Chicago, Illinois on April
`
`4th, 2018, and the time is now 9:41 a.m.
`
`Will attorneys please identify
`
`themselves.
`
`MR. MATHAS: Good morning. Kurt
`
`Mathas from Winston & Strawn on behalf of the
`
`petitioner Watson Pharmaceuticals, Inc., and
`
`the witness Dr. Donovan, and for the record,
`
`I
`
`would note that the caption read on was the
`
`district court caption. We are actually here
`
`today in proceedings in two IPRs,
`
`IPR No.
`
`2017-1621 and 1622 titled Watson Laboratories,
`
`Inc., v. United Therapeutics Corp.
`
`MS. ASCARRUNZ: Good morning. My
`
`name is Veronica Ascarrunz from the law firm
`
`Wilson Sonsini Goodrich & Rosati
`
`in Washington,
`
`D.C. here representing the patent owner. With
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 5 of 201
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`Page 6
`
`MAUREEN DONOVAN, Ph.D.
`
`me are co-counsel Stephen Maebius and Natash
`
`Iyer of Foley & Lardner in Washington, D.C.
`
`also representing the patent owner.
`
`THE VIDEOGRAPHER: Will
`
`the court
`
`reporter please swear in the witness.
`
`(WHEREUPON,
`
`the witness was duly
`
`sworn.)
`
`MAUREEN DONOVAN, Ph.D.,
`
`called as a witness herein, having been first
`
`duly sworn, was examined and testified as
`
`follows:
`
`BY MS. ASCARRUNZ:
`
`EXAMINATION
`
`
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Dr. Donovan.
`
`Good morning.
`
`Could I get you to state your
`
`full name for the record, please.
`
`A.
`
`C:.
`
`Maureen Donovan.
`
`And you have been deposed
`
`before, correct?
`
`A.
`
`Q
`
`Yes,
`
`I have.
`
`Approximately how many times?
`
`A.
`
`About 11 times.
`
`Have you been deposed in an
`Q
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 6 of 201
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`Page 7
`
`MAUREEN DONOVAN, Ph.D.
`
`IPR proceeding before?
`
`A.
`
`Q.
`
`Yes,
`
`I have.
`
`And,
`
`therefore,
`
`I -- I know
`
`you understand the ground rules.
`
`I'm going to
`
`go over just a few of the most important ones
`
`to make sure we are on the same page.
`
`You understand that you are
`
`here today to testify truthfully because you
`
`are under oath just as if you were ina
`
`courtroom or in front of the Board?
`
`A.
`
`QO.
`
`Yes.
`
`And because we have a court
`
`reporter taking down our questions and answers,
`
`I would ask that you wait until I finish asking
`
`my question before you begin to answer.
`
`
`
`A.
`
`Q.
`
`Is that fair?
`
`Yes.
`
`And if you don't understand
`
`one of my questions, will you please let me
`
`know?
`
`A.
`
`Okay.
`
`Otherwise, if you answer my
`
`question,
`
`I will assume that you understood it.
`
`Is that fair?
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 7 of 201
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`Page 8
`
`MAUREEN DONOVAN, Ph.D.
`
`Yes.
`
`We will probably take a few
`
`A.
`
`Q.
`
`
`
`breaks about on the hour or a little bit longer
`
`than an hour.
`
`If you need to take a break any
`
`time before I call for one, please just let me
`
`know.
`
`A.
`
`0:
`
`Okay.
`
`The only thing I will ask is
`
`if there's a question pending, let's answer the
`
`question first, and then we can take a break.
`
`A.
`
`QO.
`
`Sure.
`
`Are you aware of anything that
`
`prevent you from providing complete and
`
`truthful answers today?
`
`A.
`
`Q.
`
`No.
`
`I will start by handing you
`
`the first exhibit which is marked Exhibit 1002
`
`in case IPR 2017-01622.
`
`(WHEREUPON, a certain document
`
`was marked Deposition Exhibit
`
`1002, for identification,
`
`as of 4/4/18.)
`
`BY MS. ASCARRUNZ:
`
`is this a copy of
`Dr. Donovan,
`Q..
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 8 of 201
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`Page 9
`
`MAUREEN DONOVAN, Ph.D.
`
`your expert declaration provided in case IPR
`
`2017-01622 in connection with Patent No.
`
`9,339,,5077
`
`A.
`
`Q.
`
`It appears to be, yes.
`
`And does this declaration bear
`
`your signature on page 105 of 105?
`
`A.
`
`Yes, it does.
`
`
`
`(WHEREUPON, a certain document
`
`was marked Deposition Exhibit
`
`1002, for identification,
`
`as of 4/4/18.)
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And for the record,
`
`the court
`
`reporter has just handed you Exhibit 1002 in
`
`IPR proceeding 2017-01621.
`
`Dr. Donovan,
`
`is this exhibit
`
`your expert declaration provided in case IPR
`
`2017-01621 in connection with Patent No.
`
`9,358,240?
`
`A.
`
`O.
`
`It appears to be, yes.
`
`And does this bear your
`
`signature on page 91 of 91?
`
`A.
`
`Yes, it does.
`
`So I notice that the two
`Q.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 9 of 201
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`Page 10
`
`MAUREEN DONOVAN, Ph.D.
`
`declarations have obviously different page
`
`numbers.
`
`I understand that there are also a
`
`number of other differences between the two
`
`declarations?
`
`yes.
`
`A.
`
`Q.
`
`There's several differences,
`
`Okay.
`
`One of the major
`
`
`
`differences is that you rely on the Chaudry
`
`reference in connection with the '507 patent,
`
`but not
`
`the '240 patent, correct?
`
`Pe
`
`I believe that's correct, yes.
`
`I could double check, but that's correct.
`
`Q.
`
`Okay.
`
`Since the '507 patent
`
`declaration contains additional pages and the
`
`discussion of Chaudry,
`
`is it fair to
`
`characterize that declaration as containing
`
`more information than is provided in the '240
`
`declaration?
`
`A.
`
`Well,
`
`the declaration for the
`
`'507 addresses issues that aren't pertinent to
`
`the '240.
`
`So it contains additional
`
`information.
`
`Q.
`
`Okay. Apart from those
`
`differences and additional sort of differences
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 10 of 201
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`Page 11
`
`MAUREEN DONOVAN, Ph.D.
`
`in wording, et cetera,
`
`that are found between
`
`the two,
`
`is your opinion between the '240
`
`declaration and the '507 declaration
`
`consistent?
`
`
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I guess there's a number of
`
`items in each of these reports that I express
`
`an opinion about.
`
`So I
`
`think it probably would
`
`be most helpful to step through each one of
`
`those individual items and describe whether my
`
`opinion is consistent or not.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay. And we will. Where I
`
`am trying to go here is I don't want to ask you
`
`seven hours of questions on one and then seven
`
`hours of questions on the other.
`
`I would like
`
`to be able to use your testimony today to
`
`encompass both declarations, and where the
`
`differences are important, we can articulate
`
`those. Either I will do so in my question or
`
`if you feel the need to do so, you would do so
`
`as well.
`
`So that's the context of sort
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 11 of 201
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`Page 12
`
`MAUREEN DONOVAN, Ph.D.
`
`of where I am going with this.
`
`I am not trying
`
`to do like sort of a gotcha of, you know,
`
`equating the two together.
`
`So is it fair to characterize
`
`the two declarations as being related?
`
`A.
`
`Q.
`
`Yes.
`
`Okay. And as having some
`
`degree of overlap?
`
`A:
`
`Yes,
`
`they is speak to many of
`
`the same issues.
`
`Q.
`
`Perfect. Okay.
`
`MS. ASCARRUNZ:
`
`So Kurt with that
`
`context and background, can we agree that this
`
`transcript will be used in both proceedings?
`
`MR. MATHAS: We can agree that the
`
`transcript will be used in both proceedings,
`
`
`
`yes.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`And as I said, Dr. Donovan,
`
`where I -- where my questions are specific to
`
`one patent or the other,
`
`I will try to make
`
`that clear, and I would ask that you do the
`
`same.
`
`If your opinion would different
`
`depending on which patent we are talking about,
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 12 of 201
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`Page 13
`
`MAUREEN DONOVAN, Ph.D.
`
`please let me know.
`
`A.
`
`Q.
`
`Okay.
`
`So that you have them in front
`
`of you should you need them during the
`
`deposition,
`
`I will go ahead and give you the
`
`patents now.
`
`
`
`(WHEREUPON, certain documents
`
`was marked Deposition
`
`Exhibit 1001, 1001, for
`
`identification, as of 4/4/18.)
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`So, Dr. Donovan,
`
`the court
`
`reporter has now handed you two exhibits.
`
`For
`
`the record, one is marked Exhibit 1001 in IPR
`
`proceeding 01622, and the other is also Exhibit
`
`1001 in IPR proceeding 01621.
`
`Do you have those in front of
`
`you?
`
`A.
`
`I have things that are marked
`
`one and two.
`
`Q.
`
`A.
`
`Q.
`
`Okay.
`
`So --
`
`If that's adequate,
`
`then, yes.
`
`Okay.
`
`The two items at the
`
`the two patents, both
`top of your table there,
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 13 of 201
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`Page 14
`
`MAUREEN DONOVAN, Ph.D.
`
`of which are Exhibits 1001. Are those the two
`
`patents that are at issue in your declaration?
`
`A.
`
`Oh,
`
`I see what you mean by
`
`exhibit number.
`
`the -- the bottom numbers are listed as 1001.
`
`Actually, both of them are at
`
`
`
`Q.
`
`A.
`
`Q.
`
`Correct.
`
`Okay.
`
`And you will notice -- thank
`
`you for the clarification there. Les
`
`important
`
`to note at the bottom in the dark
`
`bold is the exhibit number as well as the
`
`proceeding and the page number.
`
`So when I
`
`am referring to page
`
`numbers, I'll typically refer to those.
`
`A
`
`i
`
`Okay.
`
`So you noted that they were
`
`both marked Exhibit 1001, correct?
`
`A.
`
`Q.
`
`That's correct.
`
`And you will notice that one
`
`is in connection with one of the proceedings,
`
`and one is in connection with the second
`
`proceeding. That's the distinction.
`
`Yes. Okay.
`A.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
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`
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`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`You are familiar with these
`
`Page 15
`
`patents, correct?
`
`
`
`Re
`
`Q..
`
`Yes,
`
`I am.
`
`Treprostinil is a component in
`
`all of the claims of those two patents,
`
`correct?
`
`A.
`
`Well,
`
`in the '507 treprostinil
`
`is mentioned in claim 1 and in claim 2, and all
`
`the rest of the claims are either dependent on
`
`one,
`
`two, or six, and six is dependent on two.
`
`So it's mentioned -- treprostinil is mentioned
`
`or dependent in all of the claims of the '507.
`
`And similarly for the '240,
`
`treprostinil is
`
`mentioned in claims 1 and 2 -- or actually
`
`claim 1. None of the other claims are
`
`dependent on claim 1, and for claim 2 and claim
`
`6,
`
`treprostinil is also mentioned in those.
`
`Q.
`
`Okay.
`
`You are using the word
`
`mentioned.
`
`Is treprostinil a limitation of all
`
`of the claims?
`
`Bic
`
`I think you would have to
`
`explain to me what you mean by a limitation in
`
`a claim.
`
`Q.
`Do you not have an independent
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
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`Page 16
`
`MAUREEN DONOVAN, Ph.D.
`
`understanding of what a limitation in a patent
`
`claim is?
`
`A.
`
`I don't keep track of legal
`
`requirements for terminologies.
`
`I have looked
`
`at others to instruct me how to use those terms
`
`when necessary.
`
`Q.
`
`Okay. Fair enough. We can
`
`move on.
`
`You recall that I deposed you
`
`in this building in June of last year in
`
`connection with the district court action
`
`between the same parties involved in this
`
`proceeding, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And your testimony in that
`
`other case included, among others, discussion
`
`about
`
`the same two patents that you have in
`
`front of you as Exhibits 1001, correct?
`
`
`
`A.
`
`Q.
`
`Correct.
`
`And at the time of that
`
`deposition, you were under oath and endeavored
`
`to answer my questions truthfully, correct?
`
`A.
`
`Yes.
`
`Have you reviewed that
`Q.
`
`
`800-642-1099
`
`David Feldman Worldwide
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`
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`Page 17
`
`MAUREEN DONOVAN, Ph.D.
`
`deposition testimony in connection with your
`
`work on this IPR?
`
`A.
`
`Q..
`
`I have.
`
`When was the last time you
`
`reviewed your deposition testimony?
`
`A.
`
`Q.
`
`Yesterday.
`
`And we previously talked about
`
`some of your expertise at that deposition.
`
`So
`
`I wouldn't rehash all of it today, but there
`
`are some issues that are probably important
`
`to
`
`discuss for these proceedings.
`
`You are an expert in
`
`Pharmaceutics, correct?
`
`A.
`
`Q.
`
`Yes.
`
`But you don't claim to be an
`
`expert in the law, correct?
`
`A.
`
`Q.
`
`No,
`
`I do not.
`
`And you are not a medical
`
`doctor, correct?
`
`
`
`A.
`
`0.
`
`No,
`
`I
`
`am not.
`
`And you do not claim to be an
`
`expert in the treatment of pulmonary
`
`hypertension, correct?
`
`No.
`A.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
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`Page 18
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`And you have not researched
`
`pulmonary hypertension in your professional
`
`experience outside of this and the prior case
`
`between the parties, correct?
`
`A.
`
`Q..
`
`Not to any significant extent.
`
`Have you researched pulmonary
`
`hypertension in your professional experience to
`
`any extent?
`
`A:
`
`I was -- both in my
`
`professional and my personal experiences,
`
`I am
`
`familiar with pulmonary hypertension and have
`
`looked at treatments and disease state
`
`
`
`progression information.
`
`Q.
`
`Okay.
`
`You have not been
`
`involved in any clinical trials related to
`
`pulmonary hypertension, correct?
`
`A.
`
`Q.
`
`That's correct.
`
`And before the district court
`
`case between the parties, you were not familiar
`
`with TYVASO, correct?
`
`A.
`
`Q.
`
`Not
`
`to any extent, no.
`
`And before your involvement
`
`in
`
`the district court case between the parties,
`
`you were not familiar with treprostinil in any
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
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`Page 19
`
`MAUREEN DONOVAN, Ph.D.
`
`form from a professional standpoint, correct?
`
`A.
`
`Q.
`
`No.
`
`And you have never published
`
`on prostacyclins, correct?
`
`A.
`
`Q.
`
`No,
`
`I have not.
`
`And you don't claim to be an
`
`expert in pulmonary hypertension, correct?
`
`A.
`
`Q.
`
`No.
`
`And you haven't developed any
`
`products that have been approved or submitted
`
`for approval
`
`to the FDA for the treatment of a
`
`disease, correct?
`
`A.
`
`Q.
`
`That's correct.
`
`And you have not developed any
`
`drug device combinations that have been
`
`approved or submitted for approval
`
`to the FDA,
`
`
`
`correct?
`
`A.
`
`Q.
`
`That's correct.
`
`And you are not an expert in
`
`the design of nebulizers, correct?
`
`A.
`
`That's correct.
`
`I have an
`
`understanding of nebulizer design, but I
`
`wouldn't
`
`lead that to I
`
`am not in an expert in
`
`the design of.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
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`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`And you have testified a
`
`number of times in patent cases, correct?
`
`Page 20
`
`
`
`As
`
`Q..
`
`Yes,
`
`I have.
`
`And in all the cases in which
`
`you have testified at trial or in deposition,
`
`they were all on behalf of a generic company,
`
`correct?
`
`A.
`
`I am trying to recall, but I
`
`actually think my very first deposition was on
`
`behalf of the brand owner.
`
`Q.
`
`Was that in Canada?
`
`A.
`
`Q.
`
`Yes, it was.
`
`In all cases in which you have
`
`testified at trial or deposition in the United
`
`States,
`
`they were all on behalf of a generic
`
`company, correct?
`
`A.
`
`Oz
`
`Yes,
`
`they were.
`
`In the course of your
`
`professional career, you have multiple
`
`publications, correct?
`
`A.
`
`Q.
`
`articles?
`
`Yes,
`
`I do.
`
`And are any of those review
`
`Yes.
`A.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
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`Page 21
`
`MAUREEN DONOVAN, Ph.D.
`
`Q.
`
`A.
`
`Qs
`
`Are any of those abstracts?
`
`Certainly, yeah.
`
`When you publish papers, you
`
`frequently have to perform literature research
`
`and cite to the publication of others, correct?
`
`A.
`
`Yes, that's true.
`
`When you are performing the
`
`research for such endeavors, what steps do you
`
`take to find relevant sources?
`
`A.
`
`Are you speaking -- are we
`
`speaking currently? Are we speaking ever since
`
`I started publishing work?
`
`2004.
`
`Q.
`
`A.
`
`Why don't we think back to
`
`Okay.
`
`So in 2004,
`
`there were
`
`
`
`sort of probably multiple avenues in the area
`
`that I was likely to be publishing in I already
`
`had familiarity with.
`
`So I probably had some
`
`key references. Maybe I had an extensive
`
`collection and was just trying to make sure
`
`that it was completely up to date, but
`
`regardless I certainly start with key
`
`references -- well, let me back up.
`
`Starting with an online
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
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`Page 22
`
`MAUREEN DONOVAN, Ph.D.
`
`literature search is certainly a process that
`
`either immediately or initially or as a follow
`
`up to a couple of key references would take
`
`place.
`
`
`
`I would look at databases
`
`that -- that are designed to have or give easy
`
`access to literature, and most of them -- many
`
`of them are linked in my library, and I have --
`
`then I can figure out whether my library owns
`
`that material that I
`
`am interested in or
`
`whether I need to request it as loan material
`
`or whatever.
`
`So I will do several
`
`literature searches.
`
`In 2004 there were
`
`probably -- and even currently -- probably
`
`about three. Maybe in 2004 there were even
`
`four databases that I would typically search if
`
`I were looking for -- it depends on what I was
`
`looking for, but if I was looking for a pretty
`
`extensive cross-section of information, and
`
`then often times if I have a key piece of
`
`literature I have identified or review article
`
`or something else or there is something I want
`
`I will look at the references
`to follow up on,
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
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`Page 23
`
`MAUREEN DONOVAN, Ph.D.
`
`that are in that particular piece of
`
`literature.
`
`I will follow up on those.
`
`I
`
`will follow up on the particular key piece by
`
`looking at who has cited that literature and
`
`sort of expand the search in that manner when I
`
`find actual papers or review articles or
`
`something that I think are particularly
`
`valuable that I want to know who else followed
`
`up on those.
`
`
`
`Q.
`
`Okay. And you mentioned that
`
`there were four databases in 2004 that you
`
`might consult.
`
`What databases are those?
`
`A.
`
`I would certainly consult with
`
`PubMed.
`
`I would consult with a database that
`
`was called International Pharmaceutical
`
`Abstracts.
`
`I would consult with what probably
`
`at the time even was the SciFinder database for
`
`the American Chemical Society, and I would look
`
`at the Web of Science database.
`
`Q.
`
`If you were performing a
`
`Similar search in 2006, would there be any
`
`major changes to what you've just described?
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
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`Page 24
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`MAUREEN DONOVAN, Ph.D.
`
`No.
`
`Is it your opinion that a
`
`A.
`
`Q.
`
`
`
`person of ordinary skill in the art as you have
`
`defined that person in this proceeding in 2006
`
`would go about performing research ina similar
`
`manner?
`
`A.
`
`0:
`
`Yes.
`
`You have indicated that you
`
`have published some abstracts, correct?
`
`A.
`
`Well, abstracts that I have
`
`presented have been published.
`
`QO.
`
`Okay. And what was the
`
`purpose of publishing those abstracts?
`
`A.
`
`Often times the abstracts
`
`that -- the abstracts that are published are
`
`abstracts of presentations that were made at a
`
`national meeting.
`
`The organizations that
`
`sponsor those meetings often times have
`
`associations with particular publications, and
`
`as part of publishing agreements and so forth,
`
`often times the abstracts appear in that
`
`publication post the -- post their
`
`presentation.
`
`As time has gone on,
`
`that --
`
`800-642-1099
`
`David Feldman Worldwide
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`
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`Page 25
`
`MAUREEN DONOVAN, Ph.D.
`
`in particular one of the organizations that I
`
`present at most frequently,
`
`they have -- they
`
`now house the abstract -- the abstracts at the
`
`national meetings on their own website.
`
`Q.
`
`And what would be the purpose
`
`of putting the abstracts for the national
`
`meetings on the website?
`
`As
`
`I -- I
`
`am going to suppose
`
`this just because I knew about the
`
`association's agreements with their previous
`
`publishers that it just became a matter of the
`
`next negotiation with the publishers of the
`
`journals that they were associated with that
`
`the association felt that it better served
`
`their members to house the abstracts on their
`
`
`
`website, and that they didn't need to be
`
`associated with any particular journal.
`
`The association had developed
`
`interactions with a number of journals.
`
`I
`
`think a number of them had different
`
`publishers.
`
`So I think it became an issue of
`
`which journal, which publisher, how do you make
`
`this all work.
`
`So given somewhat of the
`
`interdisciplinary nature of the particular
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
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`
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`Page 26
`
`MAUREEN DONOVAN, Ph.D.
`
`organization and the meeting and the materials
`
`that are presented there, it became I think
`
`easier for their members to access that
`
`information via the association's website than
`
`it did to select a particular publisher and
`
`journal
`
`to house those.
`
`Q.
`
`In the discussion of how you
`
`might have or a person of ordinary skill in the
`
`art might have gone about performing research
`
`or I guess just going back to that discussion.
`
`If you were searching for works in 2006 about
`
`treating pulmonary hypertension, would you pick
`
`up every issue of a certain periodical for the
`
`last two years and leaf through it because that
`
`periodical happened to deal with, for example,
`
`medicine?
`
`
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`A.
`
`I'm going to -- well,
`
`I'm
`
`going to answer that as a person who is
`
`interested in -- in pharmaceuticals,
`
`pharmaceutics aspects. Leafing through medical
`
`journals sometimes is a great way to actually
`
`get new ideas for potential new dosage forms or
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
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`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 26 of 201
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`Page 27
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`MAUREEN DONOVAN, Ph.D.
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`improvements to current dosage forms.
`
`So it's
`
`not out of the question that that might happen.
`
`I don't do it on a regular
`
`basis, and if I am looking for general
`
`information in a particular therapeutic area,
`
`that probably wouldn't be how I would start,
`
`but I am not going to exclude that it wouldn't
`
`be something -- especially I would choose
`
`probably a focused journal in the area to get
`
`an idea of the variety of art.
`
`
`
`The reason is that, you know,
`
`databases are dependent on the words I put into
`
`them in their search, and sometimes I want
`
`to
`
`know what
`
`the vocabulary is that I am not aware
`
`that I could be using in my search terms.
`
`So I
`
`might actually go and look at see what people
`
`are publishing currently or talking about.
`
`BY MS. ASCARRUNZ:
`
`Q.
`
`Okay. Of the four databases
`
`we discussed,
`
`is there one in particular that
`
`you think is the most popular among persons of
`
`ordinary skill in the art as you have defined
`
`that person in 2006?
`
`I guess that's how you go
`A.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 27 of 201
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`Page 28
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`MAUREEN DONOVAN, Ph.D.
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`about searching and what you're comfortable
`
`with and what you use is more of an -- not
`
`necessarily an individual preference, but it
`
`often times -- you know, it can be influenced
`
`by what access you have to those materials.
`
`So
`
`it's really difficult for me to speak for all
`
`POSAs on the matter.
`
`0:
`
`Okay.
`
`Sorry to jump around.
`
`I had realized that I forgot to ask some
`
`questions before.
`
`So going back to abstracts
`
`now, you agree with me that abstracts are not
`
`peer reviewed, correct?
`
`A
`
`No,
`
`I don't agree. When I
`
`submit an abstract for presentation, it's
`
`reviewed before it's accepted for presentation.
`
`Q.
`
`Okay. Are abstracts indexed
`
`and searchable?
`
`
`
`A.
`
`Q.
`
`A.
`
`Many times they are, yes.
`
`Is that helpful if they are?
`
`Yes.
`
`It's helpful for people
`
`who weren't able to actually attend the
`
`physical presentation to be able to access, and
`
`I cite abstracts in a number of my
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 28 of 201
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`Page 29
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`MAUREEN DONOVAN, Ph.D.
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`publications.
`
`So, yes, it's helpful
`
`to have
`
`them indexed and accessible.
`
`Q.
`
`When you cite abstracts in
`
`your publication, how do you go about finding
`
`them?
`
`A.
`
`Many times they show up in my
`
`searches.
`
`If -- again,
`
`they are -- if they are
`
`abstracts that I actually saw the presentation
`
`to, you know,
`
`I where to go look.
`
`I know which
`
`journal supplement the particular abstract is
`
`in based on what meeting I was at and what year
`
`it was during, but otherwise in many cases they
`
`actually are -- those citations show up ina
`
`literature search.
`
`Q.
`
`Okay. Have you ever published
`
`an abstract where preliminary data was
`
`conveyed, but the data did not pan out further
`
`into a full research study?
`
`
`
`A.
`
`Q.
`
`Can you ask that again?
`
`Sure. Let me ask ita
`
`different way. That probably wasn't the most
`
`articulate question.
`
`Have you ever published an
`
`abstract where you presented preliminary data
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`UNITED THERAPEUTICS, EX. 2034
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 29 of 201
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`Page 30
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`MAUREEN DONOVAN, Ph.D.
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`and then were disappointing in how further
`
`research evolved from that point?
`
`MR. MATHAS: Object to the form.
`
`BY THE WITNESS:
`
`Ax
`
`Well,
`
`I don't know that I am
`
`ever really disappointed in how the research
`
`evolves.
`
`It is what it is.
`
`It may not
`
`actually corroborate the hypothesis I had to
`
`start with, and as a result,
`
`I don't know,
`
`I
`
`may change my hypothesis and change the
`
`approach.
`
`I may decide to discontinue.
`
`I may
`
`identify that I need to do work that requires
`
`me to find a collaborator and that doesn't --
`
`doesn't either work out, or I am not able to
`
`identify a collaborator at the time to move
`
`that on at the right time.
`
`
`
`There's all sorts of things
`
`that would cause an area of research to not
`
`continue to be pursued, and I have a number of
`
`abstracts that the full body of work hasn't
`
`resulted ina -- in a publication.
`
`Some of the
`
`work ends up being resident in my students'
`
`thesis instead, and that's the appropriate
`
`place for that information.
`
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext