UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Case IPR2016—00510
`
`Case IPR2016—00512
`Case 1PR2016—00514
`
`Case IPR2D16—0O516
`
`Case IPRZO16-00517
`
`MYLAN PHARMACEUTICALS INC. and
`
`MYLAN LABORATORIES LIMITED,
`
`Petitioner,
`
`VS.
`
`UCB PHARMA GMBH,
`
`Patent Owner.
`
`DEPOSITION OF
`
`STEVEN E. PATTERSON, Ph.D.
`
`Atlanta, Georgia
`
`Tuesday, October 4, 2016
`
`Reported BY: Michelle M. Boudreaux, RPR
`
`Job No: 113362
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0001
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Case IPR2016—00510
`
`Case IPR2016—00512
`Case 1PR2016—00514
`
`Case IPR2D16—0O516
`
`Case IPRZO16-00517
`
`MYLAN PHARMACEUTICALS INC. and
`
`MYLAN LABORATORIES LIMITED,
`
`Petitioner,
`
`VS.
`
`UCB PHARMA GMBH,
`
`Patent Owner.
`
`DEPOSITION OF
`
`STEVEN E. PATTERSON, Ph.D.
`
`Atlanta, Georgia
`
`Tuesday, October 4, 2016
`
`Reported BY: Michelle M. Boudreaux, RPR
`
`Job No: 113362
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0001
`
`
`
`October 4, 2016
`
`9:10 a.m.
`
`Deposition of STEVEN E. PATTERSON,
`
`Ph.D., held at the offices of Hunton &
`
`Williams, Bank of America Plaza,
`
`Suite 4100, 600 Peachtree Street, Atlanta,
`
`Georgia pursuant
`
`to Agreement before
`
`Michelle M. Boudreaux,
`
`a Registered
`
`Professional Reporter in the State of
`
`Georgia.
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0002
`
`
`
`APPEARANCES OF COUNSEL
`
`On behalf of the Petitioner:
`
`ALYSON WOOTEN, Esq.
`Kilpatrick Townsend & Stockton
`1100 Peachtree Street Northeast
`
`Atlanta, GA 30309
`
`On behalf of the Patent Owner:
`
`JAMES TRAINOR, JR., Esq.
`White & Case
`
`1155 Avenue of the Americas
`
`New York, NY 10036
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0003
`
`
`
`STEVEN E. PATTERSON, Ph.D
`
`- I
`
`being first duly sworn, was examined and testified as
`
`follows:
`
`MR. TRAINOR:
`
`So just to clarify for the
`
`record,
`
`this deposition is being taken in
`
`conjunction with four pending inter partes
`
`reviews before the United States Patent
`
`Office.
`
`The —— these reviews —— these IPRS
`
`are numbered Case No.
`
`IPR 2016-0516, also
`
`0510, 0512, 0514, 0517. And I believe 510 is
`
`the '650, correct?
`
`MS. WOOTEN: Yes.
`
`MR. TRAINOR: Okay.
`
`EXAMINATION
`
`BY MR. TRAINOR:
`
`Q
`
`Q
`
`Now, good morning, Dr. Patterson.
`
`Good morning.
`
`Sorry for the circus here. Before we get
`
`started,
`
`I wanted to hand you the declarations that
`
`have you here today submitted in support of the
`
`aforementioned IPRS.
`
`I'm handing you now what is,
`
`in
`
`IPR 510,
`
`the declaration you submitted, and that IPR,
`
`the number is Exhibit 1003.
`
`A
`
`Uh-huh.
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0004
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Q
`
`And I'm also handing you a second declaration
`
`submitted in support of the remaining IPR numbers.
`
`In
`
`all of those IPRs,
`
`this is also designated as Exhibit
`
`10003 [sic].
`
`Now, if I could just ask your assistance,
`
`this is probably the one document —— these are the two
`
`documents that don't have the numbers on them,
`
`so maybe
`
`we could just take a quick second and put the sticker
`
`on these.
`
`The rest of them should all be marked,
`
`if
`
`that's all right.
`
`(Discussion off the record.)
`
`(Exhibit 1003 marked for identification.)
`
`Q
`
`(By Mr. Trainor) All right.
`
`Now, first of
`
`all, Dr. Patterson,
`
`I
`
`take it you've had your
`
`deposition taken before?
`
`A
`
`This is the first time I have testified in
`
`court, but not --
`
`Q
`
`A
`
`Testified at a deposition?
`
`I'm not sure. Actually in a court proceeding
`
`before the judge. Not for this case,
`
`though.
`
`I'm
`
`sorry.
`
`I guess that's what you're asking.
`
`Q
`
`A
`
`Let me just back up.
`
`Okay.
`
`Have you testified before in a court
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0005
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`
`
`STEVEN E. PATTERSON, Ph.D.
`
`proceeding?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes, sir.
`
`Okay.
`
`How many times?
`
`Once.
`
`Okay. And in that proceeding, did you give a
`
`deposition before you testified at trial or in court?
`
`A
`
`Q
`
`I don't recall doing that, no, sir.
`
`Okay.
`
`In that case, I'll just let you know,
`
`I'm going to make a record today of some questions that
`
`I'm going to have for you, and hopefully you can answer
`
`those to the best of your ability.
`
`If anything is
`
`unclear, please let me know.
`
`I'll try to clarify for
`
`you.
`
`If you'd like to take a break at any time,
`
`please just let me know. We can take as many breaks as
`
`you'd like.
`
`Just please don't ask for a break while a
`
`question is pending.
`
`A
`
`Q
`
`Sure.
`
`Okay.
`
`So, Dr. Patterson, with regard to the
`
`two exhibits numbered 1003 in front of you, are those
`
`exhibits —- are those declarations that you recall
`
`preparing?
`
`A
`
`Q
`
`Yes.
`
`Okay.
`
`Is it fair to say -— to try to make
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0006
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`things easy today,
`
`is it fair to say that the substance
`
`of those two declarations is more or less the same?
`
`MS. WOOTEN: Objection,
`
`form.
`
`You still
`
`can respond.
`
`THE WITNESS:
`
`I'm sorry.
`
`Oh, okay.
`
`Q
`
`(By Mr. Trainor)
`
`I mean, are there any
`
`material differences in the declaration testimony you
`
`provided?
`
`A
`
`Without taking time to review them carefully,
`
`I believe —— the differences that I
`
`remember are simply
`
`just Correction of typos from one to the other.
`
`Q
`
`Okay. Okay.
`
`So,
`
`I mean, my take on this is
`
`that they're really quite similar.
`
`If there's an
`
`occasion today where you think that may not be the
`
`case,
`
`let me know, and if there's any occasion where I
`
`think that might not be the case, I'll let you know.
`
`But
`
`to make things easy, why don't we just work with
`
`one of the documents, and why don't we work off of
`
`the -- let's see what
`
`I have here. We'll work off of
`
`the one that is —— the one that is actually
`
`pre—stamped, okay,
`
`so this is the one in the --
`
`A
`
`Q
`
`The one that we do not have the sticker on?
`
`Yeah,
`
`the one that says '65O patent at the
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0007
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Okay.
`
`So the stickered one you can put aside.
`
`Okay.
`
`And again,
`
`I'm not trying to --
`
`I understand.
`
`—— pull anything over you.
`
`I just think
`
`A
`
`Q A
`
`Q A
`
`Q
`
`they're more or less the same document,
`
`so —— right
`
`down to the paragraph numbers,
`
`so hopefully that will
`
`make it easy to make the record here today.
`
`Okay.
`
`Now, Dr. Patterson,
`
`in the court
`
`proceeding that you testified in previously, what was
`
`the nature of that dispute,
`
`if you recall?
`
`A
`
`It was a dispute involving my work in
`
`industry between Gilead and Idenix.
`
`Q
`
`A
`
`Q
`
`A
`
`And I'm sorry?
`
`And Idenix.
`
`Okay. Which was your previous employer?
`
`My previous employer was Pharmasset.
`
`Pharmasset was acquired by Gilead.
`
`Q
`
`Okay.
`
`So you testified in that proceeding as
`
`a fact witness as opposed to as an expert witness?
`
`A
`
`Q
`
`Yes, sir.
`
`Okay. Have you ever consulted as an expert
`
`witness or as an expert consultant for litigation prior
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0008
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`
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`STEVEN E. PATTERSON, Ph.D.
`
`to this proceeding?
`
`A
`
`Q
`
`A
`
`Not
`
`in the same way that we're doing now.
`
`In what different way?
`
`I've had people call me for comments about
`
`one thing or another. This is the first time where,
`
`you know, I've been so involved as to prepare, you
`
`know, documents and such.
`
`Q
`
`Uh—huh.
`
`In the prior consultations that you
`
`referred to, were you working with attorneys or --
`
`Yes.
`
`—— nOn—attOrneyS?
`
`Attorneys.
`
`Okay.
`
`My understanding is that they were attorneys,
`
`A
`
`Q A
`
`Q
`
`A
`
`in any event.
`
`Q
`
`Okay.
`
`In—house attorneys at a company or
`
`external counsel; do you recall?
`
`A
`
`Q
`
`I don't recall.
`
`That's fine.
`
`Okay.
`
`Now, Dr. Patterson, please feel free
`
`to refer to Exhibit 1003 at any time. And we'll be
`
`looking at it together for a good part of the day. But
`
`if I ask you questions that aren't directly related to
`
`what's set forth in the declaration, you know, you can
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0009
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`
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`STEVEN E. PATTERSON, Ph.D.
`
`always feel free to refer to that.
`
`And I'd also like to invite you to ask me at
`
`any time if you see another exhibit referenced in
`
`there, which I should have here, and you'd like to see
`
`it,
`
`just let me know, because what we're here to do
`
`today is give me the opportunity and my clients the
`
`opportunity to sort of Cross—examine the substance of
`
`this declaration.
`
`So given that, you've got a number of
`
`citations in there.
`
`I should have copies of all of
`
`them.
`
`I might show them to you on my own volition, but
`
`if you say,
`
`"Hey, I'd like to see this," please feel
`
`free to let me know --
`
`A
`
`Q
`
`Okay.
`
`—— because we want to know what your take on
`
`that stuff is.
`
`So, Dr. Patterson, without
`
`looking at the
`
`declaration for a moment,
`
`in the time frame of 1998 and
`
`1999, could you describe for me in your words what you
`
`understood to be the state—of—the—art
`
`in the field of
`
`OAB drug development?
`
`A
`
`There were very few treatments out there
`
`approved. There were some issues with many of them
`
`regarding selectivity such that many of —- you know, at
`
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0010
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`
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`STEVEN E. PATTERSON, Ph.D.
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`Page ll
`
`least one of them, you know,
`
`some of the patients, as I
`
`understood, or the persons treated with the drug, you
`
`know, discontinued treatment because of some of the
`
`side effects.
`
`Q
`
`And putting aside the OAB treatments that you
`
`referred to as approved, was there research and
`
`development ongoing that was publicly known that may or
`
`may not have led later to an approved drug?
`
`A
`
`According to reviews that I recall -- you
`
`know, recall looking at,
`
`there were multiple —— let's
`
`call them classes or drugs that were thought that might
`
`work by different, you know, mechanisms under
`
`investigation.
`
`Q
`
`And they were being reported in the prior art
`
`as of that time?
`
`A
`
`Q
`
`A
`
`Q
`
`I believe so.
`
`Okay.
`
`I think so.
`
`Okay. Why don't I
`
`show you Exhibit --
`
`MR. TRAINOR:
`
`I'm going to show the
`
`witness what's been marked as Exhibit 1006
`
`in all of the proceedings. This is a
`
`publication with the lead author Andersson.
`
`Q
`
`(By Mr. Trainor)
`
`Now, Dr. Patterson, feel
`
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0011
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`
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`STEVEN E. PATTERSON, Ph.D.
`
`free to review that exhibit.
`
`Is this the review,
`
`Exhibit 1006,
`
`that you were just referring to?
`
`A
`
`I believe it is.
`
`I recall the tables on the
`
`second -- or the -- yeah,
`
`the table. That's a single
`
`table, actually.
`
`It goes from the second to the third
`
`page of the paper.
`
`Q
`
`A.
`
`Q
`
`Uh—huh.
`
`And that's what
`
`I was thinking about.
`
`Okay. And maybe if it helps,
`
`in your
`
`declaration, Exhibit 1003,
`
`if you turn to page 4,
`
`beginning on page 4, you set forth a comprehensive
`
`chart of the materials that you considered.
`
`Do you see
`
`the Exhibit No. 1006 --
`
`Right.
`
`—— "Andersson Review"?
`
`Right.
`
`Okay.
`
`So if you ever need to refer to --
`
`A
`
`Q A
`
`Q
`
`we'll try to cross—reference one of the documents I'm
`
`showing you.
`
`I'm fairly certain that all of the
`
`documents I'll show you are exhibits to your
`
`declaration.
`
`So this might refresh what they are, and
`
`here's the Exhibit No. 1006 on page 4 of your
`
`declaration.
`
`So, first of all, how was it that you came
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0012
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`STEVEN E. PATTERSON, Ph.D.
`
`upon this Andersson review, Exhibit 1006?
`
`A
`
`It was either referenced by counsel or I did
`
`a literature search on my own and found it. Both
`
`could,
`
`in fact, be true.
`
`Q
`
`Okay.
`
`So is it fair to say that in the
`
`preparation of this declaration,
`
`some documents were
`
`provided to you by counsel?
`
`A.
`
`Q
`
`It is. That is true.
`
`And other documents were procured by you
`
`independently?
`
`A
`
`Q
`
`A
`
`I recall doing a literature search.
`
`Okay.
`
`And I recall discussing the —— well,
`
`I
`
`shouldn't say that. Sorry.
`
`Q
`
`A
`
`Okay.
`
`I recall doing a literature search,
`
`I think,
`
`in order to protect our private discussion.
`
`Q
`
`That's okay. Okay. Well, right now I'm not
`
`as concerned about, you know,
`
`the source. What was
`
`the —— do you have an understanding as to how the
`
`search was conducted, what search terms were used or
`
`something of that nature?
`
`A
`
`I can't tell you what counsel did, but
`
`I can
`
`tell you the terms I —— as best I can recall, because
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`STEVEN E. PATTERSON, Ph.D.
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`Page 14
`
`it was nearly a year ago, but
`
`I can —— I went
`
`to PubMed
`
`and did a keyword search.
`
`I don't recall the exact
`
`keywords.
`
`Q
`
`Okay. Okay.
`
`Do you recall why you did that
`
`search given that you were being provided documents by
`
`counsel?
`
`MS. WOOTEN: Objection,
`
`form.
`
`Go
`
`ahead.
`
`THE WITNESS:
`
`Should I answer? Oh.
`
`That's my practice.
`
`I prefer to be, you
`
`know, aware of what's out there.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor)
`
`Now, are you aware of any
`
`other publications that were prior art as of 1999 or
`
`1998 that,
`
`in substance, disclosed the goings—on in the
`
`research and development in the OAB field, or was it
`
`just this Andersson paper?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: What
`
`I remember --
`
`I answer?
`
`MS. WOOTEN: Yes.
`
`THE WITNESS: Okay.
`
`MS. WOOTEN: When I make objections,
`
`it's just for the record. Unless I instruct
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`STEVEN E. PATTERSON, Ph.D.
`
`you not
`
`to answer ——
`
`THE WITNESS:
`
`You will tell me?
`
`MS. WOOTEN:
`
`I will tell you.
`
`THE WITNESS: All right, good.
`
`Thank
`
`you.
`
`I appreciate that.
`
`I
`
`remember the Andersson paper best
`
`because —— I think, because I don't remember
`
`much others, it was just a nice review.
`
`I
`
`don't recall that I found other reviews that
`
`were useful
`
`in the way Andersson was.
`
`MR. TRAINOR: Okay.
`
`Q
`
`A
`
`(By Mr. Trainor) Useful for what purpose?
`
`To help demonstrate what was —— what had been
`
`in the literature previous to 1999.
`
`Q
`
`Okay. But you understand if there are other
`
`review papers besides the Andersson paper that were in
`
`publication at or before that time,
`
`they would also be
`
`considered within the prior art?
`
`A
`
`Q
`
`That's my understanding, yes.
`
`Okay. Okay.
`
`Now,
`
`the Andersson paper --
`
`let's take a look at that here.
`
`Now,
`
`is it fair to say that a skilled
`
`artisan,
`
`reading the Andersson paper at the time of its
`
`publication, would have understood at least the
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`STEVEN E. PATTERSON, Ph.D.
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`disclosure that the primary pharmacotherapy in the
`
`field of OAB to date had been antimuscarinic drugs?
`
`A
`
`Yes.
`
`MS. WOOTEN: Objection,
`
`form.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor)
`
`Now, did you understand the
`
`Andersson paper to suggest that the current research,
`
`with respect to antimuscarinic drugs, was focused on
`
`antimuscarinics that were selective for M3 receptors?
`
`A
`
`My —— I'm not certain that Andersson
`
`suggested that, but that's sort of a lesson that I
`
`remember, you know,
`
`that —— you know,
`
`that that seemed
`
`to be a very reasonable way to proceed.
`
`Q
`
`A
`
`Uh-huh.
`
`And why was that?
`
`Many of the side effects from the existing
`
`were due to poor selectivity, and thus you would
`
`conclude that you'd get
`
`improved selectivity and have a
`
`better profile.
`
`Q
`
`Okay. And poor selectivity for the various
`
`antimuscarinic subtypes would lead to side effects why?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: These muscarinic receptors
`
`are involved in other processes not related
`
`to the desired. Alternatively, you know, one
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`STEVEN E. PATTERSON, Ph.D.
`
`might
`
`look for tissue selectivity.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor)
`
`Now, are you familiar with
`
`tolterodine?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes.
`
`How about atropine?
`
`Yes.
`
`Okay. And do you understand that drugs such
`
`as tolterodine and atropine were nonselective
`
`antimuscarinics?
`
`A
`
`Q
`
`Yes.
`
`Meaning that they bound to muscarinic
`
`receptors everywhere they could be found in the body,
`
`correct?
`
`A
`
`The studies had the multiple muscarinics
`
`expressed in Cell culture. And so, yeah, you might
`
`expect that there would be found —— you know,
`
`that this
`
`would happen. But
`
`the data showed that in these
`
`culture models, you know,
`
`such agents were not
`
`selected.
`
`Q
`
`A
`
`Uh—huh.
`
`Now, what happens in vivo might,
`
`in fact, be
`
`slightly different because the drug might not be
`
`equally distributed across the body.
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0017
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Page 18
`
`Q
`
`Okay.
`
`Now,
`
`the thinking at the time was that
`
`the M3 subtype was most responsible for activity in the
`
`bladder;
`
`is that right?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS:
`
`I'm sorry, could you
`
`repeat that?
`
`MR. TRAINOR: Yes.
`
`Q
`
`(By Mr. Trainor)
`
`The thinking at the time
`
`was that M3 receptors predominated the bladder as
`
`opposed to other subtypes, correct?
`
`A
`
`I believe the line of thought at that time
`
`was that the M3 was important for bladder function.
`
`Q
`
`Okay. And so it was understood at the time
`
`that one direction of research would be to develop
`
`drugs that selected only for that M3 receptor, correct?
`
`A
`
`Yes.
`
`MS. WOOTEN: Objection,
`
`form.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor)
`
`Now,
`
`the Andersson paper
`
`goes on to talk about other mechanisms of action that
`
`had been investigated and reported at least up till
`
`that time, correct?
`
`A
`
`Q
`
`Yes.
`
`So besides antimuscarinic drugs -— and
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0018
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`perhaps it's best if we can look at the table that you
`
`have in your declaration, which begins on the second
`
`page of the —— well,
`
`in your declaration,
`
`that would
`
`be -- let's get there anyway.
`
`A
`
`Q
`
`Okay.
`
`That's a good idea.
`
`So in your declaration,
`
`this is around --
`
`A.
`
`Q
`
`If you prefer Andersson,
`
`that's fine.
`
`No,
`
`they're both the same, but just for the
`
`record, we can make clear.
`
`Okay,
`
`if you go to -— yeah, page 39 of
`
`Exhibit 1003 --
`
`A
`
`Q
`
`Yes.
`
`—— I believe is a reproduction of Table 2
`
`in
`
`the Andersson paper, which is Exhibit 1006, correct?
`
`A
`
`Q
`
`Yes.
`
`Okay.
`
`So looking at either one,
`
`this might
`
`be the best bird's—eye view of the other research that
`
`was being reported.
`
`So besides antimuscarinic drugs,
`
`Andersson reports on drugs acting on membrane channels.
`
`Do you see that?
`
`A
`
`Q
`
`Uhehuh. Let me *~
`
`It's in italics.
`
`So the first italic is
`
`"antimuscarinic."
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0019
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`A
`
`Yeah, "adrenoceptor."
`
`I'm just trying to
`
`find —— there it is.
`
`It's the —— yes.
`
`Q
`
`Okay. And Andersson also discloses
`
`investigation of drugs with mixed actions, correct?
`
`A
`
`Q
`
`Yes.
`
`And it also discloses investigation of the
`
`use of alpha—adrenoceptor antagonists, correct?
`
`Right.
`
`And beta-adrenoceptor antagonists [sic]?
`
`Right.
`
`Antidepressants?
`
`Right.
`
`Prostaglandin synthesis inhibitors?
`
`Right.
`
`Vasopressin analogue?
`
`Right.
`
`And then a number of other sort of
`
`A
`
`Q A
`
`Q A
`
`Q A
`
`Q A
`
`Q
`
`uncharacterized drugs,
`
`including Baclofen and
`
`capsaicin.
`
`Do you see that?
`
`A
`
`Q
`
`Yes.
`
`And then there's -— and all of those
`
`mechanisms of action fall under the greater heading of
`
`"Bladder Hyperactivity."
`
`Do you see that?
`
`A
`
`Right.
`
`TSG Reporting — Worldwide — 877-702-9580
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`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0020
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Page 21
`
`Q
`
`Okay. And then there's a mention of a number
`
`of investigations for treatments of stress
`
`incontinence, and I'm not sure that really falls within
`
`the definition of OAB or at least the indication for
`
`Toviaz, which is why we're here today. But if you jump
`
`down to "Overflow Incontinence," you see that there's a
`
`further investigation of alpha—adrenoceptor
`
`antagonists?
`
`A
`
`Q
`
`A
`
`Q
`
`see that?
`
`A
`
`Q
`
`(No audible response.)
`
`Yes?
`
`Yes.
`
`Oh, yes.
`
`Again, muscarinic receptor agonists; do you
`
`Yes.
`
`And on the following page, continuing on,
`
`anticholinesterase inhibitor?
`
`A
`
`Q
`
`see that?
`
`A
`
`Q
`
`Yes.
`
`And again, a number of other drugs.
`
`Do you
`
`Yes.
`
`Okay. And so for bladder hyperactivity,
`
`which you understand to encompass these symptoms of
`
`OAB, correct --
`
`A
`
`I
`
`think so.
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0021
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Q
`
`—-
`
`there are nine mechanisms of action that
`
`were investigated, or eight in addition to
`
`antimuscarinic drugs, correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS:
`
`I haven't counted, but if
`
`that's your count,
`
`I won't argue with it.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor) And for overflow
`
`incontinence, which you understand to be a symptom of
`
`OAB, correct,
`
`that's actual
`
`incontinence?
`
`A
`
`Clinically, it might be difficult to tell
`
`them apart.
`
`Q
`
`Okay.
`
`In any event,
`
`the Andersson paper
`
`reports on the investigation of four different
`
`mechanisms of action, correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`WITNESS:
`
`If that's your count --
`
`MR. TRAINOR: Okay.
`
`THE WITNESS:
`
`-— I won't —- yeah.
`
`Q
`
`(By Mr. Trainor)
`
`Now, under each of these
`
`mechanisms of action which are detailed beyond this
`
`table in the text of the Andersson paper,
`
`there are a
`
`number of specific compounds falling as within
`
`affecting that mechanism of action, correct?
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0022
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`I'm sorry, say again.
`
`So for each mechanism of action,
`
`such as
`
`A
`
`Q
`
`antimuscarinic activity,
`
`the Andersson paper reports
`
`the degree of investigation with respect to a number of
`
`different compounds falling under that mechanism of
`
`action.
`
`Do you see that?
`
`A
`
`Yes,
`
`I do.
`
`MS. WOOTEN: Objection,
`
`form.
`
`Q
`
`(By Mr. Trainor)
`
`So,
`
`for example, atropine,
`
`propantheline --
`
`A
`
`Q
`
`A
`
`Q
`
`Yes.
`
`—— emepronium, and so forth, correct?
`
`Yes,
`
`I see the columns there.
`
`Now,
`
`is it fair to say that this table
`
`summarizes, with respect to each of the compounds that
`
`are reported, whether those compounds have,
`
`in the
`
`first column,
`
`shown efficacy, by the letter E, or have
`
`been shown to be effective, rather?
`
`If you see the
`
`legend on the following page --
`
`Yes.
`
`—— it says E means effective.
`
`You mean the ~-
`
`First column.
`
`Right,
`
`the first column after the drug
`
`TSG Reporting — Worldwide — 877-702-9580
`
`A
`
`Q A
`
`Q
`
`A
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0023
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Right.
`
`Yes.
`
`Okay.
`
`So for Table 2
`
`in the Andersson paper,
`
`A
`
`Q
`
`E means that the compound has been shown effective, and
`
`U means it's been shown —— unproven that it's
`
`effective, correct?
`
`A
`
`Q
`
`Yes.
`
`All right.
`
`Now,
`
`in the next column of
`
`Table 2, under the heading "Clinical," there are one of
`
`four designations, and A meaning that a good quality
`
`RCT has been undertaken.
`
`Do you see that?
`
`A
`
`Q
`
`correct?
`
`A
`
`Q
`
`Yes.
`
`And RCT means random controlled trial,
`
`I believe that's correct.
`
`And that's sort of the gold standard of
`
`clinical trials, correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS:
`
`The FDA desires ——
`
`actually requires, you know —— and there are
`
`exceptions to that, however.
`
`MR. TRAINOR: Okay.
`
`(By Mr. Trainor)
`
`And I'm not sure you
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0024
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`completed the thought,
`
`so since we have to get
`
`the
`
`record completely,
`
`the FDA requires, generally,
`
`RCT—type clinical trials?
`
`A
`
`Q
`
`Yes.
`
`Okay.
`
`Now, continuing on,
`
`the designation A
`
`in Table 2 under "Clinical" suggests that —— excuse me,
`
`we just did it.
`
`The designation B means that there have been
`
`some clinical studies and, by inference, not
`
`necessarily RCT level, but some clinical studies,
`
`correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: Yes,
`
`that's what the table
`
`appears to say.
`
`Q
`
`(By Mr. Trainor) Right. And if the
`
`designation C appears under "Clinical," would you
`
`understand it to mean that no actual clinical study has
`
`ever been conducted, but there's some expert opinion
`
`out there that supports the claim of effectiveness?
`
`A
`
`Q
`
`I
`
`think that's a reasonable interpretation.
`
`Okay.
`
`So I don't know that you need to
`
`necessarily count
`
`them, but with respect to all of the
`
`mechanisms of action and all of the subsidiary
`
`compounds that have been investigated and reported in
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0025
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`this Andersson paper,
`
`I believe that —- count for
`
`yourself, but
`
`I believe that it's about 27 of the
`
`compounds have been reported as showing effectiveness
`
`in treating either bladder hyperactivity or overflow
`
`incontinence. Does that seem fair?
`
`MS. WOOTEN: Objection,
`
`form.
`
`(By Mr. Trainor) You're free to count.
`
`would you like me to count?
`
`No.
`
`Okay.
`
`If that's your count,
`
`I --
`
`Okay.
`
`No dispute with that.
`
`Great. And some smaller number —— I believe
`
`Q A
`
`Q
`
`A
`
`Q A
`
`Q
`
`it's about 20 —— have been in either an RCT or other
`
`clinical study as opposed to not having been examined
`
`in a clinical itself. Does that seem about right,
`
`just
`
`eyeballing this chart?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: That seems close,
`
`I
`
`suppose.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor)
`
`So —— and that would
`
`include —— among the compounds that would fall into the
`
`category of having being shown effective and have been
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0026
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`the subject of a clinical trial are a number of the
`
`antimuscarinic drugs —— do you see that --
`
`propantheline, emepronium,
`
`trospium, and tolterodine?
`
`A
`
`Q
`
`I see that.
`
`Okay. And oxybutynin is not classified as an
`
`antimuscarinic per se.
`
`He reports it as a drug with
`
`mixed action.
`
`Do you see that?
`
`A.
`
`Q
`
`I see that.
`
`But you understand that oxybutynin,
`
`among its
`
`actions, has antimuscarinic action, correct?
`
`A
`
`Correct.
`
`MS. WOOTEN: Objection,
`
`form.
`
`Q
`
`(By Mr. Trainor)
`
`So the question that I have
`
`is:
`
`The person of ordinary skill in the 1998 or 1999
`
`time frame would have a number of research options
`
`available if the endeavor was to develop a new OAB
`
`drug, correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: Correct.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor)
`
`And in your declaration ——
`
`let's turn back to that.
`
`I believe it begins around ——
`
`you addressed the Andersson paper around paragraph 71.
`
`And there you're just sort of describing Andersson.
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0027
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`But if you turn to paragraph 76 of your declaration,
`
`paragraph 76 appears under a new heading that says
`
`"Selection of a Compound for Obviousness Analysis."
`
`Do
`
`you see that?
`
`A
`
`Q
`
`I have found it.
`
`Okay.
`
`Now,
`
`the sentence reads that you were
`
`first asked to look at the market for overactive
`
`bladder compounds as a skilled artisan in drug design
`
`and development and determine where a person of
`
`ordinary skill would begin possible development.
`
`Do
`
`you see that?
`
`A
`
`Q
`
`Yes.
`
`Okay.
`
`So I
`
`take it the "asked" refers to
`
`being asked by counsel?
`
`A
`
`No, sir.
`
`I was thinking being asked by a
`
`director as a scientist in a laboratory.
`
`Q
`
`Uh—huh.
`
`So that being the case,
`
`that
`
`paragraph should read, "I would have first been asked,"
`
`or something like that;
`
`is that right?
`
`A
`
`Oh,
`
`I'm sorry.
`
`I misunderstood the —— I
`
`was —— in this case, yes. Yeah,
`
`the —- yeah,
`
`I was
`
`asked by counsel.
`
`I'm sorry.
`
`Q
`
`A
`
`Okay.
`
`Yes.
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0028
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Q
`
`Now,
`
`is it your view that a person of
`
`ordinary skill in drug development at the relevant time
`
`would have only considered the compounds that were
`
`available on the market at the time in terms of a
`
`platform for research?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: Not only, but as a
`
`starting point.
`
`MR. TRAINOR: Uh-huh. Okay.
`
`Q
`
`(By Mr. Trainor)
`
`So just so I have the
`
`record Correctly,
`
`in your Opinion, a person of ordinary
`
`skill in the art charged with trying to develop a new
`
`OAB drug would have begun looking for lead compounds
`
`exclusively among those that were on the market at the
`
`time;
`
`is that right?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: Not exclusively, but as a
`
`starting point.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor) Well, where else might you
`
`look for a starting point?
`
`A
`
`I would look for compounds in my
`
`institution's library.
`
`Q
`
`Even if they had nothing to do or no previous
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0029
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`relation to urology?
`
`A
`
`Q
`
`Indeed, yes.
`
`Okay. And if you were to go about doing
`
`that, separate from looking at the drugs on the market,
`
`what
`
`types of compounds in your library would you be
`
`looking for?
`
`A
`
`I would look for molecules that bear
`
`structural similarity to what
`
`I would perceive as a
`
`structure -- from the structures that were known.
`
`Q
`
`Uh—huh. Okay. Okay. And that would be the
`
`case, again, even if some structural analog in your
`
`library had never been experimented with before for the
`
`purpose,
`
`in this case, of uses in OAB treatment,
`
`correct?
`
`A
`
`Yes.
`
`MS. WOOTEN: Objection,
`
`form.
`
`MR. TRAINOR: Okay.
`
`MS. WOOTEN:
`
`Pause and give me a moment
`
`to make an objection.
`
`THE WITNESS: Okay.
`
`Sorry. Yeah,
`
`you're right. Okay.
`
`Q
`
`(By Mr. Trainor)
`
`And would you or the person
`
`of ordinary skill in the art at the time also consider
`
`the literature irrespective of whether the literature
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0030
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`published about marketed products exclusively?
`
`A
`
`Yes.
`
`MS. WOOTEN: Objection,
`
`form.
`
`WITNESS: Sorry.
`
`MR. TRAINOR: Okay.
`
`Q
`
`(By Mr. Trainor) Would the Andersson paper
`
`be an example of such literature,
`
`a review paper like
`
`that?
`
`A
`
`Q
`
`It would.
`
`It would, okay, and so would it be —— would
`
`it be at least as reasonable to investigate Compounds
`
`with different mechanisms of action other than those
`
`currently marketed as it would be to look at those
`
`compounds that were presently marketed?
`
`MS. WOOTEN: Objection,
`
`form.
`
`(By Mr. Trainor)
`
`As starting points?
`
`I'm not —— so could you ask that again to
`
`Q
`
`A
`
`make sure I understand you correctly?
`
`Q
`
`Okay.
`
`So when I asked you where a skilled
`
`artisan would look to try to find a starting point for
`
`a new OAB drug at the relevant time,
`
`in 1998 or 1999,
`
`and correct me if I'm wrong, one place you would look
`
`is at the currently marketed products in the field,
`
`correct?
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0031
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`Correct.
`
`A second place you would look,
`
`to the extent
`
`A
`
`Q
`
`that you had access, was a library with compounds
`
`having structural similarity to compounds known to
`
`have --
`
`A
`
`Q
`
`Yes.
`
`—— been effective?
`
`Yes.
`
`MS. WOOTEN: Objection,
`
`form.
`
`Q
`
`(By Mr. Trainor)
`
`And from your last answer,
`
`I'm just asking, would it be just as reasonable to look
`
`for a starting point in a review article like Andersson
`
`that is proposing novel approaches to the problem,
`
`although not necessarily with drugs in the class of
`
`compounds that were presently marketed?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS:
`
`I disagree that Andersson
`
`is proposing novel approaches. Andersson is
`
`merely reporting what's been described in the
`
`literature.
`
`Q
`
`(By Mr. Trainor)
`
`Fair enough. And what's
`
`being described in the literature is that a great
`
`number of researchers were,
`
`in fact, at the time
`
`researching and trying to develop new OAB treatments
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0032
`
`
`
`STEVEN E. PATTERSON, Ph.D.
`
`that employed mechanisms of action other than classic
`
`antimuscarinic treatment, correct?
`
`MS. WOOTEN: Objection,
`
`form.
`
`THE WITNESS: My opinion is that the
`
`skilled artisan would look —— would look to
`
`find out what's already known and then
`
`proceed from there ——
`
`MR. TRAINOR: Right.
`
`THE WITNESS:
`
`-- and choose what would
`
`be perceived —— what that person perceived as
`
`the easiest approach first.
`
`Q
`
`A
`
`(By Mr. Trainor) Why the easiest?
`
`Why begin with something difficult?
`
`It's the
`
`easiest, but it's the most efficient way to work.
`
`Q
`
`Well, how else does medicine progress if
`
`everybody just looks for the easiest solution?
`
`A
`
`Q
`
`A
`
`Q
`
`It's where you begin.
`
`I see.
`
`It's not always --
`
`Okay. Okay.
`
`Be that as it may,
`
`in terms of
`
`what's known,
`
`I
`
`think you said,
`
`there are at least 20
`
`different compounds reported in Andersson that were
`
`known,
`
`reported as effective, and had actually been in
`
`clinical trials, correct?
`
`TSG Reporting — Worldwide — 877-702-9580
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2020 - 0033
`
`
`
`STEVEN E. PATTER
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