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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MODERNA THERAPEUTICS, INC., )
` )
` Petitioner, )
` )
` vs. ) No. IPR 2018-0739
` )
`PROTIVA BIOTHERAPEUTICS, )
`INC., )
` )
` Patent Owner. )
`---------------------------- )
`
` TRANSCRIPT OF CONFERENCE CALL
` BEFORE JUDGE SUSAN L.C. MITCHELL
`
` Seattle, Washington
` Tuesday, April 30, 2019
`
` Reported by:
` DIANE RUGH, RMR, RPR, CRR, CCR No. 2399
` JOB NO. 160091
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`PROTIVA - EXHIBIT 2057
`Moderna Therapeutics, Inc. v. Protiva Biotherapeautics, Inc.
`IPR2018-00739
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MODERNA THERAPEUTICS, INC., )
` )
` Petitioner, )
` )
` vs. ) No. IPR 2018-0739
` )
`PROTIVA BIOTHERAPEUTICS, )
`INC., )
` )
` Patent Owner. )
`---------------------------- )
`
` TRANSCRIPT OF CONFERENCE CALL
` BEFORE JUDGE SUSAN L.C. MITCHELL
`
` Seattle, Washington
` Tuesday, April 30, 2019
`
` Reported by:
` DIANE RUGH, RMR, RPR, CRR, CCR No. 2399
` JOB NO. 160091
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`PROTIVA - EXHIBIT 2057
`Moderna Therapeutics, Inc. v. Protiva Biotherapeautics, Inc.
`IPR2018-00739
`
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` April 30, 2019
` 11:00 a.m. PST
`
` Conference call held at the offices of
` Wilson Sonsini Goodrich & Rosati, 701 Fifth
` Avenue, Suite 5100, Seattle, Washington, before
` Diane Rugh, a Registered Professional Reporter,
` Registered Merit Reporter, Certified Realtime
` Reporter of the State of Washington.
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` A P P E A R A N C E S:
`
` IRELL & MANELLA
` Counsel for Petitioner
` 1800 Avenue of the Stars
` Los Angeles, California 90067
` BY: MACLAIN WELLS, ESQ. (Via telephone)
` MICHAEL FLEMING, ESQ.
`
` WILSON SONSINI GOODRICH & ROSATI
` Counsel for Patent Owner
` 701 Fifth Avenue
` Seattle, Washington 98104
` BY: MICHAEL ROSATO, ESQ.
` SONJA GERRARD, ESQ.
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` - oOo -
` THE COURT: This is Judge Mitchell,
` and with me on the line are Judge Smith
` and Judge Snedden. We're here for a
` conference call in IPR 2018-00739.
` And if I could start by getting a
` roll call. First, who is here for
` Petitioner?
` MR. WELLS: Maclain Wells of Irell &
` Manella who is here for Petitioner; and
` with me is Mike Fleming. And we also have
` a court reporter.
` THE COURT: Oh, great, thank you.
` Just, you know, I'm sure you plan on doing
` this, but as soon as you get the
` transcript, if you could file it in the
` record, that would be fantastic.
` MR. WELLS: Yes, Your Honor.
` THE COURT: Thank you.
` And who is on the line for Patent
` Owner?
` MR. ROSATO: Good morning, Your
` Honor. At least on the West Coast good
` morning. Good afternoon.
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` Mike Rosato on behalf of Patent
` Owner. I have Sonja Gerrard here with me,
` both of Wilson Sonsini. And we -- I guess
` underscoring the benefits of communication
` between counsel, we also have a court
` reporter.
` THE COURT: Oh, great. If you would
` also, when you get that transcript, if you
` would get that one on file too. That
` would be fantastic.
` MR. ROSATO: Of course.
` THE COURT: Well, let's get started.
` I know that Petitioner originally sought
` the call so let me start with Petitioner.
` MR. WELLS: Yes, Your Honor.
` We've asked for authorization to file
` a Motion to Strike regarding new evidence
` and new arguments that the Patent Owner
` submitted with their surreply brief. The
` Trial Practice Guide is clear that, and
` this is a quote, "The surreply may not be
` accompanied by new evidence other than
` deposition transcripts of the
` cross-examination of any reply witness."
` By submitting new evidence and new
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` arguments in their surreply brief for the
` first time, they've prejudiced our client.
` We don't have the opportunity to respond
` or counter or address the relevance of
` this evidence, and all of this evidence is
` publicly available documents that were
` foreseeable. And so we would like
` permission to bring a Motion to Strike.
` THE COURT: All right. Let me hear
` from Patent Owner.
` MR. ROSATO: Thank you, Your Honor.
` So a couple things that don't warrant the
` relief in this instance. All these
` materials, for one, are in a case where
` there's both a Motion to Amend and in
` addition to the briefing in the case in
` chief. So these are materials and
` evidence that are properly of record in
` the context of the reply brief in the
` Motion to Amend, as well as exhibits in
` evidence that were properly brought in
` during cross-examination of Petitioner's
` witness specifically for impeachment
` purposes. So these are all properly of
` record at least in that regard.
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` But in addition to that, this is a
` somewhat unique situation where the
` references that are being brought in, the
` reason they're being brought in for
` impeachment purposes is, you know, one,
` they're in direct conflict with arguments
` that are advanced in the reply materials,
` but two, these are really Petitioner's own
` publications that we're talking about.
` And when Petitioner has, as they
` noted, public documents that they should
` have known about that are running in
` direct and unquestionable conflict with
` the arguments they're advancing, those
` should have been disclosed. And the fact
` that we were, fortunately, able to find
` some of them doesn't extinguish the
` obligation under Rule 51 that Petitioner
` has to provide those documents to us. We
` shouldn't be left in the position of
` having to search for that information.
` And whatever other information might be
` out there sort of, you know, if anything,
` underscores the issue here.
` Beyond that, it's difficult to go
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` through the reply materials and the
` surreply materials and come to any
` conclusion other than the argument and
` evidence that's being identified is
` anything other than directly responsive to
` the arguments that were raised in reply.
` And I haven't heard anything to date
` indicating why this argument and material
` would not be deemed properly responsive to
` what's in the reply materials. And it is.
` And I'm happy to walk through what
` seemed to be the three main issues and
` point out how it's very clearly and
` directly responsive to the arguments that
` were raised.
` THE COURT: Can I ask you a quick
` question with regards to, you're saying a
` lot of the new evidence was used in
` cross-examination of a witness. Is that
` how it's been introduced in the surreply?
` Does that make sense?
` MR. ROSATO: Well, the surreply
` certainly identifies the corresponding
` testimony in the cross-examination
` transcript, and points out that the expert
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` confirmed that he had not considered this
` material, which of course calls into
` question the credibility of his testimony
` on those points.
` And if he's making a point
` affirmatively stating something like
` ionizable cationic lipids were nontoxic,
` and he confirms that he didn't consider
` Exhibits 2051 and 2052, but Petitioner's
` own publications which state expressly and
` unequivocally that they believe that
` ionizable cationic lipids are toxic, that
` raises questions as to the credibility of
` the witness's testimony. It's direct
` impeachment evidence and it was raised in
` the context of that cross-examination.
` So both -- so yes, if what you're
` asking is did we cite to the
` cross-examination testimony, the answer is
` yes, we certainly did.
` THE COURT: Okay.
` MR. WELLS: May I respond, Your
` Honor?
` THE COURT: So let me --
` MR. WELLS: So at the deposition of
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` the expert, what counsel did was put two
` new references before him that had never
` been made of the record, never been
` introduced, and said, Did you consider
` these. And they were objected to as
` outside the scope of his testimony. And
` there was an objection to each of these
` exhibits on the record noting that they
` were improper new evidence being admitted
` for improper purposes outside the scope.
` And those objections were all noted.
` And then in their reply -- or their
` surreply, I'm sorry -- they reference the
` testimony, but then they also go into
` these exhibits and start pulling out one
` phrase out of a 300-page patent
` application and say, oh, out of context,
` this one phrase directly contradicts the
` assertions. We obviously have a different
` opinion regarding what those references
` disclose, but our expert hasn't had an
` opportunity to opine on them because of
` the timing here.
` And their allegation that these are
` proper references that were brought up in
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` the surreply appropriately is, one, not
` accurate, first of all. All of these
` references, again, were public. They had
` access to this information. That isn't
` information that was hidden. This isn't
` test data that was unknown to them and
` that they couldn't have access to. And it
` was foreseeable that they could have
` searched and found this information
` readily for the purposes of their Patent
` Owner response.
` It does not directly contradict
` anything that the Petitioner has said. We
` obviously very much disagree with that.
` And so we haven't -- there's been no
` discovery misconduct that warrants this
` kind of late disclosure. And the rules
` are entirely clear that surreplies are not
` allowed to include additional evidence
` other than transcripts of
` cross-examination. And that's the Trial
` Practice Guide from 2018 at Page 14.
` THE COURT: Well, if it's introduced
` in relation to testimony for impeachment
` purposes, how is that not introducing
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` evidence in relation to testimony?
` MR. WELLS: Well, they're allowed to
` cite to the deposition transcript and
` they're allowed to -- but they're not
` allowed to put random articles in front of
` an expert that wasn't part of either their
` expert's opinions or our expert's
` opinions, and then in the surreply attach
` those articles, characterize the content
` thereof without any support from an
` expert, only attorney argument, and
` deprive us of the opportunity to respond.
` The Trial Practice Guide is clear
` that the whole point of the surreply was
` to be a substitute for the prior
` observation practice. And the prior
` observation practice wouldn't have allowed
` the citation of new evidence with attorney
` argument and no expert opining on the
` content of these articles to deprive the
` other party of the opportunity to respond.
` THE COURT: Okay. Let me ask you, so
` were these particular new exhibits also
` part of the Motion to Amend briefing or
` not?
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` MR. WELLS: Some of them were.
` There's a subset that are also cited in
` the Motion to Amend. They're cited to
` make the same arguments in the Motion to
` Amend that they're including in the
` surreply where they also make these
` arguments.
` And one, we don't think that the
` motion to -- a reply on the Motion to
` Amend is meant to be an end run around
` limitations on the content and
` introduction of new evidence in an
` untimely manner. And two, there's
` arguments in their surreply regarding
` these exhibits that has nothing to do with
` the Motion to Amend.
` THE COURT: Okay.
` MR. WELLS: In addition, there are
` exhibits that aren't part of the Motion to
` Amend.
` THE COURT: Okay. But you still --
` Petitioner still has an opportunity to
` respond, right, to what they --
` MR. WELLS: Well, in theory we would
` have an opportunity to respond to the
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` arguments and the Motion to Amend, to the
` subset of exhibits that were addressed in
` the Motion to Amend, not to the ones that
` weren't.
` THE COURT: Okay. But there are some
` that you want --
` MR. WELLS: And given it's a
` surreply, we're limited on what we can
` include. They didn't include an expert
` declaration addressing any of these so we
` can't include cross-examination evidence,
` and we can't include any responsive
` materials. And we can't -- in theory,
` unless the Board authorizes further brief,
` further declarations from our expert, we
` can't submit expert evidence in response
` either.
` THE COURT: Okay.
` Patent Owner, would you like to
` respond? I know we sort of interrupted
` what you were saying originally.
` MR. ROSATO: No problem, Your Honor.
` Thank you. I guess a couple points.
` This is a bit of what I find a
` circular argument by Petitioner that
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` because an expert declaration didn't
` accompany the reply and arguing that new
` evidence shouldn't be included in a reply
` and then complaining that an expert
` declaration wasn't submitted with the
` reply, it sort of loses sight of what's
` going on here.
` And what's going on here is they
` submitted an expert declaration with their
` reply materials. That declaration had
` opinions, and those opinions are
` contradicted by their own publications.
` Their expert confirmed he didn't consider
` conflicting evidence in rendering his
` opinions. That calls into question the
` credibility and reliability of those
` opinions. And that's the point of
` impeachment evidence.
` So it's somewhat circular to say,
` well, it shouldn't be considered because
` there wasn't a corresponding set of
` further evidence, which they're
` complaining is not permissible. So this
` all loops back to the same point. This is
` impeachment evidence. This directly
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` contradicts what they argued. It's
` directly responsive to what they argued.
` So that doesn't really make sense from
` that regard.
` And I would further say that one of
` the points that Your Honor touched on was
` the opportunity for additional briefing.
` I will note that there has been objections
` to the same evidence filed in this case,
` so we're assuming that Petitioner is going
` to file a Motion to Exclude and brief the
` same issues. So I would say there's an
` additional factor. There's a concern
` for -- you know, whether it's to the
` benefit of the parties and the Board, to
` have the record flooded with additional
` briefing and various forms addressing the
` same content.
` And in terms of the alleged improper
` evidence, I think all of these exhibits --
` I think most of these exhibits were
` actually cited in the Motion to Amend. So
` I think they were all there, but this is
` the first I have heard of that argument.
` MR. WELLS: If I can respond, Your
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` Honor. Or would you like me to --
` THE COURT: Yeah, I will in a minute.
` Let me ask, Mr. Rosato, you're asking if
` we do grant the authorization to file the
` Motion to Strike, were you also asking for
` a Motion for Sanctions because these
` particular exhibits were not produced to
` you by Petitioner?
` MR. ROSATO: Our position is the
` Board's fully capable of looking at the
` record and assessing whether Petitioner's
` arguments are supported by evidence or
` whether they're contradicted by evidence.
` But to do that, the record has to reflect
` reality. And for that to happen here,
` Petitioner's own publications, which
` directly contradict their arguments,
` should be of record.
` That was the approach and what seemed
` to make most sense in terms of efficiency,
` from our perspective. And we were really
` surprised that some of these arguments
` were being advanced and that the
` corresponding references were never
` disclosed. But that's the approach
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` Petitioner chose to take.
` That being said, if we're getting
` into arguing that key evidence be struck
` from the record, I mean, that's a bit of a
` surprising argument and approach as well.
` And if we're looking at Rule 51 and Rule
` 12, I mean, we're seeing what really
` should have been an obligation as routine
` discovery under Rule 51, which wasn't
` observed, and that lack of disclosure
` combined with the arguments advanced in
` the Petitioner's reply, is sanctionable
` conduct under Rule 12.
` And given these particular issues,
` the appropriate remedy is what is
` specifically outlined in Rule 12(b). And
` that includes holding that certain facts
` be established in precluding Petitioner
` from contesting corresponding issues. So
` under the letter of the rule, it's
` perfectly appropriate. As a practical
` matter, we have confidence that the Board
` can assess the evidence and see that the
` arguments that Petitioner is advancing
` lacks supporting evidence and that the
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` exhibits that are in dispute right now are
` contradictory evidence.
` And I just want to make one other
` note. Petitioner mentioned something
` about experimental testing. This does
` sort of underscore another point here,
` which is this lack of disclosure has
` become a pervasive issue in this
` proceeding. Because in this very same
` deposition of Petitioner's expert, we
` learned for the first time, even though we
` had asked previously, but we learned for
` the first time very late stage of the case
` that Petitioner had commissioned outside
` testing specifically for the purposes of
` these IPRs, commissioned experimental
` testing, had results, never disclosed them
` either to us or the Board. And when asked
` about why that was, the expert told us
` that he felt that data was unreliable so
` they chose not to submit it.
` It was a surprise to hear that
` experimental work that was specifically
` commissioned for litigation purposes was
` not disclosed and not identified when
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` previously asked. And the only reasonable
` conclusion is it wasn't helpful to their
` case. But the expert also tried to spin
` that information to touch on some of the
` same issues that we're talking about here
` today.
` So there's an issue with lack of
` disclosure here. And, you know, I think
` the most efficient thing for the Board to
` do is let published literature stay of
` record, make the assessment that we think
` the Board is capable of making. But if
` that's going to remain a disputed issue, I
` think we have to -- I think we have to
` observe the appropriate remedies that are
` available to us, and that includes a
` Motion for Sanctions.
` THE COURT: Thank you.
` Mr. Wells, I'll certainly let you
` respond, but let me ask you first, why is
` the Motion to Exclude not sufficient for
` your purposes to address --
` MR. WELLS: Yes, Your Honor.
` So the Motion to Strike is the
` appropriate motion, I believe, for
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` materials that are attached improperly to
` a surreply. A Motion to Exclude may be
` warranted on the basis that this is
` unreliable evidence and they haven't put
` -- and all they have is attorney argument
` regarding what they allege the content of
` this stuff is. And obviously we have a
` disagreement on that fact.
` But the Trial Practice Guide is clear
` that you're not supposed to make Motion to
` Strike arguments as part of a Motion to
` Exclude. So we do think that the Motion
` to Exclude is the proper remedy for the
` untimely and improper attachment of new
` evidence to a surreply.
` Does that answer your question
` regarding the Motion to Exclude?
` THE COURT: Yes.
` MR. WELLS: Now if I can to respond
` to a couple of the things that counsel
` raised.
` Counsel raised at the last part this
` testing evidence. Well, our expert did do
` testing regarding the '435 patent. This
` was never asked about previously by
`
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` counsel with regard to the '435 patent
` which the testing related to. And he
` basically determined that after spending
` time and money, the testing couldn't --
` they couldn't make the system work with
` the payloads that they were looking at.
` That's an enablement argument. That
` wouldn't normally be part of an IPR
` process. It could potentially be relevant
` to the Motion to Amend, but it certainly
` wasn't something that would have been
` relevant prior to their Motion to Amend
` being brought. And the fact that the
` disclosures are not enabling doesn't
` undercut our position at all, and in fact
` would support non-enablement arguments.
` So the fact that the expert decided
` not to rely on that doesn't -- there was
` no obligation to disclose that
` information. When asked about it, he did
` so. And it certainly wasn't anything that
` the Patent Owner has brought up in regards
` to the pending motion or the request for
` authorization on the Motion to Strike.
` Now, regarding letting evidence in
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` being attached to a surreply and being
` characterized by Patent Owner as having
` certain disclosures and certain
` ramifications without allowing us the
` opportunity to respond is prejudicial to
` the Petitioner and it sets a dangerous
` precedent to go against the Trial Practice
` Guide and allow introduction of new
` evidence as a surreply. Not all of the
` exhibits are addressed in the Motion to
` Amend. And in addition, the Motion to
` Amend shouldn't be used as an end run
` around those disclosures.
` These disclosures, again, are public
` documents they could have found, if they
` really thought they supported their
` position, in the course of preparing their
` Patent Owner response. They didn't do so.
` And we don't have a fair opportunity to
` have our expert weigh in on the evidence
` and what the potential import is.
` THE COURT: All right. I think we
` understand your position.
` What if Petitioner did have an
` opportunity to reply to the new evidence?
`
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` Would that obviate the need for a Motion
` to Strike and any requisite sanctions
` motion that Patent Owner would like to
` file?
` MR. WELLS: If we have the
` opportunity for our expert to weigh in and
` for us to weigh in on the alleged import
` of this evidence and whatnot as additional
` briefing, and I don't know that that, one,
` is necessary and contemplated by the
` rules, but that would help ameliorate the
` prejudice. But we do think we need the
` opportunity to respond. The timing is
` what I'm concerned about.
` THE COURT: Yeah, okay. That's fair.
` Mr. Rosato, what would you say if we
` allowed a reply to the evidence?
` MR. ROSATO: I'm a little struck by
` the comment of prejudice. Again, we're
` talking about their own publications, and
` the point is their expert didn't consider
` them. So that's sort of the point. So to
` say that they're prejudiced because their
` expert didn't consider them misses that
` point.
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` This is evidence that should have
` been considered, and there's no prejudice
` in not having the opportunity to address
` their own evidence because our point is
` they should have addressed it. So the
` prejudice thing really doesn't make sense
` to me.
` In terms of the type of response, I
` heard Petitioner argue -- again, they're
` saying we're not allowed to include
` evidence in a reply, and didn't include an
` expert witness testimony, but now asking
` for an opportunity to have their witness
` come and comment on this? So we would
` certainly oppose that.
` Submission of new declaration
` testimony at this stage does not seem to
` be practical or possible. They've already
` had two declarations from their witness
` and had the opportunity where they're the
` party carrying the burden of proof. So a
` third bite of the apple, I think we would
` oppose that.
` If this was something other than
` references that should have been
`
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` considered, they should have been
` disclosed in the first place. There may
` be a more sympathetic position, but that's
` the -- you know, this is the situation
` here.
` THE COURT: Okay. I think we
` understand the different positions. And
` if you all will hold for just a minute and
` let me confer with the panel, I will be
` back in just a minute. Thanks.
` (Pause in proceedings.)
` THE COURT: This is Judge Mitchell
` back with the panel, Judges Smith and
` Snedden.
` We would like to take this under
` advisement. Sorry we were not able to do
` an order today, but in the next day or so.
` So I'm not sure how fast you can get the
` transcript done. I know that's
` sometimes -- but anyway, we will take the
` request for authorization under advisement
` and issue an order shortly.
` So are there any more issues or
` questions from Petitioner?
` MR. WELLS: No, Your Honor.
`
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` THE COURT: Okay.
` And from Patent Owner?
` MR. ROSATO: Thank you, Your Honor.
` There is one other issue to discuss.
` There was an issue of -- this may have
` gotten lost in some email communications
` and we apologize for the nature of those,
` but there was an issue surrounding some
` certain deposition transcript exhibits
` that were filed by Petitioner.
` And rather than submitting clean
` copies of the deposition transcripts, they
` submitted exhibits that were marked up
` with various highlighting sections. We
` had thought this was inadvertent and
` communicated with Petitioner to let them
` know that it looked like the wrong
` versions of the documents had been
` submitted, but we had been told by
` Petitioner that they meant to do that and
` that those were the exhibits they wanted
` on file.
` So in any event, our position is that
` the record should have clean copies of
` deposition transcripts, not transcripts
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` that are marked up by one party. So our
` proposal would be that clean copies be
` submitted in replacement and the marked-up
` versions be expunged.
` THE COURT: Okay.
` MR. WELLS: Your Honor, we submitted
` transcripts of the depositions and we
` highlighted the portions that are cited in
` the brief for easier reading for Your
` Honors. We're happy to submit a clean
` copy. If for some reason they want a
` clean copy on the record when we get the
` signed version, I'm happy to do so. If
` Your Honors don't think a highlighted
` version is useful to you, we're happy to
` remove it, but other courts ha
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