` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` MYLAN PHARMACEUTICALS INC.,
` Petitioner
` v.
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
`
` IPR2018-01670, Patent No. 8,679,069
` IPR2018-01676, Patent No. 8,603,044
` IPR2018-01678, Patent No. 8,992,486
` IPR2018-01679, Patent No. 8,882,486
` IPR2018-01680, Patent No. 9,526,844
` IPR2018-01682, Patent No. 9,526,844
` *REVISED*
` TELEPHONIC CONFERENCE
` November 18, 2019
`
`REPORTED BY: CARRIE LAMONTAGNE, CSR No. 13393
`JOB NO. 172254
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` PTAB TELECONFERENCE - 11/18/19
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` November 18, 2019
` 1:01 p.m., EST
`
` Telephonic proceedings, held before
`Administrative Patent Judges Hyun J. Jung, Bart A.
`Gerstenblith, and James A. Tartal, before Carrie
`LaMontagne, a Certified Court Reporter for the State
`of California.
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`A P P E A R A N C E S:
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` WILSON SONSINI GOODRICH & ROSATI
` Attorneys for Petitioner Mylan
` 1700 K Street NW
` Washington, DC 20006
` BY: RICHARD TORCZON, ESQ.
` WESLEY DERRYBERRY, ESQ.
` LORA GREEN, ESQ.
` TASHA THOMAS, ESQ.
`
` WINSTON & STRAWN
` Attorneys for Petitioner Pfizer
` 1700 K Street, NW
` Washington, DC 20006
` BY: JOVIAL WONG, ESQ.
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`A P P E A R A N C E S continued:
` WEIL, GOTSHAL & MANGES
` Attorneys for Patent Owner
` 2001 M Street, NW
` Washington, DC 20036
` BY: SUTTON ANSLEY, ESQ.
`
` and
` FISH & RICHARDSON
` Attorneys for Patent Owner
` 601 Lexington Avenue
` New York, NY 10022
` BY: JOHN GOETZ, ESQ.
` JOSHUA GRISWOLD, ESQ.
` MATTHEW COLVIN, ESQ.
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` JUDGE JUNG: Hello, this is Judge Jung,
`and this is conference for IPR2018-1670, 1676, 1678,
`1679, 1680 and 1682 between petitioners Mylan and
`Pfizer and Patent Owner Sanofi.
` With me are Judges Gerstenblith and Tartal.
` Counsel for Petitioner Mylan, please introduce
`yourself.
` MR. TORCZON: Good afternoon, Your Honor.
`This is Richard Torczon from Mylan. I wanted to
`advise the Board that there is a court reporter on
`the line, and that we will be providing a transcript
`promptly. Also on the line for Mylan is Lora Green,
`Wes Derryberry, and Tasha Thomas. And Jovial Wong
`is on the line for Pfizer.
` JUDGE JUNG: Okay. Thank you,
`Mr. Torczon.
` Counsel for Patent Owner, please introduce
`yourself.
` MR. ANSLEY: Good afternoon, Your Honor.
`This is Sutton Ansley from Weil, Gotshal & Manges
`here on behalf of Sanofi. On the line with me from
`the same firm are Anish Desai and Brian Chang. I
`believe counsel from Fish & Richardson is also on
`the line.
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` MR. GOETZ: Yes, Your Honor, John Goetz
`from Fish & Richardson, also for Patent Owner. And
`with me is Josh Griswold and Matt Colvin, also from
`Fish & Richardson.
` JUDGE JUNG: Okay. Thank you, Mr. Ansley,
`and thank you, Mr. Goetz.
` Let's see, the Petitioner Mylan scheduled this
`conference to discuss Patent Owner's filing of
`Exhibit 2319 and citations in Patent Owner's
`sur-replies to Exhibit 2319. And then in another
`e-mail there was a request for guidance regarding
`the date for deposing Dr. Slocum. So we can tackle
`each of those topics one at a time.
` Going back first to Exhibit 2319, it looks
`like -- let me get some confirmations from the
`parties before we start the actual presentation.
` It looks like 2319 was filed with these six
`cases, 1670, 76, 78, 79, 80, and 82, but it was only
`cited in the sur-replies for 1670, 76, 78, and 82.
` So starting with Mr. Torczon, is that a correct
`statement?
` MR. TORCZON: That sounds correct to me,
`Your Honor.
` JUDGE JUNG: And turning to Mr. Ansley, do
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`you have any additions to that?
` MR. ANSLEY: Sounds correct.
` JUDGE JUNG: Okay. All right.
`Mr. Ansley, can you give us a brief summary why you
`thought filing Exhibit 2319 was necessary.
` MR. ANSLEY: Thank you, Your Honor. This
`is Mr. Ansley. First I want to note that the
`parties have agreed to expunge 2319, if that will
`alleviate the problem. I understand that the
`Petitioners still want to strike the sentence that
`precedes the citation of that exhibit.
` The reason that sentence was made in the reply,
`Petitioners argued that Sanofi did not present
`Mr. Veasey as a witness in this case. And so the
`statement we made in the sur-reply that petitioners
`would like to strike is that Sanofi did provide a
`declaration from Mr. Veasey in which he discussed
`the creation of an animation explaining physical
`model. And that was a declaration that was served
`as supplemental evidence back in July.
` And so we made the statement, just to respond,
`to correct a statement that was made in the reply
`and the exhibit was cited -- I'm sorry, in the
`reply, and the exhibit was cited as support for that
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`statement.
` JUDGE JUNG: Okay. All right. Thank you,
`Mr. Ansley.
` Turning back to Mr. Torczon. Since you made
`the request, you can start with your presentation
`whenever you're ready.
` MR. TORCZON: Okay. I'd like to correct
`something that was just said and that is the parties
`haven't agreed to the expungement.
` Certainly given that we are asking for an
`opportunity to strike it, we would like the
`declaration out of the case. As I indicated, just
`taking the declaration out of the case is an
`incomplete solution because that leaves an inference
`in the record about an opportunity being presented
`with regard to cross-examining Mr. Veasey, which in
`the context of the sur-reply, in the context of
`discussing whether there was actual presentation of
`the bases that he provided to Dr. Slocum, is
`inaccurate and potentially very misleading.
`Certainly --
` JUDGE JUNG: Before you go on, you do
`agree that you do want that exhibit expunged, right?
`And that's what I think I heard from Patent Owner's
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`counsel, Mr. Ansley, that he is willing to expunge
`or have Exhibit 2319 expunged from these six cases.
` MR. TORCZON: We see it as an all or
`nothing solution just because our concern --
` (Simultaneous speaking.)
` JUDGE JUNG: -- [indiscernible] sur-reply.
`Before we move on to the sur-reply, you would agree
`that the exhibit itself can be and should be
`expunged?
` MR. TORCZON: Yeah, if both are expunged,
`that would be fine. But the alternative and the
`default, of course, under the rules is it's
`currently in the record at the moment. And if it's
`in the record, we get to cross-examine Mr. Veasey.
` And the practice guide indicates that this is a
`situation where a directed sur-reply, you know,
`would take the place of observations. So we're
`comfortable with either solution. We think that
`striking it all is the more efficient one, but we're
`happy to go with either direction.
` JUDGE JUNG: Okay. So agree to the
`expunging of the Exhibit 2319, and you also want
`certain sentences in the sur-replies to be struck.
`And I wasn't clear from the e-mail which part
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`exactly you want struck from the sur-replies.
` Will you clarify, do you want the entire
`sur-reply struck or certain portions or certain
`sentences?
` MR. TORCZON: No, no, Your Honor. So
`there's a sentence that specifically references this
`particular Veasey declaration. We would like that
`excised. Certainly, the surrounding two sentences
`also contribute, but we think the key is the
`sentence that specifically identifies the Veasey
`declaration as providing opportunity, because we
`don't -- you know, it gives no notice of the issue
`that's being discussed in that section of the
`sur-reply.
` Even assuming that it would have been proper to
`cross-examine him on the supplemental declaration,
`we wouldn't have known from that declaration that we
`needed to cross-examine him on what he had spoken to
`Professor Slocum about. And, you know, undoubtedly
`Sanofi would have said that any questions in that
`direction were out of the scope.
` It sort of creates a catch 22, and we think
`it's fundamentally unfair that if they had wanted to
`rely on Mr. Veasey as the source of critical bases
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`for Dr. Slocum's testimony, they should have put in
`a declaration that provided those bases.
` JUDGE JUNG: Okay.
` MR. ANSLEY: Your Honor, if I may?
` JUDGE JUNG: Is that you, Mr. Ansley?
`Before I come back to Mr. Ansley, Mr. Torczon, do
`you have anything else to present on this particular
`topic?
` MR. TORCZON: I'm happy to stop.
` JUDGE JUNG: All right. Mr. Ansley, your
`response.
` MR. ANSLEY: Hi. The Veasey declaration
`is very fairly limited. The purpose is -- as
`supplemental evidence and is fairly limited. It's a
`five-page declaration and it just discusses
`authenticity of the animation that was made
`describing the collar friction model.
` And the statement that petitioners would like
`struck simply says that Sanofi, however, provided a
`declaration from Mr. Veasey in which he discussed
`the creation of an animation explaining the physical
`model. That statement was made in response to a
`statement by Petitioners in their reply that Sanofi
`did not present Mr. Veasey as a witness in this
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`case.
` We're not offering -- Mr. Veasey hasn't been
`offered as a witness in this case for anything more
`than authenticity, an animation describing the
`physical model. To the extent that there's an
`implication that they could -- they would have the
`right to depose him on anything outside of that, we
`think that's incorrect.
` We also think that Petitioners did have an
`opportunity to depose Mr. Veasey. There is a case
`out there -- that's IPR2014-00221, and the facts of
`that case are fairly similar to what's at issue
`here.
` There the parties served a declaration of
`authenticity of supplemental evidence, and then
`after the reply brief had been filed, the other
`party sought to depose this declarant should the
`declaration be submitted as an exhibit along with
`the motion to exclude.
` The Board denied that request because the
`parties already had the opportunity to depose the
`declarant but it chose not to. The Board explained
`that a party could have taken the deposition of the
`declarant even though the declaration was only
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`served, not filed, as supplemental evidence. That
`was paper 27 in that case.
` Our point that we're making is simply a
`response to their argument that Mr. Veasey was not
`presented as a witness in this case. It's a very
`narrow argument. And our very narrow response was
`yes, he was. We submitted a declaration as
`supplemental evidence and they had the opportunity
`to depose him on that.
` JUDGE JUNG: Okay. And then a question
`for you, Mr. Ansley, if you're willing to agree to
`expunge Exhibit 2319, why aren't you further willing
`to strike a few sentences from your sur-reply?
` MR. ANSLEY: It's a factually accurate
`statement that was made about a mischaracterization
`in this case. So, again, the reply states that
`Mr. Veasey was not presented as a witness in case,
`and we're addressing that inaccuracy with a factual
`statement of what actually has happened in this
`case.
` It is purely within the scope of the reply.
`It's rebutting an argument that was made in the
`reply and we think it's proper to be made and
`doesn't need to be stricken.
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` JUDGE JUNG: Okay. Then there was a line
`in your e-mail talking about reserving your right to
`refile the exhibit.
` What did you mean by that exactly?
` MR. ANSLEY: One moment, I'm sorry. Thank
`you, Your Honor. If they were to end up filing a
`motion to exclude, for example, on the animation on
`of the collar friction model, then we want an
`opportunity to refile it in an opposition for a
`motion to exclude. That's what we meant.
` JUDGE JUNG: Okay.
` MR. ANSLEY: It would be in line with the
`ordinary procedures and customs regarding the
`supplemental evidence.
` JUDGE JUNG: Hold on a second. I think my
`panel has a question.
` Do you have a rule to cite for what you just
`discussed?
` MR. ANSLEY: Yeah, I should have one here.
`37 CFR 42.64, the party relying on evidence to which
`an objection is timely served and respond to the
`objection by serving supplemental evidence within
`ten days. That's what happened here. There was an
`objection made to the animation for the physical
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`model. We served the Veasey declaration
`authenticating that.
` And what we're saying is if Petitioners would
`like to file a motion to exclude this exhibit, then
`we would reserve the right to file the supplemental
`evidence as is normally done in these cases to
`oppose the motion to exclude based on authenticity
`grounds, for example.
` JUDGE JUNG: I see. Okay. Thank you.
`All right. Let me see if there's any more questions
`for you from the Panel. Give me a moment. There
`doesn't seem to be any more questions for the Panel
`for the Patent Owner.
` Turning back to Mr. Torczon, do you have a
`short reply?
` MR. TORCZON: Yes. This is not really a
`dispute about the authentication. This is a dispute
`about the representation that they appear to be
`making in context in their sur-replies that Mylan
`had legitimate notice and opportunity to
`cross-examine Mr. Veasey about the contributions he
`made to Dr. Slocum's testimony.
` That contribution is significant. Even
`Professor Slocum says he didn't know anything about
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`the industry and relied on Mr. Veasey for input.
`There was no notice that that was going to be the
`basis of the testimony. So for them to put Veasey
`in now suggests that we were somehow on notice.
` And once again, even if the Board understands
`that that's not true, there are still going to be
`these statements that they will be able to point to
`in the record on appeal, and we just think that has
`a hugely prejudicial potential to be misleading.
`The fact is they chose not to put the evidence in
`the case that they needed. We pointed that out, and
`now they're scrambling.
` Now I will say if they want a clarification
`that when we said that Mr. Veasey had been made a
`witness in the case, we're happy to stipulate that
`he was made a witness solely on the issue of
`authentication. With that clarification we're
`perfectly happy to make that. But the fact remains
`that in the context of the sur-reply where they are
`talking about Mr. Veasey's contributions to
`Dr. Slocum's testimony and his various technical and
`theoretical studies, the suggestion is that Veasey
`was made available as a witness on those topics and
`that simply wasn't true.
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` JUDGE JUNG: Mr. Torczon, you made an
`objection, Patent Owner filed -- served you with
`supplemental information in the form of the Veasey
`declaration. You also agree that you had an
`opportunity to depose Mr. Veasey after you were
`served with his declaration?
` MR. TORCZON: I think that's unclear. I
`mean, Mr. Ansley pointed to a single Board decision.
`I think if you read the rule in combination with the
`Board's scheduling order, it's really not clear.
`But the point remains if we had crossed him -- in
`fact, Mr. Ansley said it earlier in the call. If we
`had crossed him at the time, all we would have been
`able to cross him on was the authentication, and
`that's not the context that it's being used for now.
`It's being used to suggest that we had this sort of
`open-ended opportunity to cross him, and that's
`simply not true.
` JUDGE JUNG: Do you agree that the Patent
`Owner did not in any way make Mr. Veasey unavailable
`for deposition?
` MR. TORCZON: I disagree with that
`entirely, Your Honor. In fact, when they put in the
`declaration, we specifically asked to cross both
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`Dr. Slocum and Mr. Veasey.
` JUDGE JUNG: Back in July, when you were
`first served with the declaration, did Patent Owner
`in any way impede your access to Mr. Veasey?
` MR. TORCZON: No, we did not ask to cross
`him on his authenticating testimony. That would be
`a true statement, but it's also in the context of
`the sur-reply sort of irrelevant. I mean, that's
`why we think that actually removing the declaration
`without striking the reference to it -- you know,
`the Board would understand that that's an
`unsupported assertion without the declaration in the
`case.
` But in any case, without the declaration there
`to show that it had nothing to do with the issue
`that they're discussing, it actually makes it even
`more prejudicial.
` JUDGE JUNG: All right. So by not
`deposing Mr. Veasey back in July, do you agree that
`your objection to the authentication of these
`animations has been satisfied?
` MR. TORCZON: Well, that's a separate
`issue. We'll have to wait until the motion to
`exclude. If the question is are we conceding that
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`we did not ask to cross-examine Mr. Veasey on his
`authenticating testimony at that time, that is true;
`but, again, because of the way it's being used now,
`it's less relevant. Plus the fact that they put it
`into the record now opens it up for
`cross-examination and response for the way it's been
`used.
` JUDGE JUNG: Okay.
` MR. ANSLEY: Your Honor, if I can make --
` JUDGE JUNG: Let me just ask the Panel if
`they have any questions for Mr. Torczon before I
`turn back to you, Mr. Ansley.
` MR. ANSLEY: Okay. Thank you.
` JUDGE JUNG: Hold on for a few more
`minutes, please.
` The Panel wants confirmation from Mr. Torczon
`that the only implication that you're worried about
`is that Mr. Veasey could have been crossed on
`anything other than the authentication issues; is
`that correct, Mr. Torczon?
` MR. TORCZON: That is correct, and if we
`had a statement from the Board or from Sanofi that
`we never had an opportunity to cross him on the
`bases that he was supplying to Dr. Slocum, I think
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`we would be happy.
` JUDGE JUNG: Okay. Thank you,
`Mr. Torczon.
` Back to you, Mr. Ansley, you wanted a short
`reply.
` MR. ANSLEY: Yeah. So there's two points.
`One, again, Petitioners didn't take the deposition
`of Mr. Veasey on his limited declaration on
`authenticity that was served back in July. They
`didn't do it in September or October, and they
`didn't seek to take his deposition, Mr. Veasey's
`deposition, as additional discovery when Dr. Slocum
`told them that he relied on Mr. Veasey for certain
`things.
` The request to take his deposition, a
`broad-based deposition now on those types of things
`we think comes at an interesting time. The parties
`are actually scheduled to go to trial in two weeks.
`The trial starts two weeks from today. And
`Mr. Veasey is Sanofi's [indiscernible] fact witness
`on these device patents in that case, and we have
`concerns that the motivation to make Mr. Veasey
`available for a deposition now as opposed to months
`ago when they were first on notice of Mr. Veasey's
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`declaration and when Dr. Slocum was told that he was
`relying on Mr. Veasey for certain things, we think
`that could be an attempt to disrupt the trial prep
`and the trial itself that is on ongoing here.
` We -- we don't think a deposition here is
`warranted especially this late in the case after all
`the substantive briefings and filings have been put
`in. Again, the sentence in the sur-reply that
`Petitioners complain of, we think it's clear that
`it's not stating that Mr. Veasey provided a
`declaration on a broad base of things. We are
`simply saying he was made available as a witness in
`this case.
` JUDGE JUNG: So it sounds like you agree
`with Mr. Torczon that Mr. Veasey was not deposed or
`crossed on any issue other than authentication?
` MR. ANSLEY: He certainly hasn't been
`deposed or crossed on anything, let alone
`authentication. And we agree that his declaration
`is limited to authentication, but we just want to
`make the point that they are aware that Mr. Veasey's
`role or relevance in forming Dr. Slocum's opinions
`and could have sought additional discovery if they
`had wanted it.
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` JUDGE JUNG: Okay.
` MR. TORCZON: May I do just a really quick
`response, Your Honor?
` JUDGE JUNG: Go ahead, Mr. Torczon.
` MR. TORCZON: Real quick just to point out
`that that would constitute a burden shift. They
`should have put in relevant testimony if they wanted
`to. To say that it's our fault for not asking for
`discovery particularly given the significant
`thresholds that have to be met to get additional
`discovery is a pretty clear burden shift.
` MR. ANSLEY: And, Your Honor, we're just
`saying now it's too late to seek additional
`discovery on Mr. Veasey. If it were going to
`happen, our point is simply it should have happened
`months ago.
` JUDGE JUNG: Understood. Okay. Shifting
`over to the second topic. There's dispute between
`the parties about the date of deposing Dr. Slocum in
`1679, 1680, and 1682.
` From my understanding from the e-mail, trial is
`scheduled for December 3rd to the 6th, and
`Dr. Slocum would be available on December 10. I'm
`not exactly sure what the dispute is about --
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`Mr. Torczon, do you want to begin.
` MR. TORCZON: Sure. So we timely
`requested very early -- I think well before the
`cross period began -- in fact, I think it's not
`quite begun even yet -- that we wanted the testimony
`of Dr. Slocum. We were told that he was not
`available during the cross period.
` Now, as we understand it, the trial doesn't
`begin until the cross period is over. So it
`certainly doesn't explain why he -- the trial itself
`does not explain why he's not available during the
`period. We understand that he's got commitments.
`We understand some of those commitments may even
`include preparing for trial. But we've had this
`request out for quite some time.
` The suggestion from the e-mail from Mr. Goetz
`was that they offered a schedule change and we
`rejected it. That's not accurate. The fact of the
`matter is we've been willing to work with them on
`dates. What the schedule change proposals was was
`that they would offer on some indefinite date well
`after the close of the cross period in exchange for
`some adjustments to the schedule.
` We indicated that we couldn't do something that
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`was open ended like that because, as you can
`imagine, both preparing for the cross and filing the
`opposition requires preparation and time to actually
`execute those things. So we said if they would give
`us a cross-examination no later than December 11,
`then, you know, we would be willing to work with
`them. And it was, in fact, Sanofi that rejected
`that compromised decision.
` The default, again, is that we do the cross
`during the period. They have not given an adequate
`excuse for why the witness that they chose to put on
`with full knowledge of, one, when the trial was
`going to happen -- they've known that for, I think,
`two months now. And presumably knowing his
`schedule, you know, we have a right to take his
`testimony during the cross period. We have offered
`to work outside of that and they're the ones who've
`rejected our compromise position.
` I would also point out that this is not without
`precedent. A year ago Sanofi and Mylan were facing
`off in the formulation part of this case. We had an
`expert, who, because of his very busy schedule --
`again, he was also an MIT professor like
`Dr. Slocum -- could not make himself available
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`during the cross-examination period. We offered
`dates that were a couple weeks out, just as is the
`case here, and Sanofi rejected it.
` The Board said quite reasonably you knew when
`the schedule was, you knew he had to be
`cross-examined, you should have made him available,
`and we ultimately did. He ultimately had to
`rearrange his travel schedule, took a red-eye so
`that he would be available during a travel day to do
`his cross-examination.
` So we've tried to be reasonable, but the bottom
`line here is they've got to offer him up for cross
`and there's plenty of time before the trial for that
`to happen, although that window's closing pretty
`rapidly. Once again, we will need to make travel
`plans.
` I think we're almost past any reasonable time
`to actually give the ten-day notice, but we can
`expedite that. But even so we need a little bit of
`time to plan these things. So we kind of need an
`answer soon. And an indefinite date sometime in mid
`December, if possible, doesn't meet that standard.
` JUDGE JUNG: Okay. I guess, Mr. Ansley or
`Mr. Goetz.
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` MR. GOETZ: Yes, Your Honor, this is
`John Goetz on behalf of the Patent Owner. Really
`the issue here, Judge, is that the trial starts, I
`think on December 2nd, and the judge in New Jersey,
`Judge Chesler, has set it for three days, but the
`issue is that there's also a criminal trial that's
`scheduled to begin on that same day. So the exact
`three days is a little unclear as to when that will
`happen. I suppose the criminal trial could plead
`out.
` To my understanding it's not likely to go
`longer than two or three days. But it is clear that
`the criminal trial's going to be first. And what
`that means is that Dr. Slocum will be available for
`deposition, you know, almost certainly the week of
`the 9th. It's just not a metaphysical certainty
`because we don't know exactly what's going to
`happen.
` So we are not in the position now to give a
`date certain during that week; but, again, it's a
`near certainty that it can happen that week. And if
`it does happen that week, that will be within the
`cross period under the proposed schedule that I
`think the parties are generally in agreement on --
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`these were the dates that were permitted to move
`under the scheduling order -- would allow time for
`that cross-examination to happen before they're --
`Petitioner's opposition to the revised motion to
`amend is due.
` And so that's really the only dispute. We
`can't really give a date certain because of that
`trial and the uncertainties with that trial. But we
`can say with near certainty it should go forward the
`week of the 9th. And it should be a pretty limited
`deposition.
` So this is Dr. Slocum's declaration in support
`of our revised motion to amend. He also submitted a
`declaration in our original motion to amend and was
`deposed on that and there is substantial overlap in
`subject matter. And so the deposition will be short
`and it can happen soon after the trial as we can get
`it.
` So what I would propose is that we, Your
`Honors, allow us to update the schedule with the new
`dates that we've proposed with the understanding
`that that deposition of Dr. Slocum will occur in all
`likelihood the week of the 9th and if there's an
`issue with that, we will come back to the Board at
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`that point when the issue is more ripe.
` JUDGE JUNG: