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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS, ) Case Nos.
`INC., ) IPR2018-01670
` ) IPR2018-01675
` ) IPR2018-01676
` Petitioner, ) IPR2018-01678
` ) IPR2018-01679
` ) IPR2018-01680
` vs. ) IPR2018-01684
` ) IPR2019-00122
` )
`SANOFI-AVENTIS DEUTSCHLAND ) Patent Nos.
`GMBH, ) 8,679,069
` ) 8,603,044
` ) 8,992,486
` Patent Owner. ) 9,526,844
`-------------------------- ) 9,604,008
`
` PTAB CONFERENCE CALL
` Wednesday, December 11, 2019
`
`Reported by:
`Stacey L. Daywalt
`JOB NO. 173552
`
`
`
`Mylan Ex.1110
`Mylan v. Sanofi - IPR2018-1676
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS, ) Case Nos.
`INC., ) IPR2018-01670
` ) IPR2018-01675
` ) IPR2018-01676
` Petitioner, ) IPR2018-01678
` ) IPR2018-01679
` ) IPR2018-01680
` vs. ) IPR2018-01684
` ) IPR2019-00122
` )
`SANOFI-AVENTIS DEUTSCHLAND ) Patent Nos.
`GMBH, ) 8,679,069
` ) 8,603,044
` ) 8,992,486
` Patent Owner. ) 9,526,844
`-------------------------- ) 9,604,008
`
` PTAB CONFERENCE CALL
` Wednesday, December 11, 2019
`
`Reported by:
`Stacey L. Daywalt
`JOB NO. 173552
`
`
`
`Mylan Ex.1110
`Mylan v. Sanofi - IPR2018-1676
`
`
`
`Page 2
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` Wednesday, December 11, 2019
` 11:01 a.m.
`
` PTAB Conference Call, held before
`Administrative Patent Judges Hyun J. Jung,
`Bart A. Gerstenblith, James A. Tartal and
`Lynne H. Browne, before Stacey L. Daywalt, a
`Court Reporter and Notary Public of the
`District of Columbia.
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`A P P E A R A N C E S:
`(All appearances are telephonic)
`
` WILSON SONSINI GOODRICH & ROSATI
` Attorneys for Petitioner
` 1700 K Street NW
` Washington, DC 20006
` BY: RICHARD TORCZON, ESQ.
` LORA GREEN
`
` WEIL, GOLSHAL & MANGES
` Attorneys for Patent Owner
` 201 Redwood Shores Parkway
` Redwood Shores, California 94065
` BY: BRIAN CHANG, ESQ.
` ANISH DESAI, ESQ.
`
` FISH & RICHARDSON
` Attorneys for Patent Owner
` 601 Lexington Avenue
` New York, New York 10022
` BY: JOHN GOETZ, ESQ.
` KENNETH DARBY, ESQ.
`
`ALSO PRESENT: JOVIAL WONG, ESQ., Pfizer
`
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` ADMINISTRATIVE PATENT JUDGE: Good
`morning. This is Judge Jung. This is a
`conference for several related proceedings
`between Petitioners Mylan and Pfizer and Patent
`Owner Sanofi-Aventis.
` With me are Judges Brown,
`Gerstenblith and Tartal.
` The proceedings in particular are
`IPRs 2018-01670, 75, 76, 78, 79, 80, 84 and
`2019-00122.
` Counsel for Petitioner Mylan please
`introduce yourself.
` MR. TORCZON: Good morning, Your
`Honor. This is Richard Torczon for Mylan.
` I believe Lora Green is also on the
`line. And Jovial Wong is on the line for
`Pfizer.
` And I'd like the Board also to know
`that there is a court reporter on the line, and
`we will get you a transcript promptly.
` ADMINISTRATIVE PATENT JUDGE: Thank
`you, Mr. Torczon.
` Counsel for Patent Owner, please
`introduce yourself.
`
`
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` MR. CHANG: Morning, Your Honor.
`This is Brian Chang for the Patent Owner
`Sanofi.
` Also with me are Anish Desai and
`John Goetz.
` MR. GOETZ: And also, Your Honor --
`this is John Goetz of Fish & Richardson. I
`have Kenneth Darby on the line, also of Fish &
`Richardson. Thank you.
` ADMINISTRATIVE PATENT JUDGE: Thank
`you, Mr. Chang and Mr. Goetz.
` I'd first like to note that although
`there are four judges on the call, none of the
`panels of any of these proceedings have been
`expanded.
` Is that understood, Mr. Torczon?
` MR. TORCZON: Yes, Your Honor.
` ADMINISTRATIVE PATENT JUDGE: Is
`that -- same question, Mr. Chang.
` MR. CHANGE: Understood, Your Honor.
` ADMINISTRATIVE PATENT JUDGE: Okay.
` The purpose of this conference is to
`discuss an e-mail dated November 26th. In that
`e-mail, Patent Owner requested authorization to
`
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`file a one-page non-argumentative statement in
`each of these proceedings I listed earlier to
`preserve Patent Owner's right to raise
`Appointments Clause challenges on appeal
`because of the recent decision in Arthrex.
` Mr. Chang, if you have any remarks,
`you may -- you have the floor now.
` MR. CHANG: Thank you, Your Honor.
` As Your Honor noted, the request is
`for a one-page non-argumentative paper both in
`view of Arthrex as well as the follow-on cases
`that are currently pending in the Federal
`Circuit.
` In that paper I think Sanofi intends
`to preserve the assertion that any final
`written decisions, institutional decisions and
`preliminary guidance on proposed claim
`amendments would violate the Appointments
`Clause.
` And the reason that we're making
`this request now is that Arthrex didn't issue
`until after Sanofi filed its last sur-reply in
`each of these proceedings, so there was no
`substantive paper available to Sanofi following
`
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`the Arthrex decision in which to preserve the
`issue.
` We don't expect that the requested
`paper would disrupt the schedule in the
`proceedings since we're not requesting any
`substantive briefing on the merits of issue and
`nor are we requesting that the issue be raised
`at the oral hearing.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`So if you're able to discuss it, what do you
`propose stating in your one-page
`non-argumentative paper? Just that you're
`attempting to preserve this challenge?
` MR. CHANG: Yes, Your Honor.
` So the paper would assert that the
`final written decisions, institution decisions
`and preliminary guidance are unconstitutional
`but would not further go into any of the
`arguments behind that assertion.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`And if we allowed it, how long would it take
`you to file this paper?
` MR. CHANG: We could have it filed
`within the week, if it were allowed -- or
`
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`within the end of this week. Sorry.
` ADMINISTRATIVE PATENT JUDGE: All
`right.
` And on what basis does Patent Owner
`seek authorization to file its proposed
`statement? Can you cite, I don't know, a rule,
`a case or some regulation?
` MR. CHANG: Yeah, I don't think that
`we have a particular rule or regulation in
`mind.
` I think the basis of the request is,
`as I mentioned, simply because of the timing of
`the decisions of the Federal Circuit. We would
`have otherwise included this in one of the
`substantive papers that are provided for in the
`procedures, but because of the timing, that
`option was no longer available to us.
` ADMINISTRATIVE PATENT JUDGE: Okay.
` Mr. Chang, do you agree that an
`argument based on the Appointments Clause
`challenge was not previously raised in any of
`these proceedings in any of the papers?
` MR. CHANG: Yes, Your Honor, I would
`agree with that.
`
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` ADMINISTRATIVE PATENT JUDGE: So
`would it be correct to say that it's only
`because of the Arthrex decision that you want
`to raise it now?
` MR. CHANG: That's correct.
` We believe that the Arthrex decision
`represents a change in the law as the parties
`previously understood it.
` And also because of the -- I think
`there is ongoing uncertainty, given that there
`are additional pending appeals that are
`evaluating this issue and have requested
`further briefing on this issue in the Federal
`Circuit.
` ADMINISTRATIVE PATENT JUDGE: So
`would you agree that there's really nothing to
`preserve regarding the Appointments Clause?
` MR. CHANG: I wouldn't agree that
`there is nothing to preserve.
` I think that there is -- given the
`current state of the decisions from the Federal
`Circuit, there is -- I guess the way to put it
`would be that there is no -- I think there's no
`real question as to what the Board response
`
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`would be to the arguments raised and/or to the
`statements raised in the paper if the Board
`were to now rule on it.
` And I think out of an abundance of
`caution, because of the uncertainty of how the
`Federal Circuit ultimately will resolve the
`pending appeals, Patent Owner feels that it
`would be more prudent to preserve the argument
`at this stage rather than raising it for the
`first time on appeal if there were to be some
`change in law in the interim.
` ADMINISTRATIVE PATENT JUDGE: I see.
` And just to explore your position a
`little bit further, you would agree that
`raising any other argument at this point in the
`proceedings after all the briefing has been
`filed would be normally considered a new
`argument that would be considered waived, and
`thus the panel would not need to consider it?
` MR. CHANG: I would agree that if we
`were raising, for example, any substantive new
`argument to rebut the assertions of the
`petition that have not been previously raised
`in the proceeding, that those would be waived,
`
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`yes.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`And should Petitioner be able to respond to
`your one-page non-argumentative statement?
` MR. CHANG: I think if Petitioner
`wished to file a reciprocal one-page
`non-argumentative response, we would have no
`objection to that.
` ADMINISTRATIVE PATENT JUDGE: Okay.
` So would you have any issues if we
`ordered the parties to file a joint paper
`regarding Arthrex?
` It may be more than one page in that
`case.
` MR. CHANG: No, I think that we
`wouldn't have any issues with that.
` I guess I'm assuming in responding
`that it would essentially be a joint
`non-argumentative paper where the Patent Owner
`would provide the statement that we intend to
`provide and Petitioner would then provide their
`responsive statement.
` So we would have no issue with that,
`Your Honor.
`
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` ADMINISTRATIVE PATENT JUDGE: Okay.
` And as a follow-up, if it was a
`separate paper, would you have any issues or
`objections to that?
` MR. CHANG: And if I'm
`understanding, if by separate paper --
` (Simultaneous crosstalk.)
` ADMINISTRATIVE PATENT JUDGE: -- if
`it was a responsive paper.
` MR. CHANG: Right. We would
`similarly have no issue with a responsive paper
`that was likewise also non-argumentative.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`Thank you, Mr. Chang.
` Let me check with my panel to see if
`they have any other questions before I move on
`to Mr. Torczon.
` (Recess was held from 11:09 a.m. to
`11:10 a.m.)
` ADMINISTRATIVE PATENT JUDGE: Okay.
`I have a question from the panel.
` Mr. Chang, do you agree that any
`result after Arthrex is applied to all cases
`anyway?
`
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` And if so, do you really need to say
`anything?
` MR. CHANG: Yeah, I think it's
`unclear and it would be improper for me at this
`point to speculate how the Federal Circuit
`would apply any result after Arthrex.
` I think that uncertainty is
`precisely in part why we're seeking approval
`for this paper now out of an abundance of
`caution.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`All right. Thank you, Mr. Chang.
` Now, Mr. Torczon, do you have any
`response?
` MR. TORCZON: Yes, I do, Your Honor.
`Thank you very much.
` I think several of your questions
`already hit some points I would make.
` I would start by pointing out that
`the Petitioners believe that this is a waste of
`Board and party resources.
` At Page 6 of the slip opinion in
`Arthrex, the panel said that the Board could
`not act on any such request anyway, so that if
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`there would have been waiver -- or there would
`not have been waiver.
` There are two possibilities. Either
`the Arthrex panel was correct about that, in
`which case Sanofi doesn't need to file
`anything.
` The second possibility is the
`Arthrex panel was wrong about that, in which
`case a non-argumentative paper by definition
`does not preserve arguments because it doesn't
`actually state the arguments that they're
`trying to preserve in any meaningful way.
`There's ample case law that says things like
`passing references do not preserve arguments.
`So it's either too much or too little, but this
`can't be the right solution.
` I understand Sanofi's point that
`they believe the case law has changed. I think
`there's several problems with that. The first
`would be that we already know what the court
`says the law is now, in which case they don't
`need to file anything.
` They are correct that there are --
`the government has indicated that it is going
`
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`to seek rehearing on the issue. There's
`several contingencies there. One possibility
`is that the court reverses itself en banc, in
`which case the issue's moot.
` There's no issue in this case until
`the Board issues a final written decision. I
`realize that they have pointed to the
`institution decision and the guidance, and I'll
`address that in a moment.
` And there's plenty of time between
`the final written decisions in this case and
`the Board acting -- or the court acting in
`Arthrex, at which point if Sanofi is going to
`be authorized to file a paper, it would make
`more sense to have them file a paper once
`there's more clarity on the issue. So the
`issue's premature.
` We also think the request is
`self-contradictory and futile. As we
`indicated, there's no way that you can preserve
`an argument without making it. That would
`prejudice Mylan because Sanofi would be able to
`preserve the concept of an argument and then be
`able to morph it into whatever arguments it
`
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`ultimately wants to make, and Mylan would be
`prejudiced if it could not substantively
`oppose.
` Among other things, we think that
`this is a waste of resources and a distraction
`from the merits of the case. We actually think
`there's no legitimate purpose served even by
`this request.
` But we also think that at least a
`couple of the arguments they're making are
`outright frivolous and in fact, if taken to
`their logical conclusion, would mean that
`Sanofi's patents were not constitutionally
`issued and so the whole case is void.
` Alternatively if Sanofi's request is
`granted or if -- Sanofi's request would be
`untimely. Questions about the Appointments
`Clause have been swirling for years. They've
`been openly in question since November 1999
`when the America Invents Act was passed.
`They've been openly in question since Professor
`Duffy's 2007 article. There have been ample
`opportunities for Sanofi to brief this issue.
` And the rule that Your Honor was
`
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`asking about earlier, I believe, would probably
`be Rule 42.5(C3), or at least 42.5, and that
`gets to taking extra actions in cases.
` But one of the things Sanofi would
`have to do is show why there is good cause or
`an interest in justice for not raising the
`issue earlier. We don't believe they can make
`that showing.
` And we'd be prejudiced because
`essentially what they're doing is asking for
`additional pages on briefing that they should
`have already put in in their earlier cases, and
`Mylan would be prejudiced if it had to spend
`resources on it.
` Finally, if Sanofi gets to file a
`bare preservation notice, Mylan would like
`authorization to do the same thing.
` We should note that Mylan and Pfizer
`are paying the full cost of these proceedings,
`and we're frankly entitled to a constitutional
`decision regardless of the outcome. So if
`there is any lingering constitutional defect,
`it prejudices us as much as it does Sanofi.
` ADMINISTRATIVE PATENT JUDGE: Thank
`
`
`
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`you, Mr. Torczon.
` And at the moment we're considering
`several options, so similar questions that I
`asked earlier to Mr. Chang I'll now ask you.
` Do you have any issues or objections
`to filing a joint statement regarding Arthrex?
` MR. TORCZON: Just because the
`parties' positions are so diametrically
`opposed, I don't see any particular value in
`that.
` I also think that given the way that
`the issue's been framed, it makes sense for us
`to file something responding to what they do.
`I think we could probably offer to do that
`within a very short turnaround. If they're
`filing a one-page paper, we could probably give
`you a one-page paper within a business day or
`two.
` But as Your Honors no doubt know,
`there's a very, very compressed schedule at
`this point, and we have the holidays
`approaching as well.
` I think trying to work out a joint
`statement in one page between the parties, or
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`even a couple pages, is likely to prove more
`distracting than any value that comes from it.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`So your preference is for a responsive one-page
`non-argumentative statement instead of a joint.
`Is that correct?
` MR. TORCZON: That's correct.
` And I think we could get that to you
`within a day or two. It's -- we're pretty sure
`we know what they're going to argue, so...
` ADMINISTRATIVE PATENT JUDGE: All
`right. Hold on a second. Let me check with
`the panel and see if they have any questions
`for you, Mr. Torczon.
` (Recess was held from 11:17 a.m. to
`11:18 a.m.)
` ADMINISTRATIVE PATENT JUDGE: All
`right, Mr. Torczon. No questions from the
`panel for you.
` We will try to issue an order in
`short order, but I cannot guarantee that it
`will come out any time soon.
` And as another complicating factor,
`I will not be available during the last half of
`
`
`
`Mylan Ex.1110
`Mylan v. Sanofi - IPR2018-1676
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`December until after the new year.
` So with that in mind, are there any
`other questions or issues that the parties want
`to bring to the panel's attention before I
`adjourn this conference, starting with
`Petitioner, Mr. Torczon?
` MR. TORCZON: Yes, Your Honor.
` Yesterday we raised with counsel
`from Sanofi the possibility of getting a page
`extension on the two oppositions that are
`coming up.
` At that point we didn't get an
`affirmative firm opposition, although I think
`we did get a tentative opposition, and I
`haven't heard back from them.
` Those would be due on the 17th, so
`we kind of need to know the answer to that as
`soon as we can. We were going to ask for 40
`pages total in the post 1679 case and 45 pages
`in the 80 and 82 cases. That's going to be the
`same paper in both cases. That's why it's
`slightly longer.
` And we would not object to a
`proportional increase in any subsequent replies
`
`
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`and sur-replies.
` So that's the gist of it, and --
` ADMINISTRATIVE PATENT JUDGE: Okay.
`So it sounds like you're still in the middle of
`a meeting and conferring.
` So thank you for bringing the issue
`to our attention, but I'll wait to hear and see
`if there's any results from your conversations
`with the Patent Owner.
` Anything else, Mr. Torczon?
` MR. TORCZON: No. That's it from
`us, Your Honor.
` ADMINISTRATIVE PATENT JUDGE: Okay.
` Mr. Wong, any issues or questions
`for Petitioner Pfizer?
` MR. WONG: Nothing for Pfizer.
`Thank you.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`Thank you.
` And lastly, Mr. Chang, any other
`issues or questions for Patent Owner?
` MR. CHANG: Nothing further, Your
`Honor. Thank you.
` ADMINISTRATIVE PATENT JUDGE: Okay.
`
`
`
`Mylan Ex.1110
`Mylan v. Sanofi - IPR2018-1676
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` PTAB Conference Call
`Thank you to all parties. I hope everyone has
`a safe holiday. And I will talk to you in the
`next year.
` This conference is adjourned.
` (Time Noted: 11:21 a.m.)
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`District of Columbia, to wit:
`I, Stacey L. Daywalt, a Notary
`Public of the District of Columbia, do hereby
`certify that the proceedings were recorded
`stenographically by me and this transcript is a
`true record of the proceedings.
`I further certify that I am not of
`counsel to any of the parties, nor an employee
`of counsel, nor related to any of the parties,
`nor in any way interested in the outcome of
`this action.
`As witness my hand and Notarial Seal
`this 11th day of December, 2019.
`
`~~
`-----------------------------------
`Stacey L. Daywalt, Notary Public
`My Commission Expires: 4/14/2021
`
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`Mylan Ex.1110
`Mylan v. Sanofi - IPR2018-1676
`
`
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