Conference Call
`
`1/6/2022
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` __________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` __________
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
` Petitioner,
`
` vs. Case No.
` IPR2021-00816
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC, Patent No. 9,220,631
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
` Patent Owners.
`
` TRANSCRIPT OF PROCEEDINGS of the status
`
`conference in the above-entitled cause, held
`
`telephonically before THE HONORABLE ROBERT
`
`KINDER, THE HONORABLE ERICA A. FRANKLIN, and
`
`THE HONORABLE KRISTI RUPERT SAWERT, reported by
`
`Margaret M. Lanier, CSR (IL), RMR, CRR, and
`
`Notary Public for the District of Columbia,
`
`taken on January 6, 2022, at the hour of
`
`3:00 p.m., Eastern Standard Time.
`
`REPORTED BY: Margaret M. Lanier, CSR, RMR, CRR
`LICENSE NO.: 084-003036
`JOB NO.: 112029
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`1/6/2022
`Page 1
`
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` __________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` __________
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
` Petitioner,
`
` vs. Case No.
` IPR2021-00816
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC, Patent No. 9,220,631
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
` Patent Owners.
`
` TRANSCRIPT OF PROCEEDINGS of the status
`
`conference in the above-entitled cause, held
`
`telephonically before THE HONORABLE ROBERT
`
`KINDER, THE HONORABLE ERICA A. FRANKLIN, and
`
`THE HONORABLE KRISTI RUPERT SAWERT, reported by
`
`Margaret M. Lanier, CSR (IL), RMR, CRR, and
`
`Notary Public for the District of Columbia,
`
`taken on January 6, 2022, at the hour of
`
`3:00 p.m., Eastern Standard Time.
`
`REPORTED BY: Margaret M. Lanier, CSR, RMR, CRR
`LICENSE NO.: 084-003036
`JOB NO.: 112029
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 2
`
`APPEARANCES:
`
` WEIL GOTSHAL & MANGES
` (appearing telephonically), by
` MR. ANISH R. DESAI
` MS. ELIZABETH WEISWASSER
` MR. CHRISTOPHER M. PEPE
` 2001 M Street, N.W.
` Suite 600
` Washington, DC 20036
` (202) 682-7000
` anish.desai@weil.com
` elizabeth.weiswasser@weil.com
` christopher.pepe@weil.com
`
` Representing the Petitioner;
`
` GOODWIN PROCTER LLP
` (appearing telephonically), by
` MS. ELIZABETH J. HOLLAND
` MR. NICHOLAS K. MITROKOSTAS
` 620 Eighth Avenue
` New York, New York 10018
` (212) 813-8800
` eholland@goodwinlaw.com
` nmitrokostas@goodwinlaw.com
`
` Representing the Patent Owners.
`
`ALSO PRESENT:
`
` PETRO SCAMBOROVA (attending telephonically)
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 3
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` THE COURT: Good afternoon. This is
`
`Judge Kinder, and with me on the call today are
`
`Judges Erica Franklin and Kristi Sawert.
`
` Today's conference call is in regard to
`
`IPR2021-00816.
`
` If we can get a quick roll call to see
`
`who is on the line for petitioner.
`
` MR. DESAI: Good afternoon, Your Honor. This
`
`is Anish Desai. I'm here from Weil on behalf of
`
`petitioner Regeneron. I believe also on the
`
`line with me are Elizabeth Weiswasser and
`
`Chris Pepe from Weil, and also Petra Scamborova
`
`from Regeneron.
`
` THE COURT: All right. I appreciate that.
`
`Thank you.
`
` And for patent owner, who do we have on
`
`the call today?
`
` MS. HOLLAND: Good afternoon. This is
`
`Elizabeth Holland from Goodwin Proctor. With me
`
`is Nicholas Mitrokostas from Goodwin Proctor.
`
` Just to give a one-minute preface to
`
`this, I am under a prosecution bar from
`
`participating in the motion to amend. So I'm on
`
`the call as lead counsel, but the discussion is
`
`going to be handled by Mr. Mitrokostas. Should
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.003
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 4
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`we need to get into any substantive issues, then
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`I will likely need to drop off.
`
` THE COURT: All right. Give me one second.
`
` COURT REPORTER WILSON: Your Honor, also this
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`is Vickie Wilson, the court reporter. We have
`
`two court reporters who have been scheduled. If
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`we could address if we both need to take these
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`proceedings or if one of us should be dismissed.
`
` THE COURT: So I guess both parties have a
`
`court reporter on the line, Mr. Desai, is that
`
`right? Does the petitioner have one as well?
`
` MR. DESAI: Yeah. You know what, we probably
`
`-- each side probably didn't communicate with
`
`each other and we should have. I apologize for
`
`that. We definitely only need one court
`
`reporter on the line.
`
` THE COURT: All right. You know, I don't
`
`want to tell you all what to do, but if you just
`
`would have one and maybe split the cost, I don't
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`know. Whatever you all want to do is fine with
`
`us. But, you know, if you want to keep two, we
`
`can have two transcripts. We don't personally
`
`care.
`
` MR. DESAI: Your Honor, we're happy to have
`
`one. We can stick with the court reporter that
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.004
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 5
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`we had brought to this. I'm not sure which
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`court reporter is the one that we requested.
`
` THE COURT: Ms. Holland, do you have any
`
`objection?
`
` COURT REPORTER WILSON: My name is Vickie
`
`Wilson and I was scheduled to be here by Goodwin
`
`Proctor. If I could just be informed whether to
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`stay or go.
`
` MR. MITROKOSTAS: Your Honor, this is
`
`Nick Mitrokostas from Goodwin Proctor. We're
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`fine with the proposal that petitioner makes.
`
` So, Ms. Wilson, thank you for your
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`time. And I apologize for the duplicate effort,
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`but you're free to go and we can use
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`petitioner's court reporter. That's fine.
`
` COURT REPORTER WILSON: Thank you very much.
`
`No problem at all.
`
` (Ms. Wilson exited the proceedings.)
`
` THE COURT: This is Judge Kinder. I think
`
`because we have so many people on the line,
`
`we'll try to identify ourselves for the court
`
`reporter. If you need to get names or
`
`spellings, we can do that at the very end. Just
`
`jump in and remind me right before we hang up.
`
` I do want to broach the subject of the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.005
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 6
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`prosecution bar for motion to amend, which is,
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`in essence, essentially kind of new prosecution.
`
` Mr. Desai, did I say your name
`
`correctly?
`
` MR. DESAI: Yes, you said it correctly.
`
` THE COURT: Have you all met and conferred on
`
`that particular issue, or do you have any
`
`objections to that?
`
` MS. HOLLAND: So, your Honor, we did -- oh,
`
`I'm sorry. I don't know who that was addressed
`
`to. Let me just go ahead for a second.
`
` I'm going to say we had an email meet
`
`and confer where petitioner raised the issue of
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`Goodwin Procter participating. We informed
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`petitioner that we were very careful under the
`
`protective order and that we were following
`
`strictly its guidelines, which permitted other
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`lawyers from Goodwin Procter who were not
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`involved and did not have access to confidential
`
`information of Regeneron's from any other
`
`proceeding to essentially work on the motion to
`
`amend.
`
` Petitioner came back to us just today
`
`and asked us what exactly had been put in place
`
`in terms of walling off Mr. Mitrokostas and his
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.006
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 7
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`team and we explained that our conflicts group
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`within Goodwin Procter put something in place
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`where Mr. Mitrokostas and his team cannot ask
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`anything from any case, including this IPR.
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`There's a separate -- whatever he's working on
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`is done completely separately behind an ethical
`
`wall.
`
` We've also instructed all team members
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`who do have access to Regeneron confidential
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`information or petitioner's confidential
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`information that they may not disclose any of
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`that to the team of people who worked on the
`
`motion to amend. So we believe we strictly
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`complied with the protective order and that
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`there should be no issue.
`
` THE COURT: Mr. Desai, if you want to respond
`
`to that.
`
` And from the board's standpoint -- I
`
`guess I'd have to confer with my panel -- but
`
`personally I think I might have an issue with
`
`the lead attorney in a case, not just somebody
`
`entering an appearance, but the lead attorney is
`
`barred from any discussion of any topic within
`
`the particular case, including a motion to amend
`
`that's pending.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.007
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 8
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` Mr. Desai, I just want to know what
`
`your thoughts are on that.
`
` MR. DESAI: Sure, your Honor.
`
` I think, first of all, we have had an
`
`email exchange and there are prosecution bars
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`from an ITC protective order and a District
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`Court protective order that prohibit anyone
`
`who's had access or could have access to
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`Regeneron's confidential information from
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`participating in any way in amendment of claims.
`
` Obviously, when we found out that
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`Goodwin Procter was going to be handling a
`
`motion to amend, we emailed and have had a few
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`conversations by email about that.
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` They have informed us today about the
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`procedures that they have put in place to avoid,
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`I guess, a violation of the protective orders,
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`and obviously we take them at their word with
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`what they've done so far.
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` I'm not sure I'm aware of another
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`instance where lead counsel was prohibited from
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`participating in a substantial part of an IPR,
`
`and I guess that's probably more of a question
`
`for your Honors. But as of right now from the
`
`information we have, we understand that they're
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.008
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 9
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`attempting to abide by the terms of the
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`protective order. But obviously, you know,
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`there are individuals from the same firm
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`participating in the same IPR, and so I think
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`we're just going to continue to monitor the
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`situation.
`
` THE COURT: Okay.
`
` MS. HOLLAND: Your Honor, if I can comment on
`
`the lead counsel piece of it, and I understand
`
`that the board may have a different perspective.
`
`But when we negotiated the protective orders, we
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`specifically negotiated them so that I could
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`participate as lead counsel in an IPR -- lead
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`counsel or otherwise, I should say -- as well as
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`the rest of the team who worked on the District
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`Court and ITC cases. So at least the parties
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`had contemplated a situation like this, but I
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`understand, your Honor, that your reason could
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`be different from the board's perspective.
`
` THE COURT: I guess the only concern we would
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`have is lead counsel is expected to be able to
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`discuss any topic in the case. I don't recall
`
`any time where we've had a lead that was
`
`potentially barred from the motion to amend. So
`
`we will look at that. We might do a follow-up
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.009
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 10
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`call; I don't want to spend any more time on
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`that today. And I don't want to tell you who
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`should be lead or who shouldn't be lead, but
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`we'll look at that. And I think if we have
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`issues, we will get back with you by email and
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`set up another call.
`
` I presume, Ms. Holland, from your prior
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`access to information from either the District
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`Court or ITC that you're subject to the
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`prosecution bar as well?
`
` MS. HOLLAND: Yes, your Honor.
`
` THE COURT: Okay.
`
` MR. DESAI: Your Honor, could I just quickly
`
`add something?
`
` Ms. Holland is correct that the way in
`
`which we set up the protective orders, it was
`
`contemplated that the folks who had access to
`
`the confidential information could still
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`participate in the IPR. So that is absolutely
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`correct.
`
` I will say actually I believe there may
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`have been IPRs involving a motion to amend
`
`where, in fact, there were two different firms
`
`where one firm was handling the motion to amend
`
`and the other firm was handling the rest of the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.010
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 11
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`IPR. So I believe there are situations where
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`that has happened.
`
` THE COURT: I appreciate that. I wasn't
`
`trying to say it was wrong; it's just one of
`
`those few instances where I don't think I've
`
`seen that particular circumstance.
`
` So with that being said, let's go ahead
`
`and move on then to the purpose of today's call
`
`which is the motion to amend.
`
` So there are a lot of things that have
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`changed in the last couple years with motions to
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`amend. We have a pilot program that's out
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`there, and we'll talk a little bit today about
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`that, as far as the preliminary guidance pilot
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`program.
`
` And I think, Ms. Holland, I'd just like
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`to start by opening up with you to see if you
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`have any particular questions or concerns about
`
`the motion to amend from a procedural standpoint
`
`or if you have any insight you'd like to give us
`
`on what you're envisioning.
`
` MS. HOLLAND: So I think that from a
`
`procedural perspective, your Honor, we're
`
`familiar with the new guidelines and the pilot
`
`program and plan to use those in connection with
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.011
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 12
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`our motion to amend.
`
` I don't want to speak to any
`
`particulars about the motion because I'm not
`
`involved with that, but perhaps I can turn it
`
`over to Mr. Mitrokostas for that point.
`
` THE COURT: Yeah, of course. And we're not
`
`looking for substance here as far as what you
`
`plan to amend or why, but I just wanted to get
`
`an overview of what you're envisioning.
`
` MR. MITROKOSTAS: Your Honor, this is
`
`Nick Mitrokostas from Goodwin on behalf of
`
`patent owner.
`
` On the procedural issue, just one point
`
`of clarification if you could provide for us. I
`
`understand from your guidance that the request
`
`for the pilot program and preliminary guidance
`
`to the pilot program should be made in the
`
`motion itself. But if you have any other
`
`specific guidance as to requirements from the
`
`board's perspective how to make that request, we
`
`would appreciate understanding that.
`
` And what we're envisioning, your Honor,
`
`is just a straightforward motion to address the
`
`issues that have been raised in the institution
`
`decision with supporting expert declarations
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.012
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 13
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`that demonstrate the patentability of the
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`proposed amendments to be made.
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` THE COURT: Okay. We'll do. And I'll kind
`
`of go through a couple more things, too. If we
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`would through everything --
`
` MR. MITROKOSTAS: I --
`
` THE COURT: I'm sorry. Go ahead.
`
` MR. MITROKOSTAS: Sorry, your Honor. I
`
`didn't mean to interrupt, but I should have also
`
`stated this is the contingent motion to amend.
`
`So it would only be addressed in the event your
`
`Honors determined that the original claims were
`
`unpatentable.
`
` THE COURT: Okay. And, of course, you
`
`can just -- in your actual motion to amend, you
`
`can state that as well. It helps to clarify.
`
`Sometimes parties actually leave that out.
`
` So if we went through everything, it
`
`would take about an hour and a half for this
`
`call. So we want to hit some highlights; I'll
`
`address your two questions.
`
` Your first question dealt with the
`
`request for preliminary guidance. And the fact
`
`that you're letting us know is actually very
`
`helpful because the board itself has a very
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.013
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 14
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`quick turnaround time; I believe it's four weeks
`
`from the date that all the papers are filed
`
`essentially to provide that kind preliminary
`
`guidance.
`
` So like you said, you can just request
`
`that in the motion itself and make sure it's --
`
`you know, you could even do it up front on the
`
`cover page or in the very first paragraph. Just
`
`make sure it's conspicuous when you request it.
`
` So we're not going to be able to go
`
`through everything in detail, but please refresh
`
`yourself and look at the rules. 37 CFR 42.24
`
`has the page limits. Parties sometimes start
`
`writing these motions or the reply to the
`
`motions and then they're like, wow, there's
`
`actually some pretty strict page limits.
`
` So if you have an issue with those page
`
`limits, meet and confer early, as early as
`
`possible, with the other side and work that out
`
`if you can amongst yourselves. And let us know
`
`if both parties might need an additional few
`
`pages or whatever.
`
` Again, you have to show good reason for
`
`that type of request. But the page limit is
`
`pretty strict, so personally speaking -- not
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.014
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 15
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`speaking for the panel or any other judge -- you
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`know, I think 25 pages in some instances could
`
`be kind of tricky to get everything written and
`
`briefed within.
`
` Also, 42.121 is the main amendment of
`
`the patent provision. But also look really
`
`closely at the guidance we give you in the Trial
`
`Practice Guide, and I think the last update was
`
`later in 2019. And then the Electrosonic case,
`
`which is presidential for us, that came out in
`
`2019 as well.
`
` The procedure for the preliminary
`
`guidance is set out in the Federal Register
`
`notice. And then there's actually two of those
`
`notices. We had another one came out in late
`
`summer that extended the pilot program, I think,
`
`through September of 2022. So the pilot program
`
`is still in effect which means you can still
`
`request preliminary guidance. And the fact that
`
`you're letting us know that, we appreciate that.
`
` I think you have the due dates for the
`
`motion to amend. Due date one, I think, is
`
`January 18th, but, again, that's in the
`
`scheduling order.
`
` The petitioner's opposition to that
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.015
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 16
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`will be due date two.
`
` If the patent owner requests that the
`
`motion to amend that PTAB provide the guidance
`
`for the pilot program, I think our date for that
`
`will be approximately due date -- four weeks
`
`after due date two. But, again, I have to look
`
`at the schedule.
`
` Once you go down that route, we
`
`actually will issue an amended scheduling order
`
`depending on which option that you take after
`
`the preliminary guidance.
`
` As far as the requirements for an
`
`initial motion to amend, those are laid out in
`
`the Trial Practice Guide in the Electrosonic
`
`case we talked about. Sometimes we -- and I'm
`
`going to add a couple of things that I've seen
`
`personally that sometimes cause a little bit of
`
`issue.
`
` The patent owner can only propose
`
`substitute claims, not necessarily amendments to
`
`the original claims. So just from a procedural
`
`standpoint, be aware that you're proposing
`
`substitute claims, which means, you know, it has
`
`to be for a challenge claim. So you can't
`
`really propose substitute claims for
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.016
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 17
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`unchallenged claims. You see that as an issue
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`sometimes.
`
` Of course, the number has to be
`
`reasonable. There's a presumption that one for
`
`one is reasonable. And then all the other
`
`substantive requirements that has to be
`
`responsive to a ground of unpatentability
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`actually involved in the trial.
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` Enlargement, you can't enlarge scope
`
`obviously.
`
` Patent owner, you should make sure that
`
`you clearly identify the contingency of the
`
`substitution. Sometimes we've seen that as an
`
`issue.
`
` Another thing I've seen personally
`
`quite frequently is when you do your showing of
`
`support, it has to go back to the original
`
`disclosure for each claim. And so, you know,
`
`you need to look back to the original
`
`application as filed, not necessarily an issued
`
`patent. Or if you show that there's disclosure
`
`and the patent are identical, I guess that would
`
`be fine as well, but you have to kind of make
`
`that showing.
`
` And then one problem I've seen is the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.017
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 18
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`support for the whole claim which in a way
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`doesn't make a lot of -- facially, it doesn't
`
`necessarily jump out at you as what you have to
`
`do. But most people just focus on the added
`
`features and presume that the original claim had
`
`support because it issued, but because we're
`
`essentially stepping into the role as -- I don't
`
`want to say Examiners, but stepping into the
`
`role of the Office to look at the claim as a
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`whole, we have to make sure that the claim from
`
`a 112 standpoint is supported as a whole.
`
` And then the support has to actually be
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`provided in the motion. So, again, sometimes
`
`that can create issues with all the page limits
`
`that we have. So look at that ahead of time and
`
`don't wait until the last week to figure out
`
`anything you might need as far as page limits or
`
`any other issue.
`
` So the pilot program, we talked about
`
`you make the request in your motion. And then
`
`within about four weeks after the initial papers
`
`are filed, PTAB provides the preliminary
`
`guidance on the motion to amend after the
`
`petitioner files its opposition.
`
` At that point, after we provide the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.018
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 19
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`preliminary guidance, essentially the patent
`
`owner, you would have four options -- and these
`
`I think are pretty clearly laid out, but I'll
`
`just highlight the four options real quick.
`
` Option one, you can file a reply to the
`
`petitioner's opposition to the motion to amend
`
`and/or to our preliminary guidance. I think
`
`that would be due date three.
`
` Option two, you can file a revised
`
`motion to amend. That will still be due date
`
`three.
`
` And then there's a lot of different
`
`things that you have to look at as far as the
`
`requirements for that revised motion to amend.
`
`So if you're going to go that route, it might
`
`even be worth it to set up another conference
`
`call a couple weeks beforehand to discuss that
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`because there are some pitfalls there if you're
`
`going to file that revised motion to amend.
`
` And then there's several things -- I'm
`
`not going to go through them all, but I think
`
`it's not worth our time to go through them all
`
`unless you decide to go that option. So if you
`
`do go that option, my recommendation is to set
`
`up a quick conference call where we can get
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.019
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 20
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`together and discuss those and see if the
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`parties have any issues with the additional
`
`briefing schedules.
`
` Then option three, patent owner can
`
`simply take no action, file no reply or revise
`
`motion to amend. And then if the board has not
`
`issued preliminary guidance, no further briefing
`
`is authorized. But if the board has issued
`
`preliminary guidance, of course, petitioner may
`
`file a reply to that guidance.
`
` Option four, the patent owner may also
`
`withdraw the initial motion to amend, which, of
`
`course, then it wouldn't be addressed in the
`
`board's final written decision.
`
` So if you do choose to file a revised
`
`motion to amend, we need to issue a new
`
`scheduling order. So that would be another
`
`reason for setting up a conference call ahead of
`
`time to accommodate the necessary additional
`
`briefing that we would need to set up.
`
` So to be honest with you, I've only had
`
`a couple of these preliminary guidance cases
`
`with revised motions to amend. It's under a
`
`pilot program, so it's obviously still somewhat
`
`new for us as well as a board. So if you have
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.020
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 21
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`any questions during the process, feel free to
`
`set up another call.
`
` Ms. Holland, I hope I didn't lose you
`
`on anything. Are you still with us?
`
` MS. HOLLAND: I am, and that was extremely
`
`helpful. Thank you very much, your Honor.
`
` THE COURT: All right. So the main thing is
`
`look at the guidance; look at your options
`
`obviously ahead of time; understand how the
`
`process flows once you get into the realm of
`
`preliminary guidance.
`
` Mr. Desai, same to you. Look through
`
`all the guidance and see if you have any issues,
`
`anything that you know about ahead of time that
`
`needs to be addressed.
`
` Are there any other questions at this
`
`time? I guess we could start with petitioner,
`
`Mr. Desai.
`
` MR. DESAI: Your Honor, no questions.
`
` The comment about page limits is
`
`something we'll obviously pay close attention
`
`to. Our initial impression is that it's likely
`
`we're going to need more than the 25 pages we're
`
`going to be afforded, but I think we can wait to
`
`see how the motion to amend looks and then
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.021
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 22
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`quickly meet and confer with the other side
`
`about potential changes to page limits.
`
` THE COURT: From a personal standpoint,
`
`petitioner, you have your other briefing. You
`
`have your -- you have your actual petition as
`
`far as the foundational part of the claims. But
`
`we also have guidance not to incorporate by
`
`reference, we sometimes frown upon that.
`
` So it is a tricky line as far as
`
`getting everything you may need to get in.
`
`Obviously, we have the rule against
`
`incorporation by reference, but we also have the
`
`realistic expectation that you do have the
`
`petition filed and there are arguments
`
`essentially made for the foundational elements
`
`of some of the claims, depending on how you look
`
`at that.
`
` Again, we encourage the parties to meet
`
`and confer if page limits are going to be an
`
`issue. And for petitioner, I understand you
`
`probably can't even fathom what your page issue
`
`will be until you have a chance to really study
`
`the motion to amend and understand how you're
`
`going to address it.
`
` So, again, meet and confer. If you
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.022
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 23
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`guys have an agreement, we are typically more
`
`inclined to bless it.
`
` MR. DESAI: Thank you, your Honor.
`
` THE COURT: Ms. Holland, do you have any
`
`other questions or comments?
`
` MS. HOLLAND: Not at the moment, your Honor.
`
`But I do want to check in with Mr. Mitrokostas
`
`to see if he has anything.
`
` MR. MITROKOSTAS: No. It was all very clear,
`
`your Honor. Thank you.
`
` THE COURT: All right. Again, like I said,
`
`if you're doing the preliminary guidance, look
`
`over the two Federal Register numbers and I
`
`think it lays out. And then I think also the
`
`Trial Practice Guide might have some additional
`
`insights.
`
` Again, we appreciate you letting us
`
`know that you might invoke the preliminary
`
`guidance, because, like I said, it's a pretty
`
`quick turnaround for us. And we kind of need
`
`to -- it helps us actually to plan for that and
`
`to, you know, essentially get everything ready
`
`for that.
`
` Again, just to let you know and to
`
`reiterate, it is just preliminary guidance.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.023
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 24
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`Again, it's pre oral argument. So sometimes
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`that preliminary guidance is indicative of what
`
`our final decision might be, but it certainly
`
`doesn't have to be and it doesn't bind us
`
`essentially to our final decision, whatever that
`
`may be in the underlying case.
`
` So I don't know if that helped or hurt,
`
`but, again, that's the name of it; it is just
`
`preliminary.
`
` Are there any other --
`
` MS. HOLLAND: Thank you.
`
` THE COURT: All right. Are there any other
`
`questions?
`
` MR. DESAI: Nothing from petitioner.
`
` THE COURT: All right. Ms. Holland, do you
`
`have anything else?
`
` MS. HOLLAND: No, your Honor. Thank you.
`
` THE COURT: Okay. Before we conclude, let's
`
`ask the court reporter if they have any
`
`questions or need to get anyone's name. I
`
`apologize, I did not get the court reporter's
`
`name.
`
` (Whereupon, a discussion was had
`
` off the record.)
`
` THE COURT: Very good. Again, if anything
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1097.024
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Conference Call
`
`1/6/2022
`Page 25
`
`comes up and the parties have issues, we
`
`encourage you to meet and confer and then reach
`
`out and get ahold of us for a conference call.
`
` Those due dates are coming up quick, so
`
`try to look ahead of time so you're not pressed
`
`the last couple days to try to work out issues.
`
`Like I said, there are things with page limits
`
`and other things that the parties can get
`
`together and work on if they need to. Okay?
`
` MS. HOLLAND: Yes, thank you.
`
` THE COURT: All right. I appreciate
`
`everyone's time this afternoon, or morning if
`
`you were still out West. I think we're all East
`
`Coast, but I appreciate your time. And this
`
`
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