`
`10/29/2020
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` __________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` __________________
`
` REGENERON PHARMACEUTICALS, INC.,
`
` Petitioner,
`
` V.
`
` NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY, LLC,
`
` NOVARTIS PHARMACEUTICALS CORPORATION,
`
` Patent Owner.
`
` __________________
`
` Case IRP2020-01317
`
` Patent 9,220,631
`
` HEARING BY TELECONFERENCE
`
` October 29, 2020
`
` __________________________________________________
`
` Hearing by Teleconference, commencing at
`
` 11:00 a.m., on the above date, before the
`
` Honorable Robert L. Kinder, the Honorable Erica A.
`
` Franklin, and the Honorable Kristi L.R. Sawert,
`
` preliminary panel, pursuant to the rules of the
`
` Patent and Appeal Board.
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 2
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` APPEARANCES:
`
`Anish Desai, Esq.
`
`Elizabeth Weiswasser, Esq.
`
`Brian Ferguson, Esq.
`
`WEIL, GOTSHAL & MANGES, LLP
`
`(Appearing on behalf of the Petitioner)
`
`767 Fifth Avenue
`
`New York, New York 10153
`
`212.310.8730
`
`Anish.desai@weil.com
`
`Elizabeth Holland, Esq.
`
`Linnea Cipriano, Esq.
`
`GOODWIN PROCTER
`
`The New York Times Building
`
`620 Eighth Avenue
`
`New York, NY 10018
`
`212.813.8800
`
`eholland@goodwinlaw.com
`
`Also Present: Petra Scamborova and James Evans
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`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 3
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` This cause came on to be heard on
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`the 29th day of October, 2020, before the Patent
`
`Trial and Appeal Board, preliminary panel, when
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`the following proceedings were had, to-wit:
`
` THE COURT: Since there is a
`
` court reporter, if the party that's
`
` sponsoring the court reporter could
`
` please file the transcript as an
`
` exhibit, we would appreciate it.
`
` To begin again, this is Judge
`
` Kinder; and with me on the call are
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` Judges Franklin and Sawert.
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` As I mentioned, this panel is
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` preliminary until the Board actually
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` starts issuing orders or decisions in
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` the proceeding. So most likely, this
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` will be the panel, though.
`
` Now, if we can get a roll call
`
` for petitioner, please.
`
` MR. DESAI: Yes. Good morning,
`
` Your Honor. This is Anish Desai here
`
` for petitioner. Also on the line is
`
` Elizabeth Weiswasser and Brian Ferguson
`
` from my firm. And we have two client
`
` representatives, I think, also sitting
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.003
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 4
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` in, Petra Scamborova and James Evans.
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` THE COURT: Mr. Desai, who is
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` going to speak for petitioner today?
`
` MR. DESAI: I will be.
`
` THE COURT: All right. Thank
`
` you. And since you do have client
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` representatives, I presume there is not
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` going to be any confidential information
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` discussed today, party-sensitive
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` information. But if that is incorrect,
`
` please let me know now.
`
` MR. DESAI: That is correct.
`
` THE COURT: Okay. For the patent
`
` owner?
`
` MS. HOLLAND: Yes. Good morning.
`
` This is Elizabeth Holland of Goodwin
`
` Procter for patent owner. With me are
`
` Bill James and Linnea Cipriano, also
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` from Goodwin Procter.
`
` THE COURT: Ms. Holland, who is
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` going to speak today on behalf of patent
`
` owner?
`
` MS. HOLLAND: I will.
`
` THE COURT: All right. Very
`
` good. So I understand petitioner has
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.004
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 5
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` requested potentially additional
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` preliminary briefing. So I'll let
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` petitioner present their case.
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` Again, we don't want to get into
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` the merits on this particular phone
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` call. This is to determine whether
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` we're going to justify additional
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` briefing. Hopefully, both parties have
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` looked at some of our recent decisions
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` related to discretionary factors, and
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` our decisions to allow additional
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` briefing to address those or not to
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` allow.
`
` So, petitioner, if you can open
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` it up, please.
`
` MR. DESAI: Thank you, Your
`
` Honor.
`
` So Regeneron submits that there
`
` is good cause for reply brief. I'll
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` address the 314 and the 325 issues
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` separately.
`
` But before I get into those
`
` issues, to the extent -- I don't know
`
` that it will be, but if the issue
`
` becomes about the amount of pages,
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.005
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 6
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` Regeneron is flexible on that point. I
`
` think in our email exchanges with
`
` Novartis, it didn't appear the issue was
`
` page limits. But our understanding is
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` that they oppose the reply regardless of
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` how many pages.
`
` We propose 20, because that was
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` how many pages they roughly dedicated to
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` the issue. But on further
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` consideration, we would be fine with 15
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` pages, roughly split 10 and 25, between
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` the 314 and the 325 issues.
`
` Also, Novartis has not asked.
`
` But if Novartis wants a sur-reply, we
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` don't have a problem with that. I
`
` think, ultimately, we want the Board to
`
` have the complete set of facts and the
`
` perspective from both parties on these
`
` issues.
`
` Let me start with a reply on 314.
`
` We've seen a number of decisions from
`
` the Board granting replies on a 314
`
` issue. I have like a list of eight at
`
` least. I don't think I need to run down
`
` those lists.
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.006
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 7
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` So it seems that it's fairly
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` common for replies to be given on 314
`
` issues. Here, there is certainly good
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` cause.
`
` Regeneron filed these IPRs five
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` days before the ITC case was instituted.
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` In these circumstances, if 314 precludes
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` PTAB review, then the PTAB review is
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` effectively foreclosed for patent
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` asserting ITC.
`
` I think that's even more
`
` problematic here where the petition is
`
` based on prior art that was never
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` considered by the patent office.
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` As far as good cause goes,
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` Novartis hinged its argument to the
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` Board's decision in IPR2020-00772
`
` involving FitBit. That case is heavily
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` cited in the patent owner preliminary
`
` response, and that decision issued on
`
` October 19, 2020.
`
` So, obviously, our petition was
`
` filed in July. We could not have
`
` addressed and distinguished that
`
` specific case. We should certainly be
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.007
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 8
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` permitted to discuss and explain why
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` that case doesn't control here.
`
` THE COURT: Can you refresh me?
`
` The specific case you're referring to,
`
` the recent one, is there any
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` precedential or informative value on
`
` that case?
`
` MR. DESAI: I do not believe it
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` has been identified as precedential.
`
` THE COURT: I just wanted to make
`
` sure.
`
` MR. DESAI: There are also
`
` additional facts regarding the ITC case
`
` that Regeneron should be allowed to put
`
` in the record in a reply brief.
`
` I think, first, Novartis's brief
`
` says, quote, "The ITC investigation will
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` be tried in approximately nine months
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` and decided in approximately six
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` months," before any final written
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` decision here.
`
` And, then again, in the brief,
`
` the POPR, it says, quote, "The ITC is
`
` set to issue a decision on validity of
`
` the 631 patent by July 29, 2021."
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.008
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 9
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` To say that the ITC's decision
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` will issue on July 29th is just flat out
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` wrong. That is the date for the ALJ
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` initial determination, which is very
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` different than the Commission's
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` decision.
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` The Commission's decision is due
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` November 29, 2021, and the 60-day
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` precedential review period ends January
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` 29, 2022. The Board's final decision on
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` these IPRs would fall within that
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` precedential review period on or about
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` January 22, 2022.
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` There is also a dispute at the
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` ITC regarding whether another company is
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` a necessary party to that investigation.
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` I can't get into the details of that
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` because of the ITC protective order.
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` But our reply brief will identify this
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` as an issue at a high level, as creating
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` uncertainty regarding the ITC schedule
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` and whether the ITC will actually reach
`
` the merits.
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` This third party also has rights
`
` in the patent that provide a reason why
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.009
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 10
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` the IPR should proceed irrespective of
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` the ITC case. So those are facts
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` that --
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` MS. HOLLAND: I'm sorry. To the
`
` extent you're getting into confidential
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` information in front of your client, I
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` do object to that.
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` MR. DESAI: Elizabeth, that is
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` not confidential. That information is
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` in a public antitrust complaint that was
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` filed in the Southern District of New
`
` York. So I am not --
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` MS. HOLLAND: I just want to make
`
` sure you're not discussing any
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` particularities about the agreement
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` between patent owner and the third
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` party.
`
` MR. DESAI: I was not intending
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` to.
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` THE COURT: Mr. Desai, go ahead
`
` and continue.
`
` MR. DESAI: So from our email
`
` exchanges, to sort of summarize, those
`
` are -- I think I've listed off what I
`
` think are some facts and relevant
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0010
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 11
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` information that we should be permitted
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` to put in our reply.
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` From our email exchanges, I
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` understand Novartis's position that
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` Regeneron should not get a reply because
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` it should have addressed 314 in our
`
` petition. I think they hinge this on
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` the Fintiv case, having been made
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` precedential before our petitions were
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` filed. We don't agree that that means
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` Regeneron should have predicted
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` Novartis's argument and addressed it in
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` the petition.
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` Prior to our petition being
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` filed, the Panel in IPR2018-01545
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` rejected a 314 argument based on an ITC
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` case, noting that the ITC does not have
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` authority to invalidate a patent and
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` also noting the different evidentiary
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` standards and burdens that apply.
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` There was only one other decision
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` from the Board we found prior to the
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` filing of our petitions, where the Board
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` denied a petition based on a 314 in view
`
` of a pending ITC case. That was in
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0011
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 12
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` Bio-Rad, IPR2019-00568.
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` In the Bio-Rad case, the ITC case
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` was instituted on February 14, 2018; and
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` the IPR was filed 11 months later on
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` January 15, 2019, so right on the cusp
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` of the one-year statutory deadline.
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` That case bears no resemblance to
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` the Regeneron situation. There's really
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` no reason why Regeneron should have
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` predicted that Novartis would be making
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` this argument in this case. And I think
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` suggesting that a petitioner needs to
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` predict any and all 314/325 procedural
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` arguments and deal with those in the
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` petition is really contrary to the
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` statutory requirements for the content
`
` of a petition.
`
` That's 35 U.S.C. 312; the Board's
`
` role in the content of that petition,
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` 37 CFR 42.104; and the Trial Practice
`
` Guide, none of which make it a
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` requirement for a petitioner to address
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` 314 and 325 arguments in the petition.
`
` I think I would say, for the
`
` Board's benefit, briefing on these
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0012
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 13
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` procedural arguments will be far more
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` focused and issues will be properly
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` joined if petitioners are responding to
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` actual arguments made by patent owner
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` rather than trying to predict what a
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` patent owner might say.
`
` So unless Your Honor has any
`
` questions, I can turn to the 325 issue.
`
` THE COURT: Give me one second,
`
` Mr. Desai.
`
` Okay. You can proceed to 325.
`
` MR. DESAI: As I mentioned, we
`
` can address the 325 issue of fewer
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` pages. And our petition already
`
` explained how the prior art used in the
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` petition was not before the examiner,
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` and it's different from the art that was
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` before the examiner. We're not going to
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` rehash those points in our reply.
`
` What we would like is for our
`
` reply to address a handful of statements
`
` by the patent owners that, in our view,
`
` misrepresent the prosecution history.
`
` Specifically, an example stating that
`
` the examiner was aware of terminal
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0013
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 14
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` sterilization art and that terminal
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` sterilization was a focal point of the
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` examiner's argument during prosecution.
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` Now, I appreciate that we had the
`
` opportunity to address the prosecution
`
` history in our petitions, and we did at
`
` pages 20 and 21 of a 1318 petition, for
`
` example -- sorry, 1317 petition. We
`
` pointed out how the examiner was focused
`
` on silicone for three office actions.
`
` In the fourth office action, the
`
` examiner continued to reject and pointed
`
` out that the patent owner was making an
`
` argument based on terminal sterilization
`
` that was not claimed. The claim was
`
` amended to allow terminal sterilization,
`
` and the examiner allowed the claim.
`
` It was clearly missing from the
`
` prosecution history as any terminal
`
` sterilization history prior art. So
`
` even though we do address the
`
` prosecution history in our petition, we
`
` couldn't predict that petitioner would
`
` try to recast its prosecution history as
`
` somehow involving terminal sterilization
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0014
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 15
`
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` prior art that was considered a focal
`
` point of the examination.
`
` While Your Honors certainly can
`
` read the four office actions and the
`
` notice of allowance and figure that out
`
` on your own, it would certainly be
`
` easier if you have briefing from both
`
` sides.
`
` I know the patent owner replied
`
` to our email to the Board, asking for
`
` the details on what we believe was
`
` misrepresented so that they could
`
` address those issues on this conference
`
` call. But we don't believe that this
`
` conference call is the right place for
`
` these issues to be argued without the
`
` benefit of a reply brief from Regeneron.
`
` It makes far more sense for us to brief
`
` these issues and let Your Honors make a
`
` fully-informed decision.
`
` Ultimately -- this is an
`
` important issue -- this is a patent that
`
` is being used by Novartis in an attempt
`
` to limit availability of an important
`
` drug that's relied on by millions of
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0015
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 16
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` patients suffering from CSI diseases
`
` that cause vision loss and blindness.
`
` Let's put together a complete
`
` record; allow us a reply brief; if
`
` Novartis needs a sur-reply, we don't
`
` oppose that; and let Your Honors make an
`
` informed decision.
`
` Thank you.
`
` THE COURT: Mr. Desai, I
`
` appreciate it. Before I have any
`
` questions for you at the end or
`
` follow-up after patent owner gets an
`
` opportunity, we will bring those up at
`
` the time.
`
` Ms. Holland, if you can, present
`
` your case and why the patent owner
`
` opposes additional briefing.
`
` MS. HOLLAND: Yes, I can. Thank
`
` you.
`
` I want to -- before I get into
`
` the meat of what I want to say, I just
`
` want to address the last point that
`
` Mr. Desai made about this being an
`
` important issue.
`
` Patent owner also thinks it's an
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0016
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 17
`
` 1
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` important issue. That's why we brought
`
` suit against Regeneron in the ITC. The
`
` point here is not for this Panel right
`
` now to decide how important the issues
`
` are. The point is that the issue is
`
` being decided by another forum as we
`
` speak. That case is well under way. So
`
` I just wanted to make that clear before
`
` I started.
`
` So let me get to the 314(c)
`
` argument. Mr. Desai acknowledged that
`
` the defense's decision did issue before
`
` petitioner filed this petition. To be
`
` clear on the dates, defense's decision
`
` issued in March. And what's most
`
` important, I would say, is that it
`
` became precedential in May. And that
`
` was two months before petitioner filed
`
` its petition.
`
` Now, Mr. Desai said, Well, how
`
` were we supposed to anticipate that
`
` patent owner was going to address this?
`
` He points to an IPR that was a 2018 IPR
`
` that went the other way.
`
` But what's important is that the
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0017
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 18
`
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` decision in Fintiv became precedential
`
` in May. At that point in time, what
`
` came before it in terms of
`
` nonprecedential, noninformative
`
` decisions really doesn't bear on the
`
` issue.
`
` As of May, petitioner should have
`
` known about the defense's decision,
`
` either knew or should have known about
`
` the decision, about its precedential
`
` value, and also understood that the
`
` decision explicitly addresses the
`
` situation we're in now, which is the
`
` possibility of the Board exercising its
`
` discretion not to institute based on
`
` parallel ITC proceedings. That was very
`
` clear in defense's position.
`
` As of the time that petitioner
`
` filed this petition -- I know it says
`
` that it was three days before -- there
`
` was not really any doubt at that point
`
` in time that it was going to be
`
` instituted. But, regardless, petitioner
`
` had the opportunity to take some number
`
` of words in his petition to address this
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0018
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 19
`
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` issue.
`
` And it's not a matter of
`
` responding to our argument. There are
`
` several factors. Those factors could
`
` have been addressed from the
`
` petitioner's point of view in the
`
` petition as filed.
`
` There was obviously a strategic
`
` position here not to take up the words
`
` in the petition to address Fintiv,
`
` which, as I said, was a precedential
`
` opinion directly applicable to the
`
` matter before the panel today.
`
` This is, in our view, essentially
`
` a way to backdoor in this argument
`
` without expanding the word count in
`
` their petition but expanding the word
`
` count by addressing it in a reply.
`
` I understand that now Mr. Desai
`
` is saying that they don't really mean
`
` they want 20 pages, but I think that's
`
` an indication that this really is a way
`
` of addressing an issue that should have
`
` been addressed in its petition.
`
` Mr. Desai also said that the
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0019
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 20
`
` 1
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` reason they wanted 20 pages is because
`
` that's the number of pages that patent
`
` owners took in its preliminary response
`
` on this issue. But, again, I want to
`
` note that that was a decision on patent
`
` owner's part.
`
` We also had a limited number of
`
` words, and we chose to use some of those
`
` limited number of words on this issue
`
` rather than making more extensive
`
` arguments on the other issue.
`
` So this is all a choice of how to
`
` use word count. We chose to use our
`
` word count in that particular way. The
`
` petitioner chose not to address it in
`
` his petition, even though it was or
`
` should have well been aware of Fintiv
`
` and Fintiv's discussion and specifically
`
` directing the issue of parallel ITC
`
` proceedings.
`
` THE COURT: Ms. Holland, this is
`
` Judge Kinder again. Can I interrupt you
`
` real quick?
`
` MS. HOLLAND: Sure.
`
` THE COURT: Since that Fintiv
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0020
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 21
`
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` decision came out, we have a very
`
` limited number, I think, of cases that
`
` address it at the preliminary phase,
`
` because it takes about six months for us
`
` to start issuing initial decisions,
`
` preliminary initial decisions.
`
` Are there any other initial
`
` decisions from the Board where we've
`
` refused to allow petitioner a response
`
` when they didn't address Fintiv up
`
` front?
`
` MS. HOLLAND: Since the time that
`
` it has become precedential?
`
` THE COURT: Correct. I mean, it
`
` would be a pretty limited window, three
`
` or four months, I believe, that we've
`
` been issuing initial decisions after
`
` petitions were filed after the Fintiv
`
` decision.
`
` MS. HOLLAND: Let me ask my
`
` colleague, Ms. Cipriano, if she's aware
`
` of any cases like that.
`
` MS. CIPRIANO: No, Your Honor,
`
` I'm not aware of any.
`
` THE COURT: I think that's
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0021
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 22
`
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` something that's important for your
`
` position, if there were other cases
`
` where we've done what you're requesting
`
` to not allow additional briefing.
`
` But go ahead. Continue, please,
`
` Ms. Holland.
`
` MS. HOLLAND: Thank you very
`
` much.
`
` So I understand what you're
`
` saying. And, again, I want to stress
`
` that it is very -- it is, you know,
`
` several months since the Fintiv
`
` decision, that period of time. But I
`
` think the critical thing is that it was
`
` two months prior to filing the petition
`
` here. So there's no reason why it
`
` shouldn't have been addressed at least
`
` to some extent in this petition, and it
`
` wasn't.
`
` And to take up words now, you
`
` know, 20 pages or even 15 pages, on the
`
` issue, seems unfair, given that it is an
`
` issue that should have been addressed.
`
` THE COURT: Okay.
`
` MS. HOLLAND: Let me just say a
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0022
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 23
`
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` few more things that -- address a couple
`
` of more things that Mr. Desai brought up
`
` in his argument.
`
` First of all, the facts about the
`
` ITC case, if you look at almost every
`
` Fintiv decision or decision even
`
` preceding Fintiv where the discretion
`
` was exercised to deny institution based
`
` on a parallel proceeding, you'll see
`
` that the trial of the matter is the
`
` decisive time point that's looked at.
`
` So we've emphasized in our papers
`
` that the ITC case is going to be tried
`
` nine months prior to any final written
`
` decision here. It will be decided, at
`
` least by initial determination, as of
`
` July 29th.
`
` And the only time frame that will
`
` not have been satisfied, as Mr. Desai
`
` conceded on his call, would be the
`
` 60-day precedential review. And that is
`
` a formal kind of review that is not
`
` often or almost never used to overturn a
`
` decision of the ITC. And it would not
`
` be something that affected the merits of
`
`~ff Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2003.0023
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Conference Call
`
`10/29/2020
`Page 24
`
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` the patent decision that the -- in any
`
`