Conference Call
`
`10/29/2020
`Page 1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS,
`
`INC.,
`
`Petitioner,
`
`Vv.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY, LLC,
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`Cases IRP2020-01317
`and IRP2020-01318
`
`Patent 9,220,631
`
`HEARING BY TELECONFERENCE
`
`October 29, 2020
`
`Patent and Appeal Board.
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.001
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.001
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`10/29/2020
`Page 1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS,
`
`INC.,
`
`Petitioner,
`
`Vv.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY, LLC,
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`Cases IRP2020-01317
`and IRP2020-01318
`
`Patent 9,220,631
`
`HEARING BY TELECONFERENCE
`
`October 29, 2020
`
`Patent and Appeal Board.
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.001
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.001
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 2
`
`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
`
`Also Present: Petra Scamborova and James Evans
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.002
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.002
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 3
`
`This cause came on to be heard on
`
`the 29th day of October, 2020, before the Patent
`
`Trial and Appeal Board, preliminary panel, when
`
`the following proceedings were had,
`
`to-wit:
`
`I think, also sitting
`
`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
`
`Judges Franklin and Sawert.
`
`As I mentioned,
`
`this panel is
`
`preliminary until the Board actually
`
`starts issuing orders or decisions in
`
`the proceeding.
`
`So most likely,
`
`this
`
`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,
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.003
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.003
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 4
`
`So I understand petitioner has
`
`in, Petra Scamborova and James Evans.
`
`THE COURT: Mr. Desai, who is
`
`going to speak for petitioner today?
`
`MR. DESAI:
`
`I will be.
`
`THE COURT: All right.
`
`Thank
`
`you. And since you do have client
`
`representatives,
`
`I presume there is not
`
`going to be any confidential information
`
`discussed today, party-sensitive
`
`information. But if that is incorrect,
`
`please let me know now.
`
`MR. DESAI: That is correct.
`
`THE COURT: Okay.
`
`For the patent
`
`MS. HOLLAND: Yes. Good morning.
`
`This is Elizabeth Holland of Goodwin
`
`Procter for patent owner. With me are
`
`Bill James and Linnea Cipriano, also
`
`from Goodwin Procter.
`
`THE COURT: Ms. Holland, who is
`
`going to speak today on behalf of patent
`
`owner?
`
`MS. HOLLAND:
`
`I will.
`
`THE COURT: All right. Very
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.004
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.004
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 5
`
`requested potentially additional
`
`preliminary briefing.
`
`So I'll let
`
`petitioner present their case.
`
`Again, we don't want to get into
`
`the merits on this particular phone
`
`call. This is to determine whether
`
`we're going to justify additional
`
`briefing. Hopefully, both parties have
`
`looked at some of our recent decisions
`
`related to discretionary factors, and
`
`our decisions to allow additional
`
`briefing to address those or not to
`
`allow.
`
`So, petitioner, if you can open
`
`it up, please.
`
`MR. DESAI:
`
`Thank you, Your
`
`becomes about the amount of pages,
`
`So Regeneron submits that there
`
`is good cause for reply brief.
`
`I'll
`
`address the 314 and the 325 issues
`
`separately.
`
`But before I get into those
`
`issues,
`
`to the extent -- I don't know
`
`that it will be, but if the issue
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.005
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.005
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 6
`
`those lists.
`
`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
`
`that they oppose the reply regardless of
`
`how many pages.
`
`We propose 20, because that was
`
`how many pages they roughly dedicated to
`
`the issue. But on further
`
`consideration, we would be fine with 15
`
`pages,
`
`roughly split 10 and 5, between
`
`the 314 and the 325 issues.
`
`Also, Novartis has not asked.
`
`But if Novartis wants a sur-reply, we
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.006
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.006
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 7
`
`specific case. We should certainly be
`
`So it seems that it's fairly
`
`common for replies to be given on 314
`
`issues. Here,
`
`there is certainly good
`
`cause.
`
`Regeneron filed these IPRs five
`
`days before the ITC case was instituted.
`
`In these circumstances, if 314 precludes
`
`PTAB review,
`
`then the PTAB review is
`
`effectively foreclosed for patent
`
`asserting ITC.
`
`I think that's even more
`
`problematic here where the petition is
`
`based on prior art that was never
`
`considered by the patent office.
`
`As far as good cause goes,
`
`Novartis hinged its argument to the
`
`Board's decision in IPR2020-00772
`
`involving FitBit. That case is heavily
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.007
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.007
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 8
`
`the 631 patent by July 29, 2021."
`
`permitted to discuss and explain why
`
`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
`
`precedential or informative value on
`
`that case?
`
`MR. DESAI:
`
`I do not believe it
`
`has been identified as precedential.
`
`THE COURT:
`
`I just wanted to make
`
`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
`
`be tried in approximately nine months
`
`and decided in approximately six
`
`months," before any final written
`
`decision here.
`
`And,
`
`then again,
`
`in the brief,
`
`the POPR, it says, quote,
`
`"The ITC is
`
`set to issue a decision on validity of
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.008
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.008
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 9
`
`in the patent that provide a reason why
`
`To say that the ITC's decision
`
`will issue on July 29th is just flat out
`
`wrong. That is the date for the ALJ
`
`initial determination, which is very
`
`different than the Commission's
`
`decision.
`
`The Commission's decision is due
`
`November 29, 2021, and the 60-day
`
`precedential review period ends January
`
`29, 2022.
`
`The Board's final decision on
`
`these IPRs would fall within that
`
`precedential review period on or about
`
`January 22, 2022.
`
`There is also a dispute at the
`
`ITC regarding whether another company is
`
`a necessary party to that investigation.
`
`I can't get into the details of that
`
`because of the ITC protective order.
`
`But our reply brief will identify this
`
`as an issue at a high level, as creating
`
`uncertainty regarding the ITC schedule
`
`and whether the ITC will actually reach
`
`the merits.
`
`This third party also has rights
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.009
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.009
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 10
`
`the IPR should proceed irrespective of
`
`the ITC case.
`
`So those are facts
`
`that --
`
`MS. HOLLAND:
`
`I'm sorry.
`
`To the
`
`extent you're getting into confidential
`
`information in front of your client,
`
`I
`
`do object to that.
`
`MR. DESAI: Elizabeth,
`
`that is
`
`not confidential. That information is
`
`in a public antitrust complaint that was
`
`filed in the Southern District of New
`
`York.
`
`So I am not --
`
`MS. HOLLAND:
`
`I just want to make
`
`sure you're not discussing any
`
`particularities about the agreement
`
`between patent owner and the third
`
`party.
`
`MR. DESAI:
`
`I was not intending
`
`think are some facts and relevant
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.010
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.010
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 11
`
`information that we should be permitted
`
`to put in our reply.
`
`From our email exchanges,
`
`I
`
`understand Novartis's position that
`
`of a pending ITC case. That was in
`
`Regeneron should not get a reply because
`
`it should have addressed 314 in our
`
`petition.
`
`I think they hinge this on
`
`the Fintiv case, having been made
`
`precedential before our petitions were
`
`filed. We don't agree that that means
`
`Regeneron should have predicted
`
`Novartis's argument and addressed it in
`
`the petition.
`
`Prior to our petition being
`
`filed,
`
`the Panel
`
`in IPR2018-01545
`
`rejected a 314 argument based on an ITC
`
`case, noting that the ITC does not have
`
`authority to invalidate a patent and
`
`also noting the different evidentiary
`
`standards and burdens that apply.
`
`There was only one other decision
`
`from the Board we found prior to the
`
`filing of our petitions, where the Board
`
`denied a petition based on a 314 in view
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.011
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.011
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 12
`
`Board's benefit, briefing on these
`
`Bio-Rad,
`
`IPR2019-00568.
`
`In the Bio-Rad case,
`
`the ITC case
`
`was instituted on February 14, 2018; and
`
`the IPR was filed 11 months later on
`
`January 15, 2019,
`
`so right on the cusp
`
`of the one-year statutory deadline.
`
`That case bears no resemblance to
`
`the Regeneron situation. There's really
`
`no reason why Regeneron should have
`
`predicted that Novartis would be making
`
`this argument in this case. And I think
`
`suggesting that a petitioner needs to
`
`predict any and all 314/325 procedural
`
`arguments and deal with those in the
`
`petition is really contrary to the
`
`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,
`
`37 CFR 42.104; and the Trial Practice
`
`Guide, none of which make it a
`
`requirement for a petitioner to address
`
`314 and 325 arguments in the petition.
`
`I think I would say, for the
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.012
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.012
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 13
`
`the examiner was aware of terminal
`
`procedural arguments will be far more
`
`focused and issues will be properly
`
`joined if petitioners are responding to
`
`actual arguments made by patent owner
`
`rather than trying to predict what a
`
`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 in fewer
`
`pages. And our petition already
`
`explained how the prior art used in the
`
`petition was not before the examiner,
`
`and it's different from the art that was
`
`before the examiner. We're not going to
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.013
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.013
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 14
`
`somehow involving terminal sterilization
`
`sterilization art and that terminal
`
`sterilization was a focal point of the
`
`examiner's argument during prosecution.
`
`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 our 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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.014
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.014
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 15
`
`drug that's relied on by millions of
`
`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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.015
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.015
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 16
`
`patients suffering from eye 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
`
`Patent owner also thinks it's 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
`
`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.
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.016
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.016
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 17
`
`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.
`
`But what's important is that the
`
`So let me get to the 314 (c)
`
`argument. Mr. Desai acknowledged that
`
`the Fintiv decision did issue before
`
`petitioner filed this petition.
`
`To be
`
`clear on the dates, Fintiv 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.
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.017
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.017
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 18
`
`of words in its petition to address this
`
`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 Fintiv 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 the
`
`Fintiv 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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.018
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.018
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 19
`
`Mr. Desai also said that the
`
`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 ina 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.
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.019
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.019
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 20
`
`reason they wanted 20 pages is because
`
`that's the number of pages that patent
`
`owners took in their preliminary
`
`response on this issue. But, again,
`
`I
`
`want to note that that was a decision on
`
`patent owners' 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
`
`Since that Fintiv
`
`real quick?
`
`MS. HOLLAND:
`
`Sure.
`
`THE COURT:
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.020
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.020
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 21
`
`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 think that's
`
`I'm not aware of any.
`
`THE COURT:
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.021
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.021
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 22
`
`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
`
`MS. HOLLAND: Let me just say a
`
`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.
`
`\F Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.022
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.022
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 23
`
`be something that affected the merits of
`
`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 this 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
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.023
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.023
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 24
`
`there's absolutely no indication
`
`the patent decision that the -- in any
`
`event.
`
`So the merits of the dispute
`
`between the parties on the validity of
`
`the 631 patent will be finally decided
`
`prior to the Board's final written
`
`decision, if institution should be
`
`granted.
`
`The other point that Mr. Desai
`
`made is -- and I didn't know we were
`
`going to be getting into this on the
`
`call today, but I want to address it
`
`just because it was brought up.
`
`This issue about another company
`
`being a necessary party in the ITC case,
`
`I don't want to discuss the merits here.
`
`I just want to say that the motion
`
`hasn't been filed. We think it isa
`
`very unmeritorious motion that is not
`
`going to be granted, and we don't
`
`believe that the remote possibility that
`
`something happens like that should in
`
`any way affect the decision here with
`
`respect to institution because, as of
`
`now,
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.024
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.024
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 25
`
`essentially showed that it was a simple
`
`that there will be any delay in the
`
`proceedings or trial of the proceedings.
`
`Unless there are any questions,
`
`I
`
`can move to the 325(d) point.
`
`THE COURT: Ms. Holland,
`
`this is
`
`Judge Kinder.
`
`Just give me one minute.
`
`Okay.
`
`Go ahead and proceed,
`
`Ms. Holland -- thank you -- with the
`
`325(d)
`
`issue.
`
`MS. HOLLAND:
`
`Thank you.
`
`I want
`
`to start off by saying that the email
`
`that was sent to the Board had a serious
`
`accusation about misrepresentations.
`
`I
`
`didn't believe that that word was used
`
`purposefully.
`
`I thought it was just a
`
`poor word choice, but it was used again
`
`on the call today.
`
`I want to point out that words
`
`have meaning. We were really taken
`
`aback when we saw Mr. Desai's email
`
`using that word. As he said, we had
`
`asked him to list with particularity
`
`what those misrepresentations were.
`
`We got a list back that
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.025
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.025
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 26
`
`disagreement with our argument,
`
`that
`
`they interpret the prosecution history
`
`one way,
`
`the patent one way, and we
`
`interpret it another way perhaps.
`
`But I would say that everything
`
`in our papers was backed up by citations
`
`to the prosecution history and to the
`
`patent specifications.
`
`So, certainly,
`
`there's nothing there that requires more
`
`briefing.
`
`It's an issue that Mr. Desai said
`
`the petitioner knew was a dispute in
`
`terms of terminal sterilization. That's
`
`one of the arguments that they make in
`
`their petition.
`
`So it should have been
`
`clear that we would have been addressing
`
`that accusation in response.
`
`I would say that the fact that
`
`terminal sterilization was in the prior
`
`art is right in the specification of the
`
`Saying the Board knew that terminal sterilization -- the Examiner knew that
`
`patent.
`
`I don't think there's any
`
`dispute on that.
`
`So to say that we
`
`somehow misrepresented anything by
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.026
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.026
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 27
`
`terminal sterilization was in the prior
`
`art is just -- it's not untenable on its
`
`face.
`
`I mean, it's right there in the
`
`specifications.
`
`So we don't see any reason for
`
`giving more word count and word space to
`
`this argument right now for petitioner.
`
`It is certainly something that is an
`
`issue that was the crux of their
`
`petition. We responded to it, saying
`
`that it was cumulative, because it was;
`
`and there's nothing that can be in any
`
`way, shape, or form construed as a
`
`misrepresentation in our papers.
`
`So I can address any questions on
`
`address it.
`
`325(d).
`
`THE COURT: Ms. Holland,
`
`thank
`
`you.
`
`I was just conferring with the
`
`panel.
`
`I want to give Mr. Desai a chance
`
`to respond really quick just to the
`
`things you brought up, if there's any
`
`response needed. And then if he raises
`
`anything new, I'll allow you a chance to
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.027
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.027
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 28
`
`Mr. Desai, do you have any
`
`further response?
`
`MR. DESAI:
`
`Just a few quick
`
`points.
`
`35 U.S.C. 312, 37 C.F.R. 42.104. None
`
`We've looked, and we're not aware
`
`of a case where PTAB disallowed a reply
`
`brief on a 314 issue. We just haven't
`
`seen it.
`
`Even in the FitBit case,
`
`they
`
`relied on -- it's confusing, because
`
`there's Fintiv and FitBit. FitBit is
`
`the October 19, 2020, decision that
`
`Novartis relied on, and the petitioner
`
`got a reply.
`
`We've seen PTAB decisions
`
`allowing 314 and 325 replies even where
`
`the petitioner addresses those issues in
`
`the petition.
`
`So whether or not you
`
`address it in the petition is not the
`
`determinative factor.
`
`It's whether
`
`there's good cause. And here,
`
`there is.
`
`I went through those issues.
`
`And then this argument about the
`
`word count,
`
`I mean,
`
`the requirements for
`
`a petition are set by statute and rule,
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.028
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.028
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 29
`
`that response.
`
`of those require addressing 314 and 325
`
`issues, and neither does the Trial
`
`Practice Guide.
`
`So I think if the Board is now
`
`going to set a requirement that
`
`petitions have to address 314 and 325
`
`issues, that's something that should
`
`probably go in the Trial Practice Guide.
`
`But it's not there right now.
`
`So I
`
`think there's tons of precedent here for
`
`giving a reply.
`
`And then on the 325 issue,
`
`let me
`
`just say the misrepresentation here --
`
`that word was used properly, because the
`
`issue here is, was their terminal
`
`sterilization art disclosed to the
`
`Examiner? That's the language that the
`
`patent owner used in their POPR, "prior
`
`art." And the answer is there was not.
`
`And we would like that to be made clear
`
`in our reply brief.
`
`THE COURT: Mr. Desai,
`
`I
`
`appreciate your response.
`
`I don't
`
`necessarily mean we agree with you on
`
`WF Trustpoint.One Alderson
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`Regeneron Exhibit 1065.029
`Regeneron v. Novartis
`IPR2020-01318
`
`Regeneron Exhibit 1065.029
`Regeneron v. Novartis
`IPR2020-01318
`
`
`
`Conference Call
`
`10/29/2020
`Page 30
`
`there are plenty of decisions that I
`
`You know,
`
`there is certainly -- I
`
`certainly understand your point about it
`
`not being in the rules or statute. But,
`
`you know, you have to consider granting
`
`institution is completely discretionary
`
`on our part.
`
`So when we're talking
`
`about discretion,
`
`then we have a
`
`precedential decision out there in
`
`Fintiv.
`
`The patent owner
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