`
`·1· · · UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·2· · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·3
`· · ·AQUESTIVE THERAPEUTICS· · · )
`·4· ·INC.,· · · · · · · · · · · ·)
`· · · · · · · · · · · · · · · · ·)
`·5· · · · · · · Petitioner,· · · )· Case No.
`· · · · · · · · · · · · · · · · ·)· IPR2019-00451
`·6· · · · vs.· · · · · · · · · · )
`· · · · · · · · · · · · · · · · ·)· Patent No.
`·7· ·NEURELIS, INC.,· · · · · · ·)· 9,763,876
`· · · · · · · · · · · · · · · · ·)
`·8· · · · · · · Patent Owner.· · )
`· · ·--------------------------· )
`·9
`
`10
`
`11
`
`12
`
`13· · · · · · · · ·PTAB CONFERENCE CALL
`
`14· · · · · · · Tuesday, February 11, 2020
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23· ·Reported by:
`
`24· ·Stacey L. Daywalt
`
`25· ·JOB NO. 176956
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 2
`
`·1
`
`·2
`
`·3· · · · · · · · · · · · ·Tuesday, February 11, 2020
`
`·4· · · · · · · · · · · · ·4:03 p.m.
`
`·5
`
`·6
`
`·7· · · · · · · PTAB Conference Call, held before
`
`·8· ·Administrative Patent Judges Jamie T. Wisz,
`
`·9· ·Jon B. Tornquist and Zhenyu Yang, before Stacey
`
`10· ·L. Daywalt, a Court Reporter and Notary Public
`
`11· ·of the District of Columbia.
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 3
`
`·1· ·A P P E A R A N C E S:
`
`·2· ·(All appearances are telephonic)
`
`·3
`
`·4· · · · HOFFMANN & BARON
`
`·5· · · · Attorneys for Petitioner
`
`·6· · · · · · · 6 Campus Drive
`
`·7· · · · · · · Parsippany, New Jersey 07054
`
`·8· · · · BY:· ·MICHAEL CHAKANSKY, ESQ.
`
`·9· · · · · · · DANIEL SCOLA, JR., ESQ.
`
`10· · · · · · · MATTHEW SOLOW, ESQ.
`
`11
`
`12· · · · WILSON SONSINI GOODRICH & ROSATI
`
`13· · · · Attorneys for Patent Owner
`
`14· · · · · · · 1700 K Street NW
`
`15· · · · · · · Washington, DC 20006
`
`16· · · · BY:· ·RICHARD TORCZON, ESQ.
`
`17· · · · · · · JEFFREY GUISE, ESQ.
`
`18· · · · · · · LORELEI WESTIN, ESQ.
`
`19· · · · · · · NATHANIEL LEACHMAN, ESQ.
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 4
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Hi,
`
`·3· ·everyone.· Good afternoon.· This is Judge Wisz.
`
`·4· · · · · · · With me on the line are
`
`·5· ·Judge Tornquist and Judge Yang.
`
`·6· · · · · · · This is a conference call for
`
`·7· ·IPR2019-00451.
`
`·8· · · · · · · And do we have Petitioner on the
`
`·9· ·line?
`
`10· · · · · · · MR. CHAKANSKY:· Yes, you do, Your
`
`11· ·Honor.· Michael Chakansky, Daniel A. Scola and
`
`12· ·Matthew Solow.
`
`13· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`14· ·Thank you.
`
`15· · · · · · · And is Patent Owner on the line?
`
`16· · · · · · · MR. GUISE:· Yes.· This is Jeff Guise
`
`17· ·with Wilson Sonsini.
`
`18· · · · · · · With me is Rick Torczon, Nate
`
`19· ·Leachman and Lori Westin, I believe.
`
`20· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Thank
`
`21· ·you.
`
`22· · · · · · · And is there a court reporter on the
`
`23· ·line?
`
`24· · · · · · · MR. TORCZON:· There is, Your Honor.
`
`25· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Great.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 5
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · And who ordered the court reporter?
`
`·3· · · · · · · MR. TORCZON:· The Patent Owner
`
`·4· ·ordered the court reporter, and we intend to
`
`·5· ·submit a transcript promptly after this call.
`
`·6· · · · · · · ADMINISTRATIVE PATENT JUDGE:
`
`·7· ·Perfect.· That's what I was going to ask, so
`
`·8· ·thank you very much.
`
`·9· · · · · · · So we understand that this call was
`
`10· ·requested by Patent Owner to request
`
`11· ·authorization to file a motion to strike.
`
`12· · · · · · · And so Patent Owner, please go ahead
`
`13· ·and tell us what material you're looking to
`
`14· ·strike and why you believe such a motion is
`
`15· ·justified.
`
`16· · · · · · · MR. TORCZON:· Thank you very much,
`
`17· ·Your Honor.
`
`18· · · · · · · This is Richard Torczon.· I'll be
`
`19· ·speaking for Neurelis in the call.
`
`20· · · · · · · The basic point here is that
`
`21· ·substituting in a new expert without warning
`
`22· ·this late is prejudicial.
`
`23· · · · · · · This is not an example where the --
`
`24· ·Aquestive has demonstrated that their original
`
`25· ·expert is unavailable or unwilling to testify
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 6
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·again, nor is this an example where, as they've
`
`·3· ·indicated, they are just supplying a new expert
`
`·4· ·to address a specific issue.· They suggest it's
`
`·5· ·long-felt need.· But in fact, this is a
`
`·6· ·complete substitution of experts for all
`
`·7· ·positions.
`
`·8· · · · · · · The new expert does not even commit
`
`·9· ·to or elaborate on the original expert
`
`10· ·Dr. Peppas's testimony.· We shouldn't have to
`
`11· ·guess at what the correlation between the
`
`12· ·positions of the original declarant and the
`
`13· ·current declarant are.· Neither should the
`
`14· ·Board.
`
`15· · · · · · · Dr. Wermeling, the substitute
`
`16· ·declarant, assiduously avoids discussing
`
`17· ·Dr. Peppas's testimony except to embrace his
`
`18· ·ultimate conclusions, which wouldn't be a
`
`19· ·proper focus for expert testimony anyway.
`
`20· · · · · · · And the lack of notice in this case
`
`21· ·is particularly prejudicial.· Aquestive had
`
`22· ·months to prepare for our expert.· We will only
`
`23· ·have a few weeks to prepare to cross-examine
`
`24· ·their expert.
`
`25· · · · · · · On the facts of this specific case,
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 7
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·it's troubling because Dr. Wermeling has had
`
`·3· ·past dealings with both Neurelis officials and
`
`·4· ·with our expert, each of whom have
`
`·5· ·independently indicated that Wermeling has
`
`·6· ·given them the opposite positions in past
`
`·7· ·dealings.
`
`·8· · · · · · · Because the critical date here is 12
`
`·9· ·years ago, we are scrambling to look for
`
`10· ·supporting impeaching documents and potentially
`
`11· ·disqualifying documents.· But once again, the
`
`12· ·surprise nature of this, the fact that they
`
`13· ·gave no warning that this was going to happen,
`
`14· ·really puts us in a tight spot, plus the sheer
`
`15· ·volume of testimony and exhibits.· Given the
`
`16· ·short time to respond, the limited number of
`
`17· ·pages and the inability to provide countering
`
`18· ·testimony to their new positions at this point
`
`19· ·or to amend the claims is significantly
`
`20· ·prejudicial.
`
`21· · · · · · · As an example of a new argument,
`
`22· ·Dr. Peppas admitted that he was not aware of
`
`23· ·any ethanol benzyl alcohol mixtures in this
`
`24· ·field.· All of a sudden, we are getting this
`
`25· ·for the first time in a reply declaration that
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 8
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·should have been in the original petition.· But
`
`·3· ·that's one of many examples.
`
`·4· · · · · · · Plus, as the Board knows, we
`
`·5· ·continue to maintain that there was never an
`
`·6· ·incorporation challenge in the original
`
`·7· ·petition.· So any testimony trying to plug that
`
`·8· ·gap at this point is going to be new testimony
`
`·9· ·or is going to be testimony on a new issue
`
`10· ·which they didn't raise.
`
`11· · · · · · · To the extent that it's just being
`
`12· ·offered to knock down positions that Neurelis
`
`13· ·has had to take, it is an improper burden
`
`14· ·shift.
`
`15· · · · · · · And so this is a classic example of
`
`16· ·new theory, as is their new basis for ethanol
`
`17· ·benzyl alcohol mixtures.
`
`18· · · · · · · So because of all this, we actually
`
`19· ·think the entire declaration and any testimony
`
`20· ·or any reference to it in the reply brief
`
`21· ·should be struck.
`
`22· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`23· ·Thank you.
`
`24· · · · · · · Petitioner, would you like to
`
`25· ·respond?
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 9
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · MR. CHAKANSKY:· Yes, Your Honor.
`
`·3· ·It's Michael Chakansky.· I'll be speaking on
`
`·4· ·behalf of Petitioner.
`
`·5· · · · · · · To begin with, we are not
`
`·6· ·substituting an expert.· Dr. Peppas is still in
`
`·7· ·this case.· We have Dr. Wermeling, who is being
`
`·8· ·responsive to arguments made in Patent Owner's
`
`·9· ·response and the latest papers, as well as the
`
`10· ·decision.· And he need not address every one of
`
`11· ·the paragraphs in Dr. Peppas's because he's
`
`12· ·here to simply rebut arguments brought by
`
`13· ·Patent Owner.
`
`14· · · · · · · Additionally, it's kind of strange
`
`15· ·to hear counsel argue that the number of
`
`16· ·exhibits or the page number is relevant, when
`
`17· ·in a very similar IPR where they represented
`
`18· ·the Petitioner, I quote:· "The page count and
`
`19· ·number of exhibits in their expert declaration
`
`20· ·are irrelevant, and the Federal Circuit has
`
`21· ·allowed declarations by new experts."· This is
`
`22· ·in IPR2017-1528 in response to a motion to
`
`23· ·strike by Patent Owner.
`
`24· · · · · · · In that case Petitioner went ahead
`
`25· ·and submitted four new declarants with its
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 10
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·reply, including one by a Dr. Langer, who was
`
`·3· ·world-renowned like Dr. Peppas, and for the
`
`·4· ·first time, without notice apparently, and a
`
`·5· ·petition to support the motion to strike.
`
`·6· · · · · · · The Board went ahead and den- -- and
`
`·7· ·finding the claims unpatentable, denied the
`
`·8· ·motion to strike, allowing in the reply as well
`
`·9· ·as the declaration of their expert.· And this
`
`10· ·was upheld by the Court of Appeals for the
`
`11· ·Federal Circuit recently, in November of last
`
`12· ·year, in a case called Sanofi versus Mylan.
`
`13· · · · · · · And so we find that the case law
`
`14· ·supports our position that we have the right to
`
`15· ·present evidence in order to respond and rebut
`
`16· ·arguments, that the fact that it's a different
`
`17· ·expert is of no consequence and is irrelevant.
`
`18· · · · · · · In the case that I've just referred
`
`19· ·to, the IPR, that expert, Dr. Langer, there was
`
`20· ·an objection that he submitted something like
`
`21· ·60 exhibits along with his testimony.
`
`22· · · · · · · We needed the exhibits because -- to
`
`23· ·cover in part an argument that the other side
`
`24· ·made to long-felt need covering an expanse of
`
`25· ·30 years.· We've filled in the gaps with our
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 11
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·testimony from Dr. Wermeling.
`
`·3· · · · · · · Also, there were many, many
`
`·4· ·arguments that we needed to address, and we
`
`·5· ·did.
`
`·6· · · · · · · Additionally, the argument about
`
`·7· ·benzyl alcohol and ethyl alcohol, Dr. Peppas
`
`·8· ·may have testified -- I'm not sure he did or
`
`·9· ·didn't -- that he was unaware of the use of
`
`10· ·benzyl alcohol with ethanol in an intranasal
`
`11· ·solution that was emanative to humans. I
`
`12· ·believe Dr. -- the expert for Patent Owner,
`
`13· ·Dr. Gizurarson, also testified.
`
`14· · · · · · · Well, Dr. Wermeling, who's
`
`15· ·experienced in that area, experienced with
`
`16· ·benzodiazepine, has dealt with developing these
`
`17· ·things, was able to point us in the direction
`
`18· ·to the fact that it was used by EMS workers
`
`19· ·throughout the country in connection with the
`
`20· ·use intranasally of diazepam IV and other
`
`21· ·benzodiazepine IV solutions which contains
`
`22· ·benzyl alcohol and ethanol, and that addressed
`
`23· ·the long-felt need.· And that's one of the
`
`24· ·secondary considerations they brought up, and
`
`25· ·we're allowed to submit evidence for it.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 12
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · Additionally, we proffered, in both
`
`·3· ·the petition as well as in Dr. Peppas's
`
`·4· ·declaration, to the fact that our reference
`
`·5· ·was -- had an early effective filing date
`
`·6· ·before the effective filing date of Patent
`
`·7· ·Owner's patent because the provisional
`
`·8· ·application, the '558 application, did not
`
`·9· ·reference alka glycoside.· And that's in this
`
`10· ·case.
`
`11· · · · · · · At that point the burden went over
`
`12· ·to Patent Owner to show why it did support the
`
`13· ·effective filing date.· And in that respect,
`
`14· ·Patent Owner was able to ask Dr. Peppas whether
`
`15· ·or not alka glycoside appears in this
`
`16· ·reference, the Sigma reference, that was
`
`17· ·incorporated by reference.
`
`18· · · · · · · And Dr. Peppas said, yes, alka
`
`19· ·glycosides are there.· What's not mentioned is
`
`20· ·it's among about 150 other things.
`
`21· · · · · · · Okay.· And in his petition -- in his
`
`22· ·declaration, Dr. Peppas also testified the
`
`23· ·combination of ethanol and benzyl alcohol, on
`
`24· ·the other hand, as a solvent for
`
`25· ·pharmaceuticals is very well-known, going back
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·to the 1970s.· And that happens to be a true
`
`Page 13
`
`·3· ·statement.
`
`·4· · · · · · · And in any event, if Your Honors --
`
`·5· ·and then finally -- excuse me -- we already
`
`·6· ·have a sur-reply schedule.· We already have a
`
`·7· ·date where, if necessary, Dr. Wermeling can be
`
`·8· ·deposed.· He's available on that date.· Patent
`
`·9· ·Owner will also be able to go ahead and make
`
`10· ·arguments at oral argument.
`
`11· · · · · · · And basically, Patent Owner's only
`
`12· ·entitled to notice and the opportunity to
`
`13· ·respond.
`
`14· · · · · · · And in this trial, Petitioner is
`
`15· ·allowed to rebut and respond to arguments made
`
`16· ·by the Patent Owner, and that's what we've
`
`17· ·done.· Thank you.
`
`18· · · · · · · MR. TORCZON:· Your Honor, this is
`
`19· ·Rick Torczon.· If I may?
`
`20· · · · · · · Your Honor?
`
`21· · · · · · · ADMINISTRATIVE PATENT JUDGE
`
`22· ·TORNQUIST:· Sure.
`
`23· · · · · · · This is Judge Tornquist stepping in.
`
`24· ·Judge Wisz dropped off the call just briefly,
`
`25· ·but she'll be right back on.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 14
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · So why don't you -- we're going to
`
`·3· ·have a transcript.
`
`·4· · · · · · · Why don't you go ahead and briefly
`
`·5· ·respond.
`
`·6· · · · · · · MR. TORCZON:· Okay.· First of all,
`
`·7· ·I'd like to address the Sanofi/Mylan precedent.
`
`·8· ·Completely different case.
`
`·9· · · · · · · For one thing, Aquestive's counsel
`
`10· ·neglected to note that the primary technical
`
`11· ·expert, Dr. Yalkowsky, not only submitted a
`
`12· ·declaration with the petition but also
`
`13· ·submitted a declaration with the reply.· So we
`
`14· ·had continuity of the same expert on the same
`
`15· ·issue.
`
`16· · · · · · · The fact that an additional
`
`17· ·technical expert was brought in to address
`
`18· ·additional issues is not that surprising.
`
`19· · · · · · · He also mentioned several other
`
`20· ·experts but neglected to note that all of those
`
`21· ·were addressing testimony from Sanofi's
`
`22· ·secondary considerations experts.
`
`23· · · · · · · And so once again, the testimony of
`
`24· ·the additional experts was limited to
`
`25· ·additional points.· That's not the case here.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 15
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · What we didn't hear from Aquestive
`
`·3· ·is that they're willing to limit
`
`·4· ·Dr. Wermeling's testimony to the specific issue
`
`·5· ·that they say is the only reason they put in an
`
`·6· ·additional expert, and that is to address
`
`·7· ·long-felt need.· Had they done that, this would
`
`·8· ·be a very different case, but they haven't
`
`·9· ·offered to do that.
`
`10· · · · · · · As far as -- well, I think that
`
`11· ·probably pretty much covers it.
`
`12· · · · · · · There are a lot of other issues.· We
`
`13· ·disagree with Mr. Chakansky's characterization
`
`14· ·of the record to date.
`
`15· · · · · · · And certainly, again, it is highly
`
`16· ·prejudicial.· They haven't identified a single
`
`17· ·case where somebody has been able to wholesale
`
`18· ·substitute an expert at this late in the
`
`19· ·proceeding without something like a death
`
`20· ·occurring.
`
`21· · · · · · · So that would be the basic position.
`
`22· · · · · · · Certainly if Your Honors deny the
`
`23· ·motion, we will proceed, you know, under
`
`24· ·protest and go ahead and cross-examine.· But
`
`25· ·that's neither here nor there.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 16
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · The fact that we are left with
`
`·3· ·proceeding under prejudice doesn't make the
`
`·4· ·prejudice somehow acceptable.
`
`·5· · · · · · · MR. CHAKANSKY:· Your Honors, may I
`
`·6· ·just speak for a minute?
`
`·7· · · · · · · It's Michael Chakansky.
`
`·8· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Yes,
`
`·9· ·go ahead.
`
`10· · · · · · · MR. CHAKANSKY:· Okay.· Two things.
`
`11· · · · · · · One, the -- incorporation by
`
`12· ·reference is not the only thing that
`
`13· ·Dr. Wermeling is talking to.· There were many
`
`14· ·other issues, as can be seen just by looking at
`
`15· ·his declaration or at the reply, including
`
`16· ·criticality, bioavailability, benzyl alcohol
`
`17· ·combinations, motivation to combine,
`
`18· ·precipitation concerns.· I could go on.
`
`19· · · · · · · That being said, Patent Owner's
`
`20· ·counsel has said that we haven't shown any case
`
`21· ·that says that you can make a substitution
`
`22· ·without an expert dying or being unavailable.
`
`23· ·I point out neither has Patent Owner provided a
`
`24· ·case saying that is a requirement for new
`
`25· ·evidence in the form of declaration testimony.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 17
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · Thank you.
`
`·3· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Yeah,
`
`·4· ·actually, I was going to ask the Patent Owner.
`
`·5· · · · · · · Do you have a case to support your
`
`·6· ·position that a new expert is not proper in a
`
`·7· ·reply?
`
`·8· · · · · · · MR. TORCZON:· The only cases I've
`
`·9· ·seen this allowed are cases where the expert's
`
`10· ·died or moved overseas or somehow is otherwise
`
`11· ·significantly unavailable.
`
`12· · · · · · · Again, given the way that the Board
`
`13· ·has structured these proceedings, this last
`
`14· ·round is very, very limited both in terms of
`
`15· ·time and in terms of what we can do in
`
`16· ·response.
`
`17· · · · · · · If you substitute somebody in at the
`
`18· ·last minute, it's just an invitation for game
`
`19· ·playing.· So I submit that the precedent that
`
`20· ·will be set here is the one Mr. Chakansky is
`
`21· ·asking for, which is to let people drop in
`
`22· ·total surprise witnesses at the end.
`
`23· · · · · · · I think it's also significant that
`
`24· ·he points out that in fact Dr. Wermeling does
`
`25· ·go well beyond the issue that the e-mail to the
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 18
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·Board suggested was the point of his testimony,
`
`·3· ·which was to address long-felt need, because he
`
`·4· ·had the expertise that Dr. Peppas did not.
`
`·5· ·Instead, as Mr. Chakansky just has accurately
`
`·6· ·noted, Dr. Wermeling addresses all sorts of
`
`·7· ·issues, including issues that Dr. Peppas either
`
`·8· ·did or should have addressed in his initial
`
`·9· ·petition.
`
`10· · · · · · · So yes, this is very much a
`
`11· ·substitution where there may just be incidental
`
`12· ·additional addressing of long-felt need.
`
`13· · · · · · · MR. CHAKANSKY:· Okay.
`
`14· · · · · · · Your Honors, we are not
`
`15· ·substituting -- this is Michael Chakansky.
`
`16· · · · · · · We are not substituting.· Dr. Peppas
`
`17· ·is still in here.· There's a case, Belvin, in
`
`18· ·which the Petitioner had no declarant along
`
`19· ·with his petition, I believe, and if I remember
`
`20· ·correctly, then went ahead and in reply first
`
`21· ·put in a declarant.
`
`22· · · · · · · There is no surprise here.· When
`
`23· ·there is a complaint made about the experience
`
`24· ·of the expert and where there's a complaint
`
`25· ·made about the experience actually in
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 19
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·benzodiazepine, as well as many arguments going
`
`·3· ·to why there's no motivation to combine and we
`
`·4· ·have a fact -- we have an expert who can
`
`·5· ·address that directly, we're entitled to bring
`
`·6· ·it in in connection with the reply.
`
`·7· · · · · · · We have the same grounds.· We are
`
`·8· ·not changing the grounds.· We are not changing
`
`·9· ·the prior art.· We're relying on the grounds.
`
`10· ·We are merely going ahead and being responsive
`
`11· ·to the arguments that Patent Owner made.
`
`12· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`13· ·Thank you.
`
`14· · · · · · · And for Patent Owner, you did
`
`15· ·request in your e-mail, in the alternative,
`
`16· ·some additional pages in the sur-reply.
`
`17· · · · · · · How many additional pages do you
`
`18· ·think you would need in this case?
`
`19· · · · · · · MR. TORCZON:· Well, given the
`
`20· ·surprise, I don't know that additional pages
`
`21· ·would be an adequate remedy here.
`
`22· · · · · · · I mean, in part, as I've said, we
`
`23· ·don't have time to go and, you know, do the
`
`24· ·sort of research that we need to do to show
`
`25· ·that Dr. Wermeling isn't an inappropriate
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 20
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·witness.
`
`·3· · · · · · · As we pointed out, they've nearly
`
`·4· ·doubled the volume of testimony in this case
`
`·5· ·compared to what Dr. Gizurarson offered, so
`
`·6· ·it's hard to imagine any number of pages that
`
`·7· ·would undo that damage.
`
`·8· · · · · · · I believe we're actually under word
`
`·9· ·count.· So doubling the word count -- not
`
`10· ·doubling, but at least a 50 percent increase in
`
`11· ·the word count would help, because we believe
`
`12· ·that even with the short amount of time, we're
`
`13· ·going to be able to get a lot out of
`
`14· ·Dr. Wermeling at his cross-examination that we
`
`15· ·will need to bring to the Board's attention, as
`
`16· ·well as address sort of the spread that they've
`
`17· ·done with this new witness in their reply.
`
`18· · · · · · · MR. CHAKANSKY:· And Your Honor --
`
`19· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Sorry.
`
`20· ·Go ahead.
`
`21· · · · · · · MR. CHAKANSKY:· And Your Honors,
`
`22· ·essentially Neurelis brought this upon
`
`23· ·themselves by having so many issues, including
`
`24· ·secondary considerations along with the --
`
`25· ·including the long-felt need.
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 21
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · We shouldn't be prejudiced.· We had
`
`·3· ·the word count in our reply.· And if they have
`
`·4· ·the same amount in their sur-reply, I think
`
`·5· ·that that's a balancing of the parties' rights
`
`·6· ·in this matter.
`
`·7· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Well,
`
`·8· ·may I ask you, would you object to that amount
`
`·9· ·of additional words that Patent Owner has
`
`10· ·requested?
`
`11· · · · · · · MR. CHAKANSKY:· Yes.· Yeah.
`
`12· ·50 percent is quite a lot, especially -- it's
`
`13· ·an extra 12 pages or so.
`
`14· · · · · · · I know it's a word count.
`
`15· · · · · · · You know, we'd be amenable to an --
`
`16· ·the equivalent of five extra pages.
`
`17· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`18· · · · · · · Unless anyone has anything else at
`
`19· ·this point, we're going to put you on a brief
`
`20· ·hold so we can confer.
`
`21· · · · · · · MR. CHAKANSKY:· Thank you, Your
`
`22· ·Honor.
`
`23· · · · · · · ADMINISTRATIVE PATENT JUDGE:· All
`
`24· ·right.· Thank you.
`
`25· · · · · · · (Recess was taken from 4:24 p.m. to
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 22
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·4:34 p.m.)
`
`·3· · · · · · · ADMINISTRATIVE PATENT JUDGE:· This
`
`·4· ·is Judge Wisz.· Thank you for holding.
`
`·5· · · · · · · Are Patent Owner and Petitioner
`
`·6· ·still on the line?
`
`·7· · · · · · · MR. CHAKANSKY:· Yes, Your Honor.
`
`·8· · · · · · · MR. TORCZON:· Yes, Your Honor.
`
`·9· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`10· ·Thank you.
`
`11· · · · · · · So we're not going to authorize the
`
`12· ·motion to strike.· As you know, striking a
`
`13· ·portion or the entirety of a brief or an expert
`
`14· ·declaration is an exceptional remedy that the
`
`15· ·Board expects to be granted rarely.
`
`16· · · · · · · However, we would like a specific
`
`17· ·identification of what Patent Owner believes
`
`18· ·are the new arguments.
`
`19· · · · · · · And so what we would request is a
`
`20· ·joint filing by both parties.· We're
`
`21· ·envisioning two columns.· You know, the
`
`22· ·left-hand column could be Patent Owner where
`
`23· ·you identify by page and line number and
`
`24· ·paragraph number what you believe to be the new
`
`25· ·material.· And then the right-hand column could
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 23
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· ·be Petitioner's response to Patent Owner's
`
`·3· ·identification, Patent Owner's argument.
`
`·4· · · · · · · I think about five pages should be
`
`·5· ·sufficient for that.· But if for some reason it
`
`·6· ·seems like you need another page or two, let us
`
`·7· ·know.· That should be fine.
`
`·8· · · · · · · I think, just so you know, we will
`
`·9· ·not consider any new arguments in our final
`
`10· ·written decision.· So if we do agree that some
`
`11· ·of these are new arguments, they will not be
`
`12· ·considered in the final written decision.
`
`13· · · · · · · We think perhaps two weeks for that
`
`14· ·filing.
`
`15· · · · · · · Does that -- would that work with
`
`16· ·Patent Owner and Petitioner?
`
`17· · · · · · · MR. CHAKANSKY:· Your Honor, you
`
`18· ·perceive like one week for Patent Owner to put
`
`19· ·together its list and then one week for us to
`
`20· ·respond to them and then we submit one jointly?
`
`21· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Yes.
`
`22· · · · · · · MR. TORCZON:· Patent Owner can make
`
`23· ·that work.
`
`24· · · · · · · ADMINISTRATIVE PATENT JUDGE:
`
`25· ·Petitioner, does that work?
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 24
`
`·1· · · · · · · · ·PTAB Conference Call
`
`·2· · · · · · · MR. CHAKANSKY:· Oh, yes.
`
`·3· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`·4· · · · · · · And then also we will granting an
`
`·5· ·extra thousand words in the Patent Owner's
`
`·6· ·sur-reply.
`
`·7· · · · · · · And so when -- both in filing that
`
`·8· ·paper and in including the additional words,
`
`·9· ·you can just reference this call as the
`
`10· ·authorization to do so.
`
`11· · · · · · · MR. TORCZON:· Will do, Your Honor.
`
`12· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`13· · · · · · · Are there any other issues that need
`
`14· ·to be addressed on this call?
`
`15· · · · · · · MR. CHAKANSKY:· Nothing from
`
`16· ·Petitioner right now.
`
`17· · · · · · · MR. TORCZON:· Nothing from Patent
`
`18· ·Owners, Your Honor.
`
`19· · · · · · · ADMINISTRATIVE PATENT JUDGE:· Okay.
`
`20· · · · · · · Well, thank you all very much.
`
`21· · · · · · · With that, this call is adjourned.
`
`22· · · · · · · (Time Noted: 4:37 p.m.)
`
`23
`
`24
`
`25
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`Page 25
`
`·1· ·District of Columbia, to wit:
`
`·2· · · · · · · I, Stacey L. Daywalt, a Notary
`
`·3· ·Public of the District of Columbia, do hereby
`
`·4· ·certify that the proceedings were recorded
`
`·5· ·stenographically by me and this transcript is a
`
`·6· ·true record of the proceedings.
`
`·7· · · · · · · I further certify that I am not of
`
`·8· ·counsel to any of the parties, nor an employee
`
`·9· ·of counsel, nor related to any of the parties,
`
`10· ·nor in any way interested in the outcome of
`
`11· ·this action.
`
`12· · · · · · · As witness my hand and Notarial Seal
`
`13· ·this 11th day of February, 2020.
`
`14
`
`15
`
`16· · · · · · ·____________________________________
`
`17· · · · · · · Stacey L. Daywalt, Notary Public
`
`18· · · · · · · My Commission Expires:· ·4/14/2021
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Neurelis - EX.2027
`Aquestive Therapeutics, Inc. v. Neurelis, Inc. - IPR2019-00451
`
`