HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`1
`
`·1· · · · · · · · · · · · ·STATE OF GEORGIA
`
`·2· ·MYLAN PHARMACEUTICALS INC.,· ·)
`· · · · · · · · · · · · · · · · · ·)
`·3· · · · · · · · · Plaintiffs,· · )
`· · · · · · · · · · · · · · · · · ·)
`·4· ·vs.· · · · · · · · · · · · · ·)· · IPR 2018-00892
`· · · · · · · · · · · · · · · · · ·)
`·5· ·BRISTOL-MYERS SQUIBB COMPANY· )
`· · ·and PFIZER, INC.,· · · · · · ·)
`·6· · · · · · · · · · · · · · · · ·)
`· · ·· · · · · Defendants.· · · · ·)
`·7
`
`·8
`
`·9
`· · · · · · · HEARING BEFORE THE HONORABLE JUDGE SNEDDEN
`10· · · · · · · · · ·AND THE HONORABLE JUDGE YANG
`
`11· · · · · · · · · · · · November 16, 2018
`· · · · · · · · · · · · · · · 1:00 p.m.
`12
`
`13
`
`14
`· · · · · · · · · · Vickie E. Wiechec, CVR-M, CCR
`15
`
`16
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
`
`MYLAN EXHIBIT 1046
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`1
`
`·1· · · · · · · · · · · · ·STATE OF GEORGIA
`
`·2· ·MYLAN PHARMACEUTICALS INC.,· ·)
`· · · · · · · · · · · · · · · · · ·)
`·3· · · · · · · · · Plaintiffs,· · )
`· · · · · · · · · · · · · · · · · ·)
`·4· ·vs.· · · · · · · · · · · · · ·)· · IPR 2018-00892
`· · · · · · · · · · · · · · · · · ·)
`·5· ·BRISTOL-MYERS SQUIBB COMPANY· )
`· · ·and PFIZER, INC.,· · · · · · ·)
`·6· · · · · · · · · · · · · · · · ·)
`· · ·· · · · · Defendants.· · · · ·)
`·7
`
`·8
`
`·9
`· · · · · · · HEARING BEFORE THE HONORABLE JUDGE SNEDDEN
`10· · · · · · · · · ·AND THE HONORABLE JUDGE YANG
`
`11· · · · · · · · · · · · November 16, 2018
`· · · · · · · · · · · · · · · 1:00 p.m.
`12
`
`13
`
`14
`· · · · · · · · · · Vickie E. Wiechec, CVR-M, CCR
`15
`
`16
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`17
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`18
`
`19
`
`20
`
`21
`
`22
`
`23
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`24
`
`25
`
`MYLAN EXHIBIT 1046
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`
`
`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`2
`
`·1· · · · · · · · · · · · · · · · · · · · · · ·APPEARANCES:
`
`·2· ·FOR THE PATENT OWNER:
`· · ·MS. HEATHER PETRUZZI
`·3· ·WILMER HALE
`· · ·175 Pennsylvania Avenue Northwest
`·4· ·Washington D.C.· 20006
`· · ·(202) 663-6028
`·5· ·Heather.petruzzi@wilmerhale.com
`
`·6· ·MR. KEVIN PRUSSIA
`· · ·WILMER HALE
`·7· ·60 State Street
`· · ·Boston, Massachusetts· 02109
`·8· ·(617) 526-6243
`· · ·Kevin.prussia@wilmerhale.com
`·9
`· · ·MR. TIM COOK
`10· ·WILMER HALE
`· · ·60 State Street
`11· ·Boston, Massachusetts· 02109
`· · ·(617) 526-6005
`12· ·Tim.cook@wilmerhale.com
`
`13· ·FOR THE PETITIONER:
`· · ·MR. ROBERT FLORENCE
`14· ·PARKER POE
`· · ·1180 Peachtree Street Northeast
`15· ·Suite 3300
`· · ·Atlanta, Georgia· 30309
`16· ·(678) 690-5701
`· · ·robertflorence@parkerpoe.com
`17
`· · ·MS. KAREN CARROLL
`18· ·PARKER POE
`· · ·1180 Peachtree Street Northeast
`19· ·Suite 3300
`
`20· ·Atlanta, Georgia· 30309
`
`21· ·(678) 690-5704
`
`22· ·Karencarroll@parkerpoe.com
`
`23
`
`24
`
`25
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`
`
`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`3
`
`·1· · · · · · · · · ·INDEX TO EXHIBITS
`
`·2· ·(No exhibits were presented during this hearing.)
`
`·3
`
`·4
`
`·5
`
`·6
`
`·7
`
`·8
`
`·9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`
`
`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`4
`
`·1· · · · · · · · · · · · TELEPHONE HEARING
`
`·2· · · · · · · · · · · · November 16, 2018
`
`·3· · · · · · ·THE COURT:· Good afternoon.
`
`·4· · · · · · ·This is Judge Snedden.· I have with me on the
`
`·5· · · · call Judge Yang.
`
`·6· · · · · · ·This is a teleconference for IPR 2018 00892.
`
`·7· · · · · · ·I will start with a roll call.
`
`·8· · · · · · ·Who do we have on the line for petitioner?
`
`·9· · · · · · ·MR. FLORENCE:· Yes, Your Honor.
`
`10· · · · · · ·This is Robert Florence from Parker, Poe, Adams
`
`11· · · · and Bernstein on behalf of petitioner.
`
`12· · · · · · ·I also have my colleague, Karen Carroll on the
`
`13· · · · line and our paralegal, Crystal Reagan.
`
`14· · · · · · ·THE COURT:· Okay.
`
`15· · · · · · ·And for patent owner?
`
`16· · · · · · ·MS. PETRUZZI:· Yes, Your Honor.· This is Heather
`
`17· · · · Petruzzi on the line for patent owner.
`
`18· · · · · · ·I’m joined by my colleagues, Tim Cook and Kevin
`
`19· ·Prussia.
`
`20· · · · · · ·THE COURT:· Okay.· And is there a court reporter?
`
`21· · · · I’ll take that as a no.
`
`22· · · · · · ·THE COURT REPORTER:· This is the court reporter.
`
`23· · · · · · ·THE COURT:· Okay.
`
`24· · · · · · ·THE COURT REPORTER:· And, I'm sorry, could the
`
`25· · · · parties please repeat their names or the -- I’m sorry
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
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`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`5
`
`·1· ·-- counsel for the parties.
`
`·2· · · · MR. FLORENCE:· Yeah.· I can go first.· This is
`
`·3· ·Robert Florence with the law firm of Parker, Poe,
`
`·4· ·Adams and Bernstein, present on behalf of the
`
`·5· ·petitioner.
`
`·6· · · · And with me is my colleague and attorney and
`
`·7· ·partner, Karen Carroll.
`
`·8· · · · THE COURT REPORTER:· Okay.
`
`·9· · · · MS. PETRUZZI:· And for patent owners, this is
`
`10· ·Heather Petruzzi with Wilmer Hale.
`
`11· · · · THE COURT REPORTER:· And, Heather, can you spell
`
`12· ·your last name for me, please?
`
`13· · · · MS. PETRUZZI:· Sure.· It’s P, as in Peter, E-T-R-
`
`14· ·U-Z-Z-I (spelling).
`
`15· · · · THE COURT REPORTER:· Okay.
`
`16· · · · MS. PETRUZZI:· And I’m -- and I’m joined by my
`
`17· ·colleagues, Tim Cook and Kevin Prussia, also from
`
`18· ·Wilmer Hale.
`
`19· · · · THE COURT:· And how -- how would I spell Kevin’s
`
`20· ·last name?
`
`21· · · · MS. PETRUZZI: Prussia.
`
`22· · · · THE COURT REPORTER:· Okay.
`
`23· · · · And I got Judge Yang and could I have the other
`
`24· ·Judge’s name, pleas?
`
`25· · · · THE COURT:· Judge Snedden, S-N-E-D-D-E-N
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`
`
`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`·1· ·(spelling).
`
`November 16, 2018
`November 16, 2018
`6
`
`·2· · · · THE COURT REPORTER:· Thank you.
`
`·3· · · · THE COURT:· And who requested the court reporter?
`
`·4· · · · MR. FLORENCE:· Petitioners did, Your Honor.
`
`·5· · · · THE COURT:· Okay.· Would you mind filing the
`
`·6· ·transcript after the call?
`
`·7· · · · MR. FLORENCE: Not at all.· Not at all.
`
`·8· ·Absolutely.
`
`·9· · · · THE COURT:· Okay.· One more question.· When do
`
`10· ·you think the -- the transcript would be ready for
`
`11· ·filing?
`
`12· · · · THE COURT REPORTER:· I believe I was told that
`
`13· ·you needed it in ten days.
`
`14· · · · THE COURT:· In ten days.· Okay.
`
`15· · · · THE COURT REPORTER:· The 26th.
`
`16· · · · THE COURT:· Great.
`
`17· · · · THE COURT REPORTER:· That's what they told me. I
`
`18· ·believe it was the 26th.· I apologize.· It's -- That's
`
`19· ·the date, I believe, they told me.
`
`20· · · · THE COURT:· All right.· That will be fine.
`
`21· · · · Okay.· Mr. Florence, you requested the
`
`22· ·teleconference.· I'll let you begin.
`
`23· · · · MR. FLORENCE:· I did, Your Honor.· Thank you very
`
`24· ·much.· Thank you for taking the time to do this call.
`
`25· · · · I requested the teleconference for -- Pursuant to
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`
`
`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`7
`
`·1· ·the Court scheduling order, the parties were required
`
`·2· ·to submit any lists of proposed motions that were not
`
`·3· ·otherwise provided for by the Court’s scheduling or
`
`·4· ·the rules.· And there are two motions that we are
`
`·5· ·requesting.· One we think that we probably need to
`
`·6· ·file for sure, but the other one, we would like the
`
`·7· ·Board's guidance on.
`
`·8· · · · But the first is a motion to correct a clerical
`
`·9· ·or typographical mistake pursuant to 37-CFR Section
`
`10· ·42-104(c).· And that would be to correct errors the
`
`11· ·petition and the declaration of Dr. Park that was
`
`12· ·filed in support of petition relating to the Rudnick
`
`13· ·reference, which is Exhibit 1010.
`
`14· · · · And I can elaborate on that and certainly can do
`
`15· ·so in any motion, but essentially, the mistake
`
`16· ·originated from the Rudnick reference itself, which as
`
`17· ·the Board knows and I'll remind the Board, is that
`
`18· ·Rudnick is -- is a chapter from a treatise or a
`
`19· ·textbook.· It's chapter ten from the textbook of
`
`20· ·Modern Pharmaceutics.· But there's more than one
`
`21· ·edition of Modern Pharmaceutics.
`
`22· · · · And essentially, the Exhibit itself, the 1010,
`
`23· ·petitioner's counsel received a copy of that reference
`
`24· ·that was only just a chapter, but the reference that
`
`25· ·we received was indicated with a citation and B, to
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
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`HEARING
`HEARING
`
`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`8
`
`·1· ·the fourth edition of Modern Pharmaceutics which was
`
`·2· ·published in 2002.
`
`·3· · · · When in fact, turns out that the reference
`
`·4· ·itself, at least to chapter 10 from the reference that
`
`·5· ·was provided in· the petition was actually from the
`
`·6· ·third edition, which was published in 1996.
`
`·7· · · · So, there is an error in the Exhibit 1010 itself
`
`·8· ·that was submitted and then there are errors in the
`
`·9· ·petition and the declaration.
`
`10· · · · And so, what we are asking is for permission from
`
`11· ·the Board to file a motion to correct those clerical
`
`12· ·and typographical errors so that we can fix it.
`
`13· · · · And we weren’t aware that what was provided to us
`
`14· ·was from the third edition because what was provided
`
`15· ·was just the chapter itself, without any cover page
`
`16· ·and without any publishing information.· But it was
`
`17· ·cited to us as being from the fourth edition and that
`
`18· ·has permeated through the preceding.· It's permeated
`
`19· ·through, essentially, everything we've done with it
`
`20· ·since we received it in -- in the outside case that's
`
`21· ·related to this proceeding as well, the underlying
`
`22· ·litigation.
`
`23· · · · But, we became aware of -- of this error with
`
`24· ·patent -- I think it’s one of the -- When patent
`
`25· ·owners provided the preliminary response, they -- they
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`9
`
`·1· ·provided a table of contents as an exhibit that
`
`·2· ·purported to be from the fourth edition.· And that
`
`·3· ·table of contents indicated that chapter 10 did not
`
`·4· ·quite match up to the page number that were on chapter
`
`·5· ·10 that was provided for Rudnick.
`
`·6· · · · And so, we started to investigate that and we
`
`·7· ·purchased copies of the whole textbook so that we
`
`·8· ·could compare the chapters.· And we also obtained an
`
`·9· ·outside expert librarian to obtain us a copy of the
`
`10· ·correct publication information and cover page and
`
`11· ·table of contents for the Rudnick exhibit after we
`
`12· ·discovered that indeed, there was an error that, you
`
`13· ·know, because we were provided with that wrong
`
`14· ·citation, but no cover page, you know, we asked our
`
`15· ·librarian to get us a cover page and we provided that
`
`16· ·put it together as Exhibit 1010 and submitted it
`
`17· ·incorrectly with the wrong cover page and with the
`
`18· ·wrong publication information.
`
`19· · · · So what would you propose to --
`
`20· · · · THE COURT:· I -- I --
`
`21· · · · MR. FLORENCE:· -- to correct those?
`
`22· · · · THE COURT:· Just one question.· And this -- So I
`
`23· ·can get a sense of how potentially serious this --
`
`24· ·this error might be.
`
`25· · · · I imagine since the edition provided, as the
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`10
`
`·1· ·exhibit, was the third edition and the citation was to
`
`·2· ·the fourth edition, that it -- that this error doesn’t
`
`·3· ·impact the prior art status of either edition, right
`
`·4· ·-- or, I mean, of the document you provided?
`
`·5· · · · MR. FLORENCE:· That -- That's correct.· That is
`
`·6· ·our position.· And nor does it impact the substance
`
`·7· ·that was provided to the Board and to patent owners in
`
`·8· ·our petition and the declaration of Dr. Park.· Because
`
`·9· ·what was actually provided as Exhibit 1010 marks
`
`10· ·chapter 3 -- I mean, chapter 10 -- from the third
`
`11· ·edition, although, we misidentified it as being from
`
`12· ·the fourth edition.
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`13· · · · And that reference -- Patent owners already
`
`14· ·acknowledge in their preliminary response and the
`
`15· ·Board acknowledged in the decision initiating that the
`
`16· ·preceding was -- that -- that the -- that the prior
`
`17· ·status of Rudnick in all the reference, in fact, would
`
`18· ·predate the earliest prior art reference for -- The
`
`19· ·earliest priority date for the 945 patent is the
`
`20· ·subject of the petition.
`
`21· · · · So, it wouldn't affect it as far as prior art
`
`22· ·status and it wouldn’t affect the substance because
`
`23· ·the pinpoint citations, the descriptions and the
`
`24· ·(inaudible) of all the -- involve the petition of Dr.
`
`25· ·Park’s declaration were all to the third edition.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`11
`
`·1· · · · So, the page numbers are correct, but the overall
`
`·2· ·citation to the fourth edition and the publication
`
`·3· ·date are incorrect.
`
`·4· · · · THE COURT:· Okay.· Understood.· Thank you.
`
`·5· · · · MR. FLORENCE:· And -- and so, essentially, what
`
`·6· ·we would like to do is we would like to file a motion
`
`·7· ·to correct and clear up the typographical errors,
`
`·8· ·explain how it happened, cite to authority for why we
`
`·9· ·are allowed to fix it and, in fact, fix it.
`
`10· · · · We would be -- There are only -- I think there
`
`11· ·are only two references -- two sentences -- that we
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`12· ·would be fixing in the petition and only, I think, one
`
`13· ·-- one heading of Dr. Park’s declaration and one
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`14· ·sentence that repeat correctly the -- refers to the
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`15· ·publication date in Dr. Park’s declaration, which is -
`
`16· ·- which is Exhibit 10002.
`
`17· · · · And we would also like to fix the reference
`
`18· ·itself, the exhibit, Rudnick 1010, by replacing it
`
`19· ·with the correct -- with a copy that has the correct
`
`20· ·title page, the correct publication information and
`
`21· ·table of contents and -- and the correct chapter.· But
`
`22· ·we wouldn't be addressing any new substance in any
`
`23· ·way.· We would just be replacing those portions that
`
`24· ·are -- are proposed here.
`
`25· · · · THE COURT:· So just so I understand, so you will
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`12
`
`·1· ·keep the third edition and just correct the cover
`
`·2· ·page, which was -- which would -- to -- to account for
`
`·3· ·the fact that -- to correct the citation, essentially?
`
`·4· ·Okay.
`
`·5· · · · MR. FLORENCE:· Yes.· Yeah.· That -- that is
`
`·6· ·correct.· However, one thing I would make clear, turns
`
`·7· ·out that the -- that the third edition, the chapter 10
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`·8· ·in the third edition that we were provided, it had
`
`·9· ·some -- some -- what would, I guess, best be
`
`10· ·characterized as Bates numbering on it on the top
`
`11· ·because apparently, the -- the person that provided it
`
`12· ·to us pulled it from, I believe, the European
`
`13· ·opposition of the counter -- counter foreign patent to
`
`14· ·the 945 patent and then they misidentified it as the
`
`15· ·wrong edition.
`
`16· · · · But the replacement version that we obtained
`
`17· ·through the librarian, does not have that on because
`
`18· ·what he did was he -- he obtained from a -- from a
`
`19· ·textbook copy of it itself.· So that's what we would
`
`20· ·be providing.· So that wouldn’t -- that indicia
`
`21· ·wouldn’t be on there anymore in chapter 10, but the
`
`22· ·chapter 10 would still be identical -- it's still from
`
`23· ·the same chapter 10 that we coincided to in the
`
`24· ·original version of Exhibit 1010, Rudnick, that we
`
`25· ·provided with the petition upon filing.
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`13
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`·1· · · · THE COURT:· Okay.· Understood.· Anything further?
`
`·2· · · · MR. FLORENCE:· Not -- not on that motion, Your
`
`·3· ·Honor.
`
`·4· · · · And I’m -- I’m happy to move on to the other
`
`·5· ·proposed motion or take any questions that you may
`
`·6· ·have.
`
`·7· · · · MS. PETRUZZI:· I would like to respond before
`
`·8· ·they move on to the next motion as well.
`
`·9· · · · THE COURT:· Okay.· And so, Ms. Petruzzi, I -- Are
`
`10· ·you going to oppose this request?
`
`11· · · · MS. PETRUZZI:· Well, I’m -- I’m -- I just want to
`
`12· ·understand the scope of the request a little bit
`
`13· ·better because I thought that it was just a
`
`14· ·typographical error.
`
`15· · · · We do want an opportunity to respond if there's a
`
`16· ·motion to file supplemental information because first,
`
`17· ·I just want to correct that we did not make any
`
`18· ·admissions that I'm aware of in our POPR that this was
`
`19· ·-- this was all prior art.· In fact, we were confused
`
`20· ·about what really was being cited because it said that
`
`21· ·the fourth edition was being cited, but we couldn’t
`
`22· ·match up the page numbers.
`
`23· · · · So we -- we raise that in our POPR, that we
`
`24· ·weren't sure what the reference was, but we didn't see
`
`25· ·how the fourth edition could be the proper reference.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`14
`
`·1· · · · And what we’re learning through conversations
`
`·2· ·with petitioner's counsel is that it really should
`
`·3· ·have been the third edition.· So all the citations are
`
`·4· ·wrong and all -- and the cover pages are wrong.· But,
`
`·5· ·you know, that could be considered pre-substantive
`
`·6· ·because it’s either that that was wrong or then the --
`
`·7· ·or the citations wrong and it should have been to the
`
`·8· ·fourth edition or something like that.
`
`·9· · · · So, I just want to understand, you know -- I
`
`10· ·don’t have a problem with them correcting
`
`11· ·typographical errors in their -- in their petition if
`
`12· ·it's just a citation issue.· But it seems a little bit
`
`13· ·more substantive to that.
`
`14· · · · So, you know, we do want some -- an opportunity
`
`15· ·to respond if they do file supplemental information to
`
`16· ·put in --
`
`17· · · · THE COURT:· How about on the motion to correct or
`
`18· ·the clerical or typographical mistake?
`
`19· · · · MS. PETRUZZI:· Yes.· If it’s just to correct the
`
`20· ·citation that is not to a pin site, but it’s just to
`
`21· ·the name of the reference, we don't oppose that.
`
`22· · · · THE COURT:· Okay.· So, they want to change the
`
`23· ·citation from the fourth addition to the third
`
`24· ·edition.· Do you oppose that?
`
`25· · · · MS. PETRUZZI:· No.· I don't oppose the citation
`
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`15
`
`·1· ·change.· It's just that it's not clear that the third
`
`·2· ·edition is in the record right now.
`
`·3· · · · THE COURT:· Okay.· Understood.
`
`·4· · · · Okay, anything further, Ms. Petruzzi?
`
`·5· · · · MS. PETRUZZI:· No, that's everything.· Thank you.
`
`·6· · · · THE COURT:· Okay.· Mr. Florence, you can discuss
`
`·7· ·your motion to file supplemental information.
`
`·8· · · · MR. FLORENCE:· Yes.· Thank you, Your Honor.
`
`·9· · · · Yes, so for the motion to file supplemental
`
`10· ·information, we made the request so that it would be
`
`11· ·timely as -- as required, but what -- what we’re -- We
`
`12· ·-- we provided supplemental evidence.· We timely
`
`13· ·served supplemental evidence in response to patent
`
`14· ·owner’s objections that they filed, but as of yet, of
`
`15· ·-- of course, we have not filed any of that
`
`16· ·supplemental evidence with the Board.
`
`17· · · · So, but -- but that supplemental evidence
`
`18· ·consisted of several things.· In addition to
`
`19· ·information relating to this typographical error from
`
`20· ·our experts and from the library expert providing a
`
`21· ·different copy in the third edition, that supplemental
`
`22· ·evidence also addressed other objections that had been
`
`23· ·raised by the patent owners relating to authenticity,
`
`24· ·availability of certain references as -- as of the
`
`25· ·publication dates that we have provided in our
`
`800.211.DEPO (3376)
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`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`·1· ·petition.
`
`November 16, 2018
`November 16, 2018
`16
`
`·2· · · · And it’s -- it’s my understanding that generally,
`
`·3· ·petitioners would be allowed to submit any -- serve
`
`·4· ·supplemental evidence in response to any motion to
`
`·5· ·exclude in the event that patent owners maintain their
`
`·6· ·objections to such evidence.· There are -- And there's
`
`·7· ·precedent for that and I can cite it if you want it,
`
`·8· ·but I can also put it in any motions.
`
`·9· · · · But, in particular to understanding that we would
`
`10· ·be able to provide -- you know, we would be able to
`
`11· ·file, in any opposition to a motion to exclude any
`
`12· ·(inaudible) evidence that's being served or to also
`
`13· ·file a reply to the patent owner’s response,
`
`14· ·indicating a reply declaration or other reply evidence
`
`15· ·that we had searched.
`
`16· · · · So there’s a -- It’s my understanding there's an
`
`17· ·opportunity to the -- to still do that but, where we
`
`18· ·have this issue with the Rudnick -- with the Rudnick
`
`19· ·reference, it -- it seems like it could be somewhat
`
`20· ·borderline.
`
`21· · · · No new substance is -- will be -- is being
`
`22· ·provided as it relates to this reference because the
`
`23· ·chapter 10 that we provided and the pinpoint sites in
`
`24· ·the announcement to it were -- was to the -- to the
`
`25· ·exact pages of that chapter that’s still being
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`17
`
`·1· ·provided with the replacement reference.
`
`·2· · · · However, because it is one of the references that
`
`·3· ·we’re relying on for our grounds, we’re -- you know,
`
`·4· ·if the -- if the Board would like us to, we can also
`
`·5· ·seek to have the new Rudnick reference entered as
`
`·6· ·supplemental information as well.
`
`·7· · · · I -- I don’t think it has to be.· I think there
`
`·8· ·is case law that we can substitute and fix clerical
`
`·9· ·errors in exhibits that have been submitted on behalf
`
`10· ·of the petition.· But as a precautionary measure,
`
`11· ·we’re -- we’re certainly willing to do that as well.
`
`12· · · · The -- the issue is, though, the supplemental
`
`13· ·evidence that we’ve provided to be served on patent
`
`14· ·owner, it -- it currently addresses the broader
`
`15· ·universal of all their objections.
`
`16· · · · So I guess what we’re -- what we’re asking here
`
`17· ·is, you know, whether or not if it -- One, does the
`
`18· ·Board want us to also seek to file the new Rudnick
`
`19· ·reference as supplemental information?· And we’re
`
`20· ·happy to do that if that's the case.
`
`21· · · · But -- And if so, I assume that the Board doesn’t
`
`22· ·want us to attach all of the supplemental evidence and
`
`23· ·the full breadth of the new declarations that are
`
`24· ·provided when we serve them on the patent lawyers.
`
`25· · · · THE COURT:· I think -- I think there -- there is
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`18
`
`·1· ·a difference between supplemental evidence and
`
`·2· ·supplemental information.· And I think you're correct
`
`·3· ·in that -- in that supplemental evidence is there to
`
`·4· ·address the evidentiary objections.
`
`·5· · · · But it's different.· That doesn't -- that doesn’t
`
`·6· ·necessarily mean that everything needs to come in
`
`·7· ·under the supplemental information under 123.· So,
`
`·8· ·rule -- Rule 123.
`
`·9· · · · So, there's -- I don't -- And so, in terms of
`
`10· ·trying to understand the nature of your request or
`
`11· ·your motion for supplemental information under 123,
`
`12· ·what -- what would you want to submit as supplemental
`
`13· ·information?
`
`14· · · · MR. FLORENCE:· Sure.· At -- at this time, we I --
`
`15· ·We would not be submitting all of the supplemental
`
`16· ·evidence that we’ve served on patent owners.· I think
`
`17· ·the only thing -- If -- if the Court thinks it's
`
`18· ·necessary that -- for us to seek to have entered as
`
`19· ·supplemental information would be the evidence and
`
`20· ·information -- and the -- to the new reference to the
`
`21· ·-- to the replacement Rudnick reference that would
`
`22· ·replace the cover pages with the correct cover pages,
`
`23· ·the correct publication information and table of
`
`24· ·contents.
`
`25· · · · As I said, we’re not changing the substance
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`19
`
`·1· ·because we would still be attaching the same chapter
`
`·2· ·10, which didn't become -- come from the third edition
`
`·3· ·of Modern Pharmaceutics and wouldn’t be doing any new
`
`·4· ·analysis related to that.· We would just be changing
`
`·5· ·the citations in the petition and Dr. Park's original
`
`·6· ·declaration.
`
`·7· · · · So, it -- It's a little unclear to me whether or
`
`·8· ·not we need to file a motion to have it also entered
`
`·9· ·as supplemental evidence, that the replacement exhibit
`
`10· ·for Exhibit 1010, but I’m happy to -- We’re happy to
`
`11· ·brief that if -- if the Board thinks it's necessary.
`
`12· · · · THE COURT:· Oh, okay.· Understood.· I think to
`
`13· ·the extent necessary, it depends on -- to the extent
`
`14· ·patent owner will oppose this request.
`
`15· · · · Ms. Petruzzi, would you -- Let me -- This phrase
`
`16· ·is -- Let me make sure I -- I have it -- I -- I
`
`17· ·understand myself.
`
`18· · · · Would you -- Or do you oppose a motion to file
`
`19· ·supplemental information under Rule 123 that's limited
`
`20· ·to supplying a copy of chapter 4 of the Rudnick
`
`21· ·reference?
`
`22· · · · MS. PETRUZZI:· Well, Your Honor, I think that
`
`23· ·they’re asking to -- I just want to make sure I
`
`24· ·understand as well.
`
`25· · · · I think they’re asking to file a -- the -- the
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`20
`
`·1· ·third edition of chapter 10 of the Rudnick reference.
`
`·2· ·That might --
`
`·3· · · · MR. FLORENCE:· That -- that -- That's absolutely
`
`·4· ·correct.
`
`·5· · · · MS. PETRUZZI:· Okay.· I’m just wanted --
`
`·6· · · · MR. FLORENCE:· The only difference would be that
`
`·7· ·the indicia on the front of the reference, that the
`
`·8· ·title page, the publication information, the table of
`
`·9· ·contents, would, this time, actually come from the
`
`10· ·third edition instead of from the fourth edition that
`
`11· ·was incorrectly applied to the reference that was
`
`12· ·submitted originally.
`
`13· · · · MS. PETRUZZI:· Okay.
`
`14· · · · THE COURT:· Okay.
`
`15· · · · MS. PETRUZZI:· So --
`
`16· · · · THE COURT:· Okay.· Well -- well, let me -- let me
`
`17· ·pause you there and make sure I understand because I'm
`
`18· ·getting a little confused here.
`
`19· · · · So, are we -- Mr. Florence, you have -- you’re
`
`20· ·suggesting two motions here.· Are these motions in the
`
`21· ·alternative?· Because the -- the way I am seeing it
`
`22· ·here is you have one motion to -- to make it correct -
`
`23· ·- to correct a clerical error.· That would be
`
`24· ·replacing the exhibit with -- with Exhibit 110 to
`
`25· ·basically fix the cover page to reflect that this
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`21
`
`·1· ·chapter 10 of the Rudnick reference is coming from the
`
`·2· ·third edition of the -- of the -- of the textbook.
`
`·3· · · · MR. FLORENCE:· That’s -- that's correct.· But --
`
`·4· · · · THE COURT:· If you -- If we do that, then why
`
`·5· ·would we also need to have supplemental information in
`
`·6· ·terms of another -- another chapter 10 from the third
`
`·7· ·edition?
`
`·8· · · · MR. FLORENCE:· I -- I don't --
`
`·9· · · · THE COURT:· Are these requested in the
`
`10· ·alternative or -- or --
`
`11· · · · MR. FLORENCE:· Well, I -- I guess what I'm
`
`12· ·requesting is the --in the alternative as it relates
`
`13· ·to fixing the exhibit itself to replacing the original
`
`14· ·Exhibit 110 with the corrected Exhibit 110.
`
`15· · · · I would -- I wouldn’t be moving -- We would not
`
`16· ·be moving in the alternative as it relates to
`
`17· ·correcting the typographical errors in the petition
`
`18· ·and the original Park declaration that resulted from
`
`19· ·that -- from that error because those absolutely, I
`
`20· ·think, can be fixed pursuant to the motion to correct
`
`21· ·typographical or clerical errors.
`
`22· · · · And -- and I think that we can also correct the
`
`23· ·reference itself by correcting the references as we
`
`24· ·propose.
`
`25· · · · So I guess as it relates to the reference -- to
`
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`22
`
`·1· ·replacing that reference, yes, we would be moving in
`
`·2· ·the alternative to just that portion.· But it really
`
`·3· ·depends in -- in our minds on whether or not patent
`
`·4· ·owners oppose that, us doing that.· If they oppose us
`
`·5· ·doing that a -- through motions to correct the
`
`·6· ·typographical error, I would want to move in the
`
`·7· ·alternative to have it replaced through the filing of
`
`·8· ·supplemental information, a motion were made to that.
`
`·9· ·But I don't know -- entirely sure -- what they oppose
`
`10· ·at this point.
`
`11· · · · THE COURT:· Okay.
`
`12· · · · Ms. Petruzzi, what do you think?
`
`13· · · · MS. PETRUZZI:· Sure.· So, this is a little bit
`
`14· ·new to us because it's a little bit different than
`
`15· ·what we discussed on our meet and confer.· We
`
`16· ·understood the request for a motion to correct to be
`
`17· ·limited to the Park declaration and the petition and
`
`18· ·just fixing the citation to read from the fourth
`
`19· ·edition to the third edition.
`
`20· · · · THE COURT:· Okay.
`
`21· · · · MR. PETRUZZI:· And -- and that they weren’t
`
`22· ·asking that they actually correct Exhibit 1010, which
`
`23· ·is the Rudnick reference as a clerical error.· We did
`
`24· ·not understand that from our correspondence and we
`
`25· ·would oppose that because we don't believe that
`
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`23
`
`·1· ·changing the exhibit in this nature is a clerical
`
`·2· ·error or a typographical error.· It's something that
`
`·3· ·substantive.· It goes your ability to understand what
`
`·4· ·the reference is, whether it’s prior art.
`
`·5· · · · You know, in Your Honor’s decision on
`
`·6· ·institution, it’s relying on Exhibit 1010, which is
`
`·7· ·the Rudnick reference of the fourth edition.· That we
`
`·8· ·also need to change because it’s not the fourth
`
`·9· ·edition, it’s the third edition we are now learning.
`
`10· · · · We had no ability to analyze that or understand
`
`11· ·that until we had our, you know, our supplemental
`
`12· ·information from petitioner that was served on us
`
`13· ·where they finally explained how we were supposed to
`
`14· ·understand this reference.· So, we do think that
`
`15· ·substantive.
`
`16· · · · So we would oppose -- If the question now is
`
`17· ·there’s a motion to correct and that includes
`
`18· ·correcting Exhibit 1010, we would oppose that.· And we
`
`19· ·don't think that this is a proper use of filing
`
`20· ·supplemental information because it's completely
`
`21· ·changing a reference.· And so, we would like -- You
`
`22· ·know, if the Board were to grant petitioner the
`
`23· ·opportunity to file a motion --
`
`24· · · · THE COURT:· It’s not really changing the
`
`25· ·reference, right?· It's just changing -- It’s still
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`HEARING
`HEARING
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`MYLAN V. BRISTOL-MYERSMYLAN V. BRISTOL-MYERS
`
`November 16, 2018
`November 16, 2018
`24
`
`·1· ·the same chapter 10, it’s just the -- the first two
`
`·2· ·pages identifying which text it comes from?
`
`·3· · · ·
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