Paper _____
`
` Date filed: June 16, 2017
`
`
`
`Filed on behalf of: Acrux DDS Pty Ltd. and Acrux Limited
`
`
`By: E. Anthony Figg, Lead Counsel
` Aydin H. Harston, Backup Counsel
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` 607 14th St., N.W., Suite 800
`
` Washington, DC 20005
` Phone: 202-783-6040
` Fax: 202-783-6031
` Emails: efigg@rfem.com
`
`
` aharston@rfem.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD. AND ACRUX LIMITED,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONER’S SUBMISSION OF TRANSCRIPT OF
`JUNE 13, 2017 CONFERENCE CALL
`
`
`
`
`
`
`
`
`
`

`

`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
`Submitted Electronically via the PTAB E2E System
`
`Your Honors:
`
`As discussed during Tuesday’s telephone conference, Petitioners Acrux
`
`DDS Pty LTD. & Acrux Limited hereby submit the attached transcript of the June
`
`13, 2017 telephone conference.
`
`
`
`
`
`
`
`Date: June 16, 2017
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By:
`
`
`/ Aydin H. Harston /
`
`E. Anthony Figg, Reg. No. 27,195
`Aydin H. Harston, Reg. No. 65,249
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040; Fax: 202-783-6031
`
`Counsel for Petitioners
`
`
`
`
`
`
`
`
`
`2
`
`

`

`CERTIFICATE OF SERVICE
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`I, hereby certify that a true copy of the foregoing PETITIONER’S
`
`SUBMISSION OF TRANSCRIPT OF JUNE 13, 2017 CONFERENCE
`
`CALL, was served via electronic mail this 16th day of June, 2017, on the following
`
`counsel of record for Patent Owners Kaken Pharmaceutical Co., Ltd. and Valeant
`
`Pharmaceuticals International, Inc.:
`
`John D. Livingstone, Esq.
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`271 17th Street, NW, Suite 1400
`Atlanta, GA 30363-6209
`Emails: john.livingstone@finnegan.com
`KakenIPR@finnegan.com
`
`Naoki Yoshida
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., NW
`Washington, DC 20001-4413
`Email: naoki.yoshida@finnegan.com
`
`Toan P. Vo
`Valeant Pharmaceuticals North America LLC
`1400 N. Goodman Street
`Rochester, New York 14609
`Email: toan.vo@bausch.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`By:
`
`
`
`
`
`
`/ Erik van Leeuwen /
`Erik van Leeuwen
`Litigation Operations Coordinator
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`
`
`
`
`
`3
`
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`Page 1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE PATENT TRIAL AND APPEAL BOARD
`
` ACRUX DDS PTY LTD. & ACRUX LIMITED,
` Petitioners,
` v.
` KAKEN PHARMACEUTICAL CO., LTD., and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
` Patent Owner and Licensee.
`
` Case IPR2017-00190
` U.S. Patent 7,214,506
`__________________________________________
`
` Teleconference
` New York, New York
` June 13, 2017
` 2:30 p.m.
`
` Transcript of Proceedings
` * * *
`
`212-267-6868
`
`Veritext Legal Solutions
`www.veritext.com
`
`516-608-2400
`
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`Page 2
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`A P P E A R A N C E S:
`Presiding:
` The Honorable SUSAN MITCHELL,
` Administrative Patent Judge
`
`Attorneys for Petitioner:
` E. ANTHONY FIGG, ESQ.
` AYDIN H. HARSTON, ESQ.
` Rothwell, Figg, Ernst & Manbeck, P.C.
` 607 14th Street, N.W., Suite 800
` Washington, DC 20005
`
`Attorneys for Patent Owner:
` JOHN D. LIVINGSTONE, ESQ.
` Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
` 271 17th Street, NW, Suite 1400
` Atlanta, Georgia 30363-6209
`
`ALSO PRESENT:
` JUDGE SCOTT BOALICK
` JUDGE BEVERLY FRANKLIN
` * * *
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` HON. MITCHELL: Good afternoon,
` everyone. My name is Judge Mitchell
` and on the phone with me is Judges
` Franklin and Boalick. We are here
` today for a conference call in
` IPR2017-00190. Before we get started
` if I could get a roll call beginning
` with Petitioner. Who is on the line
` for the Petitioner?
` MR. FIGG: Good afternoon, Your
` Honor. This is Tony Figg from
` Rothwell Figg and with me is Aydin
` Harston for the Petitioner.
` HON. MITCHELL: Great. Thank
` you.
` MR. FIGG: By the way, there's a
` court reporter on the line as well.
` HON. MITCHELL: Great. Thank
` you so much. Can I trust, Mr. Figg,
` that you will get the transcript filed
` in the IPR when it's available?
` MR. FIGG: We certainly will.
` Thank you.
` HON. MITCHELL: Thank you. And
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` let me see who is on the line for the
` Patent Owner?
` MR. LIVINGSTONE: Good
` afternoon, Your Honor. My name is
` John Livingston from Finnegan and
` joining me today is my partner from
` our Tokyo office Naoki Yoshida from
` very early in the morning on the other
` side of the world.
` HON. MITCHELL: Great. And
` welcome to both of you. This is a
` conference call that was sought by the
` Petitioners regarding a possible
` motion to stay prosecution of a
` reissue application pending resolution
` of this IPR. And that application is
` No. 16-405171 filed on January 12,
` 2017. So with that in mind because
` the Petitioner has asked for the call,
` I will start with Petitioner.
` MR. FIGG: Thank you, Your
` Honor. This is Tony Figg. As you may
` recall in the telephone conference
` that we had on February 21st which was
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` pre-institution we had raised this
` issue. The Patent Owner had filed a
` reissue application after our IPR
` petition was filed. And so we raised
` this issue during our initial phone
` conference and the Board -- and if you
` want to refer to the transcript, it's
` around page 32 and 33 -- said that the
` request was premature because the IPR
` had not yet been instituted and that
` the Petitioner could raise this issue
` again when and if institution
` occurred. And Patent Owner also made
` that argument that our Petition was
` premature.
` So the IPR has now been
` instituted, so we are raising this
` point again. The reissue application
` that has been filed contains two
` claims that are identical or virtually
` identical to claims that are subject
` to review in the IPR and it contains
` other claims that are dependant on
` them and may very well suffer whatever
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` fate the claims that are being
` reviewed suffer. And so it's our view
` that this reissue proceeding should be
` stayed to avoid duplication of efforts
` in the patent office to avoid
` potentially inconsistent results and
` to avoid, you know, unnecessary
` activities by the parties as well.
` We have looked, you know, at the
` Board's prior decisions on this issue.
` We have been unable to find any case
` in which a request to stay proceedings
` on a reissue application that was
` filed after the IPR petition was filed
` has been denied. There are a number
` of cases in which the Board has
` granted that request, and I can just
` quickly name a few for the record.
` Demurrer versus Pure Form which
` is IPR2015-01593, Legend 3D versus
` Prime Focus which is IPR 2016-00806,
` GEOSYS International versus Farmer's
` Edge Precision Consulting which is IPR
` 2015-00709, Unified Patents Inc.
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`Page 7
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` Versus IMTX Strategic which is
` IPR2015-01061.
` So we think what we are asking
` the Board to do here is very
` conventional, and we think it will
` make life easier for the Board as well
` as the parties.
` HON. MITCHELL: Great. Let me
` ask you one question, are there any
` claims involved in the issue that are
` not similar to the claims that are in
` the IPR, the instituted IPR?
` MR. FIGG: We think that all of
` the claims are similar. Certainly
` they have introduced claims that have
` additional limitations or are
` different, but I think it begs the
` question of what would be the fate of
` those claims. For example, if the
` Board were to determine that the basic
` claims covering the invention were
` held to be unpatentable, that the
` cover -- the method were held to be
` unpatentable, is there anything in
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`Page 8
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` these dependant claims that would not
` also fall as a result of the estoppel
` provisions. And, you know, that is
` exactly the kind of issue I think that
` should be addressed after the IPR has
` been decided.
` HON. MITCHELL: Okay. Let me
` hear from the Patent Owner.
` MR. LIVINGSTONE: Thank you,
` Your Honor. This is John Livingstone.
` We oppose Petitioner's request to
` brief this issue frankly because we
` believe it's the resources of the
` parties and the Board for some of the
` reasons that you just questioned and
` mentioned.
` First, the Board has stated a
` number of times that it will not
` ordinarily stay an reissue application
` in the absence of good cause because
` reissues are given special status.
` And as Mr. Figg just pointed out, in
` determining whether good cause exists
` the Board typically looks to whether
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` the proceedings will render
` inconsistent decisions will result in
` a duplication of efforts. Those
` concerns we believe do not exist here
` because the claims in the IPR and the
` claims in the reissue are not
` identical.
` And while Mr. Figg says there
` are others claims in the reissue
` application, there are 31 additional
` dependant claims in the reissue
` application that introduce patently
` distinct elements that are not
` addressed by Petitioner and are very
` different from the elements in the
` institution decision.
` And so quite frankly, just
` because there's no chance of
` inconsistent judgements or of a
` duplication of efforts, we believe
` this distinction alone should
` foreclose a motion to stay counsel
` against briefing the issue.
` HON. MITCHELL: Okay. Thank
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`Page 10
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` -Proceedings-
` you.
` Petitioner, would you like to
` have the last word in response?
` MR. FIGG: Well, I would. And,
` you know, we acknowledge that they
` have added a lot of new claims and Mr.
` Livingstone is making the argument now
` that they are patently distinct, but
` that is an issue that is going to
` require him considerable effort to
` decide, and there will be an
` opportunity of deciding that with
` clarity after the fate of the
` claims of the issued patent has been
` decided by the Board.
` For example, as the Board is
` aware that the broad claims here cover
` a method of treating onychomycosis, a
` nail infection by topically applying
` this antifungal compound to the nail.
` They have added claims where they say
` this treatment is a model therapy.
` They have added claims where they
` identify specific organisms which are
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` also identified in the basic patent.
` They added claims that say where in
` the nail is a toenail. They add
` claims wherein the method allegedly
` results in a complete cure.
` These are all things that just
` saying that they are patentably
` distinct doesn't make it so. And I
` think that will be something that will
` be much easier to determine once the
` Board has decided on patentability and
` has explained the bases for its
` decision.
` HON. MITCHELL: Let me ask you
` this, are there claims that are very
` similar between the IPR and the
` reissue proceeding? I mean both of
` you talked about the dates and the
` claims where additional limitations
` are added, but are there really
` overlapping claims between, you know,
` one proceeding and the other where the
` independent claims are very similar?
` MR. FIGG: Yes, Claims 1 and 2
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` are essentially identical. There was
` a change in the chemical nomenclature
` in Claim 2, but there's no indication,
` and I think the Patent Owner would
` agree, they are not trying to claim a
` different compound, it's just
` different chemical nomenclature used
` to describe exactly the same compound.
` So Claims 1 and 2 of the reissue
` application are identical to Claims 1
` and 2 of the issue patent that is
` being reviewed.
` MR. LIVINGSTONE: If I may, Your
` Honor?
` HON. MITCHELL: Sure.
` MR. LIVINGSTONE: I would agree
` with Mr. Figg that Claims 1 and 2 are
` at least in substance identical. Any
` change to the language has been in
` form. The additional 31 claims are
` all dependant claims from Claim 2 that
` add additional limitations to the
` claims.
` HON. MITCHELL: Let me ask you
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`Page 13
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` this, Mr. Livingston, how is the
` Patent Owner prejudiced if you did
` have to wait until resolution of the
` IPR to pursue the reissue application?
` MR. LIVINGSTONE: Well, I think
` there's a very serious prejudice to us
` because we expect ANDA litigation on
` these patents next summer, and we
` won't get the decision here until May
` and should the patent claims survive
` or if they go down, either way we can
` move forward with the reissue
` application. But those claims will
` not be in effect at the time of ANDA
` litigation which is a severe prejudice
` to the Patent Owner.
` Also, one of the potential
` things that I have seen in some of the
` cases is that you can consolidate the
` proceedings. Here I don't know that
` that works because adding an
` additional 31 claims to the IPR to
` further burden the parties can present
` time issues. And I know in other IPR
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`Page 14
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` decisions that has been a factor that
` the Board has taken into account. And
` one that I wouldn't mind putting in
` the record is IPR2014-00041 in which
` there was a reissue application
` pending when the IPR was instituted
` and there wasn't a first office action
` in it just like the one we have before
` us. There is an additional 19 claims
` and that have passed because they
` believe the newly presented claims
` were not before them and it would
` prejudice the Patent Owner.
` MR. FIGG: Your Honor, this is
` Tony Figg. I think that case if it's
` the same one I am thinking of is very
` distinguishable. The reissue was
` filed before the IPR petition there.
` I believe there was a re-examination
` pending, and there was actually a stay
` that was ordered as a result of the
` re-examine. Mr. Livingstone and I may
` possibly be thinking of different
` cases, but if it's the one, we only
`
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`Page 15
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` found one case in which the reissue
` was not stayed and that was very
` distinguishable and it was a
` prepetition reissue application.
` Every single case where the Board has
` considered this after the petition was
` filed, a reissue application filed
` after the petition was filed has been
` stayed.
` And with respect to the ANDA
` litigation, I mean we are involved in
` ANDA litigation all the time where
` there is a pending reissue
` application. I mean this is not an
` unusual situation for Patent Owners to
` find themselves in if they have claims
` that have some vulnerabilities that
` are going to be exploited by
` Defendants in ANDA litigation.
` MR. LIVINGSTONE: I too have
` been involved in cases where there's a
` pending of reissue and it's a burden
` on the Patent Owner. And we try to
` get all of our patents before we get
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`Page 16
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` into the ANDA litigation for just that
` reason.
` MR. FIGG: Well, your Honor, the
` Patent Owner knew that ANDA litigation
` was on the horizon a long time before
` now, and they chose to file their
` reissue application after we filed our
` IPR petition and presumably in
` response to it.
` HON. MITCHELL: Well, thank you
` both. I think we understand the
` issue. Give me one moment, I'm going
` to put you guys on hold and confer
` with the panel, and I will be right
` back.
` (There was a pause in the
` proceeding.)
` HON. MITCHELL: This is Judge
` Mitchell back. I think that the
` issues it sounds like appear close
` enough in the IPR in the reissue that
` we would like to see formal briefing
` on it. So we would, the Panel would
` authorize the motion for stay and
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` limit it to five pages for the opening
` brief, five pages for the responsive
` brief and then three pages for the
` reply brief and hopefully that should
` be sufficient to explain why or
` concretely why that they should or
` shouldn't happen. Any questions from
` the Petitioner?
` MR. FIGG: Just on the timing of
` the briefing, Your Honor.
` HON. MITCHELL: Let me ask what
` the parties would propose.
` MR. FIGG: Well, I guess maybe I
` can ask the Patent Owner for
` clarification. I don't think there's
` been any action on the reissue
` application at all yet, has there?
` MR. LIVINGSTONE: Not that we
` know of.
` MR. FIGG: I think if we could
` have ten days to get our opening brief
` in and have a few days for a reply
` brief, that would be okay for the
` Petitioner.
`
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`Page 18
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` -Proceedings-
` HON. MITCHELL: Okay, 15
` calendar days.
` MR. FIGG: Yes.
` THE HEARING OFFICER: Okay. And
` then Patent Owner would you like ten
` calendar days to respond?
` MR. LIVINGSTONE: Yes, Your
` Honor, we would.
` HON. MITCHELL: Okay. And then
` I would go five calendar days for the
` reply. And I will certainly put this
` in an order so you will know exactly
` when which is always helpful.
` MR. FIGG: Yes, Your Honor.
` HON. MITCHELL: So I think that
` resolves the issues. So, Petitioner,
` do you have anything further?
` MR. FIGG: No, Your Honor.
` Thank you.
` HON. MITCHELL: And Patent
` Owner?
` MR. LIVINGSTONE: No, Your
` Honor. Just thanks everybody for
` their time today.
`
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`Page 19
`
` -Proceedings-
` HON. MITCHELL: All right.
` Thank you and we are adjourned.
` MR. FIGG: Thank you.
` MR. LIVINGSTONE: Thank you.
` (Time noted: 2:50 p.m.)
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`Page 20
`
` CERTIFICATION
`
` I, Lisa Sansone, a Notary Public for
`and within the State of New York, do
`hereby certify:
` That the within transcript of the
`foregoing proceedings is a true and
`accurate transcription of my stenographic
`notes.
` I further certify that I am not
`related to any of the parties to this
`action by blood or marriage, and that I am
`in no way interested in the outcome of
`this matter.
` IN WITNESS WHEREOF, I have hereunto
`set my hand this 16th day of June, 2017.
`
` <%Signature%>
` _____________________
` LISA SANSONE
` * * *
`
`212-267-6868
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`[& - counsel]
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`15 18:2
`16-405171 4:18
`16th 20:17
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`19 14:10
`2
`2 11:25 12:4,10,12
`12:18,22
`20005 2:9
`2015-00709 6:25
`2016-00806 6:22
`2017 1:17 4:19
`20:17
`21st 4:25
`271 2:13
`2:30 1:17
`2:50 19:6
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`32 5:9
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`acknowledge 10:6
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`action 14:8 17:17
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`add 11:4 12:23
`added 10:7,22,24
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`adding 13:22
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`addressed 8:6
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`adjourned 19:3
`administrative 2:4
`afternoon 3:2,11
`4:5
`agree 12:6,17
`allegedly 11:5
`anda 13:8,15
`15:11,13,20 16:2,5
`anthony 2:7
`antifungal 10:21
`appeal 1:4
`appear 16:21
`application 4:16
`4:17 5:4,19 6:14
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`applying 10:20
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`argument 5:15
`10:8
`asked 4:20
`asking 7:4
`atlanta 2:14
`attorneys 2:6,11
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`available 3:22
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`aware 10:18
`aydin 2:7 3:13
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`back 16:16,20
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`basic 7:21 11:2
`beginning 3:8
`begs 7:18
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`beverly 2:19
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`boalick 2:18 3:5
`board 1:4 5:7 6:17
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`board's 6:11
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`case 1:13 6:12
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`cause 8:21,24
`certainly 3:23
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`certification 20:2
`certify 20:6,11
`chance 9:19
`change 12:3,20
`chemical 12:3,8
`chose 16:7
`claim 12:4,6,22
`claims 5:21,22,24
`6:2 7:11,12,15,16
`7:20,22 8:2 9:6,7
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`clarification 17:16
`clarity 10:14
`close 16:21
`complete 11:6
`compound 10:21
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`concerns 9:5
`concretely 17:7
`confer 16:14
`conference 3:6
`4:13,24 5:7
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`10:11
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`consolidate 13:20
`consulting 6:24
`contains 5:20,23
`conventional 7:6
`counsel 9:23
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`

`[court - international]
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`14:2
`defendants 15:20
`demurrer 6:20
`denied 6:16
`dependant 5:24
`8:2 9:12 12:22
`describe 12:9
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`determining 8:24
`different 7:18 9:16
`12:7,8 14:24
`distinct 9:14 10:9
`11:9
`distinction 9:22
`distinguishable
`14:18 15:4
`dunner 2:13
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`9:4,21
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`e
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`easier 7:7 11:11
`edge 6:24
`effect 13:15
`effort 10:11
`efforts 6:5 9:4,21
`either 13:12
`elements 9:14,16
`ernst 2:8
`esq 2:7,7,12
`essentially 12:2
`estoppel 8:3
`everybody 18:24
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`10:17
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`[introduce - petition]
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`[petitioner - think]
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