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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` _____________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _____________
`
`MYLAN PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS
`
` USA, INC., and AKORN, INC.
`
` Petitioners,
`
` v.
`
` ALLERGAN, INC.
`
` Patent Owner.
`
` _____________
`
` Case No. IPR2016-01127
` Patent No. 8,685,930 B2
`
` Case No. IPR2016-01128
` Patent No. 8,629,111 B2
`
` Case No. IPR2016-01129
` Patent No. 8,642,556 B2
`
` Case No. IPR2016-01130
` Patent No. 8,648,048
`
` Case No. IPR2016-01132
` Patent No. 9,248,191
`
` _____________
`
` TELEPHONE CONFERENCE CALL
` September 26, 2017
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`
`PROTECTIVE ORDER MATERIAL
`
`MYLAN - EXHIBIT 1143
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`
`
`Conference Call - September 26, 2017
`
`Page 2
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` A P P E A R A N C E S
` (All appearances telephonically)
`
`PRESIDING:
` MR. SHERIDAN K. SNEDDEN
` Administrative Patent Judge
`
` MS. TINA E. HULSE
` Administrative Patent Judge
`
` MR. CHRISTOPHER G. PAULRAJ
` Administrative Patent Judge
`
`ON BEHALF OF PETITIONER MYLAN PHARMACEUTICALS, INC.:
`
` WILSON, SONSINI, GOODRICH & ROSATI
` BY: MR. STEVEN W. PARMELEE, ESQ.
` MR. JAD A. MILLS, ESQ.
` 701 Fifth Avenue, Suite 5100
` Seattle, WA 98104
` (206)883-2542
` e-mail: sparmelee@wsgr.com
` AND
` WILSON, SONSINI, GOODRICH & ROSATI
` MR. RICHARD TORCZON
` MS. TASHA THOMAS
` 1700 K Street, N.W., 5th Floor
` Washington, D.C. 20006
` (202) 973-8811
` e-mail: rtorczon@wsgr.com
`
`ON BEHALF OF PETITIONER TEVA PHARMACEUTICALS USA,
`INC.:
` CARLSON, CASPERS, VANDENBURGH, LINDQUIST &
` SCHUMAN, P.A.
` BY: MR. GARY SPEIER
` 225 South Sixth Street, Suite 4200
` Minneapolis, Minnesota 55402
` (612) 436-9600
` e-mail: gspeier@carlsoncaspers.com
`
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`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Conference Call - September 26, 2017
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`Page 3
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` APPEARANCES: (Continued)
`
`ON BEHALF OF PETITIONER AKORN, INC.:
`
` SUGHRUE MION, PLLC
` BY: MR. TRAVIS RIBAR
` 2100 Pennsylvania Avenue, N.W.
` Washington, D.C. 20037
` (202) 293-7060
` e-mail: tribar@sughrue.com
`
`ON BEHALF OF ALLERGAN, INC.:
`
` Fish & Richardson, P.C.
` BY: MS. DOROTHY P. WHELAN
` MR. MICHAEL KANE
` 3200 RBC Plaza
` 60 South Sixth Street
` Minneapolis, Minnesota 55402
` (612) 335-5070
` e-mail: PTABInbound@fr.com
`
`ON BEHALF OF THE ST. REGIS MOHAWK TRIBE:
`
` SHORE, CHAN, DePUMPO, LLP
` BY: MR. MICHAEL W. SHORE
` MR. CHRISTOPHER EVANS
` MS. MARSHA SCHMIDT (pro hac vice)
` 901 Main Street, Suite 3300
` Dallas, Texas 75202
` (214) 593-9110
` e-mail: mshore@shorechan.com
` cevans@shorechan.com
` marsha@mkschidtlaw.com
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`PROTECTIVE ORDER MATERIAL
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`Conference Call - September 26, 2017
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`Page 4
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` APPEARANCES: (Continued)
`
`ON BEHALF OF MYLAN PHARMACEUTICALS, INC.:
`
` PERKINS COIE, LLP
` BY: MR. BRANDON M. WHITE
` MS. SHANNON M. BLOODWORTH (pro hac vice pending)
` MR. CHARLES G. CURTIS, JR. (pro hac vice pending)
` 700 13th Street, N.W., Suite 600
` Washington, D.C. 20005-3960
` (202) 654-6200
` e-mail: BMWhite@perkinscoie.com
` SBloodworth@perkinscoie.com
` CCurtis@perkinscoie.com
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`PROTECTIVE ORDER MATERIAL
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`Conference Call - September 26, 2017
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` THE COURT: Good afternoon. This is
`
`Judge Snedden.
`
` I have on the line with me Judges Hulse
`
`and Paulraj.
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` Mr. Torczon, are you on the line?
`
` MR. TORCZON: I am, your Honor.
`
` THE COURT: All right.
`
` And do we have anyone from the Tribe
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`present?
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` MR. EVANS: Yes, your Honor, Christopher
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`Evans and Marcia Schmidt are here representing the
`
`Tribe.
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` THE COURT: Allergan?
`
` MS. WHALEN: Dorothy Whelan and Michael
`
`Kane representing Allergan.
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` THE COURT: And who else do we have on
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`the line?
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` MR. SHORE: Michael Shore is on the line
`
`as well.
`
` MR. RIBAR: Travis Ribar representing
`
`Akorn.
`
` MR. SPEIER: Gary Speier on behalf of
`
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`PROTECTIVE ORDER MATERIAL
`
`
`
`Conference Call - September 26, 2017
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`Page 6
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`Teva.
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` THE COURT: I understand we have a court
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`reporter.
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` MR. TORCZON: We do, your Honor.
`
` I also believe we have Brandon White,
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`Shannon Bloodworth, and Charles Curtis of Perkins Coie
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`for Mylan.
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` THE COURT: Mr. Torczon, you requested
`
`the call, I will let you begin.
`
` MR. TORCZON: Thank you very much, your
`
`Honor. Thank you for scheduling this call.
`
` Our request falls basically into two
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`parts. There was originally ordered production we
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`believe is incomplete, and there is also additional
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`discovery related to that that we believe we should be
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`entitled to. It will be limited to discovery
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`regarding the immunity claim.
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` On the first point the Tribe voluntarily
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`filed a short form agreement which referred to the
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`long form agreement. The board ordered the patent
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`owner and Tribe to produce the long form agreement.
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` The long form agreement itself
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`PROTECTIVE ORDER MATERIAL
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`
`Conference Call - September 26, 2017
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`incorporates additional agreements that are used to
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`define Allergan's powers and responsibilities.
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` We don't believe the agreement is fully
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`comprehensible without this. We believe that they are
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`within the scope of the originally ordered discovery
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`or production and Allergan should have all of it in
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`its possession.
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` Allergan disagrees with our position that
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`it is within the scope of the original discovery, and
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`the Tribe has indicated that it doesn't have to
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`produce anything.
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` We would like the board to consider the
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`issue and immediately order production of those
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`documents. Failing that we believe that it is
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`certainly within the scope of any additional
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`discovery.
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` Along the same lines, it is important to
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`note that Mylan disagrees that the Tribe has
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`established that it is the owner--it believes the
`
`assignment is a sham--and Mylan believes that Allergan
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`has retained all effective rights.
`
` The Tribe's residual interest is
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`PROTECTIVE ORDER MATERIAL
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`
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`Conference Call - September 26, 2017
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`insufficient for to be a necessary party. So we
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`believe in support of that we should be able to get
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`all agreements and understandings between Allergan and
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`the Tribe regarding patents so that we can determine
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`who actually owns the rights, holds the rights and
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`whether the agreements are valid.
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` We would note that any discovery against
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`nonparty participants does not implicate tribal
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`sovereign immunity. Even where tribal sovereign
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`immunity is implicated, the burden is on the Tribe to
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`establish it is entitled to it in these situations.
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` We note that the federal government,
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`which is a full-fledged sovereign, regularly has to
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`provide discovery. We are happy to cite cases on that
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`point.
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` We note that decision, Finn versus Great
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`Plains, which we already pointed out to the board,
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`showed the same concept applies to Tribe. They are
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`not a full-fledged sovereign, they are domestic
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`sovereign, and their rights are correspondingly less.
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` Similar concerns to the one the Tribe has
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`already raised and also has concerns similar to ours,
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`PROTECTIVE ORDER MATERIAL
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`Conference Call - September 26, 2017
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`such as control by non-tribal entity, benefits
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`allocated to a non-tribal entity, action to evade
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`regulatory review, prejudice no production to the
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`requester and defined set of fact issues that will
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`help target the discovery.
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` We note in the foreign sovereign immunity
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`context, again, full-fledged sovereign, Finn cites to
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`the Hansen case, which says that such -- that
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`requester should have ample opportunity to secure and
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`present evidence on this issue. We believe the Tribe
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`has expressly waived immunity for the purposes of
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`contesting immunity, and that would include --
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`necessarily include discovery on that assertion.
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` The Tribe has already voluntarily
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`produced one agreement and complied with an order to
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`produce another agreement.
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` The Tribe and Allergan control all of
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`material facts here: that has often been considered an
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`important factor in ordering such discovery. We are
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`really not asking for anything that is any broader
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`than what the board would require in the case of the
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`settlement, which is all agreements and understandings
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`PROTECTIVE ORDER MATERIAL
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`
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`Conference Call - September 26, 2017
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`underlying this transaction.
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` The Tribe has the burden of production in
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`fact. There is the California case Owen versus Miami
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`Nations. It says that in a context like this where
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`there is an assertion of immunity and the party -- the
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`Tribe controls fact or the party asserting immunity
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`controls the fact, the burden is on them to produce.
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` And, finally, along those lines we note
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`that there has actually been no representation to date
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`that all of the agreements between them regarding
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`these or any other patents, you know, like an umbrella
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`agreement that would cover any patent agreements
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`between them, have been produced. And even if we get
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`a representation to that effect today, it won't be
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`evidence, it would be a bare representation.
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` A lot of inconsistencies that justify
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`discovery and jurisdictional issues, the parties --
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`the Tribe and Allergan having engaged in actions that
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`are contrary to the agreements. Allergan is supposed
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`to be responsible for the litigation, yet we have
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`recently seen the Tribe telling Allergan what it can
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`and can't do. The license appears to require Allergan to
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`PROTECTIVE ORDER MATERIAL
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`
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`Conference Call - September 26, 2017
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`perform statutory functions that are reserved for the
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`owner.
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` Allergan and the Tribe each say the other
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`side initiated the agreements, which suggest that
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`there is some confusion about what actually happened
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`in what order. The order of the transaction could be
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`significant here.
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` One of the things is: it is facially
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`improbable that Allergan would surrender rights to such
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`valuable patents, patents that are bringing in
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`millions of dollars a day, without some blanket
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`understanding or agreement to agree or something like
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`that in place.
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` The Tribe's webpage when it explains
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`these agreements to its members has indicated that
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`additional agreements provide protection in the event
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`that they lose infringement suit, protections that
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`aren't readily apparent from the agreements that have
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`been produced so far.
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` So if we apply the factor here we see
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`that there is more than a possibility that there is
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`additional evidence. We see that there is not any
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`PROTECTIVE ORDER MATERIAL
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`Conference Call - September 26, 2017
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`possibility that we are seeking underlying litigation
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`bases, the trial is over. We don't have to worry
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`about -- I am sorry, there is no other way we can
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`generate relevant information because necessarily the
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`information is only in the hands of these parties.
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` As far as easily understandable
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`instructions, that is something we can commit to
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`providing.
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` As far as the request not being
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`burdensome, the Tribe has represented that all
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`activity in this case has occurred between August and
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`September. All of these documents should be readily
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`at hand.
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` Again, we are really not requesting
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`anything beyond what they would be expected to produce
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`for a settlement agreement, so it is -- it can't be an
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`unreasonable request.
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` Specifically what we would be looking for
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`is all agreements incorporating references to Allergan
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`license grants, any side agreements, supplemental
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`agreements, agreements to agree, term sheets,
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`documents sufficient to show all drafts of the
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`Conference Call - September 26, 2017
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`assignment, license agreement, documents sufficient to
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`show communications between Allergan and the Tribe or
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`the Tribe's attorneys regarding IPRs or patents
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`including any marketing material.
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` We also would like any documents showing
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`good and valuable consideration that the Tribe gave to
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`Allergan as part of this transaction.
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` We would also request that any --
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` THE COURT: It is your position that
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`there are agreements that are necessary for you to
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`establish that Allergan is a party with substantial
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`interests in these patents?
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` MR. TORCZON: Our position is that we
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`have received a couple documents that the Tribe and
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`Allergan have chosen to present here. We never
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`received any representation that that represents the
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`sum total of the documents. They're inconsistencies
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`in the behaviors of the parties and their public
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`statements compared to what is said in the documents.
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` And, as analysts and others have noted,
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`it seems very unlikely that Allergan would have given
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`up such significant rights without some overarching
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`agreement to ensure that it would get the license
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`back. So --
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` THE COURT: What is the legal position
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`that you are trying to support with this?
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` MR. TORCZON: I am sorry, yes, okay, so
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`there are at least a couple of lines that are involved
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`here.
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` One is the question of whether in fact
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`the Tribe is the owner.
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` And the other would be whether the --
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`whether Allergan has retained enough rights and
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`whether the Tribe has retained enough rights such that
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`either Allergan can proceed alone or the Tribe is not
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`a necessary party.
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` So all of these are factors that have
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`been considered as relevant to sovereign immunity,
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`several of them have come up indeed in past board
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`decisions regarding state sovereign immunity, so these
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`are squarely within the scope of what we would expect
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`to be able to discover.
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` THE COURT: And it is your position that
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`you can't make -- it is not possible to make the
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`determination or make the arguments to support that
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`allegation based on the license and the agreements
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`that are already of record?
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` MR. TORCZON: Precisely, because we've
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`only seen the parts of the agreement that the Tribe
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`and Allergan have chosen to let us see.
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` This comes up regularly in the case law.
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`For instance, in some of the federal sovereign
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`immunity cases the agencies have actually presented
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`documents, there was reason to believe that more was
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`going on or more should have been going on.
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` THE COURT: Can you walk me through the
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`license agreement and tell me why, tell me what
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`language it is and why you believe what is of record
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`is --
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` MR. TORCZON: So, for instance, I don't
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`have the agreement open in front of me, but an example
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`would be that patent term extensions, Allergan is --
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` THE COURT: Hold on a second, I just
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`noticed that these agreements are --
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` MR. TORCZON: You are right, your Honor,
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`I am sorry.
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` THE COURT: This is okay, we can submit
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`this transcript as parties and board only.
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` MR. TORCZON: I believe everybody on the
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`call is either already of record -- at least on our
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`side, on the Petitioner's side, I believe everybody is
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`either of record or has a pending pro hac vice motion,
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`and I believe everybody on the Petitioner's side has
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`filed or has signed a protective order.
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` THE COURT: I think it will be useful for
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`us to do that, if you can file the transcripts of the
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`parties on board, that will be helpful.
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` MR. TORCZON: And, also we can point out, if you
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`authorize the motion, we can do this in specific
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`detail.
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` But just a general example, who controls
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`the litigation, we are seeing behavior that is
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`inconsistent with that: patent term extension, the
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`patent owner's responsibility, we see Allergan doing that. So
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`it is things like that that suggest there is something
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`else going on.
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` As I said, the Tribe has indicated to its
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`constituents that there are agreements in place that
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`protect it in the case that it loses infringement
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`suit. We are not seeing a basis of that in the
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`agreement. So there are inconsistencies like that.
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` As I said, it also just logical
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`conclusion that there must have been a term sheet or
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`an agreement to agree or something that was in place
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`before Allergan would take the remarkable step of
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`signing over rights to the Tribe in the hope that
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`exclusive license would somehow come off and come back
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`to them.
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` So there are a lot of reasons to suspect
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`that there is additional agreements out there. To the
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`extent there aren't, it is no burden at all to the --
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` THE COURT: There might be other
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`agreements, we are trying to understand why they might
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`be useful to this case.
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` I mean, these agreements, I understand,
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`were entered into for before the Tribe came about, got
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`involved, so the answer is -- the question is why are
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`those -- why are those agreements useful for this
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`particular -- is it a mere allegation or --
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` MR. TORCZON: Those --
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` THE COURT: It sounds like a mere
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`allegation, more than a mere allegation.
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` MR. TORCZON: Your Honor, in terms of the
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`long -- in terms of the things that we believe are
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`already within the scope, in each of those cases those
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`agreements are used to define Allergan rights and
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`responsibilities, and so for us to know what it is
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`that Allergan -- what powers and responsibilities
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`Allergan has under the agreement and therefore
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`understand the scope of how much control they have
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`versus how much control the Tribe has, we need to see
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`what those agreements are. We are not the ones who
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`structured the agreement between the Tribe and
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`Allergan to include these other agreements, but they
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`are effectively incorporated by reference. And so we
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`should get those even without additional discovery.
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` THE COURT: Okay, let me ask one
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`question. I know you might not be -- who is speaking
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`for Allergan today?
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` MR. SHORE: This is Michael Shore, this
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`is Michael Shore, and I am only speaking for the
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`Tribe.
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` THE COURT: I need --
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` MS. WHELAN: Your Honor, this is Dorothy
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`Whelan, I am speaking for Allergan, and I am here for
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`the limited purpose of addressing the issue of whether
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`Allergan complied with the board's September 8th order
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`to produce the long form assignment.
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` THE COURT: Well, I think this question
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`is relevant anyway, I have not received your request
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`for Allergan's counsel to withdraw from this case, and
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`so the question I have is why do you remain a party to
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`this case and do you deny that you remain in this case
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`as a party that has substantial interest in these
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`patents?
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` MS. WHELAN: Your Honor, actually, we
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`will -- this is Dorothy Whelan on behalf of Allergan,
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`we would like to use this call as an opportunity to
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`seek leave to withdraw from the proceedings because
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`Allergan is not a patent owner. Allergan is only an
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`exclusive field of license holder. So we would like
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`leave to file a motion to withdraw from the
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`proceedings.
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` THE COURT: Let me just -- I will confirm
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`with my panel and get back to you on the answer for
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`that, yes, I understand your question.
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` Okay, and so, Mr. Shore --
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` MR. SHORE: Yes?
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` THE COURT: Do you deny that Allergan
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`remains a party with substantial rights in these
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`patents?
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` MR. SHORE: Under the statute there is
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`only two proper parties, the requester and the patent
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`owner. Allergan doesn't fit into either one of those
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`slots, so by statute they are not a proper party to
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`the case.
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` THE COURT: And are there any --
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`Mr. Shore, are there any agreements between Allergan
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`and the Tribe relating to -- any other agreements
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`relating to the challenged patents that are not
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`already of record?
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` MR. SHORE: No.
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` The only agreements that I am aware of,
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`the only agreements that I know that exist are the
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`agreements that are of record in the case.
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` THE COURT: And is Allergan -- under
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`mandatory notice you must identify any real parties of
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`interest. Is Allergan a real party of interest?
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` MR. SHORE: No, they are not a patent
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`owner and they are not a requester.
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` MS. WHELAN: We are a real party in
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`interest.
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` MR. SHORE: I am sorry, you mean someone
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`who has an interest in the outcome.
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` MS. WHELAN: Well, we are a real party in
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`interest under the statute, and that is why the
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`mandatory notices reflect Allergan as a real party in
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`interest, but we are not the patent owner.
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` THE COURT: Understood, all right.
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` And, Mr. Shore, what about term sheets,
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`are there any term sheets that have not been
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`submitted, term sheets that exist that have not been
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`made of record?
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` MR. SHORE: There is nothing -- there are
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`no term sheets, there never were any term sheets in
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`the case.
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` MR. TORCZON: Can I respond to some of the
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`things?
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` MR. SHORE: Michael Shore on behalf of
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`St. Regis Mohawk Tribe, simply requesting that before
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`the panel takes into account what they heard as being
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`in any way factual or truthfully, it is not.
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` THE COURT: I understand, Mr. Shore. You
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`get a chance to speak, I had questions. I am going to
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`let Mr. Torczon finish and then you can respond.
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` MR. SHORE: Okay.
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` THE COURT: Mr. Torczon, are you
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`finished?
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` MR. TORCZON: I just wanted to point out
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`that it varies from the proceeding, there has been
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`suggestion that delay would be appropriate either for
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`discovery or I believe now in the context of amicus
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`briefing.
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` I just would like to reiterate that the
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`petitioners believe that delay only helps Allergan, it
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`hurts everybody else. Specifically it undermines the
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`integrity of the system, the patent system.
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` There is uncertainty about whether the
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`board has power to act, this creates uncertainty for
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`petitioners. This creates uncertainty for patent
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`owners who are being approached daily by tribes to
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`know what to do. This actually hurts the board
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`itself. It has led -- this very proceeding has led to
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`regular attacks on the integrity of the board.
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` THE COURT: What we are trying to figure
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`out here is why -- what information, what useful
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`information do you expect to obtain from additional
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`discovery.
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` MR. TORCZON: Well --
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` THE COURT: What legal position are you
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`trying to establish and what evidence is missing.
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` MR. TORCZON: Your Honor, this is Richard
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`Torczon.
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` Again, if the agreements are shams, that
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`would go directly to the question of ownership
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`control, whether the tribes are even a necessary
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`party, whether they are even an appropriate party to
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`the proceeding.
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` I understand that your Honors have asked
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`Mr. Shore just now whether there are other agreements
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`and he carefully said to the best of his knowledge
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`there were not. I note that that is attorney
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`argument, not evidence. And, frankly, in a case that
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`has this much at stake, both in monetary terms and in
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`terms of the integrity of the system --
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` THE COURT: So you would want to
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`establish that this agreement is a sham. What do you
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`need to establish that it is a sham? What evidence do
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`you need?
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` MR. TORCZON: We believe that it is
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`almost unbelievable that there aren't additional side
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`agreements and that those side agreements would tend
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`to show things like additional license-back provisions
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`or things to that effect.
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` Until we have had a chance to see all
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`such agreements or at least establish as a matter of
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`evidence that no such agreements exist, we are
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`fighting blindfolded.
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` And the only people that have that
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`evidence is the Tribe and Allergan, and they have got
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`a legal obligation to produce it. They have only
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`produced what we have seen so far.
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` So we need to fully explore this
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`question, this ample case law for both federal,
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`foreign tribal sovereign immunity claims, that once
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`you have asserted a claim of sovereign immunity,
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`discovery to test that claim is perfectly appropriate.
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` MR. SHORE: Your Honor, may I respond?
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` THE COURT: One moment, please.
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` Mr. Shore, you may respond.
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` MR. SHORE: Your Honor, first, there are
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`no other agreements. Let me be unequivocal as I
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`possibly can, there are no side agreements, there are
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`no license-back agreements, there are no expansion of
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`license rights agreements. There are no give-back
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`agreements. There are no agreements at all in any
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`way, shape, form, or fashion that have not already
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`been produced in the case, none, zero, nada.
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` Number two, the Tribe status as a
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`sovereign is absolutely established as a matter of
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`law. The cases that get into such sovereignty,
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`whether sovereignty attaches, is where you have tribes
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`or foreign sovereigns or states that set up separate
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`corporations and give them limited powers to do
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`limited activity. And you can go in, there has been
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`discovery in cases where you go in and look at how
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`those corporations were set up, how those corporations
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`are managed, whether or not those corporations are
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`backed fully by the state if the judgment is against
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`them, et cetera.
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` That is not the case here. The Tribe
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`holds the patents directly. There is no intervening
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`tribal entity to which you might need to look and see
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`whether or not that tribal entity has been given the
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`full color of immunity.
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` All of those cases, including the cases
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`you cited in the e-mail, have nothing to do with the
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`situation where the Tribe, the sovereign, the
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`undisputable sovereign, 100% sovereign Tribe, holds
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`the asset, in this case the patents.
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` The only issues in this case are whether
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`or not the Tribe is sovereign, which is undisputed,
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`and whether or not sovereign immunity attaches to the
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`PTAB proceedings, which has already been adjudicated
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`four times in favor of the sovereigns.
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` Those are the only issues, those are the
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`only issues which the Tribe agreed to participate in
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`this case, have the case dismissed on sovereign
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