throbber
No. 18-
`
`
`
`IN THE
`Supreme Court of the United States
`
`
`
`
`SAINT REGIS MOHAWK TRIBE AND ALLERGAN, INC.,
`
`Petitioners,
`
`v.
`
`MYLAN PHARMACEUTICALS, INC.,
`TEVA PHARMACEUTICALS USA, INC., AND
`AKORN, INC.,
`
`
`
`ON PETITION FOR WRIT OF CERTIORARI TO
`THE U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`Respondents.
`
`
`
`
`
`
`PETITION FOR WRIT OF CERTIORARI
`
`
`MARSHA KOSTURA SCHMIDT
`ATTORNEY AT LAW
`14928 Perrywood Drive
`Burtonsville, MD 20866
`Tel: (301) 949-5176
`
`
`
`
`
`
`JONATHAN S. MASSEY
` Counsel of Record
`MASSEY & GAIL LLP
`1325 G St., N.W., Suite 500
`Washington, DC 20005
`Tel: (202) 652-4511
`
`ROBERT A. LONG, JR.
`MICHAEL W. SHORE
`JEFFREY B. ELIKAN
`ALFONSO GARCIA CHAN
`THOMAS R. BRUGATO
`CHRISTOPHER L. EVANS
`ALAINA M. WHITT
`JOSEPH F. DEPUMPO
`SHORE CHAN DEPUMPO LLP COVINGTON & BURLING LLP
`901 Main St., Suite 3300
`850 Tenth Street, N.W.
`Dallas, TX 75202
`Washington, DC 20001-4956
`Tel: (214) 593-9110
`Tel: (202) 662-5612
`
`Counsel for Saint Regis
`Mohawk Tribe
`
`Counsel for Allergan, Inc.
`
`Dated: December 20, 2018
`
`BATEMAN & SLADE, INC.
`
`BOSTON, MASSACHUSETTS
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 1
`
`

`

`QUESTION PRESENTED
`
`This case involves the legal characterization of
`the inter partes review procedure for patents,
`created by the Leahy–Smith America Invents Act,
`Pub. L. No. 112-29, 125 Stat. 284 (2011). This Court
`has described inter partes review as a “procedure
`allow[ing] private parties to challenge previously
`issued patent claims in an adversarial process
`before the Patent Office that mimics civil litigation.”
`SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1352 (2018).
`
`In this case, the Federal Circuit held that a
`federally recognized Indian tribe owning a patent
`could not assert tribal sovereign immunity in an
`inter partes
`review proceeding because
`the
`proceeding is “more like an agency enforcement
`action than a civil suit brought by a private party.”
`Pet. App. 9a.
`
`The Question Presented is:
`
`Whether inter partes review before the Patent
`Trial and Appeal Board is the type of proceeding in
`which tribal sovereign immunity may be asserted.
`
`
`
`
`
`i
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 2
`
`

`

`PARTIES TO THE PROCEEDING
`
`The caption to the case contains the names of all
`parties.
`
`RULE 29.6 STATEMENT
`
`The Saint Regis Mohawk Tribe is a federally
`recognized Indian tribe.
`
`Allergan plc is the parent company of Allergan,
`Inc. and owns more than 10% of its stock.
`
`
`
`
`
`
`
`
`
`
`
`ii
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 3
`
`

`

`TABLE OF CONTENTS
`
`QUESTIONS PRESENTED ....................................... i
`
`PARTIES TO THE PROCEEDING ........................... ii
`
`RULE 29.6 STATEMENT .......................................... ii
`
`TABLE OF CONTENTS ........................................... iii
`
`TABLE OF AUTHORITIES .................................... vii
`
`PETITION FOR A WRIT OF CERTIORARI ............ 1
`
`OPINIONS BELOW ................................................... 1
`
`JURISDICTION ......................................................... 1
`
`STATUTORY PROVISIONS INVOLVED ................ 1
`
`STATEMENT ............................................................. 2
`
`A. Statutory Background. .................................. 4
`
`B. Procedural History Of This Case. ................. 7
`
`1.
` Factual And Procedural Background. .... 7
`
`
` The Board’s Decision Rejecting 2.
`Tribal Immunity In IPRs. ..................... 10
`
`C. The Decision Under Review. ....................... 11
`
`REASONS FOR GRANTING THE WRIT............... 13
`
`A. The Federal Circuit’s Judgment Is
`Inconsistent With This Court’s Decision
`In SAS. ......................................................... 15
`
`B. The Federal Circuit’s Judgment Is
`Inconsistent With This Court’s Decision
`In Alden. ...................................................... 18
`
`iii
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 4
`
`

`

`
` The Federal Circuit’s Decision 1.
`Conflicts With The Decisions Of
`Other Circuits That Have Followed
`Alden v. Maine. ..................................... 22
`
`C. The Federal Circuit’s Decision Is
`Inconsistent With FMC. .............................. 26
`
`1.
` The Federal Circuit Misconstrued
`FMC. ...................................................... 26
`
`
` The Court Of Appeals Created A 2.
`Conflict With Other Circuits That
`Have Followed FMC. ............................ 29
`
`D. This Court’s Decisions In Oil States And
`Cuozzo Do Not Support The Federal
`Circuit’s Judgment. ..................................... 31
`
`E. This Case Presents An Important
`Question Of Federal Law That Should Be
`Resolved By This Court............................... 32
`
`F. This Case Is A Suitable Vehicle To
`Review The Question Presented. ................ 35
`
`CONCLUSION ......................................................... 36
`
`APPENDIX
`
`Appendix A
`
`Opinion of United States Court of Appeals
`for the Federal Circuit in Saint Regis
`Mohawk Tribe, Allergan, Inc. v. Mylan
`Pharmaceuticals Inc., Teva
`Pharmaceuticals USA, Inc., Akorn, Inc.
`dated July 20, 2018 .................................... 1a-28a
`
`iv
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 5
`
`

`

`Appendix B
`
`Decision of the Patent Trial and Appeal
`Board in Mylan Pharmaceuticals Inc.,
`Teva Pharmaceuticals USA, Inc. and
`Akorn Inc. v. Saint Regis Mohawk Tribe
`entered February 23, 2018 ...................... 29a-73a
`
`Appendix C
`
`Order of The Patent Trial and Appeal
`Board in Mylan Pharmaceuticals Inc.,
`Teva Pharmaceuticals USA, Inc. and
`Akorn Inc. v. Saint Regis Mohawk Tribe
`entered February 23, 2018 ...................... 74a-80a
`
`Appendix D
`
`Order of the United States Court of
`Appeals for the Federal Circuit in Saint
`Regis Mohawk Tribe, Allergan, Inc. v.
`Mylan Pharmaceuticals Inc., Teva
`Pharmaceuticals USA, Inc., Akorn, Inc.
`entered March 28, 2018 ............................ 81a-83a
`
`Appendix E
`
`Order of the United States Court of
`Appeals for the Federal Circuit in Saint
`Regis Mohawk Tribe, Allergan, Inc. v.
`Mylan Pharmaceuticals Inc., Teva
`Pharmaceuticals USA, Inc., Akorn, Inc.
`entered October 22, 2018 ......................... 84a-86a
`
`v
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 6
`
`

`

`Appendix F
`
`Order of the United States Court of
`Appeals for the Federal Circuit in Saint
`Regis Mohawk Tribe, Allergan, Inc. v.
`Mylan Pharmaceuticals Inc., Teva
`Pharmaceuticals USA, Inc., Akorn, Inc.
`entered November 13, 2018 ..................... 87a-88a
`
`Appendix G
`
`Judgment of the United States Court of
`Appeals for the Federal Circuit in
`Allergan, Inc., Saint Regis Mohawk Tribe
`v. Teva Pharmaceuticals USA, Inc.,
`Akorn, Inc., Mylan Pharmaceuticals Inc.,
`Mylan, Inc. ordered on November 13, 2018
` ................................................................... 89a-91a
`
`Appendix H
`
`Relevant Statutory Provisions ............... 92a-104a
`
`vi
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 7
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`
`Alden v. Maine,
`527 U.S. 706 (1999) ..................................... passim
`
`Allergan, Inc. v. Teva Pharm. USA, Inc.,
`No. 2:15-cv-1455-WCB, 2017 WL 4619790 (E.D.
`Tex. Oct. 16, 2017) ............................................... 9
`
`Allergan, Inc. v. Teva Pharm. USA, Inc.,
`No. 2:15-cv-1455-WCB, 2017 WL 4803941 (E.D.
`Tex. Oct. 16, 2017) ........................................... 7, 9
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................ 5
`
`Blatchford v. Native Village of Noatak,
`501 U.S. 775 (1991) ............................................ 21
`
`Chao v. Virginia Dept. of Transportation,
`291 F.3d 276 (4th Cir. 2002) ....................... 23, 24
`
`Conn. Dep’t of Envtl. Prot. v. OSHA,
`356 F.3d 226 (2d Cir. 2004) ............................... 30
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................12, 21, 31, 32
`
`EEOC v. Karuk Tribe Housing Authority,
`260 F.3d 1071 (9th Cir. 2001) ........................... 25
`
`Federal Maritime Comm’n v. S.C. State Ports Auth.,
`535 U.S. 743 (2002) ..................................... passim
`
`Goldstein v. Moatz,
`364 F.3d 205 (4th Cir. 2004) ............................. 23
`
`vii
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 8
`
`

`

`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ........................ 6, 7
`
`Michigan v. Bay Mills Indian Community,
`134 S. Ct. 2024 (2014) ........................................ 33
`
`NLRB v. Little River Band of Ottawa
` Indians Tribal Gov’t,
`
`788 F.3d 537 (6th Cir. 2015) ............................. 25
`
`Oil States Energy Services, LLC v.
` Greene’s Energy Group, LLC,
`138 S. Ct. 1365 (2018) ................................. passim
`
`Okla. Tax Comm’n v. Citizen Band Potawatomi
`Indian Tribe of Okla.,
`498 U.S. 505 (1991) ............................................ 11
`
`Pauma v. NLRB,
`888 F.3d 1066 (9th Cir. 2018) ........................... 25
`
`Progressive Consumers Fed. Credit Union v.
` United States,
`79 F.3d 1228 (1st Cir. 1996) .............................. 23
`
`R.I. Dep’t of Envtl. Mgmt. v. United States,
`304 F.3d 31 (1st Cir. 2002) ........................... 29-30
`
`S.C. Ports Auth. v. Fed. Mar. Comm’n,
`243 F.3d 165 (4th Cir. 2001),
`aff’d, 535 U.S. 743 (2002) .................................. 32
`
`San Manuel Indian Bingo & Casino v. NLRB,
`475 F.3d 1306 (D.C. Cir. 2007) .......................... 25
`
`SAS Inst. Inc. v. Iancu,
`138 S. Ct. 1348 (2018) ................................. passim
`
`viii
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 9
`
`

`

`Seminole Tribe of Florida v.
` Florida Dept. of Revenue,
`750 F.3d 1238 (11th Cir. 2014).......................... 23
`
`U.S. ex rel. Foulds v. Tex. Tech Univ.,
`171 F.3d 279 (5th Cir. 1999) ....................... 22, 23
`
`U.S. v. Alabama Dept. of Mental Health and
` Mental Retardation,
`673 F.3d 1320 (11th Cir. 2012).......................... 24
`
`Upper Skagit Indian Tribe v. Lundgren,
`138 S. Ct. 1649 (2018) ................................... 32-33
`
`Vermont Agency of Nat. Res. v. U.S. ex rel. Stevens,
`529 U.S. 765 (2000) ............................................ 19
`
`Wilton v. Seven Falls Co.,
`515 U.S. 277 (1995) ............................................ 23
`
`Constitutional Provisions and Statutes
`
`28 U.S.C. § 1254 ......................................................... 1
`
`28 U.S.C. § 1295 ......................................................... 1
`
`28 U.S.C. § 2348 ....................................................... 28
`
`31 U.S.C. § 3730 ....................................................... 19
`
`35 U.S.C. § 141 ........................................................... 1
`
`35 U.S.C. § 311 ........................................................... 4
`
`35 U.S.C. § 312 ....................................................... 4, 5
`
`35 U.S.C. § 313 ..................................................... 5, 22
`
`ix
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 10
`
`

`

`35 U.S.C. § 314 ..................................................... 5, 21
`
`35 U.S.C. § 316 ........................................................... 5
`
`35 U.S.C. § 317 ......................................................... 28
`
`46 U.S.C. App. § 1710 .............................................. 29
`
`Leahy–Smith America Invents Act, Pub. L. No. 112-
`29, 125 Stat. 284 (2011) ....................................... 1
`
`Regulations
`
`37 C.F.R. § 42.2 .................................................... 4, 20
`
`37 C.F.R. § 42.4 .......................................................... 5
`
`37 C.F.R. § 42.12 ...................................................... 22
`
`37 C.F.R. § 42.51 ............................................. 5, 21-22
`
`37 C.F.R. § 42.52 ........................................................ 5
`
`37 C.F.R. § 42.53 ........................................................ 5
`
`37 C.F.R. § 42.54 .................................................. 5, 22
`
`37 C.F.R. § 42.55 ........................................................ 5
`
`37 C.F.R. § 42.56 ........................................................ 5
`
`37 C.F.R. § 42.57 ........................................................ 5
`
`37 C.F.R. § 42.58 ........................................................ 5
`
`37 C.F.R. § 42.59 ........................................................ 5
`
`37 C.F.R. § 42.60 ........................................................ 5
`
`x
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 11
`
`

`

`37 C.F.R. § 42.61 ........................................................ 5
`
`37 C.F.R. § 42.62 ........................................................ 5
`
`37 C.F.R. § 42.63 ........................................................ 5
`
`37 C.F.R. § 42.64 ........................................................ 5
`
`37 C.F.R. § 42.65 ........................................................ 5
`
`37 C.F.R. § 42.73 ........................................................ 6
`
`37 C.F.R. § 42.74 ........................................................ 6
`
`37 C.F.R. § 42.100 ...................................................... 4
`
`Other Authorities
`
`77 Fed. Reg. 48,766 .................................................... 6
`
`77 Fed. Reg. 48,767 .................................................... 6
`
`77 Fed. Reg. 48,768 .................................................... 7
`
`Apple, Inc. v. OpenTV, Inc.,
`Nos. IPR2015-00969, IPR2015-00980, IPR2015-
`01031, Paper 29 (PTAB Sept. 10, 2016) ............ 28
`
`Pam Baker, The Positive Impact of Academic
`Innovations on Quality of Life, THE BETTER
`WORLD REPORT (2010) ....................................... 34
`
`Clio USA, Inc. v. The Proctor and Gamble Co.,
`No. IPR2013-00438, Paper No. 57 (PTAB
`October 31, 2014) ............................................... 28
`
`xi
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 12
`
`

`

`Covidien LP v. Univ. of Fla. Research Found. Inc.,
`No. IPR2016-01274, Paper 21 (PTAB Jan. 25,
`2017) ................................................................... 10
`
`
`Rubén Muñoz et al., How New Testimonial Evidence
`Affects IPR Institution, Law360
`(Jun. 5, 2018) ..................................................... 22
`
`Mylan Pharmaceuticals Inc. v. Saint Regis
` Mohawk Tribe,
`No. IPR2016-01128 (PTAB Nov. 30, 2018) ....... 35
`
`NeoChord, Inc. v. Univ. of Md., Balt.,
`No. IPR2016-00208, Paper 28 (PTAB May 23,
`2017) ................................................................... 10
`
`Reactive Surfaces, Ltd. v. Toyota Motor Corp.,
`No. IPR2017-00572, 2017 WL 2992435 (PTAB
`July 13, 2017) ..................................................... 10
`
`RPX Corp. v. Applications in Internet Time, LLC,
`No. IPR2015-01750, 2015 WL 6157114 (PTAB
`Oct. 20, 2015) ..................................................... 21
`
`RPX Corp. v. Applications in Internet Time, LLC,
`No. IPR2015-01750, 2015 WL 7889318 (PTAB
`December 4, 2015) ............................................. 22
`
`
`
`RPX Corp. v. Applications in Internet Time, LLC,
`No. IPR2015-01750, 2016 WL 3577873 (PTAB
`July 21, 2016) ..................................................... 22
`
`
`USPTO, Trial Practice Guide Update (Aug. 2018) ... 6
`
`xii
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 13
`
`

`

`PETITION FOR A WRIT OF CERTIORARI
`
`Petitioners the Saint Regis Mohawk Tribe (the
`“Tribe”) and Allergan, Inc. (“Allergan”) respectfully
`petition for a writ of certiorari to review the
`judgment of the United States Court of Appeals for
`the Federal Circuit in this case.
`
`OPINIONS BELOW
`
`The opinion of the Federal Circuit (Pet. App. 1a-
`28a) is published at 896 F.3d 1322 (2018). The
`decisions of the Patent Trial and Appeal Board (Pet.
`App. 29a-73a, 74a-80a) are published at 2018 WL
`1100950 and 2018 WL 1055669.
`
`JURISDICTION
`
`Petitioners’ position is that the Patent Trial and
`Appeal Board
`(“PTAB”
`or
`“Board”)
`lacked
`jurisdiction below, due to the doctrine of tribal
`sovereign immunity, but the PTAB rejected that
`objection. Pet. App. 39a-47a. The Court of Appeals
`had jurisdiction to review the PTAB’s decision
`pursuant to 35 U.S.C. § 141(c) and 28 U.S.C. § 1295
`(a)(4)(A). The Court of Appeals issued its decision on
`July 20, 2018 (Pet. App. 1a) and denied Petitioners’
`timely petition for rehearing en banc on October 22,
`2018. Pet. App. 84a-86a. This Court has jurisdiction
`under 28 U.S.C. § 1254 (1).
`
`STATUTORY PROVISIONS INVOLVED
`
`Relevant statutory provisions, including portions
`of the Leahy–Smith America Invents Act, Pub. L.
`No. 112-29, 125 Stat. 284 (2011) (“AIA”) are
`reproduced in the Appendix. Pet. App. 92a-104a.
`
`1
`
`
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 14
`
`

`

`STATEMENT
`
`This case presents the question whether inter
`partes review (“IPR”) before the PTAB is the type of
`proceeding in which a federally recognized Indian
`tribe – or indeed any sovereign – may assert
`sovereign immunity. In Federal Maritime Comm’n
`v. S.C. State Ports Auth., 535 U.S. 743 (2002)
`(“FMC”), this Court held that sovereign immunity
`applies in administrative adjudications between
`private parties, even when the proceedings concern
`“public rights.”
`
`In SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018),
`this Court unequivocally concluded that an IPR is a
`“procedure allow[ing] private parties to challenge
`previously issued patent claims in an adversarial
`process before the Patent Office that mimics civil
`litigation.” Id. at 1352. In Oil States Energy
`Services, LLC v. Greene’s Energy Group, LLC, 138
`S. Ct. 1365 (2018), this Court confirmed that IPRs
`use “court-like procedures” before “an adjudicatory
`body” composed of “judges” and include “some of the
`features of adversarial litigation.” Id. at 1371, 1378.
`
`A straightforward application of the legal rule
`established by FMC to the nature of IPR proceedings
`as described in SAS leads to the conclusion that
`sovereign immunity applies in IPRs.
`
`In this case, however, the Federal Circuit held
`that sovereign immunity does not apply in IPRs
`because they are “more like an agency enforcement
`action than a civil suit brought by a private party,”
`Pet. App. 9a, despite
`this Court’s contrary
`understanding of IPRs in SAS. The Court of Appeals
`described the Director of the U.S. Patent &
`
`2
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 15
`
`

`

`(“Director”) – who has the
`Trademark Office
`authority under the statute to decide whether to
`institute a privately-filed petition for IPR – as a
`“politically accountable,
`federal
`official” who
`exercises “political responsibility
`for each suit
`prosecuted.” Id. at 9a-10a (citation and internal
`quotation marks omitted).
`
`In so holding, the Federal Circuit wrongly
`decided an important question of federal law in a
`manner inconsistent with this Court’s precedent,
`and in doing so created conflicts with decisions of
`other circuits.
`
`Moreover, the Federal Circuit’s rationale applies
`equally to state sovereign immunity and other kinds
`of sovereign immunity in IPR proceedings. In its
`amicus brief below, the United States described the
`sovereign immunity issue in this case as one of
`“cross-cutting significance.” U.S. Brief Amicus
`Curiae, at 1 (May 11, 2018). The broad implications
`of the Federal Circuit’s decision stem from the fact
`that it turns on the nature of IPRs, rather than the
`identity of the patent owner. Under the Federal
`Circuit’s decision, IPRs filed by private parties
`regarding patents owned by state universities and
`other sovereigns (including the United States) will
`evade any defense of sovereign immunity, putting at
`risk the sovereign’s dignity and treasury. No fewer
`than nine States or state entities filed amici briefs in
`support of rehearing en banc, reflecting the
`importance of this case for principles of state
`sovereign immunity. This Court should grant review
`to decide whether IPRs are the type of proceeding in
`which Indian tribes, state universities, or indeed any
`sovereign entity may assert sovereign immunity.
`
`3
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 16
`
`

`

`A. Statutory Background.
`
`Last Term, this Court twice addressed the nature
`of IPRs (created as part of the 2011 AIA), in SAS and
`Oil States. This Court observed that “[t]he new inter
`partes review regime looks a good deal more like
`civil
`litigation”
`than previous
`systems
`for
`administrative review of patents. SAS, 138 S. Ct. at
`1353.
`It described
`IPRs as
`“party-directed,
`adversarial” proceedings before neutral PTAB judges
`with “many of the usual trappings of litigation” such
`as discovery, briefing, and oral hearing. Id. at 1354-
`55. The Board’s own rules define IPRs as “trials.”
`37 C.F.R. § 42.100(a).
`
`Private parties, not the Director or PTAB, file the
`petition, determine the issues adjudicated (or not
`adjudicated), and prosecute the case. As this Court
`explained, a private party “must file ‘a petition to
`institute an inter partes review of [a] patent.’” 138 S.
`Ct. at 1353 (quoting 35 U.S.C. § 311 (a)). The PTAB
`and Director are not parties to the proceeding, 37
`C.F.R. § 42.2, and lack authority to initiate an IPR
`without a private party’s petition. Indeed, “inter
`partes” means “between parties.”
`
`The private-party petitioner has complete and
`exclusive control over the claims challenged and the
`grounds of the attacks. “The petition ‘may request to
`cancel as unpatentable 1 or more claims of [the]
`patent’ on the ground that the claims are obvious or
`not novel.” 138 S. Ct. at 1353 (quoting 35 U.S.C.
`§ 311 (b)). “In doing so, the petition must identify
`‘each claim challenged,’ the grounds
`for the
`challenge, and
`the evidence
`supporting
`the
`challenge.” Id. (quoting 35 U.S.C. § 312 (a)(3)). “The
`patent owner,
`in turn, may respond with
`‘a
`
`4
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 17
`
`

`

`preliminary response to the petition’ explaining ‘why
`no inter partes review should be instituted.’” Id.
`(quoting 35 U.S.C. § 313).
`
`As this Court explained, “[w]ith the parties’
`submissions before him, the Director then decides
`‘whether
`to
`institute
`an
`inter partes
`review . . . pursuant to [the] petition.’” 138 S. Ct. at
`1353 (quoting 35 U.S.C. § 314 (b)). In practice, the
`PTAB exercises this authority on behalf of the
`Director, because he has delegated his power in this
`respect to the Board. Id. (citing 37 C.F.R. § 42.4(a)).
`
`Once an IPR is initiated, neither the statute nor
`regulations provide any role for the PTAB or any
`federal officer to act as advocates in the proceedings,
`to add (or remove) patent claims to an existing IPR,
`or to add prior art to that cited by the petition. The
`private-party petitioner provides the evidence, 35
`U.S.C. § 312 (a)(3)(B), and shoulders the burden of
`proof. Id. at § 316 (e).
`
`This Court explained that, once instituted, an IPR
`“proceeds before the Board with many of the usual
`trappings of
`litigation.
` The parties conduct
`discovery and join issue in briefing and at an oral
`hearing.” SAS, 138 S. Ct. at 1353-54 (citing 35
`U.S.C. §§ 316 (a)(5), (6), (8), (10), (13)). The parties
`(i.e., the petitioner and patent owner) can seek
`discovery, which the PTAB can enforce through
`sanctions. 37 C.F.R. §§ 42.51-42.65. The PTAB and
`Director have no power to initiate discovery.
`
`The Federal Rules of Evidence generally apply to
`IPRs. Id. at § 42.62. The parties (but not the Board)
`may offer rebuttal evidence “which is responsive to
`the adversary’s evidence.” Belden Inc. v. Berk-Tek
`LLC, 805 F.3d 1064, 1082 (Fed. Cir. 2015) (emphasis
`
`5
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 18
`
`

`

`added). The Board must decide the case based on
`the “arguments that were advanced by a party.” In
`re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364,
`1380-81 (Fed. Cir. 2016). The PTAB has continued
`to borrow judicial practices for IPR trials, including
`recently revised procedures for expert testimony,
`word counts, motion practice, and other matters.1
`
`At the conclusion of an IPR, the three PTAB
`“judges” issue a final written decision known as a
`“judgment.” 77 Fed. Reg. at 48,766-67. As this
`Court held in SAS, the PTAB must resolve all the
`claims presented by the private-party petitioner; it
`may not choose to limit its review to only some of
`them. 138 S. Ct. at 1353. The loser of the IPR may
`be subject to estoppel. 37 C.F.R. § 42.73(d)(3). The
`Board, which is not a party, is not estopped.
`
`If a patent owner withdraws from an IPR, the
`Board may issue an “adverse judgment” cancelling
`the patent owner’s claims. 37 C.F.R. § 42.73(b)(4).
`The judgment is strictly limited to the grounds
`raised by petitioner. The parties may settle the IPR,
`but “the Board is not a party to the settlement,” id.
`at § 42.74(a), and the Board lacks authority to settle
`an IPR if the petitioner wishes to proceed. The
`Board’s authority
`to
`either
`“terminate
`the
`proceeding or issue a final written decision” upon
`settlement does not empower the Board to take over
`“prosecution” of the IPR. Oil States, 138 S. Ct. at
`1371.
` Even in written decisions issued after
`settlements, the Board may adjudicate only the
`
`
`1 USPTO, Trial Practice Guide Update, at 4, 6, 16 (Aug.
`2018), available at https://www.uspto.gov/patents-application-
`process/patent-trial-and-appeal-board/ptab-trial-practice-guide-
`august-2018.
`
`6
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 19
`
`

`

`arguments made by the parties. See Magnum Oil,
`829 F.3d at 1380-81. Typically, settlement ends the
`proceeding “unless the Board has already decided
`the merits.” 77 Fed. Reg. at 48,768.
`
`B. Procedural History Of This Case.
`
`1.
` Factual And Procedural Background.
`
`This case involves patents related to Restasis®,
`an FDA-approved cyclosporin product for treating a
`condition known as “dry eye,” by increasing a
`patient’s natural tear production. Pet. App. 4a, 51a.
`In 2015, Allergan
`sued Respondents Mylan
`Pharmaceuticals,
`Inc.
`(“Mylan”),
`Teva
`Pharmaceuticals USA, Inc. (“Teva”), Akorn, Inc.
`(“Akorn”), and other parties in the Eastern District
`of Texas, alleging infringement of Restasis® patents.
`Id. at 4a-5a. On June 3, 2016, Mylan petitioned for
`IPR of six Restasis® patents, and subsequently Teva
`and Akorn filed similar petitions. Id. at 5a. The
`Board instituted IPRs.
`
`Meanwhile, the Eastern District of Texas held a
`week-long bench trial beginning August 28, 2017 on
`the infringement action. The trial involved thirteen
`claims in four of the six Restasis® patents. Allergan,
`Inc. v. Teva Pharm. USA, Inc., No. 2:15-cv-1455-
`WCB, 2017 WL 4803941, at *15 (E.D. Tex. Oct. 16,
`2017).2
`
`
`2 Allergan agreed that the thirteen litigated claims would
`be representative of any other originally asserted claims in the
`four patents and that “any remedy that [the Court] might enter
`as to the representative claims would apply equally to the
`unasserted claims.” Allergan, 2017 WL 4803941, at *15.
`
`7
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 20
`
`

`

`In September 2017, during the pendency of the
`IPRs and the infringement action in the Eastern
`District of Texas, Allergan and the Tribe entered
`into an assignment transferring the Restasis®
`patents from Allergan to the Tribe and granting
`Allergan an exclusive field-of-use license. Pet. App.
`5a. The assignment was recorded with the USPTO
`on September 8, 2017. Id.
`
`The Tribe granted Allergan an exclusive license
`“for all FDA-approved uses in the United States.”
`Appx2578-2579.3 The Tribe retained all rights
`under the patents “not expressly granted” to
`Allergan. Appx2579. These retained rights include
`the right to practice the patents (subject to certain
`limitations)4 in all other fields of use outside the
`Allergan license.
`
`For example, if the Tribe were to conduct clinical
`trials for a cyclosporin product and obtain FDA
`approval for it without reference to or reliance on the
`Restasis® New Drug Applications (“NDAs”) and with
`a different indication, the Tribe would be able to
`practice the patents and retain all rights in that
`product. The Tribe also retains the right to use and
`practice the patents for “research, scholarly use,
`teaching, education, patient care incidental to the
`foregoing [and] sponsored research” in connection
`with the FDA-approved use of Restasis®, as well as
`off-label uses. Appx2579.
`
`
`3 Citatio ns to “Appx__” are references to the Appendix in
`the Federal Circuit.
`
`4 The Tribe may not develop a product relying on the
`Restasis® NDAs or qualifying as or competing with a “Licensed
`Product.” Appx2575, Appx2579.
`
`8
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 21
`
`

`

`In addition, the Tribe retained the first right to
`enforce the patents against third parties with
`respect to any infringement outside of Allergan’s
`field-of-use. Appx2582-2583. Although the license
`grants Allergan the right to enforce the patents
`against generic equivalents of Restasis®, the Tribe
`has the right to sue third parties in this field-of-use
`if Allergan declines to do so. Appx2582. Moreover,
`the Tribe must approve any settlements relating to
`the patents, even
`in Allergan’s
`field-of-use.
`Appx2583. In the license, Allergan agreed to pay the
`Tribe a lump sum of $13,750,000 and quarterly
`royalties of $3,750,000. Appx2580, Appx2593.
`
`On October 13, 2017, the Eastern District of
`Texas issued findings of fact and conclusions of law
`holding thirteen representative claims for four of the
`Restasis® patents invalid for obviousness. See
`Allergan, 2017 WL 4803941, at *51. The court found
`that Mylan, Teva, and Akorn infringed all the
`asserted claims, that the Restasis® patents were not
`invalid for anticipation, and that the patents were
`not invalid for lack of enablement or improper
`inventorship. Id. at *52-*63. Indeed, the district
`court acknowledged that “[t]here is no doubt that
`Allergan has invented a useful and successful
`pharmaceutical product.” Id. at *63. The court
`indicated it was “not required to decide whether the
`assignment . . . was valid,” but in dicta it criticized
`the business arrangement between the Tribe and
`Allergan. Allergan, Inc. v. Teva Pharm. USA, Inc.,
`No. 2:15-cv-1455-WCB, 2017 WL 4619790, at *4
`(E.D. Tex. Oct. 16, 2017).
`
`The judgment of the Eastern District of Texas
`was appealed separately to the Federal Circuit and
`is not part of the instant petition for certiorari. On
`
`9
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 22
`
`

`

`November 13, 2018, the Federal Circuit affirmed the
`district court’s judgment. Pet. App. 89a-91a. A
`petition for rehearing is due December 21, 2018.
`
`
` The Board’s Decision Rejecting Tribal 2.
`Immunity In IPRs.
`
`Before the PTAB, the Tribe made a special
`appearance and moved to terminate the IPRs on the
`ground that the Board had no jurisdiction over the
`Tribe because of tribal sovereign immunity. Pet.
`App. 5a. Allergan moved to withdraw from the IPRs
`on the ground that it was no longer the patent
`owner. Id. The Board invited amici curiae briefs on
`the issues raised by the Tribe. Id. at 31a. A PTAB
`Judge noted it was the “very first time that the
`board has authorized the filing of amicus briefs in
`any of [its] cases.” Appx2617.
`
`On February 23, 2018, the Board denied the
`Tribe’s motion to terminate and Allergan’s motion to
`withdraw. Pet. App. 29a-73a, 74a-80a. Even though
`the PTAB had repeatedly recognized IPR sovereign
`immunity defenses by state universities that own
`and license patents,5 in this case the Board held that
`
`
`5 In proceedings involving state universities, the PTAB
`concluded that “the analysis in FMC applies to” IPRs, Covidien
`LP v. Univ. of Fla. Research Found. Inc., 2017 WL 4015009, at
`*8 (PTAB Jan. 25, 2017); that sovereign immunity applies even
`in IPRs involving licensing arrangements, NeoChord, Inc. v.
`Univ. of Md., Balt., No. IPR2016-00208, Paper 28, at 7 (PTAB
`May 23, 2017); and, that “under FMC . . . inter partes reviews
`are similar to lawsuits” and therefore trigger sovereign
`immunity. Reactive Surfaces, Ltd. v. Toyota Motor Corp., No.
`IPR2017-00572, 2017 WL 2992435, at *2 (PTAB July 13, 2017).
`
`
`
`10
`
`Patent Owner Saint Regis Mohawk Tribe
`Ex. 2009, p. 23
`
`

`

`an IPR “is not the type of ‘suit’” to

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