Filed: December 1, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC., TEVA
`PHARMACEUTICALS USA, INC., and AKORN INC.,
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`v.
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`SAINT REGIS MOHAWK TRIBE,
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`Petitioners,
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`Patent Owner.
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`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132(US 9,248,191 B2)
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`BRIEF OF AMICUS CURIAE U.S. INVENTOR, LLC
`IN SUPPORT OF PATENT OWNER, THE SAINT REGIS
`MOHAWK TRIBE
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`1
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`ISSUE OF FIRST IMPRESSION PRESENTED
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`Whether the Patent Trial and Appeals Board (the “Board”) has the authority to
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`decide whether the Saint Regis Mohawk Tribe – which is a federally recognized,
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`sovereign Native American Tribe and which is indisputably a non-consenting
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`sovereign – is subject to the jurisdiction of the Board.
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`INTERESTS OF AMICUS CURIAE – U.S. INVENTOR, LLC1
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`U.S. Inventor, LLC is a nation-wide inventor advocacy organization which
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`lobbies Capitol Hill, private trade organizations and the public to encourage strong
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`patent protection in order to foster and protect American innovation and American
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`inventors. U.S. Inventor has over 13,000 members including, independent inventors,
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`early-stage businesses, members of the venture capital community, patent holders,
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`research organizations, emerging technology companies, and patent-dependent
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`enterprises. U.S. Inventor has been at the forefront of teaching, promoting and
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`defending the invention processes and business methods used by American inventors
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`and innovators to develop cutting edge products and services which will extend and
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`enhance American global competitiveness in the 21st Century and beyond.
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`U.S. Inventor has a direct and vital interest in this issue because its members are
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`concerned that the Board may attempt to usurp Congressional authority over Native
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`American tribal sovereign immunity and contravene long-standing, black-letter U.S.
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`Supreme Court precedent by unilaterally and unjustifiably abrogating Congressionally
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`1 No counsel for any party to these proceedings participated in or authored this brief
`in whole or in part. No person or entity other than the amicus curaie or their counsels
`made a monetary contribution to the preparation or submission of this brief. Because
`this is an issue of first impression, the Board has authorized the filing of briefs in this
`case by interested amicus curaie. See e.g. Paper No. 98 in IPR2016-01128.
`2
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`mandated Native American tribal sovereign immunity. Moreover, the value of
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`intellectual property assets (and the ability of inventors to protect products and services
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`that they have created against unauthorized copying and misappropriation) will be
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`significantly affected by whether such inventors – under the appropriate circumstances
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`– have the ability to partner with groups and organizations that can assert and maintain
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`sovereign immunity in Board proceedings which have been initiated by infringers of
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`intellectual property.
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`RELEVANT PTAB HISTORY2
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`On June 3, 2016, Mylan Pharmaceuticals Inc. (“Mylan”) filed six petitions for
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`inter partes review against U.S. Patent Nos. 8,685,930, 8,629,111, 8,642,556,
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`8,633,162, 8,648,048, and 9,248,191 (collectively, the “Patents-at-Issue”) which were
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`then owned by Allergan, Inc. (“Allergan”).3
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`On September 8, 2017, Allergan, Inc. assigned the Patents-at-Issue to the Saint
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`Regis Mohawk Tribe (the “Saint Regis Tribe”). Concurrently with this assignment, the
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`Saint Regis Tribe granted back to Allergan an exclusive limited field-of-use license and
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`then notified the Board that it was the new owner of the Patents-In-Issue. On
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`September 22, 2017, the Saint Regis Tribe filed a Motion to Dismiss For Lack of
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`2 For purposes of brevity, the history of the District Court proceedings between the
`parties has been omitted from this brief. Due the Board’s familiarity with this case,
`this Brief also generally omits citations to filings submitted by the parties.
`3 See IPR2016-01127; IPR2016-01128; IPR2016-01129; IPR2016-01130; IPR2016-
`01131; IPR2016-01132. Additional petitions for inter partes review of the Patents-
`In-Issue were then filed by Teva Pharmaceuticals USA, Inc. (“Teva”) (IPR2017-00576;
`IPR2017-00578; IPR2017-00579; IPR2017-00583; IPR2017-00585; IPR2017-
`00586) and by Akorn Inc. (“Akorn”) (IPR2017-00594; IPR2017-00596; IPR2017-
`00598;
`IPR2017-00599;
`IPR2017-00600;
`IPR2017-00601).
` Each of
`the
`corresponding Mylan, Teva and Akorn petitions for inter partes review were
`subsequently joined See, e.g., Paper Nos. 18 and 19 in IPR2016-01127
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`Jurisdiction Based on Tribal Sovereign Immunity (the “Motion To Dismiss”).
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`Subsequently, the Board received requests from two organizations (unaffiliated with
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`any of the parties) seeking leave to file briefs as amicus curiae on the issues raised
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`by Allergan’s assignment of the Patents-In-Issue to the Saint Regis Tribe and by the
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`subsequently filed Motion To Dismiss. On November 3, 2017, the Board granted
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`leave to these organizations as well as to any other interested parties which wanted to
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`file briefs in this case as amicus curiae.4
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`ARGUMENTS AND AUTHORITY
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`A. Only Congress May Limit Tribal Sovereign Immunity.
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`It is undisputable that as domestic dependent nations, Native American tribes
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`possess and exercise inherent sovereign immunity. It is also undisputable that such
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`power may be abrogated, limited or qualified only by the express and unequivocal
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`action of Congress. In Kiowa Tribe of Oklahoma v Manufacturing Technologies, Inc.,
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`the U.S. Supreme Court explicitly affirmed that no court or administrative agency may
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`interfere with that power absent Congressional legislation.5
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`The U.S. Supreme Court has been steadfast in upholding this principle against
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`any challenges to the breadth and scope of Native American tribal sovereign immunity.
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`In Bay Mills, which was decided just three years ago, the Court noted that the holding
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`in Kiowa Tribe was unambiguous, had been relied on by Native American tribes and
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`by parties in subsequent cases, and had been considered (and left alone) by Congress,
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`making any departure from it unwarranted.6 The Court reaffirmed that Native
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`4 See Paper No. 98 in IPR2016-01128
`5 523 U.S. 751 (1998)
`6 Michigan v Bay Mills Indian Community, et al, 134 S. Ct. 2024, 2026 (2014)
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`American tribes are domestic dependent nations that exercise sovereignty based on the
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`fact that immunity “is ‘a necessary corollary to Indian sovereignty and self-
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`governance.’”7 and that tribal immunity is qualified only to the extent it has been
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`placed “in Congress’s hands.”8 The Court also noted that in Kiowa Tribe, it had refused
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`to limit tribes’ inherent immunity to commercial activities on Indian land, deferring
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`any such action to Congress.9 And that after the Court’s decision in Kiowa Tribe,
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`Congress considered legislation specifically meant to proscribe tribal immunity, but
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`tellingly chose not to pass any such limiting legislation.10 In re-affirming Kiowa Tribe,
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`the Court in Bay Mills held that “[i]t is fundamentally Congress’s job . . . to determine
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`whether and how to limit tribal immunity.” and that absent congressional limitations,
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`tribes exercise unqualified immunity.11 The Court even went so far as to note that “a
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`fundamental commitment of Indian law is judicial respect for Congress’s primary role
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`in defining the contours of tribal sovereignty.”12
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`In Bay Mills, the Court, when presented with an opportunity to abrogate,
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`or at least qualify, tribal sovereign immunity, instead chose to unequivocally
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`underscore that the power to qualify or limit tribal immunity is within the sole purview
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`of Congress and that tribal immunity is clearly not subject to judicial review or
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`administrative agency oversight.
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`B. The Board Should Not Decide The Issue of Sovereign Immunity.
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`1. Only Congress has the authority to qualify or limit sovereign
`immunity.
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`7 Id. at 2030 (quoting Three Affiliated Tribes of Fort Berthold Reservation v. World
`Engineering, P. C., 476 U.S. 877, 890 (1986))
`8 Id.
`9 Id. at 2031
`10 Id. at 2038
`11 Id. at 2037
`12 Id. at 2039
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`As noted in the preceding section, Congress has the sole and exclusive right and
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`authority to decide whether and in what context Native American tribal sovereign
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`immunity applies. It would be a flagrant encroachment on Congressional authority for
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`the Board to take the position that an administrative agency has the right and authority
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`to supplant the regulatory power of Congress. Particularly, in the context of Native
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`American tribal sovereign immunity where even the U.S. Supreme Court has conceded
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`it is without authority to act because the administration and oversight of federal tribal
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`law is within the exclusive dominion of Congress. Stated another way, it would be
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`inconceivable that an Article I administrative agency has the authority to make binding
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`decisions concerning the applicability of Native American tribal sovereign immunity
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`when the U.S. Supreme Court – which has plenary judicial oversight of that same
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`administrative agency – has declared that absent Congressional legislation, the Court
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`does not have the power to qualify or limit the assertion of Native American sovereign
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`immunity.
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`2. The Board is not equipped to undertake the relevant analysis.
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`Even assuming arguendo that the Board has the power (which it doesn’t) to
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`decide whether sovereign immunity may be used by a patent owner to divest the Board
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`of jurisdiction over an administrative patent challenge, the Board is simply not the
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`appropriate venue to make this determination for at least the following three reasons:
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`First, every assertion of sovereign immunity to defeat the Board’s jurisdiction in a
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`particular case will necessarily involve intensive factual discovery and analysis –
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`regardless of whether that discovery is being sought to prove/disprove that the
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`assignment of a challenged patent is a sham transaction (as alleged by Mylan in this
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`case) or whether discovery is being pursued to ascertain if the patent assignee is indeed
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`a bona-fide claimant to sovereign immunity.13 The proceedings before the Board –
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`which afford parties only limited discovery coupled with the fact that the Board has
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`no subpoena powers over non-parties – means that the relevant factual determination
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`will likely be incomplete or even fatally flawed. Second, a finding by a panel of the
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`Board that sovereign immunity is proper in a particular case will not be binding on
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`future petitioners as a result of due process prerogatives. This will undoubtedly lead
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`to serial challenges to assertions of sovereign immunity thereby increasing costs to
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`both patent owners and petitioners. Third, although sovereign immunity which
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`precludes the Board’s assertion of jurisdiction is necessarily a gateway matter, it is
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`also a collateral issue to the central function of Board proceedings which are to
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`adjudicate the validity of challenged patents. Requiring panels of the Board and
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`litigants to determine whether a particular assignment to an alleged sovereign was a
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`bona-fide transaction or requiring parties to contest/defend whether a particular
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`assignee is entitled to claim sovereign immunity will undoubtedly further tax the time
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`and resources of both the Board and litigants who are already laboring under a
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`compressed trial schedule to determine the core issue of patent validity.
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`C. The Proper Forum For Parties To Challenge Tribal Sovereign Immunity
`Is Federal District Court
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`If a party that is contesting an assertion of sovereign tribal immunity does
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`believe that it should be allowed to challenge that claim (notwithstanding the fact that
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`the U.S. Supreme Court has unequivocally held that Congress has the sole authority
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`to review or qualify the scope of tribal sovereign immunity), the proper forum to raise
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`a challenge to tribal sovereign immunity is not the Board. Instead, and based on
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`13 See the “arm of the tribe” discussion infra.
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`analogous proceedings involving Indian tribes, the correct forum for such challenges
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`is clearly in federal district court.
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`For example, when a party challenges whether the relationship between the tribe
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`and the entity asserting immunity is sufficiently close to properly permit that entity to
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`share in the tribe’s immunity, federal district courts do undertake an analysis of the
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`bona-fides of an assertion of sovereign tribal immunity.14 This analysis is commonly
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`referred to as the “arm of the tribe” test. To that end, all of the federal courts of appeals
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`have developed standards for determining which tribally affiliated entities are allowed
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`immunity from regulation and legal suit. Rather than depending on the nature of the
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`business a tribe is conducting through a particular entity, the question of whether tribal
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`immunity is to be extended to the entity depends on whether, the entity is an “arm of
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`the tribe” such that the activities of the challenged entity are properly deemed to be
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`those of the tribe.15
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`As part of that analysis, each of the federal courts of appeals applies a unique
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`arm of the tribe test, taking numerous and varied factors into consideration when
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`determining which entities are entitled to tribal sovereign immunity. In general, the
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`federal courts of appeals implement tests that typically evaluate the following: (1) the
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`creation, funding and control of the entity; (2) the benefits accorded to the tribe by the
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`entity; (3) the amount of control the tribe exerts over the entity; and (4) whether the
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`14 See Ninigret Dev. Corp. v. Narragansett Indian Wetuomuch Housing Authority, 207
`F.3d at 29 (stating that tribal housing authority “as an arm of the Tribe, enjoys the full
`extent of the Tribe’s sovereign immunity”); Marceau v. Blackfeet Housing Authority,
`455 F.3d 974, 978 (9th Cir.2002) (recognizing that tribal sovereign immunity “extends
`to agencies and subdivisions of the tribe”).
`15 Allen v. Gold Country Casino, 464 F.3d at 1046; see also Hagen v. Sisseton-
`Wahpeton Community College, 205 F.3d at 1043; Ninigret Dev. Corp. v. Narragansett
`Indian Wetuomuch Housing Authority, 207 F.3d at 29.
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`policies of tribal sovereign immunity would be served by holding the entity as an arm
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`of the tribe.16
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`Having parties raise and prosecute or defend in federal district court challenges
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`to assertions of sovereign tribal immunity would also not impose any undue hardship
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`or unfair burden upon litigants. Based on a five-year study (from 2012 through the
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`end of the second quarter of 2017), nearly 80% of patents being challenged in Board
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`proceedings are also subject to concurrent district court litigation.17 For the great
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`majority of parties, asking the district court to resolve the issue of whether sovereign
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`immunity applies in a particular case would be a relatively simple matter of filing
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`motions in an already pending district court litigation. Moreover, federal district
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`courts with their broad jurisdictional discovery powers and ability to issue subpoenas
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`to third-party witnesses are uniquely situated to allow the parties a full and fair
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`opportunity to develop a comprehensive factual record to challenge or defend
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`assertions of sovereign immunity. In addition, given that more than 70% of district
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`court proceedings get stayed once a petition for inter partes review has been granted,18
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`a motion to challenge an assertion of sovereign immunity will almost certainly get
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`decided in short order given the lack of other activity in the district court in that
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`particular case. Finally, having parties adjudicate tribal sovereign immunity
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`challenges in federal district court will remove that burden from panels of the Board
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`16 See Ninigret Dev. Corp. v. Narragansett Indian Wetuomuch Hous. Auth., 207 F.3d
`21 (1st Cir.2000); Hagen v. Sisseton-Wahpeton Cmty. Coll., 205 F.3d 1040 (8th Cir.
`2000); Allen v. Gold Country Casino, 464 F.3d 1047 (9th Cir.2006); Breakthrough
`Management Group, Inc. v. Chukchansi Gold Casino and Resort, 629 F.3d 1173, 1181
`(10th Cir.2010)
`17 See https://www.patexia.com/feed/patexia-chart-44-80-percent-of-ipr-filings-are-
`for-defensive-purposes-20171107 (last accessed on November 28, 2017)
`18
`https://www.morganlewis.com/-/media/files/publication/report/ptab-post-grant-
`proceedings_fin_screen.ashx (last accessed on 11-28-17)
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`which are already under intense pressure to adjudicate the issue of patent validity
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`within a statutorily proscribed time-frame.
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`CONCLUSION
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`Because the Board lacks the adjudicatory authority to decide the applicability
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`of tribal sovereign immunity, the Motion to Dismiss For Lack of Jurisdiction Based
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`on Tribal Sovereign Immunity filed by patent owner Saint Regis Mohawk Tribe should
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`be granted.
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`Dated: December 1, 2017
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`Respectfully submitted,
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`/Terry Fokas/
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`Terry Fokas, Esq.
`Texas Bar No. 24027309
`terryfokas_esq@yahoo.com
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`17440 N Dallas Parkway, Suite 230
`Dallas, Texas 75287
`Telephone (214) 414-2363
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`Counsel for Amicus Curiae U.S. Inventor, LLC
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`CERTIFICATE OF SERVICE
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`I hereby certify that on December 1, 2017, I caused the foregoing Brief of
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`Amicus Curiae U.S. Inventor, LLC in Support of Patent Owner Saint Regis Mohawk
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`Tribe to be served by email on the following counsel of record:
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`PETITIONER MYLAN:
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`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`rtorczon@wsgr.com
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`PETITIONER TEVA:
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`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURH, LINDQUIST & SCHUMAN, P.A.
`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
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`PETITIONER AKORN:
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`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
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`PATENT OWNER:
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`Dorothy P. Whelan
`Michael Kane Susan
`Coletti
`Robert Oakes
`FISH & RICHARDSON P.C.
`whelan@fr.com
`PTABInbound@fr.com
`coletti@fr.com oakes@fr.com
`singer@fr.com
`
`Alfonso Chan Joseph
`DePumpo Michael
`Shore
`Christopher Evans
`SHORE CHAN DEPUMPO LLP
`achan@shorechan.com
`jdepumpo@shorechan.com
`mshore@shorechan.com
`cevans@shorechan.com
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`Marsha Schmidt
`marsha@mkschmidtlaw.com
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`Dated: December 1, 2017
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` /Terry Fokas/
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`Terry Fokas
`Counsel for Amicus Curiae U.S. Inventor, LLC
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