UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC., and AKORN INC., 1
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`_____________
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`_____________
`
`CORRECTED PATENT OWNER’S MOTION TO DISMISS FOR LACK
`OF JURISDICTION BASED ON TRIBAL SOVEREIGN IMMUNITY
`
`
`
` 1
`
` Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017- 00596,
`
`IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017- 00599,
`
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601 have
`
`respectively been joined with the captioned proceedings. The word-for-word
`
`identical paper is filed in each proceeding identified in the caption pursuant to the
`
`Board’s Scheduling Order (Paper 10).
`
`

`

`Proceeding No.: IPR2016-01127
`
`TABLE OF CONTENTS
`
`
`I. 
`SUMMARY OF MOTION .................................................................................. 1 
`THE SAINT REGIS MOHAWK TRIBE ............................................................ 1 
`II. 
`III.  RELEVANT PROCEDURAL BACKGROUND .............................................. 6 
`A. District Court Proceedings. .............................................................................. 6 
`B. PTAB Proceedings. .......................................................................................... 7 
`IV.  ARGUMENTS AND AUTHORITY .................................................................. 8 
`A. The Tribe Possesses Immunity From Suit. ..................................................... 8 
`1. Congress has not unequivocally abrogated the Tribe’s sovereign
`immunity. ...................................................................................................... 10 
`2. The Tribe has not unequivocally and expressly waived its
`immunity to these proceedings. ................................................................... 12 
`B. The Tribe’s Sovereign Immunity Applies to all Adjudicatory
`Proceedings, Including IPR. .......................................................................... 14 
`C. This Case Cannot Proceed Without the Tribe. ............................................. 16 
`1. The Tribe is an indispensable party under the Board’s identity-of-
`interests test................................................................................................... 16 
`2. The Tribe is an indispensable party under F.R.C.P. 19. .......................... 20 
`3. Allergan lacks authority under the statutory scheme to continue to
`participate in these proceedings. .................................................................. 24 
`CONCLUSION ................................................................................................... 25 
`
`V. 
`
`
`
`
`
`i
`
`

`

`Proceeding No.: IPR2016-01127
`
`TABLE OF AUTHORITIES
`
`
`CASES
`A123 Sys. Inc. v. Hydro-Quebec,
`626 F.3d 1213 (Fed. Cir. 2010) .............................................................. 16, 17, 20, 22
`
`
`Am. Greyhound Racing, Inc. v. Hull,
`305 F.3d 1015 (9th Cir. 2002) ................................................................................... 21
`
`
`Amerind Risk Mgmt. Corp. v. Malaterre,
`633 F.3d 680 (8th Cir. 2011) ..................................................................................... 14
`
`
`Bassett v. Mashantucket Pequot Tribe,
`204 F.3d 343 (2d Cir. 2000) ...................................................................................... 12
`
`
`Blue Legs v. U.S. Bureau of Indian Affairs,
`867 F.2d 1094 (8th Cir. 1989) ................................................................................... 10
`
` C
`
` & L Enters. Inc. v. Citizen Band Potawatomi Tribe of Okla.,
` 532 U.S. 411 (2001) ..................................................................................................... 9
`
`Coach Servs., Inc. v. Triumph Learning LLC,
` 668 F.3d 1356 (Fed. Cir. 2012) ................................................................................. 25
`
`Demontiney v. U.S. ex rel. Dept. of Interior, Bureau of Indian Affairs,
`255 F.3d 801 (9th Cir. 2001) ....................................................................................... 9
`
`
`Enter. Mgmt. Consultants Inc v. United States,
`883 F.2d 890 (10th Cir. 1989) ............................................................................. 19, 21
`
`
`Ethicon Endo-Surgery, Inc. v. Covidien LP,
`812 F.3d 1023 (Fed. Cir. 2016) ................................................................................. 15
`
`
`Fed. Mar. Comm’n v. S.C. State Ports Auth.,
`535 U.S. 743 (2002) ............................................................................................. 14, 15
`
`
`Florida Paraplegic, Ass'n, Inc. v. Miccosukee Tribe of Indians of Florida,
`166 F.3d 1126 (11th Cir. 1999) ................................................................................. 10
`
`
`
`ii
`
`

`

`Proceeding No.: IPR2016-01127
`
`Florida Prepaid Postsecondary Education Expense Bd. v. College Savings Bank,
`527 U.S. 627 (1999) ................................................................................................... 11
`
`
`Florida v. Seminole Tribe of Florida.,
`181 F.3d 1237 (11th Cir. 1999) ....................................................................... 9, 11, 12
`
`
`Friends of Amador Cty. v. Salazar,
`554 F. App'x 562 (9th Cir. 2014) ................................................................................ 1
`
`
`Garcia v. Akwesasne Housing Authority,
`268 F.3d 76 (2d Cir. 2001) ........................................................................................ 12
`
`
`Great Plains Lending, LLC v. Conn. Dep’t of Banking,
`No. HHBCV156028096S, 2015 WL 9310700 (Conn. Super. Ct.
` Nov. 23, 2015) ........................................................................................................... 15
`
`Home Bingo Network v. Multimedia Games, Inc.,
`No. 1:05-CV-0608, 2005 WL 2098056 (N.D.N.Y. Aug. 30, 2005) ....................... 11
`
`
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ................................................................................. 15
`
`
`Jamul Action Committee v. Chaudhuri,
`200 F. Supp. 3d 1042 (E.D. Cal. 2016) .............................................................. 19, 22
`
`
`Kiowa Tribe of Okla. v. Mfg. Techs. Inc.,
` 523 U.S. 751 (1998) ......................................................................................... 8, 12, 13
`
`Klamath Tribe Claims Comm. v. United States,
`106 Fed. Cl. 87 (2012) ......................................................................................... 19, 21
`
`
`Koniag, Inc., Vill. of Uyak v. Andrus,
` 580 F.2d 601, 614 (D.C. Cir. 1978) .......................................................................... 25
`
`Lomayaktewa v. Hathaway,
`520 F.2d 1324 (9th Cir.1975) .................................................................................... 23
`
`
`Mesa Grande Band of Mission Indians v. United States,
`121 Fed. Cl. 183 (2015) ............................................................................................. 21
`
`
`
`iii
`
`

`

`Proceeding No.: IPR2016-01127
`
`Michigan v. Bay Mills Indian Community,
` 134 S.Ct. 2024 (2014) ........................................................................................ 5, 8, 13
`
`Okla. Tax Comm’n v. Citizen Band Potawatomi Indian Tribe of Okla.,
` 498 U.S. 505 (1991) ........................................................................................... 8, 9, 12
`
`Osage Tribal Council ex rel. Osage Tribe of Indians v. U.S. Dep’t of Labor,
`187 F.3d 1174 (10th Cir. 1999) ................................................................................. 10
`
`
`Pan Am. Co. v. Sycuan Band of Mission Indians,
`884 F.2d 416 (9th Cir. 1989) ..................................................................................... 12
`
`
`Puyallup Tribe, Inc. v. Dep’t of Game,
`433 U.S. 165 (1977) ..................................................................................................... 8
`
`
`Quileute Indian Tribe v. Babbitt,
`18 F.3d 1456 (9th Cir. 1994) ..................................................................................... 22
`
`
`Ransom v. St. Regis Mohawk Educ. and Cmty. Fund, Inc.,
`86 N.Y.2d 553 (1995) .................................................................................................. 9
`
`
`Republic of Philippines v. Pimentel,
`553 U.S. 851 (2008) ................................................................................................... 21
`
`
`Ritchie v. Simpson,
` 170 F.3d 1092, 1095 (Fed. Cir. 1999) ...................................................................... 25
`
`Santa Clara Pueblo v. Martinez,
`436 U.S. 49 (1978) ................................................................................................... 8, 9
`
`
`SAS Inst., Inc. v. ComplementSoft, LLC,
`825 F.3d 1341 (Fed. Cir. 2016) ................................................................................. 15
`
`
`Specialty House of Creation, Inc. v. Quapaw Tribe,
`No. 10-CV-371-GKF-TLW, 2011 WL 308903 (N.D. Okla. Jan. 27, 2011) .......... 11
`
`
`U.S. ex rel. Hall v. Tribal Development Corp.,
`100 F.3d 476 (7thth Cir. 1996) .................................................................................. 23
`
`
`
`iv
`
`

`

`Proceeding No.: IPR2016-01127
`
`U.S. v. U.S. Fid. & Guar. Co.,
`309 U.S. 506 (1940) ..................................................................................................... 8
`
`
`Union Pac. R.R. Co. v. Runyon,
`No. 3:17-cv-00038-AA, 2017 WL 923915 (D. Or. Mar. 8, 2017) .......................... 20
`
`
`University of Utah v. Max-Planck-Gesellschaft Zur Forderun-der Wissenschaften,
`734 F.3d 1315 (Fed. Cir. 2013) ................................................................................. 22
`
`
`Ute Distrib. Corp. v. Ute Indian Tribe,
`149 F.3d 1260 (10th Cir. 1998) ................................................................................. 13
`
`
`Vas-Cath, Inc. v. Curators of Univ. of Missouri,
`473 F.3d 1376 (Fed. Cir. 2007) ................................................................................. 15
`
`
`White v. Univ. of Cal.,
`765 F.3d 1010 (9th Cir. 2014) ................................................................................... 21
`
`
`Williams v. Poarch Band of Creek Indians,
`839 F.3d 1312 (11th Cir. 2016) ................................................................................... 9
`
`
`Worcester v. State of Ga.,
`31 U.S. 515 (1832) ....................................................................................................... 8
`
`
`Xechem Int'l, Inc. v. Univ. of Tex. M.D. Anderson Cancer Ctr.,
`382 F.3d 1324 (Fed. Cir. 2004) ................................................................................. 11
`ADMINISTRATIVE ORDERS:
`Alhameed v. Grand Traverse Resort & Casino,
`10 OCAHO 1126 ....................................................................................................... 16
`
`
`Covidien LP v. Univ. of Fla. Research Found. Inc.,
` Case IPR 2016-01274, Paper 21 (Jan. 25, 2017) ............................................... 11, 14
`
`In the Matter of Jamal Kanj v. Viejas Band of Kumeyaay Indians,
`2007 WL 1266963 (DOL Adm. Rev. Bd. Apr. 27, 2007) ....................................... 15
`
`
`In the Matter of Private Fuel Storage,
`56 N.R.C. 147 (Oct. 1, 2002) .................................................................................... 16
`
`v
`
`

`

`Proceeding No.: IPR2016-01127
`
`
`In the Matter of Tammy Stroud v. Mohegan Tribal Gaming Authority,
`2014 WL 6850018 (DOL Admin Rev. Bd. Nov. 26, 2014) .................................... 16
`
`
`Neochord, Inc. v. Univ. of Md., et al,
` Case IPR2016-00208, Paper 28 (May 23, 2017) ............................................. passim
`
`Reactive Surfaces Ltd., LLP v. Toyota Motor Corp.,
` Case IPR2016-01914, Paper 36 (July 13, 2017) ......................................... 14, 17, 20
`STATUTES:
`25 U.S.C. § 1451 .............................................................................................................. 4
`
`25 U.S.C. § 5302 .............................................................................................................. 4
`
`28 U.S.C. § 1498 ............................................................................................................ 10
`
`25 U.S.C. § 5302 .............................................................................................................. 4
`
`35 U.S.C. § 102 .......................................................................................................... 7, 24
`
`35 U.S.C. § 103 .......................................................................................................... 7, 24
`
`35 U.S.C. § 112 ................................................................................................................ 7
`
`35 U.S.C. § 296 .............................................................................................................. 11
`
`35 U.S.C. § 311 ................................................................................................. 11, 24, 25
`
`35 U.S.C. §§ 312-319 .............................................................................................. 11, 25
`
`REGULATIONS:
`37 C.F.R. § 42.100-123 .......................................................................................................................... 25
`RULES:
`FED. R. CIV. P. 19 ......................................................................................... 1, 16, 20, 21
`
`
`
`vi
`
`

`

`
`
`LIST OF EXHIBITS
`
`Proceeding No.: IPR2016-01127
`
`EX. 2002
`EX. 2003
`
`EX. 2004
`EX. 2005
`EX. 2006
`
`EX. 2007
`EX. 2008
`EX. 2009
`
`EX. 2010
`EX. 2011
`
`Exhibit No. Description
`EX. 2001
`NDA 21-023 Cyclosporine Ophthalmic Emulsion 0.05%,
`Original NDA Filing, Vol. 1 (Feb. 24, 1999)
`U.S. Pat. No. 4,839,342
`Said et al., Investigative Ophthalmology & Visual Science, vol.
`48, No. 11 (Nov. 2007):5000-5006
`Alba et al., Folia Ophthalmol. Jpn. 40:902-908 (1989)
`Stedman’s Medical Dictionary, definition of therapeutic
`Dorland’s Illustrated Medical Dictionary, definition of
`therapeutic
`Stedman’s Medical Dictionary, definition of palliative
`RESTASIS® label
`Murphy, R., “The Once and Future Treatment of Dry Eye,”
`Review of Optometry, pp. 73-75 (Feb. 15, 2000)
`RESERVED
`Agarwal, Priyanka and Ilva D. Rupenthal, “Modern Approaches
`to the Ocular Delivery of Cyclosporine A,” Drug Discovery
`Today, vol. 21, no. 6 (June 2016)
`Damato et al., “Senile Atrophy of the Human Lacrimal Gland:
`The Contribution of Chronic Inflammatory Disease,” British
`Journal of Ophthalmology (1984)
`Higuchi, “Physical Chemical Analysis of Percutaneous
`Absorption Process From Creams and Ointments,” Seminar,
`New York City (1959)
`Lallemand et al., “Cyclosporine a Delivery to the Eye: A
`Pharmaceutical Challenge,” European Journal of Pharmaceutics
`and Biopharmaceutics (2003)
`
`EX. 2012
`
`EX. 2013
`
`EX. 2014
`
`vii
`
`

`

`Proceeding No.: IPR2016-01127
`
`EX. 2015
`
`EX. 2016
`
`EX. 2017
`EX. 2018
`
`EX. 2019
`
`EX. 2020
`
`EX. 2021
`
`EX. 2022
`
`EX. 2023
`EX. 2024
`EX. 2025
`EX. 2026
`EX. 2027
`EX. 2028
`EX. 2029
`
`das Neves et al., “ Mucosal Delivery of Biopharmaceuticals:
`Biology, Challenges and Strategies,” Springer Science (2014)
`Power et al., “Effect of Topical Cyclosporin A on Conjunctival T
`Cells in Patients with Secondary Sjögren’s Syndrome,” Cornea
`12(6): 507-511 (1993)
`Schaefer et al., “Skin Permeability,” Springer-Verlag (1982)
`Stern et al., “The Pathology of Dry Eye: The Interaction Between
`the Ocular Surface and Lacrimal Glands,” Cornea 17(6): 584-589
`(1998)
`Wepierre, Jacques and Jean-Paul Marty, “Percutaneous
`Absorption of Drugs,” Elsvier/North-Holland Biomedical Press
`(1970)
`Williamson et al., “Histology of the Lacrimal Gland in
`Keratoconjunctivitis Sicca,” Brit. F. Ophthal /91973)
`“Approved Drug Products with Therapeutic Equivalence
`Evaluations,” U.S. Department of Health and Huma Services,
`37th Edition (2017)
`Lemp, Michael A., “ Report of the National Eye
`Institute/Industry Workshop on Clinical Trials in Dry Eyes,”
`CLAO Journal, vol. 21, no. 4 (October 1995)
`Deposition transcript of Mansoor Amiji, Ph.D.
`Declaration of John D. Sheppard, M.D., M.M.Sc.
`Declaration of Dr. Thorsteinn Loftsson, Ph.D.
`Declaration of Eric Rubinson
`Allergan PK-98-074 Report
`Declaration of Robert S. Maness, Ph.D.
`DiMasi, “Risks in New Drug Development: Approval Success
`Rates for Investigational Drugs,” Clinical Pharmacology and
`Therapeutics, May 2001
`
`viii
`
`

`

`Proceeding No.: IPR2016-01127
`
`EX. 2030
`EX. 2031
`EX. 2032
`
`EX. 2033
`
`EX. 2034
`
`EX. 2035
`EX. 2036
`
`EX. 2037
`
`EX. 2038
`EX. 2039
`
`EX. 2040
`
`EX. 2041
`EX. 2042
`
`EX. 2043
`EX. 2044
`EX. 2045
`EX. 2046
`
`FDA Review, “The Drug Development and Approval Process”
`Allergan – NYSE: AGN – Company Profile
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`overview.process&ApplNo=021023
`Drugs@FDA: FDA Approved Drug Products, Restasis
`Approved,
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-
`023_Restasis_Approv.PDF
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`overview.process&ApplNo=050790
`Facts About Dry Eye, https://nei.nih.gov/health/dryeye/dryeye
`Christopher Glenn, “New Thinking Spurs New Products,”
`Review of Ophthalmology, February 15, 2003
`Mark B. Abelson, MD and Jason Casavant, “Give Dry Eye a
`One-two Punch,” Review of Ophthalmology, March 15, 2003
`Deposition of David LeCause, February 17, 2017
`Joan-Marie Stiglich ELS, “Restasis: the road to approval,”
`Ocular Surgery News, March 1, 2003
`Lynda Charters, “Increased Tear Production,” Ophthalmology
`Times, February 1, 2003
`RESERVED
`Jonathan R. Pirnazar, MD, “Taking a Custom Approach to Dry
`Eye Treatment,” Ophthalmology Management, February 1, 2004
`RESERVED
`FDA label for Xiidra®
`RESERVED
`Restasis Strategic Plan Forecast 2009-2013
`
`ix
`
`

`

`Proceeding No.: IPR2016-01127
`
`EX. 2047
`
`EX. 2048
`
`EX. 2049
`
`EX. 2050
`
`EX. 2051
`EX. 2052
`
`EX. 2053
`EX. 2054
`EX. 2055
`EX. 2056
`
`EX. 2057
`
`EX. 2058
`EX. 2059
`EX. 2060
`
`EX. 2061
`EX. 2062
`
`EX. 2063
`
`Allergan Inc., Credit Suisse First Boston Equity Research
`Report, Jan 30, 2003
`Allergan Inc., Buckingham Research Group Equity Research
`Report, Feb 5, 2003
`Allergan Inc., SalomonSmithBarney Equity Research Report,
`Feb 12, 2003
`Allergan Inc., Morgan Stanley Equity Research Report, Jan 30,
`2003
`Restasis P&L (US Only excl. Canada and Puerto Rico)
`Allergan Inc., Morgan Stanley Equity Research Report, Apr 30,
`2004
`Allergan Inc., JP Morgan Equity Research Report, Nov 1, 2005
`RESERVED
`“commercial Restasis Formulary June 2006.xls”
`“NOVEMBER 2006 input MHC Report Restasis Playbook
`data.ppt”
`Restasis® 2013 Managed Markets Tactics & Preliminary
`Budget, August 8, 2012
`RESERVED
`RESERVED
`“Allergan Inc. (AGN) - Q4 2002 Financial Release Conference
`Call
`Wednesday, January 29, 2003 11:00 am” Fair Disclosure
`Financial Network
`Restasis Launch Marketing Plan, dated February 12-13, 2003
`Allergan Dry Eye, “Dry Eye Franchise 2014 Business Plan,”
`2014 U.S. Eye Care Sales & Marketing Plan, September 9, 2013
`Allergan Eye Care, “US Dry Eye Strat Plan Narrative: Summary
`Version,” April 16, 2011
`
`x
`
`

`

`EX. 2064
`
`EX. 2065
`EX. 2066
`
`EX. 2067
`EX. 2068
`
`EX. 2069
`
`EX. 2070
`
`EX. 2071
`
`EX. 2072
`EX. 2073
`EX. 2074
`EX. 2075
`
`EX. 2076
`
`EX. 2077
`
`EX. 2078
`
`Proceeding No.: IPR2016-01127
`
`Kline, Kate, “Restasis Professional Critical Issues,” Allergan Dry
`Eye, 2010
`Allergan Dry Eye, “Restasis Business Update,” August 16, 2010
`“Sales-Units_2011-2016_AllData_NSP_Feb-19-
`2017_RESTASIS.xlsx”
`RESERVED
`Iazuka and Jin, “The Effect of Prescription Drug Advertising on
`Doctor Visits,” Journal of Economics and Management Strategy,
`2007
`Bradford, Kleit, Nietert, et al, “How Direct-to-Consumer
`Television Advertising for Osteoarthritis Drugs Affect
`Physicians’ Prescribing Behavior,” Health Affairs, 2006
`Calfee, Winston, and Stempski, “Direct-to-Consumer
`Advertising and the Demand for Cholesterol Reducing Drugs,”
`Journal of Law and Economics, 2002
`Bradford, Kleit, Nietert, et al, “Effects of Direct-to-Consumer
`Advertising of Hydroxymethylglutaryl Coenzyme A Reductase
`Inhibitors or Attainment of LDL-C Goals,” Clinical
`Therapeutics, 2006
`Restasis NPA Monthly
`Restasis Projects, Global R&D Cost
`Refresh Endura Lubricant Eye Drops (Allergan), Theodora
`Declaration of Jonathan Singer in support of Petitioner’s Motion
`for Pro Hac Vice Admission
`Memorandum Opinion and Order, Allergan, Inc. v. Teva
`Pharmaceuticals USA, Inc., et al., Case No. 2:15-cv-1455-WCB
`Nussenblatt, R. et al. Local Cyclosporine Therapy for
`Experimental Autoimmune Uveitis in Rats. Arch Ophthalmology,
`Volume 103, October 1985.
`Medical Officer’s Review of NDA 21-023
`
`xi
`
`

`

`Proceeding No.: IPR2016-01127
`
`EX. 2079
`
`EX. 2080
`EX. 2081
`EX. 2082
`EX. 2083
`EX. 2084
`EX. 2085
`EX. 2086
`EX. 2087
`EX. 2088
`
`EX. 2089
`
`EX. 2090
`EX. 2091
`EX. 2092
`EX. 2093
`EX. 2094
`EX. 2095
`
`EX. 2096
`
`EX. 2097
`
`EX. 2098
`
`Correction to Sall article (Ex. 1007), Opthalmology, Vol. 107,
`No. 7, July 2000.
`GraphPad Calculation of Bloch Table 2 – 3 mo. B vs A.
`GraphPad Calculation of Bloch Table 2 – 3 mo. C vs A.
`Deposition transcript of Andrew F. Calman, M.D., Ph.D.
`Deposition transcript of Daniel A. Bloch, Ph.D.
`Deposition transcript of Ivan T. Hofmann
`Assignment (Short form)
`Assignment Agreement (Long form)
`Patent License Agreement
`Declaration of Christopher Evans in Support of Motion for Pro
`Hac Vice Admission
`Declaration of Michael Shore in Support of Motion for Pro Hac
`Vice Admission
`Transcript of Conference Call held on 09/11/17
`Federal Register, Vol. 82, No. 10, January 17, 2017
`Treaty with the Seven Nations of Canada, 1776
`Executive Order 13647
`TCR-2017-36
`Covidien LP v. Univ. of Fla. Research Found. Inc., Case IPR
`2016-01274, Paper 21 (Jan. 25, 2017)
`Neochord, Inc. v. Univ. of Md., et al, Case IPR2016-00208,
`Paper 28 (May 23, 2017)
`Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., Case
`IPR2016-01914, Paper 36 (July 13, 2017)
`Order, Allergan, Inc. v. Teva Pharmas USA, Inc. et al, No. 2:15-
`cv-1455 (E.D. Tex.), Docket No. 478 (September 8, 2017)
`
`xii
`
`

`

`Proceeding No.: IPR2016-01127
`
`EX. 2099
`
`EX. 2100
`
`EX. 2101
`EX. 2102
`EX. 2103
`
`Joint Pre-Trial Order in Allergan, Inc. v. Teva Pharmaceuticals
`USA, Inc., et al., No. 2:15-cv-1455 (E.D. Tex.), Docket No. 379
`(July 25, 2017)
`National Congress of American Indians, Current Tax Needs in
`Indian Country
`National Congress of American Indians, Securing Our Futures
`National Congress of American Indians, Taxation
`Recorded Assignment
`
`xiii
`
`

`

`Proceeding No.: IPR2016-01127
`
`I. SUMMARY OF MOTION
`The Saint Regis Mohawk Tribe (“Tribe”), a federally recognized, sovereign
`
`American Indian Tribe, is the owner of U.S. Patent Nos. 8,685,930, 8,629,111,
`
`8,642,556, 8,633,162, 8,648,048, and 9,248,191 (hereinafter “Patents-at-Issue”) that
`
`are at issue in these proceedings. The Tribe is a sovereign government that cannot
`
`be sued unless Congress unequivocally abrogates its immunity or the Tribe expressly
`
`waives it. Neither of these exceptions apply here. As Patent Owner, the Tribe is an
`
`indispensable party to this proceeding whose interests cannot be protected in its
`
`absence. Accordingly, the Tribe makes a special appearance before this Board to
`
`challenge the Board’s jurisdiction over the Tribe and the Board’s authority to
`
`adjudicate the status of the Tribe’s propertythe Patents-at-Issue. See, e.g., Friends
`
`of Amador Cty. v. Salazar, 554 F. App'x 562, 564 (9th Cir. 2014) (“The Tribe made
`
`a special appearance to file a motion to dismiss based on the Appellants' failure and
`
`inability to join the Tribe as a required and indispensable party under Rule 19.”).
`
`The Tribe does not otherwise submit to the jurisdiction of this Board. As a result,
`
`this proceeding must be dismissed.
`
`II. THE SAINT REGIS MOHAWK TRIBE
`The Tribe is a federally recognized Indian tribe with reservation lands in northern
`
`New York. EX. 2091 at 4. The Tribe’s reservation was established by a federal treaty
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`approved and ratified by the United States. EX. 2092. The Tribe’s current
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`Proceeding No.: IPR2016-01127
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`reservation constitutes 14,000 acres spanning Franklin and St. Lawrence Counties.
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`The Tribe has over 15,600 enrolled tribal members, with approximately 8,000 tribal
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`members living on the reservation.
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`Like any sovereign government, the Tribe provides essential government
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`functions such as education, policing, infrastructure, housing services, social
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`services, and health care. See https://www.srmt-nsn.gov/about-the-tribe.
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`But unlike other sovereign governments, the Tribe’s ability to raise revenues
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`through taxation is extremely limited. This is a problem faced by all American Indian
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`Tribes as described by the National Congress of American Indians (“NCAI”):
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`In general, tribal governments lack parity with states,
`local governments, and the federal government in
`exercising taxing authority. For example, tribes are
`unable to levy property taxes because of the trust status
`of their land, and they generally do not levy income taxes
`on tribal members. Most Indian reservations are plagued
`with disproportionately high levels of unemployment and
`poverty, not to mention a severe lack of employment
`opportunities. As a result, tribes are unable to establish a
`strong tax base structured around the property taxes and
`income taxes typically found at the local state
`government level. To the degree that they are able, tribes
`use sales and excise taxes, but these do not generate
`enough revenue to support tribal government functions.
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`Proceeding No.: IPR2016-01127
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`EX. 2102 at 1.
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`In its “Tax Reform Briefing Paper,” NCAI further highlights the problem:
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`When Indian tribal governments undertake economic
`development efforts, one reality that almost all tribes
`confront is the lack of a tax base. Tribes are not able to
`impose property tax on trust lands, and imposing an
`income tax on reservation residents or the businesses that
`choose to locate on reservations is rarely feasible. Recent
`federal court decisions have compounded the "tribal tax
`gap" by permitting the imposition of state taxation on
`Indian lands, while limiting the ability of tribal
`governments to tax nonIndians.
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`EX. 2100 at 7.
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`These issues are compounded by barriers to access to capital. “Over 40% of
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`Native people have limited or no access to mainstream financial services (one of the
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`highest rates in the nation), a full 26.8 percent of American Indian and Alaska native
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`households are underbanked (have a bank account but use alternative financial
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`services), and an additional 14.5 percent are completely unbanked.” EX. 2101 at 11.
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`Because of these disparities, a significant portion of the revenue the Tribe uses to
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`provide basic governmental services must come from economic development and
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`investment rather than taxes or financing.
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`As a result, the federal government has long supported efforts by tribes to achieve
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`Proceeding No.: IPR2016-01127
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`economically self-sufficient and stable communities. In
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`the Indian Self-
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`Determination and Education Assistance Act, 25 U.S.C. § 5302(b), Congress stated
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`the U.S. government policy:
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`The Congress declares its commitment to the
`maintenance of the Federal Government’s unique and
`continuing relationship with, and responsibility to,
`individual Indian tribes and to the Indian people as a
`whole through the establishment of a meaningful Indian
`self-determination policy … the United States is
`committed to supporting and assisting Indian tribes in the
`development of strong and stable tribal governments,
`capable of administering quality programs and
`developing the economies of their respective
`communities.
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` Congress reaffirmed this policy in the Indian Financing Act, 25 U.S.C. § 1451:
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`It is hereby declared to be the policy of Congress to
`provide capital on a reimbursable basis to help develop
`and utilize Indian resources, both physical and human, to
`a point where the Indians will fully exercise
`responsibility for the utilization and management of their
`own resources and where they will enjoy a standard of
`living from their own productive efforts comparable to
`that enjoyed by non-Indians in neighboring communities.
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`In 2013, a Presidential Executive Order recognized “a government-to-
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`government relationship,” the “tribe’s inherent sovereignty,” and the U.S.
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`Proceeding No.: IPR2016-01127
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`government’s policy “to promote the development of prosperous and resilient tribal
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`communities” through “sustainable economic development, particularly energy,
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`transportation, housing, other infrastructure, entrepreneurial, and workforce
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`development to drive future economic growth and security.” EX. 2093.
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`The economic disadvantages facing American Indian Tribes were also
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`recognized by the Supreme Court in Justice Sotomayor’s concurring opinion in
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`Michigan v. Bay Mills Indian Community:
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`A key goal of the Federal Government is to render Tribes
`more self-sufficient, and better positioned to fund their
`own sovereign functions, rather than relying on federal
`funding. And tribal business operations are critical to the
`goals of tribal self-sufficiency because such enterprises in
`some cases “may be the only means by which a tribe can
`raise revenues.” This is due in large part to the
`insuperable (and often state-imposed) barriers Tribes face
`in raising revenue through more traditional means.
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`134 S. Ct. 2024, 2043–44 (2014) (Sotomayor, J., concurring) (internal citations
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`omitted).
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`To overcome these economic disadvantages, the Tribe took steps to diversify its
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`economy with investments in innovative businesses and various enterprises to foster
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`jobs and entrepreneurship. Looking to the business model already utilized by state
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`universities and their technology transfer offices, the Tribe adopted a Tribal
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`Proceeding No.: IPR2016-01127
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`Resolution endorsing the creation of a technology and innovation center for the
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`commercialization of existing and emerging technologies. EX. 2094.
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`This new Tribal enterprise will be called the Office of Technology, Research and
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`Patents and will be part of the Tribe’s Economic Development Department. See
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`https://www.srmt-nsn.gov/economic-development. The Office’s purpose is to
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`strengthen the Tribal economy by encouraging the development of emerging science
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`and technology initiatives and projects, and promoting the modernization of Tribal
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`and other businesses. The objective is to create revenue, jobs, and new economic
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`development opportunities for the Tribe and its members. The Office will also
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`promote the education of Mohawks in the fields of science, technology, engineering,
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`and math.
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`All revenue generated by the Office of Technology, Research and Patents will go
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`into the Tribal General Fund and be used to address the chronically unmet needs of
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`the Tribal community, such as housing, employment, education, healthcare, cultural
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`and language preservation.
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`III. RELEVANT PROCEDURAL BACKGROUND
`A. District Court Proceedings.
`Allergan, Inc. (“Allergan”) filed suit against Mylan, Teva, and Akorn in the
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`Eastern District of Texas on August 24, 2015, alleging infringement of the Patents-
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`at-Issue. A week-long bench trial was held in front of Judge Bryson in the Eastern
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`District of Texas starting on August 28, 2017. EX. 2098. At that trial, Mylan, Teva,
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`and Akorn took full advantage of this opportunity by asserting numerous invalidity
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`defenses under 35 U.S.C. §§ 102, 103, and 112. EX. 2099 at 13-17. The parties are
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`currently engaged in post-trial briefing that will be filed on September 22, 2017.
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`B. PTAB Proceedings.
`On June 3, 2016, Mylan Pharmaceuticals Inc. (“Mylan”) filed six petitions for
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`inter partes review against the Patents-at-Issue. IPR2016-01127; IPR2016-01128;
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`IPR2016-01129; IPR2016-01130; IPR2016-01131; IPR2016-01132.
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`On January 6, 2017, Teva Pharmaceuticals USA, Inc. (“Teva”) filed an additional
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`six petitions for inter pa