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896 F.3d 1322
Fed. Cir.
2018
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Background

  • Allergan owned patents covering Restasis; multiple generics (Mylan, Teva, Akorn) filed IPR petitions challenging those patents after related district-court litigation.
  • While IPRs were pending, Allergan assigned the Restasis patents to the Saint Regis Mohawk Tribe and the assignment was recorded with the USPTO.
  • The Tribe asserted tribal sovereign immunity and moved to terminate the IPRs; Allergan moved to withdraw from the proceedings.
  • The Patent Trial and Appeal Board denied both the Tribe's motion to terminate and Allergan's motion to withdraw; Allergan and the Tribe appealed.
  • The Federal Circuit reviewed whether tribal sovereign immunity can bar IPR proceedings and whether the Board erred in denying the motions; it affirmed the Board.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether tribal sovereign immunity bars IPR proceedings Tribe: IPR is a contested, adjudicatory proceeding like FMC, so tribal immunity applies to bar review Appellees: IPR is an agency reconsideration/enforcement action by the USPTO, thus immunity doesn't apply; assignment is a sham/waiver arguments IPR is an agency reconsideration (hybrid but primarily agency action); tribal sovereign immunity does not bar IPRs — affirmed
Whether the Director's and USPTO's role permits agency action against a sovereign Tribe: petitioner-driven nature of IPR (party-defined contours) shows private-adjudicative character Appellees: Director has gatekeeping discretion and USPTO can proceed without petitioner, showing exercise of federal authority Court: Director's discretion to institute and USPTO's ability to continue/defend proceedings means the USPTO acts as the United States; immunity inapplicable
Procedural parity with civil litigation (impact on immunity analysis) Tribe: IPR mimics civil litigation (SAS emphasis) so FMC analogy supports immunity Appellees: IPR procedures differ substantially from district-court litigation (limited discovery, claim-amendment rules, short hearings) so FMC does not control Court: Differences from district-court procedures (limited discovery, USPTO control, ability to proceed without parties) support treating IPR as agency reconsideration, not private-party adjudication
Whether other defenses (sham assignment or waiver) must be decided Tribe/Allergan relied on assignment and immunity; Tribe argued sovereign status; Allergan sought withdrawal Appellees argued assignment was sham and Tribe waived immunity by prior suit Court: Declined to reach sham/waiver issues because holding that tribal immunity does not apply to IPRs disposed of the appeal

Key Cases Cited

  • Okla. Tax Comm'n v. Citizen Band Potawatomi Indian Tribe of Okla., 498 U.S. 505 (tribal sovereign immunity doctrine)
  • Santa Clara Pueblo v. Martinez, 436 U.S. 49 (tribal sovereign immunity as common-law doctrine)
  • Fed. Maritime Comm'n v. S.C. State Ports Auth., 535 U.S. 743 (agency adjudication v. sovereign immunity analysis)
  • Alden v. Maine, 527 U.S. 706 (government political responsibility and suits by the sovereign)
  • Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (IPR as agency reconsideration of patent grants)
  • Oil States Energy Servs. v. Greene's Energy Grp., LLC, 138 S. Ct. 1365 (USPTO role and IPR as reconsideration of grant)
  • SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (adversarial, party-directed features of IPR)
  • Miccosukee Tribe of Indians of Fla. v. United States, 698 F.3d 1326 (tribes may not invoke immunity against superior sovereign actions)
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Case Details

Case Name: Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.
Court Name: Court of Appeals for the Federal Circuit
Date Published: Jul 20, 2018
Citations: 896 F.3d 1322; 2018-1638, 2018-1639, 2018-1640, 2018-1641, 2018-1642, 2018-1643
Docket Number: 2018-1638, 2018-1639, 2018-1640, 2018-1641, 2018-1642, 2018-1643
Court Abbreviation: Fed. Cir.
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