The Question of Sovereign Immunity: A Legitimate Means of Pharmaceutical Patent Protection?

April 23, 2018 11:15am

Nicolas G. Barzoukas
Reed Smith LLP (Huston, TX)

Josephine Liu, Ph.D., J.D.
Head, US IP Litigation
Sandoz Inc. (Princeton, NJ)

Stephen B. Maebius
Foley & Lardner LLP (Washington, DC)

Don J. Mizerk
Husch Blackwell LLP (Chicago, IL)

Steven J. Moore
Withers Bergman LLP (Greenwich, CT)

Jason A. Wietjes
Polsinelli PC (Dallas, TX)


Steven M. Coyle
Partner and Litigation Department Co-Chair
Cantor Colburn LLP (Hartford, CT)

In an inspired attempt to “rent” sovereign immunity, a major pharmaceutical company, tried to avail itself of the auspices of this protection by assigning its patents to a lucrative drug to a Native American Indian tribe. Upon review of the assigned patent portfolio last fall, a U.S. District Court Judge found the patents invalid due to obviousness, and expressed trepidation about the validity of the use or misuse of sovereign immunity in this matter. In February 2018, the PTAB denied the St. Regis tribe’s motion to dismiss several IPRs challenging the validity of the Allergan Restasis patents it was assigned on the basis of the Sovereign Immunity Doctrine, thus opening the door for the Federal Circuit to act.

This use of sovereign immunity as a means of patent protections is now at the center of a larger discussion, as more companies may try to avoid IPRs by assigning rights away while seeking the protections of sovereign immunity. Last fall, Sen. Claire McCaskill, D-Mo., introduced S.1948 which seeks to prevent Native American tribes from avowing sovereign immunity in these types of cases. Pending the passage of such a bill, patent holders will continue to wonder whether this strategy is a sustainable means of patent protection meant to evade invalidation.

  • Reviewing the status of the Allergan, Inc. v. Teva Pharmaceuticals
    • Examining the PTAB’s opinion denying the St. Regis tribe’s invocation of the sovereign immunity defense
    • Anticipating the Federal Circuit’s review of this matter
  • Analyzing the findings of the House Judiciary Committee’s Subcommittee on IP’s hearing on sovereign immunity and the intellectual property system
  • Update on the status of S.1948
  • Examining the investigations of other entities transferring patent rights to Native American tribes