Administrative Law, Drug Patents, and Tribal Sovereign Immunity: Saint Regis Mohawk Tribe Files Cert in Pharmaceutical Patent Case

Megan Dollenmeyer, Associate Member, University of Cincinnati Law Review

A private patent with sovereign immunity from litigation and administrative proceedings would be a powerful tool. Allergan may have found a way to achieve this goal. In anticipation of an inter partes review (“IPR”) before the Patent Trial and Appeal Board (“PTAB”),[1] the pharmaceutical company, Allergan, transferred patents for the prescription dry-eye drug, Restasis, to the Saint Regis Mohawk Tribe in New York.[2] Under the deal, the Tribe granted Allergan an exclusive license “for all FDA-approved uses in the United States,” but retained all other rights to the patent not explicitly granted to Allergan.[3] The Saint Regis Mohawk Tribe and Allergan assert that tribal sovereign immunity protects the Tribe from suits and IPR proceedings by generic drug companies seeking to challenge the patent.[4]

In the 2018 appeal of the PTAB’s decision, the U.S. Court of Appeals for the Federal Circuit held that the tribe cannot claim sovereign immunity to protect drug patents in an administrative proceeding.[5] The St. Regis Mohawk Tribe and Allergan later filed a writ of certiorari in December 2018.[6] Although the Federal Circuit Court acknowledged tribal sovereign immunity briefly, it ultimately distinguished the doctrine inapplicable, as the PTAB’s IPR decision was a “hybrid proceeding,”[7] which was “less like a judicial proceeding and more like a specialized agency proceeding.”[8] The petitioners argue in their cert petition that the Appellate Court’s decision directly contradicts the Supreme Court’s holdings in other cases, which deemed the IBR’s more similar to proceedings between civil litigants rather than an agency proceeding.[9]

Aside from issues of administrative law, this case raises issues of tribal sovereignty. Per United States v. Wheeler, Indian tribes have “inherent powers of a limited sovereignty which has never been extinguished.” [10]In 2014, the Court held that “[a]mong the core aspects of sovereignty that tribes possess . . . is the ‘common law immunity from suit traditionally enjoyed by sovereign powers.’”[11] Only Congress has the authority to limit tribal sovereign immunity and must do so explicitly.[12] Among other things, immunity protects tribes from suits filed by states and extends to entities in which the tribe is involved, even if that activity is commercial.[13] For a tribe to waive sovereign immunity absent congressional action, the waiver must be “clearly done.”[14] Moreover, a Ninth Circuit decision held that a “tribe’s participation in an administrative decision does not waive tribal immunity in an action filed by another party seeking review of the agency’s decision.”[15]

While the Federal Circuit appeared to limit its decision to tribal sovereign immunity, the decision may also impact state sovereign immunity. In 2017, the PTAB decided that state sovereign immunity precluded the company Covidien from challenging a University of Florida patent.[16] Given the wealth of case law reiterating tribal sovereign immunity without express congressional abrogation, in theory, the Supreme Court should side with the tribe. However, given the 5-4 Bay Mills decision in 2014 and the changes in Justices since then, it is unclear how the Court will determine whether tribal sovereignty immunity applies in administrative proceedings.

[1] The America Invents Act authorizes the PTAB to hear IPR proceedings, which are administrative hearings brought by private parties challenging a patent. 31 U.S.C. §§ 311-314 (2011). Appeals to IPR decisions are still heard by Federal Circuit Courts and parties may still issue patent challenges in Circuit Courts rather than via IPR hearings. Id. at §§ 315, 319.

[2] Robert Pear, Indian Tribe Joins Big Pharma at the Supreme Court, Defending a Lucrative Deal, The New York Times (Jan. 26, 2019), https://www.nytimes.com/2019/01/26/us/politics/allergan-eye-drops-indian-tribe.html.

[3] Petition for Writ of Certiorari, St. Regis Mohawk Tribe v. Mylan Pharms., 896 F.3d 1322 (Fed. Cir. 2018) (No. 18-899).  

[4] See id. at 3.

[5] See St. Regis Mohawk Tribe. Mylan Pharms., Inc., 896 F.3d 1322, 1326 (Fed. Cir. 2018).

[6] See Petition for Writ of Certiorari.

[7] St. Regis Mohawk Tribe, 896 F.3d at 1326.

[8] Id. (quoting Cuozzo Speed Techs., LLC v. Lee,136 S. Ct. 2131, 2143 (2016)).

[9] See Petition for Writ of Certiorari at 2.

[10] 435 U.S. 313, 322-323 (1978).

[11] Michigan v. Bay Mills Indian Cmty., 572 U.S. 782, 782 (2014) (quoting Santa Clara Pueblo v. Martinez, 436 U.S. 49, 58 (1978).

[12] Michigan v. Bay Mills Indian Cmty., 572 U.S. 782, 789 (2014).

[13] Kiowa Tribe v. Mfg. Techs., Inc., 523 U.S. 751 (1998).

[14] Cohen’s Handbook of Federal Indian Law §7.05[1][c].

[15] Quileute Indian Tribe v. Babbitt, 18 F.3d 1456, 1460 (9th Cir. 1994).

[16] Matthew Bultman, PTAB Says State Sovereign Immunity Applies to IPRs, Law360 (Jan. 26, 2017), https://advance.lexis.com/document/?pdmfid=1000516&crid=ea7d6ddd-951e-4688-9395-4d288587794d&pddocfullpath=%2Fshared%2Fdocument%2Flegalnews%2Furn%3AcontentItem%3A5MR5-P6Y1-JGPY-X0SM-00000-00&pddocid=urn%3AcontentItem%3A5MR5-P6Y1-JGPY-X0SM-00000-00&pdcontentcomponentid=122080&pdteaserkey=sr7&pditab=allpods&ecomp=1yrLk&earg=sr7&prid=67a8f85f-6051-4c79-b71b-4b4ebb27d059.