In a creative move to take advantage of recent PTAB decisions regarding Sovereign Immunity, (see e.g., Covidien LP v. University of Florida Research Foundation, IPR2016-01274 and Neochord, Inc. v. University of Maryland, IPR2016-2016-00208; Reactive Surfaces LTD., LLP v. Toyota Motor Corp., IPR2017-00572) Allergan PLC announced that it will transfer six Orange Book (OB) listed patents for RESTASIS® to the Saint Regis Mohawk Tribe (US Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; and 9,248,191). https://www.allergan.com/news/news/thomson-reuters/allergan-and-saint-regis-mohawk-tribe-announce-agr.
Allergan asserted the six OB-listed patents in infringement actions against ANDA filers Mylan, Teva Pharmaceuticals, and others. Mylan, Teva, Argentum Pharmaceuticals, Famy Care Limited, and Akorn, Inc, have all filed IPR petitions against the six OB-listed patents. The IPRs involving Argentum, and Famy Care have been terminated by agreement of the parties pursuant to settlements. The IPR filed by Mylan is scheduled for Oral hearing on September 13, 2017, and trials on the IPRs filed by Teva and Akorn were instituted on March 31, 2017. Thus, this patent ownership change comes in the middle of ongoing IPR instituted trials.
The Saint Regis Mohawk Tribe is a sovereign tribal government, and Allergan and the Saint Regis Mohawk Tribe intend to assert the Saint Regis Mohawk Tribe’s sovereign immunity as a defense in the pending IPR proceedings. Allergan states that the Saint Regis Mohawk Tribe will file motions to terminate the pending IPRs on the grounds that the Saint Regis Mohawk Tribe, as a sovereign entity, is immune from involvement in IPRs.
Under the disclosed terms of the deal, Allergan will transfer full ownership of the six OB-listed patents to the Saint Regis Mohawk Tribe, pay the Saint Regis Mohawk Tribe $13.75 million, and Allergan will receive an exclusive license to the six OB-listed patents. The Saint Regis Mohawk Tribe will also be eligible to receive $15 million in annual royalties.
This case can potentially limit or expand the reach of sovereign immunity as a defense in IPR. The PTAB’s previous sovereign immunity decisions have been based on immunity under the Eleventh Amendment, which grants sovereign immunity to States, but is silent as to other sovereign entities. As the Saint Regis Mohawk Tribe is not a State, it may present different arguments to the PTAB than those relied on in previous sovereign immunity decisions. This could open the door to sovereign immunity as a defense to other sovereigns, such as foreign governments. It will also be interesting to see how the PTAB handles the motions to terminate where the ownership of the patents has changed specifically to take advantage of sovereign immunity.