Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., No. 18-1638 (Fed. Cir. 2018)Annotate this Case
Allergan’s Restasis Patents relate to a treatment for alleviating the symptoms of chronic dry eye. In 2015, Allergan sued, alleging infringement of the Restasis Patents based on Mylan’s filings of Abbreviated New Drug Applications. Mylan, Teva, and Akorn sought inter partes review of the patents. The Patent Board instituted IPR and scheduled a consolidated oral hearing. Before the hearing, Allergan and the Tribe entered into an agreement Mylan alleges was intended to protect the patents from review. A patent assignment transferring the Restasis patents from Allergan to the Tribe was recorded with the Patent Office. The Tribe moved to terminate the IPRs, arguing it is entitled to assert tribal sovereign immunity; Allergan moved to withdraw. The Board denied both motions. The Federal Circuit affirmed. IPR is neither clearly a judicial proceeding instituted by a private party nor clearly an enforcement action brought by the federal government: tribal sovereign immunity may not be asserted in IPR proceedings.