Allergan and Saint Regis Mohawk Tribe Announce Agreements Regarding RESTASIS® Patents

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and the Saint Regis Mohawk Tribe today announced that the Tribe now owns all Orange Book-listed patents for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, and that Allergan has been granted exclusive licenses in the patents related to the product. The Tribe, a recognized sovereign tribal government, is filing a motion to dismiss the ongoing inter partes review (IPR) of the RESTASIS® patents based on their sovereign immunity from IPR challenges.  The agreement with the Tribe has no impact on the pending abbreviated new drug application (ANDA) patent litigations regarding the RESTASIS® patent family which recently completed a five-day trial in Federal District Court in Marshall, Texas. 

"The Saint Regis Mohawk Tribe and its counsel approached Allergan with a sophisticated opportunity to strengthen the defense of our RESTASIS® intellectual property in  the upcoming inter partes review proceedings before the Patent Trial and Appeal Board," said Bob Bailey, Allergan's Chief Legal Officer. "Allergan evaluated this approach closely, with expert counsel in patent and sovereign immunity law.  This included a thorough review of recent case law such as Covidien LP v. University of Florida Research Foundation Inc. and Neochord, Inc. v. University of Maryland, in which the PTAB dismissed IPR proceedings against the universities based upon their claims of sovereign immunity. We are impressed with the Tribe's thoughtful and enterprising approach, which will allow them to achieve their goals of self-reliance and help them address the most urgent needs in their community."

In a unified statement about the agreement with Allergan, the Saint Regis Mohawk Tribal Council stated, "This is a viable and sound opportunity for the Saint Regis Mohawk Tribe to enter into the patent, technology and research sector as part of our overall economic diversification strategy. We realize that we cannot depend solely on casino revenues and, in order for us to be self-reliant, we must enter into diverse business sectors to address the chronically unmet needs of the Akwesasne community; such as housing, employment, education, healthcare, cultural and language preservation."

Under the terms of the agreement, the Tribe will receive $13.75 million upon execution of the agreement.  Additionally, the Tribe will be eligible to receive $15 million in annual royalties. 

The patents transferred to the Tribe include United States Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930 and 9,248,191. The patents are listed in the Orange Book for RESTASIS® and expire on August 27, 2024.