In an unusual strategy to protect Restasis from generic competition, Allergan announced that is it has sold the drug's patents to an Indian tribe in upstate New York.
Allergan and the Saint Regis Mohawk Tribe announced that the Indian 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.
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 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," Bob Bailey, Allergan's Chief Legal Officer, said in a company news release. "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."
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.