Pharmaceutical giant Allergan has taken the unusual step of transferring the patents of its blockbuster dry eye drug Restasis to the Saint Regis Mohawk Tribe in a bid to gain sovereign immunity from inter partes review (IPR) challenges.
Allergan said 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.
Allergan said 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 the Tribe’s sovereign immunity from IPR challenges.
The Tribe will receive $13.75 million upon execution of the agreement and 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,” 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.”
The Saint Regis Mohawk Tribal Council said: “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.
Allergan said 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.