US Senators Seek Additional Information on Allergan’s Use of Sovereign Immunity for PatentsBy
A group of US Senators have sent a letter to Allergan’s chairman, president, and chief executive officer, Brenton Saunders, seeking further information about the company’s recent transfer of patents covering one of the company’s top-selling drugs, Restasis (cyclosporine ophthalmic emulsion), a drug to treat dry eyes, to the Saint Regis Mohawk Tribe, a recognized sovereign tribal government. The drug, which had 2016 sales of $1.4 billion, is the subject of patent litigation with several generic-drug manufacturers.
In September 2017, Allergan transferred all Orange Book-listed patents for Restasis to the Saint Regis Mohawk Tribe and then licensed the patents from the tribe. The patents are listed in the Orange Book, which publishes all US Food and Drug Administration-approved drug products with therapeutic equivalence, and are set to expire on August 27, 2024 and relate to methods of providing therapeutic effects using cyclosporin components.
The tribe filed a motion to dismiss an ongoing inter partes review (IPR) of the Restasis patents based on its sovereign immunity from IPR challenges. At the time of the agreement, Allergan said that the agreement with the tribe had no impact on then pending abbreviated new drug application patent litigation regarding the Restasis patent-family case being considered in a Texas federal district court. The Saint Regis Mohawk Tribe subsequently wrote a letter to the US Senate Judiciary Committee to clarify certain claims and misperceptions made in recent media coverage in a September 27, 2017 letter.
In October 2017, the US District Court for the Eastern District of Texas ruled the four asserted patents covering Restasis were invalid based on obviousness. Allergan is appealing the decision.
In the letter, US Sens. Sherrod Brown (D-OH), Patty Murray (D-WA), Amy Klobuchar (D-MN), Al Franken (D-MN), and Maggie Hassan (D-NH) questioned Allergan’s transfer of the Restasis patents. “We fully support the fundamental protections that sovereign immunity grants tribes and states to protect their own rights and property,” the senators said. “However, it is difficult to conceive of Allergan’s transaction as anything other than a sham to subvert the existing intellectual property system, which Congress established to set forth clear rules and expectations for the ownership and use of intellectual property.”
The letter was sent ahead of a hearing from the US Senate’s Judiciary Committee’ s Subcommittee on Intellectual Property to consider Allergan’s transaction with the tribe and how sovereign immunity impacts the patent-review system for prescription drugs.