In September 2017, Allergan agreed to pay the Saint Regis Mohawk Tribe of Upstate New York $15 million a year to take ownership of the company’s Restasis patents. As a sovereign entity, the tribe claimed immunity from civil patent challenges.
Following this move, Mylan NV, Teva Pharmaceutical Industries Ltd., and Akorn Inc all filed challenges against Allergan, who maintained tribal immunity. On Friday, however, a U.S. appeals court ruled that Allergan and St. Regis Mohawk Indian Tribe can’t use tribal sovereign immunity to shield patents on the dry-eye drug Restasis from challenges at the U.S. Patent and Trademark Office.
Restastis is the company’s second-best selling drug, second only to the company’s wrinkle treatment, Botox. Sales from the dry-eye drug make up more than 9 percent of the company’s total revenue, generating $1.5 billion in sales last year. That number, though, is anticipated to drop significantly if low-cost versions enter the market.
Reviews of the challenges filed against Allergan will now proceed at the Patent Trial and Appeal Board in Alexandria, Virginia. To shield Restasis from generic competition before the patents’ 2024 expiration date, the company will need to win in both venues.