The U.S. Patent Trial and Appeal Board ruled last week that the tribal immunity granted to Native American tribes in the U.S. does not shield tribes from patent challenges.
The ruling is a setback for Allergan (NYSE:AGN); the pharmaceutical company transferred patent rights for its blockbuster eye drug, Restasis, to the St. Regis Mohawk Tribe last year in an attempt to avoid inter partes review.
After inking a deal with the tribe, the group sought to dismiss the IPR challenges brought by Mylan (NSDQ:MYL) and other generic pharma companies, arguing that sovereign immunity exempted them from review.
But in its 42-page opinion, the board wrote that “reconsideration of the patentability of issued claims via inter partes review is appropriate without regard to the identity of the patent owner.”
It’s not yet clear how the tribe’s legal team intends to proceed.
“The PTAB’s ruling reinforces our belief that Allergan’s maneuvers to engage the St. Regis Mohawk Tribe for patent protection were a sham,” Mylan CEO Heather Bresch said in prepared remarks. “We will continue to be steadfast in our efforts on both the legal and regulatory fronts to bring a generic version of Restasis to patients as quickly as possible.”