Generic drug company Mylan said the US Patent Trial and Appeal Board (PTAB) “has denied the St. Regis Mohawk Tribe’s motion to terminate Mylan’s patent challenge regarding six patents related to Allergan’s Restasis.”
PTAB declined a request to dismiss litigation brought by Mylan challenging the validity of Allergan’s patents on its dry eye medicine Restasis.
In September, Allergan transferred its patents covering Restasis to the St. Regis Mohawk Tribe, arguing that the New York-based tribe’s status as a sovereign entity meant the patents could not be reviewed by the board because of sovereign immunity.
Mylan CEO Heather Bresch said: “Mylan has always been vocal in its efforts to challenge and break down barriers to access.
“The PTAB’s ruling reinforces our belief that Allergan’s maneuvers to engage the St. Regis Mohawk Tribe for patent protection were a sham.
“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.”
The full 42-page PTAB decision can be read here.
Mylan added: “In a move admittedly designed to protect the Restasis patents from cancellation by the PTAB, Allergan announced last September that it had assigned the rights of six patents to the Tribe.
“The Tribe immediately moved to dismiss the proceedings, arguing that its tribal sovereign immunity prevented the PTAB from reviewing the patents.
“On Feb. 23, the PTAB denied the Tribe’s motion on multiple grounds.
“The PTAB held that the Tribe did not establish that the doctrine of tribal sovereign immunity applied to inter partes review (IPR) proceedings.
“Alternatively, the PTAB held that even if tribal sovereign immunity did apply, the IPR proceedings could continue without the Tribe because Allergan retained ownership interests in the patents.
“The PTAB tentatively scheduled an oral hearing on the merits for April 3, 2018, and stated that it would render a final written decision on the patentability of the challenged patents by June 6, 2018.”