Patent Board Denies Allergan, Mohawk Bid to Shield Restasis Patents

Generics-maker Mylan can proceed with patent challenge

Allergan’s attempt to protect six Restasis patents by assigning them to the St. Regis Mohawk Tribe has hit a snag: The U.S. Patent Trial and Appeal Board (PTAB) has denied the tribe’s motion to terminate Mylan's patent challenge.

"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. “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."

Allergan declined to comment.

Allergan announced in September 2017 that it had assigned the rights of six patents on Restasis (cyclosporine ophthalmic emulsion) to the tribe, which immediately moved to dismiss the PTAB proceedings, arguing that its tribal sovereign immunity prevented the PTAB from reviewing the patents.

On February 23, Mylan said, 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, Mylan said, 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 of the patent issue for April 3, 2018, and said that it would render a final written decision on the challenged patents by June 6, 2018.  

Mylan previously announced that the Eastern District of Texas held Allergan's patents invalid after a trial on the merits. The case is on appeal before the U.S. Court of Appeals for the Federal Circuit.

Allergan’s decision to assign the patents to the Mohawk Tribe drew responses last year ranging from “innovative” to “sleazy.” Under the maneuver, Allergan said it would pay the New York tribe $13.75 million up front, plus up to $15 million in royalties per year. If successful, the arrangement would represent a new way for pharma to circumvent the inter partes review system. But some observers blasted the company on Twitter, calling the deal unscrupulous and sure to bring more criticism to the industry.

Sources: Mylan; February 26, 2018; PTCommunity; September 11, 2017.