- A U.S. patent board on Friday denied a motion by the St. Regis Mohawk Tribe to dismiss challenges to patents protecting Allergan's dry eye drug Restasis, delivering a blow to the Irish pharma's bid to fend off generic competition through an unusual deal with the Indian tribe last fall.
- In a 42-page decision, three administrative judges of the U.S. Patent Trial and Appeal Board (PTAB) ruled the St. Regis Mohawk Tribe could not use its legal immunity as a sovereign government to defeat a type of legal challenge known as inter partes review (IPR).
- The order undermines Allergan's aim of sidestepping PTAB reviews and allows for efforts by generic drugmakers Mylan N.V., Teva Pharmaceuticals Industries Ltd. and Akorn Inc. to overturn the Restasis patents to continue.
Allergan's deal with the St. Regis Mohawk Tribe sparked backlash as soon as it was announced last September, inviting criticism from U.S. lawmakers and even from within the industry itself. Now, the ruling from the PTAB pokes major holes in the legal rationale that drove Allergan to try the unorthodox arrangement.
Under the deal, Allergan transferred ownership of its Restasis patents to the tribe while simultaneously licensing exclusive use of those same patents for all indications approved by the Food and Drug Administration. Effectively, the agreement sought to exploit the tribe's sovereign immunity as a shield to block IPR proceedings.
The PTAB, however, disagreed with Allergan's thinking.
"We determine that the Tribe has not established that it is entitled to assert its tribal immunity in these inter partes review proceedings," wrote the three judges who issued the decision.
Furthermore, the judges ruled that the tribe "has not retained anything more than an illusory or superficial right to sue for infringement of the challenged patents," as Allergan's exclusive licensing of all applicable rights made it the effective patent owner.
With this decision, the administrative court will continue to hear the IPR challenges brought by Mylan, Teva and Akorn against the Restasis patents. An oral hearing on the merits is tentatively scheduled for April 3, with a final written decision on the patentability of the patents in question by June 6.
"The PTAB's ruling reinforces our belief that Allergan's maneuvers to engage the St. Regis Mohawk Tribe for patent protection were a sham," said Mylan CEO Heather Bresch in a Feb. 26 statement. "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."
For its part, Allergan has said it doesn't expect market entry of generic copies to Restasis before the second quarter of this year. Sales of the dye eye drug totaled $1.47 billion last year.
In separate court proceedings, a federal judge in Texas invalidated four patents protecting Restasis last October.
Allergan declined to comment on the PTAB's ruling.