Native American tribe not entitled to sovereign immunity: PTAB

The Patent Trial and Appeal Board (PTAB) rejected the Saint Regis Mohawk Tribe’s attempt to dismiss inter partes reviews (IPRs) related to dry-eye treatment Restasis (cyclosporine ophthalmic emulsion) late last week.

On Friday, February 23, the PTAB determined that the tribe, which had acquired the rights to Restasis in September last year, had not established that the doctrine of tribal sovereign immunity should be applied to the proceedings.

Allergan paid the tribe $13.75 million to acquire Restasis and the company was then granted an exclusive licence to the treatment.

Mylan, one of the generics companies that had requested six IPRs of the patents, claimed it was a “desperate” and “transparent” delay tactic, in a filing at the US District Court for the Eastern District of Texas, Marshall Division.

Soon after, the tribe filed a motion to dismiss the IPRs of the patents, based on the tribe’s sovereign immunity from IPR challenges.

US universities have successfully employed this strategy—in May last year, LSIPR reported that a heart valve patent owned by the University of Maryland, Baltimore was immune to IPR.

Because of the public interest, the board invited parties to file briefs as amicus curiae. The Computer & Communications Industry Association and the Association for Accessible Medicines urged the board to dismiss the Native American tribe’s case.

On Friday, not only did the PTAB find that the tribe doesn’t have sovereign immunity in this case, it also determined that the proceedings could continue without the tribe’s participation in view of “Allergan’s retained ownership interests in the challenged patents”.

“In view of the recognised differences between the state sovereign immunity and tribal immunity doctrines, and the lack of statutory authority or controlling precedent for the specific issue before us, we decline the tribe’s invitation to hold for the first time that the doctrine of tribal immunity should be applied in IPR proceedings,” said the PTAB.

The board added that, based on the terms of the licence between Allergan and the tribe, the licence transferred “all substantial rights” in the challenged patents back to Allergan, so the proceedings can continue with Allergan as the patent owner.

In January, Allergan attempted to remove itself from the IPRs, claiming that it was “no more than an exclusive field-of-use licensee”.

According to the PTAB, based on the record before it, the tribe has not retained anything more than an “illusory or superficial right” to sue for infringement of the challenged patents.

Heather Bresch, CEO of Mylan, 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 manoeuvres to engage the Saint Regis Mohawk Tribe for patent protection were a sham.”

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.

Join us at LSPN North America on April 26,  find out more here.