Allergan and tribe ask for stay pending SCOTUS appeal

Allergan and the Saint Regis Mohawk Tribe have urged the US Court of Appeals for the Federal Circuit to stay its ruling against them pending an appeal to the US Supreme Court.

This is the latest development in a closely-followed dispute centring on the application of tribal sovereign immunity in inter partes reviews (IPRs).

In September last year, Allergan paid the tribe $13.75 million to acquire dry-eye treatment Restasis (cyclosporine ophthalmic emulsion) from it and then grant the pharmaceutical company an exclusive licence to the treatment.

Allergan attempted to remove itself from the IPRs, which had been brought against Restasis by Mylan and other generic makers, claiming that it was “no more than an exclusive field-of-use licensee”.

However, in February, the Patent Trial and Appeal Board (PTAB) rejected the tribe’s attempt to dismiss the IPRs based on tribal immunity. The board also found that Allergan retained ownership in the patents and that the tribe retained nothing more than an “illusory or superficial right” to sue for infringement of the challenged patents.

The tribe and Allergan appealed against the decision but, in July, three Federal Circuit judges affirmed the PTAB’s finding that tribal sovereign immunity cannot be asserted in IPRs.

A month after the Federal Circuit affirmed the PTAB’s findings, Allergan and the tribe requested a panel rehearing and an en banc rehearing.

In late October, the Federal Circuit denied the petitions.

Then, on Friday, October 26, the Saint Regis Mohawk Tribe and Allergan asked the Federal Circuit to stay its decision, pending the filing of a petition for a writ of certiorari.

“This case presents a substantial question of fundamental importance: whether a federally recognised Indian tribe—and, indeed, any sovereign—may assert sovereign immunity in an IPR before the PTAB,” said the filing.

The filing added that the nature of the question presented by the decision is “underscored by the fact that its implications are not limited to this case”.

Without a stay, the board will resume the IPRs during the period when the Supreme Court is considering Allergan’s and the tribe’s petition for certiorari.

“The tribe will then face irreparable injury from the resumption of the IPRs proceedings, regardless of their outcome,” noted the filing.

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