Federal Circuit refuses tribal immunity rehearing
In a blow to Allergan and the Saint Regis Mohawk Tribe, the US Court of Appeals for the Federal Circuit yesterday refused to reconsider an earlier decision that rejected use of tribal sovereign immunity in inter partes reviews (IPRs).
Allergan and the tribe had requested a panel rehearing and an en banc rehearing in August this year, a month after three circuit judges affirmed a Patent Trial and Appeal Board (PTAB) decision that the tribal immunity defence couldn’t be used to dismiss IPRs filed against Allergan.
Dry-eye treatment Restasis (cyclosporine ophthalmic emulsion) is at the centre of the clash. In September last year, Allergan paid the tribe $13.75 million to acquire the drug from it and then grant the pharmaceutical company an exclusive licence to the treatment.
Allergan subsequently tried 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”.
But, in February this year, the PTAB rejected the attempt to dismiss based on tribal sovereign immunity. It found that Allergan retained ownership in the patents and the tribe retained nothing more an “illusory or superficial right” to sue for infringement of 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.
Soon after, Allergan and the tribe revealed plans to appeal against the PTAB’s decision and, in late March, the Federal Circuit ordered a stay of the proceedings.
In July, the Federal Circuit backed the PTAB, concluding that tribal sovereign immunity cannot be asserted in IPRs.
A month after the three Federal Circuit judges affirmed the PTAB’s findings, Allergan and the tribe requested the rehearings.
Despite the Federal Circuit’s decision to deny the petition for a panel rehearing and an en banc rehearing, Allergan and the tribe can still appeal to the US Supreme Court.
A spokesperson for the Saint Regis Mohawk Tribe said the tribe was disappointed with the decision to deny its petition for a rehearing.
“We continue to maintain that the court’s decision declaring an IPR an action of the US is not supported by the statute. In light of the order, our legal department is currently considering our options.”
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