Allergan and tribe claim PTAB can’t decide on Restasis patents

Allergan and the Saint Regis Mohawk Tribe have argued that the Patent Trial and Appeal Board (PTAB) doesn’t have the jurisdiction to decide on the validity of patents concerning a dry-eye treatment while its recent decision is being appealed.

In February, the board rejected the tribe’s attempt to dismiss inter partes reviews (IPRs) related to Restasis (cyclosporine ophthalmic emulsion), after finding that the Saint Regis Mohawk Tribe had not established that the doctrine of tribal sovereign immunity should be applied to the proceedings.

That’s not all—the PTAB also determined that the proceedings could continue without the tribe’s participation in view of “Allergan’s retained ownership interests in the challenged patents”.

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

Soon after, the tribe filed a motion to dismiss the IPRs of the patents (which had been instituted by generics companies including Mylan), based on the tribe’s sovereign immunity from IPR challenges.

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

But, according to the PTAB, the tribe had not retained anything more than an “illusory or superficial right” to sue for infringement of the challenged patents.

At the end of February, Allergan and the tribe filed a formal notice of appeal with the PTAB, announcing plans to take the decision to the US Court of Appeals for the Federal Circuit.

This was followed by a joint motion on the board’s jurisdiction, submitted on Thursday, March 8.

The two claimed that when the notice of appeal was filed in February, the PTAB was divested of jurisdiction.

“Because the issue on appeal is whether the board may proceed at all, the board cannot exercise jurisdiction concurrently with the Federal Circuit,” it said.

The Saint Regis Mohawk Tribe said it would be “irreparably harmed” if the PTAB were to proceed in its absence, since it is the “tribe’s immunity from the process itself that the tribe seeks to protect on appeal”.

If the PTAB doesn’t acknowledge it is divested of jurisdiction, the joint motion states that the board should issue a stay of proceedings.

It added: “If this board went forward despite the appeal, the tribe will be forced to choose between appearing before the board, thereby losing its immunity, or risk losing its substantial property rights in absentia.”

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