Federal Circuit orders stay of PTAB’s Restasis proceedings
The US Court of Appeals for the Federal Circuit has ordered the Patent and Trial Appeal Board (PTAB) to halt its review of patents covering a dry eye medication while the court considers arguments that tribal immunity protects the patents from board proceedings.
The Federal Circuit ordered the PTAB to pause its inter partes reviews (IPRs) of Restasis (cyclosporine ophthalmic emulsion) patents yesterday, March 28, while the court considers the Saint Regis Mohawk Tribe's tribal immunity arguments.
Last month, the PTAB rejected an attempt to dismiss the IPRs after finding that the Saint Regis Mohawk Tribe had not shown that the doctrine of tribal sovereign immunity should apply to protect the patents from IPRs.
Subsequently, Allergan and the Saint Regis Mohawk Tribe filed a joint motion, arguing that the PTAB does not have the necessary jurisdiction to decide on the validity of patents while its recent decision is being appealed.
“Because the issue on appeal is whether the board may proceed at all, the board cannot exercise jurisdiction concurrently with the Federal Circuit,” said the motion.
In September 2017, Allergan paid the tribe $13.75 million in an agreement which saw the Saint Regis Mohawk Tribe acquire the Restasis patents and grant Allergan an exclusive licence to the treatment.
The tribe then sought to dismiss the IPRs, which had been instigated by generics companies Mylan, Teva, and Akorn. In the submission, the tribe argued that it had tribal immunity from IPR challenges.
Allergan attempted to remove itself from the PTAB proceedings in January this year by claiming that it was a licensee of the patents and not the owner.
However, in its February decision, the PTAB said that the licence transferred “all substantial rights” in the challenged patents back to Allergan.
The Federal Circuit’s order to stay proceedings means that the PTAB’s final hearing regarding the matter will not go ahead as scheduled on April 3. The stay has been granted until June 2018, when oral arguments in the case are due to commence.
According to a statement provided by the Saint Regis Mohawk Tribal Council to LSIPR, the tribe is pleased with the decision.
It said: "The stay will give the tribe the opportunity to show that the PTAB was wrong when it refused to recognise the tribe’s sovereignty applies to the board’s proceedings and that going forward would be harmful to tribal sovereignty."
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