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15 May 2018Patents

Mixed fortunes for the appeal boards

Back in 2012, it would have been hard to envision the type of cases that would take centre stage at the US Patent Trial and Appeal Board (PTAB). As the board was introduced that year, with the newly-formed inter partes review (IPR) falling within its remit, Native American tribes and the question of sovereign immunity almost certainly crossed no-one’s mind.

But in 2018, an IPR dispute involving the Saint Regis Mohawk Tribe is rumbling on, in what is arguably the second major controversy to grip the PTAB. Like the first—in which hedge fund manager Kyle Bass challenged numerous drug companies’ patents, inviting allegations he was trying to short the stock of those organisations—the tribe affair concerns major pharmaceutical manufacturers.

The furore around Bass may have died down, but the same cannot be said for the Saint Regis Mohawk Tribe case. It comes as the very constitutionality of the IPR process itself is being questioned—and may even be under threat.

When Mylan, Teva and Akorn filed IPRs against Restasis (cyclosporine ophthalmic emulsion), a dry-eye treatment owned by Allergan, they probably didn’t expect the next move. Allergan paid the Saint Regis Mohawk Tribe $13.75 million in exchange for the tribe’s acquiring the Restasis patents and then granting Allergan an exclusive licence to the treatment. The tribe sought to dismiss the IPRs, arguing that it had tribal immunity from such challenges.

In February, the PTAB rejected the dismissal attempt after finding that the Saint Regis Mohawk Tribe had not shown that the doctrine of tribal sovereign immunity should apply to protect the patents against IPRs. One month later, the US Court of Appeals for the Federal Circuit ordered the PTAB to halt its review of the patents while the court considers the tribe’s arguments. The Federal Circuit’s stay has been granted until June 2018, when oral arguments in the case are due to begin.

Mike Schuster, assistant professor at the Spears School of Business at Oklahoma State University, says he is anxiously awaiting the Federal Circuit review in the case, which comes against a wider backdrop of controversy.

“Some see this as the PTAB establishing a willingness to take firm stances within its area of expertise, but others assert that the PTAB is merely a group of bureaucrats who have eschewed precedent in favour of their own whims.

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