Mohawk tribe and Allergan seek en banc hearing in Restasis case

Allergan and the Saint Regis Mohawk Tribe asked the full US Court of Appeals for the Federal Circuit on Friday to review an earlier decision that rejected use of tribal sovereign immunity in the inter partes review (IPR).

In July, three circuit judges affirmed a decision by the Patent Trial and Appeal Board (PTAB) that the tribal immunity defence, raised by Allergan and the tribe, could not be used to dismiss IPRs filed against Allergan.

The case centres on dry-eye treatment Restasis (cyclosporine ophthalmic emulsion), which is made by Allergan. 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.

In January, Allergan  attempted to remove itself from the IPRs that had been brought against Restasis, claiming that it was “no more than an exclusive field-of-use licensee”.

But, according to the board’s decision in February, Allergan retained ownership in the patents and the tribe has nothing more an “illusory or superficial right” to sue for infringement of the challenged patents.

The deal had been heavily criticised by Mylan, one of the companies that brought the original IPRs against Restasis.

Now, a month after the three Federal Circuit judges affirmed the PTAB’s findings, Allergan and the tribe have requested an en banc hearing.

According to the Federal Circuit’s “Internal Operating Procedures”, the reasons to grant an en banc hearing can include necessity to secure or maintain uniformity of decisions and involvement of an exceptionally important question.

In the aftermath of the July decision, lawyers told LSIPR that parties would need to think twice before entering into similar deals until either the US Supreme Court or Congress weighs in on the issue of tribal sovereign immunity.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.