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16 April 2019Americas

SCOTUS refuses to hear tribal immunity suit

The US Supreme Court has declined to hear a closely-watched case on tribal immunity involving pharmaceutical company Allergan and the Saint Regis Mohawk Tribe, a Native American tribe.

Yesterday, April 15, the US’s highest court  denied the Saint Regis Mohawk Tribe’s and Allergan’s writ of certiorari.

The refusal to hear the case affirms a lower court’s decision to uphold the Patent Trial and Appeal Board’s (PTAB) rejection of the tribe’s attempt to dismiss a series of inter partes reviews (IPRs) based on tribal immunity.

The IPRs had been brought by generic makers including Mylan, that were seeking to market a generic version of dry-eye treatment Restasis (cyclosporine ophthalmic emulsion).

But, in Septemeber 2017, Allergan paid the tribe $13.75 million to acquire the dry-eye treatment from Allergan then grant the pharmaceutical company an exclusive licence to the treatment.

After Allergan attempted to remove itself from the IPRs by claiming it was “no more than an exclusive field-of-use licensee” and the tribe attempted to dismiss the proceedings based on tribal immunity, the PTAB handed down its decision.

In February 2018, the board  rejected the tribe’s attempt to dismiss the IPRs based on tribal immunity and found that Allergan had retained ownership in the patents.

The Federal Circuit  affirmed the PTAB’s decision in July that year.

Allergan and the tribe requested a panel rehearing and an en banc rehearing, both of which were  denied by the Federal Circuit in later October.

The pair then  urged the Federal Circuit to stay its ruling against them pending an appeal to the US Supreme Court, before filing their petition in December last year.

In response to the petition, Mylan  claimed: “Moreover, even if the applicability of tribal sovereign immunity in IPRs were an issue worthy of this court’s review, this case would be an exceptionally poor vehicle for deciding it.”

In separate proceedings, the Restasis patents have been invalidated.

Back in October 2017, Judge William Bryson of the US District Court for the Eastern District of Texas  found that although the Restasis patents were infringed by generic drugmaker Teva, Teva had demonstrated the patents were invalid.

The following November, the Federal Circuit affirmed the district court’s ruling without issuing a formal opinion and, in March this year, the Federal Circuit  refused to rehear the decision.

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More on this story

Big Pharma
20 March 2019   Allergan and the Saint Regis Mohawk Tribe have again urged the US Supreme Court to hear their closely-followed litigation on tribal sovereign immunity, following a submission from generic maker Mylan in the case.
Americas
29 October 2018   Allergan and the Saint Regis Mohawk Tribe have urged the US Court of Appeals for the Federal Circuit to stay its ruling against them pending an appeal to the US Supreme Court.

More on this story

Big Pharma
20 March 2019   Allergan and the Saint Regis Mohawk Tribe have again urged the US Supreme Court to hear their closely-followed litigation on tribal sovereign immunity, following a submission from generic maker Mylan in the case.
Americas
29 October 2018   Allergan and the Saint Regis Mohawk Tribe have urged the US Court of Appeals for the Federal Circuit to stay its ruling against them pending an appeal to the US Supreme Court.