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7 November 2018Americas

Teva and Mylan implore Fed Circuit not to stay immunity ruling

Generic makers Teva, Mylan and Akorn asked the US Court of Appeals for the Federal Circuit not to stay to its sovereign immunity ruling pending an appeal by Allergan and the Saint Regis Mohawk Tribe to the US Supreme Court.

On Monday, November 5, the three generic makers (which are also named as appellees in the case) urged the Federal Circuit to refuse a stay of the decision, which held that tribal sovereign immunity doesn’t apply in inter partes reviews (IPRs).

Three Federal Circuit judges affirmed the Patent Trial and Appeal Board’s (PTAB) finding that immunity cannot be asserted in IPRs, in July this year.

A month later, Allergan and the tribe requested a panel rehearing and an en banc rehearing, but these were denied in October.

In late October, LSIPR reported that the Saint Regis Mohawk Tribe and Allergan asked the Federal Circuit to stay its decision pending the filing of a petition for a writ of certiorari.

“This case presents a substantial question of fundamental importance: whether a federally recognised Indian tribe—and, indeed, any sovereign—may assert sovereign immunity in an IPR before the PTAB,” said the filing.

However, the generic makers have claimed that Allergan and the tribe have “not come close” to showing the extraordinary circumstances required for a stay.

“Although appellants contend that this case ‘presents a substantial question’, they have not even attempted to demonstrate a reasonable probability that the US Supreme Court will grant certiorari or a fair prospect that the court will reverse,” said the brief.

The generic makers claimed that the case would be a “poor vehicle” for considering the Eleventh Amendment implications of PTAB proceedings.

The Eleventh Amendment prohibits the federal courts from hearing certain suits against states.

“The Eleventh Amendment does not apply to Indian tribes, and the panel decision is expressly limited to tribal sovereign immunity, ‘leav[ing] for another day the question of’ state immunity,” added the filing.

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More on this story

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.
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7 March 2019   The US Court of Appeals for the Federal Circuit yesterday, March 6, refused to rehear a decision which found Allergan and the Saint Regis Mohawk Tribe’s patents for dry-eye treatment Restasis (cyclosporine ophthalmic emulsion) are invalid.
Big Pharma
6 November 2020   The US Court of Appeals for the Federal Circuit has narrowed the landscape in which patent infringement suits over generic drugs suits can be filed, in a ruling handed down yesterday, November 5.

More on this story

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.
Americas
7 March 2019   The US Court of Appeals for the Federal Circuit yesterday, March 6, refused to rehear a decision which found Allergan and the Saint Regis Mohawk Tribe’s patents for dry-eye treatment Restasis (cyclosporine ophthalmic emulsion) are invalid.
Big Pharma
6 November 2020   The US Court of Appeals for the Federal Circuit has narrowed the landscape in which patent infringement suits over generic drugs suits can be filed, in a ruling handed down yesterday, November 5.