FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Allergan Rivals Ask Supreme Court Not to Review St. Regis Tribe Patent Deal

March 22, 2019

Three drugmakers urged the U.S. Supreme Court not to review a lower court’s decision on the controversial patent deal between Allergan and the St. Regis Mohawk tribe.

Akorn, Mylan and Teva said the Federal Circuit’s ruling, which found tribal sovereign immunity cannot shield it from a federal agency’s enforcement, should stand. In 2017, Allergan transferred the patents covering its blockbuster eye drug Restasis (cyclosporine) to the tribe, which invoked its sovereign immunity against patent challenges from generics makers, including Mylan and Teva.

Last February, the Patent Trial and Appeal Board ruled tribes cannot use sovereign immunity to block inter partes reviews (IPR), a finding a federal appeals court upheld five months later.

In January, Allergan and the tribe asked the Supreme Court to reverse the decision, arguing an IPR is not an agency enforcement action. But the three rival drugmakers disagreed, writing that the lower court correctly identified IPR proceedings as closer to an agency enforcement action than a civil action.

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