Supreme Court sends Allergan packing over Restasis tribal licensing strategy

Allergan has fought hard—and controversially—to protect its patents for blockbuster eye medicine Restasis with the help of a Native American tribe, but that effort seems to be reaching an end.

In a summary of Supreme Court orders for Monday, the Supreme Court refused to take up Allergan’s argument over a tribal licensing deal that involved transferring Restasis patents to the Saint Regis Mohawk Tribe and licensing them back. The move left in place a lower court’s ruling that the patent protection strategy is invalid.

An Allergan spokeswoman declined to comment.

The fight over Allergan’s tribal licensing deal has played out for about a year and a half. In September 2017, the drugmaker struck its deal with the Saint Regis tribe, aiming to sidestep a patent review at the U.S. Patent and Trademark Office on grounds that the tribe has “sovereign immunity” from such reviews.

But when Allergan inked the agreement, pharma watchers blasted it, saying it could further hurt the industry’s reputation as drugmakers faced swelling scrutiny over pricing. A group of U.S. senators wrote to Allergan CEO Brent Saunders saying that the move, paired with Allergan’s “social contract” on pricing, amounted to “hypocrisy.”

Still, Allergan stuck with the move, even when a U.S. Court of Appeals for the Federal Circuit ruled that it wouldn’t protect against reviews at the U.S. Patent and Trademark Office. Allergan and the tribe then took their arguments to the Supreme Court.

Separately, Allergan’s Restasis patents have been hit in federal court. In October 2017, a U.S. court piled on the pain with a ruling that Restasis’ patents were invalid; Allergan cut 1,400 jobs in response. Generic drugmakers are seeking to market copycats but haven’t yet won FDA approval. Last year, Restasis pulled in $1.26 billion, a 14% decline from 2017.

Meanwhile, Allergan also faces competitive threats to its top seller Botox, and it’s suffered from other recent setbacks, too. Last month, the company reported a phase 3 failure for closely watched depression drug candidate rapastinel.

https://www.fiercepharma.com/pharma/supreme-court-sends-allergan-packing-over-tribal-licensing-gambit