Published: Wed, October 18, 2017
Sci-tech | By Carrie Guzman

Judge invalidates Allergan's key patents for dry-eye treatment Restasis

Judge invalidates Allergan's key patents for dry-eye treatment Restasis

A US judge has invalidated patents on Allergan PLC's dry-eye medicine Restasis (cyclosporine ophthalmic emulsion) on grounds that the patents cover ideas that are obvious, sending shares of the pharmaceutical company down 3.5%. In the 135 page opinion, Judge Bryson held as invalid and obvious all 13 asserted claims (representative of 113 claims) in 4 Orange Book Listed patents covering the drug Restasis®.

Judge William Bryson issued the ruling in federal court in Marshall, Texas, in a longstanding dispute between Allergan and generic drug-makers Mylan NV, Teva Pharmaceutical Industries Ltd., and Akorn, Inc.

Allergan said it planned to appeal the decision. For purposes of the judgment, the Court allowed the Indian Tribe to join as co-plaintiff, without finding the patent assignment to them to be valid.

Still, the decision was a setback for the company, whose stock dipped more than 5 percent on the news.

The case was regarding Restasis, a blockbuster eye drug whose patents Allergan had in September given to the Saint Regis Mohawk Tribe. The tribe did not claim sovereign immunity in that case.

Bryson also criticized Allergan's recent deal to transfer the patents to a Native American tribe, which the company has said was an effort to protect them from administrative review by the U.S. Patent and Trademark Office, not challenges in federal court.

"While Allergan has pointed to evidence of objective considerations such as commercial success and long-felt unmet need, the force of that evidence is considerably blunted by the fact that, based on protection from a succession of patents, Allergan was able to foreclose competition in cyclosporin/glyceride emulsion formulations from the early 1990s until 2014", the decision said. But his decision on Monday rendered Allergan's move largely meaningless, since he invalidated the Restasis patents himself instead of waiting for the patent office to rule.

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Bryson said "sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities".

But Monday's decision wasn't made by that patent review board.

"The Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed", Bryson said.

The tribe had countered that it was within its rights and that further deals could serve as an added source of revenue for its community of more than 15,000 people in a rural, economically depressed region near the Canadian border.

It was unclear exactly when a generic version of Restasis might be available to consumers.

David Maris, an analyst for Wells Fargo, estimated in a note to investors Monday that a generic alternative would likely not enter the market until 2019.

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