US Patent Board Allows Mylan’s Challenge to Restasis Patents to Move Forward

March 2, 2018: By Joan McKenna

Mylan announced Feb. 26 that its inter partes review challenge of six patents protecting Allergan’s Restasis will go forward after the US Patent Trial and Appeal Board (PTAB) denied a motion to terminate the challenge.

The St. Regis Mohawk Tribe, which now holds the patents, filed the motion in 2017 on the grounds that it has sovereign immunity from patent challenges.

Allergan transferred Restasis’ patents to the tribe in September 2017 and licensed them back.

Mylan said the PTAB denied the tribe’s motion Feb. 23, holding that the tribe did not establish that tribal sovereign immunity applied to inter partes review proceedings.

Mylan said the patent board tentatively scheduled an oral hearing April 3 and said it would render a final decision on the patentability of the challenged patents by June 6.

In October 2017, the Eastern District of Texas held Allergan’s Restasis patents invalid in the US courts system. The case is currently on appeal.

Dublin-based Allergan has been preparing for the launch of a generic version of Restasis in 2018 by paring costs.

Competitors are also lining up to challenge Allergan’s Botox brand. On March 1, Mylan, of Canonsburg, Pennsylvania, announced plans to bring a lower-priced biosimilar version of Botox to market through a collaboration with Newark, California-based Revance Therapeutics.

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