Restasis Drugs Held Invalid as Obvious by Eastern District Court of Texas

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The St. Regis Mohawk Tribe's blockbuster deal to protect drug patents in exchange for millions of dollars has hit a roadblock.

Monday, October 16, 2017, Federal Circuit Judge William Bryson (sitting by designation in the Eastern District of Texas) ruled in favor of Sughrue's Client, Akorn, stating that four patents covering Allergan's dry eye drug Restasis® were invalid as obvious.

It said that Allergan had "invoked the benefits of the patent system", but refused to accept the limitations of those benefits. Restasis earned $1.5 billion a year ago. Allergan also paid the tribe nearly $14 million.

According to Mylan, the court's decision was also binding against the Saint Regis Mohawk Tribe, which had been added as a plaintiff to the case following a deal with Allergan.

Bryson's decision "will make patent owners question the arrangement, but I don't know if the ruling will prevent it entirely", Landau said. It was in federal court, where Allergan had said at the time of the deal it wouldn't try to use the Mohawks' sovereign immunity.

"This should flash some serious yellow lights, if not red lights, in front of parties considering a deal like this", said Michael Carrier, a professor of patent law at Rutgers Law School.

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Legal experts said the rebuke from a prominent judge will make other patent owners reluctant to copy Allergan's maneuver.

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".

"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.

So what does this all mean?

Allergan stock should decline more than it already has if it loses the case "because we believe most investors assume some odds of a win", said Bernstein analyst Ronny Gal last week, adding that he believes "the stock will recover to above current price" even in the case of a loss. But up to this point, no generic version of Restasis has received federal approval.

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