Court rejects Allergan's tribal licensing strategy, striking another blow to its generic Restasis defense

Allergan has been the subject of harsh criticism on his attempt to protect Restasis patents through sovereign immunity, and now a court of appeal has ruled that the strategy would not fly away

. The minutes from the US Patent and Trademark Office – which Outgan attempted to work around with his controversial licensing agreement – "look more like an agency's enforcement action." "in a civil suit brought by a private party".

A representative of Allergan declined to comment. A spokesman for the Saint Regis Mohawk tribe said the tribe was "very disappointed with the decision" and that it was "fundamentally" at odds with this position. The tribe examines the decision and consults its lawyers, he said.

Mylan retaliated with the court's approach, and after the decision, CEO Heather Bresch said in a statement that the decision is a "victory in our ongoing efforts to stop patent abuses by the companies of brand and contribute to access to more affordable medicines. "

Already in the Restasis saga, a federal court has overruled the drug patents in a case brought by Mylan and other drug makers . More recently, the Patent Board of Appeal and Appeal decided that it could proceed with its inter partes reviews despite the licensing agreement. The March Court of Appeal put this process on hold while she could re-examine the case.

In a Monday note, Bernstein's badyst, Ronny Gal, said the decision was "another nail in the Restasis IP coffin". He said that a generic launch is possible this week or the next. Allergan entered into its Restasis tribal licensing agreement in September 2017, seeking to apply sovereign immunity to protect cost-effective eye medication from US Patent Court and Appeal hearings. The strategy has prompted immediate criticism from industry observers and members of Congress.

Part of the reasons that Allergan executives claim to have entered into the agreement is a flawed patent review system that forces manufacturers to defend their intellectual property. . Allergan's CEO, Brent Saunders, called the system a "double jeopardy." Brand-name drug companies have expressed concerns about the IPR process for years, but the Supreme Court ruled in April that the revisions were constitutional.

Allergan executives have already predicted that Restasis will face generic competition between April of this year and July.