Ruling negates company’s deal with Mohawk tribe to avoid patent board review

A US federal court has ruled that four patents relating to Allergan’s Restasis (ciclosporin) eye drops are invalid. The ruling opens the way for challengers Mylan and Teva to introduce generic versions. Allergan has said it will appeal the decision.

The ruling renders Allergan’s transfer of these patents to the St Regis Mohawk tribe null and void – Allergan intended the deal to shield the company from a parallel challenge through the US Patent and Trade Office, by employing the Native American tribe’s sovereign immunity from such challenges.

At the same time, Allergan had struck a deal with Pfizer subsidiary Innopharma to resolve litigation over the same patents. Allergan has granted Innopharma a license to market a generic cyclosporin eye treatment in the US in February 2024 – about six months before its patents were due to expire – or earlier under certain circumstances. It is unclear how the court’s ruling would affect this deal.

Allergan noted in a statement that neither Mylan nor Teva has yet received regulatory approval for their generic cyclosporine eye drops. However, both companies already produce the drug in capsule form, and the ruling clears the way for them to be launched as soon as they are approved.