Regulatory Affairs

US federal judge invalidates Allergan patents on Restasis

PBR Staff Writer Published 17 October 2017

A US federal judge has ruled four of Allergan’s patents over its dry eye medicine Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% to be invalid for covering obvious ideas.

Allergan said that it will appeal against the ruling given by Judge William Bryson in the United States District Court for the Eastern District of Texas.

The lawsuit pertains to a long-standing dispute between Allergan and generic drugmakers that included Mylan and Teva Pharmaceutical Industries and Akorn which have been looking to create and launch generic versions of Restasis.

Allergan chief legal officer Robert Bailey said: “We are disappointed by the Federal District Court's decision on the RESTASIS patents. We are carefully reviewing the decision and are considering all options.

“Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients.”

Allergan claims that none of the proposed generic versions of Restasis would be able to launch in the market with their approval yet to be given by the US Food and Drug Administration (FDA).

The four patents in question were recently transferred by Allergan to a Native American tribe named Saint Regis Mohawk Tribe. Judge William Bryson criticized the patent transfer from was a move from Allergan as a move to protect them from administrative review.        

Mylan which has been leading the lawsuit stated that the court had recognized that the patent protection over Restasis held by Allergan had ended in 2014. Thereby, it said that the court came to the conclusion that the Dublin-based firm cannot renew its patent rights through a second wave of patent protection.

Mylan CEO Heather Bresch said: “For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients.

Bresch concluded that Mylan will continue to work with the FDA to expeditiously launch more affordable, generic Restasis version to patients.

Image: Allergan dry eye medicine Restasis. Photo: courtesy of ALLERGAN.