Allergan, a global biopharmaceutical company, acknowledged that the U.S. District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% are invalid. The company will appeal the Court's ruling.
"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," said Robert D. Bailey, Chief Legal Officer, Allergan. "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."
To date, none of the proposed generic versions of Restasis have received approval and none of these products would be able to launch in the market.
The patents include United States Patent Nos. 8,629,111; 8,648,048; 8,685,930 and 9,248,191. These patents, along with United States Patent Nos. 8,633,162 and 8,642,556, are listed in the Orange Book for Restasis and expire on August 27, 2024.