Four patents for Allergan’s blockbuster dry eye drug Restasis were invalidated by a federal judge on Monday, potentially leaving the drug open to generic copies. In a win for generic drugmakers Teva, Akorn and Mylan, Judge William Bryson of the federal court in Marshall, Texas found that the patents were invalid on the grounds of obviousness.
The patents in question have an expiry date of 2024, but in light of the ruling, its unlikely that Allergan will be able to continue to enjoy market exclusivity until then. In fact, Bryson said those patents should never have been granted to the Ireland-based company.
“We are disappointed by the Federal District Court’s decision on the Restasis patents,” said Robert D. Bailey, Chief Legal Officer, Allergan, in a statement about the ruling. “We are carefully reviewing the decision and are considering all options.”
In 2016, sales of Restasis reached nearly $1.5 billion, making it Allergan’s second most-lucrative franchise after its cosmetic product Botox. The US Food and Drug Administration (FDA) has yet to approve a generic version of Restasis, however the collapse of four of Allergan’s patents for the ophthalmic medication could pave the way for generics to hit the market as soon as the end of 2018.
In an attempt to avoid another type of patent challenge known as inter partes review, Allergan recently inked a controversial deal with New York’s Saint Regis Mohawk Tribe to transfer patents to Restasis. As the Native American tribe enjoys sovereign immunity to such patent challenges, Allergan plans to license the drug and protect its blockbuster from competition.
“What Allergan seeks is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits,” said Bryson, in a comment about the unusual deal.
Allergan has faced bipartisan criticism from various members of the US government, including US Senator Claire McCaskill. She’s already drafted a bill designed to prevent other drugmakers from using this loophole to avoid patent challenges in the future.