Is Restasis – an eye drug protected from Generic Competition?

Allergan has already faced heaps of scrutiny for its strategies to protect blockbuster eye drug Restasis from generic competition, but it’ll have to defend itself against a new group of plaintiffs now that four retail pharmacies have launched a lawsuit. A U.S. administrative court said it has the authority to decide the validity of patents Allergan Plc transferred to a Native American tribe, dealing a setback to a strategy the company adopted to protect one of its best-selling medicines from generic competition.

In September Allergan transferred its patents covering Restasis to the Saint Regis Mohawk Tribe, arguing that the New York-based tribe’s status as a sovereign entity meant the patents could not be reviewed by the board because of a legal doctrine called sovereign immunity. Allergan filed the lawsuits simply to trigger the automatic thirty-month stay of FDA approval and delay the entry of its generic competitors,” the lawsuit says, referring to a provision of the Hatch-Waxman Act that puts copycat drugs on hold as patent fights are sorted out. The retailers’ lawsuit calls the licensing deal “another attempt to maintain its monopoly in the relevant market by insulating the invalid follow-on patents from review.” The plaintiffs are asking for permanent injunctive relief, damages, legal costs and more.

Allergan has said the patent board is a flawed and unfair forum. The drug company said it would not object to the patents being reviewed in federal court.

U.S. lawmakers from both political parties have criticized Allergan’s maneuver, with one U.S. senator introducing a bill to ban attempts to take advantage of tribal sovereignty. The patent board said in Friday’s ruling that tribal immunity does not apply to patent review proceedings.

The tribunal also said Allergan had retained an ownership interest in the challenged patents so the proceedings could continue without the tribe’s participation. Allergan’s Restasis generated $1.41 billion in the U.S. last year, making it among the drug maker’s bestselling drugs. Allergan has said it expects generic competition to the key brand by July.

The Patent Trial and Appeal Board, a court run by the U.S. patent office, declined on Friday a request to dismiss litigation brought by the generic drug company Mylan NV challenging the validity of Allergan’s patents on its dry eye medicine Restasis.


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