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.
Walgreen, Kroger, Albertsons and HEB Grocery Company sued Allergan Wednesday for an "unlawful scheme" to protect Restasis' branded sales. The companies—which all operate retail pharmacies—allege the drugmaker made "material misrepresentations" to obtain follow-up patents as its original IP shields were expiring. If not for those misrepresentations and Allergan's conduct afterward, generics would have rolled out in May 2014, the plaintiffs contend, allowing them to sell cheaper alternatives.
An Allergan representative said the company doesn't comment on current litigation. Plaintiffs filed their suit in New York federal court.
After it sewed up its new batch of patents, Allergan improperly listed them in the FDA's Orange Book—the agency's official listing of patents and exclusivity granted to branded drugs—and sued generic drugmakers for "infringement of those invalid and unenforceable patents," the lawsuit claimed. "[N]o reasonable litigant" would have expected to win those lawsuits, Allergan included, the plaintiffs contend.
"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.
Allergan's controversial Restasis licensing deal with the Saint Regis Mohawk Tribe also makes an appearance in the suit. Under the deal, Allergan transferred Restasis patents to the tribe and licensed them back, seeking to sidestep a patent review at the U.S. Patent and Trademark Office. Allergan entered the deal in September and ran into tough pushback; the strategy is now under appeal.
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's Restasis generated $1.41 billion in the U.S. last year, making it among the drugmaker's bestselling drugs. Allergan has said it expects generic competition to the key brand by July.