Lawsuit: Allergan Engages in Scheme to Delay Approval of Restasis Generic Alternatives

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Allergan, Inc. is on the receiving end of a proposed class action lawsuit that accuses it of violating antitrust laws with respect to its prescription drug Restasis. The suit claims the defendant attempted to “extend its monopoly” over the market for cyclosporine emulsion eyedrops, which are used to treat dry-eye disease, by:

• issuing new patents for the drug before the old patents were set to expire by falsely claiming its new formulation produced “new and unexpected results;”
• listing the new patents in the U.S. Food and Drug Administration’s (FDA) Orange Book, thereby requiring any competitors to notify the defendant before launching generic alternatives;
• filing lawsuits against generic competitors that delayed their entrance into the market by automatically triggering a 30-month stay of FDA approval;
• filing “repetitive sham citizen petitions” against competitors that further delayed generic approval by requiring the FDA to spend time and resources responding to the defendant’s “baseless arguments;” and
• transferring the new patents to the Saint Regis Mohawk Tribe and licensing them back, essentially “renting” the tribe’s sovereign immunity to protect Allergan from having to defend itself in the U.S. Patent and Trademark Office’s proceedings against it.

The suit argues that the defendant’s behavior was an attempt to delay competition, allowing it to charge consumers higher prices for their prescription medicine for as long as possible.