Allergan Facing Latest Restasis Antitrust Suit in Texas

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Allergan, Inc. has faced a series of lawsuits alleging it unlawfully delayed the entrance to the market of generic alternatives to its cyclosporine ophthalmic emulsion drug, Restasis, causing consumers to be overcharged for the medicine by millions of dollars. The latest suit, filed in Texas, details the defendant’s alleged “scheme,” claiming the drug manufacturer attempted to “prolong its monopoly” over the market in the following ways:

• issuing false “second wave patents” for Restasis by misrepresenting to the U.S. Patent and Trademark Office (PTO) that new clinical trials of a lower strength version of the drug produced “unexpected effectiveness and surprising results;”
• wrongfully listing the new patents in the Food and Drug Administration’s Orange Book despite knowing the patents were invalid and would not hold up against competitors’ applications for approval of generic alternatives;
• filing “baseless” petitions with the FDA demanding the organization impose “unnecessary, time-consuming, and unsupported requirements” on potential competitors, all of which were denied;
• filing infringement actions against competitors that automatically delayed the approval of their new drugs; and
• transferring ownership of the second wave patents to the Saint Regis Mohawk Tribe in an attempt to “hide under [the tribe’s] cloak of sovereign immunity” and hinder the PTO’s ability to invalidate the patents.

The suit argues that absent Allergan’s allegedly unlawful actions, generic alternatives to Restasis would have been available as early as May 2014, offering consumers significant cost savings for the needed medicine.