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WASHINGTON — The Federal Trade Commission has filed a complaint in federal district court alleging that AbbVie Inc. and Teva Pharmaceuticals USA Inc. illegally blocked U.S. consumers’ access to generic versions of the testosterone gel AndroGel.
Filed on Monday, the FTC complaint claims that AbbVie and its partner Besins Healthcare Inc. filed "baseless" patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of AndroGel, a testosterone replacement medication.
In addition, the FTC charges that while those the lawsuits were pending, AbbVie entered into an anticompetitive pay-for-delay settlement agreement with Teva to further delay the introduction of a generic AndroGel version.
Also named as defendants in the complaint, filed in U.S. District Court for the Eastern District of Pennsylvania, were AbbVie’s predecessor company, Abbott Laboratories, and its subsidiary Unimed Pharmaceuticals LLC.
The complaint reflects regulators’ concerns about controversial "pay for delay" settlements between drug makers in bringing new generic drugs to market.
In these settlements, generic drug makers reach a financial agreement with the manufacturer of the corresponding branded drug to delay the introduction of their generic product for a specified amount of time, under the rationale that the agreement will avoid costly, time-consuming litigation that would keep the lower-cost generic out of the market even longer. But opponents of these deals say the settlements cost the public, government and payers millions of dollars by forcing them to buy more expensive brand-name drugs when lower-cost generic versions could be made available.
Key to the FTC’s complaint is its claim that AbbVie and Besins engaged in monopolistic activity by filing unfounded patent infringement lawsuits against Teva and Perrigo Co. in order to delay Food and Drug Administration approval of AndroGel generics. Meanwhile, the FTC alleges that Teva — after countersuing AbbVie and Besins and claiming that the infringement suit was baseless — subsequently accepted illegal payments from AbbVie to drop its patent challenge and refrain from bringing its competing product to market. The complaint charges AbbVie and Teva with illegally restraining trade.
"The FTC is acting today to stop anticompetitive conduct by AbbVie, Besins Healthcare and Teva, which has forced consumers to overpay hundreds of millions for the drug AndroGel," FTC chairwoman Edith Ramirez said in a statement. "This action also reinforces the commission’s longstanding commitment to protect American consumers from collusive arrangements between branded and generic pharmaceutical companies that inflate the prices of prescription drugs and harm competition."
