The US Federal Trade Commission (FTC) on Monday sued drugmakers AbbVie Inc and Teva Pharmaceuticals Industries Ltd for allegedly illegally preventing generic versions of AndroGel, for men with low testosterone, from getting to market.
The FTC, which says AndroGel users paid hundreds of millions of dollars more than needed because of the firms’ actions, asked the US District Court for the Eastern District of Pennsylvania to order AbbVie to refund users that money.
This case is the second that the FTC has filed focused on AndroGel, AbbVie’s No. 2 product in sales, with sales of US$472 million in the first half of this year, according to a company filing with the US government.
In the latest case, the FTC accused AbbVie of filing “baseless” patent infringement lawsuits against Israeli firm Teva and a second company to stop them from selling generic AndroGel. AbbVie then reached an agreement with Teva in which Teva agreed to refrain from bringing out a cheaper version of AndroGel in exchange for winning AbbVie’s permission to sell an authorized generic of the cholesterol drug Tricor.
AbbVie declined to comment on the lawsuit filed on Monday, but the company said in an e-mail that “our patent infringement lawsuits were appropriate and our settlement agreements were lawful, as well as in the best interest of all parties.”
This case is one of several the FTC has filed that are aimed at stopping the practice of branded drug companies compensating generic companies for not bringing out cheaper copies of drugs.
The FTC has fought these “pay for delay” deals for more than 10 years and has pushed for legislation to ban the patent settlements or to make it easier for the FTC to challenge them.
In a previous case focused on AndroGel, the FTC in 2009 sued Solvay Pharmaceuticals, saying it and three generic companies acted illegally when Solvay allegedly paid them millions of dollars each not to release a generic version of AndroGel.
Solvay subsequently sold the drug to Abbott Laboratories, which spun off its branded drug business last year into what is now AbbVie. A fight over whether the FTC had the right to bring the case went to the US Supreme Court and was decided in the FTC’s favor in June; litigation on the main issue is ongoing.
A third pending case involves Cephalon Inc, now owned by Teva. In 2008, the FTC accused Cephalon of paying four companies not to sell a generic version of its stimulant, Provigil. That case is pending.
In four other cases, the FTC lost one and settled three.
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