AbbVie and Besins to pay FTC $448m in sham litigation case
Pharmaceutical companies AbbVie and Besins Healthcare have been ordered to pay the US Federal Trade Commission ( FTC) $448 million for using “sham litigation” to block access to generic versions of a testosterone drug.
The US District Court for the Eastern District of Pennsylvania made the decision on Friday, June 29.
Its judgment of $448 million in damages represents the largest-ever monetary award in a litigated FTC antitrust case.
The court sided with the FTC and agreed that AbbVie and Besins used unfair methods of competition to maintain their monopoly over the testosterone replacement drug AndroGel (testosterone gel).
AndroGel acts as a transdermal testosterone replacement therapy (TTRT) for men with low testosterone. According to the FTC, it has annual US sales of more than $1 billion.
The product is covered by the patent “Pharmaceutical composition and method for treating hypogonadism” (US number 6,503,894).
“This decision is a double victory, both for patients who rely on AndroGel and for competition more broadly,” said FTC chairman Joe Simons.
“It sends a clear signal that pharmaceutical companies can’t use baseless litigation to forestall competition from low-cost generics.”
The FTC filed its complaint against AbbVie and its partner Besins in 2014, alleging that the companies were illegally blocking US consumers from accessing lower-cost alternatives to AndroGel by filing baseless patent infringement lawsuits against potential generic competitors.
According to the FTC, AbbVie and Besins filed baseless patent infringement claims against generics companies Teva and Perrigo Company. The lawsuits were allegedly filed to delay Food and Drug Administration approval of generic versions of AndroGel. While these lawsuits were pending, AbbVie entered into an anti-competitive pay-for-delay settlement agreement with Teva to further delay generic drug competition, the FTC alleged.
The FTC claimed that Teva accepted illegal payments from AbbVie to drop a counterclaim and not to bring its competing product to market.
The district court found that the FTC had established that AbbVie possessed a monopoly over the market by filing sham litigation.
“This sham litigation delayed the entry of much less expensive competitive generic products into the TTRT market to the detriment of consumers and protected the defendants against loss of hundreds of millions of dollars in sales and profits.”
While the court ordered AbbVie and Besins to pay $448 million in damages, it refused an injunction requested by the FTC for being “overbroad and punitive”.
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