The case began in 2014 and revolved around two allegations brought against AbbVie and Besins, though also extending to include Teva, regarding their Androgel testosterone replacement gel.
The initial charges were that AbbVie and Besins had filed ‘baseless’ patent infringement lawsuits against Teva and Perrigo Company that were designed to delay the US Food and Drug Administration (FDA)’s decision on their proposed generic competitors to Androgel.
The second charge against the companies related to the practice of ‘pay for delay’, wherein the company owning the originator product confers illegal payment to the company looking to introduce generic competition in order for them to hold back commercial release.
In this case, the Federal Trade Commission (FTC) alleged that Teva accepted illegal payment from AbbVie to drop its patent challenge and to desist in bringing its generic competition to the market.
The product was a blockbuster for AbbVie in 2013, bringing in sales of $1.03bn, but in 2014, after the antitrust lawsuit, as well as the FDA investigating health concerns, sales fell to $934m.
The US District Court for the Eastern District of Pennsylvania found in favour of the FTC and ordered the largest monetary award delivered in a litigated FTC antitrust case.
In a statement, FTC Chairman, Joe Simmons, concluded: “This decision is a double victory, both for patients who rely on Androgel and for competition more broadly. It sends a clear signal that pharmaceutical companies can’t use baseless litigation to forestall competition from low-cost generics.”
A spokesperson for AbbVie responded to a request for comment by stating: “We are disappointed by the ruling. We believe our conduct was lawful and the damages award is improper. We intend to appeal.”
Falling foul of US policy marks a turnaround for the company, which announced at the beginning of the year that it would use the country’s tax changes to expand its manufacturing network with a huge cash injection of $2.5bn.