Regulatory Focus™ > News Articles > 7 > AbbVie Ordered to Pay $448M in Androgel Generic Delay Suit

AbbVie Ordered to Pay $448M in Androgel Generic Delay Suit

Posted 02 July 2018 | By Michael Mezher 

AbbVie Ordered to Pay $448M in Androgel Generic Delay Suit

A district court judge on Friday ordered drugmaker AbbVie to pay a $448 million disgorgement for using anticompetitive tactics to delay generic competition for its blockbuster testosterone replacement therapy Androgel.

The ruling stems from a 2014 complaint against AbbVie and Besins Healthcare filed by the Federal Trade Commission (FTC), alleging the companies filed "baseless" patent infringement suits against generic drugmakers Teva Pharmaceuticals and Perrigo.

"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," said FTC Chairman Joe Simons.

According to FTC, AbbVie's patent no. 6,503,894 only covers a formulation of Androgel that includes a specific penetration enhancer, isopropyl myristate (IPM). While the initial patent filing sought to include all penetration enhancers, the patent examiner rejected the claim and after a series of amendments the patent was issued with IPM as the sole listed penetration enhancer.

Yet AbbVie filed patent infringement suits against both Perrigo and Teva after they submitted applications for generic versions of Androgel, despite the fact that the generic formulations used different penetration enhancers.

The penalty is the largest ever awarded as a result of a litigated FTC antitrust case, though the awarded amount falls short of the $1.35 billion the agency sought.

The penalty comes after the court found last September that AbbVie and its partners engaged in sham litigation to extend their monopoly for Androgel. However, for FTC to prove its case the agency also had to establish that AbbVie had subjective intent to block competition and maintained a monopoly by doing so.

In the ruling, the judge found that FTC proved that AbbVie extended its monopoly for Androgel and maintained market share for a year and a half longer than it would have had it not filed the sham suits.

"Defendants were able to exclude competition illegally in the TTRT [topical testosterone replacement therapy] market from June 2013 until the end of December 2014 as a result of sham litigation and the settlement of sham litigation," the judge wrote.

While FTC also alleged that AbbVie entered into a pay-for-delay agreement with Teva by negotiating a December 2014 launch date for Teva's Androgel generic while agreeing to allow Teva to launch an authorized generic version of its cholesterol drug Tricor. Despite FTC's claims, the judge wrote that there was no evidence that the agreement was related to the companies' Androgel settlement.

FTC, Order
 

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe