Federal Judge Allows AbbVie, Teva to Continue Delay of Testosterone Drug Launch

A federal judge last week said AbbVie and Teva can continue an arrangement that delays the launch of generic versions of the testosterone drug Androgel — rejecting the FTC’s request that he reconsider his earlier decision that the agreement was not pay-for-delay.

AbbVie, along with its partners Unimed Pharmaceuticals and Besins Healthcare, sued Teva in 2011 after claiming Teva’s testosterone product infringed on Androgel’s patents. In a subsequent settlement, AbbVie supplied Teva with a generic version of its cholesterol drug TriCor (fenofibrate) in exchange for Teva withdrawing its patent challenge.

The FTC filed suit against AbbVie, its partners and Teva in September 2014, saying they violated federal antitrust laws.

In May, U.S. District Court Judge Harvey Bartle dismissed the FTC’s suit, saying Teva was only defending itself from what it deemed a sham lawsuit, and the settlement could not be considered pay for delay because Teva is paying AbbVie for generic TriCor — not being paid to stay out of the testosterone market.

The FTC based its motion for reconsideration on a recent ruling by the Third Circuit in King Drug Co. of Florence v. SmithKline Beecham Corp. that found non-cash exchanges could fall under anticompetitive reverse settlements, as they represent a “transfer of value.”

Bartle refused to hear the motion, saying King Drug involved a single drug, whereas this case involved two. He said the TriCor supply agreement did nothing more than facilitate competition in the market for that drug, thereby lacking anticompetitive effects. Additionally, Teva received an early entry data for its generic AndroGel, accelerating competition in the synthetic testosterone gel market.

The case, Federal Trade Commission v. AbbVie Inc., et al., was heard in the U.S. District Court for the Eastern District of Pennsylvania. — Kellen Owings