Sensipar Antitrust Litigation

ABOUT THE SENSIPAR LAWSUIT

The complaint alleges that Amgen, the branded Sensipar manufacturer, delayed competition from generic manufacturers by suing them for patent infringement and then using “acceleration” and “grace” provisions in a series of settlements from 2017 to 2018. Under these agreements, numerous generic manufacturers would be permitted to come to market if any generic launched a cinacalcet product “at risk” (i.e., without Amgen’s authorization), but only if Amgen did not block other generics’ “acceleration” to the market by agreeing with the at-risk launcher to cease the sale of the at-risk generic within the “grace” period. These agreements disincentivized early generic entry, the purchasers allege, because entry by multiple generics would quickly commoditize the market, driving down the price and the ability to turn a profit for cinacalcet. The complaint claims these agreements also unlawfully lengthened Amgen’s monopoly over Sensipar.

When a generic competitor, Teva, finally did launch its generic product at risk in late December 2018, the purchasers allege Amgen and Teva quickly entered into a settlement agreement in which Amgen and Teva allocated the Sensipar market and Teva got paid off. Amgen permitted Teva to retain hundreds of millions in profits so long as it did not sell any additional product, and gave Teva an “acceleration” clause of its own, signaling to other generics that if they launched at risk, Teva would immediately come back to market, driving down the price for generic Sensipar. With Teva off the market, Amgen continued selling Sensipar at supra-competitive prices without further generic competition, and at least ten additional generics were effectively blocked from coming to market. 

Absent the anticompetitive scheme by Amgen and its market allocation and delay agreement with Teva, the purchasers allege, several non-infringing generic competitors would have come to market by May 2018, and the price of cinacalcet would have decreased significantly.  The direct purchasers’ complaint includes pleaded monopolization counts against Amgen, and conspiracy to allocate the cinacalcet market and entry into an agreement in restraint of trade against both Amgen and Teva, all in violation of the Sherman Antitrust Act. The class seeks treble damages for the overcharges paid, plus attorneys’ fees and the costs of suit.

The defendants have twice moved to dismiss the direct purchasers’ complaint. The Court denied both motions, in part, upholding the direct purchasers’ allegations that Amgen and Teva entered into an unlawful reverse payment agreement, while dismissing aspects of the direct purchasers’ claims. The parties have each moved for certification of select issues in the order for interlocutory appeal before the Third Circuit. Those motions are fully briefed and await decision from the Court.