Fourth Circuit Revives Tracleer Purchasers’ Suit

Purchasers of a blood pressure drug, Tracleer, secured a reversal of a district court decision finding that they had filed suit outside of the four-year statute of limitations for antitrust claims.

The Purchasers allege that Actelion, a pharmaceutical company with an exclusive license under the patent for Tracleer, engaged in a years-long scheme to block generic manufacturers from filing applications for approval of a generic version of the drug.  Specifically, beginning in 2009, Actelion refused to provide samples of its branded drug to its would-be generic competitors—a prerequisite for any generic manufacturer to conduct the bioequivalence studies necessary to seek FDA approval.  When the generic manufacturers threatened to sue, Actelion filed a preemptive action seeking a declaratory judgment that it had no duty to provide Tracleer samples to the generic manufacturers. The generic manufacturers filed counterclaims, alleging antitrust violations. The parties settled on undisclosed terms in early 2014.  

The Purchasers filed their complaint in late 2018, alleging violations of state and federal antitrust laws.  They alleged that they paid supracompetitive prices for Tracleer because generic competition would otherwise have been available after the Tracleer patent expired had it not been for Actelion’s refusal to deal with the generic manufacturers.  Looking to these allegations, the district court dismissed the Purchasers’ antitrust claims because the “last overt anticompetitive act” alleged by the Purchasers was the 2014 settlement with the generic manufacturers—more than four years before filing suit.

On appeal, the Fourth Circuit rejected the district court’s analysis.  It held that the Purchasers’ claims did not accrue at the time of the “last overt anticompetitive act” but at the time the Purchasers were injured—that is, when they paid supracompetitive prices for Tracleer.  The court clarified that it was not Actelion’s refusals to deal that caused Purchasers’ injury; “Rather, that was the means by which Actelion was able to extend illegally its patent monopoly following the patent’s expiration.”  Indeed, “each supracompetitive sale that Acetlion made after November 2015,” when the patent expired, was a new injury for which the Purchasers could recover.  Accordingly, the court vacated the district court’s decision and permitted the Purchasers to pursue their antitrust claims.  

The case is Mayer & City Council of Baltimore v. Actelion Pharmaceuticals, Ltd., No. 19-2233 (4th Cir. Apr. 13, 2021).