Class-action accuses Takeda of ‘pay-for-delay’ deal with Par
Takeda Pharmaceuticals organised a pay-for-delay deal with Par Pharmaceuticals to prevent a generic version of its constipation treatment from releasing, according to a complaint submitted to the US District Court for the District of Massachusetts.
The class-action complaint submitted by FWK Holdings—which comprises direct buyers of the anti-constipation drug Amitza—claimed they had suffered antitrust injury as a result of alleged anticompetitive conduct to block generics of the treatment.
Takeda had paid Par to keep its generic Amitiza off the market for up to six more years in late 2014, FWK claimed.
“The deal preserved Amitiza’s monopoly, and with it Amitiza’s monopoly profits which were shared between Takeda and Par.”
FWK claims that the deal came just after the patent for the drugs active pharmaceutical ingredient lubiprostone expired in 2014. This led to only “weak and easily-designed-around” patents left preventing a generic variant.
Par was the first generic to seek approval, which grants it a six-month exclusivity period for the generic rights. According to the complaint, “at least six” other generics manufacturers had filed applications to make their own Amitiza variant but were delayed due to the pay-for-delay deal.
The “no-authorised-generic” (AG) agreement between Takeda and Par lasted “300% longer than even the typical no AG agreement found unlawful in many similar cases,” the complaint said.
FWK estimated that the new AG agreement was worth approximately $29 million and as much as $280 million.
The complaint said: “Had Takeda and Par resolved their dispute without payment, the plaintiffs and members of the class would have been able to purchase Amitiza’s generic equivalents earlier and for far less money. Instead, they have suffered many hundreds of millions of dollars in overcharges as a result of the defendants’ conduct.”
FWK is seeking class damages for an amount to be determined at trial before a jury.
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