A federal jury has returned a verdict of $474.89 million against Takeda Pharmaceuticals in a direct-purchaser class action involving the irritable bowel syndrome medication…
A federal jury has returned a verdict of $474.89 million against Takeda Pharmaceuticals in a direct-purchaser class action involving the irritable bowel syndrome medication Amitiza. Under the trebling provisions of federal antitrust law, the award is expected to increase to approximately $1.4 billion, placing the case among the most consequential pharmaceutical antitrust verdicts in recent memory. The decision follows a five-week trial and is likely to reverberate throughout the brand and generic pharmaceutical industries.
Plaintiffs alleged that Takeda, together with Sucampo, entered into a reverse-payment, or pay-for-delay, arrangement with Par Pharmaceutical that postponed the market entry of a competing generic version of Amitiza. According to the plaintiffs, this arrangement suppressed competition and allowed the brand manufacturer to maintain supracompetitive pricing, causing direct purchasers to overpay for the medication during the period of delayed generic entry. The jury's verdict reflects an acceptance of the theory that such settlements, when they involve large and otherwise unexplained payments from a brand manufacturer to a generic challenger, can constitute unlawful restraints on trade.
The trial was led by Hagens Berman attorney Thomas M. Sobol, whose team secured the verdict on behalf of the certified class of direct purchasers. The outcome reinforces a continuing trend in federal courts following the Supreme Court's recognition that reverse-payment settlements may, under certain circumstances, give rise to substantial antitrust liability. For direct purchasers, the result provides a meaningful blueprint for organizing, certifying, and trying complex antitrust class actions against pharmaceutical defendants.
For brand pharmaceutical companies, the verdict highlights the substantial financial exposure associated with patent settlements that include compensation flowing from the patent holder to the alleged infringer. Companies that have entered into, or are contemplating, settlements resolving Hatch-Waxman patent disputes should carefully evaluate the structure of those agreements, the economic terms exchanged, and the documentation supporting any value transferred. Wholesalers, distributors, and other direct purchasers should likewise assess whether they may have claims arising from similar arrangements affecting medications they have acquired.
This article is provided for general informational purposes only and does not constitute legal advice. Clients and prospective clients facing issues related to antitrust litigation or reverse-payment settlements should seek tailored counsel addressing the specific facts of their situation.