Jury finds Takeda liable for $885m in pay-for-delay lawsuit

A jury in a Boston court has put Takeda on the hook for damages of $885 million – and potentially almost $2.5 billion – after concluding the company unlawfully delayed generic competition to its constipation drug Amitiza.

In the judgment of the jurors, Takeda entered into an agreement with generic drugmaker Par Pharma to delay the introduction of its copycat version of the Amitiza (lubiprostone), causing the plaintiffs – which include wholesalers, insurers, health funds, and retailers – to pay too much for the drug over several years.

Takeda said in a statement that the damages are subject to further proceedings before a final judgment can be reached, adding that it will "vigorously pursue post-trial motions and an appeal." Under federal antitrust law, almost $822 million of the damages would be automatically trebled on final judgment to $2.47 billion.

According to the Federal Trade Commission (FTC), pay-for-delay or 'reverse payment' deals generally involve patent litigation settlements that amount to the brand owner paying generic companies not to bring lower-cost alternatives to market.

The financial regulator has previously published a study claiming that antitrust deals of this type cost consumers and taxpayers $3.5 billion in higher drug costs every year, and has litigated several cases against pharma groups in recent years, including one which resulted in a landmark, $1.5 billion settlement with Teva in 2015.

Amitiza was originally developed by Sucampo Pharma, making peak revenues of almost $500 million a year in the late-2010s, and was the main asset in Mallinckrodt's $1.2 billion takeover of Sucampo in 2018. Takeda was the commercial partner for the drug from its first launch in 2006 to 2024, when its license was terminated.

Takeda insists that its patent agreement with Par was "consistent" with legal frameworks and allowed Par to launch an authorised generic at the start of 2021 – more than six years before patents covering Amitiza would have expired and 17 months before Par's generic was eventually approved.

"The jury's verdict is not enforceable until the court enters judgment at a later date, and the amount of any liability that may ultimately be imposed on Takeda has not yet been finalised," the company insisted, further claiming that "evidentiary and legal errors" were made during the trial that could affect the final outcome.

Last week, the Japan-headquartered company announced sweeping workforce reductions in the US in a bid to slice nearly $1.3 billion off its annual costs as it contends with the loss of patent protection for brands like attention-deficit/hyperactivity disorder (ADHD) blockbuster Vyvanse (lisdexamfetamine) and antidepressant Trintellix (vortioxetine).