Takeda plans to appeal after a federal jury found it liable in a landmark pay-for-delay antitrust case and ordered the Japanese drugmaker to pay $885 million in damages, a figure that could be roughly tripled under antitrust law.
In the U.S. District Court in Boston, after a month-long trial, the jury ruled that Takeda conspired with a competitor to delay the entry of a generic version of its constipation drug Amitiza. It is the first time a federal jury has found a drugmaker liable in a pay-for-delay case.
The class-action lawsuit dates to 2021 and was filed by pharmacies, health funds, insurers and retailers—including giants such as CVS and Walgreens—who claimed that the pay-for-delay arrangement forced them to overpay for Amitiza.
Shortly after the verdict late on Monday afternoon, Takeda posted a release, saying it will “vigorously pursue post-trial motions and an appeal.”
“We remain firm in our conviction that the plaintiffs’ case lacks merit,” the company added. “We also believe that there were both evidentiary and legal errors made during the trial.”
Takeda said that direct purchasers of Amitiza were awarded $475 million, while individual retailers were collectively awarded $347 million and that these damages will be automatically trebled—or tripled—per antitrust law upon “entry of judgment,” which is the final recording of the decision. That would bring the jury’s award to about $2.5 billion. The verdict can’t be enforced, and the liability figure isn't finalized until the court enters the judgment, Takeda explained.
Takeda and its partner on the drug at the time, Sucampo Pharmaceuticals, negotiated a $210 million settlement in 2014 with Par Pharmaceutical, which resolved litigation and delayed the launch of a less-expensive generic version of Amitiza until 2021. Since then, other generics have entered the market for Amitiza, which was originally approved in 2006.
Attorneys from Seattle-based law firm Hagens Berman, which represented direct purchasers, said that the delay resulted in “hundreds of millions of dollars in overcharges” to its clients.
“The jury spent five weeks listening to incredibly detailed testimony about patent litigation, FDA regulation and pharmacoeconomics, and they fundamentally understood that paying a competitor to stay out the market harms competition and harms the American healthcare system,” Kristen Johnson of Hagens Berman said of the trial results.
Takeda claims that its settlement with Par allowed the New York generics specialist to launch its Amitiza knockoff more than six years before Takeda’s patents would have expired.
In Takeda’s 2020 fiscal year, which included the first three months when Par’s generic was on the market, it reported sales of Amitiza at 21.2 billion Japanese yen ($191 million), which were down nearly 25% from JPY 28.1 billion ($253 million) in the previous year.
Takeda no longer sells Amitiza as its license agreement with Sucampo ended in 2024.