Takeda Pharmaceutical plans to appeal after a federal jury found it liable in a landmark delay-damages antitrust case and ordered the Japanese drugmaker to pay $885 million in damages, an amount that could be roughly tripled under antitrust laws.
After a month-long trial in U.S. District Court in Boston, a jury ruled that Takeda Pharmaceutical conspired with a competitor to delay the release of a generic version of the laxative drug Amitiza. This is the first time a federal jury has found a pharmaceutical company liable in a delay damages lawsuit.
The class action lawsuit dates back to 2021 and was filed by pharmacies, health funds, insurance companies, and retailers (including major companies such as CVS and Walgreens) who allege that late fee arrangements forced them to overpay Amitiza.
Shortly after the ruling late Monday afternoon, Takeda posted a release saying he would “vigorously pursue post-trial motions and appeals.”
The company added, “We continue to believe that plaintiffs’ lawsuit is without merit.” “We also believe there were evidentiary and legal errors during the trial.”
Mr. Takeda said that Amitiza’s direct purchasers would be awarded $475 million in damages, while individual retailers would be awarded a total of $347 million in damages, and that with the final entry of the judgment, the “Entry of Judgment,” these damages would be automatically tripled, or tripled, in accordance with antitrust laws. That would put the jury’s award at about $2.5 billion. Mr. Takeda explained that the judgment cannot be enforced and the amount of liability cannot be determined until the court makes its decision.
Takeda and its then-partner on the drug, Sucampo Pharmaceuticals, negotiated a $210 million settlement with Par Pharmaceuticals in 2014, resolving the lawsuit and delaying the launch of a cheaper generic version of Amitiza until 2021. Since then, other generic drugs have entered the market for Amitiza, which was first approved in 2006.
Lawyers at the Seattle-based law firm Hagens Berman, which represents direct buyers, said the delay resulted in “hundreds of millions of dollars in overcharges” to their clients.
“The jury spent five weeks hearing incredibly detailed testimony about patent litigation, FDA regulation, and pharmacoeconomics, and found a fundamental understanding that paying competitors to keep them out of the market hurts competition and harms the U.S. health care system,” Kristen Johnson of Hagens Berman wrote in a statement.
Takeda claims the settlement with Parr allowed the New York generic drug specialist to launch a copy of Amitiza more than six years before Takeda’s patent expired.
In Takeda’s fiscal year 2020, which includes the first three months when Parr’s generic drug was on the market, sales of Amitiza were reported at 21.2 billion yen ($191 million), down about 25% from 28.1 billion yen ($253 million) a year earlier.
Takeda Pharmaceutical no longer sells Amitiza because its license agreement with Sucampo ended in 2024.
