By Nate Raymond
BOSTON, May 18 (Reuters) – A U.S. jury on Monday found that Takeda Pharmaceutical caused purchasers of medications and insurers to sustain about $885 million in damages by delaying the release of a generic version of its constipation treatment Amitiza through an anticompetitive scheme.
Jurors in federal court in Boston found Takeda liable in lawsuits by pharmacies, insurers, health funds and retailers including CVS and Walgreens, who claimed the scheme caused them to overpay hundreds of millions of dollars for the drug.
Their lawsuits, which were filed in 2021, were some of the many cases filed in recent years by federal regulators or class-action lawyers concerning so-called reverse payment, or pay-for-delay, agreements that they say violate antitrust law.
Such deals involve pharmaceutical companies paying generic drugmakers to delay releasing cheaper versions of branded medicines in exchange for resolving patent lawsuits.
The trial marked the first time a drugmaker has been found liable by a jury in class-action litigation over alleged illegal reverse-payment agreements since the U.S. Supreme Court in 2013 held such deals can violate antitrust law. Three similar cases that went to trial ended in defense verdicts.
The $885 million in damages is just a baseline of what the company could ultimately be forced to pay. Under federal antitrust law that governs many of the plaintiffs’ claims, any damages awarded would be subject to automatic tripling.
Lawyers for Takeda and the plaintiffs had no immediate comment.
The trial concerned Amitiza, a medication developed by Sucampo Pharmaceuticals, which partnered with Takeda to market and sell the drug in the United States after it won U.S. approval in 2006.
In 2012, Par Pharmaceutical sought FDA approval to bring a generic version of Amitiza to market. Sucampo and Takeda sued, alleging patent infringement, and Par countered that the patents covering the drug were invalid.
The companies reached a settlement in 2014 under which Par agreed to not bring its generic to market until January 2021, when it could sell an authorized generic version of Amitiza, known chemically as lubiprostone, supplied by Sucampo pursuant to a 50-50 profit split.
Lawyers for the plaintiffs in their closing arguments on Thursday said the agreement constituted an illegal “payoff” worth about $210 million that gave Par a lucrative partnership with Sucampo, which Mallinckrodt acquired in 2018, while causing generic drug competition to be delayed by six years.
(Reporting by Nate Raymond in Boston; Editing by Chris Reese and Bill Berkrot)
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