Jury in Boston Set to Decide Takeda’s Fate in Amitiza Antitrust Trial

Jurors are expected to begin deliberations on Friday following five weeks of testimony and closing arguments in lawsuits brought by pharmacies, insurers, health funds and retailers, including CVS Health and Walgreens Boots Alliance. The plaintiffs allege they paid inflated prices for Amitiza because of an unlawful agreement involving Takeda and a potential generic competitor, per Reuters.

The case marks one of only a handful of so-called “pay-for-delay” antitrust cases involving pharmaceutical companies to reach a jury since the Supreme Court of the United States ruled in 2013 that settlements between brand-name drugmakers and generic challengers can violate antitrust law. According to Reuters, many similar cases brought by the Federal Trade Commission and private plaintiffs have either been dismissed or settled before trial.

Amitiza was originally developed by Sucampo Pharmaceuticals, which partnered with Takeda to market the drug in the United States after it received approval from the U.S. Food and Drug Administration in 2006. In 2012, Par Pharmaceutical sought FDA approval to introduce a generic version of the drug, leading to patent litigation between the companies.

That dispute ended in a 2014 settlement under which Par agreed not to launch a generic version until January 2021. Instead, it would sell an authorized generic version of Amitiza, known as lubiprostone, supplied by Sucampo under a profit-sharing arrangement.

During closing arguments on Thursday, lawyers for the plaintiffs argued that the settlement amounted to an illegal payment worth roughly $210 million that effectively kept generic competition off the market for six years. “It’s a payoff to stay off,” said Jonathan Stratton, an attorney representing five retailers including CVS and Walgreens.

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Thomas Sobol, representing a class of direct purchasers, told jurors, “the core, immovable truth is Takeda, Sucampo and Par conspired with each other to delay generic competition and keep prices high.”

According to Reuters, Sobol told the jury that his clients suffered damages of as much as $759.5 million. Separate health plan plaintiffs are seeking up to $103.5 million in damages, while retailers allege they were overcharged by $527 million. Any damages awarded would automatically be tripled under U.S. antitrust law, potentially exposing Takeda to billions of dollars in liability.

Takeda has denied wrongdoing. Joshua Barlow, one of the company’s attorneys, argued that the settlement was lawful and ultimately benefited competition.

“It was a good settlement,” Barlow told jurors. “It increased competition.”

Barlow also argued that the patents protecting Amitiza were strong and said that without the settlement, a generic version of the drug might still not be available because key patents do not expire until October 2027, according to Reuters.

Takeda is the only remaining defendant in the trial after claims against Par were dropped following the 2022 bankruptcy filing of its parent company, Endo International.

The case is being heard in the U.S. District Court for the District of Massachusetts under the title In re Amitiza Antitrust Litigation.

Source: Reuters