SAN FRANCISCO (CN) — Trial for a sprawling antitrust lawsuit involving pharmaceutical giant Gilead Sciences began drawing to a close Tuesday as attorneys wrapped up presenting evidence on Gilead's alleged scheme to maintain a monopoly on drugs treating HIV.
The trial began in late May 2022, after several years spent in litigation. Plaintiffs explained during the trial why they brought over a dozen counts of anticompetitive and anti-consumer practices — including charging "exorbitant" prices for critical HIV drugs and limiting the ability of generics to come on the market — against Gilead and other pharmaceutical companies.
A group of customers accused Gilead Sciences of a "long-running scheme" to restrain competition for Tenofovir, part of the antiretroviral therapy treatment regimen used to treat HIV, in a class action first filed in 2019 in a federal court in California. Among those customers were health funds and workers' unions that bought the drugs for their members.
At the crux of the suit is whether or not Gilead Sciences brokered a deal with Teva, an Israeli generic pharmaceuticals manufacturer, to slow the entry of generic versions of the drugs to the market. Gilead, based in Foster City, California, had more than $28 billion in revenue in 2022. Teva took in more than $16 billion in 2021.
Teva, the plaintiffs claimed, had been "challenging the validity of Gilead’s vulnerable patents," including those on HIV drugs. Rather than fighting those suits, Gilead instead allegedly entered an anticompetitive settlement with the company, "in exchange for which Teva [allegedly] agreed to delay marketing its generic products." Gilead also allegedly profited from this deal, but Teva lost its bid for approval from the Food and Drug Administration, forfeiting the regulatory exclusivity period.
The plaintiffs must prove Gilead holds the market power, and that it paid Teva to delay entering generic versions of the HIV treatment drugs into the market so that it could avoid the risk of competition. They also must prove why Gilead’s conduct caused them such injury that they are entitled to relief via damages.
Both sides finished with all witnesses and exhibits Tuesday, with the plaintiffs having the first shot at closing arguments for most of the day.
Attorney for the plaintiffs, Tom Sobol of Hagens Berman Sobol Shapiro, said that case is about manipulation of the country’s drug approval system.
Sobol said that Gilead made a reverse payment deal with Teva to keep HIV treatment pills as expensive as possible, for as long as possible, at the expense of the plaintiffs.
“For decades, Gilead charged tens of thousands a dollars a year for these lifesaving HIV drugs,” he said. “They will say whatever it takes to preserve their monopoly. That’s what one of the defendants in this room said about its own co-defendant in this case.”
Sobol pointed the jury to evidence that Gilead wanted exclusivity in the market, and that Teva financially benefited from waiting six years to pursue generic drugs after having tried to challenge Gilead’s patents in court before.
“That is ‘pay for delay,’” he said, adding that “reasonable, law abiding” companies would enter into a settlement with the competition without a payoff. He and other attorneys for the plaintiffs said that their evidence proved this because customers who rely on the treatment regimen faced Gilead’s high prices, and the company ensured that they could not seek any generic option.
The defense’s side began with attorney Christopher Holding of Goodwin Procter, representing Teva.
Holding said Teva knew it was in trouble with Gilead’s patents in 2014, and the company thought it was unlikely to win.
“The evidence overwhelmingly showed that Gilead’s patents were strong, and that the generic companies likely would fail in their attempts to invalidate them,” he said. “Teva did not delay its entry in return for a payment from Gilead. There was no delay in generic entry, period.”
U.S. District Judge Edward Chen, an Obama appointee, said that the case is, "in a sense a patent case wrapped in an antitrust case,” and told the jury Monday that he wanted instructions followed for handling patent cases as well as for antitrust cases, when coming to a verdict.
Attorneys for both sides objected to that decision, saying they did not think that should be left up to the jurors in this type of case.
“If you want to submit joint language, I’ll take a look at that,” Chen retorted.
Chen reminded the jury Tuesday that they must decide if the plaintiffs have met their burden of proof to show that Gilead’s conduct — including a reverse payment to Teva — caused anticompetitive effects that outweighed any and all pro-competitive effects.
Lawyers for Teva and Gilead will continue closing arguments Wednesday.
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