SAN FRANCISCO (CN) — A jury is now deliberating in a yearslong class action claiming Gilead Sciences deliberately manipulated the market in order to continue charging high prices for HIV treatment drugs.
Closing arguments wrapped Wednesday, leaving the jury to consider weeks of evidence regarding the pharmaceutical giant’s conduct and deal with Israeli generic drugmaker Teva. Plaintiffs brought over a dozen claims of anticompetitive and anti-consumer practices, and accused Gilead of a "long-running scheme" to restrain competition for Tenofovir, part of the antiretroviral therapy treatment regimen used to treat HIV.
At the crux of the suit is whether Gilead Sciences brokered a deal with Teva to slow the entry of generic versions of the drugs to the market. According to the plaintiffs, when Teva challenged Gilead’s patents for the drugs, Gilead paid Teva to delay marketing its generic products.
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.
Attorney for the plaintiffs, Tom Sobol of Hagens Berman Sobol Shapiro, said Tuesday that the case is about manipulation of the country’s drug approval system. 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.
On Wednesday, Teva attorney Chris Holding pointed to opinion letters Teva received when seeking legal advice, which he said told the company it would be better to settle rather than risk further delay, and therefore profit loss, in bringing its generic drugs to market.
Holding said that in negotiations with Gilead, Teva agreed to wait to place its drugs on the market until September 2020, “before the idea of exclusivity was even on the table for discussion.” He said the jury has a paper trail to check that internal negotiators doubted they had better than an 18% chance of entering the market before 2020, if they did not take Gilead’s settlement offer.
Gilead attorney Bart Williams said the case is about Gilead exercising its legal rights as the patent holder of the original drugs.
He emphasized the “patent ecosystem,” which defines how long a company holding patents can maintain exclusivity in the market with their product.
“That exclusivity ends when all of the patents covering a particular drug expire, or get invalidated,” Williams said.
He called the plaintiffs’ claims “a theory based on hindsight” and accused their lawyers of misusing evidence to speculate about Gilead’s intentions. He claimed the plaintiffs did not provide sound evidence the claimed “pay to delay” deal between Gilead and Teva ever took place, and that no reports show a payment that resulted in delay.
“Speculation is not evidence,” Williams said.
He added: “If the patents are so weak, why did so many generic companies make the business decision to file certifications saying they weren't going to challenge the patents at all? Why did they wait for Teva to take the burden to litigate with my client?”
On rebuttal, Sobol said Gilead and Teva never explained why the settlement reached in 2014 contained contractual exclusivity for Gilead’s drugs.
“Why is it there? What is it accomplishing? No explanation at all,” he said.
Sobol also criticized Gilead’s framing of the case as proving its rights under patent law, saying those rights are limited under federal antitrust laws.
“There is no instruction Judge Chen has given you that says since drug companies spend a lot of money, they can violate antitrust laws. Why is this company trying to mislead you?” Sobol asked the jury. “It’s all there in plain view."
U.S. District Judge Edward Chen, a Barack 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.
The jury must decide if the plaintiffs have met their burden of proof to show that Gilead’s conduct — including proving a reverse payment to Teva — caused anticompetitive effects that outweighed any and all pro-competitive effects.
Deliberations continue Thursday.
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