Gilead schemed with J&J, Bristol-Myers to keep their HIV combo monopoly, lawsuit claims

Gilead Sciences used its monopoly on one critical component in HIV combo meds to stifle generic competition and keep prices high, a new lawsuit claims—and the Big Biotech did so with the help of combo partners Johnson & Johnson and Bristol-Myers Squibb.

In a class action lawsuit, HIV and AIDS activists say Gilead teamed with Bristol-Myers, J&J's Janssen unit and Japan Tobacco to knock back competition to HIV cocktail meds. The companies agreed to stick with patent-protected ingredients in their fixed-dose combination drugs, rather than sub in low-cost generics, even after patents expired on the individual components, the lawsuit claims.

The strategy forced much higher prices over time, the lawsuit claims. Even after exclusivity lapsed for some components of the meds—which are key to HIV treatment because they drastically reduce the number of pills patients need to take—Gilead’s fixed-dosed-combination drug Complera sells for $35,000 per year, the plaintiffs say. A version using available generic components—plus Janssen’s still-patent-protected Edurant—would cost half that, the suit alleges. 

A Gilead spokesman said the company "entered into partnerships with other companies with the goal of bringing life-saving therapies to patients in need."

"Any suggestion that we had improper motives is absolutely false," he added.

A BMS representative said the company is reviewing the complaint; J&J didn't immediately respond to a request for comment.

The lawsuit follows a string of headlines about Gilead's HIV business over the past week: First, the company disclosed Truvada, its drug approved to treat and prevent infection, would face early generics, and then it agreed to pony up free drugs as part of a national PrEP push. And earlier this week, a California judge refused to dismiss a separate lawsuit claiming Gilead illegally delayed its next-gen HIV meds to milk as much revenue as possible from its current generation before the older drugs went off patent. 

That lawsuit claimed Gilead's delays came at the expense of patient safety. In addition to bringing similar arguments, the new complaint says Gilead and its codefendants' “long-running scheme to restrain competition” reduced patient access and cost the federal government billions on overpriced drugs. 

“Even more of the costs of these unlawfully monopolized drugs are borne by union health and welfare funds, other third-party payers, state and local governments, and the patients themselves,” the suit says. “Worse, the high cost of these life-saving medications prevents many patients from gaining access to the drugs at all.” 

Aside from the “no-generics” clauses in their combo development agreements, the plaintiffs also say Gilead struck pay-for-delay agreements with companies seeking to market copycats.

Longtime AIDS and gay rights activist Peter Staley, a prominent member of the group ACT UP, is the lead plaintiff in the case. He said in a statement that the group “successfully fought for a dramatically lower price on AZT, the first AIDS drug, resulting in far lower prices on the next ten drugs that came to market.” 

“Now Gilead and its co-conspirators have turned back the clock to monopolistic practices and pricing,” Staley added. “We will not let this stand." 

Other plaintiffs involved in the suit include activists Gregg Gonsalves, Brenda Goodrow and Andrew Spieldenner.

The high-profile lawsuit comes as Gilead recently disclosed it expects generics to big-selling HIV drug Truvada to hit the market next year instead of 2021. And late last week, the company struck a deal with the Trump administration to provide up to 2.4 million free bottles of the drug over 10 years in a preventative push against the disease. Critics said the donation wouldn’t be enough for all people who could benefit and would instead benefit shareholders.

As the class action suit gets underway, Gilead also recently lost a motion to dismiss a separate case claiming the company delayed safer TAF-based HIV drugs to protect sales for its older generation of TDF-based medicines.