Gilead plans with J & J and Bristol-Myers to keep their monopoly HIV combo, court claims

Gilead Sciences has used its monopoly on an essential component of combination anti-HIV drugs to stifle generic competition and keep prices high, a new trial has announced, and Big Biotech has done it with help from its Johnson & Johnson and Bristol-Myers Squibb combos partners.

In a class action suit, HIV and AIDS activists say Gilead has teamed up with Bristol-Myers, J & J's Janssen unit and Japan Tobacco to roll back competition at a cocktail party. HIV drugs. The companies have agreed to keep patent-protected ingredients in their fixed-dose drugs, rather than in low-cost generic drugs, even after patent expiry on the claimed individual components.

The strategy has forced much higher prices over time, claims prosecution. Even after the end of the exclusivity of certain drug components, essential for the treatment of HIV because they significantly reduce the number of pills that patients must take, the Combead fixed dose drug Complera is sold at $ 35,000 per year , say the complainants. A version using generic components available – plus Edurant still protected by a Janssen patent – would cost half that amount, according to the lawsuit.

A spokesman for Gilead said the company "has partnered with other companies to offer life-saving therapies to patients in need."

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

A BMS representative stated that the company was reviewing the complaint. J & J did not immediately respond to a request for comment.

The complaint follows a series of headlines about Gilead's HIV-related activities over the past week: First, the company revealed that Truvada, its drug approved to treat and prevent infections, would face early generics, then agreed to pay for free drugs in the national PrEP push. And earlier this week, a California judge refused to file a separate action alleging Gilead had illegally delayed his next-generation anti-HIV drugs in order to make the most of the current generation's earnings before older drugs are patented. .

According to this lawsuit, Gilead's delays occurred at the expense of patient safety. In addition to making similar arguments, the new complaint indicates that Gilead and its "long-standing ploy to curtail competition" have reduced patient access and cost the federal government billions of dollars in overpriced drugs.

"The costs of these illegally monopolized drugs are largely borne by the health and social welfare funds of the unions, third-party payers, state and local governments, and the patients themselves," the report said. pursuit. "Worse still, the high cost of these life-saving drugs is preventing many patients from having access to medication."

In addition to the "non-generic" clauses in their combined development agreements, the complainants also indicated that Gilead had in-the-money agreements with companies seeking to commercialize imitators.

Peter Staley, a long-time advocate for AIDS and gay rights, a leading member of the ACT UP group, is the main complainant in this case. In a statement, he said the group "has successfully defeated AZT, the first anti-AIDS drug, to be dramatically lowered, which has resulted in a significant reduction in the prices of the drugs." ten marketed drugs ".

"Now, Gilead and his co-conspirators have returned to monopolistic practices and pricing," Staley added. "We will not let that stand."

Activists Gregg Gonsalves, Brenda Goodrow and Andrew Spieldenner are among the other plaintiffs involved in the lawsuit.

The high-profile lawsuit comes as Gilead recently announced that it expects Truvada's generic truvada, a widely sold anti-HIV drug, to be on the market next year. instead of 2021. And last week, the company reached an agreement with the Trump administration to provide 2.4 million free bottles of the drug over 10 years in a preventative push against the disease. Critics said the donation would not be enough for everyone who could benefit and would rather benefit the shareholders.

As the class action began, Gilead also recently lost a motion to dismiss a separate case claiming that the company had delayed the marketing of safer TAF-based anti-HIV drugs to protect sales. of its old generation of TDF-based drugs.