Bristol Myers settles anti-generic HIV drug scheme allegations for almost $11M
Although Bristol Myers Squibb isn’t admitting to any wrongdoing, the biopharma company agreed to pay almost $11 million to settle allegations filed in a California district court that the company took part in an unlawful scheme with other pharma companies like Gilead and Janssen to protect their HIV drug profits while slowing generic competition.
Specifically, the complaint filed in 2019 alleged that as imminent generic competition to Gilead’s HIV drugs — Viread, Emtriva, Truvada and others — approached, Gilead agreed with each of BMS, Janssen, and Japan Tobacco to create and market FDCs that combined their third agents with Gilead’s NRTIs.
“Collectively, the unlawful agreements between Gilead and each of its coconspirators effectively foreclosed competition for drugs essential to cART regimens. In 2018, the agreements covered more than 75% of all sales of NRTIs [nucleoside/nucleotide reverse transcriptase inhibitors], more than 50% of all sales of third agents, and more than 75% of all sales of booster drugs for use in a cART regimen in the United States,” the complaint said.
Each agreement also included a so-called “No-Generics Restraint” clause, according to the suit, by which BMS and the others agreed not to create or market a competing fixed-dose combination made with generic or comparable versions of Gilead’s NRTIs even after the patents expired.
“In exchange, they each shared in the supracompetitive profits that the impairment of competition made possible,” the complaint said.
Gregg GonsalvesThe Gilead/BMS agreement also prevented any other manufacturer from competing against their HIV drug Atripla, even after Gilead’s patents expired. Gilead and BMS later broadened the scope of their agreement to include blocking generic competition for a BMS HIV drug, atazanavir sulfate or Reyataz.
In addition to the $10.8 million (and $200,000 for providing notice to the payers), the proposed settlement, which a judge tentatively approved this week, provides that BMS will forever waive enforcement of contractual provisions that would otherwise prohibit Gilead from making, or licensing others to make, a version of Evotaz formulated with generic atazanavir (i.e., a generic of BMS’s Reyataz).
Gregg Gonsalves, an associate professor of epidemiology at Yale who was also one of the plaintiffs in the case, told Endpoints News, “What is important to me is that we have secured injunctive relief as part of this settlement, in which BMS will stop these anti-competitive, collusive agreements with other HIV drug manufacturers that raise prices for individuals and payors, restricting generic access to the combination antiretroviral therapy market.”
