Gilead, Bristol Myers face lawsuit from major pharmacies over HIV generic drug delays
Major pharmacy chains CVS and Rite Aid recently sued Gilead Sciences, Teva and Bristol Myers Squibb, claiming the pharma companies deliberately stalled the introduction of cheaper generic versions of several blockbuster HIV drugs.
The suit specifically goes after billions of dollars worth of reverse-payment agreements between the pharma companies that withheld from the market generic versions of HIV drugs Viread, Atripla, Truvada and Evotaz.
“From 2004 to 2017, Gilead made tens of billions of dollars from HIV medications while introducing only a single new pharmaceutical compound,” the suit alleges. “In connection with these settlement agreements, collusive collaborations and product-hopping schemes, Gilead unfairly increased the already exorbitant pricing for its HIV medications to wring the last bit of available profits from its HIV franchises when faced with imminent generic competition.”
In the case of Viread, the suit also explains how Gilead and Teva dropped a clause from their formal patent settlement that would have forced Gilead to not launch an authorized generic, as part of an attempt to avoid scrutiny from the Federal Trade Commission. But the suit claims that the two companies “continued to honor the clause in purpose and effect.”
In other instances, the suit explains some of Gilead’s schemes, adding:
By unfairly suppressing competition for TDF [tenofovir disoproxil fumarate] and acting to protect its profits from the sale of TDF as a component of FDC HIV medications like Truvada and Atripla, Gilead was able to maintain profits without innovating and rolling out safer and more effective TAF. Gilead withheld TAF-based HIV medications from the market until the entry of generic TDF was imminent. In the interim, Gilead launched multi-layered schemes to stall generic competition and maximize profits for its TDF-based drugs to the detriment of purchasers of those drugs.
The suit also goes after the fact that Gilead, which collaborated with Bristol Myers Squibb on developing some of the drugs, is not the inventor of tenofovir, which came from Czech institutions in the 1980s.
CVS and Rite Aid lawyers, who are seeking overcharge damages among other provisions, also note that numerous courts have agreed with the FTC and found that “no authorized generic” clauses can and do constitute anticompetitive reverse payments to filers of generic drug applications.
Gilead said in a statement to Endpoints News: “The lawsuits filed against Gilead, along with two other companies, distorts and misstates Gilead’s history, its collaborations with its partners, and its settlement agreements. Gilead believes this lawsuit and its antitrust allegations are without merit. The allegations against Gilead are misguided and do not accurately reflect antitrust laws or Gilead’s history of innovative collaboration and competition in HIV medicines.”