may additionally 2 (reuters) - gilead sciences inc. (GILD.O) will go to trial this week in Delaware federal court to defend itself against claims that it owes the United States government a portion of the multibillion-dollar profits it makes from its HIV-prevention drug regimen.
For allegedly failing to compensate the Centers for Disease Control and Prevention (CDC) for discovering that Gilead's HIV-treatment drug Truvada could aid in disease prevention, the government is seeking more than $1 billion from Gilead.
In the case, which marks one of the first times the United States government has sued a pharmaceutical company to enforce its patent rights, jury selection begins on Tuesday.
In the middle of the 2000s, Gilead, based in Foster City, California, worked with the CDC to see if Truvada could both treat and prevent HIV.
Four patents were granted to the government for HIV prevention drug regimens developed by CDC researchers. According to the lawsuit, Gilead's pre-exposure prophylaxis (PrEP) drug regimen to lower HIV infection risk is also covered by the patents.
In 2012, Gilead's Truvada was approved for use in the prevention of HIV, and in 2019, the drug Descovy, which is related to Truvada, was also approved for use in the same way.
gilead made greater than $2 billion closing year from universal offers of truvada and descovy, as per an corporation record. Descovy, Gilead's fourth-best-selling drug, brought in more than $1.8 billion last year, trailing only the HIV medications Biktarvy and Genvoya and the COVID-19 treatment Veklury.
The central government sued Gilead for patent encroachment in 2019, guaranteeing Gilead "overstated" its part in creating PrEP, disregarded the CDC's commitments and would not permit the CDC's licenses.
Gilead has argued that the patents are invalid and denied the allegations. Gilead's claim that the patents are invalid due to government misconduct will be separately considered by Delaware U.S. District Judge Maryellen Noreika in parallel to the jury trial.
One more court concluded in a different claim last year that the public authority penetrated research concurrences with Gilead by applying for the licenses without giving adequate notification.
The damages in that case haven't been decided yet, but they could cover any money the government gets from the infringement lawsuit.
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