A courtroom clash is expected when the US Government takes on Gilead Sciences in Delaware this week, with the drug company fighting claims that it owes the government a share of multibillion-dollar profits from its HIV-prevention drug regimen, allegations it has vehemently denied.
The government is seeking more than $1bn from Gilead for allegedly failing to compensate the US Centres for Disease Control and Prevention (CDC) for its “groundbreaking contributions” in the development of Gilead’s HIV-treatment drug Truvada.
This is one of the first times the US Government has sued a pharmaceutical company to enforce its patent rights – and the ensuing intellectual property rights battle is expected to be massive, Reuters reports.
Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent HIV as well as treat it.
However, the lawsuit alleges, CDC researchers began studying the preventive use of HIV treatment drugs – like tenofovir, or TDF, and emtricitabine, FTC, the two compounds in a Truvada tablet – as early as 1998, before Gilead sought a patent.
The government received four patents for HIV prevention drug regimens that CDC researchers invented. Its lawsuit claims the patents also cover Gilead’s pre-exposure prophylaxis (PrEP) drug regimen for lowering HIV infection risk.
The Food and Drug Administration approved Truvada for HIV prevention in 2012 and Gilead’s related drug Descovy for the same purpose in 2019.
Gilead made more than $2bn last year from worldwide sales of Truvada and Descovy, and the government contends it deserves some of those earnings because it helped develop the intervention.
Descovy, which earned Gilead more than $1.8bn in 2022, is its fourth-best selling drug behind the HIV drugs Biktarvy and Genvoya and Covid-19 treatment Veklury.
The government claims Gilead “exaggerated” its role in developing PrEP, ignored the CDC’s contributions and refused to license the CDC’s patents.
"Gilead has profited from research funded by hundreds of millions of taxpayer dollars … but has not paid any royalties to CDC,” according to the lawsuit, and its conduct “was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith”.
Gilead has argued the patents are invalid.
In parallel to the jury trial, Delaware US District Judge Maryellen Noreika will separately consider Gilead’s argument that the patents are unenforceable based on government misconduct.
Another court decided in a separate lawsuit last year that the government breached research agreements with Gilead by applying for the patents without giving sufficient notice.
The damages in that case have not yet been determined but could offset any award the government wins in the infringement lawsuit.
Reuters article – Gilead, US square off in billion-dollar HIV drug patent trial (Open access)
See more from MedicalBrief archives:
US Health department sues Gilead Sciences over Truvada patent rights (Open access)
FDA approves new PrEP drug from Gilead Sciences
Gilead accused of anti-competitive deals to block ARV generics
Generic drug manufacturers win HIV-drug appeal against Gilead