Gilead prevails against US government in billion-dollar patent trial

In an unusual move, the federal government had accused the biotech firm of infringing its patents related to HIV prevention

A six-member jury in a Delaware federal court rejected on Tuesday the US government’s claims that biotech company Gilead had infringed its patents in its blockbuster HIV drugs Truvada and Descovy.

The government was seeking more than $1bn from the company alleging that Gilead had not compensated its agency Centers for Disease Control and Prevention (CDC) for its patents relating to pre-exposure prophylaxis (or PrEP) for HIV prevention and recognising that Gilead’s HIV treatment drug Truvada could help disease prevention as well as treatment, among other related claims. 

After a multi-day trial, the jury found that the patent claims on the government’s PrEP were not valid.

The case is novel being one of the first instances the federal government has taken action against a drug company to enforce its patent rights.

The dispute dates back to the mid 2000s, when Gilead collaborated with the CDC on various research studies relating to the use of antiretroviral agents for prevention of HIV, including whether Truvada could help prevent HIV infection.

The US government had filed the patent infringement lawsuit in 2019 on behalf of the Department of Health and Human Services (HHS) – the CDC is a federal agency under this department – alleging that Gilead had profited from ‘research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada and Descovy’.

The US government noted that originally Gilead obtained FDA approval for the use of those products for post-infection HIV treatment in combination with other drugs. But after the CDC’s ‘groundbreaking PrEP work and subsequent human trials, Gilead also obtained FDA approvals for Truvada, and more recently Descovy, to be used as PrEP regimens’.

Gilead's executive vice president and general counsel Deb Telman said: “The jury’s verdict recognises Gilead’s commitment to transforming the lives of the communities we serve. Gilead is proud to have invented and developed Truvada and Descovy.  

"The decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it. Gilead will continue to champion collaborations, including our efforts with the HHS and CDC that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere.”

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Commenting on the case, Withers' Steven Moore said: “The long period of time over which Gilead dealt with the government in respect of the dispute without backing away from any of their positions, its earlier win at the Court of Federal Claims on contract claims, the manner in which the provisional patent applications were filed and belatedly disclosed to Gilead, as well as the large number of counsel that Gilead employed at trial in the dispute, all suggested that Gilead had a very strong case."

He continued that he didn't expect the jury verdict to be upended by the district court judge. However, he expected the federal government to appeal the adverse ruling. "From what I have seen, I believe the verdict will ultimately be upheld at the appellate level."

He added: "If this case teaches the government a lesson, it is to only bring cases wherein the background of the case indicates that the government agency was completely squeaky-clean in its dealings with the company that collaborated with it.  Just because certain public forces push for a case, does not mean it should be taken irrespective of the factual background."

Future government cases, however, could have a significant impact on the willingness of companies to collaborate with governmental agencies such as the HHS and CDC. “This would not benefit the public,” he concluded. 

Gilead financial statements state that Descovy sales increased 13% to $537m for the fourth quarter 2022 compared to the same period in 2021.

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