US government sues pharmaceutical company over rights to PrEP

The drug manufacturer is being sued by the Trump Administration for infringing on patents owned by the federal government

Gilead Sciences’ PrEP drug Truvada pouring out of the bottle

On Wednesday, November 6, the US government sued the drug manufacturer Gilead Sciences on behalf of the Department of Health and Human Services (HHS) alleging the company had infringed on patents owned by the federal government. Gilead produces and sells the pre-exposure prophylaxis (PrEP) drugs Truvada and Descovy which prevents the transmission of the HIV virus.

The importance of these drugs is immense, with the CDC reporting that when taken correctly, PrEP can reduce the risk of contracting HIV through sexual transmission by around 99%. 

The HHS is filing the suit against the drug giant for what they view as avoidance of US patent laws. Secretary of the HHS, Alex Azar, acknowledged the importance of  Gilead’s role in the distribution of the life-saving drug, however, he stated that this would not be possible if not for “the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”

Since PrEP’s approval for human use in 2012, the US government has been granted several patents for the treatment regimens it developed using Truvada donated by Gilead in 2015.

The US government is now seeking rights and royalties to the drug that they helped develop through this suit, the hope of many is that this is in order to reproduce the treatment at a cheaper cost. Truvada currently costs a whopping $20,000 per year in the US making it inaccessible for many without health insurance. Gilead has made billions off the sales of PrEP alone in the past few years, profiting around $3 billion in 2018 alone, with the US government receiving no royalties at all. 

Although it is still unclear whether or not the government would be able to leverage its patents in order to lower the prices of the drug, with a generic version of Truvada expected to be available in the US in 2020. The advocacy group PrEP4All issued a statement in relation to the case saying the suit is a “first step” in lowering the costs of PrEP drugs. 

Speaking about the case, co-founder of PrEP4All James Krellenstein stated: “If the federal government is just going to use these lawsuits and whatever money they recover to just redistribute them back into the general fund and not do anything to help the most impacted communities who need access to PrEP, then it won’t do anything. We need a commitment from the Department of Health and Human Services to include communities in all of the discussions about how this leverage and this money is going to be utilised.”

A petition has been created to call on the US National Institutes of Health to break the patent around Truvada as PrEP in hopes that an alternative generic version will become available and more accessible to those who need, similar to the new programme that has just been introduced in Ireland.

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