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The US government is suing PrEP manufacturer Gilead

Reiss Smith November 7, 2019
A bottle of Truvada and PrEp pills

The United State government has lodged a patent infringement lawsuit against Gilead Sciences, manufacturer of PrEP pill Truvada.

The Department of Health and Human Services (HSS) has accused Gilead of “wilfully and deliberatively” infringing its own patents on the drug, which can prevent HIV transmissions.

“As a result of such infringement, Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada and Descovy [a newly-approved PrEP drug],” the government said in a statement.

According to the complaint, PrEP was developed by the US Centers for Disease Control and Prevention (CDC), with HSS holding four patents “that protect CDC’s work and the taxpayers’ investment”.

“These patents entitle HHS to license CDC’s PrEP regimens and receive a reasonable royalty for their use,” it explains.

“Two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS.”

Gilead ‘refused’ to obtain PrEP licenses.

HSS says that Gilead has “repeatedly refused” to obtain such licenses.

The pharma giant currently has a monopoly on the HIV-preventing drug in the US, with an annual supply of its branded pill, Truva, costing $20,000.

Long criticised for “price gouging”, Gilead reportedly made $3billion in sales on Truvada in 2018.

PrEP4All co-founder James Krellenstein told Out that “the amount of money that Gilead owes us for backpay, or the amount of money we are paying because of Gilead’s price gouging – if we could redirect all of that money to a universal PrEP program, we can ensure that every single person that needs PrEP in this country, gets it, for free”.

With the amount of money that Gilead owes… we can ensure that every single person that needs PrEP in this country, gets it, for free.

Krellenstein added: “We should be really clear that 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.”

Gilead announced in May that it would donate enough PrEP pills to treat 200,000 patients annually for up to 11 years. The supply would eventually switch from Truvada to Descovy, a move which critics said could be “a way they make sure they grow the market” for the new pill once generic versions of Truvada hit the market.

More: Department of Health and Human Services, Gilead, PrEP, Truvada

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