Gilead will challenge US government patent on PrEP drug Truvada

Gilead Sciences has said it plans to challenge patents held by the US government on the use of its HIV drug Truvada for pre-exposure prophylaxis (PrEP).

In a move that will incense critics who claim the company relied on government-funded research in the development of Truvada (emtricitabine/tenofovir disoproxil fumarate), Gilead has filed petitions with the US Patent and Trademark Office seeking to overturn patents held by the government on PrEP and post-exposure prophylaxis (PEP).

The Financial Times has reported that Gilead didn’t apply for market exclusivity on the preventive use of Truvada, so could owe the US government “at least $1 billion in royalties and damages.”

HIV patient advocates have long argued that the patents held by the US Department of Health and Human Services (HHS) – granted in 2015 – could be used to help bring the price of Truvada down and make it more affordable for people at higher risk of contracting the virus.

Earlier this year, the HHS said it was negotiating with Gilead in an attempt to reduce the cost of Truvada, and reportedly was using its patents as leverage to try to reduce the annual spend on the drug.

Truvada is still the only FDA-approved PrEP regimen, and analysts suggest that upwards of $2 billion of its $3 billion sales last year came from use in HIV prevention, with more than 200,000 people taking it for PrEP at the end of 2018.

A generic version is however set to reach the market in 2020, a year ahead of its US patent expiry, while Gilead is also trying to position a follow-up drug called Descovy (emtricitabine/tenofovir alafenamide) as a successor to Truvada, citing a cleaner safety profile.

The latter product has just been recommended for approval as PrEP by an FDA advisory committee, although with a narrower label than its predecessor.

In a statement published yesterday, Gilead said it “strongly believes that the patents granted to HHS…for PrEP and PEP are not valid.”

It maintains that the use of antiretroviral drugs to prevent HIV infection – including Truvada - was well established well before HHS claimed to have invented the concepts of PrEP and PEP in 2006, pointing to HIV guidelines published two years earlier on the use of these drugs in high-risk individuals.

Gilead also says that its existing patents cover the use of Truvada for PrEP, and that is why it didn’t file for additional protection on the drug.

Pressure group PrEP4all – which claims Truvada costs around $1,600 per month as PrEP – recently petitioned the US government to exert its existing patents on the drugs used in HIV prevention.

It said this would “open the door not only to cheaper generics, but also allow the government to reroute funds already in use to help break down structural barriers that keep the most vulnerable populations from accessing the medication.”