Gilead Sciences, the maker of HIV drug Truvada, is moving to challenge patents held by the US government on the preventive use of the drug, which is known as PrEP, amid criticism it used publicly-funded research to bring the drug to market at too steep a price.
In a statement on Wednesday, the drugmaker said it strongly believes that the patents granted to HHS for two prophylactic uses of the drug are not valid.
Gilead’s petition to the US Patent and Trademark Office is to request a so-called inter partes review, which re-examines the claims in a patent to determine if they are valid. If the proceeding is instituted, determinations are usually reached within a year.
The Financial Times reported on Sunday that the company did not apply for exclusivity for the preventive use of the drug in the United States, and that it could owe the US government at least $1bn in royalties and damages.
Gilead said it disagreed with the premise that royalties or damages were due, and that its patents for Truvada covered all uses of the drug, and that it did not obtain new patents for the PrEP indication.
Gilead has been under political pressure to justify the high cost of the drug — which can run to $20,000 a year in the US — and if used by more people, could wipe out the HIV epidemic.
In Wednesday’s statement, Gilead said: “The ongoing dialogue about these patents is a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP.”
When approached by the FT for the first story, Gilead declined to rule out price increases for the drug — which has grown threefold since 2004 — and to disclose the manufacture and sales cost for Truvada.
It is able to write the latter down for tax when it donates batches of Truvada. It recently moved to do so in the US, for up to 2.4 million bottles of Truvada for PrEP through 2030.
Gilead, which says the main barrier to access the drug isn’t price but stigma and other structural hurdles, currently faces no price competition in the sale of Truvada for PrEP in the United States. A generic version of the drug is set to enter the market later next year.
“The petition for inter partes review filed by Gilead today is a sign of fear — and Congress and investors should take note,” said James Krellenstein of advocacy group PrEP4All.
He added: “As we’ve said for months, the US and European Patent offices examined the CDC’s patents carefully and repeatedly”.
“Gilead’s arguments appear similar to what these patent offices have already considered, and they concluded that the CDC’s patents are valid . . . The CDC was the first to show with laboratory evidence that Truvada works as PrEP, which makes the CDC the inventor of PrEP and the rightful holder of patents on PrEP.”
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