US govt PrEP patents are invalid, Gilead tells court

Gilead Sciences has accused a US government agency of withholding information from the US Patent and Trademark Office (USPTO) when filing two patents for HIV pre-exposure prophylaxis (PrEP).

The allegations come as part of the pharmaceutical company’s counterclaim to a patent infringement suit filed by the US government last November.

The Centers for Disease Control and Prevention (CDC) owns several patents covering antiretroviral medications as PrEP.

But Gilead has now argued that two of the patents (US numbers 9,937,191 and 9,579,333) should be invalidated, as the government’s own 2005 guidelines (referred to in the court filings as ‘CDC-PEP’) on PrEP render the claims obvious.

“The government’s failure to disclose the CDC-PEP reference materially affected the prosecution of the ’509 and ’333 Patents because at least some claims of those patents would not have been allowed if the CDP-PEP reference had been disclosed during prosecution,” the court filing stated.

The claims closely mirror the allegations put forward by Gilead in its petition to the USPTO, filed last August, for inter partes review of the CDC patents.

The US government argues that its patents cover the use of both Truvada (emtricitabine/tenofovir) and Descovy (emtricitabine/tenofovir alafenamide) as PrEP.

Gilead rejected the government’s claims that CDC researchers had “succeeded where others had not” in discovering the effectiveness of the antiretrovirals in preventing transmission of HIV.

Commenting on the filing of the infringement suit last November, Health and Human Services secretary Alex Azar said that “Gilead must respect the US patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs”.

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