Gilead suffers defeat at PTAB in government PrEP battle

Gilead has suffered a blow in its efforts to invalidate the US government’s patent rights for PrEP, as the Patent Trial and Appeal Board (PTAB) threw out two of its four patent challenges.

The drugmaker asked the PTAB last August to cancel four US government-owned patents covering the use of Gilead’s Truvada (emtricitabine/tenofovir) and Descovy (emtricitabine/tenofovir alafenamide) as PrEP.

The government claims that the use of the drugs as PrEP was discovered through publicly funded research at the Centers for Disease Control and Protection (CDC).

Gilead, meanwhile, argues that the government patents are invalid as obvious because of advice issued by the CDC itself in 2005.

The drugmaker argued that the government had withheld the 2005 reference from the US Patent and Trademark Office when filing the petitions.

The PTAB ruled yesterday, January 5, that Gilead had failed to prove that two of its petitions were likely to succeed. The other two challenges are still pending.

US Secretary for Health and Human Services Alex Azar has 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”.

As well as the proceedings at the PTAB, the two parties are embroiled in a patent lawsuit, filed by the government last November.

The government claims that Gilead has “repeatedly refused” to obtain licences for its PrEP patents.

Gilead has also faced political pressure over the cost of its HIV drugs, with Democrats such as Bernie Sanders and Alexandria Ocasio-Cortez calling on the government to block Gilead from extending its patent terms on the drugs.

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