Gilead fails to have US government patents invalidated

Gilead Sciences has failed in its efforts to have US government patents covering the use of HIV drugs as pre-exposure prophylaxis (PrEP) invalidated.

Earlier this month, two of Gilead’s four  inter partes  review (IPR) petitions were thrown out by the Patent Trial and Appeal Board (PTAB), as Gilead failed to prove that its claims were likely to succeed.

The PTAB has now reached the same conclusion regarding the other two petitions, meaning Gilead must now face patent infringement claims in court.

Last November, the US government took the unusual step of suing Gilead for infringing the four patents, owned by the Centers for Disease Control and Prevention (CDC).

The lawsuit came as Gilead faces mounting criticism over the costs of its HIV drugs Truvada (emtricitabine/tenofovir) and Descovy (emtricitabine/tenofovir alafenamide).

Critics of Gilead say the research into the groundbreaking HIV medication was largely funded by public money.

US presidential candidate Bernie Sanders has called on the USPTO to block a requested extension to Gilead’s patent term for Descovy.

Sanders, and congresswoman Alexandria Ocasio-Cortez, have accused Gilead of delaying the development of Descovy so as to maximise profits on Truvada.

This was despite knowing that Descovy was more effective and carried a lower potential risk to patients, said a letter to the USPTO, signed by the two.

Ocasio-Cortez had previously written to the US Secretary of Health and Human Services, Alex Azar, seeking answers on the government’s efforts to protect the four CDC patents.

A generic version of Truvada is expected to hit the market this year after Gilead reached a settlement with generics maker Teva Pharmaceuticals.

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