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22 August 2019Americas

Gilead challenges US govt patents on HIV drug Truvada

Gilead Sciences, the maker of HIV drug Truvada (emtricitabine/tenofovir), has asked the US Patent and Trademark Office (USPTO) to review patents granted to the government covering preventative use of the drug.

In an announcement published yesterday, August 21, Gilead said that it had requested inter partes reviews to review patents held by the US Department of Health and Human Services (HHS) for HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

“We strongly believe that the patents granted to HHS since 2015 for PrEP and PEP are not valid,” said Gilead.

It added: “Published materials clearly show that well before HHS claims to have invented the concepts of PrEP and PEP in 2006, others had conceived of using an antiretroviral therapy, including Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets), for both forms of prophylaxis.”

In May this year,  Gilead’s CEO told a US House of Representatives committee that three HIV prevention patents, owned by the Centers for Disease Control, a HHS division, were invalid.

At a hearing, Gilead CEO Daniel O’Day argued that the CDC patents were invalid as the use of Truvada for PrEP was widely known at the time of their filing in 2015.

Although “CDC scientists claim that they conceived of the idea to use Truvada for PrEP by February 2006, the HIV community has known since the 1990s that antiretroviral drugs like tenofovir disoproxil fumarate (a component of Truvada) suppress HIV replication”, O’Day told the committee.

The following month, A US congressman and senator have asked the country’s audit institution, the Government Accountability Office, to review the management of government-owned IP in the health sector.

In particular, the letter to the audit institution noted that numerous reports suggested that Gilead may be infringing a number of CDC patents.

“If true, this would mean that a private entity has generated billions of dollars in revenue over several years while infringing on government-owned IP, and that the government either failed to detect the infringement or was aware but failed to prevent it,” the letter said.

Now, Gilead has claimed that this ongoing dialogue about the patents is a “distraction from the important work being done” by Gilead and its many community partners to reduce barriers to PrEP.

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

Gilead, in its latest announcement, added: “Resolving the patent issues will refocus the public dialogue about PrEP on what matters most: the real-world obstacles that prevent people at risk for HIV from accessing effective prevention.”

Those with the greatest need for PrEP reportedly face significant social and structural barriers, such as limited access to affordable healthcare, stigma, and discrimination.

Truvada retails from $1,758 for 30 100-150mg tablets and, according to the CDC, “people who use PrEP must commit to taking the drug every day” for maximum efficacy.

A generic version of Truvada will hit the market in 2020, a year earlier than expected, following a  settlement agreement with Teva.

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Americas
27 January 2020   Gilead Sciences has accused a US government agency of withholding information from the US Patent and Trademark Office when filing two patents for HIV pre-exposure prophylaxis.
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21 February 2020   Gilead Sciences has failed in its efforts to have US government patents covering the use of HIV drugs as pre-exposure prophylaxis invalidated.
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22 September 2020   Biopharmaceutical company Gilead is being sued for allegedly scheming to prevent a generic rival from releasing a competing version of its HIV drug Truvada, according to a class action lawsuit filed by investors in the drug manufacturer.

More on this story

Americas
27 January 2020   Gilead Sciences has accused a US government agency of withholding information from the US Patent and Trademark Office when filing two patents for HIV pre-exposure prophylaxis.
Americas
21 February 2020   Gilead Sciences has failed in its efforts to have US government patents covering the use of HIV drugs as pre-exposure prophylaxis invalidated.
Americas
22 September 2020   Biopharmaceutical company Gilead is being sued for allegedly scheming to prevent a generic rival from releasing a competing version of its HIV drug Truvada, according to a class action lawsuit filed by investors in the drug manufacturer.

More on this story

Americas
27 January 2020   Gilead Sciences has accused a US government agency of withholding information from the US Patent and Trademark Office when filing two patents for HIV pre-exposure prophylaxis.
Americas
21 February 2020   Gilead Sciences has failed in its efforts to have US government patents covering the use of HIV drugs as pre-exposure prophylaxis invalidated.
Americas
22 September 2020   Biopharmaceutical company Gilead is being sued for allegedly scheming to prevent a generic rival from releasing a competing version of its HIV drug Truvada, according to a class action lawsuit filed by investors in the drug manufacturer.