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9 December 2019AmericasRory O'Neill

Sanders calls on USPTO to block Gilead patent extension

US presidential candidate Bernie Sanders has called on the US Patent and Trademark Office (USPTO) to block extensions to two Gilead Sciences patents covering HIV prevention drugs including Descovy (tenofovir alafenamide/embicitrane).

The news comes after HIV prevention activists accused Gilead of deliberately holding back safer and more effective HIV treatments in order to maximise patent terms and profits.

In a letter to the USPTO, seen by The Guardian, Sanders and Democratic congresswoman Alexandria Ocasio-Cortez said that Gilead’s delay in releasing new HIV drugs to the market was “deceitful and immoral”.

The original allegations were made by the PrEP4All campaign in a submission to the USPTO last Wednesday, December 4.

Gilead’s first HIV prevention drugs came to market in the early 2000s, and were based on the compound tenofovir disoproxil fumarate (TDF).

After it was first approved by the US Food and Drug Administration (FDA) in 2004, Truvada (TDF/embicitrane) has been one of Gilead’s most successful products of recent years.

Gilead filed its first provisional application for tenofovir alafenamide (TAF) in 2000, but the first products containing the compound were not approved by the FDA until 2015.

The pharmaceutical company is now seeking an extension on the term length of two patents covering TAF-based HIV treatments (US numbers 7,390,791; and 7,803,788).

In the filing, the campaign accused Gilead of pausing development and release of TAF until the patent terms covering the TDF-based drugs had expired.

This was despite TAF being a more effective, safer alternative to Truvada, PrEP4All alleged.

In a statement to The Washington Post last week, Gilead spokesperson Ryan McKeel denied PrEP4All’s allegations.

“Patient safety is of foremost importance to us, and any implication that Gilead delayed the development of a drug known to be safer than [TDF] is false,” McKeel said.

Gilead officially paused development of TAF in 2005, resuming its application for the new drug with the US Food and Drug Administration (FDA) in 2010.

The FDA approved Descovy (TAF/emtricitabine) as pre-exposure prophylaxis (PrEP) this year.

“Gilead’s apparent strategy of delaying clinical development and withholding new drugs from patients in need in an opportunistic attempt to manipulate its patent monopoly is unfair, unjust, and dangerous to public health and safety,” the PrEP4All filing said.

In her letter, Ocasio-Cortez said: “[Gilead] kept a safer drug off the market to extract profit. In doing so, they have inhibited efforts to end the HIV epidemic. I am proud to join Senator Sanders today in calling on the USPTO to deny their patent extension request.”

The US government is currently suing Gilead for infringing Centers for Disease Control (CDC) patents covering the use of Truvada and Descovy as PrEP.

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More on this story

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7 November 2019   The US government is suing Gilead for patent infringement, claiming that the pharmaceutical company has been piggybacking on public research to earn billions from its HIV drugs.
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22 August 2019   Gilead Sciences, the maker of HIV drug Truvada, has asked the US Patent and Trademark Office to review patents granted to the government covering preventative use of the drug.
Americas
16 December 2019   The US Patent and Trademark Office is coming under increasing pressure to review allegations that Gilead delayed development of its latest HIV drug in order to maximise profits.

More on this story

Americas
7 November 2019   The US government is suing Gilead for patent infringement, claiming that the pharmaceutical company has been piggybacking on public research to earn billions from its HIV drugs.
Americas
22 August 2019   Gilead Sciences, the maker of HIV drug Truvada, has asked the US Patent and Trademark Office to review patents granted to the government covering preventative use of the drug.
Americas
16 December 2019   The US Patent and Trademark Office is coming under increasing pressure to review allegations that Gilead delayed development of its latest HIV drug in order to maximise profits.