shutterstock_1569359980_sundry_photography
Sundry Photography / Shutterstock.com
2 April 2020Big PharmaRory O'Neill

Gilead told to waive remdesivir patent rights

Almost 150 health and poverty activist campaigns, including  Médecins Sans Frontières, have urged  Gilead Sciences to waive patent and exclusivity rights for potential COVID-19 treatment remdesivir.

In an open letter to Gilead CEO and chairman Daniel O’Day, the groups said that an “an exclusivity and monopoly-based approach will fail the world in combating the COVID-19 pandemic”.

It comes amid concern over Gilead having a potential monopoly on remdesivir, an experimental antiviral initially developed as an Ebola drug.

While the drug has not yet been approved for use for any purpose, it is hoped that clinical trials will prove its efficacy and safety.

“We are seriously concerned with Gilead’s current approach to remdesivir, which may obscure access to this potentially critical treatment for COVID-19,” said the groups, which also include Global Justice Now, War on Want and AIDS Action Europe.

The company has so far declined to rule out enforcing its patent rights for remdesivir, despite an open letter from O’Day which pledged to make the drug affordable for patients.

Gilead also sought an ‘orphan drug’ designation for remdesivir in the US, which carries benefits such as marketing exclusivity for seven years.

After  public criticism, including from Democratic presidential candidate Bernie Sanders, Gilead took the unusual step of asking the US Food and Drug Administration (FDA) to rescind the designation.

Gilead  announced this week that it was expanding access to remdesivir, which has previously only been available in the US to individual patients on “compassionate use” grounds.

Compassionate use allows the use of an unapproved, experimental drug such as remdesivir for severely ill patients where there are no other treatment options.

The company said the new expanded access system would allow doctors and hospitals to request a supply of remdesivir to treat multiple seriously ill COVID-19 patients at a time.

But Gilead has now been asked to go further and pledge not to stand in the way of the mass production and distribution of remdesivir to COVID-19 patients around the world.

“We request Gilead to fully recognise the scale and potential consequences of pursuing exclusive rights as opposed to enabling the scale-up of production and affordable supply of remdesivir during this pandemic,” the letter said.

In particular, the company should promise to “not enforce and claim exclusive rights on patents and regulatory and trial data, or any other types of exclusivity anywhere in the world,” the letter said.

Remdesivir is currently undergoing clinical trials in COVID-19 patients to determine its safety and efficacy, and has not currently been approved for use anywhere.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.


More on this story

Generics
14 May 2020   Gilead has agreed to license its antiviral remdesivir to five generic makers for distribution during the COVID-19 pandemic.
Big Pharma
22 October 2020   Swiss pharmaceutical company Roche will pay $350 million for the rights to develop and distribute an investigational COVID-19 antiviral outside of the US.
Americas
1 April 2021   The US government doesn't co-own patents covering Gilead Science’s drug remdesivir, according to a report by the Government Accountability Office.

More on this story

Generics
14 May 2020   Gilead has agreed to license its antiviral remdesivir to five generic makers for distribution during the COVID-19 pandemic.
Big Pharma
22 October 2020   Swiss pharmaceutical company Roche will pay $350 million for the rights to develop and distribute an investigational COVID-19 antiviral outside of the US.
Americas
1 April 2021   The US government doesn't co-own patents covering Gilead Science’s drug remdesivir, according to a report by the Government Accountability Office.