Gilead Can't Sit On Remdesivir Alternative, Activists Say

By Kevin Stawicki
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Law360 (August 7, 2020, 6:15 PM EDT) -- Consumer advocates are pushing the federal government to go it alone in developing an alternative to Gilead's antiviral drug remdesivir if the pharmaceutical giant continues to sit on patent holdings for a potentially effective drug to treat COVID-19.

Gilead Sciences Inc.'s alternative to the experimental drug remdesivir — GS-441524 — is simpler and easier to synthesize with considerable advantages over remdesivir, but has been all but ignored by the government and Gilead, consumer advocacy group Public Citizen said in a letter to the company, the FDA and other agencies.

"It is unclear why Gilead and federal scientists have not been pursuing GS-441524 as aggressively as remdesivir, but we cannot help but note that there are significant financial incentives tied to Gilead's current patent holdings," Public Citizen wrote in the letter dated Tuesday, noting the difference in patent approval dates on both drugs.

"Gilead's monopoly power over remdesivir may have at least five additional years of enforceability beyond that of GS-441524," Michael A. Carome, Public Citizen's Health Research Group's director, wrote in the letter.

Public Citizen asked the FDA, Dr. Anthony Fauci of the National Institutes of Health and others to commit to developing the "seemingly obvious drug candidate," or explain why it's inappropriate to develop. The group also asked Gilead to let government scientists develop the drug if it won't conduct further investigations independently.

Trials have shown that GS-441524, which is similar in chemical structure to remdesivir, has had success in treating a coronavirus disease in cats, leading researchers to suggest that the treatment may be applicable to humans, Public Citizen said, adding that the drug would also be easier to manufacturer.

But Gilead, which did not respond to requests for comment on Friday, has been at odds with the government and consumer advocates about access to its patented drugs that treat COVID-19.

As early as March, when the coronavirus pandemic raged across the country, Gilead sought seven years of exclusivity for the experimental "orphan" drug remdesivir over arguments by lawmakers and others that coronavirus treatments should not be eligible for exclusivity, which gives drugmakers a temporary monopoly on selling medicines they developed without competition from generic offerings.

Although the FDA granted the exclusivity request, Gilead ultimately abandoned the effort after a public outcry.

Activists continued to double-down on Gilead's monopoly on the remdesivir patents as tens of thousands of people kept dying, some making the case that the federal government is the rightful co-owner of patents covering remdesivir, and that the government should harness that ownership to make the medication accessible and affordable.

On Tuesday, a group of 34 state attorneys general urged the Trump administration to exercise march-in rights to force Gilead to license its patents on remdesivir to other companies so they can make the COVID-19 drug more widely available, saying "Gilead should not profit from the pandemic and it should be pushed to do more to help more people."

In a response, Gilead said it is "deeply disappointed that a group of state attorneys general have chosen to misrepresent facts."

"The use of 'march-in' rights under the Bayh-Dole Act will do nothing to produce additional doses of remdesivir this year and will discourage other manufacturers from investing in the development of new therapies and vaccines," it said.

The federal agencies didn't respond to requests for comment.

--Additional reporting by Dani Kass, Hailey Konnath and Andrew Kragie. Editing by Adam LoBelia.

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