For the past several months, the U.S. government has been lambasted by AIDS activists for ostensibly failing to seek royalties from Gilead Sciences (GILD) for an expensive HIV prevention pill sold by the company and therefore not using the funds to help thwart the virus.
Now the federal government may have another chance — or yet another dispute may arise.
On Tuesday, the Department of Health and Human Services was awarded a new patent that broadly covers medicines derived from tenofovir and used to prevent HIV. Tenofovir is the basis for both an older Gilead drug called Truvada and its newer Descovy pill.
The new HHS patent may provide a fresh opportunity for the agency to leverage its rights and obtain royalties from Gilead, which has resisted such an arrangement for Truvada. Gilead instead recently agreed to donate a large amount of the medicine to the federal government over the next 11 years.
Gilead has been selling Truvada, which is also known as PrEP, or pre-exposure prophylaxis, for HIV prevention since 2012, but at an increasingly higher price. The pill costs about $1,750 a month, or $21,100 a year, up from a wholesale cost of $650 a month when it was approved in 2004 for treating HIV. AIDS activists claim the high price has limited access and made it harder to eradicate the virus.
Now, though, AIDS activists argue there is no reason why HHS should not pursue royalties on Descovy, currently approved for treating HIV. Gilead hopes to win Food and Drug Administration approval to sell it for HIV prevention later this year. The timing is especially important to the company because Truvada as an HIV treatment faces generic competition in late 2020.
The added usage and wider market for Descovy mean that Gilead will be selling a more lucrative medicine, which generated nearly $1.6 billion in sales last year.
“The granting of this new patent further reinforces the position that PrEP, whether it is Descovy or Truvada, is the invention of the American government and its long past due for the government to start using these patents for the benefit of the American people,” said James Krellenstein, a member of the PrEP4All Collaboration and a founding member of the Prevention of HIV Action Group at ACT UP/New York.
“In an age when nearly one new infection occurs every 15 minutes, the government approach to prevention and scaling up the use of PrEP has failed. We need to start getting answers from the government about what they’re doing with these assets.”
Christopher Morten, a patent expert and fellow at the Global Health Justice Partnership, a joint program of Yale Law School and the Yale School of Public Health, who has analyzed HIV patents held by the HHS, explained that the newest patent is significant because it has a broader scope that “clearly” covers the use of both Truvada and Descovy for preventing HIV.
“This gives the government a new tool they can use to ensure fair pricing and reasonable access,” he told us. “The question is whether they have the will to act.”
The HHS declined to comment.
The high price and lack of royalties have increasingly stirred controversy beyond the AIDS community.
In May, a Congressional committee held a hearing into the issue. At the session, Gilead chief executive Daniel O’Day argued that pricing pays for further innovation, financial assistance programs offered by the company help patients, and the older government patent is actually invalid.
But last month, two lawmakers asked the Government Accountability Office to review how HHS manages patents and licenses for drugs that were discovered with the help of taxpayer dollars. And last week, the House Committee on Oversight and Reform asked Gilead to explain Truvada price hikes over the past decade, as well as correspondence with federal agencies about donations to the U.S. government and patents related to HIV prevention. The committee also wants data on the cost to manufacture Truvada and Descovy.
Wall Street, meanwhile, expects Descovy to quickly supplant Truvada.
A recent survey of 40 physicians by SVB Leerink found they expect to be treating nearly double the number of PrEP patients from 2018 to 2020, and 63% were familiar with recent Descovy Phase 3 trial data. Already, some are using the newer drug for prevention and over half expected to use Descovy for prevention to increase overall prevention treatment by 17%. Moreover, the physicians expected to quickly migrate 60% of their PrEP treatments to Descovy through next year.
By Ed Silverman