November 14, 2019

Is PrEP the Intellectual Property of DHHS or of Gilead?

On Nov. 6, the U.S. Department of Justice filed suit against Gilead Sciences Inc. in connection with research that was done well over a decade ago.

PEP and PrEP were, arguably, created in 2005-06 when a group of CDC researchers demonstrated “that daily tenofovir alone protected animals when ‘challenged’ with a rectal dose of SHIV (an SIV/HIV hybrid).” Since one drug, tenofivir, only provided partial protection, the researchers repeated the experiment, adding another Gilead drug called emtricitabine or FTC to the mix. In its subsequent claim against Gilead, the CDC states that “two human PrEP trials already underway changed their drug regimens to match CDC’s new PrEP regimen” when they saw the combination’s “superior effectiveness.” They called the breakthrough Truvada.

The question at the heart of the current legal challenge is whether the patents associated with it belong to Gilead who developed emtricitabine and tenofovir – the two elements comprising Truvada – or the CDC researchers who took the step of combining them and unveiling the effectiveness of hybrid combination.

In 2012, the FDA approved Truvada for human use as PrEP, enabling Gilead to make billions by selling it for up to $1800 per month, according to the Washington Post.

In 2015, the CDC was awarded four patents for their work in developing Truvada for PrEP. Gilead, however, refuses to recognize these patents as legitimate. The company declines to get a license from CDC in order to use Truvada. The CDC’s case, filed in federal court, in turn alleges that “Gilead has profited from research funded by hundreds of millions of taxpayer dollars. Indeed, Gilead has reaped billions from PrEP . . . but has not paid any royalties to CDC.’’

Gilead’s high price tag on Truvada, the government adds, “is a major reason that many at risk of HIV infection in the United States are not currently taking Truvada for PrEP.’’ This controversy is likely to be further aggravated now that the FDA has approved Descovy for HIV prevention – giving Gilead another patented PrEP product to replace Truvada when it goes off patent in the near future.

Gilead maintains that “the patents granted to HHS since 2015 for PrEP . . . are not valid” and “HHS improperly filed for patents without alerting Gilead, despite its obligation to do so.’’ Most recently, Gilead has formally challenged the CDC patents through the U.S. Patents and Trademark Office. That case is expected to take years to resolve.

Some observers speculate that the more immediate purpose of DHHS’ case is to pressure Gilead to reduce its drug prices. Reducing drug prices is a priority of the Trump administration and many members of Congress. Last May, the Congressional Oversight Committee held a hearing entitled, “HIV Prevention Drugs: Billions in Corporate Profits After Millions in Investments.”

Gilead’s CEO, Daniel O’Day, attended as a witness and was questioned by the late Rep. Elijah Cummings, then Chair of the Committee, and his colleagues. On questioning,O’Day cited the price of PrEP as about $1700 per month. The Chair noted that this meant that, of the approximately 1.1 million Americans who could benefit from PrEP, only about 200,000 were receiving it.