Descovy is a fixed-dose combination of tenofovir alafenamide and emtricitabine used as pre-exposure prophylaxis (PrEP) to prevent HIV, in addition to being used as part of HIV treatment regimens. Gilead Sciences is currently the only company selling Descovy in the U.S. Gilead charges more than $2000 a month—or $24,000 per year—for Descovy. (1)
Over 1.1 million people need PrEP, but only about 250,000 are currently able to access it. (2) Just 9 percent of Black people for whom PrEP is recommended are taking the drug. (3) Even though PrEP is underutilized, the U.S. healthcare system spends US$1.7 billion on Descovy alone every year. (4) If generic versions were available, that outlay could provide HIV prevention drugs and associated PrEP care to everyone in the U.S. who needs them.
While Gilead today enjoys exclusive control of Descovy, the U.S. government conducted and paid for foundational research on the use of the drug as HIV PrEP. The U.S. government patented its research. (5) In November 2019, the Department of Health and Human Services sued Gilead Sciences for patent infringement. (6) The suit is ongoing. To date, Gilead has not paid a dime for its use of the U.S. government’s patented technology, despite earning many billions from sales of HIV PrEP. Gilead lists three active patents in the Orange Book for Descovy.
Table: Descovy patents
|Patent Number||Patent Expiration (7)|
The U.S. government can help increase medicine access by using Section 1498. Descovy is a strong candidate for government patent use because multiple generic versions exist. No fewer than nine separate generic drug manufacturers had filed Abbreviated New Drug Applications as of late 2019, and at least one has already been approved. Unfortunately, generic manufacturers are still embroiled in patent infringement litigation with Gilead Sciences. By using Section 1498, the federal government can partner with generic manufacturers immediately, immunizing these manufacturers from infringement liability and allowing them to proceed to market. In doing so, the U.S. government can help bring more affordable HIV prevention to more patients, and take an important step towards ending the HIV epidemic.
(4) Centers for Disease Control and Prevention. Interactive Atlas of HIV, hepatitis, STDs, tuberculosis, and social determinants of health. https://www.cdc.gov/nchhstp/atlas/index.htm. Accessed February 25, 2022. Gilead Sciences, Inc “2021 Form 10-K Annual Report” URL: https://investors.gilead.com/static-files/9084889f-c0bc-4e41-995c-387a2ff1a4fc.
(5) U.S. Patents Nos. 9,044,509; 9,579,333; 9,937,191; and 10,335,423.
(6) United States v. Gilead Sciences Inc. https://www.prep4all.org/s/United-States-of-America-v-Gilead-Sciences-Inc-and-Gilead-Sciences-Ireland-UC-1.pdf.
(7) This includes six months pediatric exclusivity.