At today’s House Oversight Hearing on PrEP, one of issues will be access to Truvada (FTC+TDF), but also Descovy (FEMTRICITABINE+TENOFOVIR ALAFENAMIDE), a two drug combination, that uses TAF instead of TDF, and is less toxic than Truvada.
The Goodrx price for Descovy is about $1,800 per month, or $21,600 per year, for a drug that can be used to prevent an infection.
At present, the US government has rights in two of the Orange Book patents for Descovy, and Gilead holds four more.
For Truvada, only the two government-funded patents (6,642,245 and 6,703,396) are listed in the Orange Book.
The PrEP for all activists are also pushing to have the CDC enforce its patents on PrEP (which are for a method of use) on Truvada sales. These include U.S. Patent Nos. 9,044,509, 9,579,333, and 9,937,191. The 509 patent was filed January 31, 2007. The 191 patent was filed January 13, 2017.
The Truvada Orange Book patents, licensed from Emory and extended for pediatric testing, expire in September 2021.
The CDC and Descovy patents expire much later.
Any extensive use of PrEP will be expensive, unless prices fall considerably.
Outside the United States, a generic version of Truvada can be obtained for less than $0.12 per day, compared to about $60 per day for Gilead’s version in the United States.
A year ago, HIV patients began a “break the patent” campaign on https://breakthepatent.org/, calling for HHS to use its march-in or royalty-free rights on the Truvada patent to expand access for PrEP.
More recently, several of these groups, as well as academic advisors from the Yale Global Health Justice Partnership and other allies, have changed the focus to insist that HHS enforce the CDC method of use patents for PreP.
One week ago, HHS and Gilead reached an agreement for Gilead to donate Truvada to patients lacking insurance coverage.
The HHS/Gilead announcement was met with derision from the PrEP for all camp, as an inadequate response. (See: https://twitter.com/akapczynski)
Separately, two days ago, Mark Lemley and others filed a class action antitrust case against Gilead on behalf of several patients and payers, alleging a variety of anticompetitive actions relating to blocking competition for both Truvada and Descovy.
KEI is not enthusiastic about the granting or expanding enforcement of method of use patents for older drugs, including the FTC+TDF or FTC+TAF combinations.
Wholly apart from and in addition to the Lemley antitrust action, which should also be taken into account, KEI suggests policy makers should focus on why the federal government has failed to use the royalty-free or march-in rights on Truvada, despite massive evidence public health needs were not being met, and to consider the use of 28 USC § 1498(a), to authorize generic production of FTC+TAF, as a prophylactic against HIV infections.
One of the most challenging issues for a § 1498 case concerns the compensation to patent holders. In the case of Descovy, two primary patents (the same two in Orange Book for Truvada) have government rights declared, and the compensation for those inventions would be zero. And, if the use is limited to using FTC+TAF for PrEP, the impact on Gilead’s current sales for that use are small, because of the high price, a factor that can work in the U.S. government’s favor under existing § 1498 caselaw.
These are the Descovy Orange Book Patents:
6642245: Emory. The U.S. Government has rights in this invention arising out of the partial funding of work leading to this invention through the National Institutes of Health Grant Nos. AI-26055, AI-28731, NIH 5-21935, as well as a Veteran’s Administration Merit Review Award. Expires, 05/04/2021.
6703396: Emory. U.S. Government has rights in this invention arising out of the partial funding of work leading to this invention through the National Institutes of Health Grant Nos. NIH 5-21935 and NIH AI-26055, as well as a Veteran’s Administration Merit Review Award. Expires, 09/09/2021.
7390791: Gilead: No Government rights. Expires, 05/07/2022.
7803788: Gilead: No Government rights, Expires, 02/02/2022.
8754065: Gilead: No Government rights, Expires, 08/15/2032
9296769: Gilead: No Government rights. 08/15/2032