US government claims patent infringement by Gilead Sciences over use of F/TAF and FTC/TDF as PrEP

15 November 2019. Related: Treatment access, HIV prevention and transmission.

Simon Collins, HIV i-Base

On 6 November 2019, the US Department of Health and Human Services (HHS) website included a news release about filing action with US courts over patents for PrEP. [1]

The complaint alleges infringement on HHS patents by Gilead Sciences who manufacture and market the two FDA-approved formulations of TDF/FTC and F/TAF in the US. It also seeks damages for the millions of dollars of public funding for the CDC research that led to the development of PrEP and for the profits made by Gilead since.

Earlier this year, a coalition of community organisations (PrEP4all) filed a class action lawsuit over delayed access to generic versions of TDF/FTC. There were also open hearings by the US House Oversight and Reform Committee. [2]

Gilead have issued a statement claiming HHS improperly filed for the patents and that they want the court to stop the lawsuit to settle in an out-of-court inter parte review. [3]

A detailed analysis of the implications of these actions are reported in an open-access article in the journal Science. [4]

comment

Although the HHS press release looked like an activist stunt to hi-jack the government website – similar convincing actions have been successful [5] – this story is indeed real news.

References

1. US DHHS press release. United States Files Patent Infringement Lawsuit Against Gilead Related to Truvada and Descovy for Pre-exposure Prophylaxis of HIV. (06  November 2019).
   https://www.hhs.gov/about/news/2019/11/06/us-files-patent-infringement-lawsuit-against-gilead-pre-exposure-prophylaxis-hiv.html
2. Activists challenge block to generic PrEP and current US price of TDF/FTC. HTB Jul 2019.
   https://i-base.info/htb/36246
3. Gilead Sciences. Gilead statement on U.S. Government complaint regarding HIV PrEP and PEP patents (7 November 2019).
   https://www.gilead.com/news-and-press/company-statements/gilead-statement-on-us-government-complaint-regarding-hiv-prep-and-pep-patents
4. Cohen J et al. Untangling the Trump administration’s lawsuit over an HIV prevention drug. Science (2019); 9 November. doi:10.1126/science.aba1556.
   https://www.sciencemag.org/news/2019/11/untangling-trump-administration-s-lawsuit-over-hiv-prevention-drug
5. Collins S. Activists convince Washington Post that Pfizer lowers prices: global action highlights fairer alternatives – this story has been removed! Web blog. (2 April 2016).
   https://i-base.info/blog/2016/04/activists-convince-washington-post-that-pfizer-lowers-prices-global-action-highlights-fairer-alternatives-this-story-has-been-removed