U.S. Government Sues Gilead over Alleged Infringement on HIV Prevention Drug
According to recent filings,
Gilead Sciences Inc.
generated HIV product sales of US$ 11.9 billion for the nine months ended September 30, 2019, compared to US$ 10.6 billion for the same period in 2018.
Gilead markets two drugs, Truvada and Descovy, as part of a regimen to help prevent HIV.
These drug regimens are a key piece to reduce infections. Increased usage of Truvada has been a key component of revenue growth for Gilead.
The HIV prevention business
is big business for Gilead as total HIV drugs for the nine months ended September 30, 2019 were US$ 11.861 billion versus total product sales of US$ 16.323 billion.
Vanguard Group and BlackRock are the largest institutional shareholders of Gilead.
Norway Government Pension Fund Global holds 12,771,885 shares of Gilead at the end of December 31, 2018.
DOJ Files Complaint
The U.S. Department of Justice (DOJ)
disclosed that the U.S. government filed a complaint in the U.S. District Court for the District of Delaware
alleging infringement by Gilead Sciences Inc. and Gilead Sciences Ireland UC (collectively, Gilead) of four U.S. patents awarded to and owned by the United States, Department of Health and Human Services (HHS).
These patents
cover specific drug regimens used for pre-exposure prophylaxis (commonly referred to as PrEP) that prevents HIV transmission.
The Department of Health and Human Services alleges that the U.S. government owns the PrEP patent for both Truvada and Descovy.
The DOJ
alleges that Gilead had repeatedly refused to obtain a license for use of the patented drug regimens, while continuing to profit from hundreds of millions of dollars of publicly funded research.
Gilead
has challenged the validity of all four patents before the U.S. Patent and Trademark Office (PTO).
SWFI